Medical heating system

Abstract

The present invention relates to a medical heating system comprising an insert (e.g., a biodegradable thermal modulator) and methods for using the same, wherein the insert comprises a first medical implant including a first material having a first thermal conductivity, and a second medical implant including a second material having a second thermal conductivity different from the first thermal conductivity.

Description

MEDICAL HEATING SYSTEMCROSS-REFERENCE TO RELATED APPLICATION[00011 This application claims priority to United States Provisional Patent Application No. 63 / 559,983 filed on March 1, 2024 and entitled “MEDICAL HEATING SYSTEM”, the content of which is hereby incorporated by reference.TECHNICAL FIELD

[0002] An embodiment generally relates to a medical heating system comprising an insert (e.g., a biodegradable thermal modulator) and methods for using the same. Although embodiments will be illustrated, explained, and exemplified by an insert such as one used for spacing / insulating implants (being treated with alternating magnetic field (AMF)) from critical structures / tissues, it should be appreciated that embodiments can also be applied to any place in or adjacent the patient’s body where a thermal insulating barrier is needed between a heat source and critical structures / tissues.BACKGROUND

[0003] Prosthetic joint replacement has become an effective and widespread medical treatment for aging and damaged joints. However, prosthetic joints may be susceptible to infection due to the buildup of bacterial biofilms on the joint. A biofilm matrix may include an extracellular polymeric substance (EPS) biofilm matrix on the surface of an implant. It is estimated that between 1% and 5% of prosthetic joint replacement patients suffer from these types of infections. Prior methods of treating these infections include additional surgeries and regiments of prescribed oral and / or intravenous (IV) antibiotics. However, these treatments may not be completely effective and are very costly.

[0004] A varying magnetic field (VMF) such as an alternating magnetic field (AMF) is a non-invasive approach to treat implant-associated infections, in which an external transducer coil generates time- varying AMF in the vicinity of an electrically conductive, usually metal, implant in the body, such as a total hip or knee replacement. The AMF generates surface electrical currents on the implant, which leads to heating generally restricted to the surface ofthe implant. In the case of an infected implant, bacteria, which may be in the form of a biofilm, adhere to the surface within this heated range. This localized heating can be used to eradicate the bacteria or sensitize them to antimicrobial treatment.

[0005] However, most medical implants (e.g., a knee implant) are asymmetric (possibly employing one or more different materials), and simple magnetic field transmitters (e.g., solenoid, Helmholtz, loop coil) do not produce uniform heating of the implant. Such an irregular heating can lead to overheating or underheating of the implant and either inadequate infection removal or excess tissue damage. In other words, exposing an implant to a conventional uniform magnetic field results in a very non-uniform current density pattern on the implant, which may be responsible for non-uniform heating and ultimately heterogeneous treatment of biofilm and / or undesired tissue damage. Complicating matters further is the fact that the different components of an implant often have different electrical properties since they are made from different materials (such as different alloys), which results in different current densities / distribution and rates of heating for the individual components.

[0006] During AMF therapy treating a prosthetic joint infection (PJI), the temperature of conductive (e.g., metallic) surfaces needs to be maintained low enough so that surrounding critical structures / tissues don’t receive a thermal dose that leads to irreversible damage. However, the higher the thermal dose, the more effective AMF treatment is at reducing or eliminating biofilm / bacteria.BRIEF DESCRIPTION OF THE DRAWINGS

[0007] Features and advantages of embodiments of the present invention will become apparent from the appended claims, the following detailed description of one or more example embodiments, and the corresponding figures. Where considered appropriate, reference labels have been repeated among the figures to indicate corresponding or analogous elements.

[0008] Figure 1 includes an embodiment of a heating system.

[0009] Figures 2A, 2B, 2C, 2D present views of an implant and an embodiment of a thermal modulator.

[0010] Figures 3A, 3B, 3C, 3D present views of an implant and an embodiment of a thermal modulator.

[0011] Figures 4A, 4B includes embodiments of heating systems.

[0012] Figure 5 A presents an implant and an embodiment of a thermal modulator. Figures 5B and 5C address thermal aspects of the system of Figure 5A.

[0013] Figure 6 presents an implant and an embodiment of a thermal modulator.

[0014] Figure 7 presents an study of thermal effects on an implant. Figures 8A, 8B, 9A,9B, 9C, 9D, 9E address the results of that study.DETAILED DESCRIPTION|0015 | Reference will now be made to the drawings wherein like structures may be provided with like suffix reference designations. In order to show the structures of various embodiments more clearly, the drawings included herein are diagrammatic representations of structures. Thus, the actual appearance of the fabricated structures, for example in a photo, may appear different while still incorporating the claimed structures of the illustrated embodiments (e.g., walls may not be exactly orthogonal to one another in actual fabricated devices). Moreover, the drawings may only show the structures useful to understand the illustrated embodiments. Additional structures known in the art may not have been included to maintain the clarity of the drawings. For example, not every layer of a device is necessarily shown. “An embodiment”, “various embodiments” and the like indicate embodiment(s) so described may include particular features, structures, or characteristics, but not every embodiment necessarily includes the particular features, structures, or characteristics. Some embodiments may have some, all, or none of the features described for other embodiments. “First”, “second”, “third” and the like describe a common object and indicate differentinstances of like objects are being referred to. Such adjectives do not imply objects so described must be in a given sequence, either temporally, spatially, in ranking, or in any other manner. Further, figures may use common labels for similar embodiments of an element. For example, Figures 1 and 2A both include element “3” even though the element in Figure 2A is not necessarily an exact duplicate of the element in Figure 1. “Connected” may indicate elements are in direct physical or electrical contact with each other and “coupled” may indicate elements co-operate or interact with each other, but they may or may not be in direct physical or electrical contact. Phrases such as “comprising at least one of A or B” include situations with A, B, or A and B.

[0016] Where a numerical range is disclosed herein, unless otherwise specified, such range is continuous, inclusive of both the minimum and maximum values of the range as well as every value between such minimum and maximum values. Still further, where a range refers to integers, only the integers from the minimum value to and including the maximum value of such range are included. In addition, where multiple ranges are provided to describe a feature or characteristic, such ranges can be combined.

[0017] In light of the above, Applicant realized a need exists to overcome the aforementioned problems regarding irregular heating of implants. Advantageously, an embodiment provides a medical heating system comprising an insert (such as a biodegradable thermal modulator) which exhibits numerous technical merits. For example, an embodiment allows for more aggressive AMF treatment of PJI’s while reducing unwanted tissue damage.

