JP2022521011A - Systems and methods for high tibial osteotomy - Google Patents

Abstract

A system and method for guiding a medial cut, a system and method for guiding an anterior cut, and a system for providing fixation and compression to a lateral hinge during high tibial osteotomy (HTO). Devices and methods for HTO, including methods and methods, are disclosed. Each of the devices may be stand-alone. The system for creating inner cuts may include retractors, linkable cutting guides, and pins. The system for guiding the forward cut may include a guide for sliding over the pin, an alignment surface, and fixing means. Devices for fixing and compressing the lateral hinges may include a plate, an adjustable drill guide for adjusting the offset of the plate from the bone surface, and a bi-angle drill guide. [Selection diagram] Fig. 2K

Description

The present invention generally relates to surgical devices and methods, more specifically to devices and methods for high tibial osteotomy (HTO), to create devices and methods for making medial cuts, anterior cuts. Includes devices and methods for providing fixation and compression to the lateral hinges during the HTO.

Knee osteotomy is an important technique for treating knee osteoarthritis. In essence, knee osteotomy can be used to adjust the geometry of the knee joint to transfer weight load from the arthritic portion of the joint to the relatively unaffected portion of the joint. Knee osteotomy is also an important technique for dealing with abnormal knee geometry, for example due to birth defects, injuries, and the like. Most knee osteotomy is designed to modify the geometry of the tibia to adjust how the load is transmitted across the knee joint. One way to adjust the orientation of the tibia is to make a cut in the upper part of the tibia, the tibia is manipulated to open a wedge-like opening in the bone, and then the bone is fixed in this position (eg,). By screwing a metal plate into the bone, or by inserting a wedge-shaped implant into the opening in the bone), thereby turning the lower part of the tibia with respect to the tibial plateau, thus loading from the femoral bone. It is an open wedge technique that regulates the mode transmitted to the tibia. Create a consistent wedge-like opening in the bone with the required precision and at the correct angle, minimizing trauma to surrounding tissues (eg, the structure of nerves and blood vessels on the back of the knee). That is procedurally difficult. In addition, with open wedge osteotomy, it can be difficult to stabilize the upper and lower tibias with each other and keep them in this position during healing. Some attempted solutions have tried to provide the system, but due to its complexity it has not adequately addressed the needs of the industry. The present invention is intended for high tibial osteotomy of the knee as a medial open wedge, which provides improved accuracy with a streamlined system in creating wedge-shaped openings in the bone. It is intended to provide stability to the upper and lower tibial bones while healing is occurring.

A detailed description of the exemplary embodiment is here with reference to the accompanying drawings.

FIG. 1A shows a tibia with vertical anatomical marker lines for marking the boundaries of the lateral hinges. FIG. 1B shows a tibia with vertical anatomical marker lines for marking the boundaries of the lateral hinges. FIG. 2A shows a retractor disposed in the posterior portion of the tibia according to the present disclosure. FIG. 2B shows retractors and cutting guides disposed around the tibia according to the present disclosure. FIG. 2C shows a cutting datum plane defined by retractors and cutting guides according to the present disclosure. FIG. 2D shows a cut datum plane defined by a retractor and a cut guide oriented to pass through the tibia according to the present disclosure. FIG. 2E shows retractors, cutting guides, and anterior pins oriented with respect to the tibia according to the present disclosure. FIG. 2F shows a view of the datum plane according to the present disclosure. FIG. 2G shows the cut datum planes and boundaries defined by retractors and cut guides and pins according to the present disclosure. FIG. 2H shows a link guide system aligned with the tibia according to the present disclosure. FIG. 2I shows an alternative view of a link guide system aligned with the tibia according to the present disclosure. FIG. 2J shows a method of aligning front pins according to the present disclosure. FIG. 2K shows a K-wire and depth gauge extending through a cutting guide according to the present disclosure. FIG. 2L shows a view of a link guide system with a saw passing through it according to the present disclosure. FIG. 2M shows an anterior view of the system for the tibia according to the present disclosure. FIG. 3A illustrates a medial-anterior view and anterior amputation guide of the pinned tibia according to the present disclosure. FIG. 3B shows a method of aligning anterior cutting guides according to the present disclosure. FIG. 3C shows a method of aligning anterior cutting guides according to the present disclosure. FIG. 3D shows a method of aligning anterior cutting guides according to the present disclosure. 4A-B show alternative embodiments and uses of anterior cutting guides according to the present disclosure. 4A-B show alternative embodiments and uses of anterior cutting guides according to the present disclosure. FIG. 5A illustrates an exploded view of the layered spreader according to the present disclosure. FIG. 5B illustrates a side view of a layered spreader according to the present disclosure. FIG. 5C illustrates the tip of a layered spreader placed in a cut (10) according to the present disclosure. FIG. 6A illustrates a plurality of wedges according to the present disclosure. FIG. 6B illustrates a method of using the wedge of FIG. 6A according to the present disclosure. FIG. 7A shows a method of compressing a lateral hinge using a plate and drill system according to the present disclosure. FIG. 7B shows a method of compressing a lateral hinge using a plate and drill system according to the present disclosure. FIG. 7C shows a method of compressing a lateral hinge using a plate and drill system according to the present disclosure. FIG. 7D shows a method of compressing a lateral hinge using a plate and drill system according to the present disclosure. FIG. 7E shows a method of compressing a lateral hinge using a plate and drill system according to the present disclosure. FIG. 7F shows a method of compressing a lateral hinge using a plate and drill system according to the present disclosure. FIG. 7G shows a method of compressing a lateral hinge using a plate and drill system according to the present disclosure. FIG. 8A shows a top view and a cross-sectional view of a bimodal drill guide according to the present disclosure, respectively. FIG. 8B shows a top view and a cross-sectional view of the bimodal drill guide according to the present disclosure, respectively. 9A-B show an exploded view and a cross-sectional view of the adjustable drill guide according to the present disclosure, respectively. 9A-B show an exploded view and a cross-sectional view of the adjustable drill guide according to the present disclosure, respectively. FIG. 10 illustrates the dynamics of compressing the lateral hinges according to the present disclosure. FIG. 11 shows an isometric view of an embodiment of a plate contoured and aligned with the tibia according to the present disclosure. FIG. 12A schematically illustrates an embodiment of a contoured plate according to the present disclosure. FIG. 12B schematically illustrates an embodiment of a contoured plate with respect to the tibial diaphyseal axis according to the present disclosure.

