阅读说明：本技术 基于计算机辅助的置入骶髂螺钉方向调节装置及调节方法 (Computer-aided implanted sacroiliac screw direction adjusting device and adjusting method ) 是由 韩庆辉 王署光 汪方 孙贵新 甘迪 陈春华 陈大伟 于 2021-01-21 设计创作，主要内容包括：本发明公开了一种基于计算机辅助的置入骶髂螺钉方向调节装置,涉及医疗辅助器械技术领域,基于体表建立骶髂螺钉安全通道耗时、风险高,本装置为一种计算机辅助下的个性化手术导板方向调整装置系统。通过数字骨科技术在计算机内进行装置组配,分析组配后的方位参数,按照参数在体外安装该装置,即可获得骶髂螺钉理想的安全通道。具体方案为：包括固定机构和导向机构,固定机构连接设有第一连接杆,导向机构连接设有第二连接杆,第一连接杆和第二连接杆通过球形万向节连接。传统透视下置入骶髂螺钉,透视次数可达数十次甚至近百次,通过该技术可以控制在数次之内,明显减少术中时间及透视次数,减少医务人员及患者的射线暴露量。(The invention discloses a computer-aided implanted sacroiliac screw direction adjusting device, relates to the technical field of medical auxiliary instruments, and is time-consuming and high in risk when a sacroiliac screw safety channel is established on the basis of a body surface. The device assembly is carried out in a computer by digital orthopedics technology, the orientation parameters after the assembly are analyzed, and the device is installed in vitro according to the parameters, so that the ideal safe channel of the sacroiliac screw can be obtained. The specific scheme is as follows: the device comprises a fixing mechanism and a guide mechanism, wherein a first connecting rod is connected and arranged on the fixing mechanism, a second connecting rod is connected and arranged on the guide mechanism, and the first connecting rod and the second connecting rod are connected through a spherical universal joint. The sacroiliac screw is placed under the traditional fluoroscopy, the fluoroscopy times can reach dozens of times or even nearly hundreds of times, and the technology can be controlled within several times, thereby obviously reducing the time and the fluoroscopy times in the operation and reducing the ray exposure of medical staff and patients.)

1. The computer-aided implanted sacroiliac screw direction adjusting device is characterized by comprising a fixing mechanism (1) and a guide mechanism (2), wherein the fixing mechanism (1) is connected with a first connecting rod (3), the guide mechanism (2) is connected with a second connecting rod (4), and the first connecting rod (3) is connected with the second connecting rod (4) through a spherical universal joint (5); an angle sensor is arranged on the second connecting rod (4).

2. The computer-aided implantation sacroiliac screw direction adjustment apparatus according to claim 1, wherein the first connecting rod (3) is provided with a sensing point (6) near the ball joint (5), and the second connecting rod (4) is provided with a sensing point (6) near the ball joint (5).

3. The computer-aided implantation sacroiliac screw direction adjustment apparatus according to claim 2, wherein the first connecting rod (3) or the second connecting rod (4) is a loop bar arrangement.

4. The computer-aided implantation sacroiliac screw direction adjustment apparatus according to claim 3, wherein the first connecting rod (3) or the second connecting rod (4) of the loop bar arrangement is marked with a scale.

5. The computer-aided implantation sacroiliac screw direction adjustment apparatus according to claim 1, wherein the guide mechanism (2) comprises a second connecting rod (4), a connecting plate (201), and a surgical guide rod (202), the second connecting rod (4) and the connecting plate (201) being integrally formed, the surgical guide rod (202) being fixedly connected with the connecting plate (201).

6. The computer-aided implantation sacroiliac screw direction adjustment apparatus according to claim 1, wherein the fixation mechanism (1) is a fixation plate and a self-tapping screw (101) threaded to the fixation plate.

7. The computer-aided implantation sacroiliac screw orientation adjustment apparatus according to claim 1, wherein the orientation adjustment apparatus further comprises an angle fixation apparatus comprising a clamping apparatus that clamps the second connecting rod (4).

8. A computer-aided implantation sacroiliac screw direction adjusting device adjusting method based on any one of claims 1 to 7, comprising the steps of:

s1: fixing the fixing mechanism on the ilium through self-tapping screws;

s2: performing three-dimensional modeling through three-dimensional CT scanning to manufacture a sacroiliac screw fixing mechanism;

s3: the fixing mechanism is used as a reference point, and the direction of the guide mechanism is adjusted;

s4: orientation parameters are obtained through a digital orthopedics technology, direction matching adjustment is carried out through a spherical universal joint in vitro, and a guide mechanism is fixed;

s5: the guide needle is placed in the human body through the guide mechanism.

