Source: https://patents.google.com/patent/US10016591B2/en
Timestamp: 2019-07-19 12:59:08
Document Index: 646864457

Matched Legal Cases: ['art 12', 'art 12', 'art 12', 'art 12', 'art 12', 'art 12', 'art 12', 'art 12', 'art 12', 'art 12', 'art 12']

US10016591B2 - Medical electrical lead - Google Patents
US10016591B2
US10016591B2 US14/523,058 US201414523058A US10016591B2 US 10016591 B2 US10016591 B2 US 10016591B2 US 201414523058 A US201414523058 A US 201414523058A US 10016591 B2 US10016591 B2 US 10016591B2
US14/523,058
US20160114151A1 (en
Linda L Franke
2014-10-24 Application filed by Medtronic Inc filed Critical Medtronic Inc
2014-10-24 Priority to US14/523,058 priority Critical patent/US10016591B2/en
2015-01-13 Assigned to MEDTRONIC, INC. reassignment MEDTRONIC, INC. ASSIGNMENT OF ASSIGNORS INTEREST (SEE DOCUMENT FOR DETAILS). Assignors: CLEMENS, WILLIAM J, FRANKE, LINDA L, SOMMER, JOHN L
2015-10-23 Priority claimed from CN201580057488.4A external-priority patent/CN107073271A/en
2016-04-28 Publication of US20160114151A1 publication Critical patent/US20160114151A1/en
2018-07-10 Publication of US10016591B2 publication Critical patent/US10016591B2/en
The present disclosure may comprise an improvement to the prior art leads as disclosed above. One embodiment is directed to an intravenous medical electrical lead that includes an elongated lead body. The elongated lead body comprises a length between proximal and distal ends with a longitudinal axis extending therebetween. The distal end of the lead body includes a plurality of electrodes forming first and second pairs of electrodes. The first pair of electrodes comprises one electrode electrically connected to another electrode circumferentially and diagonally spaced apart along the longitudinal axis. The second pair of electrodes comprising one electrode electrically connected to another electrode circumferentially and diagonally spaced apart along the longitudinal axis.
The present disclosure pertains to medical electrical leads, and, more particularly, to implantable medical electrical leads that increase delivery of electrical stimuli options.
Implantable medical devices, for example cardiac pacemakers and defibrillators, often include elongate medical electrical leads having one or more electrodes to sense electrical activity and deliver therapeutic stimulation. With the advent of left ventricular pacing to alleviate heart failure, leads have been advanced into the coronary veins in order to position the electrodes of the leads at left ventricular pacing sites, typically located in proximity to the base of the left ventricle. Although a variety of left ventricular pacing leads, along with methods for implanting such leads, have been developed, there is still a need for a lead including features that facilitate delivery to, and fixation at, sites in the coronary vasculature.
Numerous types of medical electrical leads can be adapted for placement in coronary vasculature. Exemplary active fixation leads include U.S. Pat. No. 7,860,580, issued to Sommer, et al., U.S. Pat. No. 7,532,939, issued to Sommer, et al. and U.S. patent application Ser. No. 13/793,622, filed Mar. 11, 2013 by Sommer, et al., all of which are incorporated herein by reference in their entirety. Shaped leads can also be adapted for placement in the coronary vasculature. Exemplary shaped leads or catheters include U.S. Pat. No. 7,313,444, issued to Pianca et al., U.S. Pat. No. 5,387,233, issued to Alferness, et al., U.S. Pat. No. 5,925,073, issued to Chastain, et al., U.S. Pat. No. 6,430,449, issued to Hsu, et al., U.S. Pat. No. 6,129,750, issued to Tockman et al., U.S. Pat. No. 6,321,123 issued to Morris. Some implantable medical devices are configured to pace from multiple electrodes on the lead such as U.S. Pat. No. 8,036,743. However, ring electrodes spaced apart and aligned longitudinally provide limited electrical field gradients that may not achieve optimal stimulation locations for some patients. It is therefore desirable to develop a medical electrical lead that provides increased options for delivery of effective therapy.
The present disclosure may comprise an improvement to the prior art leads as disclosed above. One embodiment is directed to an intravenous medical electrical lead that includes an elongated lead body. The elongated lead body comprises a length between proximal and distal ends with a longitudinal axis extending therebetween. The distal end of the lead body includes a plurality of electrodes forming first and second pairs of electrodes. The first pair of electrodes comprises one electrode electrically connected to another electrode circumferentially and diagonally spaced apart along the longitudinal axis. The second pair of electrodes comprising one electrode electrically connected to another electrode circumferentially and diagonally spaced apart along the longitudinal axis. In one or more other embodiments, each electrode is protrudes away from the outer circumference of the lead body.
In one more other embodiments, the lead can be shaped in numerous configurations (i.e. straight, canted, S-Shaped or pigtailed). In still yet another embodiment, a helix for active fixation can be added to the lead. In another embodiment, the implantable medical device (e.g. ICD, IPG etc.) can be configured or programmed to tie two pairs of two electrodes together as anodes and the other two pairs of two electrodes can be cathodes.
For some patients, increased cardiac resynchronization response rate can be achieved through multiple diagonal electrodes on a lead coupled to an IS-4 connector module. In addition, greater tissue contact and reduced pacing thresholds is attained through the outer electrode surface, extending or protruding beyond the outer diameter of the lead body.
The following drawings are illustrative of particular embodiments of the present disclosure and therefore do not limit the scope of the disclosure. The drawings are not to scale (unless so stated) and are intended for use in conjunction with the explanations in the following detailed description. Embodiments of the present disclosure will hereinafter be described in conjunction with the appended drawings, wherein like numerals denote like elements.
FIG. 2B is a diagram of an enlarged view of a lead distal end disposed in the left ventricle of FIG. 2A.
