Search Images Maps Play YouTube News Gmail Drive More »
Sign in
Screen reader users: click this link for accessible mode. Accessible mode has the same essential features but works better with your reader.

Patents

  1. Advanced Patent Search
Publication numberUS20090149900 A1
Publication typeApplication
Application numberUS 12/371,153
Publication date11 Jun 2009
Filing date13 Feb 2009
Priority date11 Apr 2005
Also published asEP1871460A1, EP2277583A2, EP2277583A3, EP2301623A2, EP2301623A3, US7499748, US8929990, US20060229677, US20110082537, US20150119790, WO2006110338A1
Publication number12371153, 371153, US 2009/0149900 A1, US 2009/149900 A1, US 20090149900 A1, US 20090149900A1, US 2009149900 A1, US 2009149900A1, US-A1-20090149900, US-A1-2009149900, US2009/0149900A1, US2009/149900A1, US20090149900 A1, US20090149900A1, US2009149900 A1, US2009149900A1
InventorsJulia Moffitt, Imad Libbus
Original AssigneeJulia Moffitt, Imad Libbus
Export CitationBiBTeX, EndNote, RefMan
External Links: USPTO, USPTO Assignment, Espacenet
Transvascular neural stimulation device
US 20090149900 A1
Abstract
This document discusses, among other things, apparatus, systems, and methods for transvascularly stimulation of a nerve or nerve trunk. In an example, an apparatus is configured to transvascularly stimulate a nerve trunk through a blood vessel. The apparatus includes an expandable electrode that is chronically implantable in a blood vessel proximate a nerve trunk. The expandable electrode is configured to abut a predetermined surface area of the vessel wall along a predetermined length of the vessel. An electrical lead is coupled to the expandable electrode. An implantable pulse generator is coupled to the lead and configured to deliver an electrical stimulation signal to the electrode through the lead. In an example method, an electrical signal is delivered from an implanted medical device to an electrode chronically implanted in a blood vessel proximate a nerve trunk to transvascularly deliver neural stimulation from the electrode to the nerve trunk.
Images(13)
Previous page
Next page
Claims(23)
1. An implantable apparatus for transvasculary stimulating a vagus nerve trunk in a cervical region from an internal jugular vein (IJV) to provide a heart failure therapy, the apparatus comprising:
an expandable electrode chronically implantable in the IJV, the expandable electrode configured to abut an intravascular surface of the IJV in the cervical region proximate the vagus nerve trunk;
an implantable pulse generator configured to use the electrode to transvascularly stimulate the vagus nerve trunk from the IJV;
a controller to operate on programmed instructions for delivering the heart failure therapy using the pulse generator and the electrode, wherein the heart failure therapy includes transvascularly stimulating the vagus nerve in the cervical region.
2. The apparatus of claim 1, wherein the expandable electrode is configured to abut a wall of the IJV along a predetermined length of the IJV, wherein the predetermined length is about 1 centimeter.
3. The apparatus of claim 1, wherein the expandable electrode has an expanded diameter between about 0.5 cm to 1.5 cm.
4. The apparatus of claim 1, wherein the expandable electrode is configured to abut a predetermined surface of a wall of the IJV, wherein the predetermined surface area is about 0.25 to 0.5 cm2.
5. The apparatus of claim 1, wherein the expandable electrode includes a mesh, at least part of the mesh being conductive.
6. The apparatus of claim 1, wherein the expandable electrode includes a drug-eluting component that is configured to be implanted inside the IJV, wherein the drug-eluting component is adapted to elute a drug to prevent occlusion.
7. The apparatus of claim 1, wherein the expandable electrode includes a drug-eluting component that is configured to be implanted inside the IJV, wherein the drug-eluting component is adapted to elute a drug to reduce inflammation.
8. The apparatus of claim 1, wherein the expandable electrode included platinum or platinum-iridium.
9. The apparatus of claim 1, further comprising a right ventricle lead and a left ventricle lead, wherein the apparatus is configured to capture myocardial tissue using the right ventricle lead and the left ventricle lead, and the apparatus is adapted to deliver cardiac resynchronization therapy using the left and right ventricle leads.
10. The apparatus of claim 1, further comprising at least one of a right ventricle lead or a left ventricle lead, wherein the apparatus is configured to pace the right or left ventricle using the right ventricle lead or the left ventricle lead.
11. The apparatus of claim 1, wherein the expandable electrode has a surface area to touch a wall of the IJV, and all of the surface area is conductive.
12. The apparatus of claim 1, wherein the expandable electrode has a surface area to touch a wall of the IJV, and some of the surface area is non-conductive.
13. The apparatus of claim 1, wherein the instructions are further operable on the controller to transvascularly stimulate the vagus nerve trunk to deliver antiarrhythmia therapy following myocardial infarction.
14. A system for transvasculary stimulating a vagus nerve trunk in a cervical region from an internal jugular vein (IJV) in a cervical region to provide a heart failure therapy, the system comprising:
an expandable electrode implantable in the IJV within the cervical region proximate the vagus nerve trunk;
a lead assembly coupled to the expandable electrode, the lead assembly including an electrical lead adapted to be intravascularly fed into the IJV; and
an implantable device coupled to the lead assembly, the implantable device including a controller circuit to communicate with a neural stimulator, wherein the implantable device is programmed with instructions used by the controller to implement the heart failure therapy, wherein the programmed heart failure therapy includes instructions used by the controller to control the neural stimulator to transvascularly stimulate the vagus nerve in the cervical region using the lead and the electrode.
15. The system of claim 14, wherein the instructions are further operable on the controller to transvascularly stimulate the vagus nerve trunk to deliver antiarrhythmia therapy following myocardial infarction.
16. The system of claim 14, wherein:
the expandable electrode is configured to abut a predetermined surface area of the internal jugular vein along about 1 centimeter of the IJV, the expandable electrode having an expanded diameter dimensioned and configured to fix the electrode in place in the blood vessel by frictional forces; and
the expandable electrode includes a mesh, at least part of the mesh being conductive.
17. The system of claim 14, wherein the expandable electrode includes a drug-eluting coating that prevents inflammation of stimulated tissue.
18. The system of claim 14, wherein the expandable electrode has a surface area to touch a wall of the IJV, and all of the surface area is conductive.
19. The system of claim 12, wherein the expandable electrode has a surface area to touch a wall of the IJV, and some of the surface area is non-conductive.
