Heating device and method

Abstract

A medical induction heating device (10) for heating at least a portion of a prosthesis or implant. The device (10) has at least one external induction coil that is external to a body or housing of the device (10). The coil (12) is sized and dimensioned to be smaller than the body portion associated with the prosthesis or implant.

Description

Technical Field

[0001] The present invention relates to an apparatus for heating. The present invention relates in particular, but not exclusively, to an apparatus and method for inductively heating a prosthesis or implant or at least a part thereof, such as for treating biofilm infections of metal implants. Background Art

[0002] Implant infection is a major problem in elective and trauma surgery. A significant proportion of prosthetic implants, and an even greater proportion of implants in fractures, become infected.

[0003] Such infections can trigger an immune response, at least to help fight infection, especially when used in combination with antibiotics and / or other drugs. However, especially in the case of undesirable biofilms generated on or at the prosthesis, treatment is usually performed by invasive surgery. The infected area is opened, cleaned and treated. In order to effectively eradicate the infection, it may be necessary to keep the wound open for a considerable period of time, which usually causes discomfort to the patient. Some prior art processes disclose heating of a limb or patient including an implant, but require very high field strengths and may cause internal burns due to the difficulty in controlling the spread of heat.

[0004] For example, in the case where a hip prosthesis is associated with infection, an existing (or new) wound is opened to access the hip prosthesis. The hip prosthesis is exposed to allow attempts to eradicate the infection by thoroughly cleaning the prosthesis and surrounding tissue. In some cases, the infection may require removal of the prosthesis, such as to replace it with a new prosthesis.

[0005] US-A-2011 / 251687 discloses a small coil device to inductively heat a small oral shape memory material implant for less than 5 seconds so that the small oral shape memory material returns to its original shape after being introduced into the human ear. However, the size of the coil does not allow the generation of a sufficiently strong field to heat the implant or prosthesis, thereby reducing the biofilm on the surface of the implant or prosthesis, as exemplified in the data related to the eddy current penetration depth in nitinol summarized herein. WO2018 / 013935 discloses a method and apparatus for heating an implant by subjecting the entire body of the patient to a magnetic field. Although this method can heat the implant, it is difficult to control the supplied field and energy to quantify or concentrate the field and energy at a specific area, resulting in increased tissue damage, which may lead to failure of fixation and subsequent revision surgery. Moreover, in the presence of infection, the heat generated may be quickly dissipated by the surrounding fluid, thus making the disclosed method unsuitable.

[0006] An object of one or more aspects, examples, embodiments or claims of the present disclosure is to solve or at least alleviate one or more problems of the prior art such as described herein or otherwise. Summary of the invention

[0007] According to a first aspect, there is provided an apparatus for heating at least part of a prosthesis or implant.

[0008] The apparatus may comprise an induction heating apparatus for inductively heating a portion of a prosthesis or implant.

[0009] The portion of the prosthesis or implant may be heatable by induction.The portion of the prosthesis or implant may be directly heatable by induction.

[0010] The device may include a coil configured to inductively heat the portion of the prosthesis or implant. The coil may be configured to inductively heat only the 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 be applied directly to the portion of the prosthesis or implant. In at least some examples, the induction coil may be configured to directly contact the prosthesis or implant. The device may be configured to transfer energy to the portion of the prosthesis or implant without the energy first passing through the patient's skin. The size and dimensions of the coil may be designed to be smaller than the body portion associated with the prosthesis or implant. For example, the coil may include a diameter and / or longitudinal length that is smaller than a limb associated with the prosthesis or implant (e.g., the coil may include a diameter that is smaller than the diameter of the patient's leg). The device may be configured to position the portion of the prosthesis or implant within a distance from the coil or within a distance of the coil, the distance being less than or equal to the size of the coil. For example, the device may be configured to position the coil closer to the portion of the prosthesis or implant than the diameter of the coil. The coil may be configured to be inserted into or through a surgical incision.

[0011] The prosthesis or implant may comprise a conductive material. The portion of the prosthesis or implant may comprise a conductive material. The prosthesis or implant may comprise a metal. The prosthesis or implant may comprise one or more of the following materials: steel; titanium; one or more alloys; cobalt chromium. The conductive material may be induction heatable.

[0012] The device may include a handheld device. The device may include a one-handed device. The device may be configured to be used by a single hand of a user. The device may include a pistol-style device. The device may include a handle for grasping by a single hand. The single hand may be a left hand or a right hand, or either of the left hand or the right hand. The handle may include a pistol grip. The device may be configured to be controlled by the grasping hand. The device may include an actuator for operation by the grasping hand. The actuator may include a trigger. The actuator may be used to at least partially control the heat applied by the device, such as by controlling the power supplied to the induction coil, such as the amount and / or duration of the power.

[0013] 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 less than or equal to about 60 volts. In at least some examples, the voltage may be less than or equal to about 50 volts; less than or equal to about 30 volts; less than or equal to about 20 volts; or equal to about 12 volts. The device may be configured to provide an operating frequency of a pulsed electromagnetic field (PEMF) of less than about 100 kHz. The device may include a battery powered device. Additionally or alternatively, the device may include a mains or grid powered device, such as power distribution or supply via a cable and plug.

[0014] 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 the bacteria to a critical temperature whereby the bacteria are at least weakened, thereby assisting in controlling the infection by other means such as administered medications and / or immune defense mechanisms. The device may be configured to apply heat to a biofilm associated with a prosthesis or implant.

[0015] The portion of the prosthesis or implant includes at least one boundary or surface configured to engage, interact, or interface with tissue, such as muscle and / or bone and / or cartilage tissue.

[0016] The term "prosthesis or implant" in this article may relate to an orthopedic implant, for example, total joint replacement, total or hemi-arthroplasty; a total joint prosthesis; a joint replacement; for example, a hip prosthesis; a joint replacement implant; a joint prosthesis; a joint reconstruction prosthesis; a joint reconstruction implant; a fracture fixation device, including but not limited to plates, screws, nails, staples, rods, wires, pins, external fixators; a joint distraction device, i.e., an external fixator. Preferably, the term "prosthesis or implant" refers to a loaded or loadable implant. For example, during a joint replacement surgery, also known as replacement arthroplasty, a joint implant is inserted or otherwise attached to a bone that is ready to receive the implant, and the implant is fastened to achieve reliable stability or fixation for supporting the load. Therefore, the term "prosthetic implant" in this article preferably refers to a (partial) metal device that has a biomechanical function (one or more) of being implanted near a bone, implanted into a bone, or implanted into a bone.

[0017] The term "invasive species" may relate to specific invasive microorganisms, particularly bacteria, to form colonies and ultimately form biofilms. Biofilms generally include aggregates of microbial organisms embedded in a highly hydrated matrix of an exopolymer that is generally a polysaccharide and / or other macromolecular mass. Biofilms may include single or multiple microbial species and are easily adhered to the surface of a prosthesis and / or implant. Due to the structural matrix established during biofilm formation, colonized cells are generally allowed to withstand conventional therapeutic doses of antibiotics, and the glycocalyx matrix appears to act as a barrier to protect and isolate microorganisms from host defense mechanisms, such as antibodies and phagocytes, and antimicrobial agents (including surfactants, biocides, and antibiotics), so it is generally difficult to prevent the colonization of microorganisms associated with biofilms and to eradicate microorganisms associated with biofilms. Once established, biofilms themselves may be difficult to treat, and in fact provide an infection reservoir that may cause infection recurrence after antibiotic treatment. Biofilm infections are generally associated with septic arthritis, where formation of biofilms on joints or implant surfaces can lead to chronic and recurrent infections. In addition to sepsis, biofilm infections can also cause destruction of joint surface materials, particularly in implants such as bone prostheses, necessitating an additional surgery or surgeries, often referred to as corrective or revision surgeries, to remove infectious material, as well as necrotic or infected tissue.