[0018] An embodiment provides a medical heating system comprising an insert and a heating device. At least a part of the insert is inserted between an implant or a prosthesis (implant / prosthesis and sometimes referred to herein as a “implant”) located within or attached to a patient’s body and a tissue immediately adjacent to the implant. The insert alters a thermal interaction between the implant / prosthesis and the tissue when the implant and / or the insert are (is) heated by the heating device.

[0019] An embodiment provides a method for heating an implant / prosthesis (such as a surface thereof) and / or an insert. The method includes the steps of (i) providing a heating device; (ii) delivering the insert in between the implant / prosthesis that is located within or attached to a patient’s body and a tissue of said patient’s body immediately adjacent to said implant / prosthesis; and (iii) directly or indirectly heating the implant / prosthesis (such as a surface thereof) and / or the insert using the heating device.

[0020] An embodiment provides a method for preparing a medical heating system. The method includes the steps of: (1) providing a heating device; (2) providing an insert; and (3) combining the heating device and the insert to prepare the medical heating system. The insert is designed for inserting between an implant or a prosthesis located within or attached to a patient’s body and a tissue of said patient’s body immediately adjacent to the implant. The heating device is configured for heating, directly or indirectly, the implant / prosthesis (such as a surface thereof) and / or the insert.

[0021] As shown in Figure 1, an embodiment provides a medical heating system 01 comprising a heating device 02 and an insert 03. At least a part of the insert 03 is inserted between an implant or a prosthesis 04 located within or attached to a patient’s body and a tissue 05 immediately adjacent to the implant 04. The insert alters a thermal interaction between implant 04 and tissue 05 when the implant and / or the insert are (is) heated by the heating device.

[0022] For example, in Figures 2A, 2B, 2C, 2D an insert 03 may be used (e.g., during a surgery) to separate sensitive tissues 05 (not shown) from the heated implant surface such as a knee implant. The insert 03 may be designed to fit within existing spaces / pockets in the implant, such as a space between the femoral component 04A and the tibial component 04B of a knee implant. As shown in Figures 2A, 2B, 2C, 2D, one embodiment of the insert 03 has horizontal extensions.

[0023] Another embodiment of the insert 03 is non-biodegradable and has more of a wall around the implant 04, as shown in Figures 3A, 3B, 3C, 3D.

[0024] In various embodiments, such as the embodiment Figure 4A, the insert 03 may have a single layer 03. In other embodiments, such as the embodiment Figure 4B, the insert 03 may have two different layers (03a, 03b) or more (e.g., 3, 4, 5 or more layers), one of which (03a) faces the adjacent tissue 05 and another one of which (03b) faces the implant 04.

[0025] The insert 03, either biodegradable or non-biodegradable, may be temporarily inserted between the implant and tissue during a surgery (such as an AMF treatment) to push away critical tissues; and it is then removed before the surgery is completed. Alternatively, the insert 03 (possibly biodegradable but may be non-biodegradable) may remain between the implant and tissue after a surgery (such as an AMF treatment) is completed. In some embodiments, two inserts 03 or more may be used. For example, a first insert (typically non- biodegradable) may be temporarily inserted between the implant and tissueduring a surgery (such as an AMF treatment) to push away critical tissues; and the first insert is then removed before the surgery is completed; and a second insert (possibly biodegradable) may be inserted between the implant and tissue after a surgery (such as an AMF treatment) is completed and remain between the implant and the tissue thereafter.

[0026] In some embodiments, the first insert may have an electrical conductivity lower than 0.38 S / m and a thermal conductivity lower than 0.47 W / m / K (ligament). For example, the first insert may be made of silicone having an electrical conductivity 3.48E-14 S / m and a thermal conductivity of 0.2 W / m / K. The first insert may be made of other polymeric materials such as plastics (e.g. polyethylene).

[0027] In some embodiments, the insert 03 may surround the entire implant or prosthesis 04. In other embodiments, the insert 03 may surround a part of the implant 04. In some embodiments, the insert 03 may be in contact with the implant 04 without any “void space” or “pocket” between them. In other embodiments, the insert 03 may be in contact with the implant 04 with one or more “void spaces” or “pockets” between them.

[0028] In an embodiment, the heating device 02 (e.g., Figure 1) may be a medical transducer 02 configured for non-invasively and simultaneously heating an electricallyconductive target using magnetic induction. In some embodiments, the implant 04 is electrically conductive and is therefore a direct heating target of the medical transducer 02. The insert 03 may also be electrically conductive and is therefore also a direct heating target of the medical transducer 02.

[0029] In an embodiment, the implant 04 is electrically conductive and is therefore a direct heating target of the medical transducer 02, while the insert 03 is not electrically conductive and therefore is not a direct heating target of the medical transducer 02.

[0030] An embodiment provides a biodegradable spacer 03 to protect critical tissues 05 during thermal therapy for PIIs (prosthetic joint infections). For example, an insert like a biodegradable gel 03 can be placed around an implant (knee, hip, or other) 04 to separate critical structures 05 (e.g., tendons, ligaments, blood vessels, nerves, etc.) from the metal surface that’s being heated (e.g., by AMF) during treatment for thermal protection of the critical structures / tissues 05. The gel may be one layer of a multilayer insert (e.g., layer 03a in Figure 4B).

[0031] In an embodiment, the insert 03 may be a thermal barrier 03 that provides additional distance and thermal insulation between the heated surface of the implant 04 and critical structures / tissues 05, thereby enabling higher temperatures on the surface of the implant 04; and reducing thermal dose to those critical structures / tissues 05. The insert 03 can also be a physical insulator 03 temporarily placed in select location(s), during a temporary swap of the regular spacer or patella, Debridement and Implant Retention (DAIR) procedure, for example.

[0032] In an embodiment, the insert 03 acts as a protective spacer 03 to protect the adjacent tissue 05 from thermal damage. In an embodiment, the insert 03 has a thermal conductivity substantially equal to, or lower than, that of the adjacent tissue 05; and it functions as a thermal insulator 03 that reduces heat conduction from the surface of said implant or prosthesis 04 to the adjacent tissue 05, thereby alleviating or eliminating thermal damage of the adjacent tissue 05.

[0033] In an embodiment as illustrated in the Figures 5A, 5B, a spacer 03 is placed between a knee implant 04 and a ligament 05 based on modeling. Effect of the thermal spacer 03 in such a human knee model shows significant reduction in irreversible tissue damage (CEM43 > 240 min) due to implant heating.

[0034] Figure 5 A shows a 1-mm thick spacer that is placed in between medial collateral ligament (MCL) 05 and knee implant 04. Figure 5B shows irreversible thermal tissue damage 501 of around 43% in the MCL 05 without spacer 03. Figure 5C shows a reduction of irreversible MCL 05 issue damage 502 down to 17% with the addition of spacer 03.

