Guides, instruments, and techniques for brachial surgery for use in tissue-preserving shoulder arthroplasty.
Patent Information
- Application Number
- JP2026513309
- Authority / Receiving Office
- JP · JP
- Patent Type
- Applications
- Current Assignee / Owner
- Priority Date
- 2023-08-31
- Filing Date
- 2024-09-03
- Publication Date
- 2026-09-03
AI Technical Summary
【0046】 本明細書に説明される特徴部又は変形例のいずれも、いくつかの異なる組み合わせで、本開示の任意の特定の態様又は実施形態に適用することができる。任意の特定の組み合わせの明確な記述はないが、それは単に、不必要に長くなること、又は繰り返すことを回避するためである。
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Abstract
Description
[[Technical Field]]
[0001] The present disclosure relates to devices, methods, and techniques for use in shoulder joint repair procedures such as shoulder arthroplasty, and more specifically to devices and related methods for use in preparing a humeral surgical site within a limited space such as the rotator interval while leaving surrounding tendons such as the subscapularis tendon intact. [[Background Art]]
[0002] In a patient's life, for example, it may be necessary for the patient to undergo shoulder arthroplasty as a result of disease or trauma. Various forms of this type of surgery exist, the most important objectives of which are to remove damaged or missing portions of an anatomical structure and / or replace the same with prosthetic components. For example, as shown in FIG. 1A, in total anatomical shoulder arthroplasty, a humeral prosthesis 10 can be used to replace the patient's natural humeral head. Typically, the humeral prosthesis 10 includes an elongated post component 12 that is implanted within the intramedullary canal of the patient's humerus, and a hemispherical prosthetic head component 14 fixed to the post component 12. In addition, the natural glenoid surface of the scapula may be resurfaced or otherwise replaced with an anatomical glenoid implant 20. The anatomical glenoid implant 20 typically includes a concave bearing surface 24 over which the prosthetic head component 14 of the humeral prosthesis 10 articulates. A peg or keel 22 may protrude from the distal end of the implant 20 and may be fixed (e.g., cemented) within the glenoid cavity of the patient's scapula.
[0003] Figure 1A provides an anatomical total shoulder arthroplasty, but in other examples, the arthroplasty may be a partial shoulder arthroplasty, meaning that only a portion of the anatomical structure of the shoulder may be replaced with an implant. This may include, for example, providing a humeral prosthesis without a glenoid implant, or only a glenoid implant without a humeral prosthesis, among other modifications that are understood by those skilled in the art. Furthermore, while Figure 1A provides an anatomical procedure, reverse procedures for repairing the shoulder are also known. These may be useful, for example, when a patient's natural shoulder has degenerated into severe joint instability and pain. Reverse procedures can alter the mechanism of the shoulder and reverse the anatomical structure or structure of a healthy shoulder. For example, as shown in Figure 1B, in a reverse total shoulder arthroplasty, a humeral prosthesis 50 may be used to replace the patient's natural humeral head. Typically, the humeral prosthesis 50 includes an elongated post component 52 that is embedded in the intramedullary canal of the patient's humerus, and a concave prosthesis head component 54, known as a humeral cup, is fixed to the post component 52. In addition, an inverted glenoid implant, such as the hemispherical Glenosphere 60, can be fixed to the glenoid bone of the patient's scapula. This inverted configuration allows the patient's deltoid muscle, one of the larger and stronger shoulder muscles, to lift the arm.
[0004] Among the various types of shoulder arthroplasty, there is soft tissue that obstructs access to the surgical arthroplasty site. This tissue typically includes the patient's subscapularis tendon. In many conventional surgical approaches, the subscapularis tendon is separated from its humeral attachment on the humerus to provide better access to the surgical site. In at least some arthroplasty, the humerus is then rotated externally to allow access to the joint cavity, essentially dislocating the humeral head. This allows the surgeon to fully visualize the humeral head and glenoid cavity after humeral head resection. In anatomical procedures where the humeral head is replaced, once the humeral head is exposed, the convex portion of the bone is resected into a flat surface and prepared to receive a humeral prosthesis. In the reverse procedure, after the humeral head has been rotated externally, the position in which the humeral head typically occupies may be prepared to receive a prosthesis head component (e.g., a humeral cup).
[0005] Once sufficient access to the surgical site is obtained and the humeral head is resected, the surgeon often uses various tools to create an appropriate geometric shape within the resected surface of the humerus (hereinafter referred to as the "humeral resection surface"). This geometric shape ensures that the implant and / or prosthesis fits securely into the bone and, as a result, can function properly within the joint space, depending at least in part on the selected implant and / or prosthesis, and / or any patient-related anatomical or diseased issues at the surgical site. Generally, to create such a geometric shape, the humeral resection surface is reamed, cut, or otherwise shaped to the desired form, and then the reamed surface is broached or otherwise embedded before insertion of the implant and / or prosthesis. Among other instruments used in such procedures, existing reaming and broaching tools are designed for use in procedures where the subscapularis tendon is separated from its humeral attachment point, allowing a complete 360° view of the anatomical structure of the humeral head, while manipulating the reaming and broaching tools and using supporting tools. The size, shape, and function of such tools are based on having access to and visualization of the joint cavity without being obstructed by the subscapularis tendon and / or other tissues that may interfere with access to the surgical site. For example, a sufficient amount of downward force is applied to the humeral resection surface by the tool to form the appropriate geometric shape of the humeral resection surface. Direct access to the humeral resection surface is necessary to apply a consistent amount of downward force across the entire humeral resection surface. After surgery, the subscapularis tendon is reattached. Tendon repair and healing are important for the proper function of the joint, and incomplete healing leads to complications, pain, and instability.
[0006] Alternatively, the procedure can be performed while preserving the attached subscapularis tendon, a technique called tissue preservation, where the surgeon works only within the limited joint space above and below the tissue boundary of the subscapularis muscle. In such cases, the surgeon is limited in accessing the humeral head to evaluate anatomical structures relevant to the procedure, such as evaluating the cross-sectional and / or bone surfaces, because the humeral head cannot be externally rotated and essentially dislocated. As long as the surgeon uses existing arthroplasty tools that are not specifically designed for tissue preservation approaches, the surgeon will manipulate the subscapularis tendon during tool insertion to allow the tool to access the surgical site. This is because conventional tools are not suitable for use in such tissue preservation procedures and / or are not designed for such procedures. In addition to the visual problems mentioned above, the limited joint space makes it difficult for the surgeon to consistently apply sufficient force necessary to prepare the humerus. Unless the surgeon dislocates and fully externally rotates the humerus, the coracoid and acromion typically restrict vertical access to and exposure of the cutting or resection surface, in the manner in which the humerus is prepared in known shoulder arthroplasty techniques. Furthermore, since transhumeral approaches to shoulder arthroplasty were not performed at least prior to this disclosure, conventional arthroplasty tools have not been used during transhumeral procedures. At the very least, existing arthroplasty tools are designed for use when the subscapularis tendon is separated, making them bulky and cumbersome for use in tissue-preserving procedures. Existing tools lack the versatility of movement, size, and function to provide consistent, sufficient force to access the limited joint space and properly prepare the humeral resection surface for prosthesis reception. The size and / or trajectory of existing tools are insufficient. Existing tools are not designed to be low-profile to work in confined spaces, nor are they modular to allow assembly / disassembly within the joint space. Furthermore, as long as existing devices possess at least some such capabilities, they are typically not easy to use, meaning that existing devices are insufficient to provide surgeons with adequate utility. [Overview of the project] [Problems that the invention aims to solve]
[0007] Therefore, there is a need for humeral arthroplasty tools and instruments that can be used in tissue-sparing arthroplasty where access is limited, while minimizing damage to surrounding soft tissues, as well as adjacent neurovascular and bone structures. [Means for solving the problem]
[0008] This disclosure generally covers various embodiments of surgical guides and handle assemblies, commonly referred to as humeral guides, for performing surgical procedures on the shoulder. The humeral guides disclosed herein can help set the paths and / or positions to which various instruments used to perform surgical procedures should be positioned relative to the surgical site (in illustrated embodiments, the humeral resection surface). Handle assemblies can be coupled to the guide (e.g., the humeral guide) and used to position various tools for performing various functions of the surgical procedure at the surgical site. In particular, the handle assemblies and related disclosures described herein enable the ability to perform tasks such as reaming and / or broaching, while the subscapularis tendon remains intact along with its humeral attachment point for the duration of the surgical procedure.
[0009] More specifically, the humeral guide may include an arm that helps define two positions at the surgical site. The proximal portion of the arm may have one or more fixation features associated with it, such as a clamp, which is configured to fix the guide to the humerus by controlling the placement of one or more bone pins into the humerus. The proximal portion may also include a hub or carriage configured to receive a bullet-shaped portion with a cannula or a drill cannula, which can advance toward the surgical site and engage, for example, with the lateral cortex of the humerus. The combination of one or more bone pins and a drill cannula may be used to fix the position of the humeral guide relative to the humerus.
[0010] The distal end of the arm may be configured to receive a handle assembly. In at least some embodiments, an adapter may be disposed at the distal end of the arm to assist in selectively attaching and detaching the handle assembly from the arm of the humeral guide. Once the handle assembly is attached to the arm, the handle assembly can position tools for use in surgical procedures close to the humeral resection surface. As described herein, these tools may include reamers and / or brazers (i.e., tools for broaching). Furthermore, the distal end of the arm may also be configured to receive other attachments, such as a humeral sizer attachment, which may be used to assist in determining the appropriate size of an implant and to initially position the location where the path defined by the drill cannula crosses the humeral resection surface. More specifically, the humeral sizer attachment may assist in defining a substantial central position on the humeral resection surface so that the drill or guide pin, after passing through the drill cannula and the humerus, enters the center of the humeral resection surface perpendicular to the humeral resection surface.
[0011] After the tool for use at the surgical site is positioned by the humeral guide and handle assembly, the drill bit or guide pin can be introduced into the surgical site by passing through a drill cannula held by the humeral guide. The guide pin can be captured by an attachment associated with the tool and then used to operate the tool from a position below the humeral resection surface. More specifically, power can be supplied to the guide pin to rotate it, and then the tool on the attachment to which the guide pin is coupled can be rotated. The attachment and tool can be pressed into the bone surface to perform the desired function (e.g., reaming, broaching), and after the use of the tool is complete, the handle assembly can be operated to detach the attachment and tool from the guide pin. Once reaming, broaching, and / or other desired bone treatment operations are performed, the implant can be introduced into the surgical site and embedded therein. The humeral guide and / or handle assembly can also be used in these procedures. Subsequently, in at least some embodiments, a prosthesis can be attached to the implant, thereby completing the introduction of the implant and prosthesis into the surgical site.
[0012] The various instruments and tools disclosed herein, as well as techniques that can be performed in conjunction with them, provide unique, adaptable, and / or versatile designs that enable the completion of shoulder joint procedures in a tissue-preserving manner. For example, the humeral guide and handle assembly disclosed herein can be used in conjunction with various parts of surgical procedures (e.g., cutting, broaching, etc.) that enable the preservation of surrounding tissues (e.g., subscapularis tendon) and the minimization of any damage to such tissues. More specifically, the humeral guide may help to set the paths and / or positions in which various instruments used to perform various aspects of the surgical procedure will be positioned relative to the surgical site (e.g., the humeral resection surface), and the handle assembly may be coupled to a guide such as the humeral guide disclosed herein and used to position various tools for performing various functions of the surgical procedure (e.g., cutting, broaching, etc.) at the surgical site. The humeral guide and handle assembly, and their associated disclosures, enable the ability to perform operations such as cutting and / or broaching, while the subscapularis tendon remains intact along with its humeral attachment point for the duration of the surgical procedure.
[0013] Furthermore, the guides and handle assemblies disclosed herein are inherently universal in that they can be easily used by surgeons who primarily use both hands (left or right), and from any side of the body and / or any side of the guide / frame / assembly being operated by the surgeon. Various other “ease of use” features are provided in various designs of the humeral guides, handle assemblies, and associated components (e.g., arms, hubs, guides, drill cannulas, attachments, tools, etc.). These features enable the use of these components at the surgical site during tissue-preserving arthroplasty. This is because they provide an alternative approach to supplying the force necessary to perform functions (in non-limiting examples, such as reaming and / or broaching) and prepare the humeral resection surface to receive the implant. Such features can also facilitate the identification of various points of interest, and / or their position on some of the instruments or at the surgical site, during use.
[0014] One embodiment of a surgical guide includes a rigid arm, at least one support rod, and at least one bone pin clamp. The rigid arm has a proximal and distal portion, the distal portion is configured to have an attachment to which it is coupled, and the proximal portion has a cannula receiving opening formed in the proximal portion, so that the plane defined by the principal surface of the distal end of the attachment coupled to the distal portion of the rigid arm is substantially perpendicular to the longitudinal axis extending through the cannula receiving opening, which defines the path of movement of the drill cannula. At least one support rod is configured to be coupled to the rigid arm. At least one bone pin clamp is coupled to at least one support rod. Furthermore, at least one bone pin clamp is configured to provide multiple degrees of freedom so that a bone pin coupled to at least one bone pin clamp can be manipulated over multiple degrees of freedom. Furthermore, the surgical guide is configured to be used with one or more bones that are in or adjacent to the surgical site.
[0015] In some embodiments, the surgical guide may further include a hub associated with the proximal portion of a rigid arm, the hub having a cannula-receiving opening formed in the hub. Alternatively, or additionally, the surgical guide may include a cannula locking mechanism which can be configured to selectively lock a drill cannula disposed within the cannula-receiving opening at a selected position. In at least some such embodiments, the cannula locking mechanism may be at least partially disposed within the hub, and further, the cannula locking mechanism may include cannula-engaging teeth disposed within the cannula-receiving opening and configured to engage with a drill cannula disposed within the cannula-receiving opening to selectively lock the drill cannula at a selected position.
[0016] The surgical guide may also include a drill cannula. The drill cannula may be configured to enter and pass through the cannula receiving opening and engage with the opposite face of one of one or more bones where the distal end of an attachment coupled to the distal end of a rigid arm is located. The drill cannula may include a plurality of ratchet teeth formed along its length. In at least some embodiments, the surgical guide may include an adapter. The adapter may be disposed at the distal end of a rigid arm and slidable to selectively engage with an attachment, allowing the attachment to selectively couple to and discouple from the distal end of the rigid arm. The guide may include at least one indicator marking disposed on the rigid arm. The marking may include, for example, a line indicating when the tool being operated on the arm has reached a certain depth so that the adapter coupled to the distal arm reaches at least the line.
[0017] A bone pin clamp may include a guide coupling portion and a pin engagement portion. The guide coupling portion may be configured to be coupled to a support rod, and the pin engagement portion may be configured to selectively unlock and lock the bone pin so that the entry position of the bone pin into the bone and / or the entry angle of the bone pin into the bone can be adjusted. In at least some such embodiments, the guide coupling portion may be configured to selectively unlock and lock relative to a rigid arm so that the entry position of the bone pin into the bone and / or the entry angle of the bone pin into the bone can be adjusted.
[0018] A surgical guide may be positioned at or near the surgical site such that a path of movement defined by a drill cannula received through a cannula receiving opening is traversed by a tool operating shaft, allowing the tool operating shaft to engage with one or more tools associated with the distal end of a rigid arm. In at least some such embodiments, the surgical guide may be configured to provide both planar and axial alignment of a plane defined by the principal surface of the distal end of an attachment coupled to the distal end of a rigid arm. Alternatively, or additionally, the surgical guide may be configured to allow the manipulation of one or more tools at the surgical site by actions performed outside the body where the surgical site is located. One or more tools may include multiple tools, each of which can be engaged by a tool operating shaft for tool manipulation.
[0019] One or more bones may include the humerus, and the attachment may be configured to be operated in such a way that the subscapularis tendon adjacent to the humerus remains intact. In at least some embodiments, at least a portion of the attachment may be configured to be inserted into a surgical site that includes the humerus either above or below an intact subscapularis tendon.
[0020] In at least some embodiments, the surgical guide may include an attachment that can be configured to be coupled to the distal end of a rigid arm. The attachment may include a distal end having a principal surface that defines a plane substantially perpendicular to a longitudinal axis extending through a cannula receptacle opening, which defines the path of movement of a drill cannula. The attachment may include, for example, a sizer attachment. The sizer attachment may be configured to be used to define the central position of a receptacle of one of one or more bones at a surgical site, and / or to determine the size of the receptacle. The sizer attachment may include a plate having a distal end with a central opening that can be configured to define the central position of a bone receptacle at a surgical site. Furthermore, the central opening may be configured to be positioned on a longitudinal axis extending through a cannula receptacle opening, which defines the path of movement of a drill cannula when defining the central position of a bone receptacle at a surgical site. In at least some embodiments, the sizer attachment may be configured to receive a plurality of different sized sizer plates for use in determining the size of the receptacle.
[0021] In at least some embodiments, the attachment may include a handle assembly. The handle assembly may include a humeral preparation device coupled to the distal end of the handle assembly. Furthermore, the handle assembly may be configured to position the humeral preparation device in close proximity to one of one or more bones at the surgical site such that the plane defined by the principal surface of the humeral preparation device is substantially perpendicular to a longitudinal axis extending through a cannula receiving opening that defines the path of movement for the drill cannula. In at least some embodiments, the handle assembly may include a mounting portion disposed at the distal end of the handle assembly. The mounting portion may be configured to receive the humeral preparation device. The mounting portion may be slidable between a locked position in which the humeral preparation device can be gripped by the mounting portion and an unlocked position in which the humeral preparation device can be released from the mounting portion.
[0022] The handle assembly may also include a guide receiving opening. The guide receiving opening may be coupled to the distal end of the receiving arm and configured to fixate the handle assembly to the guide assembly for operation of the humeral preparation device. In at least some embodiments, the handle assembly may include a quick-release mechanism. The quick-release mechanism may be configured to remove the humeral preparation device from the handle assembly. In at least some embodiments, the handle assembly may include a selectively lockable guide mounting mechanism. The selectively lockable guide mechanism may include a slider, which may be configured to operate the selectively lockable guide mounting mechanism to move the slider between a locked position and an unlocked position. The locked position may be a position in which the selectively lockable guide mechanism can securely connect the handle assembly to the distal end of the arm of the surgical guide, and the unlocked position may be a position in which the handle assembly can be detached from the surgical guide.
[0023] In at least some embodiments, the surgical guide may include a tool attachment. The tool attachment may include, for example, a bone preparation device, a mount, and a slidable capture plate. The mount may include a proximal end which can be configured to be gripped by a handle assembly and a distal end which can be coupled to the bone preparation device. The slidable capture plate may include an opening formed inside. The capture plate may be disposed between the bone preparation device and the mount, and the capture plate may be movable between a locked position and an unlocked position. The locked position may be a position in which the capture plate can be configured to engage with a guide pin disposed through the opening of the slidable capture plate, thereby coupling the guide pin to the handle assembly, and the unlocked position may be a position in which the guide pin can be disengaged from the capture plate and therefore from the handle assembly. In at least some such embodiments, the opening of the capture plate may have a first portion having a first diameter and a second portion having a second diameter, where the first diameter is greater than the second diameter. In such embodiments, when the slidable capture plate is in the locked position, the guide pin may be located within a second portion of the opening of the capture plate, and when the slidable capture plate is in the unlocked position, the guide pin may be located within a first portion of the opening of the capture plate.
[0024] One embodiment of a handle assembly for use in positioning a bone preparation device in close proximity to the location where bone is to be treated includes an arm, a mounting portion, and a receiving portion. The arm has a proximal portion and a distal portion, the mounting portion is disposed on the distal portion of the arm, and the receiving portion is disposed on the proximal portion of the arm. The mounting portion is configured to receive a bone preparation device for use at the location where bone is to be treated. The receiving portion is configured to allow the handle assembly to be appropriately positioned so that the distal end of the mounting portion is selectively coupled to a guide that positions the handle assembly in close proximity to the location where bone is to be treated.
[0025] The attachment portion may include a biased capture plate that may be configured to selectively engage with the bone preparation instrument, for example, by sliding along the arm. In at least some of such embodiments, the handle assembly may also include a latch on the opposite side of the arm from the capture plate and coupled to the capture plate. The latch may be configured to selectively disengage the capture plate from the bone preparation instrument by acting against the biased capture plate to slide the capture plate along the arm. In at least some embodiments, the capture plate may include an alignment slot that may be configured to receive a corresponding protrusion of the bone preparation instrument such that the bone preparation instrument is properly aligned with the handle assembly.
[0026] The receiving portion may include a guide receiving opening coupled to the distal end of the receiving arm and configured to fixedly couple the handle assembly to a guide for manipulation of the bone preparation instrument. In at least some embodiments, the handle assembly may include a quick release mechanism that may be configured to detach the bone preparation instrument from the handle assembly. The handle assembly may include a selectively lockable guide attachment mechanism. Such a mechanism may, for example, include a slider that may be configured to operate the selectively lockable guide attachment mechanism to move the slider between a locked position and an unlocked position. The locked position may be a position in which the slider enables the handle assembly to be fixedly coupled to the distal end of the arm of the guide, and the unlocked position may be a position in which the handle assembly can be uncoupled from the guide.
[0027] The handle assembly may also include one or more tool attachments. The tool attachment may include a bone preparation instrument, a mount, and a slidable capture plate. The mount may have a proximal end that may be configured to be gripped by the handle assembly, and a distal end that may be coupled to the bone preparation instrument. The slidable capture plate may have an opening formed therein. The capture plate may be disposed between the bone preparation instrument and the mount, and the capture plate may be movable between a locked position and an unlocked position. In the locked position, the capture plate may be configured to engage a guide pin disposed through the opening of the slidable capture plate to couple the guide pin to the handle assembly, and in the unlocked position, the guide pin may be uncoupled from the capture plate and thus from the handle assembly. In at least some such embodiments, the opening of the capture plate may have a first portion having a first diameter and a second portion having a second diameter, wherein the first diameter is larger than the second diameter. Further, when the slidable capture plate is in the locked position, the guide pin may be disposed within the second portion of the opening of the capture plate, and when the slidable capture plate is in the unlocked position, the guide pin may be disposed within the first portion of the opening of the capture plate.
[0028] The bone that may be used with the handle assembly may be a humerus. In at least some such embodiments, the bone preparation instrument may be received by an attachment portion and may be configured to be disposed on the humerus such that the subscapularis tendon proximal to the humerus remains intact. Further, in at least some such embodiments, at least a portion of the attachment portion may be configured to be inserted into a surgical site including the humerus at least one of superior to the intact subscapularis tendon or inferior to the intact subscapularis tendon.
[0029] One embodiment of the surgical method includes inserting a guide pin into the humerus from the lateral cortex and moving it to a position close to the humeral resection surface on the opposite side of the lateral cortex, close to the glenoid fossa. The method further includes capturing the guide pin with a tool attachment positioned close to the humeral resection surface, the tool attachment having a bone preparation device, and rotating the guide pin to rotate the tool attachment, and therefore the bone preparation device. Furthermore, the method includes moving the guide pin toward the lateral cortex while continuing to rotate the guide pin, moving the tool attachment toward the humeral resection surface, and treating the bone. The method also includes detaching the guide pin from the tool attachment.
[0030] The guide pin can be positioned centrally on the humeral resection plane and substantially perpendicular to the humeral resection plane. The method may further include connecting the humeral guide to the humerus and engaging the lateral cortex of the humerus with the distal end of the drill cannula. The drill cannula may be movably connected to the humeral guide, and the humeral guide may define the path of movement of the guide pin through the humerus within the drill cannula. The action of inserting and passing the guide pin through the humerus from the lateral cortex may include passing the guide pin through the drill cannula along the path of movement. In at least some such embodiments, the humeral guide can provide both planar and axial alignment for operation of the bone preparation device without requiring adjustment of the position of the bone preparation device. The method may further include operating the bone preparation device from a position lateral to the body where the humerus is located.
[0031] The operation of connecting the humeral guide to the humerus may include inserting at least one bone pin into the humerus, the bone pin being coupled to a pin receiving component coupled to the humeral guide. In at least some such embodiments, the method may include adjusting the entry position of the bone pin into the humerus and / or the entry angle of the bone pin into the humerus into which at least one bone pin is inserted. In some embodiments, the method may include adjusting both the entry position of the bone pin into the humerus and the entry angle of the bone pin into the humerus into which at least one bone pin is inserted. Inserting at least one bone pin into the humerus may include moving at least one bone pin over multiple degrees of freedom. For example, the pin receiving component may include a bone pin clamp, and moving at least one bone pin over multiple degrees of freedom may include adjusting the bone pin clamp to move over multiple degrees of freedom. In at least some such embodiments, adjusting the bone pin clamp to move over multiple degrees of freedom may include selectively unlocking and locking the bone pin relative to the bone pin clamp to adjust the entry position of the bone pin into the humerus and / or the entry angle of the bone pin into the humerus into which at least one bone pin is inserted. Alternatively or additionally, adjusting the bone pin clamp to move over multiple degrees of freedom may include selectively unlocking and locking the bone pin clamp relative to the humeral guide to adjust the entry position of the bone pin into the humerus and / or the entry angle of the bone pin into the humerus into which at least one bone pin is inserted.
[0032] In at least some embodiments, the method may include connecting the proximal end of a humeral sizer attachment to the distal end of an arm of a humeral guide, and positioning the distal end of the humeral sizer attachment in proximity to the humeral resection surface. The distal end of the humeral sizer attachment may include a plate having a central opening formed at the distal end. The method may further include positioning the central opening of the plate at the distal end of the humeral sizer attachment so as to align with the longitudinal axis of a drill cannula. The drill cannula may be movably coupled to the proximal end of an arm of a humeral guide. In at least some such embodiments, the method may further include coupling one or more sizer plates to the distal end of the humeral sizer attachment. Next, using the size plates, the positioning of one or more size plates relative to the humeral resection surface and the size of one or more size plates attached to the distal end of the humeral size plate attachment can be used to evaluate at least one of the following: the size of the humeral resection surface, the size of the implant to be placed in the humeral resection surface based on the size of the humeral resection surface, and / or the size of the prosthesis to be embedded in the humeral resection surface.
[0033] The method may further include coupling a handle assembly to the distal end of the arm of a humeral guide. The handle assembly may have a tool attachment coupled to its distal end, the tool attachment may include a bone preparation device. The method may also include positioning the bone preparation device in close proximity to the humeral resection surface. In at least some such embodiments, coupling the handle assembly to the distal end of the arm of a humeral guide may include sliding an adapter disposed at the distal end of the arm toward the handle assembly to securely couple the handle assembly to the distal end of the arm of the humeral guide. The method may also include uncoupling the handle assembly from the distal end of the arm of the humeral guide. This operation may include, for example, operating a slider disposed on the handle assembly. In some other embodiments, disengaging the handle assembly from the distal end of the arm of the humeral guide may include operating a slider disposed on the handle assembly and sliding an adapter disposed at the distal end of the arm toward the proximal end of the arm of the humeral guide so as to move away from the handle assembly.
[0034] The operation of capturing a guide pin with a tool attachment positioned close to the humeral resection surface may include inserting the guide pin into the tool attachment and allowing the tool attachment's capture plate to capture and hold the guide pin. In at least some such embodiments, the operation of detaching the guide pin from the tool attachment may include moving the capture plate to an unlocked position and removing the guide pin from the tool attachment.
[0035] The method may include coupling a tool attachment to the distal end of a handle assembly. In at least some such embodiments, coupling a tool attachment to the distal end of a handle assembly may include moving a mounting portion of the handle assembly to an unlocked position, inserting the proximal end of a tool attachment into a chamber defined within the mounting portion, and moving the mounting portion to a locked position to secure the tool attachment to the distal end of the handle assembly. The method may further include moving a mounting portion to an unlocked position, removing a tool attachment from the distal end of a handle assembly, inserting the proximal end of a second tool attachment into a chamber within the mounting portion, and moving the mounting portion to a locked position to secure the second tool attachment to the distal end of the handle assembly.
[0036] The action of engaging the distal end of the drill cannula with the lateral cortex of the humerus may include ratcheting the drill cannula toward and into the lateral cortex of the humerus. In at least some embodiments, the tool attachment may include a reamer, and the action of treating the bone may include reaming the bone with the reamer, moving the tool attachment toward the humeral resection surface by continuing to rotate the guide pin toward the lateral cortex. In at least some embodiments, the tool attachment may include a blazer, and the action of treating the bone may include broaching the bone with the blazer, moving the tool attachment toward the humeral resection surface by continuing to rotate the guide pin toward the lateral cortex. If the handle assembly is coupled to the distal end of the arm of the humeral guide, the action of broaching the bone may include engaging the handle assembly with the insertion tool and providing insertion force to the blazer by providing force to the insertion tool that is transmitted to the blazer through the handle assembly.
[0037] The tool attachment may be coupled to the distal end of the handle assembly, and the tool attachment may include a bone preparation device. In at least some such embodiments, the method may include positioning the bone preparation device in close proximity to the humeral resection surface. Securing a guide pin with a tool attachment positioned in close proximity to the humeral resection surface may include inserting the guide pin into the tool attachment and allowing the tool attachment's capture plate to capture and hold the guide pin. In at least some such embodiments, detaching the guide pin from the tool attachment may include moving the capture plate to an unlocked position and removing the guide pin from the tool attachment. The method may also include coupling the tool attachment to the distal end of the handle assembly. This may include, for example, moving the mounting portion of the handle assembly to an unlocked position, inserting the proximal end of the tool attachment into a chamber defined within the mounting portion, and moving the mounting portion to a locked position to secure the tool attachment to the distal end of the handle assembly. In at least some embodiments, the method may further include moving the mounting portion to an unlocked position, removing the tool attachment from the distal end of the handle assembly, inserting the proximal end of the second tool attachment into a chamber within the mounting portion, and moving the mounting portion to a locked position to secure the second tool attachment to the distal end of the handle assembly. In at least some such embodiments, the second tool attachment may include a second bone preparation device, and the method may further include inserting and passing at least one of the guide pin or the second guide pin through the humerus to a position close to the humeral resection surface, capturing at least one of the guide pin or the second guide pin with the second tool attachment, and rotating at least one of the guide pin or the second guide pin to rotate the second tool attachment, and thus the second bone preparation device.In at least some cases where a second guide pin is used, the planar alignment and axial alignment with respect to the humeral resection surface may be the same for the second guide pin as for the first guide pin.