20. A method, comprising:
implanting an electrode in an internal jugular vein (UV) within a cervical region and proximate to a vagus nerve trunk, wherein the electrode is configured to be chronically implanted in the IJV;
implanting an implantable neural stimulator; and
implementing a programmed heart failure therapy using the electrode and the neural stimulator, wherein the heart failure therapy transvascularly stimulates the vagus nerve trunk in the cervical region from the IJV.
21. The method of claim 20, wherein implanting the electrode includes intravascularly feeding a lead with the electrode into the IJV.
22. The method of claim 20, wherein implanting the electrode includes intravascularly feeding the electrode into the IJV and expanding the electrode after the electrode is fed into a desired position in the IJV.
23. The method of claim 20, further comprising implementing a programmed antiarrhythmia therapy using the electrode and the neural stimulator, wherein antiarrhythmia therapy transvascularly stimulates the vagus nerve in the cervical region from the IJV.
Description
    CROSS REFERENCE TO RELATED APPLICATION
  • [0001]
    This application is a continuation of U.S. application Ser. No. 11/103,245, filed Apr. 11, 2005, which is hereby incorporated by reference in its entirety.
  • TECHNICAL FIELD
  • [0002]
    This patent document pertains generally to neural stimulation devices and methods, and more particularly, but not by way of limitation, to transvascular neural stimulation devices and methods.
  • BACKGROUND
  • [0003]
    The automatic nervous system (ANS) regulates “involuntary” organs. The ANS includes the sympathetic nervous system and the parasympathetic nervous system. The sympathetic nervous system is affiliated with stress and the “fight or flight response” to emergencies. The parasympathetic nervous system is affiliated with relaxation and the “rest and digest response.” The ANS maintains normal internal function and works with the somatic nervous system. Autonomic balance reflects the relationship between parasympathetic and sympathetic activity. A change in autonomic balance is reflected in changes in heart rate, heart rhythm, contractility, remodeling, inflammation and blood pressure. Changes in autonomic balance can also be seen in other physiological changes, such as changes in abdominal pain, appetite, stamina, emotions, personality, muscle tone, sleep, and allergies, for example.
  • [0004]
    Reduced autonomic balance (increase in sympathetic and decrease in parasympathetic cardiac tone) during heart failure has been shown to be associated with left ventricular dysfunction and increased mortality. Research also indicates that increasing parasympathetic tone and reducing sympathetic tone may protect the myocardium from further remodeling and predisposition to fatal arrhythmias following myocardial infarction. Direct stimulation of the vagal parasympathetic fibers has been shown to reduce heart rate via the sympathetic nervous system. In addition, some research indicates that chronic stimulation of the vagus nerve may be of protective myocardial benefit following cardiac ischemic insult.
  • [0005]
    Some target areas can be difficult to stimulate or isolate. For example, it may be difficult to stimulate a nerve that is located deep in the body or behind an organ. Improved neural stimulation devices are needed.
  • SUMMARY
  • [0006]
    Various aspects of the present subject matter relate to an implantable apparatus. In an example, an apparatus is configured to transvascularly stimulate a nerve trunk through a blood vessel. The apparatus includes an expandable electrode that is chronically implantable in a blood vessel proximate a nerve trunk. The expandable electrode is configured to abut an area of the vessel wall along a length of the vessel. An electrical lead is coupled to the expandable electrode. An implantable pulse generator is coupled to the lead and configured to deliver an electrical stimulation signal to the electrode through the lead.
  • [0007]
    Various aspects of the present subject matter relate to a method. In an example method, an electrical signal is delivered from an implanted medical device to an electrode chronically implanted in a blood vessel proximate a nerve trunk to transvascularly deliver neural stimulation from the electrode to the nerve trunk.
  • [0008]
    This Summary is an overview of some of the teachings of the present application and not intended to be an exclusive or exhaustive treatment of the present subject matter. Further details about the present subject matter are found in the detailed description and appended claims. Other aspects will be apparent to persons skilled in the art upon reading and understanding the following detailed description and viewing the drawings that form a part thereof, each of which are not to be taken in a limiting sense. The scope of the present invention is defined by the appended claims and their equivalents.
  • BRIEF DESCRIPTION OF THE DRAWINGS
  • [0009]
    FIG. 1A shows a medical device implanted in a patient and leads extending into a heart, according to embodiments of the present subject matter.
  • [0010]
    FIG. 1B is an illustration of a heart and leads extending into the heart, according to embodiments of the present subject matter.
  • [0011]
    FIGS. 1C and 1D are illustrations of a heart and related blood vessels.
  • [0012]
    FIG. 1E is an illustration of blood vessels and nerve trunks.
  • [0013]
    FIGS. 2A and 2B are illustrations of stimulation targets.
  • [0014]
    FIGS. 2C and 2D show neural pathways.
  • [0015]
    FIG. 2E is an illustration of an internal jugular vein near a vagus nerve.
  • [0016]
    FIGS. 3A and 3B are illustrations of expandable electrodes chronically implanted in a blood vessel.
  • [0017]
    FIG. 4 is a schematic illustration of an implantable system for delivering transvascular stimulation.
  • [0018]
    FIGS. 5 and 6 are flowcharts that illustrate methods of delivering transvascular stimulation.
  • DETAILED DESCRIPTION
  • [0019]
    The following detailed description of the present subject matter refers to the accompanying drawings which show, by way of illustration, specific aspects and embodiments in which the present subject matter may be practiced. These embodiments are described in sufficient detail to enable those skilled in the art to practice the present subject matter. Other embodiments may be utilized and structural, logical, and electrical changes may be made without departing from the scope of the present subject matter. References to “an”, “one”, or “various” embodiments in this disclosure are not necessarily to the same embodiment, and such references contemplate more than one embodiment. Additionally, the identified embodiments are not necessarily exclusive of each other, as some embodiments may be able to be combined with other embodiments. The following detailed description is, therefore, not to be taken in a limiting sense, and the scope is defined only by the appended claims, along with the full scope of legal equivalents to which such claims are entitled.