[0035] In an embodiment, insert 03 may have a thermal conductivity higher than that of the adjacent tissue 05; and it functions as a thermal diffuser or facilitator 03 that increases heat conduction from the surface of said implant or prosthesis 04 to adjacent tissue 05. For example, it channels heat away from a sensitive area such as critical nerves 05.

[0036] The biodegradable thermal spacer 03 can also be used to improve the heating of certain regions of the implant 04 where temperature is lower enough to produce no or little therapeutic effect to reduce infections by channeling heat towards such a region.

[0037] The biodegradable / biocompatible thermal spacer 03 can be used for protection near critical tissues 05 and may be removed after the AMF treatment. For example, the spacer 03 will be inserted surgically (before or after DAIR treatment) and once the AMF heating is applied the spacer 03 may be removed.

[0038] In various embodiments, the medical transducer 02 is entirely external to (or outside of) the patient’s body. It may be configured for applying a varying magnetic field (VMF) such as an alternating magnetic field (AMF) through the entire body of the patient; or only a portion of the patient’s body around the implant / prosthesis 04, such as an entire limb, or a portion of a limb.

[0039] The implant 04 may be selected from, without limitation and for example only, knee implants, hip implants, shoulder implants, elbow implants, spine implants, screws,plates, nails, and pins. The adjacent tissue 05 typically needs protection from thermal injury during a medical treatment; for example and without limitation, the adjacent tissue 05 may be selected from tendons, ligaments, blood vessels, nerves, muscles, cartilage, bones, skin, and any combination thereof.

[0040] In various embodiments, the insert 03 may be a preformed flexible spacer 03 such as a gel or foam that can be inserted manually between implant / prosthesis the implant / prosthesis 04 and the adjacent tissue 05. For example, it can be a thin gel sheet spacer that is premade and can be used as a “shim.” In other embodiments, the insert 03 may be formed from a gel (e.g., hydrogel) or a liquid (as a gel precursor) that can be injected in between the implant / prosthesis 04 and the adjacent tissue 05. As such, the medical heating system 01 may further include an injection device such as a syringe and a needle for delivering the insert 03 in between the implant / prosthesis 04 and the adjacent tissue 05.

[0041] In an embodiment, the insert 03 may be provided as part of a kit that includes the syringe(s) and other accessory material, to orthopedic surgeons and hospitals equipped with the medical transducer 02.

[0042] The chemical properties of the insert 03 can ensure that a majority of the insert 03 remains within the patient’s body for a predetermined period to maintain its thermal regulation function. The predetermined period is sufficient for a treatment that lasts at least one treatment session, preferably multiple treatment sessions.

[0043] In a variety of embodiments, the insert 03 may be loaded with a diagnostic or therapeutic agent (such as antibiotics), and the agent is gradually released (or unloaded) from the thermal modulator 03 into the surroundings as the thermal modulator 03 degrades, for the purpose of treating the adjacent tissue 05.

[0044] In an embodiment, the insert 03 is implemented with a biodegradable (-30 days) 2-part hydrogel that can be injected into the patient’s body. This gel 03 may be formulated to reduce thermal conductivity; and may also be formulated to release antibiotics locally for treatment.

[0045] In various embodiments, the implant 04, such as a knee implant, includes one or more curved parts at least partially curving around a void space (optionally filled with bone or tissue) with two open ends. The medical transducer 02 may be so configured or positioned that at least a part of the flux flow of the VMF passes though said void space from one open end to the other.

[0046] In an embodiment, the medical transducer 02 may include a housing with a semicylinder shape for harboring said portion of the patient’s body. The housing includes a first side compartment for accommodating a first coil, a second side compartment for accommodating a second coil, and a connecting compartment for connecting the two side compartments and for accommodating other components of the medical transducer 02.Preferably, the first coil and the second coil are either symmetrical or asymmetrical relative to a conceptual mirror plane.

[0047] An embodiment provides a method for heating an implant / prosthesis 04 (such as a surface thereof) and / or a biodegradable thermal modulator 03. The method includes the steps of (i) providing a heating device 02; (ii) delivering the insert 03 in between the implant / prosthesis 04 that is located within or attached to a patient’s body and the adjacent tissue 05; and (iii) directly or indirectly heating the implant / prosthesis 04 (such as a surface thereof) and / or the insert 03 using the heating device 02.

[0048] In an embodiment, the spacer / insulating material 03 may be placed at the time of a procedure of Debridement and Implant Retention (DAIR) or other procedure, but injection is the preferred method.

[0049] In an embodiment, the spacer / insulating material is placed external to the patient, for example, on the skin, and acts as a heatsink to modulate the temperature internal to the body. For example, the device may be an ice pack, thermal cooling pad, or Peltier device, which acts as a heatsink to lower the temperature of the skin and tissues internal to the patient, such as ligaments and muscles, in order to minimize potential damage to those tissues while enabling maximal thermal dose to the implant being treated for a biofilm infection.

[0050] In an embodiment, the heating device 02 may include an alternating magnetic field (AMF) transmitter configured to apply one or more AMF pulses to the implant / prosthesis 04; one or more sensors; and a control system comprising at least one processor. The sensor may be selected from acoustic sensors, temperature sensors, and optical sensors. An acoustic sensor may be configured to detect one or more acoustic waves emitted from the adjacent tissue 05 to the implant / prosthesis 04 and / or the insert 03 when heated to a particular temperature threshold. The acoustic sensors may be configured to detect one or more acoustic waves having a frequency between 200 Hz and 1000 Hz. The temperature sensor may include one or more internal temperature sensors embedded into the surface of the implant / prosthesis 04 and / or the insert 03. The optical sensor may include one or more external optical receiver devices configured to detect photons emitted from one or more thermoluminescent materials embedded into the surface of the implant / prosthesis 04 and / or the insert 03. The thermoluminescent material is configured to emit photons upon sensing a temperature greater than a predetermined threshold on the surface of the implant / prosthesis 04 and / or the insert 03.

[0051] The control system may be configured to enable the one or more external transmitter devices to apply one or more AMF pulses to the implant / prosthesis 04 for a predetermined time period, for a predetermined pulse duration, for a predetermined pulse repetition frequency, and at a predetermined power level; and receive one or more signals from the one or more sensors.

[0052] The control system may be further configured to determine that one or more signals indicate that a temperature of the implant / prosthesis 04 is sufficient to disrupt a biofilm matrix on a surface of the implant / prosthesis 04.