[0038] The tool attachment may include a reamer. In at least some such embodiments, the action of treating the bone by moving the tool attachment toward the humeral resection surface while continuously rotating the guide pin toward the lateral cortex may include reaming the bone with a reamer. In at least some embodiments, the tool attachment may include a blazer. In at least some such embodiments, the action of treating the bone by moving the tool attachment toward the humeral resection surface while continuously rotating the guide pin toward the lateral cortex may include broaching the bone with a blazer. The method may further include operating the bone preparation instrument from a position lateral to the body where the humerus is located.
[0039] In at least some embodiments, the method may include inserting an implant into one or more openings formed in the bone by a tool attachment. When the handle assembly is coupled to the distal end of the arm of the humeral guide, the action of inserting an implant into one or more openings formed in the bone may include coupling the implant adapter to the distal end of the handle assembly and bringing the implant into contact with the implant adapter. The method may further include capturing a guide pin using the implant adapter in a position close to the humeral resection surface, engaging the handle assembly with the insertion tool, and supplying insertion force to the implant adapter and therefore to the implant to insert the implant into one or more openings formed in the bone. In at least some such embodiments, the method may include inserting a prosthesis in a position close to the humeral resection surface and coupling the prosthesis to the implant.
[0040] The methods provided herein can be performed using a subscapularis tendon that remains intact throughout the procedure. In at least some embodiments, the tool attachment can be inserted into the humeral resection surface at least one of the following: above or below the intact subscapularis tendon. If the distal end of the humeral sizer attachment is positioned close to the humeral resection surface, the distal end of the humeral sizer attachment can be inserted into close to the humeral resection surface at least one of the following: above or below the intact subscapularis tendon. Furthermore, if the bone preparation device is coupled to the distal end of the handle assembly and positioned close to the humeral resection surface, the distal end of the handle assembly and the bone preparation device can be inserted into close to the humeral resection surface at least one of the following: above or below the intact subscapularis tendon. In at least some embodiments, the method may further include increasing visibility by manipulating the subscapularis tendon to move it away from its natural position while keeping it intact.
[0041] Another embodiment of the surgical method includes connecting a humeral guide to the humerus and engaging the lateral cortex of the humerus with the distal end of a drill cannula. The drill cannula is movably connected to the proximal end of the arm of the humeral guide, and the humeral guide defines a path of movement through the humerus that is collinear with the longitudinal axis of the drill cannula. The method may also include connecting the proximal end of a humeral sizer attachment to the distal end of the arm of the humeral guide and positioning the distal end of the humeral sizer attachment in a position close to the humeral resection surface on the opposite side of the lateral cortex, close to the glenoid fossa. The distal end of the humeral sizer attachment includes a plate having a central opening formed internally. Furthermore, the method includes positioning the central opening of the plate at the distal end of the humeral sizer attachment to align with the longitudinal axis of the drill cannula.
[0042] The method may also include passing a drill cannula through a guide pin and through the central opening of the humeral sizer attachment. In at least some such embodiments, the guide pin can be positioned centrally on the humeral resection surface and substantially perpendicular to the humeral resection surface. Optionally, the humeral sizer attachment may have a sizer plate coupled to its distal end. In at least some embodiments, the method may further include coupling one or more sizer plates to the distal end of the humeral sizer attachment and evaluating at least one of the size of the humeral resection surface, the size of an implant to be disposed on the humeral resection surface based on the size of the humeral resection surface, and / or the size of a prosthesis to be implanted on the humeral resection surface, based on at least one of the positioning of one or more sizer plates relative to the humeral resection surface or the size of one or more sizer plates coupled to the distal end of the humeral sizer attachment.
[0043] The operation of connecting the humeral guide to the humerus may include inserting at least one bone pin into the humerus, the bone pin being coupled to a pin receiving component that can be coupled to the humeral guide. In at least some such embodiments, the method may include adjusting the entry position of the bone pin into the humerus and / or the entry angle of the bone pin into the humerus into which at least one bone pin is inserted, and in at least some cases, it may include adjusting both the entry position of the bone pin into the humerus and the entry angle of the bone pin into the humerus into which at least one bone pin is inserted. The operation of inserting at least one bone pin into the humerus may include moving at least one bone pin over multiple degrees of freedom. For example, if the pin receiving component includes a clamp for the bone pin, moving at least one bone pin over multiple degrees of freedom may include adjusting the clamp for the bone pin to move over multiple degrees of freedom. Adjusting the bone pin clamp to move across multiple degrees of freedom may include selectively unlocking and locking the bone pin relative to the bone pin clamp to adjust the entry position of the bone pin into the humerus and / or the entry angle of the bone pin into the humerus into which at least one bone pin is inserted. Alternatively or additionally, adjusting the bone pin clamp to move across multiple degrees of freedom may include selectively unlocking and locking the bone pin clamp relative to the humeral guide to adjust the entry position of the bone pin into the humerus and / or the entry angle of the bone pin into the humerus into which at least one bone pin is inserted.
[0044] The operation of connecting the proximal end of the humeral sizer attachment to the distal end of the arm of the humeral guide may include sliding an adapter disposed at the distal end of the arm toward the humeral sizer attachment to securely connect the humeral sizer attachment to the distal end of the arm of the humeral guide. The method may also include disengaging the humeral sizer attachment from the distal end of the arm of the humeral guide. In at least some embodiments, engaging the distal end of the drill cannula with the lateral cortex of the humerus may include ratcheting the drill cannula toward and toward the lateral cortex of the humerus.
[0045] The method provided herein can be performed using a subscapularis tendon that remains intact throughout the procedure. In at least some embodiments, the distal end of the humeral sizer attachment and the plate can be inserted into the humeral resection surface either above or below the intact subscapularis tendon. In at least some embodiments, the method may include manipulating the subscapularis tendon to move it away from its natural position while keeping it intact, thereby increasing its visibility.
[0046] Any feature or modification described herein can be applied in several different combinations to any particular aspect or embodiment of the present disclosure. There is no explicit description of any particular combination, simply to avoid unnecessary length or repetition. [Brief explanation of the drawing]
[0047] This disclosure will be better understood by reading the following detailed description in conjunction with the attached drawings. [Figure 1A] This is a lateral, partially translucent view of an example of anatomical shoulder joint reconstruction, including a conventional anatomical glenoid implant connected to the scapula. [Figure 1B] This is a translucent lateral view of an example of reverse shoulder joint reconstruction, including a conventional reverse glenoid implant connected to the scapula. [Figure 2] This is a perspective view of the human humeral glenoid joint and associated joint cavity, including the humerus with its humeral resection surface and elongated shaft. [Figure 3A] This is a top perspective view of one embodiment of a humeral guide, which includes a rigid arm, a hub, a support rod, and a clamp for a bone pin. The figure also includes a drill cannula associated with the hub and a humeral sizer attachment coupled to the rigid arm. [Figure 3B] Figure 3A is a side perspective view of the rigid arm, hub, support rod, and bone pin clamp of the humerus guide, as well as the drill cannula. [Figure 4] Figure 3A is a side view of the rigid arm. [Figure 5] This is a side view of one of the support rods shown in Figure 3A. [Figure 6A] This is a side view of one of the bone pin clamps shown in Figure 3A. [Figure 6B] This is a side perspective view of the bone pin clamp shown in Figure 6A, which is fixed to the support rod in Figure 5 and the rigid arm in Figure 4. [Figure 6C] Figure 6A is an exploded perspective view of a bone pin clamp. [Figure 6D] Figure 3A shows a side view of another embodiment of a bone pin clamp that can be used in conjunction with the humerus guide, the bone pin clamp receiving both a support rod and a bone pin. [Figure 6E] Figure 6D is an exploded perspective view of the bone pin clamp, and also shows the support rod and bone pin shown in Figure 6D. [Figure 7] This is a side view of one embodiment of a bone pin that can be used in conjunction with the humeral guide shown in Figure 3A. [Figure 8] Figure 3B is a side view of the drill cannula. [Figure 9] This is a side view of one embodiment of a drill bit that can be used in conjunction with the humerus guide in Figure 3A. [Figure 10A] Figure 3A is a top view perspective of the humerus sizer attachment. [Figure 10B] Figure 10A is a bottom perspective view of the humerus sizer attachment. [Figure 10C] This is an exploded side perspective view of another embodiment of the humeral sizer attachment. [Figure 10D] Figure 10C is a bottom view of the humerus sizer attachment. [Figure 10E] Figure 10C is a side perspective view of a humeral sizer attachment to which one embodiment of a sizer plate is fixed. [Figure 10F] Figure 10E is a bottom perspective view of the sizer plate. [Figure 10G]Figure 10C shows a top perspective view of the sizer plate after it has been removed from the humeral sizer attachment and from the joint cavity, as shown in Figure 10F. [Figure 10H] Figure 10C is a top perspective view of another sizer plate attached to the humerus sizer attachment. [Figure 11] This is a side perspective view of another embodiment of a humeral guide, which includes a rigid arm, a hub, a guide, a collar, a lock block, a hub knob, a guide knob, a base, and an operating post, and this figure also includes a drill cannula associated with the hub and a humeral sizer attachment coupled to the rigid arm. [Figure 12A] Figure 11 is an enlarged side perspective view of the rigid arm, hub, guide, collar, lock block, and drill cannula. [Figure 12B] Figure 11 is a side perspective view of the hub. [Figure 12C] Figure 11 is a top perspective view of the rock block. [Figure 12D] Figure 11 is a side perspective view of the carriage knob, lock block, and drill cannula, further illustrating the nut with cannula engagement teeth, with the hub hidden from view. [Figure 12E] Figure 11 is a top perspective view of the guide. [Figure 12F] Figure 11 is a color top perspective view. [Figure 12G] Figure 11 is a side perspective view of the guide knob. [Figure 12H] Figure 11 is a side perspective view of the guide knob, collar, base, and drill cannula, with the guide hidden from view. [Figure 12I] Figure 11 is a side perspective view of the base and operating post. [Figure 13]Figure 2 is a lateral perspective view of the humeral guide of Figure 3A coupled to the humeral resection surface, which also includes a universal handle assembly coupled to the rigid arm of the humeral guide via an adapter, the handle assembly having a reamer attachment coupled thereto, the reamer attachment is shown translucently, and the drill bit of Figure 9 is positioned within the drill cannula. [Figure 14] Figure 13 is a perspective view of the adapter. [Figure 15A] Figure 13 is a side perspective view of the universal handle assembly. [Figure 15B] Figure 15A is a bottom perspective view of the distal end of the mounting portion of the handle assembly. [Figure 15C] Figure 13 is an exploded side perspective view of the handle assembly. [Figure 16A] Figure 13 is a side view of the reamer attachment. [Figure 16B] Figure 16A is an exploded side perspective view of the reamer attachment. [Figure 16C] Figure 16A is a side cross-sectional view of the reamer attachment coupled to the handle assembly of Figure 15A, with the drill bit of Figure 9 in relation to it, and the reamer attachment is shown translucently. [Figure 17A] This is a side view of another embodiment of the reamer attachment. [Figure 17B] Figure 17A is an exploded side perspective view of the reamer attachment. [Figure 17C] Figure 17A is a partially translucent side perspective view of a portion of the reamer attachment, with a portion of it obscured from view, and this figure includes a guide pin that engages with the capture plate of the reamer attachment. [Figure 17D] Figure 17C is a bottom view of the capture plate and guide pin. [Figure 18A] This is an exploded side perspective view of one embodiment of a humeral blazer attachment. [Figure 18B] Figure 18A is a bottom view perspective of the humeral blazer attachment. [Figure 18C] Figure 18A is a top view perspective of the humeral blazer attachment. [Figure 19A] This is a lateral perspective cross-sectional view of another embodiment of the humeral blazer attachment, in which the humeral blazer attachment is connected to a guide pin. [Figure 19B] Figure 19A is a partially translucent top perspective view of the humeral blazer attachment, with some components shown to be semi-transparent. [Figure 20] Figure 3A is a reproduction showing a top perspective view of a humeral guide including a rigid arm, a hub, a support rod, and a clamp for a bone pin. This figure also includes a drill cannula associated with the hub and a humeral sizer attachment coupled to the rigid arm. [Figure 21A] Figure 20 is a top view of the humeral sizer attachment, which is aligned with and centered on the humeral resection surface shown in Figure 2. [Figure 21B] Figure 21A is a perspective view of the humeral sizer attachment and the humeral resection surface. [Figure 22A] This is a side perspective view of a drill cannula connected to the humerus, having a humeral guide (Figure 20) connected to the humeral resection surface (Figure 2) by a humeral sizer attachment, and a drill bit (Figure 9) positioned within the drill cannula. [Figure 22B] Figure 22A shows a humeral guide, humeral sizer attachment, and a lateral perspective view of the humeral resection surface, the humeral guide having a plurality of bone engagement pins associated with it, as shown in Figure 7. [Figure 22C] Figure 22B is a side perspective view of the humeral guide, showing the drill bit passing through the drill cannula and the humeral resection surface, forming a humeral penetration hole in the humerus. [Figure 22D] Figure 22C is a lateral perspective view of the humeral guide with the drill bit removed from the drill cannula. [Figure 23A] This is a lateral perspective view of the humeral sizer attachment shown in Figure 22D, which has been removed from the humeral guide in Figure 22D at the surgical site. [Figure 23B]This is a side perspective view of the adapter shown in Figure 14, which is connected to the arm of the humerus guide in Figure 23A. [Figure 24A] This is a reproduction of Figure 16A, showing a side perspective view of the reamer attachment in Figure 13. [Figure 24B] This is a side perspective view of the reamer attachment in Figure 24A before it is coupled to the handle assembly in Figure 15A. [Figure 24C] This is a side perspective view of the reamer attachment of Figure 24B, coupled to the handle assembly of Figure 24B. [Figure 25A] Figure 24C is a lateral perspective view of the handle assembly and reamer attachment, which are connected to a portion of the humeral guide in Figure 23B, with the reamer attachment positioned close to the humeral resection surface. [Figure 25B] Figure 25A shows the reamer attachment and handle assembly, and Figure 22D shows a side perspective view of the drill bit, with the reamer of the reamer attachment shown as semi-transparent. [Figure 25C] Figure 25A shows a humeral guide coupled to the humerus having a humeral resection surface, and Figure 25B shows a lateral perspective view of a reamer attachment attached to a handle assembly, the handle assembly being coupled to the humeral guide, engaging with a drill bit, and moving to ream the humeral resection surface, the reamer attachment being shown translucently. [Figure 25D] Figure 25C is a side perspective view of the reamer attachment mounted on the handle assembly, which is substantially coplanar with the humeral resection surface. [Figure 25E] This is a side perspective view of the reamer attachment mounted on the handle assembly shown in Figure 25D, disengaged from the humeral resection surface. [Figure 25F] Figure 25E is a side perspective view of the handle assembly with the reamer attachment disengaged from the humerus guide. [Figure 25G]Figure 25F is a lateral perspective view of the humeral resection surface reamed with a reamer attachment, where the humeral guide is still attached, and the handle assembly, and therefore the reamer attachment, is no longer attached to the humeral guide. [Figure 25H] This is a side perspective view of the reamer attachment in Figure 25F, disengaged from the handle assembly in Figure 25F. [Figure 26] Figure 25H shows a side perspective view of the humeral blazer attachment (Figure 18C) coupled to the mounting portion of the handle assembly. [Figure 27A] Figure 25G is a lateral perspective view of the humeral guide, where the combination of the humeral blazer attachment and handle assembly (Figure 26) is coupled to the humeral guide and positioned close to the reamed humeral resection surface for subsequent broaching. [Figure 27B] Figure 27A is a side perspective view of an insertion tool having an end effector configured to supply insertion force to a humeral blazer attachment and handle assembly. [Figure 27C] Figure 27B is a top perspective view of the embedded tool end effector. [Figure 27D] Figure 27C is a side perspective view of the insertion tool, coupled to the handle assembly having the blazer attachment shown in Figure 27A. [Figure 27E] Figure 27D is a side perspective view of the insertion tool and handle assembly, showing additional aspects of the humeral guide and surgical site, along with the insertion tool used to supply insertion force to the humeral blazer attachment. [Figure 27F] Figure 27E is a detailed side perspective view of the humeral blazer attachment coupled to the handle assembly, which is substantially coplanar with the surface of the reamed humeral resection surface. [Figure 27G] Figure 27F shows a side perspective view of the humeral blazer attachment coupled to the handle assembly, disengaged from the broached and reamed humeral resection surface. [Figure 27H]Figure 27G is a side perspective view of the handle assembly disengaged from the humerus guide. [Figure 28A] This is a perspective view of a broached and reamed humeral resection surface, with the humeral driver shaft located proximally. [Figure 28B] Figure 28A is a top perspective view of the insertion tool used to grasp the implant to be embedded in the broached and reamed humeral resection surface. [Figure 28C] Figure 28B is a lateral perspective view of the implant seated in the broached and reamed humeral resection surface shown in Figure 28A, with the drill bit shown in Figure 25C positioned proximally in place of the humeral driver shaft shown in Figure 28A. [Figure 28D] Figure 28C is a lateral perspective view of the implant seated in the broached and reamed humeral resection surface shown in Figure 28A, with the humeral driver shaft of Figure 28A located proximal to it. [Figure 29A] This is a perspective view of an implant adapter. [Figure 29B] This is a side perspective view of the implant adapter shown in Figure 29A, coupled to the mounting portion of the handle assembly shown in Figure 26. [Figure 29C] This is a side perspective view of the implant adapter coupled to the handle assembly shown in Figure 29B, which engages with the implant shown in Figure 28C. [Figure 29D] Figure 29C shows a side perspective view of the implant, implant adapter, and handle assembly coupled to the humeral guide in Figure 27H. [Figure 29E] Figure 27B is a side perspective view of the implantation tool coupled to the handle assembly having the implant adapter shown in Figure 29D. [Figure 29F] Figure 29E is a side perspective view of the implant adapter coupled to the handle assembly, disengaged from the broached and reamed humeral resection surface. [Figure 29G] This is a side perspective view of the implant adapter of Figure 29F, disengaged from the handle assembly of Figure 29F. [Figure 29H] This is a side perspective view of the distal end of the implantation tool shown in Figure 27B, to which the implant adapter shown in Figure 29A is attached. [Figure 29I] Figure 29F shows a broached and reamed humeral resection surface, and Figure 29H shows a side perspective view of the insertion tool and implant adapter used in this surface. [Figure 30A] Figure 28C is a side perspective view of the implant positioned within the broached and reamed humeral resection surface. [Figure 30B] Figure 28C is a lateral perspective view of the humeral guide in Figure 20 after the implant has been broached and reamed into the humeral resection surface. [Figure 31A] This is a side perspective view of one embodiment of an insertion tool for grasping at least one of a humeral head trial or humeral head prosthesis. [Figure 31B] Figure 31A is a side perspective view of the insertion tool used to position the humeral head trial in the implant positioned within the broached and reamed humeral resection surface shown in Figure 30A. [Figure 31C] This is a frontal perspective exploded view of one embodiment of a humeral head prosthesis. [Figure 31D] This is a side view of another embodiment of an insertion tool for grasping at least one of a humeral head trial or humeral head prosthesis, the tool grasping the humeral head prosthesis shown in Figure 31C. [Figure 31E] Figure 30A shows the broached and reamed humeral resection surface, and Figure 31C shows the humeral head prosthesis positioned above the implant, in a lateral perspective view. [Figure 31F] Figure 27B is a side perspective view of the implantation tool, which has an implant-engaging end effector instead of the end effector shown in Figure 27B. The implant-engaging end effector is coupled to the humeral head prosthesis of Figure 31E and supplies the implantation force to the humeral head prosthesis. [Figure 31G] Figure 31F is a detailed side perspective view of the implantation tool and humeral head prosthesis. [Modes for carrying out the invention]
[0048] To provide a comprehensive understanding of the structure, function, manufacture, and principles of use of the devices and methods disclosed herein, specific embodiments are described below. One or more examples of these embodiments are illustrated in the accompanying drawings. Those skilled in the art will understand that the devices and methods specifically described herein and illustrated in the accompanying drawings are non-limiting embodiments, and that the scope of this disclosure is defined solely by the claims. Feature elements illustrated or described in relation to one embodiment may be combined with feature elements of other embodiments. Such modifications and variations are intended to be included within the scope of this disclosure. Thus, not all aspects and features of an embodiment may be described in relation to each embodiment, but those aspects and features are applicable to various embodiments unless the description or understanding is contrary to that. Furthermore, while some human anatomical structures are shown, those skilled in the art will understand the location of omitted anatomical structures unless other parts of the same region of anatomical structure are explicitly shown. In at least some examples, omitted anatomical structures are not included to improve visualization for the provided description and illustration. Those skilled in the art will still understand how the devices and methods provided herein can interact with such omitted anatomical structures without the need for their specific illustration.
[0049] In some embodiments, the movement of one component and / or part of the body is described in relation to another component, but those skilled in the art will recognize that other movements are also possible. In addition, various terms may be used interchangeably throughout the disclosure, which will be understood by those skilled in the art. As an unrestricted example, the terms subscapularis muscle, subscapularis tissue, subscapularis tendon, subscapularis muscle, and other variations thereof may be used interchangeably, and unless several such terms appear, they are encompassed by the use of other terms. As a further unrestricted example, the terms “prosthesis” and “implant” may be used interchangeably, and the terms “broach” and “braze” (and other forms, e.g., broaching and brazing) may be used interchangeably.
[0050] To the extent that this disclosure describes “joining,” “fitting,” or other similar terms relating to bringing an instrument or tool into contact with a part of a patient’s anatomical structure, such as bone, this term includes engagement or contact between an instrument or tool and a part of a patient’s anatomical structure, and does not necessarily require any fixing or bonding relationship between the two, unless otherwise indicated or understood by a person skilled in the art, to essentially form a fixing / bonding relationship and / or for such fixing / bonding required for proper performance. Furthermore, to the extent that linear or circular dimensions are used in the description of the disclosed devices, components, systems, and methods, such dimensions are not intended to limit the type of shape or size of such devices, components, and systems. A person skilled in the art will recognize that equivalents of such linear and circular dimensions can be readily determined for any geometric shape (for example, references to width and diameter can be readily adapted by a person skilled in the art to circular and linear dimensions, respectively). For this purpose, to the extent that the term “perimeter” is used, a person skilled in the art will understand that “outer circumference” or “edge” are equally acceptable terms to use, unless the equivalent of what is described is circular. Similarly, to the extent that this disclosure discusses identifying a center or center point or other similar location (e.g., substantially center), and / or positioning and / or passing an instrument through and / or at the center or center point or other similar location (e.g., substantially center), a person skilled in the art will understand that in at least some cases the “center” or “center point” may be substantially centered with respect to the surface being referenced, and / or another location that is not centered may be used, and such location may be selected by the surgeon on at least in part, among other factors, the anatomical structure of the patient, the configuration of the instrument and / or tool being used, and / or the surgeon’s preference.
[0051] The size and shape of the components of the humeral guide, handle assembly, and related components, instruments, etc., may depend, at least in part, on the size and shape of other components used in conjunction with the guide and related components, the anatomical structure of the object being operated on, and the type of procedure being performed. Furthermore, insofar as each feature, aspect, or step is described as “first” or “second,” such numerical order is generally arbitrary, and therefore such numbering may be interchangeable. Similarly, the order in which actions are presented in a claim is by no means limiting. An order is applicable only if the claim explicitly requires a particular order. For example, a claim describing passing a guide pin through a second humeral penetration hole is described after the description of introducing the handle assembly to the surgical site, but may be performed before such introduction, for example, because the guide pin was used to form a second humeral penetration hole and / or was used in a humeral sizer attachment.
[0052] As used herein, terms such as “proximal” and “distal” are primarily used as reference points to describe two parts or ends of an instrument, tool, component, device, system, or location within the body. Therefore, unless explicitly indicated, no specific location is assigned meaning to “proximal” or “distal” without distinguishing one from the other. For example, what is referred to herein as a proximal part or proximal end may be considered distal during operation, and similarly, what is referred to herein as a distal part or distal end may be considered proximal during operation.
[0053] In this disclosure, components of a similar number in various embodiments generally have similar characteristics if they are of a similar nature and / or serve a similar purpose, unless otherwise specified or understood by those skilled in the art. To the extent that terms such as “approximately,” “about,” and “substantially” are used herein, those skilled in the art will understand the scope that these words convey in the context of their use. During surgical procedures, among other positioning, it can be difficult to obtain a particular arrangement of degrees of freedom, a particular distance of degrees of freedom, and / or a particular alignment of degrees of freedom, and therefore the use of terms such as “approximately,” “about,” and “substantially” is intended to address this difficulty. Those skilled in the art will understand that what constitutes how close a particular dimension or arrangement is should still fall within the scope of the quantifications and descriptions provided herein. Even when such terms are not used and the dimension or arrangement includes terms of number or arrangement (e.g., “parallel” is used instead of “substantially parallel”), those skilled in the art will understand that unless expressly indicated, terms such as “approximately,” “about,” and “substantially” are also applicable to those dimensions and arrangements. Notwithstanding the foregoing, a person skilled in the art will understand that terms such as “approximately,” “about,” and “substantially” encompass dimensions that are at least ±10%, 10°, etc. of the quantity provided, or ±5%, 5°, etc. of the quantity provided, unless otherwise indicated or known to a person skilled in the art. The disclosure also understands that a person skilled in the art will, in consideration of the disclosure, understand preferred arrangements for various features of the disclosed systems, devices, instruments, and / or implants, and any relevant components thereof, and therefore will understand other possible arrangements or positions without affecting the overall procedure, unless it is expressly indicated that a particular arrangement or position is required to the extent that a particular arrangement or position is described.
[0054] This disclosure, among other operations provided herein, concerns preparing the resected surface of the humerus (referred to herein as the “humeral resection surface”) by reaming and / or broaching (broaching may also be referred to herein as blazing) to enable the reception of an implant and / or prosthesis (e.g., a stemless implant and / or humeral head prosthesis), and inserting the implant and / or prosthesis into the surgical site. This procedure enables proper preparation of the surgical site and tissue-sparing insertion of the implant (sometimes also referred to as a prosthesis) into the surgical site, leaving the major rotator cuff muscles and tendons, such as the subscapularis tendon, attached to the respective bones. This procedure allows operations such as reaming, broaching, and implantation to be performed, at least in part, through narrow rotator cuff gaps that have not been previously accessible, and does not require the removal of one or more tendons and / or muscles from the bone. In addition to providing such procedures, this disclosure provides a variety of instruments, devices, tools, instruments, and associated attachments that enable the performance of these tissue-sparing procedures.
[0055] Relevant anatomical structures for shoulder joint procedures This disclosure relates to systems, devices, and methods for preparing a humeral resection surface to receive an implant and / or prosthesis, and more specifically, to devices and related methods for assisting reaming and broaching of the humeral resection surface to make it receptive to an implant and / or prosthesis (also known in other terms as a prosthesis implant). This specification discloses embodiments of corresponding devices for use with such guides, including surgical guides described as humeral guides (other terms that can be used for humeral guides include humeral guide frames, humeral frames, guides, or frames), and devices for preparing a humeral resection surface to receive an implant and / or prosthesis. Two such bone preparation devices that can be used with such guides include a device for reaming bone and a device for broaching bone.
[0056] A humeral prosthesis and / or implant may be a humeral head prosthesis, such as the prosthesis 10 in Figure 1A, which includes a convex humeral head 14 intended to mimic the anatomically correct humeral head in anatomical shoulder arthroplasty. The convex humeral head 14 of the prosthesis is then received by a concave receiving prosthesis, such as the prosthesis 24 in Figure 1A. Alternatively, as a further example, a humeral implant or prosthesis may be a concave receiving humeral prosthesis, such as the prosthesis 50 in Figure 1B, which includes a concave receiving surface 54 intended to mimic the glenoid surface formed on the humerus to receive a prosthesis head component associated with the glenoid fossa, such as the convex prosthesis head 60 in Figure 1B, as used in reverse shoulder arthroplasty. The prosthesis 10 in Figure 1A includes a stem as provided herein, but in other examples, an implant or prosthesis equivalent to the prosthesis 10 may be stemless.
[0057] Whether or not implants and / or prostheses are to be placed for anatomical or reverse shoulder joint procedures, the humeral resection surface must be adequately prepared to receive the implants and / or prostheses, so that such implants and / or prostheses can be securely bonded to the humerus. Specifically, the humeral resection surface is typically reamed and / or broached to a geometric shape corresponding to the geometric shape of the chosen implant and / or prosthesis. The humeral guides of this disclosure enable surgeons to perform these preparation steps, as well as other steps associated with shoulder repair procedures, such as implanting the implants and / or prostheses. Furthermore, the guides include various features that enable surgeons to perform these repairs in smaller spaces, such as in procedures performed using tissue-preserving techniques that do not separate the subscapularis tendon from its natural attachment point. In other words, the subscapularis muscle remains intact during the procedure. Notwithstanding the foregoing, the instruments and techniques provided herein can be used for training and / or in conjunction with more conventional procedures in which the subscapularis muscle is separated.
[0058] This disclosure provides tissue-preserving procedures in which the subscapularis tendon remains intact throughout the procedure. Maintaining the attachment of the subscapularis tendon means that the space for performing the procedure is more limited, and the devices, tools, and systems disclosed herein enable the same type of procedure (e.g., shoulder arthroplasty) to be performed with less harm and injury to the tissue and surrounding anatomical structures. In some embodiments, for example, when a tight joint is involved, a portion of the subscapularis tendon may be cut or sacrificed to increase access to the joint. This may involve, for example, cutting a few millimeters from the upper part of the subscapularis tendon, which can then be sutured back after sufficient access has been obtained to perform the procedure. In further examples, less than about 10% of the subscapularis muscle may be sacrificed, while more than about 90% of the subscapularis muscle may remain intact. Even when a portion of the subscapularis tendon and / or other tendons are cut or sacrificed, this can be considered tissue preservation for the purposes of this disclosure and can be considered to involve the subscapularis muscle remaining intact. In other words, “undamaged” does not necessarily mean completely undamaged, and may include those that are not completely undamaged and / or include the subscapularis tendon that is “substantially undamaged,” and “substantially undamaged” may include any case where 20% or less of the subscapularis muscle is scarred, or 15% or less of the subscapularis muscle is scarred, or 10% or less of the subscapularis muscle is scarred.
