Abstract:
Systems, devices, and methods are provided for orthopedic implants. The implants may include a base member, such as an acetabular shell or an augment, that is configured to couple with an augment, flange cup, mounting member, or any other suitable orthopedic attachment. A cup member that fits within an implantable shell and has mounting members that anchor an implant to a patient&#39;s bone or soft tissue may be provided. The cup member may fit within the shell and have an exterior surface configured to mate with a corresponding interior surface of the shell to couple the cup member to the shell. The mounting members may be integral with the cup member, or may be adjustable to provide flexibility to accommodate a specific implant or patient anatomy.

Description:
CROSS-REFERENCE TO RELATED APPLICATIONS 
       [0001]    This application claims the benefit of U.S. Provisional Patent Application No. 61/352,705, filed Jun. 8, 2010, U.S. Provisional Application No. 61/352,722, filed Jun. 8, 2010, U.S. Provisional Application No. 61/422,903, filed Dec. 14, 2010, and U.S. Provisional Application No. 61/466,817, filed Mar. 23, 2011, which are hereby incorporated by reference herein in their entireties. 
     
    
     BACKGROUND 
       [0002]    Joints often undergo degenerative changes due to a variety of reasons. When joint degeneration becomes advanced or irreversible, it may become necessary to replace the natural joint with a prosthetic joint. Artificial implants, including hip joints, shoulder joints, and knee joints are widely used in orthopedic surgery. Specifically, hip joint prostheses are common. The human hip joint acts mechanically as a ball and socket joint, wherein the ball-shaped head of the femur is positioned within the socket-shaped acetabulum of the pelvis. Various degenerative diseases and injuries may require replacement of all or a portion of a hip using synthetic materials, typically metals, ceramics, or plastics. 
         [0003]    More particularly, natural hips often undergo degenerative changes, requiring replacement of the hip joint with a prosthetic joint. Often, the hip is replaced with two bearing surfaces between the femoral head and the acetabulum. The first bearing surface is typically a prosthesis shell or acetabular cup, which may be formed of metal, ceramic material, or as otherwise desired. A liner (conventionally formed of polyethylene material such as ultra high molecular weight polyethylene, a ceramic material, or in some cases, even a metal liner) is then fit tightly within the shell to provide an inner bearing surface that receives and cooperates with an artificial femoral head in an articulating relationship to track and accommodate the relative movement between the femur and the acetabulum. 
         [0004]    The cup (or a cup and liner assembly) is typically fixed either by placing screws through apertures in the cup or by securing the cup with cement. In some cases, only a liner is cemented in a patient due to poor bone stock. In other cases, a cup having a porous surface may be press fit into the reamed acetabular surface. 
         [0005]    It may become necessary to conduct a second or subsequent surgery in order to replace a prosthetic joint with a (often larger) replacement joint. Such surgeries often become necessary due to further degeneration of bone or advancement of a degenerative disease, requiring removal of further bone and replacement of the removed, diseased bone with a larger or enhanced prosthetic joint, often referred to as a revision prosthesis. For example, bone is often lost around the rim of the acetabulum, and this may provide less rim coverage to securely place a press-fit cup. Such surgeries may thus be referred to as revision surgeries. 
         [0006]    In acetabular revision surgery, an acetabular prosthesis generally includes additional mounting elements, such as augments, flanges, hooks, plates, or any other attachment or mounting points or members that provide additional support and/or stability for the replacement prosthesis once positioned. These additional mounting or attachment members are often required due to bone degeneration, bone loss, or bone defects in the affected area (in this instance, the hip joint). 
         [0007]    Various types of these mounting members (which term is intended to include but not be limited to flanges, blades, plates and/or hooks) may be provided in conjunction with a prosthesis system in order to help the surgeon achieve optimal fixation, non-limiting examples of which include iliac flanges (providing securement and fixation in and against the ilium region of the pelvis), ischial blades (providing securement and fixation in and against the ischium), and obturator hooks (providing securement and inferior fixation by engaging the obturator foramen). Although there have been attempts to provide such mounting attachments with modularity, the solutions to date have generally fallen short of providing true modularity. Instead, they typically provide a few discrete positions at which the mounting members may be positioned, without providing the surgeon a fuller range of decision options. 
         [0008]    Additionally, in some primary surgeries and more often in revision surgeries, the acetabulum may have a bone defect or void that the surgeon must fill with bone grafts before inserting a new shell. This can be time consuming and expensive, and may subject the patient to additional health risks. Some techniques use an augment in connection with the acetabular shell, which can be coupled to or otherwise attached to the outer surface of the shell. 
