Abstract:
A method and apparatus for coupling soft tissue to a prosthetic is disclosed. Soft tissue attachment pads having porous metal attachment regions and suture accepting holes are selectively positioned onto an implantable prosthetic to provide coupling locations.

Description:
CROSS-REFERENCE TO RELATED APPLICATIONS 
       [0001]    This application is a divisional of U.S. patent application Ser. No. 13/085,538 filed on Apr. 13, 2011, which claims the benefit of U.S. Provisional Application No. 61/323,666, filed on Apr. 13, 2010. The entire disclosure of each of the above applications is incorporated herein by reference in its entirety. 
     
    
     FIELD 
       [0002]    This invention relates generally to a method and apparatus for use in orthopedic surgery and, more particularly, to a method and apparatus for providing a prosthesis having a modular soft tissue coupling mechanism. The soft tissue coupling mechanism is a member configured to be optionally and selectively coupled to the implant and includes a fixation flange and porous metal portion, both of which are configured of being coupled to soft tissues. 
       BACKGROUND 
       [0003]    It is generally known in the art to provide prostheses that replace or reinforce various portions of bone during an orthopedic surgical procedure. However, the current prior art prostheses along with the associated surgical components and instruments utilized during orthopedic surgery may suffer from many disadvantages. 
         [0004]    For example, because the extent of degradation is not always evident until during the surgery, extensive bone resection may be necessary. Additionally, etiologies such as bone tumors or those requiring revision of an implanted joint require significant bone removal which may remove soft tissue fixation sites. In these cases, soft tissue fixation to the prosthesis may or may not be necessary. To provide for soft tissue attachment, some replacement joint components provide an integral flange configured to accept soft tissue attached to a lateral surface of the prosthetic replacement joint head. These fixed fixation flanges, however, may not provide the proper locational adaptivity needed during the orthopedic surgical procedure and leave the surgeon with little flexibility or no options as to soft tissue attachment. 
         [0005]    An example of an orthopedic transplant is a shoulder prosthesis which typically comprises a humeral component and a glenoid component. The humeral component and the glenoid component are designed to be surgically attached to the distal end of the humerus and the scapula, respectively. The humeral component is further designed to cooperate with the scapula component in simulating the articulating motion of an anatomical shoulder joint. 
         [0006]    Motion of a natural shoulder is kinematically complex. During a relatively broad range of flexion and extension, the articular or bearing surfaces of a natural shoulder experience rotation, medial and lateral angulation, translation, rollback and sliding. Shoulder joint prostheses, in combination with ligaments and muscles, attempt to duplicate this natural shoulder motion, as well as absorb and control forces generated during the range of motion. Depending on the degree of damage or deterioration of the shoulder tendons and ligaments, however, it may be necessary for a shoulder joint prosthesis to eliminate one or more of these motions in order to provide adequate stability. 
         [0007]    What is needed then is a prosthesis and associated surgical components for use in orthopedic surgery which does not suffer from the above-mentioned disadvantages. This in turn, will provide a prosthesis which is stable and secure and increases the overall flexibility for a surgeon to fix soft tissues. It is, therefore, an object of the present invention to provide such a prosthesis and associated surgical components for use in orthopedic surgery. 
       SUMMARY 
       [0008]    This section provides a general summary of the disclosure, and is not a comprehensive disclosure of its full scope or all of its features. 
         [0009]    In accordance with the present teachings, an apparatus and method for providing a prosthetic having a modular soft tissue attachment mechanism is disclosed. The apparatus and method employ modular soft tissue attachment mechanisms having porous metal pads for use during the orthopedic surgical procedure. 
         [0010]    In one embodiment, an orthopedic implant has a body that is at least partially implantable within a bone. A mechanism for coupling soft tissue to the body is provided. The mechanism for coupling soft tissue to the body has an attachment member operable to prevent movement of the coupling mechanism with respect to the body. The mechanism defines a suture accepting aperture configured to couple soft tissue to the mechanism and has a porous soft tissue engaging surface. 
         [0011]    A method for implanting a shoulder prosthetic is further disclosed. The method includes selecting an appropriately sized prosthetic component. Next, a determination is made if soft tissue fixation to the implant is necessary. Should it be necessary to couple soft tissue to the implant, a soft tissue fixation having a porous metal component is attached to the implant. The implant is subsequently implanted. Soft tissue is positioned adjacent to the porous metal component and allowed to grow into the porous metal component. 
