CN115607248B

CN115607248B - Intelligent orthopaedics implant activity judging method

Info

Publication number: CN115607248B
Application number: CN202110504723.5A
Authority: CN
Inventors: 请求不公布姓名
Original assignee: Chengdu Zekang Zhigu Technology Co ltd; Shangrao Rongshang Optical Instrument Co ltd
Current assignee: Shangrao Rongshang Optical Instrument Co ltd
Priority date: 2021-05-10
Filing date: 2021-05-10
Publication date: 2025-11-21
Anticipated expiration: 2041-05-10
Also published as: CN115607248A

Abstract

This invention relates to the field of orthopedic implants, specifically to an intelligent orthopedic implant and its system, monitoring, mobility assessment, and dislocation detection method. It achieves real-time and accurate judgment of the wear state of orthopedic implants and provides corresponding early warnings based on the wear state, greatly improving the safety of orthopedic implant use. Furthermore, it can monitor the mobility of the implant in real time. The intelligent orthopedic implant of this invention includes an implant body with multiple capacitor plates internally, each corresponding to a specific capacitor plate. The capacitance between the corresponding capacitor plates changes accordingly with implant wear. An integrated module is provided inside the implant body, including a MEMS unit. Each capacitor plate is connected to the MEMS unit, which is used to detect the capacitance data between the corresponding capacitor plates in real time. This invention is applicable to the intelligent monitoring of orthopedic implants.

Description

Intelligent orthopaedics implant activity judging method

Technical Field

The invention relates to the field of orthopedic implants, in particular to an intelligent orthopedic implant activity judgment method.

Background

The orthopedic implant products mainly comprise spinal products, trauma products, artificial joints products, neurosurgery products (skull repairing titanium mesh, skull bone plate), thoracic surgery orthopedic products (such as sternum internal fixation implant, rib internal fixation implant products, etc.), and the like. Common orthopedic implants include interbody fusion cages, bone plates, orthopedic nail rod fixation systems (e.g., posterior pedicle screw fixation systems, anterior spinal nail rod fixation systems, etc.), orthopedic nail-plate systems, hip joint prostheses, knee joint prostheses, artificial vertebral bodies, intramedullary nails, elbow joint prostheses, wrist joint prostheses, shoulder joint prostheses, ankle joint prostheses, screws, titanium meshes, orthopedic fixation needles, orthopedic fixation cables, orthopedic fixation rivet implants, orthopedic external fixation stent implants (the nails and needles of the fixation stents are implants, the connecting rods are 2 types of medical devices), orthopedic personalized implants, orthopedic tumor implant products, orthopedic implant shims, etc. Orthopedic implant types include, but are not limited to, the above-described product types and categories;

After the orthopedic implant is implanted into a human body, the orthopedic implant can have failure conditions such as bending deformation, stress concentration, loosening, withdrawal, displacement, fracture, abrasion, dislocation and the like along with the bone healing process of a patient or the rehabilitation process of the patient, so that operation failures such as fracture of a bone plate, fracture loosening of a screw and the like are caused, and secondary repair operation is often required for serious patients. The existing orthopedic implant cannot self-monitor implant failure and early warn implant failure, which is a significant disadvantage of the current orthopedic implant;

Implant failure may be due to an accumulated process of prolonged action such as loosening, deformation, displacement, nail withdrawal, breakage, etc., of micro-motion, stress concentration, etc., or may be an instantaneous force exceeding the load of the implant, instantaneously creating loosening, deformation, displacement, nail withdrawal, breakage, etc.

For example, in the design of artificial joint products, the degree of coincidence (conformity) -and the degree of restriction (constraint) of the corresponding surfaces of the joints are important for the surface wear of the joint of the prosthesis, the degree of coincidence of the joint surfaces is high, the contact area is large, the average stress born by the prosthesis is relatively small, and the wear is reduced. In addition, the high degree of constraint is also beneficial to reducing wear because it reduces the sliding and rolling components during articulation. The damage of the joint surface of the prosthesis caused by abrasion can cause the joint to lose a normal movement form, so that uneven stress distribution is caused to loose, and the prosthesis can be accelerated to loose due to bone dissolution caused by abrasive dust to lose bone support. The abrasive particles may have toxic reactions, immune reactions, cause bone resorption and aseptic loosening, initiate allergies, localized tumor formation, and may trigger systemic reactions to occur.

The prior art scheme and the defects are as follows:

current joint wear measurement methods:

the current artificial joint wear measurement method is divided into two main types, namely actual artificial joint prosthesis wear measurement and in-vitro artificial joint prosthesis experimental wear measurement.

The wear detection of the implanted prosthesis mainly comprises imaging detection (in vivo medical detection of artificial joint wear realized by X-ray detection, CT tomography, nuclear magnetic resonance and other technologies) and detection of wear of the extracted implanted prosthesis. With the development of computer technology, two-dimensional computer digital technology has emerged in the nineties of the last century as the method of measuring artificial joint wear by digitizing standard images to create femoral head and hip cup prosthesis models and accurately calculating the wear level therefrom, such as the image automatic analysis method proposed by Hardinge in 1991 and the digital image edge detection method proposed by Shaver equal to 1997. The two-dimensional computer digital technology has the advantage of higher accuracy in measuring abrasion, but still belongs to a plane measuring method, is more troublesome to operate and is inconvenient to popularize and use clinically. Two-dimensional computer digital technology is soon developed, three-dimensional computer measurement technology is studied, polyethylene lining abrasion three-dimensional measurement technology based on metal mortar bottom is first introduced by Devane in 1995, then computer three-dimensional digital measurement methods are also introduced by Martell and Berdian in 1997, abrasion conditions are mostly determined through cross section digital reconstruction, the repeatability is reported to be ten times better than that of Livermore method, but errors in cross section reconstruction are still to be discussed, and the method is more complex and high in cost than planar measurement and is difficult to clinically popularize. In addition to manual and computerized image digital measurement techniques, researchers have used radiometric stereometric analysis to evaluate the wear condition, which has been proposed by Baldursson H as early as 1979, and since then, particularly in the 1990 s and 2000 s, the related methods have been endless, which use markers to be placed on the prosthesis, at the same time take the prosthesis from 3 different angles, and reconstruct it in three dimensions using digital techniques to determine the wear condition, which better avoids the cross-sectional reconstruction errors of three-dimensional computerized measurement techniques, but which is invasive, difficult to operate, more costly and risky, and makes it difficult to popularize.

