Devices, systems and methods for monitoring hip replacements

Abstract

To provide hip replacement prostheses.SOLUTION: A hip replacement prosthesis comprises an artificial femoral stem, an artificial femoral head coupled to the femoral stem, an artificial acetabular assembly coupled to the femoral head, and a plurality of sensors coupled to at least one of the femoral stem, femoral head and acetabular assembly.SELECTED DRAWING: Figure 5

Description

[Technical field]

[0001] The present invention relates generally to hip replacement surgery, and more particularly to instruments and methods for monitoring the performance of total and partial hip replacement surgeries.

[0002] Description of Related Applications This application is a claim of benefit under 35 U.S.C. § 119(e) of U.S. Provisional Patent Application No. 61 / 789,170, filed March 15, 2013, which is incorporated by reference in its entirety. [Background technology]

[0003] Hip replacement surgery is one of the most common orthopedic procedures. It may be performed when a patient has lost full use of the hip joint, typically due to trauma to the hip joint, avascular necrosis of the hip joint, or for the treatment of severe and / or persistent joint pain (e.g., due to various types of arthritis, such as rheumatoid arthritis or osteoarthritis).

[0004] Hip replacements may take many different forms. In a total hip replacement or total hip replacement (THR), both the femoral head and the acetabulum are replaced. In a hemi (partial) hip arthroplasty, only the femoral head is replaced, and the patient's own acetabulum is retained. The femoral component of the hip replacement may be a single piece with the head and stem as one complete unit, or it may be made in several pieces, for example, a prosthetic femoral stem bonded to a separate femoral head component and neck section (often done to provide a custom fit for the patient in length and / or femoral head size). The femoral component may be cemented in place with bone cement (cemented hip joint) or it may be held in place without cement, fitting precisely within the femoral intermedullary space of the femur (AML - anatomic medullary locking - stem design). Similarly, the acetabular component of a THR may also be a single piece that is attached to the hip joint space to receive the femoral head, or it may be a two-piece component that includes a shell that is attached to the pelvic bone and an inner liner attached to the shell. The acetabular component of a THR may be held in place by screws and / or cement, or it may be attached without cement.

[0005] Currently, the various components may be made of the same material (e.g., all parts may be made of metal) or the individual components may be made of a wide variety of materials. For example, acetabular components typically have a metal shell with an exterior coating to facilitate bone attachment and ingrowth, and an interior liner made of polyethylene, ultra-high molecular weight polyethylene, ceramic, or surgical stainless steel. Similarly, there may be several different combinations of materials used to construct the femoral head. For example, the femoral head may be made of a metal, usually cobalt chrome (but may also be stainless steel or titanium) or ceramic material, while the femoral stem is typically metal (stainless steel, titanium, or cobalt chrome) and often has a surface coating to facilitate bonding of the implant into the femur.

[0006] Figure 1 shows a complete hip prosthesis of a type known in the art. Figure 2 shows an exploded view of the complete hip prosthesis of Figure 1. The acetabular shell (which, unless the context requires, is meant to refer to "prosthetic acetabular shell" even if not otherwise specified) can be made of any suitable material, preferably metal or ceramic, and the inner liner can also be made of any suitable material that is compatible with the material for the acetabular shell. For example, the liner can be made of polyethylene, ultra-high molecular weight polyethylene, ceramic, metal, or other types of materials. The femoral head (which will also be referred to hereinafter, unless the context requires otherwise, even if the text does not specify otherwise, as the "prosthetic femoral head") may be made of metal or ceramic and may be of the same or different material as that constituting the acetabular liner (which will also be referred to hereinafter, unless the context requires otherwise, even if the text does not specify otherwise), such as a ceramic femoral head on a ceramic acetabular liner (ceramic-on-ceramic hip joint; COC), a metal femoral head on a metal acetabular liner (metal-on-metal hip joint; MOM) or alternatively a metal or ceramic femoral head on a polyethylene acetabular liner (metal-on-polyurethane, MOP; metal-on-crosslinked polyurethane, MOXP; ceramic-on-polyurethane, COP; ceramic-on-crosslinked polyurethane, COXP), or any other combination thereof. A femoral stem (which will hereafter be referred to as "prosthetic femoral stem" unless otherwise specified, unless the context requires otherwise) is typically made of a biocompatible metal (stainless steel, titanium, cobalt chrome) for long-term use within the patient's body, and such a femoral stem is inserted into the femoral shaft and held in place with or without bone cement.

[0007] Unfortunately, the insertion of a full hip joint can result in various complications over time. For example, as shown in FIG. 3, wear can occur between the femoral head and the acetabular liner, resulting in improper operation of the artificial hip joint. In addition, the patient can develop inflammation and experience pain even with slight movement or displacement of any of the components. Depending on the type of material used for the acetabular liner (if present, as in the case of THR) and the femoral head (both THR and hemiarthroplasty), wear can occur on the acetabular liner and / or femoral head, resulting in loosening or partial (or complete) displacement of the joint and poor performance of the hip joint, resulting in difficulty in movement and walking, and causing pain and inflammation to the patient. A second common complication is that over a long period of time (e.g., 8-12 years), bone loss can occur in the tissues surrounding the implant in either the pelvis and / or femur due to a process known as bone softening or osteolysis.

[0008] Erosion of bone around the implant may be caused by material debris (metal, ceramic, and / or polyurethane fragments) that is generated by friction between the femoral head and the acetabular cup and penetrates into the tissue surrounding the implant, causing inflammation and bone loss. Other potential causes of inflammation and bone softening are vibration and movement of the implant, mechanical wear and tear, lack of biocompatibility of the implant material with the surrounding bone, metal allergies, and lack of biocompatibility of the bone cement with the surrounding bone. Additional complications include infection, nerve damage, material sensitivity, nerve impingement, and hip dislocation (more likely if muscles have not healed adequately, usually during the first 4-12 weeks after surgery).

[0009] Currently, postoperative in-hospital monitoring of patients undergoing hip replacement surgery is performed by personal visits by hospital staff and medical teams, with medical monitoring (vital signs, etc.), evaluation of hip range of motion (ROM), physical therapy (including early mobilization and activity), and diagnostic imaging and blood studies as needed. Once the patient is discharged from the hospital, prosthesis performance and patient satisfaction are checked during regular physician office visits, where a full medical history, physical examination, and complementary imaging and diagnostic studies are used to monitor the patient's progress and identify the occurrence of any potential complications. During such visits, the surgeon typically evaluates the hip range of motion, attempts to identify any pain that occurs during certain movements or activities, and questions the patient to determine activity level, daily function, pain control, and rehabilitation progress. Summary of the Invention [Problem to be solved by the invention]

[0010] Unfortunately, the majority of a patient's recovery time occurs between hospital visits or clinic visits. It can be extremely difficult to accurately measure and follow full joint range of motion (ROM may vary depending on pain control, degree of anti-inflammatory medication, time of day, recent activity, and / or how the patient feels at the time of presentation), "real life" prosthesis performance, patient activity level, exercise tolerance, and the effectiveness of rehabilitation efforts (physical therapy, medication, etc.) from the date of surgery to full recovery. For much of this information, physicians rely on patient self-reporting or third-party observation to gain insight into post-operative treatment effectiveness and recovery and rehabilitation progress, which is often further complicated by patients who are unclear about what to look for, uninformed about what a "normal / expected" post-operative recovery looks like, non-compliant, or unable to communicate these symptoms effectively. Furthermore, identifying and tracking complications (in and out of hospital) before they become symptomatic and occur between physician visits, or whose presence is difficult to detect, also provides valuable and additional information to the management of THR patients. Currently, in all cases, neither physicians nor patients have access to the type of "real-time," continuous, objective measurement of prosthesis performance that they might otherwise have. [Means for solving the problem]

[0011] The present invention discloses novel total and partial hip replacements that overcome many of the shortcomings of conventional artificial hip joints, methods for constructing and monitoring these novel hip replacements, and further provides other related advantages.

[0012] In summary, total and partial hip prostheses are provided with a number of sensors for monitoring the health and effectiveness of the hip prosthesis within the patient. The sensors may be located on the exterior surface of the hip prosthesis, on the interior surface of the hip prosthesis, within the prosthesis material itself (stainless steel, titanium, cobalt chrome, polyurethane, high molecular weight polyurethane, ceramics, etc.), between the various components that make up the hip prosthesis, within the bone cement (e.g., PMMA, or PMMA and MMA copolymer blends) used to secure the hip prosthesis (if present), and / or within the tissue surrounding the prosthesis. In certain embodiments, the sensors are of a type that is passive and thus does not require its own power source.

[0013] In one aspect of the invention, an assembly is provided for positioning and placing an implant in a patient's body that includes a total or partial hip prosthesis and sensors disposed on, in, or around the hip prosthesis. In various embodiments, the sensors may be located on the exterior surface of the hip prosthesis, on the interior surface of the hip prosthesis, in the material used to construct the hip prosthesis, between the various components that make up the hip prosthesis, on or in the bone cement used to secure the hip prosthesis, on or in the tissues surrounding the hip prosthesis (typically bone or bone marrow, but also muscles, ligaments, tendons, joint capsules, and / or synovial compartments), or any combination thereof. Representative examples of sensors suitable for use within the present invention include accelerometers (acceleration sensors, tilt sensors, vibration sensors, shock sensors, and rotation sensors), pressure sensors, contact sensors, position sensors, chemical microsensors, tissue metabolism sensors, mechanical stress sensors, and temperature sensors. In particularly preferred embodiments, the sensors are wireless sensors or sensors connected to a wireless microprocessor.

[0014] In another embodiment, multiple sensors as described above are placed on, in, or around the hip joint (bone cement or tissue), and in a preferred embodiment, the hip joint may include one or more types of sensors (e.g., one or more of the following sensors: acceleration sensors, tilt sensors, vibration sensors, shock sensors, rotational sensors, pressure sensors, contact sensors, position sensors, chemical microsensors, tissue metabolism sensors, and mechanical stress sensors, or any combination thereof).

[0015] According to various embodiments, sensors are placed at various locations within the replacement hip prosthesis to monitor the action, motion, function, wear, performance, potential side effects and medical condition of the prosthesis and its interface with the patient's living tissue. Live, continuous, in situ monitoring of patient activity, patient function, prosthesis activity, prosthesis function, prosthesis performance, and potential side effects is provided. In addition, information is available about many aspects of the replacement hip prosthesis and its interaction with the patient's own body tissue, including clinically significant measurements not currently available through anthropometry, medical imaging, and diagnostic medical studies.

[0016] According to one embodiment, the sensor provides assessment data regarding the range of motion (ROM) of the prosthetic hip joint. Currently, ROM is typically measured clinically by a physician passively moving the prosthetic hip joint through its range of motion during a physical and recording the results (flexion, extension, abduction, adduction, external rotation, internal rotation, and degree of rotation during flexion). Motion sensors and accelerometers can be used to accurately determine the total ROM of the prosthetic hip joint both during the physical and during normal daily activities between visits.

[0017] According to one embodiment, contact sensors are provided between the prosthesis and the bone around it, between the prosthesis and the bone cement around it, and / or between the bone cement and the bone around it to measure the erosion of the bone around the implant and the loosening around the implant. In another embodiment, strain gauges are provided to detect the strain between the prosthesis and the bone around it, between the prosthesis and the bone cement around it, between the bone cement and the bone around it, and also the strain on various parts of the prosthesis. It is understood that a sudden increase in strain can cause too much stress on the replacement prosthesis, which can cause more damage to the body. For example, a gradual decrease in strain over a long period of time can cause resorption of the bone around the implant, which can cause loosening of the prosthesis or fracture around the prosthesis.

[0018] According to other embodiments, accelerometers are provided to detect vibration, shock, tilt and rotation. In other embodiments, sensors that measure surface wear, such as contact or pressure sensors, may be embedded at various depths within the femoral head, acetabulum, and / or acetabular cup to monitor the articular surfaces. In other embodiments, position sensors and other types of sensors are provided to indicate range of motion and to monitor whether there is partial (or complete) hip dislocation during actual use over a period of time.

