BONE HEALING PROBE

A bone healing monitoring system, which includes a probe configured to measure at least one physical condition. The probe includes an optical fiber and a control unit attached to the optical fiber. The system also includes a surgically implantable device having a channel extending along at least a portion of the implantable device and is configured to receive the optical fiber therein.

BACKGROUND OF THE INVENTION

The proper healing of bone and tissue depends on multiple factors. Some of these factors include the age and biology of a patient, type and severity of the patient's injuries, and infections. Healing can be monitored through radiography, blood sample analysis and the like. However, these current monitoring solutions are not suitable to predict either bone healing failures or normal bone formation. As such, complications, such as nonunions and surgical site infections, are often recognized too late in clinical practice.

Nonunions are a serious complication that can result in psuedarthrosis or poor bone alignment, which may require surgical intervention. Such nonunions may be caused by bone migration during the healing process, poor blood supply and infection, to name a few.

Surgical site infections (SSI) can occur in the wound created by an invasive surgical procedure and are a significant cause of healthcare-associated infections. Such infections are a general health risk to the patient and can lead to non-unions in bone healing, particularly when left untreated. Further information on the risks and complications of SSI's can be found in National Collaborating Centre for Women's and Children's Health,Surgical Site Infection Prevention and Treatment of Surgical Site Infection Clinical Guideline(2008).

Adequate and early prediction of nonunions and SSI's, along with other clinical problems, can help healthcare professionals implement early intervention to combat their occurrences and ill effects. However, current monitoring practices and techniques are inadequate. Bone healing progress is often monitored using radiography and evaluation of functional outcomes, such as pain. Infections are currently monitored by blood sampling and other techniques. However, all of these techniques have significant predictive limitations. Radiography is a non-continuous technique that cannot predict load bearing properties of the fracture site and is potentially hazardous especially if overused. Blood sampling and analysis is also non-continuous and valuable time for fighting an infection is often lost between blood draws. Moreover, other than their predictive limitations, radiography, blood analysis, and other clinical diagnostic measures often require physically limited patients to make burdensome trips to a healthcare facility just to receive such testing.

BRIEF SUMMARY OF THE INVENTION

The present disclosure describes devices, systems, and methods for continuously monitoring conditions involved in the bone healing process to facilitate early recognition of complications so that early intervention can be realized. More particularly, the present disclosure describes a biocompatible optical fiber that is placed along an implant and/or fracture/osteotomy site to locally and continuously monitor site conditions such as fracture deflection, temperature, pressure, strain, pH, and other molecular characteristics. Such probe can be intraoperatively placed in an open manner or through an arthroscope or needle. Patches, glue, implant channels, sutures and other means of fixation may be used to hold the fiber in place during the healing process. Once healing and monitoring is complete, the probe can be extracted non-invasively. Features, such as an elastic sleeve, may help keep the probe in position during the healing process and facilitate extraction. Data gathered by the bone probe can be stored on a memory chip and sent to a display, mobile device, or healthcare provider for continuous monitoring.

In one aspect of the present disclosure, a bone healing monitoring system includes a probe configured to measure at least one physical condition and has an optical fiber and a control unit attached to the optical fiber. The system also includes and an implantable device that has a channel extending along at least a portion of the implantable device and is configured to receive the optical fiber therein.

Additionally, the control unit may include a laser and a detector. The optical fiber may also include at least one Bragg mirror sensor configured to return a wavelength of light to the detector indicative of the physical condition. The at least one physical condition may be one of deflection, pressure, strain, temperature and pH. The optical fiber may include a plurality of Bragg mirror sensors distributed along the length of the fiber each being tuned to a different bandwidth of light for returning a multiplexed signal to the detector. Each Bragg mirror sensor may comprise a section of the optical fiber defined by intervals of varying refractive index.

Continuing with this aspect, the laser may be a semiconductor laser. The control unit may include a processor and memory. The processor and memory may comprise a three-dimensional semiconductor package.

Also, the implantable device may be one of an elastic sleeve, joint prosthesis, intramedullary nail, bone plate, and external fixator. The surgically implantable device may be implantable by one of open surgery, arthroscopic surgery, and percutaneous needle insertion. The optical fiber may be removable from the channel once received therein. The channel may be formed along an outer surface of the implantable device.

In another aspect of the present disclosure, a bone healing monitoring system includes an implantable device having a length defined between a first and second end thereof, and a probe configured to measure at least one physical condition and having an optical fiber and a control unit attached to the optical fiber. The optical fiber is removably attachable to the implantable device between the first and second ends.

