Patent Publication Number: US-2023157704-A1

Title: Tibial cutting guide assemblies and associated instrumentation for performing surgical methods

Description:
CROSS-REFERENCE TO RELATED APPLICATION 
     This is a divisional of U.S. patent application Ser. No. 17/116,489, filed on Dec. 9, 2020, the entire disclosure of which is incorporated herein by reference. 
    
    
     BACKGROUND 
     This disclosure relates to surgical devices, and more particularly to orthopedic surgical devices for performing arthroplasties. 
     Arthroplasty is an orthopedic surgical procedure performed to repair or replace diseased joints. For example, total knee arthroplasty (TKA) may be performed to treat patients with diseased knee joints. Specific tools and instruments are required for preparing knee bones for receiving arthroplasty implants. 
     SUMMARY 
     A tibial cutting guide assembly according to an exemplary aspect of the present disclosure includes, among other things, a tibial cutting block including a biasing clip, and a slope setting pin biased toward a surface of the tibial cutting block by the biasing clip. 
     In a further non-limiting embodiment of the foregoing tibial cutting guide assembly, the slope setting pin is adjustably received within a pin receiving slot of the tibial cutting block. 
     In a further non-limiting embodiment of either of the foregoing tibial cutting guide assemblies, the surface is an upper wall of a block body of the tibial cutting block that delineates a portion of the pin receiving slot. 
     In a further non-limiting embodiment of any of the foregoing tibial cutting guide assemblies, a block body of the tibial cutting block includes a unitary, monoblock design and is made of a polymeric material. 
     In a further non-limiting embodiment of any of the foregoing tibial cutting guide assemblies, the tibial cutting block includes a first cutting slot and a second cutting slot that is separated from the first cutting slot by an interior wall of the tibial cutting block. 
     In a further non-limiting embodiment of any of the foregoing tibial cutting guide assemblies, a first fixation pin hole and a second fixation pin hole extend through the tibial cutting block and open into the first cutting slot. 
     In a further non-limiting embodiment of any of the foregoing tibial cutting guide assemblies, a third fixation pin hole extends through the tibial cutting block and opens into the second cutting slot. 
     In a further non-limiting embodiment of any of the foregoing tibial cutting guide assemblies, the biasing clip includes a first end portion integrally formed with an inner wall of a front side of the tibial cutting block, a second end portion arranged adjacent to an inner wall of a tibial attachment side of the tibial cutting block, and an arced curvature between the first end portion and the second end portion. 
     In a further non-limiting embodiment of any of the foregoing tibial cutting guide assemblies, the biasing clip establishes a floor of a pin receiving slot of the tibial cutting block, and further wherein the slope setting pin is movably received within the pin receiving slot. 
     In a further non-limiting embodiment of any of the foregoing tibial cutting guide assemblies, the slope setting pin includes an elongated shaft including a distal section that includes a hook-shaped tip and a pair of flat surfaces. 
     In a further non-limiting embodiment of any of the foregoing tibial cutting guide assemblies, the slope setting pin includes an elongated shaft including a proximal section, a distal section, and a mid-section. The proximal section includes a first diameter that is smaller than a second diameter of the mid-section. 
     An arthroplasty instrument set according to another exemplary aspect of the present disclosure includes, among other things, a tibial cutting block assembly, a varus-valgus alignment device, and at least two fixation pins. 
     A method of preparing a bone for receiving an arthroplasty implant includes, among other things, positioning a slope setting pin of a tibial cutting guide assembly within a joint space between a femur and a tibia, securing a tibial cutting block of the tibial cutting guide assembly to the tibia with a first fixation pin, bending a portion of the slope setting pin away from the tibial cutting block, inserting a second fixation pin through the tibial cutting block, and making a first cut in the tibia through a first cutting slot of the tibial cutting block. 
     In a further non-limiting embodiment of the foregoing method, positioning the slope setting pin includes positioning a hook-shaped tip of the slope setting pin against a posterior surface of the tibia. 
     In a further non-limiting embodiment of either of the foregoing methods, prior to bending the portion of the slop setting pin, the method includes inserting a third fixation pin through the tibial cutting block. 
     In a further non-limiting embodiment of any of the foregoing methods, bending the portion of the slope setting pin includes bending a proximal section of an elongated shaft of the slope setting pin, thereby altering a position of a handle of the slope setting pin relative to the tibial cutting block. 
