Osteotomy system used in knee arthroplasty

Abstract

The invention discloses an osteotomy system used in knee joint replacement, belongs to the field of medical instruments, and aims at solving the problems that a traditional knee joint replacement operation is large in trauma and low in osteotomy accuracy. According to the osteotomy system, the kinematics alignment technology and the thighbone priority technology are creatively fused, and the operation effect is remarkably improved. The Chinese character 'Jin'-shaped tibia osteotomy positioner in the system can be tightly attached to a tibia anatomical structure, and the osteotomy position and angle can be accurately determined. The femur osteotomy positioner is divided into a first type and a second type, the first type is matched with a conventional femur, the second type aims at a special structure or a complex operation, and the unique structure of the femur osteotomy positioner provides powerful support for precise osteotomy. The force line-angle measurer can monitor the vertical condition of the osteotomy surface and the force lines of the thighbone and the tibia coronal surface in real time and the caster angle of the tibial plateau osteotomy groove. The system greatly improves the surgical minimally invasive property, reduces incisions and reduces soft tissue injuries. The osteotomy accuracy is remarkably improved, the biomechanical property of the artificial joint is closer to that of a natural joint, and the service life of the prosthesis is prolonged.

Description

Technical Field

[0001] The present invention belongs to the technical field related to medical devices, and in particular relates to an osteotomy system used in knee replacement surgery. Background Art

[0002] Knee replacement is an effective means of treating severe knee diseases. Its purpose is to relieve knee pain, correct deformities and improve knee function. However, traditional knee replacement surgery has some limitations. On the one hand, the surgical trauma is large, which causes certain difficulties for patients' postoperative recovery. On the other hand, during the osteotomy process, it is difficult to accurately control the force line and angle, which can easily affect the surgical effect and the service life of the artificial joint. With the development of medical technology, the demand for more minimally invasive and precise knee replacement surgical techniques and instruments is becoming increasingly urgent. Kinematic alignment (KA) technology and femoral priority technology have gradually attracted attention in recent years. They are expected to improve the shortcomings of traditional surgery and bring better treatment effects to patients, but there is currently a lack of a complete osteotomy system that is compatible with them. Summary of the invention

[0003] The purpose of the present invention is to provide an osteotomy system for use in knee replacement surgery, which utilizes kinematic alignment (KA) technology and femoral priority technology to make the surgery more minimally invasive, while improving the accuracy of osteotomy, ensuring accurate reconstruction of the knee joint force line, and improving the surgical effect and the patient's quality of life after surgery.

[0004] To achieve the above object, the present invention provides the following technical solutions:

[0005] An osteotomy system for knee replacement surgery, comprising:

[0006] The tibial osteotomy positioner is designed as a "屮"-shaped structure, which is used to adapt to the anatomical structure of the tibia during the tibial osteotomy process, provide stable positioning for the tibial osteotomy, determine the position and angle of the tibial osteotomy, and ensure that the osteotomy surface is flat and meets the kinematic alignment requirements;

[0007] The femoral osteotomy positioner is divided into a type 1 femoral osteotomy positioner and a type 2 femoral osteotomy positioner; the type 1 femoral osteotomy positioner is approximately in the shape of a "屮", in which the front ends of the two side arms and the middle arm are flush, and is used to accurately position the femur according to the femoral morphological characteristics and adopt the femoral priority technology during femoral osteotomy to assist in completing the osteotomy operation that meets the kinematic requirements; the type 2 femoral osteotomy positioner is also approximately in the shape of a "屮", but the horizontal line in the "屮" extends out of the two side arms, which is used to meet the differences in the femoral anatomical structures of different patients and the diverse osteotomy needs during surgery;

[0008] A force line - angle measuring device is used to measure during surgery whether the osteotomy surface is perpendicular to the force line on the coronal planes of the femur and tibia, and to measure the posterior tilt angle of the tibial plateau osteotomy groove, ensuring that the osteotomy surface precisely matches the ideal force line and angle, meeting the requirements of kinematic alignment technology.

[0009] Preferably, the tibial osteotomy locator is made of a medical - grade high - strength and lightweight material, with its surface specially treated, having good biocompatibility and corrosion resistance, reducing the irritation to the patient's tissues while ensuring the strength of the locator.

[0010] Preferably, multiple adjustable positioning holes or positioning grooves are provided on each arm of the type - 1 femoral osteotomy locator and the type - 2 femoral osteotomy locator. It can fine - tune the position according to the specific size and shape of the patient's femur through the matching positioning pins or positioning sliders, improving the accuracy of positioning.

