WO2007008301A2

WO2007008301A2 - Medical device with an electrically conductive anti-antenna member

Info

Publication number: WO2007008301A2
Application number: PCT/US2006/020765
Authority: WO
Inventors: Robert W. Gray
Original assignee: Biophan Technologies, Inc.
Priority date: 2005-07-12
Filing date: 2006-05-31
Publication date: 2007-01-18
Also published as: WO2007008301A3; EP1909661A2; EP1909661A4

Abstract

A lead includes a conductor having a distal end and a proximal end and a resonant circuit connected to the conductor. The resonant circuit has a resonance frequency approximately equal to an excitation signal's frequency of a magnetic resonance imaging scanner or a resonance frequency not tuned to an excitation signal's frequency of a magnetic resonance imaging scanner so as to reduce the current flow through a tissue area, thereby reducing tissue damage. The resonant circuit may be included in an adapter that provides an electrical bridge between a lead a medical device such as an electrode, sensor, or signal generator. The resonant circuit may also be included directly in the housing of a medical device.

Description

MEDICAL DEVICE WITH AN ELECTRICALLY CONDUCTIVE ANTI-ANTENNA MEMBER

TECHNICAL FIELD

[0001] The present invention relates generally to a medical device that includes an anti- antenna device to prevent or significantly reduce damaging heat, created by currents or voltages induced by outside electromagnetic energy, to a tissue area. More particularly, the present invention is directed to a medical device that includes an anti-antenna device to prevent or significantly reduce damaging heat, created by currents or voltages induced by magnetic- resonance imaging, to a tissue area.

BACKGROUND ART

[0002] Magnetic resonance imaging has been developed as an imaging technique adapted to obtain both images of anatomical features of human patients as well as some aspects of the functional activities of biological tissue. These images have medical diagnostic value in determining the state of the health of the tissue examined.

[0003] In a magnetic-resonance imaging process, a patient is typically aligned to place the portion of the patient's anatomy to be examined in the imaging volume of the magnetic- resonance imaging apparatus. Such a magnetic-resonance imaging apparatus typically comprises a primary magnet for supplying a constant magnetic field (B₀) which, by convention, is along the z-axis and is substantially homogeneous over the imaging volume and secondary magnets that can provide linear magnetic field gradients along each of three principal Cartesian axes in space (generally x, y, and z, or X₁, X₂ and X₃, respectively). A magnetic field gradient (ΔB₀ /ΔXj) refers to the variation of the field along the direction parallel to B₀ with respect to each of the three principal Cartesian axes, Xj. The apparatus also comprises one or more radio- frequency coils which provide excitation signals to the patient's body placed in the imaging volume in the form of a pulsed rotating magnetic field. This field is commonly referred to as the scanner's "B1" field and as the scanner's "RF" or "radio-frequency" field. The frequency of the excitation signals is the frequency at which this magnetic field rotates. These coils may also be used for detection of the excited patient's body material magnetic-resonance imaging response signals.

[0004] The use of the magnetic-resonance imaging process with patients who have implanted medical assist devices; such as cardiac assist devices or implanted insulin pumps; often presents problems. As is known to those skilled in the art, implantable devices (such as implantable pulse generators and cardioverter/defibrillator/pacemakers) are sensitive to a variety of forms of electromagnetic interference because these enumerated devices include sensing and logic systems that respond to low-level electrical signals emanating from the monitored tissue region of the patient. Since the sensing systems and conductive elements of these implantable devices are responsive to changes in local electromagnetic fields, the implanted devices are vulnerable to external sources of severe electromagnetic noise, and in particular, to electromagnetic fields emitted during the magnetic resonance imaging procedure. Thus, patients with implantable devices are generally advised not to undergo magnetic resonance imaging procedures.

[0005] To more appreciate the problem, the use of implantable cardiac assist devices during a magnetic-resonance imaging process will be briefly discussed.

[0006] The human heart may suffer from two classes of rhythmic disorders or arrhythmias: bradycardia and tachyarrhythmia. Bradycardia occurs when the heart beats too slowly, and may be treated by a common implantable pacemaker delivering low voltage (about 3 Volts) pacing pulses.

[0007] The common implantable pacemaker is usually contained within a hermetically sealed enclosure, in order to protect the operational components of the device from the harsh environment of the body, as well as to protect the body from the device.

[0008] The common implantable pacemaker operates in conjunction with one or more electrically conductive leads, adapted to conduct electrical stimulating pulses to sites within the patient's heart, and to communicate sensed signals from those sites back to the implanted device.

[0009] Furthermore, the common implantable pacemaker typically has a metal case and a connector block mounted to the metal case that includes receptacles for leads which may be used for electrical stimulation or which may be used for sensing of physiological signals. The battery and the circuitry associated with the common implantable pacemaker are hermetically sealed within the case. Electrical interfaces are employed to connect the leads outside the metal case with the medical device circuitry and the battery inside the metal case.

[0010] Electrical interfaces serve the purpose of providing an electrical circuit path extending from the interior of a hermetically sealed metal case to an external point outside the case while maintaining the hermetic seal of the case. A conductive path is provided through the interface by a conductive pin that is electrically insulated from the case itself.

[0011] Such interfaces typically include a ferrule that permits attachment of the interface to the case, the conductive pin, and a hermetic glass or ceramic seal that supports the pin within the ferrule and isolates the pin from the metal case.

[0012] A common implantable pacemaker can, under some circumstances, be susceptible to electrical interference such that the desired functionality of the pacemaker is impaired. For example, common implantable pacemaker requires protection against electrical interference from electromagnetic interference or insult, defibrillation pulses, electrostatic discharge, or other generally large voltages or currents generated by other devices external to the medical device. As noted above, more recently, it has become crucial that cardiac assist systems be protected from magnetic-resonance imaging sources.

[0013] Such electrical interference can damage the circuitry of the cardiac assist systems or cause interference in the proper operation or functionality of the cardiac assist systems. For example, damage may occur due to high voltages or excessive currents introduced into the cardiac assist system.

[0014] Therefore, it is required that such voltages and currents be limited at the input of such cardiac assist systems, e.g., at the interface. Protection from such voltages and currents has typically been provided at the input of a cardiac assist system by the use of one or more zener diodes and one or more filter capacitors.

[0015] For example, one or more zener diodes may be connected between the circuitry to be protected, e.g., pacemaker circuitry, and the metal case of the medical device in a manner which grounds voltage surges and current surges through the diode(s). Such zener diodes and capacitors used for such applications may be in the form of discrete components mounted relative to circuitry at the input of a connector block where various leads are connected to the implantable medical device, e.g., at the interfaces for such leads.

[0016] However, such protection, provided by zener diodes and capacitors placed at the input of the medical device, increases the congestion of the medical device circuits, at least one zener diode and one capacitor per input/output connection or interface. This is contrary to the desire for increased miniaturization of implantable medical devices.

[0017] Further, when such protection is provided, interconnect wire length for connecting such protection circuitry and pins of the interfaces to the medical device circuitry that performs desired functions for the medical device tends to be undesirably long. The excessive wire length may lead to signal loss and undesirable inductive effects. The wire length can also act as an antenna that conducts undesirable electrical interference signals to sensitive CMOS circuits within the medical device to be protected.

[0018] Additionally, the radio-frequency energy that is inductively coupled into the wire causes intense heating along the length of the wire, and at the electrodes that are attached to the heart wall. This heating may be sufficient to ablate the interior surface of the blood vessel through which the wire lead is placed, and may be sufficient to cause scarring at the point where the electrodes contact the heart. A further result of this ablation and scarring is that the sensitive node that the electrode is intended to pace with low voltage signals becomes desensitized, so that pacing the patient's heart becomes less reliable, and in some cases fails altogether.

[0019] Another conventional solution for protecting the implantable medical device from electromagnetic interference is illustrated in Figure 1. Figure 1 is a schematic view of an implantable medical device 12 embodying protection against electrical interference. At least one lead 14 is connected to the implantable medical device 12 in connector block region 13 using an interface.

[0020] In the case where implantable medical device 12 is a pacemaker implanted in a body 10, the pacemaker 12 includes at least one or both of pacing and sensing leads represented generally as leads 14 to sense electrical signals attendant to the depolarization and repolarization of the heart 16, and to provide pacing pulses for causing depolarization of cardiac tissue in the vicinity of the distal ends thereof.

[0021] Conventionally protection circuitry is provided using a diode array component.

The diode array conventionally consists of five zener diode triggered semiconductor controlled rectifiers with anti-parallel diodes arranged in an array with one common connection. This allows for a small footprint despite the large currents that may be carried through the device during defibrillation, e.g., 10 amps. The semiconductor controlled rectifiers turn ON and limit the voltage across the device when excessive voltage and current surges occur. [0022] Each of the zener diode triggered semiconductor controlled rectifier is connected to an electrically conductive pin. Further, each electrically conductive pin is connected to a medical device contact region to be wire bonded to pads of a printed circuit board. The diode array component is connected to the electrically conductive pins via the die contact regions along with other electrical conductive traces of the printed circuit board. [0023] Other attempts have been made to protect implantable devices from magnetic- resonance imaging fields. For example, United States Patent 5,968,083 describes a device adapted to switch between low and high impedance modes of operation in response to electromagnetic interference or insult. Furthermore, United States Patent 6,188,926 discloses a control unit for adjusting a cardiac pacing rate of a pacing unit to an interference backup rate when heart activity cannot be sensed due to electromagnetic interference or insult. [0024] Although, conventional medical devices provide some means for protection against electromagnetic interference, these conventional devices require much circuitry and fail to provide fail-safe protection against radiation produced by magnetic-resonance imaging procedures. Moreover, the conventional devices fail to address the possible damage that can be done at the tissue interface due to radio-frequency induced heating, and they fail to address the unwanted heart stimulation that may result from radio-frequency induced electrical currents. [0025] Thus, it is desirable to provide devices that prevent the possible damage that can be done at the tissue interface due to induced electrical signals that may cause thermally-related tissue damage.