     In a further non-limiting embodiment of any of the foregoing methods, prior to bending the portion of the slop setting pin, the method includes inserting a drop rod of a varus-valgus alignment device through the tibial cutting block and adjusting a varus-valgus alignment of the tibial cutting block relative to the tibia via the drop rod. 
     In a further non-limiting embodiment of any of the foregoing methods, the method includes making a second cut in the tibia through a second cutting slot of the tibial cutting block. 
     In a further non-limiting embodiment of any of the foregoing methods, the slope setting pin establishes a patient specific tibial slope when positioned in the joint space. 
     In a further non-limiting embodiment of any of the foregoing methods, the slope setting pin is biased against a surface of the tibial cutting block by a biasing clip of the tibial cutting block. 
     The embodiments, examples, and alternatives of the preceding paragraphs, the claims, or the following description and drawings, including any of their various aspects or respective individual features, may be taken independently or in any combination. Features described in connection with one embodiment are applicable to all embodiments, unless such features are incompatible. 
     The various features and advantages of this disclosure will become apparent to those skilled in the art from the following detailed description. The drawings that accompany the detailed description can be briefly described as follows. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         FIG.  1    illustrates an exemplary tibial cutting guide assembly of an arthroplasty instrument set. 
         FIG.  2    is a front view of a tibial cutting block of the tibial cutting guide assembly of  FIG.  1   . 
         FIG.  3    is a rear view of the tibial cutting block of  FIG.  2   . 
         FIG.  4    is an end view of the tibial cutting block of  FIG.  2   . 
         FIG.  5    is a cross-sectional view through section  5 - 5  of  FIG.  2   . 
         FIG.  6    is a cross-sectional view through section  6 - 6  of  FIG.  2   . 
         FIG.  7    is a perspective view of a slope setting pin of the tibial cutting guide assembly of  FIG.  1   . 
         FIG.  8    is a front view of the slope setting pin of  FIG.  7   . 
         FIGS.  9 ,  10 ,  11 ,  12 ,  13 ,  14 ,  15 ,  16 ,  17 ,  18 , and  19    schematically illustrate an exemplary method for preparing a bone for receiving an arthroplasty implant. 
     
    
    
     DETAILED DESCRIPTION 
     This disclosure is directed to tibial cutting guide assemblies for preparing a tibia for receiving an arthroplasty implant. Exemplary tibial cutting guide assemblies may include a tibial cutting block for making precise cuts in the tibia, and a slope setting pin for establishing a patient specific tibial slope. The tibial cutting guide assemblies allow for a level resection while providing surgical control over internal/external rotation and varus/valgus alignment. These and other features of this disclosure are discussed in greater detail in the following paragraphs of this detailed description. 
       FIG.  1    illustrates a tibial cutting guide assembly  10  that may be used to prepare a patient for the implantation of an arthroplasty implant, such as during an arthroplasty procedure. In an embodiment, the tibial cutting guide assembly  10  is part of an arthroplasty instrument set that may be used to prepare a patient&#39;s tibia and femur, such as by sizing, marking, and making numerous cuts in the tibia and the femur, for preparing the knee joint for the implantation of one or more knee arthroplasty implants. However, the illustrated instruments are not limited to uses associated with the tibia and femur and could have additional applications for preparing for the implantation of any total joint implant. 
     The tibial cutting guide assembly  10  may include a tibial cutting block  12  and a slope setting pin  14 . As further discussed below, the tibial cutting block  12  may be used for making precise cuts in a patient&#39;s tibia, and the slope setting pin  14  may be movably received within a pin receiving slot  16  of the tibial cutting block  12  for establishing a patient specific tibial slope. The tibial cutting guide assembly  10  may further provide for a level resection of the tibia while facilitating surgical control over internal/external rotation and varus/valgus alignment. 
     The tibial cutting block  12  of the tibial cutting guide assembly  10  of  FIG.  1    is further illustrated with reference to  FIGS.  2 - 6   . The tibial cutting block  12  may include a block body  18  having a unitary, monoblock design that includes a tibial attachment side  20 , a front side  22  opposed to the tibial attachment side  20 , a right side  24 , and a left side  26 . In this embodiment, the right side  24  is oriented to the cruciate ligament while the left side  26  is oriented either medially or laterally. Therefore, the tibial cutting block  12  may be used medially at the left tibia or laterally at the right tibia. A tibial cutting block for use laterally at the left tibia or medially at the right tibia would be oriented as the mirror image of the tibial cutting block  12  shown in  FIGS.  2 - 6   . 