         [0012]    Use of the present teachings provides an apparatus and method for providing a prosthetic having a modular soft tissue attachment mechanism for use during an orthopedic surgical procedure. As a result, the aforementioned disadvantages associated with the currently available prostheses and associated surgical components have been substantially reduced or eliminated. 
         [0013]    Further areas of applicability will become apparent from the description provided herein. The description and specific examples in this summary are intended for purposes of illustration only and are not intended to limit the scope of the present disclosure. 
     
    
     
       DRAWINGS 
         [0014]    The drawings described herein are for illustrative purposes only of selected embodiments and not all possible implementations, and are not intended to limit the scope of the present disclosure. 
           [0015]      FIGS. 1A and 1B  are an assembled view of the prosthetic component according to the teachings of one embodiment; 
           [0016]      FIG. 2  is a side view of an alternate base humeral component with humeral head according to the present teachings; 
           [0017]      FIG. 3  represents an alternate view of the humeral component shown in  FIG. 2  according to the present teachings; 
           [0018]      FIG. 4  represents a soft tissue fixation member coupled to the humeral component of the present teachings; 
           [0019]      FIGS. 5-7  represent perspective, side and rear views of a prosthetic according to the present teachings; 
           [0020]      FIGS. 8A-8C  represent the top, end and side views of a soft tissue fixation member according to the present teachings; 
           [0021]      FIG. 9  represents a sectional view of the soft tissue coupling member of  FIGS. 8A-8C ; 
           [0022]      FIGS. 10A and 10B  represent soft tissue coupling mechanisms according to the present teachings; 
           [0023]      FIG. 11  represents a perspective view of the soft tissue coupling mechanism without the porous coupling member; 
           [0024]      FIG. 12  represents a side view of the soft tissue coupling member of  FIG. 10B ; 
           [0025]      FIG. 13  represents the coupling of the soft tissue coupling mechanism to a prosthetic stem; 
           [0026]      FIG. 14  represents a subassembly of soft tissue coupling mechanisms coupled to a head fixation member; 
           [0027]      FIG. 15  represents the coupling of soft tissue coupling members to a femoral component; 
           [0028]      FIG. 16  represents an alternate soft tissue coupling member; 
           [0029]      FIG. 17  represents an exploded view of the soft tissue coupling member being fixed to a coupling surface on a prosthetic; 
           [0030]      FIGS. 18A and 18B  represent the coupling of the soft tissue coupling member according to  FIGS. 16  to a femoral prosthetic; 
           [0031]      FIG. 19  represents an implanted view of the soft tissue coupling member according to  FIG. 16  coupled to a humeral prosthetic; 
           [0032]      FIG. 20  represents the use of the soft tissue coupling member on a femoral prosthetic; 
           [0033]      FIG. 21  represent a cross-sectional view of the soft tissue coupling member coupled to the humeral stem of  FIG. 19 ; and 
           [0034]      FIGS. 22A and 22B  represent femoral head coupling members having soft tissue coupling mechanisms according to the present teachings. 
       
    
    
       [0035]    Corresponding reference numerals indicate corresponding parts throughout the several views of the drawings. 
       DETAILED DESCRIPTION 
       [0036]    Example embodiments will now be described more fully with reference to the accompanying drawings.  FIGS. 1A and 1B  represent components used in a shoulder arthroplasty according to the present teachings. As shown, a modular humeral component  31  has a base member  32 , and a head member  33  having an articulating bearing surface. Optionally, the modular humeral component  31  can have a fixation stem  34  (see  FIG. 1A ) or an elbow prosthesis  35  (see  FIG. 1B ). 
         [0037]    The base member  32  is configured to be coupled to the fixation stem  34  and head  33  using coupling tapers (not shown). The fixation stem  34  can be used to attach the modular humeral component  31  to a resected bone of the humerus. 
         [0038]    If a total humeral replacement is being conducted, the modular humeral component  31  shown in  FIG. 1B  can be used. The elbow prosthesis  35  can be coupled to a fixation stem  34  using locking tapers or other suitable coupling mechanism. 
         [0039]    Attached to the modular humeral component  31  is a plurality of modular soft tissue attachment pads  37 . The soft tissue attachment pads  37  have a coupling surface  38  which is configured to be selectively coupled to a coupling surface  39  on the modular humeral component  31 . In this regard, the modular humeral component  31  has a plurality of apertures  40  defined at various locations on the surface of the modular humeral component  31  therein. The apertures  40  are configured to accept coupling fasteners which are configured to couple the soft tissue attachment pads  37  to specific locations on the modular humeral component  31 . 
