Electrical lead for an electronic device such as an implantable device

[0001] This application claims the benefit of U.S. Provisional Application No. 60/677,418, entitled “MRI Compatible Implantable Devices,” which was filed on May 4, 2005, the disclosure of which is incorporated herein by reference.

[0002] The present invention relates to electrical leads for devices such as, without limitation, implantable devices, and in particular to an electrical lead which resists the induction of currents from an external electromagnetic field and therefore reduces the likelihood of excessive heating from such fields.

[0003] Magnetic resonance imaging (MRI) is generally regarded as an extremely safe, non invasive diagnostic technique. MRI may, however, pose a threat to patients that have implantable devices, such as, without limitation, a deep brain stimulation (DBS) device, a pacemaker, a neurostimulator, or a cardio defibrillator. Currently, patients with metallic implants are not allowed to undergo an MRI scan. One of the main reasons for this is the excessive heating caused by the electromagnetic field concentration around the leads of an implant during an MRI procedure.

[0004] Many cases with substantial temperature increase during MRI scanning have been reported and reviewed. For example, in Achenbach S, Moshage W, Diem B, Bieberle T, Schibgilla V, Bachmann K., “Effects of Magnetic Resonance Imaging on Cardiac Pacemakers and Electrodes,” Am Heart J 1997; 134:467-473, a maximum temperature increase of 63.1° C. was reported during 90 seconds of MRI scanning. Additionally, in an in vitro evaluation of 44 commercially available pacemaker leads, it was reported in Sommer T, Hahlhaus C, Lauck G, et al., “MR Imaging and Cardiac Pacemakers: In Vitro Evaluation and In Vivo Studies in 51 patients at 0.5 T.,” Radiology 2000; 215:869-879, that a temperature increase of 23.5° C. was observed in a 0.5 Tesla experiment. Substantial temperature increases were also observed in MRI scans involving patients with neurostimulators, as reported in Gleason C A, Kaula N F, Hricak H, et al., “The Effect of Magnetic Resonance Imagers on Neurostimulators,” Pacing Clin Electrophysiology 1992; 15:81-94. Furthermore, 1.5 T and a SAR of 3.0 W/kg have been shown to cause severe necrosis in the mucous membranes of dogs with transesophageal cardiac pacing leads as reported in Hofman M B, de Cock C C, van der Linden J C, et al., “Transesophageal Cardiac Pacing During Magnetic Resonance Imaging: Feasibility And Safety Considerations,” Magn Reson Med 1996; 35:413-422.

[0005] Moreover, a 16.8° C. temperature increase on a half wavelength wire in a gel-phantom experiment was observed and reported in Smith C D, Kildishev A V, Nyenhuis J A, Foster K S, Bourland J D, “Interactions Of MRI Magnetic Fields With Elongated Medical Implants,” J Applied Physics 2000; 87:6188-6190. As reported in Konings M K, Bartels L W, Smits H J, Bakker C J, “Heating Around Intravascular Guidewires By Resonating RF Waves,” J Magn Reson Imaging 2000; 12:79-85, temperature increases due to endavascular guidewires between 26° C. and 74° C. were observed in saline bath experiments of up to 30 seconds of scan time. In another experiment with saline solution, reported in Nitz W R, Oppelt A, Renz W, Manke C, Lenhart M, Link J., “On The Heating Of Linear Conductive Structures As Guide Wires And Catheters In Interventional MRI,” J Magn Reson Imaging 2001; 13:105-114, up to 34° C. of temperature increase was observed for a half wavelength wire. It should be noted that first, second or third order bums were observed in many of the in-vivo studies mentioned above.

[0006] A recent study was performed for one of the most widely used neurostimulation systems, the Activa Tremor Control System sold by Medtronic. Different configurations were evaluated to assess worst case and clinically relevant positioning scenarios, and in vitro experiments were performed at 64 MHz MR system using gel phantoms to represent human tissue. As reported in Rezai A R, Finelli D, Nyenhuis J A, et al., “Neurostimulator For Deep Brain Stimulation: Ex Vivo Evaluation Of MRI-Related Heating At 1.5-Tesla,” J Magn Reson Imaging 2002; 15:241-250, the highest temperature change observed was 25.3° C. for the RF coil and 7.1° C. for the head coil. These results indicate that heating may be hazardous under certain MRI scanning conditions.