     The tibial attachment side  20  of the block body  18  may include a slightly arced curvature that mimics the curvature of the anterior surface of the proximal tibia. The front side  22  of the block body  18  may also be slightly curved to facilitate handling of the tibial cutting block  12 . 
     The pin receiving slot  16 , a first cutting slot  28 , a second cutting slot  30 , a first fixation pin hole  32 , a second fixation pin hole  34 , and a third fixation pin hole  36  may be formed through the block body  18  and may extend in an anterior-posterior direction for penetrating through both the tibial attachment side  20  and the front side  22 . The pin receiving slot  16  has a length in the left-right direction (relative to a patient) and is configured to receive the slope setting pin  14 . In an embodiment, the pin receiving slot  16  is located superior to, or vertically above, the first cutting slot  28 . 
     The first cutting slot  28  has a length in the left-right direction and is configured as a capture for guiding a saw blade or other cutting tool through the block body  18  for making horizontal cuts in a tibia. The second cutting slot  30  has a length in the superior-inferior direction and is configured as another capture for guiding a saw blade or other cutting tool through the block body  18  for making vertical cuts in the tibia. In an embodiment, the second cutting slot  30  is located axially between the first cutting slot  28  and the right side  24  of the block body  18 . An interior wall  25  of the block body  18  separates the second cutting slot  30  from the first cutting slot  28  such that these slots do not intersect one another. 
     The first fixation pin hole  32 , the second fixation pin hole  34 , and the third fixation pin hole  36  may establish anterior-posterior oriented channels through the block body  18  and are each configured to allow for the insertion of a fixation pin (not shown in  FIGS.  2 - 6   ) for temporarily fixating the tibial cutting block  12  to the tibia. The first and second fixation pin holes  32 ,  34  may be positioned just above (i.e., superior to) the first cutting slot  28  and may open into the first cutting slot  28 . The third fixation pin hole  36  may be positioned just below (i.e., inferior to) the second cutting slot  30  and may open into the second cutting slot  30 . 
     The first and second fixation pin holes  32 ,  34  may converge toward one another at an angle α (see  FIG.  5   ) in the anterior-to-posterior direction. In an embodiment, the angle α is between 10 and 30 degrees. In another embodiment, the angle α is between 15 and 25 degrees. In yet another embodiment, the angle α is about 15 degrees. The angle α is designed help prevent the tibial cutting block  12  from being pulled away from the tibia during use. 
     An alignment rod hole  38  (best shown in  FIGS.  2  and  5   ) may be formed through the right side  24  of the block body  18 . The alignment rod hole  38  may include a length extending in the superior-inferior direction and is configured to receive a varus-valgus alignment device (not shown in  FIGS.  2 - 6   ). 
     As best shown in  FIGS.  4  and  6   , a biasing clip  40  may be integrally formed as part of the block body  18 . In an embodiment, the biasing clip  40  establishes a floor of the pin receiving slot  16 . The biasing clip  40  may include a cantilevered design in which a first end portion  42  is integrally formed with an inner wall  44  of the front side  22  of the block body  18 , and a second end portion  46  extends adjacent to an inner wall  48  of the tibial attachment side  20  but is unattached thereto. The biasing clip  40  may include an arced curvature between the first and second end portions  42 ,  46 . Due at least in part to the cantilevered design and the arced curvature, the biasing clip  40  may induce a biasing force for biasing the slope setting pin  14  toward a surface of the block body  18 , thereby firmly securing the slope setting pin  14  within the pin receiving slot  16  while still allowing for movement and adjustability (e.g., internal/external rotation) of the tibial cutting block  12  relative to the slope setting pin  14 . In an embodiment, the biasing clip  40  biases the slope setting pin  14  against an upper wall  50  that delineates an upper portion of the pin receiving slot  16 . 
     The tibial cutting block  12  may be an additionally manufactured part made of a polymeric material (e.g., nylon). However, other manufacturing techniques and materials could be utilized to construct the tibial cutting block  12  within the scope of this disclosure. 
