JP6095800B2 - Surgical perforation guide - Google Patents

Description

  The present invention relates to a surgical perforation guide, particularly for performing open and closed wedge osteotomy of the knee.

  Knee osteotomy is a surgical technique used to rearline the large joints of the lower limbs, ie hip joints, knee joints and ankle joints. When the axis of the limb is properly aligned, the center of the hip joint, the intercondylar bulge of the tibial plateau, and the center of the ankle joint are in a straight line, forming the so-called Mikulitz line, which is the lower limb function axis .

  This alignment can be inhibited, for example, by joint damage on one side of the knee, congenital misalignment, or traumatic injury, which can cause excessive wear on the knee joint cartilage. This is known as knee arthropathy.

  The purpose of the knee osteotomy surgical procedure is to rebalance the force applied to the knee from the knee injury site to the healthier site on the opposite side. Thereby, the force which generate | occur | produces in a knee joint with a patient's weight and muscles can be disperse | distributed favorably.

  In clinical practice, two procedures are common: open wedge osteotomy and closed wedge osteotomy. Both procedures aim to partially or completely reconstruct the above-mentioned Mikulitz line.

  When the closed wedge method is performed, the bone below the tibial plateau is removed in a wedge shape. The tibial plateau is then pulled down to close the gap and secured with a trauma plate and screws.

  In performing the open wedge method, the bone below the tibial plateau is cut horizontally over approximately 80% of the surface area. Then, a wedge-shaped spacer is inserted. For this reason, one side of the tibial plateau is lifted and the lower limb axis is corrected. The wedge-shaped spacer can be composed of natural bone, artificial bone, or other biocompatible or bone-binding material. The spacer is typically secured to the bone by a plate and screws.

  Osteotomy offers significant benefits to the patient because it is useful to postpone the possibility of total knee replacement for up to 10 years.

  Many guides are known in the past to assist surgeons in wedge osteotomy. For example, U.S. Pat. No. 7,185,645 (Hudson Surgical Design Inc.) discloses an apparatus that provides a guide surface for a planar cutting tool such as a vibrating bone saw. The cutting tool is guided by a tangent plane of a plurality of pin members arranged inside the bone to be modified. Two or more of the pin members define a target plane of the cut surface formed by the cutting tool.

  US Patent Application Publication No. 2008/0262500 (Howmedica Osteonics Corp.) discloses an osteotomy procedure having a first arm with a first guide surface and a second arm with a second guide surface. A cutting guide for performing the above is described. The first and second arms are pivotally connected to each other. In addition, the surface of the cutting guide may be provided with a circular groove that constitutes a drill guide that allows the drill to be guided into the bone when the two arms are in the closed position.

  US Pat. No. 5,021,056 (Intermedics Orthopedics Inc.) discloses a method and apparatus for performing osteotomy. The apparatus includes a first guide assembly including a pair of mirror clamp arm assemblies each having a clamp plate. The clamp arm is freely slidable along the first guide assembly. Each clamp plate features a plurality of bores and guide slots for cutting tools. By using the first guide assembly, a first cut is made in the bone through the guide slot, so that the clamp plate is stabilized by the bone fasteners inserted into the plurality of bores. The first guide assembly is then removed and the second guide assembly is placed on the bone and a flat blade element is inserted into the bone cut. The second guide assembly includes a plurality of guide slots capable of forming a suitable wedge in the bone by forming a cut at a different angle than the first cut.

  Despite the benefits offered by open and closed wedge osteotomy, this procedure is often associated with complications that make the patient feel uncomfortable during the recovery or complicate the surgical procedure itself There is. For example, one of the major challenges during surgery is to cut the bone to a certain depth and then lift the tibial plateau above the osteotomy without fracture or detachment of the proximal tibial plateau (so-called iatrogenic fracture) Is mentioned.

US Pat. No. 7,185,645 US Patent Application Publication No. 2008/0262500 US Pat. No. 5,021,056

  The object of the present invention is a perforation guide for the technical field described first, which facilitates the implementation of open and closed wedge osteotomy and reduces the risk of iatrogenic fractures during the procedure. It is to create.

  The solution of the invention is defined by the features of claim 1. According to the present invention, the surgical perforation guide is fixed to the bone of interest and comprises at least one first elongated slot or at least one projection defining a first osteotomy plane. . The surgical drilling guide further comprises a plurality of drill guide bores each having a diameter and a central axis, the central axes of the plurality of drill guide bores being parallel to the first osteotomy plane, the plurality of drills The diameter of each guide bore intersects the first osteotomy plane. Further, each of the plurality of drill guide bores includes a drill seat that provides a stop surface for the drill, and each of the stop surfaces is associated with each of the plurality of drill guide bores to determine a drilling depth that is necessary. Limit to depth.

