Heating device and heating method

Abstract

To provide a medical induction heating device (10) for heating at least part of a prothesis or an implant.SOLUTION: A device (10) includes at least one outer induction coil which is provided at a body part of the device (10) or outside of a housing. A size and dimension of the coil (12) is smaller than a body part related to the prothesis or an implant.SELECTED DRAWING: Figure 1

Description

[Technical Field]

[0001] The present invention relates to an apparatus for heating, particularly, but not exclusively, to an apparatus and method for inductively heating a prosthesis or implant, or at least a portion thereof, such as to treat biofilm infections on metal implants. [Background technology]

[0002] Implant infections are a major problem in elective and trauma surgery: a significant proportion of prosthetic implants and an even larger proportion of implants in fractures become infected.

[0003] Such infections can trigger an immune response that can at least help combat the infection, especially in combination with antibiotics and / or other drugs. However, treatment often involves invasive surgery, especially when undesirable biofilms form at or on the prosthesis. The infected area is incised, cleaned, and treated. To effectively eradicate the infection, the wound must be left open for a significant period of time, often causing discomfort to the patient. Some prior art techniques disclose heating the limb or patient containing the implant, but these require very strong magnetic fields and are difficult to control the effective application of heat, potentially leading to internal burns.

[0004] For example, if a hip prosthesis becomes infected, an existing (or new) wound is opened to access the prosthesis. The prosthesis is exposed, and the prosthesis and surrounding tissue are thoroughly cleaned to eradicate the infection. In some cases, infection may require removal of the prosthesis, such as for replacement with a new prosthesis.

[0005] U.S. Patent Application Publication No. 2011 / 251687 discloses a miniature coil device that performs induction heating on a small oral shape-memory material implant in less than five seconds, returning it to its original shape after introduction into the human ear. However, the size of this coil does not allow for a magnetic field strong enough to heat the implant or prosthesis and reduce biofilm on its surface, as exemplified by the data related to eddy current penetration depth of Nitinol summarized herein. International Publication No. WO 2018 / 013935 discloses a method and apparatus for heating implants by exposing the patient's entire body to a magnetic field. While this method can heat the implant, the magnetic field and energy delivered are difficult to control and difficult to administer or focus in a specific area, resulting in significant tissue damage and, in some cases, loss of fixation and subsequent revision surgery. Furthermore, in the presence of infection, the generated heat can be quickly dissipated by the surrounding fluid, making the disclosed method unsuitable. [Prior art documents] [Patent documents]

[0006] [Patent Document 1] U.S. Patent Application Publication No. 2011 / 251687 [Patent Document 2] International Publication No. WO2018 / 013935 Summary of the Invention [Problem to be solved by the invention]

[0007] An aim of one or more aspects, examples, embodiments, or claims of the present disclosure may be to solve or at least alleviate one or more of the problems in the prior art, such as those described herein or otherwise. [Means for solving the problem]

[0008] According to a first aspect, there is provided an apparatus for heating at least a portion of a prosthesis or implant.

[0009] The apparatus may include an induction heating device for inductively heating a portion of the prosthesis or implant.

[0010] A portion of the prosthesis or implant may be heatable by induction. A portion of the prosthesis or implant may be heatable directly by induction.

[0011] The device may include a coil configured to inductively heat a portion of the prosthesis or implant. The coil may be configured to inductively heat only a portion of the prosthesis or implant. The device may include an induction coil. The device may include at least one external induction coil. The external induction coil may be external to the body and / or housing of the device. The induction coil may be configured to apply directly to only a portion of the prosthesis or implant. In at least some examples, the induction coil may be configured to be in direct contact with the prosthesis or implant. The device may be configured to transfer energy to a portion of the prosthesis or implant without the energy first passing through the patient's skin. The coil may be of a size and dimensions smaller than the body portion associated with the prosthesis or implant. For example, the coil may have a diameter and / or longitudinal extent smaller than the limb associated with the prosthesis or implant (e.g., the coil may have a diameter smaller than the diameter of the patient's leg). The device may be configured to position a portion of the prosthesis or implant within a certain distance from or of the coil, the distance being equal to or less than the dimensions of the coil. For example, the device may be configured to position the coil closer than a diameter of the coil to a portion of the prosthesis or implant. The coil may be configured for insertion into or through a surgical incision.

[0012] The prosthesis or implant may be constructed of an electrically conductive material. A portion of the prosthesis or implant may be constructed of an electrically conductive material. The prosthesis or implant may be constructed of a metal. The prosthesis or implant may be constructed of one or more of steel, titanium, alloys, and cobalt chrome. The electrically conductive material may be inductively heatable. The device may include a handheld device.

[0013] The device may include a one-handed device. The device may be configured for one-handed use by a user. The device may include a pistol-style device. The device may include a handle for gripping with one hand. The one hand may be the left hand or the right hand, or either the left hand or the right hand. The handle may include a pistol-style grip handle. The device may be configured to be controlled by the gripping hand. The device may include an actuator for operation with the gripping hand. The actuator may include a trigger. The actuator may be for at least partially controlling the supply of heat by the device, such as by controlling power, such as the amount and / or duration of power, supplied to the induction coil.

[0014] The device may include a portable device. The device may include a low-power device. The device may include a low-voltage device. The voltage may be about 60 volts or less. In at least some examples, the voltage may be about 50 volts or less, about 30 volts or less, about 20 volts or less, or about 12 volts. The device may be configured to provide a pulsed electromagnetic field (PEMF) operating frequency of less than about 100 kHz. The device may include a battery-powered device. Additionally or alternatively, the device may include a device that is powered from the mains or from the power grid, such as powered via a cable and plug.

[0015] The device may be configured to treat an infection. The device may include an infection treatment device. The device may be configured to at least assist in killing bacteria. The device may be configured to heat bacteria to a critical temperature at which the bacteria are at least weakened, such as to assist in infection prevention measures by administered drugs and / or other means, such as immune defense mechanisms. The device may be configured to apply heat to a biofilm associated with a prosthesis or implant.

[0016] A portion of the prosthesis or implant comprises at least one boundary or surface configured to engage, interact with, or interface with tissue, such as muscle and / or bone and / or cartilage tissue.

[0017] The term "prosthesis or implant" herein may relate to orthopedic implants, such as total joint replacements, total or hemiarthroplasties, total artificial joints, joint replacements, e.g., hip replacements, joint replacement implants, artificial joints, joint reconstructions, joint reconstruction implants, fracture fixation devices including but not limited to plates, screws, nails, staples, rods, wires, pins, external fixators, joint distraction devices, i.e., external fixators. Preferably, the term "prosthesis or implant" refers to a loaded or loadable implant. As an example, in joint replacement surgery, also known as joint arthroplasty, a joint implant is inserted or otherwise attached into a bone prepared to receive the implant, and the implant is fixed to achieve reliable stabilization or fixation for bearing loads. Therefore, the term "prosthetic implant" herein preferably refers to a (partial) metallic device with biomechanical function implanted near, at, or within a bone.

[0018] The term "invasive species" may refer to specific invasive microorganisms, particularly bacteria, that colonize and ultimately form biofilms. Biofilms typically comprise a mass of microorganisms embedded in a highly hydrated matrix of exopolymers, typically polysaccharides and / or other polymers. Biofilms contain single or multiple microbial species and readily adhere to prosthetic and / or implant surfaces. Preventing and eradicating biofilm-associated microbial colonization is often difficult because the structural matrix established during biofilm formation typically allows colonizing cells to withstand standard therapeutic doses of antibiotics. The glycocalyx matrix appears to function as a barrier that protects and sequesters the microorganisms from host defense mechanisms such as antibodies and phagocytes, as well as antimicrobial agents, including surfactants, biocides, and antibiotics. Once established, the biofilm itself can render treatment ineffective, effectively serving as a reservoir of infection and potentially leading to recurrence of infection even after antibiotic treatment. Biofilm infections are often associated with septic arthritis, and the formation of biofilms on joint or implant surfaces can lead to chronic and recurrent infections. In addition to sepsis, biofilm infections can cause destruction of the articular surface material, particularly in implants such as artificial bones and the like, thereby necessitating one or more additional surgical procedures, commonly referred to as corrective or revision surgery, to remove the infectious material and, in turn, the necrotic or infected tissue.

