This document pertains generally, but not by way of limitation, to apparatuses and methods for performing arthroplasty procedures. More particularly, this disclosure relates to, but not by way of limitation, intra-operative planning techniques for selecting the position of a prosthetic device component for a patient into which the prosthetic device component will be implanted.
A shoulder joint comprises the juncture of the scapula, the clavicle and the humerus. The head of the humerus fits into a shallow socket of the scapula called the glenoid fossa to form a mobile joint. When the joint is articulated, the humeral head moves in the glenoid fossa to provide a wide range of motion. The shoulder joint may suffer from various maladies including rheumatoid arthritis, osteoarthritis, rotator cuff arthropathy, avascular necrosis, bone fracture or failure of previous joint implants. If severe joint damage occurs and no other means of treatment is found to be effective, then shoulder reconstruction may be necessary.
A shoulder joint prosthesis generally includes the replacement of the ball (glenosphere) of the humerus and, optionally, the socket (glenoid) of the shoulder blade with specially designed artificial components. The bio-kinematics, and thus the range of motion in the shoulder vary greatly among prospective patients for reconstruction shoulder surgery. The humeral component typically can have a metal shaft or stem with a body portion that can be embedded in the resected humerus and a generally hemispherical head portion supported on the stem. The head portion can slidingly engage a glenoid implant on the glenoid fossa. During reconstructive surgery, the components of the prosthesis can be matched with the bio-kinematics of the patient in an effort to maintain the natural range of motion of a healthy shoulder joint. Thus, a shoulder prosthesis design can be readily adaptable to a wide range of bio-kinematics for prospective patients.
In this regard, shoulder prostheses are generally available as either unitary structures or modular components. With unitary shoulder prosthesis, a large inventory of differently sized prostheses must sometimes be maintained to accommodate the different bone sizes and joint configurations of the prospective patients. With such unitary shoulder prosthesis, the patient can typically be evaluated by X-ray to determine approximate sizes of prostheses needed for reconstruction. A number of differently sized prostheses can be selected as possible candidates based upon this preliminary evaluation. Final selection of the appropriately sized prosthesis can be made during the surgery. With unitary shoulder prosthesis, each design can represent a compromise that is unable to achieve all of the natural range of motion of a healthy shoulder joint because of the fixed geometric configuration in their design.
Modular prostheses systems that can reduce the need to maintain large inventories of various sized components are known in the art. Conventionally, a humeral prosthesis can include two components: a humeral stem component and a spherical head releasably coupled to the stem. Alternatively, a three component design is known in which the stem and spherical head are interconnected with an adapter. In either of the two-piece or three-piece designs, a radial offset or angulator inclination of the head relative to the stem can be provided in individual components. Different radial offsets or angular inclinations are achieved through the use of different adapters or heads. In this regard, conventional modular shoulder prosthesis kits can include multiple components such as adapters and heads to achieve a range of prosthetic options.
While providing an advantage over the unitary design in reducing the number of components needed, an inventory of head components and/or adapter components must sometimes be maintained to provide the desired range of geometric configurations with the conventional modular shoulder prostheses. These components can be readily adaptable to provide a range of geometric configurations, i.e. radial offsets of angular inclination while minimizing the number of components required.
Examples of humeral head trialing devices are described in U.S. Pat. No. 8,647,387 to Winslow, U.S. Pat. No. 7,431,736 to Maroney et al., U.S. Pat. No. 6,736,852 to Callaway et al., U.S. Pat. No. 6,673,114 to Hartdegen et al., and U.S. Pub. No. 2016/0030187 to Sperling et al.
The present inventors have recognized, among other things, that a problem to be solved relates to the need for surgeons to have to select a desired position (i.e. location and orientation) of a humeral head and a corresponding humeral head trial. This process can be complex and can involve the movement of several components that are intricately attached to each other, marking of bone in several locations, cross-referencing different types of indicia on the humeral head and on the humeral head trial, cross-referencing various other criteria (e.g., bone coverage, location of a top dead center, location of a maximum offset, etc.) in order to properly position the humeral head for the shoulder prosthesis. Because of the complexity involved, the surgeon can be left with making an informed estimate of the desired humeral trial position when positioning the humeral head prosthesis. Thus, translating the position of the humeral head trial to that of the humeral head may not always be accurately performed.
The present subject matter can help provide a solution to various problems associated with the trialing of a humeral head by providing a trialing apparatus that can be configured to couple directly to a humeral stem. The trialing apparatus can also be positionally adjustable (relative to bone and the humeral stem) in a manner similar to that of the humeral head and stem adaptor. The trialing apparatus can include indicia that are the same as or very similar to those of the humeral head and stem adaptor. These indicia can be more widely spaced apart so incremental sizes can be easier to achieve. The configuration of the trialing apparatus makes selecting a proper location of the humeral head and stem adaptor easier and more intuitive. Furthermore, the present subject matter contemplates that one or more components of the trialing apparatus can be transparent or translucent. This allows one or more indicia on a bone facing side of the trialing apparatus to be visible to the surgeon during adjusting of a relative position between components of the trial apparatus. This enhanced visibility also allows the surgeon to adjust positions and mark the bone more accurately with reference to the one or more indicia.
