The present disclosure relates to implantable medical devices (IMDs), and in particular to a system and method for use of an implanted lead that includes active magnetic resonance imaging/electromagnetic interference (MRI/EMI) protection powered by and responsive to an interfering external field.
The statements in this section merely provide background information related to the present disclosure and may not constitute prior art.
The human anatomy includes many types of tissue that can either voluntarily or involuntarily, perform certain functions. However, after disease or injury, certain tissues may no longer operate within general anatomical norms. For example, after disease, injury, age, or combinations thereof, the heart muscle may begin to experience certain failures or deficiencies. Some of these failures or deficiencies can be corrected or treated with implantable medical devices (IMDs). These devices can include implantable pulse generator (IPG) devices, pacemakers, implantable cardioverter-defibrillator (ICD) devices, cardiac resynchronization therapy defibrillator devices, or combinations thereof
One of the main portions of the IMD can include a lead that is directly connected to tissue to be affected by the IMD. The lead can include a distal end that is located adjacent to the tissue, such as a muscle bundle brain tissue, cardiac tissue of a heart or the like, and a lead body that connects to the device body or therapeutic driving device. It is generally known that the device body or case portion can be implanted in a selected portion of the anatomical structure, such as in a chest or abdominal wall, and the lead can be inserted so that one or more electrodes of the lead are positioned at selected positions near or in the muscle or tissue to which therapy is provided. Additionally, the lead one or more electrodes can be positioned near nerves, such as spinal nerves, to provide therapy to a portion of a spinal column or other nerve within the patient.
The IMD generally remains with the patient during the rest of the patient's natural life. To that end, the IMD can be exposed to various environmental factors. For example, the patient may undergo a magnetic resonance imaging (MRI) procedure or other high frequency imaging procedures. In this case, portions of the IMD may act as an antenna and have current and thermal energy induced therein due to the MRI procedure. This induced heat can damage anatomical tissue thereby reducing the efficacy of therapy or sensing. Accordingly, reduction or dissipation of the induced current or thermal energy may be useful in certain circumstances.
An implantable medical device (IMD) can include implantable pulse generator (IPG) devices, implantable cardioverter-defibrillators (ICD), cardiac resynchronization therapy defibrillator devices, neurostimulators, spinal stimulators, drug pumps, or other implantable device or combinations thereof. The IMD can be positioned in a selected portion of the anatomical structure, such as a chest wall or abdominal wall, and a lead can be positioned so that a lead tip can be implanted in anatomical tissue. Various portions of the IMD, such as a case or device body, the lead body, or the lead tip, can be formed or augmented to reduce or dissipate heat production due to various external environmental factors. For example, a magnetic and/or electric field from a magnetic resonance imager (MRI), diathermy (including shortwave, microwave, or the like) or other energy field producing devices can induce currents in the lead. According to various embodiments, self-powered active circuits can be incorporated into the lead to reduce the creation of an induced current, or dissipate thermal energy created due to an induced current in the lead, to reduce or eliminate negative effects of the induced signal. The active circuits are self-powered by the incident interfering energy and thus uses the interfering field to combat any negative effects of the interfering energy. As used herein, interfering energy, interfering field, and interfering signal refer to an impinging energy, field or signal that may have a negative effect on operation of one or more components of the medical system.
An implantable medical device operable to provide therapy to an anatomical tissue is provided. An implantable medical device can include a housing having a controller including circuitry for generating the therapy and a lead having a proximal end coupled to the housing and a distal end located adjacent to an anatomical tissue of a patient. An electrode is positioned near the distal end of the lead and a conductor extends from the proximal end of the lead to the distal end of the lead such that the circuitry for generating therapy is in electrical communication with the electrode. At least one active circuit satellite is positioned within the lead and near the electrode and includes a power circuit for converting an interfering electromagnetic field into power for controlling one or more active circuits within the at least one active circuit satellite. When powered, each active circuit including circuitry performs an action to reduce negative effects of the interfering electromagnetic field. In other words, the active circuits become self-powered in the presence of an interfering external field and can take corrective action either immediately or upon confirming detection of the presence of a particular interfering field of interest.
