CN114053003B

CN114053003B - E-TKA replacement system

Info

Publication number: CN114053003B
Application number: CN202111356504.3A
Authority: CN
Inventors: 裴听国; 徐密峰; 严恭敏; 曹永平
Original assignee: Shaanxi Lin Tak Inertia Electric Co ltd
Current assignee: Shaanxi Lin Tak Inertia Electric Co ltd
Priority date: 2021-11-16
Filing date: 2021-11-16
Publication date: 2023-06-27
Anticipated expiration: 2041-11-16
Also published as: CN114053003A

Abstract

The invention relates to the technical field of medical auxiliary equipment, and discloses an e-TKA replacement system, which comprises the following components: miniature positioning and orientation combination, surgical tool and remote control computer; the miniature positioning and orientation combination comprises: a reference sensor for measuring a bone force axis of the femur or tibia; the alignment sensor is used for measuring the azimuth of the surgical tool and providing an indication for the adjustment of the surgical tool, and is electrically connected with the reference sensor and used for receiving signals of the reference sensor; the remote control computer is in signal connection with the reference sensor and the alignment sensor, is used for receiving data information of the reference sensor and the alignment sensor, processes the received information to obtain information for adjusting the azimuth of the surgical tool, and the e-TKA replacement system and the use method are beneficial to an operator to accurately orient the osteotomy face and reduce the operation time of the operation at the same time by adjusting the azimuth of the surgical tool until the azimuth of the surgical tool meets the requirement of the alignment sensor.

Description

E-TKA replacement system

Technical Field

The invention relates to the technical field of medical auxiliary equipment, in particular to an e-TKA replacement system.

Background

Research on accurate positioning and orientation of orthopaedics in China is beginning and is in the sprouting stage of development, and reports and papers on the aspect are few.

Research on accurate positioning and orientation of orthopaedics in foreign countries has been carried out earlier, and some papers and reports exist.

The traditional total knee replacement operation is to perform intramedullary and extramedullary positioning osteotomies by a mechanical guiding device in the operation according to X-ray examination images, position anatomical marks, inferior force lines and prosthesis rotation axes by naked eyes, handfeel and experience before the operation, and then manually score the osteotomies, place the prosthesis and balance the prosthesis tissues. The visual observation of limbs and prostheses is based on the human eyes to finish alignment, has great subjectivity to alignment, directly influences the reliability and the accuracy of positioning, and even leads to operation failure.

At present, the medical imaging technology, the computer technology and the space tracking technology are combined to realize positioning mainly by means of the computer-aided navigation orthopaedics technology of images in China, but the technology still adopts the traditional anatomical mark to position the lower limb force line and the rotation axis of the prosthesis, the problems existing in the traditional operation are not thoroughly solved, and meanwhile, the risk of secondary injury to the patient and medical staff is formed due to long-time exposure of the patient to X-rays.

For a long time, the lower limb force line has been regarded as a "life line" of the total knee arthroplasty, and the accuracy of the placement of the force line position in the operation determines the functional recovery of the patient after the operation, even the life of the prosthesis to a great extent. The traditional total knee replacement operation is to perform intramedullary and extramedullary positioning osteotomies by a mechanical guiding device in the operation according to X-ray examination images, position anatomical marks, inferior force lines and prosthesis rotation axes by naked eyes, handfeel and experience before the operation, and then manually score the osteotomies, place the prosthesis and balance the prosthesis tissues. The visual observation of limbs and prostheses is based on the human eyes to finish alignment, has great subjectivity to alignment, directly influences the reliability and the accuracy of positioning, and even leads to operation failure. At present, the computer aided navigation orthopaedics technology by means of images combines the medical imaging technology, the computer technology and the space tracking technology to realize positioning, but the technology still adopts the traditional anatomical mark to position the lower limb force line and the rotation axis of the prosthesis, the problems existing in the traditional operation are not thoroughly solved, and meanwhile, the risk of secondary injury to the patient and medical staff is formed due to long-time exposure of the patient to X-rays.

Disclosure of Invention

The invention provides an e-TKA replacement system, which can greatly reduce operation time, improve operation efficiency, save medical resources, reduce injury to patients and enable the patients to recover as soon as possible after operation.