The method mainly comprises the steps of (1) weighing, (2) geometric, (3) coordinate measurement, (4) optical interferometry, (5) isotope tracking and (6) empirical formula. The weighing method is the most used abrasion measuring method in the artificial joint abrasion experiment stage so far, and the international standardization organization also makes corresponding regulations on the standard measuring program of the weighing method. The method is characterized in that 1) the method obtains the whole abrasion loss, the detail of the distribution of the abraded material on the prosthesis can not be obtained everywhere, 2) the method directly obtains the whole weight/mass of the abrasion of the material, the whole weight/mass is based on the material density of the prosthesis in volume conversion, and the constant is changed due to the special working environment of the prosthesis, such as absorption of lubricating liquid, and the like, so that the abrasion volume calculation error is larger. 3) Due to Creep (crep) effects of the material in experiments, resulting in errors in the calculation of the volume of the material, measures have been taken to reduce this error, such as prosthesis Stabilization (Stabilization), giving the material sufficient time to recover after 48h or 72 h. 4) With the continuous improvement of materials and forming technology thereof, the abrasion loss of the prosthesis is smaller and smaller, so that the weighing difficulty is larger and larger, and the balance commonly used at present uses 0.01mg or 0.1mg resolution. In addition to the aforementioned problems, this method provides a relatively difficult collection of collected artificial joint wear debris, and therefore uses relatively little material, typically while obtaining wear volume during analysis of the wear particles. The geometry method is less studied, and the coordinate measurement method is used as a method which is more universal and is suitable for modern processing and analysis means in 4 geometry methods. The coordinate measuring method adopts CMM scanning to measure three-dimensional coordinate data, a digital CAD joint surface prototype can be built according to the measured curved surface data, and the abrasion of the artificial joint can be calculated on the basis. The method comprises the steps of firstly scanning the prosthesis before abrasion, constructing a digital CAD model, then abrasion the prosthesis, scanning and measuring the abraded prosthesis CAD model data again, and comparing the two.

The existing measuring method and joint prosthesis have the defects that:

(1) The existing joint prosthesis does not have the functions of automatic measurement, monitoring and early warning of wear, although the prior patent technology mentions that the wear can be monitored by implanting a sensor module, the monitoring of the wear of the prosthesis by using a sensor and a method is not clarified, and meanwhile, the wear function is difficult to monitor technically by implanting the sensor module at the distal end of the tibial prosthesis in the prior art. In addition, the prior art does not mention a method for early warning abrasion and reducing the occurrence of abrasion, and the technical scheme not only comprises measurement, monitoring and early warning, but also comprises the step of slowing down the progress of abrasion.

(2) The method for measuring the experimental wear of the artificial joint prosthesis in vitro is more, but is only suitable for testing the prosthesis in a laboratory in the stage of developing the prosthesis, and is not suitable for relevant detection in a human body.

(3) The method for detecting the joint prosthesis after being implanted into a human body by imaging (in vivo medical examination of artificial joint abrasion is realized by X-ray examination, CT tomography, nuclear magnetic resonance and other technologies) has the advantages of low detection precision, large error, incapability of detecting and early warning in real time, incapability of early warning early abrasion, search for reasons and influencing factors of the prosthesis abrasion only by detecting and detecting the early abrasion, thereby removing and reducing the dangerous factors of partial abrasion, prolonging the service life of the joint prosthesis and improving the curative effect of the operation;

therefore, the prior art also lacks a joint prosthesis and a method which can automatically measure, monitor and early warn the abrasion,

Dislocation is a common complication after artificial total hip arthroplasty (total hip arthroplasty, THA), and is inferior to aseptic loosening, and the literature reports that the occurrence rate of dislocation is very different by about 0.04% -11%. Most dislocation occurs within 3 months after surgery, i.e., most are early dislocation. Dislocation causes great pain and psychological burden to patients, and also causes great trouble to vast orthopedics doctors. In the united states, hip instability (dislocation) and mechanical loosening are the most common indications of total hip revision. One study reported 1868 cases (4.76%) of post-operative dislocation occurred after 39,271 cases of total hip replacement surgery in the united states of 1998-2007, wherein the incidence of dislocation was 3.84% (n=1506) in 2 years and 0.92% (n=362) in 2-10 years (Arthur l. Malkani et al. The Journal of Arthroplasty vol.25no.6 suppl.12010), and even if the reduction was successful, the later gait of the patient and the life of the joint prosthesis could be affected, which could have serious effects on the quality of life of the patient. Maintaining the correct position of the patient's affected limb and the correct rehabilitation after surgery is the key to preventing dislocation after total hip replacement.

The knee instability after knee joint replacement refers to the fact that the knee joint exceeds a normal angle or leaves an original normal position or is unstable in multiple directions when the knee joint turns inwards and outwards, stretches or bends after the knee joint replacement operation. According to the position, the knee is unstable in stretching, knee bending and bending, and the knee is unstable in multiple directions and half bending. The degree of instability of the inner and outer sides can be classified into symmetrical instability and asymmetrical instability according to whether the degree of instability is symmetrical.

The prior art is not enough:

In the joint prosthesis designs of the prior art, the joint prosthesis dislocation, subluxation or instability cannot be monitored in real time and early, and after dislocation occurs, the patient can go to a hospital for a doctor due to limited pain and swelling activity to find the dislocation. The doctor judges the position of the prosthesis of the patient according to the physical examination and the radiological examination, and judges whether the prosthesis is dislocated or unstable, however, the prior art has the following defects:

1. the joint prosthesis is in motion or in a specific posture, and the dislocation or the instability can be found, and the missed diagnosis risk exists in a single examination in the re-diagnosis process of a hospital, so that a method capable of monitoring in real time is needed;

2. The joint instability or subluxation of the patient cannot be found early, so that the time for early intervention and treatment is missed, and the early treatment is not easy to find early. The patient's post-operative dislocation or instability may be a cumulative process that acts for some time period due to some reason or reasons, or may be a transient force exceeding the load of the joint prosthesis, a dislocation that is instantaneously formed. A part of the patient's prosthesis is unstable, subluxated and dislocated, which is a gradual development process, so that the unstable or subluxated prosthesis is found in the early stage, thereby being beneficial to early treatment and intervention and improving the curative effect;

3. The existing joint prosthesis cannot intelligently identify itself and report unstable or dislocated joints, and lacks a self-monitoring function;

4. The existing technical means has poor sensitivity and accuracy, and is not easy to accurately identify and judge the unstable or slight subluxation of the joint prosthesis.