[0019] In another embodiment, a hip joint prosthesis (full or partial) can have sensors at a density specified for a particular placement location. For example, a hip joint prosthesis can have a sensor density of greater than 1, greater than 2, greater than 3, greater than 4, greater than 5, greater than 6, greater than 7, greater than 8, greater than 9, greater than 10 sensors (e.g., acceleration sensors, tilt sensors, vibration sensors, shock sensors, rotation sensors, pressure sensors, contact sensors, position sensors, chemical microsensors, tissue metabolism sensors, and mechanical stress sensors, or any combination thereof) per square centimeter of device. In another embodiment, a hip joint prosthesis (full or partial) can have a sensor density of greater than 1, greater than 2, greater than 3, greater than 4, greater than 5, greater than 6, greater than 7, greater than 8, greater than 9, greater than 10 sensors (e.g., acceleration sensors, tilt sensors, vibration sensors, shock sensors, rotation sensors, pressure sensors, contact sensors, position sensors, chemical microsensors, tissue metabolism sensors, and mechanical stress sensors, or any combination thereof) per cubic centimeter of device. In related embodiments, sensors (e.g., acceleration sensors, tilt sensors, vibration sensors, shock sensors, rotation sensors, pressure sensors, contact sensors, position sensors, chemical microsensors, tissue metabolism sensors, and mechanical stress sensors) may be placed at specific locations on, in, and around the hip joint prosthesis, including, for example, in the femoral stem prosthesis, femoral neck prosthesis, femoral head prosthesis, acetabular cup, acetabular lining, various parts of the devices to be connected (e.g., the connecting segments of the femoral stem, femoral neck and femoral head, the connecting segments of the acetabular cup and acetabular lining), and around the hip joint prosthesis (on or in the bone cement used to fix the hip joint prosthesis, on or in the tissues around the hip joint prosthesis, typically on or in the bone or bone marrow, but also on or in the muscles, ligaments, tendons, joint capsule and / or synovial compartments).

[0020] In certain embodiments of the invention, the total or partial hip joint prosthesis is provided with a specific unique identification number, and in other embodiments, each of the sensors on, in or around the hip joint prosthesis has either a specific unique identification number or a group identification number (e.g., an identification number that identifies the sensor as an acceleration sensor, tilt sensor, vibration sensor, shock sensor, rotation sensor, pressure sensor, contact sensor, position sensor, chemical microsensor, tissue metabolism sensor, or mechanical stress sensor). In yet other embodiments, the specific unique identification number or group identification number is specifically associated with a location on, in or around the hip joint prosthesis.

[0021] In another aspect of the invention, a method of monitoring an implanted total or partial hip prosthesis is provided, the method comprising the steps of transmitting a wireless electrical signal from a location outside the body to a location inside the body, receiving the electrical signal at a sensor located on, in or around the hip prosthesis inside the body, powering the sensor using the received signal, detecting data at the sensor, and outputting the detected data from the sensor to a receiving unit outside the body.

[0022] The health of the partial or total hip prosthesis can be wirelessly queried and the results reported periodically, allowing the patient's health to be checked periodically or at any time desired by the patient and / or physician.

[0023] In another embodiment, each of the sensors has a signal receiving circuit and a signal output circuit. The signal receiving circuit receives an interrogation signal that includes both power and data collection request components. Using power from the interrogation signal, the sensor activates the parts of the circuitry necessary to perform the detection, performs the detection, and then outputs the data to the interrogation module. The interrogation module works under the control of a control unit that includes appropriate I / O circuitry, memory, a controller in the form of a microprocessor, and other circuitry, the purpose of which is to drive the interrogation module. In yet another embodiment, the sensors (e.g., acceleration sensors, tilt sensors, vibration sensors, shock sensors, rotation sensors, pressure sensors, contact sensors, position sensors, chemical microsensors, tissue metabolism sensors, or mechanical stress sensors) are configured so that they can be easily incorporated into the prosthesis or otherwise mechanically attached thereto (e.g., by openings or other attachments that allow permanent attachment of the sensors to the prosthesis) and / or into the bone cement or tissue surrounding the prosthesis.

[0024] In yet another aspect of the invention, there is provided a method or apparatus suitable for transmitting a wireless electrical signal from a location outside the body to a location inside the body, receiving the electrical signal with one of the above-mentioned sensors located on, in or around a hip prosthesis located inside the body, powering the sensor using the received signal, detecting data at the sensor, and outputting the detected data from the sensor to a receiving unit located outside the body. In certain embodiments, the receiving unit is capable of performing an analysis of the signal provided by the sensor.

[0025] Data collected by the sensors can be stored in memory located within the prosthetic femoral stem. During a visit to a physician, data can be downloaded by the wireless sensors, providing the physician with data representative of the real-time performance of the prosthesis.

[0026] Advantages gained include more accurate monitoring of the prosthesis and accurate, on-the-spot medical reporting of data that contributes to patient health. Details of one or more embodiments are set forth in the following description. Other features, objects, and advantages will be apparent from the specification, drawings, and claims. Additionally, all patents and patent applications cited herein are incorporated by reference and their entire disclosures are hereby incorporated by reference. [Brief description of the drawings]

[0027] [Figure 1] FIG. 1 is an isometric view of a total hip replacement. [Diagram 2] FIG. 2 is an exploded view of the total hip replacement of FIG. 1. [Diagram 3] FIG. 1 illustrates a total hip replacement in a patient's pelvis. [Figure 4] FIG. 1 is an exploded view of a total hip prosthesis equipped with sensors according to various embodiments described herein. [Diagram 5] FIG. 5 shows the embodiment of FIG. 4 after replacement of the hip prosthesis, illustrating the location of contact with the patient's bone. [Figure 6A] FIG. 2 is an exploded view of an acetabular cup, liner and femoral prosthesis provided with various sensors in accordance with various embodiments described herein. [Figure 6B] FIG. 2 is a diagram showing how strain gauges are incorporated in various locations. [Figure 7A] FIG. 1 is a side view of a prosthetic femoral implant with a ball attached. [Figure 7B] FIG. 1 is a side close-up view of a prosthetic femoral implant with various sensors and power generating segments. [Figure 8A] FIG. 2 is a top view of an acetabular cup having various sensors according to embodiments described herein. [Figure 8B] FIG. 10 shows a liner in the acetabular cup of FIG. 9 provided with various sensors. [Figure 9]FIG. 1 is a side view of an assembled total hip prosthesis including examples of various sensor placement locations. [Figure 10] FIG. 10 shows the entire hip prosthesis assembly of FIG. 9 in a fully functional state within a patient, with various different types of sensors. [Figure 11A] FIG. 1 illustrates the movements of a prosthetic hip joint that can be measured and monitored in accordance with various embodiments disclosed herein. [Figure 11B] FIG. 1 illustrates the movements of a prosthetic hip joint that can be measured and monitored in accordance with various embodiments disclosed herein. [Figure 12] FIG. 1 illustrates an information and communication technology system embodiment configured to process sensor data. [Figure 13] FIG. 2 is a block diagram of a sensor, an interrogation module, and a control unit according to one embodiment of the present invention. [Figure 14] 1 is a schematic diagram of one or more sensors positioned on a hip replacement within a patient being probed to obtain data and outputting data in accordance with one embodiment of the present invention. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0028] Generally described, the present invention provides a variety of hip replacement devices that can be utilized to monitor the health and effectiveness of the device. However, before describing the invention, it may be helpful to an understanding of the invention to first provide definitions of certain terms that will be used below.

[0029] A "hip replacement," as the term is used herein, can take a variety of different forms and may involve replacing all or parts of a patient's hip joint with synthetic material. In a total hip replacement or total hip replacement (THR), both the femoral head and acetabulum are replaced. In a hemi (partial) hip arthroplasty, only the femoral head is replaced, and the patient's own acetabulum is retained. The femoral component of a hip replacement may be a single piece with the head and stem as one complete unit, or it may be made in several pieces, for example, where an artificial femoral stem is bonded to a separate femoral head component and neck section (this is often done to provide a customized fit for the patient based on length and / or femoral head size). The femoral component may be cemented in place with PMMA bone cement (glued hip joint) or may be held in place without cement by fitting the femoral component precisely within the femur's intermedullary space (AML - anatomic medullary locking - stem design). Similarly, the acetabular component of the THR may also be a single piece that is bonded to the hip joint space that receives the femoral head, or it may be a two-piece component that includes a shell that is bonded to the pelvic bone and a medial liner attached to the shell. The acetabular component of the THR may be held in place with screws and / or cement, or may be attached without cement.

[0030] Currently, the various components may be made of the same material (e.g., all parts may be made of metal) or the individual components may be made of a wide variety of materials. For example, acetabular components typically have a metal shell with an exterior coating to facilitate bone attachment and ingrowth, and an interior liner made of polyethylene, ultra-high molecular weight polyethylene, ceramic, or surgical stainless steel. Similarly, there may be several different combinations of materials used to construct the femoral head. For example, the femoral head may be made of a metal, usually cobalt chrome (but may also be stainless steel or titanium) or ceramic material, while the femoral stem is typically metal (stainless steel, titanium, or cobalt chrome) and often has a surface coating to facilitate bonding of the implant into the femur.

[0031] As used herein, unless the context specifically requires otherwise, the terms "hip implant" or "hip replacement" or "hip replacement or portion thereof" or "medical device" should be understood to mean any or all of the various components that make up a total hip joint prosthesis, including, for example, the femoral stem prosthesis, the femoral head prosthesis and the acetabular assembly, and the various subcomponents thereof. The term "replacement hip joint prosthesis" should be understood to mean either a partial or a total hip joint prosthesis.

[0032] "Sensor" refers to a device that can be used to measure one or more different aspects of the human body, a hip implant inserted therein, and / or the health, impact, effectiveness, or performance of a hip implant inserted therein. Representative examples of sensors suitable for use in the present invention include, for example, fluid pressure sensors, contact sensors, position sensors, pulse pressure sensors, blood volume sensors, blood flow sensors, chemical sensors (e.g., for blood and / or other bodily fluids), metabolic sensors (e.g., for blood and / or other bodily fluids), accelerometers, mechanical stress sensors, and temperature sensors. In certain embodiments, the sensors may be wireless sensors, or in other embodiments, the sensors may be connected to a wireless microprocessor. In another embodiment, one or more (including all) of the sensors may have a unique sensor identification number ("USI") that specifically identifies the sensor.

[0033] A wide variety of sensors (also referred to as Micro (Micro) Electromechanical Systems or "MEMS" or Nano Electromechanical Systems or "NEMS" and BioMEMS or BioNEMS, see generally https: / / en.wikipedia.org / wiki / MEMS) can be used in the present invention. Representative patents and patent applications include U.S. Pat. No. 7,383,071 and U.S. Patent Application Publication No. 2010 / 0285082. Representative publications include Albert Foch, "Introduction to BioMEMS", CRC Press, 2013; Marc J. Madow, "From MEMS to Bio-MEMS and Bio-NEMS: Manufacturing Techniques and Applications", CRC Press, 2011; Simona Badilescu, "Bio-MEMS: Science and Engineering Perspectives", CRC Press, 2011; and Steven S. Saliterman. S.Saliterman), "Fundamentals of BioMEMS and Medical Microdevices", SPIE-The International Society of Optical Engineering, 2006; Wanjunn Wang, Steven A. Soper (eds.), "Bio-MEMS: Technologies and Applications", CRC Press, 2012; Volker Kempe, "Inertial MEMS: Principles and Practice", Cambridge University Press, 2013. Press, 2011; Polla, DL et al., "Microdevices in Medicine", Ann. Rev. Biomed. Eng., 2000, Vol. 2, pp. 551-576; Yun, KS et al., "A Surface-Tnesion Driven Micropump for Low-voltage and Low Power Operations", J. Microelectromechanical Sys., October 2002, 11:5; Yeh, R. et al.), "Single Mask, Large Force, and Large Displacement Electrostatic Linear Inchworm Motors", J. Microelectromechanical Sys., August 2002, 11:4, p.330-336; Loh, NC et al., "Sub-10 cm. 3 Interferometric Accelerometer with Nano-G Resolution (Sub-10cm 3 "Interferometric Accelerometer with Nano-g Rsolution," J. Microelectromechanical Sys., June 2002, 11:3, p. 182-187, all of which publications are incorporated by reference herein in their entireties.

[0034] To further understand the various aspects of the invention provided herein, the following topics are provided below: A. Medical Uses of Hip Implants; B. Exemplary Embodiments of Hip Implants; C. Coatings Applied to Hip Implants; D. Drug-Eluting Hip Implants; E. Methods of Monitoring Infection in Hip Implants; F. Power Generation; G. Medical Uses of Sensors; H. Medical Imaging and Self-Diagnosis, Predictive Analysis and Predictive Maintenance of Assemblies Including Hip Implants; I. Methods of Monitoring Assemblies Including Hip Implants; and J. Collection, Transmission, Analysis and Distribution of Data from Assemblies Including Hip Implants.

[0035] A. Medical Uses of Hip Replacements Hip replacement is performed when a patient loses sufficient use of the hip joint resulting in disability, loss of motion and function, impaired ambulation, and / or persistent joint pain and discomfort. Common causes of hip dysfunction leading to total or partial hip replacement include trauma (typically hip fracture, often occurring at the femoral neck), avascular necrosis of the hip joint, or various forms of arthritis (e.g., rheumatoid arthritis or osteoarthritis). In most patients, surgery is successful in improving ambulation, restoring function, and reducing pain, and as a result, the surgery is one of the most common orthopedic procedures in the Western world.