In addition, an implantable lead is also provided that carries therapy to anatomical tissue. The lead includes a lead body having a proximal end configured to couple to a housing of the implantable medical device and a distal end configured to be located adjacent to an anatomical tissue of a patient. An electrode positioned near the distal end of the lead and a conductor extends from the proximal end of the lead to the distal end of the lead providing electrical communication along the lead to the electrode. One or more active circuits positioned within the at least one lead perform an action to reduce effects of an interfering electromagnetic field when powered by a power circuit positioned within the lead that converts the interfering electromagnetic field into power for the one or more active circuits such that the one or more active circuits become operational when the interfering electromagnetic field is present.
Further provided is a method of controlling a lead having active circuit satellites implanted in an anatomical structure during the presence of an interfering external field. The method can include converting an interfering electromagnetic field to a power signal and powering at least one active circuit positioned near a distal end of an implantable medical lead with the power signal. When powered the at least one active circuit and performs an action to reduce negative effects of the interfering electromagnetic field. The method can also include discontinuing corrective actions and resuming normal delivery of therapy when the external field is no longer present.
Further areas of applicability will become apparent from the description provided herein. It should be understood that the cardiac description and specific examples are intended for purposes of illustration only and are not intended to limit the scope of the present disclosure from applications in neuro stimulation, spinal stimulation or stimulation in any other part of a patient's body.
The drawings described herein are for illustration purposes only and are not intended to limit the scope of the present disclosure in any way.
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c are exemplary operation actions for step 908 of
The following description is merely exemplary in nature and is not intended to limit the present disclosure, application, or uses. It should be understood that throughout the drawings, corresponding reference numerals indicate like or corresponding parts and features. The present disclosure describes the techniques with reference to a system and method for use of a cardiac lead that includes a power circuit that converts an interfering electromagnetic field, such as that generated by an MRI, into a potential for powering one or more active circuits to become operational when the interfering electromagnetic field is present. The one or more active circuits may operate to reduce or eliminate negative effects of the interfering electromagnetic field on the patient or on circuitry within the implantable medical device. It should be noted, however, that the present teachings could be applicable to other contexts (e.g., neuro stimulation or spinal stimulation) in which it is desirable to have a component that is responsive to interfering external fields. Additionally, the techniques may be used to reduce the effects of interfering external signals from devices other than MRI devices, such as diathermy devices (including shortwave, microwave, or the like), ablation devices, electrocautery devices, radiofrequency identification (RFID) security gates or other medical or non-medical source of interfering external signals.
Further, as used herein, the term circuit is intended to include discrete circuits, integrated circuits, a processor (shared, dedicated, or group) and memory that executes one or more software or firmware programs or instructions, combinational logic circuits, and/or other suitable software, firmware programs or components that provide the described functionality. As such, the disclosure further contemplates a computer-readable medium that contains instructions that, when executed by the processor or circuit, causes the device or one or more components of the device to perform the function(s) attributed to them. Therefore, it will be understood that the following discussions are not intended to limit the scope of the appended claims.
With reference to
Contained within or associated with the case 22 can be a power device 25 (such as a battery), a controller assembly 26, and a connector body 27 (sometimes referred to as a header). The controller assembly 26 can include a circuit board having a processor, memory, transmitter, receiver, and other appropriation portions, further discussed herein. The connector body 27 can extend from or be integrated with the case 22. The connector body 27 can include multiple ports 28 that each interconnect with a respective connector terminal 30 of a lead assembly 32.
