阅读说明：本技术 用于胫骨高位截骨的系统和方法 (Systems and methods for high tibial osteotomy ) 是由 梅森·贝滕加 J·默瑟 杰弗里·怀曼 罗伯特·拉普拉德 A·格特古德 R·范海尔瓦登 M 于 2020-02-20 设计创作，主要内容包括：公开了用于胫骨高位截骨(HTO)的装置和方法,包括用于引导内侧切口的系统和方法,用于引导前侧切口的系统和方法,以及用于在HTO期间向外侧铰链提供固定和压缩的系统和方法。每个装置可以是独立的。用于产生内侧切口的系统可以包括牵开器、可连接切割引导件和销。用于引导前侧切口的系统可以包括用于在销和对准表面上滑动的引导件以及固定装置。用于固定和压缩外侧铰链的装置可以包括板、用于调节板与骨表面的偏移的可调钻引导件和双角度钻引导件。(Devices and methods for tibial high resection (HTO) are disclosed, including systems and methods for guiding a medial incision, systems and methods for guiding an anterior incision, and systems and methods for providing fixation and compression to a lateral hinge during HTO. Each device may be independent. A system for making a medial incision can include a retractor, an attachable cutting guide, and a pin. The system for guiding the anterior incision may include a guide for sliding over the pin and alignment surface and a fixation device. The means for securing and compressing the lateral hinge may include a plate, an adjustable drill guide for adjusting the plate offset from the bone surface, and a dual angle drill guide.)

1. A bone fixation system for stabilizing a lateral hinge for HTO surgery, comprising:

a bone plate having an inner surface, an outer surface, and a plurality of holes therethrough; and

a drill guide configured to adjustably extend through at least one of the plurality of openings and to adjust an offset between an inner surface of the plate and a bone surface to adjust a deflection on the bone plate.

2. The bone fixation system of claim 1, wherein the drill guide comprises an outer shaft and an axially movable inner shaft, the outer shaft configured to be operably coupled to at least one of the plurality of openings and the inner shaft configured to extend through the at least one of the plurality of openings, engage the bone surface and urge the bone plate away from the bone surface, thereby adjusting a deflection on the bone plate.

3. The bone fixation system of claim 1, wherein the plate includes a head portion configured to conform to a metaphysis of the bone, the head portion having one or more variable angle openings such that a fixation device extending through the one or more variable angle openings can be directed away from a structure within the metaphysis of the bone.

4. The bone fixation system of claim 1, 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 having a first guide axis for guiding a first fixation device configured to compress a lateral hinge into the bone at a first angle and a second guide axis for forming a guide hole in the bone at a second angle different from the first angle.

5. The bone fixation system of claim 4, wherein the bone plate includes a head portion and a rod portion extending therefrom, wherein the rod portion includes at least two openings of the plurality of openings, and wherein a first of the at least two openings is a variable angle opening configured to be operably coupled to the dual angle drill guide and a second of the at least two openings is configured to be operably coupled to an adjustable drill guide.

6. A bone fixation system, wherein at least one opening of the plurality of openings is a variable angle opening configured to receive a first fixation device therethrough at a first angle and also to receive a second fixation device therethrough at a second angle when the first fixation device is removed.

7. A method of compressing a lateral hinge of an open wedge osteotomy, comprising:

placing the bone plate over the open wedge osteotomy;

securing an upper portion of the plate to a first side of the open wedge osteotomy; and

moving a lower end portion of the bone plate away from a bone surface on a second side of the open wedge osteotomy with the upper portion fixed to create an offset to bend the bone plate;

adjusting the offset; and

temporarily securing an inner portion of the bone plate to the bone to compress a lateral hinge of the open wedge osteotomy while maintaining the offset, the inner portion disposed on a second side of the open wedge osteotomy between the upper portion and the lower end portion.

8. The method of claim 7, wherein securing the upper portion of the plate further comprises guiding a fixation device through the plate at an angle away from structures within the bone through a variable angle opening.

9. The method of claim 8, wherein the structure may comprise an Anterior Cruciate Ligament (ACL), an ACL reconstruction tunnel, or a meniscal root repair tunnel.

10. The method of claim 7, wherein moving the lower end portion of the bone plate away from the bone surface and adjusting the offset includes engaging an end of an adjustment guide handle to an opening at the lower end portion of the plate and axially moving a shaft coaxial with and operably coupled to the adjustment guide handle through the opening to engage the surface of the bone.

11. The method of claim 10, wherein the shaft is threadably coupled to the adjustment guide handle, and wherein moving the shaft through the opening comprises rotating the shaft relative to the handle.

12. The method of claim 10, wherein securing the inner portion comprises placing a temporary fixation device through an inner portion of the plate through a variable angle opening at an angle that compresses the outer hinge.

13. The method of claim 12, wherein after temporarily fixing the medial portion, fixing other portions of the bone plate to the bone; and then replacing the temporary fixation device with a permanent fixation device at a different insertion angle through the variable angle opening.

14. The method of claim 12, wherein securing the medial side portion with a temporary fixation device comprises operably coupling a dual angle guide with the variable angle opening and guiding the temporary fixation device using a first angle of the dual angle guide.

15. A connective cutting guide system for preparing a medial incision in an HTO procedure, comprising:

a retractor for insertion into the posterior side of the tibia to protect neurovascular structures and provide a visual indication under perspective of a medial-lateral tilt vector;

a cutting guide pivotally coupled to the retractor, the cutting guide configured to encircle a medial side of a tibia and including a cutting slot for receiving and controlling a cutting tool that creates a medial incision, the cutting slot defining a posterior slope cutting vector;

a front pin configured to be inserted through an opening in the cutting guide at a location that defines a front-side boundary of a preferred reference plane and also lies on the reference plane, the preferred reference plane defined by the medial-lateral tilt vector and the rear-side slope cut vector.