Various terms are used to refer to a particular system component. Different companies may refer to components by different names-this document is not intended to distinguish between components with different names but not different functions. In the following discussion and claims, the terms "include" and "comprising" are used in an unrestricted manner and thus mean "including, but not limited to,". Should be interpreted as. Also, the terms "couple" or "couples" are intended to mean either indirect or direct connections. Thus, when the first device binds to a second device, the connection can be through a direct connection or through an indirect connection through another device and connection.

In general, the present disclosure describes multiple systems, each of which can be used together, consecutively, or instead independently of each other. Each of the systems is configured to perform part of the procedure to form and stabilize an open wedge osteotomy. More specifically, these systems guide the cutting tool along the preferred anterior portion of the tibia with a first system that helps guide the cutting tool through the medial portion of the tibia along the preferred datum plane. It may include a second system to help with, a third system to extend the tibia of the bone, and a fourth system to provide compression to the lateral hinges of the open wedge. Accordingly, various embodiments are intended for various systems and methods for guiding medial and anterior cuts through the tibia and extending and compressing lateral hinges. This specification now moves on to an exemplary system.

Various embodiments extend through a plate with a plurality of holes through which and at least one of the holes and adjust the offset or standoff between the plate and the bone surface, thereby. It is intended for systems for stabilizing and compressing lateral hinges for HTO treatment systems, including tools such as drill guides configured to adjust flexion on the plate. The adjustment can be made by rotating a portion of the drill guide. In some embodiments, the tool is separated from the drill guide. The distal tip of the drill guide may be screwed into engagement with at least one of the holes, and rotating the distal tip may further translate the distal tip, for example, through the corresponding hole. ..

Another embodiment of the bone fixation system for stabilizing and compressing the lateral hinge for the HTO may include an inner surface, an outer surface, and a bone plate having multiple holes through them. The system is also configured to adjustably extend through at least one of the holes to adjust the offset between the inner surface of the plate and the surface of the bone, thereby adjusting the flexion on the bone plate. Includes drill guides. In some exemplary embodiments, the drill guide may include an outer shaft and an axially movable inner shaft so that the outer shaft is operably coupled to at least one of a plurality of holes. It is configured so that the medial shaft extends through the same hole and engages with the bone surface, pushing the bone plate away from the bone surface, thereby adjusting the flexion of the bone plate. In some exemplary embodiments, the bone plate may include a head portion shaped to fit the metaphysis of the bone, and the head portion may include one or more multiaxial openings. The system further includes fixing means such as lock screws configured to work with the multi-axis opening, thereby defining a multi-axis locking system that locks and secures the bone plate to the bone. The multiaxial locking system may be configured to orient the fixation means at an angle that avoids anatomical structures within the metaphysis of the bone, such as ligaments or ligament tunnels. Some exemplary embodiments may also include dual angle drill guides that can be operably coupled to a multiaxial opening through the bone plate. The stem portion of the bone plate may also include a multiaxial opening. The dual angle drill guide may have a first guide axis for orienting the first temporary fixing means into the bone at a first angle. The first angle is configured to move the central portion of the bone plate onto the bone surface, resulting in rotation of the diaphyseal segment of the bone around the false screw, thereby compressing the quadrate hinge. The dual angle drill guide can also be oriented at a non-zero angle with respect to the first axis to guide the drill to form a pilot hole in the bone at a second angle different from the first angle. A second guide axis may be included. In some embodiments, the bone plate comprises a head portion and a stem portion extending from the head portion, wherein the stem portion comprises at least two of a plurality of openings and at least two openings. The first of the portions is a multiaxial opening configured to operably couple to the dual angle drill guide, and the second of at least two openings is adjustable. It is configured to operably connect to a drill guide. In some embodiments, at least one of the plurality of openings is a multiaxial opening configured to receive the first fixing means at a first angle through it, and also a second. When the fixing means of 1 is removed, the multi-axis opening is configured in the second fixing means at a second angle through the fixing means.

A method of compressing the lateral hinge of an open wedge osteotomy is also disclosed, with the step of placing the bone plate on top of the open wedge osteotomy and the first part of the open wedge osteotomy on the upper part of the plate. A step of fixing to the side of the bone and a step of moving the lower end of the bone plate away from the bone surface on the second side of the open wedge osteotomy to form a stand-off that arches the bone plate. The step of adjusting the standoff and the step of temporarily fixing the central part of the bone plate to the bone so as to compress the lateral hinge of the open wedge osteotomy while maintaining the adjusted standoff. The central portion comprises, on the second side of the open wedge osteotomy, a temporary fixation step disposed between the upper portion and the lower end portion. In some exemplary methods, the upper portion of the plate may include at least one variable angle opening, and fixing the upper portion of the plate is through the variable angle opening at an angle away from the structure within the bone. Includes orienting the fixing means. The structure may include anterior cruciate ligament (ACL), ACL reconstruction tunnel, or meniscal root repair tunnel. In some exemplary methods, the lower end of the bone plate can be moved away from the bone surface, and the standoff can be adjusted to open the end of the adjustment guide handle with the opening at the lower end of the plate. Engagement involves axially moving the shaft, which is coaxial with the adjustment guide handle and operably coupled, through the opening to engage the surface of the bone. In some exemplary methods, the shaft may be screwed onto the adjustment guide handle and rotation of the shaft causes the shaft to move axially along the adjustment guide handle. In some exemplary methods, the central portion may include a variable angle opening, and fixing the central portion is a variable angle opening at an angle that applies a rotational load to the second side of the open wedge osteotomy. It involves placing a temporary fixing means through, thereby compressing the lateral hinges. In some exemplary methods after the central portion is provisionally fixed, other parts of the bone plate can be permanently fixed to the bone, and then the provisional fixation means have different insertion angles through the variable angle opening. Can be replaced with a permanent fixing means. In some exemplary embodiments, the temporary fixing means may be placed using dual angle guides so that the dual angle guides also point the drill along different insertion angles to form a pilot hole. It has an axis oriented to.