The invention provides an e-TKA replacement system, comprising:

miniature positioning and orientation combination, surgical tool and remote control computer;

the miniature positioning and orientation combination comprises:

the reference sensor is fixedly connected with the femur or the tibia through the first bracket, coincides with the bone force axis of the femur or the tibia and is used for measuring the bone force axis of the femur or the tibia;

the alignment sensor is fixedly connected with the femur or the tibia through the second bracket and is used for measuring the azimuth of the surgical tool and providing an indication for the adjustment of the surgical tool, and the alignment sensor is electrically connected with the reference sensor and is used for receiving the signal of the reference sensor;

the surgical tool is fixedly connected with the alignment sensor through the azimuth adjusting device;

and the remote control computer is in signal connection with the reference sensor and the alignment sensor, is used for receiving data information of the reference sensor and the alignment sensor, processing the received information to obtain information for adjusting the azimuth of the surgical tool, and adjusting the azimuth of the surgical tool through the azimuth adjusting device until the azimuth of the surgical tool meets the requirement of the alignment sensor.

Further, the reference sensor and the alignment sensor each include:

a tri-axial gyroscope for measuring angular acceleration of femur or tibia or surgical tool motion;

a tri-axial accelerometer for measuring linear acceleration of the femur or tibia or surgical tool as it moves;

the microprocessor is used for processing the angular acceleration and the linear acceleration data and receiving a control instruction of the remote control computer;

and the wireless communication module is connected with the microprocessor and used for sending data and receiving control instructions.

Further, the surgical tool includes:

the femur operation tool is used for cutting femur according to the control signal;

a tibial surgical tool for cutting a tibia in accordance with a control signal.

Further, the reference sensor is provided with a plurality of first indicator lamps for indicating a plurality of movement directions of the femur or the tibia, and the reference sensor is also provided with a first buzzer for reminding when the femur or the tibia moves to the set movement direction;

the alignment sensor is provided with a plurality of second indicator lamps for indicating scale marks, a plurality of alignment directions and multi-level direction errors, and is also provided with a second buzzer for reminding when the movement of the surgical tool reaches the set alignment direction;

the first indicator lamp, the first buzzer, the second indicator lamp and the second buzzer work respectively according to control instructions of the microprocessor.

Compared with the prior art, the invention has the beneficial effects that:

the e-TKA replacement system is characterized in that a reference sensor and a femur or tibia which are fixedly connected move together according to requirements, a bone force axis of the femur or tibia is determined, data of the bone force axis are transmitted to an alignment sensor through the reference sensor, reference dynamic conversion is achieved, the reference sensor is detached, a working space is reserved for a joint surface to be cut by an operation tool, the position of the operation tool is positioned according to the indication of the alignment sensor, and finally compared with other computer navigation technologies, the technology does not destroy the operation flow of the traditional operation, is more beneficial to faster operation of an operator, greatly reduces operation time, improves operation efficiency, saves medical resources, reduces injury to a patient, and enables the patient to recover as soon as possible after operation. The e-TKA replacement system overcomes the instability of the traditional operation quality, reduces the requirements of operators, reduces the difficulty of joint replacement operation, enables primary hospital operation to be possible, and can lead more patients to be cured in time and well.

Drawings

FIG. 1 is a schematic diagram of an e-TKA replacement system according to the present invention.

Fig. 2 is a schematic diagram of a reference director provided by the present invention.

Fig. 3 is a schematic diagram of an alignment director provided by the present invention.

Fig. 4 is a schematic diagram of an orientation model structure of the femur sensor provided by the present invention.

Fig. 5 is a schematic view of an orientation model structure of the tibial sensor provided by the invention.

Reference numerals illustrate:

1-crotch bone, 2-femur, 3-tibia, 4-reference sensor, 5-alignment sensor.

Detailed Description

One embodiment of the present invention will be described in detail below with reference to fig. 1-5, but it should be understood that the scope of the present invention is not limited by the embodiment.