         [0009]    With current augments, the surgeon can attach the augment to the bone and then implant the cup. However, many acetabular shells rely on bone screws to achieve proper fixation and the augment often gets in the way of a screw. In short, surgeons need the freedom to place screws in the best location, but this compromises their ability to use augments. With current systems, it also takes an increased amount of time surgical time to trial the component orientation and then try to find good bone fixation for the cup. The surgeon will often have to free-hand the amount of bone removed while estimating the size of augment needed. In the cases where bone is often deficient, surgeons are hesitant to take away any more bone than necessary. 
         [0010]    Various additional features and improved features intended for use and application with various types of joint implants are also described herein, such as improved bone screws, improved coatings, and various augment removal and insertion options. 
       SUMMARY 
       [0011]    Disclosed herein are systems, devices, and methods for providing modular orthopedic implants. The implants may include a base member, such as an acetabular shell or an augment, that is configured to couple with an augment, flange cup, mounting member, any other suitable orthopedic attachment, or any combinations thereof. Mounting members include, for example, flanges, blades, hooks, and plates. In some embodiments, the orthopedic attachments may be adjustably positionable about the base member or other attachments thereby providing modularity for assembling and implanting the device. Various securing and/or locking mechanisms may be used between the components of the implant. In certain embodiments, the orthopedic attachments are removably coupled to the base member or other components. In certain embodiments, the orthopedic attachments are integrally provided on the base member or other components, yet may still be adjustably positionable thereabout. In some embodiments, expandable augments, base members, or other bone filling devices are provided. In some embodiments, surface features are provided that create friction and allow for surrounding bone ingrowth at the interface of the implants and a patient&#39;s bone. 
         [0012]    Systems, devices, and methods described herein provide implants that can include a flange cup. In certain embodiments, an acetabular implant system includes an acetabular shell, a cup member that fits positionably within the acetabular shell, and at least one mounting member coupled to the cup member, where the at least one mounting member has a first portion that is attachable to a patient&#39;s bone to thereby anchor to the patient&#39;s bone. The mounting member may include a flange that is adjustably positionable about the cup member and has a first end with an attachment portion that anchors to the patient&#39;s bone. In some embodiments, the cup member includes a distal tapered end that locks to an attachment site within the acetabular shell. In some embodiments, the attachment site within the acetabular shell is further configured to receive a liner. In some embodiments, the system includes a liner disposed within the cup member. The cup member may be configured as a band or as a full cup such that the liner is fully supported within the cup member. The at least one mounting member may include a flange, hook, or plate, and the at least one mounting member may be removably attached to the cup member. Alternatively, the at least one mounting member is integrally provided on the cup member. 
         [0013]    In certain embodiments, a method of forming a surgical implant includes inserting an implant within a patient&#39;s acetabulum, providing a cup member, having at least one mounting member, within the inserted implant, aligning the cup member with the implant so that the at least one mounting member aligns with a patient bone site, and attaching the at least one mounting member to the patient&#39;s bone. The method may also include adjustably positioning the at least one mounting member about the cup member, wherein the at least one mounting member has a first end with an attachment portion that anchors to the patient&#39;s bone, locking a distal tapered end of the cup member to an attachment site within the implant, and disposing a liner within the attachment site. In some embodiments, the method may further include disposing a liner within the cup member, where the cup member is provided as band or a full cup such that the liner is fully supported within the cup member. The at least one mounting member may include a flange, hook, or plate, and the method may further include removably attaching the at least one mounting member to the cup member. Alternatively, the at least one mounting member may be integrally provided on the cup member. 
     
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         [0014]    The foregoing and other objects and advantages will be apparent upon consideration of the following detailed description, taken in conjunction with the accompanying drawings, in which like reference characters refer to like parts throughout, and in which: 
           [0015]      FIG. 1  shows a side elevation view of an illustrative cup member; 
           [0016]      FIG. 2  shows a top plan view of the illustrative cup member of  FIG. 1 ; 
           [0017]      FIG. 3  shows an exploded view of an illustrative cup member and acetabular shell with an optional liner therebetween; 
           [0018]      FIG. 4  shows a perspective view of an illustrative cup member and acetabular shell; and 
           [0019]      FIG. 5  shows a side elevation view of an illustrative band cup member. 
