Shoulder prosthesis components and shoulder prosthesis assemblies
Patent Information
- Authority / Receiving Office
- JP · JP
- Patent Type
- Applications
- Current Assignee / Owner
- HOWMEDICA OSTEONICS CORP
- Filing Date
- 2026-01-26
- Publication Date
- 2026-05-08
AI Technical Summary
The use of numerous tools and components in shoulder prosthesis procedures increases treatment cost and complicates the implantation process, particularly in anatomical and reverse shoulder reconstructions.
Development of improved humeral anchors with elongated distal fins and common tool sets for both stemless and stemmed anchors, allowing for secure implantation and reducing the number of tools required.
Facilitates secure and efficient implantation of shoulder prostheses with reduced complexity and cost, enabling intraoperative adaptation to improve surgical outcomes.
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Abstract
Description
[Technical Field]
[0001] Invocation by reference to a priority claim application Any application in which a claim of foreign or domestic priority is provided for in the application data sheet filed with this application shall be incorporated by reference to this application under Rule 1.57 of Title 37 of the Federal Code of Rules. [Background technology]
[0002] This application relates to an apparatus and method for a reverse shoulder prosthesis and / or an anatomical shoulder prosthesis.
[0003] Explanation of related technologies Arthroplasty is the standard treatment for shoulder arthritis. A typical anatomical shoulder replacement attempts to replicate the anatomical state. A metal humeral stem and a humeral head replacement are attached to the humerus of the arm, replacing the humeral side of the arthritised shoulder joint. Such a humeral head replacement can articulate with the original glenoid socket or with an opposing glenoid surface reconstruction device.
[0004] In more severe cases, reverse reconstruction can be used. In reverse reconstruction, a spherical device (sometimes called a glenoid bulb) is fixed to the glenoid cavity, and a humeral implant with a cavity that can receive this glenoid bulb is implanted, thereby reversing the kinematic properties of the shoulder joint.
[0005] Depending on the treatment method, clinicians may use kits containing many different components and tools for implanting anatomical and inverse anatomical shoulder reconstructions. The use of numerous tools can increase the cost of the treatment procedure and unnecessarily complicate it. Therefore, continuous improvement of shoulder prosthesis components and assemblies is needed. [Overview of the project] [Means for solving the problem]
[0006] Improvements to humeral components, kits, assemblies, and methods are needed to make the implantation of anchors into the humerus (whether stemless or stemmed) more secure. Various embodiments disclosed herein relate to improved stemless humeral anchors having elongated distal fins that perform bone-filling functions. Furthermore, it may be desirable to utilize kits that reduce the number of humeral anchors and / or the number of tools used to implant the anchors. Various embodiments disclosed herein relate to kits and systems that provide a common tool set for stemless and stemmed humeral anchors so that clinicians can use a common tool set for implanting stemless and stemmed anchors, and for performing both anatomical and reverse anatomical reconstructions.
[0007] In one embodiment, a humeral anchor is disclosed. This humeral anchor may include a distal portion extending proximal to the distal end of the humeral anchor, the distal portion being configured to occupy a portion of the metaphysis of the humerus when implanted. The humeral anchor may include a proximal portion extending distally to the proximal end of the humeral anchor. The humeral anchor may include a recess extending distally to the proximal end of the humeral anchor. The humeral anchor may include an inner circumferential surface positioned around the recess adjacent to the proximal end of the humeral anchor. The surface may include a concave locking mechanism located on the inner surface. The inner surface may include a convex locking mechanism located on the inner surface, wherein the concave locking mechanism is spaced apart from the convex locking mechanism.
[0008] In some embodiments, a concave locking mechanism may include a first concave locking mechanism and a second concave locking mechanism positioned opposite the first concave locking mechanism. The first and second concave locking mechanisms may be positioned on the medial and lateral portions of the humeral anchor, respectively. A convex locking mechanism may include a first convex locking mechanism and a second convex locking mechanism positioned opposite the first convex locking mechanism. The first and second convex locking mechanisms may be positioned on the anterior and posterior portions of the humeral anchor, respectively. A concave locking mechanism may be configured to provide a locking mechanism for an articular body including a concave articular surface. A convex locking mechanism may include an elongated fin projecting toward the concave portion. A humeral anchor may include a stemless humeral anchor. The distal portion includes a first section and a second section distal to the first section, the second section of which may include a fin extending distally from the first section. The second section may include multiple fins extending distally from the first section. The first section may include a second recess distal to the recess. A stem may extend from the distal end of the humeral anchor.
[0009] In another embodiment, a humeral anchor is disclosed. The humeral anchor may include a distal portion extending proximal to the distal end of the humeral anchor, the distal portion being configured to occupy a portion of the metaphysis of the humerus when implanted. The humeral anchor may include a proximal portion extending distally to the proximal end of the humeral anchor and having an extended outer surface that occupies at least a large portion of the volume of the metaphysis of the humerus in which the humeral anchor is placed. The proximal portion may have a lateral surface configured to be positioned adjacent to the cortical wall of the lateral part of the metaphysis of the humerus and a medial surface configured to be spaced apart from the cortical wall of the medial surface of the metaphysis of the humerus. The humeral anchor may include a bone compression surface positioned at the proximal end of the humeral anchor, the bone compression surface being positioned around the medial surface of the proximal portion and configured to extend from the medial surface of the proximal portion to the cortical wall of the medial surface of the metaphysis of the humerus when implanted in the humerus.
[0010] In some embodiments, the bone compression surface may include a flange extending laterally from the proximal end of the proximal portion of the humeral anchor. The flange may include a circular outer surface having a radius corresponding to the radius of the outer surface of the proximal portion. An annular surface may be located on the proximal surface of the humeral anchor, and the flange may include a portion of the annular surface on the proximal surface. A rotational orientation marker may be formed on or within the annular surface located on the proximal surface of the humeral anchor. A recess may extend distally from the proximal end of the humeral anchor to the proximal portion, and includes an inner surface located around the recess adjacent to the proximal end of the humeral anchor, the inner surface including a locking mechanism located on the inner surface, the locking mechanism being aligned with the bone compression surface.
[0011] In another embodiment, a kit for a shoulder prosthesis is disclosed. The kit may include a first stemless humeral anchor, which includes a first distal portion configured to occupy a portion of the metaphysis of the humerus when implanted. The first stemless humeral anchor may include a first proximal portion extending proximal from the proximal end of the first distal portion to the proximal end of the first humeral anchor. The first stemless humeral anchor may include a first recess extending from the proximal end of the first humeral anchor to the first proximal portion. The first stemless humeral anchor may include a first fin extending distally, the first fin extending distally from the first distal portion to the distal end of the first humeral anchor, and having a first height between the proximal and distal ends of the first humeral anchor. The kit may include a second stemless humeral anchor, which includes a second distal portion configured to occupy a portion of the metaphysis of the humerus when implanted. The second stemless humeral anchor extends from the proximal end of the second distal portion to the proximal end of the second humeral anchor. The second stemless humeral anchor may include a second proximal portion extending proximally to the proximal end. The second stemless humeral anchor may include a second recess extending from the proximal end of the second humeral anchor to the second proximal portion. The second stemless humeral anchor may include a second fin extending distally, the second fin extending distally from the second distal portion to the distal end of the second humeral anchor, and a second height being defined between the proximal and distal ends of the second humeral anchor. The ratio of the second height to the first height may be in the range of 1.15 to 2.5.
[0012] In some embodiments, the kit may include a first stemmed humeral anchor having an anchor body and a stem extending distally from the anchor body. The kit may include one or more articular components configured to connect to the first and second humeral anchors. One or more articular components may include an anatomical articular component having a rounded convex surface configured to engage with the glenoid surface of a patient. One or more articular components may include a reverse articular body having a rounded concave surface.
[0013] In another embodiment, a humeral anchor is disclosed. The humeral anchor may include an inner surface disposed around a first recess between a first end and a second position of the humeral anchor, and around a second recess between a second position and a third position, having a different volume from the first and second recesses. The humeral anchor may include a distally extending fin, the fin extending distally from a third position to a second end of the humeral anchor, and the fin having a fin height of at least 10% of the total height of the humeral anchor.
[0014] In some embodiments, the humeral anchor may include a plurality of distally extending fins extending distally from a third position to a second end. The plurality of fins may include a first fin extending downward along the anchor and a second fin having directional components extending upward and in either the anterior or posterior direction. The humeral anchor may include an inner surface disposed around a first recess adjacent to the first end of the humeral anchor. The inner surface may include a concave locking mechanism disposed on the inner surface. The inner surface may include a convex locking mechanism disposed on the inner surface, wherein the concave locking mechanism is spaced apart from the convex locking mechanism.
[0015] In another embodiment, a method for implanting a shoulder prosthesis in a patient is disclosed. The shoulder prosthesis may include a stemless humeral anchor having an anchor body and a plurality of fins extending distally from the anchor body. The method may include removing a portion of the patient's humerus to form a cavity in the humerus. The method may include oriented the stemless humeral anchor relative to the humerus such that a first fin of the plurality of fins is oriented downward, and a second fin of the plurality of fins is oriented to have directional components along the upward and anterior and posterior directions. The method may include inserting the stemless humeral anchor into the cavity in the humerus.
[0016] In some embodiments, the method may include orienting the stemless humeral anchor with respect to the humerus such that the second fin is oriented to have directional components along the upward and anterior directions. The method may further include orienting the stemless humeral anchor with respect to the humerus such that the third fin of a plurality of fins is oriented to have directional components along the upward and posterior directions. The first and second fins may be angled with respect to each other at a first angle, and the second and third fins may be angled with respect to each other at a second angle equal to the first angle. The method may include resecting the humerus to form a resection surface before removing a portion of the humerus. Removing a portion of the humerus may include reaming the humerus to form a cavity. The method may include reaming the cavity The method may include drilling a second cavity located in the same position and having a smaller diameter compared to the cavity. The method may include connecting the articular body to a stemless humeral anchor.
[0017] In another embodiment, a humeral anchor is disclosed. The humeral anchor may include a distal portion extending proximal to the distal end of the humeral anchor, the distal portion extending along the longitudinal axis of the humeral anchor and tapering inward along the longitudinal axis toward the distal end of the humeral anchor. The humeral anchor may include a proximal portion extending distally to the proximal end of the humeral anchor. The humeral anchor may include a recess extending distally to the proximal end of the humeral anchor. The humeral anchor may include an inner surface disposed around a recess adjacent to the proximal end of the humeral anchor. The inner surface may include a concave locking mechanism disposed on the inner surface. The inner surface may include a convex locking mechanism disposed on the inner surface, the concave locking mechanism being spaced apart from the convex locking mechanism.
[0018] In some embodiments, the concave locking mechanism may include a first concave locking mechanism and a second concave locking mechanism disposed opposite the first concave locking mechanism. The first concave locking mechanism and the second concave locking mechanism may be disposed on the inner and outer portions of the humeral anchor, respectively. The convex locking mechanism may include a first convex locking mechanism and a second convex locking mechanism disposed opposite the first convex locking mechanism. The first convex locking mechanism and the second convex locking mechanism may be disposed on the front and rear portions of the humeral anchor, respectively. The concave locking mechanism may be configured to provide an interference fit to an articular body including a concave articular surface. The convex locking mechanism may include an elongated fin protruding toward the concave portion.
[0019] In another embodiment, a humeral anchor is disclosed. The humeral anchor may include a distal portion extending proximally from the distal end of the humeral anchor, the distal portion may include a distal portion extending along the longitudinal axis of the humeral anchor. The humeral anchor may include a proximal portion extending distally from the proximal end of the humeral anchor and having an outer surface that is expanded to occupy at least a majority of the volume of the metaphysis of the humerus where the humeral anchor is disposed. The proximal portion may have an outer side surface configured to be disposed adjacent to the cortical wall of the outer portion of the humeral metaphysis and an inner side surface configured to be spaced from the cortical wall of the inner side surface of the humeral metaphysis. The humeral anchor may include a bone compression surface disposed adjacent to the proximal end of the humeral anchor, the bone compression surface may be disposed only around the inner side surface of the proximal portion and may be configured to extend from the inner side surface of the proximal portion to the cortical wall of the inner side surface of the humeral metaphysis when implanted in the humerus.
[0020] In some embodiments, the bone compression surface may include a flange extending outward from the proximal end of the proximal portion of the humeral anchor. The flange may include a circular outer peripheral surface having a radius corresponding to the radius of the outer side surface of the proximal portion. An annular surface may be disposed on the proximal surface of the humeral anchor, and the flange may include a part of the annular surface of the proximal surface. A rotational orientation mark may be formed on or in the annular surface disposed on the proximal surface of the humeral anchor. A recess may extend distally from the proximal end of the humeral anchor to the proximal portion, and an inner peripheral surface is disposed around the recess adjacent to the proximal end of the humeral anchor. The inner peripheral surface includes a locking mechanism disposed on the inner peripheral surface, and the locking mechanism is aligned with the bone compression surface.
[0021] In another embodiment, a humeral anchor is disclosed. The humeral anchor may include a proximal portion having an extended outer surface extending distally from the proximal end of the humeral anchor. The humeral anchor may include a distal portion extending between the proximal portion and the distal end of the humeral anchor, and the distal portion may include a distal portion extending along the longitudinal axis of the humeral anchor. The distal portion may include a circular peripheral portion at a first position along the longitudinal axis of the humeral anchor adjacent to the distal end. The distal portion may include an oval peripheral portion at a second position disposed between the first position and the proximal end of the humeral anchor. The distal portion may include at least a partially polygonal peripheral portion at a third position disposed between the second position and the proximal end of the humeral anchor. The distal portion may include at least partially anti-rotation fins disposed on the edges of the polygonal peripheral portion.
[0022] In some embodiments, one or more circular peripheries are positioned along the length of the humeral anchor from the distal end to a first position. The oval periphery may include a first dimension in the anterior-posterior direction and a second dimension in the medial-lateral direction, the second dimension being greater than the first dimension. The at least partially polygonal periphery may include a curved convex side configured to be oriented outward and a substantially anterior-posterior oriented side positioned between the ends of the convex side. The anti-rotation fin may include a projection extending medially from the substantially anterior-posterior oriented side. The at least partially polygonal periphery may be oriented at an angle to the longitudinal axis of the distal end and in a cross section oriented parallel to the proximal end of the humeral anchor. The humeral anchor may include a second at least partially polygonal periphery positioned at a fourth position between a third position and the proximal end of the humeral anchor, with the anti-rotation fin positioned on the second at least partially polygonal periphery. The anti-rotation fin may extend continuously from at least a partially polygonal periphery at a third position to at least a partially polygonal periphery at a fourth position.
[0023] In another embodiment, a bone anchor inserter is disclosed. The bone anchor inserter may include a first end and a second end opposite to the first end. The bone anchor inserter may include an elongated body extending along the longitudinal axis between the first end and the second end. The bone anchor inserter may include a handle positioned between the first end and the second end, wherein the handle has a first configuration and a second configuration. The bone anchor inserter may include a bone anchor connecting portion positioned at the second end, wherein the bone anchor connecting portion has a bone anchor retaining configuration corresponding to the first configuration of the handle and a bone anchor release configuration corresponding to the second configuration of the handle. The bone anchor inserter may include a first impact head coupled to the elongated body and positioned at a first angle with respect to its longitudinal axis. The bone anchor inserter may include a second impact head coupled to the elongated body and positioned at a second angle with respect to its longitudinal axis. The force applied to the first impact head directs the impact force toward the first bone anchor in a direction coincident with the longitudinal axis of the first bone anchor, thereby embedding the first bone anchor into the bone. The force applied to the second impact head directs the impact force toward the second bone anchor, and the impact force applied to the second impact head is directed perpendicular to the bone resection surface, thereby embedding the second bone anchor into the bone.
[0024] In some embodiments, the first impact head may be positioned at an angle to the second impact head. The angle between the first and second impact heads may be between 35 and 65 degrees. The handle may be pivotably coupled to the elongated body, and the first and second configurations are provided by rotating the handle. A spring may be placed between the handle and the elongated body to facilitate the positioning and retention of the bone anchor connection portion in the bone anchor retaining configuration.
[0025] In another embodiment, a bone anchor inserter is disclosed. The bone anchor inserter may include a first end and a second end opposite to the first end. The bone anchor inserter may include an elongated body extending along a longitudinal axis between the first and second ends. The bone anchor inserter may include a bone anchor connection portion located at the second end, the bone anchor connection portion having a bone anchor holding configuration and a bone anchor release configuration. The bone anchor inserter may include an impact head coupled to the elongated body and located at the end of the elongated body adjacent to the second end and opposite to the first end. A force applied to the impact head can direct an impact force to the stem portion of the bone anchor, and the impact force applied to the impact head is directed in a direction coincident with the longitudinal axis of the bone anchor, embedding the stem portion of the bone anchor into the pulp canal.
[0026] In some embodiments, the impact head is oriented at an acute angle to the longitudinal axis of the elongated body. obtain.
[0027] In another embodiment, a kit is disclosed. The kit may include a stemless bone anchor, the first portion of which is configured to advance toward the metaphysis so as to be positioned between the resection surface and a continuous extension of bone located between the resection surface and the medullary canal of the bone. The stemless bone anchor may include a second portion opposite to the first portion, the second portion of which includes an inserter connection portion. The bone anchor inserter may include a bone anchor comprising a first portion and a second portion opposite to the first portion, wherein the first portion includes a stem configured to advance toward the diaphysis and the medullary canal of the bone and the second portion, and the second portion includes an inserter connection portion. The bone anchor inserter may include an inserter having a bone anchor connection portion, the bone anchor connection portion being configured to engage with an inserter connection portion of a stemless bone anchor or an inserter connection portion of a bone anchor including a stem.
