WO2019033551A1

WO2019033551A1 - Auxiliary tool for inner side high tibial osteotomy

Info

Publication number: WO2019033551A1
Application number: PCT/CN2017/107590
Authority: WO
Inventors: 朱忠林; 朱健
Original assignee: 上海起励生物技术服务中心
Priority date: 2017-08-17
Filing date: 2017-10-25
Publication date: 2019-02-21
Also published as: CN107320153B; CN107320153A

Abstract

Disclosed is an auxiliary tool for inner side high tibial osteotomy including an osteotomy guiding template (10) comprising a main body (11), wherein the main body (11) has a fitting curved surface fitting with the curved surface in the area under the inner side of a tibial platform; a lower tibial wedge-shaped osteotomy guiding structure (15) and a lower tibial tubercle osteotomy guiding structure (16) are provided on the opposite surface of the fitting curved surface; a first positioning claw (12) contacting the highest apophysis point of the tibial tubercle is provided on one side of the main body (11); and a second positioning claw (13) and a third positioning claw (14) contacting the inner side of the tibial platform are provided at the upper part of the main body (11). By designing individually and customizing a special osteotomy guiding template (10) suitable for a patient condition,a doctor can rapidly perform an operation with the special osteotomy guiding template (10) to reduce operation time, and positioning is accurate and convenient in the operation, osteotomy accuracy can be significantly improved, the number of fluoroscopy in the operation can be reduced, and thus surgical success rate is improved,and intraoperative infection rate and recurrence rate are reduced.

Description

A medial high osteotomy osteophyte aid

Technical field

The invention relates to the field of medical auxiliary equipment, in particular to an auxiliary tool for the medial high osteotomy of the tibia.

Background technique

The medial open wedge humerus high osteotomy (HTO) is used to treat the medial osteoarthritis of the knee caused by varus deformity, and the wedge-shaped osteotomy of the medial aspect of the humerus can correct the lower limb force line and delay the joint degeneration. The purpose of the knee.

In the medial open wedge HTO, osteotomy was performed along the A line (the wedge osteotomy line below the tibia) and the B line (the osteotomy line below the tibial tuberosity). The line A was taken from the 35-40 mm range below the medial tibia platform to the humerus. The tip of the head; the B line is at an angle of about 110° to the sagittal plane of the human body; the intersection of the A and B lines is 10-20 mm from the anterior cortical bone, and the inner open wedge HTO is highly demanding for the doctor's operation. In the traditional medial open wedge HTO, the doctor uses the clinical practice experience and the existing measurement tools to perform the osteotomy operation, which results in the deviation of the osteotomy accuracy due to different operators, and the measurement while the surgery will lead to longer operation time, and Frequent X-ray fluoroscopy during surgery increases X-ray exposure for patients and surgeons.

Summary of the invention

In view of the above problems, the object of the present invention is to provide an auxiliary tool for the medial high osteotomy of the tibia, which adopts a personalized design of the medial high osteotomy osteophyte assisting tool to assist the doctor to perform the operation more quickly, reduce the operation time, and locate the operation. Accurate and convenient, greatly improve the accuracy of osteotomy, reduce the number of intraoperative fluoroscopy, thereby improving the success rate of surgery, reducing the intraoperative infection rate and recurrence rate.

To achieve the above object, the present invention adopts the following technical solutions:

A tibia medial high osteotomy aid, comprising an osteotomy guide template, the osteotomy guide template comprising a body having a conforming surface for conforming to a curved surface of a region below the tibial plateau; and an opposite surface of the conforming surface The wedge-shaped osteotomy guiding structure below the humerus and the osteotomy guiding structure below the tibial tuberosity are provided; one side of the main body is provided with a first positioning claw contacting the highest protuberance of the tibial tuberosity; the upper part of the main body is provided with the inner side of the tibial plateau The second positioning claw and the third positioning claw that are in contact.

Further, the wedge-shaped osteotomy guiding structure below the tibia is formed by the opposite surface of the conforming curved surface of the main body to at least two guiding holes or osteotomy grooves of the conforming curved surface, and the osteotomy guiding structure below the tibial tuberosity is the fitting of the main body The opposite side of the curved surface extends through at least two guiding holes or osteotomy grooves that fit the curved surface.

Further, when the wedge-shaped osteotomy guiding structure below the tibia and the osteotomy guiding structure below the tibial tuberosity are both osteotomy grooves, the main body is further provided with a fixing structure for fixing the osteotomy guiding template on the tibia.