[0036] B. Exemplary Embodiments of Hip Implants 4 shows a prosthesis 10 in the form of a replacement hip joint including one or more sensors 22 as described herein. The replacement hip joint has an acetabular shell 12 in which an acetabular liner 14 is housed. The replacement hip joint further has two components, a femoral prosthesis assembly 16 including a prosthetic femoral head 18 and a prosthetic femoral implant or stem 20 (which further includes a prosthetic femoral neck 17).

[0037] Figure 5 shows an exploded view of a replacement hip prosthesis 10 positioned within a patient. As shown in Figure 5, the acetabular shell 12 is secured to a pelvic bone 23. A femoral stem 20 is coupled to a femur 24, with the femoral head 18 shown ready for placement on the femoral stem 20 and entry into the acetabular shell liner 14. Figures 4 and 5 are discussed together to explain various embodiments.

[0038] A number of sensors 22 are positioned within the prosthesis 10 for in situ or in situ monitoring of real-time operation of the patient's activities and prosthesis performance. A variety of these sensors will now be described according to various embodiments.

[0039] In one embodiment, contact sensors 22 are provided on the outer surface of the acetabular shell 12. These sensors 22 detect and record contact between adjacent parts, for example, between the acetabular shell 12 and the pelvis 23 and / or between the acetabular shell and the bone cement (if present) and / or between the bone cement (if present) and the pelvis. The contact sensors 22 can detect loosening of the prosthesis 10 and its connection to the surrounding cement (if present) and / or the pelvic bone. Acetabular loosening is a common complication that occurs when bone loss occurs in the pelvic bone around the acetabulum (typically over 8-12 years) (e.g., due to a process called bone softening or osteolysis). Erosion of the bone around the implant can be caused by material debris (metal, ceramic, and / or polyurethane chips) that is generated by friction between the femoral head and the acetabular cup and that can enter the tissue surrounding the implant, causing inflammation and bone loss. Other potential causes of inflammation and bone softening are vibration and movement of the implant, mechanical wear and tear, lack of biocompatibility of the implant material with the surrounding bone, metal allergies, and lack of biocompatibility of the bone cement with the surrounding bone. Additionally, the contact sensor 22 can indicate that it is positioned farther from the pelvic bone 23 than desired as a result of material debris building up over time and / or the presence of inflammation between the shell and the pelvic bone. Multiple contact sensors 22 are positioned at different locations around the acetabular shell 12. In the illustrated embodiment, multiple sensors are shown positioned on the exterior surface of the acetabular shell 12. In various embodiments, the sensors can be positioned in a variety of patterns based on the location of contact with the pelvic bone and / or the surrounding bone cement (if present). For example, the sensors may be arranged in an X-shaped pattern, as ovals or concentric rings around the acetabular shell from the outermost periphery to the crown, or in various other patterns to gather accurate data regarding the physical contact of the acetabular shell 12 with the pelvic bone 23 and / or surrounding bone cement (if present).In various embodiments, contact sensors may also be distributed and / or arranged within the bone cement (if present) to collect data regarding the physical contact of the bone cement with the acetabular prosthesis and / or the physical contact of the bone cement with the pelvic bone.

[0040] The contact sensors 22 may also be positioned at various locations on the two surfaces of the acetabular liner 14. Thus, the contact sensors 22 can detect contact (and / or relative motion) between the acetabular liner and the acetabular shell (the sensors may be "paired" to detect slippage between the acetabular liner and the shell) as well as contact between the femoral head and the acetabular liner. Similarly, the contact sensors 22 may be positioned at various locations on the femoral head to detect contact between the femoral head and the acetabular liner. Thus, in the embodiment of Figures 4 and 5, various contact sensors are provided to monitor contact between the bone and the acetabular component and between the femoral head and the acetabular liner. Dislocation of the femoral head from the natural acetabulum or the synthetic acetabulum of an artificial hip joint is a common complication of hip joint replacements that occurs shortly after surgery (especially while the surrounding supporting tissues are healing from surgery), and sensors on the femoral head and / or acetabulum can alert the patient and health care provider if joint dislocation occurs. Partial or incomplete displacement (subluxation) of the hip joint may also occur, which may not be readily apparent to the patient or physician; contact sensors on the femoral head and acetabulum can determine whether the joint is functioning correctly (tracking) and whether subluxation (even if subclinical or asymptomatic) is occurring.

[0041] Additional contact sensors may also be located on the femoral stem to monitor contact between the femur and / or between the femoral stem and the surrounding bone cement (if present). Contact sensors may also be distributed and / or arranged within the bone cement (e.g., 22B, if present) to collect data regarding the physical contact between the bone cement and the femoral prosthesis and / or between the bone cement and the femoral canal. These sensors 22, 22B may detect and record contact between the connecting components in the modular femoral prosthesis, such as the femoral head 18, femoral neck 17, and / or femoral stem 20. These sensors, which may be located in corresponding pairs on adjacent components, may be used to ensure that the connecting elements of the modular femoral prosthesis are correctly aligned and attached. A sensor on the femoral body 20 can be used to monitor the contact of the femoral body with the femur and / or with the surrounding bone cement (if present), and a sensor in the bone cement can be used to monitor the contact of the bone cement (e.g., 22B, if present) with the femur. A contact sensor on the femoral body 22 can detect loosening of the prosthesis and its connection to the surrounding cement (if present) and / or the femur. Femoral body loosening is a common complication that occurs when bone loss occurs in the femoral canal around the femoral body due to osteolysis (typically over 8-12 years). As mentioned above, bone erosion around the implant can be caused by material debris (metal, ceramic, and / or polyurethane chips) that is generated by friction between the femoral head and the acetabular cup and can enter the tissue around the femoral prosthesis, causing inflammation and bone loss. Other potential causes of inflammation and bone softening are implant vibration and movement, mechanical wear and tear, lack of biocompatibility of the implant material with the surrounding bone, metal allergies, and lack of biocompatibility of the bone cement with the surrounding bone. A number of contact sensors 22 are positioned at different locations around the femoral shaft. As shown in Figures 4 and 5, the sensors are shown positioned on the outer surface of the femoral shaft.In various embodiments, the sensors may be positioned in a variety of different patterns based on the location of contact with the femoral canal and / or surrounding bone cement (if present). For example, the sensors may be arranged in a spiral pattern, as vertical lines or concentric rings around the femoral body, or in various other patterns to gather accurate data regarding the physical contact of the femoral body 20 with the femur and / or surrounding bone cement (if present). In various embodiments of the invention, the contact sensors are positioned on the femoral body and femoral bone and / or bone cement at a density of greater than 1, greater than 2, greater than 3, greater than 4, greater than 5, greater than 6, greater than 7, greater than 8, greater than 9, greater than 10 sensors per square centimeter or cubic centimeter of the device.

[0042] FIG. 6A is an exploded view of the acetabular shell 12, liner 14, and femoral head 18 to allow clear illustration of various locations for strain gauges 26 that may be placed on the prosthesis. Contact sensors 22, not shown in FIG. 6, may be used simultaneously with the strain gauges, which may be placed adjacent to each other or may be the same sensor. The strain gauges 26 may be placed at various locations on the acetabular shell 12 to detect stresses between the prosthesis and the preceding bone. A decrease in strain indicates bone resorption (loss) and thus a prosthesis loosening or fracture is likely. The strain sensors 26 provide a different data point than the contact sensors 22, which only specify whether there is currently contact between adjacent structures, thus providing a good indication of whether abutting contact between two surfaces is occurring. However, these contact sensors do not provide an indication of whether strain is present on any of the surfaces, whereas the strain sensor 26 outputs data representative of the mechanical strain forces being applied to the entire implant which, if not corrected, may be a precursor to future loosening and failure of the prosthesis. Additionally, the strain gauge 26 may be of a type that indicates strain occurring between two surfaces, such as between the acetabular liner and the pelvic bone or between the acetabular shell 12 and the acetabular liner 14. Furthermore, such a strain gauge may gather data regarding the strain between the femoral head 18 and the acetabular liner 14 and the location of such strain.

[0043] As shown in Fig. 6B, strain gauges may be provided on the femoral prosthesis, particularly on the femoral stem, but also on the femoral neck and head. Strain gauges may be placed at various locations on the femoral stem to detect strains occurring between the prosthesis and the surrounding bone. A decrease in strain indicates that bone resorption (loss) has occurred in the femoral canal, which may indicate a loosening of the prosthesis or a fracture of the femur. The strain sensors provide an indication of the strains present in the femoral body and may measure the most important mechanical strain stresses being applied to the entire implant, which, if not corrected, will result in a high probability of loosening and failure of the prosthesis. In various embodiments of the invention, strain sensors are positioned on the acetabular shell, acetabular liner, femoral shaft, and femoral bone and / or bone cement at a density of 1 or more, 2 or more, 3 or more, 4 or more, 5 or more, 6 or more, 7 or more, 8 or more, 9 or more, or 10 or more sensors per square centimeter or cubic centimeter of the device.

[0044] 7A and 7B show an embodiment in which accelerometers are placed at various locations in and on the femoral body 18, the femoral neck and the femoral head. Specifically, as shown in FIG. 7A, one or more accelerometers may be placed on the femoral head 18. In addition, one or more acceleration sensors 42 in the form of an accelerometer or gyroscope may be placed on the surface of or inside the femoral body portion 18. The accelerometers provide the advantage of being able to detect acceleration, vibration, shock, tilt and rotation of various components. This allows the performance of the prosthesis 10 to be measured under various conditions and over time. In this particular example, the prosthesis 10 is a replacement hip joint. Of course, it could be any other prosthesis, such as an artificial elbow, shoulder, metacarpal, talocrural (ankle) joint, etc. In various embodiments of the invention, strain sensors are positioned on the acetabular shell, acetabular liner, femoral shaft, and femur and / or bone cement at a density of greater than 1, greater than 2, greater than 3, greater than 4, greater than 5, greater than 6, greater than 7, greater than 8, greater than 9, or greater than 10 sensors per square centimeter or cubic centimeter of the device.

[0045] Shortly after the hip joint replacement, the lower leg is first made to move passively, then actively, and shortly thereafter, the patient begins to gradually bear weight on the joint. The accelerometer 42 will measure the motion of the hip joint space during movement, including walking, as the leg swings forward, strikes the ground, and is lifted off the ground and the body is propelled forward. In addition, the accelerometer will measure the impact of the foot striking the ground and the force exerted through the femur to the pelvic bone, as well as any vibration, impulse, or rotation that may occur at different locations within the prosthesis 10. As the patient continues to improve their range of motion post-operatively, the accelerations occurring at different locations within the artificial hip joint can be monitored. As expected, as the patient heals from surgery, the level of activity will gradually improve, the ambulation will improve, the steps will become quicker (and more fluid), and in addition, a longer stride length will be achieved with each step. This can result in a large impact whenever the foot strikes the ground, which can be measured over time (and compared to previous values) by various accelerometers 42 located on the femoral head 18, in the femoral stem 20, and elsewhere on the prosthesis 10. Postoperative progress can be monitored (readings can be compared daily, weekly, etc.), and information can be compiled and communicated to both the patient and the attending physician, so that rehabilitation can be followed and compared to expected (typically age group) standards. In certain embodiments, the wearable device queries the sensors in a selected or randomized manner, capturing and / or storing the collected sensor data. This data can then be downloaded to another system or device (as described in more detail below).

[0046] By integrating the data collected by the sensors described herein (e.g., contact sensors, strain gauges and / or accelerometers) with simple and widely available commercially available analytical techniques, such as pedometers and Global Positioning System (GPS) capabilities, further clinically relevant data can be collected, such as, but not limited to, the patient's degree of ambulation (time, distance, steps, speed, cadence), the patient's activity level (activity frequency, duration, intensity), exercise tolerance (work, calories, power, training effect), range of motion (described below), and prosthesis performance under various "real world" conditions. It is difficult to overstate the value of this information in enabling better management of the patient's recovery. The attending physician (or physical therapist, rehabilitation specialist) only observes the patient episodically during scheduled visits, and the degree of the patient's functioning at the exact time of the visit may be affected by many non-correlated factors, such as the presence or absence of pain, the presence or absence of inflammation, stiffness, time of day, compliance and timing of medication use (pain medications, anti-inflammatories), recent activity and exercise level, the patient's endurance, mood, language barriers, characteristics of the physician-patient relationship, or the patient's ability to accurately describe his or her symptoms, to name a few. Continuous monitoring and data collection allows the patient and physician to objectively monitor progress by providing information about the patient's functioning under many conditions and circumstances, thereby allowing evaluation of how performance has been affected by various interventions (pain control, exercise, physical therapy, anti-inflammatories, respiration, etc.), and comparison of rehabilitation progress with previous and future expected function. Better treatment decisions and better patient compliance can be expected when both physician and patient have the advantage of observing the effects of various treatment modalities on the patient's rehabilitation, activity, function, and overall performance.

