1. Field of the Invention
The present invention relates to devices and methods for repairing the shoulder joint and more specifically to shoulder prostheses and methods of performing a shoulder arthroplasty.
2. Background
Until relatively recently, a total repair of the shoulder joint, or shoulder arthroplasty, required the removal of the entire head of the humerus bone, commonly at or below the anatomic neck, in order to accommodate the insertion of an elongated shaft of the device into the diaphysis of the bone. An articulation surface attached or attachable to the proximal end of the shaft and cooperates with a second articulation surface attached to the boney portion of the scapula. A relatively recent advance in total shoulder repair has been the introduction of the humeral head prosthesis, a device that mounts or attaches to a prepared surface of the humeral head. These devices also include a joint head having an articulation surface typically formed as a spherical segment configured to articulate against a cooperating surface attached to the boney portion of the scapula. The joint head is mounted to a mounting fixture which, according to the present state of the art, includes a variety of configurations. The mounting fixture is attached to the humeral head at a site located substantially at and coplanar to a distal margin of the anatomical head that has been modified by sawing, shaping and/or drilling to accommodate attachment of the mounting fixture to the modified humeral head.
In U.S. Published Patent Application 2009/0292364 by Linares, a shoulder joint implant assembly is described that includes a plastic ball secured to a first bone end face and a plastic receiver secured to a second bone end face. A fastener is secured to the first bone end face and over which is mounted the plastic ball. The receiver is anchored by a pair of inwardly extending mounting tabs that extend into cavities machined in the first bone.
U.S. Pat. No. 7,648,530 to Habermeyer, et al., describes a humeral head prosthesis including a joint head including a nearly spherical joint surface. A hollow screw fixes a mounting disk to a planed surface of the bone. The hollow screw is driven into the bone through a medial hole located in a collar formed on the proximal surface of the mounting disk. A cone shaped receiver is formed within the joint head and is suitably configured to receive the collar in a press fit.
U.S. Pat. No. 7,611,539 to Bouttens, et al., describes a shoulder prosthesis that includes a mounting plate having a central tubular mounting bushing. A joint head including an articulation surface formed as a spherical segment having an axial screw is fit over the mounting plate and the axial screw is screwed into the tubular mounting bushing.
U.S. Pat. No. 7,608,109 to Dalla Pria, describes a first articulation element associated with the top of the humerus that includes a two piece support member the first piece including a threaded stud for insertion into the humeral head, a second piece having a post that inserts into the core of the stud, the second piece also including several tabs that extend over the surface of the proximal end of the bone with screws that attach to the bone through the tabs. A joint head including an articulation surface formed as a spherical segment is attachable to the support structure.
In U.S. Pat. No. 6,969,406 to Tornier, a multi-piece shoulder prosthesis is described that has at least four principal assembled components including:
While the devices and methods discussed above resolve some of the challenges related to providing a humeral head prosthesis, still a need exists to provide increasingly simplified humeral head prosthetic devices and systems. Additionally, a need exists to refine and improve upon the means by which the prosthesis is located on and secured to a prepared site located on the proximal humerus bone. In addition there is a need to provide a prosthetic device and system that includes improved means and features that allow for easier removal of the device in cases where such removal is indicated. Another issue left unaddressed by the current state of the art is the osteolysis that tends to occur in regions where there is no growth of the bone into the implant. Additionally, osteolysis is known to occur at the calcar region in patients who receive a prosthetic shoulder that includes a shaft that extends into the diaphysis of the bone. Other improvements may be seen in a humeral head prosthetic device by the addition of means for attaching a suture to the prosthesis so that the prosthesis may be utilized as an anchor for sutures that are used to re-attach connective tissue to the bone following installation of the prosthesis.
Therefore one object of the present invention is to provide a humeral head resurfacing prosthetic device. Another object of the present invention is to provide a prosthetic device and system that includes improved means and features that allow for easier removal of the device in cases where such removal is indicated. Yet another object of the present invention is to provide a modular system for repair of the humeral head that includes a variety of device anchors having a range of diameters and lengths and a variety of prosthetic heads having a range of head sizes and diameters. Another object of the present invention is to provide an improved methodology for locating the humeral head prosthetic device with respect to a modified humeral head. Another object of the present invention is to provide a prosthetic device for a long bone that reduces the tendency of osteolysis that has been observed in connection with the use of some prosthetic implants. Another object of the present invention is to provide a humeral head prosthetic device that includes one or more apertures through which a suture may be passed, the apertures adapted and optimized to facilitate the use of sutures for augmenting soft tissue connection. An additional object of the present invention is to provide a humeral head prosthetic device that has been optimized for removal in the event that such removal is indicated.
The present invention is directed to a humeral head prosthetic device includes a chassis having a base element from which a tapered and multifaceted anchor element projects distally. The tapered and multifaceted anchor element is fixed to or formed upon or attachable to an articulation surface. In the preferred embodiment the humeral head prosthetic device the articulation surface is formed as a semi-spherical segment that is removably attachable to the chassis.