[0007] The FREEHAND System Implantable Functional Neurostimulator is a commercially available RF-powered motor control neuroprosthesis that consists of both implanted and external components sold by NeuroControl Corporation of Cleveland, Ohio. Findings from of an MRI-induced heating experiment during which the FREEHAND System was exposed to a whole-body-averaged SAR of 1.1 W/kg for 30 minutes showed that localized temperature increases were no greater than 2.7° C. with the device in a gel-filled phantom. A patient with a FREEHAND system can thus only undergo an MRI procedure under certain input power levels for a 1.5 Tesla scanner.

[0008] Due to the safety concerns created by the potential for excessive heating as described above, several strategies have been developed to promote MRI safety for patient's having metallic implants. One of the basic ones is to set a power threshold that ensures only a reasonable amount of heating will occur. A methodology for such a power limitation was previously published in Yeung C J, Susil R C, Atalar E., “RF Safety Of Wires In Interventional MRI: Using A Safety Index,” Magn Reson Med 2002; 47:187-193. However, many modem MRI pulse sequences, such as fast spin-echo or steady-state free precession (SSFP), require high RF power levels and therefore there is no guarantee that good quality images can be acquired if RF power is limited.

[0009] Most of the studies on the heating of metallic implants concentrate on the heating of the leads of the implant rather than the generator of the implant. This is primarily due to the fact that generators are typically smooth devices with curved edges and are therefore less threatening structures than the leads in terms of electromagnetic field concentration. As a result, less heating is observed and smaller temperature increase is expected in generators. See, for example, the results reported in Ferhanoglu O, Tasci O. T, El-Sharkawy A, Altintas A, Atalar E, “Investigating RF Heating Of Pacemakers In MRI Using A Safety Index”, Proc. International Society of Magnetic Resonance in Medicine, 12^th Scientific Meeting, Kyoto, 2004, and Ferhanoglu O, El-Sharkawy A, Atalar E, “RF Heating At The Tip Of Pacemaker Leads,” Proc. European Society of Magnetic Resonance in Medicine and Biology, 21^st Scientific Meeting, Copenhagen, 2004.

[0010] U.S. Pat. No. 6,284,971 discloses a coaxial cable which may be a magnetic resonance imaging coaxial cable designed for enhanced safety so as to reduce the risk of excessive heating or bums to a user. The cable has an elongated axially oriented inner conductor and an axially oriented outer shield conductor in spaced relationship with respect thereto with a first dielectric material disposed therebetween. However in this design, high permittivity materials must be employed. This requirement may create flexibility problems since high permittivity materials are brittle and rigid. In addition, there may be more than one the lead which may require usage of separate coaxial cables. In such a case, miniaturization of the design is a difficult task.

[0011] RF chokes and filters have been used in several previous studies. For example, as described in Susil R C, et al., “Multifunctional Interventional Devices for MRI: A Combined Electrophysiology/MRI Catheter”, MRM 47:594-600 (2002), RF chokes were used in the design of a combined electrophysiology/MRI catheter, and as described in Ladd M E, et. al., “Reduction of Resonant RF Heating in Intravascular Catheters Using Coaxial Chokes”, MRM 43:615-619 (2000), triaxial chokes were used to present a high impedance to currents flowing on the outer surface of the triax.

[0012] U.S. Pat. No. 6,539,253 discloses an implantable medical device incorporating integrated circuit notch filters, and U.S. Pat. No. 5,817,136 discloses a pacemaker with EMI protection. Both of the designs ensure electromagnetic interference is not a problem, however safety in terms of heating is not guaranteed. High current may still be flowing through long cables and these high currents may cause excessive heating and buns.

[0013] U.S. Pat. No. 5,217,010 describes optical signal transmission in between the generator and the organ in a pacemaker, which provides safety since there is no coupling with the optical system and the electromagnetic field. However, the electrical to optical and optical to electrical energy conversion efficiency is limited and therefore the lifetime of the pulse generator is reduced significantly. Miniaturization in this case is also a difficult task.

