WO2006115877A1 - Vagal nerve stimulation using vascular implanted devices for treatment of atrial fibrillation - Google Patents

Vagal nerve stimulation using vascular implanted devices for treatment of atrial fibrillation Download PDF

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Publication number
WO2006115877A1
WO2006115877A1 PCT/US2006/014387 US2006014387W WO2006115877A1 WO 2006115877 A1 WO2006115877 A1 WO 2006115877A1 US 2006014387 W US2006014387 W US 2006014387W WO 2006115877 A1 WO2006115877 A1 WO 2006115877A1
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WIPO (PCT)
Prior art keywords
radio frequency
stimulator
frequency signal
electrodes
electrical voltage
Prior art date
Application number
PCT/US2006/014387
Other languages
French (fr)
Inventor
Stephen Denker
Cherik Bulkes
Arthur J. Beutler
Original Assignee
Kenergy, Inc.
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Kenergy, Inc. filed Critical Kenergy, Inc.
Priority to CA002606237A priority Critical patent/CA2606237A1/en
Priority to EP06758371A priority patent/EP1871472A1/en
Publication of WO2006115877A1 publication Critical patent/WO2006115877A1/en

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Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61NELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00Electrotherapy; Circuits therefor
    • A61N1/18Applying electric currents by contact electrodes
    • A61N1/32Applying electric currents by contact electrodes alternating or intermittent currents
    • A61N1/36Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
    • A61N1/3605Implantable neurostimulators for stimulating central or peripheral nerve system
    • A61N1/3606Implantable neurostimulators for stimulating central or peripheral nerve system adapted for a particular treatment
    • A61N1/36114Cardiac control, e.g. by vagal stimulation
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61NELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00Electrotherapy; Circuits therefor
    • A61N1/18Applying electric currents by contact electrodes
    • A61N1/32Applying electric currents by contact electrodes alternating or intermittent currents
    • A61N1/36Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
    • A61N1/372Arrangements in connection with the implantation of stimulators
    • A61N1/37211Means for communicating with stimulators
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61NELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00Electrotherapy; Circuits therefor
    • A61N1/18Applying electric currents by contact electrodes
    • A61N1/32Applying electric currents by contact electrodes alternating or intermittent currents
    • A61N1/36Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
    • A61N1/372Arrangements in connection with the implantation of stimulators
    • A61N1/378Electrical supply
    • A61N1/3787Electrical supply from an external energy source
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61NELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00Electrotherapy; Circuits therefor
    • A61N1/18Applying electric currents by contact electrodes
    • A61N1/32Applying electric currents by contact electrodes alternating or intermittent currents
    • A61N1/36Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
    • A61N1/372Arrangements in connection with the implantation of stimulators
    • A61N1/37205Microstimulators, e.g. implantable through a cannula
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61NELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00Electrotherapy; Circuits therefor
    • A61N1/18Applying electric currents by contact electrodes
    • A61N1/32Applying electric currents by contact electrodes alternating or intermittent currents
    • A61N1/38Applying electric currents by contact electrodes alternating or intermittent currents for producing shock effects
    • A61N1/39Heart defibrillators
    • A61N1/395Heart defibrillators for treating atrial fibrillation

Definitions

  • the present invention relates to implantable medical devices which deliver
  • Such devices are commonly referred to as cardiac pacing devices and defibrillators.
  • a cardiac pacing device is a small electronic apparatus
  • Electrical leads extend from the pulse generator to electrodes placed adjacent to specific
  • pulse generator modifies that rate by tracking the activity at the sinus node of the heart
  • the exterior heart surface with wires extending through tissue to the pacing device.
  • a defibrillator A defibrillator
  • the implanted defibrillator senses
  • the defibrillator generates a much more intense electrical
  • a common heart condition is atrial fibrillation in which the upper chambers,
  • vagal nerve stimulation can be employed to slow the rapid ventricular rate induced by
  • An apparatus for stimulating a vagal nerve in an animal includes a power
  • a stimulator for implantation in a blood
  • vessel adjacent the vagal nerve in the animal has a pair of electrodes and an electrical
  • the electrical circuit receives the radio frequency signal and from the
  • the derived voltage is stored by a capacitor and
  • a switch is periodically operated to apply the stored voltage across the pair of electrodes.
  • vagal nerve stimulation apparatus can be combined into conventional vagal nerve stimulation apparatus
  • FIGURE 1 is a representation of a cardiac pacing device implanted in a
  • FIGURE 2 is a block diagram of an electrical circuit for the pacing device
  • FIGURE 3 is an isometric cut-away view of a cardiac blood vessel with a
  • intravascular electrode implanted therein;
  • FIGURE 4 is a block diagram of an electrical circuit on the intravascular
  • FIGURE 5 illustrates a defibrillator that employs intravascular electrodes
  • FIGURE 6 is a block diagram of a control circuit for the circuit defibrillator
  • FIGURE 7 is a block diagram of a pulsing circuit on a intravascular
  • FrGURE " 8" is shows " an intravascular vagal nerve stimulation apparatus Tor
  • FIGURE 9 is an isometric cut-away view of a blood vessel in which a vagal
  • nerve stimulator is implanted
  • FIGURE 10 is an isometric cut-away view of a blood vessel in which
  • vagal nerve stimulator is implanted.