[0053] The control system may be further configured to determine that the one or more signals indicate heating of the implant / prosthesis 04 and / or the insert 03 sufficient to disrupt a biofilm matrix on a surface the implant / prosthesis 04 but avoid excessive damage to the adjacent tissue 5.

[0054] The control system may be further configured to enable the one or more external transmitter devices to shut off for a predetermined delay period after applying the one or more AMF pulses; and to reapply the one or more AMF pulses to the implant / prosthesis 04 and / or the insert 03 after the predetermined delay period.

[0055] The control system may be further configured to enable the one or more external transmitter devices to reapply the one or more AMF pulses to the implant / prosthesis 04 and / or the insert 03 when the one or more signals correspond to one or more acoustic emission signatures that indicate that a temperature of the implant / prosthesis 04 and / or the insert 03 is insufficient to disrupt the biofilm matrix on the surface of the implant / prosthesis 04.

[0056] The control system may be further configured to determine that the one or more signals correspond to one or more acoustic emission signatures that indicate that the temperature of the implant / prosthesis 04 and / or the insert 03 is sufficient to reduce a number of bacteria on the surface of the implant / prosthesis 04.

[0057] The external transmitter devices may be one or more of a solenoid coil, a saddle coil, a pancake coil, Helmholtz coil, completely custom coil, phased array or any type of transducer that heats the implant 03 to reduce bacterial infections.

[0058] The control system may be further configured to receive one or more signals associated with a temperature from an acoustic sensor; and adjust at least one of a duration, frequency, and amplitude of one or more AMF pulses based on the one or more signals associated with the temperature to maintain the surface of the implant / prosthesis 04 and / or the insert 03 at a desired temperature for a specific time period.

[0059] The control system may be further configured to receive one or more signals associated with a temperature from one or more internal temperature sensors; and adjust a duration of one or more AMF pulses based on the one or more signals associated with the temperature to maintain the surface of the implant / prosthesis 04 and / or the insert 03 at a desired temperature for a specific time period.

[0060] The control system may be further configured to receive one or more signals from one or more external optical receiver devices when photons are detected; and enable the one or more external transmitter devices to shut off upon receipt of the one or more signals from the one or more external optical receiver devices.

[0061] An embodiment provides a method for preparing a medical heating system 01. The method includes the steps of (1) providing a heating device 02; (2) providing a biodegradable thermal modulator 03; and (3) combining the heating device 02 and the insert 03 to prepare the medical heating system 01. The insert 03 is configured for delivering in between an implant or a prosthesis 04 located within or attached to a patient’s body and the adjacent tissue 05. The heating device 02 is configured for heating, directly or indirectly, the implant / prosthesis 04 (such as a surface thereof) and / or the insert 03.

[0062] EXAMPLES

[0063] Various examples are now discussed. Different example sets are shown. A reference to, for example, “Example 1” in Example Set 2 is a reference to Example 1 of Example Set 2 — not Example Set 1.

[0064] EXAMPLE SET 1

[0065] Example 1. A medical heating system comprising an insert and a heating device; wherein at least a part of the insert is inserted between an implant or a prosthesis located within or attached to a patient’s body (hereinafter “the implant”) and a tissue immediately adjacent to the implant (hereinafter “the adjacent tissue”); and wherein the insert alters a thermal interaction between the implant / prosthesis and the tissue when the implant and / or the insert are (is) heated by the heating device.

[0066] Example 2. The medical heating system according to example 1, wherein the insert has a single layer.

[0067] Example 3. The medical heating system according to example 1, wherein the insert has two different layers, one of which faces the adjacent tissue and another one of which faces the implant.

[0068] Example 4. The medical heating system according to example 1 , wherein the insert (biodegradable or non-biodegradable) is temporarily inserted between the implant / prosthesis and the tissue during a surgery (such as an AMF treatment) to push away critical tissues; and it is then removed away before the surgery is completed.

[0069] Example 5. The medical heating system according to example 1, wherein the insert (preferably biodegradable) remains between the implant / prosthesis and the tissue after a surgery (such as an AMF treatment) is completed.

[0070] Example 6. The medical heating system according to example 1, wherein the insert includes a first insert (e.g. non-biodegradable insert) that is temporarily inserted between the implant / prosthesis and the tissue during a surgery (such as an AMF treatment) to push away critical tissues; and the first insert is then removed away before the surgery is completed; and a second insert (preferably biodegradable) that is inserted between the implant / prosthesis and the tissue after a surgery (such as an AMF treatment) is completed and it remains between the implant / prosthesis and the tissue thereafter.

[0071] Example 7. The medical heating system according to example 4, wherein the insert has an electrical conductivity lower than 0.38 S / m and a thermal conductivity lower than 0.47 W / m / K (ligament).

[0072] Example 8. The medical heating system according to example 7, wherein the insert is made of silicone having an electrical conductivity 3.48E-14 S / m and a thermal conductivity of 0.2 W / m / K.

[0073] Example 9. The medical heating system according to example 4, wherein the insert is made of a polymeric material such as plastics such as polyethylene.

[0074] Example 10. The medical heating system according to example 1, wherein the insert is designed to fit within existing spaces / pockets in the implant.

[0075] Example 11. The medical heating system according to example 11, wherein the existing spaces / pockets include a space between the femoral component and the tibial component of a knee implant.

[0076] Example 12. The medical heating system according to example 1 , wherein said heating device is a medical transducer configured for non-invasively heating an electrically conductive target using magnetic induction.

[0077] Example 13. The medical heating system according to example 12, wherein the implant is electrically conductive and is therefore a direct heating target of the medical transducer, and wherein the insert is also electrically conductive and is therefore also a direct heating target of the medical transducer.

[0078] Example 14. The medical heating system according to example 12, wherein the implant is electrically conductive and is therefore a direct heating target of the medical transducer, while the insert is not electrically conductive and therefore is not a direct heating target of the medical transducer.

[0079] Example 15. The medical heating system according to example 14, wherein the insert acts as a protective spacer to protect the adjacent tissue from thermal damage.

[0080] Example 16. The medical heating system according to example 14, wherein the insert has a thermal conductivity substantially equal to, or lower than, that of the adjacent tissue; and it functions as a thermal insulator that reduces heat conduction from the surface of the implant to the adjacent tissue, thereby alleviating or eliminating thermal damage of the adjacent tissue.

[0081] Example 17. The medical heating system according to example 14, wherein the insert has a thermal conductivity higher than that of the adjacent tissue; and it functions as thermal diffuser or facilitator that increases heat conduction from the surface of the implant tothe adjacent tissue. For example, it channels heat away from a sensitive area such as critical nerves.