[0014] It is thus apparent that a need exists for an electrical lead which may be used with, for example, metallic implants, which resists the induction of currents from an external electromagnetic field, such as the field that is present during MRI scanning, and therefore reduces the likelihood of excessive heating from such fields.

[0015] In one embodiment, the invention relates to lead for an electronic device which resists the induction of a current from an electromagnetic field external to the lead, as may be present during an MRI process. The lead includes one or more pairs of adjacent segments of electrical wire, each of the pairs including a first segment of electrical wire and a second segment of electrical wire. The adjacent segments of electrical wire may be single conductor electrical wires or multiple conductor electrical wires. The lead also includes one or more shielded RF chokes, wherein each of the shielded RF chokes is provided between the first segment of electrical wire and the second segment of electrical wire of a respective one of the one or more pairs of adjacent segments. The shielded RF chokes have a first end operatively coupled to the first segment of electrical wire and a second end operatively coupled to the second segment of electrical wire of the respective pair of adjacent segments. Preferably, the one or more pairs of adjacent segments comprises a plurality of pairs of adjacent segments of electrical wire and the one or more shielded RF chokes comprises a plurality of shielded RF chokes.

[0016] In one particular embodiment, the electromagnetic field includes electromagnetic energy having a first wavelength, and the first segment of electrical wire and the second segment of electrical wire in each of the plurality of pairs of adjacent segments of electrical wire each has a length of no more than about a predetermined percentage, such as twenty five percent, of the first wavelength. The electronic device may be a device carried by the body of a patient, such as an implantable device.

[0017] The shielded RF chokes may include an inductor covered by one or more layers of conductive shielding material, such as a metallic shielding material. Preferably, a first end of the one or more layers of conductive shielding material is electrically connected to the inductor and a second end of the one or more layers of conductive shielding material is either floating or connected to an insulator. In addition, each inductor in the shielded RF chokes may include a core, such as a paramagnetic core. Alternatively, the shielded RF chokes may comprise toroidal inductors, wherein a coil is wrapped around a doughnut-shaped core. Additionally, one or more electrical shielding layers, such as metallic layers, may be provided around the toroidal inductor to provide additional shielding.

[0018] In another embodiment, the lead may further include a layer of insulating material covering at least a portion of the one or more pairs of adjacent segments of electrical wire and at least a portion the one or more shielded RF chokes.

[0019] In one particular embodiment, one or more of the one or more shielded RF chokes comprises a first conductor and a first inductor connected in series and provided between the first segment of electrical wire and the second segment of electrical wire of the respective one of the one or more pairs of adjacent segments, at least one layer of conductive shielding material covering the first conductor and the first inductor, and a capacitor provided between the first conductor and the at least one layer of conductive shielding material.

[0020] In yet another embodiment, the invention relates to an apparatus that may be implanted within a patient's body which resists the induction of a current from an electromagnetic field external to the apparatus. The apparatus includes a generator for generating one or more electrical pulses, and a lead for delivering the one or more electrical pulses to tissue within the patient's body. The lead in the apparatus may be structured according to the various embodiments described above.

[0021] In still a further embodiment, the invention relates to a method of making an implantable device including the various embodiments of the lead described above. In particular, the method includes providing one or more pairs of adjacent segments of electrical wire, each of the pairs including a first segment of electrical wire and a second segment of electrical wire, and providing a shielded RF choke, as described in the various embodiments above, between the first segment of electrical wire and the second segment of electrical wire of each one of the one or more pairs of adjacent segments.

[0029] FIG. 1 is a schematic diagram of an electrical lead 5 for an electronic device carried by the body of a patient according to a first embodiment of the present invention. As used herein, the term “patient”shall refer to any member of the animal kingdom, including human beings. As used herein, the terms “carried by the body of the patient” in reference to as device shall mean that the device may be implanted within the patient body, worn on or attached externally to the patient's body, or some combination thereof. In the preferred embodiment as shown schematically in FIG. 2, the electrical lead 5 shown in FIG. 1 forms a part of an implantable device 10, such as, without limitation, a deep brain stimulation (DBS) device, a pacemaker, a neurostimulator, or a cardio defibrillator, to deliver electrical signals (e.g., electrical pulses) from a generator 15 to a location 20, such as an organ or some other tissue, within the body to which the electrical signals are to be applied (for illustrative purposes, FIG. 2 shows a DBS device). As described in greater detail herein, the electrical lead 5 allows for safer MRI scanning of patients by decreasing the amount of heating caused by the RF field.