  • FIGURE 11 is a block diagram of the electrical circuit in the vagal nerve
  • stimulation to pace a heart 10 comprises a pacing device 12 and one or more
  • intravascular electrodes located in blood vessels, such as arteries 14, which supply
  • the pacing device 12 As will be described in greater detail, the pacing device 12
  • intravascular electrodes thereby stimulating the heart muscle.
  • the pacing device 12 comprises a conventional pacing device 12
  • pacing signal generator 20 similar to that utilized in previous cardiac pacers that use
  • Both the pacing signal are applied to an input of a radio frequency (RF) transmitter 22. Both the pacing signal
  • ⁇ generator2O and the RF ' transmitter " 22 are powered by a battery (nofsKowriy.
  • the radio frequency transmitter 22 generates a correspondingly long pulse of the stimulation signal (also known as a pacing signal) from the generator 20, the radio frequency transmitter 22 generates a correspondingly long pulse of the stimulation signal (also known as a pacing signal) from the generator 20, the radio frequency transmitter 22 generates a correspondingly long pulse of the stimulation signal (also known as a pacing signal) from the generator 20, the radio frequency transmitter 22 generates a correspondingly long pulse of the stimulation signal (also known as a pacing signal) from the generator 20, the radio frequency transmitter 22 generates a correspondingly long pulse of the stimulation signal (also known as a pacing signal) from the generator 20, the radio frequency transmitter 22 generates a correspondingly long pulse of the stimulation signal (also known as a pacing signal) from the generator 20, the radio frequency transmitter 22 generates a correspondingly long pulse of the stimulation signal (also known as a pacing signal) from the generator 20, the radio frequency transmitter 22 generates a correspondingly long pulse of the stimulation signal (also known as
  • radio frequency signal 16 that is transmitted throughout the chest cavity via an antenna
  • the antenna 24 either is located relatively close to the heart or is of a
  • Figure 3 illustrates an intravascular stimulator 30 that is placed in a blood
  • the body 33 of the intravascular stimulator 30 has a design
  • vascular stents have a generally tubular design that
  • That assembly then is inserted through an incision in
  • the balloon is deflated, the catheter is removed from the patient, and the incision is closed.
  • the intravascular stimulator 30 remains in the blood vessel without
  • stimulator body may be utilized.
  • the intravascular stimulator 30 has a
  • the 32 includes an antenna 34, a radio frequency signal detector 36, and a stimulator, that is
  • the antenna 34 is
  • the detector 36 converts the energy of that
  • Electrodes 40 form an electric circuit path with the patient's heart tissue
  • radio frequency signal 16 a pulse of electrical current is produced in the vicinity of the
  • intravascular stimulator 30 thereby stimulating the heart muscle adjacent to that
  • the present invention extending through the vascular system and even the heart itself, the present invention
  • the present intravascular stimulators 30 and 31 can be
  • implanted in various veins or arteries of the heart muscle can be tuned to different parameters
  • the radio frequency transmitter 22 also is
  • the pacing signal generator 20 an electrical control signal from the pacing signal generator 20.
  • generator 20 now specifies the duration and the frequency of the RF signal 16 in order
  • the plurality of intravascular stimulators 30 can be any one of the plurality of intravascular stimulators 30 that can be any one of the plurality of intravascular stimulators 30.
  • the heart chambers to increase cardiac efficiency.
  • Intravascular electrodes also can be employed with a cardiac defibrillator
  • the defibrillator 50 has a control circuit 51 which detects
  • intravascular stimulator 52 located in a vein or artery 53 in one section of the heart.
  • the intravascular stimulator 52 includes an electronic circuit 54 and a first electrode 55.
  • the electronic circuitry 54 is connected to a secondary intravascular electrode 58
  • a conductor 56 in the form of a wire that extends through the vascular system.
  • secondary intravascular electrode 58 is located in another blood vessel 59 in a different
  • Additional intravascular secondary electrodes 60 and 62 can be placed into other veins
  • These secondary electrodes 60 and 62 have a structure
  • the intravascular stimulator 52 connected by wires to the intravascular stimulator 52.
  • the intravascular stimulator 52 is connected by wires to the intravascular stimulator 52.
  • intravascular electrodes 58, 60 and 62 may be significantly smaller that the
  • intravascular stimulator 52 as they do not contain electronic circuitry, such as a charge
  • the secondary intravascular electrodes can be any type of storage capacitor as will be described.