5. The existing joint stability is judged through radiological examination, so that the joint stability has radiation hazard;

6. the prior art means can not monitor remotely, and patients go to and from hospitals for multiple examinations, so that various costs such as miswork, traffic, examination fees and the like exist, and the medical burden is not reduced.

Therefore, there is still a need for an intelligent orthopedic implant design that can realize self-real-time remote intelligent monitoring, accurately judge the failure state of the implant, and early warn according to the corresponding state.

Disclosure of Invention

The invention aims to provide an intelligent orthopedic implant and a system, a monitoring method, a mobility and dislocation judging method thereof, which realize real-time accurate judgment of the wear state of the orthopedic implant, and carry out corresponding early warning prompt according to the wear state of the orthopedic implant, thereby greatly improving the use safety of the orthopedic implant and also being capable of carrying out real-time monitoring on the mobility of the implant.

The intelligent orthopedic implant comprises an implant body, wherein a plurality of capacitor plates are arranged in the implant body, the capacitor plates are in one-to-one correspondence, and the capacitance between the corresponding capacitor plates correspondingly changes along with the movement of the implant.

Further, an integrated module is arranged inside the implant body, the integrated module comprises an MEMS (Micro-Electro-MECHANICAL SYSTEM) unit, each capacitor plate is connected with the MEMS unit, and the MEMS unit is used for detecting capacitance data between the corresponding capacitor plates in real time.

Further, the integrated module further comprises a communication unit, and the communication unit is used for sending the capacitance data to an external terminal.

Further, the implant is an ankle prosthesis comprising a first prosthesis component and a second prosthesis component, both of which are non-metallic prosthesis components.

Further, a plurality of capacitor plates are arranged in the first prosthesis component, and a plurality of capacitor plates are arranged in the second prosthesis component.

Further, each capacitor plate in the first prosthesis component corresponds to each capacitor plate in the second prosthesis component one by one, and the capacitance between the corresponding capacitor plates increases along with the abrasion of the contact surface of the first prosthesis component and the second prosthesis component.

Further, the implant is a shoulder prosthesis comprising a non-metallic sphere, a cup, and a liner.

Further, a plurality of capacitor plates are arranged inside the sphere, and the capacitor plates are arranged below the contact surface of the sphere and the lining.

Further, a plurality of capacitor plates are arranged in the cup.

Further, each capacitor plate in the sphere corresponds to each capacitor plate in the cup one by one, and the capacitance between the corresponding capacitor plates increases along with the abrasion of the lining and the surface of the sphere.

Further, a plurality of capacitor plates are arranged in the lining.

Further, each capacitor plate in the lining corresponds to each capacitor plate in the sphere one by one, and the capacitance between the corresponding capacitor plates increases along with the abrasion of the contact surface of the lining and the sphere.

Further, the implant is a hip prosthesis comprising a non-metallic sphere, a cup and a liner.

Further, a plurality of capacitor plates are arranged inside the sphere of the hip joint prosthesis, and the capacitor plates are arranged below the contact surface of the sphere and the lining.

Further, a plurality of capacitor plates are arranged inside the cup of the hip joint prosthesis.

Further, each capacitor plate in the cup of the hip joint prosthesis is in one-to-one correspondence with each capacitor plate in the sphere of the hip joint prosthesis, and the capacitance between the corresponding capacitor plates is increased along with the abrasion of the contact surface of the lining and the sphere.

Further, a plurality of capacitor plates are arranged inside the inner lining of the hip joint prosthesis.

Further, each capacitor plate in the inner lining of the hip joint prosthesis corresponds to each capacitor plate in the sphere of the hip joint prosthesis one by one, and the capacitance between the corresponding capacitor plates increases along with the abrasion of the contact surface of the inner lining of the hip joint prosthesis and the sphere.

Further, the implant is a wrist prosthesis comprising a non-metallic sphere, a cup, and a liner.

Further, a plurality of capacitor plates are arranged inside the ball of the wrist joint prosthesis, and the capacitor plates are arranged below the contact surface of the ball of the wrist joint prosthesis and the lining.

Further, a plurality of capacitor pole plates are arranged in the cup of the wrist joint prosthesis.

Further, each capacitor plate in the cup of the wrist joint prosthesis is in one-to-one correspondence with each capacitor plate in the ball of the wrist joint prosthesis, and the capacitance between the corresponding capacitor plates increases along with the abrasion of the contact surface between the liner of the wrist joint prosthesis and the ball.

Further, a plurality of capacitor plates are arranged inside the inner lining of the wrist joint prosthesis.

Further, each capacitor plate in the inner lining of the wrist joint prosthesis corresponds to each capacitor plate in the ball of the wrist joint prosthesis one by one, and the capacitance between the corresponding capacitor plates increases along with the abrasion of the contact surface between the inner lining of the wrist joint prosthesis and the ball.

Further, the implant is a knee prosthesis that includes a non-metallic femoral prosthesis component, a shim, and a non-metallic tibial prosthesis component.

Further, a plurality of capacitor plates are arranged in the femoral prosthesis component, and a plurality of capacitor plates are arranged in the gasket.

Further, each capacitor plate in the gasket corresponds to each capacitor plate in the femoral prosthesis component one by one, and the capacitance between the corresponding capacitor plates increases along with the abrasion of the contact surface of the gasket and the femoral prosthesis component.

Further, a plurality of capacitive plates are disposed within the tibial prosthetic component.

Further, each capacitor plate in the tibial prosthesis component corresponds to each capacitor plate in the gasket one by one, and the capacitance between the corresponding capacitor plates increases along with the abrasion of the contact surface of the gasket and the tibial prosthesis component.

Further, the implant is an intervertebral disc prosthesis comprising the intervertebral disc prosthesis comprising a first vertebral surface, a second vertebral surface, and a nucleus.