Further, the diameter of the guiding hole is 1.5 mm to 5 mm, the shape of the guiding hole is circular, the guiding depth of the guiding hole is >10 mm, and the guiding orientation of the guiding hole is a preset target orientation.

Further, the first positioning claw, the second positioning claw and the third positioning claw are both arc-like structures which are curved toward the tibia and are adapted to the outer surface of the tibia, and the first positioning claw, the second positioning claw and the third positioning claw are The thickness is 2mm-10mm.

Further, the osteotomy guiding template is an organic material or a metal material, and the osteotomy guiding template is obtained by rapid processing by machining or 3D printing.

Further, the main body is further provided with an indicating structure for indicating the position of the fixing steel plate screw hole, and the indicating structure is an indicating hole or an indicating groove.

Further, the posterior tibial high osteotomy aid of the present invention further includes a wedge template group or a spreader for maintaining the cut tibia at a predetermined slope after assisting osteotomy using any of the aforementioned osteotomy guide templates. .

Further, the wedge template group includes a plurality of wedge templates, the wedge template includes a crank and a wedge block disposed at both ends of the crank, the wedge block has a maximum thickness of 5 mm to 20 mm, and the wedge block has a slope of 5 to 20 degrees.

Further, the two wedge blocks at both ends of the crank have different maximum thicknesses and/or slopes.

Due to the adoption of the above technical solutions, the present invention has the following beneficial technical effects as compared with the prior art:

1. The osteotomy guide template of the present invention can be customized and customized according to the patient's condition, and the doctor can use this special osteotomy guide template in combination with the wedge template to perform the operation more quickly and reduce the operation time. And the intraoperative positioning is accurate and convenient, greatly improving the accuracy of osteotomy and reducing the number of intraoperative fluoroscopy, thereby improving the success rate of surgery and reducing the intraoperative infection rate and recurrence rate.

2. Based on rapid prototyping technology such as 3D printing, the osteotomy guide template of the present invention can be quickly manufactured, which makes the osteotomy more simple and accurate, and becomes a development trend of HTO surgery, and has broad application prospects.

DRAWINGS

The following drawings are only intended to illustrate and explain the present invention, and do not limit the scope of the invention. among them:

1 is a schematic illustration of an exemplary osteotomy guide template of the posterior tibial high osteotomy aid of the present invention;

2 is a schematic illustration of another exemplary osteotomy guide template of the posterior tibial high osteotomy aid of the present invention;

Figure 3 is a schematic illustration of the use of the exemplary osteotomy guide template shown in Figure 1;

4 is a schematic illustration of the use of the exemplary osteotomy guide template shown in FIG. 2;

Figure 5 is a schematic illustration of an exemplary wedge template of the posterior tibial high osteotomy aid of the present invention;

Fig. 6 is a schematic view showing the use of the wedge-shaped template shown in Fig. 5.

Reference mark:

10- osteotomy guide template 11-body 12-first positioning claw 13-second positioning claw

14-third positioning claw 15-crown osteotomy guiding structure under the humerus

16- osteotomy guiding structure below the tibial tuberosity

20-wedge template

31-First Zone 32-Second Zone 33-Third Zone

Detailed ways

The present invention will be further described in detail below with reference to the embodiments of the present invention. It is understood that the specific embodiments described herein are merely illustrative of the invention and are not intended to limit the invention.

Referring to Figures 1 and 2, a posterior tibial high osteotomy aid according to the present invention includes an osteotomy guide template 10 including a body 11 having a body for use with the inside of the tibial plateau a curved surface that conforms to the curved surface of the region; the opposite surface of the conforming curved surface is provided with a wedge-shaped osteotomy guide structure 15 for guiding the surgeon to perform osteotomy along the wedge-shaped osteotomy line below the tibia and for guiding the surgeon along An osteotomy guiding structure 16 below the tibial tuberosity for osteotomy under the tibial tuberosity; a side of the main body 11 is provided with a first positioning claw 12 in contact with the highest protuberance of the tibial tuberosity; the upper portion of the main body 11 is provided with a second positioning claw 13 and a third positioning claw 14 that are in contact with the inner side of the tibial plateau. Preferably, the above-mentioned conforming curved surface is a bone anatomy of the patient.

