CN104869919A - Surgical perforation guide - Google Patents

Abstract

The present application relates to a surgical perforation guide (200) to be fixated against a target bone. Said surgical perforation guide (200) comprises at least one first elongated slot (201) or at least one protrusion (250) defining a first osteotomy plane (A) and multiple drill guiding bores (202a - 202z). The multiple drill guiding bores (202a - 202z) have a diameter and a central axis (X), the central axes (X) of the drill guiding bores (202a - 202z) lying parallel to said first osteotomy plane (A). The diameter of the multiple drill guiding bores (202a - 202z) intersects the osteotomy plane (A).; Each of the multiple drill guiding bores (202a - 202z) comprises a drill seat (203a - 203z) providing a stop surface for a drill (400), said drill seat (203a - 203z) limiting the drilling depth to a specific required drilling depth (312) for each of the multiple drill guiding bores (202a - 202z).

Description

surgical perforation guide

technical field

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

Background technique

Knee osteotomy is a surgical procedure used to align the Mikulicz-line of the large joints of the lower extremity, namely the hip, knee and ankle. In normal axial alignment of the limb, the center of the hip, the intercondylar eminence of the tibial plateau, and the center of the ankle joint lie in a line, the so-called Mikulicz line, the mechanical axis of the lower extremity. This alignment may be disturbed and cause excessive wear of the knee cartilage, eg due to arthritic injury, congenital misalignment or traumatic damage on one side of the knee. This is also known as arthrosis of the knee.

The purpose of the knee osteotomy surgical technique is to rebalance the forces in the knee from the damaged area of the knee to the opposite healthy area. This allows for a better distribution of the forces generated by the patient's body weight and muscles on the knee joint. There are two common techniques in clinical practice, the open wedge osteotomy and the closing wedge osteotomy. Both techniques aim at partially or completely reconstructing the aforementioned Mikulicz line.

When performing a closed wedge osteotomy, the wedge-shaped bone is removed under the tibial plateau. The tibial plateau is then pulled down to close the gap and secured with trauma plates and screws.

When performing the open wedge technique, a horizontal osteotomy is made over approximately 80% of the surface below the tibial plateau. Then insert the wedge spacers. Thus, the tibial plateau is forced up on one side to correct the leg axis. The wedge spacer can be made of natural bone, artificial bone or other biocompatible or osseointegrative material. Spacers are usually secured to the bone with plates and screws. It is written that this osteotomy provides a significant benefit to the patient as it helps to delay the possible replacement of the entire knee by up to 10 years.

In order to assist the surgeon in performing wedge osteotomies, several guides are known in the prior art. For example, US 7,185,645 (Hudson Surgical Design Inc.) discloses a device that provides a guide surface for planar cutting tools such as vibrating bone saws. The cutting tool is thus guided by the tangential faces of the pins inside the bone to be corrected. Two or more of said pins define a predetermined plane of the cut surface to be generated by the cutting tool.

US 2008/0262500 A1 (Howmedica Osteonics Corp.) describes a cutting guide for performing osteotomy surgery of bone, which has a first arm and a second arm, the first arm having formed therein a first guide surface, and the second arm has a second guide surface formed therein. The first arm and the second arm are pivotally connected to each other. In addition, the cutting guide surface may comprise a circular groove forming a drill guide allowing a drill to be guided into the bone when the two arms are in the closed position.

US 5,021,056 (Intermedics Orthopedics Inc.) discloses a method and device for performing osteotomies. The device includes a first guide assembly having a pair of mirrored jaw arm assemblies each including a splint. The clamp arm is free to slide along the first guide assembly. Each cleat features multiple bores and guide slots for cutting tools. With the help of the first guide assembly, a first incision is made in the bone through the guide slot, whereby the splint is stabilized by bone fasteners inserted into the plurality of bores. Then, the first guide assembly is removed, and a second guide assembly is placed on the bone, with the flat blade element inserted into the cut in the bone. The second guide assembly contains several guide slots allowing incisions to be made at different angles to the first incision in order to create a suitable wedge in the bone.

Despite the advantages offered by open and closed wedge osteotomies, the technique is frequently associated with complications that can cause patient discomfort during recovery or complicate the surgical procedure itself. For example, one of the greater challenges during surgical procedures is to cut the bone only to a certain depth and then elevate the proximal tibial plateau to the cut without breaking or detaching the tibial plateau (so-called iatrogenic fractures). above the bone.