  • Overview
  • [0020]
    Referring now to FIG. 1A, an embodiment of an implantable cardiac device 100 is placed subcutaneously or submuscularly in a patient's chest with leads 200 extending toward the heart. At least one lead 200 is coupled to an electrode 295 that is placed in a blood vessel and positioned to transvascularly stimulate a nerve on or near the extravascular surface of the vessel. Transvascular stimulation avoids direct contact with nerves during stimulation and reduces problems associated with neural inflammation or injury induced by direct stimulation. Leads can be implanted through the vasculature, thus maintaining the integrity of the thorax. Transvascular stimulation using intravascularly-fed leads provides relatively non-invasive access to anatomical targets and points of innervation in comparison to cuff electrodes.
  • [0021]
    FIGS. 1B-1E and FIGS. 2A-2B illustrate examples of electrode placement. FIGS. 2B-2C show neural pathways. FIGS. 3A-3B show an example an electrode implanted in a blood vessel. FIG. 4 shows a schematic representation of an example of an implantable system for delivering transvascular stimulation. FIGS. 5 and 6 are flow charts that illustrate methods of delivering transvascular stimulation.
  • ELECTRODE EXAMPLES
  • [0022]
    FIG. 3A is shows a cross-section of an example expandable electrode 305 implanted in a blood vessel 310. In an example, the expandable electrode includes a mesh, at least part of which is electrically conductive. In an example, the expandable electrode is formed from Platinum or Platinum-Iridium. In an embodiment, the expandable electrode 305 is similar to a stent.
  • [0023]
    Referring again to FIG. 3A, a nerve trunk 320 extends on or near an extravascular surface 325 of the blood vessel 310. An expandable electrode 305 is implanted at or near a location in the blood vessel where the nerve trunk 320 crosses the blood vessel. In an example, the expandable electrode transmits neural stimulation energy through a predetermined surface area of the wall of a blood vessel. In an example, this predetermined area is about 0.25 to 5 cm2. In an example, the expandable electrode has a length L that provides enough surface area that there is at least some flexibility in the placement of the expandable electrode in the vessel with respect to the target nerve. In an example, the length of the expandable electrode is about 0.5 to 2.0 cm.
  • [0024]
    In an example, the entire surface area of the expandable electrode that touches the blood vessel wall is conductive. In an alternative example, at least a part of the surface area of the electrode is non-conductive. For example, an electrode can be formed and positioned to deliver stimulation to through a conductive part of the electrode to a portion 330 (FIG. 3B) of a blood vessel that is proximate a nerve.
  • [0025]
    FIG. 3B shows an end view of the blood vessel and electrode of FIG. 3A. The expandable electrode has an expanded diameter D (shown in FIG. 3B) that is sized for implantation in a blood vessel of a particular size range. In one example, where the electrode is size for implantation in the internal jugular vein, the expanded diameter D is about 0.5 to 1.5 cm, and the length L of the electrode is about 1.0 cm.
  • [0026]
    In an example, the expandable electrode is covered with a drug, such as a drug that prevents occlusion, or a drug that reduces inflammation of the blood vessel near the electrode.
  • [0027]
    The expandable electrode 305 is coupled to a power source that delivers an electrical stimulation. In FIG. 3A, the illustrated expandable electrode 305 is coupled to a lead 315. The lead 315 is coupled to an implantable system or device that includes control circuitry, such as the device shown in FIG. 1 or the system shown in FIG. 4.
  • Electrode Placement and Nerve Targets
  • [0028]
    The electrode may be implanted in various locations in the body, including a variety of locations near a trunk or branch of a sympathetic or parasympathetic nerve system.
  • [0029]
    Referring again to the example shown in FIG. 1A, the location of implanted electrodes 295, 296 is denoted by an X. The implanted electrodes 295, 296 each transvascularly stimulate a sympathetic nerve or a parasympathetic nerve. In an example, the electrode 295 transvascularly stimulates a peripheral nerve trunk. Examples of a peripheral nerve trunk include the vagus nerve 287, aortic nerve 288, and carotid sinus nerve 289, which are shown in FIG. 2C. In another example, the electrode 295 stimulates a nerve branch, such as a vagal cardiac branch.
  • [0030]
    FIGS. 1B, 1C, and 1D show examples of blood vessels in which the electrode can be implanted. FIG. 1B shows an implantable device 290, leads 291, 292, 293 extending into a heart 201 and a superior vena cava 202, an aortic arch 203, and a pulmonary artery 204. Leads extending into the heart are shown as dotted lines. For simplicity, electrodes are denoted with an X. Lead 291 and electrode 298 are inserted in the superior vena cava (SVC) 202. The electrode 298 is used to transvascularly stimulate a nerve or nerve trunk on or near the SVC 202. CRM lead 292 is intravascularly inserted through a peripheral vein into the coronary sinus and into the left ventricle. Electrode 299 is implanted in the coronary sinus and coupled to the CRM lead 292. FIG. 1B also shows electrodes 294 and 295, which are examples of sensing or pacing electrodes located in the right and left ventricles respectively. Physiological data sensed by one or both of the electrodes 294, 295 is processed by the device 290, and a responsive neurostimulation therapy is delivered by one or more of the electrodes 298, 299.
  • [0031]
    FIGS. 1C and 1D illustrate other bloods vessels on the right side and left side of the heart respectively in which an electrode is implantable. FIG. 1C shows the right atrium 267, right ventricle 268, sinoatrial node 269, superior vena cava 202, inferior vena cava 270, aorta 271, right pulmonary veins 272, and right pulmonary artery 273. FIG. 1D shows the left atrium 275, left ventricle 276, right atrium 267, right ventricle 268, superior vena cava 202, inferior vena cava 270, aorta 271, right pulmonary veins 272, left pulmonary vein 277, right pulmonary artery 273, and coronary sinus 278. An electrode can be implanted in one or more of the blood vessels listed above at a location where a nerve, nerve branch, or nerve trunk passes an extravascular surface of the blood vessel. The implanted electrode transvascularly stimulates a nerve, nerve branch, or nerve trunk through the blood vessel. In one example, an electrode is implanted in the SVC 202 near a nerve a vagal nerve trunk. In another example, an electrode is implanted in the coronary sinus 278 near a vagal nerve trunk.
  • [0032]
    In another example, a cardiac fat pad is transvascularly stimulated by an implanted electrode. FIG. 1C illustrates a cardiac fat pad 274 between the superior vena cava and aorta. FIG. 1D illustrates a cardiac fat pad 279 located proximate to the right cardiac veins and a cardiac fat pad 280 located proximate to the inferior vena cava and left atrium. An electrode implanted in the superior vena cava, aorta, cardiac veins, or inferior vena cava stimulates nerve endings in fat pad 274 or 279. Nerve endings in the fat pad 280 are stimulated by an electrode located in the coronary sinus.
