US20080177364A1 - Self-locking electrode assembly usable with an implantable medical device - Google Patents

Self-locking electrode assembly usable with an implantable medical device Download PDF

Info

Publication number
US20080177364A1
US20080177364A1 US11/933,313 US93331307A US2008177364A1 US 20080177364 A1 US20080177364 A1 US 20080177364A1 US 93331307 A US93331307 A US 93331307A US 2008177364 A1 US2008177364 A1 US 2008177364A1
Authority
US
United States
Prior art keywords
nerve
electrodes
electrode assembly
electrode
coupled
Prior art date
Legal status (The legal status 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 status listed.)
Abandoned
Application number
US11/933,313
Inventor
Stephen L. Bolea
Robert S. Kieval
Bruce J. Persson
David J. Serdar
Peter T. Keith
Eric D. Irwin
Martin A. Rossing
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
CVRX Inc
Original Assignee
CVRX 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
Priority claimed from US09/671,850 external-priority patent/US6522926B1/en
Application filed by CVRX Inc filed Critical CVRX Inc
Priority to US11/933,313 priority Critical patent/US20080177364A1/en
Publication of US20080177364A1 publication Critical patent/US20080177364A1/en
Abandoned legal-status Critical Current

Links

Images

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
    • A61N1/362Heart stimulators
    • A61N1/365Heart stimulators controlled by a physiological parameter, e.g. heart potential
    • A61N1/368Heart stimulators controlled by a physiological parameter, e.g. heart potential comprising more than one electrode co-operating with different heart regions
    • A61N1/3686Heart stimulators controlled by a physiological parameter, e.g. heart potential comprising more than one electrode co-operating with different heart regions configured for selecting the electrode configuration on a lead
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61NELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00Electrotherapy; Circuits therefor
    • A61N1/02Details
    • A61N1/04Electrodes
    • A61N1/05Electrodes for implantation or insertion into the body, e.g. heart electrode
    • 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
    • A61N1/36128Control systems
    • A61N1/36146Control systems specified by the stimulation parameters
    • A61N1/36182Direction of the electrical field, e.g. with sleeve around stimulating electrode
    • A61N1/36185Selection of the electrode configuration
    • 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
    • A61N1/36117Cardiac control, e.g. by vagal stimulation for treating hypertension

Definitions

  • the present invention generally relates to medical devices and methods of use for the treatment and/or management of cardiovascular and renal disorders. Specifically, the present invention relates to devices and methods for controlling the baroreflex system for the treatment and/or management of cardiovascular and renal disorders and their underlying causes and conditions.
  • Cardiovascular disease is a major contributor to patient illness and mortality. It also is a primary driver of health care expenditure, costing more than $326 billion each year in the United States.
  • Hypertension or high blood pressure, is a major cardiovascular disorder that is estimated to affect over 50 million people in the United Sates alone. Of those with hypertension, it is reported that fewer than 30% have their blood pressure under control.
  • Hypertension is a leading cause of heart failure and stroke. It is the primary cause of death in over 42,000 patients per year and is listed as a primary or contributing cause of death in over 200,000 patients per year in the U.S. Accordingly, hypertension is a serious health problem demanding significant research and development for the treatment thereof.
  • Hypertension occurs when the body's smaller blood vessels (arterioles) constrict, causing an increase in blood pressure. Because the blood vessels constrict, the heart must work harder to maintain blood flow at the higher pressures. Although the body may tolerate short periods of increased blood pressure, sustained hypertension may eventually result in damage to multiple body organs, including the kidneys, brain, eyes and other tissues, causing a variety of maladies associated therewith. The elevated blood pressure may also damage the lining of the blood vessels, accelerating the process of atherosclerosis and increasing the likelihood that a blood clot may develop. This could lead to a heart attack and/or stroke. Sustained high blood pressure may eventually result in an enlarged and damaged heart (hypertrophy), which may lead to heart failure.
  • Heart failure is the final common expression of a variety of cardiovascular disorders, including ischemic heart disease. It is characterized by an inability of the heart to pump enough blood to meet the body's needs and results in fatigue, reduced exercise capacity and poor survival. It is estimated that approximately 5,000,000 people in the United States suffer from heart failure, directly leading to 39,000 deaths per year and contributing to another 225,000 deaths per year. It is also estimated that greater than 400,000 new cases of heart failure are diagnosed each year. Heart failure accounts for over 900,000 hospital admissions annually, and is the most common discharge diagnosis in patients over the age of 65 years. It has been reported that the cost of treating heart failure in the United States exceeds $20 billion annually. Accordingly, heart failure is also a serious health problem demanding significant research and development for the treatment and/or management thereof.
  • Heart failure results in the activation of a number of body systems to compensate for the heart's inability to pump sufficient blood. Many of these responses are mediated by an increase in the level of activation of the sympathetic nervous system, as well as by activation of multiple other neurohormonal responses.
  • this sympathetic nervous system activation signals the heart to increase heart rate and force of contraction to increase the cardiac output; it signals the kidneys to expand the blood volume by retaining sodium and water; and it signals the arterioles to constrict to elevate the blood pressure.
  • the cardiac, renal and vascular responses increase the workload of the heart, further accelerating myocardial damage and exacerbating the heart failure state. Accordingly, it is desirable to reduce the level of sympathetic nervous system activation in order to stop or at least minimize this vicious cycle and thereby treat or manage the heart failure.
  • vasodilators to reduce the blood pressure and ease the workload of the heart
  • diuretics to reduce fluid overload
  • inhibitors and blocking agents of the body's neurohormonal responses and other medicaments.
  • Heart transplantation has been proposed for patients who suffer from severe, refractory heart failure.
  • an implantable medical device such as a ventricular assist device (VAD) may be implanted in the chest to increase the pumping action of the heart.
  • a ventricular assist device VAD
  • IABP intra-aortic balloon pump
  • Other surgical procedures are available as well.
  • the wall of the carotid sinus a structure at the bifurcation of the common carotid arteries, contains stretch receptors (baroreceptors) that are sensitive to the blood pressure. These receptors send signals via the carotid sinus nerve to the brain, which in turn regulates the cardiovascular system to maintain normal blood pressure (the baroreflex), in part through activation of the sympathetic nervous system.
  • Electrical stimulation of the carotid sinus nerve has previously been proposed to reduce blood pressure and the workload of the heart in the treatment of high blood pressure and angina.
  • U.S. Pat. No. 6,073,048 to Kieval et al. discloses a baroreflex modulation system and method for stimulating the baroreflex arc based on various cardiovascular and pulmonary parameters.
  • each of the therapies has its own disadvantages.
  • drug therapy is often incompletely effective. Some patients may be unresponsive (refractory) to medical therapy. Drugs often have unwanted side effects and may need to be given in complex regimens. These and other factors contribute to poor patient compliance with medical therapy. Drug therapy may also be expensive, adding to the health care costs associated with these disorders.
  • surgical approaches are very costly, may be associated with significant patient morbidity and mortality and may not alter the natural history of the disease. Baropacing also has not gained acceptance.
  • Several problems with electrical carotid sinus nerve stimulation have been reported in the medical literature. These include the invasiveness of the surgical procedure to implant the nerve electrodes, and postoperative pain in the jaw, throat, face and head during stimulation.
  • the present invention provides a number of devices, systems and methods by which the blood pressure, nervous system activity, and neurohormonal activity may be selectively and controllably regulated by activating baroreceptors.
  • the present invention reduces excessive blood pressure, sympathetic nervous system activation and neurohormonal activation, thereby minimizing their deleterious effects on the heart, vasculature and other organs and tissues.
  • the present invention provides systems and methods for treating a patient by inducing a baroreceptor signal to effect a change in the baroreflex system (e.g., reduced heart rate, reduced blood pressure, etc.).
  • the baroreceptor signal is activated or otherwise modified by selectively activating baroreceptors.
  • the system and method of the present invention utilize a baroreceptor activation device positioned near a baroreceptor in the carotid sinus, aortic arch, heart, common carotid arteries, subclavian arteries, and/or brachiocephalic artery.
  • the baroreceptor activation device is located in the right and/or left carotid sinus (near the bifurcation of the common carotid artery) and/or the aortic arch.
  • the present invention is described with reference to the carotid sinus location.
  • the baroreceptor activation device may be activated, deactivated or otherwise modulated to activate one or more baroreceptors and induce a baroreceptor signal or a change in the baroreceptor signal to thereby effect a change in the baroreflex system.
  • the baroreceptor activation device may be activated, deactivated, or otherwise modulated continuously, periodically, or episodically.
  • the baroreceptor activation device may comprise a wide variety of devices which utilize electrodes to directly or indirectly activate the baroreceptor.
  • the baroreceptor may be activated directly, or activated indirectly via the adjacent vascular tissue.
  • the baroreceptor activation device will be positioned outside the vascular wall. To maximize therapeutic efficacy, mapping methods may be employed to precisely locate or position the baroreceptor activation device.
  • the present invention is directed particularly at electrical means and methods to activate baroreceptors, and various electrode designs are provided.
  • the electrode designs may be particularly suitable for connection to the carotid arteries at or near the carotid sinus, and may be designed to minimize extraneous tissue stimulation. While being particularly suitable for use on the carotid arteries at or near the carotid sinus, the electrode structures and assemblies of the present invention will also find use for external placement and securement of electrodes about other arteries, and in some cases veins, having baroreceptor and other electrically activated receptors therein.
  • a baroreceptor activation device or other electrode useful for a carotid sinus or other blood vessel comprises a base having one or more electrodes connected to the base.
  • the base has a length sufficient to extend around at least a substantial portion of the circumference of a blood vessel, usually an artery, more usually a carotid artery at or near the carotid sinus.
  • substantially portion it is meant that the base will extend over at least 25% of the vessel circumference, usually at least 50%, more usually at least 66%, and often at least 75% or over the entire circumference.
  • the base is sufficiently elastic to conform to said circumference or portion thereof when placed therearound.
  • the electrode connected to the base is oriented at least partly in the circumferential direction and is sufficiently stretchable to both conform to the shape of the carotid sinus when the base is conformed thereover and accommodate changes in the shape and size of the sinus as they vary over time with heart pulse and other factors, including body movement which causes the blood vessel circumference to change.
  • the electrode(s) may extend over the entire length of the base, but in some cases will extend over less than 75% of the circumferential length of the base, often being less than 50% of the circumferential length, and sometimes less than 25% of the circumferential length.
  • the electrode structures may cover from a small portion up to the entire circumferential length of the carotid artery or other blood vessel.
  • the circumferential length of the elongate electrodes will cover at least 10% of the circumference of the blood vessel, typically being at least 25%, often at least 50%, 75%, or the entire length.
  • the base will usually have first and second ends, wherein the ends are adapted to be joined, and will have sufficient structural integrity to grasp the carotid sinus.
  • an extravascular electrode assembly comprises an elastic base and a stretchable electrode.
  • the elastic base is adapted to be conformably attached over the outside of a target blood vessel, such as a carotid artery at or near the carotid sinus, and the stretchable electrode is secured over the elastic base and capable of expanding and contracting together with the base.
  • the electrode assembly is conformable to the exterior of the carotid sinus or other blood vessel.
  • the elastic base is planar, typically comprising an elastomeric sheet. While the sheet may be reinforced, the reinforcement will be arranged so that the sheet remains elastic and stretchable, at least in the circumferential direction, so that the base and electrode assembly may be placed and conformed over the exterior of the blood vessel.
  • Suitable elastomeric sheets may be composed of silicone, latex, and the like.
  • the assembly will usually include two or more attachment tabs extending from the elastomeric sheet at locations which allow the tabs to overlap the elastic base and/or be directly attached to the blood vessel wall when the base is wrapped around or otherwise secured over a blood vessel. In this way, the tabs may be fastened to secure the backing over the blood vessel.
  • Preferred stretchable electrodes comprise elongated coils, where the coils may stretch and shorten in a spring-like manner.
  • the elongated coils will be flattened over at least a portion of their lengths, where the flattened portion is oriented in parallel to the elastic base. The flattened coil provides improved electrical contact when placed against the exterior of the carotid sinus or other blood vessel.
  • an extravascular electrode assembly comprises a base and an electrode structure.
  • the base is adapted to be attached over the outside of a carotid artery or other blood vessel and has an electrode-carrying surface formed over at least a portion thereof.
  • a plurality of attachment tabs extend away from the electrode-carrying surface, where the tabs are arranged to permit selective ones thereof to be wrapped around a blood vessel while others of the tabs may be selectively removed.
  • the electrode structure on or over the electrode-carrying surface.
  • the base includes at least one tab which extends longitudinally from the electrode-carrying surface and at least two tabs which extend away from the surface at opposite, transverse angles.
  • the electrode-carrying surface is rectangular, and at least two longitudinally extending tabs extend from adjacent corners of the rectangular surface. The two transversely angled tabs extend at a transverse angle away from the same two corners.
  • the electrode structure preferably includes one or more stretchable electrodes secured to the electrode-carrying surface.
  • the stretchable electrodes are preferably elongated coils, more preferably being “flattened coils” to enhance electrical contact with the blood vessel to be treated.
  • the base is preferably an elastic base, more preferably being formed from an elastomeric sheet.
  • the phrase “flattened coil,” as used herein, refers to an elongate electrode structure including a plurality of successive turns where the cross-sectional profile is non-circular and which includes at least one generally flat or minimally curved face. Such coils may be formed by physically deforming (flattening) a circular coil, e.g., as shown in FIG. 24 described below.
  • the flattened coils will have a cross-section that has a width in the plane of the electrode assembly greater than its height normal to the electrode assembly plane.
  • the coils may be initially fabricated in the desired geometry having one generally flat (or minimally curved) face for contacting tissue.
  • Fully flattened coils e.g., those having planar serpentine configurations, may also find use, but usually it will be preferred to retain at least some thickness in the direction normal to the flat or minimally curved tissue-contacting surface. Such thickness helps the coiled electrode protrude from the base and provide improved tissue contact over the entire flattened surface.
  • a method for wrapping an electrode assembly over a blood vessel comprises providing an electrode assembly having an elastic base and one or more stretchable electrodes.
  • the base is conformed over an exterior of the blood vessel, such as a carotid artery, and at least a portion of an electrode is stretched along with the base. Ends of the elastic base are secured together to hold the electrode assembly in place, typically with both the elastic backing and stretchable electrode remaining under at least slight tension to promote conformance to the vessel exterior.
  • the electrode assembly will be located over a target site in the blood vessel, typically a target site having an electrically activated receptor.
  • the electrode structures of the present invention when wrapped under tension will flex and stretch with expansions and contractions of the blood vessel.
  • a presently preferred target site is a baroreceptor, particularly baroreceptors in or near the carotid sinus.
  • a method for wrapping an electrode assembly over a blood vessel comprises providing an electrode assembly including a base having an electrode-carrying surface and an electrode structure on the electrode-carrying surface.
  • the base is wrapped over a blood vessel, and some but not all of a plurality of attachment tags on the base are secured over the blood vessel.
  • the tabs which are not used to secure an electrode assembly will be removed, typically by cutting.
  • Preferred target sites are electrically activated receptors, usually baroreceptors, more usually baroreceptors on the carotid sinus.
  • the use of such electrode assemblies having multiple attachment tabs is particularly beneficial when securing the electrode assembly on a carotid artery near the carotid sinus.
  • the active electrode area can be positioned at any of a variety of locations on the common, internal, and/or external carotid arteries.
  • the present invention comprises pressure measuring assemblies including an elastic base adapted to be mounted on the outer wall of a blood vessel under circumferential tension.
  • a strain measurement sensor is positioned on the base to measure strain resulting from circumferential expansion of the vessel due to a blood pressure increase.
  • the base will wrap about the entire circumference of the vessel, although only a portion of the base need be elastic.
  • a smaller base may be stapled, glued, clipped or otherwise secured over a “patch” of the vessel wall to detect strain variations over the underlying surface.
  • Exemplary sensors include strain gauges and micro machined sensors (MEMS).
  • electrode assemblies according to the present invention comprise a base and at least three parallel elongate electrode structures secured over a surface of the base.
  • the base is attachable to an outside surface of a blood vessel, such as a carotid artery, particularly a carotid artery near the carotid sinus, and has a length sufficient to extend around at least a substantial portion of the circumference of the blood vessel, typically extending around at least 25% of the circumference, usually extending around at least 50% of the circumference, preferably extending at least 66% of the circumference, and often extending around at least 75% of or the entire circumference of the blood vessel.
  • the base will preferably be elastic and composed of any of the materials set forth previously.
  • the at least three parallel elongate electrode structures will preferably be aligned in the circumferential direction of the base, i.e., the axis or direction of the base which will be aligned circumferentially over the blood vessel when the base is mounted on the blood vessel.
  • the electrode structures will preferably be stretchable, typically being elongate coils, often being flattened elongate coils, as also described previously.
  • At least an outer pair of the electrode structures will be electrically isolated from an inner electrode structure, and the outer electrode structures will preferably be arranged in a U-pattern in order to surround the inner electrode structure.
  • the outer pair of electrodes can be connected using a single conductor taken from the base, and the outer electrode structures and inner electrode structure may be connected to separate poles on a power supply in order to operate in the “pseudo” tripolar mode described hereinbelow.
  • the present invention provides electrode designs and methods utilizing such electrodes by which the blood pressure may be selectively and controllably regulated by inhibiting or dampening baroreceptor signals.
  • the present invention reduces conditions associated with low blood pressure.
  • FIG. 1 is a schematic illustration of the upper torso of a human body showing the major arteries and veins and associated anatomy.