DISCLOSURE OF THE INVENTION

[0026] One aspect of the present invention is a lead. The lead includes a conductor having a distal end and a proximal end and a resonant circuit operatively connected to the conductor, the resonant circuit having a resonance frequency approximately equal to an excitation signal's frequency of a magnetic-resonance imaging scanner.

[0027] A second aspect of the present invention is a bipolar pacing lead circuit. The bipolar pacing lead circuit includes first and second conductors, the first and second conductors each having a distal end and a proximal end, and a resonant circuit operatively connected to the first conductor. The resonant circuit has a resonance frequency approximately equal to an excitation signal's frequency of a magnetic-resonance imaging scanner.

[0028] Another aspect of the present invention is an adapter for a lead. The adapter includes a housing having a first connector and a second connector, the first connector providing a mechanical and electrical connection to a lead, the second connector providing a mechanical and electrical connection to a medical device, and a resonant circuit operatively connected to the first and second connectors. The resonant circuit has a resonance frequency approximately equal to an excitation signal's frequency of a magnetic-resonance imaging scanner.

[0029] Another aspect of the present invention is an adapter for a bipolar pacing lead. The adapter includes a housing having a first connector and a second connector, the first connector providing a mechanical and electrical connection to each lead of a multi-conductor lead, the second connector providing a mechanical and electrical connection to a medical device, and a resonant circuit operatively connected to the first and second connectors. The resonant circuit has a resonance frequency approximately equal to an excitation signal's frequency of a magnetic-resonance imaging scanner.

[0030] Another aspect of the present invention is an adapter for a lead. The adapter includes a housing having a first connector said first connector providing a mechanical and electrical connection to a lead; a resonant circuit operatively connected to the first connector; and a medical device operatively connected to the resonant circuit. The resonant circuit has a resonance frequency approximately equal to an excitation signal's frequency of a magnetic- resonance imaging scanner.

[0031] Another aspect of the present invention is a medical device. The medical device includes a housing having electronic components therein; a lead operatively connected to the electronic components within the housing; and a resonant circuit, located within the housing, operatively connected to the lead and the electronic components. The resonant circuit has a resonance frequency approximately equal to an excitation signal's frequency of a magnetic- resonance imaging scanner.

[0032] Another aspect of the present invention is a medical device. The medical device includes a housing having electronic components therein; a multi-conductor lead circuit operatively connected to the electronic components within the housing; and a resonant circuit, located within the housing, operatively connected to a conductor of the multi-conductor lead circuit and the electronic components. The resonant circuit has a resonance frequency approximately equal to an excitation signal's frequency of a magnetic-resonance imaging scanner.

[0033] Another aspect of the present invention is a lead. The lead includes a conductor having a distal end and a proximal end and a resonant circuit operatively connected to the conductor. The resonant circuit has a resonance frequency approximately equal to a frequency of an electromagnetic radiation source.

[0034] Another aspect of the present invention is a medical device. The medical device includes a housing having electronic components therein; a lead operatively connected to the electronic components within the housing; and a resonant circuit, located within the housing, operatively connected to the lead and the electronic components. The resonant circuit has a resonance frequency approximately equal to a frequency of an electromagnetic radiation source.

[0035] Another aspect of the present invention is a medical device. The medical device includes a housing having electronic components therein; a multi-conductor lead operatively connected to the electronic components within the housing; and a resonant circuit, located within the housing, operatively connected to the multi-conductor lead and the electronic components. The resonant circuit has a resonance frequency approximately equal to a frequency of an electromagnetic radiation source.

[0036] Another aspect of the present invention is an adapter for a lead. The adapter includes a housing having a first connector and a second connector, the first connector providing a mechanical and electrical connection to a lead, the second connector providing a mechanical and electrical connection to a medical device; and a resonant circuit operatively connected to the first and second connectors. The resonant circuit has a resonance frequency approximately equal to a frequency of an electromagnetic radiation source.

[0037] Another aspect of the present invention is an adapter for a lead. The adapter includes a housing having a first connector and a second connector, the first connector providing a mechanical and electrical connection to each lead of a multi-conductor lead, the second connector providing a mechanical and electrical connection to a medical device; and a resonant circuit operatively connected to the first and second connectors. The resonant circuit has a resonance frequency approximately equal to a frequency of an electromagnetic radiation source.

[0038] Another aspect of the present invention is an adapter for a lead. The adapter includes a housing having a first connector the first connector providing a mechanical and electrical connection to a lead; a resonant circuit operatively connected to the first connector; and a medical device operatively connected to the resonant circuit. The resonant circuit has a resonance frequency approximately equal to a frequency of an electromagnetic radiation source.

[0039] Another aspect of the present invention is a lead. The lead includes a conductor having a distal end and a proximal end and a resonant circuit operatively connected to the conductor, the resonant circuit having a resonance frequency not tuned to an excitation signal's frequency of a magnetic-resonance imaging scanner.

[0040] Another aspect of the present invention is a bipolar pacing lead circuit. The bipolar pacing lead circuit includes first and second conductors, the first and second conductors each having a distal end and a proximal end, and a resonant circuit operatively connected to the first conductor. The resonant circuit has a resonance frequency not tuned to an excitation signal's frequency of a magnetic-resonance imaging scanner.

[0041] Another aspect of the present invention is an adapter for a lead. The adapter includes a housing having a first connector and a second connector, the first connector providing a mechanical and electrical connection to a lead, the second connector providing a mechanical and electrical connection to a medical device, and a resonant circuit operatively connected to the first and second connectors. The resonant circuit has a resonance frequency not tuned to an excitation signal's frequency of a magnetic-resonance imaging scanner. [0042] Another aspect of the present invention is an adapter for a bipolar pacing lead. The adapter includes a housing having a first connector and a second connector, the first connector providing a mechanical and electrical connection to each lead of a multi-conductor lead, the second connector providing a mechanical and electrical connection to a medical device, and a resonant circuit operatively connected to the first and second connectors. The resonant circuit has a resonance frequency not tuned to an excitation signal's frequency of a magnetic- resonance imaging scanner.

[0043] Another aspect of the present invention is a medical device. The medical device includes a housing having electronic components therein; a lead operatively connected to the electronic components within the housing; and a resonant circuit, located within the housing, operatively connected to the lead and the electronic components. The resonant circuit has a resonance frequency not tuned to an excitation signal's frequency of a magnetic-resonance imaging scanner.

[0044] Another aspect of the present invention is a medical device. The medical device includes a housing having electronic components therein; a multi-conductor lead circuit operatively connected to the electronic components within the housing; and a resonant circuit, located within the housing, operatively connected to a conductor of the multi-conductor lead circuit and the electronic components. The resonant circuit has a resonance frequency not- tuned to an excitation signal's frequency of a magnetic-resonance imaging scanner. [0045] Another aspect of the present invention is a lead. The lead includes a conductor having a distal end and a proximal end and a resonant circuit operatively connected to the conductor. The resonant circuit has a resonance frequency not tuned to a frequency of an electromagnetic radiation source.

[0046] Another aspect of the present invention is a medical device. The medical device includes a housing having electronic components therein; a lead operatively connected to the electronic components within the housing; and a resonant circuit, located within the housing, operatively connected to the lead and the electronic components. The resonant circuit has a resonance frequency not tuned to a frequency of an electromagnetic radiation source. [0047] Another aspect of the present invention is a medical device. The medical device includes a housing having electronic components therein; a multi-conductor lead operatively connected to the electronic components within the housing; and a resonant circuit, located within the housing, operatively connected to the multi-conductor lead and the electronic components. The resonant circuit has a resonance frequency not tuned to a frequency of an electromagnetic radiation source.

[0048] Another aspect of the present invention is an adapter for a lead. The adapter includes a housing having a first connector and a second connector, the first connector providing a mechanical and electrical connection to a lead, the second connector providing a mechanical and electrical connection to a medical device; and a resonant circuit operatively connected to the first and second connectors. The resonant circuit has a resonance frequency not tuned to a frequency of an electromagnetic radiation source.

[0049] Another aspect of the present invention is an adapter for a lead. The adapter includes a housing having a first connector and a second connector, the first connector providing a mechanical and electrical connection to each lead of a multi-conductor lead, the second connector providing a mechanical and electrical connection to a medical device; and a resonant circuit operatively connected to the first and second connectors. The resonant circuit has a resonance frequency not tuned to a frequency of an electromagnetic radiation source. [0050] Another aspect of the present invention is an adapter for a lead. The adapter includes a housing having a first connector the first connector providing a mechanical and electrical connection to a lead; a resonant circuit operatively connected to the first connector; and a medical device operatively connected to the resonant circuit. The resonant circuit has a resonance frequency not tuned to a frequency of an electromagnetic radiation source. [0051] Another aspect of the present invention is an adapter for a lead. The adapter includes a housing having a first connector said first connector providing a mechanical and electrical connection to a lead; a resonant circuit operatively connected to the first connector; and a medical device operatively connected to the resonant circuit. The resonant circuit has a resonance frequency not tuned to an excitation signal's frequency of a magnetic-resonance imaging scanner.