FIG. 3B is another block diagram of an exemplary IMD (e.g., an implantable pulse generator) circuitry and associated leads employed in the system of FIGS. 1-2 for providing three sensing channels and corresponding pacing channels.
FIG. 4 is a schematic diagram of a front view of a set of electrodes positioned along a distal end of a lead.
FIG. 5 is a cross-sectional view of a set of electrodes positioned along a lead distal end.
FIG. 6 is a schematic diagram of the lead distal end depicted in FIG. 4 rotated clockwise by 45 degrees away from the front position shown in FIG. 4.
FIG. 7 is a schematic diagram of a back view of the lead distal end rotated clockwise by 45 degrees away from the position shown in FIG. 6.
FIG. 8 is a schematic diagram of the distal end of the lead rotated clockwise by 45 degrees away from the position shown in FIG. 7.
FIG. 9 is a schematic diagram of a front view of a set of electrodes positioned along a lead distal end of a lead that is coupled to a connector module.
FIG. 10 is a cross-sectional top view of a set of electrodes positioned along a distal end of a lead.
FIG. 11 is a schematic diagram of a human heart and of the lead through the coronary sinus as implanted along with electrical stimulation fields created from the electrodes on the lead.
FIG. 12 is a flow chart illustrating the steps of implantation of a lead according to the present disclosure.
FIG. 13 is an alternative embodiment a front view of a set of electrodes positioned along a distal end of a lead such that the diagonal electrodes are connected along a vertical longitudinal line.
FIG. 14 is a schematic diagram of the lead distal end depicted in FIG. 13 rotated clockwise by 45 degrees away from the front position shown in FIG. 13.
The following detailed description is exemplary in nature and is not intended to limit the scope, applicability, or configuration of the disclosure in any way. Rather, the following description provides practical illustrations for implementing exemplary embodiments of the present invention. Constructions, materials, dimensions, and manufacturing processes suitable for making embodiments of the present are known to those of skill in the field of the invention.
FIGS. 1-3 generally depict and provide details as to the manner in which an exemplary therapy system operating in conjunction with a medical electrical lead while FIGS. 4-11 provide the details as to the present disclosure. FIG. 1 is a conceptual diagram illustrating an exemplary therapy system 10 that may be used to deliver pacing therapy to a patient 14. Patient 14 may, but not necessarily, be a human. The therapy system 10 may include an implantable medical device 16 (IMD), which may be coupled to leads 18, 20, 22. The IMD 16 may be, e.g., an implantable pacemaker, cardioverter, and/or defibrillator, that provides electrical signals to the heart 12 of the patient 14 via electrodes coupled to one or more of the leads 18, 20, 22 (e.g., electrodes that may be implanted in accordance with the description herein, such as, with use of non-invasive selection of implantation site regions).
FIGS. 2A-2B are conceptual diagrams illustrating the IMD 16 and the leads 18, 20, 22 of therapy system 10 of FIG. 1 in more detail. The leads 18, 20, 22 may be electrically coupled to a therapy delivery module (e.g., for delivery of pacing therapy), a sensing module (e.g., for sensing one or more signals from one or more electrodes), and/or any other modules of the IMD 16 via a connector block 34. In some examples, the proximal ends of the leads 18, 20, 22 may include electrical contacts that electrically couple to respective electrical contacts within the connector block 34 of the IMD 16. A bipolar electrode is an electrode that can function as the anode of one pacing vector and the cathode of another pacing vector. An exemplary connector block (e.g. IS-4) can be seen with respect to U.S. Pat. No. 7,654,843 to Olson et al. issued Feb. 2, 2010, U.S. Pat. No. 7,601,033 to Ries et al. issued Oct. 13, 2009 and assigned to the assignee of the present invention, the disclosure of which are incorporated by reference in their entirety herein. In one or more embodiments, only one IS-4 connector is used since only four electrodes are connected to four conductors. However, if 8 individual electrodes were individually connected to eight conductors, then a bifurcated connector with two different bores could be used. The bifurcated connector with two different bores would employ the disclosure presented in U.S. Pat. No. 7,601,033. Specifically, a bifurcated connector with two individual IS-4 connectors or legs extending from the bifurcation can be used. In addition, in some examples, the leads 18, 20, 22 may be mechanically coupled to the connector block 34 with the aid of set screws, connection pins, or another suitable mechanical coupling mechanism.
Each of the leads 18, 20, 22 includes an elongated insulative lead body. As shown in FIG. 9, lead 20 optionally includes a monolithic controlled release device (MCRD) 112 (which is configured to release anti-bacterial agents over a period of time. The lead body 15 may carry a number of conductors (e.g., concentric coiled conductors, straight conductors, etc.) separated from one another by insulation (e.g., tubular insulative sheaths). In the illustrated example, bipolar electrodes 40, 142 are located proximate to a distal end of the lead 18. In addition, the bipolar electrodes 44, 45, 46, 47 are located proximate to a distal end of the lead 20 and the bipolar electrodes 48, 150 are located proximate to a distal end of the lead 22.
The electrodes 40, 44, 44, 45, 46, 47, 48 may take the form of ring electrodes, and the electrodes 142, 150 may take the form of extendable helix tip electrodes mounted retractably within the insulative electrode heads 52, 54, 56, respectively. Each of the electrodes 40, 42, 142, 44, 45, 46, 47, 48, 50, 150 may be electrically coupled to a respective one of the conductors (e.g., coiled and/or straight) within the lead body of its associated lead 18, 20, 22, and thereby coupled to respective ones of the electrical contacts on the proximal end of the leads 18, 20, 22.