         [0040]    The soft tissue attachment pads  37  function as soft tissue coupling locations. In this regard, the soft tissue attachment pads  37  define a bore  43  configured to accept a suture engaged with soft tissue such as a tendon, ligament or muscle. In practice, after the modular humeral component  31  is coupled to the patient, soft tissue is coupled to the soft tissue attachment pads  37  by passing the suture through the soft tissue and passing the suture through the bore  43 . The soft tissue can then be positioned so that the soft tissue is in contact with a porous metal surface. The soft tissue then grows into the porous metal surface, aiding in fixation. 
         [0041]      FIGS. 2-4  represent the base member  32  having associated soft tissue attachment pads  37 . As shown in  FIG. 3 , soft tissue attachment pads  37  define a fastener accepting through bore  41 . The through bore  41  is configured to be aligned with a bore  40  defined in the base member  32 . 
         [0042]      FIGS. 5-7  represent perspective, rear and front views of the base member  32 . Defined in the base member  32  are coupling tapers  50  which are used to couple the base portion to the head or the fixation stem. Also defined in the base member  32  is a plurality of threaded fastener accepting bores  41 . These fastener accepting bores  41  can be generally located at soft tissue accepting locations. It is, of course, envisioned that a physician may need to fix soft tissue to non-traditional locations due to damage to the soft tissue. 
         [0043]      FIGS. 8A through 8C  represent top, end and side views of the soft tissue attachment mechanism. The soft tissue attachment pads  37  have a plate  52  made of a biocompatible material such as titanium. Disposed on the plate is a pad of porous metal material  53  such as Regenerex. Defined through the porous metal pad  56  and plate  52  is the fastener accepting aperture. 
         [0044]    As best seen in  FIG. 8C , disposed on proximal and distal ends are a pair of flanges  54  which define suture accepting bores  43 . In use, a suture is passed through soft tissue and then passed through the suture accepting bore  43  of the pair of flanges  54 . The suture accepting bores  43  are shown as being generally parallel to the center of curvature “C” of the coupling surface  38  of the soft tissue attachment pads  37 . As described below, the suture accepting bores can be parallel to, skew or perpendicular to the coupling surface  38 . 
         [0045]      FIG. 9  represents a cross-sectional view of the soft tissue attachment pads  37 . Shown is the plate  52  having the coupling surface  38  configured to mate against an implant or bone. Also shown is the porous metal pad  56  which functions as a site for ingrowth of the soft tissue. 
         [0046]      FIGS. 10A and 10B  represent alternate soft tissue attachment pads  37 . As shown, the plate  52  can have varying axial lengths. Additionally shown is an alternate configuration for the suture accepting bores  43 . The fastener accepting bore  41  can be angularly adjusted in a non-centered manner from one of the terminal end  45  of the soft tissue attachment pad  37 . The suture accepting bores  43  are aligned so that at least a portion of the bore is disposed on a terminal end  45  of the soft tissue attachment pad  37  or plate  52 . This allows the treating physician to couple the soft tissue attachment pad  37  to the prosthetic after the coupling thereto. 
         [0047]      FIG. 11  represents the plate  52  for the soft tissue attachment pad  37 . Shown is a notched surface  47  which is configured to accept the porous metal pad  56 . Optionally, the notched surface  47  has a pair of terminal edges  49  which can define the depth of the porous metal pad  56 . Porous metal pad  56  is a separate member which can be made of porous metal, porous coated metal or some biologic material. The porous metal pad  56  can be attached to plate  52  by cement, glue, weld, sintering, etc. Alternatively, the area defined by notched surface  47  can be filled with porous plasma spray. The metal pad  56  can have a porosity of about 70% and a pore size ranging from about 300-600 microns. This pore size can improve function in vivo. The open pores allow vascularization/angiogenesis and nutrient delivery which can be important for soft tissue in-growth or insertion. Traditional plasma spray is not thought to provide these benefits. 
         [0048]      FIG. 12  represents a side view of the plate  52  shown in  FIG. 11 . Shown in the plate  52  is the defined fastener accepting bore  41 . The bore  41  has a first portion with a generally cylindrical cross-section. Optionally, a fastener bearing surface  48  can be defined in a second portion of the bore  41 . Also shown is a cross-section of the suture accepting bore  43 . The suture accepting bore  43  has a curved surface  55  which is configured to reduce the risk of breakage of the suture. The bores  43  are positioned in a way which located one end of the bore  43  on an exterior curved surface of the soft tissue attachment pad  37 . The other end of the bore can be formed in the terminal ends  45  of the soft tissue attachment pads  37 . 