As described in fig. 1, 4 and 5, an e-TKA substitution system comprises: miniature positioning and orientation combination, surgical tool and remote control computer; the miniature positioning and orientation combination comprises: the reference sensor 4 is fixedly connected with the femur 2 or the tibia 3 through a first bracket, one end of the femur 2 is connected with the crotch bone 1, and the reference sensor 4 coincides with the bone force axis of the femur 2 or the tibia 3 and is used for measuring the bone force axis of the femur 2 or the tibia 3; an alignment sensor 5 fixedly connected with the femur 2 or the tibia 3 through a second bracket and used for measuring the azimuth of the surgical tool and providing an indication for the adjustment of the surgical tool, wherein the alignment sensor 5 is electrically connected with the reference sensor 4 and used for receiving the signal of the reference sensor 4; the surgical tool is fixedly connected with the alignment sensor 5 through an azimuth adjusting device; and the remote control computer is in signal connection with the reference sensor 4 and the alignment sensor 5, and is used for receiving data information of the reference sensor 4 and the alignment sensor 5, processing the received information to obtain information for adjusting the azimuth of the surgical tool, and adjusting the azimuth of the surgical tool through the azimuth adjusting device until the azimuth of the surgical tool meets the requirement of the alignment sensor 5.

Further, the reference sensor 4 and the alignment sensor 5 each include: a tri-axial gyroscope for measuring the angular acceleration of the femur 2 or tibia 3 or of the movement of the surgical tool; a triaxial accelerometer for measuring linear acceleration of the femur 2 or tibia 3 or surgical tool during movement; the microprocessor is used for processing the angular acceleration and the linear acceleration data and receiving a control instruction of the remote control computer; and the wireless communication module is connected with the microprocessor and used for sending data and receiving control instructions.

Further, the surgical tool includes: the femur operation tool is used for cutting femur according to the control signal; a tibial surgical tool for cutting a tibia in accordance with a control signal.

Further, the reference sensor 4 is provided with a plurality of first indicator lamps for indicating a plurality of movement directions of the femur 2 or the tibia 3, and the reference sensor 4 is also provided with a first buzzer for reminding when the movement of the femur 2 or the tibia 3 reaches the set movement direction; the alignment sensor 5 is provided with a plurality of second indicator lamps for indicating scale marks, a plurality of alignment directions and multi-level direction errors, and the alignment sensor 5 is also provided with a second buzzer for reminding when the movement of the surgical tool reaches the set alignment direction; the first indicator lamp, the first buzzer, the second indicator lamp and the second buzzer work respectively according to control instructions of the microprocessor.

Accurate positioning of osteotomy face

The bone force axes of the tibia 3 and the femur 2 are accurately calculated by using an inertial instrument and a navigation technology, and the osteotomy position is accurately given by using an operation tool.

Quick positioning of osteotomy face

The bone force axis is rapidly calculated through navigation calculation, the operation tool is used for conversion of the reference, and the processes are operated in a state without static fixation, so that the speed of the bone section determination process is greatly increased.

Surgical information and data computer management.

By means of the preoperative setting and the automatic acquisition of the surgical process data, the surgical process data are established, and the computer management of the surgical process data and information is realized.

The principle of the e-TKA assistant total knee replacement system is that an inertial instrument in a reference sensor 4 and a fixedly connected femur 2 or tibia 3 move together as required, the bone force axis of the femur 2 or tibia 3 is determined according to the motion parameters of the inertial instrument, data of the bone force axis are transmitted to an alignment sensor 5 through the reference sensor 4, reference dynamic conversion is realized, the reference sensor 4 is disassembled, a working space is reserved for a surgical tool to cut a joint surface, the position of the surgical tool is adjusted according to the indication of the alignment sensor 5, and finally the operation is performed.

The e-TKA assistant total knee replacement system consists of three parts, namely a surgical tool (Auxiliary Surgical Tools-AST), a Micro positioning and orientation combination (Micro-Positioning and Orientation Determining Unite-MPOD) and a Remote control computer (Remote-Control DisplayUnit-RCDU). The micro positioning and orientation combination is divided into a reference sensor 4 and an alignment sensor 5.

