DEVICE AND METHOD FOR GENERATING AN ELECTRIC CURRENT IN A CONDUCTOR FOR REMOVAL OF BIOFILM

Abstract

The present invention is a device and a method to generate an electric current in a conductor (15). More specifically, the present invention is a device (10) that comprises a magnetic field generator element (11), a control element (12), and a support element (14). The magnetic field generator element (11) and the control element are electrically assembled, the magnetic field generator element (11) is designed to generate a varying magnetic field (B). The aforementioned varying magnetic field (B) comprises at least one varying parameter, the control element (12) is designed to control at least one varying parameter, and the support element (14) is designed to hold the magnetic field generator element (11), and the control element.

Claims

1. A device able to generate an electric current in a conductor, wherein the device comprises a magnetic field generator element, a control element, a support element, and an energy source, the magnetic field generator element, the control element, and the energy source are electrically assembled to each other, the magnetic field generator element is designed to generate a varying magnetic field, this varying magnetic field comprises at least one varying parameter, the control element is designed to control at least one varying parameter, and the support element is designed to hold the energy source, the magnetic field generator element, and the control element.

2. The device able to generate an electric current in a conductor, according to claim 1, wherein the device is a portable device.

3. The device able to generate an electric current in a conductor, according to claim 1, wherein the conductor is an implant.

4. The device able to generate an electric current in a conductor, according to claim 3, wherein the implant is a knee prosthesis.

5. The device able to generate an electric current in a conductor, according to claim 1, wherein the conductor is made of at least one of the following: titanium, steel, Teflon or chrome-cobalt.

6. The device able to generate an electric current in a conductor, according to claim 1, wherein the magnetic field generator element is a toroidal coil.

7. The device able to generate an electric current in a conductor, according to claim 1, wherein the control element is a microprocessor.

8. The device able to generate an electric current in a conductor, according to claim 1, wherein the at least one varying parameter is at least one physical variable of the varying magnetic field.

9. The device able to generate an electric current in a conductor, according to claim 8, wherein the at least one varying parameter is at least one of the following: the intensity of the varying magnetic field, the polarity of the varying magnetic field, the frequency of the varying magnetic field, and the position of the varying magnetic field.

10. The device able to generate an electric current in a conductor, according to claim 1, wherein the support element is at least one of the following: a knee brace or an elbow brace.

11. The device able to generate an electric current in a conductor, according to claim 1, wherein the energy source is designed to electrically feed the elements of the device.

12. The device able to generate an electric current in a conductor, according to claim 1, wherein the energy source is a battery.

13. A method to generate an electric current in a conductor through a device able to generate an electric current on the conductor, wherein the device comprises a magnetic field generator element, a control element, a support element, and an energy source, the magnetic field generator element, the control element, and the energy source are electrically assembled, the magnetic field generator element is designed to generate a varying magnetic field, this varying magnetic field comprises at least one varying parameter, the control element is designed to control at least one varying parameter, and the support element is designed to hold the energy source, the magnetic field generator element, and the control element, wherein the method comprises the following steps: (a) to establish one value for at least one parameter of the desired electric current; (b) to establish a period of time for operating the device; (c) to adjust at least one varying parameter of the varying magnetic field; (d) to generate the varying magnetic field; (e) to approach the device and the conductor; and (f) to induce an electric current on the metallic conductor.

14. The method to generate an electric current on a conductor, according to claim 13, wherein the steps (a) and are performed by the user.

15. The method to generate an electric current on a conductor, according to claim 13, wherein step (c) is performed by the control element.

16. The method to generate an electric current in a conductor, according to claim 13, wherein step (d) is performed by the magnetic field generator field.

17. The method to generate an electric current in a conductor, according to claim 13, wherein step (e) is performed by the user.

18. The method to generate an electric current in a conductor, according to claim 13, wherein step (f) is performed by the device.

19. A method to generate an electric current in a conductor, according to claim 13, wherein the at least one parameter of the electric current value induced during the step (f) is defined on step (a).

20. The method to generate an electric current in a conductor, according to claim 13, wherein the at least one parameter of the electric current defined on step (a) is related to at least one of the following: intensity to the electric current, the polarity of the electric current, the frequency of the electric current, and the modulation of the electric current.

21. The method to generate an electric current in a conductor, according to claim 20 wherein the intensity of the electric current has a value between 0.2 μA and 2 μA.

22. The method to generate an electric current in a conductor, according to claim 13, wherein step (f) occurs during the period of time defined on step (b).