Additionally, the optical fiber may be removably attachable to the implantable device by an adhesive. The implantable device may include a channel extending into the implantable device between the first and second ends. The channel may be configured to receive the optical fiber. The implantable device may include a channel extending into the implantable device and may extend along an outer surface or an inner surface between the first and second ends. The channel may be configured to receive the optical fiber.

In a further aspect of the present disclosure, a bone healing monitoring system may include a probe configured to measure at least one physical condition and may have an optical fiber and a control unit attached to the optical fiber. The system also includes an intramedullary nail having interior and exterior surfaces defining a sidewall therebetween and extending along a length defined between first and second ends thereof. The intramedullary nail includes a channel that one of extends through the sidewall, along the outer surfaces, and along the inner surface. The channel is configured to removably receive the optical fiber therein.

In yet another aspect of the present disclosure, a bone healing monitoring system includes a probe configured to measure at least one physical condition and includes an optical fiber and a control unit attached to the optical fiber. The system also includes a bone plate having interior and exterior surfaces defining a sidewall therebetween and extending along a length defined between first and second ends thereof. The bone plate has a channel that one of extends through the sidewall, along the outer surface, and along an edge defined by an outer periphery of the sidewall. The channel is configured to removably receive the optical fiber therein.

In an even further aspect of the present disclosure, a bone healing monitoring system includes a probe configured to measure at least one physical condition and includes an optical fiber and a control unit attached to the optical fiber. The system also includes an external fixator having rod, a plurality of pins, and a channel extending through one of the rod and pins, the channel is configured to removably receive the optical fiber therein.

In a still further aspect of the present disclosure a method for monitoring bone healing of a fracture includes implanting a probe adjacent to a bone fracture of a patient, The probe is configured to measure at least one physical condition and has an optical fiber and control unit attached to the optical fiber. The method also include measuring the at least one physical condition adjacent to the bone fracture and removing the probe from the patient.

Additionally, implanting the probe may include intraoperatively placing the probe adjacent to the fracture through an arthroscope or needle. Also, implanting the probe may include attaching a first portion of the optical fiber having a first Bragg mirror sensor to a first bone segment and a second portion of the optical fiber having a second Bragg mirror sensor to a second bone segment. The first and second bone segments may be opposite each other across the bone fracture. Implanting the probe may also include inserting at least a portion of the optical fiber into the fracture between a first and second opposed bone fragments to be joined.

Continuing with this aspect, the method removing the probe may include pulling the probe from a location external to the patient. Also, the method may include projecting light through the optical fiber from a light source in the control unit and detecting reflected light by a detector in the control unit. Measuring may include determining a wavelength of the reflected light and converting the wavelength to a unit of measure indicative of the at least one physical condition. The at least one physical condition may be one of deflection, pressure, strain, temperature, and pH.

Also, implanting may be performed intraoperatively and measuring and removing may be performed postoperatively. The method may also include attaching the optical fiber to an implant, and implanting the probe may include implanting the implant along with the optical fiber attached thereto. The implant may be one of a bone plate and IM nail. Also, implanting the probe may include inserting the optical fiber into a channel disposed in an implant. The implant may be implanted prior to inserting the optical fiber therein.

In another aspect of the present disclosure, a method for monitoring bone healing of a fracture includes implanting an implant adjacent a fracture of a patient. The implant includes a probe attached thereto. The probe has an optical fiber and a controller coupled to the optical fiber. The method also includes measuring at least one physical condition with the probe and removing the probe from the implant and the patient while the implant remains implanted.

Additionally, the implant may be one of an external fixator, intramedullary nail, and bone plate. Also, implanting may be performed intraoperatively and measuring and removing may be performed postoperatively.

DETAILED DESCRIPTION

When referring to specific directions in the following discussion of certain implantable devices, it should be understood that such directions are described with regard to the implantable device's orientation and position during exemplary application to the human body. Thus, as used herein, the term “proximal” means close to the heart and the term “distal” means more distant from the heart. The term “inferior” means toward the feet and the term “superior” means toward the head. The term “anterior” means toward the front of the body or the face and the term “posterior” means toward the back of the body. The term “medial” means toward the midline of the body and the term “lateral” means away from the midline of the body. Also, as used herein, the terms “about,” “generally” and “substantially” are intended to mean that deviations from absolute are included within the scope of the term so modified.