[0028] In some embodiments, the inserter may further include an impact head positioned between a bone anchor connection portion and an end of the inserter facing the bone anchor connection portion, the impact head configured to transmit the impact force applied to the impact head to the bone anchor including the stem, thereby embedding the stem into the bone medullary canal. The impact head is a first impact head, which may further include a second impact head positioned at a certain angle to the second impact head. The angle between the first and second impact heads may be 45 degrees. The angle between the first and second impact heads may be between 35 and 65 degrees. The inserter may include a first impact head and a second impact head positioned at a first angle to each other. The second inserter may include a bone anchor connection portion, which is configured to engage with an inserter connection portion of a stemless bone anchor or an inserter connection portion of a bone anchor including a stem, and the second inserter includes a first impact head and a second impact head positioned at a second angle to each other. The first and second angles may each be between 35 and 65 degrees.
[0029] In another embodiment, a method is disclosed. The method may include providing a first bone anchor including a stemless bone engagement portion, wherein the second bone anchor includes a stem, and each of the first and second bone anchors includes an inserter connection portion, and the inserter includes a bone anchor connection portion configured to engage with the inserter connection portion of either the first or second bone anchor. The method may include engaging the bone anchor connection portion of the inserter with the inserter connection portion of the first bone anchor. The method may include advancing the first bone anchor into the bone material exposed during bone resection. The method may include engaging the bone anchor connection portion of the inserter with the inserter connection portion of the second bone anchor. The method may include advancing the second bone anchor into the bone material during bone resection to position the stem of the second bone anchor in the medullary canal of the bone.
[0030] In some embodiments, advancing a second bone anchor into bone material may further include applying force to the impact head of an inserter to embed the stem into the bone by applying a force consistent with the second bone anchor. The impact head may be a first impact head, and advancing a first bone anchor into bone material may further include applying force to the second impact head of an inserter to apply a force perpendicular to the bone resection. Advancing a first bone anchor into bone material may further include applying force to the impact head of an inserter to apply a force perpendicular to the bone resection. The inserter may be a first inserter. The method may include providing a second inserter. The first inserter and the second inserter may each have a stemmed anchor impact head and a stemless anchor impact head. The first inserter may have a first angle between the stemmed anchor impact head and the stemless anchor impact head. The second inserter may have a stemmed A second angle may be present between the anchor impact head and the stemless anchor impact head. The second angle may differ from the first angle. The method may include selecting either the first or second inserter based on the angle at which a resection is formed in the bone. The first and second angles may be between 35 and 65 degrees.
[0031] In another embodiment, a device for removing bone is disclosed. The device may include a proximal end and a distal end. The device may include a drive shaft located at the proximal end of the device, the drive shaft being rotatable around the drive shaft axis. The device may include a reamer head rotatable around the drive shaft axis for removing bone. The reamer head may include a distal portion including a plurality of radial arms, each of which includes a lateral cutting edge. The reamer head may include a proximal portion including a distal opposite cutting edge.
[0032] In some embodiments, each of the multiple radial arms may include a first flat surface and a second flat surface opposite the first flat surface, with the first and second flat surfaces separated by a thickness. The widths of the first and second flat surfaces, measured radially, may be greater than the thickness. Each of the multiple arms may include a proximal section and a distal section, with the proximal section projecting radially outward from the distal section. A guide channel may be configured to receive a guide pin, and each of the multiple radial arms extends radially outward from the guide channel. The proximal section may include a depth stop configured to control the insertion depth of the reamer head, the depth stop being proximal to the distal face cutting edge and extending radially outward. The distal face cutting edge may be located radially outward from the multiple radial arms. The distal face cutting edge may extend circumferentially around the proximal section of the reamer head. The distal face cutting edge may include multiple cutting teeth. The proximal portion of the reamer head may include multiple openings on its proximal surface.
[0033] In another embodiment, a device for removing bone is disclosed. The device may include a first end and a second end. The device may include a drive shaft located at the first end of the device, the drive shaft being rotatable around a drive shaft axis. The device may include a reamer head rotatable around the drive shaft axis for removing bone. The reamer head may include an inner portion including an outward-facing cutting edge, the inner portion configured to form a first cavity portion in the bone, and a second cavity portion being deeper than the first cavity portion, with a stepped portion between the first and second cavity portions. An outer portion may be located radially outward of the inner portion, the outer portion including a distally facing cutting edge, the outer portion being proximal to the first cavity portion and configured to form a concave surface at least partially surrounding the first cavity portion.
[0034] In some embodiments, the shape of the distal opposite cutting edge may differ from the shape of the outward-facing cutting edge. The second cutting edge may include a plurality of cutting teeth. A guide channel may be configured to receive a guide pin. The reamer head may further include a depth stop configured to control the insertion depth of the reamer head, the depth stop being located proximal to the distal opposite cutting edge and extending radially outward.
[0035] In another embodiment, a method for removing bone is disclosed. The method involves advancing a reamer toward the end of the bone, the reamer including a drive shaft and a reaming head, which may include advancing the reamer. The method may include driving the reamer around the drive axis of the drive shaft. The method may include forming a cavity in the bone with the reaming head. The cavity may include a first cavity portion and a second cavity portion extending to a deeper depth in the bone than the first cavity portion. The cavity may include a stepped portion between the first cavity portion and the second cavity portion. The method involves forming a concave surface beneath the cut surface of the bone with the reaming head. The method may include forming a concave surface that at least partially surrounds a first cavity. The method may include positioning the implant anchor structure in the bone cavity. The method may include positioning the implant collar on the concave surface of the bone.
[0036] In some embodiments, forming a cavity in the bone and forming a concave surface may be done simultaneously. In some embodiments, forming a cavity in the bone and forming a concave surface may be done sequentially. After forming a cavity in the bone, a concave surface may be formed on the bone. Advancing the reamer may include advancing the reamer along a guide pin. The method may include forming a concave surface on the bone until the depth stop contacts the cut surface of the bone.
[0037] These and other features, aspects and advantages are described below with reference to the drawings, but these are intended for illustrative purposes only and should not be construed as limiting the scope of the embodiments. Furthermore, various features of different disclosed embodiments can be combined to form additional embodiments that are part of this disclosure. In the drawings, similar reference numerals indicate features that are consistently represented throughout similar embodiments. The drawings are described below briefly. [Brief explanation of the drawing]
[0038] [Figure 1A] This diagram shows the anatomical, complete shoulder arthroplasty system located in the humerus and glenoid fossa of the shoulder joint, which includes a stemless humeral anchor. [Figure 1B] This illustrates a reverse-type whole-shoulder arthroplasty system in the shoulder joint, which includes a humeral stem anchor. [Figure 2] This is a schematic diagram of a shoulder arthroplasty system including an arthroplasty kit that can be used to perform anatomical arthroplasty or reverse arthroplasty, or to convert from anatomical arthroplasty to reverse arthroplasty, or from reverse arthroplasty to anatomical arthroplasty, in various embodiments. [Figure 3] This is a side view showing the anatomical articular body connected to a stemless anchor of the humerus in various embodiments. [Figure 3A] This is a side view showing a reverse articular body connected to a stemless anchor of the humerus, according to various embodiments. [Figure 3A-1] Figure 2 shows a perspective view of the stemless humeral anchor and reverse joint assembly from the system before insertion of the reverse joint assembly, illustrating the engagement mechanism of these components. [Figure 3B] Figure 3A shows a cross-sectional view of the stemless humeral anchor and reverse joint assembly after the reverse joint assembly has been inserted. This cross-section is taken laterally with respect to the insertion direction of the reverse joint assembly. [Figure 3C]Figure 3A is a cross-sectional view of a stemless humeral anchor, and this cross-section is taken along the insertion direction of the reverse joint assembly. [Figure 4A] These are side views of stemless humeral anchors in various embodiments. [Figure 4B] This is a bottom view of the stemless humeral anchor shown in Figure 4A, according to an example. [Figure 4C] This is a side view of a stemless humeral anchor according to another embodiment. [Figure 4C-1] Figure 4C is a top view of the stemless humeral anchor. [Figure 4C-2] Figure 4C-1 is a cross-sectional view of another embodiment of the stemless humeral anchor having a reinforced bone-retaining structure, with the cross-section taken along the cut 4C-2-4C-2 in Figure 4C-1. [Figure 4D] This is a side view of a humeral anchor according to another embodiment. [Figure 4D-1] This is a side view of a humeral anchor according to another embodiment. [Figure 4E] This is a schematic side view of a humeral anchor having multiple stabilizing teeth according to various embodiments. [Figure 4F] This is a schematic side view of a humeral anchor having four fins according to another embodiment. [Figure 4F-1] Figure 4F shows a bottom view of a stemless humeral anchor, another example. [Figure 4G] This is a side view of a stemless humeral anchor having a bone-preserving outline according to another embodiment. [Figure 5] This is a lateral cross-sectional view of an example of a humeral stem having a distal portion that can extend into the shaft of the humerus. [Figure 6A] These are side views of humeral stem anchors in various embodiments. [Figure 6B] Figure 6A shows the proximal and medial aspects of the humeral stem anchor. [Figure 6C] Figure 6A shows the distal and lateral aspects of the humeral stem anchor, including the cancellous bone compression member. [Figure 6D]These are perspective views of the proximal portion of humeral stem anchors in various embodiments. [Figure 6E] This is a lateral cross-sectional view of the humeral stem anchor in Figure 6D, taken along the cross section 6E-6E in Figure 6D. [Figure 6F] This is a cross-sectional view of the humeral stem anchor taken along the 6F-6F cut, as shown in Figure 6E. [Figure 6G] This is a cross-sectional view of the humeral stem anchor taken along the 6G-6G cut, as shown in Figure 6E. [Figure 6H] This is a cross-sectional view of the humeral stem anchor taken along the 6H-6H cut, as shown in Figure 6E. [Figure 6I] This is a cross-sectional view of the humeral stem anchor taken along the cut 6I-6I, as shown in Figure 6E. [Figure 6J] This is a cross-sectional view of the humeral stem anchor taken along the 6J-6J cut, as shown in Figure 6E. [Figure 6K] Figure 6E shows a cross-sectional view of the humeral stem anchor taken along the 6K-6K cut. [Figure 6L] This is a cross-sectional view of the humeral stem anchor taken along the 6L-6L cut, as shown in Figure 6E. [Figure 6M] This is a side view of a stem humeral anchor having an extra-long length according to another embodiment. [Figure 7] Two exemplary methods for resecting the humerus, according to various embodiments, are shown. [Figure 8] This shows a protective step where a protective plate is placed on top of the resected humerus. [Figure 9] This document describes methods for determining the size of the humerus before implanting humeral anchors, using various embodiments. [Figure 10] This shows an example of how to ream a resected humerus. [Figure 10A] An example of a reamer configured to create a space suitable for a stemmed or stemless humeral anchor is shown. [Figure 10B]An example of a reamer configured to create a space suitable for a stemmed or stemless humeral anchor is shown. [Figure 11] This shows an example of how to braze a reamed humerus. [Figure 11A] An example of an inserter configured to position a humeral anchor in the humerus is shown. [Figure 11B] An example of an inserter configured to position a humeral anchor in the humerus is shown. [Figure 11C] An example of an inserter configured to position a humeral anchor in the humerus is shown. [Figure 11D] An example of an inserter configured to position a humeral anchor in the humerus is shown. [Figure 12] An example of a method for planing the humerus is shown. [Figure 13] An example of how to insert a reverse-type test implant or an anatomical test implant into the humerus is shown. [Figure 14] This shows an example of how to implant a stemless humeral implant into the humerus. [Figure 15] This illustrates an exemplary method by which anatomical joint components are pressed into a stemless humeral implant. [Figure 16] This shows an example of how to insert a reverse-type articular component into a stemless humeral implant. [Figure 17] To facilitate the preparation of the humerus in patients with relatively hard bones, an example of a method for drilling holes in the humerus before reaming is shown. [Figure 18] This example shows how to expand a recess in a hard bone by applying a progressive reamer technique to the humerus. [Figure 19] This example demonstrates a method of reaming a portion of the humerus using a color reamer to facilitate the preparation of the humerus in patients with relatively soft bones. [Figure 20] This example shows a method for compressing the humerus to properly form a depression in patients with relatively soft bones. [Modes for carrying out the invention]
[0039] This application relates to novel and original shoulder implants and tools that can be used to implant them in various examples. The shoulder implants can be part of a hemi-shoulder arthroplasty system and a full-shoulder arthroplasty system (as improved versions of the systems shown in Figures 1A and 1B below). In some cases, the tools can be used with either a stemless anchor or an anchor having a stem portion configured to extend into the diaphysis of the humerus (forming an example of a stemmed humeral anchor). In some cases, the tools can be used in an anatomical shoulder configuration (for example, as an improved version of the tool used to achieve the configuration in Figure 1A) and / or in a reverse shoulder configuration (for example, as an improved version of the tool used to achieve the configuration in Figure 1B). These implants and tools can be used separately or combined into a system or kit that can also be provided in the operating room, thereby allowing for intraoperative adaptation of the preoperative plan to improve the surgical outcome, which may only become fully apparent during surgery, as described below.
[0040] I. Reverse configuration and anatomical structure for total shoulder arthroplasty Figures 1A and 1B illustrate two approaches to total shoulder arthroplasty. Figure 1A shows the anatomical approach in which the humeral head is replaced by an articular body 64 having a convex articular surface 65. The glenoid cavity of the scapula can be modified with an implant 67 that provides a concave surface 68 for articular connection of the humeral articular body 64. The humeral articular body 64 is fixed to the humerus H using a stemless anchor 4 that is specific to and fits only the anatomical articular body 64.
[0041] Figure 1B shows a reverse approach in which an articular body 84 having a concave articular surface 85 is attached to the humerus H. A spherical articular body, commonly called the glenosphere 87 (sometimes called the glenofossal sphere), is attached to the glenofossal region of the scapula. In this case, the concave articular surface 85 is located on the humerus, which articulates with the glenosphere 87 fixed to the scapula. The reverse articular body 84 is attached to a tray 89 positioned between this reverse humeral articular body 84 and a stem anchor 83 surgically implanted in the humerus H. The humerus H is prepared by providing access to the medulla medullary canal of the humerus H.
[0042] Anatomical approaches and reverse approaches generally use different hardware to fix joint components. Therefore, from the anatomical configuration Converting to a reverse configuration requires the removal of the stemless anchor 4. The bone stock remaining after such removal may or may not be suitable for supporting the stem anchor 83. Furthermore, the presence of tray 89 necessitates a larger joint cavity. Therefore, the reverse configuration may only be suitable for some patients with a larger joint cavity or those who have undergone more invasive adjustments to the humerus and / or scapula. Fortunately, this implant, tool, device, system, and kit can reduce the need for modifications and revision surgeries that may not be optimal for the patient's outcome.
[0043] II. Systems and kits with shared implant components Figure 2 is a schematic diagram of a complete arthroplasty system including an arthroplasty kit 100 that can be used for performing anatomical arthroplasty or reverse arthroplasty, or for conversion from anatomical arthroplasty to reverse arthroplasty or reverse arthroplasty to anatomical arthroplasty, in various embodiments. The kit 100 may include one or more stemless humeral anchors 103, one or more stemmed humeral anchors 113, and one or more articular components 161. The stemless humeral anchor 103 may have a tapered contour between the distal portion 105 and the proximal portion 107 of the anchor 104. The distal portion 105 of the anchor 103 shown in Figure 2 may have one or more fins 109 extending distally. The fins 109 may be configured to fix the anchor 103 to the humerus.
[0044] As shown in Figure 2, the stemless anchor 103 can be provided in multiple sizes to accommodate patients of various body types, differences in humeral bone injuries, etc. In some embodiments, the lateral size of the stemless anchor 103 may be varied to fit within different resection ranges of humeral size. For example, kit 100 may include multiple stemless anchors 103A, 103B, 103C, 103D...103n, where n is the number of different sizes. Although four sizes are illustrated in Figure 2 (for example, n=4, and there are anchors 103A-103D), in other embodiments, the kit may include any preferred number of anchors. In some embodiments, the length l1 of the stemless anchors 103A-103D may also be varied to extend into the humerus by a depth selected by the clinician based on the specific patient being treated. Furthermore, as described below in relation to Figure 4A, anchors 103A-103D may have different fin lengths l to accommodate different sizes of humerus. f It may have fin 109.
[0045] In various embodiments, the fin length l of anchors 103A to 103D fThe configuration can vary substantially to provide beneficial anchoring strength to the humerus and accommodate patients with varying levels of bone injury. In the configuration shown in Figure 2, for example, the first anchor 103A has the shortest total length l1 and the shortest total fin length l f The fourth anchor 103D has the longest overall length l1 and the longest overall fin length l f In various embodiments, the ratio of the total length l1 of one anchor 103 in the kit 100 (e.g., the largest anchor 103D) to the total length l1 of another anchor 103 (e.g., the smallest anchor 103A) can be in the range of 1.1 to 2.5, 1.15 to 2.5, 1.18 to 2.5, 1.2 to 2.5, 1.2 to 2, 1.2 to 1.8, 1.2 to 1.6, 1.3 to 1.6, 1.25 to 1.4, or 1.25 to 1.35. In some embodiments, the ratio of the total length l1 of the fourth anchor 103D to the total length l1 of the second anchor 103B can be in the range of 1.1 to 1.3, 1.15 to 1.25, or 1.15 to 1.2. In some embodiments, the ratio of the total length l1 of the fourth anchor 103D to the total length l1 of the third anchor 103C may be in the range of 1 to 1.2, 1.02 to 1.15, or 1.05 to 1.15. In some embodiments, the ratio of the total length l1 of the second anchor 103B to the total length l1 of the first anchor 103A may be in the range of 1 to 1.2, 1.02 to The range may be 1.15, or 1.05 to 1.15. In some embodiments, the ratio of the total length l1 of the third anchor 103C to the total length l1 of the first anchor 103A may be in the range of 1.1 to 1.3, or 1.15 to 1.25. In some embodiments, the ratio of the total length l1 of the third anchor 103C to the total length l1 of the second anchor 103B may be in the range of 1 to 1.2, 1.02 to 1.15, or 1.05 to 1.15.