[0019] As used herein, the term "active count" relates to a measurement to determine the active or viable invasive microorganisms in or derived from a biofilm after treatment. This may be done, for example, by a probe active count assay (PAC) or by different cell counting methods or protocols.

[0020] The device may be configured to heat a boundary or surface. The device may be configured to heat the boundary or surface directly and / or indirectly. In at least some examples, the boundary or surface is comprised of an electrically conductive material. In at least some examples, the boundary or surface is comprised of a non-conductive or low-conductive material, and the non-conductive or low-conductive material is associated with an electrically conductive material. For example, a prosthesis or implant includes a non-conductive or low-conductive coating or layer, and the device is configured to indirectly heat the coating or layer by inducing heat into an associated electrically conductive material, such as beneath the coating or layer, where the heat is transferred, propagated, or passed from the electrically conductive material to the non-conductive or low-conductive material, such as by conduction.

[0021] Additionally or alternatively, the device may be configured to heat at least a portion of the prosthesis or implant to assist in installation and / or removal of the prosthesis or implant. For example, the device may be configured to heat a portion of the prosthesis or implant to expand the portion of the prosthesis or implant. In at least some examples, the portion of the prosthesis or implant that is heated may be associated with fixation of the prosthesis or implant. For example, the portion of the prosthesis or implant may include a socket or recess. The socket or recess may be associated with another portion of the prosthesis or implant, such as to receive another part or component of the prosthesis or implant. For example, if the prosthesis or implant includes a fastener or fastener for fixation, the device may be configured to heat the fitting or fastener, or at least a portion thereof, to assist in application and / or removal of the prosthesis or implant. The device may be configured to thermally expand and / or contract the portion of the prosthesis or implant. In at least some instances, the device may be configured to sequentially and / or cyclically thermally expand and contract a portion of the prosthesis or implant.

[0022] The device may be configured to weaken fasteners for or of a prosthesis or implant, such as to aid in temporary or permanent removal of a portion of the prosthesis or implant. For example, where the prosthesis or implant is secured to bone, such as directly or indirectly, the device may be configured to weaken the interface between the prosthesis or implant and the bone. The device may be configured to weaken the bond between the prosthesis or implant and the patient, such as with an adhesive or agent.

[0023] The device may be configured to heat a portion of the prosthesis or implant in vitro prior to inserting or applying the portion to a patient. Additionally or alternatively, the device may be configured to heat a portion of the prosthesis or implant in vivo while the portion is attached to or positioned within the patient.

[0024] In at least some examples, the device can be configured to heat a portion of the prosthesis or implant during a surgical procedure. The surgical procedure may include an invasive surgical procedure. Alternatively, the surgical procedure may include a non-invasive surgical procedure.

[0025] The device may be configured for in vivo use. The device may be configured to heat a portion of a prosthesis or implant while the portion is positioned within and / or attached to a body. Additionally or alternatively, the device may be configured for ex vivo use. The device may be configured for in vitro use. The device may be configured to heat a portion of a prosthesis or implant while the portion is positioned outside and / or detached from the body. In at least some examples, the device may be configured to heat a portion of a prosthesis or implant ex vivo during a surgical procedure, such as when the prosthesis or implant (or a portion thereof) is detached and / or removed from the body.

[0026] The device may be configured to heat a portion of a prosthesis or implant during a surgical procedure without excessively heating the patient's tissue. The device may be configured to heat the portion of the prosthesis or implant to a temperature below a maximum temperature, which may be associated with tissue damage. For example, the device may be configured to only heat the portion of the prosthesis or implant to a temperature not associated with undesired tissue damage.

[0027] The device may be configured to heat a portion of the prosthesis or implant to a temperature below a minimum temperature, which may be associated with infection prevention measures, for example, the minimum temperature may be associated with treating or at least combating an infection.

[0028] In at least some instances, the minimum temperature may be at least 38°C, at least 40°C, at least 50°C, at least 60°C, at least 65°C, at least 70°C, or at least 75°C, or at least 80°C, or at least 90°C. The maximum temperature may be at least 60°C, at least 65°C, at least 70°C, at least 75°C, or at least 80°C, or at least 90°C, or at least 100°C, or at least 110°C, or at least 120°C. Thus, in at least some instances, the device may be configured to heat a portion of the prosthesis or implant to a temperature within a range, such as from about 65°C to about 70°C. Preferably, the portion of the prosthesis or implant is heated to a temperature of from about 60°C to about 90°C, particularly from 65°C to 70°C, preferably for a period of time suitable for reducing the active count of biofilm-forming invasive cell species.

[0029] The device may be configured to heat a portion of the prosthesis or implant to a target temperature. The device may be controlled depending on the temperature of a portion of the prosthesis or implant and / or additional temperatures, such as other portions and / or tissues of the prosthesis or implant (e.g., bone, muscle, cartilage, nerve, etc.). The device may be controllable depending on a heat sensor or thermometer. In at least some examples, the device may be controllable depending on direct temperature measurement. The device may be configured to operate with a temperature measurement device. The temperature measurement device may include a sensor and / or a camera. The camera may comprise an infrared thermal camera. The temperature measurement device may include an augmented reality and / or virtual reality device. The device may be configured to adapt heating depending on the temperature measurement device, such as via power output to or from the coil. The device may be configured to adapt heating automatically. For example, the device may include a temperature measurement device or at least be in data communication with a temperature measurement device. Additionally or alternatively, the device may be configured to adapt heating manually. For example, an operator or user of the device may manually adapt heating through the apparatus depending on information the operator or user receives from a temperature measurement device. The apparatus may be operated depending on real-time visualization and / or measurement, such as via a display connected to or included with an infrared thermal camera. The apparatus may be configured to adapt heating depending on the amount of accumulated heating. The temperature measurement device or an associated device may be configured to calculate the amount of accumulated heating in real time.

[0030] The temperature measurement device or related devices may be configured to display the temperature and / or accumulated heat to a user or operator, such as a surgeon. In at least some examples, the apparatus may include an integrated thermal sensor and (micro)controller.

[0031] The device may be configured to heat only a portion of the prosthesis or implant. For example, the device may be configured not to heat the entire prosthesis or implant. The device may be configured to induce heat in only a single portion of the prosthesis or implant at a time. The device may be configured not to heat the entire prosthesis or implant simultaneously.

[0032] The device may be configured to selectively heat portions of a prosthesis or implant. The device may be configured to selectively heat only portions of an implant that are safe. The device may be configured to selectively heat only portions of an implant that are non-risky or low-risk. The device may be configured to avoid heating areas of the implant related to bone fixation (e.g., in the case of a total joint replacement) and / or areas of the prosthesis or implant that are close to or associated with critical anatomical structures such as nerves (e.g., in the case of an infected elbow plate). Alternatively, high-risk areas (e.g., due to loss of bone fixation or proximity of nerves / vessels) may be heated to a temperature equal to or lower than a lower temperature (e.g., for low-risk areas). The coil may be a precision coil that targets only the portions of the prosthesis or implant to be heated.