A fixation mechanism can also be included with each lead assembly 32a, 32b to affix each tip electrode 36a, 36b relative to or in a selected tissue of the patient. The fixation mechanism can be near each tip electrode 36a, 36b or define a portion of the tip electrode 36a, 36b. Fixation mechanisms (not shown in
Lead assemblies 32a, 32b also include one or more conductors (not shown in
The IMD 20, including the components discussed above, can be implanted in a patient 40 as illustrated in
The IMD 20, including the case 22 and the lead bodies 34a, 34b, can be implanted using known procedures. For example, an incision can be made in a chest wall or an abdomen wall of the patient 40 and the lead assemblies 32a, 32b can be passed through selected veins to selected portions of the heart 42 of the patient 40. The case 22 can also be positioned through the incision into a chest wall or abdominal wall of the patient 40. In a selected procedure, the leads assemblies 32a, 32b can be passed through a superior vena cava 44 of the patient 40. The lead tips or tip electrodes 36a, 36b and ring electrodes 37a, 37b can be positioned at various positions in the heart 42, such as at the ventricles or atriums thereof. The position of the lead assemblies 32a, 32b, tip electrodes 36a, 36b and ring electrodes 37a, 37b can be selected for pacing, defibrillation, sensing, or other appropriate procedures. The specific implantation procedure, position of the tip electrodes 36a, 36b, ring electrodes 37a, 37b, and the like can depend upon the patient 40, the surgeon performing the procedure, the specifics of the lead assemblies 32a, 32b, or other considerations.
As discussed above, the IMD 20, including the case 22 and the lead assemblies 32a, 32b can include various features or controls to defibrillate, pace, cardiovert, or resynchronize the heart 42. The controls can include a processor associated with the controller assembly 26 located within the case 22. The processor can be programmed to control driving of a current through the lead bodies 34a, 34b to various combinations of the tip electrodes 36a, 36b and ring electrodes 37a, 37b to defibrillate, pace, cardiovert, or resynchronize the heart 42.
With continued reference to
Moreover, the IMD 20, including the case 22 and the lead assemblies 32a, 32b, can be formed to counteract or interact with various environmental factors. For example, the lead assemblies 32a, 32b can include features or portions to re-direct or dissipate thermal energy created by an induced current. Induced currents can be created due to an external field, such as an electromagnetic field acting on the conductors of the lead assemblies 32a, 32b.
For example, according to various embodiments, the patient 40 which has the implanted IMD 20 may receive a certain therapy or diagnostic technique, such as an MRI scan. Although not illustrated, an MRI, generally understood by one skilled in the art, uses high frequency radio frequency (RF) pulses, a static magnetic field and gradient magnetic fields to create image data regarding the patient 40. An MRI may have a frequency of about 42 MHz per tesla. One common MRI system uses about 1.5 tesla magnetic fields and has a corresponding RF frequency of about 64 MHz. The techniques of this disclosure are not limited to such MRI systems. The techniques of this disclosure may be utilized with other MRI systems, such as a 3.0 tesla MRI system that has a corresponding RF frequency of about 128 MHz or other MRI system. Without being bound by the theory, the strong magnetic fields in a MRI can induce aligned spins of sub-atomic particles and the high frequency RF pulses can be used to change the alignment or otherwise affect the sub-atomic particles within the patient 40.
The gradient magnetic fields and RF pulses may induce currents within the lead assemblies 32a, 32b of the IMD 20. The current induced in the lead assemblies 32a, 32b may cause certain affects, including heating, of the various lead components or tissue of the patient 40 undergoing the MRI scan. Additionally, currents flowing toward the device 20 may affect some of the circuitry within the device. According to various embodiments, such as those discussed herein, components, controls and/or mechanisms can be provided to reduce or eliminate the amount of disruption caused by the interfering electromagnetic signals of the MRI scan, including the current that may affect the device or generate thermal energy at tip electrodes 36a, 36b or ring electrodes 37a, 37b.
According to various embodiments, and with reference to
Although described in the context of IPG 120, the techniques of this disclosure may be used in other contexts including other cardiac therapy and/or monitoring devices. Additionally, the techniques may be utilized within any device that provides electrical stimulation to a tissue site of a patient proximate a muscle, organ or nerve, such as a tissue proximate a vagus nerve, spinal cord, brain, stomach, pelvic floor or the like to treat various conditions, including movement and affective disorders such as chronic pain, Parkinson's disease, tremor and dystonia, urinary storage and voiding dysfunction, digestion dysfunction, sexual dysfunction or the like.