     Dependent, for example, on which section of the tibia requires cuts and whether the left or the right tibia need treated, the tibia cutting block could look like the tibial cutting block  12  of  FIGS.  2 - 6   . The tibial cutting block could also have reversed left and right sides, whereas, for example, the first fixation pin hole  32  would be oriented at the right side of the block body  18 , and the second cutting slot  30  and the third fixation pin hole  36  would be oriented at the left side of the block body  18 . 
     The slope setting pin  14  of the tibial cutting guide assembly of  FIG.  1    is further illustrated with reference to  FIGS.  7 - 8   . The slope setting pin  14  may include a handle  52  and an elongated shaft  54  that extends along a longitudinal axis away from the handle  52 . 
     The handle  52  of the slope setting pin  14  may be a curved handle. In an embodiment, the curvature of the handle  52  matches the curvature of the front side  22  of the tibial cutting block  12 . Together, the tibial cutting block  12  and the handle  52  may establish a gripping portion for ergonomically handling the tibial cutting guide assembly  10  during use. 
     The elongated shaft  54  of the slope setting pin  14  may include a proximal section  56 , a distal section  58 , and a mid-section  60  between the proximal section  56  and the distal section  58 . The proximal section  56  may connect at one end to the handle  52  and at an opposite end to the mid-section  60  via a tapering portion  62 . The proximal section  56  may include a first diameter D 1  that is smaller than a second diameter D 2  of the mid-section  60 . As further discussed below, the smaller first diameter D 1  of the proximal section  56  allows the elongated shaft  54  to be bent in order to reposition the slope setting pin  14  out of the path of other instruments that may need to be inserted through the tibial cutting block  12 . 
     The diameter D 1  of the proximal section  56  of the elongated shaft  54  may be configured such that the biasing clip  40  cannot bias the slope setting pin  14  toward the upper wall  50  when the proximal section  56  is positioned in the first cutting slot  28 . The slope setting pin  14  is therefore more freely movable relative to the tibial cutting block  12  when the proximal section  56  is positioned in the first cutting slot  28 . In addition, the diameter D 2  of the mid-section  60  of the elongated shaft  54  may be configured such that the slope setting pin  14  is biased by the biasing clip  40  when the mid-section  60  is positioned in the first cutting slot  28 . The slope setting pin  14  is therefore less freely movable relative to the tibial cutting block  12  when the mid-section  60  is positioned in the first cutting slot  28 . The ability to adjust the firmness of the engagement of the slope setting pin  14  relative to the tibial cutting block  12  enables numerous advantages, including but not limited to the ability to handle and maneuver the tibial cutting guide assembly  10  using only one hand. 
     The distal section  58  of the elongated shaft  54  may include a hook-shaped tip  64  at its end. The hook-shaped tip  64  may be inserted into the joint space between the femur and the tibia and then be rotated for securing the slope setting pin  14  relative to the tibia. 
     The distal section  58  of the elongated shaft  54  may additionally include a pair of flat surfaces  66 . The flat surfaces  66  help keep the slope setting pin  14  from sliding medially or laterally with respect to the femoral bone once the slope setting pin  14  is inserted into the joint space between the femur and the tibia. 
       FIGS.  9 - 19   , with continued reference to  FIGS.  1 - 8   , schematically illustrate an exemplary method for preparing a tibia  68  for receiving an arthroplasty implant. The method may be performed as part of an arthroplasty procedure. The unique design of the tibial cutting guide assembly  10  assists with tibial resection by providing patient specific tibial slope and level resectioning while providing for surgical control over internal/external rotation and varus/valgus alignment. Fewer or additional steps than are recited below could be performed within the scope of this disclosure, and the recited order of steps depicted in  FIGS.  9 - 19    is not intended to limit this disclosure. 
     Referring first to  FIG.  9   , while holding the side appropriate tibial cutting block  12  in the surgeon&#39;s hand as an extension of the handle  52  of the slope setting pin  14 , the elongated shaft  54  of the slope setting pin  14  may be inserted into the joint space between a patient&#39;s femur  70  and the tibia  68 . The elongated shaft  54  may be inserted at about the mid-line of one of the femoral condyles  72  (in the illustrated embodiment, the femoral condyle  72  is the medial condyle of a right knee). The slope setting pin  14  may then be rotated about 90 degrees in order to position the hook-shaped tip  64  against a posterior surface  74  of the tibia  68  (see  FIG.  19   ). When properly inserted, the slope setting pin  14  stabilizes the tibial cutting block  12  relative to the tibia  68  and also defines a native tibial slope as referenced by the anterior and posterior aspects of the tibia  68 . The slope setting pin  14  further establishes an appropriate tibial resection level by creating space (e.g., approximately 9 mm) from the posterior femur to the tibial resection. 