Contents of the invention

The purpose of the present invention is to create a perforation guide related to the initially mentioned technical field that facilitates the performance of open and closed wedge osteotomies and reduces the risk of genic fractures during the procedure. The solution of the invention is specified by the features of claim 1 . According to the invention, said surgical perforation guide is intended to be fixed against the target bone and comprises at least one first elongated slot or at least one protrusion defining a first osteotomy plane. Additionally, the surgical perforation guide includes a plurality of drill guide bores each having a diameter and a central axis, wherein the central axes of the plurality of drill guide bores are parallel to the A first osteotomy plane, and the diameter of each of the plurality of drill guiding bores intersects the first osteotomy plane. Additionally, each of the plurality of drill pilot bores includes a drill seat that provides a stop surface for the drill bit, wherein each of the stop surfaces limits the depth of the drill hole to the The drill guides the specific desired drilling depth for each bore in the bore. By providing a drill seat it is possible to avoid soft tissue damage on the other side of the bone caused by the surgeon advancing the drill too far. In addition, the bit holder allows precise control of the depth of the hole drilled into the bone so that the bone can be sufficiently locally weakened to increase its flexibility to avoid iatrogenic fractures when the surgeon opens or closes the wedge.

The surgical perforation guide preferably comprises a rigid body, more preferably configured as a block of biocompatible material such as stainless steel, titanium or a biocompatible polymer such as polyetherether ketone (PEEK) or polylactic acid (PLA). The rigid body is preferably generally shaped in the form of a cube having one face adapted to be placed in contact with the target bone, e.g., having a suitable curvature, wherein the length of the bone-contacting face approximately corresponds to the length of the lateral tibia. size. The at least one first elongated slot provides two guide surfaces for a planar cutting tool, such as a saw blade for a reciprocating bone saw. Thus, said at least one first elongated slot allows guiding a planar cutting tool precisely along said first osteotomy plane. Preferably, the thickness of said at least one elongated slot is selected to match the thickness of the saw blade. Alternatively, the surgical perforation guide may comprise at least one protrusion, wherein said protrusion is preferably adapted to be insertable into an incision in a bone. Thus, the at least one protrusion allows precise alignment of the surgical perforation guide into an incision made, for example, by means of a bone saw.

Each of the drill-guiding bores includes the first osteotomy plane due to the diameter of the plurality of drill-guiding bores intersecting the first osteotomy plane. Preferably, a plurality of drill guiding bores are arranged on the surgical perforation guide such that their axes lie in the first osteotomy plane. Alternatively, the axes of the plurality of drill guiding bores may also be offset from the first osteotomy plane, however by no more than half its diameter. In the present application, "offset" means the distance from the first osteotomy plane in a direction perpendicular to said first osteotomy plane.

Preferably, the axes of all said drill guiding bores are not only parallel to said first osteotomy plane, but also parallel to each other. Alternatively, at least one of the drill pilot bores may have an axis that is angled to the axis of the remaining ones of the drill pilot bores. Preferably, all axes of the drill guiding bore are offset by the same distance from the first osteotomy plane. Alternatively, at least one of the drill guiding bores may be offset by a distance that is less or greater than the axis of the remaining drill guiding bores is offset from the first osteotomy plane.

Preferably, all of the plurality of drill guiding bores are evenly distributed over the length of the bone contacting surface, ie all of the plurality of drill guiding bores are spaced the same distance from each other. Alternatively, the distance between two adjacent drill guiding bores may vary along the length of the bone contacting surface.

The term "plurality" should be understood to include any number greater than one. Preferably, the surgical perforation guide comprises 2 to 20 drill guide bores, more preferably 4 to 10 drill guide bores.

The drill pilot bore preferably has a diameter ranging from 1.2mm to 4.0mm. Accordingly, any drill bits to be used in connection with existing surgical perforation guides have matching diameters.

The drill seat is preferably configured as a surface that mates with a corresponding stop seat on the drill bit to physically prevent further advancement of the drill bit by the surgeon. The specific required drilling depth for each drill-guided bore varies depending on the area of the target bone in which the osteotomy is being performed. Typically, drill-guided bores on the side facing the surgical perforation guide require less drilling depth because these bores will be placed on both sides of the target bone; The drill guide hole in the center of the surgical perforation guide requires a relatively large drilling depth. Those skilled in the art will recognize that the desired drilling depth for multiple drill-guided bores depends on the type of target bone and the location of the osteotomy, eg, proximal tibia, distal femur, proximal femur, etc. Furthermore, the size of the patient to be treated and thus the individual size of her or his bones also affects the required drilling depth for each of the plurality of drill-guided bores.