[0047] The sensors used for contact, strain sensors and accelerometers may be of any commonly available strain acceptable type (see, for example, U.S. Pat. Nos. 7,450,332, 7,463,997 and 7,924,267, which describe various types of such sensors, including strain gauges, accelerometers and MEMS sensors that can act as many other detection functions). The particular sensor described in U.S. Pat. No. 7,450,332 detects the free fall and movement of an object relative to a gravitational field, and has a particular advantage in that it can detect and store all of the forces acting on the lower limbs and the entire movement of the lower limbs during passive and active movements of the lower limbs and as the lower limbs swing out between steps, all before, after and during impact with the ground.

[0048] Figures 7A, 8A and 8B show yet another type of sensor, namely, articular surface wear sensors 46, which can be placed at various locations within the acetabular liner and femoral head. According to one embodiment, one or more articular surface wear sensors are placed at various depths within the acetabular liner 14 and / or femoral head 18 as shown in Figures 7A and 8B. These sensors 46 for measuring the degree of surface wear may be contact pressure sensors embedded at various depths within the acetabular liner and / or femoral head to monitor the erosion of the articular surface (and provide information regarding the degree and depth of surface wear of the two components). These sensors may also be placed between the acetabular shell 12 and the acetabular liner 14 as shown in Figures 8A and 8B to monitor any given wear or deterioration of the physical contact between the acetabular shell 12 and the acetabular liner 14.

[0049] 9 shows an example of a complete prosthesis in the form of a replacement hip joint provided with a number of different sensors (e.g., 22, 24, 42, 44, 46). The prosthesis may include a number of contact sensors 22, strain gauges 24, accelerometers 42, articular wear surface sensors 46, as well as electrical power generating structures 44 within a single artificial hip joint 10. In addition, a number of position sensors may also be positioned to monitor, record, and transmit the exact position of the femoral head 18 relative to the acetabular liner 14.

[0050] FIG. 10 shows different locations where position sensors 52 and / or accelerometers 53 can be provided in the prosthesis. The position sensors 52 and accelerometers 53 can be located both proximally and distally in the femoral stem or in the femoral neck or in the femoral head. The position sensors may also be housed in the acetabular components, i.e. both the acetabular liner and the acetabular shell. By locating position sensors and / or accelerometers along the length of the femoral stem, the exact location of the femur relative to the acetabular component and the pelvis can be precisely determined and stored in memory. Similarly, by locating accelerometers in different locations in the neck and head of the femoral implant, the amount of pressure applied to different locations, the movement at those locations and the relative position of the acetabular components with respect to each other can be precisely determined. Similarly, such sensors can increase the accuracy of anthropometry and detect full or partial dislocation (subluxation) of the hip joint.

[0051] C. Coatings applied to hip joint implants In certain embodiments of the present invention, a hip implant is provided that may have one or more coatings applied on one or more surfaces of the hip implant. The coatings may be provided on the hip implant for various purposes. The coatings may be biodegradable, non-biodegradable, or combinations thereof. Representative examples of coatings are coatings based on polymers (e.g., polymers made of polyurethane, polyester, polylactic acid, polyamino acids, polytetrafluoroethylene, Teflon, Gortex), although non-polymeric coatings may also be utilized. In certain embodiments of the present invention, one or more sensors as described herein may be distributed throughout the coating (e.g., even in a random manner).

[0052] D. Drug-eluting hip implant In certain embodiments of the present invention, a drug-eluting hip implant is provided that has one or more sensors and can be utilized to release a desired agent (e.g., a drug or therapeutic agent) to a desired location in the body. Representative examples of suitable anti-scarring or anti-fibrotic agents are disclosed in U.S. Patent No. 5,716,981, U.S. Patent Application Publication Nos. 2005 / 0021126, 2005 / 0171594, 2005 / 0181005, and 2005 / 0181009, the disclosures of which are incorporated by reference in their entireties.

[0053] In related embodiments, a drug eluting delivery device may be provided within the hip implant to release a desired drug on demand (e.g., remotely activated / on demand or based on a timed schedule, see generally U.S. Patent Application Publication No. 2011 / 0092948, entitled "Remotely Activated Piezoelectric Pump For Delivery of Biological Agents to the Intervertebral Disc and Spine," which is incorporated by reference in its entirety) or upon detection of an activation event (e.g., upon detection of a leak by a pressure sensor). For example, in certain embodiments of the present invention, a biological agent may be administered with or released from the hip implant to treat or prevent disease (e.g., i) with chemotherapeutic agents in the case of cancer or to prevent restenosis, or ii) with antimicrobial agents in the case of infection).

[0054] In a preferred embodiment, one or more sensors (e.g., pressure sensors, contact sensors, and / or position sensors) may be utilized to determine proper placement of the desired drug as well as the amount and release kinetics of the drug to be released at the desired site.

[0055] E. How to monitor for infection In another embodiment, a hip implant is provided having one or more temperature sensors that can be utilized to measure the temperature of the hip joint, the temperature of the hip joint implant, and the temperature of the local tissue and environment adjacent to the hip joint implant, and a method is provided for monitoring changes in temperature over time to determine and / or provide notification (e.g., to a patient and / or health care provider) if an infection is imminent.

[0056] In certain embodiments of the present invention, metabolic and physical sensors can be used to monitor for rare but potentially life-threatening complications of joint replacement surgery. In a small percentage of patients (less than 1%), the artificial hip joint and surrounding tissues can become infected, typically due to bacteria (often Staphylococcus aureus or Staphylococcus epidermidis) that contaminate the surgical field and colonize the patient's own skin. Sensors such as temperature sensors (detecting temperature increases), pH sensors (detecting pH decreases), and other metabolic sensors can be used to indicate the presence of infection on or around the implant. Early detection of infection allows preemptive treatment with antibiotics or surgical drainage, without the need for artificial removal of the prosthesis.

[0057] F. Power Generation FIG. 7B shows a particular advantage that can be obtained when a patient is walking with a new hip prosthesis. As shown in FIG. 7B, a small electric generating unit 44 can be placed along the outer surface of the femoral stem 18 or alternatively along the inner surface. In particular, each time the user takes a step, there is a release of pressure and an increase in pressure within the internal structure of the femoral stem 16. Using suitable piezoelectric materials or micro-electrical generators, a small amount of electricity can be generated with each step. The electricity can be stored in a capacitor, also located within the femoral stem 16. This electricity can then be used to power sensors located at various locations within the prosthesis.

[0058] Various techniques have been described for extracting power from slight mechanical motion or vibration. See, for example, UK Singh et al., "Piezoelectric Power Scavenging of Mechanical Vibration Energy," Australian Mining Technology Conference, October 24, 2007, pp. 111-118. This paper provides examples of various types of power scavengers that can generate electricity from very slight motion and store this electricity for later use. The above paper also describes embodiments in which pressure is applied and extracted from certain structures to produce electricity as a result of the application of high pressure, without the need for motion, however different. As described in the embodiments of this article, when a patient takes a step and puts his / her weight on the leg, a force is applied to the internal structure of the femoral stem 16, which can generate more than enough power to operate all of the sensors described herein. Another mechanism that can generate electricity from very small amounts of repetitive motion is described in U.S. Patent Application Publication No. 2010 / 0164705, published July 1, 2010. This U.S. Patent Application Publication describes the fact that energy can be extracted during the rotation of a tire, which can then be used to power multiple different sensors, which can then output the data they have collected to a central collection location during selected periods of time. Another sensor of this type is described in issued U.S. Patent No. 7,603,894, entitled Self-Powered Tire Monitoring System.

[0059] In a preferred embodiment, the electrical generation system does not move, but rather relies only on the pressure applied during a step and the release of that pressure when the step is completed and the leg is free to swing out for the next step. Because no movement occurs, the patient does not experience any sensation due to slight changes in the position or length of the femoral stem 18 during a step. Instead, the length is kept constant and electricity is generated by a piezoelectric structure or by an internal suspension structure that is not part of the support structure of the femoral stem 18.

[0060] Other techniques are also available for harvesting power, such as those disclosed in Chandrakasan et al., "Next Generation Micro-power Systems," Symposium on VLSI Circuits Digest of Technical Papers, 2008, pp. 1-5 (see also U.S. Pat. No. 8,283,793, entitled "Device for Energy Harvesting within a Vessel," and U.S. Pat. No. 8,331,632, entitled "Devices, Methods and Systems for Harvesting Energy in the Body"). All of these patent and non-patent documents are incorporated by reference herein in their entireties.

[0061] After electricity is generated by one or more electrical generators 44, the electricity is sent to any one of the various sensors described herein. For example, the electricity can be sent to the contact sensor 22, the strain gauge 24, or the accelerometer 42. The electricity can also be sent to other sensors described later in this specification. The transmission of power can be performed by any acceptable technique. For example, if the sensor is physically coupled to the femoral stem, an electrical wire can run from the electrical generator 44 to the particular sensor, such as the accelerometer 42 or other surface wear structure that is part of the femoral stem. For sensors located within the acetabular component, the electricity can be sent wirelessly in the same manner that a wireless smart card receives power from a power source located immediately adjacent using appropriate transmitting and receiving antennas. Such techniques for transmitting and receiving power are also described in the publications, published patent applications, and issued U.S. patents mentioned above, all of which are incorporated by reference and made a part of this specification.

[0062] G. Medical Use of Sensors 11A and 11B show examples of sensor use during patient physical examinations and various types of data that can be obtained from sensors implanted according to the teachings herein. The sensor provides assessment data regarding the range of motion (ROM) of the artificial hip joint. Currently, ROM is typically measured clinically by a physician passively moving the artificial hip joint through its range of motion during physical examinations and recording the results (flexion, extension, abduction, adduction, external rotation, internal rotation, and degree of rotation during flexion). Motion sensors and accelerometers can be used to accurately determine the total ROM of the artificial hip joint both during physical examinations and during normal daily activities between visits. As shown in FIG. 11A, one major factor in the health aspect of the hip joint is the angle X that the patient can achieve at various points during physical therapy when the patient is recovering from surgery. The smaller the angle X, the more confident the physician can be that the function of the joint is improving. By tracking the angle X over time, the physical therapist can monitor the progress of the patient and evaluate whether scar tissue formation, subluxation or other pathological features are limiting / impacting the ROM of the hip joint and modify / implement treatment as necessary. With the sensor attached as instructed herein, the physical therapist or doctor does not have to assume that the angle has been achieved, but rather knows the exact angle right at the time the hip joint is being clinically evaluated when the leg is placed adjacent to the readout computer. On the other hand, if X continues not to decrease but remains large (or increases), the physical therapist or doctor may be alerted to a problem the patient may be having with rehabilitation or delayed recovery from surgery and can investigate and / or take action now rather than later. Similarly, the embodiment of FIG. 11B indicates the measurements that can be taken when the user holds the leg at exactly the 90° angle Y as shown. With the leg held firmly at 90 degrees, data can be collected from various sensors about the entire leg in order to obtain strain, contact location, acceleration and other data.A sensor used in the present invention can remind the patient that the leg is held at exactly 90 degrees, so that data collection can be accurate when the patient is being monitored and data is collected at different times over several months. Although flexion and extension are shown in the diagrams showing the sites, data can also be collected for abduction, adduction, external rotation, internal rotation, and rotation during flexion, as should be clear to one skilled in the art. Additionally, ROM can also be monitored between patient visits by interpreting the ROM that occurs during daily activities when the patient is at home.

[0063] Some aspects of operation and the advantages that result are now described. One particular advantage is the live and in situ monitoring of the patient's recovery and hip implant 10. The sensors described herein collect data in a consistent manner during normal daily activities, and even overnight if necessary. That is, strains are measured, collected, and stored periodically over long periods of time, and certain measurements are taken periodically. For example, contact sensors may obtain and report data once every 10 seconds, once a minute, or once a day. Other sensors will collect data more frequently, such as several times a second. For example, it is expected that acceleration and position data will be collected and stored several times a second. Other types of data may only need to be collected on a minute-by-minute or hour-by-hour basis. Since the femoral stem has a large inner section or solid bar of metal that is hollow in the prior art, this internal structure has more than enough space to accommodate one or more processor circuits, CPUs, memory chips, and other electronic circuits, as well as antennas for transmitting and receiving data. The processor can be programmed to collect data from the various sensors on any desired schedule set by the medical practitioner. All procedures can be continuously monitored post-operatively, and data can be collected and stored in memory located within the femoral stem 18.