16. The cut guide system of claim 15, further comprising a pin positioning guide selectively coupled to the cut guide to guide insertion of the front pin.

17. The cut guide system of claim 16, wherein the pin positioning guide comprises a pin guide coupled to the cut guide and an adjustable flag having a linear edge configured to align with the back side slope cut vector.

18. The coupling cutting guide system of claim 15, wherein the retractor includes a slot for receiving an arm of the cutting guide.

19. The articulate cutting guide system of claim 11, further comprising an anterior cutting guide system for guiding an anterior incision during HTO surgery, comprising:

a front cutting guide having a lumen for sliding over the front pin and a cutting surface for guiding a trajectory of a bone cutter; and

a fixture to couple to the cutting guide and stabilize an orientation of the cutting guide.

Technical Field

The present invention relates generally to surgical devices and methods, and more particularly to devices and methods for tibial high osteotomy (HTO), including devices and methods for creating a medial incision, devices and methods for creating an anterior incision, and devices and methods for providing fixation and compression for a lateral hinge during HTO.

Background

Knee osteotomies are an important technique for treating knee osteoarthritis. In essence, knee osteotomies may be used to adjust the geometry of the knee joint in order to transfer weight bearing loads from the arthritic portion of the joint to the relatively unaffected portion of the joint. Knee osteotomies are also an important technique to address abnormal knee geometry, e.g., due to congenital defects, injuries, etc. Most knee osteotomies are designed to alter the geometry of the tibia in order to adjust the manner in which loads are transferred across the knee. One method of adjusting the orientation of the tibia is the open wedge technique, in which a cut is made in the upper portion of the tibia, the tibia is manipulated to open a wedge-shaped opening in the bone, and the bone is then fixed in that position (e.g., by screwing a metal plate onto the bone or by inserting a wedge-shaped implant into the opening in the bone), thereby reorienting the lower portion of the tibia relative to the tibial plateau and thereby adjusting the manner in which load is transferred from the femur to the tibia. Creating a consistent wedge-shaped opening in bone with the necessary precision, correct angle, and minimal trauma to surrounding tissue (e.g., nerves and vascular structures at the back of the knee) is procedurally challenging. Furthermore, with open wedge osteotomies, it may be difficult to stabilize the upper and lower portions of the tibia relative to one another and to maintain them in this position while healing occurs. Some attempted solutions have attempted to provide a system, but due to its complexity, this has not adequately met the needs of the industry. The present invention relates to a medial open wedge, tibial high osteotomy of the knee that can and is intended to provide increased precision through a streamlined system when creating a wedge-shaped opening in the bone and stability to the upper and lower portions of the tibia as healing occurs.

Disclosure of Invention

Various terms are used to refer to particular system components. Different companies may refer to a component by different names-this document does not intend to distinguish between components that differ in name but not function. In the following discussion and in the claims, the terms "include" and "comprise" are used in an open-ended fashion, and thus should be interpreted to mean "including, but not limited to …". Furthermore, the terms "coupled" or "coupled" are intended to mean either an indirect or direct connection. Thus, if a first device couples to a second device, that connection may be through a direct connection, or through an indirect connection via other devices and connections.

In general, this disclosure describes systems that may all be used together, in series, or may alternatively be used independently of each other. Each system is configured to perform a portion of a procedure to form and stabilize an open wedge osteotomy. More specifically, these systems may include a first system that helps guide a cutting tool along a preferred reference plane through a medial portion of a tibia; a second system to help guide the cutting tool along the preferred anterior portion of the tibia, a third system to distract the bone hinge, and a fourth system to provide compression on the lateral hinge of the open wedge. Various embodiments are therefore directed to various systems and methods for guiding through medial and anterior cuts of the tibia and distracting and compressing the lateral hinge. The specification now turns to an exemplary system.

Various embodiments relate to a system for stabilizing and compressing a lateral hinge for an HTO surgical system that includes a plate having a plurality of holes therethrough and a tool, such as a drill guide, configured to extend through at least one of the plurality of holes and adjust an offset or offset (standoff) between the plate and a bone surface, thereby adjusting a deflection on the plate. The adjustment may be performed by rotating a portion of the drill guide. In some embodiments, the tool is separate from the drill guide. For example, the distal tip of the drill guide may be threadably engaged with at least one of the holes and rotating the distal tip may further translate the distal tip through the respective hole.

Another embodiment bone fixation system for stabilizing and compressing a lateral hinge for an HTO may include a bone plate having an inner surface, an outer surface, and a plurality of holes therethrough. The system also includes a drill guide configured to adjustably extend through at least one of the plurality of holes and to adjust an offset between the plate inner surface and the bone surface to adjust for deflection on the bone plate. In some example embodiments, the drill guide may include an outer shaft configured to be operably coupled to at least one of the plurality of holes and an axially movable inner shaft configured to extend through the same holes, engage the bone surface and push the bone plate away from the bone surface, thereby adjusting the deflection on the bone plate. In some example embodiments, the bone plate may include a head portion shaped to conform to a metaphyseal end of the bone, and the head portion may include one of a plurality of polyaxial openings. The system may further include a fixation device, such as a locking screw, configured to cooperate with the polyaxial opening to define a polyaxial locking system for lockingly fixing the bone plate to the bone. The polyaxial locking system may be configured to guide the fixation device at an angle that avoids anatomical structures (e.g., ligaments or ligament tunnels) within the metaphysis of the bone. Some example embodiments may also include a dual-angle drill guide that may be operably coupled with the polyaxial opening through the bone plate. The shaft portion of the bone plate may also include a polyaxial opening. The dual angle drill guide may have a first guide axis for guiding a first temporary fixation device into bone at a first angle. The first angle is configured to move the medial portion of the bone plate onto the bone surface, resulting in rotation of the dry bone segment of the bone centered on the temporary screw, thereby compressing the lateral bone hinge. The dual angle drill guide may also include a second guide axis that may be oriented at a non-zero angle relative to the first axis for guiding the drill at a second angle different from the first angle to form a pilot hole in the bone. In some embodiments, the bone plate includes a head portion and a rod portion extending therefrom, wherein the rod portion includes at least two of the plurality of openings, and wherein a first of the at least two openings is a multi-axial opening configured to operably couple to a dual-angle drill guide and a second of the at least two openings is configured to operably connect to an adjustable drill guide. In some embodiments, at least one of the plurality of openings is a multi-axis opening configured to receive a first fixation device therethrough at a first angle, and further configured to receive a second fixation device therethrough at a second angle when the first fixation device is removed.