In practical applications, the osteotomy guide template of the present invention dedicated to the patient can be customized by individual design, that is, the surgical plan is formulated according to the shape, size, and damage of the patient's tibia, and the above-mentioned fitting curved surface and the lower part of the tibia are designed according to the surgical plan. The wedge osteotomy guiding structure, the osteotomy guiding structure below the tibial tuberosity, and the first positioning claw, the second positioning claw and the third positioning claw, thereby obtaining a dedicated osteotomy guiding template conforming to the patient's condition. Using this special osteotomy guide template, doctors can perform surgery more quickly, reduce the operation time, and accurately and conveniently locate the operation, greatly improve the accuracy of osteotomy, reduce the number of intraoperative fluoroscopy, and thus improve the success rate of surgery. Reduce intraoperative infection rate and recurrence rate.

In the exemplary osteotomy guide template 10 of the medial tibial high osteotomy aid shown in Fig. 1, the tibial wedge osteotomy guide structure 15 and the tibial tuberosity lower osteotomy guide structure 16 are the conformal surfaces of the main body. The opposite face runs through the two guiding holes that fit the curved surface. The number of holes is only an example, and it can also be three or more guide holes to increase the accuracy of the guide. Also, to increase the accuracy of the guide, the guide holes may be disposed on the bosses that protrude from the opposite faces of the conforming curved surface. Wherein, the diameter of the guiding hole is 1.5mm-5mm, the shape of the guiding hole is circular, the guiding depth of the guiding hole is >10mm, the guiding orientation of the guiding hole is a preset target orientation, and the position of the guiding hole is according to the shape of the patient-based tibia The surgical plan established by the size, injury, etc. is determined. In a preferred embodiment of the invention, the guide hole has a diameter of 1.5 mm, the guide hole has a circular shape, and the guide hole has a guide depth of 11 mm; in another preferred embodiment of the invention, the guide hole has a diameter of 5 mm. The guiding hole has a circular shape, and the guiding hole has a guiding depth of 13 mm.

The at least two guiding holes are respectively used as the osteotomy guide plate and the lower tibial osteotomy guiding structure and the osteotomy guiding structure under the tibial tuberosity. In use, the Kirschner wire is first driven into the tibia under the guidance of the guiding hole, and then The osteotomy guide template was removed and the osteotomy was performed under the guidance of the Kirschner wire. The osteotomy operation space was large and flexible.

In the exemplary osteotomy guide template 10 of the posterior tibial high osteotomy aid shown in Fig. 2, the tibial wedge osteotomy guide structure 15 and the tibial nodule osteotomy guide structure 16 are the conformal surfaces of the main body. The opposite surface penetrates into the osteotomy groove that fits the curved surface. The width of the osteotomy groove matches the oscillating saw used in the operation. The length and the inclination of the osteotomy groove are based on the shape, size, and damage of the patient's tibia. The program to determine. Also provided on the main body 11 is a fixing structure (not shown) for fixing the osteotomy guide template 10 to the tibia. Preferably, the fixing structure is a fixing nail and a hole matching the fixing nail.

The truncated bone osteotomy guiding structure and the osteotomy guiding structure under the tibial tuberosity are respectively used as the osteotomy guide plate, and the osteotomy guiding template is fixed on the inner side of the tibia by the fixing structure on the osteotomy guiding stencil when in use. Then, under the guidance of the osteotomy trough, the osteotomy is performed, the osteotomy precision is high, the operation time is short, and the requirement for the surgeon is low.

In one embodiment of the invention, the tibial wedge osteotomy guide structure 15 and the tibial tuberosity lower osteotomy guide structure 16 are different, that is, the tibial wedge osteotomy guide structure 15 is two guide holes and the tibial tuberosity below the section The bone guiding structure 16 is an osteotomy groove, or the wedge osteotomy guiding structure 15 below the tibia is an osteotomy groove and the osteotomy guiding structure 16 below the tibial tuberosity is two guiding holes.

As shown in FIG. 1 and FIG. 2, the first positioning claw 12, the second positioning claw 13, and the third positioning claw 14 are both arc-like structures that are curved toward the tibia and are adapted to the outer surface of the tibia, in order to ensure that the claw has a certain The rigidity is positioned, and the thickness of the first positioning claw 12, the second positioning claw 13, and the third positioning claw 14 are both 2 mm to 10 mm. In a preferred embodiment of the present invention, the thickness of the first positioning claw 12, the second positioning claw 13, and the third positioning claw 14 are both 10 mm; in another preferred embodiment of the present invention, the first positioning claw 12, The thickness of the second positioning claw 13 and the third positioning claw 14 are both 2 mm; in still another preferred embodiment of the present invention, the thickness of the first positioning claw 12 is 8 mm, and the thickness of the second positioning claw 13 is 6 mm, and the third The thickness of the positioning claw 14 is 5 mm. In order to make the positioning more stable, the first positioning claw 12, the second positioning claw 13, and the third positioning claw 14 must have a certain rigidity.