FIG. 1depicts a bone healing probe system10. Probe10generally includes an optical fiber20and a control unit30. In some embodiments, multiple optical fibers20may be provided for a single control unit30. Probe20is capable of being inserted into a human or animal body and placed at a bone fracture site where measurements are taken of one or more physical conditions. This information can be displayed at control unit30, transmitted to a mobile device, and/or transmitted to the healthcare provider who can further evaluate the measurements to determine whether a failure mode in the healing process is indicated.

Optical fiber20includes a core22and cladding24surrounding core20. Core20and cladding24can be dimensioned and made from any materials, such as SiO2and doped variants thereof, so that the result is total internal reflection of light within core22. As shown, core22can include one or more Bragg mirror sensors26where each sensor occupies a predefined length or section of core22and along which the refractive index of core22varies. In other words, each Bragg mirror sensor26comprises a section of optical fiber20defined by intervals of varying refractive index. As light is projected down optical fiber20, each Bragg mirror sensor26reflects a wavelength of light toward controller30, which is indicative of a physical condition sensed by sensors26.

Each Bragg mirror sensor26along the length of optical fiber20can be configured to measure a different physical condition/parameter. Such physical conditions can include, but are not limited to, temperature, pressure, deflection of optical fiber20, strain, pH levels, and gas concentration levels, such as O2and CO2. The measurements of temperature, pH, and relative levels of O2and CO2at the fracture site can be used to indicate and predict bacterial infections. Pressure, deflection, strain and other mechanical conditions can be used to predict nonunion of bone fragments surrounding the fracture. Where optical fiber20includes a plurality of sensors26, each sensor26can be tuned to operate within a predefined bandwidth of light so that a multiplexed signal is sent back to controller30where it can be demuxed by a processor in controller30.

FIG. 2illustrates an exemplary control unit30. Control unit30includes a light source31, detector32, processor34, memory36, and display/interconnect38. Control unit30can include each of these components in a single, self-contained unit attachable to optical fiber20. However, in some embodiments, these components can be separated into multiple units that are attachable to one another via a physical or wireless interface.

Light source31is a laser, which is preferably supplied by a unit small enough to be attached to a human body, such as a semiconductor laser and the like. However, other larger units are contemplated.

Detector32is also preferably small enough to be attached to a human body, such as a photodiode and the like. Although, other larger units are contemplated.

Light signals detected by detector32are processed by processor34, which may include converting detected wavelengths to practical units of measure, such as those units that describe the physical conditions mentioned above. Processor34may perform such processing based on instructions stored on memory36, which may be flash memory or the like. The output from processor34may be stored on memory36in a continuous fashion. Thus, physical conditions can be continuously measured and stored. In one embodiment, memory36and processor34can be provided in a single3D integrated circuit package in order to minimize the footprint occupied by memory36and processor34so that memory36and processor34can also be attached to a human body.

Controller30also includes display or interconnection38a.In one embodiment, a small display38a,such as an LED display, can be integrated into controller30for attachment to a human body along with the other components mentioned above. Such display may communicate with processor34and display physical conditions measured at the fracture site. For example, display38amay continuously display the temperature at the fracture site. A patient can be instructed to notify their healthcare professional when the temperature reaches a certain threshold, which may be indicative of an SSI. Additionally, the display allows the patient to be intimately involved in the healing process by displaying information that allows the patient to track his or her progress. In one embodiment, the processor may display comparisons and/or graphs indicating the patient's progress. This can be highly motivating to the patient and can help the patient understand what activities, such as physical therapy, are most beneficial.

In another embodiment, controller30may include an interconnection38bin lieu of or in conjunction with display38a.Interconnection38bmay include physical hardware that allows controller30to be physically coupled to an external unit that can extract data stored on memory36.

Alternatively, interconnection38bcan include circuitry or other hardware that provides a wireless connection with an external unit. For example, controller30can include Bluetooth® or Wi-Fi components. Such components can be integrated into the processor/memory package as a system on chip (SOC). Data can then be transferred from controller30, wirelessly, to a mobile device, such as a smartphone or tablet. The mobile device can include an application that provides further processing and interactivity with the user. In addition, the application can serve as a link between probe10and healthcare provider where the mobile device application transmits information gathered by probe10to the healthcare provider for an up to the minute evaluation.

Controller30can include other components. For example, in the above description, Bragg mirror sensors26are utilized to sense physical conditions. However, in an alternative embodiment, rather than Bragg mirrors, optical time domain reflectometry (OTDR) and/or optical frequency domain reflectometry (OFDR) can be utilized to measure physical conditions at the fracture site. As such, controller can contain additional components, such as a pulse generator, to facilitate such techniques.