[0046] Thus, in some embodiments, the kit 100 can include anchors 103A - 103D of a plurality of sizes, for example, four sizes. In some embodiments, the first anchor 103A can have a fin length l in the range of 3 mm to 7 mm, or in the range of 4 mm to 6 mm f The second anchor 103B can have a fin length l in the range of 4 mm to 10 mm, in the range of 5 mm to 9 mm, or in the range of 6 mm to 8 mm f The third anchor 103C can have a fin length l in the range of 7 mm to 10 mm, or in the range of 8 mm to 9 mm f The fourth anchor 103D can have a fin length l in the range of 8 mm to 10 mm f In some embodiments, the ratio of the fin length l f of the fourth anchor 103D to the fin length l f of the first anchor 103A can be in the range of 1.5 to 2.5, in the range of 1.6 to 2, or in the range of 1.7 to 1.8. In some embodiments, the ratio of the fin length l f of the fourth anchor 103D to the fin length l f of the second anchor 103B can be in the range of 1.4 to 1.2, or in the range of 1.25 to 1.3. In some embodiments, the ratio of the fin length l f of the fourth anchor 103D to the fin length l f of the third anchor 103C can be in the range of 1 to 1.25, in the range of 1 to 1.1, or in the range of 1.02 to 1.1. In some embodiments, the ratio of the fin length l f of the second anchor 103B to the fin length l f of the first anchor 103A can be in the range of 1.1 to 1.6, in the range of 1.2 to 1.6, or in the range of1.3 to 1.5. In some embodiments, the ratio of the fin length l f of the third anchor 103C to the fin length l f of the first anchor l03A can be in the range of 1.5 to 2, or in the range of 1.6 to 1.8. In some embodiments, the ratio of the fin length l f of the third anchor 103C to the fin length l<00The ratio can be in the range of 1.1 to 1.3, or 1.15 to 1.25.
[0047] Kit 100 may also include one or more stemmed humeral anchors 113. Kit 100 may include one or more humeral stem anchors 112, each including a proximal metaphysis 120 and an elongated diaphysis 116 extending therefrom. The diaphysis 116 may be referred to herein as the stem or stem portion. In some embodiments, Kit 100 may also include a trauma or fracture stem anchor 140 that can be used in patients who have experienced a fracture of the humerus H. Stemmed humeral anchors 113 may be used in patients for whom stemless anchors 103 may not be adequately fixed to the humerus, for example, in patients who have experienced severe osteopenia. Trauma or fracture stems may be used when the humerus is fractured into one or more fragments. Similar to the stemless anchor 103, Kit 100 may include stemmed anchors 113 having multiple different sizes, for example, different lateral sizes and / or different lengths l2. For example, as shown in Figure 2, each stemmed humeral anchor 113 may have a length l2 that is longer than the length l1 of the stemless anchor 103. Beneficially, by including stemmed anchors 113 of different sizes in the kit 100, clinicians may be able to select a size appropriate for a particular patient, taking into account the patient's bone size and health condition, in order to ensure safe implantation of the anchor 113 into the patient. In various embodiments, the length l2 of the stemmed humeral anchor can range from 55 mm to 175 mm. In contrast, the length l1 of the shorter stemless humeral anchor 103 may range from 16 mm to 28 mm. In various embodiments, the stemmed humeral anchors 113, 140 may be configured to reach into the intramedullary canal of the humerus H and be further fixed.
[0048] Beneficially, Kit 100 may include one or more shared humeral components to be used with either the stemless humeral implant 103 or the stemmed humeral implant 113, depending on which implant 103 or 113 is more suitable for the anatomical structure of a particular patient's humerus. For example, the shared humeral components of Kit 100 may include multiple articular components or assemblies 161 that can be used in combination with either the stemless implant 103 or the stemmed implant 113. As described herein, both the stemless humeral anchor 103 and the stemmed humeral anchor 113 may include a shared engagement mechanism that can be used with the tools and / or articular components of the set. For example, as described herein, the stemless anchor 103 and the stemmed anchor 113 may include convex and concave locking mechanisms configured to engage with the articular components of the set.
[0049] For example, kit 100 may include an anatomical joint component 160 configured to mechanically connect to both a stemless humeral implant 103 and a stemmed humeral implant 113. A clinician may select the anatomical joint component 160 for procedures where anatomical reconstruction is appropriate. The anatomical joint component 160 may include a connector 168 and an (anatomical) articular body 164 configured to mechanically engage with the connector 168. As shown in Figure 2, the articular body 164 of the anatomical joint component 160 may include a rounded convex surface configured to engage with the glenoid surface of the patient. The connector 168 may help mechanically connect the anatomical articular body 164 (e.g., a rounded surface, or an essentially spherical surface) to either the stemless humeral implant 103 or the stemmed humeral implant 113, depending on the patient's humeral structure. The articular body 164 and connector 168 may include metals such as cobalt, chromium, or titanium. In some embodiments, the articular body includes a pyrocarbon layer on at least the articular surface. In various embodiments, kit 100 may include anatomical articular components 160 having multiple sizes.
[0050] Kit 100 may also include a reverse articular component 180 configured to mechanically connect to both stemless humeral implants 103 and stemmed humeral implants 113. A clinician may select the reverse articular component 180 for procedures where reverse anatomical reconstruction is appropriate. The reverse articular component 180 may include a reverse articular body 184 and, depending on the clinician's recommendation during the procedure, a locking device 188 configured to secure the reverse articular component 180 to either the stemless humeral implant 103 or the stemmed humeral implant 113. As illustrated, the reverse articular body 184 may include a rounded concave surface (e.g., essentially spherical) configured to engage with a glenosphere (not shown, but potentially combined with the kit to form a larger surgical kit) connected to the patient's glenoid fossa. In addition, in some embodiments, kit 100 may include a wear-resistant reverse joint component 180A, which may be substantially similar to the reverse joint component 180 but may be further formed to contain vitamin E to promote long-term compatibility with the patient's bone structure. The reverse components 180, 180A may be composed of polymers, for example, ultra-high molecular weight polyethylene. In various embodiments, kit 100 may include reverse joint components 180, 180A having multiple sizes.
[0051] During arthroplasty, clinicians can examine the bone structure of the humerus and / or scapula to determine whether the anatomical structure is suitable for a stemless humeral anchor or a stemmed humeral anchor, and whether the anatomical structure is suitable for anatomical reconstruction or reverse anatomical reconstruction. Fortunately, Kit 100, shown in Figure 2, is suitable for stemless anchors or A total arthroplasty system including components that fit with stemmed anchors and components that fit with anatomical or reverse anatomical structures can be provided to clinicians. For example, during a procedure, a clinician may find that the patient has a sufficient humeral bone structure and be able to use a stemless anchor 103 to reduce damage to the patient's anatomical structure. The clinician may also choose to proceed with either anatomical or reverse reconstruction and accordingly select either the anatomical articular component 160 or the reverse articular component 180, 180A.
[0052] Similarly, during a shoulder arthroplasty procedure, if the clinician determines that the patient's bone structure is damaged or otherwise more suitable for a stemmed anchor 113, the clinician can select a stemmed anchor 113 of the appropriate size. The clinician can then further choose whether to proceed with anatomical reconstruction or reverse reconstruction, and accordingly select either an anatomical joint component 160 or a reverse joint component 180, 180A. Conveniently, Kit 100 in Figure 2 contains interchangeable or shared components that can be used with stemmed or stemless anchors and are suitable for use in anatomical or reverse anatomical reconstruction. The shared humeral joint component 161 (e.g., anatomical or reverse anatomical joint) can be used with either a stemless or stemmed anchor 103, 113, so that the clinician can make or change reconstruction decisions during surgery. Therefore, Kit 100 can enable clinicians to quickly determine the most appropriate reconstruction procedure for a patient and provide them with the components to be used in that procedure.
[0053] As described above, in the case of a humeral fracture, kit 100 may also include one or more trauma stems 140. Beneficially, the trauma stems 140 may include engagement mechanisms that are substantially similar to or identical to those in the stemless anchors 103 and humeral stem anchors 112, so that the trauma stems 140 can be used with a common set of joint components 161 and tools. Therefore, beneficially, kit 100 can provide a set of common implantation tools and a set of common joint components 161 that can be used with stemless or stemmed humeral anchors 103, 113 and can be used for anatomical or reverse anatomical reconstruction.
[0054] In some embodiments, the connector 168 may include a proximal extension 163A and a distal extension 163B configured to connect to the articular body 164. The distal extension 163B for the fracture stem 140 can be housed in a recess 217 of the fracture stem 140 for anatomical reconstruction. A disc or intermediate portion 162 positioned between the proximal extension 163A and the distal extension 163B may be omitted because the recess 217 is raised toward the resection surface. In modified embodiments, the recess 217 is recessed from the distal end of a second recess (e.g., extending distally from the distal end of the second recess). In those embodiments, the disc or intermediate portion 162 provides a spacer function used in the trauma stem 140. Further details regarding the trauma stem can be found in the entirety of International Application PCT / US2015 / 065126, filed on 15 December 2015, the entirety of which is incorporated herein by reference as constituting a part of this specification for all purposes.
[0055] III. Examples of humeral anchors As described above, this application discloses several kits and systems that provide common components and may include multiple types of humeral anchors. Humeral anchors include stemless anchors, anchors with a stem portion (example of a stemmed humeral anchor), and stem It may include fracture anchors that have a 'mu' (a type of ligature).
[0056] A. Example of a stemless humeral anchor Some examples of stemless humeral anchors disclosed herein include mechanisms for enhancing retention of the metaphysis and / or mechanisms for enhancing connection or retention of joint components. These mechanisms can increase the proportion of patients in the patient population who can benefit from stemless approaches, which are generally less invasive than stemmed approaches.
[0057] Figures 3–3C show examples of stemless humeral anchors 203. Unless otherwise noted, the components in Figures 3–3C may be the same as or generally similar to the components of similar number in Figure 2, with the reference numbers incremented by 100. In Figures 3–3A-1, the stemless humeral anchor 203 is shown connected to (or before connected to) an articular component 161, which may include an anatomical articular component 160 or a reverse articular component 180. In Figure 3, the stemless humeral anchor 203 is shown connected to the anatomical articular body 164 of the anatomical articular component 160. In Figure 3A, the stemless humeral anchor 203 is shown connected to the reverse articular body 184 of the reverse articular component 180. The articular component 161 may be an articular assembly, e.g., a polymer articular body, and a locking component such as a locking ring.
[0058] As shown in Figures 3A-1 to 3C, the first recess 231 may extend distally from the proximal end 239 of the humeral anchor 203 into the proximal portion 207. The first recess 231 may be sized and shaped to accommodate the distal or lateral portion of the articular component 161, including the reverse articular body 184 and the locking device 288. As shown in Figure 3C, the first recess 231 may be located in the proximal portion 207 of the anchor 203. The proximal portion 207 may be at least partially defined by the first proximal outer surface 211. The second recess 232 may extend distally from the first recess 231 into the first section 205A of the distal portion 205 of the anchor 203. The second recess 232 may be sized and shaped to accommodate the distal extension 163B of the connector 168 for connecting the anatomical articular component 160 to the stemless humeral anchor 203. The first and second recesses 231 and 232 may have different volumes. For example, the volume of the first recess 231 (and / or the diameter or main transverse dimension of the first recess 231) may be larger than the volume of the second recess 232 (and / or the diameter or main transverse dimension of the second recess 232). Thus, the combined space formed by the recesses 231 and 232 may increase towards the proximal end 239 of the anchor 203 and decrease towards the distal end 37 of the anchor 203, as shown, for example, in Figure 3C.
[0059] The first segment 205A of the distal portion 205 may be at least partially defined by the second distal outer surface 212 and may be dimensioned to occupy a portion of the metaphysis of the humerus when implanted. The second segment 205B of the distal portion 205 may include one or more fins 209 configured to extend further into the metaphysis than the first segment 205A for fixing the anchor 203 to the humerus. As shown in Figure 3C, the second recess 232 may be tapered inward to engage with a connector 168, for example, the tapered surface portion of its distal extension 163B. One or more blind holes 245 may also extend distally into the second segment 205B of the distal portion 205 from the distal inner surface 235 of the proximal portion 207, which borders the distal end of the first recess 231. The blind hole 245 can be engaged with a tool that allows insertion of the humeral anchor 203 into the humerus. Examples of tools that can engage with the blind hole 245 are described in sections IV(A) and IV(B) below. As shown in Figures 3A-1 and 3C, the blind hole 245 may extend distally, angled inward toward the internal second recess 232.
[0060] The anchor 203 may include an inner surface 233 positioned around a first recess 231 adjacent to the proximal end 239 of the humeral anchor 203. The inner surface 233 may be a surface portion extending from the distal inner surface 235 to the proximal end 239 of the humeral anchor 203. The inner surface 233 may include one or more recessed locking mechanisms 243 and one or more convex locking mechanisms 241 positioned on the inner surface 233. As shown in Figures 3A-1 to 3C, in an example where both are provided, the recessed locking mechanisms 243 may be circumferentially spaced from the convex locking mechanisms 241. Furthermore, in the embodiments of Figures 3A to 3C, the anchor 203 includes a plurality of recessed locking mechanisms 243A, 243B, for example two or a pair, spaced apart from one another along the inner surface 233. The locking mechanisms 243A and 243B may be positioned opposite each other on the inner circumferential surface 233 with a recess 231 in between. In some embodiments, as shown in Figure 3B, the first recessed locking mechanism 243A may be positioned on the medial part M of the humeral anchor 203, and the second recessed locking mechanism 243B may be positioned on the lateral part L of the humeral anchor 203. In some examples, the first recessed locking mechanism 243A may be positioned on the anterior part of the humeral anchor 203, and the second recessed locking mechanism 243B may be positioned on the posterior part of the humeral anchor 203. The first recessed locking mechanism 243A and the second recessed locking mechanism 243B may be positioned opposite each other on the inner circumferential surface 233. A separation of, for example, 180 degrees, 120 degrees, 90 degrees, 60 degrees, or other angles between them can be defined between the first locking mechanism 243A and the second locking mechanism 243B. More than two locking mechanisms 243A or 243B can be provided; for example, three can be provided at 120-degree intervals, four at 90-degree intervals, or six at 60-degree intervals. The spacing between locking mechanisms 243A and 243B does not have to be equal in some embodiments.
[0061] The recessed locking mechanism 243 may include a curved surface that extends radially outward relative to the inner circumferential surface 233. The recessed locking mechanisms 243A and 243B may be sized relative to the locking mechanisms of the joint component 161, providing an interference fit connection between the joint component 161 and the locking mechanisms 243A and 243B. Such interference fits may include embodiments in which the recessed locking mechanisms 243A and 243B are smaller than the corresponding outer surfaces of the joint component 161.
[0062] Multiple, for example, two or a pair of convex locking mechanisms 241A, 241B may also be arranged facing each other along the inner circumferential surface 233. In some embodiments, as shown in Figure 3B, the first convex locking mechanism 241A may be located on the anterior A of the humeral anchor 203, and the second opposing convex locking mechanism 241B may be located on the posterior P of the humeral anchor 203. The convex locking mechanism 241 may include projections 247 extending radially inward relative to the inner circumferential surface 233 toward the first recess 231. The projections 247 may be elongated in the longitudinal direction within the first recess 231, for example, in the proximal-distal direction parallel to the insertion direction of the joint component 261. The projections 247 may extend from adjacent portions of the peripheral portion 233 toward the central portion of the first recess 231. The portion of the peripheral 231 adjacent to the projection 247 may be concave relative to the projection 247 in the structure facing the first recess 231. For example, the convex locking mechanism 241 may be adjacent to a pair of recessed recesses 242 formed on the inner circumferential surface 233. Similar to the concave locking mechanisms 243A, 243B, the convex locking mechanisms 241A, 241B can be sized relative to the corresponding locking mechanisms of the articulated component 161, providing an interference fit connection between the articulated component 161 and the convex locking mechanisms 241A, 241B. Such interference fits may include embodiments in which the convex locking mechanisms 241A, 241B are smaller than the corresponding outer surfaces of the articulated component 161, for example, the projection 247 may extend into and engage with the corresponding locking mechanism of the articulated component 161.
[0063] A circumferential groove 244 may extend circumferentially along the inner circumferential surface 233. The groove 244 may be between the concave locking mechanism 243A and the convex locking mechanism 241A, between the concave locking mechanism 243A and the convex locking mechanism 241B, between the concave locking mechanism 243B and the convex locking mechanism 241A, and between the concave locking mechanism 243A and the convex locking mechanism 241A. The groove 244 may include a plurality of segments arranged circumferentially between the locking mechanism 243A and the convex locking mechanism 241B. The groove 244 may include any number of segments, such as four, six, etc. As described below, the groove 244 may be sized relative to the locking mechanism 288 of the articulated component 161 to provide a snap-fit or interlock-fit with the locking mechanism 288 of the articulated component 161. In various embodiments, the groove 244 may include a distally facing surface that can secure the locking mechanism 288 of the articulated component 161 to the anchor 203.
[0064] A clinician can fix the joint component 161 (for example, the reverse joint component 180 shown in Figure 3A-1) to the stemless humeral anchor 203 by inserting it into the first recess 231 of the stemless humeral anchor 203. The locking mechanism 288 of the joint component 161 may include convex tabs 252 spaced apart from each other, for example on both sides of the joint component 161. The locking mechanism 288 may also include recessed slots 251 spaced apart from each other. A locking ring 253 may be circumferentially positioned within the groove of the joint component 161. A distal projection 254 extends distally from the locking mechanism 288 and may engage with the stemless humeral anchor 203 in the second recess 232.