[0082] Example 18. The medical heating system according to example 12, wherein the medical transducer is entirely external to (or outside of) the patient’s body; and wherein the medical transducer is configured for applying a varying magnetic field (VMF) such as an alternating magnetic field (AMF) through only a portion of the patient’s body around the implant / prosthesis and the insert.

[0083] Example 19. The medical heating system according to example 1, wherein the implant is selected from knee implants, hip implants, shoulder implants, elbow implants, spine implants, screws, plates, nails, and pins.

[0084] Example 20. The medical heating system according to example 1, wherein the adjacent tissue needs protection from thermal injury during a medical treatment; for example, the adjacent tissue is selected from tendons, ligaments, blood vessels, nerves, muscles, cartilage, bones, skin, and any combination thereof.

[0085] Example 21. The medical heating system according to example 1, wherein the insert is a preformed flexible spacer such as a gel or foam that can be inserted manually between the implant / prosthesis and the tissue. For example, it can be thin gel sheet spacers that are premade and can be used as “shims.”

[0086] Example 22. The medical heating system according to example 1, wherein the insert is formed from a gel or a liquid (as a gel precursor) that can be injected in between the implant / prosthesis and the tissue.

[0087] Example 23. The medical heating system according to example 22, further comprising an injection device such as a syringe and a needle for delivering the insert in between the implant / prosthesis and the tissue.

[0088] Example 24. The medical heating system according to example 1, wherein a majority of the insert remains within the patient’s body for a predetermined period.

[0089] Example 25. The medical heating system according to example 24, wherein said predetermined period is sufficient for a treatment that lasts at least one treatment session, preferably multiple treatment sessions.

[0090] Example 26. The medical heating system according to example 1 , wherein the insert is loaded with a diagnostic or therapeutic agent (such as antibiotics), and the agent is gradually released (or unloaded) from the insert into the surroundings as the insert degrades, for the purpose of treating the adjacent tissue.

[0091] Example 27. The medical heating system according to example 12, wherein the implant, such as a knee implant, includes one or more curved parts at least partially curving around a void space (optionally filled with bone or tissue) with two open ends, and wherein the medical transducer is so configured or positioned that at least a part of the flux flow of the VMF passes though said void space from one open end to the other.

[0092] Example 28. The medical heating system according to example 27, wherein the medical transducer includes a housing with a semicylinder shape for harboring said portion of the patient’s body, wherein the housing includes a first side compartment for accommodating a first coil, a second side compartment for accommodating a second coil, and a connecting compartment for connecting the two side compartments and for accommodating other components of the medical transducer.

[0093] Example 29. The medical heating system according to example 28, wherein the first coil and the second coil are either symmetrical or asymmetrical relative to a conceptual mirror plane.

[0094] Example 30. The medical heating system according to example 14, wherein the insert comprises a biodegradable / biocompatible material that can be used for protecting the adjacent tissues due to heating of the implant and that can be removed after single or multiple AMF treatments.

[0095] Example 31. The medical heating system according to example 30, where the biodegradable / biocompatible material maybe either injected externally (e.g. a gel or liquid which transforms as a solid after injection or due to heating) or a material placed surgically which can be removed after the AMF treatment.

[0096] Example 32. The medical heating system according to example 14, wherein the insert comprises a biodegradable material that can be used to improve the heating uniformity of the implant; and wherein the biodegradable material can be inj ected externally or placed manually near the entire or selected surfaces of the implant where the temperature is lower to produces no therapeutic effect.

[0097] Example 33. The medical heating system according to example 32, wherein the biodegradable material can be conductive or nonconductive in nature depending on the region where implant needs to be further heated.

[0098] Example 34. A method for heating an implant / prosthesis (such as a surface thereof) and / or an insert, comprising: (i) providing a heating device; (ii) delivering the insert in between the implant / prosthesis that is located within or attached to a patient’s body and a tissue of said patient’s body immediately adjacent to said implant / prosthesis; and (iii) directly or indirectly heating the implant / prosthesis (such as a surface thereof) and / or the insert using the heating device.

[0099] Example 35. A method for preparing a medical heating system, comprising: (1) providing a heating device; (2) providing an insert; and (3) combining the heating device and the insert to prepare the medical heating system; wherein the insert is designed for inserting between an implant or a prosthesis located within or attached to a patient’s body and a tissue of said patient’s body immediately adjacent to the implant, and wherein the heating device is configured for heating, directly or indirectly, the implant / prosthesis (such as a surface thereof) and / or the insert.

[0100] EXAMPLE SET 2

[0101] Example la. A system comprising: a first medical implant (101) including a first form factor; a second medical implant (102) including a second form factor that is complementary' to the first form factor; wherein: (a) the first medical implant includes a first material having a first thermal conductivity, (b) the second medical implant includes a second material having a second thermal conductivity that is unequal to the first thermal conductivity.

[0102] See, e.g., the Figure 6.

[0103] As noted on https: / / www.fda.gov / medical-devices / products-and-medical- procedures / implants-and-prosthetics, medical implants include devices that are placed inside or on the surface of the body. Many implants are prosthetics, intended to replace missing body parts. Other implants deliver medication, monitor body functions, or provide support to organs and tissues. Some implants are made from skin, bone or other body tissues. Others are made from metal, plastic, ceramic or other materials. Implants can be placed permanently or they can be removed once they are no longer needed. For example, stents or hip implants are intended to be permanent. But chemotherapy ports or screws to repair broken bones can be removed when they no longer needed. As used herein, a “medical implant” may be implanted within a patient for a period of time that is based on a medical provider’s discretion. The implant may be implanted only momentarily during a procedure that lasts less than a few hours or for a longer time such as months or years. Implant 102 may be a protective insert or module that insulates heat that may emanate from implant 101 (which may be at least partially metal) during AMF therapeutic applications.

[0104] In an embodiment the first and second implants may couple together in various ways. They may fixedly couple to each other via anchors such as nails, screws, wire, adhesive and the like. In other embodiments they may removably couple to one another via a “snap fit” whereby the second implant is flexible and flexes or snaps onto a portion of the first implant. In other embodiments the implants are loosely coupled to each other in that, for example, the second implant may be a shim wedged between the first implant and tissue.

[0105] Alternative version of Example la. A system comprising: a first medical implant (101) including a first form factor; a second medical implant (102) including a second form factor; wherein: (a) the first medical implant includes a first material having a first thermal conductivity, (b) the second medical implant includes a second material having a second thermal conductivity that is unequal to the first thermal conductivity.

[0106] Thus, not all embodiments require first and second form factors be complementary to each other.

[0107] Example 2a. The system of example la, wherein: the second medical implant includes first and second layers directly contacting one another; the first layer includes a third material and the second layer includes the second material; the third material has a third thermal conductivity that is unequal to the second thermal conductivity.