[0059] Generally, the disclosed humeral guides are attached to a humerus from which the humeral head has been resected in order to define the angle at which bone holes are drilled into the humerus (sometimes referred to herein as the trajectory of the bone hole). Alternatively, or additionally, the humeral guide may be fitted to or joined to the humeral resection surface resulting from the resection of the humeral head. The bone holes may be drilled from the lateral surface of the humerus (e.g., the lateral cortex), exiting centrally or substantially centrally, and perpendicular to or substantially perpendicular to the humeral resection surface. Once the bone holes are drilled, the guide can maintain its position on the humerus and further assist in guiding actions such as reaming and / or broaching of the humeral surface. As will be described in more detail below, the forces required for reaming and / or broaching may, in at least some cases, be supplied through the humeral penetration holes by connecting a suitable attachment to the guide and using lateral tensile forces through the bone holes.
[0060] The surgical techniques provided herein generally involve a transhumeral approach, meaning the approach is from a lateral position of the humerus. More specifically, in at least some cases, as provided herein, the transhumeral approach can be made from a position that allows for a surgical access hole perpendicular or substantially perpendicular to the humeral cross-section, defined by a suitable instrument (e.g., a humeral resection guide as referenced below) or otherwise created. Based on the created cross-section plane, the humeral penetration hole can be initiated at an anterolateral position that can be defined by the guide components provided herein to ensure plane-orthogonal access.
[0061] Figure 2 shows the patient's resected glenoid joint 1010, which is part of the patient's shoulder region. The glenoid joint 1010 is also referred to herein, among other names, as the joint cavity 1010 or the shoulder joint 1010. The natural shoulder joint 1010 includes the humerus 1012 and the scapula 1016. The humerus 1012 includes the head (shown resected to form the humeral resection surface 1015, although those skilled in the art will know what the unresected head looks like), the elongated shaft 1014, and the lateral cortex 1023, sometimes also called the lateral surface. The humeral resection surface 1015 has a substantially circular cross-sectional area, but in other examples it can be considered elliptical or other shapes. The scapula 1016 includes a concave surface or glenoid fossa 1018. During movement of the shoulder joint 1010, the humeral head articulates within the glenoid fossa 1018 of the scapula 1016. If the natural shoulder joint 1010 is injured by trauma or undergoes degenerative changes, the surgeon may replace either or both of the natural convex humeral head and glenoid fossa 1018 with prosthetic components using either an anatomical or reverse procedure, as detailed above. Although not shown, those skilled in the art will understand that the subscapularis tendon extends from the scapula 1016 to the humerus 1012, and that in tissue-preserving procedures in which the subscapularis tendon is not separated from the humerus (i.e., the subscapularis tendon remains intact), the subscapularis tendon may be manipulated to improve visibility to the surgical site, for example, by using a displacement wrap that is positioned around at least a portion of the subscapularis tendon and is tensioned to move the tendon downward or upward. Non-limiting examples of such wraps are disclosed in U.S. Patent Application Publication No. 2024 / 0108433, entitled "Devices and Methods for Minimizing Damage to Soft Tissue during a Surgical Procedure," the contents of which are incorporated herein by reference in their entirety.
[0062] Additional tools, such as double-curved Hohmann retractors, posterior cuff retractors (e.g., twist Hohmann retractors), anterior subscapularis retractors (e.g., right-angle Hohmann retractors), inferior subscapularis retractors (e.g., subscap Hohmann retractors), and / or other types of retractors (e.g., double-curved Hohmann retractors), can be used to further manipulate the surrounding soft tissue. However, even when displacement wraps and / or other tools are used, the amount of space created is typically insufficient for conventional bone preparation instruments and / or tools used to perform various bone preparation actions. In such cases, typically, the rotator cuff gap 1020, which can be defined between the superior edge of the subscapularis muscle and the anterior edge of the supraspinatus muscle, provides a first superior entry point for accessing the humeral resection surface 1015, and the inferior edge 1021 of the subscapularis muscle, which can be defined as the inferior lower edge of the subscapularis muscle in the lever of the anterior circumhumeral vessels (i.e., the "Three Sisters"), provides a second inferior entry point for accessing the humeral resection surface 1015.
[0063] In addition to the fact that the disclosed procedure can be performed while preserving the subscapularis muscle intact and / or without resecting it, and that the device and system enable this, the disclosure also enables the disclosed procedure to be performed without the need to rotate the humerus externally to allow access to the joint cavity. In contrast, the procedure, device and system enable the humerus not to be dislocated from its joint during the surgical technique provided herein.
[0064] As illustrated, the humeral head is typically removed or resected as part of preparing the surgical site to receive an implant and / or prosthesis, leaving a flat humeral resection surface 1015. The resection can be performed using a humeral resection guide, also known as a humeral resection guide, which is designed, among other things, for use in tissue-preserving procedures. Non-limiting examples of such resection guides are disclosed in U.S. Patent Provisional Application No. 63 / 579,942, filed August 31, 2023, entitled “Humeral Cut Guides, and Related Methods, for Use in Tissue Sparing Shoulder Arthroplasties,” and in U.S. Patent Non-Provisional Application, entitled “Humeral Resection Guides, and Related Methods, for Use in Tissue Sparing Shoulder Arthroplasties,” filed on the same date as this specification, the contents of which are incorporated herein by reference in their entirety.
[0065] In anatomical arthroplasty, the first, or at least early, step in surgery to remove the humeral head to replace it, or in reverse arthroplasty to obtain a humeral prosthesis that mimics the receptive surface of the glenoid fossa, is the resection of the humeral head. This is typically done to leave a flat plane to which the prosthesis will ultimately be fixed for use as an implant. The resection or cutting is generally performed at the articular margin, forming the humeral resection plane 1015. Thus, the cutting plane or resection plane (among other terms, also called the cutting plane) for the procedure, as indicated by the line CP transverse to the humeral resection plane 1015, is typically aligned with the articular resection plane 1015 so that the figure of the humeral resection plane 1015 can also serve as the figure of the cutting plane CP. As shown in the figure, the humeral resection plane 1015 is substantially aligned with the natural inclination angle α so that the cutting plane CP is at the natural inclination angle α, allowing for a proper mimicry of the anatomical structure. Those skilled in the art will understand that, to the extent that the implant used alters the angle that would otherwise be the natural inclination angle α, the resection and cutting, and therefore the humeral resection surface 1015 and the cutting surface CP, may be performed at an angle different from the indicated angle. This different angle at which the cutting surface CP is formed may be planned to take into account the effects caused by the implant, and as a result, the resulting angle formed when the implant is fixed to the humeral resection surface 1015 will mimic the natural inclination angle α.
[0066] While this disclosure is often described herein as applicable to tissue-preserving procedures in which the subscapularis tendon remains intact, those skilled in the art will understand that the devices, systems, and techniques described herein can also be used in conjunction with procedures in which the subscapularis tendon is separated from the humerus.
[0067] Conventional tools for preparing the humeral resection surface for prosthesis reception rely on adequate visibility and access to the joint cavity, which is provided by removing the subscapularis tendon and externally rotating the humerus 1012 so that the humeral resection surface 1015 faces laterally to the glenoid cavity 1018. With sufficient space, the surgeon can use a downward force against the humeral resection surface to ream and broach (sometimes called blazing) the surface, thereby forming the geometric shape within the humeral resection surface 1015 corresponding to the selected prosthesis. For tissue-preserving procedures, as well as other types of procedures performed in a more confined space and / or with more limited tissue displacement, devices such as humeral guides of the nature provided herein are required.
[0068] First embodiment of the humerus guide Figures 3A and 3B show an embodiment of a surgical device referred to herein as a humeral guide, guide, frame, surgical guide, surgical guide frame, or humeral guide frame 300. The humeral guide 300 can be used in a variety of surgical procedures and / or for a variety of purposes, but in at least some examples it can be used to maintain positional guidance during various steps in tissue-preserving shoulder arthroplasty in which the subscapularis muscle remains attached to the scapula and proximal humerus.
[0069] rigid arm The humeral guide 300 may include a rigid arm 310, as shown separately from the guide 300 in Figure 4. The rigid arm 310 may include a proximal portion 310p configured to receive a drill cannula 350, also referred to as a cannula, bullet portion, or bullet portion with cannula, as shown in Figures 3A-3B, and a distal portion 310d configured to receive one or more modular attachments that may be used in conjunction with the guide. These attachments may include, for example, a humeral sizer attachment 340 as shown in Figure 3A, and at least a handle assembly 1400 as shown in Figure 13.
[0070] The proximal portion 310p of the arm 310 may include a carriage or a hub 320. The hub 320 may be integrally formed as part of the arm 310, or it may be a separate component attached to the arm 310. In some embodiments, it may be the proximal portion 310p of the arm 310, so the hub 320 is not considered a separate component from the arm 310, and the proximal portion 310p is configured to receive the drill cannula 350. Those skilled in the art will understand that in such cases, various mating features may be provided on the proximal end of the proximal portion 310p of the arm 310 to receive the hub 320, selectively connect to and disconnect from the arm 310. In some embodiments, the proximal end of the proximal portion 310p of the arm 310 may be connected to the hub 320 by press-fitting or welding.
[0071] The hub 320 may include various feature parts, such as a cannula-receiving opening 322, to assist in interaction with other parts of the guide 300 and / or components used in conjunction with the guide 300. The cannula-receiving opening 322 may extend along the entire length of the body of the hub 320. The opening 322 may be substantially cylindrical in shape and may be sized to receive a drill cannula 350 in its entirety. In other embodiments, such an opening 322 may be formed in the proximal portion 310p of the arm, which has a similar size and configuration to the rest of the arm, rather than the illustrated hub 320. When positioned within the opening 322, the drill cannula 350 can translate along a longitudinal axis LC extending through the cannula-receiving opening 322, and the longitudinal axis LC defines the path of movement for the drill cannula 350.
[0072] As best shown in Figure 3B, the locking component may be contained within the hub 320 and configured to lock a drill cannula, such as a drill cannula 350, into the opening 322 at a position in contact with the lateral cortex 1023 of the humerus 1012. In the illustrated embodiment, the internal locking component includes a spring-loaded release button 328 disposed in an opening 326 formed in the hub 320. The opening 326 may extend from the outer surface 320o of the hub to the cannula receiving opening 322. The spring-loaded release button 328 may be biased toward the cannula receiving opening 322 so that its distal end extends into the cannula receiving opening 322 and can engage with the surface of the drill cannula 350 passing through it. The distal end of the button 328 may include teeth that can engage with, for example, the ratchet teeth 351 of the drill cannula 350. In one non-limiting embodiment, the button 328 may be configured to allow biasing to be applied by pressing the button 328 into the hub 320 in direction B', then moving the distal end of the button 328 away from the cannula receiving opening 322, thereby disengaging from the drill cannula 350 disposed within the cannula receiving opening 322. By releasing the force in direction B', the button 328 can be returned to its biased state, which may include re-engaging with the drill cannula 350 when the drill cannula 350 is disposed within the cannula receiving opening 322. Those skilled in the art will understand that there are various other configurations and settings (e.g., threaded screws and nuts, and / or one-way ratchet mechanisms) that may be used within the hub 320 to selectively engage and disengage the drill cannula when the drill cannula 350 is disposed within the cannula receiving opening 322.
[0073] The distal end of the distal portion 310d of the arm 310 may include a mounting feature 312 configured to receive a modular attachment, such as a humeral sizer attachment 340. As shown in Figures 3B and 4, the mounting feature 312 may include, for example, opposing U-shaped posts 312p, the U-shaped posts 312p defining an opening 312o between them, which can be configured to engage with complementary mating features of various modular attachments. Those skilled in the art will understand various other mating features that may be provided on the distal modular attachment 310d of the arm 310 to receive, selectively connect to, and disconnect from modular attachments.
[0074] Fixation feature to assist in the fitting of the humeral guide to the humerus One or more feature portions for receiving fixing feature portions, such as the fixing feature portions 330a, 330b described herein, including bone pin clamps 332a, 332b and support rods 336a, 336b, may be included as part of the arm 310. In the illustrated embodiment, an extension or flange 331, also called a support or guide support, extends from the middle portion of the arm 310 and includes an opening 334a for receiving a support rod 336a, which is an upper support rod as shown, and thus the flange 331 and its associated opening 334a support the upper fixing feature portion 330a. A second feature portion includes an opening 334b formed in the proximal portion 310p of the arm 310, which receives a support rod 336b, which is a lower support rod as shown, and thus the proximal portion 310p of the arm 310 and its associated opening 334b support the lower fixing feature portion 330b. The openings 334a, 334b may have threads throughout their interiors, and thus support rods 336a, 336b can be threaded to both sides. Those skilled in the art will understand that other embodiments may include a plurality of extensions or flanges such as flange 331, or may not include extensions or flanges, and the openings 334a, 334b are arranged along the length of the arm 310. Similarly, those skilled in the art will understand that other methods of connecting the support rods 336a, 336b to the arm 310 may also be provided, and that fewer than two or more such features may be provided to receive fixed features. In alternative embodiments, the rods 336a, 336b may pass through the openings 334a, 334b such that the rods 336a, 336b extend to both sides of each opening 334a, 334b.
[0075] In the illustrated embodiment, the extension 331 is integrally formed with the arm 310 and therefore rigidly attached; however, in other embodiments, one or more of the extensions 331 may be attached to the arm 310 and / or hub 320 using any known technique for joining one component to another (e.g., fasteners, male and female fittings, adhesives, welding, etc.). Therefore, in alternative embodiments, further flexibility can be provided by allowing the extension or flange 331 not to be rigidly attached to the arm 310 and / or hub 320.
[0076] Support rod As described above, one component of the fixed feature sections 330a and 330b may be the support rods 336a and 336b, respectively. Figure 5 shows the support rods 336a and 336b, also called pin clamp posts, more clearly. In the illustrated embodiment, the support rods 336a and 336b are identical, but in other embodiments they may be different. As shown, the support rods 336a and 336b include threaded ends 336at and 336bt, respectively, for selective coupling to and discoupling from the arms 310 via openings 334a and 334b. The ends 336ar and 336br opposite the threaded ends 336at and 336bt may include features that assist in rotating the rods 336a and 336b into openings such as 334a and 334b. As shown in the figure, the ends 336ar and 336br include gripping portions so that they can be rotated by hand, and openings 334ao and 334bo are formed in the respective heads of the rods 336a and 336b so that a tool can be received for screwing the rods 336a and 336b into the respective openings 336a and 336b. Figure 11D shows an example of the distal end of a tool 301, such as an INHANCE® T20 screwdriver, performing this operation.
[0077] As shown in Figure 3B, the rods 336a and 336b may extend substantially perpendicularly or transversely to the tangential surfaces of the arm 310 and / or hub 320 from the position where the openings 334a and 334b are formed such that a substantially right angle is formed by a longitudinal axis extending over the entire length of the rods 336a and 336b and a longitudinal axis substantially bisecting the respective portions of the flange 331 and arm 310. For example, with respect to the flange 331, the substantially perpendicular or transverse relationship with the rod 336a may be between a longitudinal axis R2 extending over the entire length of the rod 336a and a longitudinal axis E2 substantially bisecting the extension 331.
[0078] The rods 336a, 336b provide a structure to which one or more bone pin clamps 332a, 332b can be attached. Since the flange 331 and / or other fitting positions (e.g., the opening 334b) may be positioned at different locations relative to the arm 310 and / or hub 320, the rods 336a, 336b themselves, and therefore the clamps 332a, 332b, may also be positioned at different locations relative to the arm 310 and / or hub 320, and therefore more generally, the guide 300 and the surgical site. In the illustrated embodiment, the two support rods 336a, 336b are fixed to the guide 300, but any number of rods may be fixed to any portion along the length of the rigid arm 310 and / or hub 320.
[0079] Bone pin clamp The bone pin clamps 332a and 332b are configured to receive and position the bone pins 370a and 370b (see Figure 7) at a desired position relative to the humerus and thus the surgical site.
[0080] Figures 6A and 6C show one embodiment of clamps 332a and 332b. Similar to the support rods 336a and 336b, in the illustrated embodiment clamps 332a and 332b are identical, and therefore their components can be described together; however, in other embodiments, the clamps used in the same embodiment are not necessarily identical. Below, we will refer to one clamp 332a, but this description is applicable to both clamps 332a and 332b.
[0081] As shown in the figure, the bone pin clamp 332a may include a rod engaging portion 1310, a pin engaging portion 1320, a threaded screw 1330, and a lock nut 1340. The central opening 1350 may pass through, for example, the rod engaging portion, proximal upward through the lock nut 1340 that receives the screw 1330. The rod engaging portion 1310, also called the guide joint portion, and the pin engaging portion 1320 create multiple degrees of freedom for each clamp 332a for the way the clamp 332a engages with the bone pin and for the way the clamp 332a can move relative to each support rod (e.g., support rod 336a). The clamp 332a may be configured to be oriented to a preferred position and orientation on the shaft of the humerus.
[0082] As will be described in more detail below, the pin engagement portion 1320 of the bone pin clamp 332a may include a first body portion or plate 1324 and a second body portion or plate 1322 that define an opening 1326 configured to receive a bone pin. The opening 1326 may be configured to receive, for example, a bone pin (e.g., pin 370a) and / or a 4.0 mm humeral guide pin, such a guide pin may, in at least some cases, provide tactile feedback when inserted into the bone. The bone engagement portion 1320 may be used for selective unlocking and locking the position of the bone pins disposed within the opening 1326 used to fix the guide 300 to the surgical site, thus allowing for easy adjustment of the entry position of each bone pin 370a, 370b into the bone and the entry angle of each bone pin 370a, 370b into the bone.
[0083] Furthermore, as will be described in more detail below, the rod engagement portion 1310 of the bone pin clamp 332a may include a first body portion or plate 1314 and a second body portion plate 1312 that define an opening 1316 configured to receive a support rod. The rod engagement portion 1320 may be used for selective unlocking and locking the position of the clamp 332a relative to the support rod (e.g., support rod 336a) disposed within the opening 1316, and therefore relative to the guide 300 and the surgical site. This allows the surgeon to selectively position the clamp (e.g., clamp 332a) relative to the guide 300 and the surgical site, providing further adjustability regarding the entry position and entry angle of each bone pin 370a, 370b into the bone.
[0084] The upper surface of plate 1314 of the rod engagement portion 1310 may be configured to engage with the lower surface of plate 1322 of the pin engagement portion 1320. Each includes, respectively, rings of radial teeth 1317, 1319 extending circumferentially around their opposite faces for plates 1314, 1322. The radial teeth 1317, 1319 for the two faces are complementary to each other, and when the rod engagement portion 1310 and the pin engagement portion 1320 are coupled, the radial teeth engage and grip each other, allowing one to rotate relative to the other in a ratchet-like manner when clamp 332a is in the unlocked configuration, and locking relative to each other when clamp 332a is in the locked configuration.
[0085] Selective locking and unlocking of the rod engagement portion 1310 and the pin engagement portion 1320 can be provided by a threaded screw 1330 and a lock nut 1340 (also called a clamp nut) configured to receive the screw 1330. Movement of at least one of the screw 1330 and the lock nut 1340 relative to the other can position the clamp 332a in the unlocked and locked positions, thereby setting the position of at least one of the pins 370a, 370b relative to the support rod 336a and / or the guide 300. As shown in the figure, portions 1310 and 1320 are disposed between the head 1334 of the screw 1330 and the lock nut 1340. The post of the screw 1330 shown in Figure 6C, which extends distally from the head 1334, can extend through the central opening 1350 into the rod engagement portion 1310 and the pin engagement portion 1320. As a result, by rotating the screw 1330 in a locking manner, the plates 1314, 1312, and 1324, 1322 that define the respective openings or channels 1316, 1326 formed within the respective rod engagement portion 1310 and the pin engagement portion 1320 can be crushed around the components disposed within the respective channels 1316, 1326 (i.e., the support rod 336a and bone pins such as 370a, 370b), thereby locking the position of the components disposed within the openings 1316, 1326 relative to the arm 310 of the guide 300. The threaded screw 1330 can be welded in place to the lock nut 1340 so that the lock nut does not come off the clamp 332a completely.
[0086] As shown in Figure 6C, each portion 1310, 1320 may include a bottom plate or fixing plate, indicated as bottom plates 1312, 1322, and an upper plate or connecting plate, indicated as top plates 1314, 1324. Each plate 1312, 1314, 1322, 1324 includes a central opening 1312o, 1314o, 1322o, 1324o, respectively, which are aligned with each other to support the formation of the central opening 1350 of the bone pin clamp 332a. Each plate 1312, 1314, 1322, 1324 is substantially circular in nature, that is, its base and outer circumference are substantially circular. Furthermore, the surfaces of adjacent plates 1312, 1314, 1322, and 1324 (for example, the top surface of the first plate adjacent to the bottom surface of the second plate positioned directly above the first plate) are substantially complementary to each other, and thus, in the context of forming the clamp 332a, allow the plates 1312, 1314, 1322, and 1324 to fit together. Unless otherwise specified or understood by those skilled in the art, the term bottom surface as used herein may constitute a downward-facing surface as shown, and the term top surface as used herein may constitute an upward-facing surface as shown.
[0087] Each plate 1312, 1314, 1322, and 1324 may have many different configurations, but in the illustrated embodiment, the fixed plate 1312 is configured similarly to the coupling plate 1324, and the coupling plate 1314 is configured similarly to the fixed plate 1322. Thus, unless certain features are visible, a person skilled in the art will understand where those features may be located, taking into account the mirror images provided by the corresponding plates and / or as may be understood differently by a person skilled in the art in consideration of this disclosure.
[0088] The fixing plate 1312 has a bottom surface which can be configured to engage with the head 1334 of the screw 1330. Although this bottom surface of plate 1312 is not visible, for the provided mirror image configuration, a recessed area 1321 provided on the upper surface of the coupling plate 1324 provides the same configuration. As shown in the figure, the recessed area 1321 may be tapered, which allows the screw head 1334 to gradually slide into the fixing plate 1312 and tighten against the fixing plate for the purpose of the fixing plate 1312, thus helping to lock the bone pin clamp 332a.
[0089] The upper surface of the fixing plate 1312 may be configured to engage and secure a support rod (e.g., support rod 336a) from the bottom. In the illustrated embodiment, for this purpose, one or more grooves 1316a are formed on the upper surface of the fixing plate 1312. In the illustrated embodiment, the grooves 1316a are located on one side of the central opening 1312o. In other embodiments, more grooves may be provided, for example, a second groove may be located on the opposite side of the central opening 1312o, as shown in the central opening 1312o' in Figure 6E, and multiple positions are shown where the support rod 336a' may be positioned relative to the bone pin clamp 332a'. Referring back to Figure 6C, the grooves 1316a may generally be shaped and sized such that a support rod 336a or other rod can seat in the grooves 1316a and be selectively locked within the grooves 1316a, as provided herein. In the illustrated embodiment, the groove 1316a has multiple surfaces forming a hexagonal channel 1316, which may be useful in preventing rotation of the hexagonal support rod received in the hexagonal channel 1316. Other complementary shapes between the bone pin and the groove can be utilized.
[0090] The upper surface of the fixing plate 1312 may also include one or more mating features that facilitate the coupling of the fixing plate 1312 to the coupling plate 1314. In this embodiment, the mating features include two projections 1318 that extend upward from the upper surface of the fixing plate 1312 toward the coupling plate 1314 on both sides of the central opening 1312o. As shown, the projections 1318 may be arranged on an axis parallel to the groove 1316a. The projections 1318 may be configured to seat in complementary mating features formed on the bottom surface of the coupling plate 1314, such as recesses or openings 1319.
[0091] In addition to including a recess for receiving the projection 1318, the bottom surface of the coupling plate 1314 has a groove 1316b formed on its bottom surface that is complementary to groove 1316a, allowing the support rod 336a to be engaged and fixed from above. Again relying on a mirror image configuration, the groove 1316b formed on the bottom surface of the coupling plate 1314 may be the same as the groove 1326b formed on the top surface of the fixing plate 1322. The grooves 1316a of the fixing plate 1312 and 1316b of the coupling plate 1314 are sized to seat a portion of the length of the support rod 336a in the grooves 1316a and 1316b, and may be adapted in other ways, so that the grooves 1316a and 1316b form a channel 1316 between them, as shown in Figure 6A. When plates 1312 and 1314 are aligned to form the rod engagement portion 1310, grooves 1316a and 1316b are aligned to secure the support rod 336a internally. Other complementary surfaces may be formed on plates 1312 and 1314 to further assist in the secure interlocking of the two plates.
[0092] The upper surface of the coupling plate 1314 may be configured to engage with the bottom surface of the fixing plate 1322 of the pin engagement portion 1320. In the illustrated embodiment, for mirror image configuration, these two surfaces are essentially identical. Each includes a ring of radial teeth 1317 extending circumferentially around their opposite surfaces. The radial teeth for the two surfaces are complementary to each other, and when the rod engagement portion 1310 and the pin engagement portion 1320 are coupled, the radial teeth engage and grip each other, allowing one to rotate relative to the other in a ratchet-like manner when the clamp 332a is in the unlocked configuration, and locking relative to each other when the clamp 332a is in the locked configuration.
[0093] The upper surface of the fixing plate 1322 may be configured to engage with the bone pin 370 and secure it from the bottom. As shown, this engagement is achieved by grooves 1326b disposed on both sides of the central opening 1322o. Also as shown, recesses 1329 are formed on the upper surface of the fixing plate 1322, and these recesses 1329 are configured to receive projections 1328 (only one is visible) extending downward from the bottom surface of the connecting plate 1324. The bottom surface of the connecting plate 1324 may be configured to engage with the bone pin (e.g., bone pin 370) by a groove 1326a similar to the groove 1316a shown for the fixing plate 1312 and secure it from above. Similarly, the bottom surface of the connecting plate 1324 may include a projection 1328 similar to the projection 1318, which is configured to engage with the recesses 1329. The recessed portion 1321 formed on the upper surface of the coupling plate 1324 may be configured to receive the lock nut 1340, allowing the lock nut 1340 to seat in the recessed portion 1321, as shown in Figure 6A.
[0094] The bone pin clamp 332a can be moved between a locked configuration and an unlocked configuration by moving at least one of the screw 1330 and the lock nut 1340 relative to the other, for example by rotating one relative to the other. More specifically, in the illustrated embodiment, the clamp 332a controls the locked and unlocked configurations of both the support rod (and other support rods provided herein) and the bone pin (and other bone pins provided herein).
[0095] Figure 6B shows a bone pin clamp 332a in which a support rod 336a is disposed, with the support rod 336 coupled to the flange 331 of the arm 310. In the unlocked configuration, the support rod (e.g., support rod 336a) has axial and rotational degrees of freedom of movement within the channel 1316 formed by grooves 1316a and 1316b. Similarly, in the unlocked configuration, a bone pin (e.g., bone pin 370a) which may be disposed within the channel 1326 as shown elsewhere (see, for example, Figures 22B to 22D), has axial and rotational degrees of freedom of movement together with the channel 1326 formed by grooves 1326a and 1326b. When the screw 1330 and / or lock nut 1340 are rotated relative to each other, the screw head 1334 and lock nut 1340 move toward each other, compressing the rod engagement portion 1310 and the bone pin engagement portion 1320, thereby moving the bone pin clamp into the locked configuration. In the illustrated embodiment, the distal end 1332 of the screw 1330 is threaded and receives within the threaded central opening 1340o of the lock nut 1340. The lock nut 1340 may include a retaining washer 1342, which may be integrally formed with the lock nut 1340 or provided separately from the lock nut 1340 as shown in Figure 6C, to expand the threaded opening 1340o and further secure the distal end 1332 of the screw 1330. In the illustrated embodiment, the retaining washer 1342 may be positioned on the distal end 1332 of the screw 1330 and then welded in a specific position to ensure functionality while also preventing the user from unintentionally disassembling the bone pin clamps 332a, 332b by excessively loosening the lock nut 1340.
[0096] The bone pin clamp 332a may also include a spring 1390 positioned around a portion of the screw 1330 between the head 1334 and the distal end 1332. The spring 1390 can bias the screw proximal outward from the central opening 1350 in the unlocked configuration when the distal end 1332 is not screwed in through the central opening 1340o of the lock nut 1340. In the locked configuration, the screwing between the distal end of the screw 1332 and the central opening 1340o overcomes the biasing force of the spring 1390, thereby securing the screw within the central opening 1350 of the clamp 332a. In the locked configuration, at least one of the support rod or bone pin is constrained so as not to move in the axial and rotational directions. In some cases, both the support rod and the bone pin can be constrained in this way, but it is not necessary to constrain both at the same time. One can be constrained and in a locked configuration, while the other is in an unlocked configuration and can move freely in the axial and / or rotational directions. When the support rod is positioned in the locking configuration, the position of the clamp 332a along the support rod is fixed, and when the bone pin is positioned in the locking configuration, the position of the bone pin within the clamp 332a is fixed. Locking the bone pin also allows the bone pin to be fixed in a desired location or position at the surgical site. The bone pin can be fixed to the clamp 332a using a wrench or other instrument.
[0097] Subsequently, by loosening the screw 1330 and / or the lock nut 1340, one or both of the support rod or bone pin, i.e., the bone pin clamp 332a more commonly, can be returned to the unlocked configuration. In at least some examples, the clamp 332a can secure the bone pin to the support rod such that the length of the pin substantially transverses the length of the rod, and the rotational position of the pin engagement portion 1320 relative to the rod engagement portion 1310 can be adjusted before tightening the clamp 332a to set the bone pin 370a at any angle relative to the support rod. This rotational position can be adjusted, for example, by rotating the pin engagement portion 1320 relative to the rod engagement portion 1310 by teeth 1317 located on the upper surface of the coupling plate 1314 and complementary teeth located on the bottom surface of the fixing plate 1322. In addition, the clamp 332a can slide along the support rod when in the unlocked configuration to adjust the position of the clamp 332a, thereby adjusting the entry position of the bone pin into the bone.
[0098] Figures 6D to 6E provide alternative embodiments of the bone pin clamp 332a'. The bone pin clamp 332a' is similar to the bone pin clamp 332a, the main difference being that the configuration of the rod engagement portion 1310' and the pin engagement portion 1320' allows the support rod 336a' and pin 370a to be arranged on opposite sides inside. Nevertheless, those skilled in the art will understand, in consideration of this disclosure, the similarities and differences between the two embodiments of the bone pin clamp 332a, 332a', and how different features of one embodiment may be incorporated into the other embodiment. Furthermore, the diagrams in Figures 6D to 6E are useful in illustrating the arrangement of the bone pin 370a and support rod 336a for the clamp 332a'. A similar arrangement can be used for bone pin clamps 332a, 332b.