[0065] When a clinician inserts the joint component 161 into the first recess 231, the clinician can align the joint component 161 with respect to the first recess 231 such that the convex tab 252 engages with the corresponding concave locking mechanism 243 of the anchor 203, and the concave slot 251 engages with the corresponding convex locking mechanism 241 of the anchor 203. The tab 252, slot 251, concave locking mechanism 243, and convex locking mechanism 241 can be dimensioned such that an interlocking or friction fit occurs between the reverse joint component 180 and the humeral anchor 203 when the joint component 161 is inserted into the first recess 231. The concave locking mechanism 243 and convex locking mechanism 241 can function as anti-rotation mechanisms to suppress relative rotation between the anchor 203 and the joint component 161. The locking ring 253 may extend into the circumferential groove 244 of the anchor 203. The lock ring 253 can secure the joint component 180 to the anchor 203 and prevent the joint component 161 from translating vertically outward from the anchor 203.
[0066] Figure 3B shows the connection between the joint component 161 (such as the reverse joint component 180) and the anchor 203. The outer circumferential surface of the joint component 161 can be seen inside the inner circumferential surface 233 of the anchor 203. As described above, the tab 252 can engage with the recessed locking mechanisms 243A and 243B of the anchor 203 by interference fit. Similarly, the recessed slot 251 of the joint component 161 can engage with the projection 247 of the convex locking mechanisms 241A and 241B by interference fit. Although not shown in Figure 3B, the locking ring 253 can be fitted into the groove 244 of the inner circumferential surface 233.
[0067] In embodiments where one or more locking mechanisms have different configurations, the rotational position can be more easily confirmed during surgery. For example, it can be visually confirmed that the tabs 252 are correctly rotated relative to the recessed locking mechanisms 243A and 243B. By providing two opposing tabs 252, the joint component 161 can be fixed to the anchor 203 in only two rotational positions. In some cases, when the shoulder joint is assembled, the biomechanics of the shoulder joint are brought about by these two positions. These two positions are rotationally symmetrical. In other embodiments, these two positions provide two biomechanical options so that the surgeon can choose between two positions of the joint component 180 relative to the anchor 203. In the first rotational position, tab 252A is positioned in the upper recessed recess 243A, and tab 252B is positioned in the lower recessed recess 243B. In the second rotational position, tab 252A is positioned in the lower recessed recess 243B The tab 252B is positioned in the recessed recess 243B located above it.
[0068] In various embodiments, the proximal end 239 of the humeral anchor 203 may include a collar or limb 266 configured to be positioned relative to the humerus. As described below in relation to the stemmed humeral anchor 1200 in Figure 6C, the limb 266 may include a cancellous bone compression member, which may include a bone compression surface. The bone compression surface of the stemless anchor 203 may be substantially similar to the bone compression member shown in Figure 6C. For example, the bone compression surface may be adjacent to or positioned on the proximal end 239 of the humeral anchor 203, or positioned around the medial side of the proximal portion 203. As in the case of Figure 6C, the bone compression surface may be positioned only on the medial side, for example, around a portion of the periphery of the proximal end 239 that does not include the lateral side of the humeral stem. The bone compression member of the stemless anchor 203 may include substantially similar features to those described below in relation to Figure 6C.
[0069] For example, similar to the stemmed anchor 1200 in Figure 6, the cancellous bone compression member of the stemless anchor 203 can be fabricated to fit the patient. For example, in various embodiments, the patient's shoulder (e.g., humerus and / or glenoid fossa) may be imaged during preoperative imaging procedures. The cancellous bone compression member of the stemless anchor 203 can be molded to specifically fit the patient's anatomical structure based on the imaging performed preoperatively. For example, in various embodiments, the cancellous bone compression member may be manufactured using various types of additive manufacturing techniques, such as three-dimensional (3D) printing. Image data representing the patient's cancellous bone structure may be sent to a 3D printing machine that can manufacture the cancellous bone compression member to substantially fit or match the patient's cancellous bone tissue. The member may have a shape that extends at least to the inner wall of the cortical bone layer. The member may also have a shape that extends beyond the inner wall of the cortical bone layer. The member may be molded to conform to the shape of the periphery of the humerus at the resection surface. These configurations may be fabricated to fit the patient to mitigate, minimize, or eliminate stress shielding and the resulting bone loss. Therefore, the various embodiments disclosed herein can beneficially provide patient-specific structures that improve the fit of anchors within the humerus.
[0070] Figures 4A to 4G show various shapes of the outer surface of a humeral anchor. For example, Figure 4A is a schematic side view of a stemless humeral anchor 303. The humeral anchor 303 may be the same as or different from the humeral anchors 103 and 203 in Figures 2 to 3C. Unless otherwise noted, the components of Figure 4A may be the same as or generally similar to the components of the same number in Figures 3 to 3C, and the reference numbers are increased by 100 compared to the reference numbers in Figures 3 to 3C. As shown in Figure 4A, the proximal portion 307 of the stemless humeral anchor 303 may include a first proximal outer surface 311. The first section 305A of the distal portion 305 of the stemless humeral anchor 303 may include a second distal outer surface 312. The first proximal outer surface 311 may be wider than the second distal outer surface 312. For example, the first proximal outer surface 311 may be positioned around the first recess 331. The second distal outer surface 312 may be positioned around the second recess (for example, the second recess 232 shown in Figure 3C). In various embodiments, the ratio of the first width of the proximal portion 307 (for example, measured at opposing positions on the first proximal outer surface 311) to the second width of the first distal portion 305A (for example, measured at opposing positions on the second distal outer surface 312) can be in the range of 1.2 to 2, 1.2 to 1.8, 1.25 to 1.8, 1.3 to 1.75, 1.3 to 1.7, or 1.3 to 1.6. Such a ratio of the first width to the second width can beneficially perform the bone-filling function for fixing the anchor 302 to the humerus.
[0071] In the illustrated embodiments, as described above, both the first surface and the second surfaces 311, 312 can perform bone filling functions, and for example, the widths of the first surface and the second surfaces 311, 312 can be made large enough to fill the anchor 302 and fix the anchor 302 to the humerus. In some embodiments, the first proximal outer surface Surface 311 may be tapered inward. In other embodiments, the first outer surface 311 may include a linear or substantially cylindrical surface. The first outer surface 311 may form a right cylinder relative to the proximal end 339 of the humeral anchor 303. In other words, the first outer surface 311 extends perpendicularly to the plane containing the proximal end 339 of the anchor 303. In other embodiments, the first outer surface 311 may be tapered inward. Surface 311 may be oriented at an angle of 5 degrees from the perpendicular from the plane containing the proximal end 339 of the anchor 303. Surface 311 may be oriented at an angle between 1 and 10 degrees from the perpendicular from the plane containing the proximal end 339 of the anchor 303. In various embodiments, the second distal surface 312 may include a linear or substantially cylindrical surface. For example, surface 312 may also be oriented perpendicularly to the plane containing the proximal end 339 of the anchor 303. In other embodiments, the second outer surface 312 may be tapered inward. For example, the second surface 312 may be oriented at an angle of 5 degrees from the perpendicular from the plane containing the proximal end 339 of the anchor 303. The surface 312 may be oriented at an angle between 1 and 10 degrees from the perpendicular from the plane containing the proximal end 339 of the anchor 303.
[0072] As explained above in relation to Figures 3 to 3C, the fin 309 of the second distal section 305B can extend distally from the first distal section 305A to the distal end of the humeral anchor 303. Fin length l f The fin can be made long enough to reduce, minimize, or eliminate the rotation of the anchor 303 within the metaphysis when a load, such as torque, is applied to the joint component connected to the anchor. In various embodiments, for example, the length of the fin l fThis could be at least 10% of the total first length l1 of the humeral anchor 303, at least 11% of the total first length l1 of the humeral anchor 303, at least 20% of the total first length l1 of the humeral anchor 303, at least 24% of the total first length l1 of the humeral anchor 303, at least 28% of the total first length l1 of the humeral anchor 303, at least 29% of the total first length l1 of the humeral anchor 303, at least 30% of the total first length l1 of the humeral anchor 303, at least 31% of the total first length l1 of the humeral anchor 303, at least 33% of the total first length l1 of the humeral anchor 303, or at least 34% of the total first length l1 of the humeral anchor 303. In various embodiments, the length lf of the fin is in the range of 8% to 40% of the first length l1 of the entire humeral anchor 303, in the range of 10% to 40% of the first length l1 of the entire humeral anchor 303, in the range of 11% to 40% of the first length l1 of the entire humeral anchor 303, in the range of 20% to 25% of the first length l1 of the entire humeral anchor 303, in the range of 25% to 35% of the first length l1 of the entire humeral anchor 303 The radial projection 306 may be in the range of 20% to 40% of the overall first length l of 3, in the range of 20% to 35% of the overall first length l of humeral anchor 303, in the range of 24% to 40% of the overall first length l1 of humeral anchor 303, in the range of 30% to 40% of the overall first length l1 of humeral anchor 303, in the range of 8% to 35% of the overall first length l1 of humeral anchor 303, or in the range of 30% to 35% of the overall first length l1 of humeral anchor 303. Furthermore, one or more radial projections 306 may extend radially laterally from humeral anchor 303. As shown in the figure, for example, the radial projection 306 may extend laterally from the second distal surface 312. The radial projection 306 can reinforce the connection of humeral anchor 303 to the humerus. The radial projection 306 may be tapered inward and distally, as shown in the figure.
[0073] Figure 4B is a bottom view of the stemless humeral anchor 303 of Figure 4A. In the embodiment of Figure 4B, the anchor 303 may include three fins 309A, 309B, and 309C. As shown in Figure 4B, fin 309C may be oriented along the downward direction I. Fin 309A may be oriented obliquely so as to have directional components along the anterior direction A and the upward direction S, respectively. Fin 309B may be oriented obliquely so as to have directional components along the posterior direction P and the upward direction S, respectively. As illustrated, fins 309A to 309C can be positioned, for example, at equal intervals of approximately 120°. The downward I, upward S, anterior A, and posterior P directions correspond to the directions of the patient's humerus when any of the anchors 303, 403, or 503 is applied. Yes. During transplantation, the clinician can orient the humeral anchor 303 in this manner and insert the anchor 303 into the humerus in the orientation shown in the illustration. In this orientation, the anterior-superior and posterior-superior fin orientations increase the surface area facing the direction that is susceptible to lateral tilting forces (tilt-out forces), which may beneficially improve the fixation of the implant to the humerus.
[0074] Figures 4C to 4C-2 show another example of a stemless humeral anchor 403 in which the fin structure extends along the entire length of the anchor 403. Figure 4C is a side view of the anchor 403. Figure 4C-1 is a top view of the anchor 403. Figure 4C-2 is a side cross section of the stemless humeral anchor 403 taken along the cross section 4C-2---4C-2 of Figure 4C-1. Unless otherwise noted, the components of Figures 4C to 4C-2 may be the same as or generally similar to the components of similar numbering in Figure 4A, and the reference numbers are increased by 100 compared to the reference numbers in Figure 4A. For example, as in Figure 4A, the anchor 403 of Figures 4C to 4C-2 includes a distal fin 409 extending from the first distal section 405A to the distal end of the anchor 403. Furthermore, the anchor 403 includes a radial projection 406B extending radially outward from the second distal surface 412. In addition, the anchor 403 may further include a radial projection 406A extending radially outward from the first proximal surface 411. The projections 406A and 406B may be tapered inward and distally. In the illustrated embodiment, the projections 406A and 406B may further be formed to define a continuous surface with respect to each other and together with the fin 409. For example, as shown in Figures 4C and 4C-2, the fin 409 and the projections 406A and 406B may cooperate to define a radially and distally extending fin structure having a common outer rib 418. As shown, the fin 409 and the projections 406A and 406B may have rounded edges. The radially and distally extending fin structures may extend from the collar 438 at the proximal end 439 of the anchor 403 to the distal end of the anchor 403, for example, to the distal end of the fin 409. Beneficially, the use of the elongated fin structures shown in Figures 4C to 4C-2 allows for improved fixation of the anchor 403 to the humerus.
[0075] Figure 4D shows another example of a stemless humeral anchor 503. Unless otherwise noted, the components of Figure 4D may be the same as or generally similar to the similarly numbered components of Figures 4A to 4C-2, with the reference numbers incremented by 100. In the embodiment of Figure 4D, the first outer surface 511 and the second outer surface 512 may include cylindrical surfaces having vertical sidewalls, for example, sidewalls perpendicular to the collar 538 at the proximal end 539 of the anchor 503. The width of the proximal portion 507, which can be at least partially defined by the first outer surface 511, may have a first width. The width of the first distal portion 505A, which can be at least partially defined by the second outer surface 512, may have a second width that is smaller than the first width. In various embodiments, the second width may be in the range of about 0.5 mm to about 4 mm, about 1 mm to about 3 mm, or about 1.5 mm to about 2.5 mm, and may be smaller than the first width by, for example, only about 2 mm.
[0076] Figure 4D-1 is a side view of a humeral anchor 603 according to another embodiment. The humeral anchor 603 may be substantially similar to the humeral anchor 503 in Figure 4D. For example, the anchor 603 may have a fin structure extending from the collar 638 of the proximal end 639 to the distal end of the anchor 603. Furthermore, the proximal portion 607 and the first distal portion 605A may have a straight cylindrical shape. In the embodiment of Figure 4D-1, a porous material 649 may be provided on at least a portion of the fin structure. For example, in the illustrated embodiment, the porous material 649 may be provided along radial projections 606A, 606B in addition to the outer surfaces 611, 612 of the proximal portion and the first distal portions 607, 605A. The porous material 649 may be provided to promote the infiltration of bone tissue into the radial projections 606A, 606B. In other embodiments, the porous material 649 may also be provided on the fins 609.
[0077] Figure 4E is a schematic side view of a stemless humeral anchor 703 according to another embodiment. Unless otherwise noted, the components of Figure 4E may be the same as or generally similar to the similarly numbered components of Figure 4D-1, with the reference numbers incremented by 100 compared to the reference numbers in Figure 4D-1. In the embodiment of Figure 4E, multiple teeth 719 may be provided on the first proximal surface 711 and / or the second distal surface 712. In various embodiments, multiple teeth 719 may be provided on each of the first and second surfaces 711, 712. In other embodiments, teeth 719 may be provided on only one of the first and second surfaces 711, 712. As shown, each of the teeth 719 may include a proximal-facing face, surface, or range. The teeth 719 may assist in fixing the anchor 703 to the humerus. In various embodiments, the teeth 719 may be made of metal. Figure 4E shows that the teeth 719 may include one or more arcuate projections positioned around one or both of the surfaces 711, 712. In some embodiments, the teeth 719 may include annular projections. The teeth 719 may include larger structures on the proximal side and smaller structures on the distal side. The teeth 719 may include multiple aligned annular structures, e.g., two, three, four or more annular projections, on one and / or both of the surfaces 711, 712. One or more or all of the teeth 719 may present a proximal-oriented surface that engages with bone material and resists the anchor 703 from shifting outward from the humerus under expected working loads.
[0078] Figure 4F is a schematic side view of the humeral anchor 803 according to another embodiment. Figure 4F-1 is a schematic bottom view of the stemless humeral anchor 803 of Figure 4-F. Unless otherwise noted, the components of Figures 4F to 4F-1 may be the same as or generally similar to the similarly numbered components of Figure 4E, with the reference numbers incremented by 100 compared to the reference numbers in Figure 4E. Unlike the embodiment in Figure 4E, in Figures 4F to 4F-1, the anchor 803 includes four fins 809A, 809B, 809C, and 809D. Fin 809A may be oriented obliquely to the anatomical structure so as to have directional components along the anterior direction A and the superior direction S. Fin 809B may be oriented obliquely to the anatomical structure so as to have directional components along the posterior direction P and the superior direction S. Fin 809C may be oriented obliquely to the anatomical structure so as to have directional components along the posterior direction P and the inferior direction I. Fin 809D can be oriented obliquely to the anatomical structure so that it has directional components along the anterior direction A and the downward direction I, respectively. As shown in the figure, fins 809A to 809D can be arranged at equal intervals, for example, of approximately 90°. The configuration of anchor 803 is advantageous in that it provides one-third more surface area for engagement with the cancellous bone of the metaphysis of the humerus to which anchor 803 is applied. In addition, all four fins 809A to 809D are positioned to resist tilt-out forces in directions susceptible to such forces. In this way, by just one-third increase in the number of fins, the tilt-out resistance can be approximately doubled compared to the anchor configuration and orientation shown in Figure 4B.
[0079] Figure 4 is a side view of a humeral anchor 903 according to various embodiments. Unless otherwise noted, the components shown in Figure 4G may be the same as or generally similar to the components of the same number in Figures 4A to 4F-1, with the reference numbers incremented by 100 compared to Figures 4F to 4F-1. In the embodiment of Figure 4G, the first distal section 905A may be smaller than the bowl-shaped first distal sections 505A and 605A in Figures 4D to 4D-1. The proximal section 907 and the first distal section 905A may include a straight cylindrical shape with a wall perpendicular to the collar 938 at the proximal end 939 of the anchor 903. The width of the proximal section 907 may be at least 1 mm, at least 1.5 mm, or at least 2 mm greater than the width of the first distal section 905A. The narrowness of the first distal section 905A increases the area of the fin 909 that is in direct contact with the bone material at the location of the distal section 905A when the anchor 903 is implanted. The anchor 903 in Figure 4G can constitute a bone-preserving stemless anchor in which the distal section 905A of the distal portion 905 is narrower than that of the distal portions of other anchors disclosed herein. By narrowing the distal section 905A, the surface area of the fin(s) 909 used can be increased. This may make it possible to increase the surface area in which fin 909 contacts the bone, thereby making anchor 903 less susceptible to the effects of lever-out forces or other loads that could cause anchor 903 to detach.