  • the secondary intravascular electrodes can be any type of storage capacitor as will be described.
  • the defibrillator control circuit 51 preferably is
  • the control circuit 51 has a fibrillation detector 70 which employs
  • defibrillation pulse should be applied to the patient's heart. When that is to occur, the
  • fibrillation detector 70 signals the radio frequency (RF) transmitter 72 to send a wireless
  • a battery 74 provides power for the control
  • the stimulator 52 includes an antenna 80 for receiving the radio frequency signal from the
  • An RF detector 82 is tuned to the designated radio frequency
  • a discharge circuit 86 dumps the charge to the electrode
  • intravascular electrodes 58, 60 and 62 are connected by wires to the intravascular
  • the second, third and fourth electrodes 57, 64 and 66 which shocks the patient's heart
  • the radio frequency signal from the control circuit 51 has a duration that is
  • control circuit 51 may periodically send a brief
  • radio frequency signal to the electronic circuitry 54 on the intravascular stimulator 52.
  • This signal does not cause the stimulator circuit to deliver a defibrillation pulse, but is
  • capacitor 85 will be nearly fully charged when a defibrillation pulse is required and shortens the time between receipt of the defibrillation signal and delivery of an
  • the ElF transmitter 72 sends a specially designed pulse to the heart.
  • the fibrillation detector 70 that determines when to
  • stimulate the patient can be incorporated into the electronic circuit 54 on the
  • control circuit 51 outside the body merely
  • That electrical power is used to energize the circuitry on the
  • intravascular stimulator 52 and charge the capacitor for electrical stimulation.
  • An implanted intravascular stimulator according to the present design can be any implanted intravascular stimulator according to the present design.
  • vagal nerve that results from atrial fibrillation.
  • the heart has several places where a vagal nerve
  • the superior vena is close to a blood vessel, such as adjacent the inferior vena cava, the superior vena
  • an apparatus 100 for treating is illustrated in Figure 8.
  • Atrial fibrillation has an intravascular stimulator 102 implanted at the inferior vena
  • RF radio frequency
  • RF signal 103 supplies power to the intravascular stimulator 102.
  • the body 106 of the intravascular stimulator 102 is expanded to become
  • the body 106 holds an electrical circuit
  • first and second stimulation electrodes 109 and 110 which is connected to first and second stimulation electrodes 109 and 110 that
  • FIG. 1 Another embodiment of the intravascular stimulator 102, shown in Figure
  • a second stimulation electrode 130 is formed at a sharp tip of a lead
  • the lead 132 may extend through
  • the device located in which case the device produces transvascular stimulation
  • the electrical circuit 108 is connected to a receive
  • antenna 112 in the form of a wire coil wound circumferentially around the stimulator
  • An RF signal detector 114 has an input connected to the receive antenna 112
  • the RF signal detector 114 converts the energy of that RF signal into an electric
  • Periodic pulses of the RF signal charge the storage capacitor 116 so that it will have sufficient stored energy when stimulation
  • the first stimulation electrode 109 is connected to one terminal of the
  • the second stimulation electrode 110 is coupled by an
  • switch 118 is controlled by a pulse circuit 120.
  • the RF signal detector 114 responds by activating
  • the pulse circuit 120 Upon being activated the pulse circuit 42 periodically closes and
  • the power transmitter 105 may continuously transmit the RF signal 103
  • the power transmitter 105 can have circuitry similar to that
  • the pacing device 12 which detects abnormally rapid cardiac rates and responds
  • the stimulator also may have additional circuitry that performs conventional cardiac
  • a remote electrode is located in another blood vessel of the heart
  • an electrical conductor such as electrode 57 and
  • the pulse circuit 120 may also incorporate sensors so that the pattern of the stimulating pulses can be varied in response to characteristics of the
  • vagal nerve, intravascular stimulator 102 may be any suitable vagal nerve, intravascular stimulator 102 .
  • the power transmitter 105 is
  • intravascular stimulator 102 derives electrical power. That electrical power is used to

Abstract

An abnormally rapid ventricular cardiac rate that results from atrial fibrillation can be reduced by stimulating a vagal nerve of the heart. An apparatus for such stimulation includes a power transmitter that emits a radio frequency signal. A stimulator, implanted in a blood vessel adjacent the vagal nerve, has a pair of electrodes and an electrical circuit thereon. The electrical circuit receives the radio frequency signal and derives an electrical voltage from the energy of that signal. The electrical voltage is applied in the form of pulses to the pair of electrodes, thereby stimulating the vagal nerve. The pattern of that stimulating pulses can be varied in response to characteristics of the atrial fibrillation or the ventricular contractions.

Description

VAGAL NERVE STIMULATION USING VASCULAR IMPLANTED DEVICES FOR TREATMENT OF ATRIAL FIBRILLATION
Cross-reference to Related Applications
This application is a continuation in part of U.S. Patent Application No.