BRIEF DESCRIPTION OF THE DRAWINGS

[0052] The present invention may take form in various components and arrangements of components, and in various steps and arrangements of steps. The drawings are only for purposes of illustrating a preferred embodiment and are not to be construed as limiting the present invention, wherein:

[0053] Figure 1 is an illustration of conventional cardiac assist device; [0054] Figure 2 shows a conventional bipolar pacing lead circuit representation; [0055] Figure 3 is a graph illustrating the magnitude of the current, induced by magnetic- resonance imaging, flowing through the tissue at a distal end of a medical device using the bipolar pacing lead circuit of Figure 2;

[0056] Figure 4 shows a bipolar pacing lead circuit representation according to some or all of the concepts of the present invention;

[0057] Figure 5 is a graph illustrating the magnitude of the current, induced by magnetic- resonance imaging, flowing through the tissue at a distal end of a medical device using the bipolar pacing lead circuit of Figure 4;

[0058] Figure 6 is a graph illustrating the magnitude of the current, low-frequency pacing or defibrillation signals, flowing through the circuit of a medical device using the bipolar pacing lead circuit of Figure 4;

[0059] Figure 7 shows another bipolar pacing lead circuit representation according to some or all of the concepts of the present invention;

[0060] Figure 8 is a graph illustrating the magnitude of the current, induced by 64 MHz magnetic-resonance imaging, flowing through the tissue at a distal end of a medical device using the bipolar pacing lead circuit of Figure 7;

[0061] Figure 9 is a graph illustrating the magnitude of the current, induced by 128 MHz magnetic-resonance imaging, flowing through the tissue at a distal end of a medical device using the bipolar pacing lead circuit of Figure 7;

[0062] Figure 10 shows another bipolar pacing lead circuit representation according to some or all of the concepts of the present invention;

[0063] Figure 11 is a graph illustrating the magnitude of the current, induced by magnetic- resonance imaging, flowing through the tissue at a distal end of a medical device using the bipolar pacing lead circuit of Figure 10;

[0064] Figure 12 shows another bipolar pacing lead circuit representation according to some or all of the concepts of the present invention; [0065] Figure 13 is a graph illustrating the magnitude of the current, induced by magnetic- resonance imaging, flowing through the tissue at a distal end of a medical device using the bipolar pacing lead circuit of Figure 12;

[0066] Figure 14 shows another bipolar pacing lead circuit representation according to some or all of the concepts of the present invention;

[0067] Figure 15 is a graph illustrating the magnitude of the current, induced by magnetic- resonance imaging, flowing through the tissue at a distal end of a medical device using the bipolar pacing lead circuit of Figure 14;

[0068] Figure 16 is a graph illustrating the magnitude of the current, induced by magnetic- resonance imaging, flowing through the tissue at a distal end of a medical device using the bipolar pacing lead circuit of Figure 14 using an increased resistance in the resonant circuit; [0069] Figure 17 is a graph illustrating the magnitude of the current, induced by magnetic- resonance imaging, flowing through the tissue at a distal end of a medical device using a conventional bipolar pacing lead circuit;

[0070] Figure 18 is a graph illustrating the magnitude of the current, induced by magnetic- resonance imaging, flowing through the tissue at a distal end of a medical device using the bipolar pacing lead circuit with a resonant circuit in one lead;

[0071] Figure 19 is a graph illustrating the magnitude of the current, induced by magnetic- resonance imaging, flowing through the tissue at a distal end of a medical device using the bipolar pacing lead circuit with a resonant circuit in both leads;

[0072] Figure 20 is a graph illustrating the magnitude of the current, induced by magnetic- resonance imaging, flowing through the tissue at a distal end of a medical device using the bipolar pacing lead circuit with a resonant circuit in both leads and increased inductance; [0073] Figure 21 is a graph illustrating the magnitude of the current, induced by magnetic- resonance imaging, flowing through the tissue at a distal end of a medical device using the bipolar pacing lead circuit with a resonant circuit in both leads and decreased inductance; [0074] Figure 22 shows a bipolar pacing lead adaptor with a single resonant circuit according to some or all of the concepts of the present invention;

[0075] Figure 23 illustrates a resonant circuit for a bipolar pacing lead according to some or all of the concepts of the present invention;

[0076] Figure 24 is a graph illustrating the temperature at a distal end of a medical device; [0077] Figure 25 is a graph illustrating the magnitude of the current, induced by magnetic- resonance imaging, flowing through the tissue at a distal end of a conventional medical device; [0078] Figure 26 is a graph illustrating the magnitude of the current, induced by magnetic- resonance imaging, flowing through the tissue at a distal end of a medical device with a resonant circuit, according to the concepts of the present invention, at the proximal end thereof; [0079] Figure 27 is a graph illustrating the temperature at a distal end of a medical device with a resonant circuit, according to the concepts of the present invention, at the distal end thereof; and

[0080] Figure 28 is a graph illustrating the temperature at a distal end of a medical device with a resonant circuit, according to the concepts of the present invention, at the proximal end thereof.

BEST MODE FOR CARRYING OUT THE INVENTION

[0081] As noted above, a medical device includes an anti-antenna device to prevent or significantly reduce damaging heat, created by currents or voltages induced by outside electromagnetic energy (namely magnetic-resonance imaging), to a tissue area. [0082] More specifically, the present invention is directed to a medical device that includes anti-antenna device, which significantly reduces the induced current on the "signal" wire of a pacing lead when the pacing lead is subjected to the excitation signal's frequency of a magnetic- resonance imaging scanner without significantly altering a low frequency pacing signal. The low frequency pacing signal may be generated by an implantable pulse generator or other pulse generator source outside the body.

[0083] To provide an anti-antenna device, the present invention utilizes a resonant circuit or circuits in line with a lead. The lead may be a signal wire of the pacing lead. Although the following descriptions of the various embodiments of the present invention, as well as the attached claims may utilize, the term pacing lead or lead, the term pacing lead or lead may generically refer to a unipolar pacing lead having one conductor; a bipolar pacing lead having two conductors; an implantable cardiac defibrillator lead; a deep brain stimulating lead having multiple conductors; a nerve stimulating lead; and/or any other medical lead used to deliver an electrical signal to or from a tissue area of a body. The resonant circuit or circuits provide a blocking quality with respect to the currents induced by the excitation signal's frequency of the magnetic-resonance imaging scanner. The excitation signal's frequency of the magnetic- resonance imaging scanner is commonly defined as the rotational frequency of the scanner's excitation magnetic field, commonly known as the scanner's B1 field.

[0084] Figure 2 provides a conventional circuit representation of a bipolar pacing lead. As illustrated in Figure 2, the bipolar pacing lead 1000 includes two leads (100 and 200). A first pacing lead 100 includes resistance and inductance represented by a first resistor 120 and a first inductor 110, respectively. A second pacing lead 200 includes resistance and inductance represented by a second resistor 220 and a second inductor 210, respectively. At a distal end of each lead, the leads (100 and 200) come in contact with tissue.

[0085] As illustrated in Figure 2, the circuit paths from the distal ends of the leads (100 and 200) include a first tissue resistance, represented by first tissue modeled resistor 130, and a second tissue resistance, represented by second tissue modeled resistor 230. [0086] The conventional circuit representation of a bipolar pacing lead, as illustrated in

Figure 2, further includes a voltage source 300 that represents the induced electromagnetic energy (voltage or current) from magnetic resonance imaging, a body modeled resistor 400 that represents the resistance of the body, and a differential resistor 500 that represents a resistance between the leads.

[0087] In Figure 3, it is assumed that the bipolar pacing leads of Figure 2 are subjected to a

64 MHz magnetic resonance imaging environment. As demonstrated in Figure 3, the current induced by the 64 MHz magnetic resonance imaging environment and flowing through the tissue at the distal end of the bipolar pacing leads can have a magnitude between 0.85 and -0.85 amps. This magnitude of current (IRt2, which represents the current flowing through first tissue modeled resistors 130 and IRtI₁ which represents the current flowing through second tissue modeled resistors 230) at the distal end of the bipolar pacing leads can lead to serious damage to the tissue due to heat generated by the current flowing to the tissue.

[0088] To reduce the heat generated by the induced current in the tissue, Figure 4 provides a circuit representation of a bipolar pacing lead according to the concepts of the present invention. As illustrated in Figure 4, the bipolar pacing lead 1000 includes two leads (1100 and

1200). A first pacing lead 1100 includes resistance and inductance represented by a first resistor 1120 and a first inductor 1110, respectively. A second pacing lead 1200 includes resistance and inductance represented by a second resistor 1220 and a second inductor 1210, respectively. At a distal end of each lead, the leads (1100 and 1200) come in contact with tissue.

[0089] As illustrated in Figure 4, the circuit paths from the distal ends of the leads (1100 and

1200) include a first tissue resistance, represented by first tissue modeled resistor 1130, and a second tissue resistance, represented by second tissue modeled resistor 1230.

[0090] The circuit representation of a bipolar pacing lead, as illustrated in Figure 4, further includes a voltage source 300 that represents the induced electromagnetic energy (voltage or current) from magnetic resonance imaging, a body modeled resistor 400 that represents the resistance of the body, and a differential resistor 500 that represents a resistance between the leads.