Also disclosed is a method of compressing a lateral hinge of an open wedge osteotomy, comprising the steps of: placing the bone plate over the open wedge osteotomy; securing an upper portion of a plate to a first side of an open wedge osteotomy; moving the lower end portion of the bone plate away from the bone surface on a second side of the open wedge osteotomy to create an offset for bending the bone plate; adjusting deviation; and temporarily securing an inner portion of the bone plate to the bone to compress the lateral hinge of the open wedge osteotomy, the inner portion disposed on a second side of the open wedge osteotomy between the upper portion and the lower portion while maintaining the adjustment offset. In some example methods, the upper portion of the plate may include at least one variable angle opening, and the upper portion of the fixation plate includes a guide that guides the fixation device through the variable angle opening at an angle away from the intraosseous structure. The structure may include an Anterior Cruciate Ligament (ACL), an ACL reconstruction tunnel, or a meniscal root repair tunnel. In some example methods, moving the lower end portion of the bone plate away from the bone surface and adjusting the offset includes engaging an end of an adjustment guide handle with an opening at the lower end portion of the plate and axially moving a shaft coaxial with and operably coupled to the adjustment guide handle through the opening to engage the surface of the bone. In some example methods, the shaft may be threadably coupled to the adjustment guide handle, and rotation of the shaft moves the shaft axially along the adjustment guide handle. In some example methods, the medial side portion may include a variable angle opening, and securing the medial side portion includes placing a temporary fixation device through the variable angle opening at an angle that applies a rotational load on the second side of the open wedge osteotomy and thereby compresses the lateral hinge. In some example methods, after the temporary fixation of the inner portion, other portions of the bone plate may be permanently fixed to the bone; the temporary fixation device may then be replaced with a permanent fixation device at a different insertion angle through the variable angle opening. In some example embodiments, the temporary fixation device may be placed using a dual angle guide, and wherein the dual angle guide further comprises an axis oriented to guide the drill along different insertion angles to form the pilot hole.

Another embodiment system may include a connected cut guide system for preparing a medial incision during HTO surgery including a retractor for insertion into the posterior side of the tibia to protect neurovascular structures and provide a visual indication under the perspective of a medial-lateral tilt vector. The system also includes a cutting guide pivotally coupled to the retractor, the cutting guide configured to encircle a medial side of the tibia and including an elongated cutting slot for receiving and controlling a cutting tool, such as a saw, to create a medial incision. The cutting flutes define a back side slope cutting vector. The connecting cut guide system further includes a front pin configured to be inserted through an opening in the cut guide at a location that defines a boundary of a preferred reference plane and also lies on the reference plane, the preferred reference plane being defined by a medial-lateral tilt vector and a posterior slope cut vector.

The cutting guide system may further include a pin positioning guide selectively coupled to the cutting guide to guide insertion of the leading pin. The cutting guide pin positioning guide may include a pin guide coupled to the cutting guide and an adjustable flag having a linear edge that may be aligned with the back side slope cutting vector. The retractor may include a slot for receiving an arm of the cutting guide. The linked cutting guide system may also include a frontal cutting guide system for guiding a frontal incision during HTO surgery. The anterior cutting guide has a lumen for sliding on the anterior pin and a cutting surface for guiding the trajectory of the bone cutter and a fixation device for coupling to the anterior cutting guide and stabilizing the orientation of the anterior cutting guide. The fixation means may comprise a pin or screw inserted through a portion of the anterior cutting guide.

Another further embodiment system may include a cutting guide system for guiding an anterior incision during an HTO procedure. The cutting guide system may include a pin for partial insertion into the bone such that a portion of the pin is inserted into the bone and a portion is not inserted and exposed. The cutting guide system also includes a cutting guide having an inner cavity for sliding over the exposed portion of the pin, a cutting surface for guiding a trajectory of a bone cutting tool, and a fin configured to be inserted into the open wedge osteotomy and defining an orientation of the cutting surface. The cutting guide also includes a fixture for coupling to the cutting guide and stabilizing the orientation of the cutting guide.

Drawings

For a detailed description of exemplary embodiments, reference will now be made to the accompanying drawings in which:

1A-1B illustrate a tibia having vertical anatomical marker lines for marking lateral hinge boundaries;

fig. 2A illustrates a retractor disposed on a posterior portion of a tibia according to the present disclosure;

figure 2B illustrates a retractor and cutting guide disposed about a tibia according to the present disclosure;

figure 2C illustrates a cutting reference plane defined by the retractor and the cutting guide according to the present disclosure;

figure 2D illustrates a cut reference plane defined by a retractor and a cut guide oriented through a tibia according to the present disclosure;

figure 2E illustrates the retractor, cutting guide, and anterior pin oriented relative to the tibia according to the present disclosure;

FIG. 2F shows a view of a reference plane according to the present disclosure;

figure 2G illustrates a cut reference plane and boundary defined by the retractor and the cutting guide and pin according to the present disclosure;

fig. 2H illustrates a connection guide system aligned with a tibia according to the present disclosure;

fig. 2I illustrates an alternative view of a connection guide system aligned with a tibia according to the present disclosure;