[0080] On the other hand, the size of the distal section 905A can be made large enough to accommodate the distal extension portion 163B of the connector 168. In some embodiments, the width or size of the distal section 905A may be slightly larger than the width of the distal extension portion 163B among the multiple sizes of anchors 903 in the kit. As described above, some kits may provide multiple sizes of stemless anchors 903. In various embodiments, the widths of the proximal 907 and distal 905 (e.g., outer surfaces 911, 912 and fins(s) 909) of anchors 903 in the kit may be varied to fit within different sized bone structures, while the width of the second recess or distal recess (a recess similar to the second recess 232) may be approximately the same (or slightly different) for each size of anchor 903 in the kit. In some embodiments, the width of the second recess or distal recess of each anchor 903 in the kit may differ from the width of a particular anchor 903 in the kit by less than 15%, less than 10%, less than 5%, or less than 1%.
[0081] In the embodiment shown in Figure 4G, the ratio of the first width of the first proximal recess (a recess similar to the first recess 231) to the second width of the second distal recess (a recess similar to the second recess 232) may be in the range of 2:1 to 3.25:1, 2.2:1 to 3.1:1, or 2.25:1 to 3:1. As described above, in some embodiments, the width of the second distal recess of each anchor 903 in the kit may be approximately the same or slightly different. The first width of the first proximal recess of the anchors 903 in the kit may differ such that the ratio of the first width of the first proximal recess (a recess similar to the first recess 231) of the largest anchor 903 in the kit to the first width of the first proximal recess of the smallest anchor 903 in the kit falls in the range of 1.2 to 1.5, 1.25 to 1.45, or 1.3 to 1.4.
[0082] B. Example of a humeral anchor with a stem. In some patients, it is preferable to strengthen the fixation of the humeral implant within the humerus H, or to fix it in an alternative manner. This is because the bone quality of the metaphysis M may not provide sufficient tilt-out performance with a stemless anchor, or sufficient integration with the bone may not be expected. Therefore, an anchor with a distal portion fitted to reach the diaphysis D of the humerus H may be a good option for the patient.
[0083] Figure 5 shows an example of a humeral stem 1190 having a distal portion that can reach the diaphysis D of the humerus H. Positioning the humeral stem 1190 can be difficult. For example, it may be desirable for the lateral surface of the proximal end of the humeral stem 1190 (upper left in Figure 5) to abut, engage, or contact the cortical bone Co layer. This can bring about the expected performance of the humeral stem 1190 on the humerus H. On the other hand, the medial surface of the proximal end of the humeral stem 1190 (upper right in Figure 5) may be spaced apart from the cortical bone Co due to the non-circular shape of the resected humerus H. More specifically, the distance from the upper lateral edge to the lower medial edge of the resected portion may be greater than the diameter of the metaphysis of the humeral stem 1190 at its proximal end. Therefore, a portion of the cancellous bone Ca at arrow A is not engaged by the humeral stem 1190 and will be exposed after the implantation of the humeral stem 1190. The cancellous bone Ca at the position of arrow A may be compressed to some extent by the method of inserting the humeral stem 1190 (described further later), but the unengaged state of the cancellous bone Ca at this position may lead to unfavorable processes such as stress shielding that can result in bone resorption.
[0084] Figures 6A to 6M show various examples of humeral stems 1200 that can be transplanted to a resected humerus H. The humeral stem 1200 consists of multiple stemmed humeral anchors 113. One of these may be provided in kit 100. Any one or more of the mechanisms of the humeral stem 1200 may be incorporated into the humeral stem 1190 which may be provided in kit 100.
[0085] Figure 6A shows that the humeral stem 1200 includes a metaphysis 1202 and a diaphysis 1204. The metaphysis 1202 is configured to be positioned at the metaphysis M of the humerus H, and the diaphysis 1204 is configured to be positioned at the diaphysis D of the humerus H (see Figure 5). The metaphysis 1202 has a larger area than the diaphysis 1204 in any cross-section. The metaphysis 1202 is generally configured to occupy a large volume of the metaphysis M, similar to the structure of the stemless anchor described above. In some cases, the metaphysis 1202 has a total volume equal to or greater than that of the corresponding size stemless implant in Kit 100. The diaphysis 1204 may be tapered so that its periphery matches the shape and volume of the intramedullary canal of the humerus H and fits generally. At least the metaphysis 1202 has a cancellous bone contact surface 1206. The cancellous bone contact surface 1206 may include a portion of the outer surface of the humerus stem 1200 that is arranged and configured to contact the cancellous bone Ca and provide a function to produce a desired result or preserve the cancellous bone Ca between the humerus stem 1200 and the cancellous bone Ca. In some cases, the cancellous bone contact surface 1206 includes a porous section 1208 configured to provide or promote intraosseous growth in the humerus stem 1200. The porous section 1208 may be a texture or surface having pores of a size that promotes the growth of bone material in or on it. The cancellous bone contact surface 1206 may include a cancellous bone compression member 1210 configured to reduce or minimize the effect of stress shielding.
[0086] Figure 6B shows proximal and medial aspects of the humeral stem 1200. This aspect includes an articular joint portion 1212. The articular joint portion 1212 is a portion to which an articular body, such as a reverse shoulder implant articular body, can be connected. As will be described in more detail below, the articular joint portion 1212 may include a mechanism for accommodating and engaging the shape of such an articular body, as will be described further below. The articular joint portion 1212 may be located at the proximal end of the humeral stem 1200. The articular joint portion 1212 may include a marking to guide the surgeon when oriented the articular insert. The humeral stem 1200 may also include a tooling portion 1213. The tooling portion 1213 may be a hole similar to the blind hole 245 described above in relation to the stemless humeral anchor 203. In some cases, the kit 100 includes tools that can be used with both the humeral stem and the stemless anchor, as will be described later in relation to Figures 7 to 20. In such a kit 100, the tool connection portion 1213 can be made identical to the humeral stem 1200 and the stemless implant described above in relation to Figures 3A to 4G.
[0087] After the humeral stem 1200 is implanted in the humerus H, if the progress is satisfactory, the stem will be held in place within the humerus H. The anti-rotation member 1214 shown in Figures 6A and 6B can reduce the movement of the humeral stem 1200 in the humerus H, specifically the rotation of the distal portion 1216 of the humeral stem 1200 around its longitudinal axis 1222. The anti-rotation member 1214 may be positioned at the metaphysis 1202. The anti-rotation member 1214 may extend along the metaphysis 1202 toward the diaphysis 1204. Figure 6A shows that the humeral stem 1200 may have a porous portion that generally corresponds to the metaphysis 1202 and a smooth portion that extends from the distal end 1218 toward the metaphysis 1202. The anti-rotation member 1214 may include a first portion extending into the porous portion and a second portion in the smooth portion. The anti-rotation member 1214 may extend continuously from the porous metaphysis 1202 to the transition region between the metaphysis 1202 and the diaphysis 1204.
[0088] Figure 6B shows that the anti-rotation member 1214 may protrude from the sections before and after the volume reduction. These sections may be configured as proximal extended longitudinal grooves capable of accommodating the volume of the humerus preserved beneath the resection surface. These sections are formed by the anti-rotation member 121 From 4 toward the lateral half of the humeral stem 1200, it can be seen as a recessed contour on the inner half of the humeral stem 1200 body. This anterior and posterior section preserves the bone of the humerus compared to a configuration without longitudinal grooves, for example, a configuration in which the humeral stem 1200 is continuously convex in the region of the anti-rotation member 1214.
[0089] Figures 6A–6J further show that the humeral stem 1200 may include a distal portion 1216 extending proximally from the distal end 1218 along the longitudinal axis 1222. The distal portion 1216 is tapered inward along the longitudinal axis 1222 toward the distal end 1218 of the humeral anchor 1200. The humeral stem 1200 includes a proximal portion 1226. The proximal portion 1226 extends distally from the proximal end 1230 of the humeral anchor humeral stem 1200. The humeral stem 1200 includes an outer surface 1234. The outer surface 1234 in the proximal portion 1226 is expanded to occupy at least a large portion of the volume of the metaphysis of the humerus where the humeral anchor will be located. The outer surface 1234 at the distal portion 1216 can be elongated so as to fit into the intramedullary canal without substantial alteration. The outer surface 1234 may be partially porous and partially smooth.
[0090] The humeral stem 1200 includes a lateral surface 1238. The lateral surface 1238 is configured to be positioned adjacent to the cortical wall of the lateral portion of the metaphysis of the humerus. As will be further described below, the humerus may be modified by excision, reaming, and broaching to create space within it. In one approach, the lateral surface 1238 of the humeral stem 1200 is configured to be positioned adjacent to the medial surface of the lateral cortical wall or segment, e.g., the medial surface of the cortical layer. Such a configuration provides a consistent anatomical reference point in the humerus in several techniques. Such a configuration allows the medial surface 1242 to be consistently spaced away from the medial cortical wall. For example, the medial surface 1242, or the method of implanting the humeral stem 1200, may be configured so that the medial surface 1242 is spaced away from the medial cortical wall. By leaving this gap, it is possible to preserve the medial cortical wall so that when the humeral stem 1200 is applied to the patient, there is no possibility of the humeral stem 1200 penetrating the medial cortical wall.
[0091] Figures 6A and 6C provide further details of the cancellous bone compression member 1210 in various examples. The cancellous bone compression member 1210 may include a bone compression surface 1250. The bone compression surface 1250 may be located adjacent to or on the proximal end 1230 of the humeral anchor 1200. In one example, the bone compression surface 1250 is located around the medial surface 1242 of the proximal portion 1226. The bone compression surface 1250 may be located only around the medial surface 1242, for example, around a portion of the periphery of the proximal end 1230 that does not include the lateral surface 1238 of the humeral stem 1200. When implanted in the humerus, the cancellous bone compression member 1210 is configured to extend from the medial surface 1242 of the proximal portion to the cortical wall of the medial surface of the metaphysis of the humerus. Figure 5 shows a gap at arrow A between the medial surface of the humeral stem 1190 and the internal surface or internal wall of the cortical bone Co. The bone compression surface 1250 may be configured to fill the gap or space not filled by the humeral stem 1190. By closing the gap indicated by arrow A, it is possible to reduce, minimize, or even eliminate bone loss due to stress shielding. As a result, a more stable and long-lasting implant can be obtained, reducing, minimizing, or even eliminating revision surgery, which can cause psychological distress to elderly patients and may be unfeasible in some cases.
[0092] The bone compression surface 1250 may constitute the distally facing side surface of the flange 1258. The flange 1258 may extend laterally from the proximal end 1230 of the proximal portion 1226 of the humerus stem 1200. The shape of the outer circumferential surface of the flange 1258 may be any preferred shape. For example, the flange 1258 may have a circular outer circumferential surface 1266. The circular outer circumferential surface 1266 may have a radius corresponding to the radius of the outer surface of the proximal portion 1226 of the humerus stem 1200. The proximal end 1230 of the stem 1200 may have an annular surface with a circular shape. The radius of this circular shape can extend to the same outer position as the outer surface 1238 of the proximal portion 1226 adjacent to the annular surface. The radius of this circular shape can extend further inward than the inner surface 1242 of the proximal portion 1226 adjacent to the annular surface. This may provide the inner surface 1242 with an overhang configuration of the bone compression surface 1250, while the outer surface 1238 may have less or no bone compression surface at all. As a result of this configuration, the width of the bone compression surface 1250 may be tapered at at least one end, and possibly both opposing ends, from approximately 10 o'clock to approximately 2 o'clock, as seen in Figure 6C, until the bone compression surface 1250 is no longer present. In the illustrated embodiment, the bone compression surface 1250 is present on more than half of the periphery of the cancellous bone compression member 1210. The bone compression surface 1250 may be present in less than half of the peripheral edge of the cancellous bone compression member 1210, for example, only between the 8 o'clock and 4 o'clock directions in one example. The bone compression surface 1250 may be present in various widths around the entire periphery of the proximal end 1230, for example, in a smaller width on the lateral surface 1238.
[0093] In further examples, the structure of the cancellous bone compression member 1210 can be tailored to the patient. For example, in various embodiments, the patient's shoulder (e.g., the humerus and / or glenoid cavity) may be imaged during a preoperative imaging procedure. Based on the imaging performed preoperatively, the cancellous bone compression member 1210 can be molded to specifically fit the patient's anatomical structure. For example, in various embodiments, the cancellous bone compression member 1210 may be manufactured using various types of additive manufacturing techniques, such as three-dimensional (3D) printing. Image data representing the patient's cancellous bone structure may be sent to a 3D printing machine capable of manufacturing the cancellous bone compression member 1210 to substantially fit or match the patient's cancellous bone tissue. The member 1210 may have a shape that extends at least to the inner wall of the cortical bone layer. The member 1210 may have a shape that extends beyond the inner wall of the cortical bone layer. The member 1210 may be molded to conform to the shape of the periphery of the humerus at the resection surface. These configurations can be tailored to the patient to mitigate, minimize, or eliminate stress shielding and the resulting bone loss. Therefore, the various embodiments disclosed herein can beneficially provide patient-specific structures that improve the fit of anchors within the humerus.
[0094] Figure 6B shows that the humeral stem 1200 may have an annular surface 1274 positioned on the proximal surface 1278 of the humeral anchor. The flange 1258 may include a portion of the annular surface 1274 on the proximal surface 1278. In some cases, the flange 1258 includes a bone compression surface 1250 on one side and the annular surface 1274 positioned on the opposite side. The annular surface 1274 may include markers that help orient the joint component or assembly relative to the patient's humerus. The annular surface 1274 may include rotational orientation markers 1282 formed on or within the annular surface 1274 positioned on the proximal surface 1278 of the humeral anchor 1200. In the illustrated embodiment, the rotational orientation markers 1282 are numbers in the form of a clock face to indicate 12 discrete rotational positions. While this type of rotational orientation marker 1282 is intuitive, the markers may be fewer or more in number, letters, colors, or other markers, or combinations of markers. In some cases, the articular assembly or articular component that will be coupled to the humeral stem 1200 is asymmetrical in shape such that its rotational position relative to the humeral stem 1200 alters the biomechanics of the assembly. Markers on the annular surface 1274 can guide the surgeon when positioning the articular assembly or articular component, as will be further described below. In short, markers on the humeral stem 1200 (whether a test implant or a final implant) can be used to indicate the desired position during testing of a group of articular components or articular assemblies. The indicated orientation can then be reproduced when the final implant is first placed in the open joint cavity, before the final articular component or articular assembly is permanently connected to the humeral stem 1200.
[0095] Figures 6D to 6F show details of the proximal portion 1226, specifically the mechanism for connecting an articular component or articular assembly to the proximal portion 1226. The humeral stem 1200 includes a recess 1286 that extends distally from the proximal end 1230 of the humeral stem 1200 to the proximal portion 1226. The recess 1286 may be surrounded by an inner surface 1290 positioned around the recess 1286. The inner surface 1290 may be positioned adjacent to the proximal end 1230 of the humeral anchor 1200. The inner surface 1290 may be a circular wall facing toward the center of the recess 1286. The inner surface 1290 may include one or more mechanisms for engaging an articular component, such as a reverse polymer insert or an anatomical articular assembly. The inner surface 1290 may include a locking mechanism 1294 positioned on the inner surface 1290. The locking mechanism 1294, for example, the concave locking mechanism 1296A, is aligned with the bone compression surface 1250. The locking mechanism 1294 may have a structure similar to the locking mechanism described above in relation to the stemless humeral anchor 203 shown in Figures 3A-3C. In one embodiment, the locking mechanism 1294 includes a concave locking mechanism 1296 located on the inner circumferential surface 1290. The concave locking mechanism 1296 may be configured to provide an interlocking fit to or with an articular body, such as a reverse shoulder implant articular body. The concave locking mechanism 1296 may include a first concave locking mechanism 1296A and a second concave locking mechanism 1296B. The second concave locking mechanism 1296B is positioned opposite the first concave locking mechanism 1296A. In one embodiment, the first recessed locking mechanism 1296A and the second recessed locking mechanism 1296B are positioned on the medial and lateral parts of the humeral stem 1200, respectively.
[0096] The locking mechanism 1294 may include a convex locking mechanism 1298 located on the inner circumferential surface 1290. The concave locking mechanism 1298 may be spaced apart from the convex locking mechanism 1296. In one embodiment, the convex locking mechanism 1298 includes, for example, a first convex locking mechanism 1298A and a second convex locking mechanism 1298B located opposite the first convex locking mechanism 1298A, at front and rear positions. The convex locking mechanism 1298 may include an elongated fin 1299 projecting toward the concave 12986. The elongated fin 1299 may be configured to engage with the periphery of the articulated component, as will be further described below.
[0097] The external shape of the humeral stem 1200 can be configured to combine a snug fit at the diaphysis D of the humerus H with enhanced engagement with the bone at the metaphysis M of the humerus H. The distal portion 1216, for example, the diaphysis 1204, may include a circular periphery 1300 at a first position 1304 along the longitudinal axis 1222 of the humeral anchor 1200, adjacent to the distal end 1218, as shown in Figure 6I. The first position 1304 may be located along a length 1308. The length 1308 may have one or more circular peripheries located along the length 1308, for example, from the distal end 1218 to the first position 1304, or from the distal end 1218 beyond the first position 1304.
[0098] The shape of the humeral stem 1200 can change from a circular shape at or adjacent to the distal end 1218 to an oval periphery 1316 at a second position 1320 located between a first position 1304 and a proximal end 1230 of the humeral stem 1200, as shown in Figure 6J. The oval periphery 1316 may include a first dimension 1324 in the anterior-posterior direction and a second dimension 1328 in the medial-lateral direction. The second dimension 1328 is larger than the first dimension 1324. In one configuration, the oval shape at the second position 1320 can result in a circular periphery having the same radius as or greater than the radius at the first position 1304 on the lateral surface of the humeral stem 1200, for example, resulting in a second curved shape on the medial surface of the humeral stem 1200. For example, the second curved outer shape can have a smaller radius of curvature so that the medial surface of the humeral stem 1200 occupies more medially space when positioned on the humerus H than the lateral surface of the circular curve, or it can be a non-circular shape such as an ellipse or oval. The second position 1320 may be proximal to the first position 1304.