Further, a plurality of capacitor plates are arranged in the vertebral nucleus, a plurality of capacitor plates are arranged in the first vertebral surface, each capacitor plate in the vertebral nucleus corresponds to each capacitor plate in the first vertebral surface one by one, and the capacitance between the corresponding capacitor plates increases along with the abrasion of the contact surface of the vertebral nucleus and the first vertebral surface.

Further, a plurality of capacitor plates are arranged in the second vertebral surface, each capacitor plate in the vertebral nucleus corresponds to each capacitor plate in the second vertebral surface one by one, and the capacitance between the corresponding capacitor plates increases along with the abrasion of the contact surface of the vertebral nucleus and the second vertebral surface.

The intelligent orthopaedics implant monitoring system comprises an intelligent terminal and the intelligent orthopaedics implant, wherein the intelligent terminal is used for carrying out corresponding analysis and early warning on the abrasion and the activity of the implant according to capacitance data.

The intelligent orthopaedics implant monitoring method is applied to the intelligent orthopaedics implant monitoring system and comprises the following steps:

monitoring capacitance data between the corresponding capacitance plates in real time, and prompting that the implant is worn if the capacitance between the corresponding capacitance plates is increased;

and if the capacitance between the corresponding capacitance polar plates is larger than the set threshold capacitance, early warning is carried out.

The intelligent orthopaedics implant activity judging method is applied to the intelligent orthopaedics implant monitoring system and comprises the following steps:

The capacitor plates arranged in the cup or the liner are respectively A1, A2 and A3. Each capacitor plate in the sphere is respectively B1, B2 and B3..Bn, A1, A2 and A3..an is respectively in one-to-one correspondence with B1, B2 and B3..Bn;

if n capacitance pole plates are respectively arranged in the ball body, the mortar cup or the lining, when Ax corresponds to By, the activity degree of the implant is theta, N is an integer of 1 or more.

The intelligent orthopaedics implant dislocation judging method is applied to the intelligent orthopaedics implant monitoring system and comprises the following steps:

and monitoring capacitance data between the corresponding capacitance plates in real time, and if the capacitance of each corresponding capacitance plate is smaller than the set second threshold capacitance, judging that dislocation of the implant occurs, and carrying out dislocation early warning.

According to the invention, the plurality of capacitor plates are arranged in the orthopedic implant, the capacitor plates are in one-to-one correspondence, the capacitance between the corresponding capacitor plates is increased along with the movement of the implant, the implant can be worn or dislocated due to the movement of the implant, so that the distance between the corresponding capacitor plates can be changed along with the movement of the implant, the change of the capacitance between the corresponding capacitor plates can be caused by the small change of the distance, the wear and dislocating condition of the implant can be judged through the change of the capacitance between the corresponding capacitor plates, the accuracy of judging the wear and dislocating condition of the orthopedic implant is greatly improved, and the use safety of the orthopedic implant is greatly improved by prompting or early warning according to the degree of the wear and dislocating condition.

Drawings

Fig. 1 is a schematic view of an ankle prosthesis.

Fig. 2 is a schematic view of the structure of a shoulder joint prosthesis.

Fig. 3 is a schematic view of the structure of a hip joint prosthesis.

Fig. 4 is a schematic view of the structure of a wrist prosthesis.

Fig. 5 is a schematic view of the structure of a knee prosthesis.

Fig. 6 is a schematic illustration of the structure of an intervertebral disc prosthesis.

In the drawing, 1 is a first prosthesis component, 2 is a second prosthesis component, 3 is a sphere, 4 is a lining, 5 is a cup, 6 is a femur prosthesis component, 7 is a tibia prosthesis component, 8 is a gasket, 9 is a first vertebral surface, 10 is a second vertebral surface, 11 is a vertebral nucleus, 12 is a spherical bearing, 13 is a base, and 101 is a capacitor plate.

Detailed Description

During the movement of the implant, the abrasion and dislocation of the implant may occur, and the capacitance between the corresponding capacitance plates may change correspondingly with the abrasion and dislocation of the implant.

The implant body is internally provided with an integrated module, the integrated module comprises MEMS units, each capacitor electrode plate is connected with the MEMS units, and the MEMS units are used for detecting capacitance data between each corresponding capacitor electrode plate in real time.

The capacitive plates are connected to the MEMS element by measurement leads, wherein each capacitive plate has a separate lead. The capacitance calculation formula between the corresponding capacitance plates is C=epsilon S/4 pi kd, epsilon is the dielectric constant of the medium between the capacitance plates, S is the area of the capacitance plates, and d is the distance between the capacitance plates.

The integrated module further comprises a communication unit for transmitting the capacitance data to an external terminal.

The implant may be an ankle prosthesis comprising a first prosthesis component and a second prosthesis component, both of which are non-metallic prosthesis components.

The first prosthesis component is internally provided with a plurality of capacitor plates, and the second prosthesis component is internally provided with a plurality of capacitor plates.

Each capacitance polar plate in the first prosthesis component corresponds to each capacitance polar plate in the second prosthesis component one by one, and the capacitance between the corresponding capacitance polar plates increases along with the abrasion of the contact surface of the first prosthesis component and the second prosthesis component.

The implant may be a shoulder prosthesis comprising a non-metallic sphere, a cup, and a liner.

The inside of the sphere is provided with a plurality of capacitor plates, and the capacitor plates are arranged below the contact surface of the sphere and the lining.

The inside of the mortar cup is provided with a plurality of capacitor plates, each capacitor plate in the ball body corresponds to each capacitor plate in the mortar cup one by one, and the capacitance between the corresponding capacitor plates increases along with the abrasion of the lining and the surface of the ball body.

The lining is internally provided with a plurality of capacitor plates, each capacitor plate in the lining corresponds to each capacitor plate in the sphere one by one, and the capacitance between the corresponding capacitor plates increases along with the abrasion of the contact surface of the lining and the sphere.

The implant may be a hip prosthesis comprising a non-metallic sphere, a cup, and a liner.

The sphere of the hip joint prosthesis is internally provided with a plurality of capacitance polar plates, and the capacitance polar plates are arranged below the contact surface of the sphere and the lining.