FIG. 2J illustrates a method of aligning a front pin according to the present disclosure;

FIG. 2K illustrates a K-wire and depth gauge extending through a cutting guide according to the present disclosure;

FIG. 2L shows a view of the connection guide system with a saw passing therethrough according to the present disclosure;

fig. 2M illustrates an anterior view of a system according to the present disclosure relative to a tibia;

fig. 3A illustrates a medial-anterior view of a tibia with an inserted pin and an anterior cutting guide according to the present disclosure;

3B, 3C, and 3D illustrate a method of aligning an anterior cutting guide according to the present disclosure;

fig. 4A and 4B illustrate an alternative embodiment of an anterior cutting guide and method of use according to the present disclosure;

FIG. 5A shows an exploded view of a sheet dilator according to the present disclosure;

FIG. 5B shows a side view of a sheet dilator according to the present disclosure;

FIG. 5C shows the tip of the sheet dilator placed within the incision (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;

7A-7G illustrate a method of compressing an outboard hinge using a plate drilling system according to the present disclosure;

figures 8A and 8B illustrate top and cross-sectional views, respectively, of a dual mode drill guide according to the present disclosure;

figures 9A and 9B illustrate exploded and cross-sectional views, respectively, of an adjustable drill guide according to the present disclosure;

FIG. 10 illustrates the mechanics of compressing the outboard hinge according to the present disclosure;

fig. 11 illustrates an isometric view of an embodiment of a plate molded and aligned with a tibia, according to the present disclosure;

FIG. 12A schematically illustrates a forming plate embodiment according to the present disclosure; and

fig. 12B schematically illustrates a shaped plate embodiment relative to the tibial diaphyseal axis according to the present disclosure.

Detailed Description

The following discussion is directed to various embodiments of the invention. Although one or more of these embodiments may be preferred, the embodiments disclosed should not be interpreted, or otherwise used, as limiting the scope of the disclosure, including the claims. In addition, one skilled in the art will understand that the following description has broad application, and the discussion of any embodiment is meant only to be exemplary of that embodiment, and not intended to intimate that the scope of the disclosure, including the claims, is limited to that embodiment.

The present disclosure may generally include four systems; a first system for precisely creating a cut extending from the medial side of the tibia, a second system for creating an anterior cut in the tibia, the anterior cut extending from the medial cut, a third system for distracting the two bone segments to a desired wedge angle, and a fourth system for stabilizing the open wedge formed by opening the medial and anterior cuts. These systems may be used together, but may also be used independently of each other. In other words, as an example, a first system may be used to form a medial incision in the tibia and an anterior incision may not be necessary, or may be created using a different system not disclosed. As another example, the entire open wedge may be prepared using a system not disclosed herein, and the fourth system may be used only to secure and compress the lateral hinges.

The first system is a joint guide system 90, best seen generally in fig. 2J and 2L, configured to define and control a reference plane for a medial cut or osteotomy line in the tibia. The connection guide system 90 generally includes a posterior retractor 100, a cutting guide 150, an anterior pin 200, and a means of aligning the anterior pin 250. The connection guide system 90 provides a method of aligning the retractor 100 and the cutting guide 150 to define a medial cutting plane and retract and protect neurovascular structures during a medial open wedge osteotomy. Fig. 1A and 1B show a tibia 5 on which an exemplary open wedge osteotomy is to be performed. According to the invention, the open wedge osteotomy is achieved by first making a cut 10 in the upper tibia, and then manipulating the lower portion of the tibia 5 to open a wedge-shaped opening in the bone (shown in fig. 6B) configured to accommodate the manner in which load is transferred from the femur to the tibia. If a vertical (anterior cut) is to be made in a posterior step, it is preferable to mark line 15 along the medial side of tibial spine 20, line 15 being parallel to the anterior face 25 of the tibial plateau. This line 15 may later be used as the intersection of the medial and anterior incisions.

The cutting plane and advancement of the cutting tool can be visualized directly or under fluoroscopy. The connection guide system 90 may include a posterior retractor 100 that may be curved to aid in placement on the posterior portion of the tibia 5, and a cutting guide 150 connected to the retractor 100. As shown in fig. 2A, posterior retractor 100 includes a handle 105, an opening 110, and a retraction portion 120 (the retraction portion is shaded in fig. 2A due to being posterior to the tibia). Handle 105 is generally sized and shaped to be held by a user and to position back retractor 100 at the correct angle. Slot 110 may be disposed between handle 105 and retraction portion 120 and may be sized to couple with a cutting guide 150 (see later figures). As shown in fig. 2A, retractor 100 is inserted into the posterior side of tibia 5 to protect neurovascular structures and provide a visual indication under the perspective of medial-lateral tilt vector 130(MLI vector). The posterior retractor 100 may be inserted to retract and lift the MCL, or inserted behind the MCL to allow a medial cutting guide (described later) to provide retraction. Retracting portion 120 may include markings, such as a series of holes 122 aligned along the longitudinal axis (X-X) of retractor 100, to align retractor 100 with a desired vector 130. Retracting portion 120 may also include a series of slots 124 oriented perpendicular to the longitudinal axis (X-X) to provide measurements when visualized under fluoroscopy. The slots 124 may be spaced a set and equal distance from each other to assist the surgeon in measuring the depth of the saw through the tibia, so the slots 124 are openings that are wide enough to view the saw blade passing therethrough. For example, the slots 124 may be spaced 10mm apart. In addition, the slot 124 is long enough, or extends on both sides of the longitudinal axis X-X, to observe deviations of the saw blade away from the longitudinal axis X-X (explained in more detail in later figures). Retractor 100 is preferably made of metal so that it is easily sterilized and therefore reusable. The retractor is preferably visible under fluoroscopy. In alternative embodiments, retractor 100 may at least partially comprise a translucent or transparent polymer, such as PEEK, for better viewing of the blade path. Metal ribs may be added at locations approximately equivalent to the location of the slots 124 to increase the rigidity of the retractor 100 and also to protect the PEEK from saw blade damage and from the formation of PEEK cuttings in the patient. The metal ribs are also preferably visible in perspective.