Another embodiment of the system may include a link cutting guide system for preparing a medial cut during HTO treatment, which protects the neurovascular structure and under fluoroscopy of the medial-lateral tilt vector. Includes a retractor for insertion into the posterior aspect of the tibia to provide a visual indication. The system also includes a cutting guide pivotally coupled to the retractor, which is configured to wrap around the medial aspect of the tibia and accepts and controls cutting tools such as saws to create medial cuts. Includes an elongated cutting slot for The cutting slot establishes a backward tilted cutting vector. The link disconnection guide system also defines the boundaries of the preferred datum plane and includes a front pin configured to be inserted through an opening in the cleavage guide at a location lying on the datum plane, the preferred datum plane. It is defined by an inward-lateral tilt vector and a backward tilt cut vector.

The cutting guide system may also include a pin positioning guide that selectively couples to the cutting guide to guide the insertion of the anterior pin. The cutting guide pin positioning guide may include a pin guide coupled to the cutting guide and an adjustable flag with a linear edge that can be aligned with the backward tilted cutting vector. The retractor may include a slot for receiving the arm of the cutting guide. The link disconnection guide system may also include an anterior disconnection guide system for guiding the anterior cut during the HTO procedure. The anterior cutting guide is connected to the lumen for sliding over the anterior pin, the cutting surface for guiding the trajectory of the bone cutting machine, and the anterior cutting guide, and is fixed to stabilize the orientation of the anterior cutting guide. Means and. The fixing means may include a pin or screw inserted through a portion of the anterior cutting guide.

Another further embodiment of the system may include a cutting guide system for guiding anterior cuts during HTO procedures. This cutting guide system may include a pin for partial insertion into the bone, whereby a portion of the pin is inserted into the bone and the portion is not inserted and is not exposed. The cutting guide system is also inserted into a cavity for sliding over exposed parts of the pin, a cutting surface to guide the trajectory of the bone cutting tool, and an open wedge osteotomy to define the orientation of the cutting surface. Includes a cutting guide with fins configured as such. The cutting guide also includes a fixing means for binding to the cutting guide and stabilizing the orientation of the cutting guide.

The following discussion is directed to various embodiments of the invention. Although one or more of these embodiments may be preferred, the disclosed embodiments should not be construed as limiting the scope of the present disclosure, including the claims, or as such. Should not be used. In addition, one of ordinary skill in the art will appreciate that the following description has a wide range of applications, the discussion of any embodiment is intended only as an example of that embodiment, and the scope of the present disclosure, including the claims, is in that embodiment. You will understand that it is not intended to imply being limited.

The present disclosure is generally a first system for accurately creating a cut extending from the medial side of the tibia, a second system for creating an anterior cut within the tibia, where the anterior cut is medial. A second system extending from the cut, a third system for extending the two bone segments to the desired wedge angle, and a second system for stabilizing the open wedge formed by opening the medial and anterior cuts. It may include 4 systems of 4 systems. T These systems can be used together, but may also be used independently of each other. In other words, as an example, the first system can be used to create a medial cut in the tibia, and the anterior cut can be made using another system that is not needed or disclosed. It may be either. As a further example, the entire open wedge may be prepared using a system not disclosed herein, a fourth system may be applied only to secure and compress the lateral hinges. ..

The first system is the link guide system 90, the whole of which is most commonly seen in FIGS. 2J and 2L and is configured to define and control the datum plane for the medial cut or osteotomy line in the tibia. To. The link guide system 90 generally includes a rear retractor 100, a cutting guide 150, an anterior pin 200, and a means 250 for aligning the anterior pin. The link guide system 90 aligns the retractor 100 with the cutting guide 150 to define the medial cutting plane and provides a method of storing and protecting the neurovascular structure during medial open wedge osteotomy. 1A and 1B show the tibia 5 in which an exemplary open wedge osteotomy is performed. According to the present invention, open wedge osteotomy involves first making a cut 10 in the upper tibia and then manipulating the lower part of the tibia 5 to open the wedge-shaped opening of the bone (shown in FIG. 6B). The wedge-shaped opening is configured to coordinate how the load is transmitted from the femur to the tibia. If a vertical (anterior cut) is made in a later step, the line 15 is preferably marked along the medial side of the tibial tubercle 20, and the line 15 is parallel to the anterior surface 25 of the tibial plateau. This line 15 can be used later as the intersection of the inner cut and the anterior cut.

The cutting plane and the advance of the cutting tool can be visualized directly or under fluoroscopy. The link guide system 90 may include a posterior retractor 100 that may be curved to aid in placement of the posterior portion of the tibia 5 and a cutting guide 150 that links to the retractor 100. As seen in FIG. 2A, the posterior retractor 100 includes a handle 105, an opening 110, and a containment portion 120, which is shaded to be behind the tibia of FIG. 2A. The handle 105 is generally held by the user and is sized and shaped to position the rear retractor 100 at the correct angle. The slot 110 may be disposed between the handle 105 and the storage portion 120 and may be sized to link with the cutting guide 150 (see later figure). The retractor 100 shown in FIG. 2A is inserted into the posterior aspect of the tibia 5 to protect the neurovascular structure and provide a visual indication under fluoroscopy of the medial-lateral tilt vector 130 (MLI vector). To. The rear retractor 100 can be inserted to retract and raise the MCL, or can be inserted behind the MCL to allow the medial cutting guide (discussed below) to provide containment. The storage portion 120 may include markings such as a series of holes 122 aligned along the longitudinal axis (XX) of the retractor 100 so that the retractor 100 is aligned with the desired vector 130. The storage portion 120 may also include a series of slots 124 oriented perpendicular to the longitudinal axis (XX) to provide measurements when visualized under fluoroscopy. Slots 124 can be at equal distances from each other at regular intervals to assist the surgeon in measuring the depth of the saw through the tibia, so slot 124 sees the blade of the saw through it. The opening is wide enough for. The slots 124 may be spaced by, for example, 10 mm. In addition, the slot 124 is long enough or extends to both sides of the longitudinal axis XX to observe the deviation of the saw blade away from the longitudinal axis XX (more detailed in later figures). Explained in). The retractor 100 is preferably made of metal, whereby it is easily sterilized and therefore reusable. The retractor is preferably visible under fluoroscopy. In an alternative embodiment, the retractor 100 may contain at least a translucent or transparent polymer such as PEEK in order to better observe the saw blade path. Metal ribs may be added approximately equal to the location of slot 124 to increase the stiffness of the retractor 100 and also protect PEEK from the formation of saw blades and PEEK shavings in the patient. The metal ribs are also preferably visible under fluoroscopy.