The IPG 120 can include a control system 122 and at least one IPG stimulation lead 124 which can be implanted into an anatomical structure, similar to the placement of the IMD 20 relative to the heart 42, as shown in
The controller 122a can be in communication with and responsive to the programmer 50 to receive a desired treatment plan for the heart 42, such as a desired voltage for the electrical stimulation of the heart 42. The controller 122a can also be in communication with the lead 124 to receive the sensed electrical activity of the heart 42 and transmit the sensed electrical activity to programmer 50, as will be discussed. As such, controller 122a may include a transmitter and/or receiver for wireless communication, e.g., via RF, inductance or the like. The pulse generator 122b can be in communication with and responsive to the controller 122a to generate the desired therapy (i.e., electrical stimulation or pulse) for the heart 42. The pulse generator 122b can be in electrical communication with the lead 124 to supply the lead 124 with the desired therapy, e.g., via at least one conductor.
The satellite communication circuit 122c communicates with one or more active circuit satellites 146 (see, e.g.,
The active circuit satellite 146 may, in some instances, communicate with the satellite communication circuit 122c of IPG 120. In one embodiment, the active circuit satellite 146 may communicate with the satellite communication circuit 122c using a conductor via which therapy is provided from controller 122a to tip electrode 142 or ring electrode 140. This communication can be accomplished by any multiplexed communication scheme. For example, time division multiple access (TDMA) communication signals may be multiplexed with pacing pulses. In other examples other communication techniques may be used such as frequency division multiple access (FDMA), code division multiple access (CDMA), or any other channel access technique In another embodiment, multiplexed communication need not be used provided that the communication signals have an amplitude that are sub-threshold to a pacing pulse. Using the pacing conductor (e.g., the conductor that electrically couples either tip electrode 142 or ring electrode 140 to the pulse generator) has the advantage of reducing the size of the lead 124, which allows for a more flexible lead that may be easier for the physician to place. Alternatively, as discussed below in conjunction with
The communication between the satellite communication circuit 122c and the active circuit satellites 146 can be uni-directional or bi-directional. That is, in one embodiment, the active circuit satellite 146 communicates uni-directionally with the satellite communication circuit 122c. For example, active circuit satellite 146 may only send signals to the satellite communication circuit 122c. In this manner, the active circuit satellite 446 may alert the control circuitry 26 of IPG 120 that it is now operating in an adverse MRI/EMI field. In this way, therapy changes or other corrective actions can be taken by control system 122 of IPG 120 during the time the IPG 120 and lead 124 are within the interfering field.
In another embodiment, communication between the active circuit satellite 146 and the satellite communication circuit 122c is bi-directional or two-way. In this case, the satellite communication circuit 122c may send instructions to the active circuit satellite 146 regarding what actions to take with the now powered active circuits in addition to receiving alerts from active circuit satellite 146. Changes in actions taken can be based upon the strength or nature of the interfering field or can be programmed by the physician using the external programmer 50 discussed above in conjunction with
With reference to
In another embodiment, the power circuit 132 is divided into a broad-band power circuit 132a such that any sufficiently strong energy field powers the active circuits and a narrow-band field sensor 132b to verify that a particular interfering energy field is present before allowing the active circuits to take an action to prevent the intrusion of the interfering energy field. In this case, active circuits do not take action until narrow-band field sensor 122b confirms that the field is a particular interfering energy field, e.g., an MRI-generated field. As such, the active circuits may take the action when in the presence of an MRI field (as detected by the narrow-band field sensor 132b) and not take the action when in the presence of another interfering field, e.g., a RFID security gate. A Hall effect sensor or the magnetic field sensor 60 disclosed in commonly assigned U.S. Pat. No. 7,050,855, incorporated herein by reference in its entirety can be used as the narrow-band field sensor 132b to verify the presence of a particular interfering electromagnetic field. Alternately, the field sensor 132b can comprise another suitable field sensor used to detect an external field.
