Methods and apparatus for detecting and localizing partial conductor failures of implantable device leads

Abstract

Method and apparatus for diagnosis of conductor anomalies, such as partial conductor failures, in an implantable lead for an implantable medical device are disclosed. In various embodiments, small changes in the lead impedance are identified by the use of a small circuit element that is incorporated as part of the distal end of the implantable lead. In various embodiments, the small circuit element is electrically connected to a lead conductor and/or electrode of the implantable lead. Methods of diagnosing conductor anomalies in accordance with these embodiments generate measured values that depend only on the impedance of the conductors and electrodes of the lead, and not on the behavior of the conductor-tissue interface and other body tissues.

Claims

1. An implantable medical system comprising: an implantable lead that includes a small circuit element positioned within a distal end of the lead and continuously electrically connected between a ring conductor of the lead and one of a tip conductor or a stimulation electrode; and an implantable electromedical device to which the implantable lead is adapted to be connected, the device including a control system programmed to cause: a therapeutic pulse to be selectively delivered to the stimulation electrode, and a DC pulse to be periodically delivered to the lead through the small circuit element to test for a partial conductor failure of the lead by automatically calculating a resistance for the DC pulse through the small circuit element and providing an indication of a partial conductor failure based upon the resistance for the DC pulse through the small circuit element; wherein the small circuit element remains electrically connected between the ring conductor of the lead and one of the tip conductor or the stimulation electrode when the therapeutic pulse is being delivered.

2. The system of claim 1 where the device causes the DC pulse to be delivered as a moderate frequency signal to the lead.

3. The system of claim 1 wherein the small circuit element is a passive circuit selected from the set consisting of a diode, a capacitor, a diode, and a LC tank circuit.

4. The system of claim 1 wherein the small circuit element is an active circuit including a diode and capacitor circuit controlled by a digital circuit, and wherein device causes a trigger signal to be delivered to the lead to activate the active circuit element for a short period of time during which the DC pulse is caused to be delivered.

5. The system of claim 1 wherein the small circuit element is positioned in the distalmost 10 cm of the lead.

6. The system of claim 1 wherein the small circuit element is a capacitor between the ring conductor and the tip conductor.

7. The system of claim 1 wherein the small circuit element is a capacitor is between the ring conductor and the stimulation electrode conductor.

8. The system of claim 1 wherein the small circuit element is a diode between the ring conductor and the tip conductor.

9. The system of claim 1 wherein the small circuit element is a diode between the ring conductor and the electrode conductor.

10. A medical system comprising: an implantable lead that is adapted to be implanted in a patient and includes a small circuit element positioned within a distal end of the lead and continuously electrically connected between a ring conductor of the lead and one of a tip conductor or a stimulation electrode; and an external test device to which the implantable lead is adapted to be connected, the test device including a control system programmed to cause: a therapeutic pulse to be selectively delivered to the stimulation electrode, and a DC pulse to be periodically delivered to the lead through the small circuit element to test for a partial conductor failure of the lead by automatically calculating a resistance for the DC pulse through the small circuit element and providing an indication of a partial conductor failure based upon the resistance for the DC pulse through the small circuit element; wherein the small circuit element remains electrically connected between the ring conductor of the lead and one of the tip conductor or the stimulation electrode when the therapeutic pulse is being delivered.

11. The system of claim 10 where the device causes the DC pulse to be delivered as a moderate frequency signal to the lead.

12. The system of claim 10 wherein the small circuit element is a passive circuit selected from the set consisting of a diode, a capacitor, a diode, and a LC tank circuit.

13. The system of claim 10 wherein the small circuit element is an active circuit including a diode and capacitor circuit controlled by a digital circuit, and wherein device causes a trigger signal to be delivered to the lead to activate the active circuit element for a short period of time during which the DC pulse is caused to be delivered.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

(1) The invention may be more completely understood in consideration of the following detailed description of various embodiments of the invention in connection with the accompanying drawings, in which:

(2) FIG. 1 shows a radiograph or x-ray of an implantable cardioverter defibrillator (ICD) implanted in a human body where the lead has a small area of stress from a tight suture.

