Patent Document

PRIORITY 
       [0001]    Priority is claimed to U.S. Provisional Patent Application Ser. No. 61/817,449, filed in the U.S. Patent &amp; Trademark Office on Apr. 30, 2013. 
     
    
     FIELD OF THE INVENTION 
       [0002]    This disclosure concerns the method and apparatus for maintaining a joint alignment and spacing of a knee of the human body during recovery from infected knee prosthesis replacement. 
       BACKGROUND OF THE DISCLOSURE 
       [0003]    Approximately 800,000 primary total knee replacements are performed in the USA annually. This number is expected to be 1.5 million knee replacements by the year 2020 and 3.5 million knee replacements per year by the year 2030. 
         [0004]    Recent publications have indicated a knee sepsis rate of three percent in primary total knee replacements (“TKRS”) and 12 to 16 percent in revision of TKRS. This indicates that over 20,000 surgical procedures for septic prosthetic knees are performed annually. 
         [0005]    The procedure for replacing the sepsic knee prosthesis usually is a two stage procedure. Stage one includes the removal of the implanted prosthesis from the infected knee joint, clean the area, inserting a temporary implant in the infected knee during the infection recovery, and after the infection has been eradicated, removing the temporary implant and inserting a revision replacement knee implant. It is estimated that by the year 2020 there will be about 45,000 revisions for knee sepsis of knee prosthesis performed per year. 
         [0006]    Generally, there are two types of stage one implants, articulating spacers and static spacers. The articulating spacers allow the knee to move while the static spacers maintain the leg in its extended position. Recent studies have suggested that articulating spacers are not superior to static spacers. It has been reported that articulating spacers increase bone loss due to range of motion and weight bearing. A known complication of static spacers is subluxation. Approximately twelve percent of patients fail current treatment for prosthetic knee sepsis, with above-the-knee amputation sometimes being required. 
       SUMMARY OF THE INVENTION 
       [0007]    The transarticular intramedullary rod system disclosed herein is intended to supply the surgeon with a very stable static spacer system for the human leg to maintain the joint space of the knee after the initial knee prosthesis has become infected and removed, and before the replacement prosthesis is inserted. 
         [0008]    The proposed method and apparatus increases the delivery of antibiotic to the infected bone and essentially eliminates subluxation risk during a two staged procedure. It also allows the surgeon to customize antibiotic type and concentration in the spacer system. It redistributes the compressive forces to the articular surfaces to the more proximal and distal cortical bone. It is an excellent treatment option for infected total knee replacements “TKRS” with extensor mechanism injuries, some of which are ultimately treated with above the knee amputation. Also, it&#39;s a much more comfortable scenario for the patient during the two months that is typically needed to eradicate the infection by reducing recurrent fatigue associated standard spacer utilization. 
     
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         [0009]      FIGS. 1-3  are cross sectional views of the anti-septic transarticular intramedullary rod system extending from the femur into the tibia, showing in  FIG. 1  the anterior view, in 
           [0010]      FIG. 2  the medial view and in 
           [0011]      FIG. 3  the posterior view. 
           [0012]      FIG. 4  is a side view of the rods of the implant with its femur rod aligned with the tibia rod and the connector collars attached to each other. 
           [0013]      FIG. 5  is a close up side cross sectional view of the collar connectors as shown in the circle of  FIG. 4 , showing how the collars of the collar connectors become juxtaposed when connected together. 
           [0014]      FIG. 6  is a side view of the implant, similar to  FIG. 4 , but showing the PMMA mantle applied to the rods. 
           [0015]      FIG. 7  is a detail view of the collar connectors as shown in the circle of  FIG. 6 . 
       
    
    