[0099] The bone pin clamps 332a, 332b, and 332a' allow for flexibility when attaching the guide 300 to the humerus 1012. Loosening the lock nut 1340 allows for lateral loading of the clamp 332a into the guide 300 and / or the pins 370a and 370b into the clamp 332a. When the nut 1340 is tightened, the options for lateral loading and pin removal are reduced and / or eliminated. The clamps 332a, 332b, and 332a' may be attached to the support rods 336a, 336b using any of the openings provided herein, and the lock nuts 1340 are shown positioned closer to the distal end 310d of the arm 310 than to the opposing ends where the bottom plate 1312 is disposed. In other embodiments, the clamps 332a, 332b, and 332a' may be rotated 180 degrees so that what is shown as the top of the clamps 332a, 332b, and 332a' becomes the bottom of the clamps 332a, 332b, and 332a', and vice versa.
[0100] The bone pin clamps 332a, 332b, and 332a' are designed to provide multiple degrees of freedom to one or both of the bone pins (e.g., bone pins 370a, 370b, and 370a') and / or support rods (e.g., support rods 336a, 336b, and 336a') that are received within the openings 1326 and 1316. The multiple degrees of freedom provided herein include any combination of sliding, rotation, and orientation.
[0101] Before initiating the drilling, it may be desirable for the surgeon to plan the placement of the bone pin clamps 332a, 332b, 332a', pins 370a, 370b, and other components. Therefore, before drilling, the surgeon can position pins 370a and 370b within the bone pin clamps 332a, 332b, and 332a' and lay out the placement of pins 370a and 370b relative to the bone 1012. Factors to consider during planning include, but are not limited to, the surgeon's preferences, the patient's anatomical structure, and the location of soft tissues and neurovascular structures. Typically, it is best for pins 370a and 370b to have bicortical fixation when spaced at least 5 mm apart, and to be positioned below the entry point of the drill cannula 350 to ensure space for the humeral preparation device and implant. It may also be desirable to ensure that the pins 370a and 370b do not intersect the longitudinal axis L extending through the drill cannula 350, thereby ensuring no competition with the humeral penetration drilling instrument.
[0102] For procedures involving the left shoulder, better anatomical fixation can be provided by positioning the pins 370a, 370b and bone pin clamps 332a, 332b on the left side of the guide 300. Conversely, for procedures involving the right shoulder, better anatomical fixation can be provided by positioning the pins 370a, 370b and clamps 332a, 332b on the right side of the guide 300. The guide 300 and its associated components are flexible to allow for simultaneous positioning of pins on both sides as desired for optimal fixation.
[0103] Those skilled in the art will understand other ways in which bone pins 370a, 370b can be coupled to guide 300. For example, in another embodiment disclosed herein, described with reference to Figures 11–12I, guides 2330 and associated components are provided to assist in guiding and positioning bone pins at the surgical site. With respect to bone pin clamps 332a, 332b, 332a', those skilled in the art will understand that bone pin clamps 332a, 332b, 332a' are merely examples of many embodiments that can be used to assist in providing the ability to manipulate the entry position and / or entry angle of bone pins into the humerus. This disclosure intends to provide other clamps or other bone pin coupling mechanisms (including those having similar capabilities without many components or parts) that allow multiple degrees of freedom to perform such adjustments to bone pins into the humerus.
[0104] Additional aspects of rigid arms To facilitate user use, various labels may be provided on the arm 310. For example, a boundary line 399, shown as a laser line, may be formed within or on the arm 310, as shown on the distal portion 310d of the arm 310. As described below, the boundary line 399 can be used in conjunction with other components (e.g., adapters as shown in Figure 14) to help determine when the tool being used at the surgical site has entered the humerus to a desired depth. In at least some cases, the boundary line 399 may be machined into the arm 310 so that the line 399 can function as a mechanical stopper. Also, as shown in the figure, a label labeled "left" may be displayed on one side of the arm 310, and a label labeled "right" may be displayed on the opposite side of the arm 310, although it is not visible. These labels correspond to the patient's surgical side. Furthermore, one or more alignment lines 361a, 361b may be formed on various parts of the arm 310. In the illustrated embodiment, alignment lines 361a are formed on the distal portion 310d to assist in the alignment of components such as adapters (see Figure 14) on the arm 310, and alignment lines 361b are formed on the hub 320 to assist in the alignment of the drill cannula 350.
[0105] The rigid arm 310 may be sized and shaped to allow proper centering and alignment between, for example, the drill cannula 350 and one of various modular attachments that can be coupled to the distal portion 310d. The size and / or shape of the arm 310 may depend, at least in part, on the patient's size and anatomical structure (e.g., child vs. adult, male vs. female, etc.) and / or the surgeon's preference. In the illustrated embodiment, the length of the rigid arm 310 is such that its shape is generally curved or angled as it extends from the proximal end of the proximal portion 310p of the arm 310 to the distal end of the distal portion 310d of the arm 310, with the proximal and distal ends being the ends of the arm 310 that define the length of the arm 310. The rigid arm 310 may be sized and shaped to allow one-handed gripping during surgical procedures and can provide a universal fit so that it can be gripped in an equally convenient and easy-to-use manner with the user's right or left hand without needing to change grip and / or position during surgical procedures. The guide 300 can provide further universal fit so that it can be positioned on either the left or right side of the patient's anatomical structure. For example, the same guide 300 can be used for arthroplasty of the right or left shoulder. Thus, the humeral guide 300 can be considered a universal humeral guide. More specifically, the support rods 336a, 336b, used in conjunction with the support bone pin clamps 332a, 332b, can be positioned on one side or the other side of the guide 300, depending on whether the procedure being performed is on the right side of the left shoulder. In the illustrated embodiment, the rods 336a, 336b are positioned on one side of the arm 310 for use in a procedure on the left shoulder. In a procedure on the right shoulder, the rods 336a, 336b may be positioned on the opposite side of the arm 310.
[0106] bone pins Figure 7 shows bone pins 370a and 370b, which can be used in conjunction with bone pin clamps 332a and 332b, and more generally with the humerus guide 300. Although pins 370a and 370b are identical in this disclosure, those skilled in the art will understand that different pins may be used in the same embodiment. Furthermore, in some embodiments, the pins may be used as guide pins or the like in other situations, such as assisting the use of a tool attached to a handle assembly (e.g., handle assembly 1400).
[0107] As shown in Figure 7, bone pins 370a, 370b may include a proximal portion 370p, a distal portion 370d, and an intermediate length extending between them. The proximal portion 370p may include an indicator 377, which is a raised radial ridge, as shown in the figure, but in other embodiments, the indicator may be a laser marking or other indicator known to those skilled in the art, designed to provide a visual indication of the position of bone pin 370a relative to another component. This is analogous to an indicator 381 formed on a drill bit 380, as will be described below with respect to Figures 9 and 22A.
[0108] The distal portion 370d may include a bone engagement tip or distal tip 370t, a relief portion 375, a thread 371, and a recess 373 formed proximal to the thread 371. The relief portion 375 can provide tactile feedback to the user after initial entry into the cortical bone, as it allows the bone pin 370a to advance rapidly without applying pressure to the distal cortical wall. In some procedures, the drill pin 380 can be embedded in the distal cortex by advancing the bone pin 370a approximately 3 to 5 millimeters further, while simultaneously fixing the threaded portion 371 to resist cantilever forces and providing sufficient stability. The thread 371 can allow for measured insertion of pins 370a and 370b into the bone by rotating the pins 370a and 370b, and the recess 373 can provide relief for producing the thread 371 of the bone pins 370a and 370b. Non-limiting embodiments of bone pins 370a and 370b are 4.00 mm threaded Schanz screws available from DePuy Synthes (Raynham, MA). In alternative embodiments, the bone pins may not be threaded and may provide desired tactile and / or comfort to at least some surgeons. The configurations of bone pins 370a and 370b may be identical or substantially identical as used herein, and as shown in various embodiments, pin 370a is the upper bone pin and pin 370b is the lower bone pin. Thus, references to the configuration of one pin, etc., are equally applicable to the other.
[0109] Drill cannula As shown in Figures 3A, 3B, and 8, the drill cannula 350, also called a cannula, bullet-shaped section, or bullet-shaped section with cannula, may be an elongated, substantially cylindrical or tubular shaft having a base or handle 358 located at a proximal end 350p, a distal end 350d with a distal tip 350t, and an intermediate section or length extending between them. A planar contact surface 353 may be disposed on the outer surface of the intermediate section of the drill cannula 350 to provide a surface for a lock nut to contact and lock in place on the drill cannula 350. In some embodiments, ratchet teeth 351 (see at least Figure 3B, also see teeth or grooves 2351 of the drill cannula 2350 in Figure 11) may be disposed on the outer surface of the intermediate section of the drill cannula 350, or along the planar contact surface 353, and may be engaged by teeth associated with the distal end of the button 328 as described above. The drill cannula 350 further includes an opening 356 extending along the entire length of the drill cannula 350. The opening 356 may be sized and shaped such that a drilling component, such as a drill pin or guide pin 380, passes through the drill cannula 350 and enters the bone into which a bone hole is formed, so that the distal end 380d of the drill exits the center of the humeral resection surface 1015 and is perpendicular thereto, as shown in Figure 22C. The distal end 350d of the drill cannula 350 may be tapered, for example, by varying the thickness of the wall of the drill cannula 350, to make it easier for the drill cannula 350 to pass through soft tissue and press against the surface of the humerus. In some embodiments, bone engagement features such as teeth 359 may be formed on the distal tip 350t. The teeth 359 may help to stabilize the position of the distal end 350t of the bullet-shaped portion relative to the bone. Furthermore, the distal end of the distal portion 350d of the drill cannula 350 can be angled to match the angle of the humerus 1012. By stabilizing with features such as the teeth 359 and the angled distal end 350d, a more precise trajectory of the bone tunnel can be established.The cannula receiving opening 322, together with the drill cannula 350, sets the position and trajectory of the bone hole or bore drilled through the humerus from the lateral cortex 1023 to the humeral resection surface 1015, the center or substantial center of the bone hole, and its perpendicularity or substantial perpendicularity to the humeral resection surface 1015. The terms hole and bore will be used interchangeably throughout this specification relating to the formation of a hole in bone.
[0110] Drill bit Figure 9 shows one non-limiting embodiment of a drill bit that can be used in conjunction with the present disclosure. As shown, the drill bit 380 may include a proximal portion 380p, a distal portion 380d, and an intermediate length extending between them. The proximal portion 380p may include an indicator 381, which is a raised radial ridge, as shown, but in other embodiments, the indicator may be a laser marking or other indicator known to those skilled in the art, designed to provide a visual indication of the position of the drill bit 380 relative to another component. For example, in the illustrated embodiment, as further shown by Figure 22A, the indicator 381 is designed to inform the user that the drill bit 380 has moved to a position that provides a desired docking of the guide 300. More specifically, when the drill bit 380 has advanced about 10 millimeters into the humerus 1012, the indicator 381 is positioned on the base 358 and thus provides a visual indication that the drill bit is in the desired docking position. The distal portion 380d includes a distal tip portion 382 and a portion 383 having a wider diameter. The distal tip portion 382 allows for better formation of the pilot hole, and the wider diameter portion 383 can then drill a bore of a larger diameter.
[0111] Humerus sizer attachment As described above, various modular attachments can be coupled to the guide 300 at the distal end 310d of the rigid arm 310, or otherwise associated. In Figure 3A, such a modular attachment is provided in the form of a sizer attachment or humeral sizer attachment 340. The attachment 340 shown in Figures 10A-10B may include a substantially flat rigid base 342 having an arm portion 342a and an alignment and sizing portion 342b, also called a plate portion. As shown, the arm portion 342a may extend from the nearest end 342p, where the attachment 340 can be coupled to the rigid arm 310, and terminate at the beginning of the circular shape that mainly constitutes the plate portion 342b. In the illustrated embodiment, the plate portion 342b comprises an annular body 341 formed at the distal end 342d of the base 342, the annular body 341 having a plurality of openings 343a, 343b formed in the annular body 341. As shown in the illustration, there are four outer openings 343b, each of similar size and shape, arranged radially around the central opening 343a. The rigid base 342 has a length from the nearest end, indicated by the proximal end 342p, to the central opening 343a, so that when the humeral sizer attachment 340 is fitted with the rigid arm 310, the central opening 343a lies on the same axis LC as the cannula receiving opening 322 of the hub 320. Furthermore, the plane PL defined by the plate portion 340b of the attachment 342 may be perpendicular to or substantially perpendicular to the longitudinal axis LC. As shown in the figure, the planar PL extends through the main surface of the sizing portion 342b of the attachment 340, such as the entire top surface.
[0112] The central opening 343a may be centrally located relative to the annular body 341 and may be configured to receive a drill bit or guide pin, such as a drill bit 380 (not shown in Figure 3A, see Figure 22C), which has passed through the drill cannula 350. As will become clearer with this disclosure, the drill bit or guide pin 380 may more commonly be referred to as a tool operating shaft or drive shaft. This is because the various guide pins provided herein may also be used to operate one or more tools associated with the guide 300, for example, by a universal handle assembly further disclosed herein (e.g., universal handle assembly 1400). The central opening 343a may be used, for example, to provide alignment of other parts of the guide 300, or components used in the guide 300, such as the drill cannula 350 and the drill bit 380. More specifically, the central opening 343a may be used to find and / or mark the approximate center point of the humeral resection surface 1015, for example, as will be considered below with respect to Figures 21A-21B.
[0113] A window 344 may be formed at the distal end of the proximal arm portion where the arm portion 342a joins with the plate portion 342b. The user can align anatomical landmarks such as the bicephalic groove within the window 344. The arm portion may further include markings related to the humeral resection surface or various dimensions of an appropriately sized implant. As will be described in more detail below with respect to Figures 21A and 21B, by referring to the humeral resection surface 1015, the user can select a nominal size sizer and refer to the markings or indicators 345 on the arm portion 342a. Thus, once the sizer attachment 340 is inserted into the joint space, the user can align lines such as the line 1011 shown in Figure 21B, formed on the bicephalic groove within the window 344, laterally and push the sizer attachment 340 into the joint until it reaches the reference marking 345, thereby setting the medial-lateral position on the humeral resection surface 1015. Maintaining that position, the user can manually perform anterior-posterior centering using the bone and plate portion 342b, for example, by palpation or visual criteria. The provided locator can center the sizer attachment 340 relative to the user's desired position and, if desired, can ignore the lowest position from which the bone can be gradually shaved downwards. This positioning process can set the final implant so that it is properly positioned within the muscles of the rotator cuff.
[0114] A feature for fitting the attachment 340 into the mounting feature 312 of the arm 310 is provided on the proximal portion 340p. As best shown in Figure 10B, the receiving feature 340r may be located at the proximal end 340p of the humeral sizer attachment 340. The receiving feature 340r may include a central opening 340o and a plurality of channels 340c complementary to the U-shaped post 312p of the mounting feature 312 of the arm 310. Thus, the humeral sizer attachment 340 can slide onto the distal end 340d of the arm 310 by advancing the attachment 340 in direction D and sliding the post 312p of the arm 310 within the channels 310c, as shown in Figure 3A. The humeral sizer attachment 340 can be locked in place on the arm 310 by a knob 348, also shown in Figure 3A, which engages with a threaded post 347 to selectively lock and unlock the attachment 340 to the arm 310. As also shown in Figure 10B, one or more engaging teeth 346 may be formed on the base of the attachment 340 or on the surface facing the humeral resection surface. As shown, there are four teeth 346, each arranged radially at equal distances around the annular body 341. The teeth 346 may be configured to engage with bone to assist in positioning the humeral sizer attachment 340 relative to the bone. Any number and configuration of teeth may be used without departing from the spirit of this disclosure.
[0115] The sizer attachment 340 can be used both to define the center or central position of the humeral resection surface 1015, or other desired position for receiving an implant, and to determine the size of the humeral resection surface 1015 in order to determine the size of the implant and / or prosthesis to be used at the surgical site. The sizer attachment 340, having plate portions 342b of various sizes with various lengths and various diameters (e.g., very small, small, medium, large, very large), can be provided with guides 300 to accommodate the diameters and anatomical structures of the humeral resection surface of various patients. The illustrated embodiment of the attachment 340 has a large diameter, as designated by "L" in Figure 10A (the corresponding attachment 340 in Figures 21A and 21B has a medium diameter, as designated by "M" in those figures). The size of the sizer attachment 340 may be based, for example, on the size of the implant (e.g., stemless implant) and / or the size of the reamer or reamer attachment used to ream the humeral resection surface 1015.
[0116] In at least some examples, a sizer attachment 340 of appropriate size may be selected such that the outer edge of the plate portion 342b lies within the cortical boundary of the humeral resection surface 1015. Often, it may be useful for the outer circumference of the annular body 341 to be located just inside the cortical boundary and not in contact with any portion of the cortical periphery. As shown in Figure 10A, a marking or indicator 345 on the arm portion 342a of the sizer attachment 340 may allow the sizer attachment 340 to be centered and measured on the humeral resection surface 1015 having a larger outer circumference than the annular body 341, as will be described in more detail with respect to Figures 21A-21B. The marking 345 may be a laser line or another type of marking known to those skilled in the art. The annular body 341 may be substantially flat in shape and designed to fit into the rotator cuff parity 1020 above the subscapularis muscle.
[0117] Upon entering the joint space, the plate portion 342b may be aligned tactile to and parallel to or substantially parallel to the humeral resection surface 1015, such that the openings 343a, 343b indicate the center point or approximately center point of the humeral resection surface 1015. Aligning the central opening 343a with the center point of the humeral resection surface 1015 allows the drill cannula 350 to be positioned correctly on the lateral cortex 1023 of the humerus 1012, such that the distal tip 382, located at the distal end 380d of the drill bit 380, emerges from the center and is perpendicular or substantially perpendicular (also called orthogonal or substantially orthogonal) to the humeral resection surface 1015, as the drill bit or guide pin 380 passes through the drill cannula 350 and the humerus 1012. As described below, the distal end 380d may be used to operate a modular attachment associated with a universal handle assembly coupled to the humeral guide 300. Furthermore, the distal tip 382 may be used, if desired, to puncture tissue and / or perforate bone. The humeral sizer attachment 340 further works together with the distal tip 350t of the drill cannula 350 to generate a clamping force at the humeral resection surface 1015, thereby maintaining the position of the guide on the humerus until the bone pins 370a, 370b pass through the fixation features 330a, 330b and the bone pin clamps 332a, 332b as shown, to fix the guide 300 to the bone.
[0118] Those skilled in the art will understand that sizer plates such as the INHANCE® humeral head trial (from Johnson & Johnson, New Brunswick, NJ) can be used in conjunction with or in place of the humeral sizer attachment 340 and / or other similarly designed humeral sizer attachments.
[0119] Another embodiment of the sizer attachment 1140 is shown in Figures 10C to 10E, and Figures 10E to 10H show a sizer plate 1172 that can be used with the sizer attachment 1140. Those skilled in the art will understand how a sizer plate such as plate 1172 can be used with other sizer attachments, such as the humeral sizer attachment 1140. In the illustrated embodiment, the sizer attachment 1140 is configured such that the sizer plate 1172 is twisted onto the attachment 1140.
[0120] The attachment 1140 may include a substantially flat rigid base 1142 having an arm portion 1142a and an alignment and sizing portion 1142b. As shown in the illustration, the arm portion 1142a may extend from the nearest end 1142p, where the attachment 1140 can be coupled to the rigid arm 310, to the end of an elongated section of the arm portion 1142a, and in the illustrated embodiment, terminates at the point where the circular shape that mainly constitutes the alignment and sizing portion 1142b begins. In the illustrated embodiment, the alignment and sizing portion 1142 includes an annular body 1141 formed at the distal end 1142d of the base 1142, the annular body 1141 having a central opening 1143a formed in the annular body 1141. The rigid base 1142 has a length from the nearest end, indicated by the proximal end 1142p, to the central opening 1143a, so that when the sizer attachment 1140 is fitted with the rigid arm 1110, the central opening 1143a is on the same axis as the cannula receiving opening 322 of the hub 320. Furthermore, the plane PL' defined by the alignment and sizing portion 1142b of the attachment 1140 may be similar to plane PL and may be substantially perpendicular to the longitudinal axis LC. As shown in the figure, plane PL' extends through the main surface of the sizing portion 1142b of the attachment 1140, such as the entire upper surface.
[0121] In the illustrated embodiment, the annular body 1141 includes a plurality of notches 1144 formed on the outer circumference of the annular body 1141, the notches 1144 configured to receive various sizer plates. In this embodiment, the notches 1144 are formed along the outer circumference of the annular body 1141 and are configured to receive and fix a sizer plate 1172, also called a humeral resection surface sizer or humeral resection surface sizer plate. As shown in Figures 10C to 10D, three substantially equal-sized and shaped notches may be formed radially around the outer circumference of the annular body 1141, but any number of notches of any shape, configuration, and / or layout may be formed along the outer circumference. A portion of the notches 1144 extending through the lower surface of the circular portion (the surface facing the hub 320 when in use) may be wider than a portion of the notches 1144 extending through the upper surface of the annular body 1141 opposite the lower surface. As shown in Figures 10C to 10D, this creates tabs 1145 on the annular body 1141 within the notch 1144, which can be used to assist in securing the sizer plate to the attachment 1140.
[0122] One or more engaging teeth or projections 1146, as shown in Figure 10D, may be provided on the lower surface of the annular body 1141. As shown, there are four teeth 1146 arranged symmetrically around the central opening 1143a, but in other embodiments, the teeth may not be arranged symmetrically or may be arranged radially equidistant around the outer circumference of the annular body 1141. The teeth 1146 may be configured to engage with bone to assist in positioning the sizer attachment 1140 relative to the bone. Any number and configuration of teeth may be used without departing from the spirit of this disclosure.
[0123] The central opening 1143a may be centrally located relative to the annular body 1141 and may be configured to receive a drill, drill bit, drive shaft, or guide pin (e.g., drill bit 380) passing through the drill cannula 350. The central opening 1143a may be used, for example, to provide alignment of other parts of the guide 300, or components used in the guide 300, such as the drill cannula 350 and the drill bit 380. More specifically, the central opening 1143a may be used, more generally, to locate and / or mark the center point of the glenoid surface and / or glenoid plane, and / or the humeral resection plane. In conjunction with this, in at least some cases, the attachment 1140 and the drill cannula 350 may work together to generate a clamping force on the humerus 1012 to hold the guide 300 in place, before and / or in conjunction with fixing the position of the guide 300 relative to the humerus 1012 using bone pins 370a, 370b. The drill bit 380 can pass through the drill cannula 350 and enter the humerus 1012, exiting through the humeral resection surface and the central opening 1141a of the attachment 1143 to form a humeral penetration hole.
[0124] The sizer attachment 1140 can be fitted onto the distal end 310d of the rigid arm 310 via the mounting feature 312 by moving the sizer attachment 1140 toward the distal end 310d of the rigid arm 310 in direction B. Figure 10D shows the receiving feature 1140r located at the proximal end of the sizer attachment 1140. As shown, the receiving feature 1140r may include a central opening 1140o and a plurality of channels 1140c complementary to the U-shaped post 312p of the mounting feature 312 of the arm 310. Thus, the sizer attachment 1140 can slide onto the distal end 310d of the arm 310 by advancing the attachment 1140 in direction F and sliding the post 312p of the arm 310 within the channels 1140c. The humeral sizer attachment 1140 can be locked in place against the arm 1110 by a knob 1148 (Figure 10C) that enters and passes through an opening 1146 formed in the rigid base arm portion 1142a. The knob 1148 may include a threaded component 1147 having a threaded upper portion 1147a configured to screw into a central opening 1148o of the knob 1148, and a threaded bottom portion 1147b configured to pass through the opening 1146 and engage with an opening 312o formed in the arm 310. A seating extension 1149 may be disposed between the threaded upper portion 1147a and the threaded bottom portion 1147b, and the seating extension 1149 is configured to be installed within the opening 1146. Rotation of the knob 1148 may be operable to securely connect the sizer attachment 1140 to the arm 310 and to disconnect the sizer attachment 1140 from the arm 310, through interaction between the threaded base 1147b and the mounting feature 312.
[0125] When in use, the sizer attachment 1140 may be positioned just medial to the cortical boundary of the humeral resection surface 1015. The sizer attachment 1140 can be used both to define the center or central position of the humeral resection surface 1015, or other desired position for receiving an implant, and to determine the size of the humeral resection surface 1015 in order to determine the size of the implant and / or prosthesis to be used at the surgical site. It can also be used in conjunction with a sizing method for implanting a prosthesis within the glenoid fossa 1018.
[0126] Multiple head trial components or sizer plates 1172 of various sizes may be used in conjunction with the sizer attachment 1140, as shown in Figures 10E–10F. The sizer plate 1172 may be used to determine the diameter of the humeral resection surface 1015 and to assist in the central or near-central positioning of the humeral resection surface 1015. The sizer plate 1172, shown separately from the sizer attachment 1140 in Figure 10F, may be manufactured in various diameters to accommodate the diameters of the humeral resection surfaces of various patients. In at least some cases, a sizer plate 1172 of the appropriate size may be selected so that the outer edge of the sizer plate 1172 lies within the cortical boundary of the humeral resection surface 1015. Often, it may be useful for the outer periphery of the sizer plate 1172 to be located just inside the cortical boundary and not in contact with any part of the cortical periphery. Both the annular body 1141 and the sizer plate 1172 are substantially flat in shape and may be designed to fit into the rotator cuff interval 1020 above the subscapularis muscle. The sizer plate 1172 can be considered a twist-on sizer, as it is configured to be twisted onto or off the sizer attachment 1140. The plate 1172 may be attached to the sizer attachment 1140 before or after the sizer attachment 1140 is attached to the distal end 310d of the arm 310.
[0127] As shown in Figure 10F, the circular recess 1174 may be formed on the underside of the sizer plate 1172, the underside being the surface facing the attachment 1140. The recess 1174 may be sized to seat on the attachment 1140 so that the annular body 1141 of the rigid base 1142 seats inside it. Multiple tabs 1176 may extend from the side walls of the recess 1174 toward the central opening 1178 formed in the plate 1172. The tabs 1176 may be sized to pass through the notches 1144 formed around the annular body 1141, and then the plate 1172 may be twisted to allow the tabs 1176 to engage with the tabs 1145 formed on the annular body 1141. These twist-on connection features allow various plates to be easily fixed to and removed from the base 1142 to determine the size of the humeral resection surface 1015. In this embodiment, three tabs 1176 are radially arranged around a recess 1174 to correspond to three notches 1144 and three tabs 1145 formed as part of the attachment 1140. Furthermore, three openings 1177 may be formed in the sizer plate 1172, such openings 1177 aligning with the tabs 1176. This configuration allows the openings 1177 to be used to help confirm that the tabs 1176 are engaged with the tabs 1145 and to help fix the position of the sizer plate 1172 relative to the attachment 1140.
[0128] In the illustrated embodiment, the sizer plate 1172 also includes an arm or extension 1179 as part of its proximal portion 1172p. As shown, the arm 1179 can be sized to substantially fit within the width of the attachment body 1142. Furthermore, a further method can be provided in which an opposing engaging tab 1179t is provided at the proximal end 1179p of the arm 1179 to fix the sizer plate 1172 to the attachment 1140 or otherwise position it.
[0129] A bone-engaging tongue or projection 1175 may be positioned at the distal end 1172d of the sizer plate 1172. The tongue 1175 may be configured to grip the edge of the humeral resection surface 1015 when the attachment 1140 to which the sizer plate 1172 is attached is centered on the humeral resection surface 1015, such as by positioning the cortical margin. The central opening 1178 of the sizer plate 1172 may be used to align with the central opening 1143a of the attachment 1140 and the cannula-receiving opening 1122 of the hub 320. Those skilled in the art will understand how such a sizer plate may be used to determine the size of the humeral resection surface. A non-limiting embodiment of a usable sizer plate is the INHANCE® humeral head trial from DePuy Synthes.
[0130] Once inside the joint space, the sizer attachment 1140 can be aligned parallel to the humeral resection surface 1015 such that its openings 1143a and 1178 point to the center of the humeral resection surface 1015. Aligning the central openings 1143a and 1178 with the center of the humeral resection surface 1015 allows the drill cannula 350 to be positioned correctly on the lateral cortex 1023 of the humerus 1012 such that the distal tip 382 emerges from the center and is perpendicular (also called orthogonal) to the humeral resection surface 1015 as the drill or guide pin, such as a drill bit 380, passes through the drill cannula 350 and the humerus 1012. Furthermore, the distal tip 382 may be used, if desired, to puncture tissue and / or perforate bone. The sizer attachment 1140 works further with the distal tip 350d of the drill cannula 1150 to generate a clamping force at the humeral resection surface 1015, thereby maintaining the position of the humeral guide on the humerus 1012 until at least the bone pins 370a, 370b pass through the bone pin clamps 332a, 332b and fix the humeral guide 300 to the bone.
[0131] After use of the sizer plate 1172, and / or when it is necessary to replace the sizer plate with a plate of a different size and / or configuration, the sizer plate can be removed from the humeral sizer attachment 1140. As shown in Figure 10G, this can be achieved, for example, by removing the engaging tab 1179t from the base 1142 and then removing the sizer plate 1172 from the articular space. More specifically, the engaging tab 1179t can be pushed and the sizer plate 1172 can be separated from the attachment 1140 by moving the portion containing the tab 1179t in direction R, and then rotating the sizer plate 1172 to detach it from the attachment 1140. Additional sizer plates 1172 may be attached and removed until the centering of the guide 300 is achieved and the appropriate size of the instrument to be used with the humeral resection surface 1015, implants, prostheses, and / or other devices to be used and / or implanted at the surgical site is determined. The guide 300 may remain in its set position for the remainder of the surgical procedure, assisting in the guidance of other instruments for precise preparation of the glenoid cavity and / or humerus. The attachment 1140 may similarly remain attached to the guide 300 for at least part of the subsequent procedure.
[0132] In some embodiments, centering and sizing can be further confirmed by introducing another sizer component, such as the INHANCE humeral sizer or sizer plate 1172' available from DePuy Synthes, as shown in Figure 10H. The INHANCE humeral sizer 1172' may include a central boss (not visible) extending distally toward the attachment 1140 in the illustrated embodiment of Figure 10H. A central opening 1178' may extend through the sizer 1172', including through the central boss. The boss may be inserted into the opening 1143a of the attachment 1140 so that the opening 1143a and the central opening 1178' are aligned. As shown, the sizer 1172' may be located just medial to the cortical margin, with no points of contact with the cortical margin. During the procedure, the user can evaluate this positioning of the sizer 1172' relative to the humeral resection surface 1015. After confirming the positioning of the guide 300, the user can ensure that all connection points, including but not limited to the bone pins 370a, 370b, rods 336a, 336b, bone pin clamps 332a, 332b, drill cannula 350, and attachment 1140 (or attachment 340 in other embodiments), are securely fixed.
