IMPLANTABLE ELECTRONIC DEVICE AND ENDOPROSTHESIS

Abstract

An implantable electronic device (12) and an endoprosthesis activity monitoring system (10) with a knee prosthesis (11) are developed. Knee prosthesis (11) has at least two blind cavities (35.1, 35.2), one in a lateral aspect of a femoral component (11.1) or tibial component (11.2), within which devices (12) are removably mounted and remote device (18) in wireless communication with devices (12) to receive data transmitted from it. Devices (12) are configured to track movement of the prosthesis (11) and to report same to the remote device (18). Devices (12) are self-contained and include an accelerometer (13), memory (15), a wireless communication module (14), processor (17) and a battery (16). Activity information analysed allows for early diagnosis of implant specific problems like loosening of the prosthesis. Location of devices (12) in the lateral aspects improves accessibility. Devices can be removed by minor surgery without compromising structural integrity of the knee prosthesis.

Claims

1. An implantable electronic device which includes: an electromechanical motion sensor which is configured to measure acceleration and rotation of the implantable electronic device; memory coupled to the electromechanical motion sensor; the memory being configured to store data measured by the electromechanical motion sensor; a wireless communication module which is communicatively linked to the electromechanical motion sensor and/or memory and is configured to communicate with a remote device; and a power source configured to power the wireless communication module; wherein the implantable electronic device is in the form of a self-contained, one-piece, integrated form factor and further includes a casing which defines an inner cavity, the casing being configured to house the electromechanical motion sensor, memory, wireless communication module and power source in the inner cavity such that, the implantable electronic device, as a whole, is configured to be removably mounted to a lateral aspect of a femoral or tibial condyle of a knee prosthesis in an area of a knee which has least soft tissue cover which renders the electronic device easily removable, serviceable and/or replaceable by way of only minor surgery without compromising structural integrity of the knee prosthesis.

2. The implantable electronic device as claimed in claim 1, wherein the casing includes two complementary parts which are operatively disconnectably coupled together to form a serviceable pod.

3. The implantable electronic device as claimed in claim 2, wherein the casing is manufactured from cobalt chrome molybdenum alloy, titanium or titanium alloy.

4. The implantable electronic device as claimed in claim 1, which is configured to be mounted in a blind cavity formed in the lateral aspect of the femoral or tibial condyle of the knee prosthesis, the blind cavity having dimensions of 20 mm in length, 15 mm depth, and 3.5 mm breadth.

5. The implantable electronic device as claimed in claim 4, wherein the accelerometer is a three-axis piezoelectric accelerometer.

6. The implantable electronic device as claimed in claim 5, wherein the power source includes a battery which is configured to power the electromechanical motion sensor and the wireless communication module and wherein the battery is configured to be received in the blind cavity.

7. The implantable electronic device as claimed in claim 1, wherein the power source includes an inductive charger which includes a receiving circuit coupled to the electromechanical motion sensor and the wireless communication module and an inductive charging circuit which is operatively not mounted to the implantable electronic device nor to the knee prosthesis but is configured inductively to power the receiving circuit.

8. The implantable electronic device as claimed in claim 1, which includes a processor which is coupled to the electromechanical motion sensor, memory and the wireless communication module.

9. The implantable electronic device as claimed in claim 4, wherein the blind cavity has dimensions of 15 mm length, 15 mm depth and 3.5 mm breadth.

10. The implantable electronic device as claimed in claim 1, including first and second electromechanical motion sensors, wherein the first electromechanical motion sensor is configured to be accommodated in a blind cavity formed in the lateral aspect of the femoral condyle of the knee prosthesis and the second electromechanical motion sensor is configured to be received in a second blind cavity formed in a lateral aspect of the tibial condyle of the knee prosthesis.

11. An endoprosthesis which is configured to be fitted to a subject as a replacement body part, the endoprosthesis having a first part articulating with a second part and a first implantable electronic device as claimed in claim 1 removably installed in a blind cavity defined in either one of the first part or second part and wherein the endoprosthesis is a knee prosthesis, the first part being a femoral component and the second part being a tibial component of the knee prosthesis, and wherein the blind cavity is formed in a lateral aspect of a femoral condyle of the femoral component of the knee prosthesis, the blind cavity having dimensions of 20 mm in length, 15 mm depth, and 3.5 mm breadth and being configured removably to receive the first implantable electronic device therein thus allowing for easy access to the first implantable electronic device by way of only minor surgery to remove/replace the first implantable electronic device, if need be.