  • FIG. 2A is a cross-sectional schematic illustration of the carotid sinus and baroreceptors within the vascular wall.
  • FIG. 2B is a schematic illustration of baroreceptors within the vascular wall and the baroreflex system.
  • FIG. 3 is a schematic illustration of a baroreceptor activation system in accordance with the present invention.
  • FIGS. 4A and 4B are schematic illustrations of a baroreceptor activation device in the form of an implantable extraluminal conductive structure which electrically induces a baroreceptor signal in accordance with an embodiment of the present invention.
  • FIGS. 5A-5F are schematic illustrations of various possible arrangements of electrodes around the carotid sinus for extravascular electrical activation embodiments.
  • FIG. 6 is a schematic illustration of a serpentine shaped electrode for extravascular electrical activation embodiments.
  • FIG. 7 is a schematic illustration of a plurality of electrodes aligned orthogonal to the direction of wrapping around the carotid sinus for extravascular electrical activation embodiments.
  • FIGS. 8-11 are schematic illustrations of various multi-channel electrodes for extravascular electrical activation embodiments.
  • FIG. 12 is a schematic illustration of an extravascular electrical activation device including a tether and an anchor disposed about the carotid sinus and common carotid artery.
  • FIG. 13 is a schematic illustration of an alternative extravascular electrical activation device including a plurality of ribs and a spine.
  • FIG. 14 is a schematic illustration of an electrode assembly for extravascular electrical activation embodiments.
  • FIG. 15 is a schematic illustration of a fragment of an alternative cable for use with an electrode assembly such as shown in FIG. 14 .
  • FIG. 16 illustrates a foil strain gauge for measuring expansion force of a carotid artery or other blood vessel.
  • FIG. 17 illustrates a transducer which is adhesively connected to the wall of an artery.
  • FIG. 18 is a cross-sectional view of the transducer of FIG. 17 .
  • FIG. 19 illustrates a first exemplary electrode assembly having an elastic base and plurality of attachment tabs.
  • FIG. 20 is a more detailed illustration of the electrode-carrying surface of the electrode assembly of FIG. 19 .
  • FIG. 21 is a detailed illustration of electrode coils which are present in an elongate lead of the electrode assembly of FIG. 19 .
  • FIG. 22 is a detailed view of the electrode-carrying surface of an electrode assembly similar to that shown in FIG. 20 , except that the electrodes have been flattened.
  • FIG. 23 is a cross-sectional view of the electrode structure of FIG. 22 .
  • FIG. 24 illustrates the transition between the flattened and non-flattened regions of the electrode coil of the electrode assembly FIG. 20 .
  • FIG. 25 is a cross-sectional view taken along the line 25 - 25 of FIG. 24 .
  • FIG. 26 is a cross-sectional view taken along the line 26 - 26 of FIG. 24 .
  • FIG. 27 is an illustration of a further exemplary electrode assembly constructed in accordance with the principles of the present invention.
  • FIG. 28 illustrates the electrode assembly of FIG. 27 wrapped around the common carotid artery near the carotid bifurcation.
  • FIG. 29 illustrates the electrode assembly of FIG. 27 wrapped around the internal carotid artery.
  • FIG. 30 is similar to FIG. 29 , but with the carotid bifurcation having a different geometry.
  • FIG. 1 is a schematic illustration of the upper torso of a human body 10 showing some of the major arteries and veins of the cardiovascular system.
  • the left ventricle of the heart 11 pumps oxygenated blood up into the aortic arch 12 .
  • the right subclavian artery 13 , the right common carotid artery 14 , the left common carotid artery 15 and the left subclavian artery 16 branch off the aortic arch 12 proximal of the descending thoracic aorta 17 .
  • brachiocephalic artery 22 connects the right subclavian artery 13 and the right common carotid artery 14 to the aortic arch 12 .
  • the right carotid artery 14 bifurcates into the right external carotid artery 18 and the right internal carotid artery 19 at the right carotid sinus 20 .
  • the left carotid artery 15 similarly bifurcates into the left external carotid artery and the left internal carotid artery at the left carotid sinus.
  • oxygenated blood flows into the carotid arteries 18 / 19 and the subclavian arteries 13 / 16 .
  • oxygenated blood circulates through the head and cerebral vasculature and oxygen depleted blood returns to the heart 11 by way of the jugular veins, of which only the right internal jugular vein 21 is shown for sake of clarity.
  • oxygenated blood circulates through the upper peripheral vasculature and oxygen depleted blood returns to the heart by way of the subclavian veins, of which only the right subclavian vein 23 is shown, also for sake of clarity.
  • the heart 11 pumps the oxygen depleted blood through the pulmonary system where it is reoxygenated.
  • the re-oxygenated blood returns to the heart 11 which pumps the re-oxygenated blood into the aortic arch as described above, and the cycle repeats.
  • baroreceptors 30 Within the arterial walls of the aortic arch 12 , common carotid arteries 14 / 15 (near the right carotid sinus 20 and left carotid sinus), subclavian arteries 13 / 16 and brachiocephalic artery 22 there are baroreceptors 30 .
  • baroreceptors 30 reside within the vascular walls of the carotid sinus 20 .
  • Baroreceptors 30 are a type of stretch receptor used by the body to sense blood pressure. An increase in blood pressure causes the arterial wall to stretch, and a decrease in blood pressure causes the arterial wall to return to its original size. Such a cycle is repeated with each beat of the heart.
  • baroreceptors 30 are located within the arterial wall, they are able to sense deformation of the adjacent tissue, which is indicative of a change in blood pressure.
  • the baroreceptors 30 located in the right carotid sinus 20 , the left carotid sinus and the aortic arch 12 play the most significant role in sensing blood pressure that affects the baroreflex system 50 , which is described in more detail with reference to FIG. 2B .
  • FIG. 2B shows a schematic illustration of baroreceptors 30 disposed in a generic vascular wall 40 and a schematic flow chart of the baroreflex system 50 .
  • Baroreceptors 30 are profusely distributed within the arterial walls 40 of the major arteries discussed previously, and generally form an arbor 32 .
  • the baroreceptor arbor 32 comprises a plurality of baroreceptors 30 , each of which transmits baroreceptor signals to the brain 52 via nerve 38 .
  • the baroreceptors 30 are so profusely distributed and arborized within the vascular wall 40 that discrete baroreceptor arbors 32 are not readily discernable.
  • FIG. 2B are primarily schematic for purposes of illustration and discussion.
  • Baroreceptor signals are used to activate a number of body systems which collectively may be referred to as the baroreflex system 50 .
  • Baroreceptors 30 are connected to the brain 52 via the nervous system 51 .
  • the brain 52 is able to detect changes in blood pressure, which is indicative of cardiac output. If cardiac output is insufficient to meet demand (i.e., the heart 11 is unable to pump sufficient blood), the baroreflex system 50 activates a number of body systems, including the heart 11 , kidneys 53 , vessels 54 , and other organs/tissues. Such activation of the baroreflex system 50 generally corresponds to an increase in neurohormonal activity.
  • the baroreflex system 50 initiates a neurohormonal sequence that signals the heart 11 to increase heart rate and increase contraction force in order to increase cardiac output, signals the kidneys 53 to increase blood volume by retaining sodium and water, and signals the vessels 54 to constrict to elevate blood pressure.
  • the cardiac, renal and vascular responses increase blood pressure and cardiac output 55 , and thus increase the workload of the heart 11 . In a patient with heart failure, this further accelerates myocardial damage and exacerbates the heart failure state.
  • the present invention basically provides a number of devices, systems and methods by which the baroreflex system 50 is activated to reduce excessive blood pressure, autonomic nervous system activity and neurohormonal activation.
  • the present invention provides a number of devices, systems and methods by which baroreceptors 30 may be activated, thereby indicating an increase in blood pressure and signaling the brain 52 to reduce the body's blood pressure and level of sympathetic nervous system and neurohormonal activation, and increase parasypathetic nervous system activation, thus having a beneficial effect on the cardiovascular system and other body systems.
  • the present invention generally provides a system including a control system 60 , a baroreceptor activation device 70 , and a sensor 80 (optional), which generally operate in the following manner.
  • the sensor(s) 80 optionally senses and/or monitors a parameter (e.g., cardiovascular function) indicative of the need to modify the baroreflex system and generates a signal indicative of the parameter.
  • the control system 60 generates a control signal as a function of the received sensor signal.
  • the control signal activates, deactivates or otherwise modulates the baroreceptor activation device 70 .
  • activation of the device 70 results in activation of the baroreceptors 30 .
  • deactivation or modulation of the baroreceptor activation device 70 may cause or modify activation of the baroreceptors 30 .
  • the baroreceptor activation device 70 may comprise a wide variety of devices which utilize electrical means to activate baroreceptors 30 .
  • the control system 60 when the sensor 80 detects a parameter indicative of the need to modify the baroreflex system activity (e.g., excessive blood pressure), the control system 60 generates a control signal to modulate (e.g. activate) the baroreceptor activation device 70 thereby inducing a baroreceptor 30 signal that is perceived by the brain 52 to be apparent excessive blood pressure.
  • the control system 60 When the sensor 80 detects a parameter indicative of normal body function (e.g., normal blood pressure), the control system 60 generates a control signal to modulate (e.g., deactivate) the baroreceptor activation device 70 .
  • the baroreceptor activation device 70 may comprise a wide variety of devices which utilize electrical means to activate the baroreceptors 30 .
  • the baroreceptor activation device 70 of the present invention comprises an electrode structure which directly activates one or more baroreceptors 30 by changing the electrical potential across the baroreceptors 30 . It is possible that changing the electrical potential across the tissue surrounding the baroreceptors 30 may cause the surrounding tissue to stretch or otherwise deform, thus mechanically activating the baroreceptors 30 , in which case the stretchable and elastic electrode structures of the present invention may provide significant advantages.
  • the baroreceptor activation device 70 may be positioned anywhere baroreceptors 30 are present. Such potential implantation sites are numerous, such as the aortic arch 12 , in the common carotid arteries 18 / 19 near the carotid sinus 20 , in the subclavian arteries 13 / 16 , in the brachiocephalic artery 22 , or in other arterial or venous locations.
  • the electrode structures of the present invention will be implanted such that they are positioned on or over a vascular structure immediately adjacent the baroreceptors 30 .
  • the electrode structure of the baroreceptor activation device 70 is implanted near the right carotid sinus 20 and/or the left carotid sinus (near the bifurcation of the common carotid artery) and/or the aortic arch 12 , where baroreceptors 30 have a significant impact on the baroreflex system 50 .
  • the present invention is described with reference to baroreceptor activation device 70 positioned near the carotid sinus 20 .
  • the optional sensor 80 is operably coupled to the control system 60 by electric sensor cable or lead 82 .
  • the sensor 80 may comprise any suitable device that measures or monitors a parameter indicative of the need to modify the activity of the baroreflex system.
  • the sensor 80 may comprise a physiologic transducer or gauge that measures ECG, blood pressure (systolic, diastolic, average or pulse pressure), blood volumetric flow rate, blood flow velocity, blood pH, O2 or CO2 content, mixed venous oxygen saturation (SVO2), vasoactivity, nerve activity, tissue activity, body movement, activity levels, respiration, or composition.
  • suitable transducers or gauges for the sensor 80 include ECG electrodes, a piezoelectric pressure transducer, an ultrasonic flow velocity transducer, an ultrasonic volumetric flow rate transducer, a thermodilution flow velocity transducer, a capacitive pressure transducer, a membrane pH electrode, an optical detector (SVO2), tissue impedance (electrical), or a strain gauge. Although only one sensor 80 is shown, multiple sensors 80 of the same or different type at the same or different locations may be utilized.
  • An example of an implantable blood pressure measurement device that may be disposed about a blood vessel is disclosed in U.S. Pat. No. 6,106,477 to Miesel et al., the entire disclosure of which is incorporated herein by reference.
  • An example of a subcutaneous ECG monitor is available from Medtronic under the trade name REVEAL ILR and is disclosed in PCT Publication No. WO 98/02209, the entire disclosure of which is incorporated herein by reference.
  • Other examples are disclosed in U.S. Pat. Nos. 5,987,352 and 5,331,966, the entire disclosures of which are incorporated herein by reference. Examples of devices and methods for measuring absolute blood pressure utilizing an ambient pressure reference are disclosed in U.S. Pat. No.
  • the sensor 80 is preferably positioned in a chamber of the heart 11 , or in/on a major artery such as the aortic arch 12 , a common carotid artery 14 / 15 , a subclavian artery 13 / 16 or the brachiocephalic artery 22 , such that the parameter of interest may be readily ascertained.
  • the sensor 80 may be disposed inside the body such as in or on an artery, a vein or a nerve (e.g. vagus nerve), or disposed outside the body, depending on the type of transducer or gauge utilized.
  • the sensor 80 may be separate from the baroreceptor activation device 70 or combined therewith. For purposes of illustration only, the sensor 80 is shown positioned on the right subclavian artery 13 .
  • control system 60 includes a control block 61 comprising a processor 63 and a memory 62 .
  • Control system 60 is connected to the sensor 80 by way of sensor cable 82 .
  • Control system 60 is also connected to the baroreceptor activation device 70 by way of electric control cable 72 .
  • the control system 60 receives a sensor signal from the sensor 80 by way of sensor cable 82 , and transmits a control signal to the baroreceptor activation device 70 by way of control cable 72 .
  • the system components 60 / 70 / 80 may be directly linked via cables 72 / 82 or by indirect means such as RF signal transceivers, ultrasonic transceivers or galvanic couplings. Examples of such indirect interconnection devices are disclosed in U.S. Pat. No. 4,987,897 to Funke and U.S. Pat. No. 5,113,859 to Funke, the entire disclosures of which are incorporated herein by reference.
  • the memory 62 may contain data related to the sensor signal, the control signal, and/or values and commands provided by the input device 64 .
  • the memory 62 may also include software containing one or more algorithms defining one or more functions or relationships between the control signal and the sensor signal.
  • the algorithm may dictate activation or deactivation control signals depending on the sensor signal or a mathematical derivative thereof
  • the algorithm may dictate an activation or deactivation control signal when the sensor signal falls below a lower predetermined threshold value, rises above an upper predetermined threshold value or when the sensor signal indicates a specific physiologic event.
  • the algorithm may dynamically alter the threshold value as determined by the sensor input values.
  • the baroreceptor activation device 70 activates baroreceptors 30 electrically, optionally in combination with mechanical, thermal, chemical, biological or other co-activation.
  • the control system 60 includes a driver 66 to provide the desired power mode for the baroreceptor activation device 70 .
  • the driver 66 may comprise a power amplifier or the like and the cable 72 may comprise electrical lead(s).
  • the driver 66 may not be necessary, particularly if the processor 63 generates a sufficiently strong electrical signal for low level electrical actuation of the baroreceptor activation device 70 .
  • the control system 60 may operate as a closed loop utilizing feedback from the sensor 80 , or other sensors, such as heart rate sensors which may be incorporated or the electrode assembly, or as an open loop utilizing reprogramming commands received by input device 64 .
  • the closed loop operation of the control system 60 preferably utilizes some feedback from the transducer 80 , but may also operate in an open loop mode without feedback.
  • Programming commands received by the input device 64 may directly influence the control signal, the output activation parameters, or may alter the software and related algorithms contained in memory 62 .
  • the treating physician and/or patient may provide commands to input device 64 .
  • Display 65 may be used to view the sensor signal, control signal and/or the software/data contained in memory 62 .
  • the control signal generated by the control system 60 may be continuous, periodic, alternating, episodic or a combination thereof, as dictated by an algorithm contained in memory 62 .
  • Continuous control signals include a constant pulse, a constant train of pulses, a triggered pulse and a triggered train of pulses.
  • periodic control signals include each of the continuous control signals described above which have a designated start time (e.g., beginning of each period as designated by minutes, hours, or days in combinations of) and a designated duration (e.g., seconds, minutes, hours, or days in combinations of).
  • Examples of alternating control signals include each of the continuous control signals as described above which alternate between the right and left output channels.
  • Examples of episodic control signals include each of the continuous control signals described above which are triggered by an episode (e.g., activation by the physician/patient, an increase/decrease in blood pressure above a certain threshold, heart rate above/below certain levels, etc.).
  • the stimulus regimen governed by the control system 60 may be selected to promote long term efficacy. It is theorized that uninterrupted or otherwise unchanging activation of the baroreceptors 30 may result in the baroreceptors and/or the baroreflex system becoming less responsive over time, thereby diminishing the long term effectiveness of the therapy. Therefore, the stimulus regimen maybe selected to activate, deactivate or otherwise modulate the baroreceptor activation device 70 in such a way that therapeutic efficacy is maintained preferably for years.
  • the stimulus regimens of the present invention may be selected reduce power requirement/consumption of the system 60 .
  • the stimulus regimen may dictate that the baroreceptor activation device 70 be initially activated at a relatively higher energy and/or power level, and subsequently activated at a relatively lower energy and/or power level.
  • the first level attains the desired initial therapeutic effect
  • the second (lower) level sustains the desired therapeutic effect long term.
  • the energy required or consumed by the activation device 70 is also reduced long term. This may correlate into systems having greater longevity and/or reduced size (due to reductions in the size of the power supply and associated components).
  • a first general approach for a stimulus regimen which promotes long term efficacy and reduces power requirements/consumption involves generating a control signal to cause the baroreceptor activation device 70 to have a first output level of relatively higher energy and/or power, and subsequently changing the control signal to cause the baroreceptor activation device 70 to have a second output level of relatively lower energy and/or power.