Preferably, each drill seat is arranged on said perforation guide to limit the drilling depth according to patient specific data. More preferably, the desired drilling depth of each of the plurality of drill guide bores corresponds to the distance to the cortex of the bone opposite the fixation side of the surgical perforation guide.

The patient-specific data are preferably imaging data collected prior to the surgical procedure, eg by means of X-ray computed tomography (CT scan), magnetic resonance imaging (MRI scan) or 3D X-ray imaging. From this patient-specific imaging data, an optimum desired drilling depth for each of the plurality of drill-guiding bores may be determined. Preferably, the surgical perforation guide according to the invention is custom made for each patient. This allows easy adaptation of the position of the drill seat for each of the plurality of drill guiding bores.

Providing the desired drill depth to match the distance to the cortical bone on the side opposite the fixation side or fixation region of the surgical perforation guide can allow the cortex to be sufficiently weakened so that it is not affected by subsequent wedge closure or opening. will not break during the process. This greatly reduces the incidence of iatrogenic fractures.

Preferably, the surgical perforation guide further comprises a face for contacting a target bone, the bone contacting face having a shape matching the outer shape of the target bone. This facilitates placement and attachment of the surgical perforation guide on the target bone.

Again, the shape is preferably adapted according to patient-specific data, preferentially according to imaging data collected prior to the surgical procedure. Those skilled in the art will appreciate that either the bone contacting surface is machined to have the correct shape, or the surgical perforation guide is custom made for each patient.

The surgical perforation guide preferably includes at least one elongated slot and an outer face providing a guiding surface for the saw blade to limit the depth of resection of the saw blade into the bone.

The outer face is thus arranged on the side opposite the bone contacting face and is configured to act as a stop face for a blade seat on the saw blade. The shape is thus chosen so as to give an optimal geometry to the cut made with the saw blade in the target bone. Preferably, said outer face is concave. Such a geometry of the outer face produces a cutting depth of the saw blade within the target bone that is shallower toward the sides of the bone and deeper toward the center of the bone.

Preferably, the shape of the outer face is configured such that the depth of resection varies along the at least one elongated slot, preferably according to patient-specific data. Preferably, the shape of the outer face is configured such that the geometry of the incision made by the bone saw blade is optimized for the target bone of the patient by cooperation with the blade seat of the bone saw blade. Thus, the shape of the outer face is most preferably determined based on patient-specific data, preferably patient-specific imaging data. The surgical perforation guide preferably includes a first elongated slot and a second elongated slot, the second elongated slot defining a second osteotomy plane disposed relative to the first elongated slot. The elongated slot is angled, wherein a second elongated slot is configured such that the second osteotomy plane intersects the first osteotomy plane within the bone. The provision of a second elongated slot allows precise cutting of the target bone along said second osteotomy plane, resulting in two cuts arranged in a wedge shape. Preferably, said angle of said second elongated slot and the position of said second elongated slot on said surgical perforation guide are selected on the basis of patient specific data, preferably patient specific imaging data, to enable Allows precise cutting of the wedge, which will result in optimal realignment of the Mikulicz lines once the wedge is removed.

Preferably, the surgical perforation guide includes a plurality of protrusions sized and shaped for insertion into a resection incision of said target bone. When performing a closed wedge osteotomy, such a configuration of the surgical perforation guide can be used because placing the plurality of protrusions into the incision can allow the surgical perforation guide to be precisely aligned with the incision. alignment. Thus, by using such a surgical perforation guide, the surgeon can precisely place the drill hole into the target bone because the drill guide bore will also be precisely placed at the correct location.

The surgical perforation guide preferably also includes at least one fastener receiving aperture. The surgical perforation guide can 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 present application also relates to a kit comprising at least one surgical perforation guide according to the invention and at least one drill bit with a stop seat.

The stop seat of the drill bit is configured to cooperate with the bit seat of the drill pilot bore. The stop seat is thereby arranged at a fixed distance from the drill tip. Preferably, the kit may comprise several drill bits, each drill bit having a stop seat arranged at a different distance from the drill tip. Alternatively, instead of the stop seat, the at least one drill bit may comprise at least one marking arranged at a defined distance from the drill tip. In this case, once the markers are in registration with the drill seat, the surgeon can determine whether a particular desired drilling depth has been achieved.