The inside of the cup of the hip joint prosthesis is provided with a plurality of capacitance polar plates.

Each capacitance polar plate in the cup of the hip joint prosthesis corresponds to each capacitance polar plate in the sphere of the hip joint prosthesis one by one, and the capacitance between the corresponding capacitance polar plates increases along with the abrasion of the contact surface of the lining and the sphere.

The inner lining of the hip joint prosthesis is internally provided with a plurality of capacitance polar plates, each capacitance polar plate in the inner lining of the hip joint prosthesis is respectively in one-to-one correspondence with each capacitance polar plate in the sphere of the hip joint prosthesis, and the capacitance between the corresponding capacitance polar plates is increased along with the abrasion of the contact surface of the inner lining of the hip joint prosthesis and the sphere.

The implant may be a wrist prosthesis comprising a non-metallic sphere, a cup, and a liner.

The inside of the sphere of the wrist joint prosthesis is provided with a plurality of capacitor polar plates, and the capacitor polar plates are arranged below the contact surface of the sphere of the wrist joint prosthesis and the lining.

The inner part of the cup of the wrist joint prosthesis is provided with a plurality of capacitor plates, each capacitor plate in the cup of the wrist joint prosthesis is respectively in one-to-one correspondence with each capacitor plate in the sphere of the wrist joint prosthesis, and the capacitance between the corresponding capacitor plates is increased along with the abrasion of the contact surface between the liner of the wrist joint prosthesis and the sphere.

The inner lining of the wrist joint prosthesis is internally provided with a plurality of capacitor plates, each capacitor plate in the inner lining of the wrist joint prosthesis is respectively in one-to-one correspondence with each capacitor plate in the sphere of the wrist joint prosthesis, and the capacitance between the corresponding capacitor plates is increased along with the abrasion of the contact surface of the inner lining of the wrist joint prosthesis and the sphere.

The implant may be a knee prosthesis that includes a non-metallic femoral prosthetic component, a spacer (i.e., an artificial meniscus), and a non-metallic tibial prosthetic component.

The femoral prosthesis component is internally provided with a plurality of capacitor plates, and the gasket is internally provided with a plurality of capacitor plates.

Each capacitance polar plate in the gasket is in one-to-one correspondence with each capacitance polar plate in the femoral prosthesis component, and the capacitance between the corresponding capacitance polar plates is increased along with the abrasion of the contact surface of the gasket and the femoral prosthesis component.

The tibia prosthesis component is internally provided with a plurality of capacitor plates, each capacitor plate in the tibia prosthesis component is respectively in one-to-one correspondence with each capacitor plate in the gasket, and the capacitance between the corresponding capacitor plates is increased along with the abrasion of the contact surface of the gasket and the tibia prosthesis component.

The implant may be an intervertebral disc prosthesis comprising the intervertebral disc prosthesis including a first vertebral surface, a second vertebral surface, and a nucleus.

The inside a plurality of electric capacity polar plates that are provided with of vertebra nucleus, the inside a plurality of electric capacity polar plates that are provided with of first vertebra face, each electric capacity polar plate of inside a vertebra nucleus respectively with each electric capacity polar plate one-to-one of inside a vertebra face, the electric capacity between the corresponding electric capacity polar plate increases along with the wearing and tearing of vertebra nucleus and first vertebra face contact surface.

The inside a plurality of electric capacity polar plates that are provided with of second vertebral surface, each electric capacity polar plate in the centrum is respectively with each electric capacity polar plate in the inside a second vertebral surface one-to-one, and the electric capacity between the corresponding electric capacity polar plate increases along with the wearing and tearing of centrum and second vertebral surface contact surface.

Example 1 the implant is a hip joint prosthesis, the way of arranging the capacitance plates and the integrated modules in the hip joint prosthesis is shown in figure 3, the hip joint prosthesis comprises a sphere 3, an inner village 4 and a cup 5, a plurality of capacitance plates are arranged in the sphere 3 and can be arranged in the sphere at a certain distance from the surface of the sphere contacted with the inner village 4, and the capacitance plates in the sphere are arranged on a sphere arc concentric with the sphere and can be arranged at equal intervals. The capacitor pole plates are prevented from being worn, and the distance can be set according to the situation.

The inner part of the cup 5 of the hip joint prosthesis is provided with a plurality of capacitance polar plates in a mode that the capacitance polar plates are arranged on a spherical arc concentric with the sphere, each capacitance polar plate in the cup 5 corresponds to each capacitance polar plate in the sphere one by one, and the capacitance between the corresponding capacitance polar plates increases along with the abrasion of the contact surface of the lining and the sphere.

A plurality of capacitor plates can also be arranged in the inner liner 4 of the hip joint prosthesis, each capacitor plate in the inner liner 4 corresponds to each capacitor plate in the sphere one by one, and the capacitance between the corresponding capacitor plates increases along with the abrasion of the contact surface of the inner liner and the sphere.

The integrated module is arranged in the sphere and comprises an MEMS unit and a communication unit, and the communication unit sends capacitance data among the corresponding capacitance polar plates to the intelligent terminal.

The intelligent terminal monitors capacitance data between the corresponding capacitance polar plates in real time, and if the capacitance between the corresponding capacitance polar plates is increased, the hip joint prosthesis is prompted to be worn;

Example 2 the implant is a knee prosthesis, the schematic structure of which is shown in fig. 5, a non-metallic femoral prosthesis component 6, a spacer (artificial meniscus) 8 and a non-metallic tibial prosthesis component 7, the patellar prosthesis component being located on the back of the femoral prosthesis component 6;

the femoral prosthesis component 6 is connected with the tail end of the femur. It has a recess that allows the patella component to slide smoothly up and down as the knee is flexed and straightened.

The spacer (artificial meniscus) 8-the spacer is offset and two pieces of metal and polyethylene (plastic) are partially attached to the tibia. A stem is inserted into the tibial prosthetic component to remain stable. The moldable part, or tibial insert, provides cushioning between the femoral prosthetic component 6 and the tibial prosthetic component 7.

The piece of plastic is dome-shaped to match the shape of the patella surface. Because the patella rests on the femur, alignment of the patella component and the femoral component is critical to proper function. The patella is fixed by the quadriceps and patellar tendons.