[0033] The device may be configured to inductively heat a first portion of the prosthesis or implant and not to inductively heat a second portion of the prosthesis or implant. The device may be configured to allow heat transfer from the first portion of the prosthesis or implant to the second portion of the prosthesis or implant. The device may be configured to utilize the second portion of the prosthesis or implant as a heat sink for the first portion of the prosthesis or implant. Additionally or alternatively, the device may include a cooling system. The cooling system may include an active cooling system. The cooling system may be for cooling the coil.

[0034] The device may be configured to heat two or more portions of a prosthesis or implant sequentially, such as by heating a first portion before heating a second portion of the prosthesis or implant.

[0035] In at least some instances, at least a portion of a prosthesis or implant includes the entire prosthesis or implant.

[0036] The device may be configured for sterilization. The device may be configured for sterilization using a sterilization device for sterilizing surgical instruments, such as a standard sterilization device for sterilizing items such as surgical drills, surgical saws, or the like. Sterilization may include one or more of autoclaving, dry heat, chemical sterilants, mechanical and / or ultrasonic cleaning. The device may be sized and dimensioned to be placed within conventional or standard sterilization procedures for items such as surgical drills, surgical saws, or the like.

[0037] The device may include one or more disposable components. For example, the device may include one or more batteries. In at least some instances, the batteries are removed prior to sterilization. A new battery may be inserted into or provided with the device after sterilization for subsequent use of the device. The device may also include one or more removable components. For example, the external coil may be detachable and optionally reattachable.

[0038] In at least some examples, the coil may be deformable depending on the portion of the prosthesis or implant. The deformation may be plastic and / or elastic. The coil may be configured to deform to accommodate the prosthesis or implant. The coil may be configured to be deformed by the prosthesis or implant. The coil may be configured to be deformed by manipulation by a user. For example, a user may plastically and / or elastically deform the coil to conform to the shape of a particular prosthesis or implant.

[0039] The prosthesis or implant may include a prosthesis or implant for implantation and / or attachment to a human body. Alternatively, the prosthesis or implant may include a prosthesis or implant for implantation and / or attachment to a non-human body, such as a non-human mammal.

[0040] According to a further aspect, a system or assembly for heating at least a portion of a prosthesis or implant is provided. The system or assembly may include a device and at least a portion of the prosthesis or implant. The device may include a device of any other aspect, claim, example, or embodiment. The at least a portion of the prosthesis or implant may include at least a portion of the prosthesis or implant of any other aspect, claim, example, or embodiment. The device may be configured depending on at least a portion of the prosthesis or implant. For example, the device may include a coil and / or a power source configured for the characteristics of at least a portion of the prosthesis or implant. The system or assembly may include an array of coils, such as replaceable and / or disposable coils. The system or assembly may include a temperature control mechanism. The temperature control mechanism may be of any other aspect, example, claim, or embodiment. The temperature control mechanism may be part of, integrated into, or coupled to the heating device. Alternatively, the temperature control mechanism may be at least partially separate from the heating device. The temperature control mechanism may include a temperature sensor or measuring device. The temperature measurement device may be of any other aspect, claim, embodiment, or example.

[0041] A further aspect provides a method of heating at least a portion of a prosthesis or implant.

[0042] The method may include in vitro heating. The method may include ex vivo heating. Additionally or alternatively, the method may include in vivo heating.

[0043] The method may include an induction heating method for inductively heating a portion of the prosthesis or implant.

[0044] The method may include directly heating a portion of the prosthesis or implant by induction.

[0045] In one aspect, the present invention relates to a method for reducing the active count of microorganisms that form biofilms on the surface of a prosthesis or implant. In another aspect, the present invention provides a method for enhancing the effect of an antibiotic composition in reducing biofilms, which negates the antibiotic effect when the antibiotic in the absence of treatment may not be able to attack the biofilm in the absence of heat treatment. In a typical embodiment, the biofilm is composed predominantly of bacteria, and the biocide comprises an antibiotic such as one of the following: penicillins, cephalosporins, aminoglycosides, tetracyclines, sulfonamides, and quinolones. Alternatively, the biocide may comprise a compound useful for sterilization, such as chlorhexidine. Also included in the present invention is a method for enhancing the effect of an antibiotic composition in reducing the active count of microorganisms that form biofilms on the surface of a prosthesis or implant, wherein the antibiotic effect is enhanced by heat treatment of the prosthesis or implant, and the biofilm microorganisms are attacked from the interior surface of the biofilm in the presence of the antibiotic, and the concentration of the antibiotic is lower than the concentration effective for reducing the biofilm microorganisms in the absence of heat treatment.

[0046] The method may include configuring a coil to inductively heat a portion of the prosthesis or implant. The method may include inductively heating only a portion of the prosthesis or implant. The method may include inductive heating with an external induction coil external to the body and / or housing of a heating device, such as the heating device of any other aspect, embodiment, example, or claim. The method may include configuring a coil for direct application to a portion of the prosthesis or implant. The method may include directly applying the coil to the portion of the prosthesis or implant. The method may include directly contacting the prosthesis or implant with the coil. The method may include transferring energy to the portion of the prosthesis or implant without the energy first passing through the patient's skin. The method may include avoiding or at least minimizing passage of energy through the patient's skin and / or tissue. The method may include positioning the portion of the prosthesis or implant from or within a distance of the coil, the distance being equal to or less than a dimension of the coil. The method may include positioning the coil and / or the portion of the prosthesis or implant. For example, the method may include positioning the coil closer than a diameter of the coil to a portion of the prosthesis or implant. The method may include inserting the coil into or through a surgical incision.

[0047] The method may include supplying heat via a handheld device. The method may include controlling the administration of heat at least in part, such as by controlling power, such as the amount and / or duration of power, supplied to an induction coil.

[0048] The method may include providing an operating frequency of the pulsed electromagnetic field (PEMF) of less than about 100 kHz.

[0049] The method may include treating an infection, such as a prosthetic joint infection (PJI).

[0050] The method may include a method for treating an infection. The method may include at least assisting in killing an invading species, such as bacteria. The method may include heating the invading species, particularly bacteria, to a critical temperature at which the bacteria are at least weakened, such as to assist in infection prevention measures by administered drugs and / or other means, such as immune defense mechanisms. The method may include applying heat to a biofilm associated with a prosthesis or implant.

[0051] The method may include heating at least one boundary or surface configured to engage, interact, or interface with tissue, such as muscle and / or bone and / or cartilage tissue, and the like. The method may include heating the boundary or surface. The method may include directly and / or indirectly heating the boundary or surface. In at least some examples, the boundary or surface is comprised of a non-conductive or low-conductive material, the non-conductive or low-conductive material being associated with a conductive material. For example, the prosthesis or implant may include a non-conductive or low-conductive coating or layer, and the method may include indirectly heating the coating or layer. The method may include inducing heat to an associated conductive material, such as beneath the coating or layer, where the heat is transferred or propagated, such as by conduction, from the conductive material to the non-conductive or low-conductive material or through the conductive material.