At least four of the LV electrodes 40, 42, 44, 45, 46, 47, 48, 50, 52 (e.g. 40, 46, 48, and 50 shown in FIG. 2B) may be connected directly to four different conductors emanating from connector 34 (e.g. IS-4 connector etc.). The four different conductors (e.g. each individual polymeric coated filars present in a “multiconductor” conductor coil). Each individually insulated filars is a separate “conductor” and is crimped to each of the four contacts on the connector block 34.
The electrodes 40, 42, 142, 44, 45, 46, 47, 48, 50, 150, 52 may further be used to sense electrical signals (e.g., morphological waveforms within electrograms (EGM)) attendant to the depolarization and repolarization of the heart 12. The sensed electrical signals may be used to determine which of the electrodes 40, 42, 142, 44, 45, 46, 47, 48, 50, 52, 150 are the most effective in improving cardiac function. The electrical signals are conducted to the IMD 16 via the respective leads 18, 20, 22. In some examples, the IMD 16 may also deliver pacing pulses via the electrodes 40, 142, 44, 45, 46, 47, 48, 150 to cause depolarization of cardiac tissue of the patient's heart 12. In some examples, as illustrated in FIG. 2A, the IMD 16 includes one or more housing electrodes, such as housing electrode 58, which may be formed integrally with an outer surface of a housing 60 (e.g., hermetically-sealed housing) of the IMD 16 or otherwise coupled to the housing 60. Any of the electrodes 40, 42, 142, 44, 45, 46, 47, 48 and 50, 150, 52 may be used for unipolar sensing or pacing in combination with housing electrode 58. In other words, any of electrodes 40, 42, 142, 44, 45, 46, 47, 48, 50, 52, 150, 58 may be used in combination to form a sensing vector, e.g., a sensing vector that may be used to evaluate and/or analyze the effectiveness of pacing therapy. It is generally understood by those skilled in the art that other electrodes can also be selected to define, or be used for, pacing and sensing vectors. Further, any of electrodes 40, 42, 142, 44, 45, 46, 47, 48, 50, 52, 150, 58, which are not being used to deliver pacing therapy, may be used to sense electrical activity during pacing therapy.
As described in further detail with reference to FIG. 2A, the housing 60 may enclose a therapy delivery module that may include a stimulation generator for generating cardiac pacing pulses and defibrillation or cardioversion shocks, as well as a sensing module for monitoring the patient's heart rhythm. The leads 18, 20, 22 may also include elongated electrodes 62, 64, 66, respectively, which may take the form of a coil. The IMD 16 may deliver defibrillation shocks to the heart 12 via any combination of the elongated electrodes 62, 64, 66 and the housing electrode 58. The electrodes 58, 62, 64, 66 may also be used to deliver cardioversion pulses to the heart 12. Further, the electrodes 62, 64, 66 may be fabricated from any suitable electrically conductive material, such as, but not limited to, platinum, platinum alloy, and/or other materials known to be usable in implantable defibrillation electrodes. Since electrodes 62, 64, 66 are not generally configured to deliver pacing therapy, any of electrodes 62, 64, 66 may be used to sense electrical activity (e.g., for use in determining electrode effectiveness, for use in analyzing pacing therapy effectiveness, etc.) and may be used in combination with any of electrodes 40, 142, 44, 45, 46, 47, 48, 150, 58. In at least one embodiment, the RV elongated electrode 62 may be used to sense electrical activity of a patient's heart during the delivery of pacing therapy (e.g., in combination with the housing electrode 58 forming a RV elongated coil, or defibrillation electrode-to-housing electrode vector). It should be understood that merely a portion of the electrodes are placed in or near the heart and that more electrodes can be placed in the heart. The node (i.e. 150, 48) which refers to any point on a circuit where two or more circuit elements meet, is shown in FIGS. 3A-3B. The nodes were created from the electrodes and are merely exemplary in order to generally depict nodes. All of the possible nodes that can be made from lead 20 are not shown in order to avoid obscuring the invention.
The configuration of the exemplary therapy system 10 illustrated in FIGS. 1-3 is merely one example. In other examples, the therapy system may include epicardial leads and/or patch electrodes instead of or in addition to the transvenous leads 18, 20, 22 illustrated in FIG. 1. Further, in one or more embodiments, the IMD 16 need not be implanted within the patient 14. For example, the IMD 16 may deliver various cardiac therapies to the heart 12 via percutaneous leads that extend through the skin of the patient 14 to a variety of positions within or outside of the heart 12. In one or more embodiments, the system 10 may utilize wireless pacing (e.g., using energy transmission to the intracardiac pacing component(s) via ultrasound, inductive coupling, RF, etc.) and sensing cardiac activation using electrodes on the can/housing and/or on subcutaneous leads.
The control module 81 may be used to determine the effectiveness of the electrodes 40, 42, 142, 44, 45, 46, 47, 48, 150, 58, 62, 64, 66 using the exemplary methods and/or processes described herein according to a selected one or more programs, which may be stored in the memory 82. Further, the control module 81 may control the therapy delivery module 84 to deliver therapy (e.g., electrical stimulation therapy such as pacing) to the heart 12 according to a selected one or more therapy programs, which may be stored in the memory 82. More, specifically, the control module 81 (e.g., the processor 80) may control various parameters of the electrical stimulus delivered by the therapy delivery module 84 such as, e.g., AV delays, pacing pulses with the amplitudes, pulse widths, frequency, or electrode polarities, etc., which may be specified by one or more selected therapy programs (e.g., AV delay adjustment programs, pacing therapy programs, pacing recovery programs, capture management programs, etc.). As shown, the therapy delivery module 84 is electrically coupled to electrodes 40, 42, 142, 44, 45, 46, 47, 48, 150, 58, 62, 64, 66, e.g., via conductors of the respective lead 18, 20, 22, or, in the case of housing electrode 58, via an electrical conductor disposed within housing 60 of IMD 16. Therapy delivery module 84 may be configured to generate and deliver electrical stimulation therapy such as pacing therapy to the heart 12 using one or more of the electrodes 40, 42, 142, 44, 45, 46, 47, 48, 150, 58, 62, 64, 66.