  • [0033]
    Referring now to FIG. 1E, in an example, electrodes 131, 132, 133, 134 are implanted at locations in blood vessels near a vagus nerve. Portions of arteries are shown cut-away so that the electrodes are visible in the figure. The aortic arch 116, pulmonary artery 118, carotid arteries 124, 126 and subclavian arteries 128, 130 are shown in FIG. 1E. The right vagus nerve trunk 120 extends near carotid artery 124 and subclavian artery 128. The left vagus nerve 122 extends near carotid artery 126 and subclavian artery 130. Electrode 131 is implanted in carotid artery 124. The illustrated electrode 131 is an expandable electrode such as a stent. Electrode 132 is implanted in carotid artery 126. Electrode 133 is implanted in subclavian artery 128. Electrode 134 is implanted in subclavian artery 130. Electrode 140 is implanted in the carotid sinus 141 near the carotid sinus nerve 142. In an example, only one of electrodes 131, 132, 133, 134, 140 is implanted in a patient. In another example, two or more electrodes are implanted in a patient and used to transvascularly stimulate a nerve trunk.
  • [0034]
    FIGS. 2A and 2B provide additional illustrations of nerve target examples near the heart. FIG. 2A shows left vagus nerve 250 extending next to a subclavian artery 251. Various nerves extend around the arch of the aorta 255. Vagus nerve 250 also extends past the ligamentum arteriosum 256. The anterior pulmonary plexus 257 crosses the left pulmonary artery 258. Right vagus nerve 259 extends past a subclavian artery 260 and the cupola of pleura 261. Cardiac nerves 262 extend past the brachiocephalic trunk 263 near the trachea 264. Cardiac nerves 262 also extend past the arch of an azygos vein 265 to the right pulmonary artery 273. In the lower portion of FIG. 2A appear the right lung 281, left lung 282, esophagus 283, a lower portion 284 of the left vagus nerve 250, and a lower portion 285 of the aorta. FIG. 2B shows a left phrenic nerve 240 extending past a cupola of pleura 241, an internal thoracic artery 242, and left pulmonary artery 258 Vagus nerve 250, recurrent laryngeal nerves 252, cardiac nerves 253, and the anterior pulmonary plexus 257 extend near the left pulmonary artery 258 and ligamentum arteriosum. An expandable electrode, such as a stent, is chronically implantable in the blood vessels shown in FIG. 2A or 2B to transvascularly stimulate a nerve or nerve trunk that extends on or near the blood vessel. In one example, the vagus nerve is transvascularly stimulated from the azygos vein 265 or internal jugular vein.
  • [0035]
    FIGS. 2C and 2D show nerve pathways. FIG. 2C generally illustrates afferent nerves to vasomotor centers. An afferent nerve conveys impulses toward a nerve center. A vasomotor center relates to nerves that dilate and constrict blood vessels to control the size of the blood vessels. FIG. 2D generally illustrates efferent nerves from vasomotor centers. An efferent nerve conveys impulses away from a nerve center. Afferent and efferent nerves can be stimulated transvascularly.
  • [0036]
    FIG. 2E shows the vagus nerve 286 near the internal jugular vein 287. In an example, the vagus nerve 286 is transvascularly stimulated from the internal jugular vein 287. A common carotid artery 124 and subclavian artery 128 are also shown in FIG. 2E.
  • [0037]
    In other examples, nerve trunks innervating other organs, such as the lungs or kidneys are transvascularly stimulated. In an example, an expandable electrode such as a stent is implanted in a blood vessel proximate a nerve or nerve trunk that innervates the lungs or kidneys.
  • Device and System
  • [0038]
    Referring again to the example shown in FIG. 1A, an implantable device 100 is coupled to a lead 200 that is inserted into a blood vessel and coupled to an electrode 295. An electrical signal is delivered through the lead 200 to the electrode 295, which transvascularly stimulates a nerve on an extravascular surface of the blood vessel. The device 100 can optionally also deliver cardiac resynchronization therapy (CRT) through one or more CRT leads that are threaded intravenously into the heart. The CRT leads connect the device 100 to electrodes 300 that are used for sensing or pacing of the atria and/or ventricles. Transvascular stimulation electrode 296 is coupled to a CRT lead. Some embodiments process intrinsic electrical heart signals and deliver a responsive neural stimulation therapy through one of the electrodes 295, 296. An optional satellite unit 110 includes an electrode for neural stimulation and a communication circuit that communicates with the device 100 via a wireless link or conduction through the body. The satellite unit 110 electrode is implanted in a blood vessel, such as an internal jugular vein, to transvascularly stimulate a nerve, such as a vagus nerve, through the wall of the blood vessel.
  • [0039]
    FIG. 4 is a schematic illustration of an example transvascular stimulation system that includes an implantable device 401, an electrical lead 420 coupled to the implantable device 401, and an expandable stimulation electrode 425. The implantable device includes a controller circuit 405, a memory circuit 410, a telemetry circuit 415, and a neural stimulation circuit 435. The controller circuit 405 is operable on instructions stored in the memory circuit to deliver an electrical stimulation therapy. Therapy is delivered by the neural stimulation circuit 435 through the lead 420 and the electrode 425. The telemetry circuit 415 allows communication with an external programmer 430. The illustrated system also includes optional sensor circuitry 440 that is coupled to a lead 445. The controller circuit 405 processes sensor data from the sensor circuitry and delivers a therapy responsive to the sensor data.
  • Therapies
  • [0040]
    Neural stimulation therapies can be used to treat one or more of a variety of conditions, including but not limited to arrhythmias, heart failure, hypertension, syncope, or orthostatic intolerance. In an example, an efferent peripheral nerve is transvascularly stimulated by an implanted expandable electrode. In another example, an afferent peripheral nerve is stimulated.
  • [0041]
    In an example, electrical stimulation is transvascularly delivered to a parasympathetic nerve to reduce chronotropic, ionotropic, and dromotropic responses in the heart. In a therapy example, electrical stimulation is transvascularly delivered to a parasympathetic nerve trunk during heart failure. In another therapy example, electrical stimulation is transvascularly delivered to a parasympathetic nerve trunk following a myocardial infarction to protect against arrhythmias or prevent cardiac remodeling.