The containment portion 120 may have a shape with a contour similar to the curvature of the posterior superior part of the tibia 5 for use as a physical and visual reference during placement. For example, the retractable portion 120 engages with the corresponding curved portion of the tibia 5 and around the perimeter portion of the retractable portion 120 in order to better maintain the position of the medial-lateral tilt vector 130 and the retractor 100. It may include a curved rim 126. Slot 110 may be disposed between the storage portion 120 and the handle 105 so that when the storage portion is placed on the posterior portion of the tibia 5, it is located adjacent to the medial outer edge surface of the tibia 5. .. The kit may include multiple retractors 100 that may have different configurations, such as different contours, curvatures, and longer storage portions 120, to accommodate variations in tibial size.

As seen in FIGS. 2B and 2F, the retractor handle 105 is relative to the retractor portion 120 in order to better avoid the patient's anatomy, store tissue, and visualize the placement of the containment portion. It may be offset. Jog / offset raises the MCL and places the MCL on the outer surface side of the storage portion 120 indicated by M on the retractor 100, or raises the MCL to a minimum and places the retractor outside the MCL. Either allows access to the rear side, where the MCL is at location M'.

The cutting guide 150 is configured to be substantially located on the medial side of the tibia 5. The cutting guide 150 may define a curve configured to wrap around the medial side of the upper tibia. The cutting guide 150 includes a link end 155 and a free end 175, the link end 155 being configured to link with slot 110 of the retractor 100. When the retractor 100 is in a preferred location, the cutting guide 150 may be linked to the retractor 100. A kit containing multiple cutting guides may be provided, the cutting guides being configured to accommodate different tibial anatomical sizes. As shown in FIG. 2C, the link end 155 comprises an elongated arm 157 sized to fit through slot 110 and may have a substantially rectangular cross section. The elongated arm 157 and slot 110 are configured to cooperate with each other to allow some pivotal movement along the plane 170 and some restricted sliding movement of the cutting guide 150 along the plane 170. Will be done. However, the elongated arm 157 and slot 110 are configured to work together to maintain the saw slot 160 on the plane 170. The saw slot 160 in the inner cutting guide 150 serves to define the backward tilted cutting vector (PSC vector) 180. The MLI130 and PSC180 vectors define a datum plane 170 for a saw (described later) to follow while forming a medial cut or osteotomy. The retractor 100 and the cutting guide 150 are linked such that the two vectors MLI 130 and PSC 180 maintain this cutting plane 170 even when they "hinge" open and close. FIG. 2D shows a retractor 100 and a cutting guide 150, vectors MLI 130 and PSC 180 for defining a cutting plane 170 through the tibia. The cutting guide 150 may first be coupled to handle 260 (discussed in more detail later) and then linked to slot 110 of the retractor using handle 260.

As most commonly seen in FIGS. 2E, 2F and 2G, the system may also include anterior pins 200 extending into tibia 5 through the thickness of the cutting guide 150. The cutting guide 150 includes an opening 165 configured to receive the pin 200, which may be disposed at the end of the saw slot 160 and continuous with the saw slot 160. The opening 165 may define a lateral end of the saw slot or may define an opening larger than the saw slot 160. The opening 165 can be restricted so that the front pin 200 is aligned with the saw slot 160, but can be oval so that it can move laterally closer to or farther from the free end 175. .. In other words, the opening 165 limits the location of the pin so that its central axis is on the plane 170, while the relative location of the pin 200 to the retractor 100 is the tibia 5. May be adjustable depending on the size of. As best shown in FIG. 2F, the distance D is selectable up to the boundary defined by the opening 165. The front pin 200 is shown with a threaded end 201 and a coupling end 203. In some embodiments, the front pin may be perfectly smooth, similar to the K wire. The coupling end 203 may be configured to engage an insertion tool (not shown) and may be hexagonal or square to better transmit rotational movement from the insertion tool for screwing into the front pin 200. It may have a non-circular cross section, such as a cross section. Of note, the curved rim 126 of the retracted portion 120 is readily observed in FIGS. 2F and 2G. As shown in the later figure, the cutting guide 150 may be anchored in place by a speed pin or fixing means extending into the tibia 5 through the hole 162.

The front pin 200 can be accurately positioned using the pin guide 250 with a flag 300 that can be selectively coupled to the cutting guide 150. All lines through the front pin 200, the cutting guide slot 160, and the retractor 122 may demarcate the cutting plane 170 and its boundaries. The anterior pin 200 may preferably be located in a position collinear with the intersecting axes of the inner cut and the anterior cut (discussed below). The anterior pin 200 serves at least two functions, it provides protection from the saw to the tibial tubercle during the medial cut (discussed in a later figure) and also assists the anterior cut in later steps. A stabilizing means for the guide 150 is provided. The line 15 shown in FIG. 2B can be seen through the inner cutting guide 150 (visible through the opening 165 in the figure). Due to the thickness of the inner cut guide 150, the anterior pins 200 are arranged parallel to and aligned with the inner cut datum plane. Therefore, the remaining degree of freedom for pinout is the angle at which it is drilled with respect to the PSC vector.