[0052] Additionally or alternatively, the method may include heating at least a portion of the prosthesis or implant to assist in attachment and / or detachment of the prosthesis or implant. For example, the method may include heating a portion of the prosthesis or implant to expand the portion of the prosthesis or implant. In at least some examples, the portion of the prosthesis or implant that is heated may be associated with fixation of the prosthesis or implant. For example, the portion of the prosthesis or implant may include a socket or recess. The socket or recess may be associated with another portion of the prosthesis or implant, such as to receive another part or component of the prosthesis or implant. For example, if the prosthesis or implant includes a fixation fixture or fastener, the method may include heating the fitting or fixture, or at least a portion thereof, to assist in attachment and / or detachment of the prosthesis or implant. The method may include thermally expanding and / or contracting the portion of the prosthesis or implant. The method may include heating a portion of the prosthesis or implant before and / or during attachment, connection, or insertion of the portion of the prosthesis or implant. The method may include heating to facilitate attachment, connection, or insertion, such as by thermally adapting clearances or tolerances to provide a looser fit upon attachment, connection, or insertion. The method may include subsequent cooling, such as passive cooling, to thermally adapt clearances or tolerances to provide a tighter fit upon attachment, connection, or insertion. The method may include heating a portion of the prosthesis or implant upon temporary or permanent removal or loosening of the prosthesis or implant, such as in an invasive procedure. The method may include heating a portion of the prosthesis or implant to loosen the portion of the prosthesis or implant. In at least some examples, the method may include sequentially and / or cyclically thermally expanding and contracting a portion of the prosthesis or implant.

[0053] The method may include weakening fasteners for or of the prosthesis or implant, such as to aid in temporary or permanent removal of a portion of the prosthesis or implant. For example, where the prosthesis or implant is secured to bone, such as directly or indirectly, the method may include weakening the interface between the prosthesis or implant and the bone. The method may include weakening an attachment, such as by an adhesive or agent, between the prosthesis or implant and the patient.

[0054] The method may include heating a portion of the prosthesis or implant in vitro prior to inserting or applying the portion of the prosthesis or implant to the patient. Additionally or alternatively, the method may include heating a portion of the prosthesis or implant in vivo while the portion of the prosthesis or implant is attached to or disposed within the patient.

[0055] In at least some examples, the method may include heating a portion of a prosthesis or implant during a surgical procedure. The method may include an invasive surgical procedure. Alternatively, the method may include a non-invasive procedure. The method may involve treatment of a prosthesis or implant, but may not involve treatment of a patient as such.

[0056] The method may include in vivo use. The method may include heating a portion of the prosthesis or implant while the portion is positioned within and / or attached to the body. Additionally or alternatively, the method may include ex vivo use. The method may include in vitro use. The method may include heating a portion of the prosthesis or implant while the portion is positioned outside and / or detached from the body. In at least some examples, the method may include heating a portion of the prosthesis or implant ex vivo during a surgical procedure, such as when the prosthesis or implant (or a portion thereof) is detached and / or removed from the body.

[0057] The method can include heating a portion of a prosthesis or implant in a surgical procedure without excessively heating the patient's tissue. The method can include heating the portion of the prosthesis or implant to a temperature below a maximum temperature.

[0058] The maximum temperature may be associated with tissue damage. For example, the method may include only heating a portion of the prosthesis or implant to a temperature that is not associated with undesired tissue damage. The method may include preventing or at least minimizing tissue damage.

[0059] The method may include heating a portion of the prosthesis or implant to a temperature equal to or below a minimum temperature. The minimum temperature may be associated with infection prevention measures. For example, the minimum temperature may be associated with treating or at least combating an infection. The method may include heating a portion of the prosthesis or implant to a temperature within a range, such as from about 65°C to about 70°C. The method may include heating a portion of the prosthesis or implant to a target temperature. The method may include controlling the heating depending on the temperature of the portion of the prosthesis or implant and / or additional temperatures of other portions and / or tissues of the prosthesis or implant (e.g., bone, muscle, cartilage, nerve, etc.). The method may include controlling the heating depending on a heat sensor or thermometer. The method may include direct temperature measurement. The method may include operating a temperature measurement device. The method may include providing augmented reality and / or virtual reality. The method may include adapting the heating depending on the temperature measurement device, such as via power output to or from a coil. The method may include automatically adapting the heating.

[0060] Additionally or alternatively, the method may include manually adapting the heating. For example, the method may include an operator or user of the device manually adapting the heating depending on information the operator or user receives from a temperature measurement device. The method may include real-time visualization and / or measurement, such as provided by a display connected to or associated with the infrared thermal camera. The method may include adapting the heating depending on an accumulated amount of heating. The method may include calculating the accumulated amount of heating in real time. The method may include displaying the temperature and / or the accumulated amount of heating to a user or operator, such as a surgeon. In at least some examples, the method may include automatically adapting the heating with an integrated thermal sensor and (micro)controller included in the heating device.

[0061] The method may include heating only a portion of the prosthesis or implant. For example, the method may include not heating the entire prosthesis or implant. The method may include inducing heat to only a single portion of the prosthesis or implant at a time. The method may include not heating the entire prosthesis or implant simultaneously.

[0062] The method may include selectively heating a portion of a prosthesis or implant. The method may include selectively heating only a portion of an implant that is safe. The method may include selectively heating only a portion of an implant that is non-risk or low-risk. The method may include avoiding heating areas of the implant related to bone fixation (e.g., in the case of a total joint replacement) and / or areas of the prosthesis or implant that are close to or related to critical anatomical structures such as nerves (e.g., in the case of an infected elbow plate). Alternatively, high-risk areas (e.g., for loss of bone fixation or proximity of nerves / vessels) may be heated to a temperature equal to or lower than a lower temperature (e.g., for low-risk areas). The method may include targeting only the portion of the prosthesis or implant to be heated, such as with a precision coil.

[0063] The method may include inductively heating a first portion of the prosthesis or implant and not inductively heating a second portion of the prosthesis or implant. The method may include allowing heat transfer from the first portion of the prosthesis or implant to the second portion of the prosthesis or implant. The method may include utilizing the second portion of the prosthesis or implant as a heat sink for the first portion of the prosthesis or implant. Additionally or alternatively, the method may include cooling, such as actively cooling, the coil, and / or a portion of the prosthesis and / or another portion of the prosthesis or implant, and / or patient tissue.

[0064] The method may include sequentially heating two or more portions of the prosthesis or implant, such as by heating a first portion before heating a second portion of the prosthesis or implant.

[0065] In at least some instances, the method includes heating the entire prosthesis or implant.

[0066] The method may include sterilization. The method may include sterilizing using a sterilization device for sterilizing surgical instruments, such as a standard sterilization device for sterilizing items such as surgical drills, surgical saws, or the like. Sterilization may include one or more of autoclaving, dry heat, chemical sterilants, mechanical and / or ultrasonic cleaning.

[0067] In at least some examples, the method may include deforming the coil in dependence on a portion of a prosthesis or implant. The deformation may be plastic and / or elastic. The method may include deforming the coil to accommodate the prosthesis or implant. The method may include deforming the coil with the prosthesis or implant, such as by pressing the coil or the prosthesis or implant against the other of the coil or the prosthesis / implant. The method may include deforming the coil through manipulation by a user. For example, the method may include plastically and / or elastically deforming the coil so that the user conforms to the shape of a particular prosthesis or implant.

[0068] The method may include heating the prosthesis or implant for implantation and / or installation in a human body. Alternatively, the method may include heating the prosthesis or implant for implantation and / or installation in a non-human body, such as a non-human mammal. The method may include implanting and / or installing the prosthesis or implant. Additionally or alternatively, the method may include removing and / or detaching the prosthesis or implant.

[0069] The present invention may include one or more corresponding aspects, embodiments, or features, either separately or in various combinations, whether or not specifically set forth (including claimed) in that combination or separation. For example, it will be readily understood that a feature described as optional with respect to one aspect, example, embodiment, or claim may additionally be applicable with respect to another aspect, example, embodiment, or claim, without the need to explicitly and unnecessarily recite their various combinations and permutations herein (e.g., an apparatus of one aspect may include features of any other aspect). Optional features described with respect to a method may additionally be applicable to an apparatus or device, and vice versa. For example, an apparatus may be configured to perform method features of other aspects, examples, embodiments, or claims. Additionally, corresponding means for performing one or more of the described functions are also within the scope of this disclosure.