  • the first output level may be selected and maintained for sufficient time to attain the desired initial effect (e.g., reduced heart rate and/or blood pressure), after which the output level may be reduced to the second level for sufficient time to sustain the desired effect for the desired period of time.
  • the second output level may have a power and/or energy value of X 2 , wherein X 2 is less than X 1 .
  • X 2 may be equal to zero, such that the first level is “on” and the second level is “off”.
  • power and energy refer to two different parameters, and in some cases, a change in one of the parameters (power or energy) may not correlate to the same or similar change in the other parameter. In the present invention, it is contemplated that a change in one or both of the parameters may be suitable to obtain the desired result of promoting long term efficacy.
  • each further level may increase the output energy or power to attain the desired effect, or decrease the output energy or power to retain the desired effect. For example, in some instances, it may be desirable to have further reductions in the output level if the desired effect may be sustained at lower power or energy levels. In other instances, particularly when the desired effect is diminishing or is otherwise not sustained, it may be desirable to increase the output level until the desired effect is reestablished, and subsequently decrease the output level to sustain the effect.
  • the transition from each level may be a step function (e.g., a single step or a series of steps), a gradual transition over a period of time, or a combination thereof.
  • the signal levels may be continuous, periodic, alternating, or episodic as discussed previously.
  • the output (power or energy) level of the baroreceptor activation device 70 may be changed by adjusting the output signal voltage level, current level and/or signal duration.
  • the output signal of the baroreceptor activation device 70 may be, for example, constant current or constant voltage.
  • several pulse characteristics may be changed individually or in combination to change the power or energy level of the output signal.
  • Such pulse characteristics include, but are not limited to: pulse amplitude (PA), pulse frequency (PF), pulse width or duration (PW), pulse waveform (square, triangular, sinusoidal, etc.), pulse polarity (for bipolar electrodes) and pulse phase (monophasic, biphasic).
  • FIGS. 4A and 4B show schematic illustrations of a baroreceptor activation device 300 in the form of an extravascular electrically conductive structure or electrode 302 .
  • the electrode structure 302 may comprise a coil, braid or other structure capable of surrounding the vascular wall. Alternatively, the electrode structure 302 may comprise one or more electrode patches distributed around the outside surface of the vascular wall. Because the electrode structure 302 is disposed on the outside surface of the vascular wall, intravascular delivery techniques may not be practical, but minimally invasive surgical techniques will suffice.
  • the extravascular electrode structure 302 may receive electrical signals directly from the driver 66 of the control system 60 by way of electrical lead 304 , or indirectly by utilizing an inductor (not shown) as described in copending commonly assigned application Ser. No. 10/402,393 (Attorney Docket No. 21433-000420), filed on the same day as the present application, the full disclosure of which is incorporated herein by reference.
  • FIGS. 5A-5F show schematic illustrations of various possible arrangements of electrodes around the carotid sinus 20 for extravascular electrical activation embodiments, such as baroreceptor activation device 300 described with reference to FIGS. 4A and 4B .
  • the electrode designs illustrated and described hereinafter may be particularly suitable for connection to the carotid arteries at or near the carotid sinus, and may be designed to minimize extraneous tissue stimulation.
  • the carotid arteries are shown, including the common 14 , the external 18 and the internal 19 carotid arteries.
  • the location of the carotid sinus 20 may be identified by a landmark bulge 21 , which is typically located on the internal carotid artery 19 just distal of the bifurcation, or extends across the bifurcation from the common carotid artery 14 to the internal carotid artery 19 .
  • the carotid sinus 20 and in particular the bulge 21 of the carotid sinus, may contain a relatively high density of baroreceptors 30 (not shown) in the vascular wall. For this reason, it may be desirable to position the electrodes 302 of the activation device 300 on and/or around the sinus bulge 21 to maximize baroreceptor responsiveness and to minimize extraneous tissue stimulation.
  • the device 300 and electrodes 302 are merely schematic, and only a portion of which may be shown, for purposes of illustrating various positions of the electrodes 302 on and/or around the carotid sinus 20 and the sinus bulge 21 .
  • the electrodes 302 may be monopolar, bipolar, or tripolar (anode-cathode-anode or cathode-anode-cathode sets). Specific extravascular electrode designs are described in more detail hereinafter.
  • the electrodes 302 of the extravascular electrical activation device 300 extend around a portion or the entire circumference of the sinus 20 in a circular fashion. Often, it would be desirable to reverse the illustrated electrode configuration in actual use.
  • the electrodes 302 of the extravascular electrical activation device 300 extend around a portion or the entire circumference of the sinus 20 in a helical fashion. In the helical arrangement shown in FIG. 5B , the electrodes 302 may wrap around the sinus 20 any number of times to establish the desired electrode 302 contact and coverage. In the circular arrangement shown in FIG. 5A , a single pair of electrodes 302 may wrap around the sinus 20 , or a plurality of electrode pairs 302 may be wrapped around the sinus 20 as shown in FIG. 5C to establish more electrode 302 contact and coverage.
  • the plurality of electrode pairs 302 may extend from a point proximal of the sinus 20 or bulge 21 , to a point distal of the sinus 20 or bulge 21 to ensure activation of baroreceptors 30 throughout the sinus 20 region.
  • the electrodes 302 may be connected to a single channel or multiple channels as discussed in more detail hereinafter.
  • the plurality of electrode pairs 302 may be selectively activated for purposes of targeting a specific area of the sinus 20 to increase baroreceptor responsiveness, or for purposes of reducing the exposure of tissue areas to activation to maintain baroreceptor responsiveness long term.
  • the electrodes 302 extend around the entire circumference of the sinus 20 in a criss cross fashion.
  • the criss cross arrangement of the electrodes 302 establishes contact with both the internal 19 and external 18 carotid arteries around the carotid sinus 20 .
  • the electrodes 302 extend around all or a portion of the circumference of the sinus 20 , including the internal 19 and external 18 carotid arteries at the bifurcation, and in some instances the common carotid artery 14 .
  • the electrodes 302 extend around all or a portion of the circumference of the sinus 20 , including the internal 19 and external 18 carotid arteries distal of the bifurcation.
  • the extravascular electrical activation devices 300 are shown to include a substrate or base structure 306 which may encapsulate and insulate the electrodes 302 and may provide a means for attachment to the sinus 20 as described in more detail hereinafter.
  • the electrodes 302 of the activation device 300 there are a number of suitable arrangements for the electrodes 302 of the activation device 300 , relative to the carotid sinus 20 and associated anatomy.
  • the electrodes 302 are wrapped around a portion of the carotid structure, which may require deformation of the electrodes 302 from their relaxed geometry (e.g., straight).
  • the electrodes 302 and/or the base structure 306 may have a relaxed geometry that substantially conforms to the shape of the carotid anatomy at the point of attachment.
  • the electrodes 302 and the base structure or backing 306 may be pre shaped to conform to the carotid anatomy in a substantially relaxed state.
  • the electrodes 302 may have a geometry and/or orientation that reduces the amount of electrode 302 strain.
  • the backing or base structure 306 may be elastic or stretchable to facilitate wrapping of and conforming to the carotid sinus or other vascular structure.
  • the electrodes 302 are shown to have a serpentine or wavy shape.
  • the serpentine shape of the electrodes 302 reduces the amount of strain seen by the electrode material when wrapped around a carotid structure.
  • the serpentine shape of the electrodes increases the contact surface area of the electrode 302 with the carotid tissue.
  • the electrodes 302 may be arranged to be substantially orthogonal to the wrap direction (i.e., substantially parallel to the axis of the carotid arteries) as shown in FIG. 7 .
  • the electrodes 302 each have a length and a width or diameter, wherein the length is substantially greater than the width or diameter.
  • the electrodes 302 each have a longitudinal axis parallel to the length thereof, wherein the longitudinal axis is orthogonal to the wrap direction and substantially parallel to the longitudinal axis of the carotid artery about which the device 300 is wrapped. As with the multiple electrode embodiments described previously, the electrodes 302 may be connected to a single channel or multiple channels as discussed in more detail hereinafter.
  • FIGS. 8-11 schematically illustrate various multi-channel electrodes for the extravascular electrical activation device 300 .
  • FIG. 8 illustrates a six (6) channel electrode assembly including six (6) separate elongate electrodes 302 extending adjacent to and parallel with each other.
  • the electrodes 302 are each connected to multi-channel cable 304 . Some of the electrodes 302 may be common, thereby reducing the number of conductors necessary in the cable 304 .
  • Base structure or substrate 306 may comprise a flexible and electrically insulating material suitable for implantation, such as silicone, perhaps reinforced with a flexible material such as polyester fabric.
  • the base 306 may have a length suitable to wrap around all (360.degree.) or a portion (i.e., less than 360.degree.) of the circumference of one or more of the carotid arteries adjacent the carotid sinus 20 .
  • the electrodes 302 may extend around a portion (i.e., less than 360.degree. such as 270.degree., 180.degree. or 90.degree.) of the circumference of one or more of the carotid arteries adjacent the carotid sinus 20 .
  • the electrodes 302 may have a length that is less than (e.g., 75%, 50% or 25%) the length of the base 206 .
  • the electrodes 302 may be parallel, orthogonal or oblique to the length of the base 306 , which is generally orthogonal to the axis of the carotid artery to which it is disposed about.
  • the base structure or backing will be elastic (i.e., stretchable), typically being composed of at least in part of silicone, latex, or other elastomer. If such elastic structures are reinforced, the reinforcement should be arranged so that it does not interfere with the ability of the base to stretch and conform to the vascular surface.
  • the electrodes 302 may comprise round wire, rectangular ribbon or foil formed of an electrically conductive and radiopaque material such as platinum.
  • the base structure 306 substantially encapsulates the electrodes 302 , leaving only an exposed area for electrical connection to extravascular carotid sinus tissue.
  • each electrode 302 may be partially recessed in the base 206 and may have one side exposed along all or a portion of its length for electrical connection to carotid tissue. Electrical paths through the carotid tissues may be defined by one or more pairs of the elongate electrodes 302 .
  • the multi-channel electrodes 302 may be selectively activated for purposes of mapping and targeting a specific area of the carotid sinus 20 to determine the best combination of electrodes 302 (e.g., individual pair, or groups of pairs) to activate for maximum baroreceptor responsiveness, as described elsewhere herein.
  • the multi-channel electrodes 302 may be selectively activated for purposes of reducing the exposure of tissue areas to activation to maintain long term efficacy as described, as described elsewhere herein. For these purposes, it may be useful to utilize more than two (2) electrode channels.
  • the electrodes 302 may be connected to a single channel whereby baroreceptors are uniformly activated throughout the sinus 20 region.
  • the device 300 includes sixteen (16) individual electrode pads 302 connected to 16 channel cable 304 via 4 channel connectors 303 .
  • the circular electrode pads 302 are partially encapsulated by the base structure 306 to leave one face of each button electrode 302 exposed for electrical connection to carotid tissues.
  • electrical paths through the carotid tissues may be defined by one or more pairs (bipolar) or groups (tripolar) of electrode pads 302 .
  • the device 300 includes sixteen (16) individual circular pad electrodes 302 surrounded by sixteen (16) rings 305 , which collectively may be referred to as concentric electrode pads 302 / 305 .
  • Pad electrodes 302 are connected to 17 channel cable 304 via 4 channel connectors 303
  • rings 305 are commonly connected to 17 channel cable 304 via a single channel connector 307 .
  • the circular shaped electrodes 302 and the rings 305 are partially encapsulated by the base structure 306 to leave one face of each pad electrode 302 and one side of each ring 305 exposed for electrical connection to carotid tissues.
  • two rings 305 may surround each electrode 302 , with the rings 305 being commonly connected. With these arrangements, electrical paths through the carotid tissues may be defined between one or more pad electrode 302 /ring 305 sets to create localized electrical paths.
  • the device 300 includes a control IC chip 310 connected to 3 channel cable 304 .
  • the control chip 310 is also connected to sixteen (16) individual pad electrodes 302 via 4 channel connectors 303 .
  • the control chip 310 permits the number of channels in cable 304 to be reduced by utilizing a coding system.
  • the control system 60 sends a coded control signal which is received by chip 310 .
  • the chip 310 converts the code and enables or disables selected electrode 302 pairs in accordance with the code.
  • control signal may comprise a pulse wave form, wherein each pulse includes a different code.
  • the code for each pulse causes the chip 310 to enable one or more pairs of electrodes, and to disable the remaining electrodes.
  • the pulse is only transmitted to the enabled electrode pair(s) corresponding to the code sent with that pulse.
  • Each subsequent pulse would have a different code than the preceding pulse, such that the chip 310 enables and disables a different set of electrodes 302 corresponding to the different code.
  • the IC chip 310 may be connected to feedback sensor 80 , taking advantage of the same functions as described with reference to FIG. 3 .
  • one or more of the electrodes 302 may be used as feedback sensors when not enabled for activation.
  • a feedback sensor electrode may be used to measure or monitor electrical conduction in the vascular wall to provide data analogous to an ECG.
  • such a feedback sensor electrode may be used to sense a change in impedance due to changes in blood volume during a pulse pressure to provide data indicative of heart rate, blood pressure, or other physiologic parameter.
  • FIG. 12 schematically illustrates an extravascular electrical activation device 300 including a support collar or anchor 312 .
  • the activation device 300 is wrapped around the internal carotid artery 19 at the carotid sinus 20
  • the support collar 312 is wrapped around the common carotid artery 14 .
  • the activation device 300 is connected to the support collar 312 by cables 304 , which act as a loose tether.
  • the collar 312 isolates the activation device from movements and forces transmitted by the cables 304 proximal of the support collar, such as may be encountered by movement of the control system 60 and/or driver 66 .
  • a strain relief (not shown) may be connected to the base structure 306 of the activation device 300 at the juncture between the cables 304 and the base 306 .
  • the base structure 306 of the activation device 300 may comprise molded tube, a tubular extrusion, or a sheet of material wrapped into a tube shape utilizing a suture flap 308 with sutures 309 as shown.
  • the base structure 306 may be formed of a flexible and biocompatible material such as silicone, which may be reinforced with a flexible material such as polyester fabric available under the trade name DACRON® to form a composite structure.
  • the inside diameter of the base structure 306 may correspond to the outside diameter of the carotid artery at the location of implantation, for example 6 to 8 mm.
  • the wall thickness of the base structure 306 may be very thin to maintain flexibility and a low profile, for example less than 1 mm. If the device 300 is to be disposed about a sinus bulge 21 , a correspondingly shaped bulge may be formed into the base structure for added support and assistance in positioning.
  • the electrodes 302 may comprise round wire, rectangular ribbon or foil, formed of an electrically conductive and radiopaque material such as platinum or platinum iridium.
  • the electrodes may be molded into the base structure 306 or adhesively connected to the inside diameter thereof, leaving a portion of the electrode exposed for electrical connection to carotid tissues.
  • the electrodes 302 may encompass less than the entire inside circumference (e.g., 300.degree.) of the base structure 306 to avoid shorting.
  • the electrodes 302 may have any of the shapes and arrangements described previously. For example, as shown in FIG. 12 , two rectangular ribbon electrodes 302 may be used, each having a width of 1 mm spaced 1.5 mm apart.
  • the support collar 312 may be formed similarly to base structure 306 .
  • the support collar may comprise molded tube, a tubular extrusion, or a sheet of material wrapped into a tube shape utilizing a suture flap 315 with sutures 313 as shown.
  • the support collar 312 may be formed of a flexible and biocompatible material such as silicone, which may be reinforced to form a composite structure.
  • the cables 304 are secured to the support collar 312 , leaving slack in the cables 304 between the support collar 312 and the activation device 300 .
  • sutures 311 may be used to maintain the position of the electrical activation device 300 relative to the carotid anatomy (or other vascular site containing baroreceptors).
  • Such sutures 311 may be connected to base structure 306 , and pass through all or a portion of the vascular wall.
  • the sutures 311 may be threaded through the base structure 306 , through the adventitia of the vascular wall, and tied. If the base structure 306 comprises a patch or otherwise partially surrounds the carotid anatomy, the corners and/or ends of the base structure may be sutured, with additional sutures evenly distributed therebetween.
  • a reinforcement material such as polyester fabric may be embedded in the silicone material.
  • other fixation means may be employed such as staples or a biocompatible adhesive, for example.
  • FIG. 13 schematically illustrates an alternative extravascular electrical activation device 300 including one or more electrode ribs 316 interconnected by spine 317 .
  • a support collar 312 having one or more (non electrode) ribs 316 may be used to isolate the activation device 300 from movements and forces transmitted by the cables 304 proximal of the support collar 312 .
  • the ribs 316 of the activation device 300 are sized to fit about the carotid anatomy, such as the internal carotid artery 19 adjacent the carotid sinus 20 .
  • the ribs 316 of the support collar 312 may be sized to fit about the carotid anatomy, such as the common carotid artery 14 proximal of the carotid sinus 20 .
  • the ribs 316 may be separated, placed on a carotid artery, and closed thereabout to secure the device 300 to the carotid anatomy.
  • Each of the ribs 316 of the device 300 includes an electrode 302 on the inside surface thereof for electrical connection to carotid tissues.
  • the ribs 316 provide insulating material around the electrodes 302 , leaving only an inside portion exposed to the vascular wall.
  • the electrodes 302 are coupled to the multi-channel cable 304 through spine 317 .
  • Spine 317 also acts as a tether to ribs 316 of the support collar 312 , which do not include electrodes since their function is to provide support.
  • the multi-channel electrode 302 functions discussed with reference to FIGS. 8-11 are equally applicable to this embodiment.