[0091] In addition to the elements discussed above, the circuit representation of a bipolar pacing lead, as illustrated in Figure 4, includes a resonant circuit 2000 in series or inline with one of the pacing leads, namely the second lead 1200. The resonant circuit 2000 includes a LC circuit having an inductor 2110 in parallel to a capacitor 2120. The resonant circuit 2000 acts as an anti-antenna device, thereby reducing the magnitude of the current induced through the tissue at the distal end of the pacing leads (1100 and 1200).

[0092] In Figure 5, it is assumed that the bipolar pacing leads of Figure 4 are subjected to a

64 MHz magnetic resonance imaging environment. As demonstrated in Figure 5, the current (IRt2, which represents the current flowing through tissue modeled resistor 1230 of Figure 4) induced by the 64 MHz magnetic resonance imaging environment and flowing through the tissue at the distal end of the second bipolar pacing lead 1200 can be greatly reduced. It is noted that the current (IRtI, which represents the current flowing through tissue modeled resistor 1130 of Figure 4) induced by the 64 MHz magnetic resonance imaging environment and flowing through the tissue at the distal end of the second bipolar pacing lead 1100 can have a magnitude between 1.21 and -1.21 amps. This reduced magnitude of current (IRt2, which represents the current flowing through tissue modeled resistor 1230 of Figure 4) at the distal end of the bipolar pacing lead can significantly reduce the damage to the tissue due to heat generated by the current flowing to the tissue.

[0093] Notwithstanding the inclusion of the resonant circuit 2000, the bipolar pacing leads can still provide an efficient pathway for the pacing signals, as illustrated by Figure 6. As can be seen when compared to Figure 3, the current magnitudes shown in Figure 6 through tissue resistors 1130 and 1230, shown in Figure 4, are approximately the same as the magnitudes of the currents passing through tissue resistors 130 and 230, shown in Figure 2. Thus, with the resonant circuit 2000 inserted into the circuit of Figure 4, the low frequency pacing signals are not significantly altered.

[0094] To provide a further reduction of the heat generated by the induced current in the tissue, Figure 7 provides a circuit representation of a bipolar pacing lead according to the concepts of the present invention. As illustrated in Figure 7, the bipolar pacing lead 1000 includes two leads (1100 and 1200). A first pacing lead 1100 includes resistance and inductance represented by a first resistor 1120 and a first inductor 1110, respectively. A second pacing lead 1200 includes resistance and inductance represented by a second resistor 1220 and a second inductor 1210, respectively. At a distal end of each lead, the leads (1100 and 1200) come in contact with tissue.

[0095] As illustrated in Figure 7, the circuit paths from the distal ends of the leads (1100 and 1200) include a first tissue resistance, represented by first tissue modeled resistor 1130, and a second tissue resistance, represented by second tissue modeled resistor 1230. [0096] The circuit representation of a bipolar pacing lead, as illustrated in Figure 7, further includes a voltage source 300 that represents the induced electromagnetic energy (voltage or current) from magnetic resonance imaging, a body resistor 400 that represents the resistance of the body, and a differential resistor 500 that represents a resistance between the leads. [0097] In addition to the elements discussed above, the circuit representation of a bipolar pacing lead, as illustrated in Figure 7, includes two resonant circuits (2000 and 3000) in series or inline with one of the pacing leads, namely the second lead 1200. The first resonant circuit 2000 includes a LC circuit, tuned to about 64 MHz, having an inductor 2110 in parallel to a _^ capacitor 2120. The second resonant circuit 3000 includes a LC circuit, tuned to about 128 MHz, having an inductor 3110 in parallel to a capacitor 3120.

[0098] The resonant circuits (2000 and 3000) act as an anti-antenna device, thereby reducing the magnitude of the current induced through the tissue at the distal end of the pacing lead (1200).

[0100] In Figure 8, it is assumed that the bipolar pacing leads of Figure 7 are subjected to a 64 MHz magnetic resonance imaging environment. As demonstrated in Figure 8, the current (IRtI, which represents the current flowing through tissue modeled resistor 1230 of Figure 7) induced by the 64 MHz magnetic resonance imaging environment and flowing through the tissue at the distal end of the second bipolar pacing lead 1200 can be greatly reduced. It is noted that the current (IRt2, which represents the current flowing through tissue modeled resistor 1130 of Figure 7) induced by the 64 MHz magnetic resonance imaging environment and flowing through the tissue at the distal end of the first bipolar pacing lead 1100 can have a magnitude between 1.21 and -1.21 amps. This reduced magnitude of current (IRtI, which represents the current flowing through tissue modeled resistor 1230 of Figure 7) at the distal end of the bipolar pacing lead can significantly reduce the damage to the tissue due to heat generated by the current flowing to the tissue.

[0101] In Figure 9, it is assumed that the bipolar pacing leads of Figure 7 are subjected to a 128 MHz magnetic resonance imaging environment. As demonstrated in Figure 9, the current (IRtI₁ which represents the current flowing through tissue modeled resistor 1230 of Figure 7) induced by the 128 MHz magnetic resonance imaging environment and flowing through the tissue at the distal end of the second bipolar pacing lead 1200 can be greatly reduced. It is noted that the current (IRt2, which represents the current flowing through tissue modeled resistor 1130 of Figure 7) induced by the 128 MHz magnetic resonance imaging environment and flowing through the tissue at the distal end of the first bipolar pacing lead 1100 can have a magnitude between 1.21 and -1.21 amps. This reduced magnitude of current (IRtI, which represents the current flowing through tissue modeled resistor 1230 of Figure 7) at the distal end of the bipolar pacing lead can significantly reduce the damage to the tissue due to heat generated by the current flowing to the tissue.

[0102] It is noted that by including the two resonant circuits (2000 and 3000), the bipolar pacing leads can reduce heat generation, notwithstanding the operational frequency of the magnetic resonance imaging scanner. It is noted that further resonant circuits may be added, each tuned to a particular operational frequency of a magnetic resonance imaging scanner. [0103] To reduction of the heat generated by the induced current in the tissue, Figure 10 provides a circuit representation of a bipolar pacing lead according to the concepts of the present invention. As illustrated in Figure 10, the bipolar pacing lead 1000 includes two leads (1100 and 1200). A first pacing lead 1100 includes resistance and inductance represented by a first resistor 1120 and a first inductor 1110, respectively. A second pacing lead 1200 includes resistance and inductance represented by a second resistor 1220 and a second inductor 1210, respectively. At a distal end of each lead, the leads (1100 and 1200) come in contact with tissue.

[0104] As illustrated in Figure 10, the circuit paths from the distal ends of the leads (1100 and 1200) include a first tissue resistance, represented by first tissue modeled resistor 1130, and a second tissue resistance, represented by second tissue modeled resistor 1230.

[0105] The circuit representation of a bipolar pacing lead, as illustrated in Figure 10, further includes a voltage source 300 that represents the induced electromagnetic energy (voltage or current) from magnetic resonance imaging, a body resistor 400 that represents the resistance of the body, and a differential resistor 500 that represents a resistance between the leads.

[0106] In addition to the elements discussed above, the circuit representation of a bipolar pacing lead, as illustrated in Figure 10, includes two resonant circuits (2000 and 3000) in series or inline with one of the pacing leads, namely the second lead 1200. The first resonant circuit

2000 includes a LC circuit, tuned to about 64 MHz, having an inductor 2110 in parallel to a capacitor 2120. The second resonant circuit 3000 includes a LC circuit, tuned to about 128

MHz, having an inductor 3110 in parallel to a capacitor 3120.

[0107] The resonant circuits (2000 and 3000) act as an anti-antenna device, thereby reducing the magnitude of the current induced through the tissue at the distal end of the pacing lead (1200).

[0108] Lastly, the circuit representation of a bipolar pacing lead, as illustrated in Figure 10, includes a capacitance circuit 4000 (a capacitor and resistor), which may represent parasitic capacitance or distributive capacitance in the second pacing lead (1200) or additional capacitance added to the pacing lead. It is noted that the parasitic capacitance or distributive capacitance is the inherent capacitance in a pacing lead along its length. Moreover, it is noted that the parasitic capacitance or distributive capacitance may be the inter-loop capacitance in a coiled wire pacing lead. The location of the capacitance circuit 4000 positions the resonant circuits (2000 and 3000) at the proximal end of the pacing lead (1200).

[0109] In Figure 11 , it is assumed that the bipolar pacing leads of Figure 10 are subjected to a magnetic resonance imaging environment having an operating radio frequency of approximately 64 MHz. As demonstrated in Figure 11 , the current (IRtI, which represents the current flowing through tissue modeled resistor 1230 of Figure 10) induced by the magnetic resonance imaging environment and flowing through the tissue at the distal end of the second bipolar pacing lead 1200 is not reduced by the same amount as the previous circuits. In other words, the capacitance circuit 4000 lowers the effectiveness of the resonant circuits (2000 and

3000), located at the proximal end of the lead, to block the magnetic resonance imaging induced currents.

[0110] It is noted that the current (IRt2, which represents the current flowing through tissue modeled resistor 1130 of Figure 10) induced by the magnetic resonance imaging environment and flowing through the tissue at the distal end of the first bipolar pacing lead 1100 can have a magnitude between 1.21 and -1.21 amps.

[0111] Although the resonant circuits (2000 and 3000) still reduce the induced current, the capacitance circuit 4000 reduces the effectiveness of the resonant circuits (2000 and 3000). To increase the effectiveness of the resonant circuits (2000 and 3000), the resonant circuits (2000 and 3000) are moved to the distal end of the pacing lead, as illustrated in Figure 12.