[0108] For example, one layer may act to insulate heat while another operates as a “heat pipe” to convey heat to a certain location. For instance, portions of implant 102 expected to be in contact with sensitive tissue (e.g., area 121) may be largely insulative to heat. However, areas expected to be in contact with metal portions of the implant that may receive maximum exposure to AMF energy (e.g., area 122) may have relatively higher thermal conductivity. The higher thermally active material may be formed to route heat to portions of the implant that may be somewhat shielded from maximum exposure to AMF energy (e.g., area 123) to thereby help eradicate biofilm in implant 101 areas that are more difficult to treat with AMF energy. Therefore, implant 102 in Figure 6 may appear to be monolithic and formed of a single material but in certain embodiments implant 102 may include a single piece that includes differing materials with routing of highly conductive materials formed in implant 102 similarly to how traces may be formed in a circuit board.

[0109] Alternative version of Example 2a. The system of example la, wherein the second medical implant includes a third material with a third thermal conductivity that is unequal to the second thermal conductivity.

[0110] Thus, the second and third materials of an embodiment of the second implant do not necessarily have to be in separate layers or any specific arrangement with regard to one another.[001 11 ] Example 3a. The system according to any of examples 1 a-2a, wherein: the first medical implant includes a void (103); the second medical implant is at least partially included in the void.

[0112] For example, area 123 of implant 102 is included in void 103.

[0113] Example 4a. The system of example 3a, wherein: an axis (111) intersects a first portion (104) of the first medical implant, the second medical implant, and a second portion (105) of the first medical implant; the second medical implant is between the first and second portions of the first medical implant.

[0114] Example 4.1a The system of example 4a, wherein: the first medical implant is a knee implant; the first portion of the first medical implant is a femoral component of the knee implant and the second portion of the second medical implant is a tibial component of the knee implant.

[0115] Example 5a. The system according to any of examples la-2a, wherein: an axis (112) intersects a first portion (106) of the second medical implant, the first medical implant, and a second portion (107) of the second medical implant; the first medical implant is between the first and second portions of the second medical implant.

[0116] Example 6a. The system according to any of examples la-2a, wherein: an axis (111) intersects a first portion (104) of the first medical implant, the second medical implant, and a second portion (105) of the first medical implant; the second medical implant is between the first and second portions of the first medical implant; an axis (112) intersects a first portion (106) of the second medical implant, the first medical implant, and a second portion (107) of the second medical implant; the first medical implant is between the first and second portions of the second medical implant.

[0117] Example 7a. The system according to any of examples la-6a, wherein the first material is metal and the second material is non-metal.

[0118] Example 8a. The system according to any of examples la-7a, wherein the second material is biodegradable.

[0119] Example 9a. The system according to any of examples la-7a, wherein the second material is non-biodegradable.

[0120] Example 10a. The system according to any of examples la-9a, wherein the first medical implant includes at least one of a knee implant, a hip implant, a shoulder implant, an elbow implant, a spine implant, a bone anchor, a bone plate, or combinations thereof.

[0121] Example Ila. The system according to any of examples la-lOa, wherein: (a) the first material has a first electrical conductivity, and (b) the second material has a second electrical conductivity that is unequal to the first electrical conductivity.

[0122] Example 12a. The system according to any of examples la-lla, wherein the second material has an electrical conductivity lower than 0.38 S / m.

[0123] Example 13a. The system according to any of examples la- 12a, wherein the second material has a thermal conductivity lower than 0.47 W / m / K (ligament).

[0124] Example 14a. The system according to any of examples la-13a, wherein the second material includes silicone.

[0125] Example 15a. The system according to any of examples la- 14a, wherein the first material is less flexible than the second material.

[0126] Example 16a. The system according to example 15 a, wherein the first medical implant is less flexible than the second medical implant.

[0127] Example 17a. The system according to any of examples la-16a, wherein the second medical implant is a shim.

[0128] Example 18a. The system according to any of examples la-17a, wherein: the second medical has a maximum length, a maximum width, and a maximum thickness; the maximum thickness is less than 1 mm.

[0129] For example, see the 1 mm thick shim in Figure 5 A.

[0130] Example 19a. The system according to any of examples la-18a, wherein the second medical implant has a surface that is curvilinear.

[0131] For example, in Figure 6 where the outer perimeter of implant 102 intersects a horizontal plane that includes axis 112 would be, at least in some areas, curvilinear.

[0132] Example 20a. The system according to any of examples la- 18a, wherein the second medical implant has a surface (108) that is planar.

[0133] Example 21a. The system according to any of examples la-20a, wherein the second material is a foam, gel, liquid, or combinations thereof.

[0134] Example 22a. The system according to any of examples la-2 la comprising a third medical implant including a third form factor that is complementary to the first form factor; wherein the third medical implant includes a third material having a third thermal conductivity.

[0135] For example, the second implant may act to insulate heat while the third implant operates as a “heat pipe” to convey heat to a certain location. For instance, the second implant may be expected to be in contact with sensitive tissue and may be largely insulative to heat. However, the third implant may be located in areas expected to be in contact with metal portions of the implant that may receive maximum exposure to AMF energy and the third implant may have relatively higher thermal conductivity. The higher thermally active implant may be formed to route heat to portions of the implant that may be somewhat shielded from maximum exposure to AMF energy to thereby help eradicate biofilm in implant areas that are more difficult to treat with AMF energy.

[0136] Example 23a. The system of example 22a, wherein the third thermal conductivity is unequal to the second thermal conductivity.

[0137] Example 24a. The system according to any of examples 22a-23a, wherein the third thermal conductivity is unequal to the first thermal conductivity.

[0138] EXAMPLE SET 3

[0139] Example lb. A system comprising: a second medical implant (102) including a second form factor that is complementary to a first form factor of a first medical implant (101); wherein: (a) the first medical implant includes a first material having a first thermal conductivity, (b) the second medical implant includes a second material having a second thermal conductivity that is unequal to the first thermal conductivity.

[0140] For example, implant 102 may be sold separately from implant 101. Implant 102 may be one of many implants a company sells wherein each of the implants is designed to have a complementary / mirror form to couple to a desired implant (e.g., a knee implant).

[0141] Example 2b. The system of example lb, wherein: the second medical implant includes first and second layers directly contacting one another; the first layer includes a third material and the second layer includes the second material; the third material has a third thermal conductivity that is unequal to the second thermal conductivity.

[0142] Example 3b. The system according to any of examples lb-2b, wherein when the first and second medical implants are coupled to one another in an implant configuration: the first medical implant includes a void (103); the second medical implant is at least partially included in the void.