[0133] Although not included as part of the procedures described with respect to Figures 20 to 31G, those skilled in the art will be able to use, in consideration of this disclosure, one or more size plates such as size plates 1172, 1172', and the INHANCE® humeral head trial, as well as related components in conjunction with sizing the humeral resection surface 1015.
[0134] Second embodiment of the humerus guide Figure 11 shows a second embodiment of the humerus guide 2300. The guide 2300 may include features similar to those of the guide 300, and therefore, a particular aspect of one guide may not be fully described even with consideration of the description of the other. Furthermore, those skilled in the art will understand how to incorporate the features of the humerus guide 300 into the humerus guide 2300, and similarly, how to incorporate the features of the humerus guide 2300 into the humerus guide 300. As a non-limiting example, the alignment features disclosed for the humerus guide 300 can be used in conjunction with the humerus guide 2300, and the use of components and features for locking the position of a drill cannula relative to the humerus guide, such as the drill cannula 2350 relative to the humerus guide 300, can be used in conjunction with the humerus guide 2300 and the drill cannula 350.
[0135] The humeral guide 2300 may include a rigid arm having a carriage or hub 2320 coupled to and / or disposed on the arm 2310. The rigid arm 2310 may be sized and shaped to allow proper centering and alignment between, for example, a bullet-shaped or drill cannula 2350 coupled to or otherwise associated with the hub 2320 and one of various modular attachments that can be used in conjunction with the guide 2300, such as a humeral sizer attachment 2340. The humeral sizer attachment 2340 may be constructed similarly to the humeral sizer attachment 340, and some of its features are labeled in Figure 11 (see, for example, the arm portion 2342a in which a window 2344 is formed, the plate portion 2342b having an annular body 2341 with multiple openings 2343a, 2343b, the knob 2348, and the plane PL''''' (which may be similar to planes PL and PL' and may be perpendicular or substantially perpendicular to the longitudinal axis L) defined by the plate portion 2342b). The size and / or shape of the arm 2310 may depend, at least in part, on the patient's size and anatomical structure (e.g., child vs. adult, male vs. female, etc.) and / or the surgeon's preference. In the illustrated embodiment, the length of the rigid arm 2310 is curved or arched as it extends from the proximal end 2310p to the distal end 2310d of the arm 2310, with its end defining the length of the arm 2310. In some cases, the shape of the arm 2310 can be described as a J-shaped configuration, as in the illustrated embodiment, but other configurations are also possible. In various embodiments, the rigid arm 2310 may be sized and shaped to allow for one-handed gripping during surgical procedures, and further, it may provide a universal fit so that it can be gripped in an equally convenient and easy-to-use manner with the user's right or left hand without the need to change gripping method and / or position during surgical procedures. Thus, the humeral guide 2300 can be considered a universal humeral guide.
[0136] As shown at least in Figures 11 and 12A, the proximal end 2310p of the arm 2310 may include a receiving block 2314 configured to receive the hub 2320. In the illustrated embodiment, the receiving block 2314 is an integral feature of the arm 2310; in other configurations, the receiving block may be coupled to the arm 2310. The receiving block 2314 may be sized such that the carriage 2320 can directly mate into the receiving block. The carriage 2320 may be selectively coupled to the receiving block 2314 in various ways or otherwise associated; however, in the illustrated embodiment, multiple screws 2316 pass through the receiving block 2314, such as through screw receiving openings or holes 2315, and enter a receiving opening or hole 2327 (see Figure 12B) formed in the hub 2320, assisting in the mating of the hub 2320 to the arm 2310. Those skilled in the art will understand the various other mating features that may be provided at the proximal end 2310p of the arm 2310 for receiving the hub 2320, selectively coupling the hub 2320 to the arm 2310, and for discoupling it. In some embodiments, the proximal end 2310p of the arm 2310 may be coupled to the hub 2320 by press-fitting or welding. Alternatively, the arm 2310 and carriage may be manufactured as a single, integrated part or component.
[0137] Alternatively, in other embodiments, the hub 2320 and block 2314 may be configured such that the hub 2320 has an opening facing the block 2314, is sized to receive the block 2314, and allows the block 2314 to be positioned within the hub 2320 so that the hub 2320 can slide along the block 2314. In at least some such embodiments, the hub 2320 can move and / or translate relative to the rigid arm 2310, such as moving along at least a portion of the length of the rigid arm 2310, and in such embodiments, the hub 2320 can be selectively locked at various positions or locations along the length of the arm 2310. Non-limiting examples of how such configurations can be implemented are disclosed in U.S. Patent No. 10,010,333, entitled “Side-Loading Carriage for Use in Surgical Guide,” the entirety of which is incorporated herein by reference.
[0138] Furthermore, as shown in the figure, block 2314 may have knob receiving openings or holes 2317 formed in block 2314 to receive a hub or carriage knob 2318, which may be used to assist in positioning the guide 2330 (sometimes called a collar). Each of the openings or holes 2315, 2317 may extend throughout the body of the receiving block 2314, thereby allowing features passing through them, such as the screws 2316 and the hub knob 2318, to engage with the carriage 2320. In at least some embodiments, part or all of the openings or holes 2315, 2317 may be threaded to match the threads of the respective screws 2316 and / or the hub knob 2318.
[0139] The hub 2320, shown in detail in Figure 12B, may include a hole or opening 2327 for receiving a screw 2316 and fitting the hub 2320 into the arm 2310. The hole 2327 may be threaded to match the threads of the screw 2316. The hub 2320 may further include a hole or opening 2329 extending between the block 2314 and the hub 2320 and configured to receive other mating components, such as a pin, which can further secure the hub 2320 to the block 2314. The hub 2320 may also include a lock block receiving opening 2323 and a nut receiving hole or opening 2325 formed in the hub 2320. As shown, the lock block receiving opening 2323 is generally sized to receive a lock block 2326 (see Figures 11, 12C, and 12D), the lock block itself is used in conjunction with setting the position of the guide 2330. The lock block receiving opening 2323 may be sized to be complementary in size and shape to the lock block 2326 and the actuating post or piston 2336, the actuating post or piston 2336 being configured to pass through a post receiving opening 2326o formed within the lock block 2326, and the post 2336 may help move the guide 2330 to various positions by moving up and down. In the illustrated embodiment, two posts 2336 are provided, but other numbers of posts, such as one or three or more, may be used. Similarly, other mechanisms known to those skilled in the art for moving components such as the guide 2330 relative to the hub 2320 may be used instead of the posts 2336. The nut receiving hole or opening 2325 may be sized to seat a nut 2352 in the nut receiving hole or opening 2325, the nut 2352 being configured to receive the hub knob 2318 when the hub knob 2318 extends toward the cannula receiving opening 2322. The hub knob 2318 may be configured to assist in setting or locking the post 2336 and / or the drill cannula 2350, with the opening 2325 extending to the cannula receiving opening 2322. The drill cannula 2350 can be translated along a longitudinal axis L extending through the cannula receiving opening 2322, the longitudinal axis L defining the path of movement of the drill cannula 2350.
[0140] Figure 12C shows a lock block 2326, which may be configured to fit into a lock block receiving opening 2323 formed in the hub 2320, as shown. In some cases, the lock block 2326 may be considered part of the hub 2320, and in other cases, it may be considered a separate component. The lock block 2326 has a body including a plurality of opposing arms 2326a (also shown in two) that define a post receiving opening 2326o (two shown). The opening 2326o defined by the arms 2326a and part of the hub 2320 may be complementary to and / or similar in size and shape to an opening 2324 formed in the hub 2320. A through hole 2326b may be formed in the body of the lock block 2326, which may be configured similarly to the knob receiving holes 2317 and 2325 (e.g., threaded) so that a knob 2318 can pass through. Slot 2326c may also be formed in the body of the lock block 2326, and slot 2326c is configured to receive block 2314.
[0141] As shown in Figure 12D, a nut 2352 may also be provided for use with the lock block 2326, hub 2320, and / or hub knob 2318. The nut 2352 may include an opening or hole (not visible) extending through the nut, which can seat within the opening 2325, for example by being press-fitted into the opening 2325, and is configured to receive the hub knob 2318, for example by being threaded. The nut 2352 may also include teeth 2352t extending distally toward a cannula receiving opening 2322, where a drill cannula 2350 may be disposed. The teeth 2352t may function as a one-way ratchet mechanism, for example by being spring-loaded, and may selectively engage with ratchet teeth 2351 formed on the outer surface of the drill cannula 2350, and may engage with the drill cannula 2350 when pressed by the hub knob 2318. The one-way ratchet mechanism allows the drill cannula 2350 to pass upward through the hub 2320 and locks the drill cannula 2350 in place, restricting its downward movement. This can provide additional strength in fixing the position of the humeral guide 2300 relative to the surgical site. The hub knob 2318 may include a distal end 2318b, a threaded portion 2318t configured to engage with threads formed in the opening of the nut 2352, and a handle 2318h having a stopper to assist in gripping and turning the knob in clockwise and counterclockwise directions. One or more of the hub knob 2318, the lock block 2326, and / or the nut 2352 may be considered, individually or in any combination, as a locking mechanism for the guide 2300 or a cannula locking mechanism. Furthermore, those skilled in the art will understand other forms or configurations of locking mechanisms that may be used to maintain the location and / or position of the drill cannula 2350.
[0142] During use, the user grasps the handle 2318h and rotates it clockwise to advance the hub knob 2318 further toward and / or into the hub 2320, and then advances the lock block 2326 toward the hub 2320. This movement of the lock block 2326 can apply additional force to the actuarial post 2336, causing the block 2326 and / or the hub 2320 to grip the actuarial post 2336 and lock it in place. In an alternative embodiment, similar movement of the knob can engage the ratchet teeth of the drill cannula, assisting in positioning the drill cannula relative to the hub, or more generally, the arm. Counterclockwise movement moves the lock block 2326 away from the hub 2320, and then reduces the force applied to the actuarial post 2336, allowing the actuarial post 2336 to move relative to the hub 2320. Movement of the actuarial post 2336 may result in movement of the guide 2330 relative to the hub 2320, such movement involves the guide moving axially along the longitudinal axis L.
[0143] The hub 2320 may include various feature parts, such as a cannula receiving opening 2322, to assist in interaction with other parts of the guide 2300 and / or components used in conjunction with the guide 2300. The cannula receiving opening 2322 may extend along the entire length of the body of the hub 2320. The opening 2322 may be substantially cylindrical in shape, as shown, and may be sized to receive a drill cannula 2350. As a further example, one or more additional openings 2324 may also be formed in the body of the hub 2320. As shown, two post receiving openings 2324 exist, each cylindrical in shape, and are configured to receive an actuation post 2336 that engages with the guide 2330 to assist in the positioning of the guide 2330. As best shown in Figure 12B, the openings 2324 may extend into the lock block receiving opening 2323 and continue on the other side of the lock block receiving opening 2323.
[0144] As shown in the figure, the hub 2320 has a roughly triangular or pyramidal shape, and the rounded outer surface on the body is consistent with the presence of cylindrical openings 2322 and 2324 formed in the hub 2320. Those skilled in the art will understand other shapes that may be used to form the body of the hub 2320.
[0145] Guide 2300 may be considered part of and / or a component of Guide 2300 and / or may include other components that can be used in conjunction with Guide 2300. For example, Guide 2330 may be coupled to the hub 2320 and then to the arm 2310 of Guide 2300, or otherwise associated. Guide 2330 may be configured to move distally and proximal along a longitudinal axis L extending through the hub 2320 and Guide 2330 respectively, and may be used to fix Guide 2300 to bone via bone pins 2370 to set the position of Guide 2300 at the surgical site. As shown in the illustration, the longitudinal axis L extends through a cannula receiving opening 2322 formed in the hub 2320 and, in at least the illustrated embodiment, also extends through a central opening 2332 formed in Guide 2330.
[0146] Figures 12A and 12E show the guide 2330 in more detail. As shown, the body of the guide 2330 can define a drill cannula 2350 (see Figures 11 and 12A) that can pass through a central opening 2332 configured to receive a collar 2360 (see Figures 11, 12A, and 12F), sometimes called a cannula receiving component, and a carriage opening 2322. The body of the guide 2330 may also include a bone receiving portion 2333 configured to engage with bone at the surgical site so that a bone pin 2370 can enter the bone received within the bone receiving portion 2333, and a knob receiving portion 2335 configured to receive a guide knob 2331 that selectively engages with the collar 2360, and therefore the drill cannula 2350 via the collar 2360, to set at least one rotational position of the guide 2330.
[0147] More specifically, a portion of the body of the guide 2330 defining the central opening 2332 may be configured to receive the collar 2360. One or more ledges 2330e may be formed as part of the body of the guide 2330 to receive the collar 2360.
[0148] The knob receiving portion 2335 of the body of the guide 2330 may include an opening 2335o formed in the knob receiving portion 2335. The opening 2335o may extend through the entire knob receiving portion 2335 of the body of the guide 2330 and may be sized in a similar manner to the opening 2326b of the locking portion 2326 (for example, it may be threaded) so as to receive the guide knob 2331 and allow the guide knob 2331 to operate as described herein.
[0149] The bone-receiving portion 2333 of the body of the guide 2330 may be configured to receive bone and / or may have a feature that allows engagement with bone to position the guide 2330 relative to the bone. As shown, the bone-receiving portion 2333 may include a plurality of arms 2333a that help define a curved surface 2333s which is concave as shown, and a receptive opening 2333b into which the bone can be disposed. One or more pin-receiving openings 2333p may be formed through the arms 2333a of the body, the openings extending through the entire body and allowing the passage of bone pins 2370 (see Figures 11 and 12A). Bone pins 2370 may be used to position the guide 2330 relative to the bone. In some embodiments, when the bone pin 2370 engages with the bone, the bone does not come into contact with the bone receiving portion 2330, and therefore with the guide 2330. In other embodiments, when the bone pin 2370 engages with the bone, the bone may come into contact with the bone receiving portion 2333, such as the curved surface 2330s.
[0150] Returning to the part of the body of the guide 2330 that defines the central opening 2332 and receives the collar 2360, the collar 2360 is illustrated in detail in Figure 12F. As shown, the collar 2360 may include an opening 2362 for receiving the drill cannula 2350. The body of the collar 2360 may include an upper ring 2364 configured to seat on the ledge 2330e, so that, as shown in Figures 11 and 12A, the end of the collar 2360, which is the uppermost surface of the upper ring 2366, seats substantially coplanar with the top surface of the guide 2330 when the ring 2364 is placed on the ledge 2330e. The collar 2360 also includes a second ring 2366 that defines a knob receiving surface 2365, together with the bottom 2364b of the upper ring 2364. In the illustrated embodiment, the second ring 2366 does not extend radially outward as much as the upper ring 2364, but both rings 2364, 2366 extend radially outward beyond the portion of the body of the collar 2360 that forms the knob receiving surface 2365. Thus, the rings 2364, 2366 are provided with ledges on which the distal end 2331b of the guide knob 2331 can be seated, for example, as shown in Figure 12H. More specifically, the guide knob 2331 can be screwed into the opening 2335 (e.g., via the threaded portion 2331t), the collar 2360 can be assembled to the guide 2330, and then the collar 2360 can rotate freely until the knob 2331 is tightened and stops moving by pressing against a groove provided as part of the collar 2360. In the illustrated embodiment, the guide 2330 houses the collar 2360 within a central opening 2332, with only the bottom portion 2368 protruding outside the hub 2320. The bottom portion 2368 may be located, for example, within a central opening 2339 of the base portion 2338.
[0151] One embodiment of the guide knob 2331 is shown in Figure 12G, and generally includes a distal collar engaging end 2331b that can engage with a bushing through which the drill cannula 2350 passes, a threaded portion 2331t configured to engage with threads formed in an opening 2335o, and a handle 2331h with a stopper to assist in gripping and rotating the knob in clockwise and counterclockwise directions. The guide 2330 may generally be configured to rotate freely around the longitudinal axis L, and therefore around the drill cannula 2350. The guide knob 2331 may be used to selectively fix the guide 2330 so that it does not rotate with respect to the longitudinal axis L. More specifically, referring to Figure 12H, when the handle 2331h is grasped by the user and rotated clockwise, the threaded portion 2331t moves along the threads formed in the opening 2335o, and the most distal surface of the distal end 2331b is pressed against the knob receiving surface 2365. This movement can apply force to the knob receiving surface 2365, which in turn prevents the movement of the collar 2360. If the application of this force exceeds a threshold amount, the rotation of the guide 2330 may be affected or come to a complete halt. Counterclockwise movement moves the most distal surface of the distal end 2331b away from the knob receiving surface 2365, thus reducing and / or eliminating the force applied to the knob receiving surface 2365, which in turn allows the rotation of the guide 2330 to occur or to occur more freely.
[0152] The guide 2330 can be seated on the base 2338, so that the guide 2330 can rotate freely around the drill cannula 2350 that has passed through the central opening 2332, while the base 2338 translates the guide 2330 along the longitudinal axis L via the working post 2336. The base 2338 and the working post 2336 are shown in Figure 12I. The base 2338 may include a cannula receiving hole or opening 2339 and a plurality of post receiving openings 2338p. The cannula receiving opening 2339 may be configured to allow the drill cannula 2350 to pass through so that the drill cannula 2350 can be translated along the central longitudinal axis L, and axis L is the same axis L shown in Figures 11 and 12A. The post receiving opening 2338p is positioned such that the working post 2336 is substantially parallel to the longitudinal axis L, in a manner similar to that of the drill cannula 2350. P The guide can be configured to pass through the actuation post 2336 so that it can be translated along the humerus. As described above, the movement of the actuation post 2336 can be locked in place by the hub knob 2318 and the lock block 2326. For example, in use, after translating the guide 2330 proximal to the humerus via the actuation post 2336, the guide 2330 can rotate around the drill cannula 2350 to form a secure fit with the humerus. Once positioned in the desired location, the guide 2330 can be locked in place by the guide knob 2331 so that it no longer rotates. More specifically, by rotating the guide knob 2331, the opening 2362 of the collar 2360 positioned around the drill cannula 2350 is tightened, fixing the position of the guide 2330 relative to the drill cannula 2350. The curved surface 2333s can be firmly fitted to the shaft of the humerus, and the bone pin 2370 can pass through the opening 2333p and enter the humerus at a bifurcation angle for optimal fixation.
[0153] Handle Assembly (IES) After the humeral guide 300 is positioned on the humerus and a humeral penetration hole is drilled in the drill cannula 350, several modular attachments can be coupled to the distal end 310d of the rigid arm 310. To achieve this, a universal handle assembly 1400 can be used. Figure 13 shows the universal handle assembly 1400 fitted to the guide 300, and Figures 15A to 15C show more detailed views of the universal handle assembly 1400. Figure 14 provides an adapter 390 that can be used to couple the universal handle assembly (e.g., assembly 1400) to the distal end 310d of the rigid arm 310.
[0154] As shown in the figure, the adapter 390 may be positioned at the distal end 310d of the arm 310 of the humeral guide 300. The adapter 390 helps to provide a feature portion into which the handle assembly 1400 can be fitted, and also provides stability to the use of the handle assembly 1400 with respect to the guide 300, and thus helps to maintain desired alignments, such as the alignment of the guide pin 380 with respect to the humeral resection surface 1015. As shown in the figure, the guide pin 380 may be associated with a modified trinkle connection 385 which can be connected to a power source and used to rotate and / or advance the guide pin 380 during any part of the procedure.
[0155] Referring to Figure 14, the adapter 390 may have a substantially rectangular shape with a flared portion 392 at the distal end 390d of the adapter, the flared portion 392 forming a base wider than the more proximal portion 390p of the body 393 of the adapter 390, and thus providing additional support for the handle assembly (e.g., handle assembly 1400) to the humeral guide (e.g., guide 300). Similarly, a handle portion 395 located as part of the proximal portion 390p may provide a feature that allows the user to easily grasp the adapter 390 and move it away from the handle assembly (e.g., handle assembly 1400). Furthermore, the illustrated bottom portion 395b of the handle portion 395 may be used for alignment purposes, as described below. The adapter 390 may be generally spring-loaded and biased toward the universal handle assembly 1400, allowing the universal handle assembly 1400 to be selectively disengaged from the arm 310. When released, the adapter 390 can generally advance distally toward the terminal end 310d of the arm 310.
[0156] The opening 391 may be formed over the entire body 393, thus allowing the distal end 310d of the arm 310 to pass through the body and enabling the adapter 390 to be mounted on the body for use with the body. The distal end 390d of the adapter 390 may also include a mount 394 extending distally from the flared portion 392, the mount 394 configured to receive the handle assembly 1400. As shown, the guide receiving opening 1454 formed in the receiving portion 1452 of the handle assembly 1400 may be sized and shaped to fit onto the mount 394, and the mount 394 is similarly complementary in configuration to receive the receiving portion 1452 of the handle assembly 1400, more specifically the guide receiving opening 1454. The mount 394 may be complementary in shape to a portion of the handle assembly designed to receive the mount when the handle assembly (e.g., handle assembly 1400) is mounted onto the guide (e.g., guide 300). In the illustrated embodiment, four engagement projections 397 are formed as part of the mount 394, and the engagement projections 397 are complementary to engagement projections 1467 formed on the slider 1460 of the handle assembly (see Figure 15C).
[0157] The adapter 390 can be fitted to the distal end 310d of the arm 310 in various ways, but in the illustrated embodiment, the adapter 390 is selectively and slidably mounted on the arm 310, allowing the adapter to be quickly and easily selectively moved between a locked position or configuration in which the adapter 390 can receive the handle assembly 1400 and an unlocked position or configuration in which the adapter 390 can be moved proximal along the arm 310 in direction P away from the mounting position of the handle assembly 1400, for example, by advancing the adapter 390 in direction Q opposite to direction P, thereby assisting in later engagement of the handle assembly or another instrument with the guide 300. A gripping feature, such as the illustrated ribbed portion formed on the flared portion 392, can be easily grasped by the user to pull the adapter 390 proximal and slide it along the arm 310 in direction P.
[0158] As shown in Figure 14, the adapter 390 may also have alignment lines 393m formed on the body 390. Like other parts of the guide 300 and related components, including various alignment lines and / or boundary lines, the line 390m may be used to assist and / or verify proper alignment between the adapter 390 and the arm 310. This alignment between the line 390m of the adapter 390 and the line 310a of the arm 361 is shown in at least Figures 13 and 23B.
[0159] Before describing how the adapter 390 engages with the handle assembly 1400, it may be useful to consider some of the features of the handle assembly 1400. Figures 15A to 15C show the handle assembly 1400.
[0160] The universal handle assembly 1400 includes an elongated arm 1422 having a proximal portion 1422p and a distal portion 1422d. The proximal portion 1422p includes a receiving portion 1452 which is configured to fit a handle or gripping portion 1450 and the distal end (e.g., distal end 310d) of an arm (e.g., arm 310) of a universal guide (e.g., guide 300). The distal portion 1422d includes a feature configured to work in cooperation with the mounting portion 1420 to selectively grasp and release an attachment or tool. The distal portion 1422d of the arm 1422 defines a plane PL''. The plane PL'' may extend through the body 1422b of the distal portion 1422d of the arm 1422d, but the plane PL'' defined by the body 1422b may similarly easily extend through another similar surface of the mounting portion 1420.
[0161] The handle assembly 1400 may include a receiving portion 1452 configured to fit onto the distal end 310d of the arm 310 of the guide 300. In the illustrated embodiment, the receiving portion 1452 includes an outer housing or cover and a guide receiving opening 1454 defined by a portion of the outer housing, which is sized and shaped to allow at least a portion of the mount 394 to pass through in order to fit the mount 394 into the receiving portion 1452. Once the mount 394 is positioned within the guide receiving opening 1454, the handle assembly 1400 may be fitted onto the mount 394 by a selectively lockable guide mounting mechanism 1456. In the illustrated embodiment, the selectively lockable guide mounting mechanism 1456 includes a pair of springs 1458, a slider 1460, and a spring receiving receptacle 1462. The spring 1458 is disposed within the receptacle 1462 and can be biased distally, i.e., away from the gripping portion 1450, toward a position where a tool such as a reamer attachment 500, 500' (see, for example, Figures 16A-16C and 17A-17D) or a blazer attachment 600, 600' (see, for example, Figures 18A-18C and 19A-19B, sometimes called a blazing attachment or broacher attachment) is selectively coupled to the handle assembly 1400. This biasing allows the guide mounting mechanism 1456 to be positioned in an engagement position or configuration, thereby biasing the spring 1458 to engage with the mount 394 when the mount 394 is positioned within the guide receiving opening 1454. Attachments such as the reamer attachment 500, 500' and the blazer attachment 600, 600' may more commonly be referred to as tool attachments, and the term tool attachment encompasses any tools that can be operated in conjunction with this disclosure. Other terms that may be used to refer to all tool attachments include humeral preparation (or preparation) instruments or tools or bone treatment tools.
[0162] The receiving portion 1452 of the universal handle assembly 1400 may also include a slider 1460 and a spring receptacle 1462. As partially considered above, these slider 1460 and spring receptacle 1462, and their associated components, cooperate with the proximal portion 1422p of the arm 1422 and an adapter (e.g., adapter 390) to selectively couple the handle assembly 1400 to and from a guide (e.g., guide 300). As shown, the slider 1460 and spring receptacle 1462 are complementary to each other and form a chamber 1469 in which a spring 1458 (two springs as shown) can be disposed. The slider 1460 may be designed to slide relative to the receptacle 1462 in direction F and in the direction opposite to direction F. Spring 1458 provides a biasing force in the opposite direction to the illustrated direction F, thereby biasing the slider 1460 toward the distal portion 1422d of the arm 1422. The slider 1460 may include opposing gripping blocks 1461, each having a groove that allows the slider 1460 to grip and slide in direction F, causing the slider 1460 to act against the biasing force of spring 1458 and slide against the spring receiving receptacle 1462. The gripping blocks 1461 of the slider 1460 may move together to move the two springs 1458 simultaneously. The gripping blocks 1461 of the slider 1460 may be operated independently to move the springs 1458 individually. The slider 1460 and the spring receptacle 1462 each include openings 1466 and 1464 formed in the slider 1460 and the spring receptacle 1462 to receive the distal portion (e.g., distal portion 390d) of an adapter (e.g., adapter 390). The spring receptacle 1462 also includes a plurality of holes 1468 for receiving screws 1468s which may be used to attach the spring receptacle 1462 to the proximal portion 1422p of the arm 1422.
[0163] The slider 1460 may include features that engage with the distal portion of the adapter to assist in securing the universal handle assembly 1400 to a guide (e.g., guide 300). More specifically, as shown, four engaging projections 1467 (two on each of the opposing inward-facing surfaces of the slider 1460) are configured to engage with complementary engaging projections (see projection 397 in Figure 14) formed on the distal portion of the adapter (see adapter 390 in Figure 14). In use, the slider 1460 may slide in direction F, allowing the mount 394 to enter and pass through openings 1464, 1466, and 1454. Once the mount 394 is properly positioned, the slider 1460 may be released and biased to return in the direction opposite to direction F. The engaging projections 1467 can engage with the engaging projections 397 to assist in securing the universal handle assembly 1400 to the adapter 390 and thus to a guide (e.g., guide 300). Those skilled in the art will, in consideration of this disclosure, understand other configurations and features that may be used for similar purposes as the selectively lockable guide mounting mechanism 1456 to enable the selective mounting of the universal handle assembly 1400 to the guide 300. Furthermore, the ease of access from both sides of the handle assembly 1400 is a feature of the receiving opening 1454 and associated components and the receiving portion 1452 such as the slider 1460, as well as other components of the handle assembly 1400 provided herein, which helps to make the handle assembly 1400 universal so that it can be operated from either side of the body with either hand.
[0164] The handle 1450, also called the gripping portion, may have various contours and features to facilitate and make gripping by either the right or left hand easy and comfortable from both sides of the assembly 1400, and to avoid the need to change gripping position during surgical procedures. In the illustrated embodiment, the proximal portion 1422p includes an elongated slot 1453 formed in the proximal portion 1422p. The slot 1453 may be used, for example, to have a gripping feature coupled thereto. The gripping portion 1450 may include a comfortable gripping material (e.g., rubber) that can be attached to a guide (not shown) that helps in the formation of the gripping portion 1450 of the handle assembly 1400. Those skilled in the art will understand how a comfortable gripping material (e.g., rubber) or other gripping feature may be fitted into the arm 1422 via the slot 1453. Furthermore, those skilled in the art will understand other ways in which the slot 1453 can be used, not necessarily involving the use of a gripping feature. That is, the arm 1422 as shown in the figure may be a handle held by a surgeon in connection with performing a surgical procedure. The receiving portion 1452 also includes a receiving opening 1454 formed in the proximal portion 1422p of the arm 1422. As described herein, this receiving opening 1454 may be configured to receive the distal end of the adapter 390.
[0165] The distal portion 1400d of the universal handle assembly 1400 may include a mounting portion 1420 configured to selectively receive various attachments or tools that can be coupled to the universal handle assembly 1400 for use in surgical procedures. In at least some embodiments, the mounting portion 1420 can selectively fit onto the gripping portion 1450 so that different configurations of gripping portions and different configurations of mounting portions can be used in combination. Those skilled in the art will understand how various removable and interchangeable coupling configurations can be provided to enable such mixing and fitting of gripping portions and mounting portions. As shown in the illustration, the mounting feature includes, among other components, a recess 1425 formed in the distal end 1422d of the arm, a capture plate 1426, and a latch 1424. The capture plate 1426 and the latch 1424 are located on opposing sides of the arm 1420 and are configured to move simultaneously to capture the mount of an attachment in the recess 1425.
[0166] Various attachments or tools can be used on the mounting portion 1420, but in the embodiment shown in Figure 13, the attachment is a reamer attachment 500 coupled to the handle assembly 1400. Those skilled in the art will understand that other attachments and / or tools disclosed herein (e.g., any of the other reamers or brazer attachments 500', 600, 600') and / or other attachments and / or tools known to those skilled in the art may also be used as attachments or tools in conjunction with the humeral guide (e.g., guide 300) and handle assembly (e.g., handle assembly 1400) of the present disclosure.