[0112] To reduction of the heat generated by the induced current in the tissue, Figure 12 provides a circuit representation of a bipolar pacing lead according to the concepts of the present invention. As illustrated in Figure 12, the bipolar pacing lead 1000 includes two leads

(1100 and 1200). A first pacing lead 1100 includes resistance and inductance represented by a first resistor 1120 and a first inductor 1110, respectively. A second pacing lead 1200 includes resistance and inductance represented by a second resistor 1220 and a second inductor 1210, respectively. At a distal end of each lead, the leads (1100 and 1200) come in contact with tissue.

[0113] As illustrated in Figure 12, the circuit paths from the distal ends of the leads (1100 and 1200) include a first tissue resistance, represented by first tissue modeled resistor 1130, and a second tissue resistance, represented by second tissue modeled resistor 1230.

[0114] The circuit representation of a bipolar pacing lead, as illustrated in Figure 12, further includes a voltage source 300 that represents the induced electromagnetic energy (voltage or current) from magnetic resonance imaging, a body resistor 400 that represents the resistance of the body, and a differential resistor 500 that represents a resistance between the leads.

[0115] In addition to the elements discussed above, the circuit representation of a bipolar pacing lead, as illustrated in Figure 12, includes two resonant circuits (2000 and 3000) in series or inline with one of the pacing leads, namely the second lead 1200. The first resonant circuit

MHz, having an inductor 3110 in parallel to a capacitor 3120.

[0116] The resonant circuits (2000 and 3000) act as an anti-antenna device, thereby reducing the magnitude of the current induced through the tissue at the distal end of the pacing leads (1100 and 1200).

[0117] Lastly, the circuit representation of a bipolar pacing lead, as illustrated in Figure 12, includes a capacitance circuit 4000 (a capacitor and resistor), which may represent parasitic capacitance in the second pacing lead (1200) or additional capacitance added to the pacing lead. The location of the capacitance circuit 4000 positions the resonant circuits (2000 and

3000) at the distal end of the pacing lead (1000).

[0118] In Figure 13, it is assumed that the bipolar pacing leads of Figure 12 are subjected to a magnetic resonance imaging environment having an operating radio frequency of approximately 64 MHz. As demonstrated in Figure 13, the current (IRt¹I₁ which represents the current flowing through tissue modeled resistor 1230 of Figure 12) induced by the magnetic resonance imaging environment and flowing through the tissue at the distal end of the second bipolar pacing lead 1200 is reduced. In other words, the moving of the resonant circuits (2000 and 3000) to the distal end increases the effectiveness of the resonant circuits (2000 and 3000), when a capacitance circuit is involved.

[0119] It is noted that the current (IRt2, which represents the current flowing through tissue modeled resistor 1130 of Figure 12) induced by the magnetic resonance imaging environment and flowing through the tissue at the distal end of the first bipolar pacing lead 1100 can have a magnitude between 1.21 and -1.21 amps.

[0120] However, space is very limited at the distal end of the lead. It is noted that the inductor and capacitor values of the resonant circuits (2000 and 3000) can be adjusted which may help reduce the space requirement when implementing the resonant circuit. [0121] The resonance frequency of the circuit is calculated by using the formula

[0122] The required inductance (L) can be reduced (thereby reducing the physical size required), by increasing the capacitance (C). So, for example, if L=50nH and C=123.7pF, and if there is no room in the distal end of the pacing lead for an inductor L having the inductance L = 5OnH, an inductor having an inductance of L=25nH could be used if the capacitor used has a capacitance of 247.4pF. The resonance frequency remains the same.

[0123] To reduction of the heat generated by the induced current in the tissue, Figure 14 provides a circuit representation of a bipolar pacing lead according to the concepts of the present invention. As illustrated in Figure 14, the bipolar pacing lead 1000 includes two leads (1100 and 1200). A first pacing lead 1100 includes resistance and inductance represented by a first resistor 1120 and a first inductor 1110, respectively. A second pacing lead 1200 includes resistance and inductance represented by a second resistor 1220 and a second inductor 1210, respectively. At a distal end of each lead, the leads (1100 and 1200) come in contact with tissue.

[0124] As illustrated in Figure 14, the circuit paths from the distal ends of the leads (1100 and 1200) include a first tissue resistance, represented by first tissue modeled resistor 1130, and a second tissue resistance, represented by second tissue modeled resistor 1230. [0125] The circuit representation of a bipolar pacing lead, as illustrated in Figure 14, further includes a voltage source 300 that represents the induced electromagnetic energy (voltage or current) from magnetic resonance imaging, a body resistor 400 that represents the resistance of the body, and a differential resistor 500 that represents a resistance between the leads. [0126] In addition to the elements discussed above, the circuit representation of a bipolar pacing lead, as illustrated in Figure 14, includes a resonant circuit (5000) in series or inline with one of the pacing leads, namely the second lead 1200. The resonant circuit 5000 includes a RLC circuit having an inductor 5110 in parallel with a current limiting resistor 5130 and a capacitor 5120.

[0127] The resonant circuit (5000) acts as an anti-antenna device, thereby reducing the magnitude of the current induced through the tissue at the distal end of the pacing lead (1200). [0128] The current limiting resistor 5130 reduces the current in the resonant circuit 5000 to make sure that the inductor 5110 is not damaged by too much current passing through it. [0129] Figure 15, it is assumed that the bipolar pacing leads of Figure 14 are subjected to a magnetic resonance imaging environment having an operating radio frequency of approximately the resonance frequency of the resonant circuit 5000. As demonstrated in Figure 15, the current (IRtI, which represents the current flowing through tissue modeled resistor 1230 of Figure 14) induced by the magnetic resonance imaging environment and flowing through the tissue at the distal end of the second bipolar pacing lead 1200 can be greatly reduced, notwithstanding the addition of the current limiting resistor 5130. It is noted that the current (IRt2, which represents the current flowing through tissue modeled resistor 1130 of Figure 14) induced by the magnetic resonance imaging environment and flowing through the tissue at the distal end of the first bipolar pacing lead 1100 can have a magnitude between 1.21 and -1.21 amps. This reduced magnitude of current (IRtI , which represents the current flowing through tissue modeled resistor 1230 of Figure 14) at the distal end of the bipolar pacing lead can significantly reduce the damage to the tissue due to heat generated by the current flowing to the tissue. It is noted that the current ILFilteri is the current through the inductor 5110 when the resistor 5130 is a small value.

[0130] Figure 16, it is assumed that the bipolar pacing leads of Figure 14 are subjected to a magnetic resonance imaging environment wherein the resistance of the current limiting resistor 5130 is increased. As demonstrated in Figure 16, the current (IRtI₁ which represents the current flowing through tissue modeled resistor 1230 of Figure 14) induced by the magnetic resonance imaging environment and flowing through the tissue at the distal end of the second bipolar pacing lead 1200 can be reduced, but the increased resistance of the current limiting resistor 5130 has a slight negative impact on the effectiveness of the resonant circuit 5000. It is noted that the current (IRt2, which represents the current flowing through tissue modeled resistor 1130 of Figure 14) induced by the magnetic resonance imaging environment and flowing through the tissue at the distal end of the first bipolar pacing lead 1100 can have a magnitude between 1.21 and -1.21 amps. This reduced magnitude of current (IRtI, which represents the current flowing through tissue modeled resistor 1230 of Figure 14) at the distal end of the bipolar pacing lead can significantly reduce the damage to the tissue due to heat generated by the current flowing to the tissue. It is noted that the current ILFilteM through the inductor 5110 has decreased with the increase in the resistance of resistor 5130, thereby illustrating controlling the current through the inductor 5110 of the resonant circuit. [0131] It is noted that the frequencies used in generating the various graphs are examples and do not represent the exact frequencies to be used in the design and manufacturing of these circuits. More specifically, the exact frequencies to be used are governed by the Larmor frequency of the proton in the Hydrogen atom and the frequency of the radio frequency of the magnetic resonance imaging scanner.

[0132] The gyromagnetic ratio for the proton in the Hydrogen atom is y = 42.57 MHz/T or Y =

42.58 MHz/T, depending on the reference used. In the following discussion y = 42.57 MHz/T will be used.

[0133] Given that the Larmor equation is f = B₀ x Y , the frequency to which the resonant circuit is to be tuned, for example, in a 1.5T magnetic resonance imaging scanner, is f = (1.5

T)(42.57 MHz/T) = 63.855 MHz.

[0134] The following table gives the resonance frequency for several cases along with example circuit parameter values for the inductor and capacitor to form the resonance circuit.

Table 1

[0135] These circuit parameter values are for the ideal case. So, it is expected that the actual values used in a real circuit could be different. That is, in the excitation signal's frequency environment of the magnetic resonance imaging scanner, there are other effects (like parasitic capacitance in the inductor) that may affect the circuit, requiring the circuit parameters to be adjusted.

[0136] It is noted that introducing the resonant circuit only into one of the two bipolar pacing wires may result in an increase in the current through the other wire.

[0137] For example, as illustrated in Figure 17, when no resonant circuits are included with the bipolar pacing leads (Figure 2), the current flowing through the first tissue modeled resistor

130 and second tissue modeled resistor 230 of Figure 2 is significant, thereby generating heat to possibly damage the tissue.