According to the requirements of the operation position, the corresponding operation tool and the miniature positioning and orientation combination are selected, the reference fixing operation tool is firmly and stably connected with bones according to the requirements, the reference sensor 4 is installed, the legs are moved according to certain requirements, and the registration of the reference sensor 4 is confirmed. Next, a cutting operation fixing tool is installed, and then registration confirmation is performed by installing an alignment sensor 5. The remote control computer calculates the positioning parameters, determines the mounting adjustment parameters of the alignment sensor 5 on the cutting tool, and adjusts the position of the cutting tool as indicated on the alignment sensor 5. Providing the physician with accurate positioning and orientation of the cutting surface for surgery. The main components are shown in fig. 2 and 3.

Composition and function of surgical tool

The surgical tool consists of a reference fixed surgical tool, a cutting surface positioning surgical tool, a reference mounting structure assembly, an alignment mounting structure assembly and the like. The connection with the relevant bones is realized, and support is provided for measurement positioning and operation implementation.

The reference fixing surgical tool is mainly firmly connected with bones, and meanwhile, the position accuracy during connection is guaranteed.

The cutting face positioning surgical tool mainly realizes the mechanical positioning determination of the cutting face. Can be used for quickly adjusting the direction and the position, and provides a positioning and orientation surface for surgical cutting.

The reference mounting structure assembly mainly satisfies the mounting of the reference sensor 4 and the connection with the reference fixed surgical tool.

The alignment mounting feature assembly primarily satisfies the mounting of the alignment sensor 5 and the connection of the cutting surface positioning surgical tool.

Composition and function of miniature positioning and orientation combination

The miniature positioning and orientation combination consists of an inertial instrument, a data processing circuit, a signal transmission circuit, a structural member and the like. The measurement and transmission of the angular displacement of the miniature positioning and directional combined installation direction are realized. The reference sensor 4 and the alignment sensor 5 are divided for convenience of use.

The reference sensor 4 enables measurement of the bone force axis of the femur 2 and tibia 3 and establishes an axis reference. For convenience of measurement, the appearance of the reference sensor 4 is marked with an indication of the direction of movement, position indication, self calibration, etc. when the reference axis is established.

An alignment sensor 5 is coupled to the cutting surface positioning surgical tool and is aligned with the reference sensor 4 to provide an indication of the adjustment of the cutting surface positioning surgical tool. For easy adjustment, the appearance of the alignment sensor 5 is provided with scale marks, direction at the time of alignment, a related direction error multi-level indicator lamp, and the like.

Composition and function of remote control computer

The remote control computer consists of a computer, a wireless signal receiving circuit and the like. And calculating, processing, receiving and outputting the parameters of the miniature positioning and orientation combination and the parameters of the surgical tool to give the positioning parameters when the surgery is implemented.

Surgical tool technological approach

The surgical tool is designed to meet the surgical requirement according to the requirements of the surgical process by adopting a mature structural form and principle.

And simultaneously, the bone cutting device meets the requirements of firm and stable connection combined with bones and micro positioning and orientation, and provides firm and stable support for surgical cutting.

The reference installation structure component is used for accurately controlling the depth of the reference installation structure component penetrating into bones and improving the azimuth precision of installation connection and the consistency of operation.

Miniature positioning and directional combination technical approach

The miniature positioning and orientation combination adopts a triaxial gyroscope, a triaxial accelerometer, a microprocessor and corresponding data processing circuits to measure azimuth, and infinite transmission is designed according to the requirement of a remote control computer.

Basic principle of miniature positioning and orientation combination

And the three-axis gyroscope and the three-axis accelerometer in the miniature positioning and orientation combination move according to certain requirements, output angle information and linear acceleration information, obtain the attitude angle of the installation position through data processing, and obtain the bone force axes of the tibia 3 and the femur 2. And meanwhile, the acceleration signal can be used for transmitting the reference.

Type of miniature positioning and orientation combination

The operation is conveniently divided into a reference sensor 4 and an alignment sensor 5. The principle of the reference sensor 4 is consistent with that of the alignment sensor 5, and most of the components are the same, and different marks and indicator lamps are only arranged for being convenient for establishing the axis reference and adjusting the operation cutting surface.