[0167] The wall 1421 may define a substantially circular recess 1425 that extends downward from the outer edge of the distal portion 1422d of the arm 1442 and is configured to receive an attachment having a mount (e.g., a mount 510 as illustrated and described in relation to at least Figures 16A and 16B). The recess 1425 may be larger in size and shape than the mount so that the mount can freely move in and out of the recess 1425 when the capture plate 1426 is moved proximal to the recess 1425. In the illustrated embodiment, the recess has a central opening 1422o formed in the recess, which can be aligned with the longitudinal axis LC, as well as the opening 343a of the humerus sizer attachment 340, the cannula receiving opening 322 of the guide 300, and therefore the drill cannula 350 disposed in the cannula receiving opening 322. This allows for the formation of a single path through which the drill guide 380 can pass, and the movement path is collinear with the longitudinal axis LC. Furthermore, the plane PL'' defined by the handle assembly 1400 may be orthogonal to or substantially orthogonal to the longitudinal axis LC.
[0168] The capture plate 1426 includes a proximal portion 1426p which may be generally elongated and a distal portion 1426d which may be more circular. The circular distal portion 1426d may have a curvature similar to that of the recess 1425 formed in the distal end 1422d of the arm. The curvature may be adapted to the curvature of the attachment mount (e.g., mount 510 as illustrated and described in at least with respect to Figures 16A and 16B), so that the distal end 1442d can contact the mount and secure the mount against the wall 1421 defining the recess 1425. The mounting portion 1420 may further include a spring 1442 configured to bias the capture plate 1426 in the distal direction S, causing the distal portion 1426d of the capture plate to close a portion of the recess 1425.
[0169] The capture plate 1426 is positioned close to the distal portion 1422d of the arm 1422 and is configured to move (e.g., slide) relative to the arm to selectively engage and disengage a tool or attachment (e.g., a reamer attachment 500). More specifically, the capture plate 1426 is positioned below and on the plane of the distal portion 1422 and is configured to slide in direction S such that the distal portion 1426d of the capture plate 1426 closes a portion of a recess 1425 formed in the distal portion 1422d of the arm 1422. In the illustrated embodiment, the capture plate 1426 includes a slot 1423a formed in its body 1426b to receive a spring 1442 such that the distal portion of the spring 1422 engages with the wall 1423w. Slot 1423a extends to the same length as slot 1422b of arm 1423 and can be aligned with slot 1423b, thereby the distal portion of spring 1442 engages with the distal wall 1423w of slot 1423a and the proximal portion of spring 1442 engages with the proximal wall 1422w of slot 1423b, biasing the capture plate 1426 in the distal direction S and closing a portion of the recess 1425.
[0170] The distal portion 1426d of the capture plate 1426 may include opposing arms 1426e, 1426f configured to engage with a tool or tool attachment. Alignment slots 1426s may be formed between the two arms 1426e, 1426f for the purpose of receiving complementary alignment features formed within a tool or tool attachment (e.g., projections 613 of the blazer attachment 600, as shown in Figures 18A and 18C).
[0171] The capture plate 1426 can be moved by a latch 1424 coupled to the capture plate 1426 to open the recess 1425. As shown in the figure, the latch 1424 is coupled to the capture plate 1426 through a slot 1423b formed in the distal portion 1422d of the arm 1422. In the illustrated embodiment, the latch 1424 includes two posts 1429 extending from the bottom of the latch 1424 through the slot 1423b into a complementary opening 1427 formed in the capture plate 1426. In other embodiments, the latch 1424 may be fitted to the capture plate 1426 by welding or other means known in the art so that they move simultaneously to capture a tool and release the tool from the mounting portion 1420. A portion of the latch 1424 may extend above the arm 1422 and may include a gripping feature indicated as a groove 1424g that can help a user grasp the latch 1424 to assist its movement. In some cases, the latch 1424 and the capture plate 1426 may be considered an integrated capture component, and therefore, in at least some cases, a reference to the latch may include both the latch and the capture plate, and similarly, a reference to the capture plate may include both the capture plate and the latch. As designed, the movement of one causes the other to move. Thus, it becomes possible for the user to use the latch 1424 to act against the biasing force on the capture plate 1426.
[0172] During use, the user can grasp the groove 1424g and pull in direction M to counteract the biasing force in direction S generated by the spring 1442. This causes the capture plate 1426 to slide proximal, against the distal portion 1422d of the arm 1422. As a result, the more distal portion 1426d of the open capture plate 1426 moves proximal, forming a recess 1425 with a larger radius to receive an attachment or tool. A roller bearing (or other equivalent mount) may be disposed within the recess 1425. When the roller bearing is in the desired position relative to the capture plate 1426 and the arm 1422, the force in direction M can be removed, allowing the capture plate 1426 to slide distally in direction S generated by the biasing force of the spring 1442. This then moves the distal portion 1426d of the capture plate 1426 toward the end of the distal portion 1422d of the arm 1422, thereby reducing the radius of the recess 1425 and capturing a roller bearing (or other equivalent mount) between the distal portion 1426d of the capture plate 1426, including the arms 1426e, 1426f, and the wall 1421 of the recess 1425, securing the attachment to the universal handle assembly 1400 for subsequent operations. The same operation for loading the attachment can be performed to unload the attachment, and by pulling in direction M, the attachment can be disengaged by the distal portion 1426d of the capture plate 1426, thereby allowing the attachment to be moved and removed from the recess 1425. Optionally, another attachment or tool can be coupled to the universal handle assembly 1400 for further surgical operations.
[0173] Attachment for handle assembly (IES) Modular attachments such as the reamer attachment 500 and the blazer attachment 600 can have various configurations, and non-limiting versions thereof are disclosed herein as reamer attachment 500' and blazer attachment 600'. Reference to one version of such attachment is applicable to other versions unless expressly specified otherwise or unless otherwise recognizable to a person skilled in the art in consideration of the descriptions and illustrations provided herein. In the illustrated embodiments, the attachments 500, 600 include tools 502, 602 and mounts 510, 610. The tools 502, 602 may include feature parts configured to perform certain functions which a person skilled in the art would understand to be typical functions of such tools, and may, in some cases, be called bone engagement devices, bone preparation devices, or humeral preparation devices, among other names. Thus, in the case of the reamer attachment 500, the tool 502 is a reamer having a plurality of reamer teeth 504 for reaming bone. Similarly, in the case of the blazer attachment 600, the tool 602 is a blazer (sometimes called a blazing tool or broaching tool) having multiple blazing fins or arms 604 (sometimes called broaching fins or broaching arms) for broaching bone.
[0174] Figures 16A and 16B show embodiments of a reamer attachment (reamer attachment 500 shown in Figure 13). Tool 502 is a reamer configured to prepare the humeral resection surface 1015 for receiving a prosthesis by engraving a geometric shape into it. To ream the bone, it is necessary to apply a sufficient amount of pressure to the bone surface with the reamer 502 to engrave the appropriate geometric shape. In conventional methods performed using known tools, the narrow rotator cuff parity maintained by the surrounding soft tissue did not provide adequate space for reaming the bone surface using a downward force applied to the bone surface. Therefore, this disclosure provides the force necessary to operate the tool by providing a retraction force supplied to the reamer attachment 500 by a drill cannula 350 and a guide pin 380 passing through a humeral perforation.
[0175] The reamer attachment 500 comprises a tool 502, a capture plate or quick-release latch or button 520, and a mount 510 including a roller bearing 514, the mount 510 also called a reamer bearing, adapter, or reamer adapter. The mount 510 can be separated from the tool 502. This is because the mount 510 may be intended for single use, while the tool 502 may be cleaned and reused in subsequent procedures. The reamer attachment 500 may be substantially circular in shape with a substantially flat profile, but other shapes and configurations are also possible. Similar to the humeral sizer attachment 340, the reamer attachment 500 may be manufactured in various diameters to accommodate the diameters of various humeral resection surfaces. The flat profile allows the reamer attachment 500 to enter the articular space through the narrow rotator cuff gap above the subscapularis muscle. The reamer attachment 500 further includes a central opening 550 configured to receive and secure a guide pin 380 therein. The central opening 550 can be defined by openings formed in various components of the reamer attachment 500, such openings and components are described in more detail below with reference to Figure 16B. The tool 502 can define plane PL''' as well as planes PL and PL'.
[0176] The tool 502 may include a cutting surface 503 on which a blade or teeth 504 are formed, and a receiving surface 506 opposite the cutting surface 503 so as to be on the opposite side of the tool 502. Multiple relief holes or openings 505 may be formed between the receiving surface 506 and the cutting surface 503, and the relief holes 505 provide a path for cut tissue, fluid, debris, and other material to pass through during operation of the reamer attachment 500. As shown in the figure, four relief holes 505 are provided, radially spaced around a central opening 502, but other configurations, shapes, and numbers of relief holes may be provided. A lip 507 may be formed on the outer edge or periphery of the tool 502, and the upper end 507t of the lip 507 and a plane extending over the entire receiving surface 506 define a chamber 513 on which components of the reamer attachment 500 may be arranged. An access port 508 may be formed in the lip 507 to provide access to the chamber 513. The central opening 502o may extend from the receiving surface 506 to the cutting surface 503.
[0177] The capture plate or release button 520 includes an opening 522. The opening 522 may have a larger first portion 522a to allow the guide pin 380 to pass through the opening 522, and a second portion 522b that is narrower than the first portion 522a so that the second portion 522b can engage with and capture the guide pin 380. The inner surface 522s of the opening 522 may be inclined. The edge 520a of the capture plate 520 may be aligned with the access port 508, and a spring 524 may be located in the chamber 513 to bias the capture plate 520 toward the access port 508 when the capture plate 520 is in a capture position or configuration, or a locked position or configuration (a position described in more detail with respect to Figure 16C) (see also the description related to Figures 17C and 17D for similar locking capabilities). At least the edge 520a may be polished to help position the capture plate more easily at the surgical site. The capture position may be the default position or configuration of the capture plate 520, or the stationary position or configuration. The spring 524 may seat in a notch 526 formed in the opposite edge 520b of the capture plate 520. The spring 524 presses against the lip 507, biasing the capture plate 520 toward the access port 508.
[0178] The distal disc or plate 512 includes a central opening 512o. The central opening 512o may be large enough to allow the shaft 509 of the roller bearing mount 510 to pass through. In the illustrated embodiment, the shaft 509 is threaded and has threads complementary to the threads formed in the opening 502o of the tool 502. Multiple relief holes or openings 515 may be formed through the disc 512, and the relief holes 515 are configured in a similar manner to the relief holes 505 formed within the tool 502, thus providing a path for cut tissue, fluids, debris, and other materials to pass through during operation of the reamer attachment 500. A screw receiving opening 517 may also be formed through the disc 512. As shown, the screw receiving opening 517 may be configured to receive a screw 532 that can be used to fit the disc 512 onto the tool 502. Complementary screw receiving openings 506s may be formed on the receiving surface 506 of the tool 502. Furthermore, an access port 518 may be formed on the edge of the disk 512 and configured to align with the access port 508 of the tool 502, thereby allowing it to contact the edge 520a of the capture plate 520 and move it from a biased capture position to an unlocked position or configuration. As shown in the figure, the edge of the disk 512 may be shaped complementary to the radially inward-facing surface of the lip 507 of the tool 502, allowing the disk 512 to be press-fitted or otherwise coupled to each other.
[0179] The proximal disk 514 of the mount 510 is a roller bearing. As shown in the illustration, the roller bearing 514 has an opening 510o formed in the roller bearing 514, the opening 510o being sized to allow the roller bearing to be positioned around the roller bearing mount 509, as shown in Figure 16A (see also Figure 17A for a similar configuration). The opening 510o may also be configured to receive a shaft 3010, as will be described in more detail below. The shaft may be, for example, a T30 driver. In the illustrated embodiment, both the opening 510o and the distal end 3010d of the shaft 3010 are hexagonal, forming a hexagonal key engagement, but other configurations, including but not limited to other key configurations, may be used. With respect to the handle assembly 1400, the roller bearing 514 may be configured to mate with the distal portion 1426d of a capture plate 1426, which includes arms 1426e, 1426f and is locked in a chamber 1428. Furthermore, the exposed portion of the roller bearing mount 509 may help provide a position in which the reamer attachment 500 can be fitted onto the distal portion 1426d of the capture plate 1426 when the capture plate 1426 is in the biased locked position and no force is applied to the latch 1424 to counteract the biasing force applied to the capture plate 1426. By using the roller bearing 514, the associated tool 502 can rotate freely while held by the handle assembly 1400. The roller bearing 514 provides smooth rotation and / or planar motion without causing seizure due to friction. Those skilled in the art will understand, in consideration of this disclosure, how to improve the roller bearing 514 to engage with the handle assembly 1400 by including, for example, a projection as part of the roller bearing 514 that can engage with the walls of the arms 1426e, 1426f defining the alignment slots 1426s, or another component (see, for example, projection 613p associated with the intermediate disc 613 in Figure 18A of the blazer attachment 600).
[0180] Mount 510 may be a separate component from tool 502, allowing one component to be discarded and the other reused. For example, in some cases, mount 510 may be disposable while tool 502 can be reused.
[0181] During use, the spring 524 pushes the capture plate 520 toward the access port 508 formed in the tool 502, causing the capture plate 520 to engage with the guide pin 380 disposed within the reamer attachment 500. Furthermore, as will be described in more detail elsewhere in this specification, the mount 510, and therefore the reamer attachment 500, is held in place by the mounting portion 1420, which is biased by the spring 1442 to form this locking configuration, as shown in Figure 16C. Once the capture plate 520 locks the guide pin 380 against the tool 502, the tool 502 can be operated using the guide pin 380. By pressing the edge 520a of the capture plate 520, it may be possible to release the guide pin 380 from the reamer attachment 500.
[0182] Figures 17A to 17D show another embodiment of the reamer attachment 500'. The reamer attachment 500' is similar to other reamer attachments provided herein, such as the reamer attachment 500, and therefore no further description is needed, nor is it necessary to specify each illustrated feature of the attachment 500'. As shown, from the proximal part of the exploded view to the distal part of the exploded view, the reamer attachment 500' may include a mount 510' including a roller bearing 514' and a distal disc or plate 512', a capture plate 520', and a tool 502' which is a reamer as shown. The mount 510' can be secured to the tool 502' via the distal disc 512' using a screw 532', and the capture plate 520' can be biased by a spring 524' that engages with the tool 502' and the capture plate 520' in the manner provided elsewhere herein. Plane PL'''', like planes PL, PL', and PL''', can be defined by tool 502'. Plane PL'''' can extend through the principal surface of tool 502', but planes defined by tool 502' can easily extend through other similar surfaces of tool 502'.
[0183] Mount 509' may extend upward from the center of tool 502', and the central opening 502o' of tool 502' extends through the tool from the roller bearing mount 509' to the distal end of the cut surface 503'. The roller bearing mount 509' may be configured to receive a roller bearing 514' around it. For example, the roller bearing 514' may be pressed and welded to the roller bearing mount 509' such that the roller bearing 514' is separated from the distal disc 512' by a certain distance. As shown in the figure, this space may form a channel 511' between the distal end of the roller bearing mount 509', which is defined as the end of the roller bearing mount 509' closest to the cut surface 503 and exposed by the space between the roller bearing 514' and the distal disc 512', and the receiving surface 506'. The channel 511' may be configured to receive the capture plate 520' and allow the capture plate 520' to engage with the guide pin as it passes through the central opening 502o' of the tool 502' to the roller bearing mount 509'.
[0184] The flat surface 519' may be formed on the edge of the disk 512' facing the access port 518', and the flat surface 519' is complementary to the flat portion of the radially inward-facing surface of the lip 507'.
[0185] The capture plate 520' shown in Figure 17B includes an opening 522' having multiple diameters, the opening being sized to pass through the roller bearing mount 509' so that the capture plate 520' seats on the receiving surface 506' within the channel 511'. As shown in Figures 17C and 17D, the first portion 522a' of the opening 522' may be larger to allow the guide pin 380 to pass through, and the second portion 522b' may be smaller so as to be configured to engage with and capture the guide pin 380. The inner surface 522s' of the opening 522' defining the transition from the first portion 522a' to the second portion 522b' may be inclined, as best shown in Figure 17D. The edge 520a' of the capture plate 520' can be aligned with the access port 508', and the spring 524' is located within the chamber 513' and can bias the capture plate 520' toward the access port 508' when the capture plate 520' is in the capture position or configuration, or the locked position or configuration (a position described in more detail with respect to Figure 17D). The capture position may be the default position or configuration or the stationary position or configuration of the capture plate 520'. The spring 524' may seat in a notch 526' formed in the opposite edge 520b' of the capture plate 520'. The spring presses against the lip 507' and biases the capture plate 520' toward the access port 508.
[0186] Figures 17C and 17D show a reamer attachment 500' that engages with a guide pin 380'. The engagement between the guide pin 380' and the reamer attachment 500' allows the reamer 502' to be positioned for use in reaming bone. The guide pin 380' is similar to the guide pin 380 and includes a distal end 380d' configured to operate a tool associated with a modular attachment coupled to a universal handle assembly, as is the case with the reamer attachment 500' when mounted to the universal handle assembly 1400, and a pointed distal tip 382' disposed on the distal end 380d'. In the illustrated embodiment, the guide pin 380' includes a groove 384' formed around the outer surface or outer circumference of the pin 380', proximal to the distal tip 382' of the distal end 380d'. As described above, the first portion 522a' of the opening 522' has a diameter larger than the diameter of the roller bearing mount 509', allowing the plate 520' to pass over the roller bearing mount 509', for example, during assembly and / or when the capture plate is in an unlocked position or configuration that allows the guide pin 380' to move longitudinally through the roller bearing mount 509' and the opening 522'. On the other hand, the second portion 522b' of the opening 522' has a diameter larger than the diameter of the guide pin 380' in the groove 384', but smaller than the diameter of the shaft of the guide pin 380' directly above and below the groove 384' (i.e., the diameter of the guide pin 380' for most of its length).
[0187] As described above, the capture plate 520' is biased by the spring 524' toward the access port 508', allowing the capture plate 520' to be moved from its default position or configuration, or its resting position or configuration, to the capture position or locked position. When the capture plate 520' is in the default position or resting position, the second portion 522b' of the opening can be substantially aligned with the opening 502o' of the tool 502'. As a result, the capture plate 520' can prevent or block a tool of a certain size, such as a guide pin 380', from passing through the central opening 502o' of the tool 502', and therefore through the central opening 550' of the reamer attachment 500'. This is because the diameter of the second portion 522b' of the opening 522' is too small for it to move through. The capture plate 520' can be moved to an unlocked position or configuration or a released position or configuration by sliding the capture plate 520' toward the portion of the lip 507' in which the spring 524' is disposed to counteract the biasing force of the spring 524', or by moving it otherwise. This may be movement along the XX axis as shown in the figure. When this movement occurs, the first portion 522a' of the opening 522' can move toward the location where the second portion 522b' is in its stationary position. When the first portion 522a' is aligned, or at least sufficiently aligned to provide a diameter large enough not to restrict the movement of the instrument through the central opening 502o' of the tool 502', the capture plate 520' can be considered to be in an unlocked position or configuration or a released position or configuration. The capture plate 520' can then be returned to its stationary position so that an instrument such as the guide pin 380' can be fixed in a desired position, and the capture plate 520' will capture the guide pin 380' in that position.
[0188] The capture plate 520 can be moved from a stationary position to a released position in various ways. For example, in at least some embodiments, when the distal end 380d' of the guide pin 380' passes through the central opening 502o of the tool 502, the larger diameter of the guide pin 380' presses against the inner surface 522s defining part of the opening 522, causing the capture plate 520 to move along the XX axis toward the portion of the lip 507 where the spring 524 is located. This allows the capture plate 520 to be positioned in the released position. The distal end 380d' of the guide pin 380' may be molded into a pointed tip 382' with an inclined surface 380r' extending from the body of the pin 380' to a pointed tip 382'. In alternative embodiments, the pointed tip 382' can be replaced with a bullet-shaped or parabolic tip, which provides a non-sharp surface to minimize damage to surrounding tissue during use, while still allowing the same function of the guide pin 380'. The inclined surface 380r' can counteract the biasing force of the spring 524 and, by contacting and sliding against the inclined inner surface 522s that defines at least a portion of the opening 522, can assist in the movement of the capture plate 520 to the release position. This then allows the capture plate 520 to slide to the release position. When the capture plate 520 is in the release position, the guide pin 380 may continue to advance, for example, until the groove 384' is positioned within the opening 522. When this occurs, there may be no resistance to the biasing force of the spring 524, and therefore the spring 524 can push the capture plate 520 back toward its resting position. However, the capture plate 520 does not return completely to its original resting position. This is because, at the very least, the capture plate 520 engages with the guide pin 380', more specifically the groove 384', to lock the position of the guide pin 380' with respect to the reamer attachment 500, and with respect to the universal handle assembly and humeral guide used with the reamer attachment 500.The engagement of the groove 384' by the capture plate 520 can provide the user with audible and / or tactile feedback that the guide pin 380' is locked in a certain position with respect to the capture plate 520, the universal handle assembly, and / or the humeral guide.
[0189] Once the guide pin 380' is locked against the capture plate 520, the guide pin 380' can be used to manipulate the tool 502, which is part of the attachment 500. For example, a surgeon can use a drill to power the guide pin 380' and rotate the reamer attachment 500 at the required speed, thereby pulling the guide pin 380' back through the bone tunnel and drill cannula 350 into which they are positioned, pressing the reaming teeth 504 against the humeral resection surface 1015 to engrave or otherwise cut the humeral resection surface 1015.
[0190] After reaming is complete, the guide pin 380' can be released from the reamer attachment 500 by applying a force in direction C to the edge 520a of the capture plate 520, which is accessible via the access port 508. The application of this force can counteract the biasing force of the spring 524 and allow the guide pin 380' to move along the longitudinal axis LC. For example, the guide pin 380' can exit the reamer attachment 500 and the drill cannula in which the guide pin is located. In an alternative embodiment, in addition to releasing the guide pin 380' by applying a force in direction C to the edge 520a of the capture plate 520, such a force in direction C may also be used to selectively move and position the guide pin 380' relative to the opening 502o of the tool 500, engage and lock the pin 380' with the tool 502, and operate the tool.
[0191] Each preparation step can be achieved in this general manner using the necessary attachments. For example, after reaming is complete, the reamer attachment 500 may be replaced with a blazer attachment 600 as shown in Figures 18A-18C, or a blazer attachment 600' as shown in Figures 19A-19B, and similar steps may be performed for that operation. Alternative terms for blazer attachment include blazing attachment or broching attachment. Those skilled in the art will understand that in further preparation of the implant and / or prosthesis, the reamed humeral resection surface 1015 can be fitted using the blazer attachments 600, 600'.
[0192] Referring to the blazer attachment 600 shown in Figures 18A to 18C, as described above, the blazer attachment 600 includes a blazing tool 602, also called a blazer, blaze, or broaching tool, and a mount 610, also called an adapter, blazer adapter, blazing adapter, or broaching adapter. The blazer 602 includes a plurality of blazing arms or fins or broaching arms or fins 604a, 604b for blazing or broaching bone. The mount 610 may have a similar purpose to the mount 610 and may include one or more feature parts to enable the orientation of the blazing fins 604a on the humeral resection surface 1015. As shown in the figure, the mount 610 may include a larger distal disc 612 configured to mate with a tool 602, a smaller proximal disc 614 configured to mate with, for example, the distal portion 1422d of an arm 1422 seating on a mounting portion 1420, and an even smaller intermediate disc 613 disposed between the distal disc 612 and the proximal disc 614. In at least some embodiments, the proximal disc 614 may be a roller bearing. Multiple alignment bosses 611 (two are shown) may be disposed on the distally facing surface 612d of the distal disc 612. As shown in Figure 18B, the blazing fin 604A may be positioned between two bosses 611 such that the bosses 611 maintain the position of the blazing fin 604A relative to the mount 610. As a result, the blazing fin 604A can maintain alignment with the rotator cuff parity, thus allowing for easier implant insertion. A projection 613p, also called a mating projection and / or alignment projection, may be formed on the intermediate disc 613 and may be used for mating and / or alignment purposes in relation to a handle assembly (e.g., handle assembly 1400), as will be described in more detail below. As shown in the figure, the projection 613p may align with an alignment arrow 603 formed on the proximal-facing surface 602p of the blazer 602. Furthermore, a threaded shaft or bolt 615 may be part of the mount 610, extending distally beneath the distal-facing surface 612d of the distal disc 612.The threaded bolt 615 may be part of the distal disk 612, or part of either the intermediate disk 613 or the proximal disk 614, and may extend distally through the distal disk 612. The threaded bolt 615 enables screwing the mount 610 to the blazer 602. More specifically, the mount 610 can be rotated relative to the blazer 602 using a tool such as a T30 screwdriver, thus ensuring a locked engagement between the two.
[0193] The blazer attachment 600 has a central opening 650 formed in the blazer attachment 600, which can receive and secure a guide pin, such as a guide pin 380. The central opening 650 can be defined by openings formed in various components of the blazer attachment 600. More specifically, each of the tool 602, distal disc 612, intermediate disc 613, and proximal disc 614 may have a central opening formed in each such that the central opening 650 extends through the entire depth of the blazer attachment 600. In the illustrated embodiment, the top of the central opening 650, i.e., the portion visible in Figure 18A, has a hexagonal configuration that engages with a hexagonal shaft, such as a T30 driver used to connect the mount 610 to the blazer 602. Like the mount 510, the mount 610 can be separated from the tool 602. This is because the mount 610 may be intended for single use, while the tool 602 may be cleaned and reused in subsequent procedures.
[0194] Similar to the blazer attachment 600' in Figures 19A and 19B, the blazer attachment 600 can be operated in the same manner as the reamer attachment 500. For example, it can be operated by connecting the attachment 600 to a guide pin such as the guide pin 380'' and / or other guide pins provided herein or otherwise known to those skilled in the art, and by retracting the guide pin 380'' laterally through the humeral penetration hole to engage it with the humeral resection surface. Broaching the humeral resection surface can be performed freehand by coupling the blazer attachment 600 to the handle assembly 1400, or by coupling the blazer attachment 600 to the handle assembly 1400 and using it in conjunction with the guide 300 to ensure that the broaching is completed on an axis perpendicular to the plane of the humeral resection surface.
[0195] Referring to the blazer attachment 600' shown in Figures 19A-19B, the blazer attachment 600', like the modular attachments 500, 500', and 600, may include a tool 602' and a mount 610. Furthermore, as shown in Figure 19A, a mount adapter 640 may be used to assist in mating the mount 610' to the tool 602'. Components such as the mount adapter 640' may be used when the tool and mount are not configured to allow direct mating to each other, and such an adapter is configured to allow coupling to both the tool and the mount, and then helps to allow the tool and mount to mating to each other.
[0196] As shown in the figure, the tool 602' may include a blazing arm or fin 604' configured to broach bone. The bottom surface of the blazing fin 604' may be molded to the same geometric shape as the prosthesis to be implanted, or may be otherwise manipulated to form that shape in the bone. The central opening 602o' may extend through the tool 602' from its most distal surface to its most proximal surface 602p', which in at least some cases may be defined by the most distal surface of the fin 604'. The central opening 602o' may be configured to receive a guide pin, such as a guide pin 380'', through the central opening 602o'. Furthermore, as shown in the figure, the central opening 602o' may include one or more feature portions configured to engage with a mount adapter 640'. More specifically, the central opening 602o' may include a threaded portion 602t', which may be configured to connect to a complementary thread 640t' formed on the distal end 640d' of the mount adapter 640'. Furthermore, as shown in the figure, the central opening 602o' includes multiple diameters, and the diameters of the central opening 602o' are complementary to the diameters of some of the mounting adapters 640 disposed within the central opening 602o' of the tool 602'.
[0197] The mount adapter 640' may be configured to assist in mating the tool 602' with the mount 610'. As shown, the distal end 640d' of the mount adapter 640' functions as a male mating feature, and the distal end 640d' comprises a plurality of diameters and a threaded portion 602t' configured to engage with a threaded portion 602t' of the central opening 602o' of the tool 602'. The proximal end 640p' of the mount adapter 640' may be configured to receive the mount 610. As shown, the proximal end 640p' includes a lip 642' defining a receiving portion or chamber 644'. The receiving portion 644' may have a capture plate 620' disposed on the receiving portion 644' and a spring 624' configured to bias the capture plate 620' to a stationary position or configuration, a locked position or configuration. An access port 646' similar to the access port 508 of tool 502 may be formed on lip 642', providing access to the edge portion 620a' of capture plate 620'. The nearest face of lip 642' may be adapted to receive the distal disk 612' of mount 610', and may be substantially flat, for example. Mount 610' may be coupled to mount adapter 640' by one or more screws 632'.
[0198] The capture plate 620' slides within the chamber 644' and can operate similarly to the capture plate 520, and can therefore move between a stationary position or configuration, a locked position or configuration, or a capture position or configuration, and an unlocked position or configuration or a release position or configuration. In the locked or capture position, the capture plate 620' may be configured to grip a groove 384'' formed in the distal end 380d'' of the guide pin 380''. As shown in the illustration, the capture plate 620' includes an edge portion 620a' which can help enable the capture plate 620' to function as a quick-release latch. In the illustrated embodiment, the edge portion 620a' is part of a tab 618 extending above the main surface of the capture plate 620', the tab 618' providing a convenient feature portion that engages for the purpose of providing quick release.
[0199] Mount 610', sometimes called an adapter, blazer adapter, blazing adapter, or broaching adapter, may further include a plurality of plates or discs. As shown, Mount 610' includes a larger distal disc or plate 612', a smaller proximal disc 614', which in at least some cases may be a roller bearing, and an even smaller intermediate disc 613', disposed between the distal disc 612' and the proximal disc 614', which in at least some embodiments may be part of a roller bearing. As shown, a notch 612n' may be formed in the distal disc 612' to provide a path through which the tab 618' can slide when operating the capture plate 620' against a bias provided by the spring 624'. Discs 612' and 614' may be analogous to, for example, discs 512 and 514, and therefore no further description of them is necessary.
[0200] As shown in Figures 19A to 19B, the distal tip 382'' of the guide pin 380'' may have a surface formed to act as an introduction so that the guide pin 380'' can assist in moving the capture plate 620' from a stationary, locked position to an unlocked or released position. As in other embodiments, the guide pin 380'' can move along the illustrated YY axis, extending through the central opening 650'. In at least some cases, the amount of force that needs to be applied to the blazer attachment 600' to enable the tool 602' to provide the desired broaching exceeds the amount of force that can be applied to the blazer attachment 600' by the guide pin 380''. In at least some such embodiments, an insertion tool may be provided to assist in providing the force required to produce the desired amount of broaching to the blazer attachment 600'. An example of such an insertion tool, insertion tool 900, is illustrated and described below with respect to at least Figures 27B to 27G.