Preferably, the kit also includes at least one saw blade having a protrusion defining a blade seat. In particular in relation to surgical perforation guides with an outer face having a defined shape, the blade holder cooperating with the shape of said outer face produces a shape that defines a shape substantially corresponding to the shape of the outer face in the first osteotomy plane. Corresponding cutout geometry. The present application also relates to a method for producing a surgical perforation guide, preferably according to the invention. In a first step, the position and required drilling depth of each drill pilot hole of the plurality of drill pilot holes is defined based on patient specific data. The patient-specific data are preferably patient-specific imaging data. In a second step, the position of the drill seat for each of the plurality of drill pilot bores is determined according to the desired drilling depth. In a third step, a surgical perforation guide is produced. Production is preferably performed by machining or additive manufacturing techniques. Those skilled in the art are aware of suitable machining techniques, such as milling, to produce a surgical perforation guide from a piece of material, such as metal. Additive manufacturing techniques include selective laser sintering, direct metal sintering, selective laser melting, selective thermal sintering, electron beam patternless manufacturing and fused deposition modeling, among others.

It should also be understood that the production of the surgical perforation guide can be performed using a number of different techniques. For example, the rigid body may be produced by additive manufacturing techniques and subsequently subjected to a machining process in order to eg produce said drill guiding bore or said at least one first elongated slot.

Preferably, the method further comprises the step of defining, prior to said producing step, the shape of the face for contacting the target bone by determining the shape of the predetermined contact zone of the target bone from patient-specific imaging data.

Preferably, the method further comprises the step of defining the shape of the outer face prior to said producing step based on the necessary resection depth from patient specific imaging data.

The following detailed description and the overall claims reveal further advantageous embodiments and combinations of features.

Description of drawings

Specific embodiments are explained below with reference to the accompanying drawings, in which:

Figure 1a, 1b Closed wedge osteotomy of the knee;

Figure 2a, 2b The open wedge osteotomy of the knee;

Figure 3a, 3b Examples of iatrogenic fractures;

Figures 4a-4c are different views of a first embodiment of a surgical perforation guide according to the invention;

Figure 5 is the bone surface of the tibia relevant to the design and manufacture of surgical perforation guides;

Figures 6a, 6b An alternative embodiment of a drill to be used in connection with a surgical perforation guide according to the present invention;

Figures 7a, 7b An alternative embodiment of a saw blade to be used in connection with a surgical perforation guide according to the invention;

Fig. 8 is used for the relevant anatomical marker point of designing and dimensioning of surgical perforation guide according to the present invention;

Figures 9a-9c are the surgical steps for the surgical perforation guide according to Figure 4a;

Figures 10a-10c are drilling steps using a surgical perforation guide according to the present invention;

The sectional view of Fig. 11 drilling;

12a-12b sawing steps using a surgical perforation guide according to the present invention;

The cross-sectional view of Fig. 13 sawing;

Figure 14 A second embodiment of a surgical perforation guide according to the present invention;

Figures 15a, 15b A third embodiment of a surgical perforation guide according to the invention;

Figures 16a, 16b Alternative embodiments of surgical perforation guides.

In the drawings, the same reference numerals are used for the same parts.

Detailed ways

Figures 1a and 1b illustrate a closed wedge osteotomy for the knee joint. Femur 100 and tibia 101 interact at knee joint 102 . A first planar resection 104 is made below the joint 102 over approximately 60-90% of the cross-sectional area through the proximal tibia at the defined resection plane. A second planar cut 107 is then formed at an angle to the first planar cut 104 . Both the first planar cut 104 and the second planar cut 107 define a wedge 103 . This wedge 103 is then removed and the distal end of the proximal tibial plateau is pushed down to reestablish the mechanical axis 106 (Mikulicz line) and fix the proximal tibial plateau, eg, with plates and screws (not shown).

Figures 2a and 2b depict the opening wedge osteotomy. A first planar cut 104 is formed. A bone wedge 105 is then inserted into the first planar resection 104 . The bone wedge 105 will elevate the tibial plateau medially and reestablish the correct mechanical axis 106 (Mikulicz line). Bone wedge 105 is secured in place, for example using plates or screws (not shown). Ideally, the uncut cortex adapts itself to tibial plateau repositioning through natural flexibility such as elastic deformation and plastic deformation. If the uncut cortex is not flexible enough and the pressure placed on it is too high, the tibial plateau may rupture.