This overview is intended to provide an overview of subject matter of the present patent application. It is not intended to provide an exclusive or exhaustive explanation of the invention. The detailed description is included to provide further information about the present patent application.
In the drawings, which are not necessarily drawn to scale, like numerals may describe similar components in different views. Like numerals having different letter suffixes may represent different instances of similar components. The drawings illustrate generally, by way of example, but not by way of limitation, various embodiments discussed in the present document.
The scapula bone S and the humerus bone H are typically reamed, resected or otherwise prepared to receive the glenoid 16 and the humeral stem 30.
As can be seen in
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The proximal end 32 of the humeral stem 30 can include a trunnion 34 (
The body 36 can have a front surface 40 (sometimes referred to herein as a non-bone facing surface, proximal surface or top surface). The body 36 can be puck shaped, dome or hemispherical shaped according to some examples. The front surface 40 can terminate at a perimeter 41 of the body 36. The body 36 can be circular in cross-section and can have a size and shape similar to that of the humeral head 18 (
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According to the example of
The snap-fit engagement can be facilitated by the one or more fingers 54 of the body 36. The thimble 38 along the perimeter 41 can have a larger proximal diameter and then a smaller distal diameter. This change in diameter can form a lip 56 on the thimble 38. The lip 56 can have a chamfer of about 30 to 40 degrees between the larger diameter proximal portion and the smaller diameter distal portion. These fingers 54 (also illustrated in
As shown in
The recess 66 can be partially formed by the one or more fingers 68. The one or more fingers 68 can be configured to elastically deflect outward toward recess 69 when the recess 66 receives the trunnion 34 of the humeral stem 30. The one or more fingers 68 can be configured to create a friction fit, snap-fit or other type of engagement with the trunnion 34 (
Thimble 138 can differ from the thimble 38 in that the head 43 can be a slot 142, for example. Thimble 138 can be made of any suitable biocompatible material (e.g., metal, metal alloy such as titanium or titanium alloy, polymer, etc.). Thimble 138 need not be translucent or transparent, although the thimble can be translucent or transparent according to some examples.
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In
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Thus, the method of
Example 1 can include a trial apparatus for selecting a position of a prosthetic head component on a humerus. The trial apparatus can optionally include a body and a thimble. The body can have a plurality of indicia and can form a portion of a joint. The thimble can be couplable to the body via the joint. The thimble can be rotatable relative to the body via the joint and can include one or more indicia for use with the plurality of indicia of the body. The thimble can be mountable to a prosthetic stem implanted in the humerus.
Example 2 is the trial apparatus of Example 1, optionally the plurality of indicia can be arranged circumferentially about a centerline axis of the body.
Example 3 is the trial apparatus of any one or combination of Examples 1-2, optionally the body can comprise a hemisphere.
Example 4 is the trial apparatus of Example 3, optionally the plurality of indicia can be on a distal surface of the body and the body can be translucent such that the plurality of indicia are visible through the body from a side opposing the distal surface.
Example 5 is the trial apparatus of any one or combination of Examples 1-4, optionally the body can define a recess that comprises the portion of the joint, the thimble can be receivable by the recess, wherein the recess can be formed by one or more fingers, and wherein the fingers can be configured to elastically deform to retain the thimble in a snap-fit engagement.
Example 6 is the trial apparatus of Example 5, optionally the thimble can have a lip configured to be engaged by the one or more fingers when the thimble is inserted in the recess.
Example 7 is the trial apparatus of any one or combination of Examples 1-6, optionally the body includes a second recess opposing the joint, the second recess can communicates with the joint.
Example 8 is the trial apparatus of Example 7, optionally the thimble can include a head on a proximal end thereof, wherein, when the body and the thimble are assembled via the joint, the head can be accessible through the second recess of the body.
Example 9 is the trial apparatus of any one or combination of Examples 1-8, optionally the thimble includes one of a recess or a stem, and wherein a finger forms at least a portion of the recess or stem, and wherein the recess or stem of the thimble can be configured to elastically deform to retain the thimble on the prosthetic stem.
Example 10 is the trial apparatus of any one or combination of Examples 1-9, optionally the thimble can be rotatable relative to the body to adjust a position of the body relative to the prosthetic stem.
Example 10 is a system for positioning a prosthetic head component with a prosthetic stem. The system can include a stem adapter, a body and a thimble. The stem adapter can have a body configured to engage the prosthetic head component and a neck configured to engage the prosthetic stem, wherein the stem adaptor can include indicia for use with a plurality of indicia of the prosthetic head component. The body can have a plurality of indicia configured in an identical manner to those of the plurality of indicia of the prosthetic head component. The thimble can be configured to couple with the body and mountable to the prosthetic stem. The thimble can be rotatable relative to the body to adjust a position of the body relative to the prosthetic stem.
Example 12 is the system of Example 11, optionally the thimble can include an indicia for use with the plurality of indicia of the body, a relative position between the stem adaptor and the prosthetic head component can be determined by replicating with the indicia of the stem adaptor and the plurality of indicia of the prosthetic head component, the relative positions of the thimble and body as determined using the indicia of the thimble and the plurality of indicia of the body.