10/197,191 filed on My 17, 2002, which is a continuation of U.S. Patent No. 6,445,953
that was filed on January 16, 2001
Statement Regarding Federally Sponsored Research or Development
Not Applicable
Background of the Invention
1. Field of the Invention
[0001] The present invention relates to implantable medical devices which deliver
energy to cardiac tissue for the purpose of maintaining or producing a regular heart rate.
Such devices are commonly referred to as cardiac pacing devices and defibrillators.
2. Description of the Related Art
[0002] A remedy for people with slowed or disrupted natural heart beating is to
implant a cardiac pacing device. A cardiac pacing device is a small electronic apparatus
that stimulates the heart to beat at regular rates. It includes a pulse generator, implanted
in the patient's chest, which produces electrical pulses to stimulate heart contractions.
Electrical leads extend from the pulse generator to electrodes placed adjacent to specific
muscles of the heart, which when electrically stimulated produce contraction of the
adjacent heart chambers. [0003] Modern cardiac pacing devices adapt their pulse rate to adjust the heartbeats
to the patient's level of activity, thereby mimicking the heart's natural beating. The
pulse generator modifies that rate by tracking the activity at the sinus node of the heart
or by responding to other sensors that monitor body motion and rate of breathing.
[0004] Different pacing needs are met by adjusting the programming of the pulse
generator and by the location of the electrodes. It is quite common that the leads
extend through blood vessels which enter the heart so that the electrodes can be placed
in the muscle of the heart chamber requiring stimulation. This requires that the leads
extend for some distance through the blood vessels and may necessitate that the leads
pass through one or two heart valves. In other patients, patch electrodes are placed on
the exterior heart surface with wires extending through tissue to the pacing device.
With either type of lead placement, it is important that the electrodes be attached to the
proper positions on the heart to stimulate the muscles and produce contractions. Thus
it is desirable to properly locate the electrodes for maximum heart stimulation with
minimal adverse impact to other physiological functions, such as blood circulation.
[0005] Other patients have hearts that occasionally go into fibrillation where the
heart has very rapid shallow contractions and, in the case of ventricular fibrillation, may
not pump a sufficient amount of blood to sustain life. Administration of a controlled
electrical shock to the heart often is required to restore a normal rhythm. A defibrillator
often is implanted in the chest cavity of a person who is susceptible to recurring episodes
of ventricular fibrillation. Similar to a pacing device, the implanted defibrillator senses
Figure imgf000004_0001
pulse through wires connected to electrodes attached to the exterior wall of the heart or to leads in the heart chamber. The defibrillator generates a much more intense electrical
pulse than is used by pacing devices which merely stimulate contractions of the heart.
[0006] A common heart condition is atrial fibrillation in which the upper chambers,
the atria, of the heart quiver instead of beating effectively. Rapid atrial beating produces
a corresponding rapid beating of the ventricles. Electrical cardioversion and drugs have
been used to restore the heart's normal rhythm. Chronic atrial fibrillation, in which a
normal rhythm could not be restored, is commonly treated with medication, such as beta
blockers, to slow the rapid heart rate.
[0007] Scientific research on dogs discovered that transvenous parasympathic, or
vagal nerve stimulation can be employed to slow the rapid ventricular rate induced by
atrial fibrillation. In this treatment, an electrode at the tip of a catheter is fed through the
blood vessels to a parasympathic nerve stimulation site in the inferior vena cava of the
heart. During atrial fibrillation, electrical pulses were applied from an external source
through a conductor in the catheter to the electrode, thereby stimulating the site in the
inferior vena cava. Specific patterns of stimulation pulses slowed the ventricular rate.
Summary of the Invention
[0008] An apparatus for stimulating a vagal nerve in an animal includes a power
transmitter that emits a radio frequency signal. A stimulator, for implantation in a blood
vessel adjacent the vagal nerve in the animal, has a pair of electrodes and an electrical
circuit thereon. The electrical circuit receives the radio frequency signal and from the
Figure imgf000005_0001
form of pulses to the pair of electrodes, thereby stimulating the vagal nerve. [0009] In the preferred embodiment, the derived voltage is stored by a capacitor and
a switch is periodically operated to apply the stored voltage across the pair of electrodes.
[0010] The vagal nerve stimulation apparatus can be combined into conventional
implanted cardiac pacing or defibrillator devices.