The reference sensor 4 is fixedly connected with the femur 2 or the tibia 3, and the bone force axis of the femur 2 or the tibia 3 can be measured through the required movement. And the installation error is eliminated through multiple measurements, the installation azimuth error of the reference sensor 4 is accurately given, and the installation azimuth error is transmitted to a remote control computer for compensation. The schematic diagram is shown in fig. 2.

The alignment sensor 5 is fixedly connected with the cutting surface positioning surgical tool, the azimuth of the real-time installation position can be given, and meanwhile, the azimuth indication for adjusting the cutting surface positioning surgical tool is given through a remote control computer in comparison with the parameters of the reference sensor 4. The schematic diagram is shown in fig. 3.

General technical approach

The transfer of system control settings and references will be described primarily.

Control system configuration

When the system works, firstly, the remote control computer is set, including the selection of body positions, the input of codes of sensors and surgical tools, the recording of other things and the like, and then, the establishment, the alignment and the check of the reference are carried out (which can be omitted). The physician does not need to leave the operating table during the reference setup, alignment and verification, and the operation is completed according to the instructions on the reference sensor 4 and the alignment sensor 5.

Reference transfer

In order to complete the total knee replacement surgery quickly and accurately, the bone axes of femur 2 and tibia 3 need to be transferred to the surgical incision plane. Three procedures are therefore required, namely the transfer of the bone force axis of femur 2 and tibia 3 to reference sensor 4, the transfer of reference sensor 4 to alignment sensor 5 and the transfer of alignment sensor 5 to the cutting face of the cutting surgical tool.

Remote control computer technology approach

An integrated computer with a wireless receiving function is selected, a popular windows system is adopted, and parameter calculation software and control software are written according to various operation requirements.

The calculation software is mainly used for carrying out data processing according to the measured data of the geometric dimension and micro positioning orientation combination of the operation tool, compensating the buckling target of the femur 2, the gradient target of the tibia 3 and the like, and giving the installation parameters for installing the operation cutting tool.

The RCDU is based on a microcomputer system, and is used for completing the algorithm technology of the lower limb force line determination and displaying audio prompts; remote MPOD information exchange and transmission is realized through a wireless (Blue-tooth) protocol; patient information, surgical information, and information using instrumentation are recorded to form an archive. After a reference MPOD and a measurement MPOD module are attached to the knee joint in the femur 2 operation, a surgeon only needs to move the knee joint within a certain movement range, the process does not need to take one minute, the bone force axis information displayed on the MPOD sensor can accurately know where the femur 2 needs to be cut, and the operation section can be verified and measured by the same method after the operation.

The tibia 3 operation consists of a reference MPOD and two measurement MPODs, the position and the posture of the tibia 3 are estimated by a motion model algorithm through simple three-position motion of the tibia 3, and meanwhile, the position of a surgical scalpel is accurately given. By using the same principle, one MPOD can also be used for postoperative section verification. The e-TKA can be used independently or in combination for the specific case of surgery. In order to adapt to different functions of MPOD calibration, normal operation, independent operation, combined operation, restarting and the like, the structure is designed to position and install the trigger combination so as to determine to start corresponding application programs.

The e-TKA system design uses the bluetooth wireless standard to communicate control displays (RCDUs) with the aseptically used MPODs.

The e-TKA can be used in combination or can be used for one function alone according to the specific situation of a patient. The lower limb information of the patient in the operation is automatically stored.

The knee joint e-TKA system ensures that the precision of the determined lower limb force line is better than 1.0 degrees and the determination time of the lower limb force line is less than 1 minute through the accurate combination (MPOD) of inertial instruments such as an accelerometer, a gyroscope and the like.

In order to ensure the accuracy, reliability and safety of the operation and give consideration to the bionics of human bodies, the femur 2 and the tibia operation auxiliary tool of the e-TKA are integrally assembled, so that the uncertainty error caused by repeated installation of the tool and the unnecessary and harmful effects on patients are reduced.