  • the ends of the ribs 316 may be connected (e.g., sutured) after being disposed about a carotid artery, or may remain open as shown. If the ends remain open, the ribs 316 may be formed of a relatively stiff material to ensure a mechanical lock around the carotid artery.
  • the ribs 316 may be formed of polyethylene, polypropylene, PTFE, or other similar insulating and biocompatible material.
  • the ribs 316 may be formed of a metal such as stainless steel or a nickel titanium alloy, as long as the metallic material was electrically isolated from the electrodes 302 .
  • the ribs 316 may comprise an insulating and biocompatible polymeric material with the structural integrity provided by metallic (e.g., stainless steel, nickel titanium alloy, etc.) reinforcement.
  • metallic e.g., stainless steel, nickel titanium alloy, etc.
  • the electrodes 302 may comprise the metallic reinforcement.
  • the base structure 306 comprises a silicone sheet having a length of 5.0 inches, a thickness of 0.007 inches, and a width of 0.312 inches.
  • the electrodes 302 comprise platinum ribbon having a length of 0.47 inches, a thickness of 0.0005 inches, and a width of 0.040 inches.
  • the electrodes 302 are adhesively connected to one side of the silicone sheet 306 .
  • the electrodes 302 are connected to a modified bipolar endocardial pacing lead, available under the trade name CONIFIX from Innomedica (now BIOMEC Cardiovascular, Inc.), model number 501112.
  • the proximal end of the cable 304 is connected to the control system 60 or driver 66 as described previously.
  • the pacing lead is modified by removing the pacing electrode to form the cable body 304 .
  • the MP35 wires are extracted from the distal end thereof to form two coils 318 positioned side by side having a diameter of about 0.020 inches.
  • the coils 318 are then attached to the electrodes utilizing 316 type stainless steel crimp terminals laser welded to one end of the platinum electrodes 302 .
  • the distal end of the cable 304 and the connection between the coils 318 and the ends of the electrodes 302 are encapsulated by silicone.
  • the cable 304 illustrated in FIG. 14 comprises a coaxial type cable including two coaxially disposed coil leads separated into two separate coils 318 for attachment to the electrodes 302 .
  • An alternative cable 304 construction is illustrated in FIG. 15 .
  • FIG. 15 illustrates an alternative cable body 304 which may be formed in a curvilinear shape such as a sinusoidal configuration, prior to implantation.
  • the curvilinear configuration readily accommodates a change in distance between the device 300 and the control system 60 or the driver 66 . Such a change in distance may be encountered during flexion and/or extension of the neck of the patient after implantation.
  • the cable body 304 may comprise two or more conductive wires 304 a arranged coaxially or collinearly as shown.
  • Each conductive wire 304 a may comprise a multifilament structure of suitable conductive material such as stainless steel or MP35N.
  • An insulating material may surround the wire conductors 304 a individually and/or collectively.
  • a pair of electrically conductive wires 304 a having an insulating material surrounding each wire 304 a individually is shown.
  • the insulated wires 304 a may be connected by a spacer 304 b comprising, for example, an insulating material.
  • An additional jacket of suitable insulating material may surround each of the conductors 304 a .
  • the insulating jacket may be formed to have the same curvilinear shape of the insulated wires 304 a to help maintain the shape of the cable body 304 during implantation.
  • the amplitude (A) may range from 1 mm to 10 mm, and preferably ranges from 2 mm to 3 mm.
  • the wavelength (WL) of the sinusoid may range from 2 mm to 20 mm, and preferably ranges from 4 mm to 10 mm.
  • the curvilinear or sinusoidal shape may be formed by a heat setting procedure utilizing a fixture which holds the cable 304 in the desired shape while the cable is exposed to heat. Sufficient heat is used to heat set the conductive wires 304 a and/or the surrounding insulating material. After cooling, the cable 304 may be removed from the fixture, and the cable 304 retains the desired shape.
  • FIGS. 16-18 illustrate various transducers that may be mounted to the wall of a vessel such as a carotid artery 14 to monitor wall expansion or contraction using strain, force and/or pressure gauges.
  • a vessel such as a carotid artery 14
  • strain, force and/or pressure gauges An example of an implantable blood pressure measurement device that may be disposed about a blood vessel is disclosed in U.S. Pat. No. 6,106,477 to Miesel et al., the entire disclosure of which is incorporated herein by reference.
  • the output from such gauges may be correlated to blood pressure and/or heart rate, for example, and may be used to provide feedback to the control system 60 as described previously herein.
  • an implantable pressure measuring assembly comprises a foil strain gauge or force sensing resistor device 740 disposed about an artery such as common carotid artery 14 .
  • a transducer portion 742 may be mounted to a silicone base or backing 744 which is wrapped around and sutured or otherwise attached to the artery 14 .
  • the transducer 750 may be adhesively connected to the wall of the artery 14 using a biologically compatible adhesive such as cyanoacrylate as shown in FIG. 17 .
  • the transducer 750 comprises a micro machined sensor (MEMS) that measures force or pressure.
  • MEMS micro machined sensor
  • the MEMS transducer 750 includes a micro arm 752 (shown in section in FIG. 18 ) coupled to a silicon force sensor contained over an elastic base 754 .
  • a cap 756 covers the arm 752 a top portion of the base 754 .
  • the base 754 include an interior opening creating access from the vessel wall 14 to the arm 752 .
  • An incompressible gel 756 fills the space between the arm 752 and the vessel wall 14 such that force is transmitted to the arm upon expansion and contraction of the vessel wall.
  • changes in blood pressure within the artery cause changes in vessel wall stress which are detected by the transducer and which may be correlated with the blood pressure.
  • FIGS. 19-21 illustrate an alternative extravascular electrical activation device 700 , which, may also be referred to as an electrode cuff device or more generally as an “electrode assembly.” Except as described herein and shown in the drawings, device 700 may be the same in design and function as extravascular electrical activation device 300 described previously.
  • electrode assembly or cuff device 700 includes coiled electrode conductors 702 / 704 embedded in a flexible support 706 .
  • an outer electrode coil 702 and an inner electrode coil 704 are used to provide a pseudo tripolar arrangement, but other polar arrangements are applicable as well as described previously.
  • the coiled electrodes 702 / 704 may be formed of fine round, flat or ellipsoidal wire such as 0.002 inch diameter round PtIr alloy wire wound into a coil form having a nominal diameter of 0.015 inches with a pitch of 0.004 inches, for example.
  • the flexible support or base 706 may be formed of a biocompatible and flexible (preferably elastic) material such as silicone or other suitable thin walled elastomeric material having a wall thickness of 0.005 inches and a length (e.g., 2.95 inches) sufficient to surround the carotid sinus, for example.
  • a biocompatible and flexible (preferably elastic) material such as silicone or other suitable thin walled elastomeric material having a wall thickness of 0.005 inches and a length (e.g., 2.95 inches) sufficient to surround the carotid sinus, for example.
  • Each turn of the coil in the contact area of the electrodes 702 / 704 is exposed from the flexible support 706 and any adhesive to form a conductive path to the artery wall.
  • the exposed electrodes 702 / 704 may have a length (e.g., 0.236 inches) sufficient to extend around at least a portion of the carotid sinus, for example.
  • the electrode cuff 700 is assembled flat with the contact surfaces of the coil electrodes 702 / 704 tangent to the inside plane of the flexible support 706 . When the electrode cuff 700 is wrapped around the artery, the inside contact surfaces of the coiled electrodes 702 / 704 are naturally forced to extend slightly above the adjacent surface of the flexible support, thereby improving contact to the artery wall.
  • the ratio of the diameter of the coiled electrodes 702 / 704 to the wire diameter is preferably large enough to allow the coil to bend and elongate without significant bending stress or torsional stress in the wire. Flexibility is a significant advantage of this design which allows the electrode cuff 700 to conform to the shape of the carotid artery and sinus, and permits expansion and contraction of the artery or sinus without encountering significant stress or fatigue.
  • the flexible electrode cuff 700 may be wrapped around and stretched to conform to the shape of the carotid sinus and artery during implantation. This may be achieved without collapsing or distorting the shape of the artery and carotid sinus due to the compliance of the electrode cuff 700 .
  • the flexible support 706 is able to flex and stretch with the conductor coils 702 / 704 because of the absence of fabric reinforcement in the electrode contact portion of the cuff 700 .
  • the flexible support 706 By conforming to the artery shape, and by the edge of the flexible support 706 sealing against the artery wall, the amount of stray electrical field and extraneous stimulation will likely be reduced.
  • the pitch of the coil electrodes 702 / 704 may be greater than the wire diameter in order to provide a space between each turn of the wire to thereby permit bending without necessarily requiring axial elongation thereof.
  • the pitch of the contact coils 702 / 704 may be 0.004 inches per turn with a 0.002 inch diameter wire, which allows for a 0.002 inch space between the wires in each turn.
  • the inside of the coil may be filled with a flexible adhesive material such as silicone adhesive which may fill the spaces between adjacent wire turns. By filling the small spaces between the adjacent coil turns, the chance of pinching tissue between coil turns is minimized thereby avoiding abrasion to the artery wall.
  • the embedded coil electrodes 702 / 704 are mechanically captured and chemically bonded into the flexible support 706 .
  • the diameter of the coil is large enough to be atraumatic to the artery wall.
  • the centerline of the coil electrodes 702 / 704 lie near the neutral axis of electrode cuff structure 700 and the flexible support 706 comprises a material with isotropic elasticity such as silicone in order to minimize the shear forces on the adhesive bonds between the coil electrodes 702 / 704 and the support 706 .
  • the electrode coils 702 / 704 are connected to corresponding conductive coils 712 / 714 , respectively, in an elongate lead 710 which is connected to the control system 60 .
  • Anchoring wings 718 may be provided on the lead 710 to tether the lead 710 to adjacent tissue and minimize the effects or relative movement between the lead 710 and the electrode cuff 700 .
  • the conductive coils 712 / 714 may be formed of 0.003 MP35N bifilar wires wound into 0.018 inch diameter coils which are electrically connected to electrode coils 702 / 704 by splice wires 716 .
  • the conductive coils 712 / 714 may be individually covered by an insulating covering 718 such as silicone tubing and collectively covered by insulating covering 720 .
  • the conductive material of the electrodes 702 / 704 may be a metal as described above or a conductive polymer such as a silicone material filled with metallic particles such as Pt particles.
  • the polymeric electrodes may be integrally formed with the flexible support 706 with the electrode contacts comprising raised areas on the inside surface of the flexible support 706 electrically coupled to the lead 710 by wires or wire coils. The use of polymeric electrodes may be applied to other electrode design embodiments described elsewhere herein.
  • Reinforcement patches 708 such as DACRON® fabric may be selectively incorporated into the flexible support 706 .
  • reinforcement patches 708 may be incorporated into the ends or other areas of the flexible support 706 to accommodate suture anchors.
  • the reinforcement patches 708 provide points where the electrode cuff 700 may be sutured to the vessel wall and may also provide tissue in growth to further anchor the device 700 to the exterior of the vessel wall.
  • the fabric reinforcement patches 708 may extend beyond the edge of the flexible support 706 so that tissue in growth may help anchor the electrode assembly or cuff 700 to the vessel wall and may reduce reliance on the sutures to retain the electrode assembly 700 in place.
  • bioadhesives such as cyanoacrylate may be employed to secure the device 700 to the vessel wall.
  • an adhesive incorporating conductive particles such as Pt coated micro spheres may be applied to the exposed inside surfaces of the electrodes 702 / 704 to enhance electrical conduction to the tissue and possibly limit conduction along one axis to limit extraneous tissue stimulation.
  • the reinforcement patches 708 may also be incorporated into the flexible support 706 for strain relief purposes and to help retain the coils 702 / 704 to the support 706 where the leads 710 attach to the electrode assembly 700 as well as where the outer coil 702 loops back around the inner coil 704 .
  • the patches 708 are selectively incorporated into the flexible support 706 to permit expansion and contraction of the device 700 , particularly in the area of the electrodes 702 / 704 .
  • the flexible support 706 is only fabric reinforced in selected areas thereby maintaining the ability of the electrode cuff 700 to stretch.
  • the electrode assembly of FIGS. 19-21 can be modified to have “flattened” coil electrodes in the region of the assembly where the electrodes contact the extravascular tissue.
  • an electrode-carrying surface 801 of the electrode assembly is located generally between parallel reinforcement strips or tabs 808 .
  • the flattened coil section 810 will generally be exposed on a lower surface 803 of the base 806 ( FIG. 23 ) and will be covered or encapsulated by a parylene or other polymeric structure or material 802 over an upper surface 805 thereof.
  • the coil is formed with a generally circular periphery 809 , as best seen in FIGS.
  • the flattened coil structure is particularly beneficial since it retains flexibility, allowing the electrodes to bend, stretch, and flex together with the elastomeric base 806 , while also increasing the flat electrode area available to contact the extravascular surface.
  • Electrode assembly 900 comprises an electrode base, typically an elastic base 902 , typically formed from silicone or other elastomeric material, having an electrode-carrying surface 904 and a plurality of attachment tabs 906 ( 906 a, 906 b, 906 c, and 906 d ) extending from the electrode-carrying surface.
  • the attachment tabs 906 are preferably formed from the same material as the electrode-carrying surface 904 of the base 902 , but could be formed from other elastomeric materials as well. In the latter case, the base will be molded, stretched or otherwise assembled from the various pieces.
  • the attachment tabs 906 are formed integrally with the remainder of the base 902 , i.e., typically being cut from a single sheet of the elastomeric material.
  • the geometry of the electrode assembly 900 is selected to permit a number of different attachment modes to the blood vessel.
  • the geometry of the assembly 902 of FIG. 27 is intended to permit attachment to various locations on the carotid arteries at or near the carotid sinus and carotid bifurcation.
  • a number of reinforcement regions 910 are attached to different locations on the base 902 to permit suturing, clipping, stapling, or other fastening of the attachment tabs 906 to each other and/or the electrode-carrying surface 904 of the base 902 .
  • a first reinforcement strip 910 a is provided over an end of the base 902 opposite to the end which carries the attachment tabs.
  • Pairs of reinforcement strips 910 b and 910 c are provided on each of the axially aligned attachment tabs 906 a and 906 b, while similar pairs of reinforcement strips 910 d and 910 e are provided on each of the transversely angled attachment tabs 906 c and 906 d .
  • all attachment tabs will be provided on one side of the base, preferably emanating from adjacent corners of the rectangular electrode-carrying surface 904 .
  • the structure of electrode assembly 900 permits the surgeon to implant the electrode assembly so that the electrodes 920 (which are preferably stretchable, flat-coil electrodes as described in detail above), are located at a preferred location relative to the target baroreceptors.
  • the preferred location may be determined, for example, as described in copending application Ser. No. 09/963,991, filed on Sep. 26, 2001, the full disclosure of which incorporated herein by reference.
  • the surgeon may position the base 902 so that the electrodes 920 are located appropriately relative to the underlying baroreceptors.
  • the electrodes 920 may be positioned over the common carotid artery CC as shown in FIG. 28 , or over the internal carotid artery IC, as shown in FIGS. 29 and 30 .
  • the assembly 900 may be attached by stretching the base 902 and attachment tabs 906 a and 906 b over the exterior of the common carotid artery.
  • the reinforcement tabs 906 a or 906 b may then be secured to the reinforcement strip 910 a, either by suturing, stapling, fastening, gluing, welding, or other well-known means. Usually, the reinforcement tabs 906 c and 906 d will be cut off at their bases, as shown at 922 and 924 , respectively.
  • the bulge of the carotid sinus and the baroreceptors may be located differently with respect to the carotid bifurcation.
  • the receptors may be located further up the internal carotid artery IC so that the placement of electrode assembly 900 as shown in FIG. 28 will not work.
  • the assembly 900 may still be successfully attached by utilizing the transversely angled attachment tabs 906 c and 906 d rather than the central or axial tabs 906 a and 906 b .
  • FIG. 29 the receptors may be located further up the internal carotid artery IC so that the placement of electrode assembly 900 as shown in FIG. 28 will not work.
  • the assembly 900 may still be successfully attached by utilizing the transversely angled attachment tabs 906 c and 906 d rather than the central or axial tabs 906 a and 906 b .
  • the lower tab 906 d is wrapped around the common carotid artery CC, while the upper attachment tab 906 c is wrapped around the internal carotid artery IC.
  • the axial attachment tabs 906 a and 906 b will usually be cut off (at locations 926 ), although neither of them could in some instances also be wrapped around the internal carotid artery IC.
  • the tabs which are used may be stretched and attached to reinforcement strip 910 a, as generally described above.
  • the assembly 900 may be attached using the upper axial attachment tab 906 a and be lower transversely angled attachment tab 906 d .
  • Attachment tabs 906 b and 906 c may be cut off, as shown at locations 928 and 930 , respectively.
  • the elastic nature of the base 902 and the stretchable nature of the electrodes 920 permit the desired conformance and secure mounting of the electrode assembly over the carotid sinus. It would be appreciated that these or similar structures would also be useful for mounting electrode structures at other locations in the vascular system.
  • anti-inflammatory agents e.g., steroid eluting electrodes
  • anti-inflammatory agents e.g., steroid eluting electrodes
  • Such agents reduce tissue inflammation at the chronic interface between the device (e.g., electrodes) and the vascular wall tissue, to thereby increase the efficiency of stimulus transfer, reduce power consumption, and maintain activation efficiency, for example.

Abstract

An electrode assembly for an implantable medical device, including a spine, and a plurality of electrodes protruding from the spine. At least two electrodes protrude from the spine in opposing directions and define a nerve-receiving channel. When the electrode assembly is not coupled to a nerve and the electrodes are in a relaxed state position, the nerve receiving channel comprises a cross-sectional area that is substantially less than a cross-sectional area of a nerve to which the electrode assembly is adapted to be coupled. And when coupled to the nerve, each electrode wraps around and directly contacts at least 60% of the circumference of the nerve.