The retracting portion 120 has a shape that can be contoured and similar to the curvature of the posterior superior portion of the tibia 5 to serve as a physical and visual reference during placement. For example, the retracting portion 120 can include a curved edge 126 around a portion of the circumference of the retracting portion 120 to engage a corresponding curved portion of the tibia 5 and better maintain the medial-lateral tilt vector 130 and the position of the retractor 100. Slot 110 may be disposed between retraction portion 120 and handle 105 so as to be located near the medial outer edge surface of tibia 5 when the retraction portion is placed on the posterior portion of tibia 5. A kit may be provided with multiple retractors 100 that may have different configurations from one another, such as different profiles, curvatures, and longer retracting portions 120 to accommodate variations in tibial dimensions.

As shown in fig. 2B and 2F, the retractor handle 105 may be offset relative to the retractor portion 120 to better bypass the patient anatomy and retract tissue, and also to visualize placement of the retracted portion. The rocking/offsetting allows access to the posterior side by lifting the MCL and placing the MCL on the outer surface side of the retractor portion 120 (indicated by M on the retractor 100) or minimally lifting the MCL and placing the retractor on the outside of the MCL, where the MCL will be in position M'.

The cutting guide 150 is configured to be placed substantially medial to the tibia 5. The cutting guide 150 may define a curve configured to encircle the medial side of the upper tibia. Cutting guide 150 includes a coupled end 155 and a free end 175, the coupled end 155 configured to couple with the slot 110 of the retractor 100. Once the retractor 100 is in the preferred position, the cutting guide 150 may be coupled to the retractor 100. A kit may be provided that includes a plurality of cutting guides configured to accommodate various tibial anatomical sizes. As shown in fig. 2C, the link end 155 includes an elongated arm 157 that is sized to fit through the slot 110 and may be generally rectangular in cross-section. The elongated arm 157 and the slot 110 are configured to cooperate with each other to allow some pivotal movement along the plane 170, and also to allow some limited sliding movement of the cutting guide 150 along the plane 170. However, the elongated arm 157 and the slot 110 are configured to cooperate to retain the saw slot 160 on the flat 170. The saw slots 160 in the inboard cutting guide 150 help define a rear side slope cut vector (PSC vector) 180. The MLI 130 and PSC 180 vectors define a reference plane 170 (described in later figures) that the saw follows when making a medial cut or osteotomy. The retractor 100 and the cutting guide 150 are connected such that the two vectors MLI 130 and PSC 180 will maintain the cutting plane 170 even when they "hinge" open and closed. Fig. 2D shows the retractor 100 and the cutting guide 150, the vector MLI 130 and the PSC 180 to define a cutting plane 170 through the tibia. The cutting guide 150 can be first coupled to a handle 260 (described in more detail later) and then connected to the slot 110 of the retractor using the handle 260.

As best shown in fig. 2E, 2F, and 2G, the system may further include an anterior pin 200 that extends through the thickness of the cutting guide 150 and into the tibia 5. The cutting guide 150 includes an opening 165 configured to receive the pin 200, the opening 165 disposed at an end of the saw slot 160, and may be continuous with the saw slot 160. The opening 165 may define a lateral end of the saw slot, and may also define a larger opening than the saw slot 160. The opening 165 may be oblong such that the front pin 200 may be constrained to align with the saw slot 160, but may move laterally closer to or further from the free end 175. In other words, the opening 165 restricts the pin position so that its central axis lies on the plane 170, but the relative position of the pin 200 and the retractor 100 can be adjusted according to the size of the tibia 5. 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 as having a threaded end 201 and a coupling end 203. In some embodiments, the front pin may be completely smooth, similar to a k-wire. The coupling end 203 may be configured to engage with an insertion tool (not shown) and may have a non-circular cross-section, such as a hexagonal or square cross-section, to better transmit rotational motion from the insertion tool to screw in the front pin 200. Notably, curved edge 126 of retracting portion 120 is readily visible in fig. 2F and 2G. As shown in later figures, the cutting guide 150 may be fixed in place with a speed pin or fixture that extends through the hole 162 and into the tibia 5.

The front pin 200 may be precisely placed using a pin guide 250 with a flag 300 that may be selectively coupled to the cutting guide 150. The front pin 200, the cutting guide slot 160, and the wire through the retractor 122 may all define the cutting plane 170 and its boundaries. The front pin 200 may be preferably placed in a position collinear with the intersecting axis of the medial cutout and the anterior cutout (described later). The front pin 200 has at least 2 functions; it provides protection for the tibial tuberosity during medial cutting (described in later figures) and also provides a stabilizing means for the cutting guide 150, which will facilitate making an anterior cut in a later step. As shown in fig. 2B, the wire 15 (seen through the opening 165 in the view) may be seen through the medial cutting guide 150. Due to the thickness of the medial cut guide 150, the front pin 200 will be placed parallel and aligned with the medial cut reference plane. Thus, the remaining degree of freedom in pin placement is its angle relative to the PSC vector borehole.

The preferred pin placement trajectory is a vector originating at the intersection of the medial incision and the score line 15 on the medial tibia and parallel to the joint line. The visual guide 250 may be coupled to the medial cutting guide 150, the medial cutting guide 150 having a 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 sized for selective insertion into the guide opening 185 to selectively align the visual guide 250 with the cutting guide 150. The handle 260 and the distal tip 255 may be disposed along and concentrically on the longitudinal axis of the visual guide 250. With reference to the anterior tibia, the visual guide 250 is configured to align, pointing anteriorly, as shown in fig. 2H, 2I, and 2J. The landmark element 300 may be coupled to the visual guide 250 and selectively moved to align the linear edge 310 of the landmark 300 with the anterior tibia. The handle 260 may include a bore 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 may be locked in place using a set screw. The logo 300 may terminate in a linear edge 310 for pin alignment. The tip of the front pin 200 may be placed in the slot 165 in the inner guide 150 and preferably inserted into the score line 15. It may be advanced through the tibial tuberosity parallel to the bottom linear edge 310 of the alignment mark 300. The linear edge 310 may be aligned with the vector 180.