Exemplary applications of probe10to the human body for monitoring fracture healing are now described.FIGS. 3A and 3Bdepict an embodiment of a method of using probe10to measure physical conditions at a fracture site. In this embodiment, an elastic sleeve40may be provided to help guide, stabilize and position probe10in the desired location and may also help with removal of optical fiber20once healing is complete. Sleeve40includes a channel for receipt of optical fiber20and may include additional features for attachment to bone.

In the method, probe10is delivered to the fracture site by open surgery, an arthroscope, or a percutaneously inserted needle. Optical fiber20may be partially inserted into the fracture space between the bone fragments to be joined. As the fracture heals, fiber20can be repositioned, if needed, so that it does not interfere with the healing process.

Sleeve40is attached to bone50via an adhesive or to soft tissue via a resorbable suture. As shown, sleeve40holds optical fiber20in position so that the end of the optical fiber20extends into a fracture space54. The end of optical fiber20may include a sensor26to measure conditions within fracture space54. Fiber20may also include various sensors26along its length to measure conditions farther away from fracture space54in order to obtain a more complete picture of fracture site conditions.

In one embodiment, fiber20itself may be attached to bone50. In such an embodiment, one sensor26may be attached to a first bone fragment, and another sensor26may be attached to a second bone fragment disposed opposite the first bone fragment across fracture space54. Alternatively or in addition to any one of the previously described embodiments, a single sensor26within fiber20can be placed so that sensor26spans across fracture54.

With optical fiber20in place and at least partially extending from the patient's skin52, controller30is attached to fiber20, if not already attached, and controller30is attached to outer skin52, which may be achieved by an adhesive patch, suture, tape or the like (seeFIG. 3B).

Controller30is activated and light source31directs light down fiber20. Reflected wavelengths or backscatter is detected by detector32and signals are sent directly or indirectly (such as through an amplifier) from detector32to processor34, which converts the detected wavelengths into units of the desired physical condition for measurement. Outputs from processor34are stored on memory36. Fiber20remains in place during the healing process and continuously monitors fracture site conditions.

Real time conditions, such as temperature, pressure, pH, deflection, and the like are sent to display38awithin controller30and attached to patient's skin52. Alternatively, conditions are uplinked periodically to a mobile device from controller30, which backs-up the data and can further process the data via a specialized application for enhanced user functionality over that of display38a.User may also forward data to a healthcare professional and/or the healthcare professional can retrieve data from the mobile device on command when connected to a wireless network. Over time, the mobile device application can be modified and can learn from data collected and assist in warning users that certain conditions, such as those indicating an SSI or nonunion, exist that warrant notifying a healthcare professional.

Once healing is completed, optical fiber20is noninvasively removed from the fracture site and patient. This may be performed by detaching controller30from the patient and pulling optical fiber20through skin30. Alternatively, optical fiber20can be removed arthroscopically. While fiber20is preferably removed from the patient, it is contemplated that controller30is detached from the patient while fiber20remains inside the patient.

FIGS. 4A and 4Billustrate a method of implementing probe10, in conjunction with an intramedullary (IM) nail140. IM nail140includes first and second ends and a length defined therebetween. As shown in the cross-sectional view ofFIG. 4B, IM nail140also includes interior and exterior surfaces144,146and a sidewall defined therebetween.

In some embodiments, IM nail140may be specifically designed to accommodate probe110, and in particular, optical fiber20. In such a design, IM nail140may include one or more channels142longitudinally extending along IM nail140. As shown, a channel142can be formed in the sidewall, on interior surface144, and/or on exterior surface146. Channels142on interior and exterior surfaces144and146may be formed by a sleeve attached one of these surfaces that either extends continuously along the length of nail140or extends in intervals along the length of nail140(as depicted inFIG. 4A) such that transverse openings are formed to expose a portion of optical fiber20when disposed therein. Each channel142is configured to receive and hold optical fiber20during the healing process, while allowing optical fiber20to be removed when desired. In other embodiments, probe10may be attached to a standard or non-specialized IM nail by adhesive or other reversible means.

In a method of use, optical fiber20is attached to IM nail140by sliding fiber20into a respective channel142in IM nail140. This may be done during the manufacturing process and delivered to the operating room in an assembled configuration, or it may be performed in the operating room. Alternatively, adhesive may be attached to IM nail140and optical fiber20attached to the adhesive. One or more optical fibers20may be attached to IM nail20as described.