         [0049]    As shown in  FIGS. 13-15 , the soft tissue attachment pads  37  according to  FIGS. 8A-12  can be coupled to various locations on disparate portions of monolithic or modular prosthetic systems depending upon the need of the treating physician. The soft tissue attachment pads  37  can have varying thicknesses of axial length depending upon the need of the patient. 
         [0050]      FIGS. 16-21  represent an alternate soft tissue attachment pad  37 . The soft tissue attachment pads  37  can have a generally planar yet circular configuration. A central portion  60  of the soft tissue attachment pads  37  can support the porous metal pad  56 . Disposed about the periphery  64  of the soft tissue attachment pads  37  is a rim  66  defining the plurality of suture accepting bore  43 . As shown in  FIG. 17 , the soft tissue attachment pad  37  has a planar coupling surface  38  which can be coupled to a curved intermediate member  68 . The curved intermediate member  68  has a planar bearing or coupling surface  39  which mates with the planar coupling surface  38  on the soft tissue attachment pad  37 . The curved intermediate member  68  has a curved surface configured to couple to a curved surface on the prosthetic. 
         [0051]    As shown in  FIGS. 18A and 18B , the soft tissue attachment pad  37  can be coupled either to a planar or a curved surface. By rotation of the soft tissue attachment pad  37  about the fastener accepting bore  41 , the location of the suture accepting bores  43  can be adjusted. By offsetting the bore  41 , rotation of the soft tissue attachment pad  37  will translate the location of the suture accepting bores  43  with respect to the prosthetic. 
         [0052]      FIGS. 19 and 20  represent implanted prosthetics  70  and  90  according to the present teachings. As shown, both the soft tissue attachment pads according to  FIGS. 1-10A  and  FIGS. 6 and 7  can be used with the same implant.  FIG. 19  represents a humeral prosthetic  70  having a humeral fixation stem  72 , an intermediate portion  74 , a head coupling portion  76 , and head  33 . As is known, the portions of the implant can be coupled together using locking tapers  78 . The use of the soft tissue attachment pads  76  allows for a treating physician to selectively attach soft tissue to various locations on the prosthetic  70 . Optionally, in instances where the soft tissue is not an appropriate length due to degradation, the soft tissue can be coupled to the prosthetic at a location which does not represent the normal location of soft tissue attachment to the bone. Multiple sutures  86  can be used to hold soft tissue at a location adjacent to the porous metal portion of the soft tissue attachment pad  37 . Optionally, the loops of sutures  88  can be arranged to couple the soft tissue  84  to the prosthetic  70 . 
         [0053]      FIG. 20  represents a femoral prosthetic  90  with associated soft tissue coupling pads according to the present teachings. Shown is the coupling of pads having both planar and curved coupling surfaces  38 . After implantation of the prosthetic  90  into the resected femur  94 , the soft tissue associated with the patella  96  can be coupled to the prosthetic  90 . Depending on the amount of damage, the soft tissue  98  can be placed in direct contact with the soft tissue attachment pad  37  or can be disassociated and coupled with suture loops  88  or artificial graft material. 
         [0054]    As briefly described above and shown in  FIG. 21 , the soft tissue attachment pads  37  can be rotatably positioned about an axis  100  generally disposed along the axis of the coupling bore  41 . After implantation of the prosthetic  70 , a treating physician can couple the soft tissue attachment pad  37  to the prosthetic  70  using a coupling mechanism such as a threaded fastener. It is envisioned the soft tissue attachment pads  37  can also be attached using other mechanism such as a locking taper, deformable flanges or translatable members. 
         [0055]      FIGS. 22A and 22B  represent alternate components  102  and  104  of a prosthetic. These intermediate femoral members are shown to illustrate some of the various surfaces which can be utilized to couple the soft tissue attachment pads  37  to the prosthetic. In this regard, it is envisioned the soft tissue attachment pads  37  can be configured to be coupled to convex rail features  110  (see  FIG. 1B ), planar features (see  FIG. 21 ) or concave channel features  112  (see  FIG. 22A ). The variety of coupling surfaces  38 ,  39  and locations is intended to give the treating physician maximum flexibility in the operating theater. 
         [0056]    While the soft tissue attachment pad  37  is shown throughout the application as a cylindrical surface disposed on an implant positioned within an intermedullary canal, it should be noted that the soft tissue fixation members can further take the form of a plate coupled to either a cylindrical or flat baseplate member. In this regard, the soft tissue fixation mechanisms can take the form of a plate member capable of accepting a suture or suture anchor. Additionally, the prosthetic need not be associated with a joint, e.g. an intercalary member. 