[0018] The term "activity count" herein relates to a measurement used to determine active or viable invasive microorganisms in or derived from a biofilm after treatment. For example, this can be accomplished by a probe activity count assay (PAC) or by different cell counting methods or protocols.

[0019] The device can be configured to heat a boundary or surface. The device can be configured to heat a boundary or surface directly and / or indirectly. In at least some examples, the boundary or surface includes a conductive material. In at least some examples, the boundary or surface includes a non-conductive or less conductive material associated with a conductive material. For example, a prosthesis or implant can include a non-conductive or less conductive coating or layer, and the device is configured to indirectly heat the coating or layer by inductive heating in an associated conductive material, such as beneath the coating or layer, with heat being transferred or propagated from the conductive material to or through the non-conductive or less conductive material, such as by conduction.

[0020] In addition or alternatively, the device can be configured to heat at least part of a prosthesis or implant to help attach and / or detach a prosthesis or implant. For example, the device can be configured to heat the portion of a prosthesis or implant to expand the portion of the prosthesis or implant. In at least some examples, the portion of the prosthesis or implant to be heated can be associated with the fixation of the prosthesis or implant. For example, the portion of the prosthesis or implant can include a recess or a notch. The recess or notch can be associated with another portion of the prosthesis or implant, such as another portion or member for receiving the prosthesis or implant. For example, in the case where the prosthesis or implant includes a fixing or a tightening member for fastening, the device can be configured to heat accessories or fasteners, or at least a portion thereof, to help apply and / or remove the prosthesis or implant. The device can be configured to thermally expand and / or contract the portion of the prosthesis or implant. In at least some examples, the device can be configured to thermally expand and contract the portion of the prosthesis or implant sequentially and / or periodically.

[0021] The device can be configured to weaken a tightening member for a prosthesis or implant, such as to assist in temporarily or permanently removing the portion of the prosthesis or implant. For example, where the prosthesis or implant has been fastened to a bone, such as directly or indirectly, the device can be configured to weaken an interface connection between the prosthesis or implant and the bone. The device can be configured to weaken a bond between the prosthesis or implant and the patient, such as by a bonding means or a bonding agent.

[0022] The device may be configured to heat the portion of the prosthesis of the implant in vitro before the portion of the prosthesis or implant is inserted or applied to the patient. Additionally or alternatively, the device may be configured to heat the portion of the prosthesis or implant in vivo while the portion of the prosthesis or implant is attached to or located within the patient.

[0023] In at least some examples, the device can be configured to heat the portion of the prosthesis or implant during a surgical procedure. The surgical procedure can include an invasive surgical procedure. Alternatively, the surgical procedure can include a non-invasive surgical procedure.

[0024] The device may be configured for in vivo use. The device may be configured to heat the portion of a prosthesis or implant while the portion of the prosthesis or implant is located within the body and / or attached to the 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 the portion of a prosthesis or implant while the portion of the prosthesis or implant is located outside the body and / or separated from the body. In at least some examples, the device may be configured to heat the portion of a prosthesis or implant ex vivo during a surgical procedure, such as at a location where the prosthesis or implant (or portion thereof) is separated from the body and / or removed from the body.

[0025] The device can be configured to heat the portion of the prosthesis or implant during a surgical procedure without unduly heating patient tissue. The device can be configured to heat the portion of the prosthesis or implant to a temperature equal to or less than a maximum temperature. The maximum temperature may be associated with tissue damage. For example, the device can be configured to heat the portion of the prosthesis or implant only to a temperature that is not associated with undesirable tissue damage.

[0026] The device may be configured to heat the portion of the prosthesis or implant to a temperature equal to or lower than a minimum temperature. The minimum temperature may be associated with infection control. For example, the minimum temperature may be associated with killing or at least combating infection.

[0027] In at least some examples, 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 examples, the apparatus may be configured to heat the portion of the prosthesis or implant to a temperature within a range, such as a temperature within a range of about 65°C to about 70°C. Preferably, the portion of the prosthesis or implant is heated to a temperature within a range 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 invasive cell species that form a biofilm.

[0028] The device may be configured to heat the portion of the prosthesis or implant to a target temperature. The device may be controlled based on the temperature of the portion of the prosthesis or implant, and / or one or more additional temperatures of one or more other portions and / or tissues (e.g., bones, muscles, cartilage, nerves, etc.) of the prosthesis or implant. The device is controllable based on a thermal sensor or thermometer. In at least some examples, the device may be controlled based on one or more direct temperature measurements. The device may be configured to operate with a temperature measuring device. The temperature measuring device may include one or more sensors and / or one or more cameras. The camera may include an infrared thermal imaging camera. The temperature measuring device may include an augmented and / or virtual reality device. The device may be configured to adjust heating based on the temperature measuring device, such as via power output to or from a coil. The device may be configured to automatically adjust heating. For example, the device may include a temperature measuring device, or at least communicate data with the temperature measuring device. In addition or alternatively, the device may be configured to manually adjust heating. For example, an operator or user of the device may manually adjust the heating through the device based on information received by the operator or user from the temperature measuring device. The device may operate, such as with a display, based on real-time visualization and / or measurement, the display being connected to or provided by the infrared thermal imaging camera. The device may be configured to adjust heating based on the cumulative thermal dose. The temperature measuring device or related device may be configured to calculate the cumulative thermal dose in real time. The temperature measuring device or related device may be configured to display one or more temperatures and / or one or more cumulative thermal doses to a user or operator such as a surgeon. In at least some examples, the device may include a thermal sensor and a (micro)controller in one piece.

[0029] The device may be configured to heat only a portion of a 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 a prosthesis or implant at a time. The device may be configured not to heat the entire prosthesis or implant at the same time.

[0030] The device can be configured to selectively heat the portion of the prosthesis or implant. The device can be configured to selectively heat only safe portions of the implant. The device can be configured to selectively heat only portions of the implant that are free of or at low risk. The device can be configured to avoid heating areas of implants associated with bone fixation (e.g., for total joint replacement), and / or areas of the prosthesis or implant that are close to or associated with important anatomical structures such as nerves (e.g., in the case of an infected plate in the elbow joint). Alternatively, high-risk areas (e.g., causing failure of bone fixation or close to nerves / blood vessels) can be heated to or reach one or more lower temperatures (e.g., relative to low-risk areas). The coil can be a precision coil for aligning only the portion of the prosthesis or implant to be heated.

[0031] The device may be configured to inductively heat a first portion of a prosthesis or implant without inductively heating a second portion of the prosthesis or implant. The device may be configured to allow heat to be transferred 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 used to cool the coil.

[0032] The apparatus may be configured to sequentially heat two or more portions of a prosthesis or implant, for example by heating a first portion before heating a second portion of the prosthesis or implant.

[0033] In at least some examples, at least a portion of a prosthesis or implant includes the entire prosthesis or implant.

[0034] The device may be configured for sterilization. The device may be configured for sterilization using a sterilization apparatus used for sterilizing surgical equipment, such as a standard sterilization apparatus used for sterilizing surgical drills, surgical saws, and the like. Sterilization may include one or more of the following: autoclaving; dry heat; one or more chemical sterilants; mechanical and / or ultrasonic cleaning. The device may be sized and dimensioned to be located in a conventional or standard sterilization apparatus such as used for surgical drills, surgical saws, and the like.

[0035] The device may include one or more disposable components. For example, the device may include one or more battery cells. In at least some examples, one or more battery cells are removed prior to sterilization. A new one or more battery cells may be inserted into or provided to the device for subsequent use of the device after sterilization. The device may include one or more detachable components. For example, an external coil may be detachable and optionally reattachable.