[0138] On the other hand, as illustrated in Figure 18, when a resonant circuit or resonant circuits are included in only one of the bipolar pacing leads (Figures 4, 7, 10 and 14), the current

(IRtI) flowing through the second tissue modeled resistor 1230 is significantly reduced in the one lead, but the current (IRt2) slightly increases in the first tissue modeled resistor 1130. It is noted that these behaviors are dependent on the characteristics of the implemented pacing lead and pulse generator system.

[0139] On the other hand, as illustrated in Figure 19, when a resonant circuit or resonant circuits are included in both bipolar leads (not shown), the current (IRtI and IRt2) flowing through the tissue modeled resistors 130 and 1130 and second tissue modeled resistor 230 and

1230 is significantly reduced.

[0140] It is noted that even if the resonant circuits of the present invention are tuned, for example to 63.86 MHz on the bench top, when the resonant circuits of the present invention are placed in the patient's body, the resonant circuits of the present invention may shift resonance a little because of inductive and capacitive coupling to the surrounding environment.

[0141] Notwithstanding the potential shift, the concepts of the present invention still significantly reduce the heat generated current in the tissue at the distal end of the bipolar pacing leads, as illustrated in Figures 20 and 21. Figures 20 and 21 provide a graphical representation of the effectiveness of the resonant circuits of the present invention as the circuits are tuned away from the ideal resonance of 63.86 MHz (for the 1.5 T case).

[0142] In Figure 20, the inductance of the resonant circuit is increased by 10%. In this instance, the resonant circuits of the present invention significantly reduce the heat generated by currents (IRtI and IRt2) in the tissue at the distal end of the bipolar pacing leads.

[0143] Moreover, in Figure 21, the inductance of the resonant circuit is decreased by 10%.

In this instance, the resonant circuits of the present invention significantly reduce the heat generated by currents (IRtI and IRt2) in the tissue at the distal end of the bipolar pacing leads.

[0144] Therefore, the resonant circuits of the present invention need not be perfectly tuned to be effective. As mentioned above, even if the resonant circuits of the present invention were perfectly tuned, once implanted into a patient, the circuits are expected to shift resonance frequency a little bit.

[0145] Figure 22 illustrates an adapter which can be utilized with an existing conventional bipolar pacing lead system. As illustrated in Figure 22, an adapter 6000 includes a male IS-1-BI connector 6200 for providing a connection to an implantable pulse generator 6900. The adapter

6000 includes a female IS-1-BI connector 6500 for providing a connection to bipolar pacing lead

6800. The female IS-1-BI connector 6500 includes locations 6600 for utilizing set screws to hold the adapter 6000 to the bipolar pacing lead 6800.

[0146] The adapter 6000 further includes connection wire 6700 to connect the outer ring of the bipolar pacing lead 6800 to the outer ring of the implantable pulse generator 6900. The adapter 6000 includes a wire 6400 to connect an inner ring of the bipolar pacing lead 6800 to a resonant circuit 6300 and a wire 6100 to the resonant circuit 6300 to an inner ring of the implantable pulse generator 6900. It is noted that an additional resonant circuit could be placed between the outer ring of the bipolar pacing lead 6800 and the outer ring of the implantable pulse generator 6900.

[0147] It is noted that the resonant circuit 6300 in Figure 22 can be multiple resonant circuits in series. It is also noted that the adaptor 6000 can be manufactured with resonant circuits in series with both wires of the bipolar pacing lead. It is further noted that this adapter is connected to the proximal end of the bipolar pacing lead.

[0148] Additionally, the adapter of the present invention may include enough mass in the housing to dissipate the heat generated by the resonant circuits. Alternatively, the adapter may be constructed from special materials; e.g., materials having a thermal transfer high efficiency, etc.; and/or structures; e.g., cooling fins, etc.; to more effectively dissipate the heat generated by the resonant circuits. Furthermore, the adapter may include, within the housing, special material; e.g., materials having a thermal transfer high efficiency, etc.; and/or structures; e.g., cooling fins, etc.; around the resonant circuits to more effectively dissipate the heat generated by the resonant circuits.

[0149] The concepts of the adapter of Figure 22 can be utilized in a different manner with an existing conventional bipolar pacing lead system. For example, an adapter may include a connector for providing a connection to an implantable electrode or sensor. On the other hand, the adapter may include an implantable electrode or sensor instead a connection therefor. [0150] The adapter may also include a connector for providing a connection to bipolar pacing lead. The connector may include locations for utilizing set screws or other means for holding the adapter to the bipolar pacing lead.

[0151] As in Figure 22, this modified adapter would include a connection wire to connect one conductor of the bipolar pacing lead to the electrode or sensor. The modified adapter would include a wire to connect the other conductor of the bipolar pacing lead to a resonant circuit and a wire to the resonant circuit to ring associated with the electrode of other device associated with the sensor, such as a ground. It is noted that an additional resonant circuit could be placed between the one conductor of the bipolar pacing lead and the electrode or sensor. [0152] It is noted that the resonant circuit can be multiple resonant circuits in series. It is also noted that the modified adaptor can be manufactured with resonant circuits in series with both wires of the bipolar pacing lead. It is further noted that this modified adapter is connected to the distal end of the bipolar pacing lead.

[0153] Additionally, the modified adapter of the present invention may include enough mass in the housing to dissipate the heat generated by the resonant circuits. Alternatively, the modified adapter may be constructed from special materials; e.g., materials having a thermal transfer high efficiency, etc.; and/or structures; e.g., cooling fins, etc.; to more effectively dissipate the heat generated by the resonant circuits. Furthermore, the modified adapter may include, within the housing, special material; e.g., materials having a thermal transfer high efficiency, etc.; and/or structures; e.g., cooling fins, etc.; around the resonant circuits to more effectively dissipate the heat generated by the resonant circuits.

[0154] It is noted that all other wires and electrodes which go into a magnetic resonance imaging environment, (and not necessarily implanted into the patient's body) can be augmented with a resonant circuit. Any wires to sensors or electrodes, like the electrodes of EEG and EKG sensor pads, can be augmented with a resonant circuit in series with their wires. Even power cables can be augmented with resonant circuits.

[0155] Other implanted wires, e.g. deep brain stimulators, pain reduction stimulators, etc. can be augmented with a resonant circuit to block the induced currents caused by the excitation signal's frequency of the magnetic resonance imaging scanner.

[0156] Additionally, the adapter of the present invention, when used within implanted devices, may contain means for communicating an identification code to some interrogation equipments external to the patient's body. That is, once the implantable pulse generator, adapter, and pacing lead are implanted into the patient's body, the adapter has means to communicate and identify itself to an external receiver. In this way, the make, model, year, and the number of series resonance circuits can be identified after it has been implanted into the body. In this way, physicians can interrogate the adapter to determine if there is a resonance circuit in the adapter which will block the excitation signal's frequency induced currents caused by the magnetic resonance imaging scanner the patient is about to be placed into.

[0157] Furthermore, the adapter of the present invention has the capability of being tested after implantation to insure that the resonance circuit is functioning properly.

[0158] Since the present invention is intended to be used in a magnetic resonance imaging scanner, care needs to be taken when selecting the inductor to be used to build the resonant circuit. The preferred inductor should not contain a ferromagnetic or ferrite core. That is, the inductor needs to be insensitive to the magnetic resonance imaging scanner's B₀ field. The inductor should also be insensitive to the excitation signal's frequency field (B1) of the magnetic resonance imaging scanner. The inductor should function the same in any orientation within the magnetic resonance imaging scanner. This might be accomplished putting the inductor (for the entire resonant circuit) in a Faraday cage.

[0159] The resonant circuit of the present invention could also be realized by adding capacitance along the bipolar pacing lead, as illustrated in Figure 23. In Figure 23, capacitors

8000 are added across the coils of the pacing lead 7000.

[0160] As illustrated in Figure 23, an oxidation layer or an insulating material is formed on the wire resulting in essentially a resistive coating over the wire form. Thus, the current does not flow through adjacent coil loop contact points, but the current instead follows the curvature of the wire. The parasitic capacitance enables electrical current to flow into and out of the wire form due to several mechanisms, including the oscillating electrical field set up in the body by the magnetic resonance imaging unit. [0161] In pacing leads and some other leads, a coiled wire is used. A thin insulative film (polymer, enamel, etc.) is coated over the wire (or a portion thereof) used to electrically insulate one coiled loop from its neighboring loops. This forms an inductor. By inserting an appropriate sized capacitor 8000 across multiple loops of the coiled wire (or a portion thereof), a parallel resonance circuit suitable for reducing the induced current, in accordance with the concepts of the present invention, can be formed.

[0162] Figure 24 shows the temperature of the tissue at the distal end of a wire wherein the wire includes a resonant circuit at the proximal end (A); the wire does not include a resonant circuit (B); and the wire includes a resonant circuit at the distal end (C).

[0163] As illustrated in Figure 24, the "Proximal End" case (A) (resonant circuit at proximal end) results in a higher temperature increase at the distal end than when the resonant circuit is located at the distal end (C). In the demonstration used to generate the results of Figure 24, a wire of 52 cm in length and having a cap at one end was utilized, resulting in a distributive capacitive coupling to the semi-conductive fluid into which the wires were placed for these magnetic resonance imaging heating experiments.