[0064] A patient will typically undergo regular medical checkups. When the patient goes to the doctor's office for a checkup, the doctor places a reader in close proximity to the implant 10, in this example a hip replacement, to transfer data from the internal circuitry in the femoral stem 18 to a database in the doctor's office. The use of wireless transmission using smart cards or other technologies is very well known in the art and need not be described in detail. Examples of such wireless transmission of data are described in the U.S. Patent Application Publications and U.S. Patents mentioned herein. Data collected based on the patient's exercise and use of the lower limb over the previous weeks or even months is transferred from the memory located in the femoral stem 18 to the doctor's computer or wireless device in the months. The computer thus analyzes the data for the presence or absence of abnormalities, unexpected changes over time, good or bad trends, and other indications of the patient's health and the working performance of the prosthesis. In addition, the doctor can collect data detailing a record of all effects on the hip joint, including the magnitude and direction of accelerations. If the physician locates a high acceleration event, such as a patient's fall or other physical activity or movement, the physician can be alerted to inquire with the patient about any issues the patient had during the fall, or alternatively, warn the patient not to engage in overly vigorous activity that could potentially cause damage to the hip joint implant. For example, if the patient decides to go skiing or jogging, the physician can monitor the effects of such activity on the implant 10, including the accelerations and strains during the event itself. The physician can then examine the health of the prosthesis in the hours and days following the event and compare this to the data prior to the event, thereby determining whether any particular event caused long-term damage, i.e., separation of the prosthesis from the surrounding bone tissue or joint subluxation, or whether the activity subjected the implant to stresses / strains / impact forces that exceed the manufacturer's performance specifications for that particular artificial hip joint.Data can be collected and compared to the current and long-term performance of the implant from strain gauges, contact sensors, surface wear sensors, or other sensors that may be present.

[0065] In one variant, the patient may also have such a reading device at home, which periodically collates data from the implant, for example once a day or once a week. Empowering the patient to continue their own rehabilitation - and allowing them to recognize the positive (and negative) effects of various lifestyle choices on their health and rehabilitation - is expected to improve compliance and improve patient outcomes. Furthermore, the patient's experience can be shared with other patients via the web, thereby comparing their progress with the expected "norm" for function and rehabilitation and alerting the patient to signs and symptoms that should be brought to the attention of their physician. The performance of different implants can be compared in different patients (different genders, weights, activity levels, etc.), thereby helping manufacturers to design better prostheses and helping orthopedic surgeons to select the right prosthesis for a particular patient type. Payers, patients, manufacturers, and physicians can all benefit from the collection of this comparative information. Finally, data collected at home could be collected and transmitted via the Internet to a physician's office for analysis - potentially eliminating unnecessary visits and possibly facilitating more rapid medical follow-up.

[0066] H. Medical imaging and self-diagnosis, predictive analysis and predictive maintenance of assemblies including hip joint implants The present invention provides a hip implant that can be imaged through the use of sensors over a variety of conditions. For example, in accordance with various aspects of the present invention, a method of imaging an assembly including a hip implant or hip replacement with sensors is provided, the method including detecting changes in sensors in, on and / or within the hip implant over time, the hip implant having a density of greater than 1, greater than 2, greater than 3, greater than 4, greater than 5, greater than 6, greater than 7, greater than 8, greater than 9, greater than 10, or greater than 20 sensors per square centimeter. In other aspects, the hip implant has a density of greater than 1, greater than 2, greater than 3, greater than 4, greater than 5, greater than 6, greater than 7, greater than 8, greater than 9, greater than 10, or greater than 20 sensors per cubic centimeter. In any of these embodiments, there may be less than 50, less than 75, less than 100, or 100 sensors per square or cubic centimeter. As discussed above, a variety of sensors may be utilized in the present invention, including, for example, contact sensors, strain gauge sensors, pressure sensors, fluid pressure sensors, position sensors, pulse pressure sensors, blood volume sensors, blood flow sensors, blood chemistry sensors, blood metabolism sensors, mechanical stress sensors, and temperature sensors.

[0067] For example, using a hip implant with sensors as described herein, the hip anatomy can be imaged with sensors capable of detecting positional motion. The sensors used may further include accelerometers and motion sensors to detect hip implant motion due to various physical changes. Changes in the position of the accelerometer and / or motion sensor over time can be used as a measure of changes in the position of the hip implant over time. Such positional changes can be used as surrogate markers of the hip anatomy - i.e., such positional changes can generate an "image" of the hip implant to provide information regarding changes in size, shape and location of the hip implant and / or movement / movement of the hip implant. For example, loosening of the hip implant (typically in the femoral stem or acetabular shell) can result in undesirable movement of the prosthesis relative to the weight-bearing bone in which the prosthesis is implanted during activity. By utilizing sensors in the present invention, it is possible to determine the location and extent of undesirable motion present during different movements and activities. Similarly, monitoring changes in the joint space (i.e., the change in the space separating the femoral and acetabular components) over time can be used as an indicator of erosion and wear of the articular surfaces (femoral head and / or acetabular liner). Finally, following the movement of the sensor through the joint's range of motion can provide a dynamic "picture" (video) of the joint, allowing the physician to monitor both the improvement and progression of joint function (and surrounding tissues) over time.

[0068] Certain exemplary embodiments will now be described in detail. One particular advantage is live and in situ monitoring of the recovery of patients with hip implants. The sensors described herein collect data in a regular manner, during normal daily activities, and even overnight if necessary. For example, a contact sensor may obtain and report data once every 10 seconds, once a minute, or once a day. Other sensors will collect data more frequently, for example, several times a second. For example, it is expected that temperature, contact, and / or position data will be collected and stored several times a second. Other types of data only need to be collected on a minute-by-minute or hour-by-hour basis. Yet other sensors may collect data only when signaled by the patient as part of an "event record" - i.e., when the patient experiences a particular event (e.g., pain, trauma, etc.) - and may send a signal to an instrument to obtain a reading at that time (by an external signal generating / triggering device), in order to enable comparison of subjective / symptomatic data with subjective / sensor data in an attempt to better understand the underlying causes or triggers of the patient's symptoms.

[0069] In certain cases, the hip implant is of sufficient size and has more than enough space to accommodate one or more processor circuits, CPUs, memory chips and other electronic circuits, and antennas for transmitting and receiving data. In other embodiments, the associated medical instrument may accommodate one or more processor circuits, CPUs, memory chips and other electronic circuits, and antennas for transmitting and receiving data. The processor may be programmed to collect data from the various sensors on any desired schedule set by the medical practitioner. All actions may be continuously monitored postoperatively, and data may be collected and stored in a memory provided within the hip implant.

[0070] A patient with a hip implant will generally undergo regular medical checkups. When the patient goes to a doctor's office for a checkup, the doctor places a reader in close proximity to the implant, in this example the hip implant, to transfer data from the internal circuitry in the hip implant to a database in the doctor's office. The use of wireless transmission using smart cards or other technologies is very well known in the art and need not be described in detail. Examples of such wireless transmission of data are described in the U.S. Patent Application Publications and U.S. Patents mentioned herein. The collected data (e.g., collected over a short period of time, over weeks, or even over months) is transferred in a few months from a memory located in the hip implant to the doctor's computer or wireless device. The computer thus analyzes the data for abnormalities, unexpected changes over time, good or bad trends, and other indications of the patient's health and the functionality of the hip implant. For example, if the patient decides to go skiing or jogging, the doctor can monitor the effects of such activity on the hip implant, including accelerations and strains during the event itself. The physician can then look at the health of the hip implant in the hours and days following the event and compare it to data from before the event to determine if any particular event caused long-term damage or if activity subjected the hip implant to forces that exceed the manufacturer's performance specifications for that particular hip implant. Data can be collected and compared to the current and long-term performance of the hip implant from strain gauges, contact sensors, surface wear sensors, or other sensors that may be present. A representative example of an Electronic Data Capture, Documentation and Clinical Decision Support System (EDDS) is described in International Publication No. WO 2012 / 061825, which is incorporated by reference in its entirety.

[0071] In one variation, the patient may also have such a reading device at home, which periodically collates data from the implant, for example once a day or once a week. As mentioned above, the patient may also "trigger" (by an external signal generating / triggering device) the device reading as part of the "event record". Empowering the patient to continue their own rehabilitation - and allowing the patient to recognize the positive (and negative) effects of various lifestyle choices on their health and rehabilitation - is expected to improve compliance and improve patient outcomes. Furthermore, the patient's experience can be shared with other patients via the web, thereby comparing their progress with expected "norms" of function and rehabilitation and alerting the patient to signs and symptoms that should be brought to the attention of their physician. The performance of different hip implants can be compared in different patients (different genders, weights, activity levels, etc.), which can help manufacturers design better devices and help surgeons and other health care providers select the right hip implant for a particular patient type. Payers, patients, manufacturers, and physicians can all benefit from the collection of this comparative information. Finally, data collected at home could be collected and transmitted via the Internet to a physician's office for analysis - potentially eliminating unnecessary visits and possibly facilitating more rapid medical follow-up.

[0072] I. How to Monitor a Hip Implant As mentioned above, the present invention also provides a method of monitoring one or more of the hip implants provided herein. Figure 12 shows a monitoring system that can be used with a hip implant 10 of the type shown in any one of the figures above. The monitoring system includes a sensor (e.g., 22, 22B, 24, 42 and / or 46), an interrogation module 124 and a control unit 126. The sensor (e.g., 22, 22B, 24, 42 and / or 46) is of a passive wireless type that can operate with power received from a wireless source. Such sensors of this type are well known and widely used in the art. Such a pressure sensor can be a MEMS pressure sensor, for example part number LPS331AP, available on the open market by STMicroelectronics. MEMS pressure sensors are well known to operate with very little power and are suitable to remain unpowered and idle for long periods of time. These pressure sensors can be wirelessly powered by an RF signal, and based on the power received wirelessly over the RF signal, these pressure sensors perform pressure detection and then output the detected data.

[0073] In one embodiment, an electrical generation system (as described above) is provided that can be utilized to power the sensors described herein. In operation, as shown in FIG. 12, the interrogation module 124 outputs a signal 128. The signal 128 is a wireless signal, typically in the RF band, that includes power for the sensor (e.g., 22, 22B, 24, 42, and / or 46) and includes an interrogation request for the sensor 22 to perform detection. Upon interrogation by the signal 128, the sensor (e.g., 22, 22B, 24, 42, and / or 46) wakes up and stores sufficient power in an on-board capacitor to sustain operation during detection and data reporting. Such power receiving circuits and power storage in on-board capacitors are well known in the art and therefore need not be shown in detail. Appropriate detection is performed by a sensor (e.g., 22, 22B, 24, 42 and / or 46) and the data is then output from the sensor and returned in the form of a signal 130 to the interrogation module 124, where the signal 130 is received at an input port of the interrogation module.

[0074] According to one embodiment, sufficient signal strength is provided in the initial signal 128 to provide power for the sensor and perform the detection operation to output a signal back to the interrogation module 124. In other embodiments, two or more signals 128 are sent, each providing additional power to the sensor to complete the detection operation and then transmit the data over the signal path 130 back to the interrogation module 124. For example, the signal 128 can be sent continuously with a detection request component in a first part of the signal, and then the sensor can be operated by subsequently providing power either as a steady signal or as a pulse. When the sensor is ready to output data, it can send a warning signal to the interrogation module 124 that data is coming and turn off the signal 128 to avoid interference. Alternatively, the interrogation signal 128 can be at a first frequency and the output signal 130 can be at a second frequency that is far enough apart that the signals 128, 130 do not interfere with each other. In a preferred embodiment, both of these signals are at the same frequency so that the same antenna on the sensor can receive signal 128 and transmit signal 130 .

[0075] The interrogation signal 128 may include data for selecting a particular sensor provided on the hip replacement. For example, the signal 128 may activate all sensors on the hip replacement simultaneously and then send requests for data from each at different selected times, such that one interrogation signal 128 is provided for a set period of time, e.g., 1-2 seconds, such that each of the sensors on the hip replacement collects data during this period, and then at the end of the period reports the data on a respective signal 130 at different times over the next 0.5-2 seconds, such that data from all sensors 22 is collected with one interrogation signal 128.

[0076] The interrogation module 124 operates under the control of a control unit 126, which contains a microprocessor for the controller, memory, I / O circuitry for interfacing with the interrogation module, and a power supply. The control unit outputs data to a computer or other device for display and use by a physician to treat the patient.

[0077] FIG. 13 shows the operation of the preferred embodiment inside a patient's body. The patient has an epidermis 132. As shown in FIG. 13, the interrogation module 124 and the control unit 126 are placed outside the patient's skin 132. The interrogation signal 128 passes through the patient's skin on a wireless RF signal, and data is received on a wireless RF signal 130 from the sensors (e.g., 22, 22B, 24, 42 and / or 46) and returned to the interrogation module 124. The wireless signal can be in any frequency range, but the RF range is preferred. Frequencies in the VLF-LF range of 3-1300 kHz are preferred to allow the signal to travel deep enough into the body with low power, but frequencies below 3 kHz and above 1300 kHz can also be used. Detection does not require the transfer of large amounts of data and low power is preferred, so a low frequency RF signal is safe. This also avoids conflicts with other wireless signal generators, e.g., Bluetooth, cell phones, etc., and avoids accidental activation by such other wireless signal generators.