Brief Description of the Drawings
[0011] FIGURE 1 is a representation of a cardiac pacing device implanted in a
medical patient;
[0012] FIGURE 2 is a block diagram of an electrical circuit for the pacing device
in Figure 1;
[0013] FIGURE 3 is an isometric cut-away view of a cardiac blood vessel with a
intravascular electrode implanted therein;
[0014] FIGURE 4 is a block diagram of an electrical circuit on the intravascular
electrode;
[0015] FIGURE 5 illustrates a defibrillator that employs intravascular electrodes;
[0016] FIGURE 6 is a block diagram of a control circuit for the circuit defibrillator
in Figure 5;
[0017] FIGURE 7 is a block diagram of a pulsing circuit on a intravascular
stimulator of the defibrillator;
^[0018] "FrGURE"8"is shows" an intravascular vagal nerve stimulation apparatus Tor
a medical patient; [0019] FIGURE 9 is an isometric cut-away view of a blood vessel in which a vagal
nerve stimulator is implanted;
[0020] FIGURE 10 is an isometric cut-away view of a blood vessel in which
another version of the vagal nerve stimulator is implanted; and
[0021] FIGURE 11 is a block diagram of the electrical circuit in the vagal nerve
stimulator.
Detailed Description of the Invention
[0022] With initial reference to Figure 1, an apparatus for applying electrical
stimulation to pace a heart 10 comprises a pacing device 12 and one or more
intravascular electrodes located in blood vessels, such as arteries 14, which supply
blood to the heart muscles. As will be described in greater detail, the pacing device 12
emits a radio frequency signal 16 which produces an electric current in the implanted
intravascular electrodes thereby stimulating the heart muscle.
[0023] Referring to Figure 2, the pacing device 12 comprises a conventional
pacing signal generator 20 similar to that utilized in previous cardiac pacers that use
electrodes connected to leads. The internal circuitry and operation of the pacing signal
generator is similar to those prior cardiac pacers which detects irregular cardiac rates or
rhythms and applies corrective electrical pulses to the heart. However, instead of the
output stimulation signals being applied to the electrodes via leads, the pacing signals
are applied to an input of a radio frequency (RF) transmitter 22. Both the pacing signal
generator2O and the RF' transmitter "22 are powered by a battery (nofsKowriy. In
response to the stimulation signal (also known as a pacing signal) from the generator 20, the radio frequency transmitter 22 generates a correspondingly long pulse of the
radio frequency signal 16 that is transmitted throughout the chest cavity via an antenna
24. Preferably the antenna 24 either is located relatively close to the heart or is of a
type which focuses the radio frequency signal toward the heart.
[0024] Figure 3 illustrates an intravascular stimulator 30 that is placed in a blood
vessel 14 of the heart 10. The body 33 of the intravascular stimulator 30 has a design
similar to well-known expandable vascular stents that are employed to enlarge a
restricted vein or artery. Such vascular stents have a generally tubular design that
initially is collapsed to a relatively small diameter enabling them to pass freely through
a blood vessel of a patient.
[0025] The procedure for implanting the intravascular stimulator 30 is similar to
that used for conventional vascular stents. For example, the balloon at the end of a
standard catheter is inserted into the intravascular stimulator 30 in a collapsed, or
reduced diameter, configuration. That assembly then is inserted through an incision in
a vein or artery near the skin of a patient and pushed through the vascular system to the
appropriate location adjacent the heart 10. Specifically, the intravascular stimulator 30
ultimately is positioned in a cardiac blood vessel 14 adjacent to a section of the heart
muscle where stimulation should be applied. The balloon of the catheter then is
inflated to expand the intravascular stimulator 30, thereby slightly enlarging the blood
vessel 14 which embeds the intravascular stimulator 30 in the wall of the vein or artery,
as seen in Figure 3. This slight enlargement of the blood vessel and the tubular design
^of^^ntravascular^stimulatofcallows^blood to-flow-relatively-unimpeded througrrthe^-^
device. The balloon is deflated, the catheter is removed from the patient, and the incision is closed. The intravascular stimulator 30 remains in the blood vessel without
any wire connecting an electrode to pacing device 12. Alternatively a self expanding
stimulator body may be utilized.
[0026] With reference to Figures 3 and 4, the intravascular stimulator 30 has a
body 33 on which is mounted a signal receiving circuit 32. The signal receiving circuit
32 includes an antenna 34, a radio frequency signal detector 36, and a stimulator, that is
formed by first and second electrodes 38 and 40, for example. The antenna 34 is
connected to an input of the radio frequency signal detector 36. That detector is tuned
to the frequency of the RF signal 16 that is emitted by the pacing device 12. Upon
detecting the radio frequency signal 16, the detector 36 converts the energy of that
signal into an electric current that is applied to the first and second electrodes 38 and
40. Those electrodes form an electric circuit path with the patient's heart tissue
allowing for stimulation of that tissue. Thus, each time the pacing device 12 emits a
radio frequency signal 16, a pulse of electrical current is produced in the vicinity of the
intravascular stimulator 30, thereby stimulating the heart muscle adjacent to that
electrode.