23. A method to remove the biofilm on a conductor inside a patient using a device able to generate an electric current with at least one varying parameter in the said conductor, wherein the magnetic field generator element, the control element, and the energy source are electrically assembled, the magnetic field generator element is designed to generate a variable magnetic field, the aforementioned varying magnetic field comprises at least one variable parameter, the control element is designed to control at least one varying parameter of the electric current and the varying magnetic field, and the support element is designed to hold the energy source, the magnetic field generator element, and the control element, wherein the method comprises the following steps: (i) to establish at least one varying parameter of the electric current required to the treatment of the biofilm on the conductor, (ii) to establish the period of time in which that electric current will be applied to the conductor, (iii) position the support element in the region of the patient's body in which the conductor is located, (iv) to activate the device, and (v) to generate an electric current with an intensity established in step (i), during the period of time established in step (ii).

24. The method to remove the biofilm on a conductor, according to claim 23, wherein the device is a portable one.

25. The method to remove the biofilm from a conductor, according to claim 23, wherein the conductor is a metallic implant.

26. The method to remove the biofilm from a conductor, according to claim 24, wherein the implant is a knee prosthesis.

27. The method to remove the biofilm from a conductor, according to claim 23, wherein the step (iv) of the device activation comprises generating the electromagnetic field with at least one varying parameter.

28. The method to remove the biofilm from a conductor, according to the claim 23, wherein the electric current with intensity established in step (i) is generated in step (v) as a function of the magnetic field with at least one varying parameter generated in the step (iv).

29. The method to remove the biofilm from a conductor, according to the claim 23, wherein the at least one parameter of the electric current defined in the step (i) corresponds to at least one of the following: intensity of the electric current, the polarity of the electric current, the frequency of the electric current, and the modulation of the electric current.

30. The method to remove the biofilm from a conductor, according to claim 29, wherein the intensity of the electric current has one value between 0.2 μA and 2 μA.

31. A method of treatment for a subject that requires the removal of the biofilm in the metallic prosthesis implanted inside his body, wherein the method comprises the following steps: (a) to establish one value of at least one parameter of the desired electric current; (b) to establish a period of time for the device operation; (c) to adjust at least one varying parameter for the varying magnetic field; (d) to generate the varying magnetic field; (e) to approach the device and the metallic implant, and (f) to induce the electric current on the metallic implant.

32. The method of treatment for a subject that requires the removal of the biofilm on a metallic prosthesis implanted in his body, according to claim 31, wherein the electric current induced on step (f) has an intensity between 0.2 μA and 2 μA.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

[0038] The present invention will now be described in greater detail based on a sample execution represented in the drawings. The drawings show:

[0039] FIG. 1—shows the device proposed herein and its elements.

[0040] FIG. 2—shows the magnetic field generator element, comprised in the proposed device.

[0041] FIG. 3—shows an embodiment of the present invention, in which the device induces a current in a conductor through the generation of an electromagnetic field.

[0042] FIG. 4—shows the proposed device, held in the support element.

[0043] FIG. 5—shows one possible embodiment of the magnetic field generator element, represented as a toroidal coil.

DETAILED DESCRIPTION OF THE INVENTION

[0044] As widely known in the state of art, the microorganisms that grow on the surface of the implants made of several materials, after being introduced in the human body, may build what is named the biofilm.

[0045] As mentioned earlier, biofilms are structured co-units of bacteria that are soaked in polymeric matrices produced by themselves. Such polymeric substances provide the bacteria protection against several types of aggression that they may suffer such as, for example, the use of antibiotic drugs or chemical agents for their removal.

[0046] In this scenery, it is common to observe the formation of a biofilm on medical implants where an infection has occurred. The infection of medical implants, more specifically the infection of prostheses, occurs in approximately 2.4% of patients with knee prostheses and in up to 40% of patients with cardiac prostheses. The required treatment is most commonly a surgical and invasive approach, in which several procedures can be performed, such as hospital admissions, rehabilitation periods and intensive treatment, or even the removal and/or exchange of the prosthesis.

[0047] Such procedures may lend to other future complications. This is because, when any surgical procedure is performed, there is a risk of other infections, as well as possible clinical complications resulting from such surgical procedures.

[0048] As stated earlier, this situation occurs due to the fact that the biofilm build on the surface of medical implants precludes the immediate therapeutic effect of antibiotic therapy as such biofilm protects bacteria from the effects of these products. As a result, the antibiotic-only treatment is usually an ineffective method in such situations, and it should, therefore, be performed with surgical intervention.

[0049] However, one way to maximize antibiotic action is to use electricity to weaken the membranes of organisms in the biofilm. Usually, invasive devices are used, positioned through an incision made at the implant site. The device is then connected to the implant and an electrical current is generated for a certain period of time. It is noteworthy that the above process has not been used in the clinical practice, and even in the experimental context, only invasive processes are known.

[0050] Anyway, and as already mentioned above, the need for performing an incision in the place of the implant is an undesirable feature that is solved with the present invention.