[0078] J. Collecting, transferring, analyzing, and distributing data from hip implants FIG. 14 illustrates one embodiment of an information and communication technology (ICT) system 800 configured to process sensor data (e.g., data from sensors (e.g., 22, 22B, 24, 42, and / or 46) of any one of the figures provided herein). In FIG. 14, the ICT system 800 is shown as including computing devices that communicate over a network 804, although in other embodiments the computing devices may communicate with each other directly or through other intervening devices, and in some cases the computing devices may not communicate at all. The computing device of FIG. 14 includes a computing server 802, a control unit 126, a query unit 124, and other devices not shown for clarity.

[0079] 14 , one or more sensors (e.g., 22, 22B, 24, 42, and / or 46) communicate with an interrogation module 124. The interrogation module 124 may be directed by a control unit 126, but in other cases, the interrogation module 124 operates autonomously to provide and receive information from the sensors 22. One or both of the interrogation module 124 and the control unit 126 may be in communication with the computing server 802.

[0080] In certain embodiments, the interrogation module and / or control unit may be a wearable device attached to the patient. The wearable device (e.g., a watch-like device, a wristband, glasses, or other device that can be carried or worn by the patient) may interrogate the sensors for a set (or random) period of time to collect data and send the data to one or more networks (804). Additionally, the wearable device may collect data on its own that may also be sent to the network. Representative examples of data that may be collected include location (e.g., GPS), body or skin temperature, and other physiological data (e.g., pulse rate). In yet another embodiment, the wearable device may directly notify the patient of any of a number of predefined conditions, including, but not limited to, potential or actual equipment failure.

[0081] The information communicated between the interrogation module 124 and the sensors (e.g., 22, 22B, 24, 42, and / or 46) may be useful for many purposes described herein. In some cases, for example, sensor data information is collected and analyzed explicitly for an individual patient's health. In other cases, the sensor data may be collected and transmitted to another computing device for aggregation with other data (e.g., sensor data from sensor 22 may be collected and aggregated with other data collected from a wearable device (e.g., which in certain embodiments may include GPS data, etc.)).

[0082] 14 illustrates a perspective of computing server 802 as a collaboration of servers that further includes computing servers 802a, 802b, and one or more other servers 802n. As will be appreciated, computing server 802 may include any number of computing servers acting individually or collectively for the benefit of users of the computing servers.

[0083] In some embodiments, the computing server 802 is configured as a cloud computing device created in one or more geographic locations, such as the United States and Canada. The computing device may be created as a MICROSOFT AZURE cloud computing device or some other virtually accessible remote computing service.

[0084] The interrogation module 124 and the control unit 126 are shown as being in communication with the computing server 802, as an option. Via the interrogation module 124 or the control unit 126, the sensor data is transferred over the network 804 to (and additionally or alternatively from) the computing server 802.

[0085] Network 804 may include some or all of a cellular communications network, a conventional cable network, a satellite network, a fiber optic network, and one or more local area networks, wide area networks, personal area networks, etc. configured as a computing network. In a preferred embodiment, network 804 includes any communications hardware and software that work together to enable users of computing devices to view and interact with other computing devices.

[0086] The computing server 802 includes a central processing unit (CPU) digital signal processing unit (DSP) 808, a communication module 810, an input / output (I / O) module 812, and a storage module 814. The components of the computing server 802 are cooperatively coupled together by one or more buses 816 that facilitate the transfer and control of information within and through the computing server 802. The communication module 810 can be configured to convey information between the computing server 802 and other computing devices (e.g., computing servers 802a, 802b, 802n, the control unit 126, the interrogation unit 124, etc.). The I / O module 812 can be configured to receive input from devices such as a keyboard, a computer mouse, a trackball, etc. The I / O module 812 can be configured to provide output to devices such as a display, a recorder, an LED, an audio device, etc.

[0087] The storage module 814 may include one or more types of storage media. For example, the storage module 814 of FIG. 14 includes a read-write memory (RAM) 818, a read-only memory (ROM) 810, a disk-based memory 822, an optical memory 824, and other types of memory storage media 826. In some embodiments, one or more database structures are configured on one or more storage devices in the storage module 814. The database structures may be used to store data collected from the sensors 22.

[0088] In some embodiments, the storage module 814 may further include one or more portions of memory organized as a non-transitory computer readable medium (CRM). The CRM is configured to store computer computation instructions executable by the CPU 808. The computer computation instructions may be stored as one or more files, each of which may include one or more computer programs. The computer programs may be stand-alone programs or may be part of a larger computer program. Alternatively or additionally, each file may include data or other computer computation support material for an application that directs the collection, analysis, processing, and / or distribution of data from a sensor (e.g., a sensor in a hip replacement). A sensor data application typically executes a set of instructions stored on a computer readable medium.

[0089] It is understood that the computing server shown and described herein is merely exemplary and does not limit the scope of the invention. The computing server 802 can be connected to other devices, not shown, including through one or more networks, such as through the Internet or through the Web embedded in the network 804. Generally speaking, a computing system or device (e.g., a "client" or "server"), or any portion thereof, may include any combination of hardware that, when optionally programmed or otherwise configured by software, can interact with each other to perform functions of the type described, including, but not limited to, desktop or other types of computers, database servers, network storage devices and other network devices, PDAs, cellular phones, wireless phones, pagers, electronic organizers, Internet appliances, television-based systems (e.g., set-top boxes and / or personal / digital video recorders), and various other products that include suitable in-house communication capabilities. Additionally, the functionality provided by the illustrated system modules may in some embodiments be combined into fewer modules or distributed among additional modules. Similarly, in some embodiments, the functionality of some of the illustrated modules may not be provided and / or other additional functionality may be available.

[0090] Additionally, while various items are shown as being stored in memory or as being stored while being utilized, these items, or portions of these items, may be transferred between memory and other storage devices for memory management and / or data integrity purposes. In at least some embodiments, the illustrated modules and / or systems are software modules / systems that include software instructions that, when executed by a CPU / DSP 808 or other processor, program the processor to automatically perform the described operations for the modules / systems. Alternatively, in other embodiments, some or all of the software modules and / or systems may operate in memory located in another device and communicate information to the illustrated computing system / device via intercomputer communications.

[0091] Furthermore, in some embodiments, some or all of the modules and / or systems may be implemented or provided in other ways, for example, at least partially in firmware and / or hardware means, including, but not limited to, one or more application specific integrated circuits (ASICs), standard integrated circuits, controllers (e.g., by executing appropriate instructions, and including microcontrollers and embedded controllers), field programmable gate arrays (FPGAs), complex programmable logic devices (CPLDs), etc. Some or all of the systems, modules, or data structures may also be stored (e.g., as software instructions or structured data) on a transient or non-transitory computer readable storage medium 814, such as a hard disk 822 or flash drive or other non-volatile storage device 826, volatile memory 818, non-volatile memory 810, network storage device, or portable media article (e.g., DVD disk, CD disk, optical disk, flash memory device, etc.), to be read by a suitable input or output system or via a suitable connection scheme. The systems, modules, and data structures may also, in some embodiments, be transmitted as generated data signals (e.g., as carrier waves or other analog or digital propagated signals) over a variety of computer-readable transmission media, including wireless and wired / cabled media. The data signals may take a variety of forms, such as part of a single or multiplexed analog signal, as multiple separate signal packets or frames, as separate or streaming settings of digital bits, or some other form. Such computer program products may take other forms in other embodiments. Accordingly, the invention may be practiced with other computer system configurations.

[0092] In Fig. 14, for example, sensor data from sensors (e.g., 22, 22B, 24, 42, and / or 46) is provided to a computing server 802. Generally speaking, the sensor data represents data retrieved from a known patient and a known sensor. The sensor data may include or further be associated with additional information, such as a USI, UDI, timestamp, location (e.g., GPS) stamp, date stamp, and other information. The difference between various sensors is that some may include more or fewer data bits that associate the data with a particular source, collection device, transmission characteristics, etc.

[0093] In some embodiments, the sensor data may include sensitive or delicate information, such as private health information associated with a particular patient. Sensitive information, such as sensor data from a sensor (e.g., 22, 22B, 24, 42, and / or 46), may include any information that a party desires not to be widely or easily leaked. Sensitive information may be independent or may be combined with other non-sensitive information. For example, patient medical information is typically sensitive information. In some cases, the storage and transmission of patient medical information is protected by government mandate (e.g., laws, regulations, etc.), such as the Health Insurance Portability and Accountability Act (HIPPA) in the United States.

[0094] As used herein, "sensitive" information includes information that is entirely sensitive and information that is any combination of sensitive and non-sensitive information. Sensitive information may be represented in a data file or in some other format. As used herein, a data file containing a patient's medical information may be referred to as "sensitive information." Other information, such as employment information, financial status, identification information, and many other types of information, may also be considered sensitive information.

[0095] A computing system may represent sensitive information through a coding algorithm (e.g., ASCII), a well-recognized file format (e.g., PDF), or some other format. In a computing system, sensitive information may be protected from wide or easy disclosure by an encryption algorithm.

[0096] Generally speaking, sensitive information can be stored by a computing system as a discrete set of data bits. A set of data bits may be referred to as "plaintext." Additionally, the computing system may utilize an encryption process to convert the plaintext into a set of data bits having a highly unreadable state (i.e., cipher text) using an encryption algorithm (i.e., cipher). A computing system with knowledge of the encryption key used to create the cipher text can restore this information to the plaintext's readable state. Thus, in some cases, sensitive data (e.g., sensor data 806a, 806b) is optionally encrypted before being communicated to the computing device.

[0097] In one embodiment, the operation of the information and communication technology (ICT) system 800 of Figure 14 includes one or more sensor data computer programs stored on a computer readable medium. The computer programs can optionally derive and / or receive data from one or more hip replacement sensors implanted in one or more patients. The sensor data computer programs can be executed in the computing server 802. Alternatively or additionally, the sensor data computer programs can be executed in the control unit 126, the interrogation unit 124.

[0098] In one embodiment, a computer program directing the collection and use of hip replacement sensor data is stored on a non-transitory computer readable medium in the storage module 814. The computer program is configured to identify a patient in whom a wireless hip replacement is inserted. The wireless hip replacement may include one or more wireless sensors.

[0099] In some cases, the computer program identifies one patient, and in other cases, two or more patients are identified, each of the patients having one or more wireless hip replacements, each of which may have one or more wireless sensors of the type described herein.

[0100] A computer program is configured to command the collection of sensor data from the wireless hip replacement device. The sensor data is typically collected by a wireless interrogation unit 124. In some cases, the program communicates with the wireless interrogation unit 124. In other cases, the program communicates with a control unit 126, which issues instructions to the wireless interrogation unit 124. In still other cases, other mechanisms for commanding the collection of sensor data are used.

[0101] Once the sensor data is collected, such data may be further processed. For example, in some cases the sensor data includes sensitive patient data that may be deleted or disassociated from such data. The sensor data may be stored individually (e.g., by unique sensor identification number, device number, etc.) or may be aggregated with other sensor data by sensor type, time stamp, location stamp, date stamp, patient type, other patient characteristics, or some other means.

[0102] The following pseudocode description is executed by the computing server 802 and is used generally to describe one example algorithm generally described herein with reference to FIG. TIFF2024026318000002.tif80143

[0103] As will be appreciated by those skilled in the art, it is customary in the art to embody devices and / or processes and / or systems and then use techniques and / or other practices to incorporate such embody devices and / or processes and / or systems into more comprehensive devices and / or processes and / or systems, i.e., at least portions of the devices and / or processes and / or systems described herein can be incorporated into other devices and / or processes and / or systems with a reasonable amount of experimentation. As will be appreciated by those skilled in the art, examples of such other devices and / or processes and / or systems may include, as appropriate for the context and application, all or part of: (a) air vehicles (e.g., airplanes, rockets, helicopters, etc.); (b) ground vehicles (e.g., automobiles, trucks, locomotives, tanks, armored personnel carriers, etc.); (c) buildings (e.g., homes, warehouses, offices, etc.); (d) appliances (e.g., refrigerators, washers, dryers, etc.); (e) communications systems (e.g., networked systems, telephone systems, voice over IP systems, etc.); (f) businesses (e.g., Internet Service Provider (ISP) businesses, such as Comcast Cable, Qwest, Southwestern Bell, etc.); or (g) wired / wireless service entities (e.g., Sprint, Cingular, Nextel, etc.).

[0104] In certain cases, use of a system or method may occur within a jurisdiction even if components are located outside the jurisdiction. For example, in a distributed computing context, use of a distributed computing system may occur within a jurisdiction even if parts of the system (e.g., repeaters, servers, processors, signal-bearing media, sending computers, receiving computers, etc., that are located outside the jurisdiction) are located outside the jurisdiction.

[0105] Similarly, the sale of a system or method may occur in a jurisdiction even if components of the system or method are located and / or used outside the jurisdiction. Furthermore, the instantiation of at least a portion of a system that performs a method in one jurisdiction does not preclude use of the system in another jurisdiction.