The components and shims are typically fixed with bone cement, but some doctors use a bone cement-free technique to assist bone growth into the implant to increase stability. The bone-free cement technique can be used for young, healthy, and patients with strong bone structures around the knee joint. Because bone cement can fall off, resulting in loosening of the prosthesis, bone cement-free knee arthroplasty is less likely to loosen over time. Therefore, bone cement knee arthroplasty is believed to be more suitable for older, less mobile patients.

Knee prostheses can be divided into the following types by material:

Metal onplastic-the most common implant. The metal strand prosthesis is attached to a polyethylene plastic gasket connected with the tibia prosthesis. Common metals are cobalt, chromium, titanium, zirconium and nickel. Metal to plastic is the cheapest implant with the longest record of safety and implant life. However, plastic implants may present a problem, namely immune response initiated by tiny particles of liner wear. This can lead to bone fracture, resulting in loosening and failure of the implant. Advances in manufacturing have greatly reduced the wear rate of plastics.

Ceramic on plastic this type uses a ceramic prosthesis instead of a metal prosthesis (or a ceramic coated metal prosthesis). It is also mounted on a plastic spacer. A person sensitive to nickel in a metal implant may choose a ceramic implant. The plastic particles of such implants also lead to immune responses.

Ceramic on ceramic both the femoral and tibial prostheses are ceramic. The ceramic component is least likely to react with the body. However, ceramic joint prostheses can be creak when walking. In rare cases, they fracture into fragments under heavy pressure and must be removed by surgery.

Metal on Metal femoral and tibial prostheses are both made of Metal. In recent years, metal-to-metal implants have been used less and less because of concerns about leakage of trace metals into the blood. The metal comes from chemical decomposition of the implant. All metal implants were originally intended to provide younger individuals with more durable joint replacements. However, trace metals cause inflammation, pain, and even organ damage. Women of child bearing age cannot receive these implants because the effect on the fetus is not yet clear.

The metal prosthesis has influence on the capacitance between the capacitance polar plates, so the non-metal knee joint prosthesis adopted by the invention.

The manner of setting the capacitor pole piece and the integrated module in the nonmetallic knee joint prosthesis is shown in fig. 5, and a plurality of capacitor pole plates 101 are arranged in the femoral prosthesis component 6, so that the capacitor pole pieces can be arranged in the femoral prosthesis component 6 at a certain distance from the contact surface of the femoral prosthesis component 6 and the artificial meniscus 8, the capacitor pole plates are prevented from being worn, and the distance can be set according to the situation.

The artificial meniscus 8 is internally provided with a plurality of capacitance polar plates 101, each capacitance polar plate in the artificial meniscus 8 is respectively in one-to-one correspondence with each capacitance polar plate in the femoral prosthesis component 6, and the capacitance between the corresponding capacitance polar plates is increased along with the abrasion of the contact surface of the artificial meniscus and the femoral prosthesis component.

The tibial prosthesis component 7 can also be provided with a plurality of capacitance plates, each capacitance plate in the tibial prosthesis component 7 corresponds to each capacitance plate in the artificial meniscus 8 one by one, and the capacitance between the corresponding capacitance plates increases along with the abrasion of the contact surface of the artificial meniscus and the tibial prosthesis component.

The integrated module is arranged in the artificial meniscus and comprises an MEMS unit and a communication unit, the communication unit sends capacitance data among the corresponding capacitance polar plates to the intelligent terminal, and the intelligent terminal correspondingly analyzes and pre-warns the abrasion, dislocation and activity of the knee joint prosthesis according to the capacitance data.

The method for monitoring the abrasion of the knee joint prosthesis comprises the steps that an intelligent terminal monitors capacitance data among all corresponding capacitance polar plates in real time, and if the capacitance among all the corresponding capacitance polar plates is increased, the knee joint prosthesis is prompted to be abraded;

The method for judging dislocation of the knee joint prosthesis comprises the steps of monitoring capacitance data among corresponding capacitance polar plates in real time, judging that dislocation occurs in the knee joint if the capacitance of each corresponding capacitance polar plate is smaller than a set second threshold value capacitance, and carrying out dislocation early warning.

Embodiment 3 the implant is an ankle joint prosthesis, the mode of arranging capacitance plates and an integrated module in the ankle joint prosthesis is as shown in fig. 1, a plurality of capacitance plates 101 are arranged in the first prosthesis component 1, the capacitance plates are arranged in the first prosthesis component 1 at a certain distance from the contact surface of the first prosthesis component 1 and the second prosthesis component 2, the capacitance plates are prevented from being worn and can be arranged automatically according to the situation, a plurality of capacitance plates are arranged in the second prosthesis component and can be arranged in a certain distance from the contact surface of the second prosthesis component and the first prosthesis component, each capacitance plate in the first prosthesis component corresponds to each capacitance plate in the second prosthesis component one by one, and the first prosthesis component can be completely attached to the second prosthesis component.

The integrated module is arranged in the first prosthesis component and comprises an MEMS unit and a communication unit, and the capacitance pole plates are connected with the MEMS unit through measurement leads, wherein each capacitance pole plate is provided with a separate lead. The capacitance calculation formula between the corresponding capacitance plates is C=epsilon S/4 pi kd, epsilon is the dielectric constant of the medium between the capacitance plates, S is the area of the capacitance plates, and d is the distance between the capacitance plates. Therefore, when the contact surface of the first prosthesis component and the second prosthesis component is worn, the distance between the corresponding capacitor plates is reduced, and the corresponding capacitance is increased.

And the communication unit sends the capacitance data between the corresponding capacitance polar plates to the intelligent terminal.

The intelligent terminal monitors capacitance data between the corresponding capacitance polar plates in real time, and if the capacitance between the corresponding capacitance polar plates is increased, the ankle joint prosthesis is prompted to be worn;

Example 4 the implant is a shoulder prosthesis, the manner in which the capacitor plates and the integrated module are arranged in the shoulder prosthesis is shown in figure 2, the shoulder prosthesis comprises a sphere 3, an inner village 4 and a cup 5, a plurality of capacitor plates are arranged in the sphere 3 and can be arranged in the sphere at a certain distance from the surface of the sphere contacted with the inner village 4, and the capacitor plates in the sphere are arranged on a sphere arc concentric with the sphere and can be arranged at equal intervals. The capacitor pole plates are prevented from being worn, and the distance can be set according to the situation.