[0051] That is because the present invention provides a device 10 and a method of generating an electric current in a conductor 15 in a non-invasive manner, so it prevents and/or treats the formation of biofilm on a conductor 15, as we will state in the following text.

[0052] As can be seen in FIGS. 1 and 3, a device 10 capable of generating an electric current in a conductor 15 is illustrated. Such a device comprises a magnetic field generator element 11 electrically assembled to a control element 12, both of them electrically assembled to an energy source 13 and mechanically assembled to a support element 14.

[0053] The magnetic field generator element 11 is designed to generate a varying magnetic field B with at least one varying parameter. This parameter may be any physical variable of the generated magnetic field including, but not limited to, the intensity of the magnetic field, the polarity of the magnetic field, a position in the magnetic field, etc.

[0054] That varying parameter is controlled by the control element 12. This control element may be, ideally, a microprocessor with a software, as well as any other electronic control device already known in the state of art.

[0055] Additionally, the magnetic field generator element 11 and the control element 12 are electrically powered by the source of energy 13. For example, the energy source could be a battery. However, such an example should not be understood as a limitation of the present invention since the source of energy 13 can be any device capable of electrically feeding the device 10, i.e., providing energy for the operation of the magnetic field generator element 11 and the control element 12.

[0056] Moreover, in only one of the possible executions that will be described below, the energy source 13 must be always deemed as being electrically associated with the magnetic field generator element 11 and to the control element 12. Therefore, throughout this document, when the magnetic field generator element 11 and the control element 12 are referred to, it must be understood that the energy source 13 is also present.

[0057] The FIGS. 4 and 5 show one of the possible executions of this invention in which the magnetic field generator element 11 is a toroidal coil and the energy source 13 is a battery. The toroidal coil and the battery are designed to be held in the support element 14 that, in an illustrative manner only and in this preferential execution, is an elbow or knee brace.

[0058] However, the execution above is not to be understood as a limitation to the present invention. The magnetic field generator element 11 may be any device or apparatus known to be able to generate a varying magnetic field, such as an electromagnet. Similarly, the support element 14 may be any other element that is capable to hold the magnetic field generator element 11, either inside or outside of it.

[0059] In any case, the preferential embodiment described above has the objective of providing a device 10 capable to generate an electric current in a conductor 15, in a way that this device 10 is a portable one, i.e., it is sized to be held in an elbow or knee brace.

[0060] Furthermore, the conductor 15, in which an electric current will be generated to operate the device is, in an only preferential way, a metallic implant. More preferably, the metallic implant is a metallic prosthesis internally arranged to the human body in the knee region. More preferably still, the metallic implant is a metallic knee prosthesis made of chromium cobalt.

[0061] However, such characteristics should not be understood as a limitation of this invention, being only an example of one of the possible executions. The conductor 15 can be any metallic conductor fit to have an electric current induced in itself. In addition, the conductor 15 can be a metallic implant positioned in any region of the human body, and can also be made of any metal alloy used in the state of the art, such as titanium, steel, Teflon, etc.

[0062] In harmony with the information presented so far, the device 10 will, when in operation, induce an electric current in the desired conductor 15.

[0063] This result occurs due to the physical effects resulting from several known laws of the state of the art. By way of example only and in a non-limiting way, the Faraday Law and the Biot-Savart Law are related to the appearance of a potential difference and a current flow in an electrical conductor in the presence of a magnetic field. In this way, an electric current is induced in the conductor 15 as a function of a varying magnetic field B generated by the magnetic field generator element 1, wherein at least one parameter of the varying magnetic field B is controlled by the control element 12.

[0064] Based on the preferential execution previously stated, in which the conductor 15 is a metallic knee prosthesis made of chromium cobalt, the magnetic field generator element 11 is a toroidal coil, and the support element 14 is a knee brace, the magnetic field generator element 11 is held internally to the support element 14. Furthermore, when the control element 12 is electrically assembled to the magnetic field generator element 11, the control element 12 is also held inside the support element 14. Thus, both elements, the control element 12 and the magnetic field generator 11, are held inside the support element 14.

[0065] However, and as mentioned above, such execution should not be understood as a limitation of this invention, being only one example of the possible executions. Alternatively, the magnetic field generator element 11 and the control element 12 can be arranged outside of the support element 14, so that the support element 14 is configured to serve, for example, as a holder.

[0066] Moreover, since the magnetic field generator element 11 may be any known element of the state of the art able to generate a varying magnetic field, the support element 14 should not have its dimensions specifically linked to the dimensions of the magnetic field generator element 11.

[0067] That is, the support element 14 can be a knee brace, as defined in the preferential execution of this invention, as well as can be a metal holder, a box, a casing, a cover, coating, etc., i.e. any apparatus fit to support the magnetic field generator element 11.