Description

    CROSS-REFERENCES TO RELATED APPLICATIONS
  • This application is a continuation of U.S. patent application Ser. No. 10/402,911, filed on Mar. 27, 2003, which is: (i) a continuation-in-part of U.S. patent application Ser. No. 09/963,777, filed on Sep. 26, 2001, which is a continuation-in-part of U.S. patent application Ser. No. 09/671,850, filed on Sep. 27, 2000, now issued as U.S. Pat. No. 6,522,926; and (ii) claims the benefit of U.S. Provisional Patent Application No. 60/368,222, filed on Mar. 27, 2002, the disclosures of each of the above being hereby incorporated by reference in their entirety. The parent application for this application has incorporated by reference the disclosures of the following U.S. patent applications: U.S. patent application Ser. No. 09/964,079, filed on Sep. 26, 2001, now issued as U.S. Pat. No. 6,985,774, and U.S. patent application Ser. No. 09/963,991, filed on Sep. 26, 2001, now issued as U.S. Pat. No. 6,850,801, now issued as U.S. Pat. No. 6,850,801, the disclosures of which are also effectively incorporated by reference herein.
  • BACKGROUND OF THE INVENTION Field of the Invention
  • The present invention generally relates to medical devices and methods of use for the treatment and/or management of cardiovascular and renal disorders. Specifically, the present invention relates to devices and methods for controlling the baroreflex system for the treatment and/or management of cardiovascular and renal disorders and their underlying causes and conditions.
  • Cardiovascular disease is a major contributor to patient illness and mortality. It also is a primary driver of health care expenditure, costing more than $326 billion each year in the United States. Hypertension, or high blood pressure, is a major cardiovascular disorder that is estimated to affect over 50 million people in the United Sates alone. Of those with hypertension, it is reported that fewer than 30% have their blood pressure under control. Hypertension is a leading cause of heart failure and stroke. It is the primary cause of death in over 42,000 patients per year and is listed as a primary or contributing cause of death in over 200,000 patients per year in the U.S. Accordingly, hypertension is a serious health problem demanding significant research and development for the treatment thereof.
  • Hypertension occurs when the body's smaller blood vessels (arterioles) constrict, causing an increase in blood pressure. Because the blood vessels constrict, the heart must work harder to maintain blood flow at the higher pressures. Although the body may tolerate short periods of increased blood pressure, sustained hypertension may eventually result in damage to multiple body organs, including the kidneys, brain, eyes and other tissues, causing a variety of maladies associated therewith. The elevated blood pressure may also damage the lining of the blood vessels, accelerating the process of atherosclerosis and increasing the likelihood that a blood clot may develop. This could lead to a heart attack and/or stroke. Sustained high blood pressure may eventually result in an enlarged and damaged heart (hypertrophy), which may lead to heart failure.
  • Heart failure is the final common expression of a variety of cardiovascular disorders, including ischemic heart disease. It is characterized by an inability of the heart to pump enough blood to meet the body's needs and results in fatigue, reduced exercise capacity and poor survival. It is estimated that approximately 5,000,000 people in the United States suffer from heart failure, directly leading to 39,000 deaths per year and contributing to another 225,000 deaths per year. It is also estimated that greater than 400,000 new cases of heart failure are diagnosed each year. Heart failure accounts for over 900,000 hospital admissions annually, and is the most common discharge diagnosis in patients over the age of 65 years. It has been reported that the cost of treating heart failure in the United States exceeds $20 billion annually. Accordingly, heart failure is also a serious health problem demanding significant research and development for the treatment and/or management thereof.
  • Heart failure results in the activation of a number of body systems to compensate for the heart's inability to pump sufficient blood. Many of these responses are mediated by an increase in the level of activation of the sympathetic nervous system, as well as by activation of multiple other neurohormonal responses. Generally speaking, this sympathetic nervous system activation signals the heart to increase heart rate and force of contraction to increase the cardiac output; it signals the kidneys to expand the blood volume by retaining sodium and water; and it signals the arterioles to constrict to elevate the blood pressure. The cardiac, renal and vascular responses increase the workload of the heart, further accelerating myocardial damage and exacerbating the heart failure state. Accordingly, it is desirable to reduce the level of sympathetic nervous system activation in order to stop or at least minimize this vicious cycle and thereby treat or manage the heart failure.
  • A number of drug treatments have been proposed for the management of hypertension, heart failure and other cardiovascular disorders. These include vasodilators to reduce the blood pressure and ease the workload of the heart, diuretics to reduce fluid overload, inhibitors and blocking agents of the body's neurohormonal responses, and other medicaments.
  • Various surgical procedures have also been proposed for these maladies. For example, heart transplantation has been proposed for patients who suffer from severe, refractory heart failure. Alternatively, an implantable medical device such as a ventricular assist device (VAD) may be implanted in the chest to increase the pumping action of the heart. Alternatively, an intra-aortic balloon pump (IABP) may be used for maintaining heart function for short periods of time, but typically no longer than one month. Other surgical procedures are available as well.
  • It has been known for decades that the wall of the carotid sinus, a structure at the bifurcation of the common carotid arteries, contains stretch receptors (baroreceptors) that are sensitive to the blood pressure. These receptors send signals via the carotid sinus nerve to the brain, which in turn regulates the cardiovascular system to maintain normal blood pressure (the baroreflex), in part through activation of the sympathetic nervous system. Electrical stimulation of the carotid sinus nerve (baropacing) has previously been proposed to reduce blood pressure and the workload of the heart in the treatment of high blood pressure and angina. For example, U.S. Pat. No. 6,073,048 to Kieval et al. discloses a baroreflex modulation system and method for stimulating the baroreflex arc based on various cardiovascular and pulmonary parameters.
  • Although each of these alternative approaches is beneficial in some ways, each of the therapies has its own disadvantages. For example, drug therapy is often incompletely effective. Some patients may be unresponsive (refractory) to medical therapy. Drugs often have unwanted side effects and may need to be given in complex regimens. These and other factors contribute to poor patient compliance with medical therapy. Drug therapy may also be expensive, adding to the health care costs associated with these disorders. Likewise, surgical approaches are very costly, may be associated with significant patient morbidity and mortality and may not alter the natural history of the disease. Baropacing also has not gained acceptance. Several problems with electrical carotid sinus nerve stimulation have been reported in the medical literature. These include the invasiveness of the surgical procedure to implant the nerve electrodes, and postoperative pain in the jaw, throat, face and head during stimulation. In addition, it has been noted that high voltages sometimes required for nerve stimulation may damage the carotid sinus nerves. Accordingly, there continues to be a substantial and long felt need for new devices and methods for treating and/or managing high blood pressure, heart failure and their associated cardiovascular and nervous system disorders.
  • U.S. Pat. No. 6,522,926, signed to the Assignee of the present application, describes a number of systems and methods intended to activate baroreceptors in the carotid sinus and elsewhere in order to induce the baroreflex. Numerous specific approaches are described, including the use of coil electrodes placed over the exterior of the carotid sinus near the carotid bifurcation. While such electrode designs offer substantial promise, there is room for improvement in a number of specific design areas. For example, it would be desirable to provide designs which permit electrode structures to be closely and conformably secured over the exterior of a carotid sinus or other blood vessels so that efficient activation of the underlying baroreceptors can be achieved. It would be further desirable to provide specific electrode structures which can be variably positioned at different locations over the carotid sinus wall or elsewhere. At least some of these objectives will be met by these inventions described hereinbelow.
  • BRIEF SUMMARY OF THE INVENTION
  • To address hypertension, heart failure and their associated cardiovascular and nervous system disorders, the present invention provides a number of devices, systems and methods by which the blood pressure, nervous system activity, and neurohormonal activity may be selectively and controllably regulated by activating baroreceptors. By selectively and controllably activating baroreceptors, the present invention reduces excessive blood pressure, sympathetic nervous system activation and neurohormonal activation, thereby minimizing their deleterious effects on the heart, vasculature and other organs and tissues.
  • The present invention provides systems and methods for treating a patient by inducing a baroreceptor signal to effect a change in the baroreflex system (e.g., reduced heart rate, reduced blood pressure, etc.). The baroreceptor signal is activated or otherwise modified by selectively activating baroreceptors. To accomplish this, the system and method of the present invention utilize a baroreceptor activation device positioned near a baroreceptor in the carotid sinus, aortic arch, heart, common carotid arteries, subclavian arteries, and/or brachiocephalic artery. Preferably, the baroreceptor activation device is located in the right and/or left carotid sinus (near the bifurcation of the common carotid artery) and/or the aortic arch. By way of example, not limitation, the present invention is described with reference to the carotid sinus location.
  • Generally speaking, the baroreceptor activation device may be activated, deactivated or otherwise modulated to activate one or more baroreceptors and induce a baroreceptor signal or a change in the baroreceptor signal to thereby effect a change in the baroreflex system. The baroreceptor activation device may be activated, deactivated, or otherwise modulated continuously, periodically, or episodically. The baroreceptor activation device may comprise a wide variety of devices which utilize electrodes to directly or indirectly activate the baroreceptor. The baroreceptor may be activated directly, or activated indirectly via the adjacent vascular tissue. The baroreceptor activation device will be positioned outside the vascular wall. To maximize therapeutic efficacy, mapping methods may be employed to precisely locate or position the baroreceptor activation device.
  • The present invention is directed particularly at electrical means and methods to activate baroreceptors, and various electrode designs are provided. The electrode designs may be particularly suitable for connection to the carotid arteries at or near the carotid sinus, and may be designed to minimize extraneous tissue stimulation. While being particularly suitable for use on the carotid arteries at or near the carotid sinus, the electrode structures and assemblies of the present invention will also find use for external placement and securement of electrodes about other arteries, and in some cases veins, having baroreceptor and other electrically activated receptors therein.
  • In a first aspect of the present invention, a baroreceptor activation device or other electrode useful for a carotid sinus or other blood vessel comprises a base having one or more electrodes connected to the base. The base has a length sufficient to extend around at least a substantial portion of the circumference of a blood vessel, usually an artery, more usually a carotid artery at or near the carotid sinus. By “substantial portion,” it is meant that the base will extend over at least 25% of the vessel circumference, usually at least 50%, more usually at least 66%, and often at least 75% or over the entire circumference. Usually, the base is sufficiently elastic to conform to said circumference or portion thereof when placed therearound. The electrode connected to the base is oriented at least partly in the circumferential direction and is sufficiently stretchable to both conform to the shape of the carotid sinus when the base is conformed thereover and accommodate changes in the shape and size of the sinus as they vary over time with heart pulse and other factors, including body movement which causes the blood vessel circumference to change.
  • Usually, at least two electrodes will be positioned circumferentially and adjacent to each other on the base. The electrode(s) may extend over the entire length of the base, but in some cases will extend over less than 75% of the circumferential length of the base, often being less than 50% of the circumferential length, and sometimes less than 25% of the circumferential length. Thus, the electrode structures may cover from a small portion up to the entire circumferential length of the carotid artery or other blood vessel. Usually, the circumferential length of the elongate electrodes will cover at least 10% of the circumference of the blood vessel, typically being at least 25%, often at least 50%, 75%, or the entire length. The base will usually have first and second ends, wherein the ends are adapted to be joined, and will have sufficient structural integrity to grasp the carotid sinus.
  • In a further aspect of the present invention, an extravascular electrode assembly comprises an elastic base and a stretchable electrode. The elastic base is adapted to be conformably attached over the outside of a target blood vessel, such as a carotid artery at or near the carotid sinus, and the stretchable electrode is secured over the elastic base and capable of expanding and contracting together with the base. In this way, the electrode assembly is conformable to the exterior of the carotid sinus or other blood vessel. Preferably, the elastic base is planar, typically comprising an elastomeric sheet. While the sheet may be reinforced, the reinforcement will be arranged so that the sheet remains elastic and stretchable, at least in the circumferential direction, so that the base and electrode assembly may be placed and conformed over the exterior of the blood vessel. Suitable elastomeric sheets may be composed of silicone, latex, and the like.
  • To assist in mounting the extravascular electrode over the carotid sinus or other blood vessel, the assembly will usually include two or more attachment tabs extending from the elastomeric sheet at locations which allow the tabs to overlap the elastic base and/or be directly attached to the blood vessel wall when the base is wrapped around or otherwise secured over a blood vessel. In this way, the tabs may be fastened to secure the backing over the blood vessel.
  • Preferred stretchable electrodes comprise elongated coils, where the coils may stretch and shorten in a spring-like manner. In particularly preferred embodiments, the elongated coils will be flattened over at least a portion of their lengths, where the flattened portion is oriented in parallel to the elastic base. The flattened coil provides improved electrical contact when placed against the exterior of the carotid sinus or other blood vessel.
  • In a further aspect of the present invention, an extravascular electrode assembly comprises a base and an electrode structure. The base is adapted to be attached over the outside of a carotid artery or other blood vessel and has an electrode-carrying surface formed over at least a portion thereof. A plurality of attachment tabs extend away from the electrode-carrying surface, where the tabs are arranged to permit selective ones thereof to be wrapped around a blood vessel while others of the tabs may be selectively removed. The electrode structure on or over the electrode-carrying surface.
  • In preferred embodiments, the base includes at least one tab which extends longitudinally from the electrode-carrying surface and at least two tabs which extend away from the surface at opposite, transverse angles. In an even more preferred embodiment, the electrode-carrying surface is rectangular, and at least two longitudinally extending tabs extend from adjacent corners of the rectangular surface. The two transversely angled tabs extend at a transverse angle away from the same two corners.
  • As with prior embodiments, the electrode structure preferably includes one or more stretchable electrodes secured to the electrode-carrying surface. The stretchable electrodes are preferably elongated coils, more preferably being “flattened coils” to enhance electrical contact with the blood vessel to be treated. The base is preferably an elastic base, more preferably being formed from an elastomeric sheet. The phrase “flattened coil,” as used herein, refers to an elongate electrode structure including a plurality of successive turns where the cross-sectional profile is non-circular and which includes at least one generally flat or minimally curved face. Such coils may be formed by physically deforming (flattening) a circular coil, e.g., as shown in FIG. 24 described below. Usually, the flattened coils will have a cross-section that has a width in the plane of the electrode assembly greater than its height normal to the electrode assembly plane. Alternatively, the coils may be initially fabricated in the desired geometry having one generally flat (or minimally curved) face for contacting tissue. Fully flattened coils, e.g., those having planar serpentine configurations, may also find use, but usually it will be preferred to retain at least some thickness in the direction normal to the flat or minimally curved tissue-contacting surface. Such thickness helps the coiled electrode protrude from the base and provide improved tissue contact over the entire flattened surface.
  • In a still further aspect of the present invention, a method for wrapping an electrode assembly over a blood vessel comprises providing an electrode assembly having an elastic base and one or more stretchable electrodes. The base is conformed over an exterior of the blood vessel, such as a carotid artery, and at least a portion of an electrode is stretched along with the base. Ends of the elastic base are secured together to hold the electrode assembly in place, typically with both the elastic backing and stretchable electrode remaining under at least slight tension to promote conformance to the vessel exterior. The electrode assembly will be located over a target site in the blood vessel, typically a target site having an electrically activated receptor. Advantageously, the electrode structures of the present invention when wrapped under tension will flex and stretch with expansions and contractions of the blood vessel. A presently preferred target site is a baroreceptor, particularly baroreceptors in or near the carotid sinus.
  • In a still further aspect of the present invention, a method for wrapping an electrode assembly over a blood vessel comprises providing an electrode assembly including a base having an electrode-carrying surface and an electrode structure on the electrode-carrying surface. The base is wrapped over a blood vessel, and some but not all of a plurality of attachment tags on the base are secured over the blood vessel. Usually, the tabs which are not used to secure an electrode assembly will be removed, typically by cutting. Preferred target sites are electrically activated receptors, usually baroreceptors, more usually baroreceptors on the carotid sinus. The use of such electrode assemblies having multiple attachment tabs is particularly beneficial when securing the electrode assembly on a carotid artery near the carotid sinus. By using particular tabs, as described in more detail below, the active electrode area can be positioned at any of a variety of locations on the common, internal, and/or external carotid arteries.
  • In another aspect, the present invention comprises pressure measuring assemblies including an elastic base adapted to be mounted on the outer wall of a blood vessel under circumferential tension. A strain measurement sensor is positioned on the base to measure strain resulting from circumferential expansion of the vessel due to a blood pressure increase. Usually, the base will wrap about the entire circumference of the vessel, although only a portion of the base need be elastic. Alternatively, a smaller base may be stapled, glued, clipped or otherwise secured over a “patch” of the vessel wall to detect strain variations over the underlying surface. Exemplary sensors include strain gauges and micro machined sensors (MEMS).
  • In yet another aspect, electrode assemblies according to the present invention comprise a base and at least three parallel elongate electrode structures secured over a surface of the base. The base is attachable to an outside surface of a blood vessel, such as a carotid artery, particularly a carotid artery near the carotid sinus, and has a length sufficient to extend around at least a substantial portion of the circumference of the blood vessel, typically extending around at least 25% of the circumference, usually extending around at least 50% of the circumference, preferably extending at least 66% of the circumference, and often extending around at least 75% of or the entire circumference of the blood vessel. As with prior embodiments, the base will preferably be elastic and composed of any of the materials set forth previously.