[0030] Referring again to FIG. 1, the electrical lead 5 includes a plurality of segments of electrical wire 25 which, in this embodiment, each comprise a single conductor wire. Preferably, each of the segments of electrical wire 25 comprises a flexible insulated single conductor wire. As seen in FIG. 1, the electrical lead 5 includes a shielded RF choke 30 that is inserted between two adjacent segments of electrical wire 25. As used herein, the term “shielded RF choke” shall refer to an inductor that traps an electromagnetic field or fields within a confined area in order to resist the penetration of external electromagnetic fields into the confined area and therefore resist interaction between external electromagnetic fields and with electromagnetic fields that may exist in the confined area.

[0031] In the embodiment shown in FIG. 1, the shielded RF choke 30 comprises an inductor 33, in the form of a coil, surrounded by a layer of electrical shielding material 35, such as a metallic shielding material like copper, aluminum, gold, silver or nitinol. The layer of shielding material 35 helps to reduce the risk of magnetic coupling during an MRI scanning process. As seen in FIG. 1, a first end of the inductor 33 is electrically coupled to one of the adjacent segments of electrical wire 25 and the opposite end of the inductor 33 is electrically coupled to the other of the adjacent segments of electrical wire 25. In addition, one end of the layer of conductive shielding material 35 is electrically connected to the inductor 33 and the other end of the layer of conductive shielding material 35 either floats or touches the insulating material, if present, surrounding the electrical wire 25.

[0032] Although only two adjacent segments of electrical wire 25 and one shielded RF choke 30 are shown in FIGS. 1 and 2, it should be understood that the electrical lead 5 may include multiple adjacent segments of electrical wire 25 and multiple shielded RF chokes 30 connected as shown in FIG. 1 and described above. In fact, in the preferred embodiment of the electrical lead 5, the electrical lead 5 includes a length consisting of multiple adjacent segments of electrical wire 25 and multiple shielded RF chokes 30 provided therebetween. In this preferred embodiment, each segment of electrical wire 25 is substantially shorter than one half of the wavelength of the electromagnetic field with which it is desired to use the electrical lead 5. As will be appreciated, if multiple electromagnetic fields are possible, then the shortest of the wavelengths is chosen for this design parameter. In the most preferred embodiment, each segment of electrical wire 25 is less than or equal to about one quarter of the wavelength (λ/4) of the electromagnetic field (e.g., the RF field to be used in an MRI scanning process; the most common frequency used in MRI scanning are 64 MHz, although 42 MHz and 128 MHz systems are also common) with which it is desired to use the electrical lead 5. In one embodiment, the preferred electrical lead 5 may be a conventional lead used for implantable devices that is serially modified to include the shielded RF chokes 30 at predetermined intervals such as intervals of at least every λ/4. Alternatively, in another embodiment, the preferred electrical lead 5 may be specially manufactured to include the shielded RF chokes 30 at predetermined intervals such as intervals of at least every λ/4.

[0033] As is known in the art, RF chokes resist the flow of currents of certain frequencies and pass currents of certain relatively lower frequencies (the term “RF trap” is also commonly used). Thus, in the electrical lead 5, the shielded RF choke or chokes 30 will resist (and possibly entirely prevent) current flow at high frequencies such as the RF field frequencies of an MRI device, and will at the same time let the current pass at lower frequencies, e.g., the frequencies of the implantable device with which it is used. As a result, the possibility of the induction of current, and therefore production of heat, due to the RF field of the MRI is reduced (and possibly entirely prevented), while still allowing the transmission of signals from a generator 15 to a location 20 as shown in FIG. 2. In the preferred embodiment, the segment of electrical wire 25 that is provided inside the location 20, such as an organ or other tissue, does not include a shielded RF choke 30, and instead is preferably shorter than λ/2 and therefore relatively safe.