The K-wire 320 may also be placed to the depth of the hinge point by the cutting guide 150, as shown in fig. 2K, and the depth measured using the depth gauge 325. The cutting guide saw slot 160 may include a series of notches 163 along the length of the saw slot 160 to receive a k-wire that may be larger in diameter than the saw slot 160. The k-wire provides depth information about how deep the saw should extend into the tibia 5.

Once the front pin 200 is placed, the visual guide 250 and the flag 300 may be removed. The medial incision 10 can be safely made and contained between the posterior retractor and the anterior pin, with depth information from the k-wire. The exemplary saw 350 is shown extending through the saw slot 160 in fig. 2L to make an inboard cut along the plane 170. An exemplary saw 350 may be a pendulum saw or osteotome adapted to pass through the medial cutting guide 150. The saw 350 will be coplanar and controlled to extend along the fiducials 170 produced by the joint guide system 90. The saw and osteotome may be advanced laterally until it reaches the desired "lateral hinge" point, guided by the k-wire and determined by the surgeon during pre-operative planning.

Second System-anterior cutting guide

The present disclosure now turns to a second system configured to guide an optional anterior incision if desired by the surgeon. The anterior incision may preferably be used to form a biplanar tibial high osteotomy (HTO). The second system is a front cutting guide 500 that can create a vertical front cut with a front pin 200 that has been placed in the previous figures, as shown in fig. 3A. The anterior cutting guide 500 may be configured as either a left or right leg, and thus the kit may include two mirror-imaged anterior cutting guides 500 to accommodate the target side of the patient. If used independently of the first system, a separate front pin may be added. Using placement of the anterior pin 200 from a previous step in the procedure, an adjustable cutting guide may be fitted over the pin 200 and used to guide the anterior incision. The pin 200 may define the intersection of the medial and anterior cutouts. Once the medial incision is complete (perhaps as described in fig. 2A-2L), the pin 200 may remain in place while the retractor 100 and cutting guide 150 may be removed. The front cutting guide 550 is configured to slide on the headless pin 200. The anterior cutting guide 550 may include an elongated lumen 560 or opening configured to slide over the pin 200 and help guide alignment. The lumen 560 is sized such that the guide can rotate about the pin 200. The medical incision 10 can be seen in fig. 3B with the pin 200 passing through the end of the medical incision. The guide 550 may also include an elongated cutting slot 570 defined between a first vertical linear edge 575 and a second parallel linear edge 580 of the guide 550. The cutting slot 570 is wide enough to receive, for example, a sagittal saw or osteotome. As shown in fig. 3C, the guide 560 may be fitted over the pin 200 and rotated to align the cutting slot 570 with the marking line 15. The cutting slot 570 may be visually aligned with the line 15 made at the beginning of the procedure and then secured in place with a temporary pin. For example, a second pin or screw or fixture 590 may be inserted through the hole 585 in the tibia 5 to fix alignment with the marker 15. In an alternative embodiment, a securing device may be inserted to abut an outer edge surface of the guide 550 to secure the guide 550 in its orientation, reducing the need for holes therethrough. The anterior cutting guide 550 may include a lip 552 to retain the guide 550 and align the cutting slot 570 with the indicia 15.

An alternative embodiment of the cutting guide system 650 is shown in fig. 4A and 4B, the guide including a lip 652 or handle to retain and align the guide 650 and a fin 654 for sliding into the medical incision 30. Similar to the previously described embodiments, the guide 650 includes an opening 660 for sliding over the pin 200 and may include a hole 680 for receiving a screw of the pin, once aligned, for securing the guide 650. The surface 690 may provide a cutting surface for guiding the saw in the correct orientation. The fins 654 may be tapered (not shown) for ease of insertion into the medial cutout 30. As shown in fig. 4B, surface 690 is not aligned with indicia 15. The inventors contemplate a series of guides with different orientations for the surface 690 so that the surgeon can select the closest one.

The main advantage of system 500 is that it uses one guide instead of several fixed angle guides to compensate for variability. The use of one guide pin 200 at the intersection of the cutting planes allows better control and management of the cut. The anterior incision can now be made safely guided using a sagittal saw.

Third System-lateral hinge distraction System

The present disclosure now turns to a third system for initiating distraction of the two bone segments on either side of the incision 10, followed by wedging the two bone segments apart according to a determined open wedge angle. The osteotome or saw 350 used with the guide 200 may have a thickness that results in a narrow opening at the medial surface of the tibia, so the sheet expander 700 with a thin tip may preferably initiate distraction of the two bone segments first. The sheet expander 700 shown in fig. 5A, 5B and 5C may thus comprise an "L" -shaped end having a pair of thin, blade-like prongs 710 movable relative to each other, the prongs being configured to wedge into the narrow opening formed by the incision 10, and thus between the opposing bone surfaces of the incision 10. The prongs 710 may be tapered 715 to further facilitate insertion into the medial boundary of the incision 10. The expander 700 further comprises means for controlling the rate of relative movement between the tines 720 and thereby the rate of distraction of the bone segments, which means comprises a pair of lever arms 720 and a set screw mechanism 725 positioned therebetween. Stretching too quickly may break the lateral hinge, so a means to limit the rate of prong separation and thus the rate of stretching is preferred to mitigate lateral hinge damage. Lever arm 720 can be hingedly attached 712 such that relative motion between the lever arms moves tip 710. The threaded knob 722 may be operably coupled to a set screw that is operably coupled to the at least one lever arm 720 such that rotating the knob 722 may pull the lever arms 720 toward each other and slowly separate the prongs 710. Additionally, portions of the dilator 700 may be formed of a flexible material (e.g., spring steel or polymer) to further limit the rate of stretch. Fig. 5C shows prong 710 placed within the narrow opening formed by incision 10 and beginning to stretch along arrow 701.