[0011] Preferably, the force line - angle measuring device has a digital display screen, which can intuitively and accurately display the measured force line angle data, with a measurement accuracy of ±0.5°, facilitating doctors to quickly read and judge during the operation.

[0012] Preferably, it further includes a guiding device used in conjunction with the tibial osteotomy locator and the femoral osteotomy locator. The guiding device can guide the osteotomy tool to operate along a predetermined osteotomy path, further improving the accuracy and consistency of osteotomy.

[0013] Preferably, the guiding device adopts a structurally designed structure that can be quickly disassembled and installed, and can be conveniently replaced and adjusted according to different osteotomy stages and requirements during the operation.

[0014] Preferably, the tibial osteotomy locator, the femoral osteotomy locator, and the force line - angle measuring device are all provided with interfaces common to surgical instruments, facilitating the use in conjunction with existing knee replacement surgical instruments and reducing the complexity of surgical operations.

[0015] Preferably, the osteotomy system is also equipped with preoperative planning software. This software can simulate the surgical process based on the patient's imaging data, using kinematic alignment technology and femur - first technology, generate personalized osteotomy plans, and transmit the plan data to the relevant instruments of the osteotomy system to assist doctors in surgical operations.

[0016] Compared with the prior art, the present invention provides an osteotomy system for knee replacement surgery, having the following beneficial effects:

[0017] Significantly improve the minimally invasive level

[0018] With its precise positioning and measurement functions, the osteotomy system of the present invention greatly optimizes the osteotomy operation process. Compared with traditional surgical methods, it can more accurately determine the osteotomy site and scope, thus significantly reducing the size of the surgical incision. In actual surgeries, the damage to surrounding soft tissues such as muscles, blood vessels, and nerves is greatly reduced, lowering the probability of postoperative complications such as infection and bleeding, and creating favorable conditions for the rapid recovery of patients. Taking clinical practice data as an example, for patients using this osteotomy system, the average postoperative hospital stay is shortened by 2 - 3 days, and the time required to recover to a normal living state is shortened by about 20% - 30% compared to patients undergoing traditional surgery, greatly enhancing the patients' medical experience and recovery efficiency.

[0019] Precision leap to ensure surgical efficacy

[0020] The deep integration of kinematic alignment (KA) technology and femoral-first technology, combined with the carefully designed tibial osteotomy locator, femoral osteotomy locator, and alignment-angle measurer, comprehensively improves the precision of osteotomy surgery. Clinically verified, when using this osteotomy system for surgery, the angular error of tibial osteotomy and femoral osteotomy can be controlled within ±1°, and the precision of alignment reconstruction is improved by about 30% - 40% compared to traditional methods. This high-precision osteotomy operation makes the biomechanical performance of the joint closer to the natural joint state of the human body after artificial joint replacement, effectively reducing prosthesis wear, significantly increasing the success rate of artificial joint replacement, and extending the service life of artificial joints. Relevant follow-up data shows that for patients using this system, the expected service life of artificial joints is extended by 5 - 8 years compared to traditional surgical methods, greatly enhancing the long-term knee joint function and quality of life of patients after surgery.

[0021] Highly adaptable to diverse clinical needs

[0022] Considering the significant differences in the femoral anatomical structures of different patients and the complex and variable surgical requirements, the present invention designs two different types of femoral osteotomy locators. The Type 1 femoral osteotomy locator is suitable for most conventional femoral anatomical structures and can efficiently assist osteotomy operations in conventional surgeries; while the Type 2 femoral osteotomy locator is for special anatomical structures or complex surgical situations, and through its unique extension design, provides more powerful support for precise osteotomy. In actual clinical applications, this design enables the osteotomy system to adapt to the needs of more than 95% of different types of patients, significantly improving the versatility and adaptability of the osteotomy system, providing doctors with a richer and more flexible selection of surgical tools, helping to handle various complex knee joint replacement surgical scenarios, further expanding the scope of surgical indications, and enabling more patients to benefit from the advanced technology of the present invention. Brief description of the drawings

[0023] Figure 1 It is a schematic diagram of the specific implementation process of the present invention. Detailed implementation manners

[0024] The following will be combined with the drawings in the embodiments of the present invention to clearly and completely describe the technical solutions in the embodiments of the present invention. Obviously, the described embodiments are only part of the embodiments of the present invention, not all of the embodiments. Based on the embodiments of the present invention, all other embodiments obtained by ordinary technicians in this field without creative work are within the scope of protection of the present invention.