The osteotomy guide template 10 of the present invention is made of an organic material or a metal material. And the osteotomy guide template 10 of the present invention is produced by machining or 3D printing rapid prototyping and other rapid prototyping techniques.

Because 3D printing rapid prototyping technology can quickly and accurately manufacture products, the personalized design and manufacture of osteotomy-oriented templates based on 3D printing rapid prototyping technology makes osteotomy more simple and precise, and becomes the development trend of HTO surgery. ,with broadly application foreground.

In an embodiment of the present invention, the main body 11 of the osteotomy guiding template 10 is further provided with an indicating structure for indicating the position of the fixing steel plate screw hole, and the indicating structure is an indicating hole or an indicating groove.

The steps of assisting the osteotomy using the osteotomy guide template 10 of the present invention include:

(1) According to the shape, size, injury and the like of the patient, a surgical plan is prepared, and a conforming curved surface, a wedge-shaped osteotomy guiding structure 15 under the tibia, an osteotomy guiding structure 16 below the tibial tuberosity, and a first positioning claw are designed according to the surgical plan. 12, the second positioning claw 13 and the third positioning claw 14, using 3D printing rapid prototyping to obtain a special osteotomy guide template 10 in accordance with the patient's condition;

(2) Determining the highest starting point of the tibial tuberosity and the tibial plateau;

(3) using the first positioning claw 12 to contact the highest end of the tibial tuberosity, and using the second positioning claw 13 and the third positioning claw 14 to contact the inside of the tibial plateau, as shown in FIG. 3, the inside of the tibial plateau is equally divided into the first region. 31. The second zone 32 and the third zone 33, the starting point of the first zone 31 is directly above the tibial tuberosity, and the stopping point of the third zone 33 is the innermost point of the tibial plateau, wherein the second positioning claw 13 is located at the The junction of a zone 31 and the second zone 32 contacts the medial cortical bone, and the third positioning claw 14 is located at the junction of the second zone 32 and the third zone 33, contacting the medial cortical bone, and then conforming to the bone using the curved surface of the template. The cortical side for precise positioning.

(4) When the wedge-shaped osteotomy guiding structure 15 below the tibia and the osteotomy guiding structure 16 below the tibial tuberosity are both guiding holes (as shown in Figures 1 and 3), the Kirschner wire is firstly driven into the wedge below the tibia. The osteotomy guide hole is to the contralateral cortical bone, and then the Kirschner wire is inserted into the osteotomy guide hole below the tibial tuberosity until the penetration is taken out, and then the osteotomy guide template 10 is taken out, and then the removed Kirschner wire is taken along the original The penetrating hole is driven in, and the oscillating saw is used to perform osteotomy under the guidance of the Kirschner wire, and the guiding direction is the target orientation preset by the surgical plan.

(5) When the wedge-shaped osteotomy guiding structure 15 below the tibia and the osteotomy guiding structure 16 below the tibial tuberosity are both osteotomy grooves (as shown in Figures 2 and 4), the artificial structure or the fixed structure on the main body 11 makes the cutting The bone template is tightly fixed on the side of the cortical bone. The oscillating saw is used to cut the bone along the osteotomy groove below the tibial tuberosity, penetrate the cortical bone, and then use the oscillating saw to cut along the wedge osteotomy groove below the tibia according to the osteotomy depth of the surgical plan. bone.

The medial tibial high osteotomy aid according to the present invention further includes a wedge template set or spreader for maintaining the cut tibia at a predetermined slope after the osteotomy is used to assist the osteotomy. Where the spreader is an existing product on the market, the present invention provides a set of wedge-shaped templates for maintaining the cut tibia at a predetermined slope after osteotomy. The wedge formwork set of the present invention comprises a plurality of wedge formwork 20 as shown in Fig. 5. The wedge formwork 20 comprises a crank and a wedge block disposed at both ends of the crank. The maximum thickness of the wedge block is 5 mm-20 mm, and the slope of the wedge block is 5 °-20°. The maximum thickness and/or slope of the two wedge blocks at the ends of the crank may be the same or different.