Once the sheet dilator stretches the opening at least a few millimeters, the sheet dilator may be removed and further stretching performed with the wedge system 750, as shown in fig. 6A and 6B. A plurality of wedges 760 may be provided as part of a kit, for example, packaged with a tray, with the plurality of wedges 760 configured to accommodate various wedge opening angles, depending on the patient's anatomy and desired correction geometry. Each wedge 760 may have a different wedge angle and may include a series of markings 755 having an indication of the respective thickness of the wedge at the markings, such as a thickness of 1-10 mm. Alternatively, each marker 755 can indicate an opening angle. The opening angle and/or opening width is preferably calculated as part of the pre-planned procedure based on a series of images (e.g., X-rays along various planes orthogonal to the target bone).

The two wedges 760a and 760b may be selectively inserted and driven into the opening 30 until the indicia 755 is aligned with the outer surface of the tibia at a value determined as part of the pre-operative plan. In some cases, biplanar correction may be preferred where the anterior wedge opening is different than the posterior side. Accordingly, wedge 760a may have a different wedge slope than wedge 760 b. Each wedge may be selectively attached to a handle system 765, which may be operably coupled to at least one wedge 760, and end 766 may be tapped to insert wedges 760a and 760 b. Two separate handles (one for each wedge) may be provided instead. In the illustrated embodiment, two wedges 706a and 760b are coupled to a single handle such that the front and rear wedge openings are formed substantially simultaneously. This may help to form a more consistent opening angle from the determined opening angle value.

Fourth system-lateral hinge compression system.

The present disclosure now turns to a fourth system comprising a fixation plate and a drill system for providing compression to the lateral hinge of the HTO to promote faster bone healing during HTO surgery. Fig. 7A shows a plate 1100 having a plurality of holes 1200 therethrough. Holes 1200 are generally configured to receive a series of fixation devices, such as non-locking/locking screws, for attaching plate 1100 to a portion of bone 5, including a distracted portion of bone (open wedge 30). The plate 1100 is an exemplary shape and the number and location of the holes 1200 may vary. The plate 110 may be contoured to approximate the outer surface of the tibia to better match the tibia, reducing irritation between adjacent soft tissue and the plate 1100. Multiple plates may be provided, not only to accommodate left or right patient legs, but also to accommodate different tibial sizes. The lateral hinge compression system is configured to avoid double holes (8-shaped or snowman-shaped holes) while still providing compression for distraction of the lateral hinge during HTO surgery. As shown in fig. 7A, three fixation devices (e.g., locking screws) have been inserted through the uppermost hole 1200a to fix the plate 1100 with the proximal portion of the tibia, above the wedge-shaped opening 30.

The adjustable drill guide 1300 may then be inserted through the lowermost hole 1200d, the adjustable drill guide 1300 including an adjustable distal tip 1310 configured to set and adjust the offset X of the portion of the plate 1100 proximate the lowermost hole from the bone 5. Adjusting the offset X allows the user to select how much offset X the lower end of plate 1100 has, thereby adjusting the amount of bending in plate 1100, and thus the compression on wedge-shaped opening 30 and bone hinge 35.

Turning to fig. 10, a brief description of the bone hinge compression mechanics is disclosed. If the lateral bone hinge breaks during surgery, compression on the lateral hinge may reduce the chance of non-healing. Compression may also allow weight to be borne earlier on the osteotomy as it preloads the osteotomy, which reduces the chance of losing correction during the healing process. In fig. 10, an example plate 1100 is shown, fixedly coupled at point a, possibly using a hole such as 1200 a. Using an adjustable drill guide such as guide 1300, the distal end can be pushed open to establish an offset value X with the bone surface at point B. The offset X may be adjustable so that the surgeon may select the level of compression to be placed on the lateral hinge. In some embodiments, distance markings may be provided on the drill guide to indicate the distance of the offset. In other embodiments, a load cell, such as a spring loaded plunger, may be operably coupled to the adjustable drill guide such that the surgeon may adjust the offset to a target force value. The offset X is maintained by the drill guide and a temporary compression screw may then be placed through the plate and into the bone at point C. This brings the middle portion of the plate 1100 to the bone surface at point C and creates rotation D on the inferior segment of the tibia 5 and resultant compressive force E on the lateral hinge 35.

Returning to fig. 7A-7G, and as best shown in fig. 7B and 9A, adjustable drill tip 1310 may include a handle 1320 that may include a passage 1322 therethrough (best seen in fig. 9A and 9B) to allow passage of a tool. The channel 1322 continues through the distal tip 1310. The adjustable drill guide 1300 also includes an outer shaft 1330 for receiving the handle 1320, the outer shaft including threads 1312 that engage corresponding threads or surfaces on at least the lowermost hole 1200 d. Outer shaft 1330 and handle 1320 may also be threadably coupled to each other between an outer surface of handle 1320 and an inner surface of shaft 1330, configured to axially advance distal tip 1310 along shaft 1330. Coupling to the lowermost hole 1200d by the threads 1312, rotating the handle 1320 relative to the shaft 1330 will thus advance or withdraw the distal tip 1310 into or out of the lower opening 1200d and move the lower portion of the plate 1100 away from or near the outer surface of the tibia. Advancing the distal tip 1310 increases plate deflection, indicated by an X in fig. 7B, thereby increasing the deflection of the plate 1100. The threaded portion 1312 may be tapered to accommodate different sizes or diameters of the bore 1200 d. In alternative embodiments, 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 may include a series of teeth or engagement elements that engage corresponding teeth or engagement elements on the outer shaft 1330. In this embodiment the axial spring may be coaxial with the outer shaft and the handle to maintain engagement.