In one embodiment the humeral head prosthetic device is configured as a unitary prosthesis wherein the articulation surface is permanently fixed to or formed at the proximal end of the chassis and a contact surface includes a configuration that is suitable for mounting against a prepared surface of the humeral head. In one embodiment of the unitary prosthesis, the tapered and multifaceted anchor element is fixed or formed against an inner concave surface of the semi-spherical segment such that the inner concave surface becomes the contact surface and the outer convex surface serves as the articulation surface. This embodiment is intended for resurfacing, as opposed to replacing, the humeral head. In another embodiment, the joint head is separable from the chassis. Whether the prosthetic device is configured for resurfacing the joint or replacing the humeral head, the device includes a multifaceted anchor element fixed to or formed on the distal surface of the articulation surface. As for the unitary humeral head prosthetic device, the advantages of this configuration lie in part in its unitary construction and therefore the potential that it has to reduce costs associated with shoulder arthroplasty hardware and procedures.
In the embodiment wherein the joint head is separable from the chassis, the joint head is held against the base element by means of a cooperating press fit between a tapered post and socket. In one embodiment the post and socket each include a cooperating Morse taper. One advantage of this configuration lies in allowing the surgeon to select a chassis of having a size that is most appropriate for the size of the humeral head being repaired and a head including an articulation surface that cooperates best with the patient's glenoid. Another advantage of this configuration lies in creating an option of placing auxiliary anchors through the base element into the humeral head which results in a more stable placement of the prosthesis in the bone, particularly immediately post surgery, before boney in-growth between the bone and the central stem member has had time to progress. Another advantage of this configuration lies in creating an option of replacement of the joint head where a condition allowing for such a repair presents itself
The tapered and multifaceted anchor element of the humeral head prosthesis is defined by an inner wall surface and an outer wall surface. The wall of the anchor element has a tapering cross-section that diminishes in thickness as the distance from the base element increases, (distally converging). The surface of the inner wall of the anchor element is relatively featureless. The surface of the outer wall of the anchor element includes a series interconnected fins, each fin comprising a pair of converging wall segments or facets that taper distally as a distance from the base element increases, (distally converging). Apertures are formed through the wall of the anchor element to promote bone growth and revascularization. In alternate embodiments, the tapered and multifaceted anchor element may be formed as a single tubular element or it may be formed as a plurality of tubular segments.
In a preferred embodiment, the invention, the converging wall segments formed on the outer wall of the anchor element converge or truncate at a distance proximal to a distal lip of the anchor element. A series of circular or oval apertures are formed through the wall of the anchor element just proximal to the distal lip. These apertures are provided to accommodate a method of the invention discussed herein below. In order to prevent surface abrasion against sutures that may be guided through the apertures, the region of the wall of the anchor element just proximal to the distal lip through which these apertures are formed may include a polished finish with the annular edges of the apertures being radiused and polished as well.
At least a portion of both the inner wall and the outer wall of the region of the anchor element proximal to the polished region, as well as the contact surface of the base element exhibit a roughened surface. For instance the surfaces may be coated with a porous coating adapted to encourage bone in-growth, and hence enhanced mechanical properties at the site of impaction. Alternately, surfaces may be roughened by a process, such as grit blasting or machining, for example.
In one embodiment, the humeral head prosthetic device includes a plurality of anchors that are adapted for placement through and engagement with the base element of the chassis. Preferably, two anchors are set into the greater tuberosity and one anchor is set into the calcar region. Once the anchors are set, and due to that fact that the three anchors diverge from one another and the primary axis of the device, the placement of the device with respect to the bone has become remarkably stable resisting both pull-out and rotational forces. It is particularly important that any humeral head prosthetic device remain stable and have good resistance to pull out particularly just following implantation and before the bony in-growth that follows surgery has occurred.
Several characteristics of bony anatomy are addressed by the configuration of the humeral head prosthetic device of the present invention. First, the head of a bone is composed of an open-celled latticed material called trabecular bone encased in a sheath of cortical bone. Trabecular bone is adapted to absorb loads at the joint. In furtherance of this adaptation, trabecular bone exhibits a latticed structure that gives it a sponge-like appearance. As an individual ages, the size of a cavernous or osteopenic region of the bone increases from the inside towards the outside of the bone, decreasing the mass and density of the trabecular bone.
A second observation about bony anatomy is stated by Wolff's law which observes that where loading on bone increases, the bone remodels itself over time to become stronger in order to resist the load. Of particular note, and consistent with Wolff's law, is the observation that internal architecture of the trabecular bone undergoes adaptive change when subjected to stress. Wolff's law also recognizes that where loading on a bone decreases, the bone will become weaker. This phenomenon has been identified at least in part for the occurrence of osteolysis at the calcar region of the humerus in patients who receive a prosthetic shoulder that includes a shaft that extends into the diaphysis of the bone, thereby relieving much of the normal stress seen at this region due simply to anatomical configuration and load bearing at the joint.