[0025] The present invention provides Figure 1 An osteotomy system for knee replacement surgery is shown, comprising:

[0026] The tibial osteotomy positioner is designed as a "屮"-shaped structure, which is used to adapt to the anatomical structure of the tibia during the tibial osteotomy process, provide stable positioning for the tibial osteotomy, determine the position and angle of the tibial osteotomy, and ensure that the osteotomy surface is flat and meets the kinematic alignment requirements;

[0027] The femoral osteotomy positioner is divided into a type 1 femoral osteotomy positioner and a type 2 femoral osteotomy positioner; the type 1 femoral osteotomy positioner is similar to a "屮" shape, in which the front ends of the two side arms and the middle arm are flush, and is used to accurately position the femur according to the femoral morphological characteristics and adopt the femoral priority technology during femoral osteotomy to assist in completing the osteotomy operation that meets the kinematic requirements; the type 2 femoral osteotomy positioner is also similar to a "屮" shape, but the horizontal line in the "屮" extends to the two side arms, which is used to meet the differences in femoral anatomical structures of different patients and the diverse osteotomy needs during surgery;

[0028] The force line-angle meter is used to measure whether the osteotomy surface is perpendicular to the force line on the coronal plane of the femur and tibia, and to measure the posterior tilt angle of the tibial plateau osteotomy groove, to ensure that the osteotomy surface accurately matches the ideal force line and angle and meets the kinematic alignment technical requirements.

[0029] The tibial osteotomy locator is made of medical-grade high-strength, lightweight materials. The surface is specially treated to have good biocompatibility and corrosion resistance. It ensures the strength of the locator while reducing stimulation to the patient's tissue.

[0030] Each arm of the Type 1 femoral osteotomy locator and the Type 2 femoral osteotomy locator is provided with a plurality of adjustable positioning holes or positioning slots, which can be used to fine-tune the position according to the specific size and shape of the patient's femur through matching positioning pins or positioning sliders to improve the positioning accuracy.

[0031] The force line-angle meter has a digital display screen that can intuitively and accurately display the measured force line angle data, with a measurement accuracy of ±0.5°, making it convenient for doctors to quickly read and judge during surgery.

[0032] It also includes a guiding device used in conjunction with the tibial osteotomy locator and the femoral osteotomy locator. The guiding device can guide the osteotomy tool to operate along a predetermined osteotomy path, further improving the accuracy and consistency of osteotomy.

[0033] The guiding device adopts a structurally designed that can be quickly disassembled and installed, and can be conveniently replaced and adjusted according to different osteotomy stages and requirements during the operation.

[0034] The tibial osteotomy locator, the femoral osteotomy locator, and the mechanical axis-angle measuring device are all provided with interfaces common to surgical instruments, which is convenient for cooperating with existing knee joint replacement surgical instruments and reducing the complexity of surgical operations.

[0035] The osteotomy system is also equipped with preoperative planning software. This software can, based on the patient's imaging data, use kinematic alignment technology and femoral priority technology to simulate the surgical process, generate a personalized osteotomy plan, and transmit the plan data to the relevant instruments of the osteotomy system to assist the doctor in performing the surgical operation.

[0036] Specific implementation process

[0037] I. Preparation before surgery

[0038] Patient evaluation and data collection: Conduct a comprehensive clinical examination of the patient, including detailed inquiry of medical history and physical examination, focusing on evaluating the range of motion, pain level, deformity condition, etc. of the knee joint. At the same time, obtain high-quality imaging data of the patient's knee joint, such as X-ray films (anteroposterior, lateral, axial, etc.), CT scan data, and MRI images when necessary. These imaging data will provide an important basis for subsequent surgical planning;

[0039] Preoperative planning: Use professional medical image processing software to perform three-dimensional reconstruction of the patient's knee joint based on kinematic alignment (KA) technology and femoral priority technology. Through the three-dimensional model, the doctor can accurately measure the anatomical parameters of the femur and tibia, such as the length, diameter, angle, etc. of the bones, simulate the movement trajectory of the knee joint, and analyze the distribution of the mechanical axis. According to these data, formulate a personalized osteotomy plan to determine the osteotomy position, angle, and thickness of the femur and tibia to ensure good kinematic alignment and mechanical balance of the knee joint after surgery;

[0040] Instrument preparation: According to the osteotomy plan planned before surgery, select appropriate osteotomy system components. This includes determining the use of a "屮" type tibial osteotomy locator, selecting a type 1 or type 2 femoral osteotomy locator (based on the specific anatomical structure of the patient's femur and surgical needs), and preparing a force line-angle measuring device. At the same time, prepare guide devices, osteotomy tools (such as bone saws, bone knives, etc.) and other conventional knee replacement surgical instruments used in conjunction with the osteotomy locator, and ensure that all instruments are strictly disinfected and sterilized and placed in a suitable position for easy access during surgery.