(3) FIG. 2A is a cross-sectional view of the Medtronic Quattro Secure Lead, a multi-lumen ICD implantable cardiac lead.

(4) FIG. 2B is a cross-sectional view of the Medtronic Sprint Fidelis Lead, a multi-lumen ICD implantable cardiac lead.

(5) FIG. 3 is a cross-sectional view of the St. Jude Medical Riata Lead, a multi-lumen ICD implantable cardiac lead.

(6) FIG. 4 illustrates regions within the human body associated with the implantation of an ICD and associated leads.

(7) FIG. 5 shows an implantable medical device in which an embodiment of the present invention may be practiced. It shows an ICD pulse generator connected to a patient's heart via a transvenous cardiac lead used for pacing and defibrillation.

(8) FIG. 6 shows a partial schematic of a pacemaker or ICD lead with the diode embodiment of the invention.

(9) FIG. 7 shows a partial schematic of a pacemaker or ICD lead with the capacitor embodiment of the invention.

(10) FIG. 8 shows a partial schematic of a pacemaker or ICD lead with the diode embodiment of the invention along with typical MRI protection components.

(11) FIG. 9 shows a partial schematic of an ICD lead with the diode embodiment of the invention.

(12) FIG. 10 depicts a plot of the impedance spectra of a Ring cable.

(13) FIG. 11 shows a partial schematic of an ICD lead with the diode embodiment of the invention along with typical MRI protection components.

(14) FIG. 12 shows a partial schematic of an ICD lead with a solid state embodiment of the invention.

(15) While the invention is amenable to various modifications and alternative forms, specifics thereof have been shown by way of example in the drawings and will be described in detail. It should be understood, however, that the intention is not to limit the invention to the particular embodiments described. On the contrary, the intention is to cover all modifications, equivalents, and alternatives falling within the spirit and scope of the invention as defined by the appended claims.

DETAILED DESCRIPTION

(16) The embodiments herein are directed to the diagnosis of lead or conductor anomalies, such as insulation failures, in an implantable medical device, such as pacemakers, vagal nerve stimulators, pain stimulators, neurostimulators, and implantable cardioverter defibrillators (ICDs). However, for clarity, discussion of lead or conductor anomalies will be made in reference to ICDs. However, those with skill in the art are cognizant of the fact that the methods and apparatus as disclosed herein are suitable for use with any one of the various implantable medical devices.

(17) FIG. 1 depicts a radiograph or x-ray of an implantable cardioverter defibrillator (ICD) implanted in a human body where the lead has a small area of stress from a tight suture.

(18) FIGS. 2A, 2B and 3 depict known multi-lumen ICD defibrillation electrodes or leads that have been diagnosed with lead conductor anomalies. While these are indicative of the type of leads that can be diagnosed, anomalies in any type of defibrillation electrodes or leads are capable of being diagnosed with the methods and apparatus as disclosed herein. FIG. 2A depicts the Medtronic Quattro Secure Lead. FIG. 2B depicts the Medtronic Sprint Fidelis Lead. FIG. 3 depicts the St. Jude Medical Riata Lead. The leads 10, while having various constructions, have similar features. These similar features are identified with the same reference numbers in the figures.

(19) The implantable cardiac lead 10 is comprised of a lumen 12 and center inner pacing coil 14 surrounded by PTFE insulation 16, a plurality of lumens 18 each containing at least one conductor 20 with each conductor 20 surrounded by ETFE insulation 22, an outer insulating layer 24, and a silicone insulation 26 disposed between the lumen 12 and the outer insulating layer 24. The conductors 20 include a sense conductor 21, a high voltage RV conductor 23, and a high voltage SVC conductor 25. The lumens 18 are disposed in the silicone insulation 26. The conductors 20 carry electric current to the pace-sense electrodes 66, 68 high voltage RV coil 64 and high voltage SVC coil 62 (see FIG. 5).