[0099] Figures 6E and 6L show that at least partially polygonal periphery 1332 may be provided at a third position 1336, further proximal to the second position 1320. The third position 1336 may be located between the second position 1320 and the proximal end 1230 of the humeral anchor 1200. The at least partially polygonal periphery 1332 may be oriented at an angle 1338 with respect to the longitudinal axis 1222 of the distal portion 1216 and positioned in a cross-section parallel to the proximal end 1230 of the humeral anchor 1200. The side surface of the at least partially polygonal periphery 1332 may include a portion 1332A having a smaller medial-lateral dimension from the widest anterior-posterior dimension to the lateral side surface of the periphery 1332, and a portion 1332B having a larger medial-lateral dimension from the widest anterior-posterior dimension to the medial side surface of the periphery 1332. Therefore, at the third position 1336, the humeral stem 1200 can extend further in the medial direction than in the lateral direction, and fill more volume. This is consistent with an approach in which the lateral surface of the humeral stem 1200 aligns with the projection of the intramedullary canal, and the medial surface protrudes medially to fill the more complex space defined between the lateral and medial cortical walls. It can be seen that the position of the recess 1286 is shifted medially to the widest part of the polygonal periphery 1332, at least partially.
[0100] Figures 6E and 6K show that a second, at least partially polygonal periphery 1354 may exist between the third position 1336 and the second position 1320. The periphery 1354 may be located at a fourth position 1358 between the second position 1320 and the proximal end 1230 of the humeral anchor 1200. The second, at least partially polygonal periphery 1354 may include curved convex sides configured to face outward. The second, at least partially polygonal periphery 1354 may include more anterior-posteriorly oriented sides 1342 located between the ends of portion 1332B. Between the fourth position 1358 and the second position 1320, the humeral stem 1200 can transition from a configuration in which its lateral portion has less curvature (e.g., is more curved) and its medial portion has greater curvature (e.g., is flatter than the lateral portion) (see Figure 6K) to a configuration in which its lateral portion has greater curvature (e.g., is flatter) and its medial portion has greater curvature (e.g., is more curved than the lateral portion) (see Figure 6L). This transition may primarily result from a change in curvature on the medial side, which reflects an increased amount of bone filling the medial side when the stem is maintained straight or in a vertical direction, for example, along the direction corresponding to the projection of the lateral medial cortical wall of the intramedullary canal.
[0101] The anti-rotation fin 1370 may be positioned along one or more sides of the humeral stem 1200. In one embodiment, the anti-rotation fin 1370 is positioned along the medial side of the humeral stem 1200. In one embodiment, the anti-rotation fin 1370 may be found on at least a partially polygonal periphery 1332 adjacent to the proximal end 1230. In one embodiment, the anti-rotation fin 1370 may be found on a second at least partially polygonal periphery 1354. In one embodiment, the anti-rotation fin 1370 includes a projection 1378 that may extend medially from a generally anterior-rear oriented side or portion of the second at least partially polygonal periphery 1354. The anti-rotation fin 1370 may extend continuously from at least a partially polygonal periphery 1338 at a third position 1336 to the second at least partially polygonal periphery 1354 at a fourth position 1358. The anti-rotation fin 1370 may appear as the humeral stem 1200 transitions from a generally rounded outer shape with a length 1308 extending proximally from the distal end 1218 to an inwardly extending configuration, for example, to at least a partially polygonal periphery between the first position 1304 and the proximal end 1230.
[0102] The anti-rotation fin 1370 is important for maintaining the stability of the humeral stem 1200 in the humerus H. The stability of the humeral stem 1200 is important to prevent implant dislocation, which in severe cases may require revision surgery, which is not the best option for the patient. This can lead to complications. Even if revision surgery is not necessary, displacement of the humeral stem 1200 can alter the biomechanics of the shoulder joint postoperatively. As described above, in some combinations, the joint components are joined to the humeral stem 1200 at a rotational position that provides a predetermined biomechanics. Rotation of the humeral stem 1200 relative to the humerus H changes the angle between the arm and the scapula, resulting in a deviation from the defined biomechanics. As a result, arm movement may become suboptimal, which can lead to scapular fatigue, injury, damage (e.g., avoidable scapular notching), and in extreme cases, the need for unwanted revision surgery.
[0103] Figure 6M is a side view of a humeral stem anchor 1400 having an extended distal portion providing a length L. Similar to the embodiments in Figures 6A to 6L, the anchor 1400 may include a proximal portion 1426 and a distal portion 1416. The distal portion 1416 may include an elongated stem 1404 extending from the proximal portion 1426. As described above, the proximal portion 1426 may include a locking or engaging mechanism common to the stemless and stemmed humeral anchors described above, so that the anchor 1400 can be used with anatomical joint components and reverse joint components. The anchor 1400 in Figure 6M may have a length L that is suitable for larger patients or patients with a greater degree of bone injury or intraoperative fracture. In various embodiments, the length L of the anchor 1400 in Figure 6M may be in the range of 120 mm to 200 mm, 130 mm to 180 mm, or 140 mm to 160 mm. Table 1 below shows examples of standard stem lengths, long stem lengths, and extra-long stem lengths.
[0104] IV. Methods and use of instruments for shoulder arthroplasty The humeral anchors described above can be implanted according to the methods described later in relation to Figures 7 to 21. These methods advantageously utilize certain tools and instruments that are interchangeable between stemless and stemmed anchors. This offers the advantage of requiring less training to complete the surgical procedure.
[0105] A. Method of transplanting a humeral anchor Figures 7 to 16 show a method for preparing the humerus H to accommodate the implant components and implant assemblies disclosed herein. This method can be used for bone of general hardness and bone quality.
[0106] In the initial part of this method, a resection step 1500 is performed. The resection step 1500 includes applying an intramedullary resection block assembly 1504 to the humerus H. The resection step 1500 may include an intramedullary rod 1506 that is advanced at the proximal end of the humerus H, for example, through the lateral portion of the articular surface of the humerus H. The intramedullary rod 1506 may have a depth stop 1508 located at its proximal end. The depth stop 1508 may be configured to limit the advancement of the intramedullary rod 1506 to a selected range. The intramedullary resection block assembly 1504 may also have a handle extending proximal to the depth stop 1508. The handle may have one or more markings and openings to assist in the process of positioning the intramedullary resection block assembly 1504, for example, aligning the assembly with the humerus H. The intramedullary resection block assembly 1504 may include a cross arm 1512 extending laterally from the handle. The cross arm 1512 can be positioned to rotate about the longitudinal axis of the intramedullary rod 1506. The intramedullary cutting block assembly 1504 may also include a boom 1516 extending from it to drill a hole in the cutting block 1520 at the appropriate position. For example, the cutting block 1520 can be suspended from the humeral anatomical neck of the humerus H. In some procedures, it is desirable to resect the humerus H at the anatomical neck to separate the articular surface of the humerus H from the rest of the humerus. Separating the articular surface from the rest of the humerus H creates a resection surface, for example, as shown in Figure 8.
[0107] In some cases, surgeons may prefer not to insert an intramedullary rod 1506 into the humerus H and may prefer to use an extramedullary cutting block assembly 1524. The amputation block assembly 1524 includes an amputation block 1520A similar to the amputation block 1520. The amputation block 1520A is supported from below by a mounting block member that can be pinned to, for example, the surface of the outer cortical wall of the diaphysis of the humerus H. The extramedullary amputation block assembly 1524 is advantageous in that there is no rod passing through the resection plane. The intramedullary amputation block assembly 1504 is advantageous in that it does not require drilling into any portion of the humerus H remaining after surgery.
[0108] Figure 8 shows that an optional protective step 1540 may be performed following the excision. In the protective step 1540, the excision surface formed in the excision step 1500 may be protected while the rest of the surgery progresses. Protecting the newly exposed cancellous bone Ca is important because this bone is to have a recess formed in a later part of this method, having an outer or outer surface and an inner contour that coincides with the distal surface of either of the anchors (e.g., the metaphysis of a stemless or stemmed anchor). The protective step 1540 can be performed by applying a protective tool 1542 to the excision surface to cover the cancellous bone Ca. The protective tool 1542 may include a protective plate 1544. The protective plate 1544 may have one or more, for example, two spikes 1548 extending from the bone-facing (distal or medial) side of the protective plate 1544. The spikes 1548 may be sufficiently sharp at their distal ends so that the spikes 1548 can be pressed into the cancellous bone Ca. The protective plate 1544 may include one or more, for example, two, operating openings 1552 located therein. In one embodiment, the operating openings 1552 may extend completely through the protective plate 1544. The operating openings 1552 can be grasped by a tool such as the scissor tool shown in Figure 13. Once the protection step 1540 is complete, other embodiments of the method may follow.
[0109] Figure 9 shows a resizing step 1572 that can be performed subsequently. The protective tool 1542 can optionally be removed before the resizing step 1572. In the resizing step 1572, the handle and measuring instrument assembly 1576 is positioned against the humerus excised with exposed cancellous bone Ca. The handle and measuring instrument assembly 1576 may allow for determination of which size of stemless humeral anchor 103 (or other anchors disclosed or claimed herein) should be used for a particular patient. For example, the handle and measuring instrument assembly 1576 may have numbers 1, 2, 3, or 4 on its surface, corresponding to four similarly labeled or numbered sizes. The handle and measuring instrument assembly 1576 preferably has an opening formed therein for arranging a guide pin 1580. The guide pin 1580 can be advanced through the opening of the handle and dimensional measuring instrument assembly 1576 into the cancellous bone Ca at the resection surface, and then advanced sufficiently deep into the humerus H to stabilize it for subsequent procedures.
[0110] Figure 9, the lower image, shows another example of the handle and dimension measuring instrument assembly 1576A. The handle and dimension measuring instrument assembly 1576A includes a head dimension measuring instrument 1584 and a handle 1588. The head dimension measuring instrument 1584 may have the same shape as an anatomical articular body, for example, with a convex surface facing away from the excision and a flat surface facing the excision. The head dimension measuring instrument 1584 may provide a very clear visual confirmation of how the anatomical head is positioned on the excision surface. The handle 1588 may include a projection 1590 that can be advanced into a lockable opening of the head dimension measuring instrument 1584. The connection between the projection 1590 and the lockable opening may be tightly fitted so that the handle 1588 can be inserted into and removed from the head dimension measuring instrument 1584 using simple hand force. The tight fit prevents the head measuring instrument 1584 from falling off the handle 1588, allowing the surgeon to place the head measuring instrument 1584 on the excised surface using the handle 1588 and remove it from the surface without the need for more complex tools such as a gripper. Sufficient holding force can be provided. The handle 1588 may have a concave lateral periphery that can be shaped to at least partially accommodate the convex curve of the surgeon's finger, making the handle 1588 comfortable and easy to grip. The handle 1588 may have a pin opening 1592 formed through it. The pin opening 1592 may have a length from the proximal side to the distal side of the handle 1588 via a projection 1590. This length may be sufficient to accurately guide the guide pin 1580 into the humerus H through the exposed cancellous bone Ca during resection.
[0111] After the pin is positioned, the handle and dimension measuring instrument assemblies 1576 and 1576A can be removed over the proximal end of the pin, leaving the pin in place.
[0112] Figure 10 shows a reaming step 1600 that may follow the excision step 1500. The reaming step 1600 is optionally performed on the guide pin 1580, and in some examples may follow a resizing step 1572 or another step in which the pin is positioned. After the reamer has advanced toward the bone, the reaming step 1600 can be used to form a recess or cavity C in the cancellous bone Ca of the humerus H exposed by the excision step 1500. The reaming step 1600 can create a stepped internal recess or cavity C in the metaphysis of the humerus H shaped to receive the humeral anchor portion, for example, a stemless anchor 103 or a stemmed anchor. The cavity C may include a first cavity or proximal cavity and a second cavity or distal cavity that extends to a greater depth into the bone than the first cavity. The distal cavity may have a reduced diameter compared to the proximal cavity. The cavity C may also include a stepped portion between the first and second portions of the cavity. The recess may be rotationally symmetrical so that, in some examples, the recess can be formed using a reamer assembly including a reamer head 1604 and a drive shaft 1608. The reamer head 1604 may also form a concave surface R below the bone excision surface P. The concave surface is proximal to the cavity C and may at least partially surround the cavity C. The concave surface R and the cavity C may be formed simultaneously (e.g., using a reamer head 1800) or sequentially (e.g., using reamer heads 1850A, B). The reamer head 1604 may be removably mounted on the drive shaft 1608 so that one of several sizes of the reamer head 1604 to be used with a common drive shaft 1608 can be selected. The size of the reamer head 1604 corresponds in some examples to the size determined in the resizing step 1572. One or both of the reamer head 1604 and the drive shaft 1608 are inserted so that the direction of reaming can be controlled by the orientation of the guide pin 1580.
[0113] Figures 10A and 10B show exemplary reamer heads that may be used in reaming step 1600.
[0114] Figure 10A shows a reamer head 1800 having a first end or proximal end 1802 and a second end or distal end 1804. The reamer head 1800 includes a drive shaft 1822 at the first end 1802. The drive shaft 1822 is configured to be detachably mounted to a drive unit. The drive unit is configured to rotate the reamer head 1800 around the axis X of the drive shaft to remove bone. The reamer head 1800 may also include an indicator 1808 located near the first end 1802. The indicator 1808 may indicate the size. Reamers of different sizes may correspond to anchors of different sizes. The indicator may be a color indicator, a numerical indicator, or other type of indicator.
[0115] The reamer head 1800 includes a proximal portion 1810 and a distal portion 1814. The proximal portion 1810 includes a proximal face 1824 of the reamer head 1800. The proximal face 1824 includes one or more openings 1826 that extend through the proximal face 1824 and can be seen by the surgeon during the procedure, so that the surgeon can visualize the bone area being reamed. The openings 1826 allow for isolation of the bone material from the reamer during reaming. The openings 1826 can also reduce the overall weight of the reamer head 1800. The proximal portion 1810 may include a depth stop 1836 configured to control the insertion depth of the reamer head 1800.
[0116] The proximal portion 1810 includes a distal opposing cutting edge 1812. The distal opposing cutting edge 1812 includes a plurality of teeth that extend circumferentially around the proximal portion 1810 of the reaming head 1800. The distal opposing cutting edge 1812 is configured to form a concave surface R with respect to the cutting surface P (see Figure 10). The depth stop 1836 may project radially outward from the distal opposing cutting edge 1812 so that the depth stop can be mounted on the cutting surface P when the distal opposing cutting edge 1812 forms the concave surface R.
[0117] The distal opposite cutting edge 1812 defines the inner circumferential surface 1830 and the outer circumferential surface 1828. The thickness of the concave surface R corresponds to the thickness of the distal opposite cutting edge 1812 measured between the inner circumferential surface 1820 and the outer circumferential surface 1828. The distal opposite cutting edge 1812 does not remove any material inside the inner circumferential surface 1820. When the anchor is implanted, the proximal end of the anchor (e.g., the proximal end 239 of anchor 203) is configured to be mounted on the concave surface R formed by the distal opposite cutting edge 1812.
[0118] The distal portion 1814 of the reamer head 1800 extends distally from the proximal portion 1810 of the reamer head 1800. The entire distal portion 1814 may be located within the inner circumferential surface 1820 of the proximal portion 1800. The distal portion 1814 forms a cavity C that extends distally from the concave surface R (see Figure 10). The cavity C is also located radially inward of the concave surface R.
[0119] As shown in Figure 10A, the distal portion 1814 includes a plurality of radial arms 1818 extending radially outward from the central region of the reamer head 1800. The plurality of radial arms 1818 may be spaced apart from each other in the circumferential direction. Each radial arm 1818 is defined by a first flat surface 1832 and a second flat surface 1834 opposite the first flat surface 1832. The first flat surface 1832 and the second flat surface 1834 are separated by a thickness. The widths of the radially measured flat surfaces 1832 and 1834 are greater than the thickness of each arm 1818. The thickness of each radial arm 1818 forms a lateral cutting edge 1820. The lateral cutting edge 1820 has a different outer shape from the distal cutting edge 1812. For example, the distal cutting edge 1812 may include multiple teeth or a serrated edge, while the lateral cutting edge 1820 forms a blade edge.
[0120] The distal portion 1814 may be configured to form a two-stage cavity C. As described above, the cavity C may include a proximal portion and a distal portion that extends deeper than the proximal portion. The two-stage cavity C is formed by the shape of the lateral cutting edge 1820. Each lateral cutting edge 1820 includes a proximal section defined by a first cutting edge 1820a. The first cutting edge 1820a may be parallel to the axis X of the drive shaft or may be angled. The first cutting edge 1820a forms the proximal portion of the cavity C.
[0121] The lateral cutting edge 1820 includes a distal section defined by the second cutting edge 1820b. The second cutting edge 1820b terminates with a sharp end at the second end 1804 of the reamer head 1800. The second cutting edge 1820b is positioned radially inward of the first cutting edge 1820a. The second cutting edge 1820b may be parallel to the drive shaft X or it may be angled. The second cutting edge 1820 is relative to the first cutting edge 1820a The cutting edges may be parallel or angled. The second cutting edge 1820b forms the distal portion of the cavity C.
[0122] The first cutting edge 1820a can be separated from the second cutting edge 1820b by a stepped portion 1820c. The stepped portion 1820c protrudes inward from the first cutting edge 1820a toward the second cutting edge 1820b. The transition between the first cutting edge 1820a and the stepped portion 1820c may form a rounded corner or a sharp corner. The transition between the stepped portion 1820c and the second cutting edge 1820b may form a rounded corner or a sharp corner. The stepped portion 1820c may form an annular ledge between the proximal and distal portions of the cavity.