  • [0042]
    Transvascular stimulation of a vagus nerve trunk is used in a number of therapies. In an example, vagal nerve stimulation simultaneously increases parasympathetic tone and decreases sympathetic myocardial tone. In an example, a vagus nerve trunk is transvascularly stimulated following cardiac ischemic insult. Increased sympathetic nervous activity following ischemia often results in increased exposure of the myocardium to epinephrine and norepinephrine. These catecholamines activate intracellular pathways within the myocytes, which lead to myocardial death and fibrosis. This effect is inhibited by stimulation of the parasympathetic nerves, such as vagus nerves. In an example, vagal stimulation from the SVC lowers heart rate, overall blood pressure, and left ventricular pressure. Stimulation of the vagal cardiac nerves following myocardial infarction, or in heart failure patients, can be beneficial in preventing further remodeling and arrhythmogenesis.
  • [0043]
    In other examples, transvascular neural stimulation is used to treat other conditions such as hypertrophic cardiomyopathy (HCM) or neurogenic hypertension, where an increase parasympathetic cardiac tone and reduction in sympathetic cardiac tone is desired. In another example, a bradycardia condition is treated by transvascularly stimulating a sympathetic nerve trunk. In another example, the ionotropic state of the heart is increased by transvascularly stimulating a sympathetic nerve trunk.
  • Methods for Delivering Transvascular Stimulation
  • [0044]
    Referring now to FIG. 5, an example method of delivering transvascular neural stimulation includes implanting a medical device, at 505. At 510, an electrode is chronically implanted in a blood vessel near a nerve trunk, such as a cardiac peripheral nerve trunk. In an example, the electrode is an expandable electrode, such as a stent. In an example, the expandable electrode has an expanded diameter that is dimensioned to fix the electrode in place by frictional forces. In an example, the expandable electrode includes a drug-eluting coating that prevents occlusion or prevents inflammation of vascular walls or nerves that receives electrical stimulation from the electrode. In an example, the electrode is implanted in a blood vessel at a location where the nerve trunk extends along an extravascular surface of the blood vessel. In an example, the electrode is implanted in a blood vessel near a peripheral nerve trunk. In an example, the peripheral nerve trunk includes a sympathetic or parasympathetic nerve. In an example, the electrode is implanted near a vagal cardiac nerve in a blood vessel such as the SVC, coronary sinus, or an azygos vein. In another example, the electrode is implanted in an internal jugular vein.
  • [0045]
    Returning to FIG. 5, at 515, an electrical signal is delivered from the implanted device to the electrode to transvascularly deliver neural stimulation to a nerve trunk near the blood vessel. In an example, the electrode delivers an electric pulse therapy that is sufficient to elicit depolarization of a target nerve. In an example, the stimulation therapy delivers about 1-10 milliamps of electrical stimulation. In an example, the controller delivers a pulse train of about 10-120 hertz to the electrode. In one example, a pulse train of about 20 hertz is used. In an example, delivery of transvascular neural stimulation near the heart is timed to occur during the cardiac refractory period to prevent fibrillation.
  • [0046]
    In an example, transvascularly stimulating a parasympathetic nerve inhibits cardiac remodeling or delivers an antiarrhythmia therapy following a myocardial infarction. In another example, transvascularly stimulating a sympathetic nerve delivers an antibradycardia therapy.
  • [0047]
    FIG. 6 is a flow chart that illustrates another method. A medical device is implanted at 605. At 610, an electrode is chronically implanted in a blood vessel near a nerve trunk. At 615, a physiologic property is sensed. In an example, an intrinsic electrical heart signal is detected. In another example, blood pressure is detected. At 620, neural stimulation responsive to the sensed physiologic property is transvascularly delivered through the implanted electrode.
Patent Citations
Cited PatentFiling datePublication dateApplicantTitle
US4003379 *24 Sep 197518 Jan 1977Ellinwood Jr Everett HApparatus and method for implanted self-powered medication dispensing
US4082097 *20 May 19764 Apr 1978Pacesetter Systems Inc.Multimode recharging system for living tissue stimulators
US4146029 *31 May 197727 Mar 1979Ellinwood Jr Everett HSelf-powered implanted programmable medication system and method
US4217910 *10 Oct 197819 Aug 1980The United States Of America As Represented By The Secretary Of The NavyInternal jugular and left ventricular thermodilution catheter
US4522208 *24 Feb 198411 Jun 1985Cardiofrance Compagnie Francaise D'electrocardiologieMethod for determining parameter values of an implanted programmable pacemaker
US4944299 *8 Aug 198931 Jul 1990Siemens-Pacesetter, Inc.High speed digital telemetry system for implantable device
US4987897 *18 Sep 198929 Jan 1991Medtronic, Inc.Body bus medical device communication system
US5042497 *30 Jan 199027 Aug 1991Cardiac Pacemakers, Inc.Arrhythmia prediction and prevention for implanted devices
US5111815 *15 Oct 199012 May 1992Cardiac Pacemakers, Inc.Method and apparatus for cardioverter/pacer utilizing neurosensing
US5199428 *22 Mar 19916 Apr 1993Medtronic, Inc.Implantable electrical nerve stimulator/pacemaker with ischemia for decreasing cardiac workload
US5203326 *18 Dec 199120 Apr 1993Telectronics Pacing Systems, Inc.Antiarrhythmia pacer using antiarrhythmia pacing and autonomic nerve stimulation therapy