With the adjustable drill guide 1300 still inserted and held at the offset X, the dual mode drill guide 1400 may then be inserted into the hole 1200C, preferably near the middle of the plate 110 and near and distal to the wedge opening 30, as shown in fig. 7C. The dual mode drill guide 1400 may include a threaded distal tip 1410 for engaging the hole 1200 c. The dual mode drill guide 1400 may have two fixed trajectories, including a standard trajectory for the final locking screw a and an angled trajectory B for inserting a temporary compression screw at the lower lateral angle. The temporary screws may include any non-locking screws, such as cortical, compression, or osteopenic screws. In an alternative embodiment, a conical guide may be provided to set a limit on the insertion angle, rather than a fixed value for the insertion angle of the fixture. As previously described, compressing plate 1100 in this manner causes the middle third of the plate to flex inwardly toward bone 5 and the resulting rotational force produces compression of lateral hinge 35. The screws or fixation means both extend through the same hole 1200c in the plate, and the angled trajectory B and the inferior lateral angle may be fixed. The hole 1200c is preferably approximately circular, having a single central axis therethrough, as opposed to a dogbone hole. The bore 1200c may define a variable angle opening such as those disclosed in U.S. patent 8888824, which is commonly owned and incorporated herein by reference in its entirety. An opening, such as opening 1200C, may be a variable angle opening, including fins or protrusions extending radially inward from an inner surface of opening 1200C and into an interior region of opening 1200C, and which is configured to engage or mate with a head portion of a bone fastener. In use, the fins engage the head portion of the bone fastener to secure the bone fastener in a desired position and a desired angular orientation within the variable angle opening 1200C. Additional information regarding the operation and configuration of fins can be found in the following patents: U.S. patent application No. 15/706,877, with an earliest filing date of 25/7/2005, is now U.S. patent No. 10,092,337 entitled "Systems and Methods for Using polymeric Plates" and; U.S. patent application No. 13/524,506 entitled "Variable Angle Locking Implant" filed on day 6, 15 of 2012 and U.S. patent application No. 62/858,727 entitled "Orthopedic Implant with improved Variable Angle Locking Mechanism" filed on day 6, 7 of 2012, the entire contents of which are incorporated herein by reference.

The dual mode drill guide 1400 thus includes a first hollow shaft 1420 that provides a channel for drilling therethrough and into bone along trajectory a to form a pilot hole along trajectory a. The dual mode drill guide 1400 may also include a second shaft 1430 providing a channel for screws to pass therethrough and into the bone along trajectory B. The dual modality drill guide can best be seen in fig. 8A and 8B. The second shaft 1430 may be smaller in diameter and the screw head 1450 may remain outside of and spaced apart from the bore 1200c, as shown in fig. 7D. This allows easy access to remove the temporary screw. As previously described, the temporary screw 1450 may pull the plate onto the outer surface of the bone and place the lateral hinge 35 in compression. The first hollow shaft may be configured to allow the drill to pass completely through to form a pilot hole for later placement of the locking screw. First hollow shaft 1420 may be longer than second hollow shaft 1430, with first hollow shaft 1420 also serving as a means to steer/hold the dual-modality drill guide, or in other words, as a handle. Once the temporary fixation device is inserted in the oblique trajectory B, two remaining locking screw holes 1200e located below the osteotomy may now be drilled and implanted, as shown in fig. 7D.

The offset drill guide may then be used to drill a pilot hole through the opening 1200d and then removed to allow a fixation device, such as a locking screw, to further fix the plate 1100 to the bone. The temporary screw 1450 inserted in an angled trajectory can then be removed, since the locking screw placed underneath is angularly stable and the flexure in the plate 1100 will remain. The dual mode drill guide 140 may be removed and a locking screw may be placed into the bone along the previously formed pilot hole. The temporary screw 1450 may be reused in the remaining hole 1200b immediately above the wedge opening.

Fig. 11 shows an alternative embodiment of a plate 1500 that includes a plurality of openings 1550 and is shaped to mate with the tibia 5. The plate may comprise a 2-3mm thick plate, formed of titanium and may include a plurality of openings 1550, some of which are variable angle locking holes, as described herein. The plate 1500 may include a first variable angle locking opening 1550a and a second variable angle locking opening 1550 d. Similar to the previously described embodiments, the plate 1500 will first be attached to the superior portion of the tibia via fixation means 1550a and 1550 b. The most anterior hole 1550a is a variable angle opening to allow placement of fixation devices and avoidance of certain structures associated with the tibia 5. For example, ACL reconstruction or meniscal root repair tunnels may have been performed simultaneously as part of the surgery. The variable angle opening at the upper end of the tibia allows the fixation device to be placed at an angle that avoids the area around or over the ACL or meniscus root. Similar to the previously described plate system embodiments, an adjustable offset drill guide, such as drill guide 1300, may then be operably coupled to opening 1550c and may form an offset X as previously described. A temporary compression screw may then be placed in opening 1550d at an angle configured to compress outside hinge 35. The fixture may then be placed in opening 1550e, then in 1550c after removal of the adjustable guide 1300. The temporary screw may be removed from the opening 1550d before placing the permanent locking screw through the opening at a different angle. The plate 1500 may include a distal bending axis 1560 to better align with the tibial diaphysis. The non-bending axis is labeled 1565 for reference.

The above discussion is meant to be illustrative of the principles and various embodiments of the present invention. Numerous variations and modifications will become apparent to those skilled in the art once the above disclosure is fully appreciated. It is intended that the following claims be interpreted to embrace all such variations and modifications.