  By providing a drill seat, it is possible to avoid damaging the soft tissue on the other side of the bone due to the surgeon overdrilling. In addition, the drill seat provides precise control over the depth of the hole drilled into the bone, which weakens the bone locally enough to increase flexibility and allow the surgeon to open or close the wedge. Occurrence of a primary fracture can be avoided.

  The surgical perforation guide preferably comprises a rigid body and is configured as a block of biocompatible material such as stainless steel, titanium, or a biocompatible polymer such as polyetheretherketone (PEEK) or polylactic acid (PLA). More preferably. The rigid body is generally formed in the form of a rectangular parallelepiped configured to be placed in contact with a target bone having an appropriate curvature, for example, and the bone contact surface is the size of the side surface of the tibia. It is preferable to have a length substantially corresponding to.

  The at least one first elongated slot provides two guide surfaces for a planar cutting tool, such as a reciprocating bone saw blade. For this reason, according to the at least one first elongated slot, the planar cutting tool can be accurately guided along the first osteotomy plane. The thickness of the at least one elongated slot is preferably selected to match the thickness of the saw blade.

  Alternatively, the surgical perforation guide may comprise at least one protrusion, which is preferably configured to be insertable into a bone cut. For this reason, according to the at least one protrusion, the surgical perforation guide can be precisely aligned with respect to a cutting portion made by, for example, a bone saw.

  Each of the drill guide bores includes a first osteotomy plane because the diameter of the plurality of drill guide bores intersects the first osteotomy plane. The plurality of drill guide bores are preferably disposed on the surgical perforation guide such that their axes are in the first osteotomy plane. Alternatively, the axes of the plurality of drill guide bores may be offset from the first osteotomy plane, but not more than half their diameter. In this application, “offset” means the distance from the first osteotomy plane in a direction perpendicular to the first osteotomy plane.

  The axes of all the drill guide bores are preferably not only parallel to the first osteotomy plane but also parallel to each other. Alternatively, at least one of the drill guide bores may have an axis at an angle with respect to the axis of the other drill guide bore. All axes of the drill guide bore are preferably offset by the same distance from the first osteotomy plane. Alternatively, at least one of the drill guide bores may be offset by any distance greater or less than the offset distance from the first osteotomy plane of the other drill guide bore axis.

  All of the plurality of drill guide bores are preferably evenly distributed over the entire length of the bone contacting surface. That is, the plurality of drill guide bores are all spaced apart from each other by the same distance. Alternatively, the distance between two adjacent drill guide bores may vary along the length of the bone contact surface.

  It is understood that the term “plurality” includes any number greater than or equal to two. The surgical drilling guide preferably comprises 2 to 20 drill guide bores, more preferably 4 to 10 drill guide bores.

  The drill guide bore preferably has a diameter in the range of 1.2 to 4.0 mm. Correspondingly, any drill used in connection with this surgical drilling guide has a diameter consistent therewith.

  The drill seat is preferably configured as a surface that cooperates with a corresponding stop seat on the drill to physically prevent the surgeon from trying to advance the drill further.

  The specific required drilling depth of each drill guide bore varies depending on the site of the targeted bone osteotomy. Typically, drill guide bores located near the sides of the surgical drilling guide will be placed simultaneously on both sides of the target bone, thus reducing the required drilling depth. On the other hand, in the case of a drill guide hole arranged at the center of the surgical drilling guide, the required drilling depth is increased. A person skilled in the art knows that the required drilling depth of the plurality of drill guide bores is the bone type of interest and the osteotomy of proximal tibia, distal femur, proximal femur, etc. It will be recognized that it depends on the location. Furthermore, the size of the patient to be treated and thus the individual size of the patient's bone also affects the required drilling depth of each of the plurality of drill guide bores.

  Each drill seat is preferably placed on a drilling guide to limit the drilling depth according to patient specific data. More preferably, the required drilling depth for each of the plurality of drill guide bores corresponds to the distance to the cortex of the bone opposite the fixed side of the surgical drilling guide.

  Patient specific data may be, for example, imaging data collected prior to a surgical procedure by X-ray computed tomography (CT scan), magnetic resonance imaging (MRI scan), or three-dimensional X-ray imaging. preferable. According to this patient-specific imaging data, the most suitable necessary drilling depth can be determined for each of the plurality of drill guide bores.

  The surgical perforation guide according to the present invention is preferably custom made for each patient. Thereby, the position of the drill seat can be easily adapted to each of the plurality of drill guide bores.