US5300875 *8 Jun 19925 Apr 1994Micron Technology, Inc.Passive (non-contact) recharging of secondary battery cell(s) powering RFID transponder tags
US5318592 *14 Sep 19927 Jun 1994BIOTRONIK, Mess- und Therapiegerate GmbH & Co., Ingenieurburo BerlinCardiac therapy system
US5324316 *3 Mar 199328 Jun 1994Alfred E. Mann Foundation For Scientific ResearchImplantable microstimulator
US5330507 *24 Apr 199219 Jul 1994Medtronic, Inc.Implantable electrical vagal stimulation for prevention or interruption of life threatening arrhythmias
US5342408 *7 Jan 199330 Aug 1994Incontrol, Inc.Telemetry system for an implantable cardiac device
US5436548 *25 Nov 199225 Jul 1995Motorola, Inc.Battery charging and discharging system and corresponding method
US5496360 *12 Apr 19945 Mar 1996Ventritex, Inc.Implantable cardiac electrode with rate controlled drug delivery
US5501703 *24 Jan 199426 Mar 1996Medtronic, Inc.Multichannel apparatus for epidural spinal cord stimulator
US5522854 *19 May 19944 Jun 1996Duke UniversityMethod and apparatus for the prevention of arrhythmia by nerve stimulation
US5531779 *24 Jan 19952 Jul 1996Cardiac Pacemakers, Inc.Stent-type defibrillation electrode structures
US5540730 *6 Jun 199530 Jul 1996Cyberonics, Inc.Treatment of motility disorders by nerve stimulation
US5707400 *19 Sep 199513 Jan 1998Cyberonics, Inc.Treating refractory hypertension by nerve stimulation
US5775338 *10 Jan 19977 Jul 1998Scimed Life Systems, Inc.Heated perfusion balloon for reduction of restenosis
US5916239 *24 Nov 199729 Jun 1999Purdue Research FoundationMethod and apparatus using vagal stimulation for control of ventricular rate during atrial fibrillation
US6073048 *17 Nov 19956 Jun 2000Medtronic, Inc.Baroreflex modulation with carotid sinus nerve stimulation for the treatment of heart failure
US6205361 *28 Jan 199920 Mar 2001Advanced Bionics CorporationImplantable expandable multicontact electrodes
US6206914 *31 Aug 199827 Mar 2001Medtronic, Inc.Implantable system with drug-eluting cells for on-demand local drug delivery
US6213942 *20 May 199910 Apr 2001Vitalcom, Inc.Telemeter design and data transfer methods for medical telemetry system
US6231516 *23 Feb 199815 May 2001Vacusense, Inc.Endoluminal implant with therapeutic and diagnostic capability
US6237398 *29 Sep 199829 May 2001Remon Medical Technologies, Ltd.System and method for monitoring pressure, flow and constriction parameters of plumbing and blood vessels
US6240316 *6 Aug 199929 May 2001Advanced Bionics CorporationImplantable microstimulation system for treatment of sleep apnea
US6358202 *14 Jan 200019 Mar 2002Sun Microsystems, Inc.Network for implanted computer devices
US6375666 *9 Dec 199923 Apr 2002Hans Alois MischeMethods and devices for treatment of neurological disorders
US6400982 *7 May 20014 Jun 2002Cardiac Pacemakers, Inc.Cardiac rhythm management system with arrhythmia prediction and prevention
US6511500 *6 Jun 200028 Jan 2003Marc Mounir RahmeUse of autonomic nervous system neurotransmitters inhibition and atrial parasympathetic fibers ablation for the treatment of atrial arrhythmias and to preserve drug effects
US6518245 *30 Jan 199811 Feb 2003The Board Of Trustees Of The Leland Stanford Jr. UniversityTreatment of arrhythmias via inhibition of a multifunctional calcium/calmodulin-dependent protein kinase
US6519488 *27 Aug 200111 Feb 2003Cardiac Pacemakers, Inc.Method and system for reducing arterial restenosis in the presence of an intravascular stent
US6522926 *27 Sep 200018 Feb 2003Cvrx, Inc.Devices and methods for cardiovascular reflex control
US6564096 *28 Feb 200113 May 2003Robert A. MestMethod and system for treatment of tachycardia and fibrillation
US6584362 *30 Aug 200024 Jun 2003Cardiac Pacemakers, Inc.Leads for pacing and/or sensing the heart from within the coronary veins
US6764498 *24 Jan 200220 Jul 2004Hans Alois MischeMethods and devices for treatment of neurological disorders
US7218964 *26 Oct 200115 May 2007Medtronic, Inc.Closed-loop neuromodulation for prevention and treatment of cardiac conditions
US7236821 *19 Feb 200226 Jun 2007Cardiac Pacemakers, Inc.Chronically-implanted device for sensing and therapy
US7499748 *11 Apr 20053 Mar 2009Cardiac Pacemakers, Inc.Transvascular neural stimulation device
US7542800 *5 Apr 20052 Jun 2009Cardiac Pacemakers, Inc.Method and apparatus for synchronizing neural stimulation to cardiac cycles
US7647114 *13 Sep 200412 Jan 2010Cardiac Pacemakers, Inc.Baroreflex modulation based on monitored cardiovascular parameter
US7657312 *3 Nov 20032 Feb 2010Cardiac Pacemakers, Inc.Multi-site ventricular pacing therapy with parasympathetic stimulation
US7660628 *23 Mar 20059 Feb 2010Cardiac Pacemakers, Inc.System to provide myocardial and neural stimulation
US7706884 *24 Dec 200327 Apr 2010Cardiac Pacemakers, Inc.Baroreflex stimulation synchronized to circadian rhythm
US7711421 *8 Aug 20074 May 2010Medtronic, Inc.Method and system for vagal nerve stimulation with multi-site cardiac pacing
US7840278 *23 Jun 200023 Nov 2010Puskas John DDevices and methods for vagus nerve stimulation
US8126561 *5 Nov 200928 Feb 2012Cardiac Pacemakers, Inc.Implantable and rechargeable neural stimulator
US20020004670 *3 May 200110 Jan 2002Florio Joseph J.Implantable cardiac stimulation device with detection and therapy for patients with vasovagal syncope
US20020026221 *2 Jul 200128 Feb 2002Medtronic, Inc.Method and device for electronically controlling the beating of a heart
US20020026222 *30 Nov 200028 Feb 2002Biotronik Mess- Und Therapiegeraete Gmbh & CoDevice for regulating heart rate and heart pumping force
US20020026228 *30 Nov 200028 Feb 2002Patrick SchauerteElectrode for intravascular stimulation, cardioversion and/or defibrillation
US20020042637 *28 Sep 200111 Apr 2002Stover Howard H.Antenna for miniature implanted medical device