For example, therapy delivery module 84 may deliver pacing stimulus (e.g., pacing pulses) via ring electrodes 40, 44, 45, 46, 47, 48 coupled to leads 18, 20, and 22, respectively, and/or helical tip electrodes 142 and 150 of leads 18 and 22. Further, for example, therapy delivery module 84 may deliver defibrillation shocks to heart 12 via at least two of electrodes 58, 62, 64, 66. In some examples, therapy delivery module 84 may be configured to deliver pacing, cardioversion, or defibrillation stimulation in the form of electrical pulses. In other examples, therapy delivery module 84 may be configured deliver one or more of these types of stimulation in the form of other signals, such as sine waves, square waves, and/or other substantially continuous time signals.
The IMD 16 may further include a switch module 85 and the control module 81 (e.g., the processor 80) may use the switch module 85 to select, e.g., via a data/address bus, which of the available electrodes are used to deliver therapy such as pacing pulses for pacing therapy, or which of the available electrodes are used for sensing. The switch module 85 may include a switch array, switch matrix, multiplexer, or any other type of switching device suitable to selectively couple the sensing module 86 and/or the therapy delivery module 84 to one or more selected electrodes. More specifically, the therapy delivery module 84 may include a plurality of pacing output circuits. Each pacing output circuit of the plurality of pacing output circuits may be selectively coupled, e.g., using the switch module 85, to one or more of the electrodes 40, 42, 142, 44, 45, 46, 47, 48, 150, 58, 62, 64, 66 (e.g., a pair of electrodes for delivery of therapy to a pacing vector). In other words, each electrode can be selectively coupled to one of the pacing output circuits of the therapy delivery module using the switching module 85.
The sensing module 86 is coupled (e.g., electrically coupled) to sensing apparatus, which may include, among additional sensing apparatus, the electrodes 40, 42, 142, 44, 45, 46, 47, 48, 150, 58, 62, 64, 66 to monitor electrical activity of the heart 12, e.g., electrocardiogram (ECG)/electrogram (EGM) signals, etc. The ECG/EGM signals may be used to measure or monitor activation times (e.g., ventricular activations times, etc.), heart rate (HR), heart rate variability (HRV), heart rate turbulence (HRT), deceleration/acceleration capacity, deceleration sequence incidence, T-wave alternans (TWA), P-wave to P-wave intervals (also referred to as the P-P intervals or A-A intervals), R-wave to R-wave intervals (also referred to as the R-R intervals or V-V intervals), P-wave to QRS complex intervals (also referred to as the P-R intervals, A-V intervals, or P-Q intervals), QRS-complex morphology, ST segment (i.e., the segment that connects the QRS complex and the T-wave), T-wave changes, QT intervals, electrical vectors, etc.
The switch module 85 may be also be used with the sensing module 86 to select which of the available electrodes are used, or enabled, to, e.g., sense electrical activity of the patient's heart (e.g., one or more electrical vectors of the patient's heart using any combination of the electrodes 40, 42, 142, 44, 45, 46, 47, 48, 150, 52, 58, 62, 64, 66). Likewise, the switch module 85 may be also be used with the sensing module 86 to select which of the available electrodes are not to be used (e.g., disabled) to, e.g., sense electrical activity of the patient's heart (e.g., one or more electrical vectors of the patient's heart using any combination of the electrodes 40, 142, 44, 45, 46, 47, 48, 150, 58, 62, 64, 66), etc. In some examples, the control module 81 may select the electrodes that function as sensing electrodes via the switch module within the sensing module 86, e.g., by providing signals via a data/address bus.
During implanting of the implantable medical device and medical electrical lead or during a follow-up visit with a physician to check the implantable medical device and patient, medical personnel can employ a programmer. Programmers that may be used during implant can include the CARELINK ENCORE™ 29901 developed and sold by Medtronic, Inc. of Minneapolis, Minn. The programmer is configured to set one or a pair of electrodes as an anode or cathode using known techniques. Typically pacing is defined as tip-ring where the tip is the anode and ring is the cathode. Another example would be LVtip-RVring, or for high voltage shocks HVA-HVB where HVA is the device can shield and HVB is the RV coil. However, the present disclosure provides many more options. In addition or alternatively to conventional devices, the present disclosure is able to set one pair of electrodes as an anode or a cathode. Since four pairs of electrodes are located at the distal end of the lead, there are numerous options available for each pair of electrodes but for every pair electrodes designated as an anode, another pair of electrodes or another electrode must be present as a cathode. The optimal vector is selected by the doctor who may consider pacing capture threshold (PCT), impedance and/or phrenic nerve stimulation.
The output amplifiers circuit 51 includes switching circuits for coupling selected pace electrode pairs from among the lead conductors and the IND_CAN electrode 20 to the RA pace pulse generator (and LA pace pulse generator if provided), RV pace pulse generator and LV pace pulse generator. Pace/sense electrode pair selection and control circuit 53 selects lead conductors and associated pace electrode pairs to be coupled with the atrial and ventricular output amplifiers within output amplifiers circuit 51 for accomplishing RA, LA, RV and LV pacing. The sense amplifiers circuit 55 contains sense amplifiers corresponding to any of those presently employed in contemporary cardiac pacemakers for atrial and ventricular pacing and sensing. High impedance P-wave and R-wave sense amplifiers may be used to amplify a voltage difference signal that is generated across the sense electrode pairs by the passage of cardiac depolarization wavefronts. The high impedance sense amplifiers use high gain to amplify the low amplitude signals and rely on pass band filters, time domain filtering and amplitude threshold comparison to discriminate a P-wave or R-wave from background electrical noise. Digital controller/timer circuit 83 controls sensitivity settings of the atrial and ventricular sense amplifiers 55.
