Abstract:
High strength suture kits and methods for shoulder fracture repair using a shoulder prosthesis. An exemplary kit contains color-coded lengths of high-strength suture and a copy of a complementary surgical plan represented and detailed by a written brochure, and an audio and/or video recording, for example. The complementary surgical plan involves pre-installing the color-coded suture, which is used for horizontal cerclage, temporary sutures, and vertical tension bands. The fractured humeral head is replaced with the prosthetic humerus, which is secured by the shoulder tuberosities using the pre-installed suture.

Description:
RELATED APPLICATIONS  
       [0001]     This application is related to and claims the benefit of U.S. Provisional Application Ser. No. 60/509,950, filed Oct. 10, 2003. 
     
    
     BACKGROUND OF THE INVENTION  
       [0002]     The present invention relates to shoulder fracture repair, and more particularly to prosthetic replacement of a fractured humerus using a high strength suture kit.  
         [0003]     Procedures for shoulder reconstructions using a shoulder prosthesis are known. Techniques are disclosed in Boileau et al., Tuberosity Osteosynthesis and Hemiarthroplasty for Four-Part Fractures of the Proximal Humerus. It would be advantageous to improve upon the Boileau et al. technique, and to provide a kit including color-coded, high strength sutures for carrying out the reconstruction.  
       BRIEF SUMMARY OF THE INVENTION  
       [0004]     The present invention provides apparatus and methods for shoulder reconstruction using a shoulder prosthesis. The apparatus includes a kit of color-coded lengths of high-strength suture and a complementary surgical plan for carrying out the reconstruction. The method includes pre-installing color-coded suture to be used for horizontal cerclage and vertical tension, replacing the fractured humeral head with a prosthetic humerus, and securing the pre-installed suture to fix the shoulder tuberosities around the prosthesis.  
     
    
     BRIEF DESCRIPTION OF THE DRAWINGS  
       [0005]      FIG. 1  illustrates the step of pre-installing cerclage sutures in connection with a shoulder arthroplasty in accordance with the present invention;  
         [0006]      FIG. 2  illustrates the step of installing temporary sutures and tensions sutures in connection with a shoulder arthroplasty in accordance with the present invention;  
         [0007]      FIG. 3  illustrates the step of removing a fractured humeral head in connection with a shoulder arthroplasty in accordance with the present invention;  
         [0008]      FIG. 4  illustrates the step of installing a prosthetic humeral head in connection with a shoulder arthroplasty in accordance with the present invention;  
         [0009]      FIG. 5  illustrates the step of tensioning cerclage suture in connection with a shoulder arthroplasty in accordance with the present invention;  
         [0010]      FIG. 6  illustrates the step of securing cerclage suture in connection with a shoulder arthroplasty in accordance with the present invention;  
         [0011]      FIG. 7  illustrates the step of threading cerclage around the lesser tuberosity in connection with a shoulder arthroplasty in accordance with the present invention;  
         [0012]      FIG. 8  illustrates the step of packing the prosthetic humeral neck with cancellous bone in connection with a shoulder arthroplasty in accordance with the present invention;  
         [0013]      FIG. 9  illustrates the step of securing additional cerclage suture in connection with a shoulder arthroplasty in accordance with the present invention;  
         [0014]      FIG. 10  illustrates the step of interval closure in connection with a shoulder arthroplasty in accordance with the present invention;  
         [0015]      FIG. 11  illustrates the step of securing vertical tension sutures in connection with a shoulder arthroplasty in accordance with the present invention; and  
         [0016]      FIG. 12  illustrates a kit including high-strength suture and a complementary surgical plan for performing the surgical method according to the present invention. 
     