US20020072776 *9 Nov 200113 Jun 2002Medtronic, Inc.Vagal nerve stimulation techniques for treatment of epileptic seizures
US20030023279 *27 Jul 200130 Jan 2003Spinelli Julio C.Method and system for treatment of neurocardiogenic syncope
US20030045909 *24 Jul 20026 Mar 2003Biocontrol Medical Ltd.Selective nerve fiber stimulation for treating heart conditions
US20030060848 *26 Sep 200127 Mar 2003Kieval Robert S.Mapping methods for cardiovascular reflex control devices
US20030060858 *26 Sep 200127 Mar 2003Kieval Robert S.Stimulus regimens for cardiovascular reflex control
US20030074039 *14 Jun 200217 Apr 2003Puskas John D.Devices and methods for vagus nerve stimulation
US20030078623 *22 Oct 200124 Apr 2003Weinberg Lisa P.Implantable lead and method for stimulating the vagus nerve
US20030078629 *25 Nov 200224 Apr 2003Peng-Sheng ChenSystem for preventing Sudden Cardiac Death by nerve sprouting from right stellate ganglion
US20030100924 *22 Apr 200229 May 2003Foreman Robert D.Cardiac neuromodulation and methods of using same
US20030114905 *27 Jan 200319 Jun 2003Kuzma Janusz A.Implantable microdevice with extended lead and remote electrode
US20030132731 *14 Jan 200217 Jul 2003Asoka Inc.Contactless battery charging device
US20040019364 *27 Mar 200329 Jan 2004Cvrx, Inc.Devices and methods for cardiovascular reflex control via coupled electrodes
US20040030362 *12 Mar 200312 Feb 2004Hill Michael R. S.Method and device for electronically controlling the beating of a heart
US20040059383 *26 Sep 200325 Mar 2004Puskas John D.Methods of indirectly stimulating the vagus nerve with an electrical field
US20040122477 *8 Dec 200324 Jun 2004Whitehurst Todd K.Fully implantable miniature neurostimulator for spinal nerve root stimulation as a therapy for angina and peripheral vascular disease
US20050018784 *21 Jul 200427 Jan 2005Akio KurobeCommunication network system, and transmission/reception apparatus, method and integrated circuit for use therein
US20050065553 *10 Jun 200424 Mar 2005Omry Ben EzraApplications of vagal stimulation
US20050085864 *18 Aug 200421 Apr 2005Schulman Joseph H.Implantable device for processing neurological signals
US20050096705 *3 Nov 20035 May 2005Pastore Joseph M.Multi-site ventricular pacing therapy with parasympathetic stimulation
US20050143412 *17 Dec 200430 Jun 2005Puskas John D.Methods of indirectly stimulating the vagus nerve with an electrical field
US20050143779 *13 Sep 200430 Jun 2005Cardiac Pacemakers, Inc.Baroreflex modulation based on monitored cardiovascular parameter
US20050143785 *8 Jun 200430 Jun 2005Imad LibbusBaroreflex therapy for disordered breathing
US20050143787 *13 Jan 200530 Jun 2005Boveja Birinder R.Method and system for providing electrical pulses for neuromodulation of vagus nerve(s), using rechargeable implanted pulse generator
US20050149126 *24 Dec 20037 Jul 2005Imad LibbusBaroreflex stimulation to treat acute myocardial infarction
US20050149127 *24 Dec 20037 Jul 2005Imad LibbusAutomatic baroreflex modulation responsive to adverse event
US20050149128 *24 Dec 20037 Jul 2005Heil Ronald W.Jr.Barorflex stimulation system to reduce hypertension
US20050149129 *24 Dec 20037 Jul 2005Imad LibbusBaropacing and cardiac pacing to control output
US20050149130 *24 Dec 20037 Jul 2005Imad LibbusBaroreflex stimulation synchronized to circadian rhythm
US20050149131 *24 Dec 20037 Jul 2005Imad LibbusBaroreflex modulation to gradually decrease blood pressure
US20050149132 *24 Dec 20037 Jul 2005Imad LibbusAutomatic baroreflex modulation based on cardiac activity
US20050149133 *24 Dec 20037 Jul 2005Imad LibbusSensing with compensation for neural stimulator
US20050149143 *24 Dec 20037 Jul 2005Imad LibbusBaroreflex stimulator with integrated pressure sensor
US20050149155 *24 Dec 20037 Jul 2005Avram ScheinerStimulation lead for stimulating the baroreceptors in the pulmonary artery
US20050149156 *24 Dec 20037 Jul 2005Imad LibbusLead for stimulating the baroreceptors in the pulmonary artery
US20060079945 *12 Oct 200413 Apr 2006Cardiac Pacemakers, Inc.System and method for sustained baroreflex stimulation
US20060106429 *18 Nov 200418 May 2006Cardiac Pacemakers, Inc.System and method for closed-loop neural stimulation
US20060116737 *30 Nov 20041 Jun 2006Cardiac Pacemakers, Inc.Neural stimulation with avoidance of inappropriate stimulation
US20060122675 *7 Dec 20048 Jun 2006Cardiac Pacemakers, Inc.Stimulator for auricular branch of vagus nerve
US20070093875 *24 Oct 200526 Apr 2007Cardiac Pacemakers, Inc.Implantable and rechargeable neural stimulator
US20100049275 *5 Nov 200925 Feb 2010Abhi ChavanImplantable and rechargeable neural stimulator
US20110082537 *15 Dec 20107 Apr 2011Julia MoffittTransvascular neural stimulation device
USRE38705 *15 Nov 200122 Feb 2005Medtronic, Inc.Method and device for electronically controlling the beating of a heart using venous electrical stimulation of nerve fibers
WO2001000273A1 *23 Jun 20004 Jan 2001Emory UniversityDevices and methods for vagus nerve stimulation
Referenced by
Citing PatentFiling datePublication dateApplicantTitle
US797914122 Sep 200912 Jul 2011Cardiac Pacemakers, Inc.Transvascular reshaping lead system
US81265615 Nov 200928 Feb 2012Cardiac Pacemakers, Inc.Implantable and rechargeable neural stimulator
US857165417 Jan 201229 Oct 2013Cyberonics, Inc.Vagus nerve neurostimulator with multiple patient-selectable modes for treating chronic cardiac dysfunction
US85774587 Dec 20115 Nov 2013Cyberonics, Inc.Implantable device for providing electrical stimulation of cervical vagus nerves for treatment of chronic cardiac dysfunction with leadless heart rate monitoring
US86005057 Dec 20113 Dec 2013Cyberonics, Inc.Implantable device for facilitating control of electrical stimulation of cervical vagus nerves for treatment of chronic cardiac dysfunction