  • The at least three parallel elongate electrode structures will preferably be aligned in the circumferential direction of the base, i.e., the axis or direction of the base which will be aligned circumferentially over the blood vessel when the base is mounted on the blood vessel. The electrode structures will preferably be stretchable, typically being elongate coils, often being flattened elongate coils, as also described previously.
  • At least an outer pair of the electrode structures will be electrically isolated from an inner electrode structure, and the outer electrode structures will preferably be arranged in a U-pattern in order to surround the inner electrode structure. In this way, the outer pair of electrodes can be connected using a single conductor taken from the base, and the outer electrode structures and inner electrode structure may be connected to separate poles on a power supply in order to operate in the “pseudo” tripolar mode described hereinbelow.
  • To address low blood pressure and other conditions requiring blood pressure augmentation, the present invention provides electrode designs and methods utilizing such electrodes by which the blood pressure may be selectively and controllably regulated by inhibiting or dampening baroreceptor signals. By selectively and controllably inhibiting or dampening baroreceptor signals, the present invention reduces conditions associated with low blood pressure.
  • BRIEF DESCRIPTION OF THE DRAWINGS
  • FIG. 1 is a schematic illustration of the upper torso of a human body showing the major arteries and veins and associated anatomy.
  • FIG. 2A is a cross-sectional schematic illustration of the carotid sinus and baroreceptors within the vascular wall.
  • FIG. 2B is a schematic illustration of baroreceptors within the vascular wall and the baroreflex system.
  • FIG. 3 is a schematic illustration of a baroreceptor activation system in accordance with the present invention.
  • FIGS. 4A and 4B are schematic illustrations of a baroreceptor activation device in the form of an implantable extraluminal conductive structure which electrically induces a baroreceptor signal in accordance with an embodiment of the present invention.
  • FIGS. 5A-5F are schematic illustrations of various possible arrangements of electrodes around the carotid sinus for extravascular electrical activation embodiments.
  • FIG. 6 is a schematic illustration of a serpentine shaped electrode for extravascular electrical activation embodiments.
  • FIG. 7 is a schematic illustration of a plurality of electrodes aligned orthogonal to the direction of wrapping around the carotid sinus for extravascular electrical activation embodiments.
  • FIGS. 8-11 are schematic illustrations of various multi-channel electrodes for extravascular electrical activation embodiments.
  • FIG. 12 is a schematic illustration of an extravascular electrical activation device including a tether and an anchor disposed about the carotid sinus and common carotid artery.
  • FIG. 13 is a schematic illustration of an alternative extravascular electrical activation device including a plurality of ribs and a spine.
  • FIG. 14 is a schematic illustration of an electrode assembly for extravascular electrical activation embodiments.
  • FIG. 15 is a schematic illustration of a fragment of an alternative cable for use with an electrode assembly such as shown in FIG. 14.
  • FIG. 16 illustrates a foil strain gauge for measuring expansion force of a carotid artery or other blood vessel.
  • FIG. 17 illustrates a transducer which is adhesively connected to the wall of an artery.
  • FIG. 18 is a cross-sectional view of the transducer of FIG. 17.
  • FIG. 19 illustrates a first exemplary electrode assembly having an elastic base and plurality of attachment tabs.
  • FIG. 20 is a more detailed illustration of the electrode-carrying surface of the electrode assembly of FIG. 19.
  • FIG. 21 is a detailed illustration of electrode coils which are present in an elongate lead of the electrode assembly of FIG. 19.
  • FIG. 22 is a detailed view of the electrode-carrying surface of an electrode assembly similar to that shown in FIG. 20, except that the electrodes have been flattened.
  • FIG. 23 is a cross-sectional view of the electrode structure of FIG. 22.
  • FIG. 24 illustrates the transition between the flattened and non-flattened regions of the electrode coil of the electrode assembly FIG. 20.
  • FIG. 25 is a cross-sectional view taken along the line 25-25 of FIG. 24.
  • FIG. 26 is a cross-sectional view taken along the line 26-26 of FIG. 24.
  • FIG. 27 is an illustration of a further exemplary electrode assembly constructed in accordance with the principles of the present invention.
  • FIG. 28 illustrates the electrode assembly of FIG. 27 wrapped around the common carotid artery near the carotid bifurcation.
  • FIG. 29 illustrates the electrode assembly of FIG. 27 wrapped around the internal carotid artery.
  • FIG. 30 is similar to FIG. 29, but with the carotid bifurcation having a different geometry.
  • DETAILED DESCRIPTION OF THE INVENTION
  • The following detailed description should be read with reference to the drawings in which similar elements in different drawings are numbered the same. The drawings, which are not necessarily to scale, depict illustrative embodiments and are not intended to limit the scope of the invention.
  • To better understand the present invention, it may be useful to explain some of the basic vascular anatomy associated with the cardiovascular system. Refer to FIG. 1 which is a schematic illustration of the upper torso of a human body 10 showing some of the major arteries and veins of the cardiovascular system. The left ventricle of the heart 11 pumps oxygenated blood up into the aortic arch 12. The right subclavian artery 13, the right common carotid artery 14, the left common carotid artery 15 and the left subclavian artery 16 branch off the aortic arch 12 proximal of the descending thoracic aorta 17. Although relatively short, a distinct vascular segment referred to as the brachiocephalic artery 22 connects the right subclavian artery 13 and the right common carotid artery 14 to the aortic arch 12. The right carotid artery 14 bifurcates into the right external carotid artery 18 and the right internal carotid artery 19 at the right carotid sinus 20. Although not shown for purposes of clarity only, the left carotid artery 15 similarly bifurcates into the left external carotid artery and the left internal carotid artery at the left carotid sinus.
  • From the aortic arch 12, oxygenated blood flows into the carotid arteries 18/19 and the subclavian arteries 13/16. From the carotid arteries 18/19, oxygenated blood circulates through the head and cerebral vasculature and oxygen depleted blood returns to the heart 11 by way of the jugular veins, of which only the right internal jugular vein 21 is shown for sake of clarity. From the sub clavian arteries 13/16, oxygenated blood circulates through the upper peripheral vasculature and oxygen depleted blood returns to the heart by way of the subclavian veins, of which only the right subclavian vein 23 is shown, also for sake of clarity. The heart 11 pumps the oxygen depleted blood through the pulmonary system where it is reoxygenated. The re-oxygenated blood returns to the heart 11 which pumps the re-oxygenated blood into the aortic arch as described above, and the cycle repeats.
  • Within the arterial walls of the aortic arch 12, common carotid arteries 14/15 (near the right carotid sinus 20 and left carotid sinus), subclavian arteries 13/16 and brachiocephalic artery 22 there are baroreceptors 30. For example, as best seen in FIG. 2A, baroreceptors 30 reside within the vascular walls of the carotid sinus 20. Baroreceptors 30 are a type of stretch receptor used by the body to sense blood pressure. An increase in blood pressure causes the arterial wall to stretch, and a decrease in blood pressure causes the arterial wall to return to its original size. Such a cycle is repeated with each beat of the heart. Because baroreceptors 30 are located within the arterial wall, they are able to sense deformation of the adjacent tissue, which is indicative of a change in blood pressure. The baroreceptors 30 located in the right carotid sinus 20, the left carotid sinus and the aortic arch 12 play the most significant role in sensing blood pressure that affects the baroreflex system 50, which is described in more detail with reference to FIG. 2B.
  • Refer now to FIG. 2B, which shows a schematic illustration of baroreceptors 30 disposed in a generic vascular wall 40 and a schematic flow chart of the baroreflex system 50. Baroreceptors 30 are profusely distributed within the arterial walls 40 of the major arteries discussed previously, and generally form an arbor 32. The baroreceptor arbor 32 comprises a plurality of baroreceptors 30, each of which transmits baroreceptor signals to the brain 52 via nerve 38. The baroreceptors 30 are so profusely distributed and arborized within the vascular wall 40 that discrete baroreceptor arbors 32 are not readily discernable. To this end, those skilled in the art will appreciate that the baroreceptors 30 shown in FIG. 2B are primarily schematic for purposes of illustration and discussion.
  • Baroreceptor signals are used to activate a number of body systems which collectively may be referred to as the baroreflex system 50. Baroreceptors 30 are connected to the brain 52 via the nervous system 51. Thus, the brain 52 is able to detect changes in blood pressure, which is indicative of cardiac output. If cardiac output is insufficient to meet demand (i.e., the heart 11 is unable to pump sufficient blood), the baroreflex system 50 activates a number of body systems, including the heart 11, kidneys 53, vessels 54, and other organs/tissues. Such activation of the baroreflex system 50 generally corresponds to an increase in neurohormonal activity. Specifically, the baroreflex system 50 initiates a neurohormonal sequence that signals the heart 11 to increase heart rate and increase contraction force in order to increase cardiac output, signals the kidneys 53 to increase blood volume by retaining sodium and water, and signals the vessels 54 to constrict to elevate blood pressure. The cardiac, renal and vascular responses increase blood pressure and cardiac output 55, and thus increase the workload of the heart 11. In a patient with heart failure, this further accelerates myocardial damage and exacerbates the heart failure state.
  • To address the problems of hypertension, heart failure, other cardiovascular disorders and renal disorders, the present invention basically provides a number of devices, systems and methods by which the baroreflex system 50 is activated to reduce excessive blood pressure, autonomic nervous system activity and neurohormonal activation. In particular, the present invention provides a number of devices, systems and methods by which baroreceptors 30 may be activated, thereby indicating an increase in blood pressure and signaling the brain 52 to reduce the body's blood pressure and level of sympathetic nervous system and neurohormonal activation, and increase parasypathetic nervous system activation, thus having a beneficial effect on the cardiovascular system and other body systems.
  • With reference to FIG. 3, the present invention generally provides a system including a control system 60, a baroreceptor activation device 70, and a sensor 80 (optional), which generally operate in the following manner. The sensor(s) 80 optionally senses and/or monitors a parameter (e.g., cardiovascular function) indicative of the need to modify the baroreflex system and generates a signal indicative of the parameter. The control system 60 generates a control signal as a function of the received sensor signal. The control signal activates, deactivates or otherwise modulates the baroreceptor activation device 70. Typically, activation of the device 70 results in activation of the baroreceptors 30. Alternatively, deactivation or modulation of the baroreceptor activation device 70 may cause or modify activation of the baroreceptors 30. The baroreceptor activation device 70 may comprise a wide variety of devices which utilize electrical means to activate baroreceptors 30. Thus, when the sensor 80 detects a parameter indicative of the need to modify the baroreflex system activity (e.g., excessive blood pressure), the control system 60 generates a control signal to modulate (e.g. activate) the baroreceptor activation device 70 thereby inducing a baroreceptor 30 signal that is perceived by the brain 52 to be apparent excessive blood pressure. When the sensor 80 detects a parameter indicative of normal body function (e.g., normal blood pressure), the control system 60 generates a control signal to modulate (e.g., deactivate) the baroreceptor activation device 70.
  • As mentioned previously, the baroreceptor activation device 70 may comprise a wide variety of devices which utilize electrical means to activate the baroreceptors 30. The baroreceptor activation device 70 of the present invention comprises an electrode structure which directly activates one or more baroreceptors 30 by changing the electrical potential across the baroreceptors 30. It is possible that changing the electrical potential across the tissue surrounding the baroreceptors 30 may cause the surrounding tissue to stretch or otherwise deform, thus mechanically activating the baroreceptors 30, in which case the stretchable and elastic electrode structures of the present invention may provide significant advantages.
  • All of the specific embodiments of the electrode structures of the present invention are suitable for implantation, and are preferably implanted using a minimally invasive surgical approach. The baroreceptor activation device 70 may be positioned anywhere baroreceptors 30 are present. Such potential implantation sites are numerous, such as the aortic arch 12, in the common carotid arteries 18/19 near the carotid sinus 20, in the subclavian arteries 13/16, in the brachiocephalic artery 22, or in other arterial or venous locations. The electrode structures of the present invention will be implanted such that they are positioned on or over a vascular structure immediately adjacent the baroreceptors 30. Preferably, the electrode structure of the baroreceptor activation device 70 is implanted near the right carotid sinus 20 and/or the left carotid sinus (near the bifurcation of the common carotid artery) and/or the aortic arch 12, where baroreceptors 30 have a significant impact on the baroreflex system 50. For purposes of illustration only, the present invention is described with reference to baroreceptor activation device 70 positioned near the carotid sinus 20.
  • The optional sensor 80 is operably coupled to the control system 60 by electric sensor cable or lead 82. The sensor 80 may comprise any suitable device that measures or monitors a parameter indicative of the need to modify the activity of the baroreflex system. For example, the sensor 80 may comprise a physiologic transducer or gauge that measures ECG, blood pressure (systolic, diastolic, average or pulse pressure), blood volumetric flow rate, blood flow velocity, blood pH, O2 or CO2 content, mixed venous oxygen saturation (SVO2), vasoactivity, nerve activity, tissue activity, body movement, activity levels, respiration, or composition. Examples of suitable transducers or gauges for the sensor 80 include ECG electrodes, a piezoelectric pressure transducer, an ultrasonic flow velocity transducer, an ultrasonic volumetric flow rate transducer, a thermodilution flow velocity transducer, a capacitive pressure transducer, a membrane pH electrode, an optical detector (SVO2), tissue impedance (electrical), or a strain gauge. Although only one sensor 80 is shown, multiple sensors 80 of the same or different type at the same or different locations may be utilized.
  • An example of an implantable blood pressure measurement device that may be disposed about a blood vessel is disclosed in U.S. Pat. No. 6,106,477 to Miesel et al., the entire disclosure of which is incorporated herein by reference. An example of a subcutaneous ECG monitor is available from Medtronic under the trade name REVEAL ILR and is disclosed in PCT Publication No. WO 98/02209, the entire disclosure of which is incorporated herein by reference. Other examples are disclosed in U.S. Pat. Nos. 5,987,352 and 5,331,966, the entire disclosures of which are incorporated herein by reference. Examples of devices and methods for measuring absolute blood pressure utilizing an ambient pressure reference are disclosed in U.S. Pat. No. 5,810,735 to Halperin et al., U.S. Pat. No. 5,904,708 to Goedeke, and PCT Publication No. WO 00/16686 to Brockway et al., the entire disclosures of which are incorporated herein by reference. The sensor 80 described herein may take the form of any of these devices or other devices that generally serve the same purpose.
  • The sensor 80 is preferably positioned in a chamber of the heart 11, or in/on a major artery such as the aortic arch 12, a common carotid artery 14/15, a subclavian artery 13/16 or the brachiocephalic artery 22, such that the parameter of interest may be readily ascertained. The sensor 80 may be disposed inside the body such as in or on an artery, a vein or a nerve (e.g. vagus nerve), or disposed outside the body, depending on the type of transducer or gauge utilized. The sensor 80 may be separate from the baroreceptor activation device 70 or combined therewith. For purposes of illustration only, the sensor 80 is shown positioned on the right subclavian artery 13.
  • By way of example, the control system 60 includes a control block 61 comprising a processor 63 and a memory 62. Control system 60 is connected to the sensor 80 by way of sensor cable 82. Control system 60 is also connected to the baroreceptor activation device 70 by way of electric control cable 72. Thus, the control system 60 receives a sensor signal from the sensor 80 by way of sensor cable 82, and transmits a control signal to the baroreceptor activation device 70 by way of control cable 72.
  • The system components 60/70/80 may be directly linked via cables 72/82 or by indirect means such as RF signal transceivers, ultrasonic transceivers or galvanic couplings. Examples of such indirect interconnection devices are disclosed in U.S. Pat. No. 4,987,897 to Funke and U.S. Pat. No. 5,113,859 to Funke, the entire disclosures of which are incorporated herein by reference.
  • The memory 62 may contain data related to the sensor signal, the control signal, and/or values and commands provided by the input device 64. The memory 62 may also include software containing one or more algorithms defining one or more functions or relationships between the control signal and the sensor signal. The algorithm may dictate activation or deactivation control signals depending on the sensor signal or a mathematical derivative thereof The algorithm may dictate an activation or deactivation control signal when the sensor signal falls below a lower predetermined threshold value, rises above an upper predetermined threshold value or when the sensor signal indicates a specific physiologic event. The algorithm may dynamically alter the threshold value as determined by the sensor input values.
  • As mentioned previously, the baroreceptor activation device 70 activates baroreceptors 30 electrically, optionally in combination with mechanical, thermal, chemical, biological or other co-activation. In some instances, the control system 60 includes a driver 66 to provide the desired power mode for the baroreceptor activation device 70. For example, the driver 66 may comprise a power amplifier or the like and the cable 72 may comprise electrical lead(s). In other instances, the driver 66 may not be necessary, particularly if the processor 63 generates a sufficiently strong electrical signal for low level electrical actuation of the baroreceptor activation device 70.
  • The control system 60 may operate as a closed loop utilizing feedback from the sensor 80, or other sensors, such as heart rate sensors which may be incorporated or the electrode assembly, or as an open loop utilizing reprogramming commands received by input device 64. The closed loop operation of the control system 60 preferably utilizes some feedback from the transducer 80, but may also operate in an open loop mode without feedback. Programming commands received by the input device 64 may directly influence the control signal, the output activation parameters, or may alter the software and related algorithms contained in memory 62. The treating physician and/or patient may provide commands to input device 64. Display 65 may be used to view the sensor signal, control signal and/or the software/data contained in memory 62.