  By matching the required drilling depth with the distance to the cortex of the bone on the fixation side of the surgical drilling guide or on the opposite side of the fixation site, the cortex is sufficiently weakened and subsequently damaged when the wedge is occluded or opened There is no longer to do. This significantly reduces the occurrence of iatrogenic fractures.

  The surgical perforation guide further includes a surface that contacts the target bone, and the bone contact surface preferably has a shape that matches the outer shape of the target bone. This facilitates placement and attachment of the surgical perforation guide on the target bone.

  As before, this shape is preferably adapted according to patient specific data, preferentially imaging data collected prior to the surgical procedure. One skilled in the art will appreciate that the bone contacting surface has an appropriate shape by machining, or that the surgical perforation guide is custom for each patient.

  The surgical drilling guide preferably comprises at least one elongate slot and an outer surface that limits the cutting depth of the saw blade within the bone by providing a guide surface for the saw blade.

  Accordingly, the outer surface is disposed on the opposite side of the bone contact surface and is configured to act as a stop surface for the blade sheet disposed on the saw blade. This shape is selected to give the target bone the optimal shape of the cut created by the saw blade. The outer surface is preferably concave. By making the outer surface into such a shape, the cutting depth of the saw blade inside the target bone is shallow near both sides of the bone and deep near the center of the bone.

  The outer shape is preferably configured such that the ablation depth varies along the at least one elongated slot, preferably in accordance with patient-specific data.

  The shape of the outer surface is configured so that the shape of the cutting portion created by the bone saw blade is optimized for the bone targeted by the patient in cooperation with the blade sheet of the bone saw blade. Is preferred. Thus, the outer surface shape is most preferably determined based on patient-specific data, preferably patient-specific imaging data.

  The surgical perforation guide includes a first elongate slot and a second elongate slot, the second elongate slot defining a second osteotomy plane disposed at an angle relative to the first elongate slot. Preferably, the second elongated slot is configured such that the second osteotomy plane intersects the first osteotomy plane within the bone.

  By providing the second elongated slot, the target bone can be precisely cut along the second osteotomy plane, so that two cutting portions arranged in a wedge shape are obtained. The angle and position of the second elongated slot on the surgical perforation guide is preferably selected according to patient-specific data, preferably patient-specific imaging data, which allows for precise cutting of the wedge, When the wedge is removed, the Mikulitz line is optimally rear lined.

  The surgical perforation guide preferably comprises a number of protrusions, which are sized and shaped to be inserted into the targeted bone resection cut.

  Such a configuration of a surgical perforation guide may be used in performing a closed wedge osteotomy. This is because the surgical perforation guide can be precisely aligned with the cutting portion by arranging a large number of protrusions on the cutting portion. Therefore, a surgeon can precisely place a drill hole in a target bone by using such a surgical perforation guide. This is because the drill guide bore is also precisely arranged at an appropriate position.

  The surgical perforation guide preferably further comprises at least one fastener receiving hole. The surgical perforation guide may be securely attached to the target bone by inserting a bone fastener such as a bone screw into the at least one fastener receiving hole.

  The application further relates to a kit comprising at least one surgical drilling guide according to the invention and at least one drill with a stop seat.

  The stop seat of the drill is configured to cooperate with the drill seat of the drill guide bore. Therefore, the stop sheet is arranged at a certain distance from the drill tip. The kit may comprise a plurality of drills, preferably each drill having a stop seat disposed at a different distance from the drill tip. Alternatively, the at least one drill may be provided with at least one marking arranged at a predetermined distance from the tip of the drill instead of the stop sheet. In this case, the surgeon may determine if the specific required drilling depth has been reached when the marking matches the drill sheet.

  The kit preferably further comprises at least one saw blade having a protrusion defining a blade sheet. In particular, in the context of a surgical drilling guide with a defined outer surface, the defined shape corresponding mainly to the shape of the outer surface in the first osteotomy plane by the cooperation of the blade sheet and the outer surface shape. Part is obtained.

  The application further relates to a method for manufacturing a surgical perforation guide according to the present invention. In the first step, the position of each of the plurality of drill guide holes and the required drilling depth are defined according to patient-specific data. The patient specific data is preferably patient specific imaging data. In the second step, the position of the drill seat of each of the plurality of drill guide bores is determined according to the required drilling depth. In the third step, a surgical perforation guide is manufactured. This production is preferably performed by machining or additive manufacturing techniques.