A preferred pinout orbit is a vector originating at the intersection of the medial cut on the medial tibia and the scribe line 15 and parallel to the joint line. The visual guide 250 may be coupled to the inner cutting guide 150, which has sufficient thickness to align the visual guide 250 on the correct trajectory. The visual guide 250 may include a handle end 260 and a distal tip 255 of a size that is selectively inserted into the guide opening 185 so that the visual guide 250 is selectively aligned with the cutting guide 150. The handle 260 and the distal tip 255 may lie along and be concentrically disposed on the longitudinal axis of the visual guide 250. As seen in FIGS. 2H, 2I and 2J, the visual guide 250 is configured so that the reference is the anterior tibia, pointing anteriorly and aligned. The flag element 300 may be coupled to the visual guide 250 and is selectively moved to align the linear edge 310 of the flag 300 with the anterior tibia. The handle 260 may include a hole configured to receive a pin or threaded shaft 265. As shown in FIG. 2H, the flag may be slidably coupled to a portion of the visual guide 250 via a threaded shaft 265. The flag element can be locked in place using a set screw. Flag 300 may be terminated at a linear edge 310 for pin alignment. The tip of the front pin 200 may be located in slot 165 within the inner guide 150, preferably inserted up to the scribe line 15. It can be advanced through the tibial nodule parallel to the bottom of the alignment flag 300, the linear edge 310. The linear edge 310 may be aligned with the vector 180.

The K-wire 320 may also be placed through the cutting guide 150 to the depth of the hinge point and the depth measured using the depth gauge 325, as shown in FIG. 2K. The cutting guide saw slot 160 may include a series of notches 163 along the length of the saw slot 160 to accept K wires that may have a larger diameter than the saw slot 160. The K-wire provides depth information on how deep the saw should extend within the tibia 5.

Once the front pin 200 is placed, the visual guide 250 and the flag 300 can be removed. The inner cut 10 can be safely made using the depth information from the K wire and may be included between the rear retractor and the anterior pin. The exemplary saw 350 is shown to extend through the saw slot 160 of FIG. 2L to make an inner cut along the plane 170. The exemplary saw 350 can be a vibrating saw or sword fitted through the medial cutting guide 150. The saw 350 is coplanar and controlled so as to extend along the datum 170 created by the link guide system 90. The saw and sword are guided by K-wire and can be advanced laterally until the desired "lateral hinge" point is reached, as determined by the surgeon during preoperative planning.

Second System-Anterior Cutting Guide The present disclosure is directed here to a second system configured to guide an optional anterior cut if the surgeon so desires. The anterior cut may preferably be for forming a biplanar high tibial osteotomy (HTO). The second system is a front cut guide 500 that can make a vertical front cut utilizing the front pins 200 already located in the previous figure, as shown in FIG. 3A. The anterior cut guide 500 may be configured on the left or right leg, so the kit may include two mirror image anterior cut guides 500 to accommodate the target side of the patient. When used independently of the first system, a stand-alone front pin may be added. The placement of the anterior pin 200 from the previous step in the procedure can be used to fit an adjustable cutting guide over the pin 200 and guide the anterior cut. The pin 200 may demarcate the intersection of the inner cut and the anterior cut. Once the inner cut is complete (possible as described in FIGS. 2A-2L), the pin 200 can remain intact while the retractor 100 and cutting guide 150 can be removed. The front cut guide 550 is configured to slide over the headless pin 200. The anterior cut guide 550 may include an elongated lumen 560 or opening configured to slide over the pin 200 to assist guide alignment. The lumen 560 is sized so that the guide can rotate around the pin 200. The medical cut 10 can be seen in FIG. 3B with a pin 200 passing through the end of the medal cut. The guide 550 may also include an elongated cutting slot 570 defined between the first vertical linear edge 575 and the second parallel linear edge 580 of the guide 550. The cutting slot 570 is wide enough to receive, for example, a sagittal saw or sword. As shown in FIG. 3C, the guide 560 fits over the pin 200 and can rotate to align the cutting slot 570 with the marked line 15. The cutting slot 570 may be visually aligned with the line 15 created at the start of the procedure and then secured in place with temporary pins. For example, a second pin or screw or fixing means 590 may be inserted into the tibia 5 through the hole 585 to fix the alignment with the marking 15. In an alternative embodiment, the fixing means is inserted adjacent to the outer edge surface of the guide 550 to fix the guide 550 in that orientation and reduce the need for holes through it. The forward cutting guide 550 may include a lip 552 to hold the guide 550 and align the cutting slot 570 with the marking 15.

An alternative embodiment of the cutting guide system 650 is shown in FIGS. 4A and 4B, where the guide is a lip 652 or handle for holding and aligning the guide 650 and fins for sliding into the medical cut 30. Includes 654. Similar to the embodiments described above, the guide 650 may include an opening 660 for sliding over the pin 200 and a hole 680 for receiving the screw of the pin to secure the guide 650 when aligned. .. The surface 690 may provide a cut surface to guide the saw in the correct orientation. The fins 654 may be tapered (not shown) to facilitate insertion into the inner cut 30. As shown in FIG. 4B, the surface 690 is not aligned with the mark 15. The inventor envisions a series of guides with different orientations for the surface 690 so that the surgeon can choose the closest one.

The main advantage of the system 500 is that it compensates for variability using one guide instead of several fixed angle guides. The use of one guide pin 200 at the intersection of the cutting planes allows for better control and management of the cut. You can now use a sagittal saw to safely make a forward cut in the guidance.