[0027] Therefore, instead of coupling the pacing device to the electrodes by wires
extending through the vascular system and even the heart itself, the present invention
employs radio frequency signals to provide that coupling. This eliminates the need for
electrical leads that extend through the blood vessels which can break thus disabling the
cardiac pacing. Furthermore, the present intravascular stimulators 30 and 31 can be
Figure imgf000009_0001
specific muscles requiring stimulation. [0028] With reference to Figure 1 , a plurality of intravascular stimulators 30 and
31 which are tuned to the same radio frequency can be positioned in cardiac blood
vessels at different locations in the heart to provide simultaneous stimulation of the
adjacent tissue regions.
[0029] Alternatively, the plurality of intravascular stimulators 30 and 31 ,
implanted in various veins or arteries of the heart muscle, can be tuned to different
radio frequencies. In this embodiment, the radio frequency transmitter 22 also is
tunable to produce output signals at several different radio frequencies, in response to
an electrical control signal from the pacing signal generator 20. The pacing signal
generator 20 now specifies the duration and the frequency of the RF signal 16 in order
to select an intravascular stimulator to stimulate the heart muscle at a particular
location. As a consequence, different portions of the heart muscle can be stimulated
independently and sequentially by varying the radio frequency of the emitted RF signal
16 to correspond to the frequency to which the intravascular stimulator 30 in a given
location is tuned. Furthermore, the plurality of intravascular stimulators 30 can be
activated in a given sequence by producing a series of pacer signals at different radio
frequencies. This enables the pacing device 12 to produce a sequential contraction of
the heart chambers to increase cardiac efficiency.
[0030] Intravascular electrodes also can be employed with a cardiac defibrillator
50 as illustrated in Figure 5. The defibrillator 50 has a control circuit 51 which detects
fibrillation of the heart via sensor 49 and sends a radio frequency control signal to a
intravascular stimulator 52 located in a vein or artery 53 in one section of the heart.
The intravascular stimulator 52 includes an electronic circuit 54 and a first electrode 55. The electronic circuitry 54 is connected to a secondary intravascular electrode 58
by a conductor 56 in the form of a wire that extends through the vascular system. The
secondary intravascular electrode 58 is located in another blood vessel 59 in a different
section of the heart and has a second electrode 57 to which the conductor 56 is attached.
Additional intravascular secondary electrodes 60 and 62 can be placed into other veins
or arteries 59 of the heart. These secondary electrodes 60 and 62 have a structure
identical to secondary intravascular electrode 58 with third and fourth electrodes 64 and
66 connected by wires to the intravascular stimulator 52. The intravascular stimulator
52 and the secondary electrodes 58, 60 and 62 are implanted using a procedure similar
to that described previously for intravascular stimulator 30. The secondary
intravascular electrodes 58, 60 and 62 may be significantly smaller that the
intravascular stimulator 52 as they do not contain electronic circuitry, such as a charge
storage capacitor as will be described. Thus the secondary intravascular electrodes can
be placed in smaller blood vessels.
[0031] With reference to Figure 6, the defibrillator control circuit 51 preferably is
implanted in the chest of the patient, but may be worn externally in close proximity to
the heart. The control circuit 51 has a fibrillation detector 70 which employs
conventional techniques to detect an irregular heart rate and determine when a
defibrillation pulse should be applied to the patient's heart. When that is to occur, the
fibrillation detector 70 signals the radio frequency (RF) transmitter 72 to send a wireless
signal via antenna 76 to the intravascular stimulator 52. The resultant radio frequency
signal has greater energy than the signal from the pacing device 12 in Figure 2 and thus
provides sufficient energy to enable the intravascular stimulator 52 to deliver a more intense defibrillation pulse to the patient. A battery 74 provides power for the control
circuit 51.
[0032] Referring to Figure 7, the electronic circuit 54 on the intravascular
stimulator 52 includes an antenna 80 for receiving the radio frequency signal from the
control circuit 51. An RF detector 82 is tuned to the designated radio frequency and
applies energy from the received signal to a charging circuit 84, that uses the signal
energy to charge a capacitor 85. When the charge on the capacitor is sufficient to
produce a defibrillation pulse, a discharge circuit 86 dumps the charge to the electrode
55 on the intravascular stimulator 52. The electrodes 57, 64 and 66 of the secondary
intravascular electrodes 58, 60 and 62 are connected by wires to the intravascular
stimulator 52 thereby providing a return path to complete an electrical circuit for the
charge pulse. This action applies an electrical pulse across the first electrode 55 and
the second, third and fourth electrodes 57, 64 and 66 which shocks the patient's heart
to restore a normal cardiac rhythm. Employing a plurality of secondary intravascular
electrodes 58, 60 and 62 to form a circuit to the intravascular stimulator electrode 55
provides a greater dispersion of the energy and avoids a local discharge.
[0033] The radio frequency signal from the control circuit 51 has a duration that is
sufficient to charge the capacitor 85 to the level necessary to deliver the electrical
defibrillation pulse. Alternatively, the control circuit 51 may periodically send a brief
radio frequency signal to the electronic circuitry 54 on the intravascular stimulator 52.