The configuration of the tapered and multifaceted anchor element of the present invention and the preferred method of implanting anchor is directed at avoiding these physical limitations of aging bony anatomy by maximizing anchor to bone surface area in order to take advantage of impacting the device in a manner that promotes bony in-growth between the anchor member and the trabecular bone. The interconnected fins formed on the outer wall of the anchor element project out and away, further towards the periphery, and further from the center of the bone. The combined configurations of the tapering cross-section of the wall of the anchor element and the configuration of the proximally diverging outer wall segments or facets against the substantially vertical walls of the circular cut made in the prepared end of the humerus create substantial hoop stresses between the anchor element and the matrix of exposed trabecular bone into which the anchor element is impacted, which creates stresses at the site of impaction which in turn stimulates bony in-growth and remodeling over time in order to resist the load. According to a preferred methodology of implanting the anchor member, the interior of the anchor member may be packed with bone graft material to accelerate and promote boney in-growth. Additionally, bone growth is stimulated where it comes in contact with the roughened surfaces of the anchor element and the entire contact surface of the base element. As such, once in-growth has progressed at the bone-to-prosthesis interface, the occurrence of osteolysis promoted by mechanical stress shielding or introduction of foreign matter such as polyethylene debris at the bone-to-prosthesis interface should reduce substantially.
In the case where removal is required, several structural adaptations have been incorporated in the design of the humeral head prosthetic device of the present invention. For example, while a substantial portion of the anchor member of the prosthesis of the present invention includes a roughened surface or a surface coated with a porous coating, the porous surface extends only a portion of the length of the anchor member, so that bony growth is not promoted the full length of the anchor member towards the distal end of the prosthesis.
Additionally, and in furtherance of the objective of facilitating removal of an implantable prosthesis in the event that removal is required, one or more of “blind” holes or slots may be formed in a surface of the implantable prosthesis that would be used to aid in the removal of the chassis from the bone once impacted. Each blind hole or slot includes a penetrable wall that in part defines the blind hole or slot. In a case where removal of an implanted prosthesis is indicated, a drill or osteotome may be used to penetrate the penetrable wall formed at the bottom of each “blind” hole or slot. The drill or osteotome may then continue through the bone to help separate the prosthesis from the bone in a controlled manner. A thin metal layer or a frangible wall composed of cement, for instance a polymethylmethacrolate cement, or plastic would serve as a barrier with the purpose of keeping foreign material, particularly polyethylene debris, from finding its way through the “blind” hole into the bone over time. The surface of the wall section that is oriented towards the bone would preferably include a roughened surface consistent with the surrounding surfaces of the base element to promote bony in-growth against the surface of the base element. Alternately a “blind” hole may be created simply by filling a portion of a hole or slot formed in the prosthesis with a cement or plastic thereby forming a penetrable wall which bony growth may readily occur.
In a preferred embodiment, the device is to be manufactured and offered in a variety of sizes. In particular the diameter at the base of the joint head and the diameter of the base element are offered in increments through a range of diameters so that the device size can be matched as closely as reasonably possible to a particular patient's bone. Preferably, the diameter of the base element is the same as the diameter of the prepared site of the proximal humerus bone such that the base element's roughened surface contacts both the trabecular bone as well as the more dense cortical bone, thereby preventing subsidence of the device in the softer trabecular bone. The in-growth of the bone to the prosthesis that occurs at the periphery of the prepared bone should also serve as a barrier with the purpose of keeping foreign material, particularly polyethylene debris, from finding its way into the bone over time.
Preferably, the device is manufactured having dimensions within the following ranges:
Head diameter=35-55 mm
Head height=12-28 mm
Anchor length=12-22 mm
Anchor element outer diameter distal end=20-30 mm
Anchor element outer diameter at base element=22-34 mm
In one embodiment, the device is manufactured having the following dimensions:
Head diameter=50 mm
Head height=19 mm
Anchor length=17 mm
Anchor element inner diameter distal end=24 mm
Anchor element inner diameter at base element=23 mm
Anchor element outer diameter distal end=28 mm
Anchor element outer diameter at base element=30 mm
Fin height at base element=2.5 mm tapering distally
Fin width at base element=2.0 mm tapering distally
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The description of the illustrated embodiments has been presented for purposes of illustration and description and is not intended to be exhaustive or to limit the invention to the precise form or to exemplary embodiment(s) and implementation(s) disclosed. Modifications and variations will be apparent to practitioners skilled in this art. Process steps described might be interchangeable with other steps in order to achieve the same result. At least one preferred embodiment was chosen and described in order to best explain the principles of the invention and a best mode of practical application, thereby to enable others skilled in the art to understand the invention and the various modifications that are suited to the particular use or implementation contemplated. The scope of the invention is defined by the claims appended hereto and their equivalents. Reference to an element in the singular is not intended to mean “one and only one” unless explicitly so stated, but rather means “one or more.” No claim element herein is to be construed under the provisions of 35 U.S.C. Sec. 112, sixth paragraph unless the element is expressly recited using the phrase “means for . . . ”
This application claims the benefit of the filing date of a prior-filed Provisional Application Ser. No. 61/589,243 entitled Humeral Head Prosthesis, filed Jan. 20, 2012, which is incorporated by reference herein.
Number | Date | Country | |
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61589243 | Jan 2012 | US |