[0036] In at least some examples, the coil can be deformed according to the portion of the prosthesis or implant. The deformation can be plastic and / or elastic. The coil can be configured to deform to fit the prosthesis or implant. The coil can be configured to deform by the prosthesis or implant. The coil can be configured to deform by manipulation by a user. For example, a user can plastically and / or elastically deform the coil to fit the shape of a particular prosthesis or implant.

[0037] The prosthesis or implant may include a prosthesis or implant for implantation into a human body and / or attachment to a human body. Alternatively, the prosthesis or implant may include a prosthesis or implant for implantation into a non-human body and / or attachment to a non-human body, such as a non-human mammal.

[0038] According to another aspect, a system or assembly for heating at least a portion of a prosthesis or implant is provided. The system or assembly may include an apparatus and at least a portion of the prosthesis or implant. The apparatus may include an apparatus of any other aspect, claim, example, or embodiment. 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 apparatus may be configured according to the at least portion of the prosthesis or implant. For example, the apparatus may include a coil and / or a power source configured for a characteristic of the at least portion of the prosthesis or implant. The system or assembly may include an array of coils, such as an interchangeable and / or disposable coil. The system or assembly may include a temperature control mechanism. The temperature control mechanism may be a temperature control mechanism of any other aspect, example, claim, or embodiment. The temperature control mechanism may be a portion incorporated into or linked 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 measuring device may be a temperature measuring device of any other aspect, claim, embodiment, or example.

[0039] According to another aspect, a method of heating at least a portion of a prosthesis or implant is provided.

[0040] The method may include in vitro heating. The method may include ex vivo heating. Additionally or alternatively, the method may include in vivo heating.

[0041] The method may comprise an induction heating method for inductively heating the portion of the prosthesis or implant.

[0042] The method may comprise directly heating the portion of the prosthesis or implant by induction.

[0043] On the one hand, the present invention also relates to a method for reducing the active count of microorganisms, which form biofilms on a wide area on the surface of a prosthesis or implant. On the other hand, the present invention also provides a method, when the untreated antibiotic cannot attack the biofilm without heat treatment, the method enhances the effect of the antibiotic component in reducing the antibiotic resistance effect of the biofilm. In a typical embodiment, the biofilm is mainly composed of bacteria, and the biocide includes an antibiotic, such as one of penicillin, cephalosporin, aminoglycoside, tetracycline, sulfonamide and quinolone. Alternatively, the biocide can include a compound that can be used for sterilization, for example, chlorhexidine. Another part of the present invention is a method, which enhances the effect of the antibiotic component in reducing the active count of microorganisms, which form biofilms on a wide area on the surface of a prosthesis or implant, wherein the effect of the antibiotic is enhanced by heat treatment of the prosthesis or implant, wherein, in the presence of the antibiotic, the biofilm microorganisms are attacked from a wide area on the inner surface of the biofilm, wherein the concentration of the antibiotic is less than the concentration required to effectively reduce the biofilm microorganisms without heat treatment.

[0044] The method may include configuring the coil to inductively heat the portion of the prosthesis or implant. The method may include inductively heating only the portion of the prosthesis or implant. The method may include inductively heating using an external induction coil, the external induction coil being external to the body and / or housing of a heating device such as any other aspect, embodiment, example or claim. The method may include configuring the coil to be applied directly to the portion of the prosthesis or implant. The method may include applying the coil directly to the portion of the prosthesis or implant. The method may include bringing the prosthesis or implant into direct contact with the coil. The method may include delivering energy to the portion of the prosthesis or implant without first passing through the patient's skin. The method may include avoiding or at least minimizing energy passing through the patient's skin and / or tissue. The method may include positioning the portion of the prosthesis or implant within a distance from the coil or within a distance of the coil that is less than or equal to the size 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 to the portion of the prosthesis or implant than the diameter of the coil. The method may include inserting the coil into or through a surgical incision.

[0045] The method may include providing heat via the handheld device.The method may include at least partially controlling the application of heat, such as by controlling power supplied to the induction coil, such as the amount and / or duration of power.

[0046] The method may include providing an operating frequency of a pulsed electromagnetic field (PEMF) of less than about 100 kHz.

[0047] The method may include treating an infection, such as a prosthetic joint infection (PJI). The method may include treating an infection. The method may include at least helping to kill an invasive species, such as bacteria. The method may include heating an invasive species, particularly bacteria, to a critical temperature, whereby the bacteria are at least weakened, thereby helping to control the infection by other means, such as administered medications and / or immune defense mechanisms. The method may include applying heat to a biofilm associated with a prosthesis or implant.

[0048] 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. 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 includes a non-conductive or less conductive material that is associated with a conductive material. For example, a prosthesis or implant may include a non-conductive or less conductive coating or layer, and the method includes indirectly heating the coating or layer. The method may include inductive heating in an associated conductive material such as beneath a coating or layer, with heat being transferred or propagated from the conductive material to or through the non-conductive or less conductive material, such as by conduction.

[0049] In addition or alternatively, the method may include heating at least a portion of a prosthesis or implant to help attach and / or detach the prosthesis or implant. For example, the method may include heating the 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 to be heated may be associated with the fixation of the prosthesis or implant. For example, the portion of the prosthesis or implant may include a recess or notch. The recess or notch may be associated with another portion of the prosthesis or implant, such as another portion or member for receiving the prosthesis or implant. For example, in the case where the prosthesis or implant includes a fixing or tightening member for fastening, the method may include heating the accessory or fastener or at least a portion thereof to help apply and / or remove the prosthesis or implant. The method may include thermal expansion and / or contraction of the portion of the prosthesis or implant. The method may include heating the 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 adjusting a gap or tolerance to provide a looser fit during attachment, connection, or insertion. The method may include subsequent cooling, such as passive cooling, of the thermally adjusted gap or tolerance to provide a tighter fit during attachment, connection, or insertion. The method may include heating the portion of the prosthesis or implant during temporary or permanent removal or loosening of the prosthesis or implant, such as during an invasive procedure. The method may include heating the portion of the prosthesis or implant to loosen the prosthesis or implant. In at least some examples, the method may include sequentially and / or periodically thermally expanding and contracting the portion of the prosthesis or implant.

[0050] The method may include weakening a fastener for a prosthesis or implant or weakening a fastener of a prosthesis or implant, such as to assist in temporarily or permanently removing the portion of the prosthesis or implant. For example, where the prosthesis or implant has been fastened, for example directly or indirectly, to a bone, the method may include weakening an interface connection between the prosthesis or implant and the bone. The method may include weakening a bond between the prosthesis or implant and the patient, such as by a bonding means or a bonding agent.

[0051] The method may include heating the portion of the prosthesis of the 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 the portion of the prosthesis or implant in vivo while the portion of the prosthesis or implant is attached to or located within the patient.

[0052] In at least some examples, the method may include heating the portion of the 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 include treatment of the prosthesis or implant without treatment of the patient itself.

[0053] The method may include in vivo use. The method may include heating the portion of a prosthesis or implant while the portion of the prosthesis or implant is located within the body 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 the portion of a prosthesis or implant while the portion of the prosthesis or implant is located outside the body and / or separated from the body. In at least some examples, the method may include ex vivo heating of the portion of a prosthesis or implant during a surgical procedure, such as at a location where the prosthesis or implant (or portion thereof) is separated from the body and / or removed from the body.

[0054] The method may include heating the portion of the prosthesis or implant during the surgical procedure without unduly heating the patient's tissue. The method may include heating the portion of the prosthesis or implant to a temperature equal to or lower than a maximum temperature. The maximum temperature may be associated with tissue damage. For example, the method may include heating the portion of the prosthesis or implant only to a temperature that is not associated with undesirable tissue damage. The method may include preventing or at least minimizing tissue damage.