  A person skilled in the art knows suitable machining techniques, such as milling, to produce a surgical drilling guide from a block of material such as metal. Examples of the additive manufacturing technique include a selective laser sintering method, a direct metal sintering method, a selective laser melting method, a selective heat sintering method, an electron beam free-form manufacturing method, and a hot melt lamination method.

  It will also be appreciated that the manufacture of the surgical perforation guide may be performed using a number of different techniques. For example, after manufacturing a rigid body by additive manufacturing techniques, a machining process may be applied to produce, for example, a drill guide bore or at least one first elongated slot.

  The method further includes the step of determining the shape of the target contact area of the target bone by determining the shape of the target contact area of the target bone based on the patient-specific imaging data prior to the manufacturing step. It is preferable to include.

  Preferably, the method further comprises the step of defining the shape of the outer surface according to the required ablation depth with patient specific imaging data prior to the manufacturing step.

  Other advantageous embodiments and combinations of features will become apparent from the following detailed description and from the entire claims.

  The drawings used to describe the embodiments show the following.

It is the figure which showed the closed wedge osteotomy of the knee joint. It is the figure which showed the closed wedge osteotomy of the knee joint. It is the figure which showed the open wedge osteotomy of the knee joint. It is the figure which showed the open wedge osteotomy of the knee joint. It is the figure which showed an example of the iatrogenic fracture. It is the figure which showed an example of the iatrogenic fracture. It is the figure which showed 1st Embodiment of the surgical perforation guide based on this invention. It is the figure which showed 1st Embodiment of the surgical perforation guide based on this invention. It is the figure which showed 1st Embodiment of the surgical perforation guide based on this invention. FIG. 7 shows the bone surface of the tibia involved in the design and manufacture of a surgical drilling guide. FIG. 6 shows another embodiment of a drill for use in connection with a surgical drilling guide according to the present invention. FIG. 6 shows another embodiment of a drill for use in connection with a surgical drilling guide according to the present invention. FIG. 6 shows another embodiment of a saw blade for use in connection with a surgical drilling guide according to the present invention. FIG. 6 shows another embodiment of a saw blade for use in connection with a surgical drilling guide according to the present invention. FIG. 3 shows relevant anatomical landmarks for the design and sizing of a surgical perforation guide according to the present invention. 4b shows a surgical step for using the surgical perforation guide according to FIG. 4a. 4b shows a surgical step for using the surgical perforation guide according to FIG. 4a. 4b shows a surgical step for using the surgical perforation guide according to FIG. 4a. 4b shows a surgical step for using the surgical perforation guide according to FIG. 4a. It is the figure which showed the drilling step by the surgical drilling guide which concerns on this invention. It is the figure which showed the drilling step by the surgical drilling guide which concerns on this invention. It is the figure which showed the drilling step by the surgical drilling guide which concerns on this invention. It is a notch figure of drill excavation. FIG. 5 shows a sawing step with a surgical drilling guide according to the present invention. FIG. 5 shows a sawing step with a surgical drilling guide according to the present invention. It is sectional drawing of sawing. It is the figure which showed 2nd Embodiment of the surgical perforation guide based on this invention. FIG. 6 is a view showing a third embodiment of the surgical perforation guide according to the present invention. FIG. 6 is a view showing a third embodiment of the surgical perforation guide according to the present invention. FIG. 10 illustrates another embodiment of a surgical perforation guide. FIG. 10 illustrates another embodiment of a surgical perforation guide.

  In the drawings, the same components are denoted by the same reference numerals.

Preferred Embodiment FIGS. 1a and 1b show a closed wedge osteotomy of the knee joint. The femur 100 and tibia 101 interact at the knee joint 102. Below the joint 102, a first planar resection 104 is created over approximately 60-90% of the cross-sectional area through the proximal tibia in a defined resection plane. And the 2nd plane cutting part 107 is created at a certain angle with respect to the 1st plane cutting part 104. FIG. Both the first flat cut section 104 and the second flat cut section 107 define the wedge 103. The wedge 103 is then removed and the functional axis 106 (Mikulitz line) is reconstructed by pushing the proximal part of the tibial plateau distally and is fixed by, for example, a plate and screws (not shown).

  2a and 2b show an open wedge osteotomy. A first plane excision 104 is created, and a bone wedge 105 is inserted into the first plane excision 104. The bone wedge 105 reconstructs the correct functional axis 106 (Mikulitz line) by lifting the inner tibial plateau. Further, the bone wedge 105 is fixed at a predetermined position by using, for example, a plate and a screw (not shown). Ideally, natural pliability, such as elastic and plastic deformation, causes the uncut cortex to self-adapt to repositioning the tibial plateau. If the uncut cortex is not flexible enough and the resulting stress becomes too great, the tibial plateau may tear.