12. The endoprosthesis as claimed in claim 11, wherein a second blind cavity is formed in a lateral aspect of a tibial condyle of the tibial component of the knee prosthesis, the second blind cavity having dimensions of 20 mm in length, 15 mm depth, and 3.5 mm breadth and wherein a second implantable electronic device as claimed in claim 1 is removably received in the second blind cavity.

13. The endoprosthesis as claimed in claim 12, which includes at least one cover which is configured removably to be secured over one of the blind cavities thus retaining the first or second implantable electronic device in the blind cavity.

14. An endoprosthesis activity monitoring system which includes: an endoprosthesis as claimed in claim 13 fitted to, or mountable to a subject; and a remote device which is communicatively coupled to the wireless communication module of the first and/or second implantable electronic device and is configured: wirelessly to interrogate the first and/or second implantable electronic device to obtain data measured by the electromechanical motion sensor; to process the obtained data to determine an activity level and/or condition of the endoprosthesis; and to report processed information to a user, wherein the endoprosthesis activity monitoring system is configured to determine relative acceleration, rotation, or tilt of the first and second implantable electronic devices received in the separate blind cavities in the first and second parts of the endoprosthesis, respectively.

Description

BRIEF DESCRIPTION OF DRAWINGS

[0034] The invention will now be further described, by way of example, with reference to the accompanying drawings.

[0035] In the drawings:

[0036] FIG. 1 shows a functional block diagram of an endoprosthesis activity monitoring system in accordance with a first aspect of the invention, which system includes an implantable electronic device in accordance with a second aspect of the invention;

[0037] FIG. 2 shows a three-dimensional view of a prior art configuration of a knee prosthesis comprising a femoral component and a tibial component;

[0038] FIG. 3 shows a three-dimensional, partially exploded view of an endoprosthesis in accordance with another aspect of the invention; and

[0039] FIGS. 4A and 4B show side elevations of the endoprosthesis of FIG. 3 fitted to a patient.

DETAILED DESCRIPTION

[0040] The following description of the invention is provided as an enabling teaching of the invention. Those skilled in the relevant art will recognise that many changes can be made to the embodiments described, while still attaining the beneficial results of the present invention. It will also be apparent that some of the desired benefits of the present invention can be attained by selecting some of the features of the present invention without utilising other features. Accordingly, those skilled in the art will recognise that modifications and adaptations to the present invention are possible and can even be desirable in certain circumstances, and are a part of the present invention. Thus, the following description is provided as illustrative of the principles of the present invention and not a limitation thereof.

[0041] In FIG. 1 reference numeral 10 refers generally to an endoprosthesis activity monitoring system in accordance with the invention. The system 10 includes an endoprosthesis 11, which in this example embodiment is in the form of a knee prosthesis configured to be fitted as a replacement body part to a subject or patient (see FIGS. 4A and 4B). The knee prosthesis illustrated in this example happens to be a complete knee prosthesis. It is envisaged that the invention may also find application in partial knee prosthesis. In this example embodiment, the endoprosthesis activity monitoring system 10 includes at least two implantable electronic devices 12.1, 12.2 (although only one implantable electronic device 12 has been illustrated in FIG. 1) which are operatively mounted to or received within separate cavities 35.1, 35.2 provided in the endoprosthesis 11, as will be explained in more detail below. The system 10 also includes an external remote device 18 which is configured wirelessly to interrogate the implantable electronic devices 12 in order to glean recordings or measurements from them. To this end, each implantable electronic device 12 includes a processor or CPU 17 and a wireless communication module 14 which is communicatively linked to the processor 17 and is configured to communicate with the remote device 18 using any suitable wireless communication protocol. The wireless communication module 14 may be laterally disposed within the cavity to ensure least possible interference between the wireless communication module 14 and the remote device 18. Each implantable electronic device 12 also includes at least one accelerometer 13 which is configured to measure acceleration and rotation of at least part of the endoprosthesis 11. The accelerometer 13 may be a three-axis piezoelectric MEMS accelerometer. The implantable electronic device 12 also includes memory 15 for storing recorded measurements, data or readings of the accelerometer 13 and a power source in the form of a battery 16. The battery 16 may be a rechargeable battery. The battery 16 may be recharged, wirelessly through use of an inductive charger. Accordingly, a receiving circuit (not shown) may be connected to the rechargeable battery for coupling with an external inductive charger which is operatively brought into close proximity to the receiving circuit. Alternatively, power sources such as kinetic energy harvesters (not shown) may also be incorporated into the implantable electronic device 12 in order to recharge the battery 16. The accelerometer 13 is configured to record and/or measure vibration, shock, tilt and rotation amongst others.