FIGS. 4, and 6-8 generally depict electrodes 40, 42, 44, 46, 48, 50, 52, and 54 placed along a distal end 120 of lead 20. Since the electrodes 40, 42, 44, 46, 48, 50, 52, and 54 are placed around the circumference of the distal end 120, the distal end 120 is shown through a 360 degree clockwise rotation by FIGS. 4, and 6-8 order to show the placement of each electrode. For example, FIG. 4 depicts a front view of the distal end 20 while FIG. 6 shows lead 20 rotated 90 degrees in a clockwise direction from the front view of FIG. 4. FIG. 7 shows a back view of lead 20 depicted in FIG. 4, which is lead 20 rotated 90 degrees in a clockwise direction from the distal end 20 shown in FIG. 6. FIG. 8 depicts lead 20 rotated 90 degrees in a clockwise direction from the position of the lead 20 depicted in FIG. 7.
First and second electrodes 40, 42 are located along the same lead body 15 length but are diametrically opposed (180 degrees apart from each other) to one another as shown by the front and back views of FIGS. 4 and 7, respectively and the top down view of FIG. 5. First and fifth electrodes 40, 48 are aligned or substantially aligned (i.e. within about 0.1 cm to about 0.2 cm of exact alignment) along the longitudinal axis 118 but the first and fifth electrodes are separated along the lead body length by about 3.95 cm to about 4.0 cm. The first and third electrodes 40, 44 are circumferentially shifted or rotationally separated by about 90 degrees as shown in FIG. 4. The first and fourth electrodes 40, 46 are also circumferentially shifted or rotationally separated by about 90 degrees as shown in FIG. 4. The first and third electrodes 40, 44 as well as the first and fourth electrodes 40, 46 are spaced apart along the longitudinal axis 118 by about L2 (e.g. 1.2 cm).
The third electrode 44 is circumferentially shifted by about 90 degrees away from the first and second electrodes 40, 42 respectively along the distal end 120. On the proximal end of the electrodes, third electrode 44 is circumferentially shifted away from fifth and sixth electrodes 48, 50 as shown in FIG. 6. The third electrode is a distance of L2 along the lead body length away from the first and second electrodes 40, 42 and L4 distance away from the fifth and sixth electrodes 48, 50.
Third and fourth electrodes 44, 46 are located along the same lead body 15 length as shown in FIGS. 4 and 7. Moreover, third and fourth electrodes 44, 46 are diametrically opposed to each other (circumferentially shifted 180 degrees away from each other). Additionally, third and fourth electrodes 44, 46 extend about 1 cm distance away from the distal tip 314 (FIG. 9) and toward the proximal end of lead 20.
Fifth and sixth electrodes 48, 50 are diametrically opposed to one another (i.e. 180 degrees away from each other). The fifth electrode 48 is circumferentially shifted about 90 degrees away from third and fourth electrodes 44, 46, respectively. Fifth electrode 48 is about L4 distance along the lead body length away from third and fourth electrodes 44, 46, respectively and L6 distance along the lead body length from the seventh and eight electrodes 52, 54, respectively.
The electrodes at the distal end 120 extend a total body length Ltotal of about 4.3 cm, which is the sum of L1, L2, L3, L4, L5, L6 and L7. In one or more embodiments, the length of each electrode, represented by L1, L3, L5, and L7, is about 0.175 mm. L1, L3, L5, and L7 represent the distance between the electrodes along the length of the lead body 15. L1, L3, L5, and L7 are each equal to about 0.175 mm. L2, L4 and L6, representing the space between electrodes, are each equal to about 1.2 cm.
Left ventricular electrodes 40, 42, 44, 46, 48, 50, 52, and 54, are electrically paired in a diagonally and circumferentially shifted (or angularly displaced) configuration in order to provide multi-electrode pacing vectors (e.g. up to four multi-site pacing vectors. The electrical connection can be made by a jumper (41, 49) which is a short length electrical conductor used to close a break in, or bypass part of, an electrical circuit. As shown, each jumper can range from about 1 cm to about 2 cm in length. As shown in FIG. 4, jumper 41 extends from electrode 40 to electrode 44. Jumper 49 extends from electrode 48 to electrode 52.
Four of the eight electrodes are connected to conductors in connector block 34. For example, the first conductor, which extends through the IS-4 connector block 34 is connected first electrode 40. First electrode 40 is also electrically connected to third electrode 44. The second conductor, which extends into or through the IS-4 connector block 34, is connected to second electrode 42. The second electrode is jumpered to the fourth electrode 46. The third conductor extends into or through the IS-4 connector block 34 and connects with the fifth electrode 48. The fifth electrode is jumpered to the seventh electrode 52. The fourth conductor extends through the IS-4 connector block 34 and connects with the sixth electrode 50. The sixth electrode 50 is jumpered to the eighth electrode 54.
First, second, fifth and sixth electrodes 40, 42, 48, 50 in combination with first through four conductors passing through connector module 34 (e.g. IS-4 connector etc.) form four different electronic circuits. For example, a first circuit comprises a first electrode, a third electrode jumpered to the first electrode, all of which are electronically connected to a first conductor passing through the connector module 34. A second circuit comprises a second electrode 42, a fourth electrode 46 jumpered to the second electrode 42, all of which are electronically connected to a second conductor passing through the connector block 34. A third circuit comprises a fifth electrode 48 connected to a seventh electrode 52 which are electronically connected to a third conductor passing through the connector module 34. A fourth circuit comprises a sixth electrode 50 connected to an eighth electrode 54, all of which and connected to a fourth conductor passing through the connector block 34.