Referring to Figures 3a and 3b, an example of an iatrogenic fracture 107 that may occur during an osteotomy is shown. Such iatrogenic fractures 107 may be the result of lifting or pulling down the proximal tibial plateau. As previously stated, such iatrogenic fractures 107 are due to insufficient flexibility in the unresected bone region 108 due to the material properties of the bone material (elastic modulus and elasticity). Furthermore, such iatrogenic fractures 107 may also result if the resection depth 110 of the first planar resection 104 is too short such that the remaining unresected bone region 108 exhibits greater resilience to any bending forces. Figure 4a shows an exemplary embodiment of a surgical perforation guide 200 according to the present invention. Surgical perforation guide 200 includes a rigid body 210 generally having a cuboid shape. The rigid body has a bone contacting surface 204 for contacting the target bone. The bone contacting surface 204 preferably exhibits a shape corresponding to the outer shape of the region of the target bone in which the osteotomy is to be performed. Opposite the bone-contacting surface 204 , the surgical perforation guide 200 includes an outer face 205 . Outer face 205 is the side of surgical perforation guide 200 that faces the surgeon during surgery. An elongated first slot 201 spans from the outer face 205 to the bone contacting face 204 and provides two guide faces for a blade of a planar cutting tool such as a reciprocating bone saw. Additionally, surgical perforation guide 200 includes seven drill guide bores 202a-202z. For the purposes of this application, the designations a to z are used to identify multiple entities of the same feature, without implying any specific limitation on the number of said entities. Each of said drill guiding bores 202a - 202z has a central axis X parallel to a first osteotomy plane A defined by said first elongated slot 201 . For simplicity, only one central axis X is shown. The central axis X of each of the drill guiding bores 202a - 202z is parallel to the first osteotomy plane A. As shown in FIG. Furthermore, in this embodiment, the central axis X of all drill guiding bores 202a - 202z coincides with said first osteotomy plane A. Furthermore, each of said drill guiding bores 202a - 202z includes a drill seat 203a - 203z recessed from said outer face 205 . The drill seats 203a - 203z provide stop surfaces for drills inserted into the drill guide bores 202a - 202z. By varying the position of each of said drill seats 203a - 203z a specific drilling depth can be defined for each of the plurality of drill guiding bores 202a - 202z. Additionally, the surgical perforation guide includes two fastener receiving holes 221a, 221b. The fastener receiving holes 221a, 221b are configured for receiving bone fasteners to attach the surgical perforation guide 200 to a target bone.

FIG. 4 b shows the surgical perforation guide 200 according to FIG. 4 a from another perspective, while FIG. 4 c shows the surgical perforation guide 200 from the bone contacting surface 204 . The following description is made with respect to FIGS. 5 to 15 regarding an open wedge osteotomy, which means a partial resection from the medial side of the tibia toward the lateral side. The resection guide is thereby secured to the anteromedial aspect of the proximal tibia and the lateral cortex of the tibia is perforated to weaken the cortical bone to allow elevation of the tibial plateau.

For the closed wedge technique, inside must be read as outside, outside must be read as inside, and forcing up must be read as forcing down.

Fig. 5 shows the bone surface area of the tibia 300 which is relevant for designing and manufacturing a surgical perforation guide 200 such as that shown in Figs. 4a-4c. As described in more detail below, the shape of the outer face 205 defines the resection depth 110 . Data on bone surfaces can be collected through CT scans, MRI scans, or 3D X-ray imaging. The shape of the bone contacting surface 204 is configured to be the negative image of the anteromedial side 301 of the tibia 300 and thus closely fits the shape of the anteromedial side 301 surface. Such shaping of the bone-contacting surface 204 allows for exact positioning of the surgical perforation guide 200 during the surgical procedure based on pre-operative planning and patient-specific data, as understood by those skilled in the art.

The lateral side of the tibia 300 is registered to define the desired drilling depth for each drill pilot bore 202a - 202z in order to perforate the lateral cortex 303 on the opposite side of the tibia 300 . The perforation ideally reaches through the lateral cortex 303, but not deeper than the outer cortex. Deeper penetration may cause damage to soft tissue structures such as muscles, arteries or nerves next to the lateral cortex 303, for example.