[0070] Embodiments of the present invention are now described, by way of example only, with reference to the accompanying drawings, in which: [Brief explanation of the drawings]

[0071] [Figure 1] 1 is a schematic diagram illustrating an apparatus for heating at least a portion of a prosthesis or implant according to a first example of the present disclosure. [Figure 2] FIG. 10 illustrates an apparatus for heating at least a portion of a prosthesis or implant according to a second example of the present disclosure. [Figure 3] FIG. 3 is a schematic diagram showing an electronic system for the device of FIGS. 1 and / or 2. [Figure 4] 3A-3C illustrate respective portions of a prosthetic implant for heating by the apparatus of FIGS. 1 and / or 2. [Figure 5] 3A-3C illustrate respective portions of a prosthetic implant for heating by the apparatus of FIGS. 1 and / or 2. [Figure 6]3A-3C illustrate respective portions of a prosthetic implant for heating by the apparatus of FIGS. 1 and / or 2. [Figure 7] 3A-3C illustrate respective portions of a prosthetic implant for heating by the apparatus of FIGS. 1 and / or 2. [Figure 8] 3A-3C illustrate respective portions of a prosthetic implant for heating by the apparatus of FIGS. 1 and / or 2. [Figure 9] 3A-3C illustrate respective portions of a prosthetic implant for heating by the apparatus of FIGS. 1 and / or 2. [Figure 10] 3A-3C illustrate respective portions of a prosthetic implant for heating by the apparatus of FIGS. 1 and / or 2. [Figure 11] 3A-3C illustrate respective portions of a prosthetic implant for heating by the apparatus of FIGS. 1 and / or 2. [Figure 12] 3 is a thermal image illustrating selective heating of an exemplary portion of a prosthetic implant by the apparatus of FIGS. 1 and / or 2. [Figure 13] 1 is a graph showing the complete eradication of Staphylococcus epidermidis biofilm from titanium alloy coupons after 3.5 minutes of heat shock at 65°C by induction heating followed by 24 hours of exposure to vancomycin 10 mg / L and rifampicin 1 mg in BHI medium. DETAILED DESCRIPTION OF THE INVENTION

[0072] 1, there is shown an apparatus 10 for heating at least a portion of a prosthesis or implant according to a first example of the present disclosure, wherein the apparatus 10 includes an induction heating device for inductively heating a portion of the prosthesis or implant (not shown in FIG. 1).

[0073] The device includes an external induction coil 12 configured to inductively heat a portion of a prosthesis or implant. The coil 12 is configured to inductively heat only a portion of the prosthesis or implant. As shown here, the external induction coil 12 is external to the body or housing 18 of the device 10. The induction coil 12 is configured for direct application to a portion of the prosthesis or implant, as shown in Figures 4 and subsequent figures. Here, the induction coil 12 is configured to directly contact the prosthesis or implant. The device 10 is configured to transfer energy to a portion of the prosthesis or implant without the energy first passing through the patient's skin. The coil 12 is sized and dimensioned smaller than the body portion associated with the prosthesis or implant. For example, here, the coil 12 has a diameter and longitudinal extent smaller than the limb associated with the prosthesis or implant (e.g., the coil 12 has a diameter smaller than the diameter of the patient's leg). Device 10 is configured to position a portion of a prosthesis or implant within a distance from or of coil 12, the distance being equal to or less than the dimension of coil 12. For example, device 10 is configured to position coil 12 closer to a portion of a prosthesis or implant than the diameter of coil 12. Coil 12 is herein configured for insertion into or through a surgical incision.

[0074] Device 10, as used herein, comprises a portable, handheld, pistol-style device for use with one hand by a user. Device 10 includes a pistol-style grip handle 15 for control with the holding hand, and includes a trigger-shaped actuator 16 operated by the holding hand. Actuator 16 is for at least partially controlling the supply of heat by device 10, such as by controlling power, e.g., the amount and / or duration, supplied to induction coil 12.

[0075] As shown in FIG. 1 , device 10 includes a low-power, low-voltage device. Such devices may be safer, more accessible, and / or easier to maintain. For example, low-voltage devices may be safer than mains- or grid-powered devices, particularly for use in surgical procedures. Here, the voltage may vary between about 12 volts and about 60 volts, depending on the specific requirements. For example, if a larger portion of the prosthesis or implant is to be heated, a larger battery may be fitted within battery compartment 14 inside device 10. Device 10 is configured to provide a pulsed electromagnetic field (PEMF) operating frequency of less than about 100 kHz.

[0076] Referring now to Figure 2, an apparatus 110 for heating at least a portion of a prosthesis or implant according to a second example of the present disclosure is shown. The apparatus 110 shown in Figure 2 is generally similar to the apparatus 10 shown in Figure 1, and like features are indicated with like reference numerals incremented by 100.

[0077] Thus, device 110 of Figure 2 includes an external induction coil 112 and a pistol-style grip handle 115. As shown in Figure 2, device 110 comprises a mains- or grid-powered device, such as powered via cable 119 and plug. It will be appreciated that mains- or grid-powered power via cable 119 is optional in that device 110 of Figure 2 may additionally or alternatively be powered via an internal battery power source.

[0078] 2, the apparatus 110 includes an active cooling system with an inlet supply 122 and an outlet supply 124 that respectively supply coolant to and from the coil 112. The coolant may be water, such as provided by a city water supply (not shown).

[0079] The apparatus 10, 110 shown in Figures 1 and 2 is configured to be sterilized using a sterilization device for sterilizing surgical instruments, such as a standard sterilization device for sterilizing items such as surgical drills, surgical saws, or the like. Sterilization may include one or more of autoclaving, dry heat, chemical sterilants, mechanical and / or ultrasonic cleaning. The apparatus 10, 110 is sized and dimensioned to be placed within a conventional or standard sterilization means for items such as surgical drills, surgical saws, or the like.

[0080] Referring now to FIG. 3, an example of an electronic system schematic 200 for the device 10, 110 of FIGS. 1 and / or 2 is shown. Accordingly, the exemplary device 10, 110 includes two internal inductors 230, 232, each greater than 75 microhenries and greater than 10 A. The external coil 212 corresponds to the coil 12, 112 shown in FIGS. 1 and 2. The pair of resistors 234, 236 shown are less than 600 ohms, with the specific value depending on the configuration of the capacitor bank 238 and the external coil 212. The capacitor bank 238 has a total capacitance of less than 10 microfarads, depending on the configuration of the external coil 212. The Schottky diodes 240, 242 are rated at greater than 60 V and 10 V, respectively. The power MOSFETs 244, 246 (metal-oxide-semiconductor field-effect transistors) are greater than 200 W and are U br dss is greater than 200 V. The battery 248 is between 12 V and 60 V, selected depending on the configuration of the external coil 212.

[0081] 4 through 11, there are shown several configurations of coils, numbered consecutively from 312 to 1012 in increments of 100 for ease of reference.

[0082] Although shown with discontinuous reference numbers for ease of reference, it will be understood that a single coil may be shown across multiple figures, such as when the coil is capable of being transformed into more than one of the configurations illustrated. Similarly, it will be understood that one or more of coils 312 through 1012 may be for the device of Figures 1 and / or 2.

[0083] 4-11 also illustrate portions of the prosthetic implants 380-1080, with FIGS. 4 and 6 illustrating the prosthetic implants 380, 580 in situ in the bone 382, ​​582. While the prosthetic implants 380, 480, 580, 680, 780, 880, 980, 1080 are illustrated ex vivo (particularly when separated from the bone 382, ​​582), it will be understood that the prosthetic implants 380, 480, 580, 680, 780, 880, 980, 1080 may be treated ex vivo, in vitro, such as before insertion or reinsertion into a patient (not shown). It will also be understood that in other examples, similar arrangements of coils 312-1012 and prosthetic implants 380-1080 may be placed in vivo within a patient (not shown).