[0201] During use, the humerus sizer attachment 340 is used to position the humerus guide 300 in the desired position, and after setting the path for guide pins such as guide pins 380, 380', and 380'' to move in order to operate such attachments, modular attachments such as reamer attachments 500, 500' and blazer attachments 600, 600' can be used. The humerus sizer attachment 340 can be removed from the humerus guide 300, but the guide 300 remains firmly fixed to the humerus via bone pins 370a, 370b. If not already attached, the adapter 390 can be coupled to the arm 310 of the humerus guide 300, and the universal handle assembly 1400 can be coupled to the humerus guide 300 via the adapter 390. In other embodiments, the adapter 390 may not be necessary, and other techniques may be used to couple the universal handle assembly 1400 to the humerus guide 300. Modular attachments such as reamer attachments 500, 500' and blazer attachments 600, 600' can be selectively coupled to the distal end 1400d of the universal handle assembly 1400. Guide pins 380, 380', or 380'' are then inserted into a central opening, for example, the central opening 550 of the reamer attachment 500, and can be used to operate a tool, for example, a reamer tool 502.
[0202] In other embodiments, the modular attachment may include all such that it includes both a tool, i.e., a part configured to perform a function, and a mount for engaging with the universal handle assembly 1400. In at least some cases, the universal handle assembly 1400 positions attachments such as reamer attachments 500, 500' and blazer attachments 600, 600' in a desired position where the distal end 380d of the guide pin 380 engages with the attachment, enabling the attachment to be operated. Furthermore, in at least some cases, it is intended that attachments or tools attached to the distal end 1400d of the handle assembly 1400 may be operated additionally or alternatively by feature parts associated with the handle assembly, such as the handle assembly 1400.
[0203] Modular attachments such as reamer attachments 500, 500' and blazer attachments 600, 600' may more commonly be called humeral preparation devices or attachments (sometimes the term tool may also be used), and may also be called humeral treatment devices or attachments (or tools). Those skilled in the art will understand other types of tools and attachments that may be used in a similar manner to the reamer attachments and blazer attachments provided herein for treating the humeral resection surface 1015. References to humeral preparation devices or attachments herein include, but are not limited to, reamer attachments and blazer attachments. Similar to the humeral sizer attachment 340, reamer attachments 500, 500' and blazer attachments 600, 600' may be available in various sizes, and reamer attachments and / or blazer attachments are selected at least in part on the patient's anatomical structure, age, and other demographics, along with the surgeon's preference, among other factors.
[0204] Humeral guides of various sizes and / or configurations, as well as support rods, clamps for bone pins, bone pins, adapters, humeral sizer attachments, plates for use with humeral sizer attachments, handle assemblies, and / or humeral preparation devices or attachments, and components used in or as part of such guides, may be provided together as a kit. This humeral guide and related component kit may include, for example, arms 310, 2310, hubs 320, 2320, support rods 336a, 336b, 336a', clamps for bone pins 332a, 332b, 332a', other components of guide 2300 as described in relation to Figures 11-12I, bone pins 370a, 370b, 3370, adapter 390, humeral sizer attachments 340, 1140, 2340, plate 1172, 1172', INHANCE® humeral head trial, drill cannula 350, 2350, guide pin 380, 380', 380'', handle assembly 1400 (and other handle assemblies that can be derived from this disclosure), and / or humeral preparation devices or attachments 500, 500', 600, 600', and any combination of any other such items that can be derived from this disclosure. Alternatively or additionally, some of these components may be divided into smaller kits, such as a handle assembly kit, which may include various components of the handle assembly and humeral preparation devices or attachments, such as the handle assembly 1400 and its associated components, and / or the humeral preparation devices or attachments 500, 500', 600, 600', and their associated components. Those skilled in the art will understand that such kits are not limited to the embodiments disclosed and expressly shown herein, but rather include a variety of configurations and iterations understood in other ways to achieve similar purposes as described herein and / or provided herein. The various components can be sized and / or molded to suit the anatomical structures of different patients (e.g., adults, children, patients with specific bone formations resulting from various diseases or disorders).Furthermore, the humeral guide kit and / or its components may more generally be part of a shoulder arthroplasty kit, or more generally, a surgical kit.
[0205] Use of humeral guides Conventional tools for preparing for procedures such as shoulder arthroplasty rely on adequate visibility and access to the joint cavity, which is created by removing the subscapularis tendon and externally rotating the humerus 1012 so that the humeral resection surface 1015 faces the lateral side of the glenoid cavity 1018. With adequate space, the surgeon can resection the humeral head at an appropriate angle of inclination and posterior tilt, and use a downward force against the humeral resection surface to ream and broach the surface, thereby forming a geometric shape within the humeral resection surface 1015 corresponding to the selected implant and / or prosthesis. Furthermore, the space created by removing the subscapularis tendon allows the surgeon to ream this surface using a downward force against the glenoid cavity surface, thereby forming a geometric shape within the glenoid cavity surface 1018 corresponding to the selected implant and / or prosthesis.
[0206] However, this disclosure deals with techniques different from the conventional and therefore requires different tools. More specifically, this disclosure enables tissue-preserving procedures in which the subscapularis tendon is kept intact throughout the procedure. Maintaining the attachment of the subscapularis tendon means that the space for performing the procedure is more limited, and the devices, tools, and systems disclosed herein enable the same type of procedure (e.g., shoulder arthroplasty) to be performed with less harm and injury to the tissue and surrounding anatomical structures. In some embodiments, for example, when a tight joint is involved, a portion of the subscapularis tendon may be cut or sacrificed to increase access to the joint. As described above, sacrificing a portion of the subscapularis tendon can still be considered as leaving the subscapularis tendon intact.
[0207] While aspects of methods for preparing the humeral resection surface to receive implants and / or prostheses are described to some extent above and will be understood by those skilled in the art in consideration of this disclosure, non-limiting examples of surgical procedures in which a humeral guide may be used in conjunction with performing tissue-sparing shoulder arthroplasty are shown in Figures 20–31F. The techniques disclosed herein may be part of a more comprehensive shoulder arthroplasty, which may also include resection of the humeral head, preparation of the glenoid cavity for receiving implants, and placement of implants and / or prostheses into the glenoid cavity. Those skilled in the art will recognize, in consideration of this disclosure, that the disclosed steps may be performed in an order different from that presented herein, and that / or modifications of the disclosed methods, systems, devices, and tools are possible.
[0208] Various actions can be performed to access the glenoid cavity 1010 shown in Figure 2, which includes the glenoid cavity 1018, the humerus 1012, and the humeral head (shown as resected). This may include, for example, subscapularis-preserving exposure, which may include downward and upward release. Those skilled in the art will understand, in consideration of this disclosure, how to achieve the desired access for performing the surgical procedures disclosed herein. Furthermore, techniques well known to those skilled in the art can be used to form the humeral resection surface 1015 as shown in the figures described in this section. These techniques may include those disclosed in two patent applications relating to humeral resection and resection guides incorporated herein by reference above. Furthermore, glenoid preparation steps, such as those provided in U.S. Patent Provisional Application No. 63 / 579,947, entitled "Transhumeral Glenoid Techniques and Instrumentation for Use in Tissue Sparing Shoulder Arthroplasties," filed on 31 August 2023, and in U.S. Patent Non-Provisional Application entitled "Transhumeral Glenoid Techniques and Instrumentation for Use in Tissue Sparing Shoulder Arthroplasties," filed on the same date (the contents of each are incorporated herein by reference in their entirety), can also be performed in conjunction with this method. Alternatively, depending on the patient's anatomical structure, glenoid preparation may be performed in accordance with the INHANCE® surgical technique disclosed at https: / / www.jnjmedtech.com / en-US / pdf / inhancetm-shoulder-system-anatomic-surgical-technique (the entire technique is incorporated herein by reference).
[0209] Considering the treatment of the humerus, access to the humeral resection surface 1015 during tissue-preserving arthroplasty can be obtained by drilling a humeral penetration hole from the lateral cortex 1023 of the humerus 1012, which is centered on and perpendicular to the humeral resection surface 1015. Any force required to prepare the humeral resection surface 1015 to receive the prosthesis can be provided by pulling a guide pin engaged with an attachment positioned against the humeral resection surface 1015 laterally through the humeral penetration hole, thereby pressing the attachment against the humeral resection surface 1015.
[0210] The guide 300 shown in Figure 20 may be used during tissue-preserving arthroplasty after humeral head resection. It may be used to create a transverse humeral axis LC that is substantially perpendicular to the humeral resection plane 1015 and centered on the humeral resection plane, thus providing a precise alignment axis during humeral preparation. More specifically, the rigid arm 310 works in conjunction with the hub 320 and drill cannula 350 to define the position and trajectory along the axis LC through which a bone hole should be drilled through the humerus 1012. Figure 20 shows a humeral sizer attachment 340 coupled to the distal portion 310d of the arm 310 of the guide 300. Other components, including but not limited to a handle assembly 1400, may be attached to the arm 310 instead of the humeral sizer attachment 340, as described herein.
[0211] Before introducing the humeral guide 300 into the surgical site, one or more retractors may be used to improve access to and visualization of the surgical site. These retractors may be the same as and / or different retractors used in a previous step. Once the retractors are in place, the humeral guide 300 may be positioned for use at the surgical site, which in this embodiment remains the human humeral glenoid-shoulder joint 1010 where the glenoid fossa 1018 of the humerus 1012 and the humeral resection surface 1015 are located. In at least some cases, it may be advantageous to extend the incision used for inserting the guide 300 into the surgical site to allow in components such as a drill cannula 350 that contacts the bone.
[0212] The support rods 336a, 336b and the bone pin clamps 332a, 332b can be attached to the guide 300 before it is delivered to the surgical site. This can be done using a T20 driver or other suitable assembly tool. The bone pin clamps 332a, 332b may be oriented based on the shoulder being treated (i.e., the right or left shoulder) and the surgeon's preference, as further described and illustrated above. In the illustrated embodiment, the guide 300 is designated for use in treatment of the left shoulder, and the rods 336a, 336b and the bone pin clamps 332a, 332b are appropriately arranged for treatment of the left shoulder. This configuration can help provide desirable anatomical fixation to the humeral guide pin (e.g., guide pin 380).
[0213] The humeral sizer attachment 340 may be used to locate the center of the humeral resection surface 1015 and to determine the appropriate size of the prosthesis to be used, such as a subsequent attachment and / or a stemless implant (e.g., implant 1900 shown in Figures 28B-28D). Humeral sizer attachments of various sizes may be used depending, at least in part, the patient's size, anatomical structure, and age, as well as the surgeon's preference, among other factors. In the illustrated embodiment of Figure 21A, the humeral sizer attachment 340 is of an intermediate size and is indicated by the letter "M" above it. The humeral resection surface 1015 may be used to select the sizer attachment that best fits medially to the cortical margin of the humeral resection surface 1015. For example, as shown in Figure 21A, the plate portion 340b of the humeral sizer attachment 342 can be aligned with the humeral resection surface 1015 such that the central opening 343a aligns with the center point of the humeral resection surface 1015. The arm portion 342a of the sizer attachment includes a window 344 configured to align with a line 1011 formed on the biceps groove, which separates the greater tubercle of the humerus 1012 from the lesser tubercle. More specifically, a mark previously placed in the biceps groove during the procedure may be visible through the window 344. The plate portion 342b may be positioned at the center of the humeral resection surface 1015, and a marking 345 on the arm portion 342a that aligns with a mark in the biceps groove allows for approximate sizing of the humeral resection surface 1015. For example, in the illustrated embodiment, the sizer portion 342b of the attachment 340 is centered with respect to the humeral resection surface, and the marking labeled 46 intersects with the outermost edge of the humeral resection surface 1015, which may also be called the cortex 1001 or cortical margin 1001, and with line 1011.
[0214] As shown in Figure 21B, the humeral sizer attachment 340 can be coupled to the guide 300, for example, by moving it in direction P toward the distal end 310d of the arm 310 and rotating the knob 348 in direction R to tighten it against the arm 310. The distal portion of the humeral sizer attachment 340 or other modular attachments can be inserted through the rotator cuff interval 1020 above the subscapularis muscle 1017 and aligned substantially parallel to the humeral resection surface 1015. The hub 320 is positioned proximal to the lateral cortex 1023 of the humerus 1012 to guide the drill cannula 350 until its distal end contacts the lateral cortex 1023 of the humerus 1012, thereby setting the position and trajectory of the humeral penetration hole. The sizer portion 342b may be positioned substantially coplanar with the humeral resection surface 1015, and appropriate markings 345 determined relative to the humeral resection surface 1015 can be aligned with the cortical edge 1001 of the biceps groove to help center the sizer portion 342b on the humeral resection surface 1015 such that the central opening 343a of the sizer portion 342b aligns with the center point of the humeral resection surface 1015. Furthermore, the sizer attachment 340 may be positioned anteroposteriorly centered by palpation and / or visual confirmation, and the sizer attachment 340 may be coplanar or substantially coplanar with the humeral resection surface 1015. This positioning of the guide 300 and the associated humeral sizer attachment 340 ensures that the trajectory of the guide pin or drill passing through the drill cannula 350 is substantially centered and substantially perpendicular to the humeral resection surface 1015.
[0215] After the guide 300 is positioned proximal to the humerus and the plate portion 342b of the sizer attachment 340 is positioned substantially in the center of the humeral resection surface 1015, the position of the sizer attachment 340 can be maintained by applying downward pressure in direction D toward the humeral resection surface 1015 at approximately the center of the plate portion 342b. Furthermore, the drill cannula 350 can be pushed in direction B along the longitudinal axis LC through the hub opening 322 to engage with the lateral cortex 1023 of the humerus 1012. The drill cannula 350 can be advanced in this direction, for example by applying force by hand to the bottom of the drill cannula, e.g., the base 358, until the distal tip 350t of the distal portion 350d is pressed against the lateral cortex 1023 of the humerus 1012, marking the proximal end of the intended bone tunnel and defining the entry position of the drilling component. A ratchet tooth 351 formed on the outer surface of the middle portion of the drill cannula 350 is provided with a unidirectional ratchet mechanism on the inner surface of the hub opening 322, which can maintain the position of the drill cannula 350. The ratchet tooth 351 allows the drill cannula 350 to pass distally through the hub opening 322, but prevents it from moving proximal, thereby maintaining the force applied to the bone surface at the distal end 350d of the drill cannula 350, and thus creating a clamping force between the humerus attachment 340 and the distal end 350d of the drill cannula 350. The drill cannula 350 passes through the hub opening 322 until its distal tip 350t contacts the lateral cortex 1023 of the humerus 1012. The distal tip 350t of the drill cannula 350 and the humeral sizer attachment 340 generate a clamping force against the humeral resection surface 1015, maintaining the position of the guide 300 relative to the humerus 1012.
[0216] While the drill cannula 350 advances in direction B, a force opposite to the force in direction B (indicated by direction C) may be applied to the upper surface of the humeral guide 300, as indicated by the hub 320, for example, by hand. The competing forces in directions B and C can be generated by gripping with one hand or both hands, resulting in initial fixation to the humerus 1012. The unidirectional ratchet feature of the drill cannula 350 can maintain its final position. If desired, the pressure on the humerus 1012 generated by the drill cannula 350 can be released by pushing the 328h of the locking screw 328 into the hub 320, allowing the drill cannula 350 to slide away from the humerus 1012 in the opposite direction B, i.e., in direction C.
[0217] As a result of this arrangement, the central opening 343a of the humeral sizer attachment 340, the hub opening 322, and the central opening 356 of the drill cannula 350 can all be aligned along the longitudinal axis LC. As shown in the figure, the humeral guide 300 is connected to the humeral resection surface 1015 and therefore to the humerus 1012, so that the proximal portion 300p of the humeral guide 300, which may include, for example, the hub 320, is positioned below the humeral resection surface 1015 and opposite to the humeral resection surface 1015, and the distal portion 300d of the humeral guide 300, which may include the distal portion 310d of the arm 310, is positioned close to the rotator cuff gap 1020, which is substantially aligned with the humeral resection surface 1015.
[0218] A locking component, such as a spring-loaded release button 328 or a one-way ratchet mechanism, can hold the drill cannula 350 against the lateral cortex 1023. In some embodiments, the drill or drill pin 380 can be held in place when the guide 300 is further secured using fixing features 330, such as bone pin clamps 332a, 332b, which are positioned on the arm 310 and / or the hub 320 of the guide 300, after passing through the opening 356 of the drill cannula 350 and entering the lateral cortex 1023 of the humerus 1012. The operation of the bone pin clamps 332a, 332b is described in detail above with reference to Figures 6A to 6C. The drill pin 380 can be advanced into the humerus 1012, for example, when positioning a bone pin (e.g., bone pins 370a, 370b) within the humerus, to assist in providing stability to the humeral guide 300. For example, the drill pin 380 can be advanced approximately 10 millimeters into the humerus 1012. A visual indication that the drill pin 380 has moved to a position that provides the desired docking of the guide 300 may be detectable by the indicator 381. In the illustrated embodiment, when the indicator 381 is positioned on the base 358, the indicator is a visual indication that the drill pin 380 is positioned approximately 10 millimeters into the humerus 1012, which in the illustrated embodiment is the docking position of the guide 300.
[0219] After the bone tunnel position and trajectory are securely established, the guide assembly 300 can be further secured to the humerus 1012 using bone pins 370a, 370b and bone pin clamps 332a, 332b. The method disclosed herein for attaching the guide 300 to the humerus 1012 allows for the free positioning of the bone pins 370a, 370b, at least in part based on the surgeon's preference and the patient's anatomical structure. Furthermore, the guide 300 and associated method enable a less invasive approach than conventional techniques, reducing the length of deltoid muscle incision and providing the ability to percutaneously place the drill cannula 350 and bone pins 370a, 370b. Furthermore, the design of the guide 300 and its associated components allows for fine adjustment of the pilot hole through the humerus before drilling, which in turn allows for fine adjustment of the centering of the sizer portion 342b on the humeral resection surface 1015 without requiring the removal of pins 370a and 370b and / or replacement of pins 370a and 370b in a new position. This, in turn, prevents excessive hole formation in the bone due to reduction, thereby reducing and / or minimizing the possibility of fracture.
[0220] With the humeral guide 300 positioned and the distal tip 350t of the drill cannula 350 in contact with the lateral cortex 1023, the bone pins 370a and 370b are introduced through the bone pin clamps 332a and 332b to further maintain the position and location of the guide 300 relative to the humeral resection surface 1015, as shown in Figure 22B. In at least some cases, the skin incision may need to be dilated distally to accommodate the drill cannula 350 in contact with the bone. Due to the configuration of the bone pins 370a and 370b, the bone pins 370a and 370b can be advanced rapidly without applying pressure to the distal cortical wall, so that the relief portion 375 can provide tactile sensation to the user after insertion and passing through the initial cortical bone. By advancing the bone pins 370a and 370b approximately 3 to 5 millimeters further, the bone pins 370a and 370b can be implanted into the distal cortex, while simultaneously fixing the threaded portion 371 to resist cantilever forces and providing sufficient stability. If the bone pins 370a and 370b can be stopped before exiting the distal cortex, this can help avoid soft tissue damage.
[0221] Prior to drilling, it may be useful to arrange bone pins 370a, 370b within bone pin clamps 332a, 332b, and / or plan the arrangement of pins 370a, 370b at a position on the humerus 1012. Such planning may help ensure that pins 370a, 370b do not interfere with the bone preparation instrument and the final placement and insertion of the implant. When carrying out such planning, soft tissue and neurovascular structures can be taken into consideration during placement of pins 370a, 370b. Soft tissue displaced from the bone at the entry point should be cleared, and any tissue wrapping during insertion should typically be avoided. During planning, the superior bone pin 370a should typically not enter at a position higher than the entry point of the drill cannula 350 in the lateral cortex 1023, and may follow a trajectory that is substantially or completely parallel to the seating plane, that is, the humeral resection surface 1015. Typically, this superior pin 370a must not intersect the axis LC of the drill cannula 350. Furthermore, the planned position of the inferior bone pin 370b may have a vertical spacing of at least about 2 centimeters from the superior bone pin 370a, which adds stability. In at least some embodiments, at least the inferior bone pin 370b may be percutaneously placed.
[0222] One or both of the rod receiving portion 1310 and the pin receiving portion 1320 may be in an unlocked position such that the bone pin clamps 332a, 332b can move relative to the rods 336a, 336b and the bone pins 370a, 370b. The bone pin clamps 332a, 332b can be oriented to a preferred position and orientation on the humeral shaft, and a person skilled in the art, in view of the present disclosure, will understand such positions. Furthermore, the bone pins 370a, 370b may be bone pins configured to provide tactile feedback during insertion into bone.
[0223] In at least some examples, the superior bone pin 370a can be placed within the bone. The bone pin clamp 332a associated with the pin 370a may initially be tightened by hand using the lock nut 1340. Alternatively or additionally, a ratchet wrench may be placed on the lock nut 1340 to tighten the nut 1340. Downward pressure in direction D on the humeral sizer attachment 340 may be maintained while providing opposing resistance by tightening the lock nut, which helps to ensure that there is no change in the positioning of the humeral guide 300. These same operations may also be performed with respect to the inferior bone pin 370b and the bone pin clamp 332b. It is possible that the inferior bone pin 370b may be placed before the superior bone pin 370a.
[0224] The multi-degree-of-freedom movement provided by the bone pin clamps 332a and 332b allows the surgeon to guide the bone pins 370a and 370b into the humerus 1012 at various positions and angles relative to the humerus 1012 and / or guide 300, for example, in directions U and V as shown in Figure 22B, respectively. In at least some embodiments, the pins 370a and 370b may be threaded, allowing for measured insertion of the pins 370a and 370b into the bone by, for example, rotating the pins 370a and 370b relative to the bone. This may also help provide tactile feedback. If the bone pins cannot be properly captured based on the position of the bone pin clamps 332a and 332b and the method of insertion of the pins 370a and 370b, readjustment of the position and / or placement of the bone pin clamps 332a and 332b, and / or readjustment of the position and / or placement of the humerus guide 300 may be appropriate. The adjustment function of the bone pin clamps 332a and 332b allows for micro-adjustment or fine-tuning of the guide after the bone pins 370a and 370b have been fixed in the humerus 1012, thereby fine-tuning the centering of the humeral sizer attachment 340 on the humeral resection surface 1015 without requiring removal of the pins 370a and 370b and / or replacement of the pins 370a and 370b in a new position. Such fine-tuning can be achieved by selectively unlocking the lock nut 1340 and making the adjustment. It may also be useful to remove tension from the drill cannula 350 by pressing the release button 328 and / or readjusting the position of the humeral guide 300 and / or sizer attachment 340 during adjustment. Fine-tuning can be performed without removing the bone pins 370a and 370b. Fine-tuning and / or adjusting the tension of the drill cannula 350 may be performed to ensure the desired positioning of the humeral guide 300.
[0225] Once the adjustment is complete, the lock nut 1340 can be locked, and if the tension on the drill cannula 350 is removed, tension can be reapplied to the drill cannula 350 to test the new configuration. Any locking or unlocking of the lock nut 1340 can be performed using a wrench. This then prevents excessive hole formation in the bone due to reduction, reducing and / or minimizing the possibility of fracture. The tips of each pin 370a, 370b can enter the proximal cortex, enter the cancellous bone, and then dock to the distal cortex. The threads 371 formed on the pins 370a, 370b can help provide optimal fixation in the proximal cortex. The pins 370a, 370b can maintain a distance of at least about 5 mm between them, bicortical fixation, and are positioned below the entry point of the drill cannula 350, ensuring space for the humeral preparation device and implant. When placing pins 370a and 370b, typically, care should be taken to avoid contact with and / or penetration of soft tissues or neurovascular structures. The surgeon may plan the placement of pins 370a and 370b onto the bone before performing the perforation.
[0226] Once the desired position of the guide 300 is set, the bone pin clamps 332a and 332b can be moved to a locked position by tightening the lock nut 1340 (see Figure 6C), for example with a wrench, thereby fixing the position of the guide 300 relative to the humerus 1012. When tightening the clamp nut 1340, it may be useful to provide a reverse torque to each bone pin 370a, 370b and / or humeral guide 300 disposed on the clamp nut 1340 to help ensure that the central position does not change. The humeral guide 300 can remain in the set position for the remainder of the surgical procedure and assist in guiding other instruments for accurate preparation of the humerus. The drill pin 380 can then be removed from the distal cannula 350 or used to perform a drill to form a humeral penetration hole.
[0227] As shown in Figure 22C, a drill pin 380, or a different drill pin or bit, can pass through the drill cannula 350 in direction W, following a trajectory set by the guide assembly 300, to form a humeral penetration hole. In some embodiments, the primary diameter of the pin 380 may be about 3.5 mm, which may be a standard size for humeral drills. The proximal end may include a hub 385 (see Figure 13), which may include an improved trinkle connector that can rotate and / or advance to provide similar movement at the distal end 380d of the pin 380, such as a distal tip 382, as shown. Using an improved Trinkle connector, the drill 380 can be connected to a power source, and the drill can be driven through the drill cannula 350 to enter and pass through the humerus 1012 until the distal tip 382 formed at the distal end 380d of the drill 380 exits the humeral resection surface 1015 through the central opening 343a of the sizer attachment 340, or it can be advanced otherwise. As a result, the drill 380 can form a humeral penetration hole 1029 that exits the humerus 1012 substantially centrally with respect to the humeral resection surface 1015 and substantially perpendicular thereto, through which the longitudinal axis LC extends. Once the humeral penetration hole 1029 has been formed, the drill 380 can be removed from the surgical site, as shown in Figure 22D.
[0228] Once the bone hole is formed, a guide pin or driver with various attachment features at its distal tip can be passed through the drill cannula and attached to various modular attachments inserted into the rotator cuff parity. The remaining steps of humeral preparation are performed through the humeral penetration hole 1029 using the humeral guide 300, maintaining correct position and alignment step by step. In at least some cases, such steps can be performed using a handle assembly, such as the handle assembly 1400, in conjunction with the guide 300, as provided herein.
[0229] To allow other instruments or tools to be attached to the guide 300, the humeral sizer attachment 340 can be removed from the guide 300, as shown in Figure 23A. To remove the sizer attachment 340, the knob 348 can be rotated counterclockwise in direction CC to detach the humeral sizer attachment 340 from the distal end 310d of the arm 310, as indicated by arrow K. After detaching the humeral sizer attachment 340, it may be necessary to adjust the tension supplied to the humeral resection surface 1015 by the drill cannula 350 before performing operations such as reaming the humerus to ensure the rigidity of the humeral guide 300.
[0230] The adapter 390 may be coupled to the distal end 310d of the arm 310, as shown in Figure 23B. Alignment lines 390m formed on the adapter 390 may align with alignment lines 361a arranged on the distal portion 310d of the arm 310. The adapter 390 can receive the distal end 310d of the arm within the opening 391, and as a result, the adapter 390 can translate along the arm 310 as described herein. In other embodiments, the adapter 390 may be associated with the arm 310 when used with the humeral sizer attachment 340. For example, in some embodiments, the adapter 390 may be positioned on the arm 310 throughout the procedure so that the adapter 390 does not slide on the arm 310 and is not easily attached or detached.
[0231] Reaming of the humeral resection surface using a humeral guide An example of a humeral preparation procedure that can be performed using the humeral guide 300 is reaming of the humeral resection surface 1015. As described herein, reaming may be performed using the reamer attachment 500 in conjunction with the handle assembly 1400.
[0232] The size of the reamer attachment 500 and / or the tool 502 associated with the reamer attachment 500 may be selected based on the size of the humeral resection surface 1015 determined by the sizer attachment 340. Before insertion into the articular space, the appropriately sized reamer attachment can be assembled and secured to a universal handle assembly such as the assembly 1400 shown in Figures 15A-15C.
[0233] Figure 24A shows one embodiment of how the tool 502 can be coupled to the mount 510. As shown, the mount 510 can be coupled to the distal end 3010d of the shaft 3010 (indicated as a T30 driver) by a hexagonal key engagement between the distal end 3010d and a wall defining the opening 510o of the mount, thereby assisting in the delivery of the mount 510 to the tool 502. The mount 510 can be coupled to the tool 502 by rotating the shaft 3010, and therefore the mount 510, in a clockwise direction CW, allowing the threads on the shaft 509 of the mount 510 to engage with the threads formed on the wall defining the opening 512 of the tool 502. After the mount 510 and the tool 502 are mounted, the shaft 3010 can be removed from the mount 510.
[0234] The assembled reamer attachment 500 can then be coupled to a handle assembly, such as a handle assembly 1400, for reaming the humeral resection surface using the attachment 500. As shown in Figure 24B, the mounting portion 1420 of the handle assembly 1400 can receive the reamer attachment 500 by sliding and / or pulling the latch 1424 proximal in direction M toward the gripping portion 1450. The reamer attachment 500 can then be inserted into the chamber 1428 by advancing it in direction N so that it can be coupled to the distal end 1422d of the arm 1422 within the chamber 1428. When the reamer attachment 500 is properly seated in the chamber 1428 and the mount 510 is close to the opening 1422o, the latch 1424 is released and can return to its position before force was applied in direction M, allowing the capture plate 1426 to slide back toward the chamber 1428, and then capture the reamer attachment 500, fixing its position relative to the handle assembly 1400 in a locked position or configuration in which the position of the reamer attachment 500 is locked relative to the arm 1422. More specifically, the arms 1426e, 1426f (only 1426e is visible in Figure 24B) can engage with the mount 510 of the reamer attachment 500 to fix the reamer attachment 500 to the handle assembly 1400, or can lock it otherwise. When the reamer attachment 500 is in the locked position, the reamer tool 502 should be freely rotatable by hand in direction R, as shown in Figure 24C.