[0055] The method may include heating the portion of the prosthesis or implant to a temperature equal to or below a minimum temperature. The minimum temperature may be associated with infection control. For example, the minimum temperature may be associated with killing or at least resisting infection. The method may include heating the portion of the prosthesis or implant to a temperature within a range, such as a temperature within a range of about 65°C to about 70°C.

[0056] The method may include heating the portion of the prosthesis or implant to a target temperature. The method may include controlling the heating based on the temperature of the portion of the prosthesis or implant, and / or one or more additional temperatures of one or more other portions and / or tissues of the prosthesis or implant (e.g., bone, muscle, cartilage, nerve, etc.). The method may include controlling the heating based on a thermal sensor or thermometer. The method may include one or more direct temperature measurements. The method may include operating a temperature measuring device. The method may include providing an augmented and / or virtual reality device. The method may include adjusting the heating based on the temperature measuring device, for example, via power output to or from the coil. The method may include automatically adjusting the heating. In addition or alternatively, the method may include manually adjusting the heating. For example, the method may include an operator or user of the device manually adjusting the heating based on information received by the operator or user from the temperature measuring device. The method may include providing real-time visualization and / or measurement, such as by a display connected to or associated with an infrared thermal imaging camera. The method may include adjusting the heating based on a cumulative thermal dose. The method may include calculating the cumulative thermal dose in real time. The method may include displaying one or more temperatures and / or one or more cumulative thermal doses to a user or operator, such as a surgeon. In at least some examples, the method may include automatically adjusting the heating using an integrated thermal sensor and (micro)controller included in the heating device.

[0057] The method may include heating only a portion of a prosthesis or implant. For example, the method may include not heating the entire prosthesis or implant. The method may include inductively heating only a single portion of a prosthesis or implant at a time. The method may include not heating the entire prosthesis or implant at the same time.

[0058] The method may include selectively heating the portion of the prosthesis or implant. The method may include selectively heating only safe portions of the implant. The method may include selectively heating only portions of the implant that are not at risk or are at low risk. The method may include avoiding heating areas of the implant associated with bone fixation (e.g., for total joint replacement), and / or areas of the prosthesis or implant that are close to or associated with important anatomical structures such as nerves (e.g., in the case of an infected plate in the elbow joint). Alternatively, high-risk areas (e.g., causing failure of bone fixation or close to nerves / blood vessels) may be heated to or reach one or more lower temperatures (e.g., relative to low-risk areas). The method may include aligning only the portion of the prosthesis or implant to be heated, such as with a precision coil.

[0059] The method may include inductively heating a first portion of a prosthesis or implant without inductively heating a second portion of the prosthesis or implant. The method may include allowing heat to transfer from the first portion of the prosthesis or implant to the second portion of the prosthesis or implant. The method may include using 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 a coil; and / or the portion of the prosthesis or implant and / or one or more other portions of the prosthesis or implant; and / or patient tissue.

[0060] The method may include sequentially heating two or more portions of a prosthesis or implant, such as by heating a first portion before heating a second portion of the prosthesis or implant.

[0061] In at least some examples, the methods include heating the entire prosthesis or implant.

[0062] The method may include sterilization. The method may include sterilization using a sterilization device for sterilizing surgical equipment, such as a standard sterilization device for sterilizing surgical drills, surgical saws, and the like. Sterilization may include one or more of the following: autoclaving; dry heat; one or more chemical sterilants; mechanical and / or ultrasonic cleaning.

[0063] In at least some examples, the method may include deforming the coil in accordance with the portion of the prosthesis or implant. The deformation may be plastic and / or elastic. The method may include deforming the coil to fit the prosthesis or implant. The method may include deforming the coil by the prosthesis or implant, such as by pressing the coil or the other of the prosthesis or implant against the coil or the prosthesis / implant. The method may include deforming the coil by manipulation by a user. For example, the method may include the user plastically and / or elastically deforming the coil to fit the shape of a particular prosthesis or implant.

[0064] The method may include heating a prosthesis or implant for implantation into a human body and / or attachment to a human body. Alternatively, the method may include heating a prosthesis or implant for implantation into a non-human body and / or attachment to a non-human body, such as a non-human mammal. The method may include implanting and / or attaching a prosthesis or implant. Additionally or alternatively, the method may include removing and / or detaching a prosthesis or implant.

[0065] The present invention may include one or more corresponding aspects, embodiments or features, either individually or in various combinations, whether or not specifically described (including claimed) in that combination or individually. For example, it will be readily understood that features described as optional with respect to one aspect, example, embodiment or claim may be additionally applied with respect to another aspect, example, embodiment or claim without explicitly and unnecessarily listing those various combinations and permutations (e.g., a device of one aspect may include features of any other aspect). Features described as optional with respect to a method may be additionally applicable to a device or apparatus; and vice versa. For example, a device may be configured to perform features of a method of any other aspect, example, embodiment or claim. In addition, corresponding devices for performing one or more of the functions discussed are also within the present disclosure. BRIEF DESCRIPTION OF THE DRAWINGS

[0066] Embodiments of the invention are described below by way of example only with reference to the accompanying drawings, in which:

[0067] Figure 1 A schematic diagram of an apparatus for heating at least a portion of a prosthesis or implant according to a first example of the present disclosure is shown.

[0068] Figure 2 An apparatus for heating at least a portion of a prosthesis or implant according to a second example of the present disclosure is shown.

[0069] Figure 3 Shown for Figure 1 and / or Figure 2 Schematic diagram of the electronic system of the device.

[0070] Figures 4 to 11 Shown for Figure 1 and / or Figure 2 Devices for heating various parts of a prosthetic implant; and

[0071] Fig.12 shows a thermal image which indicates that Figure 1 and / or Figure 2 An apparatus for selectively heating an example portion of a prosthetic implant.

[0072] Fig.13 A graph is shown which illustrates the complete eradication of Staphylococcus epidermidis biofilm from titanium alloy coupons with heat shock at 65°C for 3.5 minutes using induction heating followed by 24 hours exposure to vancomycin 10 mg / L and rifampicin 1 mg in BHI medium. DETAILED DESCRIPTION

[0073] First reference Figure 1, shows a device 10 for heating at least part of a prosthesis or implant according to a first example of the present disclosure. In this context, the device 10 includes a device for inductively heating a prosthesis or implant ( Figure 1 An induction heating device for the portion (not shown).

[0074] The device includes an external induction coil 12, the coil 12 being configured to inductively heat the portion of the prosthesis or implant. The coil 12 is configured to inductively heat only the portion of the prosthesis or implant. As shown herein, the external induction coil 12 is external to the body or housing 18 of the device 10. The induction coil 12 is configured to be applied directly to the portion of the prosthesis or implant, as described later. Figure 4 As shown. In this article, the induction coil 12 is configured to directly contact the prosthesis or implant. The device 10 is configured to transfer energy to the portion of the prosthesis or implant without first passing the energy through the patient's skin. The size and dimensions of the coil 12 are set to be smaller than the body part associated with the prosthesis or implant. For example, the diameter and longitudinal length of the coil 12 in this article are smaller than the diameter and longitudinal length of the limb associated with the prosthesis or implant (for example, the diameter of the coil 12 is smaller than the diameter of the patient's leg). The device 10 is configured to position the portion of the prosthesis or implant within a certain distance from the coil 12 or within a certain distance of the coil 12, which distance is less than or equal to the size of the coil 12. For example, in this article, the device 10 is configured to position the coil 12 closer to the portion of the prosthesis or implant than the diameter of the coil 12. The coil 12 in this article is configured for insertion into or through a surgical incision.