(20) As shown in FIG. 4, lead failures most commonly occur at three regions along the course of a pacemaker or ICD lead 10. The first region 42 is proximate the pocket, caused either by abrasion of the lead 10 insulation 24 by pressure from the housing (CAN) of the pulse generator or twisting of the lead 10 within the pocket. The second region 44 is that between the clavicle and first rib, where the lead 10 is subject to clavicular crush. The third region 46 is the intracardiac region near the tricuspid valve. This third region 46 is a particularly common site of insulation 24 failure for the St. Jude Riata lead 10 which is subject to inside-out insulation failure due to motion of the internal conductors 20 relative to the outer insulation 24.

(21) FIG. 5 depicts on ICD 52 implanted in the chest of a patient. The ICD 52 has an outer housing 54, commonly referred to as a CAN, inner circuitry 56 and a battery 58. Connection is made to the heart 60 via the lead 10. The lead 10 can have an optional proximal defibrillation coil 62 which is near the superior vena cava (SVC) and is commonly referred to as the SVC coil 62. The lead 10 also has a distal defibrillation coil 64 which is commonly referred to as the right-ventricular coil or RV coil 64. Also shown is the optional ring pacing-sensing electrode 66. Located at the distal end of the lead 10 is the tip pacing-sensing electrode 68.

(22) FIG. 6 depicts an embodiment of a circuit 70 in accordance with one aspect of the invention using a diode 72 as a small circuit element near the end of the lead to aid in identifying small changes in the lead impedance. Shown is a partial schematic of a pacemaker or ICD lead 74. The tip 76 and ring 78 of the lead 74 are used for both sensing and pacing. The sensed electrogram (EGM) signals are of low voltage (typically <30 mV) and thus the diode 72 will not conduct sensing current so it will not interfere with the sensing signals. Pacing is done with a negative voltage on the tip 76 (so-called cathodal pacing) and the diode 72 will be back-biased during this pacing pulse. Hence, the diode 72 will not interfere with pacing functions. Resistor 73 (shown as 13) and resistor 75 (shown as 35) are not discrete resistors but rather represent the resistances of the ring and tip conductors respectively.

(23) To determine an accurate conductor resistance measurement, a short positive pulse (e.g. 5 V) is fed to the tip 76 with respect to the ring 78 while the current is being monitored. The diode 72 will conduct this pulse and the conductor resistance can be accurately determined by Ohm's law. In the embodiment shown, resistor 73 can be 13 and resistor 75 can be 35, but resistor 73, 75 are not so limited. The voltage used for the calculation will be the test voltage less the diode drop to allow for the voltage loss in the diode, e.g., 4.3 V=5 V0.7 V. For example, in the situation where one of the two cables in the ring connection is broken then the total resistance will be increased from 48 to 61. FIG. 7 depicts an embodiment of a circuit 80 in accordance with another aspect of the invention using a capacitor 82 as a small circuit element near the end of the lead to aid in identifying small changes in the lead impedance. Shown is a partial schematic of a pacemaker or ICD lead 84. Useful values for the capacitor 82 are 100 pF to 100 nF. The tip 86 and ring 88 of such a lead 84 are used for both sensing and pacing. The sensed electrogram (EGM) signals are of low frequency (typically <100 Hz) and the source impedance is about 1 K. The time constant for the resulting low-pass filter is thus ranging from 100 ns to 100 s and thus the capacitor 82 will not attenuate the sensing signals.

(24) The pacing pulse is typically about 500 s and the relevant resistance is that of the conductors which is about 48 total, where the value of the first resistor 83 is about 13 and the value of the second resistor 85 is about 35. However, the values of the resistors 83, 85 are not so limited. Thus, the low-pass time constant seen by the pacing pulse is <5 s and as such is immaterial to the pacing pulse.