The inside of the cup 5 is provided with a plurality of capacitor plates, the arrangement mode is that on a sphere arc concentric with the sphere, each capacitor plate in the inside of the cup 5 is respectively in one-to-one correspondence with each capacitor plate in the sphere, and the capacitance between the corresponding capacitor plates is increased along with the abrasion of the contact surface of the lining and the sphere.

A plurality of capacitor plates can be arranged in the lining 4, each capacitor plate in the lining 4 corresponds to each capacitor plate in the sphere one by one, and the capacitance between the corresponding capacitor plates increases along with the abrasion of the contact surface of the lining and the sphere.

The intelligent terminal monitors capacitance data between the corresponding capacitance polar plates in real time, and if the capacitance between the corresponding capacitance polar plates is increased, the shoulder joint prosthesis is prompted to be worn;

When the activity degree of the shoulder joint prosthesis is judged, the capacitance polar plates in the cup 5 are respectively A1, A2 and A3. Each capacitor plate in the sphere 3 is respectively B1, B2 and B3..bn, wherein A1, A2 and a 3..an are respectively in one-to-one correspondence with B1, B2 and B3..bn; if 18 capacitor plates are provided in each of the ball 3 and the cup 5, ax and By are associated, the determination can be made according to the association activity relationship in table 1 below.

TABLE 1 criteria for judging the mobility of shoulder joint prostheses

A1

A2

...

A9

...

A17

A18

B1

0°

10°

...

80°

160°

170°

B2

-10°

0°

...

70°

150°

160°

...

B9

-80°

-70°

...

0°

80°

90°

...

B17

-160°

-150°

-80°

...

0°

-10°

B18

-170°

-160°

-90°

...

-10°

0°

The angle calculation formula is as follows: n is an integer of 1 or more.

In the process of the movement of the shoulder joint prosthesis, the dislocation situation of the shoulder joint prosthesis can also occur, for example, the dislocation of the shoulder joint prosthesis sphere 3 and the lining 4 can occur, the distance between the sphere 3 and the corresponding capacitance plate in the lining 4 can be increased, the corresponding capacitance can be smaller, and when the capacitance of each corresponding capacitance plate is smaller than the set second threshold capacitance, the dislocation of the implant is judged, and the dislocation early warning is performed.

Example 5 the implant is an intervertebral disc prosthesis.

The artificial intervertebral disc prosthesis is intended to replace the motion and cushioning functions of a damaged intervertebral disc. And have moderate variability, mainly in terms of variable bearing design, materials, implantation techniques and joint types. There are three different types of bearing designs, constrained, semi-constrained and unconstrained.

The artificial intervertebral disc prosthesis mainly comprises a three-component prosthesis and a two-component prosthesis.

One of the 3-part intervertebral disc prostheses includes a mobile biconvex nucleus, which can be connected by 2 spherical bearings (ball and socket joints). The freedom of movement is determined by the articulating nature of the bearing surfaces. A 3-piece prosthesis may have 2 knuckle bearings. A prosthesis with an incompressible core has 2 degrees of freedom in the sagittal and coronal planes, respectively.

Another example of a prosthesis with 3 joint assemblies and 2 bearings is a Mobi-C cervical artificial disc. A3 component prosthesis with a biconvex movable core will allow 3 independent angular movements (flexion-extension, lateral bending and axial rotation). Together with 2 independent translations (in the anterior-posterior and lateral directions), a total of 5 degrees of freedom. The only missing degree of freedom is the ability to compress along the disc's superior and inferior axes.

The Secure-C intervertebral disc prosthesis has a movable core, in the sagittal plane, the prosthesis allowing 2 degrees of freedom of movement. On the coronal plane, only angular motions of lateral bending are allowed at the upper spherical joint with degrees of freedom=1. The secure-c prosthesis allows 3 independent angular movements (flexion, extension, lateral bending and axial rotation) and 1 independent anterior-posterior translation, yielding a total of 4 degrees of freedom.

Two-component prosthesis, one prosthesis having two joint components and one spherical bearing (ball and socket joint), has 3 degrees of freedom because it allows only 3 independent angular movements. If the conformal bearing surfaces remain in full contact during the arc of motion, translational motion between the two components is not possible.

The saddle joint allows independent angular movements in orthogonal planes, such as flexion and extension and lateral bending (2 degrees of freedom).

The ball-and-socket joint allows translation of 3 independent angular movements and independent flexion-extension angular movements in the sagittal plane. Thus, a prosthesis with a ball-and-socket joint has 4 degrees of freedom.

The intervertebral disc prosthesis is made of three materials, namely stainless steel, cobalt and titanium. Stainless steel is rarely used because it limits the use of magnetic resonance. Cobalt and titanium are the most commonly used because of their high long term success rate on other joint replacement devices. Surface features include keels, spikes, steel wire mesh, increased porosity, screw fixation, and special coatings of plasma sprayed titanium, alumina, hydroxyapatite, and calcium phosphate, all of which are commonly used strategies. The joint type is defined in terms of the number of current centers of rotation.

Artificial disc replacement prostheses come in many different shapes and sizes, but current designs fall into four categories, composite, hydraulic, elastic and mechanical disc.

(1) Composite material the composite artificial disc consists of several parts, usually two metal endplates, with a polyethylene (plastic) spacer sandwiched between them.

(2) The hydraulic-hydraulic artificial disc comprises a dehydrated core, implanted in a compressed state. The hydraulic artificial disc provides space and flexibility between vertebral bodies.

(3) Elastic artificial intervertebral disc, like composite artificial intervertebral disc, is made of two materials, however, the core of elastic artificial intervertebral disc is polycarbonate polyurethane between two metal plates instead of a plastic core. The central core is "deformable" in the sense that it mimics the natural viscoelastic properties of an intervertebral disc.

(4) Mechanical-the mechanical artificial disc is typically composed of two joined parts, all of the same material (e.g. metal) or a composite of metal and ceramic.