[0075] The device 10 herein comprises a portable hand-held pistol device for use with a single hand of a user. The device 10 comprises a pistol grip 15 for control by the holding hand, and an actuator 16 in the form of a trigger for operation by the holding hand. The actuator 16 is used to at least partially control the application of heat by the device 10, such as by controlling the power supplied to the induction coil 12, such as the amount and / or duration of the power.

[0076] like Figure 1 As shown, the device 10 includes a low power, low voltage device. Such a device can provide safety, access and / or maintenance benefits. For example, a low voltage device may be safer than a mains or grid powered device, particularly for use in surgery. In this article, the voltage can vary between about 12 volts and about 60 volts, depending on specific requirements. For example, in the case where a larger portion of a prosthesis or implant is to be heated, a larger battery can be installed in the device 10, in the internal battery chamber 14. The device 10 is configured to provide an operating frequency of a pulsed electromagnetic field (PEMF) of less than about 100 kHz.

[0077] Reference now Figure 2, shows an apparatus 110 for heating at least a portion of a prosthesis or implant according to a second example of the present disclosure. Figure 2 The device 110 shown in FIG. Figure 1 The illustrated apparatus 10 is generally similar, with like features being indicated by like reference numerals incremented by 100. Figure 2 The device 110 in FIG. 1 includes an external induction coil 112 and a pistol grip 115. Figure 2 As shown, the device 110 comprises a mains or mains powered device, such as a power distribution or supply via a cable 119 and a plug. It will be appreciated that the mains or mains power supply via the cable 119 may be optional, as Figure 2 The device 110 may additionally or alternatively be powered via an internal battery power source.

[0078] like Figure 2 As shown, the apparatus 110 includes an active cooling system having an inflow supply 122 and an outflow supply 124 for supplying coolant to and from the coil 112, respectively. The coolant may be water, such as supplied from a tap source (not shown).

[0079] Figure 1 and Figure 2 The illustrated apparatus 10, 110 is configured for use with a sterilization apparatus for sterilizing surgical instruments, such as a standard sterilization apparatus for sterilizing surgical drills, surgical saws, and the like. Sterilization includes one or more of the following: autoclaving; dry heat; one or more chemical sterilants; mechanical and / or ultrasonic cleaning. The apparatus 10, 110 is sized and dimensioned to be located in a conventional or standard sterilization apparatus, such as for surgical drills, surgical saws, and the like.

[0080] Reference now Figure 3 , showing the Figure 1 and / or Figure 2 Schematic diagram 200 of an example of an electronic system of a device 10, 110. Thus, the exemplary device 10, 110 includes two internal inductors 230, 232, each greater than 75 microhenries and greater than 10A. The external coil 212 corresponds to Figure 1 and 2 The coils 12, 112 shown in FIG. The resistor pair 234, 236 shown are less than 600 Ohms, depending on the configuration of the capacitor bank 238 and the external coil 212. Depending on the configuration of the external coil 212, the total capacitance of the capacitor bank 238 is less than 10 microfarads. Each Schottky diode 240, 242 is rated for greater than 60V and 10A. The power MOSFETs 244, 246 (metal-oxide-semiconductor field effect transistors) are greater than 200W, and the U brdssThe voltage of the battery 248 is between 12V and 60V, which is selected according to the configuration of the external coil 212 .

[0081] Reference now Figures 4 to 11 , multiple configurations of coils are shown, and the multiple configurations of coils are sequentially numbered from 312 to 1012, in increments of 100, for ease of reference. Although represented by discrete reference numerals for ease of reference, it should be understood that a single coil may be shown in multiple figures, such as where the coil is deformable into more than one of the configurations shown. It will also be understood that one or more of the coils 312 to 1012 may be used Figure 1 and / or Figure 2 equipment.

[0082] Figures 4 to 11 Also shown are various portions of the prosthetic implant 380 to 1080, Figure 4 and Figure 6 The prosthetic implant 380, 580 is shown in place in the bone 382, ​​582. The prosthetic implant 380, 480, 580, 680, 780, 880, 980, 1080 is shown as being ex vivo (particularly when disconnected from the bone 382, ​​582), and it is understood that the prosthetic implant 380, 480, 580, 680, 780, 880, 980, 1080 can be processed ex vivo, outside the body, such as before insertion or reinsertion into the patient (not shown). It should also be understood that in other examples, similar arrangements of the coils 312 to 1012 and the prosthetic implants 380 to 1080 can be located within the patient (not shown).

[0083] Figure 4 A prosthetic implant 380 in the form of a metal implant (hip rod) in a bone 382 and a water-cooled hollow coil 312 that can selectively heat the metal implant (see, e.g., Fig.12 ).

[0084] Figure 5 Shows something like Figure 4 A prosthetic implant 480 in the form of a metal implant (hip rod) is provided where the bone has been removed.

[0085] Figure 6 A prosthetic implant 580 is shown in the form of a metal implant (hip rod) in a bone 582 and a "spring coil" 512 which can selectively heat the metal implant.

[0086] Figure 7 A prosthetic implant 680 is shown in the form of a metal implant (hip stem). Similarly, Figure 8A prosthetic implant 780 in the form of a metal implant (hip stem) and a narrow, rigid, water-cooled hollow coil 712 are shown.

[0087] Fig. 9 A prosthetic implant 880 in the form of a metal implant (hip rod), a Litz wire coil 812, and a coil holder 813 are shown. The coil holder 813 is made of an electrically and thermally insulating material (e.g., one or more plastics and / or one or more ceramics). It will be appreciated that the coil holder can be used in vitro and / or in vivo, such as to position the coil 812 relative to a portion 884 of the prosthetic implant 880.

[0088] Fig.10 A prosthetic implant 980 is shown in the form of a metal implant (hip stem) and a "spring coil" 912 which is flexible to allow manipulation during surgery, for example, to difficult to reach locations.

[0089] Fig.11 A prosthetic implant 1080 in the form of a metal implant (hip stem) and a coil 1012 are shown with wire wrapped around the implant 1080 to form a custom coil.

[0090] It will be appreciated that the portion 384, 484, 584, 684, 784, 884, 984, 1084 of the prosthetic implant 380, 480, 580, 680, 780, 880, 980, 1080 comprising a conductive metallic material as shown herein, such as one or more of the following materials: steel; titanium; one or more alloys; and / or cobalt chromium, can be directly heated by induction. Figures 4 to 11 ) can also be equipped with flux concentrators to potentially increase the efficiency of the coil.

[0091] The portion 384, 484, 584, 684, 784, 884, 984, 1084 of the prosthetic implant 380, 480, 580, 680, 780, 880, 980, 1080 includes at least one boundary or surface configured to engage, interact or interface with tissue such as muscle and / or bone and / or cartilage tissue. 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 includes a conductive material. In other examples (not shown), the boundary or surface includes a non-conductive or less conductive coating or layer, wherein the device 10, 110 is configured to indirectly heat the coating or layer by inductive heating in an associated conductive material such as beneath the coating or layer, wherein heat is transferred or propagated from the conductive material to or through the non-conductive or less conductive material, such as by conduction.

[0092] As shown herein, in at least some examples, the coils 312 to 1012 are capable of deforming according to the portion of the prosthesis or implant. The deformation is plastic and / or elastic. The coils 312 to 1012 are configured to deform to fit the prosthetic implant 380 to 1080.

[0093] It will be appreciated that when used in vivo during surgery, the device 10, 110 is configured to heat the portion of the prosthetic implant 380 to 1080 during the procedure without unduly heating the patient's tissue. The device 10, 110 is configured to heat the portion of the prosthetic implant 380 to 1080 to a temperature equal to or lower than the highest temperature associated with tissue damage. For example, the device 10, 110 is configured to heat the portion 384 to 1084 of the prosthetic implant 380 to 1080 only to a temperature that is unrelated to undesired tissue damage. In this article, the device 10, 110 is configured to heat the portion 384 to 1084 of the prosthetic implant 380 to 1080 to a temperature equal to or lower than the lowest temperature associated with infection control. For example, the lowest temperature is associated with killing or at least resisting infection.