[0164] For the "Proximal End" case (A) (resonant circuit at proximal end) only, the resonant circuit was inserted 46.5 cm along the wire's length. Since no current at 63.86 MHz can pass through the resonant circuit, this sets any resonant wave's node at 46.5 cm along the wire. This effectively shortened the length of the wire and decreased the wire's self-inductance and decreased the distributive capacitance. These changes then "tuned" the wire to be closer to a resonance wave length of the magnetic resonance imaging scanner's transmitted radio frequency excitation wave resulting in an increase in the current at the distal end of the wire. [0165] The effective length of the wire with the resonant circuit is now 46.5 cm rather than the physical length of 52 cm. That is, the inductance and capacitance of the wire is now such that its inherent resonance frequency is much closer to that of the applied radio-frequency. Hence, the modeled current through the distal end into the surrounding tissue increases from about 0.65 Amps when there is no resonant circuit at the proximal end (Figure 25) to about 1.0 Amps when the resonant circuit is inserted at the proximal end of the wire (Figure 26). [0166] As illustrated in Figure 27 (which is a close up of trace "C" in Figure 24), when the wire includes a resonant circuit at the distal end, the temperature rise is significantly less (about 0.9° C after 3.75 minutes). On the other hand, when the wire includes a resonant circuit at the proximal end, the temperature rise at the distal end is greater (See trace "A" in Figure 24). [0167] Experimental results with the resonant circuit at the proximal end of a 52 cm long bipolar pacing lead did not demonstrate a significant altering of the heating of the tissue at the distal end, as illustrated in Figure 28. The attachment of the resonant circuit to the proximal end of a pacing lead places a wave node at the end of the pacing lead (no real current flow beyond the end of wire, but there is a displacement current due to the capacitance coupling to the semi- conductive fluid). That is, adding the resonant circuit to the proximal end of the pacing lead, which does not change the effective length of the pacing lead, does not change the electrical behavior of the pacing lead.

[0168] Now referring back to Figure 15, it is noted that the current (LfilteM) through the resonant circuit inductor 5110 of Figure 14 is also illustrated. As can be seen, the current (LfHteii) through the resonant circuit inductor 5110 of Figure 14 is larger than the original current passing through a prior art lead, as illustrated in Figure 3. Although the heating of the tissue is significantly decreased with the addition of a resonant circuit, there still may be a problem in that inductors is rated for a certain amount of current before the inductor is damaged. [0169] In anticipation of a possible problem with using inductors not having a high enough current rating, the present invention may provide multiple resonant circuits, each resonant circuit being connected in series therewith and having the same inductor and capacitor (and resistor) value as the original resonant circuit.

[0170] As noted above, Figure 7 illustrates an example of multiple serially connected resonant circuits. Although previously described as having values to create different resonance values, the resonant circuits 2000 and 3000 of Figure 7 may also have substantially the same resonance values so as to reduce the current flowing through any single inductor in the resonant circuits 2000 and 3000 of Figure 7.

[0171] Moreover, in anticipation of a possible problem with using inductors not having a high enough current rating, the present invention may provide resonant circuits with inductors having larger inductive values. It is noted that it may be difficult to implement an inductor having a larger inductive value in a small diameter lead, such as a pacing lead or DBS lead. In such a situation, the inductor may be constructed to be longer, rather than wider, to increase its inductive value.

[0172] It is further noted that the resonance values of the resonant circuits 2000 and 3000 of Figure 7 may be further modified so as to significantly reduce the current through the tissue as well as the current through the resonant circuit's inductor. More specifically, the multiple resonant circuits may be purposely tuned to be off from the operating frequency of the magnetic resonance imaging scanner. For example, the resonance frequency of the resonant circuit may be 70.753 MHz or 74.05 MHz.

[0173] In this example, when one resonant circuit of the multiple resonant circuits is purposely not tuned to the operating frequency of the magnetic resonance imaging scanner, the current through the tissue is reduced, while the current through the resonant circuit's inductor is also reduced. Moreover, when two resonant circuits of the multiple resonant circuits are purposely not tuned to the operating frequency of the magnetic resonance imaging scanner, the current through the tissue is further reduced, while the current through the resonant circuit's inductor is also further reduced. [0174] It is further noted that when the two (or more) resonant circuits are not tuned exactly to the same frequency and all the resonant circuits are not tuned to the operating frequency of the magnetic resonance imaging scanner, there is significant reduction in the current through the tissue as well as the current through the resonant circuits' inductors. [0175] In summary, putting the resonant circuit at the proximal end of a pacing lead does not reduce the heating at the distal end of the pacing. However, placing the resonant circuit at the proximal end of the pacing lead can protect the electronics in the implanted pulse generator which is connected at the proximal end. To protect the circuit in the implanted pulse generator, a resonant circuit is placed at the proximal end of the pacing lead so as to block any induced currents from passing from the pacing lead into the implanted pulse generator. [0176] Since the current in the resonant circuit, when in the magnetic resonance imaging scanner (or other radio-frequency field with a frequency of the resonant frequency of the circuit) may be larger than the induced current in the lead (or wire) without the resonant circuit, there may be some heating in the resistive elements of the resonant circuit (in the wires, connection methods, inductor, etc.). Thus, it would be advantageous to connect high thermal conductive material to the resonant circuit to distribute any heating of the circuit over a larger area because heating is tolerable when it is not concentrated in one small place. By distributing the same amount of heating over a larger area, the heating problem is substantially eliminated. [0177] To distribute the heat, the inside of the pacing lead polymer jacket can be coated with a non-electrical conductive material which is also a very good thermal conductor and this connected to the circuit. Moreover, filaments of non-electrically conductive but thermally conductive material can be attached to the circuit and run axially along the inside of the pacing lead assembly.

[0178] As discussed above, a lead may include a conductor having a distal end and a proximal end and a resonant circuit connected to the conductor. The resonant circuit has a resonance frequency approximately equal to an excitation signal's frequency of a magnetic- resonance imaging scanner. The resonant circuit may be located at the distal end of the conductor or the proximal end of the conductor. The resonant circuit may be an inductor connected in parallel with a capacitor or an inductor connected in parallel with a capacitor and a resistor, the resistor and capacitor being connected in series.

[0179] It is noted that a plurality of resonant circuits may be connected in series, each having a unique resonance frequency to match various types of magnetic-resonance imaging scanners or other sources of radiation, such as security systems used to scan individuals for weapons, etc. It is further noted that the lead may include a heat receiving mass located adjacent the resonant circuit to dissipate the heat generated by the resonant circuit in a manner that is substantially non-damaging to surrounding tissue. Furthermore, it is noted that the lead may include a heat dissipating structure located adjacent the resonant circuit to dissipate the heat generated by the resonant circuit in a manner that is substantially non-damaging to surrounding tissue.

[0180] It is also noted that the above described lead may be a lead of a bipolar lead circuit. [0181] Moreover, as discussed above, an adapter for a lead may include a housing having a first connector and a second connector, the first connector providing a mechanical and electrical connection to a lead, the second connector providing a mechanical and electrical connection to a medical device, and a resonant circuit connected to the first and second connectors. The resonant circuit may have a resonance frequency approximately equal to an excitation signal's frequency of a magnetic-resonance imaging scanner. The resonant circuit may be an inductor connected in parallel with a capacitor or an inductor connected in parallel with a capacitor and a resistor, the resistor and capacitor being connected in series.

[0182] It is noted that a plurality of resonant circuits may be connected in series, each having a unique resonance frequency to match various types of magnetic-resonance imaging scanners or other sources of radiation, such as security systems used to scan individuals for weapons, etc. It is further noted that the adapter may include a heat receiving mass located adjacent the resonant circuit to dissipate the heat generated by the resonant circuit in a manner that is substantially non-damaging to surrounding tissue. Furthermore, it is noted that the adapter may include a heat dissipating structure located adjacent the resonant circuit to dissipate the heat generated by the resonant circuit in a manner that is substantially non- damaging to surrounding tissue.

[0183] Furthermore, as discussed above, medical device may include a housing having electronic components therein; a lead mechanically connected to the housing and electrically connected through the housing; and a resonant circuit, located within the housing, operatively connected to the lead and the electronic components. The resonant circuit may have a resonance frequency approximately equal to an excitation signal's frequency of a magnetic- resonance imaging scanner. The resonant circuit may be an inductor connected in parallel with a capacitor or an inductor connected in parallel with a capacitor and a resistor, the resistor and capacitor being connected in series.

[0184] It is noted that a plurality of resonant circuits may be connected in series, each having a unique resonance frequency to match various types of magnetic-resonance imaging scanners or other sources of radiation, such as security systems used to scan individuals for weapons, etc. It is further noted that the adapter may include a heat receiving mass located adjacent the resonant circuit to dissipate the heat generated by the resonant circuit in a manner that is substantially non-damaging to surrounding tissue. Furthermore, it is noted that the adapter may include a heat dissipating structure located adjacent the resonant circuit to dissipate the heat generated by the resonant circuit in a manner that is substantially non- damaging to surrounding tissue.

[0185] It is noted that although the various embodiments have been described with respect to a magnetic-resonance imaging scanner, the concepts of the present invention can be utilized so as to be tuned to other sources of radiation, such as security systems used to scan individuals for weapons, etc. In these instances, the frequency of an electromagnetic radiation source is the "normal" frequency of an electromagnetic wave. Even if the electromagnetic wave is "circularly polarized," it is not the circular frequency, but the "normal" frequency. [0186] While various examples and embodiments of the present invention have been shown and described, it will be appreciated by those skilled in the art that the spirit and scope of the present invention are not limited to the specific description and drawings herein, but extend to various modifications and changes thereof.