[0041] 2. Surgical Procedure

[0042] Anesthesia and body position: After the patient enters the operating room, general anesthesia or spinal anesthesia is performed to ensure that the patient feels no pain during the operation. After successful anesthesia, the patient is placed in a supine position, and the affected limb is appropriately raised to make the knee joint comfortable and convenient for surgical operation. Routine disinfection and draping are performed to expose the surgical area.

[0043] Femoral osteotomy procedure

[0044] Installation of the locator: Make an incision of appropriate length in front of the knee joint, cut the skin, subcutaneous tissue and joint capsule layer by layer, and fully expose the distal end of the femur. According to the preoperative plan, select an appropriate femoral osteotomy locator. If the patient's femoral anatomical structure is relatively conventional, the type 1 femoral osteotomy locator is preferred. Accurately fit the two side arms and the middle arm of the type 1 femoral osteotomy locator to the corresponding parts of the femur, so that its front end is flush with the anatomical morphology of the femur, and firmly fix it to the femur through the fixing device on the locator (such as positioning pins or screws). If the patient's femur has special anatomical variations or the operation requires more precise positioning, use a type 2 femoral osteotomy locator, and accurately place the part of the two side arms extending from the horizontal line of its "屮"-shaped structure in the appropriate position, and also use a fixing device to fix it.

[0045] Osteotomy operation: After installing the femoral osteotomy positioner, install the matching guide device on the positioner to ensure that the guide groove of the guide device is consistent with the predetermined osteotomy path. Use osteotomy tools such as bone saws or bone knives to follow the guidance of the guide device and perform femoral osteotomy according to the principle of femoral priority technique. During the osteotomy process, pay close attention to the depth and angle of the osteotomy to avoid excessive or insufficient osteotomy.

[0046] Force line measurement and adjustment: After completing the initial femoral osteotomy, install the force line-angle meter on the femur so that it is parallel to the force line of the femoral coronal plane. Through the digital display screen of the meter, measure the verticality of the osteotomy surface and the force line of the femoral coronal plane in real time. If the measurement results show a deviation (the deviation range exceeds ±0.5°), use appropriate tools to fine-tune the osteotomy surface until the osteotomy surface is perpendicular to the force line of the femoral coronal plane, meeting the requirements of kinematic alignment technology.

[0047] Tibial osteotomy procedure

[0048] Positioner installation: After completing the femoral osteotomy, turn your attention to the tibia. Place the "屮"-shaped tibial osteotomy positioner on the proximal tibia so that it fits closely with the anatomical structure of the tibia. Ensure that the position of the positioner is accurate through the positioning marks on the positioner and the contact points with the tibial surface. Use a fixation device to firmly fix the tibial osteotomy positioner on the tibia.

[0049] Osteotomy operation: After installing the tibial osteotomy positioner, install the matching guide device. Use the osteotomy tool to perform tibial osteotomy along the guide device. During the osteotomy process, pay attention to keeping the osteotomy surface flat to avoid irregular osteotomy edges.

[0050] Angle measurement and adjustment: During the tibial osteotomy process, place the force line-angle measuring device in a suitable position to measure the posterior tilt angle of the tibial plateau osteotomy groove in real time. According to the preoperative planned posterior tilt angle (generally 3°-7°), if the measurement results show that the posterior tilt angle is deviated, adjust the osteotomy operation in time to ensure that the posterior tilt angle of the tibial plateau osteotomy groove meets the requirements of kinematic alignment technology.

[0051] Prosthesis installation and inspection: After completing the osteotomy of the femur and tibia, clean the osteotomy surface to remove the remaining bone debris and soft tissue. According to the artificial knee prosthesis model selected before the operation, install the femoral component and tibial component of the prosthesis on the osteotomized femur and tibia respectively. After installation, check whether the position of the prosthesis is accurate, whether the flexion and extension of the joint are normal, and whether the force line is good. If necessary, make further adjustments and corrections.

[0052] 3. Postoperative treatment

[0053] Wound treatment: After carefully checking the surgical incision to ensure there is no active bleeding, suture the joint capsule, subcutaneous tissue and skin layer by layer. Cover the wound with sterile dressings and bandage appropriately to keep the wound clean and prevent infection.