[0094] In vivo, the device 10, 110 can be configured to heat the portion 384-1084 of the prosthetic implant 380-1080 to a temperature in the range of from about 38°C to 120°C, preferably from 60°C to about 70°C, preferably for a sufficient time to destroy at least 80% of the biofilm formed by one or more invasive species causing the infection.

[0095] The device 10, 110 is controlled based on the temperature of the portion 384-1084 of the prosthetic implant 380-1080, and / or one or more additional temperatures such as one or more other portions and / or tissues (e.g., bone, muscle, cartilage, nerve, etc.) of the prosthetic implant 380-1080. The device 10, 110 can be controlled based on a thermal sensor or a thermometer.

[0096] Reference now Fig.12 , a thermal image is shown indicating that the portion of the prosthetic implant 1180 is selectively heated to over about 60 degrees Celsius, wherein the heating is limited to the target portion within the coil 1112. It will be appreciated that the apparatus 10, 110 can be controlled based on one or more such temperature measurements. For example, such updated real-time images from an infrared thermal imaging camera can be provided to an operator during the procedure, even using augmented and / or virtual reality devices. Thus, the operator can manually adjust the heating based on the information received by the operator or user from the infrared thermal imaging camera.

[0097] In other embodiments (not shown), the device 10, 110 can be configured to automatically adjust heating. Such a device can adjust heating based on a calculated or determined cumulative thermal dose.

[0098] In alternative approaches, particularly in non-invasive approaches, temperature measurement and control may be performed via patient feedback. For example, particularly in procedures without anesthesia, temperature measurement may be provided by indications of warmth and / or heat and / or pain from the patient. An operator, such as a physician or even the patient, may adjust the provision of heat accordingly.

[0099] The following are examples of methods of using the aforementioned coils and / or devices.

[0100] The method includes configuring the coil 12, 112, 212, 312, 412, 512, 612, 712, 812, 912, 1012, 1112 to be applied directly to the portion 384-1184 of the prosthetic implant 380-1080. The method includes applying the coil 12, 112, 212, 312, 412, 512, 612, 712, 812, 912, 1012, 1112 directly to the portion 384-1184 of the prosthetic implant 380-1080. The method includes bringing the prosthetic implant 380-1080 into direct contact with the coil 12, 112, 212, 312, 412, 512, 612, 712, 812, 912, 1012, 1112. The method includes delivering energy to a portion 384 to 1184 of a prosthetic implant 380 to 1080 without first passing the energy through the patient's skin. The method includes avoiding or at least minimizing energy passing through the patient's skin and / or tissue. The method includes positioning the portion 384 to 1184 of the prosthetic implant 380 to 1080 within a distance from or within a distance of the coil 12, 112, 212, 312, 412, 512, 612, 712, 812, 912, 1012, 1112 that is less than or equal to the size 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, 312, 412, 512, 612, 712, 812, 912, 1012, 1112. The method includes inserting the coil 12, 112, 212, 312, 412, 512, 612, 712, 812, 912, 1012, 1112 into or through a surgical incision.

[0101] The method includes providing heat via the handheld device 10, 110. The method includes at least partially controlling the application of heat, such as by controlling power supplied to the induction coil 12, 112, 212, 312, 412, 512, 612, 712, 812, 912, 1012, 1112, such as the amount of power and / or duration.

[0102] The method includes providing an operating frequency of a pulsed electromagnetic field (PEMF) of less than about 100 kHz.

[0103] The methods include treating infections, such as prosthetic joint infections (PJIs). The methods include methods of treating infections. The methods include at least assisting in killing bacteria. The methods include heating the bacteria to a critical temperature whereby the bacteria are at least weakened, thereby helping to control the infection through other means such as administered medications and / or immune defense mechanisms.

[0104] Therefore, the method may also include applying a drug capable of controlling infection, preferably a biocidal or bioinhibitory drug, more preferably an antibiotic component, at a concentration suitable for obtaining a reduction in the active count of microorganisms at the location of the prosthesis or implant, to at least help treat the infection. Preferably, the antibiotic component includes at least one antibiotic compound selected from an antibiotic family or group, the antibiotic family includes penicillins, cephalosporins, aminoglycosides, tetracyclines, sulfonamides, macrolide antibiotics and / or quinolones, the group includes imipenem, aztreonam, chloramphenicol, erythromycin, clindamycin, spectinomycin, vancomycin, rifampicin, bacitracin, methenamine, tobramycin and nitrofurantoin. Preferably, the method may include applying antibiotic treatment at a dose at the biofilm site after the heat treatment, the dose effectively produces a concentration that kills or inhibits the organism, preferably a concentration that inhibits bacteria or inhibits fungi. Alternatively, antibiotics or other suitable compounds may be applied before induction heating to increase the effectiveness of heat stress. Where multiple heating cycles are required, antibiotics and other compounds may also be used between heating cycles to kill bacteria or slow their growth. The present invention therefore also relates to a medicament capable of controlling or eliminating an infection, preferably wherein the medicament comprises a biocidal component, for treating an infection in combination with a thermal treatment according to the present invention in a patient in need thereof.

[0105] Fig.13 A graph is shown showing complete eradication of Staphylococcus epidermidis biofilm from titanium alloy coupons with heat shock at 65°C for 3.5 minutes using induction heating followed by 24 hours of exposure to 10 mg / L vancomycin and 1 mg rifampicin in BHI medium. N=6 or greater per group. This experiment shows that there may be a synergistic effect between heat shock and antibiotics, and the activity counts are expressed as Log (CFU / cm 2 ) means, that is, per cm 2The number of units forming colonies. Clearly, the combination of these treatment steps shows a strong synergy between the combined infection treatment methods, including heating the bacteria to a critical temperature, thereby at least weakening the bacteria, and then controlling the infection by the administered drugs, thereby making the combination superior to individual treatments. It will be noted that the present method can also allow for a significant reduction in the amount of antibiotics.

[0106] The method includes applying heat to a biofilm associated with a prosthetic implant 380-1180. Additionally or alternatively, the method includes heating at least a portion 384-1184 of a prosthetic implant 380-1080 to assist in attaching and / or detaching the prosthetic implant 380-1180. For example, the method includes heating a portion 384-1184 of a 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 can be associated with the fixation of the prosthetic implant 380-1180. For example, the portion 384-1184 of the prosthetic implant 380-1080 includes a dimple or recess. The recess or notch may be associated with another portion 384 to 1184 of the prosthetic implant 380 to 1080, such as for receiving another portion or member of the prosthetic implant 380 to 1180. For example, the prosthetic implant 380 to 1180 includes a fixture or tightening member for fastening, and the method includes heating the fitting or fastener or at least a portion thereof to assist in the application and / or removal of the prosthetic implant 380 to 1180. The method includes thermal expansion and / or contraction of the portion 384 to 1184 of the prosthetic implant 380 to 1080. The method includes heating the portion 384 to 1184 of the prosthetic implant 380 to 1080 before and / or during attachment, connection or insertion of the portion 384 to 1184 of the prosthetic implant 380 to 1080. The method includes heating to facilitate attachment, connection or insertion, such as by thermally adjusting clearances or tolerances to provide a looser fit during attachment, connection or insertion. The method includes subsequent cooling, such as passive cooling, to thermally adjust gaps or tolerances to provide a tighter fit when attached, connected, or inserted. The method includes heating a portion 384-1184 of a 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 a 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 a portion 384-1184 of a prosthetic implant 380-1080.