[0042] With reference to FIG. 2, a conventional, prior art knee prosthesis 20 includes a femoral component 21 which is attached to a degraded distal end of the patient's femur 23 and a tibial component 22 which is connected to a tibia 24 of the patient. The femoral component 21 articulates with the tibial component 22 in order to form an artificial or replacement knee joint. In the event of a total knee replacement, a patellar prosthesis 25 may also be provided. With reference to FIG. 3, the endoprosthesis 11 includes a first part in the form of a femoral component 11.1 and a second part in the form of a tibial component 11.2. The femoral component 11.1 and the tibial component 11.2 articulate to form a knee joint. As illustrated in FIG. 2, the endoprosthesis 11 may also include a patellar prosthesis fitted to a patella, although this has not been illustrated in FIG. 3. The femoral component 11.1 includes a convexly curved, C-shaped head 31. The head 31 has an anterior, pointed protrusion 32 which defines a prominent groove 33 for accommodating and facilitating tracking of the patella. The anterior, pointed protrusion 32 is joined to a pair of posteriorly bifurcating, convexly curved femoral condyles 34. As can be seen in FIG. 3, a laterally inwardly extending blind hole or cavity 35.1, having an oblong cross-section, is provided in a lateral aspect of one femoral condyle 34 of the femoral component 11.1 of the endoprosthesis 11. A first of the two implantable electronic devices 12.1 is operatively removably received or accommodated in the blind cavity 35.1. The blind cavity 35.1 has a length of 15 mm, a breadth of 3.5 mm and a depth of 15 mm. The tibial component 11.2 includes a tibial lining 36 which interfaces with the head 31 of the femoral component 11.1 and a tibial plate 37 which is secured to the tibia 24. A second, laterally inwardly extending blind hole or cavity 35.2 is provided in a lateral aspect of the tibial plate 37 of the tibial component 11.2. This second blind hole 35.2 is configured removably to accommodate the second implantable electronic device 12.2. The second blind hole 35.2 has a length of 15 mm, a breadth of 3.5 mm and a depth of 15 mm, i.e. similar dimensions to the first cavity 35.1. The endoprosthesis activity monitoring system 10 is therefore configured to measure, record and transmit relative acceleration data of the two implantable electronic devices 12.1, 12.2 and, hence, of the femoral component 11.1 and the tibial component 11.2.

[0043] Although it has not been illustrated in the Figures, it will be appreciated that additional accelerometers or implantable electronic devices 12 may be provided in or on the patellar prosthesis. Also, multiple accelerometers may be provided on either of, or both of the femoral and tibial components in dedicated cavities or openings. Each implantable electronic device 12 may include multiple accelerometers 13.

[0044] The blind cavities 35.1, 35.2 are provided in lateral aspects of the femoral component 11.1 and tibial component 11.2, respectively, due to the fact that it is an area of the knee that has the least soft tissue cover and is easily accessible. This renders the implantable electronic devices 12.1, 12.2 easily removable, and hence serviceable, for example to replace depleted batteries or malfunctioning components, by way of only minor surgery along any one of the surgical incision lines 40, 41 shown in FIGS. 4A and 4B respectively. In this way, a life span of the implantable electronic devices 12 can be extended without having to remove or interfere with, and potentially compromise, a well-functioning stable knee prosthesis. Furthermore, the accelerometers 13 installed in the endoprosthesis 11 are connected via a wireless digital communication interface to the remote device 18 and are configured to send or transmit accurate information about the type and intensity of activity of the knee to the remote device 18 via a thinnest aspect of the knee across the soft tissue using wireless transmission technology. Furthermore, there would be less tissue signal interference when harvesting data from the implantable electronic device 12 from this location. FIG. 4B illustrates how in an alternative embodiment of the endoprosthesis where the blind cavity is provided in the lateral aspect of the postero-lateral condyle, the blind cavity can still be easily accessed with the knee placed in slight flexion.