US86307097 Dec 201114 Jan 2014Cyberonics, Inc.Computer-implemented system and method for selecting therapy profiles of electrical stimulation of cervical vagus nerves for treatment of chronic cardiac dysfunction
US863492122 Feb 201221 Jan 2014Cardiac Pacemakers, Inc.Implantable and rechargeable neural stimulator
US866064815 Nov 201225 Feb 2014Cardiac Pacemakers, Inc.Implantable and rechargeable neural stimulator
US868821220 Jul 20121 Apr 2014Cyberonics, Inc.Implantable neurostimulator-implemented method for managing bradycardia through vagus nerve stimulation
US870015030 Jun 201315 Apr 2014Cyberonics, Inc.Implantable neurostimulator for providing electrical stimulation of cervical vagus nerves for treatment of chronic cardiac dysfunction with bounded titration
US8700183 *28 Sep 201215 Apr 2014Nyxoah SADevices and methods for low current neural modulation
US89181907 Dec 201123 Dec 2014Cyberonics, Inc.Implantable device for evaluating autonomic cardiovascular drive in a patient suffering from chronic cardiac dysfunction
US89181917 Dec 201123 Dec 2014Cyberonics, Inc.Implantable device for providing electrical stimulation of cervical vagus nerves for treatment of chronic cardiac dysfunction with bounded titration
US89239649 Nov 201230 Dec 2014Cyberonics, Inc.Implantable neurostimulator-implemented method for enhancing heart failure patient awakening through vagus nerve stimulation
US892399026 Apr 201330 Dec 2014Cyberonics, Inc.Implantable device for providing electrical stimulation of cervical vagus nerves for treatment of chronic cardiac dysfunction with leadless heart rate monitoring
US892999015 Dec 20106 Jan 2015Cardiac Pacemakers, Inc.Transvascular neural stimulation device and method for treating hypertension
US896552213 Feb 201424 Feb 2015Cyberonics, Inc.Implantable neurostimulator for providing electrical stimulation of cervical vagus nerves for treatment of chronic cardiac dysfunction with bounded titration
US911426213 Nov 201425 Aug 2015Cyberonics, Inc.Implantable device for evaluating autonomic cardiovascular drive in a patient suffering from chronic cardiac dysfunction
US92721437 May 20141 Mar 2016Cyberonics, Inc.Responsive neurostimulation for the treatment of chronic cardiac dysfunction
US939341919 Nov 201419 Jul 2016Cyberonics, Inc.Implantable neurostimulator-implemented method for enhancing heart failure patient awakening through vagus nerve stimulation
US93989016 Dec 201326 Jul 2016Medtronic, Inc.Minimally invasive implantable neurostimulation system
US940902425 Mar 20149 Aug 2016Cyberonics, Inc.Neurostimulation in a neural fulcrum zone for the treatment of chronic cardiac dysfunction
US941522425 Apr 201416 Aug 2016Cyberonics, Inc.Neurostimulation and recording of physiological response for the treatment of chronic cardiac dysfunction
US944623722 Sep 201520 Sep 2016Cyberonics, Inc.Responsive neurostimulation for the treatment of chronic cardiac dysfunction
US94522909 Nov 201227 Sep 2016Cyberonics, Inc.Implantable neurostimulator-implemented method for managing tachyarrhythmia through vagus nerve stimulation
US95048328 Dec 201429 Nov 2016Cyberonics, Inc.Neurostimulation titration process via adaptive parametric modification
US951122814 Jan 20146 Dec 2016Cyberonics, Inc.Implantable neurostimulator-implemented method for managing hypertension through renal denervation and vagus nerve stimulation
US95268987 Jan 201527 Dec 2016Cyberonics, Inc.Implantable neurostimulator for providing electrical stimulation of cervical vagus nerves for treatment of chronic cardiac dysfunction with bounded titration
US953315312 Aug 20143 Jan 2017Cyberonics, Inc.Neurostimulation titration process
US95856426 Dec 20137 Mar 2017Medtronic, Inc.Minimally invasive implantable neurostimulation system
US96430089 Nov 20129 May 2017Cyberonics, Inc.Implantable neurostimulator-implemented method for enhancing post-exercise recovery through vagus nerve stimulation
US964301114 Mar 20139 May 2017Cyberonics, Inc.Implantable neurostimulator-implemented method for managing tachyarrhythmic risk during sleep through vagus nerve stimulation
US964949330 Sep 201316 May 2017Adi MashiachSystem and method for nerve modulation using noncontacting electrodes
US96692205 Aug 20166 Jun 2017Cyberonics, Inc.Neurostimulation in a neural fulcrum zone for the treatment of chronic cardiac dysfunction
US971371917 Apr 201425 Jul 2017Cyberonics, Inc.Fine resolution identification of a neural fulcrum for the treatment of chronic cardiac dysfunction
US973771612 Aug 201422 Aug 2017Cyberonics, Inc.Vagus nerve and carotid baroreceptor stimulation system
US976413823 Sep 201619 Sep 2017Cyberonics, Inc.Implantable neurostimulator-implemented method for managing tachyarrhythmia through vagus nerve stimulation
US977059912 Aug 201426 Sep 2017Cyberonics, Inc.Vagus nerve stimulation and subcutaneous defibrillation system
US978931612 Aug 201617 Oct 2017Cyberonics, Inc.Neurostimulation and recording of physiological response for the treatment of chronic cardiac dysfunction
US980862616 Sep 20167 Nov 2017Cyberonics, Inc.Responsive neurostimulation for the treatment of chronic cardiac dysfunction
US20100016927 *22 Sep 200921 Jan 2010Anthony CaparsoTransvascular reshaping lead system
US20100049275 *5 Nov 200925 Feb 2010Abhi ChavanImplantable and rechargeable neural stimulator
US20130085561 *28 Sep 20124 Apr 2013Adi MashiachDevices and Methods for Low Current Neural Modulation
CN104797291A *6 Dec 201322 Jul 2015美敦力公司Minimally invasive implantable neurostimulation system
Classifications
U.S. Classification607/3, 607/116, 607/9
International ClassificationA61N1/36
Cooperative ClassificationA61N1/362, A61N1/37288, A61N1/3611, A61N1/37217, A61M31/00, A61N1/056, A61N1/36053, A61N1/0558, A61N1/3627, A61N1/36114, A61N1/36117
European ClassificationA61N1/36Z, A61N1/05N, A61N1/36