  • The control signal generated by the control system 60 may be continuous, periodic, alternating, episodic or a combination thereof, as dictated by an algorithm contained in memory 62. Continuous control signals include a constant pulse, a constant train of pulses, a triggered pulse and a triggered train of pulses. Examples of periodic control signals include each of the continuous control signals described above which have a designated start time (e.g., beginning of each period as designated by minutes, hours, or days in combinations of) and a designated duration (e.g., seconds, minutes, hours, or days in combinations of). Examples of alternating control signals include each of the continuous control signals as described above which alternate between the right and left output channels. Examples of episodic control signals include each of the continuous control signals described above which are triggered by an episode (e.g., activation by the physician/patient, an increase/decrease in blood pressure above a certain threshold, heart rate above/below certain levels, etc.).
  • The stimulus regimen governed by the control system 60 may be selected to promote long term efficacy. It is theorized that uninterrupted or otherwise unchanging activation of the baroreceptors 30 may result in the baroreceptors and/or the baroreflex system becoming less responsive over time, thereby diminishing the long term effectiveness of the therapy. Therefore, the stimulus regimen maybe selected to activate, deactivate or otherwise modulate the baroreceptor activation device 70 in such a way that therapeutic efficacy is maintained preferably for years.
  • In addition to maintaining therapeutic efficacy over time, the stimulus regimens of the present invention may be selected reduce power requirement/consumption of the system 60. As will be described in more detail hereinafter, the stimulus regimen may dictate that the baroreceptor activation device 70 be initially activated at a relatively higher energy and/or power level, and subsequently activated at a relatively lower energy and/or power level. The first level attains the desired initial therapeutic effect, and the second (lower) level sustains the desired therapeutic effect long term. By reducing the energy and/or power levels after the desired therapeutic effect is initially attained, the energy required or consumed by the activation device 70 is also reduced long term. This may correlate into systems having greater longevity and/or reduced size (due to reductions in the size of the power supply and associated components).
  • A first general approach for a stimulus regimen which promotes long term efficacy and reduces power requirements/consumption involves generating a control signal to cause the baroreceptor activation device 70 to have a first output level of relatively higher energy and/or power, and subsequently changing the control signal to cause the baroreceptor activation device 70 to have a second output level of relatively lower energy and/or power. The first output level may be selected and maintained for sufficient time to attain the desired initial effect (e.g., reduced heart rate and/or blood pressure), after which the output level may be reduced to the second level for sufficient time to sustain the desired effect for the desired period of time.
  • For example, if the first output level has a power and/or energy value of X1, the second output level may have a power and/or energy value of X2, wherein X2 is less than X1. In some instances, X2 may be equal to zero, such that the first level is “on” and the second level is “off”. It is recognized that power and energy refer to two different parameters, and in some cases, a change in one of the parameters (power or energy) may not correlate to the same or similar change in the other parameter. In the present invention, it is contemplated that a change in one or both of the parameters may be suitable to obtain the desired result of promoting long term efficacy.
  • It is also contemplated that more than two levels may be used. Each further level may increase the output energy or power to attain the desired effect, or decrease the output energy or power to retain the desired effect. For example, in some instances, it may be desirable to have further reductions in the output level if the desired effect may be sustained at lower power or energy levels. In other instances, particularly when the desired effect is diminishing or is otherwise not sustained, it may be desirable to increase the output level until the desired effect is reestablished, and subsequently decrease the output level to sustain the effect.
  • The transition from each level may be a step function (e.g., a single step or a series of steps), a gradual transition over a period of time, or a combination thereof. In addition, the signal levels may be continuous, periodic, alternating, or episodic as discussed previously.
  • In electrical activation using a non modulated signal, the output (power or energy) level of the baroreceptor activation device 70 may be changed by adjusting the output signal voltage level, current level and/or signal duration. The output signal of the baroreceptor activation device 70 may be, for example, constant current or constant voltage. In electrical activation embodiments using a modulated signal, wherein the output signal comprises, for example, a series of pulses, several pulse characteristics may be changed individually or in combination to change the power or energy level of the output signal. Such pulse characteristics include, but are not limited to: pulse amplitude (PA), pulse frequency (PF), pulse width or duration (PW), pulse waveform (square, triangular, sinusoidal, etc.), pulse polarity (for bipolar electrodes) and pulse phase (monophasic, biphasic).
  • In electrical activation wherein the output signal comprises a pulse train, several other signal characteristics may be changed in addition to the pulse characteristics described above, as described in copending application Ser. No. 09/964,079, the full disclosure of which is incorporated herein by reference.
  • FIGS. 4A and 4B show schematic illustrations of a baroreceptor activation device 300 in the form of an extravascular electrically conductive structure or electrode 302. The electrode structure 302 may comprise a coil, braid or other structure capable of surrounding the vascular wall. Alternatively, the electrode structure 302 may comprise one or more electrode patches distributed around the outside surface of the vascular wall. Because the electrode structure 302 is disposed on the outside surface of the vascular wall, intravascular delivery techniques may not be practical, but minimally invasive surgical techniques will suffice. The extravascular electrode structure 302 may receive electrical signals directly from the driver 66 of the control system 60 by way of electrical lead 304, or indirectly by utilizing an inductor (not shown) as described in copending commonly assigned application Ser. No. 10/402,393 (Attorney Docket No. 21433-000420), filed on the same day as the present application, the full disclosure of which is incorporated herein by reference.
  • Refer now to FIGS. 5A-5F which show schematic illustrations of various possible arrangements of electrodes around the carotid sinus 20 for extravascular electrical activation embodiments, such as baroreceptor activation device 300 described with reference to FIGS. 4A and 4B. The electrode designs illustrated and described hereinafter may be particularly suitable for connection to the carotid arteries at or near the carotid sinus, and may be designed to minimize extraneous tissue stimulation.
  • In FIGS. 5A-5F, the carotid arteries are shown, including the common 14, the external 18 and the internal 19 carotid arteries. The location of the carotid sinus 20 may be identified by a landmark bulge 21, which is typically located on the internal carotid artery 19 just distal of the bifurcation, or extends across the bifurcation from the common carotid artery 14 to the internal carotid artery 19.
  • The carotid sinus 20, and in particular the bulge 21 of the carotid sinus, may contain a relatively high density of baroreceptors 30 (not shown) in the vascular wall. For this reason, it may be desirable to position the electrodes 302 of the activation device 300 on and/or around the sinus bulge 21 to maximize baroreceptor responsiveness and to minimize extraneous tissue stimulation.
  • It should be understood that the device 300 and electrodes 302 are merely schematic, and only a portion of which may be shown, for purposes of illustrating various positions of the electrodes 302 on and/or around the carotid sinus 20 and the sinus bulge 21. In each of the embodiments described herein, the electrodes 302 may be monopolar, bipolar, or tripolar (anode-cathode-anode or cathode-anode-cathode sets). Specific extravascular electrode designs are described in more detail hereinafter.
  • In FIG. 5A, the electrodes 302 of the extravascular electrical activation device 300 extend around a portion or the entire circumference of the sinus 20 in a circular fashion. Often, it would be desirable to reverse the illustrated electrode configuration in actual use. In FIG. 5B, the electrodes 302 of the extravascular electrical activation device 300 extend around a portion or the entire circumference of the sinus 20 in a helical fashion. In the helical arrangement shown in FIG. 5B, the electrodes 302 may wrap around the sinus 20 any number of times to establish the desired electrode 302 contact and coverage. In the circular arrangement shown in FIG. 5A, a single pair of electrodes 302 may wrap around the sinus 20, or a plurality of electrode pairs 302 may be wrapped around the sinus 20 as shown in FIG. 5C to establish more electrode 302 contact and coverage.
  • The plurality of electrode pairs 302 may extend from a point proximal of the sinus 20 or bulge 21, to a point distal of the sinus 20 or bulge 21 to ensure activation of baroreceptors 30 throughout the sinus 20 region. The electrodes 302 may be connected to a single channel or multiple channels as discussed in more detail hereinafter. The plurality of electrode pairs 302 may be selectively activated for purposes of targeting a specific area of the sinus 20 to increase baroreceptor responsiveness, or for purposes of reducing the exposure of tissue areas to activation to maintain baroreceptor responsiveness long term.
  • In FIG. 5D, the electrodes 302 extend around the entire circumference of the sinus 20 in a criss cross fashion. The criss cross arrangement of the electrodes 302 establishes contact with both the internal 19 and external 18 carotid arteries around the carotid sinus 20. Similarly, in FIG. 5E, the electrodes 302 extend around all or a portion of the circumference of the sinus 20, including the internal 19 and external 18 carotid arteries at the bifurcation, and in some instances the common carotid artery 14. In FIG. 5F, the electrodes 302 extend around all or a portion of the circumference of the sinus 20, including the internal 19 and external 18 carotid arteries distal of the bifurcation. In FIGS. 5E and 5F, the extravascular electrical activation devices 300 are shown to include a substrate or base structure 306 which may encapsulate and insulate the electrodes 302 and may provide a means for attachment to the sinus 20 as described in more detail hereinafter.
  • From the foregoing discussion with reference to FIGS. 5A-5F, it should be apparent that there are a number of suitable arrangements for the electrodes 302 of the activation device 300, relative to the carotid sinus 20 and associated anatomy. In each of the examples given above, the electrodes 302 are wrapped around a portion of the carotid structure, which may require deformation of the electrodes 302 from their relaxed geometry (e.g., straight). To reduce or eliminate such deformation, the electrodes 302 and/or the base structure 306 may have a relaxed geometry that substantially conforms to the shape of the carotid anatomy at the point of attachment. In other words, the electrodes 302 and the base structure or backing 306 may be pre shaped to conform to the carotid anatomy in a substantially relaxed state. Alternatively, the electrodes 302 may have a geometry and/or orientation that reduces the amount of electrode 302 strain. Optionally, as described in more detail below, the backing or base structure 306 may be elastic or stretchable to facilitate wrapping of and conforming to the carotid sinus or other vascular structure.
  • For example, in FIG. 6, the electrodes 302 are shown to have a serpentine or wavy shape. The serpentine shape of the electrodes 302 reduces the amount of strain seen by the electrode material when wrapped around a carotid structure. In addition, the serpentine shape of the electrodes increases the contact surface area of the electrode 302 with the carotid tissue. As an alternative, the electrodes 302 may be arranged to be substantially orthogonal to the wrap direction (i.e., substantially parallel to the axis of the carotid arteries) as shown in FIG. 7. In this alternative, the electrodes 302 each have a length and a width or diameter, wherein the length is substantially greater than the width or diameter. The electrodes 302 each have a longitudinal axis parallel to the length thereof, wherein the longitudinal axis is orthogonal to the wrap direction and substantially parallel to the longitudinal axis of the carotid artery about which the device 300 is wrapped. As with the multiple electrode embodiments described previously, the electrodes 302 may be connected to a single channel or multiple channels as discussed in more detail hereinafter.
  • Refer now to FIGS. 8-11 which schematically illustrate various multi-channel electrodes for the extravascular electrical activation device 300. FIG. 8 illustrates a six (6) channel electrode assembly including six (6) separate elongate electrodes 302 extending adjacent to and parallel with each other. The electrodes 302 are each connected to multi-channel cable 304. Some of the electrodes 302 may be common, thereby reducing the number of conductors necessary in the cable 304.
  • Base structure or substrate 306 may comprise a flexible and electrically insulating material suitable for implantation, such as silicone, perhaps reinforced with a flexible material such as polyester fabric. The base 306 may have a length suitable to wrap around all (360.degree.) or a portion (i.e., less than 360.degree.) of the circumference of one or more of the carotid arteries adjacent the carotid sinus 20. The electrodes 302 may extend around a portion (i.e., less than 360.degree. such as 270.degree., 180.degree. or 90.degree.) of the circumference of one or more of the carotid arteries adjacent the carotid sinus 20. To this end, the electrodes 302 may have a length that is less than (e.g., 75%, 50% or 25%) the length of the base 206. The electrodes 302 may be parallel, orthogonal or oblique to the length of the base 306, which is generally orthogonal to the axis of the carotid artery to which it is disposed about. Preferably, the base structure or backing will be elastic (i.e., stretchable), typically being composed of at least in part of silicone, latex, or other elastomer. If such elastic structures are reinforced, the reinforcement should be arranged so that it does not interfere with the ability of the base to stretch and conform to the vascular surface.
  • The electrodes 302 may comprise round wire, rectangular ribbon or foil formed of an electrically conductive and radiopaque material such as platinum. The base structure 306 substantially encapsulates the electrodes 302, leaving only an exposed area for electrical connection to extravascular carotid sinus tissue. For example, each electrode 302 may be partially recessed in the base 206 and may have one side exposed along all or a portion of its length for electrical connection to carotid tissue. Electrical paths through the carotid tissues may be defined by one or more pairs of the elongate electrodes 302.
  • In all embodiments described with reference to FIGS. 8-11, the multi-channel electrodes 302 may be selectively activated for purposes of mapping and targeting a specific area of the carotid sinus 20 to determine the best combination of electrodes 302 (e.g., individual pair, or groups of pairs) to activate for maximum baroreceptor responsiveness, as described elsewhere herein. In addition, the multi-channel electrodes 302 may be selectively activated for purposes of reducing the exposure of tissue areas to activation to maintain long term efficacy as described, as described elsewhere herein. For these purposes, it may be useful to utilize more than two (2) electrode channels. Alternatively, the electrodes 302 may be connected to a single channel whereby baroreceptors are uniformly activated throughout the sinus 20 region.
  • An alternative multi-channel electrode design is illustrated in FIG. 9. In this embodiment, the device 300 includes sixteen (16) individual electrode pads 302 connected to 16 channel cable 304 via 4 channel connectors 303. In this embodiment, the circular electrode pads 302 are partially encapsulated by the base structure 306 to leave one face of each button electrode 302 exposed for electrical connection to carotid tissues. With this arrangement, electrical paths through the carotid tissues may be defined by one or more pairs (bipolar) or groups (tripolar) of electrode pads 302.
  • A variation of the multi-channel pad type electrode design is illustrated in FIG. 10. In this embodiment, the device 300 includes sixteen (16) individual circular pad electrodes 302 surrounded by sixteen (16) rings 305, which collectively may be referred to as concentric electrode pads 302/305. Pad electrodes 302 are connected to 17 channel cable 304 via 4 channel connectors 303, and rings 305 are commonly connected to 17 channel cable 304 via a single channel connector 307. In this embodiment, the circular shaped electrodes 302 and the rings 305 are partially encapsulated by the base structure 306 to leave one face of each pad electrode 302 and one side of each ring 305 exposed for electrical connection to carotid tissues. As an alternative, two rings 305 may surround each electrode 302, with the rings 305 being commonly connected. With these arrangements, electrical paths through the carotid tissues may be defined between one or more pad electrode 302/ring 305 sets to create localized electrical paths.
  • Another variation of the multi-channel pad electrode design is illustrated in FIG. 11. In this embodiment, the device 300 includes a control IC chip 310 connected to 3 channel cable 304. The control chip 310 is also connected to sixteen (16) individual pad electrodes 302 via 4 channel connectors 303. The control chip 310 permits the number of channels in cable 304 to be reduced by utilizing a coding system. The control system 60 sends a coded control signal which is received by chip 310. The chip 310 converts the code and enables or disables selected electrode 302 pairs in accordance with the code.
  • For example, the control signal may comprise a pulse wave form, wherein each pulse includes a different code. The code for each pulse causes the chip 310 to enable one or more pairs of electrodes, and to disable the remaining electrodes. Thus, the pulse is only transmitted to the enabled electrode pair(s) corresponding to the code sent with that pulse. Each subsequent pulse would have a different code than the preceding pulse, such that the chip 310 enables and disables a different set of electrodes 302 corresponding to the different code. Thus, virtually any number of electrode pairs may be selectively activated using control chip 310, without the need for a separate channel in cable 304 for each electrode 302. By reducing the number of channels in cable 304, the size and cost thereof may be reduced.
  • Optionally, the IC chip 310 may be connected to feedback sensor 80, taking advantage of the same functions as described with reference to FIG. 3. In addition, one or more of the electrodes 302 may be used as feedback sensors when not enabled for activation. For example, such a feedback sensor electrode may be used to measure or monitor electrical conduction in the vascular wall to provide data analogous to an ECG. Alternatively, such a feedback sensor electrode may be used to sense a change in impedance due to changes in blood volume during a pulse pressure to provide data indicative of heart rate, blood pressure, or other physiologic parameter.
  • Refer now to FIG. 12 which schematically illustrates an extravascular electrical activation device 300 including a support collar or anchor 312. In this embodiment, the activation device 300 is wrapped around the internal carotid artery 19 at the carotid sinus 20, and the support collar 312 is wrapped around the common carotid artery 14. The activation device 300 is connected to the support collar 312 by cables 304, which act as a loose tether. With this arrangement, the collar 312 isolates the activation device from movements and forces transmitted by the cables 304 proximal of the support collar, such as may be encountered by movement of the control system 60 and/or driver 66. As an alternative to support collar 312, a strain relief (not shown) may be connected to the base structure 306 of the activation device 300 at the juncture between the cables 304 and the base 306. With either approach, the position of the device 300 relative to the carotid anatomy may be better maintained despite movements of other parts of the system.
  • In this embodiment, the base structure 306 of the activation device 300 may comprise molded tube, a tubular extrusion, or a sheet of material wrapped into a tube shape utilizing a suture flap 308 with sutures 309 as shown. The base structure 306 may be formed of a flexible and biocompatible material such as silicone, which may be reinforced with a flexible material such as polyester fabric available under the trade name DACRON® to form a composite structure. The inside diameter of the base structure 306 may correspond to the outside diameter of the carotid artery at the location of implantation, for example 6 to 8 mm. The wall thickness of the base structure 306 may be very thin to maintain flexibility and a low profile, for example less than 1 mm. If the device 300 is to be disposed about a sinus bulge 21, a correspondingly shaped bulge may be formed into the base structure for added support and assistance in positioning.