Nail140, along with optical fiber20, is inserted into an IM canal158of a bone150such that optical fiber20extends from nail140to a location outside of the patient. Alternatively, nail140is inserted into IM canal158and then optical fiber20is guided into channel142.

With optical fiber20in place and at least partially extending from the patient's skin, controller30is attached to fiber20, if not already attached, and controller is attached to the patient's outer skin, which may be performed by an adhesive patch, tape or the like.

Real time conditions, such as temperature, pressure, pH, deflection, and the like are sent to display38awithin controller30and attached to patient's skin52. Alternatively, conditions are uplinked periodically to a mobile device from controller30, which backs-up the data and can further process the data via a specialized application for enhanced user functionality over that of display38a.User may also forward data to a healthcare professional and/or the healthcare professional can retrieve data from the mobile device on command when connected to a wireless network. Over time, the mobile device application can be modified and can learn from data collected and assist in warning users that certain conditions, such as those indicating an SSI or nonunion, exist that warrant notifying a healthcare professional. While conditions may be measured continuously without pause, conditions can also be measured at intervals selected to conserve energy of the controller's power source while still providing up to the minute information.

Once healing is completed, optical fiber20is noninvasively removed from IM nail140and the patient. This may be performed by detaching controller30from the patient and pulling optical fiber20through the skin.

FIGS. 5A and 5Billustrate a method of implementing probe10in conjunction with a bone plate240. Bone plate240includes first and second ends and a length defined therebetween. As shown in the cross-sectional view ofFIG. 5B, the bone plate also includes interior and exterior surfaces244,246and a sidewall defined therebetween. The sidewall terminates at a periphery which defines an edge248. Bone plate240may also include a plurality of transverse through-holes241extending through the sidewall for receipt of a bone fastener.

In some embodiments, bone plate240may be specifically designed to accommodate probe10, and in particular, optical fiber20. In such a design, bone plate240may include one or more channels242longitudinally extending along plate240. As shown, channels242can be formed in the sidewall, on exterior surface246, and/or on edge248of the sidewall. Channels242on exterior surface246or edge248may generally be formed by a sleeve attached exterior surface246or edge248that either extends continuously along the length of plate240or extends in intervals (as shown inFIG. 5Aby intervals242a-d) along the length of bone plate240such that transverse openings are formed to expose a portion of optical fiber20when disposed therein. Channel242that extends through the sidewall in a longitudinal direction may be located in a portion of the bone plate that does not intersect transverse through-holes241. Each channel242is configured to receive and hold optical fiber20during the healing process, while allowing optical fiber20to be removed when desired. In other embodiments, probe10may be attached to a standard or non-specialized bone plate by adhesive or other reversible means.

In a method of use, optical fiber20is attached to bone plate240by sliding optical fiber20into a respective channel242in plate240. This may be done during the manufacturing process and delivered to the operating room in an assembled configuration, or it may be performed in the operating room. Alternatively, adhesive may be attached to bone plate240and optical fiber20attached to the adhesive. One or more optical fibers20may be attached to bone plate240as described.

With the fracture properly aligned, bone plate240is placed across fracture254and secured to opposing segments of bone250via bone fasteners. Optical fiber254may be inserted into channels242and connected to bone plate240once bone plate240is secure. Alternatively, optical fiber may be inserted into respective channels242prior to fixation of bone plate240to bone250.

With optical fiber20in place and at least partially extending from the patient's skin, controller30is attached to fiber20, if not already attached, and controller is attached to the patient's outer skin, which may be performed by an adhesive patch, tape or the like.

Real time conditions, such as temperature, pressure, pH, deflection, and the like are sent to display38awithin controller30and attached to patient's skin52. Alternatively, conditions are uplinked periodically to a mobile device from controller30, which backs-up the data and can further process the data via a specialized application for enhanced user functionality over that of display38a.User may also forward data to a healthcare professional and/or the healthcare professional can retrieve data from the mobile device on command when connected to a wireless network. Over time, the mobile device application can be modified and can learn from data collected and assist in warning users that certain conditions, such as those indicating an SSI or nonunion, exist that warrant notifying a healthcare professional.

Once healing is completed, optical fiber20is noninvasively removed from bone plate240and the patient. This may be performed by detaching controller30from the patient and pulling optical fiber20through the skin.

FIGS. 6A and 6Billustrate a method of implementing probe10in conjunction with an external fixator340. External fixator340includes a rod341and pins346assembled into a construct where pins346adjustably extend from rod342in a transverse direction therefrom. Other embodiments of external fixator340may include fixation frames and/or a plurality of rods.