This signal does not cause the stimulator circuit to deliver a defibrillation pulse, but is
Figure imgf000012_0001
capacitor 85 will be nearly fully charged when a defibrillation pulse is required and shortens the time between receipt of the defibrillation signal and delivery of an
electrical pulse to the heart. In this latter case the ElF transmitter 72 sends a specially
encoded control signal when the patient requires defibrillation. The RF detector 82
responds to that encoded control signal by triggering the discharge circuit 86 to deliver
the electrical defibrillation pulse.
[0034] In an alternative, the fibrillation detector 70, that determines when to
stimulate the patient, can be incorporated into the electronic circuit 54 on the
intravascular stimulator 52. In this case, the control circuit 51 outside the body merely
transmits a radio frequency signal from which the intravascular stimulator 52 derives
electrical power. That electrical power is used to energize the circuitry on the
intravascular stimulator 52 and charge the capacitor for electrical stimulation.
[0035] An implanted intravascular stimulator according to the present design, can
also be used to stimulate vagal nerves of the heart to slow rapid beating of the ventricles
that results from atrial fibrillation. The heart has several places where a vagal nerve
is close to a blood vessel, such as adjacent the inferior vena cava, the superior vena
cava or the coronary sinus. As illustrated in Figure 8, an apparatus 100 for treating
atrial fibrillation has an intravascular stimulator 102 implanted at the inferior vena
cava adjacent a fat pad containing a vagal nerve 104. The intravascular stimulator 102
receives a radio frequency (RF) signal 103 from a power transmitter 105 that is located
outside the patient's body and is powered by a rechargeable battery. The energy of that
RF signal 103 supplies power to the intravascular stimulator 102. [0036J With reference to Figure 9, the intravascular stimulator 102 that is implanted
in the inferior vena cava using the same technique described previously with respect to
the other embodiments of intravascular stimulators. When properly positioned adjacent
a vagal nerve, the body 106 of the intravascular stimulator 102 is expanded to become
embedded in the wall of the blood vessel 107. The body 106 holds an electrical circuit
108 which is connected to first and second stimulation electrodes 109 and 110 that
extend circumferentially around the intravascular stimulator 102 in contact with the
wall of the blood vessel 107.
[0037] Another embodiment of the intravascular stimulator 102, shown in Figure
10, has only the first stimulation electrode 109 extending circumferentially around
the body 106. A second stimulation electrode 130 is formed at a sharp tip of a lead
132 that perforates the wall of the blood vessel 107 and is embedded in the fat pad
134 containing a vagal nerve. With this version of the intravascular stimulator the
electrical pulse is applied directly to the fat pad 134. The lead 132 may extend through
the circulatory system to a different blood vessel than the one in which the body 106 is
located in which case the device produces transvascular stimulation
[0038] Referring to Figure 11, the electrical circuit 108 is connected to a receive
antenna 112 in the form of a wire coil wound circumferentially around the stimulator
body 106. An RF signal detector 114 has an input connected to the receive antenna 112
and tuned to the frequency of the RF signal 103 that is emitted by the power transmitter
105. The RF signal detector 114 converts the energy of that RF signal into an electric
Figure imgf000014_0001
components of the intravascular stimulator 102. Periodic pulses of the RF signal charge the storage capacitor 116 so that it will have sufficient stored energy when stimulation
of the heart is required.
[0039] The first stimulation electrode 109 is connected to one terminal of the
storage capacitor 116. The second stimulation electrode 110 is coupled by an
electrically operated switch 118 to the other terminal of the storage capacitor 116. The
switch 118 is controlled by a pulse circuit 120.
[0040] When the intravascular stimulator 102 receives the radio frequency signal
103 from the power transmitter 105, the RF signal detector 114 responds by activating
the pulse circuit 120. Upon being activated the pulse circuit 42 periodically closes and
opens the switch 118 to apply voltage pulses from the storage capacitor 116 across the
first and second stimulation electrodes 109 and 110. That action completes a circuit
thereby dumping applying stimulation voltage pulses to the vagal nerve that is adjacent
those electrodes.
[0041] The power transmitter 105 may continuously transmit the RF signal 103
so that the stimulator always applies a voltage pulses to the vagal nerve to control the
heart rate. Alternatively the power transmitter 105 can have circuitry similar to that
of the pacing device 12 which detects abnormally rapid cardiac rates and responds
by transmitting the RF signal 103 to produce vagal nerve stimulation. Furthermore,
the stimulator also may have additional circuitry that performs conventional cardiac
pacing in which case a remote electrode is located in another blood vessel of the heart
and connected to the stimulator by an electrical conductor, such as electrode 57 and
conductor 56 in Figure 5. The pulse circuit 120 may also incorporate sensors so that the pattern of the stimulating pulses can be varied in response to characteristics of the
atrial fibrillation.