Referring to Figure 6a, there is shown a preferred embodiment of a drill bit 400 to be used in connection with a surgical perforation guide 200 according to the present invention. The drill bit 400 has a calibrated drilling length 401 which is limited by a stop seat 402 . When drilling, the stop seats 402 will hit the drill seats 203a-203z of the drill guide bores 202a-202z into which the drill bit 400 is inserted, thereby preventing any further advancement of the drill bit 400 into the bone and thus will physically The possible drilling depths are limited to the specific desired drilling depths of the drill pilot bores 202a - 202z.

FIG. 6 b illustrates an alternative embodiment of a drill bit 400 with a calibrated drilling length 401 defined by markings 403 . When using the drill 400 according to this alternative embodiment, the surgeon must determine by sight when to stop drilling.

FIG. 7 a shows a preferred embodiment of a saw blade 500 to be used in connection with the inventive surgical perforation guide 200 . The saw blade 500 has a calibrated sawing length 501 defined by a fixed saw blade seat 502 . In operation, the blade mount 502 encounters the outer face 205 of the surgical perforation guide 200, thereby physically limiting the depth to which the surgeon can saw into the bone. The saw blade 500 has a thickness 503 corresponding to the thickness of the first elongated slot 201 . In addition, the saw blade 500 has teeth 504 at one end, and a coupling structure 505 at the opposite end. Coupling structure 505 allows attachment of saw blade 500 to a bone saw.

FIG. 7 b shows an alternative embodiment of a saw blade 500 . In this embodiment, saw blade 500 includes markings 503 that define a calibrated sawing length 501 . When using the saw blade 500 according to the present embodiment, the surgeon must visually determine when to stop sawing.

FIG. 8 shows relevant anatomical landmarks for the design and sizing of the surgical perforation guide 200 . A partial resection 316 within the tibia 300 is planned to correct the mechanical axis 106 as shown in FIGS. 1a and 1b. Interpretation of all anatomical variables and landmarks used to define the correct plane for partial resection 316 is part of the education and experience of the surgeon performing these interventions and is therefore not part of this description.

As for the remainder of the plane for partial resection 316, the outline 313 of the tibia 300 is noted. The necessary resection depth 110 of the preoperatively planned partial resection 316, the calibrated drilling length 401 of the drill 400, and the calibrated sawing length 501 of the saw blade 500 define the design of the surgical perforation guide 200, specifically, the defined The placement of the seats 203a-203z to control the desired drilling depth, the shape of the outer face 205 to control the depth of resection, and the shape of the bone-contacting surface 204 to aid in defined positioning are provided.

The surgical procedure for the use of a surgical perforation guide and/or a corresponding osteotomy kit in an open wedge surgery can be summarized as:

1. Place the surgical perforation guide on the target area of the target bone; 2. Fix with bone fixation elements for stability;

3. Drill through all drill guided bores to perforate the cortex on the other side of the bone;

4. For partial removal, sawing through the slender slot;

5. Remove the surgical perforation guide.

The next surgical steps are:

6. Bend to open up the partially resected area;

7. Insert bone wedge;

8. Fixation and stabilization with implants such as plates and screws;

9. Close soft tissue and skin.

Step 3 and Step 4 can also be performed in reverse order. Step 1 and Step 2 are depicted in Figures 9a to 9c.

As shown in Figure 9a, a surgical perforation guide 200 is placed on the anteromedial side 301 of the tibia 300 by the surgeon. The bone contacting surface 204 has a shape that matches the shape of the anteromedial side 301 . Accordingly, the shape of the bone-contacting surface 204 is preferably formed using patient-specific data. Thus, as shown in FIG. 9 b , matching the shape of the bone-contacting surface 204 to the exterior shape of the anteromedial side 301 of the tibia 300 facilitates correct placement of the surgical perforation guide 200 on the anteromedial side 301 .

Then, as shown in Figure 9c, two bone fixation elements 220a, 220b are inserted through the two fastener receiving holes 221a, 221b, and are screwed into the bone material of the tibia 300, so that as shown in Figure 9d The surgical perforation guide 200 is securely anchored to the tibia 300 . In the next step, as shown in Figure 10a, the surgeon uses a drill 400 having an effective drilling length 401 and drills through the drill guide bores 202a-202z until the stop 402 of the drill 400 aligns with the corresponding drill Seats 203a-203z collide, as shown in Figure 10b. By using the surgical perforation guide 200, especially in the case where the drill holders 203a-203z have been arranged in said surgical perforation guide 200 according to patient-specific data, the lateral cortex 303 is formed by the drill holes 310a-203z. 310z penetrates, however, no soft tissue adjacent to the lateral cortex 303 is compromised. As shown in Fig. 10c, the lateral cortex 303 is penetrated by means of said bores 310a-310z and thus weakened, which increases its flexibility. The increased flexibility reduces the risk of iatrogenic fractures when the surgeon forces the wedge open.