(25) To determine an accurate conductor resistance measurement, a moderate frequency signal is fed to the tip 86 with respect to the ring 88 while the current is being monitored. With a 100 nF capacitor 82 a 160 KHz signal is used. The capacitor impedance is then:
Z.sub.c=1/(2fC)=10.
Thus, changes of connection resistance of, for example, 13, are easily detected. The approximate propagation speed V in an implantable cardiac lead, without anomalies, was determined using the following equation:
V=c/
where c is the speed of light in a vacuum (30 cm/ns) and is the relative permeability of the insulator compared to a vacuum. The relative permeability is about 3 for silicone and about 2.5 for ETFE. For silicone insulation this results in an approximate propagation velocity of 17.3 cm/ns. This is approximate because the ICD implantable cardiac lead is more complex than a classic coaxial cable having a central conductor.

(26) For an ICD implantable cardiac lead having a common length of 65 cm, the round-trip travel distance for wave propagation is 130 cm. The frequency is determined by:
f=V/
where is the wavelength of the test frequency. Thus, with a propagation velocity of 17.3 cm/ns, a frequency of about 66 MHz of corresponds to a wavelength over the implantable cardiac lead. At this frequency, transmission line effects dominate and a short (at the tip) appears to be an open circuit at the source. Hence, test frequencies must be much lower than this or transmission line corrections must be made. It is noted that for a 160 KHz test signal the wavelength is very long compared to the lead so this does not present an issue.

(27) Alternatively, a smaller 10 nF capacitor 82 could be used with a test frequency of 1.6 MHz without problems. A 1 nF capacitor 82 could also be used with 16 MHz without resorting to transmission line corrections. A 100 pF capacitor 82 would require a test frequency on the order of 100 MHz and this can still be used albeit with transmission line corrections.

(28) FIG. 8 depicts an embodiment of a circuit 90 in accordance with another aspect of the invention using the diode embodiment 70 in conjunction with typical MRI protection components as a small circuit element near the end of the lead 94 to aid in identifying small changes in the lead impedance. In another embodiment, the capacitor embodiment 80 can be used in conjunction with typical MRI protection components near the end of the lead 94. Shown is a partial schematic of a pacemaker or ICD lead 94. A well-known approach to limiting the conduction of the MRI RF signal is to insert an LC tank circuit 91 between the lead conductor and the electrode. Since this is distal to the impedance test componenta capacitor (as in FIG. 7) or diode 72it will not affect the conductor impedance measurement.

(29) FIG. 9 depicts an embodiment of an ICD lead 100 using the diode embodiment 70 to aid in identifying small changes in the lead impedance. Shown is a partial schematic of an ICD lead 100. Conductor impedance measurements are performed as described earlier. The main phase pulse (up to 900 V) of a defibrillation shock is preferable positive (on the RV coil 106 with respect to the body) and thus the diode 72 will not conduct. For the negative (2.sup.nd phase), the diode 72 will conduct and pass some current thru the diode 72 and the ring 78 electrode. This is expected to be acceptable as some popular ICD leads (so-called integrated bipolar type) dispense with the ring electrode altogether and thus deliver current to the ring anatomical positionnear the tipwithout causing significant performance problems.

(30) The embodiment of FIG. 9 has two advantages over the integrated bipolar lead. The first is that less than one-quarter of the energy is shared with the ring as the diode blocks the much stronger positive phase. The peak current (important for electroporation stunning) is also cut in half or more. Second, after the defibrillation shock is delivered, the ring is quickly available for normal true bipolar sensing.

(31) In another embodiment, a capacitor embodiment 80 could be used for the RV coil conductor impedance measurement. The capacitance ranges discussed earlier are acceptable and would not conduct sufficient energy or current to cause damage. While there would be a short high-current spike, its duration would be too short to cause electroporation stunning.