[0034] FIG. 3 is a schematic diagram of an electrical lead 5′ according to an alternate embodiment of the present invention that is similar to the electrical lead 5 except that it includes one or more shielded RF chokes 30′ that, instead of using a single layer of shielding material 35, employ multiple layers of shielding material 35A and 35B for improved decoupling of the magnetic field. Preferably, the electrical lead 5′ includes multiple RF chokes 30 spaced at intervals as described. As seen in FIG. 3, in each layer of shielding material 35A and 35B, one end of the layer is electrically connected to the inductor 33 and the other end of the layer either floats or touches the insulating material, if present, surrounding the electrical wire 25.

[0035] FIG. 4 is a schematic diagram of an electrical lead 5″ according to a third, further alternate embodiment of the present invention that is similar to the electrical lead 5 except that it includes one or more shielded RF chokes 30″ in the form of inductors 33 that each have a core 40 provided within the inductor 33. The core 40 inside each inductor 33 provides a higher inductance for a given resistance. Preferably, a paramagnetic material, such as, without limitation, aluminum or various plastic materials, is used to form the core 40. Preferably, ferromagnetic materials should not be used for the core 40 to resist any attraction by the magnetic filed of the MRI.

[0036] FIG. 5 is a schematic diagram of an electrical lead 45 according to a yet another alternate embodiment of the present invention. The electrical lead 45 is similar to the electrical lead 5 shown in FIG. 1 in that it includes a plurality of segments of electrical wire 25. The electrical lead 45 in this embodiment includes one or more shielded RF chokes 47 each having the form of a toroidal inductor that preferably includes a torus-shaped coil 50 wrapped around a doughnut-shaped core 55. The shielded RF chokes 47 perform essentially the same function as the shielded RF chokes 30 described above as the shielded RF chokes 47 trap electromagnetic fields within the doughnut-shaped core 55 and resist the induction of currents as a result of external electromagnetic fields. Preferably, the electrical lead 45 includes multiple shielded RF chokes 47 spaced at intervals as described above in connection with the shielded RF chokes 30. When the shielded RF chokes 47 are used, there may be no need for a layer of shielding material (as in the shielded RF chokes 30, 30′ and 30″) as the electromagnetic field is trapped inside the core 55.

[0037] FIG. 6A is a schematic diagram of an electrical lead 60 according to still a further alternate embodiment of the present invention. The electrical lead 60 includes a plurality of segments of electrical wire 25′ which, in this embodiment, each comprise a multiple conductor wire, preferably in the form of a flexible insulated multiple conductor wire or a coaxial cable. The electrical lead 60 is similar to the electrical lead 5 shown in FIG. 1 as it includes a one or more shielded RF chokes 30 including an inductor 33 surrounded by layer of shielding material 35 as described above. Preferably, as shown in FIG. 6B, the electrical lead 60 includes multiple shielded RF chokes 30 spaced at intervals as described above in connection with FIG. 1. As seen in FIGS. 6A and 6B, a first end of each inductor 33 of each shielded RF choke 30 is electrically coupled to each of the wires of one of the adjacent segments of electrical wire 25′ and the opposite end of the inductor 33 of each shielded RF choke 30 is electrically coupled to each of the wires of the other of the adjacent segments of electrical wire 25′. In addition, it should be appreciated that, in variations of this embodiment, an additional layer or layers of shielding material may be provided as shown in FIG. 3, a core 40 may be provided in the shielded RF choke 30 as shown in FIG. 4, and/or a toroidal RF choke 47 as shown in FIG. 5 may be used.

[0038] FIG. 7 is a schematic diagram of an electrical lead 60′ according to another alternate embodiment of the present invention that is similar to the electrical lead 60 shown in FIG. 6. The electrical lead 60′ differs from the electrical lead 60 in that, instead of a single shielded RF choke 30 being provided between adjacent segments of electrical wire 25′, multiple shielded RF chokes 30 are provided between adjacent segments of electrical wire 25′. Specifically, as shown in FIG. 7, one shielded RF choke 30 is provided for each conductor contained in the segments of electrical wire 25′. FIG. 8 is a schematic diagram of an electrical lead 60″ according to yet another alternate embodiment of the present invention that is similar to the electrical lead 60 shown in FIG. 6 except that each shielded RF choke 30 is replaced by a toroidal shielded RF choke 47 as shown in FIG. 5.