In order to visually see the size of the wedge block (ie the maximum thickness and the slope), a number representing the thickness of the wedge block is engraved on the wedge face of the wedge block, and the slope representing the wedge block is engraved on the side of the wedge block The number.

As shown in FIG. 6, after the osteotomy guide template 10 of the present invention is used to assist the osteotomy, the wedge template 20 is selected according to the desired angle, and the wedge template 20 is inserted into the osteotomy plane to maintain the cut humerus at a predetermined angle. After the inner fixing is performed using a steel plate, the wedge-shaped template 20 is taken out. The crank of the wedge template 20 can facilitate the insertion and removal of the operation, but the orientation of the crank cannot be dried. The installation of steel plates.

The use of a wedge-shaped stencil having a fixed gauge maintains the cut tibia at a predetermined slope, which can effectively prevent the occurrence of adverse effects such as surgical failure due to the correction of the angle correction after the osteotomy or the failure of the surgical effect to achieve the desired effect.

The above-described embodiments are merely illustrative of the embodiments of the present invention, and the description thereof is more specific and detailed, but is not to be construed as limiting the scope of the invention. It should be noted that a number of variations and modifications may be made by those skilled in the art without departing from the spirit and scope of the invention. Therefore, the scope of the invention should be determined by the appended claims.

Claims

A tibia medial high osteotomy assisting tool, comprising an osteotomy guiding template, the osteotomy guiding template comprising a body having a conforming surface for fitting a curved surface with a lower inner side of the tibial plateau ;

The opposite surface of the conforming curved surface is provided with a wedge-shaped osteotomy guiding structure below the tibia and an osteotomy guiding structure below the tibial tuberosity;

One side of the body is provided with a first positioning claw that contacts the highest protuberance of the tibial tuberosity;

The upper portion of the body is provided with a second positioning claw and a third positioning claw that are in contact with the inner side of the tibial plateau.
The posterior tibial orbital osteotomy assisting tool according to claim 1, wherein the lower tibial wedge osteotomy guiding structure is formed by the opposite surface of the conforming curved surface of the main body to the conforming curved surface At least two guiding holes or osteotomy grooves, the osteotomy guiding structure below the tibial tuberosity is at least two guiding holes or cuts penetrating from the opposite faces of the conforming curved surface of the main body to the conforming curved surface Bone groove.
The posterior tibial high osteotomy aid according to claim 2, wherein when the tibial wedge osteotomy guiding structure and the tibial nodule osteotomy guiding structure are both the osteotomy groove, The body is further provided with a fixing structure for fixing the osteotomy guiding template on the tibia.
The tibia medial high osteotomy assisting tool according to claim 2, wherein the guiding hole has a diameter of 1.5 mm to 5 mm, the guiding hole has a circular shape, and the guiding depth of the guiding hole is > 10mm, the guiding orientation of the guiding hole is a preset target orientation.
The posterior tibial high osteotomy aid according to claim 1, wherein the first positioning claw, the second positioning claw and the third positioning claw are both curved toward the tibia and are opposite to the outer surface of the tibia. In an adapted arc-like structure, the first positioning claw, the second positioning claw, and the third positioning claw have a thickness of 2 mm to 10 mm.
The tibia medial high osteotomy aid according to claim 1, wherein: The osteotomy guide template is an organic material or a metal material, and the osteotomy guide template is obtained by rapid processing by machining or 3D printing.
The humeral medial high osteotomy aid according to any one of claims 1 to 6, wherein the main body is further provided with an indicating structure for indicating the position of the fixed steel plate screw hole, and the indicating structure is an indicating hole. Or indicate the slot.
The posterior tibial high osteotomy aid of claim 1 further comprising a wedge template for maintaining the cut tibia at a predetermined slope after assisting osteotomy using the osteotomy guide template Or opener.
The posterior tibial high osteotomy aid according to claim 8, wherein the set of wedge templates comprises a plurality of wedge templates, the wedge template comprising a crank and wedge blocks disposed at opposite ends of the crank, The wedge block has a maximum thickness of 5 mm to 20 mm, and the wedge block has a slope of 5 to 20 degrees.
The tibia medial high osteotomy aid according to claim 9, wherein the two wedge members at both ends of the crank have different maximum thicknesses and/or slopes.