Active circuit satellite 146 and/or power circuit 132 may be coated with a protective coating that is biocompatible with a patient. In one embodiment, active circuit satellite 146 and/or power circuit 132 is coated with a CHIPSKIN™ coating provided by Proteus Biomedical, Inc. of Redwood City, Calif. However, other biocompatible coatings may also be used. In another embodiment, active circuit satellite 146 and/or power circuit 132 may be enclosed within a hermetic enclosure. In one example, the hermetic enclosure may be sized to fit within ring electrode 140. In another example, the hermetic enclosure may be an in-line hermetic enclosure. An example in-line hermetic electronic package is described in U.S. Pat. No. 7,236,834 (referred to herein as “the '834 patent”) to Christopherson et al. entitled, “ELECTRICAL LEAD BODY INCLUDING AN IN-LINE HERMETIC ELECTRONIC PACKAGE AND IMPLANTABLE MEDICAL DEVICE USING THE SAME,” which is incorporated herein by reference in its entirety. As described in the ‘834 patent, the hermetic enclosure may located along the lead body such that a first portion of the lead body extending from the IMD is electrically coupled to one side of the hermetic enclosure and a second side of the hermetic enclosure is connected to a second portion of the lead body. In this manner, the hermetic enclosure that houses active circuit satellite 146 and/or power circuit 132 is in-line or in series with the lead body. In a further example, lead 124 may be constructed of a number of modular components that are assembled to form lead 124 and one of the module components may include active circuit satellite 145. An example lead constructed of a number of modular components is described in U.S. Pat. No. 6,473,653 to Schallhorn et al. entitled, “SELECTIVE ACTIVATION OF ELECTRODES WITHIN AN IMPLANTABLE MEDICAL DEVICE,” which is incorporated herein for its description of modular components and constructing a lead from modular components.
With reference to
As can be seen in
Each active circuit can take one or a variety of actions to combat the interfering incident energy. For example, an active switch, such as a field effect transistor (FET), can open the connection between the ring electrode 140 and the conductor 148 that couples the ring electrode 140 to the IMD 20. Alternately a low-pass filter could be switched into series between the ring electrode 140 and the conductor 148. In one embodiment, a resonant filter (also known as a notch or band-stop filter) could be switched into series between the ring electrode 140 and the conductor 148. Similar actions can be taken by the active circuit 146a for the tip electrode 142.
The active circuit 146c offers the possible action of shunting the ring electrode 140 and the tip electrode 142. The shunting could be a capacitor, a filtering circuit, a resistor or some actively switched combination thereof. For the resistive shunting, it may be desirable to dissipate heat energy from the resistor in a heat absorbing material surrounding the active circuit 146c or via a heat-sink in an energy transferring connection to the resistor. By way of example, and not as a limitation, other actions that may be taken alone or in combination with any of the actions described above are shown below in Table 1.
The actions described above may be taken alone or in combination with one another. For example, in response to the power signal received from power circuit 133, active circuits 146a and 146b may open (in the case of a switch) and a shunt with impedance may be placed between ring electrode 140 and tip electrode 142.