  3a and 3b show examples of iatrogenic fractures 107 that can occur during osteotomy. Such an iatrogenic fracture 107 may occur as a result of lifting or lowering the proximal tibial plateau. As described above, such iatrogenic fractures 107 result from insufficient flexibility of the non-resected bone site 108 due to the material properties (E module and elasticity) of the bone material. Furthermore, such an iatrogenic fracture 107 occurs when the excision depth 110 of the first planar excision 104 is too shallow and the other non-excision bone sites 108 exhibit a strong restoring force against an arbitrary bending force. There is also a case.

  FIG. 4a shows an exemplary embodiment of a surgical perforation guide 200 according to the present invention. The surgical perforation guide 200 includes a rigid body 210 having a generally rectangular parallelepiped shape. The rigid body has a bone contact surface 204 that contacts the bone of interest. It is preferable that the bone contact surface 204 has a shape corresponding to the outer shape of the site where the target bone osteotomy is performed. The surgical perforation guide 200 includes an outer surface 205 on the opposite side of the bone contacting surface 204. Outer surface 205 is the surface of surgical perforation guide 200 that faces the surgeon during the procedure. A first elongate slot 201 extends from the outer surface 205 to the bone contacting surface 204 and provides two guide surfaces for a planar cutting tool such as a reciprocating bone saw saw blade. In addition, the surgical perforation guide 200 includes seven drill guide bores 202a-202z. For this application, the subscripts a to z are used to identify multiple entities of the same feature so as not to imply any particular limitation on the number of entities. Each of the drill guide bores 202a-202z has a central axis X parallel to the first osteotomy plane A defined by the first elongated slot 201. For simplicity, only one central axis X is shown. The central axis X of each of the drill guide bores 202a to 202z is parallel to the first osteotomy plane A. Furthermore, in this embodiment, the central axis X of all the drill guide bores 202a to 202z coincides with the first osteotomy plane A. Furthermore, each of the drill guide bores 202a to 202z includes drill sheets 203a to 203z that are recessed from the outer surface 205. The drill sheets 203a-203z provide a stop surface for the drill inserted into the drill guide bores 202a-202z. By changing the position of each of the drill sheets 203a to 203z, the specific drilling depth of each of the plurality of drill guide bores 202a to 202z can be defined. In addition, the surgical perforation guide includes two fastener receiving holes 221a, 221b. The fixture receiving holes 221a and 221b are configured to attach the surgical perforation guide 200 to the target bone by receiving the bone fixture.

  FIG. 4b shows the surgical perforation guide 200 according to FIG. 4a from another point of view. FIG. 4c shows the surgical perforation guide 200 from the bone contacting surface 204 side.

  The following description with respect to FIGS. 5-15 relates to an open wedge osteotomy, which means performing a partial resection from the inside to the side of the tibia. Therefore, the resection guide is fixed to the anterior medial side of the proximal part of the tibia, and the cortical bone is weakened by perforating the side cortex of the tibia, and the tibial plateau can be lifted.

  In the case of the closed wedge method, it is necessary to read the inside as the side, the side as the inside, and the lifting as the pulling down.

  FIG. 5 illustrates the bone surface of the tibia 300, for example related to the design and manufacture of the surgical perforation guide 200 shown in FIGS. 4a-4c. The shape of the outer surface 205 defines the ablation depth 110 as will be described in detail below. The bone surface related data may be collected by CT scan, MRI scan, or 3D X-ray imaging. Since the shape of the bone contact surface 204 is configured as a negative image of the anterior medial side 301 of the tibia 300, it matches the shape of the surface of the anterior medial side 301. As those skilled in the art will appreciate, this shaping of the bone contacting surface 204 allows the surgical perforation guide 200 to be accurately positioned during surgery based on preoperative planning and patient specific data.

  The side of the tibia 300 is shown to pierce the opposite side cortex 303 of the tibia 300 by defining the required drilling depth of each drill guide bore 202a-202z. The perforations ideally reach the lateral cortex 303, but not as deep as the outer cortex. Deep penetration can cause damage to soft tissue structures such as muscles, arteries, or nerves near the lateral cortex 303, for example.

  FIG. 6a shows a preferred embodiment of a drill 400 for use in connection with a surgical drilling guide 200 according to the present invention. The drill 400 has a calibration drill excavation length 401 defined by a stop sheet 402. At the time of drilling, the stop sheet 402 collides with the drill sheets 203a to 203z of the drill guide bores 202a to 202z in which the drill 400 is inserted, so that the drill 400 does not advance further into the bone. The possible drilling depth is limited to the specific required drilling depth of the drill guide bores 202a-202z.