[0235] Referring to Figure 25A, the universal handle assembly 1400 to which the reamer attachment 500 is coupled may be navigated through the rotator cuff gap 1020 (better shown in other figures) into the glenoid fossa shoulder joint 1010, and the reamer attachment 500 may be positioned above the humeral resection surface 1015. In this position, the handle assembly 1400 may be considered to be above the humeral resection surface 1015. The handle assembly 1400 may be coupled to the humeral guide 300 by moving the assembly 1400 in direction K, where the mounting feature 312 of the distal portion 310d of the arm 310 is received in the guide receiving opening 1454 of the assembly 1400, and the guide 300 and the handle assembly 1400 are coupled to it. Furthermore, in at least some embodiments, the adapter 390 may slide along the arm 310 in direction Q to engage with the handle assembly 1400 through the guide receiving opening 1454. The adapter 390 fixes the position of the handle assembly 1400 to the humeral guide 300, maintaining alignment between the plane and the central axis while an attachment, such as a reamer attachment 500 and a related tool, such as a reamer 502, is being operated. When the adapter 390 assists in fixing the position of the handle assembly 1400 relative to the humeral guide 300, audible and / or tactile feedback can notify the user of the fixation between the two. As seen in Figure 25A, there is also visual confirmation of the fixation, with face-to-face contact between the flared portion 392 of the adapter 390 and the handle 1400, and no visible gap between them. When the handle assembly 1400 is connected to the guide 300, the plane P extends through the distal portion 1422d of the elongated arm 1422. HA And the plane P defined by the flared portion 392 of the handle. FP A proper parallel alignment should be achieved between them, and therefore, plane P HA And a plane P extending through the humeral resection surface 1015. RHHThis shows proper parallel alignment between the two. By maintaining the handle assembly 1400 in the desired position relative to the humeral guide 300, alignment between the plane and the central axis can be maintained during treatment of the humeral resection surface 1015.
[0236] The guide pin 380 can be navigated into the articular space 1010 by moving it in direction E, as shown in Figure 25B, and aligned with the reamer cannula insertion section, i.e., the central opening 550 of the reamer attachment 500. A handle (not shown) can be used to navigate and position the guide pin 380 through the drill cannula 350, assisting in the delivery of the guide pin 380 to the surgical site. As described above, the reamer attachment 500 may have the same or similar features as the quick-connect features, e.g., groove 384' (see, e.g., Figures 17C-17D), which connect to the geometric shape of the drill when the reamer attachment 500 and the guide pin 380 are properly aligned. When connected, an audible and / or tactile click can be noticed. The guide pin 380 can pass toward the surgical site by providing a slight left-right twisting motion and engage with various quick-connect features associated with the reamer attachment 500. The guide pin 380 can be rotated and / or pulled by hand to confirm its connection with the reamer attachment 500.
[0237] As shown in Figure 25C, the guide pin 380 can pass through the drill cannula 350, and thus through the cannula receiving opening 322 of the hub 320, and enter and pass through the central opening 550 of the reamer attachment 500. The distal end 380d and distal tip 382 can be captured within the central opening 550, as will be discussed in relation to various embodiments, such as those described and illustrated in Figures 16C and 17C-17D. Furthermore, the plane PL'' defined by the reamer attachment 500 (see Figure 16A), which may be substantially parallel to the plane PL'' defined by the mounting portion 1420 of the handle assembly 1400, may be orthogonal to or substantially orthogonal to the longitudinal axis LC, as shown in Figure 25C.
[0238] Using a reamer attachment 500 fixed to both the handle assembly 1400 and the guide pin 380, the reamer attachment 500 can be operated to perform a reaming operation on the humeral resection surface 1015. When the handle is used to position the guide pin 380 at the surgical site and / or to connect the guide pin to the reamer attachment 500, and therefore to the handle assembly 1400, the handle can be removed and a power source (not shown), such as a drill or motor, can be connected to the proximal end of the guide pin 380. During use, the reamer 502 may be positioned in a forward rotation position or configuration, and in at least some cases, the reamer 502 may be started at a low speed before contacting the humeral resection surface 1015. As shown in Figure 25C, the reamer 502 can be advanced toward the humeral resection surface 1015 by pulling the guide pin 380, often lightly, toward the hub 320 in direction H, and / or by pushing it in line with the mount 510, i.e., by pushing it downward on the universal handle assembly 1400 in direction R, at the distal portion 1422d of the arm 1422. As shown in Figure 25D, force may be applied to ream the humerus 1012 until the reamer 502 is coplanar with the humeral resection surface 1015. As shown, when the bottom 395b of the handle 395 of the adapter 390 reaches the boundary line 399, it indicates to the surgeon that the reamer 502 is coplanar or substantially coplanar with the humeral resection surface 1015. For example, the reamer attachment 500 can be advanced toward the humeral resection surface 1015 until the bottom 395b of the handle 395 contacts the line 399. By reaming the bone to the indicated depth, a geometric shape corresponding to the geometric shape of the selected implant can be formed on the humeral resection surface 1015.
[0239] After reaming is complete, the reamer attachment 500 can be removed from the humerus 1012. This can be done under power by pushing up in the Z direction using the guide pin 380 and / or the handle assembly 1400, as shown in Figure 25E, to return the reamer to the articular space 1010 and reposition it. In embodiments in which the reamer attachment 500 includes a release button such as a button 520, the guide pin 380 can be used to slowly rotate the reamer 502 until the edge 520a of the release button 520 is visible. After the reamer 502 stops rotating, the edge 520a can be pushed radially inward toward the mount 510 in direction S to release the guide pin 380 from the reamer attachment 500 and thus from the handle assembly 1400. The guide pin 380 can then move in direction Y opposite to direction Z to remove the reamer attachment 500 from the guide pin 380. After the guide pin 380 is removed from the reamer attachment 500, it can be pulled back so that it is directly below the cutting surface defined by the reamed humeral resection surface 1015, and is not completely removed. This is because the same guide pin 380 can be used in subsequent steps, such as assisting in the preparation and / or operation of the blazer.
[0240] As shown in Figure 25F, the handle assembly 1400 can then be removed from the humeral guide 300, and as a result, the handle assembly 1400 can be removed from the joint space 1010. More specifically, the release latch 1460 can be slid toward the handle 1450 of the handle assembly 1400 in direction F, and the adapter 390 can be slid toward direction P along the arm 310 to detach and remove the handle assembly 1400 from the humeral guide 300. The resulting configuration, consisting of a reamed humeral resection surface 1015, the handle assembly 1400 separated from the guide 300, the guide 300 remaining in place relative to the humerus 1012, and the adapter 390 seated adjacent to or coplanar with the mounting portion 312 of the arm 310, is shown in Figure 25G. The bottom portion 395b of the handle portion 395 of the adapter 399 may be coplanar with the boundary line 399 and / or may engage with the boundary line 210 (and thus not be visible).
[0241] Figure 25H shows the removal of the reamer attachment 500 from the handle assembly 1400. This typically occurs outside the articulation space 1010. As shown, the latch 1424 can be pulled, pushed, or otherwise slid in direction W toward the proximal portion 1400p of the handle assembly 1400, releasing the mount 510 from the chamber 1428, allowing the reamer attachment 500 to fall away from the handle assembly 1400, as shown. The mount can be discarded if it is designed to be disposable.
[0242] Broaching of the humeral resection surface using a humeral guide Figure 26 shows that the handle assembly 1400 has a blazer attachment 600 to which it is coupled. The blazer attachment 600 can be coupled to or mounted on the handle assembly 1400 in a similar manner to the reamer attachment 500, with at least some relevant differences described above with respect to Figures 18A-18C. Thus, the latch 1424, which can be biased toward the chamber 1428 in direction S', can be pulled in direction M with a force sufficient to overcome the biasing force in direction S', or can be slid in another way. The blazer attachment 600 can be pulled towards the receiving portion 1452 of the handle assembly 1400, and the mount 610 of the blazer attachment 600 (not visible in Figure 26, see Figures 18A and 18C) can be positioned within the chamber 1428. An arrow 603 positioned on the blazer 602 can point in the direction of the proximal portion 1400p of the handle assembly 1400, and therefore in the direction of the alignment slots 1426s formed in the capture plate 1426 (not visible in Figure 26, see Figure 15B). Once the blazer attachment 600 is positioned in the chamber 1428 as desired, the force applied in direction M can be removed, allowing the capture plate 1426 to slide back toward the chamber 1428, and then capture the blazer attachment 600, fixing its position relative to the handle assembly 1400. More specifically, arms 1426e and 1426f (only 1426e is visible) can engage with the mount 610 (not visible in Figure 26, see Figures 18A and 18C) to fix the blazer attachment 600 to the handle assembly 1400, or otherwise lock the blazer attachment 600. The projection 613p (not visible in Figure 26, see Figures 18A and 18C) can engage with the walls of arms 1426e, 1426f that form the alignment slots 1426s of the capture plate 1426 (not visible in Figure 26, see Figure 15B), thus providing the known positioning of the blazer fin 604a relative to the handle assembly 1400. The projection 613p can also provide a mating function when engaging with the walls of arms 1426e, 1426f that form the alignment slots 1426s.The selected brazer attachment 600 may be obtained based on the determination made with the humeral sizer attachment 340. Provided that the mount 610 has not yet been coupled to the brazer 602, the attachment can be performed, for example, using the procedure described above with reference to FIGS. 18A to 18C.
[0243] Referring to FIG. 27A, a universal handle assembly 1400 coupled with a brazer attachment 600 may be navigated through the rotator interval 1020 (better shown in other figures) into the glenohumeral joint 1010, and the brazer attachment 600 may be positioned above the reamed humeral resection surface 1015. The handle assembly 1400 may be coupled to the humeral guide 300 in the same manner as described above with reference to FIG. 25A, among other techniques disclosed herein or otherwise known to those skilled in the art in view of the present disclosure. Accordingly, the adapter 390 can slide along the arm 310 to engage the handle assembly 1400 through the guide receiving opening 1454. Fixing the position of the handle assembly 1400 to the humeral guide 300 by the adapter 390 maintains alignment between the plane and the central axis while a tool associated with an attachment, e.g., the brazer attachment 600, e.g., the brazer 602, is operated.
[0244] The guide pin 380 can also be used for operation of the brazer attachment 600, and the guide pin 380 can confirm and maintain axial alignment during operation of the brazer attachment 600, for example, during insertion as described herein. The brazer attachment 600 may be coupled to the guide pin 380 in a manner similar to the manner in which the reamer attachment 500 is coupled to the guide pin 380, as described with reference to at least FIGS. 25B and 25C (see FIGS. 27A and 27E). Therefore, duplicate descriptions are omitted. After the brazer attachment 600 is fixed to the guide pin 380, the guide pin 380 can be rotated to confirm the connection with the reamer attachment 600.
[0245] Subsequently, the blazer attachment 600 can be manipulated to broach the reamed humeral resection surface 1015. The guide pin 380 can be rotated to align the arrow 603 (see Figure 18C), positioned on the blazer 602, with the outermost surface of the humerus, and / or, if such alignment has not yet been achieved and / or maintained, as desired for the insertion of the final stemless implant. For example, an insertion tool can be introduced into the glenoid-shoulder joint 1010 via the rotator cuff parenchyma 1020 to assist in the manipulation of the blazer 602. One non-limiting example of such a tool, an insertion tool 900, also called an impactor handle, is shown in Figure 27B.
[0246] The insertion tool 900 may include a handle portion 902 and a distal receiving portion 907 configured to receive a removable and replaceable end effector 904, the end effector in the illustrated embodiment being the impactor of an impactor handle adapter, also known, among other names, as a blaze engagement (or other “blaze” and “broach” terms as indicated herein or otherwise known to those skilled in the art in consideration of this disclosure) end effector or flat impactor tip. The handle portion 902 includes a broad handle 906 disposed at the proximal end 902p of the handle portion 902 and an elongated rod or shaft 908 extending therefrom. In the illustrated embodiment, the broad handle 906 and the elongated rod 908 are integrally constructed, and the elongated rod 908 has a distal end 908d which also serves as the distal end 902d of the handle portion 902. The distal ends 902d, 908d include distal receiving portions 907 configured to receive and engage with the end effector 904. The broad handle 906 may include one or more surfaces adapted to be gripped by the user and / or engaged by a tool, such as a hammer or mallet, to supply a force in direction A to the tool 900. The applied force can be transmitted through the elongated rod 908 to the end effector 904 by the elongated rod 908. As shown in the figure, the outer surface of the rod 908 may include a gripping feature 910 formed thereon.
[0247] The end effector 904 is shown in more detail in Figure 27C. It can be securely fitted into the distal receptacle 907 using any technique known to those skilled in the art for joining two components together, such as screw connections, snap-fit connections, or male-female engagement mechanisms. In the illustrated embodiment, the end effector 904 includes one or more engagement features configured to engage with the universal handle assembly 1400, as shown as opposing forks or tabs 905 extending from the base 903. Each of the forks 905 may have opposing flat tips, and each fork 905 has a right angle defining the tips.
[0248] As shown in Figures 27D to 27F, during use, the fork 905 and base 903 may be positioned in contact with and / or around the mounting portion 1420 of the assembly 1400. More specifically, the fork 905 may first be positioned within the space formed by the notch 1448 (see Figures 15A to 15C). The configuration of the fork 905 and base 903 allows the end effector 904 to easily slide along the mounting portion 1420 of the handle assembly 1400 and grip it at the desired position. In the illustrated embodiment, the fork 905 is positioned around at least the opposing sides of the body 1422, and the base 903 is in contact with the upper surface of the body 1422. Once the end effector 904 is positioned at the desired position, the patient's arm may move in adduction and may often be slightly externally rotated to ensure that the insertion axis, which may be defined by the length of the rod 908, is not obstructed by the patient's anatomical structure.
[0249] As shown in Figure 27E, the rod 908 may allow force to be applied remotely to the handle assembly 1400 via a broad handle 906 (not shown) positioned laterally to the body, extending from the glenoid-shoulder joint 1010 through the rotator cuff interval (better shown in other figures). Thus, the force applied to the broad handle 906 can be translated through the tool 900 and the rod 908 to the end effector 904. Those skilled in the art will understand that the end effector 904 may have other configurations for use in broaching movements or other movements performed during surgical procedures using the humeral guide and / or handle assembly of the present disclosure, or otherwise derived therefrom, and that various other end effectors may be selectively mounted on the mounting end 1420 of the handle assembly 1400.
[0250] During use, the blazer attachment 600, and therefore the blazer 602, can be operated by manipulating the guide pin 380 in a manner similar to that of the reamer attachment 500, and therefore the reamer 502. That is, as shown in Figure 27E, the blazer attachment 600 can be advanced toward the reamed humeral resection surface 1015 by pulling the guide pin 380 toward the hub 320 in direction H. Since the operation of the blazer 602 often requires applying a greater force than that required to operate the reamer 502, the insertion tool 900 can also apply force to the blazer 602. As shown, the insertion tool 900 may be positioned such that the end effector 904 contacts the body 1422 of the mounting portion 1420 of the handle assembly 1400. The user can apply force by striking the wide handle 906 with a hammer or mallet, or by other means, thereby driving force in direction A through the tool 900 and the mounting portion 1420 toward the blazer attachment 600. Centering cannot be achieved due to anatomical structure, which is why this solution is beneficial, at least in part. In some embodiments, the end effector 904 may include a boss or threaded portion that forms an angle in the range of approximately 5° to 10° with respect to the base of the end effector 904, thereby allowing approach to the center while avoiding further proximal tissue interference of the elongated rod 908. Additionally, or alternatively, force can be applied to the blazer attachment 600 by sliding the end effector 904 along the body 1422 of the mounting portion 1420 toward the position of the blazer attachment 600 in direction B, for example, as shown in Figure 27D. When force is applied, it may be useful to support the patient's elbow.
[0251] Force from the insertion tool 900 and / or from the guide pin 380 can be applied until the blazer 602 is seated coplanar with the reamed humeral resection surface 1015, as shown in Figure 27F. As shown, when the bottom 395b of the handle 395 of the adapter 390 reaches the boundary line 399, it indicates to the surgeon that the blazer 602 is coplanar with the reamed humeral resection surface 1015. For example, the blazer attachment 600 can be advanced toward the humeral resection surface 1015 until the bottom 395b of the handle 395 contacts the line 399.
[0252] After the broaching is complete, a force is applied in the opposite direction to direction A, which is in the direction of direction A', as shown in Figure 27G, allowing the blazer 602 to be pulled out of the humerus 1012. After the blazer attachment 600 is released from the prepared bone and enters the glenoid joint 1010, the insertion tool 900 can be detached from the mounting end 1420 of the handle assembly 1400, pulled upward through the rotator cuff gap 1020, and exit the body.
[0253] Subsequently, the handle assembly 1400 and the blazer attachment 600 coupled thereto can be detached from the guide pin 380 and removed in a manner similar to that of the handle assembly 1400 and the reamer attachment 500. Such operations are supported by Figure 27H and other disclosures herein, and no further explanation is necessary. Furthermore, the blazer attachment 600 can be detached from the handle assembly 1400 by, for example, sliding the latch 1424 to disengage the mount 610 from the capture plate 1426, thereby allowing the blazer attachment 600 to be removed from the handle assembly 1400.
[0254] Introduction of the implant into the humeral resection surface using a humeral guide Following reaming and broaching of the humeral resection surface 1015, an implant, such as the implant 1900 shown in Figures 28B to 28D, can be introduced into the glenoid-shoulder joint 1010. As used herein, the term implant typically refers to a component disposed on the surface of bone and / or tissue, while a prosthesis refers to a portion that is coupled to such an implant and extends further outward from the implant, bone, and / or tissue (although it may be at least partially disposed on the implant, bone, and / or tissue), although the term implant may also refer to a prosthesis in at least some contexts. Those skilled in the art will understand that other actions besides reaming and broaching can be performed on the humeral resection surface 1015 before the introduction of the implant. For example, one or more holes may be drilled through the bone at the surgical site to place sutures in the holes, which can then be captured by the implant 1900 when it is inserted into the humeral resection surface 1015. Sutures may then be used, for example, to bring the soft tissues together upon completion of the procedure.
[0255] Figure 28A shows the humeral resection surface 1015 obtained after reaming as described in Figures 24A to 25H and broaching as described in Figures 26 to 27H. A humeral guide 300 (not shown) can be fixed in place. As shown, a humeral guide shaft 1380, also called a drive shaft, may be positioned at the surgical site in place of the guide pin 380, with its tip 1382 positioned close to the reamed and broached humeral resection surface 1015, and in the illustrated embodiment, positioned directly above it. In an alternative embodiment, the guide pin 380 (see, for example, Figure 28C) may continue to be used in place of the humeral guide shaft 1380. Figure 28C shows the guide pin 380, but including the guide pin after Figure 28A and before Figure 28D is not intended to mean that the humeral guide shaft 1380, as shown in Figure 28A, is removed and replaced with the guide pin 380, as shown in Figure 28C, and then returned in place of the guide pin 380 in Figure 28D. Rather, the illustration of the guide pin 380 in Figure 28C is intended to show another tool that can be used in conjunction with positioning the implant 1900 at the surgical site, and furthermore, Figure 28C is intended to show further details regarding the implant 1900.
[0256] As shown in Figure 28B, in the illustrated embodiment, the inserter tool 800' is a stemless baseplate inserter that operates in a scissor-like manner, also called a gripper, snap, curved snap, or snap tool, and can be used to grip the implant 1900 (shown as a stemless implant) for insertion into the humeral resection surface 1015. Although not shown in Figure 28B, in some embodiments, the tool can grip one of the four central support features 1901 of the implant 1900. Those skilled in the art will understand how to operate an inserter tool such as tool 800', and therefore no further explanation is needed. Furthermore, the implant 1900 may be similar to an implant known to those skilled in the art. The implant 1900 may generally be configured to be complementary to the shape and structure formed in the humeral resection surface 1015 so that the implant can seat within the humeral resection surface 1015. The implant 1900 may include an upper surface 1902 having a plurality of openings or holes 1904 formed thereon, which are used, for example, to fix sutures that may be useful for repairing surrounding soft tissue. For example, the sutures may be used to repair the subscapularis muscle (if removed, the disclosure provides the ability to perform the procedure without removing the subscapularis muscle, although the disclosure may also be used in conjunction with dissection of the subscapularis muscle) or other soft tissue removed to complete the procedure. The holes 1904 provide good attachment points for feeding the sutures and ensure that tissue repair heals without micromovement.
[0257] The stemless implant 1900 can be introduced into the articular space 1010 in a similar manner to how other instruments are inserted into the articular space 1010, for example, by passing through the rotator cuff gap 1020, and therefore its illustration is unnecessary. The implant 1900 can be positioned above the tip 1382 of the guide shaft 1380, as shown with respect to the tip 382 of the guide shaft 380 in Figure 28C. The geometric shape of the implant 1900 should match the complementary geometric shape formed on the humeral resection surface 1015, which is mainly formed by the blazer attachment 600. That is, a portion of the implant 1900 may be designed to fit into a portion broached by the blazer fins 604a, 604b. In at least some embodiments, such as the embodiment shown in Figure 28D, when the implant 1900 is manipulated to enter a notch formed in the humeral resection surface 1015, the implant 1900 may seat itself in approximately half of the humeral resection surface 1015, for example, by applying light pressure. Furthermore, as shown in Figure 28D, the tip 1382 of the humeral guide shaft 1380 may slide into a central opening or cannula insertion section 1906 formed within the implant 1900 (Figure 28C similarly shows the tip 382 of the guide pin 380). In at least some embodiments, the surface 1903 defining the central opening 1906 is tapered, which may help to advance components into the central opening 1906 as desired. Alternatively, the humeral guide shaft 1380 may advance the implant 1900 into the central opening 1906 after it has been positioned in the prepared humeral resection surface, i.e., the humeral resection surface 1015.
[0258] The universal handle assembly 1400 can be prepared again for use, this time by coupling the implant adapter 1920, illustrated in Figure 29A, to the mounting portion 1420 of the handle assembly 1400, as shown in Figure 29B. This attachment of the adapter 1920 to the handle assembly 1400 can be performed using techniques similar to those described herein, such as sliding the latch 1424 away from the receiving chamber 1428 and then sliding it toward the receiving chamber 1428 to capture the mount 1910 of the adapter 1920 with the capture plate 1426, and therefore no further consideration is needed therein. As shown, the implant adapter 1920 may include a central boss 922 extending distally from the distal surface of the adapter 1920. The boss 1922 has a central opening 1923 formed in the boss 1922 for receiving the guide pin 380 and / or the shaft, which may help position the adapter 1920 within the chamber 1428 of the mounting portion 1420 of the handle assembly 1400.
[0259] After introducing the handle assembly 1400, and therefore the adapter 1920, into the articular space 1010 using the technique already provided for inserting the handle assembly 1400 into the surgical site, the central boss 1922 can be positioned within the central opening 906 of the implant 1900, as shown in Figure 29C. The taper 1903 can assist in positioning the boss 1922 within the central opening 1906. As also shown in Figure 29C, the guide 300 (arm 310 and adapter 390 as shown) is used in conjunction with the handle assembly 1400. As with other embodiments of the disclosed technique, by attaching the handle assembly 1400 to the humeral guide 300, alignment of the plane and the central axis can be maintained during implant insertion and implantation.
[0260] Similar to the operation of the braser attachment 600, the adapter 1920 can be operated using the implantation tool 900. Before implantation, the patient's arm may be moved, often slightly, in adduction and external rotation, and extension may be used to ensure that the implantation axis is not obstructed by the patient's anatomical structure, thus resulting in unobstructed implantation. One or more retractors may be used to manipulate the tissue to ensure that it is removed from the implant before implantation. When used with the braser attachment 600, the tool 900 may be introduced into and positioned relative to the handle assembly 1400 in a manner similar to that described above. The tool 900 may be slid along the arm 1422 in direction B toward the implant 1900, as shown in Figure 29D, thereby advancing the implant. The surgeon can apply force by inserting the broad handle 906 (see Figure 27B) with a hammer or mallet, or by striking it otherwise, thereby driving force in direction A through the tool 900, through the mounting portion 1420, to the implant impactor 1920, and to the implant 1900, as also shown in Figure 29D. The implant impactor 920 is used as the end effector of the tool 900, although in other embodiments, a different end effector may be used. The humeral guide shaft 1380 can also be operated to assist in the movement of the implant 1900 into the prepared humeral resection surface 1015. Similar details regarding the use of the tool 900 for the braser attachment 600 are also applicable to the use of the tool 900 with respect to the implant adapter 1920 and the implant 1900, and therefore will not be further described in relation to these figures. Similarly, the humeral guide shaft 1380 can be used in the same way as the guide pin 380 for the blazer attachment 600, and therefore, the details related thereto will not be further explained with respect to these figures. The implant 1900 can be completely embedded within the humeral resection surface 1015, but to help facilitate the assembly of the humeral head prosthesis, it may be advantageous to leave the implant 1900 slightly protruding, with the surface 1902 positioned above the humeral resection surface 1015, as shown in Figures 29E-29F.As shown in the figure, when the bottom 395b of the handle 395 of the adapter 390 reaches the boundary line 399, it indicates to the surgeon that the implant 1900 is in the desired position with respect to the reamed and broached humeral resection surface 1015. For example, the implant 1900 can be advanced toward the humeral resection surface 1015 until the bottom 395b of the handle 395 contacts the line 399.
[0261] During the procedure, it may be useful to ensure that the implant 1900 is positioned in a way that reliably matches the broached geometric shape. One way to assist this may be to move the patient's arm in external rotation and extension to ensure that the implantation axis is not obstructed by the patient's anatomical structure. Obstruction can be prevented, for example, by using a displacement wrap or a subscapularis reducer, further details of which are disclosed in the aforementioned U.S. Patent Application Publication No. 2024 / 0108433. Furthermore, it may be useful to ensure that there is no trapped soft tissue between the implant 1900 and the humeral resection surface 1015 while positioning the implant 1900 and advancing it to its final position.
[0262] The implantation tool 900 and the handle assembly 1400 can then be removed from the surgical site using techniques already described herein. These actions include, but are not limited to, detaching the handle assembly 1400 from the humeral guide 300 by the adapter 390 and / or slider 1460, as shown in Figure 29F, and removing the implant adapter 1920 using the techniques described herein to remove the reamer attachment 500 and / or blazer attachment 600, among other attachments, as shown in Figure 29G. A complete description of the actions performed in Figures 29F and 29G is unnecessary given the preceding description relating to similar figures (see, for example, Figures 25F, 25H, and 27H).
[0263] A...
Claims
1. It is a surgical guide, A rigid arm having a proximal portion and a distal portion, wherein the distal portion is configured to have an attachment connected to the distal portion, and the proximal portion has a cannula receiving opening formed in the proximal portion, and as a result, the plane defined by the principal surface of the distal end of the attachment connected to the distal portion of the rigid arm is substantially perpendicular to the longitudinal axis extending through the cannula receiving opening that defines the path of the drill cannula, At least one support rod configured to be coupled to the rigid arm, The system comprises at least one bone pin clamp coupled to the at least one support rod, wherein the at least one bone pin clamp is configured to provide multiple degrees of freedom so that a bone pin coupled to the at least one bone pin clamp can be manipulated over multiple degrees of freedom, The surgical guide is configured for use with one or more bones located at or adjacent to the surgical site.
2. The surgical guide according to claim 1, further comprising a hub associated with the proximal portion of the rigid arm, wherein the hub has the cannula receiving opening formed in the hub.
3. The surgical guide according to claim 1, further comprising a drill cannula, the drill cannula being configured to enter into the cannula receiving opening, pass through the cannula receiving opening, and engage with the opposite face of one of the one or more bones where the distal end of the attachment, which is coupled to the distal end of the rigid arm, is located.
4. The aforementioned at least one bone pin clamp is A guide coupling portion configured to be coupled to at least one of the support rods, The surgical guide according to claim 1, further comprising: a pin engagement portion configured to selectively unlock and lock the bone pin so that the entry position of the bone pin into the bone and the entry angle of the bone pin into the bone can each be adjusted.
5. The surgical guide according to claim 1, further comprising an adapter disposed at the distal end of the rigid arm, wherein the adapter is slidable to selectively engage with an attachment, and selectively connects the attachment to the distal end of the rigid arm and disconnects it therefrom.
6. The surgical guide according to claim 1, wherein the surgical guide is configured to be positioned at or near the surgical site such that the movement path defined by the drill cannula received through the cannula receiving opening is traversed by the tool operating shaft, allowing the tool operating shaft to engage with one or more tools associated with the distal end of the rigid arm.
7. The surgical guide according to claim 1, further comprising an attachment configured to be coupled to the distal end of the rigid arm, the attachment having a distal end having a principal surface that defines a plane substantially perpendicular to the longitudinal axis extending through the cannula receiving opening, which defines the movement path of the drill cannula.
8. The surgical guide according to claim 7, wherein the attachment includes a sizer attachment configured to be used for at least one of the following: defining the central position of a receptive surface of one of the one or more bones at the surgical site, or determining the size of the receptive surface.
9. The surgical guide according to claim 7, wherein the attachment comprises a handle assembly, the handle assembly having a humeral preparation device coupled to its distal end, and the attachment is configured to position the humeral preparation device in close proximity to one of the one or more bones at the surgical site such that a plane defined by the principal surface of the humeral preparation device is substantially perpendicular to the longitudinal axis extending through the cannula receiving opening that defines the movement path of the drill cannula.
10. The surgical guide according to claim 9, wherein the handle assembly comprises a mounting portion disposed at its distal end and configured to receive the humeral preparation device.
11. The surgical guide according to claim 9, wherein the handle assembly further comprises a guide receiving opening configured to be coupled to the distal end of the receiving arm, thereby fixing the handle assembly to the guide assembly for operation of the humeral preparation device.
12. A handle assembly for use when positioning a bone preparation device in close proximity to the location where the bone is to be treated, An arm having a proximal portion and a distal portion, A mounting portion disposed on the distal portion of the arm, the mounting portion being configured to receive a bone preparation device for use at the position where the bone is to be treated, A handle assembly comprising: a receiving portion disposed on the proximal portion of the arm, the receiving portion being configured to enable the handle assembly to be appropriately positioned and selectively coupled to a guide that positions the distal end of the mounting portion in proximity to the position where the bone is to be treated.
13. The handle assembly according to claim 12, wherein the mounting portion comprises a biased capture plate configured to selectively engage with the bone preparation device by sliding along the arm.
14. The handle assembly according to claim 13, further comprising a latch on the arm opposite to the capture plate and coupled to the capture plate, wherein the latch is configured to act against the biased capture plate to slide the capture plate along the arm, thereby selectively disengaging the capture plate from the bone preparation device.
15. The aforementioned bone includes the humerus, The handle assembly according to claim 12, wherein the mounting portion and the bone preparation device received by the mounting portion are configured to be positioned on the humerus such that the subscapularis tendon adjacent to the humerus remains undamaged.