As previously mentioned relative to FIG. 3, the implantable medical device control circuit automatically selects the most appropriate place from which to deliver stimuli to cardiac tissue after the implantable medical device has been chronically implanted. However, when the physician is implanting the implantable medical device, a programmer is used with computer instructions to determine which diagonal electrodes are optimal for a patient.
An implantable medical device control circuit is used to activate and/or deactivate each pair of electrodes. In one embodiment, only one of the pair of electrodes is active at any given time. In another embodiment, one or more pairs of electrodes can be activated depending upon the condition of the cardiac tissue.
Presented below is Table 1 that shows the pacing vectors that may be attained through implementing the diagonal directional electrodes on the distal end of the lead 20. The truth table indicates which electrodes can be activated (“1”) for delivering therapy and/or sensing from the electrodes. Deactivated electrodes are indicated by “0”. Only four primary electrodes on lead 20 are shown in the table. Primary electrodes are those electrodes directly connected with a conductor extending from the connector block 34. It should be understood that if one of the primary electrodes such as the first, second, fifth, and sixth electrodes 40, 42, 48, 50 are activated, the electrodes jumpered to each electrode is also activated. For example, if the first electrode 40 is delivering stimuli to cardiac tissue, then the third electrode 44 is also delivering stimuli to the cardiac tissue due to the electrical connection between the first and third electrodes 40, 44.
Pacing vectors formed by diagonally connected electrodes
Pacing connected to connected connected connected to
vectors conductor 1 to conductor 2 to conductor 3 conductor 4
In yet another example, the electrode pairs on lead 20 in which four electrodes are able to deliver electrical stimulation in diagonal direction using only 2 pacing circuits. For example, assume a first pair of electrodes (e.g. electrodes 2 and 4) and second pair of electrodes (e.g. electrodes 6 and 8) were placed towards the myocardial side of the heart while third pair of electrodes (e.g. electrodes 1 and 3) and fourth pair of electrodes (e.g. electrodes 5 and 7) located on the pericardial side of the heart.
Numerous methods exist for placing lead 20 near and/or into excitable tissue (e.g. cardiac tissue such as myocardial tissue). One such method 200, depicted in FIG. 12, describes lead placement corresponding to the positioning of the lead 20 as illustrated in FIG. 11. A lead delivery device (e.g. stylet, guide wire, hybrid guidewire/stylet etc.), such as the ATTAIN HYBRID®, is inserted into an aperture at a proximal end of lead 20. Lead 20 is then inserted directly through an integrated valve of a guide catheter such as ATTAIN CATHETER® developed and sold by Medtronic, Inc. of Minneapolis, Minn. Lead 20 is introduced into the vascular system (step 202, FIG. 12) by any conventional technique. The lead 20 is then moved into the vasculature (e.g. coronary venous system etc.) to a desired location, for example by advancing the lead body 15 by means of the guide catheter. The coronary venous system includes the coronary sinus vein, great cardiac vein, middle cardiac vein, left posterior ventricular vein, and/or any other applicable cardiac veins. Lead 20 passes through the coronary sinus and into a cardiac vein extending therefrom, while substantially maintaining lead body 15 shape.
The lead 20 is then advanced further into the coronary venous system (Step 204, FIG. 12) and generally travels in a downward path of the coronary vein along the naturally curved shape of the heart. This may be accomplished by passing the lead 20 through a guide catheter, or by advancing the lead 20 over a guidewire or by means of a stylet inserted into the lead 20. A hybrid guidewire/stylet may also be used to place a lead 20 near or adjacent myocardial tissue. Any conventional mechanism for placing the lead 20 into and within the coronary venous system may be employed.
Lead 20 is located at an appropriate location, as determined by the physician (Step 206, FIG. 12). Thereafter, the lead body 15 may be moved (i.e. advanced and/or retracted) through the guide catheter until the diagonally paired electrodes are located in a desirable position (Step 206, FIG. 12). According to one embodiment, a first and second pair of diagonally paired electrodes are used. According to another embodiment, a first, second and third pair of diagonally paired electrodes are used. According to yet another embodiment, a first, second, third and fourth pair of diagonally paired electrodes are used. Determination of the position for electrode location may be accomplished by any conventional method, such as pacing threshold testing and/or measurement of R-wave amplitudes. The guide catheter analyzer cable interface is useful to perform this function. Alternatively or additionally, appropriate electrode locations may also be determined based upon determinations of hemodynamic characteristics of the heart as associated with stimulation of heart tissue at various electrode locations.
FIGS. 13 and 14 depict an alternate embodiment to FIGS. 4, 6-8. Each electrode in FIGS. 13 and 14 is in the same position as described relative to FIGS. 4, 6-8 but the electrical connection between each electrode is different. FIG. 13 is a front view while FIG. 14 is rotated clockwise by 45 degrees away from the front position shown in FIG. 13. Four of the eight electrodes are connected to conductors in connector block 34. For example, the first conductor, which extends through the IS-4 connector block 34 is connected first electrode 40. First electrode 40 is also electrically connected to fifth electrode 48. The second conductor, which extends into or through the IS-4 connector block 34, is connected to second electrode 42. The second electrode is jumpered to the sixth electrode 50. The third conductor extends into or through the IS-4 connector block 34 and connects with the third electrode 44. The third electrode 44 is jumpered to the seventh electrode 52. The fourth conductor extends through the IS-4 connector block 34 and connects with the fourth electrode 46. The fourth electrode 46 is jumpered to the eighth electrode 54. Although the electrodes are diagonally located around the distal end of the lead, as shown in FIGS. 13-14, a linear connection along the longitudinal axis exists between each electrode for each electrode pair. The embodiment shown in FIGS. 13-14 is able to achieve a minimum of 16 pacing vectors.