Claims

CLAIMS :

1. A lead, comprising: a conductor having a distal end and a proximal end; and a resonant circuit operatively connected to said conductor; said resonant circuit having a resonance frequency approximately equal to an excitation signal's frequency of a magnetic resonance imaging scanner.

2. The lead as claimed in claim 1 , wherein said resonant circuit is located at said distal end of said conductor.

3. The lead as claimed in claim 1 , wherein said resonant circuit is located at said proximal end of said conductor.

4. The lead as claimed in claim 1 , further comprising: a second resonant circuit operatively connected to said resonant circuit; said second resonant circuit having a resonance frequency approximately equal to an excitation signal's frequency of a second magnetic-resonance imaging scanner.

5. The lead as claimed in claim 1, further comprising: a heat receiving mass; said heat receiving mass being located adjacent to said resonant circuit and dissipating the heat generated by said resonant circuit in a manner that is substantially non-damaging to surrounding tissue.

6. The lead as claimed in claim 1 , further comprising: a heat dissipating structure; said heat dissipating structure being located adjacent to said resonant circuit and dissipating the heat generated by said resonant circuit in a manner that is substantially non- damaging to surrounding tissue.

7. An adapter for a lead, comprising: a housing having a first connector and a second connector, said first connector providing a mechanical and electrical connection to a lead, said second connector providing a mechanical and electrical connection to a medical device; and a resonant circuit operatively connected to said first and second connectors; said resonant circuit having a resonance frequency approximately equal to an excitation signal's frequency of a magnetic-resonance imaging scanner.

8. The adapter as claimed in claim 7, further comprising: a heat receiving mass; said heat receiving mass being located adjacent to said resonant circuit; said heat receiving mass dissipating the heat generated by said resonant circuit.

9. The adapter as claimed in claim 7, further comprising: a heat dissipating structure; said heat dissipating structure being located adjacent to said resonant circuit; said heat dissipating structure dissipating the heat generated by said resonant circuit.

10. An adapter for a lead, comprising: a housing having a first connector and a second connector, said first connector providing a mechanical and electrical connection to each conductor of a multi-conductor lead, said second connector providing a mechanical and electrical connection to a medical device; and a resonant circuit operatively connected to said first and second connectors; said resonant circuit having a resonance frequency approximately equal to an excitation signal's frequency of a magnetic-resonance imaging scanner.

11. The adapter as claimed in claim 10, further comprising: a heat receiving mass; said heat receiving mass being located adjacent to said resonant circuit; said heat receiving mass dissipating the heat generated by said resonant circuit.

12. The adapter as claimed in claim 10, further comprising: a heat dissipating structure; said heat dissipating structure being located adjacent to said resonant circuit; said heat dissipating structure dissipating the heat generated by said resonant circuit.

13. An adapter for a lead, comprising: a housing having a first connector said first connector providing a mechanical and electrical connection to a lead; a resonant circuit operatively connected to said first connector; and a medical device operatively connected to said resonant circuit; said resonant circuit having a resonance frequency approximately equal to an excitation signal's frequency of a magnetic-resonance imaging scanner.

14. The adapter as claimed in claim 13, further comprising: a heat receiving mass; said heat receiving mass being located adjacent to said resonant circuit; said heat receiving mass dissipating the heat generated by said resonant circuit.

15. The adapter as claimed in claim 13, further comprising: a heat dissipating structure; said heat dissipating structure being located adjacent to said resonant circuit; said heat dissipating structure dissipating the heat generated by said resonant circuit.

16. A medical device, comprising: a housing having electronic components therein; a lead operatively connected to said electronic components within said housing; and a resonant circuit, located within said housing, operatively connected to said lead and said electronic components; said resonant circuit having a resonance frequency approximately equal to an excitation signal's frequency of a magnetic-resonance imaging scanner.

17. A medical device, comprising: a housing having electronic components therein; a multi-conductor lead circuit operatively connected to said housing; and a resonant circuit, located within said housing, operatively connected to a conductor of said multi-conductor lead circuit and said electronic components; said resonant circuit having a resonance frequency approximately equal to an excitation signal's frequency of a magnetic-resonance imaging scanner.

18. A lead, comprising: a conductor having a distal end and a proximal end; and a resonant circuit operatively connected to said conductor; said resonant circuit having a resonance frequency approximately equal to a frequency of an electromagnetic radiation source.

19. A medical device, comprising: a housing having electronic components therein; a lead operatively connected to said electronic components within said housing; and a resonant circuit, located within said housing, operatively connected to said lead and said electronic components; said resonant circuit having a resonance frequency approximately equal to a frequency of an electromagnetic radiation source.

20. A medical device, comprising: a housing having electronic components therein; a multi-conductor lead operatively connected to said electronic components within said housing; and a resonant circuit, located within said housing, operatively connected to said multi- conductor lead and said electronic components; said resonant circuit having a resonance frequency approximately equal to a frequency of an electromagnetic radiation source.

21. An adapter for a lead, comprising: a housing having a first connector and a second connector, said first connector providing a mechanical and electrical connection to a lead, said second connector providing a mechanical and electrical connection to a medical device; and a resonant circuit operatively connected to said first and second connectors; said resonant circuit having a resonance frequency approximately equal to a frequency of an electromagnetic radiation source.

22. An adapter for a lead, comprising: a housing having a first connector and a second connector, said first connector providing a mechanical and electrical connection to each conductor of a multi-conductor lead, said second connector providing a mechanical and electrical connection to a medical device; and a resonant circuit operatively connected to said first and second connectors; said resonant circuit having a resonance frequency approximately equal to a frequency of an electromagnetic radiation source.

23. An adapter for a lead, comprising: a housing having a first connector said first connector providing a mechanical and electrical connection to a lead; a resonant circuit operatively connected to said first connector; and a medical device operatively connected to said resonant circuit; said resonant circuit having a resonance frequency approximately equal to a frequency of an electromagnetic radiation source.

24. A lead, comprising: a conductor having a distal end and a proximal end; and a resonant circuit operatively connected to said conductor; said resonant circuit having a resonance frequency not tuned to an excitation signal's frequency of a magnetic-resonance imaging scanner.

25. An adapter for a lead, comprising: a housing having a first connector and a second connector, said first connector providing a mechanical and electrical connection to a lead, said second connector providing a mechanical and electrical connection to a medical device; and a resonant circuit operatively connected to said first and second connectors; said resonant circuit having a resonance frequency not tuned to an excitation signal's frequency of a magnetic-resonance imaging scanner.

26. An adapter for a lead, comprising: a housing having a first connector and a second connector, said first connector providing a mechanical and electrical connection to each conductor of a multi-conductor lead, said second connector providing a mechanical and electrical connection to a medical device; and a resonant circuit operatively connected to said first and second connectors; said resonant circuit having a resonance frequency not tuned to an excitation signal's frequency of a magnetic-resonance imaging scanner.

27. An adapter for a lead, comprising: a housing having a first connector said first connector providing a mechanical and electrical connection to a lead; a resonant circuit operatively connected to said first connector; and a medical device operatively connected to said resonant circuit; said resonant circuit having a resonance frequency not tuned to an excitation signal's frequency of a magnetic-resonance imaging scanner.

28. A medical device, comprising: a housing having electronic components therein; a lead operatively connected to said electronic components within said housing; and a resonant circuit, located within said housing, operatively connected to said lead and said electronic components; said resonant circuit having a resonance frequency not tuned to an excitation signal's frequency of a magnetic-resonance imaging scanner.

29. A medical device, comprising: a housing having electronic components therein; a multi-conductor lead circuit operatively connected to said housing; and a resonant circuit, located within said housing, operatively connected to a conductor of said multi-conductor lead circuit and said electronic components; said resonant circuit having a resonance frequency not tuned to an excitation signal's frequency of a magnetic-resonance imaging scanner.

30. A lead, comprising: a conductor having a distal end and a proximal end; and a resonant circuit operatively connected to said conductor; said resonant circuit having a resonance frequency not tuned to a frequency of an electromagnetic radiation source.

31. A medical device, comprising: a housing having electronic components therein; a lead operatively connected to said electronic components within said housing; and a resonant circuit, located within said housing, operatively connected to said lead and said electronic components; said resonant circuit having a resonance frequency not tuned to a frequency of an electromagnetic radiation source.

32. A medical device, comprising: a housing having electronic components therein; a multi-conductor lead operatively connected to said electronic components within said housing; and a resonant circuit, located within said housing, operatively connected to said multi- conductor lead and said electronic components; said resonant circuit having a resonance frequency not tuned to a frequency of an electromagnetic radiation source.

33. An adapter for a lead, comprising: a housing having a first connector and a second connector, said first connector providing a mechanical and electrical connection to a lead, said second connector providing a mechanical and electrical connection to a medical device; and a resonant circuit operatively connected to said first and second connectors; said resonant circuit having a resonance frequency not tuned to a frequency of an electromagnetic radiation source.

34. An adapter for a lead, comprising: a housing having a first connector and a second connector, said first connector providing a mechanical and electrical connection to each conductor of a multi-conductor lead, said second connector providing a mechanical and electrical connection to a medical device; and a resonant circuit operatively connected to said first and second connectors; said resonant circuit having a resonance frequency not tuned to a frequency of an electromagnetic radiation source.

35. An adapter for a lead, comprising: a housing having a first connector said first connector providing a mechanical and electrical connection to a lead; a resonant circuit operatively connected to said first connector; and a medical device operatively connected to said resonant circuit; said resonant circuit having a resonance frequency not tuned to a frequency of an electromagnetic radiation source.