[0107] The method includes weakening a fastener for a prosthetic implant 380 to 1180 or weakening a fastener of a prosthetic implant 380 to 1180, such as to facilitate temporary or permanent removal of a portion 384 to 1184 of a prosthetic implant 380 to 1080. For example, where a prosthetic implant 380 to 1180 has been fastened to a bone, such as directly or indirectly, the method includes weakening an interface-type connection between the prosthetic implant 380 to 1180 and the bone. The method includes weakening a bond between the prosthetic implant 380 to 1180 and the patient, such as by a bonding means or a bonding agent.

[0108] The method comprises heating the portion of the prosthesis of the implant 380-1080 in vitro before inserting or applying the portion 384-1184 of the prosthetic implant 380-1080 to the patient. Additionally or alternatively, the method comprises heating the 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 located in the patient.

[0109] In at least some examples, the method includes heating a portion 384-1184 of a 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 itself.

[0110] The method includes in vivo use. The method includes heating the portion 384 to 1184 of the prosthetic implant 380 to 1080, while the portion 384 to 1184 of the prosthetic implant 380 to 1080 is located in the body and / or attached to the body. In addition or alternatively, the method includes ex vivo use. The method includes in vitro use. The method includes heating the portion 384 to 1184 of the prosthetic implant 380 to 1080, while the portion 384 to 1184 of the prosthetic implant 380 to 1080 is located outside the body and / or separated from the body. In at least some examples, the method includes ex vivo heating of the portion 384 to 1184 of the prosthetic implant 380 to 1080 during the surgical procedure, such as at a position where the prosthetic implant 380 to 1180 (or a portion thereof) is separated from the body and / or removed from the body.

[0111] The method includes heating the portion 384 to 1184 of the prosthetic implant 380 to 1080 during the surgical procedure without unduly heating the patient's tissue. The method includes heating the portion 384 to 1184 of the prosthetic implant 380 to 1080 to a temperature equal to or lower than the maximum temperature. The maximum temperature may be associated with tissue damage. For example, the method includes heating the portion 384 to 1184 of the prosthetic implant 380 to 1080 only to a temperature that is not associated with undesirable tissue damage. The method includes preventing or at least minimizing tissue damage.

[0112] The method includes heating the portion 384 to 1184 of the prosthetic implant 380 to 1080 to a temperature equal to or lower than a minimum temperature. The minimum temperature may be associated with infection control. For example, the minimum temperature may be associated with killing or at least resisting infection. The method includes heating the portion 384 to 1184 of the prosthetic implant 380 to 1080 to a temperature in the range of, for example, from about 65°C to about 70°C.

[0113] The method includes heating a portion 384 to 1184 of a prosthetic implant 380 to 1080 to a target temperature. The method includes controlling heating based on the temperature of the portion 384 to 1184 of the prosthetic implant 380 to 1080, and / or one or more additional temperatures of one or more other portions and / or tissues (e.g., bone, muscle, cartilage, nerve, etc.) of the prosthetic implant 380 to 1180. The method includes controlling heating based on a thermal sensor or thermometer. The method includes one or more direct temperature measurements. The method includes operating a temperature measurement device. The method includes providing augmented and / or virtual reality. The method includes adjusting heating based on a temperature measurement device, such as via power output to or from a coil 12, 112, 212, 312, 412, 512, 612, 712, 812, 912, 1012, 1112. The method includes automatically adjusting heating. Additionally or alternatively, the method includes manually adjusting heating. For example, the method includes an operator or user of the device manually adjusting the heating based on information received from the temperature measuring device. The method includes real-time visualization and / or measurement such as provided by a display connected to or associated with the infrared thermal imaging camera. The method includes adjusting the heating based on the cumulative thermal dose. The method includes calculating the real-time cumulative thermal dose. The method includes displaying one or more temperatures and / or one or more cumulative thermal doses to a user or operator such as a surgeon. In at least some examples, the method includes automatically adjusting the heating using an integrated thermal sensor and (micro)controller included in the heating device 10, 110.

[0114] The method includes heating only a portion 384-1184 of the prosthetic implant 380-1184. For example, the method includes not heating the entire prosthetic implant 380-1180. The method includes inductively heating in only a single portion 384-1184 of the prosthetic implant 380-1080. The method includes not heating the entire prosthetic implant 380-1180 simultaneously.

[0115] The method includes selectively heating portions 384 to 1184 of a prosthetic implant 380 to 1080. The method includes selectively heating only safe portions of the implant. The method includes selectively heating only portions of the implant that are not at risk or are at low risk. The method includes avoiding heating areas of the implant associated with bone fixation (e.g., for total joint replacement), and / or areas of the prosthetic implant 380 to 1180 that are close to or associated with important anatomical structures such as nerves (e.g., in the case of an infected plate in the elbow joint). Alternatively, high-risk areas (e.g., causing failure of bone fixation or close to nerves / blood vessels) are heated to or reach one or more lower temperatures (e.g., relative to low-risk areas).

[0116] The method includes directing only a portion 384 to 1184 of a prosthetic implant 380 to 1080 to be heated, such as with a precision coil 12 , 112 , 212 , 312 , 412 , 512 , 612 , 712 , 812 , 912 , 1012 , 1112 .

[0117] The method includes inductively heating a first portion 384-1184 of a prosthetic implant 380-1080, rather than inductively heating a second portion 384-1184 of the prosthetic implant 380-1080. The method includes allowing heat to 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, coils 12, 112, 212, 312, 412, 512, 612, 712, 812, 912, 1012, 1112; and / or portions of the prosthetic implant 380 to 1080 and / or one or more other portions; and / or patient tissue.

[0118] 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 - 1180 .

[0119] In at least some examples, the method includes heating the entire prosthetic implant 380 - 1180 .

[0120] The method includes sterilization. The method includes sterilization using a sterilization device for sterilizing surgical equipment, such as a standard sterilization device for sterilizing surgical drills, surgical saws, and the like. Sterilization includes one or more of the following: autoclaving; dry heat; one or more chemical sterilants; mechanical and / or ultrasonic cleaning.

[0121] In at least some examples, the method includes deforming the coil 12, 112, 212, 312, 412, 512, 612, 712, 812, 912, 1012, 1112 according to 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 fit the prosthetic implant 380-1180. The method includes deforming the coil 12, 112, 212, 312, 412, 512, 612, 712, 812, 912, 1012, 1112 or another of the prosthetic implants 380 to 1180, such as by pressing the coil 12, 112, 212, 312, 412, 512, 612, 712, 812, 912, 1012, 1112 or the prosthesis / implant against the coil 12, 112, 212, 312, 412, 512, 612, 712, 812, 912, 1012, 1112 or another of the prosthetic implants 380 to 1180. The method includes deforming the coil 12, 112, 212, 312, 412, 512, 612, 712, 812, 912, 1012, 1112 by manipulation of the user. For example, the method includes the user plastically and / or elastically deforming the coil 12, 112, 212, 312, 412, 512, 612, 712, 812, 912, 1012, 1112 to fit the shape of a specific prosthetic implant 380 to 1180.

[0122] The method includes heating the prosthetic implant 380 to 1180 for implantation into a human body and / or attachment to a human body. Alternatively, the method includes heating the prosthetic implant 380 to 1180 for implantation into a non-human body and / or attachment to a non-human body, such as a non-human mammal. The method includes implanting and / or attaching the prosthetic implant 380 to 1180. Additionally or alternatively, the method includes removing and / or separating the prosthetic implant 380 to 1180.

[0123] Although specific embodiments of the invention have been described above, it will be appreciated that departures from the described embodiments are possible within the scope of the invention.

[0124] It will be understood that any of the aforementioned devices may have further functions in addition to the functions mentioned, and that these functions may be performed by the same device.