Technical Field

The invention relates to the technical field of medical auxiliary instruments, in particular to a computer-aided implanted sacroiliac screw direction adjusting device.

Background

Vertical unstable pelvic fractures often present with pelvic posterior ring damage, manifested as damage to the sacroiliac joint and its surrounding structures: sacral fracture, sacroiliac joint fracture dislocation, and the like. The sacroiliac screw has good biomechanical performance, and is the preferred scheme for treating the injury of the sacroiliac joint and the surrounding structure thereof and reducing the disability rate of the sacroiliac joint and the surrounding structure thereof at present.

However, the complex anatomy of the sacrum is characterized by variability which makes screw placement difficult and provides a small safety margin for screw placement. Firstly, the sacroiliac screw is placed in the channel to be adjacent to important structures such as sacral nerve, pelvic viscera and the like, and the screw can penetrate out to cause injury of important blood vessels and nerves such as sacral nerve, internal iliac artery and vein, lumbosacral trunk, obturator nerve and the like, and can be fatal seriously; secondly, the screw placing area is narrow, and the screw placing point and the screw channel direction of the screw need to be determined through repeated perspective in the placing process, so that the situation that the internal fixation fails and the operation curative effect is influenced due to the fact that the screw placing position deviates is avoided. In addition, conventional multi-angle repeated fluoroscopy increases the exposure of the patient and the operating personnel to radiation, resulting in radiation damage and increased risk of tumor occurrence. Therefore, in order to improve the accuracy of screw implantation and reduce the fluoroscopy time, the sacroiliac screw implantation is usually performed by using a CT guidance or intraoperative navigation system in clinic, but the navigation system is expensive, and many medical institutions are not provided with conditions for performing the operation.

With the development of digital orthopedics, through digital orthopedics technique, can import the DICOM data of pelvis CT scanning into digital orthopedics software, generate the operation baffle according to predetermined best screw passageway, put into sacroiliac screw through the operation baffle is accurate, and this aspect has convenient to use, simplifies the operation degree of difficulty, improves operation precision, reduces advantages such as operation time, especially helps the doctor that experience is not enough. At present, a plurality of reports of research and clinical application of sacroiliac screw internal fixation guiders exist, but the positioning of the guiders is complex, the operation of determining the needle insertion point direction and position is relatively complex, the repeatability is low, and the clinical popularization is difficult.

Disclosure of Invention

In order to solve the technical problems, the invention provides a computer-aided sacroiliac screw implanting direction adjusting device, which is time-consuming and high in risk when a sacroiliac screw safety channel is established on the basis of a body surface. The device assembly is carried out in a computer by digital orthopedics technology, the orientation parameters after the assembly are analyzed, and the device is installed in vitro according to the parameters, so that the ideal safe channel of the sacroiliac screw can be obtained.

The technical purpose of the invention is realized by the following technical scheme:

a computer-aided implanted sacroiliac screw direction adjusting device comprises a fixing mechanism and a guide mechanism, wherein the fixing mechanism is connected with a first connecting rod, the guide mechanism is connected with a second connecting rod, and the first connecting rod and the second connecting rod are connected through a spherical universal joint; an angle sensor is arranged on the second connecting rod.

In the scheme, the fixing mechanism, the guide mechanism and the two mechanism components are subjected to laser scanning, and then scanned data are imported into digital orthopedic software for modeling. The implementation process is as follows: fixing the fixing mechanism on the ilium as a reference point, performing pelvis CT scanning, importing DICOM data scanned by CT into digital orthopedic software, performing analog assembly in a computer, producing an ideal sacroiliac screw safe channel, and analyzing the orientation parameters of the guide mechanism. Then the guide mechanism is assembled in vitro according to the parameters, so that the sacroiliac screw safe channel can be produced in vitro. Installing and implanting the sacroiliac screw: set up two spherical recesses respectively through the link at head rod and second connecting rod, place the rolling ball in the recess, the rolling ball carries out direction regulation and spacing through the friction, then adjusts the direction and makes guiding mechanism adjust to the orientation that needs, then through guiding mechanism, puts into internally with the guide pin, and hollow drill is in the same direction as the guide pin trompil, puts into hollow screw along the guide pin at last.