       
    
    
     DETAILED DESCRIPTION 
       [0020]    To provide an overall understanding of the systems, devices, and methods described herein, certain illustrative embodiments will be described. Although the embodiments and features described herein are specifically described for use in connection with acetabular systems, it will be understood that all the components, connection mechanisms, adjustable systems, fixation methods, manufacturing methods, coatings, and other features outlined below may be combined with one another in any suitable manner and may be adapted and applied to medical devices and implants to be used in other surgical procedures, including, but not limited to: spine arthroplasty, cranio-maxillofacial surgical procedures, knee arthroplasty, shoulder arthroplasty, as well as foot, ankle, hand, and other extremity procedures. 
         [0021]    Various implants and other devices described herein in their various embodiments may be used in conjunction with any appropriate reinforcement material, non-limiting examples of which include bone cement, appropriate polymers, resorbable polyurethane, and/or any materials provided by PolyNovo Biomaterials Limited, or any suitable combinations thereof. Further non-limiting examples of potential materials that may be used are described in the following references: U.S. Patent Application Publication No. 2006/0051394, entitled “Biodegradable Polyurethane and Polyurethane Ureas,” U.S. Patent Application Publication No. 2005/0197422, entitled “Biocompatible Polymer Compositions for Dual or Multi Staged Curing,” U.S. Patent Application Publication No. 2005/0238683, entitled “Biodegradable Polyurethane/Urea Compositions,” U.S. Patent Application Publication No. 2007/0225387, entitled “Polymer Compositions for Dual or Multi Staged Curing,” U.S. Patent Application Publication No. 2009/0324675, entitled “Biocompatible Polymer Compositions,” U.S. Patent Application Publication No. 2009/0175921, entitled “Chain Extenders,” and U.S. Patent Application Publication No. 2009/0099600, entitled “High Modulus Polyurethane and Polyurethane/Urea Compositions.” Each of the prior references is incorporated by reference herein in its entirety. 
         [0022]      FIGS. 1-4  show a cup member  120  intended for insertion into an acetabular cup  140  (also referred to as an “acetabular shell,” “shell,” “cage,” or “cup”), and in some embodiments, between the acetabular cup  140  and a liner  160  that may be disposed within the cup member  120 . The cup member  120  is provided with various mounting members (also referred to as “attachment members”), such as flanges, blades, hooks, or plates, where each respective mounting member may be removably or integrally provided on the cup member. As shown in  FIG. 1 , for example, cup member  120  includes blade  102 , hook  104 , and flange  106 . The mounting members such as blade  102 , hook  104 , and flange  106 , may be adjustably positionable about the cup member (e.g., about the perimeter of the cup member or about any other suitable location on the cup member). For example, a removable mounting member may be attached to the cup member and then, while still attached, positioned from a first location to a second location along the cup member. Alternatively, the removable mounting member may be removed and then repositioned. As another example, an integral mounting member (e.g., a mounting member that is not removable) may nonetheless be adjustably positionable about the cup member. In some embodiments, an integral mounting member may be rigidly fixed in a first location and may not be adjustably positionable about the cup member. 
         [0023]    The portion of the mounting members that is not attached to the cup member may be used to attach or anchor to a patient&#39;s bone. For example, as shown in  FIG. 1 , flange  106  includes a portion  108  attached to the cup member  120  and an attachment portion  110  that is attachable to a patient&#39;s bone to thereby anchor to the patient&#39;s bone. Attachment portion  110  includes a plurality of screw holes  111  for anchoring flange  106  to the patient&#39;s bone, although it will be understood that any suitable attachment mechanism may be used. For example, hook  104  includes a curved end  105  to thereby hook onto a patient&#39;s bone. Screw holes  111  may include conventional holes, locking holes, or slots. The holes may be threaded, unthreaded, or partially threaded, and may be fixed or polyaxial. In some embodiments, screw holes  111  may include variable low-profile holes that allow for locking at a variety of angles. Other suitable attachment mechanisms may include bone cement, shape-memory polymer fixation members, expanding screws, any other suitable mechanism for attaching a mounting member to a patient&#39;s bone or soft tissue, or any combinations thereof. 