  FIG. 6 b shows another embodiment of a drill 400 having a calibration drill dig length 401 defined by a marking 403. In using the drill 400 according to this alternative embodiment, the surgeon needs to optically determine when to stop drilling.

  FIG. 7a shows one preferred embodiment of a saw blade 500 for use in connection with the surgical perforation guide 200 of the present invention. The saw blade 500 has a calibration sawing length 501 defined by the fixed blade sheet 502. In operation, the blade sheet 502 impinges on the outer surface 205 of the surgical perforation guide 200 physically limits the bone depth that the surgeon saws. The saw blade 500 has a thickness 503 corresponding to the thickness of the first elongated slot 201. Further, the saw blade 500 has a saw blade 504 at one end and a coupling structure 505 at the other end. The coupling structure 505 allows the saw blade 500 to be attached to the bone saw.

  FIG. 7 b shows another embodiment of a saw blade 500. In the present embodiment, the saw blade 500 includes a marking 503 that defines a calibration sawing length 501.

  When using the saw blade 500 according to this embodiment, the surgeon needs to optically determine when to stop sawing.

  FIG. 8 shows relevant anatomical landmarks for the design and sizing of surgical perforation guide 200. A partial resection 316 in the tibia 300 is planned for the modification of the functional axis 106 shown in FIGS. 1a and 1b. The interpretation of all anatomical variables and landmarks that define the correct plane for partial resection 316 is part of the education and experience gained by the surgeon performing these procedures, and is therefore a part of this specification. It does not make.

  In the other part of the plane for the partial resection 316, the contour 313 of the tibia 300 is shown. The design of the surgical drilling guide 200, specifically the placement of the sheets 203a-203z that control the required drilling depth, the shape of the outer surface 205 that controls the cutting depth, and the bone that facilitates unambiguous positioning The shape of the contact surface 204 is defined by the required excision depth 110 of the partial excision 316 planned prior to surgery, the calibration drilling length 401 of the drill 400, and the calibration sawing length 501 of the saw blade 500. .

  The surgical steps for using a surgical drilling guide and / or corresponding osteotomy kit in open wedge surgery are summarized as follows.

  1. A surgical perforation guide is placed on the target site of the target bone.

  2. Fix and stabilize with bone fixation elements.

  3. Drill the cortex on the other side of the bone by drilling through all drill guide bores.

  4). Partial ablation is performed by sawing through the elongated slot.

  5. Remove the surgical perforation guide.

  Subsequent surgical steps are as follows.

  6). The partially excised site is bent and opened.

  7). Insert the bone wedge.

  8). It is fixed and stabilized by implants such as plates and screws.

  9. Blocks soft tissue and skin.

  Steps 3 and 4 may be performed in the reverse order. Steps 1 and 2 are shown in FIGS. 9a to 9c.

  As shown in FIG. 9 a, the surgical perforation guide 200 is placed by the surgeon on the anterior medial side 301 of the tibia 300. The bone contact surface 204 has a shape that matches the shape of the anterior inner side 301. Therefore, the shape of the bone contact surface 204 is preferably formed using patient-specific data. In this way, by matching the shape of the bone contact surface 204 with the outer shape of the anterior inner side 301 of the tibia 300, the surgical perforation guide 200 can be correctly placed on the anterior inner side 301 as shown in FIG. 9b.

  Then, as shown in FIG. 9c, two bone anchoring elements 220a, 220b are inserted through the two fastener receiving holes 221a, 221b and screwed into the bone material of the tibia 300, as shown in FIG. The perforation guide 200 is firmly fixed on the tibia 300.

  In the next step, as shown in FIG. 10a, the surgeon uses a drill 400 having an effective drilling length 401 so that the stop sheet 402 of the drill 400 is moved to each drill sheet 203a-203z, as shown in FIG. 10b. Drilling is performed through the drill guide bores 202a-202z. The side cortex 303 is drilled through the drill holes 310a-310z by using the surgical drill guide 200, particularly when the drill sheets 203a-203z are placed in the surgical drill guide 200 according to patient specific data. However, any soft tissue adjacent to the lateral cortex 303 is not damaged. As shown in FIG. 10c, the side cortex 303 is pierced by the drill holes 310a-310z, so it is weakened and becomes more flexible. The increased flexibility reduces the risk of iatrogenic fractures when the surgeon forces the wedge to open.

  The number of perforations required to prevent the occurrence of an iatrogenic fracture depends primarily on variables such as bone quality, tibial plateau size, excision depth 110, diameter of drill 400, and amount of modification of functional axis 106.