The first connecting rod and the second connecting rod are horizontally arranged as initial points, and when the second connecting rod rotates relative to the first connecting rod, the angle sensor senses the relative rotation angle of the second connecting rod so as to achieve the rotation angle of the first connecting rod relative to the second connecting rod.

The scheme can realize the adjustment of the guide mechanism in any direction, simultaneously liberates manpower and does not need manual fixation; the direction adjustment is simulated through the computer, so that the method has the accurate characteristic, and the direction of the guide mechanism is adjusted in a targeted manner after the angle needing drilling is simulated, so that the constructed channel has the advantages of being safer and more labor-saving; after the direction is fixed, the direction is determined without dozens of or even hundreds of perspectives, so that the damage caused by radiation can be reduced.

As a preferred scheme, the first connecting rod is provided with a sensing point near the ball joint, and the second connecting rod is provided with a sensing point near the ball joint.

In the preferred scheme, the distance between the two connecting rods can be accurately measured in a computer through the relative distance between the two sensing points, so that the assembly is more accurate, and the accuracy rate of in-vitro assembly is improved; the induction points can be provided with inductors or can be set as mark points which can be induced by the inductors, so that the aim of quickly acquiring the relative distance between the two induction points is fulfilled.

Preferably, the first connecting rod or the second connecting rod is a loop rod.

In above-mentioned preferred scheme, the loop bar setting, the length that can adjust first connecting rod or second connecting rod to satisfy patient's individual difference.

As a preferred scheme, scales are marked on the first connecting rod or the second connecting rod arranged on the loop bar.

In the above preferred embodiment, the scale is provided to enable the telescopic length of the first connecting rod or the second connecting rod to be known.

As a preferred scheme, guiding mechanism includes second connecting rod, connecting plate and operation guide bar, second connecting rod and connecting plate integrated into one piece, operation guide bar and connecting plate fixed connection.

In the preferred scheme, the guide needle is placed in the human body through the operation guide rod; the guide rod is arranged in a hollow mode, the guide needle is arranged in the guide rod, and then the hollow drill bit is used for drilling along the direction of the guide needle; the second connecting rod and the connecting plate are integrally formed, so that the stability of the second connecting rod and the connecting plate is improved; in the preferred scheme of difference, the second connecting rod also can be articulated with the connecting plate for the patient's epidermis can be laminated to the connecting plate, avoids appearing most advanced conflict patient's epidermis, causes unwell condition to the patient.

Preferably, the fixing means is a self-tapping screw.

In the preferred embodiment, the fixing means is fixed to the ilium by self-tapping screws, and then the direction of the guide means is adjusted.

As a preferable scheme, the direction adjusting device further comprises an angle fixing device, and the angle fixing device comprises a clamping device for clamping the second connecting rod.

In above-mentioned preferred scheme, after the angle of guide bar is confirmed, through external clamping device, fixed with the second connecting rod, then with clamping device fixed keep motionless, can realize the fixed of second connecting rod, stability when can effectively increase guiding mechanism's the use avoids too big because of exerting oneself, causes the change of the direction of ball universal joint, the condition that the direction needs to be adjusted once more.

A computer-aided adjusting method of an implanted sacroiliac screw direction adjusting device comprises the following steps:

s1: fixing the fixing mechanism on the ilium through self-tapping screws;

s2: performing three-dimensional modeling through three-dimensional CT scanning to manufacture a sacroiliac screw fixing mechanism;

s3: the fixing mechanism is used as a reference point, and the direction of the guide mechanism is adjusted;

s4: orientation parameters are obtained through a digital orthopedics technology, direction matching adjustment is carried out through a spherical universal joint in vitro, and a guide mechanism is fixed;

s5: the guide needle is placed in the human body through the guide mechanism.