     Next, as shown in  FIG.  10   , the tibial cutting block  12  may be moved into contact with an anterior surface  76  of the tibia  68 . For example, the tibial cutting block  12  may be slid along the elongated shaft  54  of the slope setting pin  14  toward the anterior surface  76  and may also be rotated towards the midline of the tibia  68 . 
     Once the tibial cutting block  12  is positioned as desired, a drop rod  78  of a varus-valgus alignment guide  80  may be inserted through the alignment rod hole  38  of the tibial cutting block  12  (see  FIG.  11   ). The drop rod  78  may then be utilized for achieving appropriate varus-valgus alignment of the tibial cutting block  12  relative to the tibia  68 . 
     An angel wing tool  82  may optionally be utilized to ensure appropriate internal/external rotation and medial/lateral positioning of the tibial cutting block  12 , and more particularly the first and second cutting slots  28 ,  30 , relative to the tibia  68  (see  FIG.  12   ). A prong  85  of the angel wing tool  82  may be inserted through the second cutting slot  30  for adjusting the internal/external rotation of the second cutting slot  30 , and thus a vertical cutting path of the tibial cutting block  12 , relative to the tibia  68 . 
     Referring now to  FIGS.  13  and  14   , the method may proceed by inserting a fixation pin in the most accessible fixation pin holes of the tibial cutting block  12 . In an embodiment, one fixation pin  84  is inserted through the second fixation pin hole  34  (see  FIG.  13   ), and another fixation pin  86  is inserted through the third fixation pin hole  36  of the tibial cutting block  12  (see  FIG.  14   ). However, the order of insertion and insertion location of the fixation pins  84 ,  86  are not intended to limit this disclosure. 
     Once satisfactory alignment of the tibial cutting block  12  has been achieved, the proximal section  56  of the elongated shaft  54  of the slope setting pin  14  may be bent in order to bend the handle  52  of the slope setting pin  14  upwardly away from the tibial cutting block  12  (see  FIG.  15   ). An additional fixation pin  88  may then be inserted through the second fixation pin hole  34  (or any other fixation pin hole that has not yet been used). If still in place, the drop rod  78  and the angel wing tool  82  may be removed from the tibial cutting block  12  (see  FIG.  16   ). 
     Referring now to  FIGS.  17  and  18   , vertical and horizontal resections can next be made in the tibia  68  by inserting a saw blade  90  or other cutting tool through the first and second cutting slots  28 ,  30  of the tibial cutting block  12 . The order of making the cuts is not intended to limit this disclosure and could vary from surgery to surgery. The fixation pins  86 ,  88  may act as a secondary guide for defining the cutting plane of the saw blade  90  when making the horizontal resections through the first cutting slot  28 . 
     Once a complete resection has been performed, the hook-shaped tip  64  of the slope setting pin  14  and the fixation pins  84 ,  86 ,  88  may be utilized to facilitate removal of the resected portions of the tibial bone. Once all cuts are made and the resected portions removed, the arthroplasty procedure can proceed to any additional steps necessary for preparing the joint for receiving one or more arthroplasty implants. 
     As alluded to above, the tibial cutting guide assembly  10  may be part of an arthroplasty instrument set. For example, the tibial cutting guide assembly  10  could be packaged together as a kit with other surgical instruments, such as the varus-valgus alignment guide  80 , the angle wing tool  82 , the fixation pins  84 - 88 , etc., for formulating the arthroplasty instrument set. 
     Although the different non-limiting embodiments are illustrated as having specific components or steps, the embodiments of this disclosure are not limited to those particular combinations. It is possible to use some of the components or features from any of the non-limiting embodiments in combination with features or components from any of the other non-limiting embodiments. 
     It should be understood that like reference numerals identify corresponding or similar elements throughout the several drawings. It should further be understood that although a particular component arrangement is disclosed and illustrated in these exemplary embodiments, other arrangements could also benefit from the teachings of this disclosure. 
     The foregoing description shall be interpreted as illustrative and not in any limiting sense. A worker of ordinary skill in the art would understand that certain modifications could come within the scope of this disclosure. For these reasons, the following claims should be studied to determine the true scope and content of this disclosure.