(32) In general, the input impedance Z.sub.in of a transmission line, with an excitation wavelength of, is given by:

(33) $Z_{in}=Z_0\frac{Z_L+{\mathrm{jZ}}_0\tan \left(l\right)}{Z_0+{\mathrm{jZ}}_L\tan \left(l\right)}$ where =2/Z.sub.L is the load impedance, and Z.sub.0 is the characteristic impedance of the transmission line.

(34) For the special case where a frequency with a multiple of a half-wavelength (of the lead) is used, the tangent terms become 0 and the equation reduces to:
Z.sub.in=Z.sub.L
so that the input impedance equals the load impedance.

(35) Modern ICD leads are complex and hence their impedance spectra are more complex than the ideal simple transmission line.

(36) The plot of the impedance spectra of a Ring cable is shown in FIG. 10. It will be seen that the real impedance climbs towards a peak near the wavelength frequency of about 67 MHz. The real impedance then decreases and fluctuates between 50 and 100. The imaginary part goes negative at about the same point and has a negative peak at about wavelength (about 133 MHz). It then fluctuates between 20 and 60.

(37) Thus, for a practical system, the impedance spectra would be determined for the ICD lead (in physiologic saline) both with and without a broken cable. In actual clinical use, the spectra best matching the findings would indicate whether a cable was broken or not.

(38) FIG. 11 depicts an embodiment of an ICD lead 110 using the diode embodiment 70 along with typical MRI protection components 91 to aid in identifying small changes in the lead impedance. Shown is a partial schematic of an ICD lead 110. This embodiment depicts the combination of the impedance-testing diode 72 for both the tip-ring conductor pair and the RV coil-ring conductor pair. Because of the diode 72 configuration, this approach has the disadvantage of conducting some of the negative (2.sup.nd) phase current thru the tip. However, the MRI LC tank 91 would be expected to limit this current to a low value.

(39) FIG. 12 depicts a solid state implementation 120 of an embodiment of the invention. The diode 121 and capacitor 123 scavenge a small amount of charge from the pacing pulses. If testing is required and there have been no pacing pulses, then a few are delivered to charge up the distal capacitor which then powers the digital circuit shown in the block diagram of FIG. 12.

(40) For lead testing, special sequence of pulses can be delivered to the pacing tip which would not have any pacing effect. For example, ten pulses each of 10 s in duration. This pulse sequence is recognized by the digital block 122 which then gives complementary drives to the two enhancement mode MOSFETs 124, 126 shown. In parallel they function as a resistor and provide a low impedance path between the tip 78 and the ring 76 for a short period of time to allow an accurate impedance measurement.

(41) In one embodiment, the short period of time is typically <1 second so as to not interfere with pacing and sensing. This time duration is determined by a small capacitor connected to the digital circuit (not shown) or alternatively by using an integrated capacitor within the digital circuit.

(42) It will be understood that other variations of a small circuit element in accordance with the various embodiments of the present invention may be used to accomplish a similar function. While the small circuit element may be a single passive circuit element, or a small combination of active circuit elements, these embodiments of the small circuit element feature a limited circuit functionality that may be easily incorporated into the distal end of a lead without the overhead, expense, size or power consumption of a larger control circuit or microcontroller. Alternatively, elements of different ones of the various embodiments of the small circuit element may be combined.

(43) The values noted above are example embodiments and should not be read as limiting the scope of this invention. Those skilled in the art will recognize that the above values may be adjusted to practice the invention as necessary depending on the electrode implantable cardiac lead technology used and the physical characteristics of the patient.

(44) While the present invention has been described with reference to certain embodiments, those skilled in the art should appreciate that they can readily use the disclosed conception and specific embodiments as a basis for designing or modifying other structures for carrying out the same purposes of the present invention without departing from the spirit and scope of the invention as defined by the appended claims.