In conclusion, the invention has the following beneficial effects:

(1) the sacroiliac screw is placed under the traditional fluoroscopy, the fluoroscopy times can reach dozens of times or even nearly hundreds of times, and the technology can be controlled within several times, so that the time and the fluoroscopy times in the operation are obviously reduced, and the ray exposure of medical staff and patients is reduced;

(2) complications associated with the traditional approach to sacroiliac screw placement are approximately 10% and fatal cases have also been reported. The new technology can accurately and precisely position the sacroiliac screw channel, the related complications in the screw implantation process can be reduced to 0, and the safety and the accuracy of sacroiliac screw implantation are obviously improved;

(3) the traditional method has higher technical difficulty for inserting the sacroiliac screw, has high technical requirements on operators and long learning curve, and all operators are high-tech doctors; the new technology has low technical requirements on operators and short learning curve, and can be implemented by doctors with low annual capital expenditure, so that the operation can be widely performed in primary hospitals;

(4) the computer-aided implanted sacroiliac screw direction adjusting device provided by the invention can effectively construct a guide channel and realize accurate implantation of a guide needle;

(5) the computer-aided implanted sacroiliac screw direction adjusting device can be adjusted in any direction, and is convenient to adjust;

(6) the computer-aided implanted sacroiliac screw direction adjusting device provided by the invention has the advantages of simple structure, good use effect, and good economical efficiency and practicability.

Drawings

Fig. 1 is a schematic structural view of a computer-aided implantation sacroiliac screw orientation adjustment apparatus in an embodiment of the invention;

FIG. 2 is an enlarged view of a portion of an embodiment of the present invention;

reference numerals:

1. a fixing mechanism; 2. a guide mechanism; 3. a first connecting rod; 4. a second connecting rod; 5. a ball joint; 6. sensing points; 101. a self-tapping screw; 201. a connecting plate; 202. a guide rod.

Detailed Description

This specification and claims do not intend to distinguish between components that differ in name but not function. In the following description and in the claims, the terms "include" and "comprise" are used in an open-ended fashion, and thus should be interpreted to mean "include, but not limited to. "substantially" means within an acceptable error range, within which a person skilled in the art can solve the technical problem to substantially achieve the technical result.

The terms in the upper, lower, left, right and the like in the description and the claims are combined with the drawings for further explanation, so that the application is more convenient to understand and is not limited to the application, and in different scenes, the upper, lower, left, right, inner and outer terms are relative.

The present invention will be described in further detail with reference to the accompanying drawings.

A computer-aided implanted sacroiliac screw direction adjusting device comprises a fixing mechanism 1 and a guide mechanism 2, wherein the fixing mechanism 1 is connected with a first connecting rod 3, the guide mechanism 2 is connected with a second connecting rod 4, and the first connecting rod 3 and the second connecting rod 4 are connected through a spherical universal joint 5; an angle sensor is arranged on the second connecting rod 4.

In the above embodiment, the fixing mechanism 1, the guiding mechanism 2 and the two mechanism components are scanned by laser, and then the scanned data is imported into digital orthopedic software for modeling. The implementation process is as follows: fixing the fixing mechanism 1 on the ilium as a reference point, performing pelvis CT scanning, importing DICOM data scanned by CT into digital orthopedic software, performing analog assembly in a computer, producing an ideal sacroiliac screw safe channel, and analyzing the orientation parameters of the guide mechanism 2. The guide mechanism 2 is then assembled in vitro according to the parameters to produce the sacroiliac screw safety channel in vitro. Installing and implanting the sacroiliac screw: set up two spherical recesses respectively through the link at head rod 3 and second connecting rod 4, place the rolling ball in the recess, the rolling ball carries out direction regulation and spacing through the friction, then adjusts the direction and makes guiding mechanism 2 adjust to the orientation that needs, then through guiding mechanism 2, puts into the guide pin internally, and the core drill is in the same direction as the guide pin trompil, puts into hollow screw along the guide pin at last.

With the first connecting rod 3 and the second connecting rod 4 horizontally set as the initial point, when the second connecting rod 4 rotates relative to the first connecting rod 3, the angle sensor senses the relative rotation angle of the second connecting rod 4, so as to reach the rotation angle of the first connecting rod 3 relative to the second connecting rod 4.

The embodiment can realize the adjustment of the guide mechanism 2 in any direction, simultaneously liberates manpower and does not need manual fixation; the direction adjustment is simulated through the computer, so that the method has the accurate characteristic, and after the angle needing to be drilled is simulated, the direction of the guide mechanism 2 is adjusted in a targeted manner, so that the constructed channel has the advantages of being safer and more labor-saving; after the direction is fixed, the direction is determined without dozens of or even hundreds of perspectives, so that the damage caused by radiation can be reduced; the simulation through calculation has accurate characteristics, so that the nail placing is safe, and serious complications in the nail placing process can be obviously reduced.