    
     DETAILED DESCRIPTION OF THE INVENTION  
       [0017]     Referring initially to  FIG. 1 , with the arm in abduction/internal rotation, three pairs  2 : 4 ,  6 : 8 ,  10 : 12  of high strength sutures are inserted around the greater tuberosity  14  through the bone-infraspinatus tendon junction  16  using a needle  18 . Pairs of sutures  2 : 4 ,  6 : 8 ,  10 : 12  are coded to distinguish the sutures in each pair. In an exemplary embodiment, sutures  2 ,  6 ,  10  are white, and sutures  4 ,  8 ,  12  are blue. The preferred high strength suture is FiberWire suture, sold by Arthrex, Inc. of Naples, Fla., and described in U.S. Patent U.S. Pat. No. 6,716,234, issued Apr. 6, 2004 to Grafton et al. and incorporated herein by reference. The exemplary suture features high strength surgical suture materials and exhibits excellent tie down characteristics. The suture features a braided cover made of a blend of ultrahigh molecular weight long chain polyethylene and polyester. The polyethylene provides strength. The polyester provides improved tie down properties.  
         [0018]     An exemplary suture construct includes a multifilament cover formed of a plurality of fibers of ultrahigh molecular weight polyethylene braided with fibers of polyester. The cover surrounds a core of twisted fibers of ultrahigh molecular weight polyethylene. Preferably, the ultrahigh molecular weight polyethylene includes about 60% of the cover fibers, with polyester making up about 40% of the cover filaments. The core comprises about 30% of the suture, the cover making up about 70%. As an enhancement, the suture is provided with a coating on the cover, as is known in the prior art. Ultrahigh molecular weight polyethylene fibers suitable for use in the suture are marketed under the Dyneema trademark by Toyo Boseki Kabushiki Kaisha.  
         [0019]     The suture advantageously has the strength of Ethibond #5 suture, yet has the diameter, feel and tie ability of #2 suture. As a result, the suture is ideal for most orthopedic procedures such as rotator cuff repair, Achilles tendon repair, patellar tendon repair, ACL/PCL reconstruction, hip and shoulder reconstruction procedures, and replacement for suture in anchors. FiberWire suture includes a multifilament cover featuring braided strands of ultrahigh molecular weight long chain polyethylene and polyester, and surrounding a core of twisted fibers of ultrahigh molecular weight polyethylene. Suture constructs can be differentiated by various colors and patterns of fibers and strands incorporated in the construct.  
         [0020]     Referring to  FIG. 2 , three temporary sutures  20 ,  22 ,  24  are inserted through the lesser tuberosity  26 , again at the bone-tendon junction. Temporary sutures  20 ,  22 ,  24  are striped, for example, to distinguish them from the blue and white pairs of suture inserted around the greater tuberosity. Drill holes  28 ,  30 , are formed in the proximal shaft of the humerus  32  to a diameter of 2.5 mm. Another pair of bi-colored high-strength sutures  34 ,  36  is inserted through holes  28 ,  30  using needle  18 . Sutures  34 ,  36  will be used as vertical tension sutures.  
         [0021]     Referring to  FIG. 3 , the greater and lesser tuberosities  14 ,  26  are gently retracted and the humeral head fragment  38  is removed using forceps  40  after resection of any capsular attachments. The glenoid and other structures of the joint are inspected, and indicated repairs are undertaken to avoid recurrent postoperative instability.  
         [0022]     Referring to  FIG. 4 , an appropriately sized prosthetic humeral head  42  is chosen and reduced into the joint after appropriate measurement of the humeral head  38  and preparation of the medullary canal  44 . Positioning of the prosthesis can be achieved by the use of appropriate instrumentation (not shown). The prosthesis preferably is cemented in place, and cancellous bone graft  46  harvested from the humeral head  38  is packed into the medullary space around the prosthetic neck  48  to facilitate bony union.  
         [0023]     Referring to  FIGS. 5 and 6 , reattachment of greater tuberosity  14  begins by tying white sutures  2 ,  6 ,  10  horizontally around prosthetic neck  48 . A suture tensioning device  50 , shown in  FIG. 5 , is utilized to apply the appropriate tension to each length of cerclage suture.  
         [0024]     Referring to  FIG. 7 , reattachment of the lesser tuberosity begins by drawing ends of each of the blue sutures  4 ,  8 ,  12  using temporary striped sutures  20 ,  22 ,  24  through holes formed in tissue of the lesser tuberosity  26 . The directional arrows in  FIG. 7  illustrate how blue suture  12  is attached to temporary striped suture  24  to be drawn through the subscapularis tendon from inside to outside.  
         [0025]     Referring to  FIG. 8 , prior to pulling the lesser tuberosity into position under the prosthetic head, cancerous bone  52  harvested from the humeral head  38  is packed around the prosthetic neck  48 .  
         [0026]     Referring to  FIG. 9 , lesser tuberosity  26  is pulled into place using horizontal cerclage sutures  4 ,  8 ,  12 .  
         [0027]     Referring to  FIG. 10 , soft tissue and rotator cuff intervals are closed using lengths  60  of high-strength suture (#2 FiberWire) with needles.  
         [0028]     Referring to  FIG. 11 , sutures  34 ,  36  are used as vertical tension bands. One suture is passed anteriorly through the subscapularis and the supraspinatus tendons. The other suture is passed posteriorly through the infraspinatus and supraspinatus tendons. The vertical tension bands provide important fixation of the tuberosity fragments to the humeral shaft.  
         [0029]     Referring to  FIG. 12 , a high-strength suture kit  70  is illustrated. Suture kit  70  includes a tray  72  containing individual packages  74  of color-coded high-strength sutures pre-cut for use as cerclage, temporary suture, and vertical tension bands, needles, and combinations thereof sufficient to carry out the shoulder reconstruction discussed above. Also included in kit  70  is a surgical plan outlining the steps of performing the reconstruction. In an exemplary embodiment, the surgical plan is a printed brochure featuring graphical representations and written instructions such as those depicted in  FIGS. 1-11  and described above. Alternatively, or in addition thereto, the surgical plan can be provided as an audio and/or video recording, for example. The surgical plan recording can be provided for playback on a removable disc, such as a CD or DVD, for example, or the kit can provide means and/or instructions for accessing the recording over a network, such as the Internet.  
         [0030]     Although the present invention has been described in connection with preferred embodiments, many modifications and variations will become apparent to those skilled in the art.