[0123] The reamer head 1800 may include a guide channel 1816 configured to receive a guide pin. The guide channel 1816 may extend through the second end 1804 of the reamer head and be centered relative to the radial arm 1818.
[0124] Figure 10B shows another reamer head system configured to form the cavity C shown in Figure 10, but having a two-part configuration. The reamer head system includes a first reamer head 1850A and a second reamer head 1850B. The first reamer head 1850A and the second reamer head 1850B may include any of the mechanisms of the reamer head 1800. Each of the first reamer head 1850A and the second reamer head 1850B is configured to be detachably mounted to a drive unit. The drive unit is configured to rotate the reamer heads 1850A and 1850B around the axis X of the drive shaft to remove bone. Each reamer head 1850A and 1850B may be driven around a guide pin so that the direction of reaming can be controlled by the orientation of the guide pin.
[0125] The first reamer head 1850A is configured to form a concave surface R and the proximal portion of the cavity C (see Figure 10). As shown in Figure 10B, the first reamer head 1850A includes a proximal portion 1860 and a distal portion 1864. When in use, the first reamer head 1850A may be used first to form the concave surface R and the proximal portion of the cavity C. Subsequently, the second reamer head 1850B can be used to form the distal portion of the cavity C and the stepped portion between the proximal and distal portions of the cavity C.
[0126] The proximal section 1860 includes a proximal surface 1874. The proximal surface 1874 may include one or more openings 1876 extending through the proximal surface 1874 and visible to the surgeon during the procedure. The proximal section 1860 may include a depth stop 1886 configured to control the insertion depth of the reamer head 1850A. The proximal section 1860 also includes a distal opposite cutting edge 1862 configured to form a concave surface R with respect to the resection surface P (see Figure 10). The distal opposite cutting edge 1862 may have a similar shape to the distal opposite cutting edge 1812.
[0127] The distal portion 1864 of the first reamer head 1850A may be configured to form the proximal portion of the cavity C. The distal portion 1864 extends distally from the proximal portion 1860. The entire distal portion 1864 may be located within the inner circumferential surface of the proximal portion 1860. As shown in Figure 10B, the distal portion 1864 includes a plurality of radial arms 1868 extending radially outward from the central region of the reamer head 1850A. The plurality of radial arms 1868 may be spaced circumferentially from one another. Each radial arm 1868 forms a lateral cutting edge 1870a. The lateral cutting edge 1870a may be parallel to the axis X of the drive shaft or may be angled. Each radial arm 1868 may also include a distal edge 1870b extending radially inward from the lateral cutting edge 1870a. The distal edge 1870b may be planar with respect to the transverse axis perpendicular to the drive shaft axis X, or it may be angled. That's fine.
[0128] The second reamer head 1850B includes a proximal section 1861 and a distal section 1865. The proximal section 1861 includes a distal opposite cutting edge 1863. The distal opposite cutting edge 1863 includes a plurality of teeth configured to form an annular ledge between the proximal and distal sections of cavity C (see Figure 10A). The distal opposite cutting edge 1863 includes an inner circumferential surface and an outer circumferential surface. The diameter of the outer circumferential surface of the distal opposite cutting edge 1863 may be approximately the same as the diameter of the distal section 1864 of the reamer head 1850A.
[0129] The distal portion 1865 may be configured to form the distal portion of the cavity C. The distal portion 1865 extends distally from the proximal portion 1861. The entire distal portion 1865 may be located within the inner circumferential surface of the proximal portion 1861. The distal portion 1865 of the second reamer head 1850B may have a reduced diameter compared to the distal portion 1864 of the first reamer head 1850A. As shown in Figure 10B, the distal portion 1865 includes a plurality of radial arms 1869 extending radially outward from the central region of the reamer head 1850B. The plurality of radial arms 1869 may be spaced circumferentially from one another. Each radial arm 1869 forms a first lateral cutting edge 1871b, which may be parallel to or angled with respect to the axis X of the drive shaft. Each radial arm 1869 may also include a distal edge 1871b extending radially inward from a lateral cutting edge 1871b. The distal edge 1871b may be planar with respect to a transverse axis perpendicular to the axis X of the drive shaft, or it may be angled.
[0130] Figure 11 shows an optional brazing step 1900. The brazing step 1900 can be performed following the reaming step 1600 to more precisely form the recess formed in the reaming step 1600. For example, it is desirable that the humeral anchors disclosed herein (e.g., stemless anchor 103 or humeral stem 1200) be positioned in a controlled manner such that the collar or annular member (e.g., bone compression surface 1250) is flush with the resection surface or the prepared portion of the cancellous bone below it, and that the fin(s) (e.g., fin 309) can be easily implanted in the humerus. If the shape of the recess is only somewhat similar to the shape of the outer surface of the anchor, and / or if the shape of the recess does not accommodate the outer surface of the fin, the anchor may not be flush with the humerus. Furthermore, without a pathway for inserting the fin(s), it may be difficult to reliably embed the fin(s) in the humerus. In the brazing step 1900, the blazer 1904 and stem impactor inserter 1908 are used to compress the cancellous bone exposed in the reaming step 1600 so that the shape of the wall around the recess in the humerus H matches the shape of the anchor outer wall at its metaphysis. Furthermore, the blazer 1904 can form a pathway or channel into which a fin(s) can be inserted. The blazer 1904 can also function as the body in which the test anchor is placed.
[0131] The blazer 1904 may be very similar to an anchor intended to be prepared to accommodate a recess in the humerus H. For example, it may have the same outer surface as the anchor. The blazer 1904 may also have the same tooling connection portion so that the stem impactor inserter 1908 can be used for the brazing step 1900 and for pressing the anchor into the humerus H, as will be described later in relation to Figure 14. The stem impactor inserter 1908 will be described in more detail below, but generally, the stem impactor inserter 1908 may have one or more impact heads. If multiple impact heads are provided, the stem impactor inserter 1908 may allow the surgeon to use a single tool for the brazing step 1900, regardless of whether the surgeon prefers a stemless or stemmed implant. Reducing the number of tools provided to the surgeon is effective, as will be described in more detail below. This results in increased efficiency and cost-effectiveness, as well as a reduction in waste and costs in the provision of this healthcare service.
[0132] Following the brazing step 1900, a planing step 2100 may be optionally performed. The planing step 2100 allows for improvement of the shape of the remaining excised surface formed in the excision step 1500, for example, the excised portion between the anchor recess in the excision and the cortical bone forming the outer wall of the humerus H. The planing step 2100 can remove any high points on the excised surface that may interfere with the placement of the articular body at the humeral anchor, as will be described later. The planing step 2100 incorporates a planer 2104. The planer 2104 is configured to fit with the blazer 1904 and be attached to the drive shaft 1608. An outwardly extending arm with distally extending teeth can be rotated around the blazer 1904 at or just below the height of the excision formed in the excision step 1500. Such rotation allows the remaining excised periphery to be given a more planar shape, free from high points that may interfere with the connection between the anchor and the articular body.
[0133] Figure 13 shows that after the humerus H has been prepared, the method can proceed to test step 2150. Test step 2150 can use a test anchor 2154, which can be positioned using the stem impactor inserter 1908 as described above. The test anchor 2154 can be more easily detached from the test head assembly 2158 (for anatomical reconstruction) or the test insert assembly 2162 (for reverse-type structures) than in the case of the final implant. Test step 2150 may allow the surgeon to select or confirm the size to be used for the final implant. Test step 2150 may allow the surgeon to find the appropriate level of eccentricity to the extent that the implant can be adjusted by the eccentric connector or connection mechanism. The eccentric connector 168 can be used to center the rotation of the resection or to provide an eccentric position from there. The level of eccentricity can be confirmed by referring to the markings formed on the proximal surface of the anchor (whether it be a humeral stem 1200 or stemless anchors 103, 203, 303, or 503). Once the final implant size, configuration, and / or orientation are confirmed, the method can proceed to the final implantation.
[0134] Figure 14 shows the stem impactor inserter 1908 coupled to the stemless anchor 103. As shown in the figure, the stem impactor inserter 1908 can be coupled to any of the other stemless anchors 203, 303, or 503. Furthermore, the stem impactor inserter 1908 can be coupled to the humeral stem 1200 at the surgeon's direction. For example, by using a common instrument, the surgeon can determine during the procedure that the stemless anchor 103 is unsuitable and then quickly switch to the humeral stem 1200, followed by any additional preparation of the humerus H to prepare the humerus for receiving the humeral stem 1200.
[0135] In the case of the stemless anchor 103, the stem impactor inserter 1908 can grip the anchor in its recess by engaging with a tool connection portion, for example, a blind hole 245. The anchor 103 can then be moved into the recess formed in the humerus H and pressed against the prepared surface. An impactor, for example a mallet, can then be used to apply a load to the impact head at the proximal end of the stem impactor inserter 1908, along its longitudinal axis. Thus, the load can be directed laterally, for example, approximately perpendicular to the plane of the resection surface formed in the resection step 1500.
[0136] In the case of a humeral stem 1200, the stem impactor inserter 1908 is used. The anchor can be gripped in its recess by engaging with the tool connection portion 1213, which may include blind holes of the same configuration as those found in the Mules anchor 103. The distal end 1218 of the humeral stem 1200 can be inserted through a recess formed in the resection surface and further into the intramedullary canal. When the diaphysis 1204 is within the diaphysis of the humerus H and the metaphysis 1202 is within the metaphysis of the humerus, it is possible to apply an impact load to the stem impactor inserter 1908. Specifically, an impactor, such as a mallet, can strike an impact head positioned adjacent to the distal end of the stem impactor inserter 1908, which drives the humeral stem 1200 to firmly engage with the humerus H along roughly the axis of the diaphysis 1204 of the humeral stem 1200.
[0137] Therefore, the insertion step 2180 can be performed using the same impactor instrument, such as the stem impactor inserter 1908, for both stemless implants such as the anchor 103 and stemmed implants such as the humeral stem 1200.
[0138] Figure 15 shows the impact step 2200 following the insertion step 2180. The impact step 2200 includes pressing the anatomical assembly into the stemless anchor 103 (or another stemless anchor 203, 303, 503). As described above, the kit 100 includes a common implant component. Therefore, the impact step 2200 can be the same for the humeral stem 1200 as it is for the stemless anchor 103. The impact step 2200 may include positioning the connector 168 adjacent to the anchor 103. The connector 168 may be a centric or eccentric connector. An eccentric connector may have a mechanism that provides a visual guide regarding the rotational position of the connector 168 relative to the anchor 103. The same position can be reproduced in the impact step 2200 within the range in which the test step 2150 showed a preferred eccentric rotational position. Specifically, in the test step 2150, the connector 168 can be rotated and positioned using visual cues. The anatomical articular body 164 can then be positioned on the connector 168, and both the anatomical articular body 164 and the connector 168 can be pressed onto the anchor 103. The same step can be performed with the humeral stem 1200, aligning the connector 168 with a mark on the proximal surface of the humeral stem 1200. The head impactor 2204 can be subjected to impact loads using a mallet or other tool.
[0139] Figure 16 shows impact application step 2250, which is similar to impact application step 2200 except that impact application step 2250 is used for a reverse articular body 180. The reverse articular body 180 can be aligned with the stemless anchor 103 (or, in modified cases, with the humeral stem 1200). In some cases, the reverse articular body 180 can be made asymmetrical so that rotating the reverse articular body 180 can result in a change in the position of the center of the articular surface of the reverse articular body 180. If the test step 2150 indicates that a particular rotational position is desirable for the reverse articular body 180, the surgeon rotates the reverse articular body 180 to that position before applying an impact load to the reverse insertion impactor 2254. The reverse-type insertion impactor 2254 may be identical to the head impactor 2204, except that the distal surface of the reverse-type insertion impactor 2254 has a convex shape and the distal end of the head impactor 2204 has a concave shape.
[0140] Typical patients can benefit from the methods described in relation to Figures 7–16, but Figures 17–20 show techniques for other patients. Figures 17–18 show one approach for patients with bone material harder than usual. This method can be performed with a drilling step 2300 following the excision step 1500 and the resizing step 1572. The drilling step 2300 can benefit from the placement of guide pins 1580. The drill head 2304 can be advanced above the guide pins 1580. Drill head 2304 may have a smaller and more rigid external shape than reaming head 1604. Drill head 2304 can form a starter hole 2308 in the cancellous bone distal to the excision formed in excision step 1500. The starter hole 2308 can be centered on the guide pin 1580 and may have a smaller volume than the final volume to be prepared, for example, about 10-25 percent of the final volume to be prepared. Following the preparation of the starter hole 2308, a larger hole closer to the final size can be formed in progressive reamer step 2350. Progressive reamer step 2350 may use an initial reamer 2354 having a smaller reamer head than reaming head 1604. Due to its smaller size, the initial reamer 2354 can be more rigid than reaming head 1604. Furthermore, if the initial reamer 2354 is tasked with removing a smaller volume of bone than the reaming head 1604, bone resistance can be reduced. The progressive reaming step 2350 can gradually increase the size of the distal recess of the resection using multiple intermediate reamers that are between the size of the initial reamer 2354 and the reaming head 1604 until the recess is of an appropriate size for the step following the reaming step 1600 in the process flow described above.
[0141] Figures 19-20 illustrate an example of treating a patient with softer-than-normal bone. In the color reaming step 2400, the surgeon can form an annular channel 2412 in the resected humerus H. The annular channel 2412 is located in the position of the outermost reamed area that would have been formed in the reaming step 1600, and can be the size of that area. The surface formed in the color reaming step 2400 is generally configured to mate with the bone compression surface 1250 and / or with the collars of stemless anchors 103, 203, 303, 503. A color reamer 2404 may be provided to form the annular channel 2412. The color reamer 2404 may be similar to the reaming head 1604, but can omit the medial and distal cutting mechanisms while retaining the annular reaming teeth 2408. As a result, the color reamer 2404 leaves the region of the cut surface located radially inward of the annular channel 2412 generally unaffected or unexpanded. After the annular channel 2412 is prepared, a compression step 2420 can be performed. The compression step 2420 may be similar to the brazing step 1900 in that the process involves axially pushing a compressor 2422 into the cancellous bone inside the annular channel 2412. The compressor 2422 may include a depth stop 2424 configured to abut against the annular channel 2412 when the compressor 2422 is fully inserted. The depth stop 2424 may include a tab or flange on the opposite side of the periphery of the proximal end of the compressor 2422. In some embodiments, the depth stop 2424 may extend entirely around the proximal end of the compressor 2422. The compressor 2422 may have a compression profile 2428 that protrudes from the distal side of the depth stop section 2424 to the distal end of the compressor 2422. This compression profile 2428 can create a compression recess that is close in volume to the recess obtained from the reaming step 1600, for example, a compression recess that is slightly smaller than the blazer 1904 so that the brazing step 1900 can complete the formation of a recess for receiving the test anchor 2154 in the process flow described above.In another example, the compression outline 2428 is roughly the same as the outline of the blazer 1904, so that the compression step 2420 can be considered as combining the preparation of the medial region achieved by the excision step 1500 with a single compression step with the brazing step 1900. The cartilage patient method can then proceed with the examination step 2150 and the remaining steps specified above.
[0142] B. Dual-purpose surgical instruments As described above, one advantage of the various kits and systems disclosed herein is that multiple different types of humeral anchors can be implanted using a common instrument. An example of the use of a common instrument is described below.
[0143] 1. Stem and stemless impactor inserter As described above, stemmed and / or stemless bone anchors may include one or more connecting mechanisms, such as blind holes, configured to engage with a tool and allow insertion of the bone anchor (e.g., a stemless or stemmed humeral anchor) into the bone. Figures 11A–11D show an inserter 2500 configured to position a stemmed and / or stemless bone anchor in the bone. As will be described in more detail below, the inserter 2500 is configured to receive impact forces, for example, from a mallet, in order to properly insert the bone anchor into the bone. The proximal surface of the bone anchor receives most of the impact force through direct contact with the distal surface 2503 of the inserter 2500.
[0144] The inserter 2500 may include an elongated body 2505. The elongated body 2505 may generally extend from a first end or proximal end 2502 to a second end or distal end 2504 of the inserter 2500. The elongated body 2505 may include a connection mechanism 2514 at the second end 2504 of the inserter 2500. The connection mechanism 2514 may be configured to engage with the inserter connection portion of the bone anchor. For example, the connection mechanism 2514 may be a fixed peg that is fixed to the rest of the inserter 2500 and does not move (see Figure 11B).
[0145] The inserter 2500 may also include a movable assembly 2506 coupled to an elongated body 2505 (see Figure 11D). The movable assembly 2506 may include a handle 2508 positioned between the first end 2502 and the second end 2504 of the inserter 2500. The handle 2508 is coupled to the elongated body 2505 at a pivot position 2518, and may be coupled, for example, pivotably.
[0146] As shown in Figure 11D, the movable assembly 2506 may also include a bone anchor connection portion 2510 positioned at the second end 2504 of the inserter 2500. The bone anchor connection portion 2510 is coupled to the elongated body 2505 at a pivot position 2519, and may be coupled, for example, pivotally. The bone anchor connection portion 2510 may include a connection mechanism 2512 configured to engage with the inserter connection portion of the bone anchor. For example, the connection mechanism 2512 may be a peg configured to function by connecting to a blind hole on the bone anchor. The convergence angle of the connection mechanism 2512 relative to the connection mechanism 2514 pulls the bone anchor towards the distal surface 2503 of the inserter 2500, which also helps to better distribute the impact force over a larger surface area of the proximal surface of the bone anchor.
[0147] The handle 2508 may be directly or indirectly connected to the bone anchor connection portion 2510. For example, the handle 2508 may be indirectly connected to the bone anchor connection portion 2510 by a spring connection portion 2516. The spring connection portion 2516 may have an arc-shaped portion and a spring gap 2520. The spring connection portion 2516 may be indirectly connected to the elongated body 2505 by the handle 2508 and / or the bone anchor connection portion 2510 without a direct connection between the spring connection portion 2516 and the elongated body 2505.