[0042] In an alternative, the vagal nerve, intravascular stimulator 102 may be
implemented with circuitry that detects when atrial fibrillation produces a significantly
rapid heart rate that stimulation is required. In this case, the power transmitter 105 is
located outside the body and merely transmits a radio frequency signal from which the
intravascular stimulator 102 derives electrical power. That electrical power is used to
energize the circuitry on the intravascular stimulator 102 and charge the capacitor 116
for electrical stimulation.
[0043] The foregoing description was primarily directed to a preferred
embodiments of the invention. Even though some attention was given to various
alternatives within the scope of the invention, it is anticipated that one skilled in the
art will likely realize additional alternatives that are now apparent from disclosure
of embodiments of the invention. Accordingly, the scope of the invention should
be determined from the following claims and not limited by the above disclosure.

Claims

CLAIMS We claim:
1. An apparatus for stimulating a vagal nerve in an animal, said apparatus
comprising:
a power transmitter that emits a radio frequency signal;
a stimulator for implantation in a blood vessel adjacent the vagal nerve in the
animal and having a pair of electrodes and an electrical circuit, wherein the electrical
circuit receives the radio frequency signal, derives an electrical voltage from energy of
the radio frequency signal and applies the electrical voltage as pulses to the pair of
electrodes thereby stimulating the vagal nerve.
2. The apparatus as recited in claim 1 wherein the stimulator comprises a
tubular body having at least one of the pair of electrodes extending circumferentially
there around.
3. The apparatus as recited in claim 2 wherein another one of the pair of
electrodes is embedded in tissue adjacent the vagal nerve and is connected to the
electrical circuit by a lead that extends through a wall of the blood vessel.
4. The apparatus as recited in claim 2 wherein the stimulator further comprises
an antenna on the tubular body for receiving the radio frequency signal and connected to
the electrical circuit.
5. The apparatus as recited in claim I wherein the electrical circuit comprises:
a storage capacitor; and
a radio frequency signal detector derives the electrical voltage from energy of the
radio frequency signal and applies that voltage to the storage capacitor.
6. The apparatus as recited in claim 5 wherein the electrical circuit further
comprises a pulse circuit that periodically causes application of voltage from the storage
capacitor to the pair of electrodes.
7. The apparatus as recited in claim 5 wherein the electrical circuit further
comprises:
a switch which selectively connects at least one of the pair of electrodes to the
storage capacitor; and
a pulse circuit that periodically activates the switch to apply voltage from the
storage capacitor across the pair of electrodes.
8. A method for stimulating a vagal nerve in an animal comprising:
implanting a stimulator adjacent the vagal nerve;
transmitting a radio frequency signal from a power transmitter;
receiving the radio frequency signal at the stimulator;
deriving an electrical voltage from energy of the radio frequency signal received
by the stimulator; and
^piyjflg^i^e.c^tricaj^pjtage^as-pulses-to-a-pair-of-€lectrodes-thereby-
stimulating the vagal nerve.
9. The method as recited in claim 8 wherein the vagal nerve is adjacent a heart
of the animal and the applying the electrical voltage provides cardiac stimualtion.
10. The method as recited in claim 8 further comprising storing the electrical
voltage derived from energy of the radio frequency signal and then applying that stored
electrical voltage as pulses to a pair of electrodes.
11. The method as recited in claim 10 wherein storing the electrical voltage
comprises applying the electrical voltage to a storage capacitor at the stimulator.
12. The method as recited in claim 10 wherein applying the electrical voltage
comprises periodically activating a switch through which that stored electrical voltage
is applied to the pair of electrodes.
13. A method for treating atrial fibrillation in an animal comprising:
implanting a stimulator adjacent a vagal nerve of the animal;
transmitting a radio frequency signal from a power transmitter;
receiving the radio frequency signal at the stimulator;
deriving an electrical voltage from energy of the radio frequency signal received
by the stimulator; and
applying the electrical voltage as pulses to a pair of electrodes thereby
stimulating the vagal nerve.
14. The method as recited in claim 13 further comprising detecting a cardiac
event produced by atrial fibrillation; and wherein applying the electrical voltage is in
response to detecting the cardiac event.
15. The method as recited in claim 14 further comprising transmitting the
radio frequency signal in response to detecting the cardiac event.
16. The method as recited in claim 13 further comprising storing the electrical
voltage derived from energy of the radio frequency signal and then applying that stored
electrical voltage as pulses to a pair of electrodes.
17. The method as recited in claim 16 wherein storing the electrical voltage
comprises applying the electrical voltage to a storage capacitor at the stimulator.
PCT/US2006/014387 2005-04-22 2006-04-18 Vagal nerve stimulation using vascular implanted devices for treatment of atrial fibrillation WO2006115877A1 (en)

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US20060241732A1 (en) 2006-10-26

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