As a preferred embodiment, the first connecting rod 3 is provided with a sensing point 6 near the ball joint 5, and the second connecting rod 4 is provided with a sensing point 6 near the ball joint 5.

In the preferred embodiment, the distance between the two connecting rods can be accurately measured in the computer by the relative distance between the two sensing points 6, so that the assembly is more accurate, and the accuracy of in-vitro assembly is improved; the sensing points 6 can be provided with sensors or can be provided with mark points which can be sensed by the sensors, so that the purpose of rapidly acquiring the relative distance between the two sensing points 6 is realized.

As a preferred embodiment, the first connecting rod 3 or the second connecting rod 4 is provided as a loop bar.

In the above preferred embodiment, the sleeve rod is provided, and the length of the first connecting rod 3 or the second connecting rod 4 can be adjusted to meet individual patient differences.

In a preferred embodiment, the first connecting rod 3 or the second connecting rod 4 of the loop bar is marked with scales.

In the above preferred embodiment, the scale is set to know the telescopic length of the first connecting rod 3 or the second connecting rod 4.

As a preferred embodiment, the guide mechanism 2 comprises a second connecting rod 4, a connecting plate 201 and a surgical guide rod 202, wherein the second connecting rod 4 and the connecting plate 201 are integrally formed, and the surgical guide rod 202 is fixedly connected with the connecting plate 201.

In the preferred embodiment described above, the guide needle is placed in the human body by the surgical guide rod 202; the guide rod 202 is arranged in a hollow mode, the guide needle is placed into the guide rod 202, and then the hollow drill bit is used for drilling along the direction of the guide needle; the second connecting rod 4 and the connecting plate 201 are integrally formed, so that the stability of the second connecting rod and the connecting plate is improved; in different preferred embodiments, the second connecting rod 4 may also be hinged to the connecting plate 201, so that the connecting plate 201 can be attached to the epidermis of the patient, and the situation that the tip of the connecting plate abuts against the epidermis of the patient and causes discomfort to the patient is avoided.

As a preferred embodiment, the fixing means 1 is a tapping screw 101.

In the preferred embodiment described above, the fixation mechanism 1 is fixed to the ilium by the tapping screw 101, and then the guide mechanism 2 is directionally adjusted.

As a preferred embodiment, the direction adjustment means further comprises angle fixing means comprising clamping means for clamping the second connecting rod 4.

In the above preferred embodiment, after the angle of the guide rod 202 is determined, the second connecting rod 4 is fixed by the external clamping device, and then the clamping device is fixed and kept still, so that the fixation of the second connecting rod 4 can be realized, the stability of the guide mechanism 2 in use can be effectively improved, and the situation that the direction of the ball joint 5 needs to be changed and adjusted again due to too much force can be avoided.

A computer-aided adjusting method of an implanted sacroiliac screw direction adjusting device comprises the following steps:

s1: the fixing mechanism 1 is fixed on the ilium through a tapping screw 101;

s2: performing three-dimensional modeling through three-dimensional CT scanning to manufacture a sacroiliac screw fixing mechanism 1;

s3: taking the fixing mechanism 1 as a reference point, and adjusting the direction of the guide mechanism 2;

s4: orientation parameters are obtained through a digital orthopedics technology, direction matching adjustment is carried out through a ball universal joint 5 in vitro, and the guide mechanism 2 is fixed;

s5: the guide needle is placed in the human body through the guide mechanism 2.

Firstly, a fixing mechanism 1 (a self-tapping screw 101 positioning and mounting system) with a sensing device is placed into an iliac crest (about 1.5cm behind an anterior superior iliac spine) under local anesthesia, three-dimensional CT scanning is carried out to introduce software for three-dimensional modeling, and an operation guide plate orientation adjusting device and the self-tapping screw 101 positioning and mounting system of an ilium are digitally modeled and assembled under digital orthopedic software, so that the sacrum can accurately enter an ideal safe passage through a guide plate screw; and (2) assembling the external operation guide plate position adjusting device with the self-tapping screw 101 of the ilium positioning and mounting system according to the digitalized assembled parameters (including accurate adjustment of position and three-dimensional direction, and matching data fed back by a sensor with the digitalized parameters).

The present embodiment is only for explaining the present invention, and it is not limited to the present invention, and those skilled in the art can make modifications of the present embodiment without inventive contribution as needed after reading the present specification, but all of them are protected by patent law within the scope of the claims of the present invention.