[0084] FIG. 4 shows a prosthetic implant 380 in the form of a metal implant (hip stem) in bone 382 and a water-cooled hollow coil 312 that can selectively heat the metal implant (see, for example, FIG. 12).

[0085] FIG. 5 shows a prosthetic implant 480 in the form of a metal implant (hip stem) similar to that of FIG. 4 with the bone removed.

[0086] FIG. 6 shows a prosthetic implant 580 in the form of a metal implant (hip stem) in bone 582 and a "spring coil" 512 that allows selective heating of the metal implant.

[0087] FIG. 7 shows a prosthetic implant 680 in the form of a similar metal implant (hip stem).

[0088] FIG. 8 shows a prosthetic implant 780 in the form of a metal implant (hip stem) and a narrow, rigid, water-cooled hollow coil 712 .

[0089] 9 shows a prosthetic implant 880 in the form of a metal implant (hip stem) and a litz wire coil 812 and coil holder 813. The coil holder 813 is made from an electrically and thermally insulating material (e.g., plastic and / or ceramic). It will be appreciated that the coil holder may be useful for in vitro and / or in vivo use, such as for positioning the coil 812 relative to a portion 884 of the prosthetic implant 880.

[0090] FIG. 10 shows a prosthetic implant 980 in the form of a metallic implant (hip stem) and a flexible "spring coil" 912 that allows manipulation during surgery, for example in hard to reach places.

[0091] FIG. 11 shows a prosthetic implant 1080 in the form of a metallic implant (hip stem) and a coil 1012 having wire that is wrapped around the implant 1080 to form a custom coil.

[0092] The portions 384, 484, 584, 684, 784, 884, 984, 1084 of the prosthetic implant 380, 480, 580, 680, 780, 880, 980, 1080 can be directly heated by induction, and the portions 384, 484, 584, 684, 784, 884, 984, 1084 of the prosthetic implant 380, 480, 580, 680, 780, 880, 980, 1080 include a conductive metallic material as shown herein, such as one or more of steel, titanium, alloys, and / or cobalt chromium. The coil (FIGS. 4-11) may also include a magnetic flux concentrator to potentially increase its efficiency.

[0093] Portions 384, 484, 584, 684, 784, 884, 984, 1084 of the prosthetic implant 380, 480, 580, 680, 780, 880, 980, 1080 include at least one boundary or surface configured to engage, interact with, or interface with tissue, such as muscle and / or bone and / or cartilage tissue, and the like. The device 10, 110 is configured to directly and / or indirectly heat the boundary or surface. In at least some examples, the boundary or surface is comprised of an electrically conductive material. In other examples (not shown), the boundary or surface includes a non-conductive or low-conductive coating or layer, and the device 10, 110 is configured to indirectly heat the coating or layer by inducing heat into an associated electrically conductive material, such as beneath the coating or layer, where the heat is transferred, propagated, or passed from the electrically conductive material to the non-conductive or low-conductive material, such as by conduction.

[0094] As illustrated herein, in at least some examples, the coils 312-1012 are deformable depending on the portion of the prosthesis or implant. The deformation may be plastic and / or elastic. The coils 312-1012 are configured to deform to accommodate the prosthetic implant 380-1080.

[0095] It will be appreciated that when used in vivo during surgery, the device 10, 110 is configured to heat a portion of the prosthetic implant 380-1080 during a procedure without excessively heating the patient's tissue. The device 10, 110 is configured to heat the portion of the prosthetic implant 380-1080 to a temperature below a maximum temperature associated with tissue damage. For example, the device 10, 110 is configured to only heat the portion 384-1084 of the prosthetic implant 380-1080 to a temperature not associated with undesired tissue damage. Here, the device 10, 110 is configured to heat the portion 384-1084 of the prosthetic implant 380-1080 to a temperature below a minimum temperature associated with infection prevention measures. For example, the minimum temperature is associated with treating or at least combating an infection.

[0096] In vivo, the device 10, 110 may be configured to heat a portion 384-1084 of the prosthetic implant 380-1080 to a temperature in the range of about 38°C to 120°C, preferably in the range of 60°C to about 70°C, preferably for a period sufficient to destroy at least 80% of the biofilm formed by one or more invasive species causing the infection.

[0097] The device 10, 110 may be controlled dependent on additional temperatures, such as the temperature of a portion 384-1084 of the prosthetic implant 380-1080 and / or other portions and / or tissues of the prosthetic implant 380-1080 (e.g., bone, muscle, cartilage, nerve, etc.). The device 10, 110 may be controlled dependent on a thermal sensor or thermometer.

[0098] 12, a thermal image is shown illustrating selective heating of a portion of a prosthetic implant 1180 to a temperature above approximately 60° C., with heating limited to the targeted portion within the coil 1112. It will be appreciated that the apparatus 10, 110 may be controllable dependent upon such temperature measurements. For example, an operator may be provided with such updating real-time images from an infrared thermal camera during a procedure, even while using an augmented reality and / or virtual reality device. Thus, the operator may manually adapt the heating dependent upon information the operator or user receives from the infrared thermal camera.

[0099] In other embodiments (not shown), the device 10, 110 may be configured to automatically adapt heating, such that the device adapts heating depending on a calculated or determined cumulative amount of heating.

[0100] In alternative methods, particularly non-invasive methods, temperature measurement and control may be achieved via patient feedback. For example, particularly in procedures without anesthetics, temperature measurement may be achieved by patient indications of warmth and / or heat and / or pain. An operator, such as a surgeon or patient, may adapt the heat delivery accordingly.

[0101] Examples of methods for using the aforementioned coils and / or devices are provided below.

[0102] The method includes configuring a coil 12, 112, 212, 312, 412, 512, 612, 712, 812, 912, 1012, 1112 for direct application to a portion 384-1184 of a prosthetic implant 380-1080. The method includes applying the coil 12, 112, 212, 312, 412, 512, 612, 712, 812, 912, 1012, 1112 directly to a portion 384-1184 of the prosthetic implant 380-1080. The method includes directly contacting the prosthetic implant 380-1080 with the coil 12, 112, 212, 312, 412, 512, 612, 712, 812, 912, 1012, 1112. The method includes transferring energy to a portion 384-1184 of the prosthetic implant 380-1080 without the energy first passing through the patient's skin. The method includes avoiding or at least minimizing the energy passing through the patient's skin and / or tissue. The method includes positioning the portion 384-1184 of the prosthetic implant 380-1080 within a distance from or of the coil 12, 112, 212, 312, 412, 512, 612, 712, 812, 912, 1012, 1112, which distance is less than or equal to a dimension of the coil 12, 112, 212, 312, 412, 512, 612, 712, 812, 912, 1012, 1112. The method includes positioning the coil 12, 112, 212, 312, 412, 512, 612, 712, 812, 912, 1012, 1112 and / or the portion 384-1184 of the prosthetic implant 380-1080. For example, the method includes positioning the coil 12, 112, 212, 312, 412, 512, 612, 712, 812, 912, 1012, 1112 closer to the portion 384-1184 of the prosthetic implant 380-1080 than a diameter of the coil 12, 112, 212, 312, 412, 512, 612, 712, 812, 912, 1012, 1112. The method includes inserting a coil 12, 112, 212, 312, 412, 512, 612, 712, 812, 912, 1012, 1112 into or surgically through a surgical incision.