[0039] FIGS. 9A and 9B are schematic diagrams of a electrical leads 65A and 65B, respectively, according to still further alternate embodiments of the present invention. As seen in FIG. 9A, the electrical lead 65A includes a plurality of segments of electrical wire 25′ which each comprise a multiple conductor wire, preferably in the form of a flexible insulated multiple conductor wire. As noted elsewhere herein, the multiple conductor wire or each conductor therein may be, for example and without limitation, a coaxial wire or a triaxial wire. The electrical lead 65A includes a one or more alternative shielded RF chokes 67A that are preferably spaced at intervals as described above in connection with FIG. 1. As seen in FIG. 9A, each shielded RF choke 67A comprises a layer of shielding material 35 as described above that covers but is not in contact with the conductor portions 75 located between the adjacent segments of electrical wire 25′, and a capacitor 70 provided between each such conductor 75 and the layer of shielding material 35. In addition, in the shielded RF choke 67A, an inductor 33 is provided between each conductor 75 and the segment of electrical wire 25′ that is electrically upstream (in terms of current flow) from the point at which the capacitor 70 is connected to the conductor 75. In the embodiment shown in FIG. 9A, the capacitors 70 are tuned. The electrical lead 65B shown in FIG. 9B is similar to the electrical lead 65A, except that in the electrical lead 65B, an inductor 33 is provided between each conductor 75 and the segment of electrical wire 25′ that is electrically downstream (in terms of current flow) from the point at which the capacitor 70 is connected to the conductor 75. In the electrical lead 65B, the capacitors 70 are short at relatively high frequencies (on the order of 100 MHz) and therefore no signal is transmitted by the electrical lead 65B, and therefore no signal is provided to the location 20 (such as the brain or some other organ or tissue within the body) shown in FIG. 2. As an alternative, in either electrical lead 65A or 65b, the inductors 33 may be wrapped together.

[0040] FIG. 10 is a variation of the embodiment shown in FIG. 6 wherein a layer of insulating material 80, such as, without limitation, Teflon, polyethylene, nylon, rubber or pvc, is provided around the segments of electrical wire 25′ and the shielded RF chokes 30 except for those areas that must remained exposed for proper operation of the implantable device with which the electrical lead 60 is to be used (as is known, some implantable devices, such as pacemakers, require one or more portions of the leads to be exposed so that an electrical connection or connections to the body can be made). The layer of insulating material 80 will provide further safety as charges may tend to accumulate at the edges of the layer of shielding material 35. The use of the layer of insulating material 80 is not limited to the electrical lead 60, but may also be used with the other embodiments shown herein. In addition, when the electrical lead 60 (or the other electrical leads described herein) are used with an implantable device, the layer of insulating material 80 may also cover the generator 15 (FIG. 2).

[0041] A number of simulations of the performance of the electrical lead 5 were performed by the present inventors. The simulation results are depicted in FIGS. 11A and 11B. FIG. 11A shows the normalized induced current on a regular wire and a lead 5. FIG. 11B shows the SAR distribution on the surface of the regular and the lead 5. From these simulations, it is obvious that the lead 5 is able to separate the wire into two wires.

[0042] In addition, in order to evaluate the effectiveness of the present invention, gel phantom experiments were performed on a regular pacemaker and a pacemaker including an electrical lead 5. The gel phantom setup is shown in FIG. 12 and includes a temperature probe 1 located at the tip of the pacemaker lead in each case and a reference probe 2. The gel phantom setup for each pacemaker (regular and safe, i.e., including the lead 5) shown in FIG. 12 was subjected to MRI scanning and profiles of the temperatures measured by the probes are shown in FIG. 13. As can be seen, the pacemaker that included the lead 5 experienced significantly less heating.

[0043] While preferred embodiments of the invention have been described and illustrated above, it should be understood that these are exemplary of the invention and are not to be considered as limiting. Additions, deletions, substitutions, and other modifications can be made without departing from the spirit or scope of the present invention. Accordingly, the invention is not to be considered as limited by the foregoing description but is only limited by the scope of the appended claims.