         [0057]    Additionally, the soft tissue fixation mechanisms can be adjustably positioned on the prosthetic in one or more fixation areas. In this regard, multiple soft tissue fixation mechanisms can be located on multiple locations of a single implant. While the soft tissue fixation mechanisms is shown on a modular prosthetic, those skilled in the art will recognize that only the soft tissue fixation mechanisms need be modular and that the soft tissue fixation mechanisms can be fixed to any single piece prosthetic device. It is envisioned that a kit can be formed utilizing various sized prosthetic as well as various types and sizes of soft tissue coupling mechanisms. 
         [0058]    Example embodiments are provided so that this disclosure will be thorough, and will fully convey the scope to those who are skilled in the art. Numerous specific details are set forth such as examples of specific components, devices, and methods, to provide a thorough understanding of embodiments of the present disclosure. It will be apparent to those skilled in the art that specific details need not be employed, that example embodiments may be embodied in many different forms and that neither should be construed to limit the scope of the disclosure. In some example embodiments, well-known processes, well-known device structures, and well-known technologies are not described in detail. 
         [0059]    The terminology used herein is for the purpose of describing particular example embodiments only and is not intended to be limiting. As used herein, the singular forms “a,” “an,” and “the” may be intended to include the plural forms as well, unless the context clearly indicates otherwise. The terms “comprises,” “comprising,” “including,” and “having,” are inclusive and therefore specify the presence of stated features, integers, steps, operations, elements, and/or components, but do not preclude the presence or addition of one or more other features, integers, steps, operations, elements, components, and/or groups thereof. The method steps, processes, and operations described herein are not to be construed as necessarily requiring their performance in the particular order discussed or illustrated, unless specifically identified as an order of performance. It is also to be understood that additional or alternative steps may be employed. 
         [0060]    When an element or layer is referred to as being “on,” “engaged to,” “connected to,” or “coupled to” another element or layer, it may be directly on, engaged, connected or coupled to the other element or layer, or intervening elements or layers may be present. In contrast, when an element is referred to as being “directly on,” “directly engaged to,” “directly connected to,” or “directly coupled to” another element or layer, there may be no intervening elements or layers present. Other words used to describe the relationship between elements should be interpreted in a like fashion (e.g., “between” versus “directly between,” “adjacent” versus “directly adjacent,” etc.). As used herein, the term “and/or” includes any and all combinations of one or more of the associated listed items. 
         [0061]    Although the terms first, second, third, etc. may be used herein to describe various elements, components, regions, layers and/or sections, these elements, components, regions, layers and/or sections should not be limited by these terms. These terms may be only used to distinguish one element, component, region, layer or section from another region, layer or section. Terms such as “first,” “second,” and other numerical terms when used herein do not imply a sequence or order unless clearly indicated by the context. Thus, a first element, component, region, layer or section discussed below could be termed a second element, component, region, layer or section without departing from the teachings of the example embodiments. 
         [0062]    Spatially relative terms, such as “inner,” “outer,” “beneath,” “below,” “lower,” “above,” “upper,” and the like, may be used herein for ease of description to describe one element or feature&#39;s relationship to another element(s) or feature(s) as illustrated in the figures. Spatially relative terms may be intended to encompass different orientations of the device in use or operation in addition to the orientation depicted in the figures. For example, if the device in the figures is turned over, elements described as “below” or “beneath” other elements or features would then be oriented “above” the other elements or features. Thus, the example term “below” can encompass both an orientation of above and below. The device may be otherwise oriented (rotated 90 degrees or at other orientations) and the spatially relative descriptors used herein interpreted accordingly. 
         [0063]    The description of the invention is merely exemplary embodiments in the present invention. One skilled in the art would readily recognize from such discussion and from accompanying drawings and claims that various changes, modifications, variations may be made therein without the spirit and scope of the invention. For example, while the soft tissue fixation mechanisms are shown being coupled to a humeral, femoral, or tibial implant, the soft tissue fixation mechanism can equally be applied to other joint implants such as, but not limited to, knees and elbows, and for whole bone replacement. 
         [0064]    The foregoing description of the embodiments has been provided for purposes of illustration and description. It is not intended to be exhaustive or to limit the invention. Individual elements or features of a particular embodiment are generally not limited to that particular embodiment, but, where applicable, are interchangeable and can be used in a selected embodiment, even if not specifically shown or described. The same may also be varied in many ways. Such variations are not to be regarded as a departure from the invention, and all such modifications are intended to be included within the scope of the invention.