[0103] The method includes supplying heat via the handheld device 10, 110. The method includes controlling the administration of the heat at least in part, such as by controlling power, such as the amount and / or duration of power, supplied to the induction coil 12, 112, 212, 312, 412, 512, 612, 712, 812, 912, 1012, 1112.

[0104] The method includes providing an operating frequency of a pulsed electromagnetic field (PEMF) of less than about 100 kHz.

[0105] The methods include treating an infection, such as a prosthetic joint infection (PJI). The methods include methods for treating an infection. The methods include killing at least the bacteria. The methods include heating the bacteria to a critical temperature at which the bacteria are at least weakened, such as to aid in infection prevention measures by administered drugs and / or other means, such as immune defense mechanisms.

[0106] Thus, the method may further comprise administering an agent capable of suppressing infection, preferably a biocide or bacteriostatic agent, more preferably an antibiotic composition effective in reducing the active count of isolated microorganisms, at a concentration at the prosthesis or implant placement suitable for achieving a reduction in the active count of microorganisms to at least assist in treating the infection. Preferably, the antibiotic composition comprises at least one antibiotic combination selected from the following antibiotic classes: penicillins, cephalosporins, aminoglycosides, tetracyclines, sulfonamides, macrolides, and / or quinolones, or the group including imipenem, aztreonam, chloramphenicol, erythromycin, clindamycin, spectinomycin, vancomycin, rifampin, bacitracin, methenamine, tobramycin, and nitrofurantoin. Preferably, the method may comprise administering the antibiotic treatment at a dose effective to produce biocidal or bacteriostatic, preferably bacteriostatic or fungistatic, concentrations at the biofilm site after heat treatment. Alternatively, antibiotics or other suitable compounds may be administered prior to induction heating, thereby increasing the effectiveness of the heat stress. Antibiotics and other compounds may also be used during heating cycles to kill or slow the growth of bacteria if multiple heating cycles are required. Thus, the present invention also relates to medicaments capable of suppressing or eliminating infections, preferably medicaments comprising biocidal compositions, used to treat infections in patients in need thereof in combination with heat treatment according to the present invention.

[0107] Figure 13 is a graph showing the complete eradication of S. epidermidis biofilm from titanium alloy coupons after 3.5 minutes of heat shock at 65°C by induction heating followed by 24 hours of exposure to vancomycin 10 mg / L and rifampicin 1 mg in BHI medium. N = 6 or more for each group. This experiment demonstrates that there can be a synergistic effect between heat shock and antibiotics, with active counts increasing by Log(CFU / cm). 2 ), i.e. 1 cm 2The results are expressed as log colony forming units per 1000 colony forming units (CFU). Clearly, the combination of these treatment steps demonstrates a strong synergistic effect between the mixed infection treatment method, which involves heating the bacteria to a critical temperature at which they are at least weakened, and the subsequent infection prevention measures with the administered drugs, and therefore this combination is superior to separate treatments. It should be noted that the method of the present invention may also allow the amount of antibiotics to be significantly reduced.

[0108] The method includes applying heat to a biofilm associated with the prosthetic implant 380-1180. Additionally or alternatively, the method includes heating at least a portion 384-1184 of the prosthetic implant 380-1080 to assist in attachment and / or detachment of the prosthetic implant 380-1180. For example, the method includes heating a portion 384-1184 of the prosthetic implant 380-1080 to expand the portion 384-1184 of the prosthetic implant 380-1080. In at least some examples, the portion 384-1184 of the prosthetic implant 380-1080 to be heated may be associated with fixation of the prosthetic implant 380-1180. For example, the portion 384-1184 of the prosthetic implant 380-1080 comprises a socket or recess. The socket or recess may be associated with another portion 384-1184 of the prosthetic implant 380-1080, such as to receive another part or component of the prosthetic implant 380-1080. For example, if the prosthetic implant 380-1180 includes a fastener or fastener for fixation, the method may include heating the fitting or fastener, or at least a portion thereof, to assist in fitting and / or removing the prosthetic implant 380-1180. The method may include thermally expanding and / or contracting the portion 384-1184 of the prosthetic implant 380-1080. The method may include heating the portion 384-1184 of the prosthetic implant 380-1080 before and / or during the attachment, connection, or insertion of the portion 384-1184 of the prosthetic implant 380-1080. The method includes heating to facilitate the mounting, connecting, or insertion, such as by thermally adapting clearances or tolerances to provide a loose fit when mounted, connected, or inserted. The method includes subsequent cooling, such as passive cooling, to thermally adapt clearances or tolerances to provide a tight fit when mounted, connected, or inserted.The method includes heating a portion 384-1184 of the prosthetic implant 380-1080 during temporary or permanent removal or loosening of the prosthetic implant 380-1180, such as during an invasive procedure. The method includes heating a portion 384-1184 of the prosthetic implant 380-1080 to loosen the prosthetic implant 380-1180. In at least some examples, the method includes sequentially and / or cyclically thermally expanding and contracting the portion 384-1184 of the prosthetic implant 380-1080.

[0109] The method includes weakening a fastener for or of the prosthetic implant 380-1180, such as to aid in temporary or permanent removal of a portion 384-1184 of the prosthetic implant 380-1180. For example, if the prosthetic implant 380-1180 is fixed to bone, such as directly or indirectly, the method includes weakening the interface between the prosthetic implant 380-1180 and the bone. The method includes weakening an adhesion, such as by an adhesive or agent, between the prosthetic implant 380-1180 and the patient.

[0110] The method includes heating a prosthetic portion of the implant in vitro prior to inserting or applying a portion 384-1184 of the prosthetic implant 380-1080 to the patient. Additionally or alternatively, the method includes heating a portion 384-1184 of the prosthetic implant 380-1080 in vivo while the portion 384-1184 of the prosthetic implant 380-1080 is attached to or positioned within the patient or while the portion 384-1184 of the prosthetic implant 380-1080 is attached to or positioned within the patient.

[0111] In at least some examples, the method includes heating a portion 384-1184 of the prosthetic implant 380-1080 during a surgical procedure. The method includes an invasive surgical procedure. Alternatively, the method includes a non-invasive procedure. The method includes treatment of the prosthetic implant 380-1180 but does not include treatment of the patient as such.

[0112] The method includes in vivo use. The method includes heating the portion 384-1184 of the prosthetic implant 380-1080 while the portion 384-1184 is positioned within and / or attached to the body. Additionally or alternatively, the method includes ex vivo use. The method includes in vitro use. The method includes heating the portion 384-1184 of the prosthetic implant 380-1080 while the portion 384-1184 is positioned outside and / or detached from the body. In at least some examples, the method includes heating the portion 384-1184 of the prosthetic implant 380-1080 ex vivo during a surgical procedure, such as when the prosthetic implant 380-1180 (or a portion thereof) is detached and / or removed from the body.

[0113] The method includes heating a portion 384-1184 of a prosthetic implant 380-1080 during a surgical procedure without excessively heating a patient's tissue. The method includes heating the portion 384-1184 of the prosthetic implant 380-1080 to a temperature below a maximum temperature. The maximum temperature may be associated with tissue damage. For example, the method includes heating the portion 384-1184 of the prosthetic implant 380-1080 only to a temperature not associated with undesired tissue damage. The method includes preventing or at least minimizing tissue damage.

[0114] The method includes heating a portion 384-1184 of the prosthetic implant 380-1080 to a temperature equal to or less than a minimum temperature. The minimum temperature may be associated with infection prevention measures. For example, the minimum temperature may be associated with treating or at least combating the infection. The method includes heating the portion 384-1184 of the prosthetic implant 380-1080 to a temperature within a range, such as a range of about 65°C to about 70°C.