The number of perforations needed to prevent iatrogenic fractures depends primarily on the following variables: bone quality, tibial plateau size, resection depth 110 , drill 400 diameter, and amount of mechanical axis 106 correction. FIG. 11 shows the situation according to FIG. 10 c in a sectional view. It can be seen that the drill seats 203a-203z are all positioned differently in the surgical perforation guide, resulting in a slightly stepped arrangement of the drill seats 203a-203z relative to each other, as indicated by the thicker lines in FIG. emphasized. In addition, it can be recognized how the stop seat 402 of the drill bit 400 cooperates with the bit holders 203a-203z to limit the drilling depth to the specific desired drilling of each of the plurality of drill guiding bores 202a-202z Depth 312. As can be seen, the confinement avoids any damage to the soft tissue since the drill 400 cannot be advanced further by the surgeon. In the figure, only a particular desired drilling depth 312 for one of the plurality of drill guiding bores 202a-202z is shown. The drilling step creates one bore 310a-310z through the tibia 300 for each drill-guided bore 202z-202z.

FIG. 12 a shows the next step, where the saw blade 500 is inserted into the elongated slot 201 . With the aid of the saw blade 500 , the surgeon can make an incision 311 into the tibia 300 as shown in FIG. 12 b . The depth of the incision 311 is maintained at the preoperatively defined maximum desired depth into the tibia 300 by the cooperation of the blade mount 502 with the outer face 205 of the surgical perforation guide.

Fig. 13 shows a cross-sectional representation of the situation according to Fig. 12b. The section thus lies in the first osteotomy plane. In this figure, it can be recognized how the depth of the cutout 311 is influenced by the shape of the outer face 205 which interacts with the blade seat 502 . The geometry of the cutout 311 in the tibia 300 substantially corresponds to the shape of the outer surface 205 because the teeth 504 of the saw blade 500 cannot be inserted deeper into the tibia 300 than the calibrated sawing length 501 .

Fig. 14 shows 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 the present embodiment also includes a second elongated slot 240 defining a second osteotomy plane B . The axis X of the drill guiding bores 202a-202z is parallel to said first osteotomy plane A, while the second osteotomy plane B is arranged at an angle to said first osteotomy plane A. Osteotomy plane A, osteotomy plane B intersect at line 315, which is located within the target bone during the surgical procedure. Using such a surgical perforation guide, the surgeon can very precisely cut the wedge into the target bone, especially when performing a closed wedge osteotomy.

Figures 15a and 15b show a further embodiment of a surgical perforation guide 200 according to the invention. In this embodiment, the surgical perforation guide 200 does not include the elongated slot 201 , but instead a plurality of protrusions 250 disposed on the bone-contacting surface 204 . The protrusions 250 are arranged parallel to each other and define a first osteotomy plane A. As shown in FIG. Again, the plurality of drill guiding bores 202a-202z are arranged such that their axes are parallel to said first osteotomy plane A. As shown in FIG. The thickness 251 of the protrusion 250 is selected such that the protrusion 250 can be inserted into the cutout 311 . This allows aligning the axes of the drill guiding bores 202a-202z parallel to said cutouts 311 .

Figures 16a and 16b illustrate an alternative embodiment of a surgical perforation guide 200, which is not part of the present invention. In this embodiment, as can be seen in Figure 16a, an elongated slot 201 defining a first osteotomy plane A and drill guiding bores 202a-202z (only one of the drill guiding bores 202 is shown) The axes X are not parallel. However, the axis X and the elongated slot 201 are arranged such that they intersect at a line 315 which is located within the target bone during the surgical procedure. Furthermore, in this embodiment, the surgical perforation guide 200 further includes a second elongated slot 240 defining a second osteotomy plane B. As shown in FIG. The second elongated slot 240 is arranged such that the second osteotomy plane B intersects the first osteotomy plane A at line 315 . Thus, the second osteotomy plane B also intersects the axis X of the drill guiding 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 . It can be recognized in this figure that the drill pilot bores 202a-202z (only one of the drill pilot bores 202 is shown) are all arranged on a single line that is aligned with the first elongated slot 201 and the second elongated slot 201 . The long slots 240 are spaced apart. In addition, the location of the two fastener receiving holes 221a, 221b can also be easily identified in this figure. Such a surgical perforation guide is particularly suitable for closed wedge osteotomy because it allows two mutually oblique incisions to be cut into the target bone, which define the bone to be subsequently removed from the target bone. wedge.