Each action, or combination of actions, are designed to reduce or eliminate damaging effects of the incident MRI/EMI energy. Accordingly, the techniques of the present disclosure offers a variety of options to address patient tissue heating issues or damage to circuitry of the IMD. Although
The power signal 133 can also constitute a signal to the controller of IPG 120 indicating that an interfering electromagnetic field is present. That is, since the power signal 133 is provided only in the presence of an interfering external field, merely sending the signal to the controller will allow the controller to determine whether to take some action of its own, such as enter a safe mode or altering the therapy delivered to the patient. In one embodiment, the power signal may be communicated to the controller via a separate conductor 147’. In this embodiment, the power signal can then be used by the controller of IPG 120 (122a in
In another embodiment, communication between the active circuit satellite 146 and the satellite communication circuit 122c may be bi-directional. In this case, the satellite communication circuit 122c may send instructions to the active circuit satellite 146 or individual ones of active circuits 146a, 146b, 146c regarding what actions to take with the now powered active circuits. Controller 122a of IPG 120 may, for example, analyze the signal further in response to receiving a power signal or other signal indicating the presence of the interfering electromagnetic field and instruct one or more of active circuits 146a, 146b, 146c regarding the action to take. Controller 122a may, for example, instruct one of the active circuits to switch in a first resonant filter between tip electrode and the IPG 120 for a 1.5 T MRI and switch in a second resonant filter between tip electrode and the IPG 120 for a 3.0 T MRI. Changes in actions taken can be based upon the strength or nature of the interfering field or can be programmed by the physician using the external programmer 50 discussed above in conjunction with
With reference to
In this embodiment, the detect signal 139 constitutes a signal to the controller of IPG 120 indicating that an interfering electromagnetic field is present. Since the detect signal 139 is provided only in the presence of a particular interfering external field, sending the detect signal 139 to the controller will allow the controller to determine whether to take some action, such as synchronizing pacing, entering a safe mode or altering the therapy delivered to the patient. In one embodiment, the detect signal 139 may be communicated to the controller via a separate conductor 147′. Additionally, the power signal could also be sent via the conductor 147′ so that the power can be used by the controller (122a in
With reference to
With reference to
With reference to
With reference to
Decision 910 determines whether communication with the implantable medical device is required. If so, step 912 communicates with the implantable medical device as discussed above in conjunction with
With reference to
With reference to
In decision 1012, it is determined whether to modify one or more electrode modes currently in operation by the one or more active circuit satellites. If so, step 1014 sends data to (and may receive from) the active circuit satellites to, for example, change the particular electrode that delivers therapy or senses information from the patient. This can be done by the implantable medical device or by one or more of the active circuit satellites. Those skilled in the art will appreciate that many number of other electrode modes could be entered, changed or suspending depending upon the desire of the lead designer.
With reference to
With reference to
With reference to
As discussed above in conjunction with
As discussed above, the distal end 136 typically terminates within an anatomical structure adjacent to the desired location for the delivery of the therapy to the heart 42, as generally known, and illustrated in
The pacing conductor 150 and the sensing/control conductor 152 can each be insulated to conduct or carry electrical signals along the body 138 of the lead 124. The pacing conductor 150 can be in communication with the pulse generator 122b to conduct or carry electrical pulses from the IPG 20 to the ring electrode 140 or the tip electrode assembly 142 to pace the heart 42. The ring electrode 140 can be disposed near the distal end 136 of the lead 124 (
With reference again to
While specific examples have been described in the specification and illustrated in the drawings, it will be understood by those of ordinary skill in the art that various changes may be made and equivalents may be substituted for elements thereof without departing from the scope of the present disclosure as defined in the claims. Furthermore, the mixing and matching of features, elements and/or functions between various examples is expressly contemplated herein so that one of ordinary skill in the art would appreciate from this disclosure that features, elements and/or functions of one example may be incorporated into another example as appropriate, unless described otherwise, above. Moreover, many modifications may be made to adapt a particular situation or material to the teachings of the present disclosure without departing from the essential scope thereof. For example, the device may include an RF generator that generates the RF signal used to power the EMI/MRI protection circuitry. Therefore, it is intended that the present disclosure not be limited to the particular examples illustrated by the drawings and described in the specification as the best mode presently contemplated for carrying out this disclosure, but that the scope of the present disclosure will include any embodiments falling within the foregoing description and the appended claims.
This application claims priority from U.S. Provisional Application No. 61/328,841, filed Apr. 28, 2010, the content of which is incorporated herein by reference in its entirety.
Number | Date | Country | |
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61328841 | Apr 2010 | US |