     DETAILED DESCRIPTION 
       [0016]    Referring now in more detail to the drawings in which like numerals indicate like parts throughout the several views,  FIGS. 1-3  disclose a temporary knee implant  10  as it would be inserted at the location of the knee joint, between the femur  12  and the tibia  13 . The three drawings show the anterior, medial and posterior views, respectively, of the position of the human body. The temporary knee implant is inserted in the medullary cavities  15  and  16  of the femur and tibia, respectively. 
         [0017]    As best shown in  FIG. 4 , the temporary knee implant  10  includes an elongated femur rod  18  and a similar elongated tibia rod  19 . The femur rod includes a femur stem  20  and the tibia rod includes its tibia stem  21  and both include connector collars  22  and  23 , respectively. The femur connector collar  22  is mounted to the distal end of the femur stem  20 , and the tibia connector collar  23  is connected to the proximal end of the tibia stem. The collars  22  and  23  are disk-shaped, but may be of other shapes that provide similar functions. 
         [0018]    As illustrated in  FIG. 5 , the femur connector collar  22  and the tibia connector collar  23  include complementary connectors formed by interfitting shapes for aligning the femur stem  20  and the tibia stem  21 . The interfitting shapes may include a tapered femur locking pin  24  that protrudes beyond the femur connector collar  23 , and a tibia socket  25  formed in the tibia connector collar  23  that is tapered and sized and shaped to receive the femur locking pin  24 . 
         [0019]    When the femur rod and tibia rod are to be connected together, the femur locking pin  24  is aligned with and moved into tibia socket  25 , as shown in  FIG. 5 . The dimensions and shapes of the femur locking pin and the tibia socket are such that the tibia connector collar  23  is likely to become closely spaced from the femur connector collar  22 . 
         [0020]    The femur and tibia connector collars  22  and  23  provide opposed bearing surfaces  31  and  32  for use by the surgeon when the femur and tibia rods are to be connected, as illustrated in  FIG. 5 . 
         [0021]    The femur and tibia rods  18  and  19  may be coated with an antibiotic of choice by the surgeon, as indicated at  29  and  30  of  FIGS. 6 and 7 . The antibiotic coatings  29  and  30  are applied to the femur and tibia stems  20  and  21 , preferably with the coating being uniformly applied along the full length of the femur and tibia stems. The antibiotic coatings  29  and  30  may be applied to the femur and tibia rods before the rods are connected together, as illustrated in  FIG. 6 . 
         [0022]    It is anticipated that the surgeon will select the femur and tibia rods of proper dimensions to fit the medullary cavities of the femur and tibia, even with the possibility that one medullary cavity might be of greater or lesser breadth than the other. Further, the femur and tibia rods are of smaller breadth than the anticipated breadth of the medullary cavities of the femur and tibia so that when an antibiotic coating  29  is applied, the antibiotic coating tends to fill the space within the medullary cavities not occupied by the stems  20  and  21  of the femur and tibia. This permits the antibiotic coating to substantially fill and contact the facing surfaces of the medullary cavities. The femur and tibia rods may have a treated surface that is adherent to polymethyl methacrylate (“PMMA”) and other medications that tend to cling to the femur and tibia rods  18  and  19 . 
         [0023]    As shown in  FIG. 4 , the exterior surface of the femur and tibia stems  20  and  21  are formed with irregular surfaces for the purpose of helping to retain the antibiotic coating  29  of  FIG. 6 . The irregular surfaces may be in the form of surface grooves  30  and  31  for the femur and tibia rods. This tends to stabilize the antibiotic/PMMA coating on the rods. 
         [0024]    When the surgeon inserts the femur and tibia rods  18  and  19  in the medullary cavities of the femur and tibia, the rods are inserted separately, not when they are joined together in the medullary cavities. Once properly installed by moving the femur and tibia rods telescopically into the medullary cavities of the femur and tibia, the femur and tibia may be moved in alignment, causing the femur and tibia rods  18  and  19  to also become aligned, and the surgeon then can align the femur locking pin  24  with the tibia socket  25 , so that the surgeon can grasp the femur and tibia connector collars  22  and  23  with an instrument that urges the connector collars toward one another with the femur locking pin  24  entering the tibia socket  25  with a friction fit. This may also be performed manually. It will be noted that the femur stem  25  is tapered, with the tibia socket having a complementary taper so that when the two are telescopically joined, a friction fit is formed between the femur locking pin  24  and the tibia socket  25 . This is shown in the circled area of  FIG. 6  and in the detailed area of  FIG. 7 . 
         [0025]    Once the femur rod is joined with the tibia rod  19  as shown in  FIGS. 6 and 7 , the surgeon has the option to fill the space between the femur and tibia and around the connector collars  22  and  23  with antibiotic coating so that substantially the entire length of the temporary knee implant is coated with antibiotic coating. 
         [0026]    The pin and socket connection  24 ,  25  maintains the femur rod and tibia rods in alignment with one another. This tends to freeze the femur and tibia of the leg of the patient in a fixed, extended position, tending to eliminate the bending of the leg so that a static connection is made. 
         [0027]    When the sepsis of the knee joint has been eradicated, usually several weeks after the static connection has been made between the femur and tibia of the patient, the surgeon can use an appropriate tool to enter in the space  27  between the connector collars  22  and  23 , and wedge or “pry” the femur and tibia connector collars apart. The femur lock pin  24  tends to withdraw axially from the tibia socket  25 . When the surgeon bends the femur with respect to the tibia, the disconnected femur rod and tibia rod are then free to be withdrawn axially from their respective medullary cavities  15  and  16 . 
         [0028]    The type of antibiotic to be used by the surgeon can be selected to meet the needs of the patient. The antibiotic can be applied to the femur and tibia rods at the site of the surgery, or can be applied by the manufacturer/supplier of the femur and tibia rods, as desired by the surgeon. 
         [0029]    While the surface of the femur and tibia rods is indicated as being formed by a series of indentations  30  and  31  at the exterior surfaces of the rods, other types of surface treatment may be used, such as but not limited to burling. 
         [0030]    The procedure includes: first, the infected prosthesis is removed by the surgeon and the knee is thoroughly washed and debrided using standard technique. The femur and tibia are then reamed and further lavaged. The appropriate diameter/length rods are then coated with the PMMA/abx mixture or the prefabricated coated rods are brought into the field. 
         [0031]    Once the coating has hardened, the rods are inserted separately into the femur and tibia with the knee flexed, and then the leg is extended until the tibia rod  19  is aligned with the femur rod  20  and the rods are locked centrally in alignment with each other. This will leave a space between the femur and the tibia that may be filled with a conventional PMMA/abx spacer that may be created by the surgeon or staff in the OR. 
         [0032]    Some of the benefits of the procedure and apparatus are the patient cannot flex the knee, the rods are easily implanted and removed, and the customized antibiotics are directly applied to the infected area. 
         [0033]    While this disclosure concerns a knee implant and procedure, this invention also may be applied to other joints of the human body. 
         [0034]    Although a preferred embodiment of the invention has been disclosed in detail herein, it will be obvious to those skilled in the art that variations and modifications of the disclosed embodiment may be made without departing from the spirit and scope of the invention as set forth in the following claims.

Technology Category: a