[0143] For example, “when the first and second medical implants are coupled to one another in an implant configuration” is shown in Figure 6 whereby the figure depicts the implants arrangement to each other after final implantation of the system.

[0144] Example 4b. The system of example 3b, wherein when the first and second medical implants are coupled to one another in an implant configuration: an axis (111) intersects a first portion (104) of the first medical implant, the second medical implant, and a second portion (105) of the first medical implant; the second medical implant is between the first and second portions of the first medical implant.

[0145] Example 4. lb The system of example 4b, wherein: the first medical implant is a knee implant; the first portion of the first medical implant is a femoral component of the knee implant and the second portion of the second medical implant is a tibial component of the knee implant.

[0146] Example 5b. The system according to any of examples lb-2b, wherein when the first and second medical implants are coupled to one another in an implant configuration: an axis (112) intersects a first portion (106) of the second medical implant, the first medical implant, and a second portion (107) of the second medical implant; the first medical implant is between the first and second portions of the second medical implant.

[0147] Example 6.b The system according to any of examples lb-2b, wherein when the first and second medical implants are coupled to one another in an implant configuration: an axis (111) intersects a first portion (104) of the first medical implant, the second medical implant, and a second portion (105) of the first medical implant; the second medical implant is between the first and second portions of the first medical implant; an axis (112) intersects a first portion (106) of the second medical implant, the first medical implant, and a second portion (107) of the second medical implant; the first medical implant is between the first and second portions of the second medical implant.

[0148] Example 7b. The system according to any of examples lb-6b, wherein the first material is metal and the second material is non-metal.

[0149] Example 8b. The system according to any of examples lb-7b, wherein the second material is biodegradable.

[0150] Example 9b. The system according to any of examples lb-7b, wherein the second material is non-biodegradable.

[0151] Example 10b. The system according to any of examples lb-9b, wherein the first medical implant includes at least one of a knee implant, a hip implant, a shoulder implant, an elbow implant, a spine implant, a bone anchor, a bone plate, or combinations thereof.

[0152] Example 11b. The system according to any of examples lb- 10b, wherein: (a) the first material has a first electrical conductivity, and (b) the second material has a second electrical conductivity that is unequal to the first electrical conductivity.

[0153] Example 12b. The system according to any of examples lb- 1 lb, wherein the second material has an electrical conductivity lower than 0.38 S / m.

[0154] Example 13b. The system according to any of examples lb-12b, wherein the second material has a thermal conductivity lower than 0.47 W / m / K (ligament).

[0155] Example 14b. The system according to any of examples lb-13b, wherein the second material includes silicone.

[0156] Example 15b. The system according to any of examples lb-14b, wherein the first material is less flexible than the second material.

[0157] Example 16b. The system according to example 15b, wherein the first medical implant is less flexible than the second medical implant.

[0158] Example 17b. The system according to any of examples lb-16b, wherein the second medical implant is a shim.

[0159] Example 18b. The system according to any of examples lb-17b, wherein: the second medical has a maximum length, a maximum width, and a maximum thickness; the maximum thickness is less than 1 mm.

[0160] Example 19b. The system according to any of examples lb-18b, wherein the second medical implant has a surface that is curvilinear.

[0161] Example 20b. The system according to any of examples lb- 18b, wherein the second medical implant has a surface (108) that is planar.

[0162] Example 21b. The system according to any of examples lb-20b, wherein the second material is a foam, gel, liquid, or combinations thereof.

[0163] Example 22b. The system according to any of examples lb-21b comprising a third medical implant including a third form factor that is complementary to the first form factor; wherein the third medical implant includes a third material having a third thermal conductivity.

[0164] Example 23b. The system of example 22b, wherein the third thermal conductivity is unequal to the second thermal conductivity.

[0165] Example 24b. The system according to any of examples 22b-23b, wherein the third thermal conductivity is unequal to the first thermal conductivity.

[0166] EXAMPLE SET 4

[0167] Example 1c. A system comprising: a first medical implant (101) including a first form factor; a second medical implant (102) including a second form factor that is complementary to the first form factor; wherein: (a) the first medical implant includes a first material having a first thermal conductivity, (b) the second medical implant includes a second material having a second thermal conductivity that is unequal to the first thermal conductivity, (c) the second medical implant has a first portion have a first thickness and a second portion having a second thickness that is greater than the first thickness.

[0168] For example, the second implant may have thicker portions where more shielding is needed (e.g., an area expected to be adjacent sensitive tissue) and thinner portions where less shielding is needed (e.g., area within or near a void of the first implant whereby eradicating biofilm may be more difficult and where relatively less sensitive tissue is located).

[0169] EXAMPLE SET 5

[0170] Example Id. A method comprising: coupling a heat sink to an exterior of a patient such that tissue of the patient is between the heat sink and medical implant that is implanted within the patient; using a medical transducer to apply an alternating magnetic field (AMF) to the medical implant; wherein at least one of a transverse or coronal plane intersects the heat sink and the medical implant.

[0171] See, for example, Figures 7, 8A, 8B, 9A, 9B, 9C, 9D, 9E.

[0172] Example 2d. The method of example Id, wherein the transverse plane intersects the heat sink and the medical implant.

[0173] Example 3d. The method of example 2d, wherein the medical implant is a hip implant, a knee implant, or a shoulder implant.

[0174] Example 4d. The method of example 2d comprising using the medical transducer to apply the AMF to the medical implant while the heat sink is coupled to the patient.

[0175] Example 5d. The method of example 2d comprising coupling the heat sink to the exterior of the patient such that tissue of the patient is between the heat sink and medical implant that is implanted within the patient in response to using the medical transducer to apply the AMF to the medical implant.

[0176] Example 5. Id. The method of example 2d comprising coupling the heat sink to the exterior of the patient such that tissue of the patient is between the heat sink and medical implant that is implanted within the patient before using the medical transducer to apply the AMF to the medical implant.

[0177] Example 5.2d. The method of example 5. Id comprising removing the heat sink from the exterior of the patient before using the medical transducer to apply the AMF to the medical implant.

[0178] Example 5.3d The method of example 2d comprising coupling the heat sink to the exterior of the patient such that tissue of the patient is between the heat sink and medical implant that is implanted within the patient before, while, and after using the medical transducer to apply the AMF to the medical implant.

[0179] Example 6d. The method according to any of examples Id to 5.3d, wherein the heat sink includes at least one of an ice pack, a thermal cooling pad, a Peltier device, or combinations thereof.

[0180] Example 7d. The method according to any of examples Id to 5.3d, wherein the heat sink includes glycol.