  FIG. 11 shows the situation according to FIG. As can be seen, the drill sheets 203a-203z are all positioned at different positions in the surgical drilling guide, and the drill sheets 203a-203z are arranged in a slightly stepped manner relative to each other, as highlighted by the bold lines in FIG. ing. Further, the stop sheet 402 of the drill 400 cooperates with the drill sheets 203a-203z to limit the drilling depth to the specific required drilling depth 312 of each of the plurality of drill guide bores 202a-202z. It can be confirmed. As can be seen, this limitation prevents any damage to the soft tissue because the surgeon cannot advance the drill 400 further. Only the specific required drilling depth 312 for one of the plurality of drill guide bores 202a-202z is shown in the figure. Through the drilling step, one drill hole 310a-310z is formed through the tibia 300 for each of the drill guide bores 202a-202z.

  FIG. 12 a shows the next step, where the saw blade 500 is inserted into the elongated slot 201. As shown in FIG. 12 b, the surgeon may use the saw blade 500 to form a cutting portion 311 in the tibia 300 by sawing. By cooperation of the blade sheet 502 and the outer surface 205 of the surgical perforation guide, the depth of the cut 311 is maintained at the maximum desired depth defined in the tibia 300 prior to surgery.

  FIG. 13 shows a cross section of the situation according to FIG. 12b. This cross section is located in the first osteotomy plane. In the figure, it is possible to confirm the influence of the shape of the outer surface 205 interacting with the blade sheet 502 on the depth of the cutting portion 311. The shape of the cutting portion 311 in the tibia 300 essentially corresponds to the shape of the outer surface 205. This is because the saw blade 504 of the saw blade 500 is not inserted into the tibia 300 deeper than the calibration sawing length 501.

  FIG. 14 illustrates another embodiment of a surgical perforation guide 200 according to the present invention. In addition to the features of the embodiment shown in FIG. 4, the surgical perforation guide according to this embodiment includes a second elongated slot 240 that defines a second osteotomy plane B. The axis X of the drill guide bores 202a-202z is parallel to the first osteotomy plane A, while the second osteotomy plane B is arranged at an angle with respect to the first osteotomy plane A. . Both osteotomy planes A and B intersect at a line 315 which is the inside of the target bone during the operation. Such a surgical perforation guide allows a surgeon to cut a wedge very precisely into the bone of interest, particularly when performing a closed wedge osteotomy.

  15a and 15b show yet another embodiment of a surgical perforation guide 200 according to the present invention. In this embodiment, the surgical perforation guide 200 includes a plurality of protrusions 250 disposed on the bone contacting surface 204 instead of not including the elongated slot 201. The protrusions 250 are arranged parallel to each other and define a first osteotomy plane A. Similarly to the above, the plurality of drill guide bores 202a to 202z are arranged so that their axes are parallel to the first osteotomy plane A. The thickness 251 of the protrusion 250 is selected so that the protrusion 250 can be inserted into the cut and cut portion 311. As a result, the axes of the drill guide bores 202 a to 202 z can be aligned in parallel with the cutting portion 311.

  FIGS. 16a and 16b show another embodiment of a surgical perforation guide 200 that is not part of the present invention. In this embodiment, as can be seen from FIG. 16a, an elongated slot 201 defining a first osteotomy plane A is provided in the drill guide bores 202a-202z (of which only one drill guide bore 202 is shown). It is not parallel to axis X. However, the axis X and the elongated slot 201 are arranged so as to intersect at a line 315 that is inside the target bone during surgery. Furthermore, also in this embodiment, the surgical perforation guide 200 includes a second elongated slot 240 that defines a second osteotomy plane B. The second elongate slot 240 is positioned such that the second osteotomy plane B intersects the first osteotomy plane A at line 315. Accordingly, the second osteotomy plane B also intersects with the axis X of the drill guide bores 202a-202z at line 315.

  FIG. 16b shows the surgical perforation guide 200 according to the embodiment shown in FIG. 16a from the bone contacting surface 204 side. As can be seen in this figure, all of the drill guide bores 202a-202z (of which only one drill guide bore 202 is shown) are all single spaced apart from the first elongated slot 201 and the second elongated slot 240. It is arranged on one line. Further, the positions of the two fixture receiving holes 221a and 221b can be sufficiently confirmed in this drawing. Such a surgical perforation guide is particularly suitable for closed wedge osteotomy. This is because it is possible to cut and form two cutting portions inclined to each other on the target bone, and these cutting portions define a wedge-shaped bone to be removed later from the target bone.