[0045] The endoprosthesis 11 will be made of strong materials that fit the purpose of the implant. The blind cavity 35.1 is provided on the most distal part of the lateral aspect of the lateral femoral condyle 34 (see FIG. 3) which means it is as close as possible to the knee joint. Although this has not been illustrated, each of the pair of femoral condyles 34 of the endoprosthesis 11 may be provided with a blind cavity 35.1 and an associated implantable electronic device 12 removably received therein.

[0046] Post-operatively, acceleration and joint rotation data recorded by the accelerometers 13 is collected and stored in memory 15. During a visit to a medical practitioner, the recorded and stored data can be downloaded to the remote device 18, which may be in the form of a smartphone, PDA, watch, wearable device, tablet, laptop, or other computing device, via the wireless communication module 14. The remote device 18 is configured to process the recorded data using suitable algorithms and/or artificial intelligence or machine learning techniques and to display the processed information to the medical practitioner. This may include information of relative acceleration, relative rotation, relative tilt, vibration or force measured across the respective implantable electronic devices 12.1, 12.2. The endoprosthesis activity monitoring system 10 in accordance with the invention provides for more accurate monitoring of the endoprosthesis 11 and permits medical reporting of accurate, in situ, data that will contribute to the health of the patient.

[0047] The endoprosthesis activity monitoring system 10 gives a healthcare practitioner an unprecedented level of objective information on physical activity of the limb or replacement body part and gives practitioners the ability to gain easy access to accurate information specific to activity levels of the replacement body part or prosthesis. Furthermore, the activity information analysed and stored can possibly allow for earlier diagnosis of implant specific problems such as loosening of the prosthesis and activity patterns which may lead to a decline in general health of the patient. Other indirect benefits would include motivation of patients with accelerometer-enhanced implants to be more active.

[0048] The endoprosthesis activity monitoring system 10 provides for accurate long-term quantification of physical activity in patients following total knee replacement surgery. Using the memory 15 of the implantable electronic devices 12 activity can be recorded over a period of months or longer. Furthermore, permanent or semi-permanent introduction of the accelerometers 13 into the lateral aspects of the endoprosthesis 11 means that the accelerometers 13 can be disposed as close as possible to the knee without causing any discomfort to the user, which consequently results in more accurate measurements. Relative acceleration, rotation, and/or tilt may also be measured by having regard to measurement of the respective implantable electronic devices 12.1, 12.2.

[0049] As can best be seen in FIGS. 1 and 3, each implantable electronic device 12 is self-contained and comprises a one-piece, integrated, compact form factor. To this end, each implantable electronic device 12 has a casing 26 which defines an inner cavity for housing components of the implantable electronic device 12. Accordingly, the casing 26 is configured to house the accelerometer 13, memory 15, wireless communication module 14 and battery 16, amongst others, in the inner cavity. Accordingly, each implantable electronic device 12.1, 12.2 is self-contained and, as a whole, is configured to be removably mounted to the respective blind cavities 35.1, 35.2 of the knee prosthesis. The blind cavities 35.1, 35.2 are disposed in areas of the knee which has the least soft tissue cover which renders the implantable electronic devices 12.1, 12.2 easily removable, serviceable and/or replaceable by way of only minor surgery, without unnecessarily compromising structural integrity of the knee prosthesis itself.

[0050] The casing 26 includes two complementary, interconnectable parts 26.1, 26.2 which are operatively disconnectably coupled together to form a serviceable pod. The casing 26 may be manufactured from cobalt chrome molybdenum alloy, titanium or titanium alloy or any other material that is compatible with the material properties of the knee prosthesis.

[0051] To retain the implantable electronic devices 12.1, 12.2 in their respective blind cavities 35.1, 35.2, each blind cavity 35.1, 35.2 has a complementary cover 28.1, 28.2 which is removably secured over an opening of the blind cavity using either fasteners such as screws 29 which screw into holes or clips (not shown) which retain the cover 28 in position. The Applicant believes that the endoprosthesis 11 has an advantage over other existing activity trackers for prosthetics due to the fact that, despite limited space and the load bearing function of the lateral condyle, provision of the blind cavities 35.1, 35.2 in the lateral aspect of the femoral or tibial condyle, improves accessibility to the self-contained, implantable electronic devices 12 and hence serviceability of these devices.