One structural implementation of an intervertebral disc prosthesis is shown in fig. 6 and comprises a first vertebral surface 9, a second vertebral surface 10 and a vertebral nucleus 11, wherein the vertebral nucleus 11 comprises a convex movable spherical bearing 12 and a base 13, and the vertebral nucleus 11 is connected with the first vertebral surface through the spherical bearing 12 and is connected with the second vertebral surface through the base 13.

The vertebral nucleus 11 is internally provided with a plurality of capacitor plates which can be arranged in a certain distance from the contact surface of the spherical bearing 12 and the first vertebral surface 9 so as to prevent the capacitor plates from being worn and can be automatically arranged according to the situation, the first vertebral surface 9 is internally provided with a plurality of capacitor plates, each capacitor plate in the vertebral nucleus is respectively in one-to-one correspondence with each capacitor plate in the first vertebral surface, and the capacitance between the corresponding capacitor plates is increased along with the wear of the contact surface of the vertebral nucleus and the first vertebral surface.

And a plurality of capacitor plates can be arranged in the second vertebral surface, each capacitor plate in the vertebral nucleus corresponds to each capacitor plate in the second vertebral surface one by one, and the capacitance between the corresponding capacitor plates increases along with the abrasion of the contact surface of the vertebral nucleus and the second vertebral surface.

The integrated module arrangement may be provided in the spherical bearing 12 or the conical surface, comprising a MEMS unit and a communication unit, the capacitive plates being connected to the MEMS unit by measuring leads, wherein each capacitive plate has a separate lead.

The communication unit sends capacitance data among the corresponding capacitance polar plates to the intelligent terminal, and the intelligent terminal correspondingly analyzes and early warns the abrasion, dislocation and activity of the intervertebral disc prosthesis according to the capacitance data.

The intelligent terminal monitors the capacitance data between the corresponding capacitance polar plates in real time, and if the capacitance between the corresponding capacitance polar plates is increased, the intervertebral disc prosthesis is prompted to be worn;

The method for judging dislocation of the intervertebral disc prosthesis comprises the steps of monitoring capacitance data among the corresponding capacitance polar plates in real time, judging that the intervertebral disc prosthesis is dislocated if the capacitance of each corresponding capacitance polar plate is smaller than a set second threshold value capacitance, and carrying out dislocation early warning.

Example 6 the implant is a wrist prosthesis, the manner in which the capacitor plates and the integrated module are arranged in the wrist prosthesis is shown in fig. 4, the wrist prosthesis comprises a sphere 3, an inner village 4 and a cup 5, a plurality of capacitor plates are arranged in the sphere 3 and can be arranged in the sphere at a certain distance from the surface of the sphere contacted with the inner village 4, and the capacitor plates in the sphere are arranged on a sphere arc concentric with the sphere and can be arranged at equal intervals. The capacitor pole plates are prevented from being worn, and the distance can be set according to the situation.

The intelligent terminal monitors capacitance data between the corresponding capacitance polar plates in real time, and if the capacitance between the corresponding capacitance polar plates is increased, the wrist joint prosthesis is prompted to be worn;

It will be appreciated that the present invention includes, but is not limited to, the above embodiments, and any orthopedic implant that uses a capacitive plate to determine wear or dislocation of the orthopedic implant body is within the scope of the present invention.

The invention has the beneficial effects that:

the conditions of abrasion, dislocation, activity and the like of the implant prosthesis can be monitored in real time, and corresponding early warning prompt is carried out in real time;

The wear can be detected and early-warned in early stage, so that a clinician and a patient are assisted to find out the reason and the cause of the wear, thereby removing or reducing the aggravating factor of the wear, reducing complications caused by the wear such as bone absorption, bone dissolution, aseptic loosening failure of joints and the like around the joint prosthesis, prolonging the service life of the prosthesis and the curative effect of joint replacement, avoiding and reducing revision surgery, benefiting the patient, and reducing the sanitary and economic burden of society;

the abrasion can be accurately monitored in real time in a noninvasive manner, and accurate abrasion detection can be completed without invasive operation;

the radiation hazard is greatly reduced without repeated ray exposure.

In summary, the invention realizes the real-time accurate judgment of the abrasion, dislocation and activity of the orthopedic implant, carries out corresponding early warning prompt, timely discovers and processes the situation in time, and can effectively avoid the deterioration of the state of illness caused by the abrasion or dislocation of the implant, thereby avoiding the secondary operation of patients, greatly improving the use safety of the orthopedic implant, and also carrying out real-time record on the activity of the implant, and greatly improving the flexibility of the implant.

Claims

1. The intelligent orthopaedics implant activity judging method is applied to an intelligent orthopaedics implant monitoring system comprising an intelligent orthopaedics implant and an intelligent terminal, wherein the intelligent orthopaedics implant comprises an implant body, and is characterized in that a plurality of capacitor plates are arranged in the implant body, the capacitor plates are in one-to-one correspondence, the capacitance between the corresponding capacitor plates changes correspondingly along with the activity of the implant, and the intelligent terminal is used for carrying out corresponding analysis and early warning on the abrasion, dislocation and activity of the implant according to capacitance data;

The implant is a shoulder joint prosthesis, a hip joint prosthesis or a wrist joint prosthesis, and the shoulder joint prosthesis, the hip joint prosthesis or the wrist joint prosthesis comprise a nonmetallic sphere, a cup and a lining;

The inner part of the ball body is provided with a plurality of capacitor plates, the capacitor plates are arranged below the contact surface of the ball body and the lining, the inner part of the cup or the lining is provided with a plurality of capacitor plates, each capacitor plate in the ball body corresponds to each capacitor plate in the cup or the lining one by one, and the capacitance between the corresponding capacitor plates increases along with the abrasion of the lining and the surface of the ball body;

if n capacitance pole plates are respectively arranged in the ball body, the mortar cup or the lining, when Ax corresponds to By, the activity degree of the implant is theta, X=1, 2., n, y=1, 2., n, n is an integer greater than or equal to 1.

2. The intelligent orthopedic implant mobility judgment method according to claim 1, wherein an integrated module is arranged inside the implant body, the integrated module comprises MEMS units, each capacitor plate is connected with the MEMS units, and the MEMS units are used for detecting capacitance data between each corresponding capacitor plate in real time.

3. The intelligent orthopaedic implant activity determination method of claim 2, wherein the integrated module further comprises a communication unit for transmitting the capacitance data to an external terminal.