The present disclosure, directed to pairs of diagonally directional electrodes, located on a single lead and directly connected to a IS-4 connector module, can selectively deliver electrical stimulation and/or sense physiological signals from the patient. By doing so, the spatially separated electrode pair configuration shown in FIGS. 4-9 achieves improved electrical stimulation fields compared to conventionally placed electrodes. For example, the diagonally paired electrodes generate an electrical stimulation field 130 (FIG. 11) that is generally rounded, and elliptical in nature which is substantially different in shape compared to the electrical stimulation field generated by a conventional electrode configuration. The electrical stimulation field may be smaller in shape as shown in FIG. 11 than conventional electrical stimulation fields but sufficiently large to capture cardiac tissue while avoiding unnecessarily stimulating other cardiac tissue.
Many alternatives leads can employ the teaching disclosed herein. For example, alternative medical electrical leads can include active or passive fixation mechanisms (e.g. helix, tines, adhesive etc.). Additionally, while the lead is described as advancing through the coronary sinus, it should be understood that other locations in the heart's venous system may also be accessed using this lead. Electrode placement may alternatively be optimized for atrial stimulation and/or sensing. Alternatively, the lead may be useful in other vascular or non-vascular location within the body wherein the distance between a suitable fixation location and a desired electrode location may be variable. Additionally, while the invention has been described with respect to lead 20, the invention can be applied to other cardiac leads or neurological leads.
Finally, the primary electrodes are described as the first, second, fifth, and sixth electrodes 40, 42, 48, 50, any one/or combination of electrodes can be designated as primary electrodes. As previously stated, primary electrode is an electrode directly connected to the conductor extending from the connector block 34. The following paragraphs enumerated consecutively from 1 through 21 provide for various aspects of the present disclosure. In one embodiment in a first paragraph (1) the present disclosure provides:
A medical electrical lead, comprising:
an elongated lead body comprising a length between a proximal end and a distal end with a longitudinal axis extending between the proximal end and the distal end,
a plurality of electrodes, located along the distal end of the lead body, forming a first pair and a second pair of electrodes;
the first pair of electrodes comprising one electrode electrically connected to another electrode that is circumferentially and diagonally spaced apart from the one electrode along the longitudinal axis; and
the second pair of electrodes comprising one electrode electrically connected to another electrode that is circumferentially and diagonally spaced apart from the one electrode along the longitudinal axis.
2. A medical electrical lead of paragraph 1, wherein one electrode of the first and second pairs of electrodes being configured to connect to first, and second conductors extending through a connector module.
3. A medical electrical lead of paragraph 1, wherein one electrode is connected to another electrode through an electrical connection disposed diagonally between each electrode for the first and second pairs of electrodes.
4. A medical electrical lead of any of paragraphs 1-3, wherein one electrode of the first and second pairs of electrodes being configured to connect to first, and second conductors extending through a connector module.
5. A medical electrical lead of any of paragraphs 1-4, wherein the plurality of electrodes further comprising a third pair of electrodes comprising one electrode electrically connected to another electrode that is circumferentially and diagonally spaced apart from the one electrode along the longitudinal axis.
6. A medical electrical lead of paragraph 5, wherein the plurality of electrodes further comprising a fourth pair of electrodes comprising one electrode electrically connected to another electrode that is circumferentially and diagonally spaced apart from the one electrode along the longitudinal axis.
7. A medical electrical lead of any of paragraphs 1-6, wherein a minimum of 16 pacing vectors are formed by diagonally connected electrodes from the first through fourth pairs of electrodes.
8. A medical electrical lead of paragraph 1, wherein the one electrode and another electrode of the first pair are jumpered together.
9. A medical electrical lead of any of paragraphs 1-8, wherein the first pair electrodes comprises one electrode circumferentially separated by about 90 degrees to the another electrode.
10. A medical electrical lead of any of paragraphs 1-9, wherein the second pair electrodes comprises one electrode angularly displaced by about 90 degrees to the another electrode.
11. A medical electrical lead of paragraph 5, wherein the one electrode of the third pair electrodes is circumferentially separated by about 90 degrees to the another electrode of the third pair of electrodes.
12. A medical electrical lead of paragraph 1, wherein the one electrode of one pair electrodes is diametrically opposed to another electrode of another pair of electrodes, the diametrically opposed electrodes are not electrically connected.
13. A medical electrical lead of paragraph 5, wherein one electrode of the a first, second, third and fourth pairs of electrodes being configured to connect to a first, second, third and fourth conductors respectively extending through a connector module.
14. A medical electrical lead of paragraph 1 configured to provide a minimum of sixteen pacing vectors solely using the plurality of electrodes on the distal end of the lead.
15. An intravenous medical electrical lead, comprising:
a plurality of electrodes, located along the distal end of the lead body, forming a first, second, third and fourth pairs of electrodes;
the first pair of electrodes comprising one electrode electrically connected to another electrode circumferentially and diagonally spaced apart along the longitudinal axis;
the second pair of electrodes comprising one electrode electrically connected to another electrode circumferentially and diagonally spaced apart along the longitudinal axis;
the third pair of electrodes comprising one electrode electrically connected to another electrode circumferentially and diagonally spaced apart along the longitudinal axis; and
the fourth pair of electrodes comprising one electrode electrically connected to another electrode circumferentially and diagonally spaced apart along the longitudinal axis.
16. A medical electrical lead of paragraph 15, wherein the first, second, third and fourth pairs of electrodes provide a minimum of sixteen different pacing vectors.
17. A medical electrical lead of paragraph 15, wherein the plurality of electrodes a minimum of 12 different pacing vectors.