As shown inFIG. 6B, rod342includes a channel342extending along a length thereof for receipt of optical fiber20. Such channel342extends through the entirety of rod341in one embodiment, and extends partially through rod341in another embodiment. In addition, pins346may also include such a channel for receipt of fiber20. While probe10may not be implanted into the patient when optical fiber20is inserted into rod341, such probe10is still useful to evaluate the stiffness of the fixator construct340, any adjustments that could be made to optimize the performance of fixator340, and conditions indicating a failure mode of healing. This could be done by using probe10to measure certain physical conditions felt by rod342, such as pressure, strain, and deflection.

In a method of use, pins346are inserted into bone fragments disposed opposite each other across the fracture space352. Pins346are coupled to rod342and adjusted in order to place the bone fragments into a desired relative position. Thereafter, optical fiber20may be inserted into channel342extending through rod341. Controller30is connected to one end of optical fiber20and connected to an end of rod341. In one embodiment, display38a,which may be physical separated from controller unit30but in communication therewith, may be attached to rod342(as shown inFIG. 6A) to display real time conditions.

Alternatively, or in addition to optical fiber20in rod341, fiber20can be inserted into each of pins346. This may be done such that an end of fiber20, which may include a sensor26for measuring temperature or some other condition, is placed within a tip of pins346, which themselves are inserted into bone350. Controller30can be attached to each fiber extending into pins346and attached to rod341.

Real time conditions, such as temperature, pressure, pH, deflection, and the like are sent to display38awithin controller30. Alternatively, conditions are uplinked periodically to a mobile device from controller30, which backs-up the data and can further process the data via a specialized application for enhanced user functionality over that of display38a.User may also forward data to a healthcare professional and/or the healthcare professional can retrieve data from the mobile device on command when connected to a wireless network. Over time, the mobile device application can be modified and can learn from data collected and assist in warning users that certain conditions, such as those indicating an SSI or nonunion, exist that warrant notifying a healthcare professional.

Where more than one optical fiber20is used, such as in each of pins346, measurements obtained from each fiber20can be processed by controller30. These measurements may be compared by a comparator, which can determine relative position or conditions at each bone fragment to be joined by the healing process. Once healing is completed, optical fiber20can be removed from the patient along with external fixator340.

FIG. 7illustrates a method of implementing probe10in the context of rehabilitation and range of motion training/evaluation. Evaluating range of motion of a joint (ROM) after an injury and/or surgical procedure involving the joint may be important in evaluating recovery progress and strategies for rehabilitation. As shown, probe10can be attached to a patient's outer skin450and across the joint452to be evaluated. In this example, a wrist. Other examples not shown, are knee, ankle, shoulder, elbow, and finger joints. Controller30is also attached to patient's outer skin450. Probe10can be worn during a physical therapy session or can be worn for more prolonged durations to obtain additional data.

Aside from helping patients recover from injuries or surgeries by evaluating ROM, probe10can be used to evaluate ROM of a healthy joint to better understand their kinematics and to evaluate forces and other external stimuli applied to the body in everyday life, which can help improve implant design.

Probe10and methods described herein provide many benefits and advantages. For example, patients are currently unaware of their healing progress and rely on their healthcare provider's interpretation of certain diagnostic tools, such as x-rays. Probe10and methods of using the probe allows the patient to be continuously aware of their healing progress, which may greatly motivate patients. In addition, healthcare providers can use the data and experience obtained from utilizing such probes and methods to identify optimum rehabilitation strategies. Additionally, optical fiber20is a passive device that does not transmit electrical or magnetic energy inside the body, which helps avoid foreign body reactions, and continuously monitors fracture site conditions so that the patient and/or healthcare provider can obtain up to the minute information, which can be used to predict failure modes in the healing process.

Although probe10has generally been described above as being applicable to predicting failure modes in the processes of bone fracture healing, it should be understood, that such probe has other clinical applications. Probe10can be used to monitor any wound, injury, or surgical site for proper healing and development of infections. In addition, probe10can be used in other orthopedic contexts not shown. For example, probe10can be utilized in conjunction with joint arthroplasty prostheses to evaluate proper joint alignment and fixation of the prosthesis. Other examples include monitoring of bone formation in distraction osteogenesis or relapse of osteotomies. Even further still, probe10can be used to determine or predict implant failure, for example, if bending exceeds a certain value. Such determination allows the healthcare professional to remove the implant before failure occurs. Regardless of the application, the principles described herein are applicable.