Example 13 is the system of any one or combination of Examples 11-12, further optionally including a driver configured to rotate the thimble relative to the body.
Example 14 is the system of any one or combination of of Examples 11-13, optionally the plurality of indicia of the body and the prosthetic head component can each be arranged circumferentially about a centerline axis.
Example 15 is the system of any one of Examples 11-14, optionally the plurality of indicia of the body can be on a distal surface of the body and the body can be translucent such that the plurality of indicia are visible through the body from a side opposing the distal surface.
Example 16 is a method for positioning a prosthetic head component with a prosthetic stem relative to a bone. The method can optionally include any one or combination of: mounting the prosthetic stem to the bone; inserting a thimble within a body; mounting the thimble on the prosthetic stem; adjusting a relative position between the body and the thimble; marking the bone; recreating the relative position with a stem adaptor and the prosthetic head component; marking the prosthetic head component with the aid of an indicia on the stem adaptor once the recreating the relative position with the stem adaptor and the prosthetic head component is achieved; aligning the marking on the bone with the marking on the prosthetic head component; and attaching the prosthetic head component to the prosthetic stem via the stem adaptor.
Example 17 is the method of Example 16, optionally adjusting the relative position between the body and the thimble comprises rotating the thimble relative to the body.
Example 18 is the method of any one or combination of Examples 16-17, optionally recreating the relative position with a stem adaptor and the prosthetic head component comprises positioning, using an indicia of the stem adaptor and a plurality of indicia of the prosthetic head component, the stem adaptor relative to the prosthetic head component and referencing the relative position of the thimble and the body as indicated by an indicia of the thimble and a plurality of indicia of the body.
Example 19 is the method of any one or combination of Examples 16-17, optionally the body can have a plurality of indicia that replicate a plurality of indicia of the prosthetic head component.
Example 20 is the method of any one or combination of Examples 18-19, optionally adjusting a relative position between the body and the thimble references at least one or more edges of the bone, and further can include viewing the indicia of the thimble and the plurality of indicia of the body through a translucent portion of the body.
Example 21 can include, or can optionally be combined with the subject matter of one or any combination of Examples previously recited.
Each of these non-limiting examples can stand on its own, or can be combined in various permutations or combinations with one or more of the other examples.
The above detailed description includes references to the accompanying drawings, which form a part of the detailed description. The drawings show, by way of illustration, specific embodiments in which the invention can be practiced. These embodiments are also referred to herein as “examples.” Such examples can include elements in addition to those shown or described. However, the present inventors also contemplate examples in which only those elements shown or described are provided. Moreover, the present inventors also contemplate examples using any combination or permutation of those elements shown or described (or one or more aspects thereof), either with respect to a particular example (or one or more aspects thereof), or with respect to other examples (or one or more aspects thereof) shown or described herein.
In the event of inconsistent usages between this document and any documents so incorporated by reference, the usage in this document controls.
In this document, the terms “a” or “an” are used, as is common in patent documents, to include one or more than one, independent of any other instances or usages of “at least one” or “one or more.” In this document, the term “or” is used to refer to a nonexclusive or, such that “A or B” includes “A but not B,” “B but not A,” and “A and B,” unless otherwise indiciated. In this document, the terms “including” and “in which” are used as the plain-English equivalents of the respective terms “comprising” and “wherein.” Also, in the following claims, the terms “including” and “comprising” are open-ended, that is, a system, device, article, composition, formulation, or process that includes elements in addition to those listed after such a term in a claim are still deemed to fall within the scope of that claim. Moreover, in the following claims, the terms “first,” “second,” and “third,” etc. are used merely as labels, and are not intended to impose numerical requirements on their objects.
The above description is intended to be illustrative, and not restrictive. For example, the above-described examples (or one or more aspects thereof) may be used in combination with each other. Other embodiments can be used, such as by one of ordinary skill in the art upon reviewing the above description. The Abstract is provided to comply with 37 C.F.R. § 1.72(b), to allow the reader to quickly ascertain the nature of the technical disclosure. It is submitted with the understanding that it will not be used to interpret or limit the scope or meaning of the claims. Also, in the above Detailed Description, various features may be grouped together to streamline the disclosure. This should not be interpreted as intending that an unclaimed disclosed feature is essential to any claim. Rather, inventive subject matter may lie in less than all features of a particular disclosed embodiment. Thus, the following claims are hereby incorporated into the Detailed Description as examples or embodiments, with each claim standing on its own as a separate embodiment, and it is contemplated that such embodiments can be combined with each other in various combinations or permutations. The scope of the invention should be determined with reference to the appended claims, along with the full scope of equivalents to which such claims are entitled.
This application claims the benefit of U.S. Provisional Patent Application Ser. No. 63/121,018, filed on Dec. 3, 2020, the benefit of priority of which is claimed hereby, and which is incorporated by reference herein in its entirety.
Filing Document | Filing Date | Country | Kind |
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PCT/US2021/061625 | 12/2/2021 | WO |
Number | Date | Country | |
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63121018 | Dec 2020 | US |