[0115] The method includes heating a portion 384-1184 of the prosthetic implant 380-1080 to a target temperature. The method includes controlling the heating depending on the temperature of the portion 384-1184 of the prosthetic implant 380-1080 and / or additional temperatures of other portions and / or tissues of the prosthetic implant 380-1180 (e.g., bone, muscle, cartilage, nerve, etc.). The method includes controlling the heating depending on a heat sensor or thermometer. The method includes direct temperature measurement. The method includes operating a temperature measurement device. The method includes providing augmented reality and / or virtual reality. The method includes adapting the heating depending on the temperature measurement device, such as via power output to or from the coil 12, 112, 212, 312, 412, 512, 612, 712, 812, 912, 1012, 1112. The method includes automatically adapting the heating.

[0116] Additionally or alternatively, the method includes manually adapting the heating. For example, the method includes manually adapting the heating by an operator or user of the device depending on information the operator or user receives from a temperature measurement device. The method includes real-time visualization and / or measurement, such as provided by a display connected to or associated with the infrared thermal camera. The method includes adapting the heating depending on accumulated heating. The method includes calculating accumulated heating in real time. The method includes displaying the temperature and / or accumulated heating to a user or operator, such as a surgeon. In at least some examples, the method includes automatically adapting the heating with an integrated thermal sensor and (micro)controller included in the heating device 10, 110.

[0117] The method includes heating only a portion 384-1184 of the prosthetic implant 380-1080. For example, the method may include not heating the entire prosthetic implant 380-1180. The method includes inducing heat to only a single portion 384-1184 of the prosthetic implant 380-1080 at a time. The method includes not heating the entire prosthetic implant 380-1180 simultaneously.

[0118] The method includes selectively heating a portion 384-1184 of the prosthetic implant 380-1080. The method includes selectively heating only the portion of the implant that is safe. The method includes selectively heating only the portion of the implant that is non-risk or low-risk. The method includes avoiding heating regions of the implant related to bone fixation (e.g., in the case of a total joint replacement) and / or regions of the prosthetic implant 380-1180 that are adjacent to or associated with critical anatomical structures such as nerves (e.g., in the case of an infected elbow plate). Alternatively, high-risk regions (e.g., for loss of bone fixation or proximity of nerves / vessels) are heated to a temperature equal to or lower than a lower temperature (e.g., for low-risk areas).

[0119] The method includes targeting only a portion 384 to 1184 of the prosthetic implant 380 to 1080 to be heated with precision coils 12, 112, 212, 312, 412, 512, 612, 712, 812, 912, 1012, 1112, etc.

[0120] The method includes inductively heating a first portion 384-1184 of the prosthetic implant 380-1080 while not inductively heating a second portion 384-1184 of the prosthetic implant 380-1080. The method includes enabling heat transfer from the first portion 384-1184 of the prosthetic implant 380-1080 to the second portion 384-1184 of the prosthetic implant 380-1080. The method includes utilizing the second portion 384-1184 of the prosthetic implant 380-1080 as a heat sink for the first portion 384-1184 of the prosthetic implant 380-1080. Additionally or alternatively, the method includes cooling, such as actively cooling, the coils 12, 112, 212, 312, 412, 512, 612, 712, 812, 912, 1012, 1112 and / or portions of the prosthesis and / or other portions of the prosthetic implants 380 to 1180 and / or patient tissue.

[0121] The method includes sequentially heating two or more portions of the prosthetic implant 380-1180, such as by heating a first portion before heating a second portion 384-1184 of the prosthetic implant 380-1080.

[0122] In at least some instances, the method includes heating the entire prosthetic implant 380-1180, 380-1180.

[0123] The method includes sterilization using a sterilization device for sterilizing surgical instruments, such as a standard sterilization device for sterilizing items such as surgical drills, surgical saws, or the like, including one or more of autoclaving, dry heat, chemical sterilants, mechanical and / or ultrasonic cleaning.

[0124] In at least some examples, the method includes deforming the coil 12, 112, 212, 312, 412, 512, 612, 712, 812, 912, 1012, 1112 in dependence upon the portion 384-1184 of the prosthetic implant 380-1080. The deformation is plastic and / or elastic. The method includes deforming the coil 12, 112, 212, 312, 412, 512, 612, 712, 812, 912, 1012, 1112 to accommodate the prosthetic implant 380-1080. The method includes deforming the coil 12, 112, 212, 312, 412, 512, 612, 712, 812, 912, 1012, 1112 or the prosthetic implant 380-1180 with the prosthetic implant 380-1180, such as by pressing the coil 12, 112, 212, 312, 412, 512, 612, 712, 812, 912, 1012, 1112 or the other of the prosthesis / implant. The method includes user manipulation to deform the coil 12, 112, 212, 312, 412, 512, 612, 712, 812, 912, 1012, 1112. For example, the method includes user plastically and / or elastically deforming the coil 12, 112, 212, 312, 412, 512, 612, 712, 812, 912, 1012, 1112 to conform to the shape of a particular prosthetic implant 380-1080.

[0125] The method includes heating the prosthetic implant 380-1180 for implantation and / or installation in a human body. Alternatively, the method includes heating the prosthetic implant 380-1180 for implantation and / or installation in a non-human body, such as a non-human mammal. The method includes implanting and / or installing the prosthetic implant 380-1180. Additionally or alternatively, the method includes removing and / or detaching the prosthetic implant 380-1180.

[0126] While particular embodiments of the present invention have been described above, it will be understood that departures from the described embodiments may still fall within the scope of the present invention.

[0127] It will be understood that any of the above-described devices may have other functions in addition to those mentioned, and that these functions may be performed by the same device.

[0128] Applicant hereby separately discloses each individual feature described in this specification and any combination of two or more such features to the extent that such feature or combination is operable based on the specification as a whole in light of the general knowledge known to anyone skilled in the art, without limiting the scope of the claims, regardless of whether such feature or combination of features solves any problem disclosed herein.

[0129] Applicant indicates that aspects of the invention may consist of any such individual feature or combination of features. It should be understood that the embodiments described herein are merely exemplary and that various modifications may be made thereto without departing from the scope or spirit of the invention. [Explanation of symbols]

[0130] 10 equipment 12 External induction coil 12 coils 14 Battery Compartment 15 Pistol grip handle 16 Actuators 18 Housing 110 Equipment 112 External induction coil 115 Pistol-shaped grip handle 119 Cable 122 Inflow supply section 124 Outflow Supply Section 212 External Coil 234, 236 resistor 238 Capacitor Bank 240, 242 Schottky diodes 244, 246 Power MOSFET 248 Battery 312 coil, water-cooled hollow coil 380 Prosthetic Implants 380 Prosthetic Implants 382 bones 384 part 412 Coil 480 Prosthetic Implants 484 part 512 "Spring Coil" 580 Prosthetic Implants 582 bones 584 part 612 Coil 680 Prosthetic Implants 684 part 712 Narrow rigid water-cooled hollow coil 780 Prosthetic Implants 784 part 812 Litz wire coil 813 Coil Holder 880 Prosthetic Implants 884 part 912 "Spring Coil" 980 Prosthetic Implants 984 part 1012 coil 1080 Prosthetic Implants 1112 Coil 1180 Prosthetic Implants 1084 part

Claims

[Claim 1] 1. A medical induction heating device configured to heat at least a portion of a prosthesis or implant to a temperature and for a time period suitable for reducing the active count of invasive cell species that form a biofilm, the device comprising at least one external induction coil, the external induction coil being external to a body or housing of the device, the coil being a coil of a size and dimensions smaller than the body portion associated with the prosthesis or implant.

Images