Claims (13)

1. A surgical perforation guide (200) to be fixed against a target bone, comprising at least one first elongated slot (201) or at least one protrusion (250) defining a first osteotomy plane (A) ), and a plurality of drill guiding bores (202a-202z) having a diameter and a central axis (X), the central axes (X) of the drill guiding bores (202a-202z) being parallel to the first cut A bone plane (A), wherein the diameters of the plurality of drill guiding bores (202a-202z) intersect the osteotomy plane (A), wherein the plurality of drill guiding bores (202a- Each borehole in 202z) includes a drill seat (203a-203z) providing a stop surface for the drill bit (400), said drill seat (203a-203z) limiting the drilling depth to said plurality of drill pilot bores. A specific desired drilling depth (312) for each bore in the holes (202a-202z). 2. The surgical perforation guide (200) according to claim 1, characterized in that each of said drill bits (203a-203z) is arranged on said surgical perforation guide (200) to Specific data constrains the drilling depth, thereby preferably producing a specific desired drilling depth (312) corresponding to the hole located at the surgical perforation guide (200). The distance between the fixed side and the opposite cortex. 3. The surgical perforation guide (200) according to any one of claims 1 or 2, wherein said surgical perforation guide (200) further comprises a bone contactor for contacting said target bone A surface (204), the bone-contacting surface (204) has a shape that matches the external shape of the target bone. 4. The surgical perforation guide (200) according to any one of claims 1-3, characterized in that said surgical perforation guide (200) comprises at least one elongated slot (201) and an outer surface (205), said at least one elongated slot (201) and outer face (205) provide a guiding surface for the saw blade (500) to limit the resection depth (110) of said saw blade (500) in said target bone ). 5. The surgical perforation guide (200) according to claim 4, characterized in that the shape of the outer face (205) is configured such that the cutting depth (110) is preferably along the Said at least one elongated slot (201) changes. 6. The surgical perforation guide (200) according to any one of claims 1-5, characterized in that said surgical perforation guide (200) comprises a first elongated slot (201) and a second an elongated slot (240), said second elongated slot (240) defining a second osteotomy plane (B) arranged to be aligned with said first osteotomy plane (A) Angled, wherein the second elongated slot (240) is configured such that the second osteotomy plane (B) intersects the first osteotomy plane (A) within the target bone. 7. The surgical perforation guide (200) according to any one of claims 1-3, characterized in that said surgical perforation guide (200) comprises a plurality of protrusions (250), said protrusions Object (250) is sized and shaped for insertion into the resection incision (311) of the target bone. 8. The surgical perforation guide (200) according to any one of claims 1-7, characterized in that said surgical perforation guide (200) further comprises at least one fastener receiving hole (221a, 221b). 9. A kit comprising at least one surgical perforation guide (200) according to any one of claims 1-8 and at least one drill bit (400) having a stop seat (402). 10. The kit according to claim 9, further comprising at least one saw blade (500) having a protrusion defining a saw blade seat (502). 11. A method for producing a surgical perforation guide (200), preferably according to any one of claims 1-8, comprising the steps of: a) defining the positions and desired drilling depths of a plurality of drill pilot holes (202a-202z) from patient specific data, preferably patient specific imaging data; b) determining the depth of each of the drill pilot holes (202a-202z) based on the desired drilling depth (312) for each of the drill pilot holes (202a-202z) The position of the bit seat (203a-203z); c) The surgical perforation guide (200) is produced, preferably by machining or by additive manufacturing techniques. 12. The method according to claim 11, further comprising the step of defining a bone for contacting the target bone by determining the shape of a predetermined contact zone of the target bone from patient specific imaging data prior to the producing step. The shape of the contact surface (204). 13. The method according to any one of claims 11-12, further comprising the step of defining said surgical perforation guide prior to said production step on the basis of the necessary resection depth (110) from patient specific imaging data The shape of the outer face (205) of (200).