[0181] For example, the heat sink may include a package comprising propylene glycol, diethylene glycol, ethylene glycol, or combinations thereof.

[0182] Example 8d. The method according to any of examples Id to 5.3d, wherein the heat sink includes a gel.

[0183] Example 9d. The method of example 8d, wherein the gel includes hydroxyethyl cellulose, sodium polyacrylate, silica, or combinations thereof.

[0184] Example lOd. The method according to any of examples Id to 9d comprising cooling the heat sink before coupling the heat sink to the exterior of the patient.

[0185] Example lid. The method of example lOd comprising cooling the heat sink to a temperature that is less than 37 degrees Celsius.

[0186] For example, a user may place the heat sink in a freezer that is less than 0 degrees Celsius to lower the heat sink temperature to less than a typical body temperature. To promote ease of heat transfer between the heat sink and tissue to be cooled, the user may cool the heat sink to a level that is X degrees below the expected temperature of the warmed tissue. For example, for efficiency of heat transfer X may be 10, 20, 30, 40 or more degreesCelsius. In other words, heat transfer efficiency may be greater between the heat sink and tissue when X is lower (e.g., 20 degrees) vs higher (e.g., 30 degrees).

[0187] Example 12d. The method according to any of examples Id- 1 Id, wherein heat sink is cooler than 37 degrees Celsius when coupling the heat sink to the exterior of the patient.

[0188] The above EXAMPLE SET 5 includes a method that does not necessarily use any spacer / insert / shield from examples 1-35, la-24a, lb-24b, 1c. However, the above EXAMPLE SET 5 example set includes a method that be used in addition to any spacer / insert / shield from examples 1-35, la-24a, lb-24b, 1c. For example, use of ice packages may be used in addition to a spacer / insert / shield located within a patient and between tissue and an implant.

[0189] The foregoing description of embodiments has been presented for the purposes of illustration and description. It is not intended to be exhaustive or to limit embodiments to the precise forms disclosed. This description and the claims following include terms, such as left, right, top, bottom, over, under, upper, lower, first, second, etc. that are used for descriptive purposes only and are not to be construed as limiting. For example, terms designating relative vertical position refer to a situation where a side of a substrate is the "top" surface of that substrate; the substrate may actually be in any orientation so that a "top" side of a substrate may be lower than the "bottom" side in a standard terrestrial frame of reference and still fall within the meaning of the term "top." The term "on" as used herein (including in the claims) does not indicate that a first layer "on" a second layer is directly on and in immediate contact with the second layer unless such is specifically stated; there may be a third layer or other structure between the first layer and the second layer on the first layer. The embodiments of a device or article described herein can be manufactured, used, or shipped in a number of positions and orientations. Persons skilled in the relevant art can appreciate that many modifications and variations are possible in light of the above teaching. Persons skilled in the art will recognize various equivalent combinations and substitutions for various componentsshown in the Figures. It is therefore intended that the scope of the embodiments be limited not by this detailed description, but rather by the claims appended hereto.

Claims

CLAIMS:

1. A system comprising: a first medical implant (101) including a first form factor; a second medical implant (102) including a second form factor that is complementary to the first form factor; wherein: (a) the first medical implant includes a first material having a first thermal conductivity, (b) the second medical implant includes a second material having a second thermal conductivity that is unequal to the first thermal conductivity.

2. The system of claim 1, wherein: the second medical implant includes first and second layers directly contacting one another; the first layer includes a third material and the second layer includes the second material; the third material has a third thermal conductivity that is unequal to the second thermal conductivity.

3. The system according to any of claims 1-2, wherein: the first medical implant includes a void (103); the second medical implant is at least partially included in the void.

4. The system of claim 3, wherein: an axis (111) intersects a first portion (104) of the first medical implant, the second medical implant, and a second portion (105) of the first medical implant; the second medical implant is between the first and second portions of the first medical implant.

5. The system of claim 4, wherein: the first medical implant is a knee implant;the first portion of the first medical implant is a femoral component of the knee implant and the second portion of the second medical implant is a tibial component of the knee implant.

6. The system according to any of claims 1-2, wherein: an axis (112) intersects a first portion (106) of the second medical implant, the first medical implant, and a second portion (107) of the second medical implant; the first medical implant is between the first and second portions of the second medical implant.

7. The system according to any of claims 1-2, wherein: an axis (111) intersects a first portion (104) of the first medical implant, the second medical implant, and a second portion (105) of the first medical implant; the second medical implant is between the first and second portions of the first medical implant; an axis (112) intersects a first portion (106) of the second medical implant, the first medical implant, and a second portion (107) of the second medical implant; the first medical implant is between the first and second portions of the second medical implant.

8. The system according to any of claims 1-7, wherein the first material is metal and the second material is non-metal.

9. The system according to any of claims 1-8, wherein the second material is biodegradable.

10. The system according to any of claims 1-9, wherein the first medical implant includes at least one of a knee implant, a hip implant, a shoulder implant, an elbow implant, a spine implant, a bone anchor, a bone plate, or combinations thereof.

11. The system according to any of claims 1-10, wherein: (a) the first material has a first electrical conductivity, and (b) the second material has a second electrical conductivity that is unequal to the first electrical conductivity.

12. The system according to any of claims 1-11, wherein the second material has an electrical conductivity lower than 0.38 S / m.

13. The system according to any of claims 1-12, wherein the second material has a thermal conductivity lower than 0.47 W / m / K (ligament).

14. The system according to any of claims 1-13, wherein the second material includes silicone.

15. The system according to any of claims 1-14, wherein the first material is less flexible than the second material.

16. The system according to claim 15, wherein the first medical implant is less flexible than the second medical implant.

17. The system according to any of claims 1-16, wherein the second medical implant is a shim.

18. The system according to any of claims 1-17, wherein: the second medical has a maximum length, a maximum width, and a maximum thickness; the maximum thickness is less than 1 mm.

19. The system according to any of claims 1-18, wherein the second medical implant has a surface that is curvilinear.

20. The system according to any of claims 1-18, wherein the second medical implant has a surface (108) that is planar.

21. The system according to any of claims 1-20, wherein the second material is a foam, gel, liquid, or combinations thereof.

22. The system according to any of claims 1-21 comprising a third medical implant including a third form factor that is complementary to the first form factor; wherein the third medical implant includes a third material having a third thermal conductivity.

23. The system of claim 22, wherein the third thermal conductivity is unequal to the second thermal conductivity.

24. The system according to any of claims 22-23, wherein the third thermal conductivity is unequal to the first thermal conductivity.

25. The system according to any of claims 1-24, wherein the second material is non- biodegradable.

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