Third System-Side Hinge Stretching System The present disclosure is here to initiate stretching of the two bone segments on either side of the cut 10 and subsequently wedge the two bone segments according to a determined open wedge angle. Directed to the third system of. The sword or saw 350 used with the guide 200 can have a thickness that provides a narrow opening on the medial surface of the tibia, so a layered spreader 700 with a thin tine is preferably initially two bone segments. Can start to stretch. The layered spreader 700 shown in FIGS. 5A, 5B and 5C may thus include an "L" shaped end having a pair of thin blade-like tines 710 that are movable relative to each other, the tines being cut. It is configured to be wedge-shaped within this narrow opening formed by the 10 and thus between the opposing bone surfaces of the cut 10. The tine 710 may be tapered 715 to further facilitate insertion of the cut 10 into the inner boundary. The spreader 700 also includes means for controlling the rate of relative movement between the tines 720 and thereby controlling bone segment elongation, which means includes a pair of lever arms 720 and a set screw mechanism 725 in between. If the extension is too fast, the lateral hinges can crack, so means of limiting the rate of tine separation, thereby limiting the extension, are preferred to reduce damage to the lateral hinges. The lever arm 720 may be hinged so that relative motion between the lever arms moves the tine 710. The threaded knob 722 is operably coupled to a set screw that is operably coupled to at least one lever arm 720 so that the rotary knob 722 pulls the lever arms 720 toward each other and allows the tine 710 to slowly separate. Can be done. In addition, the portion of the spreader 700 may be formed of a flexible material such as spring steel or polymer to further limit the rate of elongation. FIG. 5C shows a tine 710 that is placed within the narrow opening formed by the cut 10 and initiates stretching along arrow 701.

When the layered spreader stretches the opening by at least a few millimeters, the layered spreader is removed and further stretching can be performed using the wedge system 750, as shown in FIGS. 6A and 6B. Multiple wedges 760 are packaged in a tray of multiple wedges 760 configured to accommodate different wedge opening angles, for example, depending on the patient's anatomy and desired orthodontic geometry. Can be provided as part. Each wedge 760 may have a different wedge angle and may include a series of markings 755, with an indication of the corresponding wedge thickness in the markings, eg, 1-10 mm thick. Alternatively, each marking 755 may indicate an opening angle. The opening angle and / or opening width are preferably calculated as part of a pre-planned procedure based on a series of images such as X-rays along various orthogonal planes to the target bone.

Two wedges 760a and 760b may be selectively inserted and driven into the opening 30 until the marking 755 is aligned with the tibial lateral surface at the values determined as part of the pretreatment plan. In some cases, biplanar correction is preferred, where the anterior wedge opening is different from the posterior side. Thus, the wedge 760a may have a different wedge slope than the wedge 760b. Each wedge may be selectively attached to a handle system 765 that may be operably coupled to at least one wedge 760, and the end 766 may be driven in to insert the wedges 760a and 760b. Two separate handles, one for each wedge, may be an alternative configuration. In the embodiments shown, both wedges 706a and 760b are coupled to a single handle such that anterior and posterior wedge openings are formed at about the same time. This can help form a more consistent opening angle according to the determined opening angle value.

Fourth system-side hinge compression system.
The present disclosure is directed here to a fourth system, including a fixation plate and drill system to provide compression to the lateral hinges of the HTO to facilitate faster bone healing during the HTO procedure. FIG. 7A shows a plate 1100 having a plurality of holes 1200 therein. The hole 1200 is generally configured to receive a series of fixing means, such as a non-locking / locking screw, for attaching the plate 1100 to a portion of the bone 5 including above the extension portion of the bone (open wedge 30). There is. The plate 1100 is exemplary in shape and the number and location of holes 1200 may vary. The plate 110 can be contoured to approximate the tibial outer surface to provide better matching with the tibia, reducing irritation between adjacent soft tissues and the plate 1100. Multiple plates may be provided to accommodate different tibial sizes as well as to accommodate the left or right patient's leg. The lateral hinge compression system is configured to avoid dual holes (figure 8 or snowman-shaped holes) while providing compression to the lateral hinges stretched during the HTO procedure. As shown in FIG. 7A, three fixing means, such as lock screws, are inserted through the uppermost hole 1200a to secure the plate 1100 in the proximal portion of the tibia above the open wedge 30.

An adjustable drill guide 1300 may then be inserted through the bottom hole 1200d and the adjustable drill guide 1300 sets and adjusts an offset X of that portion of the plate 1100 near the bottom hole with respect to bone 5. Includes an adjustable distal tip 1310 configured to. Adjusting the offset X allows the user to select the amount of offset X that the lower end of the plate 1100 has, thereby adjusting the amount of arch in the plate 1100, thereby the wedge opening 30 and the bone hinge 35. Allows for compression.

With reference to FIG. 10, a brief description of the mechanics of bone hinge compression is disclosed. Compression of the lateral hinges may reduce the likelihood of nonunions if the lateral hinges of the bone crack during the procedure. Compression can also preload the osteotomy, thus allowing an early weight load on the osteotomy, which reduces the likelihood of loss of correction during the healing process. FIG. 10 shows an exemplary plate 1100 fixedly coupled at point A, optionally using holes such as 1200a. An adjustable drill guide, such as the guide 1300, may be used to push the distal end away to form a standoff value X from the bone surface at point B. This standoff X may be adjustable so that the surgeon can choose the level of compression placed on the lateral hinges. In some embodiments, a distance marker may be placed on the drill guide to indicate the standoff distance. In other embodiments, a force gauge, such as a spring plunger, may be operably coupled to an adjustable drill guide so that the surgeon can adjust the offset to a target force value. Temporary compression screws may then be placed in the bone at point C through the plate, with the drill guide maintaining standoff X. This brings the central portion of the plate 1100 to the bone surface at the point C, producing a rotation D on the lower segment of the tibia 5 and a consequent compressive force E on the lateral hinge 35.