[0125] The applicant discloses herein separately each individual feature described herein and any combination of two or more such features so that such feature or combination can be implemented based on the entire specification and with the help of the common knowledge of those skilled in the art, regardless of whether such feature or combination of features solves any problem disclosed herein, and is not limited to the scope of the claims.

[0126] The applicant indicates that aspects of the present invention may consist of any such single feature or combination of features. It should be understood that the embodiments described herein are exemplary only and that various modifications may be made thereto without departing from the scope or spirit of the present invention.

Claims

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 suitable for reducing the activity count of an invasive cell species that forms a biofilm, the device comprising: at least one external induction coil, the external induction coil being external to the body or housing of the device, wherein the coil is sized and dimensioned to be smaller than a body part associated with the prosthesis or implant; a temperature measurement device, the temperature measurement device being configured to calculate a cumulative thermal dose; wherein the coil comprises a smaller diameter and / or longitudinal length than a limb associated with the prosthesis or implant; and wherein the device is configured to provide a pulsed electromagnetic field (PEMF) operating frequency of less than 100 kHz, and wherein the device is configured to heat the portion of the prosthesis or implant for a period of at least 3.5 minutes to reduce the activity count of an invasive cell species that forms a biofilm, and Herein, a prosthesis or an implant is a prosthesis or an implant that supports a load.

2. The device according to claim 1, wherein: The apparatus is configured to heat the portion of the prosthesis or implant to a temperature in the range of from 38°C to 120°C for a period of time suitable to reduce the active count of an invasive cell species that forms a biofilm.

3. The device according to claim 2, wherein: The apparatus is configured to heat the portion of the prosthesis or implant to a temperature in the range of from 60°C to 90°C for a period of time suitable to reduce the active count of an invasive cell species that forms a biofilm.

4. The device according to claim 3, wherein: The apparatus is configured to heat the portion of the prosthesis or implant to a temperature in the range of from 65°C to 70°C for a period of time suitable to reduce the active count of an invasive cell species that forms a biofilm.

5. The device according to any one of claims 1 to 4, wherein: The apparatus is configured to position the coil closer to the portion of the prosthesis or implant than a diameter of the coil.

6. The device according to any one of claims 1 to 4, wherein: The coil is configured to be inserted into or through a surgical incision.

7. The device according to any one of claims 1 to 4, wherein: The device comprises a portable handheld device configured for use with a single hand of a user, the portable handheld device comprising a pistol grip having an actuator for operation by the holding hand.

8. The device according to any one of claims 1 to 4, wherein: The devices include low power devices with voltages less than or equal to 60 volts.

9. The device according to any one of claims 1 to 4, wherein: The devices include battery powered devices.

10. The device according to any one of claims 1 to 4, wherein: The devices include an infection treatment device configured to at least aid in killing bacteria by heating the bacteria to a critical temperature.

11. The device according to any one of claims 1 to 4, wherein: The apparatus is configured to heat the portion of the prosthesis or implant to assist in attaching and / or detaching the prosthesis or implant by thermally expanding and / or contracting the portion of the prosthesis or implant.

12. The device according to any one of claims 1 to 4, wherein: The apparatus is configured to heat the portion of the prosthesis of an implant in vitro prior to inserting or reinserting the portion of the prosthesis or implant into a patient.

13. The device according to any one of claims 1 to 4, wherein: The apparatus is configured to heat the portion of a prosthesis or implant in vivo while the portion of the prosthesis or implant is attached to or located within a patient.

14. The device according to any one of claims 1 to 4, wherein: The device is configured to heat the portion of the prosthesis or implant during an invasive surgical procedure.

15. The device according to any one of claims 1 to 4, wherein: The apparatus is configured to heat the portion of the prosthesis or implant ex vivo during a surgical procedure.

16. The device according to any one of claims 1 to 4, wherein: The device is configured to heat the portion of the prosthesis or implant to a temperature equal to or below a maximum temperature associated with tissue damage; and the device is configured to heat the portion of the prosthesis or implant to a temperature equal to or below a minimum temperature associated with infection control.

17. The device according to any one of claims 1 to 4, wherein: The device can be controlled based on a thermal sensor or a thermometer.

18. The device according to any one of claims 1 to 4, wherein: The device is configured to selectively heat only a portion of a prosthesis or implant; and not to heat the entire prosthesis or implant.

19. The device according to any one of claims 1 to 4, wherein: The apparatus is configured to inductively heat a first portion of a prosthesis or implant without inductively heating a second portion of the prosthesis or implant to allow heat to be transferred from the first portion of the prosthesis or implant to the second portion of the prosthesis or implant to utilize the second portion of the prosthesis or implant as a heat sink for the first portion of the prosthesis or implant.

20. The apparatus according to any one of claims 1 to 4, wherein: The apparatus includes a cooling system.

21. The apparatus according to any one of claims 1 to 4, wherein: The apparatus is configured to sequentially heat two or more portions of a prosthesis or implant by heating a first portion prior to heating a second portion of the prosthesis or implant.

22. The apparatus according to any one of claims 1 to 4, wherein: The device is configured to be sterilized using a standard sterilization apparatus capable of sterilizing surgical drills and surgical saws.

23. The apparatus according to any one of claims 1 to 4, wherein: The coil may be deformable in accordance with the portion of the prosthesis or implant.

24. The apparatus according to any one of claims 1 to 4, wherein: Prostheses or implants include joint prostheses or implants.

25. An assembly for heating at least part of a prosthesis or an implant, the assembly comprising a device according to any one of claims 1 to 24, and at least part of a prosthesis or an implant.

26. The assembly of claim 25, wherein: The assembly includes a temperature control mechanism.

27. A method of inductively heating at least a portion of a prosthesis or implant, the method comprising: Providing a medical induction heating device according to any one of claims 1-24; ex vivo heating the portion of the prosthesis or implant for a period of at least 3.5 minutes at an operating frequency of a pulsed electromagnetic field (PEMF) of less than 100 kHz to reduce the activity count of invasive cell species that form a biofilm; Real-time calculation of cumulative thermal dose; as well as Heating is adjusted based on the cumulative thermal dose.

28. The method according to claim 27, wherein: The method includes heating at least a portion of the prosthesis or implant to assist in attaching and / or detaching the prosthesis or implant.

29. The method according to claim 27, wherein: The method includes selectively heating only a portion of the prosthesis or implant, and not heating the entire prosthesis or implant.

30. The method of claim 27, wherein: The method includes sequentially heating two or more portions of a prosthesis or implant by heating a first portion prior to heating a second portion of the prosthesis or implant.

31. The method of claim 28, wherein: The method includes sterilization using a standard sterilization device that is capable of sterilizing surgical drills and surgical saws.

32. The method of claim 28, wherein: The method further includes applying a biocidal component effective to reduce the active count of invasive species at a concentration suitable to obtain a reduced active count of microorganisms at the site of the prosthesis or implant.

33. The method of claim 32, wherein the invasive species is a microbial species.

34. The method of claim 33, wherein the biocidal component comprises an antibiotic component.

35. The method of claim 34, wherein: The biocidal component comprises at least one antibiotic compound selected from the antibiotic family comprising: penicillins, cephalosporins, aminoglycosides, tetracyclines, sulfonamides, macrolide antibiotics and / or quinolones.

36. The method of claim 35, wherein: The antibiotic is selected from the group consisting of: imipenem, aztreonam, chloramphenicol, erythromycin, clindamycin, spectinomycin, vancomycin, rifampicin, bacitracin, methenamine, tobramycin and nitrofurantoin.

37. The method of claim 27, wherein: The method comprises heating the portion of the prosthesis or implant to a temperature in the range of from 38°C to 120°C.

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