         [0024]      FIGS. 1-4  depict some embodiments of a cup member  120  suitable for receiving a polymer, ceramic, or metal liner  160 , the cup member  120  having mounting members that extend radially therefrom. The cup member  120  may be placed into an acetabular shell  140 , and the mounting members such as blade  102 , hook  104 , and flange  106  may be disposed around the rim  142  of the shell  140  when the cup member  120  is inserted into and substantially fully seated in the shell  140 . As shown in  FIG. 1 , in some embodiments, the outer portion  116  of the cup member  120  may have a conical taper  112  for frictional locking engagement with a complementary conical taper  114  in an acetabular shell  140 . The taper  114  of acetabular shell may be contoured to receive the specific type of conical taper  112  of the cup member  120 . In some embodiments, multiple cup members may be available, and each may have a profile similar to conical taper  112  such that they can be interchangeably placed into acetabular shell  140 . The complementary conical taper  114  in the acetabular shell  140  may also be used to accept a ceramic liner  162  having a conical taper similar to that of the cup member  120 , providing various options during surgery. The ceramic liner  162  may be utilized to allow a cup member  120  to be used with an acetabular shell  140  even when taper  112  of the cup member does not match the taper  114  of the acetabular shell. For example, the inner surface of ceramic liner  162  may be shaped to engage the taper  112  of the cup member  120  while the exterior surface of ceramic liner  162  has a different shape to engage the taper  114  of the acetabular shell  140 . Mounting members may be provided as one or more flanges, blades, hooks, or plates which may be rigid or bendable, and which may have any other appropriate features described herein. 
         [0025]    In certain embodiments, as shown in  FIG. 3 , a polyethylene or ceramic liner  160  is placed within the cup member  120  (which may also be referred to as a “flange cup”) to line the inside of the cup member  120 . The cup member  120  may comprise integral flanges that rest superiorly of the interior surface that accepts the liner. Alternatively, if metal on metal articulation is desired, a metal liner that incorporates integrally-formed flanges may be used. However, it will be understood that the modular options described herein may also be used. The cup member may contain internal scallops suitable for use with current polyethylene liners such that it may be used with the system, for example, disclosed in the &#39;705 patent application. 
         [0026]    When the described cup members  120  are used, the liners  160  may need to be provided slightly smaller than those typically provided within an acetabular shell that does not have a cup member therein in order to provide clearance between the liner and the cup for a taper lock. Alternatively or additionally, smaller femoral heads may be used. 
         [0027]    In some embodiments, it may be desirable for a liner to sit in and be fully supported by a cup member such that the liner is not suspended. In some instances, suspended liners can creep or deform. As shown in  FIG. 3 , the cup member  120  is provided as a full cup rather than just a band with adjustable mounting members so that it can fully support a liner if used. However, in other embodiments, the cup member does not necessarily have to be a full cup, and may not necessarily even have a cup shape. For example, as shown in  FIG. 5 , a cup member  180  is provided as a band cup having mounting members  182 . A liner  164  may be placed within the band cup member  180  such that a portion  168  of the liner  164  is suspended below the band cup. 
         [0028]    In some embodiments, an advantage provided by the cup member is that the mounting or attachment members are provided on the separate cup member and not on the acetabular shell. This allows the acetabular shell to be positioned independently of the cup member, providing a greater range of modularity and adjustment options. Another advantage provided by the cup member may be seen during revision surgeries. Rather than having to remove the acetabular shell during revision surgery, a surgeon may remove the liner from within the acetabular shell, insert a cup member having one or more mounting members into the acetabular shell, and then insert a new liner into the cup member. 
         [0029]    The foregoing is merely illustrative of the principles of the disclosure, and the systems, devices, and methods can be practiced by other than the described embodiments, which are presented for purposes of illustration and not of limitation. It is to be understood that the systems, devices, and methods disclosed herein, while shown for use in acetabular systems, may be applied to medical devices to be used in other surgical procedures including, but not limited to, spine arthroplasty, cranio-maxillofacial surgical procedures, knee arthroplasty, shoulder arthroplasty, as well as foot, ankle, hand, and extremities procedures. 
         [0030]    Variations and modifications will occur to those of skill in the art after reviewing this disclosure. The disclosed features may be implemented, in any combination and subcombinations (including multiple dependent combinations and subcombinations), with one or more other features described herein. The various features described or illustrated above, including any components thereof, may be combined or integrated in other systems. Moreover, certain features may be omitted or not implemented. 
         [0031]    Examples of changes, substitutions, and alterations are ascertainable by one skilled in the art and could be made without departing from the scope of the information disclosed herein. All references cited herein are incorporated by reference in their entirety and made part of this application.