[0106] In conclusion, hip replacements utilizing various sensors can be used to serve various important clinical functions, such as safe, accurate and less traumatic placement and deployment of the hip replacement, procedural and postoperative (real-time) imaging of the hip replacement and its anatomy, occurrence of hip replacement complications, and overall health of the patient. Currently, postoperative evaluation (both inpatient and outpatient) of patients with hip replacements relies on medical monitoring supplemented with patient history, anthropometry, and diagnostic imaging studies as necessary. However, most of the patient's recovery period occurs between hospital and clinic visits, and most of the data regarding daily function is uncaptured, and furthermore, monitoring the progress of the patient by using some diagnostic imaging techniques can be expensive and invasive, and can carry its own health risks (e.g., coronary angiography). Thus, it can be extremely difficult to accurately measure and follow the onset or deterioration of symptoms and evaluate hip replacement performance in "real life". This is especially true since symptoms are related to the patient's activity level, exercise tolerance, and the effectiveness of rehabilitation efforts and medications.

[0107] Currently, neither physicians nor patients have access to any form of "real-time," continuous, objective hip replacement performance measurement that they might otherwise wish to obtain. The ability to monitor in situ the function, health, anatomy, and physiology of the hip replacement can provide the physician with useful objective information during the clinic visit, and the patient can obtain additional readings at home at various times (e.g., when pain is felt, during exercise, after taking medication, etc.) to provide the physician with important complementary clinical information (which can be sent electronically to the healthcare provider, even from a remote location). From a patient's perspective, the ability to monitor many of these same parameters at home can allow them to play a more preventative role in the patient's care and recovery, and provide the patient with either an early warning indicator or a warrant to seek medical assistance.

[0108] In one variant, the patient may also have such a reading device at home, which periodically checks the data from the hip replacement, for example once a day or once a week. In addition to empowering the patient to continue their own rehabilitation - and allowing the patient to recognize the positive (and negative) effects of various lifestyle choices on their health and rehabilitation - such information access is expected to improve compliance and improve patient outcomes. For example, in certain embodiments, the devices and systems provided herein can inform or otherwise inform the patient or an authorized third party of deviations (e.g., more than 10%, more than 20%, more than 25%, more than 50%, more than 70%, and / or more than 100%) from normal and / or set parameters. Furthermore, the patient's recovery experience can be shared with other patients via the web, thereby comparing their progress with the expected "norm" for function and rehabilitation and alerting the patient to signs and symptoms that should be brought to the attention of the patient's physician. The performance of different hip replacements can be compared for different patients (with different genders, weights, activity levels, comorbidities such as hypertension, diabetes, smoking status, obesity, etc.), thereby helping manufacturers to design better hip replacements and helping physicians to select the right hip replacement for a particular patient type. Payers, patients, manufacturers, and physicians can all benefit from the collection of this comparative information. Adulterated or unsafe products can be identified and removed from the market, and objective, long-term, valid data can be collected and analyzed. Finally, data collected at home can be collected and transmitted via the Internet to the physician's office for analysis - potentially eliminating unnecessary visits and facilitating prompt medical follow-up.

[0109] Below are some specific numbered embodiments of the systems and methods disclosed herein. These embodiments are by way of example only. It will be understood that the invention is not limited to the embodiments set forth herein for purposes of illustration, but includes all such forms of the invention that fall within the scope of the above disclosure. [Embodiment 1] 1. A replacement hip prosthesis, comprising: An artificial femoral stem; an artificial femoral head coupled to the femoral stem; A replacement hip prosthesis having an artificial acetabulum assembly coupled to the femoral head, and a plurality of sensors coupled to at least one of the femoral stem, the femoral head, and the acetabulum assembly. [Embodiment 2] 2. The artificial hip joint replacement according to claim 1, wherein said plurality of sensors includes a sensor provided on said femoral stem. [Embodiment 3] 2. The replacement hip prosthesis of embodiment 1, wherein the plurality of sensors includes a sensor provided on the femoral head. [Embodiment 4] 2. The replacement hip prosthesis of embodiment 1, wherein the plurality of sensors includes a sensor provided in the acetabulum assembly. [Embodiment 5] The replacement hip prosthesis according to any one of the embodiments 1 to 4, wherein the sensor is selected from the group consisting of an accelerometer, a pressure sensor, a contact sensor, a position sensor, a chemical microsensor, a tissue metabolism sensor, a mechanical stress sensor, and a temperature sensor. [Embodiment 6] The replacement hip prosthesis according to embodiment 5, wherein the accelerometer detects acceleration, tilt, vibration, shock and / or rotation. [Embodiment 7] 2. The replacement hip prosthesis of embodiment 1, wherein the plurality of sensors includes a contact sensor disposed between the femoral head and the acetabulum assembly. [Embodiment 8] 2. The replacement hip prosthesis of embodiment 1, wherein the plurality of sensors includes a plurality of contact sensors disposed on an outer surface of the acetabulum assembly. [Embodiment 9] 2. The replacement hip prosthesis of embodiment 1, wherein the plurality of sensors includes a plurality of contact sensors disposed on an outer surface of the acetabulum assembly. [Embodiment 10] 2. The replacement hip prosthesis of embodiment 1, wherein the plurality of sensors includes a plurality of strain sensors disposed between the femoral head and the acetabulum assembly. [Embodiment 11] 2. The replacement hip prosthesis of embodiment 1, wherein the plurality of sensors includes an accelerometer disposed on the femoral stem. [Embodiment 12] The replacement hip prosthesis of embodiment 1, wherein the acetabular assembly includes an acetabular shell and an acetabular liner. [Embodiment 13] 8. The replacement hip prosthesis of embodiment 7, further comprising a strain sensor disposed between the acetabular liner and the acetabular shell. [Embodiment 14] A medical device comprising a prosthetic femoral stem and a plurality of sensors coupled to the femoral stem. [Embodiment 15] A medical device comprising: a prosthetic femoral head; and a plurality of sensors coupled to the femoral head. [Embodiment 16] A medical device comprising: an artificial acetabulum assembly; and a plurality of sensors coupled to the acetabulum assembly. [Embodiment 17] 17. The medical device according to any one of embodiments 14 to 16, wherein the sensor is disposed in and on a surface of the medical device. [Embodiment 18] The replacement hip prosthesis according to any one of embodiments 14 to 17, wherein the sensor is selected from the group consisting of an accelerometer, a pressure sensor, a contact sensor, a position sensor, a chemical microsensor, a tissue metabolism sensor, a mechanical stress sensor, and a temperature sensor. [Embodiment 19] 19. The replacement hip prosthesis of embodiment 18, wherein the accelerometer detects acceleration, tilt, vibration, shock and / or rotation. [Embodiment 20] 20. The replacement hip prosthesis or medical device according to any one of the preceding embodiments, further comprising an electronic processor disposed within the femoral stem and electrically coupled to the sensor. [Embodiment 21] 21. The replacement hip prosthesis or medical device of embodiment 20, wherein the electrical coupling is a wireless coupling. [Embodiment 22] 22. The replacement hip prosthesis or medical instrument of embodiment 20 or 21, further comprising a memory coupled to said electronic processor and disposed within said femoral stem. [Embodiment 23] 23. The replacement hip prosthesis or medical device according to any one of embodiments 1 to 22, wherein the sensors are a plurality of sensors disposed on or within the replacement hip prosthesis or medical device at a density of greater than 1, greater than 2, greater than 3, greater than 4, greater than 5, greater than 6, greater than 7, greater than 8, greater than 9, greater than 10 or greater than 20 sensors per square centimeter. [Embodiment 24] 23. The replacement hip prosthesis or medical device according to any one of embodiments 1 to 22, wherein the sensor is a plurality of sensors disposed on or within the hip replacement at a density of greater than 1, greater than 2, greater than 3, greater than 4, greater than 5, greater than 6, greater than 7, greater than 8, greater than 9, greater than 10 or greater than 20 sensors per cubic centimeter. [Embodiment 25] 1. A method comprising: obtaining contact data from contact sensors positioned at a plurality of locations between a prosthetic femoral head and an acetabular prosthesis disposed in situ in the patient's hip joint; storing the contact data in a memory disposed in a femoral stem prosthesis coupled to the femoral head; transmitting the contact data from the memory to a location external to the femoral stem. [Embodiment 26] obtaining strain data from strain sensors positioned at a plurality of locations between a prosthetic femoral head and an acetabular prosthesis disposed in situ in the patient's hip joint; storing the strain data in a memory disposed within a femoral stem prosthesis coupled to the femoral head; 26. The method of embodiment 25, further comprising the step of transmitting said strain data from said memory within said femoral stem to a memory located at a location external to said femoral stem. [Embodiment 27] obtaining contact data from a contact sensor disposed between the acetabular assembly and a pelvic bone of the patient while in situ within the patient; storing the contact data in a memory located within the femoral stem; 26. The method of embodiment 25, further comprising the step of transmitting the contact data from the memory within the femoral stem to a memory located at a location external to the femoral stem. [Embodiment 28] obtaining acceleration data from accelerometers located at a plurality of locations on a replacement hip joint assembly placed in situ within the patient's hip; storing the acceleration data in a memory provided in a femoral stem coupled to the femoral head; and transmitting the acceleration data from the memory within the femoral stem to a memory located at a location external to the femoral stem. [Embodiment 29] a) obtaining data from a sensor of a replacement hip prosthesis or medical device according to any one of the embodiments 1 to 24; b) storing the data in a memory located at a storage site in the replacement hip prosthesis or medical device according to any one of the embodiments 1 to 24; and and c) transmitting said data from said memory to a location external to said storage site. [Embodiment 30] 30. The method of embodiment 29, wherein the replacement hip prosthesis or medical device is implanted within a patient's body and the data is transmitted to a site external to the patient. [Embodiment 31] The method of embodiment 30, wherein the data is transmitted to a watch, a wristband, a mobile phone, or glasses. [Embodiment 32] The method of embodiment 30, wherein the data is transmitted to a residence or office. [Embodiment 33] The method of embodiment 30, wherein said data is transmitted to a health care provider. [Embodiment 34] The method of any one of embodiments 25 to 33, further comprising the step of analyzing said data. [Embodiment 35] A non-transitory computer readable storage medium having stored contents for configuring a computing system to perform a method, the method comprising: identifying a patient, the identified patient having at least one wireless hip implant, the hip implant having one or more sensors; detecting a wireless interrogation unit to collect sensor data from at least one of said respective sensors; and receiving the collected sensor data. [Embodiment 36] The storage medium of embodiment 35, wherein the stored content configures a computer computing system to perform the method, further comprising the steps of removing sensitive patient data from the collected sensor data and analyzing the data according to the type or location of the sensor. [Embodiment 37] The storage medium according to embodiment 35 or 36, wherein the hip joint implant is a replacement artificial hip joint or a medical device according to any one of embodiment 1 to 24. [Embodiment 38] The storage medium according to any one of embodiments 35 to 37, wherein the data is received on a watch, a wristband, a mobile phone, or glasses. [Embodiment 39] The storage medium according to any one of embodiments 35 to 38, wherein the data is received at the patient's residence or office. [Embodiment 40] The storage medium according to any one of embodiments 35 to 39, wherein the data is provided to a healthcare provider. [Embodiment 41] The storage medium according to any one of embodiments 35 to 40, wherein the data is written to one or more websites. [Embodiment 42] The method according to any one of embodiments 25 to 34 or the storage medium according to any one of embodiments 35 to 41, wherein the data is plotted to allow visualization of changes over time. [Embodiment 43] 43. The method or storage medium of embodiment 42, wherein the data is plotted to provide a two- or three-dimensional image. [Embodiment 44] 44. The method or storage medium of claim 42 or 43, wherein the data is plotted to provide a two-dimensional or three-dimensional animation. [Embodiment 45] 45. The method or storage medium according to any one of embodiments 42 to 44, wherein the data is utilized to determine a range of motion for a patient having an artificial hip implant or medical device. [Embodiment 46] The method or storage medium according to any one of embodiments 42 to 44, wherein the data is used to determine or predict a defect or malfunction of the artificial hip joint implant or medical device. [Embodiment 47] 1. A method for detecting deterioration of a replacement hip prosthesis or medical device, comprising: a) providing a patient with an artificial hip joint implant or a medical device according to any one of embodiments 1 to 24; b) detecting changes in the sensor and thus identifying deterioration of said hip implant or medical device. [Embodiment 48] The method of embodiment 47, wherein the sensor is capable of detecting one or more physiological and / or location parameters. [Embodiment 49] 1. A method for detecting infection in a replacement hip prosthesis or medical device, comprising: a) providing a patient with an artificial hip joint implant or a medical device according to any one of embodiments 1 to 24; b) detecting a change in the sensor and thus identifying an infection of said hip implant or medical device. [Embodiment 50] The method of embodiment 49, wherein the change in the sensor is an increase in temperature. [Embodiment 51] A method of imaging a hip replacement or medical device, comprising detecting changes in a sensor disposed in, on and / or within the hip implant or medical device according to any one of embodiments 1-24, said hip implant or medical device having a density of greater than 1, greater than 2, greater than 3, greater than 4, greater than 5, greater than 6, greater than 7, greater than 8, greater than 9, greater than 10 or greater than 20 sensors per square centimeter. [Embodiment 52] A method of imaging an artificial hip implant or medical device, comprising detecting changes over time of sensors provided in, on and / or within the artificial hip implant or medical device according to any one of embodiments 1 to 24, said artificial hip implant or medical device having a sensor density of greater than 1, greater than 2, greater than 3, greater than 4, greater than 5, greater than 6, greater than 7, greater than 8, greater than 9, greater than 10 or greater than 20 sensors per cubic centimeter. [Embodiment 53] The method of embodiment 51 or 52, wherein the sensor is one or more of a fluid pressure sensor, a contact sensor, a position sensor, an accelerometer, a pressure sensor, a blood volume sensor, a blood flow sensor, a blood chemistry sensor, a blood metabolism sensor, a mechanical stress sensor, and a temperature sensor. [Embodiment 54] A method for placing an artificial hip joint implant or medical device in a patient's body, comprising the steps of: a) implanting an artificial hip joint implant or medical device according to any one of embodiments 1 to 24; and b) detecting the placement of the artificial hip joint implant or medical device by detecting a sensor. [Embodiment 55] The method of embodiment 54, wherein the artificial hip implant or medical device has two or more sections, and detection of the two or more sections can be determined by analysis of one or more sensors. [Embodiment 56] The method of embodiment 54 or 55, wherein the positioning of the artificial hip implant or medical device can be visualized by a two-dimensional or three-dimensional display or image of the one or more sensors provided on the artificial hip implant or medical device. [Embodiment 57] The method according to any one of embodiments 54 to 56, wherein the step of detecting the placement of the artificial hip implant or medical device allows for determining whether the artificial hip implant or medical device has been placed incorrectly.