[0068] Similarly, the magnetic field generator element 11 is only preferably a toroidal coil, but such an execution should not be understood as a limitation of the present invention, as it was already mentioned earlier.

[0069] Anyway, when it is operating, the control element 12 controls at least one varying parameter of the varying magnetic field B generated by the magnetic field generator element 11. Thus, it is possible to control, as a function of the control of this varying parameter, the values of the electric current induced on the conductor 15 such as, for example, the intensity i of the current, its polarity, frequency, modulation, etc. That is, the control element 12 is also designed to control the values of the parameters of the induced electrical current on the conductor 15.

[0070] In particular, the control element 12 is also designed to control the period of time in which the magnetic field will be generated by the magnetic field generator element 11 and, therefore, the period of time in which the electric current will be induced in conductor 15.

[0071] Regarding the intensity i of the electrical current induced in conductor 15, preferably only, the electric current has an intensity i that is in the range between 0.2 μA to 2 μA. However, such a range should not be understood as a limitation of the present invention, being only a preferential range established in relation to the preferential execution described here. That is, the induced electric current in the conductor 15 may have any desired value depending on the desired results in the period of time in which the device 10 will be operated.

[0072] Furthermore, and in harmony with the information described above, the present invention refers to a method to generate an electric current in a conductor 15, by means of a device 10 capable of generating the electric current in that conductor 15.

[0073] This method comprises the following steps: [0074] (a) to establish at least one value for at least one parameter of the desired electric current; [0075] (b) to establish a period of time of operating the device 10; [0076] (c) to adjust at least one variable parameter; [0077] (d) to generate a variable magnetic field B; [0078] (e) to approach the device 10 to the conductor 15; and [0079] (f) to induce an electric current on the conductor 15.

[0080] Moreover, this method represents only a preferred operation of the device 10, in which the steps (a) and (b) are performed by the user. That is, the desired current and time period values that the current will be induced in conductor 15 are defined by the user, prior to the operation of the device 10.

[0081] In this way, once defined the values of at least one parameter of the current and the period of time, the varying parameter of the magnetic field can be adjusted through the control element 12 so that an electric current with the characteristics above defined is induced on the conductor 15.

[0082] Moreover, in the only preferential execution described above, the device 10 is located inside the support element 14, so that the electric current is induced in the conductor 15 when the device 10 approaches the conductor 15.

[0083] In other words, and only in reference to the preferential execution described here, an electrical current will be induced when the device 10 inside the knee brace approaches the knee prosthesis when the user wears the knee brace.

[0084] Moreover, and in harmony with the information presented earlier, the present invention relates to a method of removing biofilm from a conductor 15 inside the body of a patient using a device 10 capable to generate an electric current with at least one varying parameter on that conductor 15.

[0085] This method to remove the biofilm from a conductor 15 inside the body of a patient comprises the following steps: [0086] (i) to establish at least one varying parameter of the electrical current required for the treatment of the biofilm on the conductor 15, [0087] (ii) to establish the period of time in which the electric current will be applied to the conductor 15, [0088] (iii) to position the support element 14 in the region of the body of the patient where the conductor 15 is located, [0089] (iv) to activate the device 10, and [0090] (v) to generate an electrical current with an intensity i established in step i, during the period of time established in step ii.

[0091] Thus, and as mentioned earlier, the activation of device 10 will result in the generation of a B magnetic field with at least one varying parameter that, in turn, will induce an electric current with at least one varying parameter in the conductor 15. Such induction of the electric current is, in an advantageous way, responsible for the removal and/or treatment of the biofilm present in the conductor 15.

[0092] Moreover, and in an only preferential way, in a possible execution of the present method, the varying parameter of the electric current is at least one of the following: the intensity i of the electric current, the polarity of the electric current, the frequency of the electric current, and the modulation of the electric current.

[0093] In addition, in this only preferred execution, the conductor 15 is a metallic implant, and more preferably still, it is a metallic prosthesis.

[0094] Furthermore, the present invention refers to a method of treatment of a subject requiring removal of the biofilm on a metallic prosthesis 15 implanted inside his body. The method comprises the following steps: [0095] (a) to establish one value for at least one parameter of the desired electric current; [0096] (b) to establish a period of time for operating the device (10); [0097] (c) to adjust at least one varying parameter of the varying magnetic field B; [0098] (d) to generate a varying magnetic field B; [0099] (e) to approach the device 10 to the metallic implant 15; and [0100] (f) to induce an electric current on the metallic implant 15
Since an example of execution has been described, it should be understood that the scope of this invention covers other possible variations, being limited only by the content of the aforementioned claims, including the possible equivalents.