DESCRIPTION OF SYMBOLS 100 Femur 101 Tibia 102 Knee joint 103 Wedge 104 First plane excision part 105 Bone wedge 106 Functional axis 107 Iatrogenic fracture 108 Non-excision bone part 110 Excision depth 200 Surgical perforation guide 201 First elongated slot 202 ( az) drill guide bore 203 (az) drill sheet 204 bone contact surface 205 outer surface 210 rectangular parallelepiped shape 220a bone fixation element 220b bone fixation element 221a fixture reception hole 221b fixture reception hole 240 second elongated slot 300 tibia 301 Front inner side 303 Side cortex 310 (az) Drill hole 311 Cutting part 312 Drilling depth 313 Contour 315 Line 316 Partial excision 400 Drill 401 Calibration drilling length 402 Stop sheet 403 Marking 500 Saw blade 501 Calibration sawing Length 502 Fixed blade Over preparative 503 thickness 504 sawtooth 505 coupling structure

Claims (15)

A surgical perforation guide (200) fixed to a target bone, having a first osteotomy plane (A), a diameter and a central axis (X), the central axis (X) being At least one first elongated slot (201) or at least one protrusion (250) defining a plurality of drill guide bores (202a-202z) parallel to the first osteotomy plane (A). Each of the plurality of drill guide bores (202a-202z) intersects the osteotomy plane (A), wherein the plurality of drill guide bores (202a-202z), comprising a drill sheet to provide a stop surface of the drill (400) (203A～203z), the drill sheet (203A～203z) is, the outer surface of the surgical drilling guide (200) (2 Is recessed from 5), for each of said plurality of drill guide bores (202A～202z), and limits the drill digging depth specific required drilling depth (312), surgical drilling Guide (200). Each drill sheets (203A～203z), characterized that you are placed on the surgical drilling guide (200) so as drilling depth according to the patient-specific data is limited, according to claim 1 Surgical drilling guide (200) as described in. Each drill seat (203a-203z) is placed on the surgical drilling guide (200) such that the drilling depth is limited according to patient-specific data, thereby providing the surgical drilling guide (200). Surgical drilling guide (200) according to claim 2, characterized in that it has a specific required drilling depth (312) corresponding to the distance to the cortex of the bone opposite the fixed side) . Further comprising a bone-contacting surface for contacting the bone to be the target (204), the bone contact surface (204) is characterized by having a matching shape to the outer shape of the bone to be the target, according to claim 1 The surgical perforation guide (200) according to any one of claims 3 to 4 . And at least one elongate slot (201), said outer surface to limit the saw blade (500) of the saw blade inside of the bone to be the target by providing a guide surface ablation depth (500) and (110) The surgical perforation guide (200) according to any one of claims 1 to 4 , characterized in that it comprises (205). Wherein the shape of the outer surface (205), along said at least one elongate slot (201), before Symbol ablation depth (110) is characterized in that it is configured to change, according to claim 5 Surgical drilling guide (200). The shape of the outer surface (205) is configured such that the ablation depth (110) varies along the at least one elongated slot (201) according to patient specific data, The surgical perforation guide (200) according to claim 6. A first elongate slot (201) and a second elongate slot (240), the second elongate slot (240) being disposed at an angle with respect to the first osteotomy plane (A). Two osteotomy planes (B), wherein the second elongated slot (240) is within the target bone and the second osteotomy plane (B) is the first osteotomy plane (B). The surgical perforation guide (200) according to any one of claims 1 to 7 , characterized in that it is configured to intersect the osteotomy plane (A). A plurality of protrusions (250), wherein the protrusions (250) are sized and shaped to be inserted into the targeted bone resection cut (311). The surgical perforation guide (200) according to any one of claims 4 to 5 . At least one fastener receiving holes (221a, 221b) further comprising the surgical drilling guide (200) according to any one of claims 1-9. The surgical perforation guide (200) includes at least one elongated slot (201), and the plurality of drill guide bores (202a-202z) are disposed within the at least one elongated slot (201). A surgical perforation guide (200) according to any one of the preceding claims, characterized in that The surgical perforation guide (200) according to any one of the preceding claims, characterized in that the surgical perforation guide (200) comprises 4-10 drill guide bores (202a-202z). ). The surgical perforation guide (200) according to any one of the preceding claims, characterized in that the drill guide bore (202a-202z) has a diameter in the range of 1.2-4.0mm. At least one surgical drilling guide according to any one of claims 1. 13 (200), comprising at least one drill with a stop seat (402) (400), a kit. The kit of claim 14 , further comprising at least one saw blade (500) having a protrusion defining a blade sheet (502).

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