18. A medical electrical lead of paragraph 16, wherein the first, second, fifth and sixth electrodes being configured to connect to a first, second, third and fourth conductors, respectively extending through a connector module, the connector module limited to connecting to four conductors.
a first pair of electrodes comprising the first electrode electrically connected to the third electrode circumferentially and diagonally spaced apart along the longitudinal axis;
a second pair of electrodes comprising the second electrode electrically connected to the fourth electrode circumferentially and diagonally spaced apart along the longitudinal axis;
a third pair of electrodes comprising the fifth electrode electrically connected to the seventh electrode circumferentially and diagonally spaced apart along the longitudinal axis; and
a fourth pair of electrodes comprising the sixth electrode electrically connected to the seventh electrode circumferentially and diagonally spaced apart along the longitudinal axis.
a first, second, third fourth, fifth, sixth, seventh and eighth electrodes, located along the distal end of the lead body;
20. A method of implanting A medical electrical lead in a patient's body, comprising:
advancing, within in the patient's body, a lead having an elongated lead body defining a longitudinal axis and carrying a set of electrodes circumferentially and diagonally spaced apart, the set of parsed into pairs of diagonally connected electrodes;
determining whether a first pair of electrodes is one of an anode and a cathode.
21. A method according to paragraph 20 wherein locating the electrode comprises moving the lead body longitudinally relative to the delivery catheter.
locating a lead in contact with a patient's tissue, the lead having an elongated lead body defining a longitudinal axis and carrying a set of electrodes circumferentially and diagonally spaced apart, the set of electrodes comprising pairs of the circumferentially and diagonally spaced apart electrodes, the electrodes of the circumferentially and diagonally apart spaced electrode pairs connected to one another electrically by conductors within the lead body extending from one electrode in each pair to the other electrode in each pair; and
delivering stimulation to the patient's tissue using a pair of the circumferentially and diagonally spaced apart and electrically connected electrodes as one of an anode and a cathode.
2. A method according to claim 1 wherein a delivery catheter is used to place the lead in cardiac tissue.
3. The method according to claim 1, wherein the set of electrodes is located solely on a distal end of the lead and forms a minimum of 16 pacing vectors.
4. The method according to claim 1, wherein the set of electrodes is located solely on a distal end of the lead and forms a minimum of 12 or more pacing vectors.
5. The method according to claim 1, wherein the set of electrodes is located solely on a distal end of the lead and forms a minimum of 8 or more pacing vectors.
6. The method according to claim 1, wherein the set of electrodes is located solely on a distal end of the lead and forms a minimum of 4 or more pacing vectors.
a lead having an elongated lead body defining a longitudinal axis and carrying a set of electrodes circumferentially and diagonally spaced apart, the set of electrodes comprising pairs of the circumferentially and diagonally spaced apart electrodes, the electrodes of the circumferentially and diagonally spaced apart electrode pairs connected to one another electrically by conductors within the lead body extending from one electrode in each pair to the other electrode in each pair, the circumferentially and diagonally spaced apart and electrically connected electrodes being one of an anode and a cathode.
8. The device according to claim 7, wherein the set of electrodes is located solely on a distal end of the lead and forms a minimum of 16 pacing vectors.
9. The device according to claim 7, wherein the set of electrodes is located solely on a distal end of the lead and forms a minimum of 12 or more pacing vectors.
10. The device according to claim 7, wherein the set of electrodes is located solely on a distal end of the and lead forms a minimum of 8 or more pacing vectors.
11. The device according to claim 7, wherein the set of electrodes is located solely on a distal end of the lead and forms a minimum of 4 or more pacing vectors.
US14/523,058 2014-10-24 2014-10-24 Medical electrical lead Active 2035-04-23 US10016591B2 (en)
US14/523,058 US10016591B2 (en) 2014-10-24 2014-10-24 Medical electrical lead
CN201580057488.4A CN107073271A (en) 2014-10-24 2015-10-23 Medical electrical lead
PCT/US2015/057118 WO2016065263A1 (en) 2014-10-24 2015-10-23 Medical electrical lead
PCT/US2015/057123 WO2016065266A1 (en) 2014-10-24 2015-10-23 Medical electrical lead
PCT/US2015/057253 WO2016069415A1 (en) 2014-10-24 2015-10-23 Coronary sinus medical electrical lead
EP15787863.8A EP3209368A1 (en) 2014-10-24 2015-10-23 Medical electrical lead
CN201580057397.0A CN107073255A (en) 2014-10-24 2015-10-23 Coronary sinus medical electrical lead
PCT/US2015/057251 WO2016065345A1 (en) 2014-10-24 2015-10-23 Coronary sinus medical electrical lead
EP15851769.8A EP3209367A4 (en) 2014-10-24 2015-10-23 Coronary sinus medical electrical lead
US20160114151A1 US20160114151A1 (en) 2016-04-28
US10016591B2 true US10016591B2 (en) 2018-07-10
ID=55791142
US14/523,058 Active 2035-04-23 US10016591B2 (en) 2014-10-24 2014-10-24 Medical electrical lead
US (1) US10016591B2 (en)
US20130131748A1 (en) 2011-11-21 2013-05-23 Medtronic, Inc. Method for efficient delivery of dual site pacing
2014-10-24 US US14/523,058 patent/US10016591B2/en active Active
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(PCT/US2015/057123) PCT Notification of Transmittal of the International Search Report and the Written Opinion of the International Searching Authority, dated Jan. 28, 2016, 12 pages.
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US20160114151A1 (en) 2016-04-28
Free format text: ASSIGNMENT OF ASSIGNORS INTEREST;ASSIGNORS:SOMMER, JOHN L;CLEMENS, WILLIAM J;FRANKE, LINDA L;REEL/FRAME:034697/0828