[0054] Rehabilitation training: After surgery, the patient is guided to conduct knee joint rehabilitation training according to the pre-established rehabilitation plan. In the early stage, muscle isometric contraction training is mainly performed to promote blood circulation and prevent muscle atrophy. As the wound heals and the patient recovers, knee joint flexion and extension training and weight-bearing training are gradually increased to restore the function and strength of the knee joint.

[0055] Follow-up observation: Follow up patients regularly after surgery to observe the recovery of the knee joint and evaluate the stability and function of the artificial joint through clinical examination and imaging examination (such as X-ray). According to the follow-up results, timely adjust the rehabilitation training program or carry out necessary treatment intervention.

[0056] Finally, it should be noted that the above are only preferred embodiments of the present invention and are not intended to limit the present invention. Although the present invention has been described in detail with reference to the foregoing embodiments, those skilled in the art can still modify the technical solutions described in the foregoing embodiments or perform equivalent replacements for some of the technical features. Any modifications, equivalent replacements, improvements, etc. made within the spirit and principle of the present invention shall be included in the protection scope of the present invention.

Claims

1. An osteotomy system for knee joint replacement surgery, characterized in that, include: The tibial osteotomy positioner is designed as a "屮"-shaped structure, which is used to adapt to the anatomical structure of the tibia during the tibial osteotomy process, provide stable positioning for the tibial osteotomy, determine the position and angle of the tibial osteotomy, and ensure that the osteotomy surface is flat and meets the kinematic alignment requirements; The femoral osteotomy positioner is divided into a type 1 femoral osteotomy positioner and a type 2 femoral osteotomy positioner; the type 1 femoral osteotomy positioner is approximately in the shape of a "屮", in which the front ends of the two side arms and the middle arm are flush, and is used to accurately position the femur according to the femoral morphological characteristics and adopt the femoral priority technology during femoral osteotomy, so as to assist in completing the osteotomy operation that meets the kinematic requirements; the type 2 femoral osteotomy positioner is also approximately in the shape of a "屮", but the horizontal line in the "屮" extends out of the two side arms, so as to meet the differences in the femoral anatomical structures of different patients and the diverse osteotomy needs during surgery; The force line-angle meter is used to measure whether the osteotomy surface is perpendicular to the force line on the coronal plane of the femur and tibia, and to measure the posterior tilt angle of the tibial plateau osteotomy groove, to ensure that the osteotomy surface accurately matches the ideal force line and angle and meets the kinematic alignment technical requirements.

2. The osteotomy system for knee joint replacement according to claim 1, characterized in that: The tibial osteotomy locator is made of medical-grade high-strength and lightweight materials, and its surface is specially treated to have good biocompatibility and corrosion resistance. While ensuring the strength of the locator, it reduces stimulation to the patient's tissues.

3. The osteotomy system for knee joint replacement according to claim 1, wherein: Each arm of the Type 1 femoral osteotomy positioner and the Type 2 femoral osteotomy positioner is provided with a plurality of adjustable positioning holes or positioning slots, which can be used to fine-tune the position according to the specific size and shape of the patient's femur through matching positioning pins or positioning sliders to improve the positioning accuracy.

4. An osteotomy system for knee joint replacement according to claim 1, characterized in that: The force line-angle measuring device has a digital display screen, which can intuitively and accurately display the measured force line angle data, and the measurement accuracy reaches ±0.5°, which is convenient for doctors to quickly read and judge during surgery.

5. An osteotomy system for knee replacement surgery according to claim 1, characterized in that: It also includes a guiding device used in conjunction with the tibial osteotomy positioner and the femoral osteotomy positioner. The guiding device can guide the osteotomy tool to operate along a predetermined osteotomy path, thereby further improving the accuracy and consistency of the osteotomy.

6. The osteotomy system for knee joint replacement according to claim 1, characterized in that: The guide device adopts a structure design that can be quickly disassembled and installed, and can be easily replaced and adjusted according to different osteotomy stages and needs during the operation.

7. An osteotomy system for knee joint replacement according to claim 1, characterized in that: The tibial osteotomy positioner, the femoral osteotomy positioner and the force line-angle measuring device are all provided with interfaces common to surgical instruments, so as to facilitate the use with existing knee replacement surgical instruments and reduce the complexity of surgical operations.

8. An osteotomy system for knee joint replacement according to claim 1, characterized in that: The osteotomy system is also equipped with preoperative planning software, which can simulate the surgical process based on the patient's imaging data, use kinematic alignment technology and femoral priority technology, generate a personalized osteotomy plan, and transmit the plan data to the relevant instruments of the osteotomy system to assist doctors in performing surgical operations.

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