Returning to FIGS. 7A-7G, as most often seen in FIGS. 7B and 9A, the adjustable drill tip 1310 has a passage 1322 (most in FIGS. 9A and 9B) there to allow passage of the tool. It may include a handle 1320 which may include (commonly seen). Passage 1322 continues through the distal tip 1310. The adjustable drill guide 1300 also includes an outer shaft 1330 for receiving a handle 1320 including a thread 1312 that engages with a corresponding thread or surface on at least the bottom hole 1200d. The outer shaft 1330 and handle 1320 may also be configured to screw into each other between the outer surface of the handle 1320 and the inner surface of the shaft 1330 to advance the distal tip 1310 axially along the shaft 1330. With the thread 1312 coupled to the lowermost hole 1200d, the rotary handle 1320 relative to the shaft 1330 thus advances or retracts the distal tip 1310 to the lower opening 1200d to push the lower portion of the plate 1100. Move away from or closer to the outer surface of the tibia. Advancement of the distal tip 1310 increases the plate offset or standoff shown as X in FIG. 7B, thereby increasing the flexion of the plate 1100. The threaded portion 1312 can be tapered to adjust for the varying size or diameter of the hole 1200d. In an alternative embodiment, the distal tip may have a constant outer diameter along its length. In an alternative adjustable drill guide, the handle 1320 may be slidably advanced relative to the outer shaft 1330 and a series of teeth or engagement elements that engage the corresponding teeth or engaging elements on the outer shaft 1330. It may include a combination element. Axial springs may be coaxial with the outer shaft and handle to maintain engagement in this embodiment.

As shown in FIG. 7C, with the adjustable drill guide 1300 still inserted and standoff X maintained, then the bimodal drill guide 1400 is preferably close to the center of the plate 110 and has a wedge opening. It may be inserted into a hole 1200c located distal to the portion 30. The bimodal drill guide 1400 may include a threaded distal tip 1410 for engaging with the hole 1200c. The bimodal drill guide 1400 may have two fixed trajectories, including a standard orbit for the final lock screw A and an angled orbit B for inserting the temporary compression screw at a downward angle. Temporary threads can include non-locking threads such as cortical, compressed, or osteopenic threads. In an alternative embodiment, a conical guide may be provided to set a limit on the insertion angle rather than a fixed value of the insertion angle of the fixing means. As mentioned above, compressing the plate 1100 in this manner causes the central third of the plate to bend inward towards the bone 5, and the resulting rotational force results in compression of the lateral hinge 35. Let me. Both the screw or the fixing means extend through the same hole 1200c in the plate and the angled trajectory B and the downward angle can be fixed. The hole 1200c is preferably an approximately circular shape with a single central axis therein, as opposed to a figure eight hole. Holes 1200c may define variable angle openings such as those disclosed in US Pat. No. 8,888,824, which are generally owned and incorporated herein by reference in their entirety. An opening, such as the opening 1200C, extends radially inward from the inner surface of the opening 1200C and into the internal region of the opening 1200C so as to engage or collaborate with the head portion of the bone fixative. It may be a variable angle opening including fins or protrusions that are configured. During use, the fins engage the head portion of the bone fixative to secure the bone fixative at the desired location within the variable angle opening 1200C and at the desired angle orientation. Additional information on fin operation and configuration is provided in US Patent Application No. 15 / 706,877, the earliest filing date of July 25, 2005, US Patent entitled "Systems and Methods for Using Positive Plates". US Pat. No. 10,092,337, US Patent Application No. 13 / 524,506, entitled "Variable Angle Locking Implant," filed June 15, 2012, and "Orthopedic Implant," filed June 7, 2012. It can be found in US Patent Application No. 62 / 858,727, entitled "with Implemented Variable Locking Mechanism," the entire contents of which are incorporated herein by reference.

Therefore, the bimodal drill guide 1400 provides a first hollow shaft 1420 that provides a passage for a drill that goes through the orbit A and into the bone so as to form a pilot hole along the orbit A. including. The bimodal drill guide 1400 may also include a second shaft 1430 that provides a passage for the screw along the trajectory B through it into the bone. The bimodal drill guide is best seen in FIGS. 8A and 8B. The second shaft 1430 may be smaller in diameter, as can be seen in FIG. 7D, and the screw head 1450 may stay outside the hole 1200c and be separated from the hole 1200c. This allows easy access for removing temporary screws. As described above, the captive screw 1450 can pull the plate to the outer surface of the bone and place the lateral hinge 35 in a compressed state. The first hollow shaft may be configured to allow full passage of the drill to later form a pilot hole for placing the lock screw. The first hollow shaft 1420 may be longer than the second hollow shaft 1430, and the first hollow shaft 1420 also serves as a means of operating / holding the bimodal drill guide, or in other words. Then, it acts as a handle. Once the temporary fixing means is inserted into the angled trajectory B, the two remaining lock screw holes 1200e below the osteotomy can be drilled and embedded here, as shown in FIG. 7D. ..

The offset drill guide may then be used to drill the pilot hole through the opening 1200d, which may then be removed to allow fixing means such as lock screws to further secure the plate 1100 to the bone. .. The false screw 1450 inserted into the angled orbit can then be removed because the lower lock screw is angle stable and the bend in the plate 1100 remains. The bimodal drill guide 140 can be removed and a lock screw can be placed in the bone along the previously formed pilot hole. The captive screw 1450 may be reused in the remaining hole 1200b just above the open wedge.

FIG. 11 shows an alternative embodiment of a plate 1500 that includes a plurality of openings 1550 and is contoured to fit the tibia 5. The plate may comprise a 2-3 mm thick plate made of titanium and may include multiple openings 1550, some of which are variable angle locking holes, as described herein. Is. The plate 1500 may include a first variable angle lock opening 1550a and a second variable angle lock opening 1550d. Similar to the embodiments described above, the plate 1500 is first attached to the upper portion of the tibia via fixation means through 1550a and 1550b. The anterior anterior hole 1550a is a variable angle opening for allowing placement of fixation means and avoiding certain structures associated with tibia 5. For example, an ACL reconstruction or meniscal root repair tunnel may be performed simultaneously as part of the procedure. A variable angle opening at the upper end of the tibia allows the fixation means to be placed at an angle that avoids the area around or above the ACL or meniscal root. Similar to the plate system embodiments described above, an adjustable offset drill guide such as the drill guide 1300 can then be operably coupled to the opening 1550c and standoff X can be formed as described above. Temporary compression screws may then be placed in the opening 1550d at an angle configured to compress the lateral hinge 35. The fixing means may then be placed in the opening 1550e and then in 1550c after removal of the adjustable guide 1300. The captive screw can be removed from the opening 1550d before placing the permanent lock screw at another angle. Plate 1500 may include a distal curved axis 1560 for better alignment with the tibial diaphysis, a non-curved axis labeled with 1565 for reference.