[0148] The handle 2508 is configured to move the bone anchor connection portion 2510 between a first configuration and a second configuration. The proximal end of the handle 2508 is free to move relative to the elongated body 2505. The transition between the first configuration and the second configuration may include rotation and / or translation of the connection mechanism 2512 relative to the elongated body 2505. For example, acting (e.g., pivoting) the handle 2508 toward the elongated body 2505 can move the bone anchor connection portion 2510 from the first configuration to the second configuration, while releasing the handle 2508 can return the bone anchor connection portion 2510 to the first configuration. In configuration 2, the connecting mechanism 2512 is rotated relative to the distal surface 2503 of the inserter 2500 and retracted at least partially. In this position, the surgeon can engage with the inserter connection portion of the bone anchor. While the connecting mechanism 2512 is engaged with the inserter connection portion of the bone anchor, the handle 2508 may be released (e.g., away from the elongated body 2505) to apply a gripping force to the bone anchor. In configuration 1, the spring coupling 2516 is compressed (e.g., the spring gap 2520 is slightly closed) and provides a spring force that helps to hold the closed connecting mechanism 2512 relative to the bone anchor.
[0149] The inserter 2500 may include at least one impact head 2522, 2524 configured to receive impact forces from, for example, a mallet. For example, the inserter 2500 may include a first impact head 2522 and a second impact head 2524. The first impact head 2522 and the second impact head 2524 may be positioned at different longitudinal positions along the elongated body 2505. For example, the second impact head 2524 may be positioned at the first end 2502 of the inserter 2500, while the first impact head 2522 may be positioned closer to the second end 2504 of the inserter 2500.
[0150] The first impact head 2522 is coupled to an elongated body 2505 and may be positioned at a first angle with respect to the longitudinal axis of the elongated body 2505. When a force is applied to the first impact head 2522, the impact force is directed towards the stemmed and / or stemless bone anchor in a direction coincident with the longitudinal axis of the bone anchor, embedding the bone anchor into the bone. The second impact head 2524 is coupled to an elongated body 2505 and may be positioned at a second angle different from the first angle with respect to the longitudinal axis of the elongated body 2505. When a force is applied to the second impact head 2524, the impact force is directed towards the stemmed and / or stemless bone anchor in a direction perpendicular to the excision surface of the bone into which the bone anchor will be embedded. For example, the first impact head 2522 can be used to insert a stemmed bone anchor, and the second impact head 2524 can be used to insert a stemless bone anchor. In another example, both the first impact head 2522 and the second impact head 2524 may be used to embed the stem portion into the bone. In yet another example, the inserter 2500 may include only the first impact head 2522.
[0151] The first impact head 2522 may be positioned at an angle to the longitudinal axis L of the second impact head 2524 and / or the elongated body 2505. The first impact head 2522 may be positioned at an acute angle to the second impact head 2524, for example, between about 35 and about 65 degrees, to accommodate a stemmed bone anchor having an inclination angle between 125 and about 155 degrees. In one example, the first impact head 2522 may be positioned at a 45-degree angle to the second impact head 2524.
[0152] The inserter 2500 may also be configured to receive a posterior tilt rod. For example, a posterior tilt rod can be inserted into one of the openings 2526. At each opening, the posterior tilt rod may be positioned at a different angle corresponding to the desired resection angle, allowing the surgeon to assess its tilt. If the proximal bone resection was not accurate, or for other reasons determined by the surgeon, the surgeon may modify the resection surface.
[0153] The inserter 2500 may form part of a kit including a stemless bone anchor and / or a stemmed bone anchor. The stemless and / or stemmed bone anchors may include any of the features of the implants described above. The bone anchor connection portion 2510 may be configured to engage with the inserter connection portion of the stemless bone anchor and / or the inserter connection portion of the stemmed bone anchor.
[0154] The kit may include a first inserter and a second inserter. Each of the first and second inserters may include any of the features described above with respect to inserter 2500. In the first inserter, the first impact head and the second impact head may be positioned at a first angle relative to each other. In the second inserter, the first and second impact heads may be positioned at a second angle relative to each other. The second angle may be different from the first angle. One of the first and second inserters may be selected based on the angle at which the resection portion is formed in the bone.
[0155] When in use, the same inserter 2500 can engage with the inserter connection portion of a first stemless bone anchor or the inserter connection portion of a second stemmed bone anchor. Stemless and / or stemmed bone anchors may include any of the features of the implants described above. For example, the inserter 2500 can engage with the inserter connection portion of a stemless bone anchor and advance the stemless bone anchor into the bone material exposed during bone resection. When advancing the stemless bone anchor, force can be applied to the second impact head 2524 of the inserter 2500 to apply a force perpendicular to the bone resection surface.
[0156] The same inserter 2500 engages with the inserter connection portion of the stemmed bone anchor, advancing the stemmed bone anchor and positioning the stem of the bone anchor within the medullary canal of the bone. When advancing the stemmed bone anchor, force is applied to the first impact head 2522 of the inserter 2500, applying force along the longitudinal axis of the stemmed bone anchor, thereby embedding the stem into the bone.
[0157] 2. Reamer for humeral preparation for stems and stemless anchors As described above, kit 100 may include stemless humeral anchors and stemmed humeral anchors. The proximal or metaphysis portions of these anchors may have the same or similar structure. For example, the proximal end 239 of humeral anchor 203 may have a protruding surface opposite the proximal surface of the anchor. The protruding surface may rest on the excised bone, for example, the cancellous bone of the humerus. Similarly, the bone compression surface 1250 of humeral anchor 1200 may be provided to protrude the same bone surface or bone portion. In the shared design concept, a shared reamer or assembly of reamers having at least one shared design mechanism can be advantageously used.
[0158] As described above, the reamer head 1800 may have an outer surface having a distally facing cutting edge configured to form a concave surface R. The concave surface R may be formed on the inner side of the cortical wall, as described above. The concave surface R may be configured to receive the overhanging surface of anchor 203 or anchor 1200 or another anchor disclosed herein. Further features of the reamer, including reamer 1800 and reamer head 1850A, are as described above.
[0159] Other reamers that can be used for preparing stemmed or stemless humeral anchors are also described herein. For example, initial reamer 2354 can be used in a progressive reamering process for preparing either stemmed or stemless anchors. Reamer 2354 can be followed by larger reamers and / or tools for accessing and preparing the intramedullary canal of the humerus. Reamer 2354 can form a concave surface R. Also, collar reamer 2404 can be used for preparing cartilage-containing humerus for either stemless or stemmed anchors. Collar reamer 2404 allows for the preparation of a concave surface that may be performed before providing access to the intramedullary canal through relatively soft bone.
[0160] Kit 100 includes instruments such as reamers usable with two or more types of humeral anchors, such as stemmed and stemless anchors. Therefore, this kit is less complex and less expensive than kits requiring separate reamers and instruments for each type of anchor. Furthermore, considering the fact that postoperative tools are sometimes discarded without reuse, this approach reduces waste and inefficiency in providing surgery to patients. This approach proves to offer multiple advantages, given the cost of such procedures.
[0161] term While specific embodiments are described herein, the implants and methods described herein can be used interchangeably with any joint component, as the context may indicate.
[0162] As used herein, the relative terms “proximal” and “distal” shall be defined from the perspective of the implant. Thus, “proximal” refers to the orientation of the joint component, and “distal” refers to the orientation of the anchor component, such as the stem, thread or porous surface of the humeral anchor, or other anchoring structure of a stemless anchor, when the implant is assembled.
[0163] Conditional language such as "can," "could," "might," or "may" is generally intended to convey that a particular embodiment includes a particular feature, element, and / or step, but other embodiments do not, unless otherwise specified or understood in the context in which it is used. Therefore, such conditional expressions are generally not intended to imply that the feature, element, and / or step is required in any way to one or more embodiments.
[0164] The terms "comprising," "including," and "having" are synonymous and are used comprehensively and openly, without excluding additional elements, features, actions, or operations. Furthermore, the term "or" is used in a comprehensive sense (not exclusively), and therefore, for example, when used to link a list of elements, "or" means one, some, or all of the elements in that list. Also, the articles "a," "an," and "the" used in this application and the attached claims shall be interpreted as meaning "one or more" or "at least one" unless otherwise specified.
[0165] The scope disclosed herein also includes any or all of its overlaps, sub-scopes, and combinations. Words such as “up to,” “at least,” “greater than,” “less than,” and “between” include the numbers listed. Numbers preceded by words such as “about” or “approximately” include the stated number and should be interpreted as appropriate to the context (e.g., as accurately as reasonably possible under the circumstances, e.g., ±5%, ±10%, ±15%). For example, “about 1” includes “1.” Phrases preceded by terms such as “substantially” and “generally” include the stated phrase and should be interpreted as appropriate to the context (e.g., as accurately as reasonably possible under the circumstances). For example, “approximately spherical” includes “spherical.” Unless otherwise noted, all measurements are taken under standard conditions, such as temperature and pressure.
[0166] Where used herein, the phrase “at least one” in a list of items refers to any combination of these items, including a single member. For example, “at least one of A, B, or C” refers to A, B, C, A and B, A and C, B and C, and A, B and C. Unless otherwise specified, the phrase “at least one of X, Y, and Z” refers to any combination of these items. Such conjunctions are generally understood in other ways, along with the context in which they are commonly used to convey that an item, term, etc., can be at least one of X, Y, or Z. Therefore, such conjunctions are not generally intended to mean that a particular embodiment requires the presence of at least one X, at least one Y, and at least one Z, respectively.
[0167] While specific embodiments and examples are described herein, it should be emphasized that many variations and modifications can be made to the humeral head assemblies illustrated and described herein, and that their elements should be understood to be combined and / or modified differently to form yet another embodiment or acceptable example. All such changes and variations are intended to be included within the scope of this disclosure herein. Various designs and approaches are possible. No feature, structure, or step disclosed herein is essential or indispensable.
[0168] Several embodiments have been described in reference to the accompanying drawings. However, it should be understood that these drawings are not drawn to scale. Distances, angles, etc., are for illustrative purposes only and do not necessarily have an exact relationship to the actual dimensions and layout of the illustrated apparatus. Components can be added, removed, and / or rearranged. Furthermore, any specific features, aspects, methods, characteristics, properties, qualities, attributes, elements, etc. disclosed herein relating to various embodiments can be used in all other embodiments described herein. Furthermore, it will be recognized that any method described herein can be carried out using any apparatus suitable for performing the described process.
[0169] For the purposes of this disclosure, specific embodiments, advantages, and novel features are described herein. It should be understood that not all such advantages are achieved according to a particular embodiment. Therefore, for example, a person skilled in the art will recognize that the disclosure may be implemented or carried out in such a way as to achieve one or a group of advantages as taught herein, without necessarily achieving other advantages as taught or suggested herein.
[0170] Furthermore, although exemplary embodiments are described herein, it will be understood by those skilled in the art that the scope of the invention extends beyond the specifically disclosed embodiments to any and all embodiments having equivalent elements, modifications, omissions, combinations or subcombinations of the particular features and embodiments of the invention (e.g., aspects across various embodiments), adaptations and / or modifications, and the uses of the invention, as understood by those skilled in the art based on this disclosure. Limitations in the claims should be interpreted broadly based on the language used in the claims and not limited to the examples described herein or in the application procedures, and these examples should be interpreted as non-exclusive. Furthermore, the actions of the disclosed processes and methods can be modified in any way, including rearranging actions and / or inserting additional actions and / or deleting actions. Accordingly, this specification and the examples are for illustrative purposes only, and the true scope and spirit are intended to be shown by the entire scope of the claims and their equivalents.
[0171] None of the methods disclosed herein must be performed in the order described herein. The methods disclosed herein include specific actions performed by the practitioner, but may also include third parties who explicitly or implicitly direct those actions. For example, an action such as “joining the glenoid guide with the glenoid rim” includes “directing the joining of the glenoid guide with the glenoid rim.”
Claims
1. A kit for a reverse shoulder prosthesis, the kit comprising a reverse joint component, The aforementioned reverse-type joint component is A first side surface including a concave articular surface, Including a second side positioned opposite the first side, The second side of the reverse-type joint component is A locking mechanism comprising at least one convex locking tab and at least one concave locking slot spaced apart from the at least one convex locking tab, A kit including a projection extending distally from the locking mechanism.
2. The kit according to claim 1, wherein the at least one convex lock tab includes a first lock tab and a second lock tab spaced apart from the first lock tab.
3. The kit according to claim 2, wherein the first lock tab and the second lock tab are arranged facing each other around the locking mechanism such that the first lock tab and the second lock tab are spaced 180 degrees apart.
4. The kit according to claim 2 or 3, wherein the at least one recessed lock slot includes a first recessed lock slot and a second recessed lock slot spaced apart from the first recessed lock slot.
5. The kit according to claim 4, wherein the first recessed lock slot and the second recessed lock slot are arranged facing each other around the locking mechanism such that the first recessed lock slot and the second recessed lock slot are spaced 180 degrees apart.
6. The kit according to claim 1, wherein the locking mechanism is sized to receive a locking ring and defines a circumferential slot.
7. The kit according to claim 1, further comprising a humeral anchor extending from a distal end to a proximal end, wherein the proximal end of the humeral anchor defines a first recess for receiving the reverse joint component therein, in order to connect the reverse joint component to the humeral anchor.
8. The first recess defined by the humeral anchor is At least one first concave locking mechanism configured to engage with the at least one convex locking tab of the reverse-type joint component, At least one first convex locking mechanism configured to engage with the at least one concave locking slot of the reverse-type joint component and The kit according to claim 7, including the following:
9. The kit according to claim 7 or 8, wherein the humeral anchor includes a stem.
10. The proximal end of the humeral anchor is A flange extending outward from the proximal end and including a circular outer surface and a bone compression surface facing distally, A porous section is located adjacent to the flange and constitutes intraosseous growth. The kit according to claim 7 or 8, comprising a cancellous bone contact surface including the above.
11. The kit according to claim 7 or 8, wherein the proximal end of the humeral anchor defines a second recess sized to receive the projection extending distally from the locking mechanism of the reverse joint component.
12. The kit according to claim 11, wherein the proximal end of the humeral anchor defines a circumferential groove within the first recess, and the circumferential groove is sized to receive a lock ring.
13. The kit according to claim 7 or 8, wherein the humeral anchor is a stemless humeral anchor.
14. A humeral anchor extending from a proximal end to a distal end, wherein the proximal end of the humeral anchor defines a first recess and a second recess, A reverse-type joint component configured to connect with the humeral anchor, A humeral implant comprising, the reverse joint component is A body having a first side and a second side positioned opposite the first side, wherein the first side includes a concave articular surface for connecting to a reverse-type articular fossa component, A locking mechanism extending from a second side of the main body and sized to be received in a first recess defined by the humeral anchor, wherein the locking mechanism includes at least one convex locking tab and at least one concave locking slot. A projection extending from the locking mechanism of the reverse-type joint component, wherein the projection is sized to be received within the second recess defined by the humeral anchor, and the projection is configured as follows: Includes humeral implants.
15. The at least one convex locking tab of the reverse joint component is A first locking tab configured to engage with a first recessed locking mechanism defined by the inner circumferential surface of the proximal end of the humeral anchor, A second locking tab spaced apart from the first locking tab, the second locking tab is configured to engage with a second concave locking mechanism defined by the inner circumferential surface of the proximal end of the humeral anchor. The humeral implant according to claim 14, including the above.
16. The at least one recessed lock slot is A first concave lock slot is configured to be sized to receive a first convex lock mechanism extending from the inner circumferential surface of the proximal end of the humeral anchor, A second recessed lock slot is spaced apart from the first recessed lock slot, and the second recessed lock slot is sized to receive a second convex lock mechanism extending from the inner circumferential surface of the proximal end of the humeral anchor, and the second recessed lock slot is configured as follows: The humeral implant according to claim 14 or 15, including the above.
17. The first lock tab and the second lock tab of the reverse joint component are arranged facing each other around the locking mechanism such that the first lock tab and the second lock tab of the reverse joint component are spaced 180 degrees apart. The humeral implant according to claim 16, wherein the first recessed lock slot and the second recessed lock slot of the reverse joint component are arranged facing each other around the locking mechanism such that the first recessed lock slot and the second recessed lock slot of the reverse joint component are spaced 180 degrees apart.
18. The locking mechanism of the reverse-type joint component is sized to receive a locking ring and defines a circumferential slot, The humeral implant according to claim 14, wherein the inner circumferential surface of the proximal end of the humeral anchor is sized to receive the lock ring and defines a circumferential groove.
19. A humeral anchor extending from a proximal end to a distal end, wherein the proximal end of the humeral anchor has an inner surface defining a first recess and a circumferential groove, A reverse joint component configured to connect with the humeral anchor, wherein the reverse joint component is A body having a first side and a second side, wherein the first side includes a concave articular surface sized to connect with a reverse-type articular fossa component, and the second side is positioned opposite the first side to the body, A locking mechanism comprising a locking mechanism that extends from the second side of the body of the reverse joint component and is sized to be received in the first recess defined by the humeral anchor, wherein the locking mechanism defines a circumferential slot and a plurality of second concave locking slots, and the locking mechanism includes a plurality of first convex locking tabs arranged circumferentially around the locking mechanism Includes a reverse-type joint component, To fix the reverse-type joint component to the humeral anchor, a locking ring is configured to be sized to fit into the circumferential slot defined by the locking mechanism and the circumferential groove defined by the humeral anchor. A reverse-type humeral implant equipped with [feature / feature].
20. The reverse humeral implant according to claim 19, wherein the reverse joint component includes a projection extending from the locking mechanism, the projection being sized to be received in a second recess defined by the proximal end of the humeral anchor.