[0110] Any of the various embodiments described above may be combined to provide another embodiment. All U.S. patents, U.S. patent application publications, U.S. patent applications, PCT application publications, foreign patents, foreign patent applications, and non-patent documents mentioned herein are incorporated by reference in their entirety. Aspects of the embodiments may be modified, if necessary, to employ concepts from various patents, patent applications, and patent application publications to provide further embodiments. These and other modifications may be made to the embodiments in light of the above detailed description. In general, in the following claims, the terms used should not be construed to limit the claimed invention to the specific embodiments disclosed herein and in the claims, but should be construed to include all possible embodiments together with the full scope of equivalents according to the claims. Thus, the claimed invention is not limited by the disclosure.

Claims

1. An artificial hip joint, A femoral stem; a femoral head connected to the femoral stem; an acetabulum assembly coupled to the femoral head; one or more sensors coupled to at least one of the femoral stem, the femoral head, and the acetabulum assembly, the one or more sensors including one or more acceleration sensors; a memory for storing data collected by the one or more sensors after implantation of the hip prosthesis in a patient; An artificial hip joint comprising:

2. The hip prosthesis of claim 1 , wherein the one or more sensors include a single sensor coupled to the femoral stem.

3. The hip prosthesis of claim 1 , wherein the one or more sensors include a single sensor coupled to the femoral head.

4. The hip prosthesis of claim 1 , wherein the one or more sensors include a single sensor coupled to the acetabular assembly.

5. 5. The hip prosthesis of claim 1, wherein the one or more sensors further comprise a sensor selected from the group consisting of a gyroscope, a pressure sensor, a contact sensor, a position sensor, a chemical microsensor, a tissue metabolism sensor, a mechanical stress sensor, and a temperature sensor.

6. 6. The artificial hip joint according to claim 1, wherein the one or more acceleration sensors detect acceleration, tilt, vibration, shock and / or rotation.

7. The hip prosthesis of claim 1 , wherein the one or more sensors further include a plurality of contact sensors disposed between the femoral head and the acetabular assembly.

8. The hip prosthesis of claim 1 , wherein the one or more sensors further include a plurality of contact sensors disposed on an outer surface of the acetabular assembly.

9. The hip prosthesis of claim 1 , wherein the one or more sensors further include a plurality of strain sensors disposed between the femoral head and the acetabular assembly.

10. The hip prosthesis of claim 1 , wherein the one or more sensors further include a plurality of acceleration sensors coupled to the femoral stem.

11. 11. The hip prosthesis of claim 1, wherein the acetabular assembly includes an acetabular shell and an acetabular liner.

12. The hip prosthesis of claim 11 further comprising a strain sensor disposed between the acetabular liner and the acetabular shell.

13. 13. The hip prosthesis of claim 1, wherein the data collected by the one or more sensors includes data relating to patient movement after implantation of the hip prosthesis.

14. 14. The hip prosthesis of claim 1, wherein the data collected by the one or more sensors includes data related to a patient's gait after implantation of the hip prosthesis.

15. A medical device, A femoral stem; one or more sensors coupled to the femoral stem; 1. A medical device, wherein the one or more sensors include one or more acceleration sensors, and the femoral stem further includes a memory that stores data collected by the one or more sensors after implantation of the medical device in a patient.

16. A medical device, The femoral head and one or more sensors coupled to the femoral head; A medical device, wherein the one or more sensors include one or more acceleration sensors, and the femoral head further includes a memory that stores data collected by the one or more sensors after implantation of the medical device in a patient.

17. A medical device comprising: an acetabular assembly; and one or more sensors coupled to the acetabular assembly, the one or more sensors including one or more acceleration sensors, the acetabular assembly further comprising a memory for storing data collected by the one or more sensors after implantation of the medical device in a patient.

18. 18. The medical device of claim 15, wherein the one or more sensors further comprise a sensor selected from the group consisting of a gyroscope, a pressure sensor, a contact sensor, a position sensor, a chemical microsensor, a tissue metabolism sensor, a mechanical stress sensor, and a temperature sensor.

19. 19. The medical device of claim 15, wherein the one or more acceleration sensors detect acceleration, tilt, vibration, shock and / or rotation.

20. 20. The medical device of claim 15, wherein the data collected by the one or more sensors includes data related to patient movement after implantation of a hip prosthesis.

21. 21. The medical device of claim 15, wherein the data collected by the one or more sensors includes data related to a patient's gait after implantation of a hip prosthesis.

22. 22. The hip prosthesis of claim 1 or claim 15, further comprising an electronic processor disposed within the femoral stem and electrically coupled to the one or more sensors.

23. 23. The hip prosthesis or medical device of claim 22, wherein the electrical coupling is a wireless coupling.

24. 24. The hip prosthesis or medical device of claim 22 or 23, further comprising a memory coupled to said electronic processor and located within said femoral stem.

25. 25. A hip prosthesis or medical device according to any one of the preceding claims, wherein the one or more sensors are located on the hip prosthesis or medical device.

26. 25. A hip prosthesis or medical device according to any one of the preceding claims, wherein the one or more sensors are located within the hip prosthesis or medical device.

27. 1. A method for monitoring a hip prosthesis, the hip prosthesis including a femoral head and acetabulum assembly, the method comprising: receiving sensor data from one or more sensors coupled to a hip prosthesis positioned within the patient's hip joint, the one or more sensors including first contact sensors positioned at a plurality of locations between the femoral head and the acetabular assembly; storing the sensor data in a memory disposed in a femoral stem coupled to the femoral head, the sensor data including data related to the patient's gait after implantation of the hip prosthesis and first contact data collected by the first contact sensor; transferring the sensor data from a memory within the femoral stem to an external memory.

28. 28. The method of claim 27, wherein the sensor data further includes strain data from a plurality of strain sensors positioned at a plurality of locations between the femoral head and the acetabular assembly disposed within the patient's hip joint, and the strain data includes data collected after implantation of the prosthetic hip joint.

29. 29. The method of claim 28, wherein the sensor data further includes second contact data from a second contact sensor positioned between the patient's pelvic bone and the acetabular assembly, the second contact data including data collected after implantation of the hip prosthesis.

30. 30. The method of claim 29, further comprising plotting one or more of the first contact data, the strain data, and the second contact data to visualize changes over time.

31. 31. The method of claim 30, wherein the plotting comprises displaying one or more of the contact data, the strain data, and the second contact data as a two-dimensional or three-dimensional image.

32. 31. The method of claim 30, wherein the plotting comprises displaying one or more of the first contact data, the strain data, and the second contact data as a dynamic two-dimensional or three-dimensional image.

33. 33. The method of any one of claims 29 to 32, further comprising determining a range of motion of the patient having the prosthetic hip joint using one or more of the first contact data, the strain data, and the second contact data.

34. 34. The method of any one of claims 29 to 33, further comprising utilizing one or more of the first contact data, the strain data, and the second contact data to determine or predict failure or malfunction of the hip prosthesis.

35. 35. The method of any one of claims 29 to 34, further comprising determining or assessing the patient's motion after implantation of the hip prosthesis using one or more of the first contact data, the strain data, and the second contact data.

36. 36. The method of any one of claims 29 to 35, further comprising analyzing one or more of the first contact data, the strain data, and the second contact data.

37. 1. A method for monitoring a hip prosthesis, the method comprising: receiving sensor data from one or more sensors coupled to a hip prosthesis positioned within the patient's hip joint; storing the sensor data in a memory located within a femoral stem coupled to a femoral head of the hip joint prosthesis, the sensor data including data related to the patient's gait after implantation of the hip joint prosthesis; transferring the sensor data from a memory within the femoral stem to an external memory.

38. 38. The method of claim 37, further comprising plotting the sensor data to visualize changes over time.

39. 39. The method of claim 38, wherein the plotting comprises displaying the sensor data as a two-dimensional or three-dimensional image.

40. 39. The method of claim 38, wherein the plotting comprises displaying the sensor data as a dynamic two-dimensional or three-dimensional image.

41. 41. The method of any one of claims 38 to 40, further comprising utilizing the sensor data to determine a range of motion of the patient with the hip prosthesis.

42. 42. The method of any one of claims 38 to 41, further comprising utilizing the sensor data to determine or predict failure or malfunction of the hip prosthesis.

43. 43. The method of any one of claims 38 to 42, further comprising utilizing the sensor data to determine or assess the patient's performance after implantation of the hip prosthesis.

44. 44. The method of any one of claims 38 to 43, further comprising analysing the sensor data.

45. 45. The method of any one of claims 38 to 44, wherein the one or more sensors include a gyroscope.

46. 46. ​​The method of any one of claims 38 to 45, wherein the one or more sensors include an acceleration sensor.

47. A non-transitory computer-readable storage medium storing computer-executable code that, when executed by a computer system, Identifying a patient having at least one hip prosthesis or medical device, said hip prosthesis or medical device comprising the hip prosthesis or medical device of any one of claims 1 to 26, detecting a wireless interrogation unit for collecting sensor data from at least one sensor of the hip joint prosthesis or the medical device; A storage medium that causes a computer system to receive collected sensor data.

48. 48. The storage medium of claim 47, wherein the code further causes the computer system to remove sensitive patient data from the collected sensor data and analyze the sensor data according to sensor type or location.

49. 49. The storage medium of claim 47 or 48, wherein the code further causes the computer system to receive the collected sensor data on a watch, wristband, cell phone, or eyeglasses.

50. 49. The storage medium of claim 47 or 48, wherein the code further causes a computer system in the patient's residence or office to receive the collected sensor data.

51. 49. The storage medium of claim 47 or 48, wherein the code further causes a computer system associated with a healthcare provider to receive the collected sensor data.

52. 52. The storage medium of any one of claims 47 to 51, wherein the code further causes the computer system to write the collected sensor data to one or more websites.

53. 53. The storage medium of any one of claims 47 to 52, wherein the code further causes the computer system to plot the collected sensor data to visualize changes over time.

54. 54. The storage medium of claim 53, wherein the code further causes the computer system to plot the collected sensor data as a two-dimensional or three-dimensional image.

55. 54. The storage medium of claim 53, wherein the code further causes the computer system to plot the collected sensor data as a dynamic two-dimensional or three-dimensional image.

56. 56. The storage medium of any one of claims 47 to 55, wherein the code further causes the computer system to use the collected sensor data to determine a range of motion of a patient having the artificial hip joint or the medical device.

57. 57. The storage medium of any one of claims 47 to 56, wherein the code further causes the computer system to utilize the collected sensor data to determine or predict a failure or malfunction of the artificial hip joint or the medical device.

58. 27. A method for monitoring gait when a patient has implanted a hip prosthesis or medical device according to any one of claims 1 to 26, comprising:

1. A method comprising: collecting sensor data during ambulation; storing the sensor data in a memory located within the hip prosthesis or the medical device; and transferring the sensor data from the memory within the hip prosthesis or the medical device to an external location.

59. 27. A method of monitoring the operation of a hip prosthesis or medical device according to any one of claims 1 to 26 when implanted in a patient, the method comprising collecting sensor data during operation, storing the sensor data in a memory located within the hip prosthesis or medical device, and transferring the sensor data from the memory within the hip prosthesis or medical device to an external location.

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