Compared with other computer navigation technologies, the e-TKA technology does not break the operation flow of the traditional operation, and is more beneficial to operators to master the system more quickly and reduce the operation time of the operation. Because MPOD positioning does not depend on the osseous sign, the osteotomy position can be verified again after osteotomy, so that the positioning operation is more flexible, and the method has unique advantages for complex operations such as severe anatomical variation, osteotomy and the like.

The knee joint e-TKA system adopts an inertial instrument, and utilizes a navigation technology to accurately calculate the bone lines of tibia and femur, accurately give out the osteotomy position, greatly improve the postoperative effect of joint replacement, overcome the instability of the traditional operation quality, reduce the requirements of operators, reduce the difficulty of joint replacement operation, enable the operation of primary hospitals to be possible, and enable more patients to be treated well in time.

The knee joint e-TKA system can be dynamically and quickly positioned, so that the operation time is greatly reduced, the operation efficiency is improved, medical resources are saved, the injury to a patient is reduced, and the patient can be recovered as soon as possible after operation.

The operation information and data computer management of the knee joint e-TKA system enables the operation process to be more scientific and standardized, and reduces the labor time of medical staff.

The knee joint e-TKA system improves the medical level of knee joint replacement, can enable patients to recover as soon as possible, enables doctors to reduce strength and improve efficiency, enables primary hospital operation to be possible, enables more patients to be cured, and has wide and profound social benefits and great practical significance. Of course, the method has great economic benefit for research enterprises and medical institutions.

The foregoing disclosure is merely illustrative of some embodiments of the invention, but the embodiments are not limited thereto and variations within the scope of the invention will be apparent to those skilled in the art.

Claims

1. An e-TKA displacement system, comprising: miniature positioning and orientation combination, surgical tool and remote control computer;

the miniature positioning and orientation combination comprises:

the reference sensor (4) is fixedly connected with the femur (2) or the tibia (3) through the first bracket, and the reference sensor (4) is overlapped with the bone force axis of the femur (2) or the tibia (3) and is used for measuring the bone force axis of the femur (2) or the tibia (3);

the alignment sensor (5) is fixedly connected with the femur (2) or the tibia (3) through a second bracket and is used for measuring the azimuth of the surgical tool and providing an indication for the adjustment of the surgical tool, and the alignment sensor (5) is electrically connected with the reference sensor (4) and is used for receiving the signal of the reference sensor (4);

the surgical tool is fixedly connected with the alignment sensor (5) through the azimuth adjusting device;

the remote control computer is in signal connection with the reference sensor (4) and the alignment sensor (5) and is used for receiving data information of the reference sensor (4) and the alignment sensor (5), processing the received information to obtain information for adjusting the azimuth of the surgical tool, and adjusting the azimuth of the surgical tool through the azimuth adjusting device until the azimuth of the surgical tool meets the requirement of the alignment sensor (5);

the reference sensor (4) and the alignment sensor (5) each include:

a tri-axial gyroscope for measuring the angular acceleration of the femur (2) or tibia (3) or of the movement of the surgical tool;

a triaxial accelerometer for measuring linear acceleration of the femur (2) or tibia (3) or surgical tool during movement;

the wireless communication module is connected with the microprocessor and used for sending data and receiving control instructions;

the reference sensor and the fixedly connected femur or tibia move together as required to determine the bone force axis of the femur or tibia, the data of the bone force axis is transmitted to the alignment sensor through the reference sensor to realize the dynamic conversion of the reference, the reference sensor is disassembled, a working space is reserved for the surgical tool to cut the joint surface, and the position of the surgical tool is positioned by adjusting the cutting surface according to the indication of the alignment sensor;

the surgical tool includes:

a tibial surgical tool for cutting the tibia in accordance with the control signal;

the reference sensor (4) is provided with a plurality of first indicator lamps for indicating a plurality of movement directions of the femur (2) or the tibia (3), and the reference sensor (4) is also provided with a first buzzer for reminding when the movement of the femur (2) or the tibia (3) reaches the set movement direction;

the alignment sensor (5) is provided with a plurality of second indicator lamps for indicating scale marks, a plurality of alignment directions and multi-level direction errors, and the alignment sensor (5) is also provided with a second buzzer for reminding when the movement of the surgical tool reaches the set alignment direction;