The above discussion is intended to illustrate the principles and various embodiments of the invention. Once the above disclosure is fully understood, a number of modifications and modifications will be apparent to those of skill in the art. The following claims are intended to be construed to include all such modifications and modifications.

Claims (19)

A bone fixation system to stabilize the lateral hinges for HTO procedures,
A bone plate with an inner surface, an outer surface, and multiple holes through it,
Adjustably extended through at least one of the plurality of openings to adjust the offset between the inner surface of the plate and the surface of the bone, thereby adjusting the flexion on the bone plate. Bone fixation system, with a drill guide. The drill guide comprises an outer shaft and an axially movable inner shaft, the outer shaft being configured to operably couple to at least one of the plurality of openings. The medial shaft extends through the at least one of the plurality of openings and engages with the bone surface, pushing the bone plate away from the bone surface, thereby flexing on the bone plate. The bone fixation system according to claim 1, wherein the bone fixation system is configured to adjust. The plate comprises a head portion configured to fit the metaphysis of the bone, the head portion having one or more variable angle openings, resulting in the one or more variable. The bone fixation system according to claim 1, wherein the fixation means extending through the angular opening can be directed away from the structure within the metaphysis of the bone. Further comprising a dual angle drill guide configured to operably couple with a variable angle opening through the bone plate, the dual angle drill guide within the bone configured to compress a lateral hinge. A first guide axis for orienting the first fixing means at a first angle and a second guide for forming a pilot hole in the bone at a second angle different from the first angle. The bone fixation system according to claim 1, comprising a shaft. The bone plate comprises a head portion and a stem portion extending from the head portion, wherein the stem portion comprises at least two of the plurality of openings and of the at least two openings. The first opening is a variable angle opening configured to operably couple to the dual angle drill guide, and the second of the at least two openings is the adjustable. 4. The bone fixation system according to claim 4, which is configured to be operably coupled to a drill guide. When at least one of the openings of the plurality of openings receives the first fixing means at a first angle passing therethrough and the first fixing means is removed, a second passing therethrough. A bone fixation system, which is a variable angle opening configured to also accept a second fixation means at an angle of. A method of compressing the lateral hinges of an open wedge osteotomy,
Placing a bone plate on top of an open wedge osteotomy,
Fixing the upper portion of the plate to the first side of the open wedge osteotomy
With the upper portion fixed, the lower end portion of the bone plate is separated from the bone surface on the second side of the open wedge osteotomy so as to form a standoff that arches the bone plate. And move it
Adjusting the standoffs
The central portion of the bone plate is provisionally fixed to the bone so as to compress the lateral hinge of the open wedge osteotomy while maintaining the standoff. A method comprising provisional fixation, which is disposed between the upper portion and the lower end portion, on the second side of the open wedge osteotomy. 7. The method of claim 7, wherein fixing the upper portion of the plate further comprises directing the fixing means through a variable angle opening through the plate at an angle away from the structure within the bone. 8. The method of claim 8, wherein the structure may include an anterior cruciate ligament (ACL), an ACL reconstruction tunnel, or a meniscal root repair tunnel. Moving the lower end portion of the bone plate away from the bone surface and adjusting the stand-off is to engage the end portion of the adjustment guide handle with the opening at the lower end portion of the plate. 7. The provision of claim 7, wherein the shaft, which is coaxial with the adjustment guide handle and operably coupled, is moved axially through the opening so as to engage the surface of the bone. the method of. 10. The method of claim 10, wherein the shaft is screwed into the adjustment guide handle and moving the shaft through the opening comprises rotating the shaft with respect to the handle. 10. The method of claim 10, wherein fixing the central portion comprises placing a temporary fixing means through a variable angle opening through the central portion of the plate at an angle that compresses the lateral hinge. Claiming that after the central portion is provisionally fixed, the other portion of the bone plate is fixed to the bone and then the temporary fixing means is replaced with a permanent fixing means at different insertion angles through the variable angle opening. 12. The method according to 12. Fixing the central portion with a temporary fixing means operably couples the dual angle guide with the variable angle opening and directs the temporary fixing means using the first angle of the dual angle guide. The method of claim 12, comprising: A link disconnection guide system for preparing medial cuts in HTO procedures,
A retractor for insertion into the posterior aspect of the tibia, to protect the neurovascular structure and provide a visual representation under fluoroscopy of the medial-lateral tilt vector,
A cutting tool pivotally coupled to the retractor, wherein the cutting guide is configured to wrap around the medial aspect of the tibia and creates the medial cut cutting slot defining a posterior tilted cut vector. With a cutting guide and a cutting slot for receiving and controlling
A front pin configured to demarcate the front boundary of the preferred datum plane and to be inserted through an opening in the cutting guide at a location lying on the datum plane, wherein the preferred datum plane is the inside. -A link disconnection guide system comprising a forward pin, defined by a lateral tilt vector and said posterior tilt cut vector. 15. The cutting guide system of claim 15, further comprising a pin positioning guide that selectively couples to the cutting guide to guide the insertion of the front pin. 16. The cutting according to claim 16, wherein the pin positioning guide comprises a pin guide coupled to the cutting guide and an adjustable flag having a linear edge configured to align with the backward tilted cutting vector. Guide system. 15. The link disconnection guide system of claim 15, wherein the retractor comprises a slot for receiving the arm of the disconnection guide. The anterior cutting guide system further comprises an anterior cutting guide system for guiding the anterior cut during the HTO procedure.
An anterior cutting guide with a lumen for sliding over the anterior pin and a cutting surface to guide the trajectory of the bone cutting machine,
The link cutting guide system according to claim 11, further comprising a fixing means for coupling to the cutting guide and stabilizing the orientation of the cutting guide.

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