  • The electrodes 302 (shown in phantom) may comprise round wire, rectangular ribbon or foil, formed of an electrically conductive and radiopaque material such as platinum or platinum iridium. The electrodes may be molded into the base structure 306 or adhesively connected to the inside diameter thereof, leaving a portion of the electrode exposed for electrical connection to carotid tissues. The electrodes 302 may encompass less than the entire inside circumference (e.g., 300.degree.) of the base structure 306 to avoid shorting. The electrodes 302 may have any of the shapes and arrangements described previously. For example, as shown in FIG. 12, two rectangular ribbon electrodes 302 may be used, each having a width of 1 mm spaced 1.5 mm apart.
  • The support collar 312 may be formed similarly to base structure 306. For example, the support collar may comprise molded tube, a tubular extrusion, or a sheet of material wrapped into a tube shape utilizing a suture flap 315 with sutures 313 as shown. The support collar 312 may be formed of a flexible and biocompatible material such as silicone, which may be reinforced to form a composite structure. The cables 304 are secured to the support collar 312, leaving slack in the cables 304 between the support collar 312 and the activation device 300.
  • In all embodiments described herein, it may be desirable to secure the activation device to the vascular wall using sutures or other fixation means. For example, sutures 311 may be used to maintain the position of the electrical activation device 300 relative to the carotid anatomy (or other vascular site containing baroreceptors). Such sutures 311 may be connected to base structure 306, and pass through all or a portion of the vascular wall. For example, the sutures 311 may be threaded through the base structure 306, through the adventitia of the vascular wall, and tied. If the base structure 306 comprises a patch or otherwise partially surrounds the carotid anatomy, the corners and/or ends of the base structure may be sutured, with additional sutures evenly distributed therebetween. In order to minimize the propagation of a hole or a tear through the base structure 306, a reinforcement material such as polyester fabric may be embedded in the silicone material. In addition to sutures, other fixation means may be employed such as staples or a biocompatible adhesive, for example.
  • Refer now to FIG. 13 which schematically illustrates an alternative extravascular electrical activation device 300 including one or more electrode ribs 316 interconnected by spine 317. Optionally, a support collar 312 having one or more (non electrode) ribs 316 may be used to isolate the activation device 300 from movements and forces transmitted by the cables 304 proximal of the support collar 312.
  • The ribs 316 of the activation device 300 are sized to fit about the carotid anatomy, such as the internal carotid artery 19 adjacent the carotid sinus 20. Similarly, the ribs 316 of the support collar 312 may be sized to fit about the carotid anatomy, such as the common carotid artery 14 proximal of the carotid sinus 20. The ribs 316 may be separated, placed on a carotid artery, and closed thereabout to secure the device 300 to the carotid anatomy.
  • Each of the ribs 316 of the device 300 includes an electrode 302 on the inside surface thereof for electrical connection to carotid tissues. The ribs 316 provide insulating material around the electrodes 302, leaving only an inside portion exposed to the vascular wall. The electrodes 302 are coupled to the multi-channel cable 304 through spine 317. Spine 317 also acts as a tether to ribs 316 of the support collar 312, which do not include electrodes since their function is to provide support. The multi-channel electrode 302 functions discussed with reference to FIGS. 8-11 are equally applicable to this embodiment.
  • The ends of the ribs 316 may be connected (e.g., sutured) after being disposed about a carotid artery, or may remain open as shown. If the ends remain open, the ribs 316 may be formed of a relatively stiff material to ensure a mechanical lock around the carotid artery. For example, the ribs 316 may be formed of polyethylene, polypropylene, PTFE, or other similar insulating and biocompatible material. Alternatively, the ribs 316 may be formed of a metal such as stainless steel or a nickel titanium alloy, as long as the metallic material was electrically isolated from the electrodes 302. As a further alternative, the ribs 316 may comprise an insulating and biocompatible polymeric material with the structural integrity provided by metallic (e.g., stainless steel, nickel titanium alloy, etc.) reinforcement. In this latter alternative, the electrodes 302 may comprise the metallic reinforcement.
  • Refer now to FIG. 14 which schematically illustrates a specific example of an electrode assembly for an extravascular electrical activation device 300. In this specific example, the base structure 306 comprises a silicone sheet having a length of 5.0 inches, a thickness of 0.007 inches, and a width of 0.312 inches. The electrodes 302 comprise platinum ribbon having a length of 0.47 inches, a thickness of 0.0005 inches, and a width of 0.040 inches. The electrodes 302 are adhesively connected to one side of the silicone sheet 306.
  • The electrodes 302 are connected to a modified bipolar endocardial pacing lead, available under the trade name CONIFIX from Innomedica (now BIOMEC Cardiovascular, Inc.), model number 501112. The proximal end of the cable 304 is connected to the control system 60 or driver 66 as described previously. The pacing lead is modified by removing the pacing electrode to form the cable body 304. The MP35 wires are extracted from the distal end thereof to form two coils 318 positioned side by side having a diameter of about 0.020 inches. The coils 318 are then attached to the electrodes utilizing 316 type stainless steel crimp terminals laser welded to one end of the platinum electrodes 302. The distal end of the cable 304 and the connection between the coils 318 and the ends of the electrodes 302 are encapsulated by silicone.
  • The cable 304 illustrated in FIG. 14 comprises a coaxial type cable including two coaxially disposed coil leads separated into two separate coils 318 for attachment to the electrodes 302. An alternative cable 304 construction is illustrated in FIG. 15. FIG. 15 illustrates an alternative cable body 304 which may be formed in a curvilinear shape such as a sinusoidal configuration, prior to implantation. The curvilinear configuration readily accommodates a change in distance between the device 300 and the control system 60 or the driver 66. Such a change in distance may be encountered during flexion and/or extension of the neck of the patient after implantation.
  • In this alternative embodiment, the cable body 304 may comprise two or more conductive wires 304 a arranged coaxially or collinearly as shown. Each conductive wire 304 a may comprise a multifilament structure of suitable conductive material such as stainless steel or MP35N. An insulating material may surround the wire conductors 304 a individually and/or collectively. For purposes of illustration only, a pair of electrically conductive wires 304 a having an insulating material surrounding each wire 304 a individually is shown. The insulated wires 304 a may be connected by a spacer 304 b comprising, for example, an insulating material. An additional jacket of suitable insulating material may surround each of the conductors 304 a. The insulating jacket may be formed to have the same curvilinear shape of the insulated wires 304 a to help maintain the shape of the cable body 304 during implantation.
  • If a sinusoidal configuration is chosen for the curvilinear shape, the amplitude (A) may range from 1 mm to 10 mm, and preferably ranges from 2 mm to 3 mm. The wavelength (WL) of the sinusoid may range from 2 mm to 20 mm, and preferably ranges from 4 mm to 10 mm. The curvilinear or sinusoidal shape may be formed by a heat setting procedure utilizing a fixture which holds the cable 304 in the desired shape while the cable is exposed to heat. Sufficient heat is used to heat set the conductive wires 304 a and/or the surrounding insulating material. After cooling, the cable 304 may be removed from the fixture, and the cable 304 retains the desired shape.
  • Refer now to FIGS. 16-18 which illustrate various transducers that may be mounted to the wall of a vessel such as a carotid artery 14 to monitor wall expansion or contraction using strain, force and/or pressure gauges. An example of an implantable blood pressure measurement device that may be disposed about a blood vessel is disclosed in U.S. Pat. No. 6,106,477 to Miesel et al., the entire disclosure of which is incorporated herein by reference. The output from such gauges may be correlated to blood pressure and/or heart rate, for example, and may be used to provide feedback to the control system 60 as described previously herein. In FIG. 16, an implantable pressure measuring assembly comprises a foil strain gauge or force sensing resistor device 740 disposed about an artery such as common carotid artery 14. A transducer portion 742 may be mounted to a silicone base or backing 744 which is wrapped around and sutured or otherwise attached to the artery 14.
  • Alternatively, the transducer 750 may be adhesively connected to the wall of the artery 14 using a biologically compatible adhesive such as cyanoacrylate as shown in FIG. 17. In this embodiment, the transducer 750 comprises a micro machined sensor (MEMS) that measures force or pressure. The MEMS transducer 750 includes a micro arm 752 (shown in section in FIG. 18) coupled to a silicon force sensor contained over an elastic base 754. A cap 756 covers the arm 752 a top portion of the base 754. The base 754 include an interior opening creating access from the vessel wall 14 to the arm 752. An incompressible gel 756 fills the space between the arm 752 and the vessel wall 14 such that force is transmitted to the arm upon expansion and contraction of the vessel wall. In both cases, changes in blood pressure within the artery cause changes in vessel wall stress which are detected by the transducer and which may be correlated with the blood pressure.
  • Refer now to FIGS. 19-21 which illustrate an alternative extravascular electrical activation device 700, which, may also be referred to as an electrode cuff device or more generally as an “electrode assembly.” Except as described herein and shown in the drawings, device 700 may be the same in design and function as extravascular electrical activation device 300 described previously.
  • As seen in FIGS. 19 and 20, electrode assembly or cuff device 700 includes coiled electrode conductors 702/704 embedded in a flexible support 706. In the embodiment shown, an outer electrode coil 702 and an inner electrode coil 704 are used to provide a pseudo tripolar arrangement, but other polar arrangements are applicable as well as described previously. The coiled electrodes 702/704 may be formed of fine round, flat or ellipsoidal wire such as 0.002 inch diameter round PtIr alloy wire wound into a coil form having a nominal diameter of 0.015 inches with a pitch of 0.004 inches, for example. The flexible support or base 706 may be formed of a biocompatible and flexible (preferably elastic) material such as silicone or other suitable thin walled elastomeric material having a wall thickness of 0.005 inches and a length (e.g., 2.95 inches) sufficient to surround the carotid sinus, for example.
  • Each turn of the coil in the contact area of the electrodes 702/704 is exposed from the flexible support 706 and any adhesive to form a conductive path to the artery wall. The exposed electrodes 702/704 may have a length (e.g., 0.236 inches) sufficient to extend around at least a portion of the carotid sinus, for example. The electrode cuff 700 is assembled flat with the contact surfaces of the coil electrodes 702/704 tangent to the inside plane of the flexible support 706. When the electrode cuff 700 is wrapped around the artery, the inside contact surfaces of the coiled electrodes 702/704 are naturally forced to extend slightly above the adjacent surface of the flexible support, thereby improving contact to the artery wall.
  • The ratio of the diameter of the coiled electrodes 702/704 to the wire diameter is preferably large enough to allow the coil to bend and elongate without significant bending stress or torsional stress in the wire. Flexibility is a significant advantage of this design which allows the electrode cuff 700 to conform to the shape of the carotid artery and sinus, and permits expansion and contraction of the artery or sinus without encountering significant stress or fatigue. In particular, the flexible electrode cuff 700 may be wrapped around and stretched to conform to the shape of the carotid sinus and artery during implantation. This may be achieved without collapsing or distorting the shape of the artery and carotid sinus due to the compliance of the electrode cuff 700. The flexible support 706 is able to flex and stretch with the conductor coils 702/704 because of the absence of fabric reinforcement in the electrode contact portion of the cuff 700. By conforming to the artery shape, and by the edge of the flexible support 706 sealing against the artery wall, the amount of stray electrical field and extraneous stimulation will likely be reduced.
  • The pitch of the coil electrodes 702/704 may be greater than the wire diameter in order to provide a space between each turn of the wire to thereby permit bending without necessarily requiring axial elongation thereof. For example, the pitch of the contact coils 702/704 may be 0.004 inches per turn with a 0.002 inch diameter wire, which allows for a 0.002 inch space between the wires in each turn. The inside of the coil may be filled with a flexible adhesive material such as silicone adhesive which may fill the spaces between adjacent wire turns. By filling the small spaces between the adjacent coil turns, the chance of pinching tissue between coil turns is minimized thereby avoiding abrasion to the artery wall. Thus, the embedded coil electrodes 702/704 are mechanically captured and chemically bonded into the flexible support 706. In the unlikely event that a coil electrode 702/704 comes loose from the support 706, the diameter of the coil is large enough to be atraumatic to the artery wall. Preferably, the centerline of the coil electrodes 702/704 lie near the neutral axis of electrode cuff structure 700 and the flexible support 706 comprises a material with isotropic elasticity such as silicone in order to minimize the shear forces on the adhesive bonds between the coil electrodes 702/704 and the support 706.
  • The electrode coils 702/704 are connected to corresponding conductive coils 712/714, respectively, in an elongate lead 710 which is connected to the control system 60. Anchoring wings 718 may be provided on the lead 710 to tether the lead 710 to adjacent tissue and minimize the effects or relative movement between the lead 710 and the electrode cuff 700. As seen in FIG. 21, the conductive coils 712/714 may be formed of 0.003 MP35N bifilar wires wound into 0.018 inch diameter coils which are electrically connected to electrode coils 702/704 by splice wires 716. The conductive coils 712/714 may be individually covered by an insulating covering 718 such as silicone tubing and collectively covered by insulating covering 720.
  • The conductive material of the electrodes 702/704 may be a metal as described above or a conductive polymer such as a silicone material filled with metallic particles such as Pt particles. In this latter embodiment, the polymeric electrodes may be integrally formed with the flexible support 706 with the electrode contacts comprising raised areas on the inside surface of the flexible support 706 electrically coupled to the lead 710 by wires or wire coils. The use of polymeric electrodes may be applied to other electrode design embodiments described elsewhere herein.
  • Reinforcement patches 708 such as DACRON® fabric may be selectively incorporated into the flexible support 706. For example, reinforcement patches 708 may be incorporated into the ends or other areas of the flexible support 706 to accommodate suture anchors. The reinforcement patches 708 provide points where the electrode cuff 700 may be sutured to the vessel wall and may also provide tissue in growth to further anchor the device 700 to the exterior of the vessel wall. For example, the fabric reinforcement patches 708 may extend beyond the edge of the flexible support 706 so that tissue in growth may help anchor the electrode assembly or cuff 700 to the vessel wall and may reduce reliance on the sutures to retain the electrode assembly 700 in place. As a substitute for or in addition to the sutures and tissue in growth, bioadhesives such as cyanoacrylate may be employed to secure the device 700 to the vessel wall. In addition, an adhesive incorporating conductive particles such as Pt coated micro spheres may be applied to the exposed inside surfaces of the electrodes 702/704 to enhance electrical conduction to the tissue and possibly limit conduction along one axis to limit extraneous tissue stimulation.
  • The reinforcement patches 708 may also be incorporated into the flexible support 706 for strain relief purposes and to help retain the coils 702/704 to the support 706 where the leads 710 attach to the electrode assembly 700 as well as where the outer coil 702 loops back around the inner coil 704. Preferably, the patches 708 are selectively incorporated into the flexible support 706 to permit expansion and contraction of the device 700, particularly in the area of the electrodes 702/704. In particular, the flexible support 706 is only fabric reinforced in selected areas thereby maintaining the ability of the electrode cuff 700 to stretch.
  • Referring now to FIGS. 22-26, the electrode assembly of FIGS. 19-21 can be modified to have “flattened” coil electrodes in the region of the assembly where the electrodes contact the extravascular tissue. As shown in FIG. 22, an electrode-carrying surface 801 of the electrode assembly, is located generally between parallel reinforcement strips or tabs 808. The flattened coil section 810 will generally be exposed on a lower surface 803 of the base 806 (FIG. 23) and will be covered or encapsulated by a parylene or other polymeric structure or material 802 over an upper surface 805 thereof. The coil is formed with a generally circular periphery 809, as best seen in FIGS. 24 and 26, and may be mechanically flattened, typically over a silicone or other supporting insert 815, as best seen in FIG. 25. The use of the flattened coil structure is particularly beneficial since it retains flexibility, allowing the electrodes to bend, stretch, and flex together with the elastomeric base 806, while also increasing the flat electrode area available to contact the extravascular surface.
  • Referring now to FIGS. 27-30, an additional electrode assembly 900 constructed in accordance with the principles of the present invention will be described. Electrode assembly 900 comprises an electrode base, typically an elastic base 902, typically formed from silicone or other elastomeric material, having an electrode-carrying surface 904 and a plurality of attachment tabs 906 (906 a, 906 b, 906 c, and 906 d) extending from the electrode-carrying surface. The attachment tabs 906 are preferably formed from the same material as the electrode-carrying surface 904 of the base 902, but could be formed from other elastomeric materials as well. In the latter case, the base will be molded, stretched or otherwise assembled from the various pieces. In the illustrated embodiment, the attachment tabs 906 are formed integrally with the remainder of the base 902, i.e., typically being cut from a single sheet of the elastomeric material.
  • The geometry of the electrode assembly 900, and in particular the geometry of the base 902, is selected to permit a number of different attachment modes to the blood vessel. In particular, the geometry of the assembly 902 of FIG. 27 is intended to permit attachment to various locations on the carotid arteries at or near the carotid sinus and carotid bifurcation.
  • A number of reinforcement regions 910 (910 a, 910 b, 910 c, 910 d, and 910 e) are attached to different locations on the base 902 to permit suturing, clipping, stapling, or other fastening of the attachment tabs 906 to each other and/or the electrode-carrying surface 904 of the base 902. In the preferred embodiment intended for attachment at or around the carotid sinus, a first reinforcement strip 910 a is provided over an end of the base 902 opposite to the end which carries the attachment tabs. Pairs of reinforcement strips 910 b and 910 c are provided on each of the axially aligned attachment tabs 906 a and 906 b, while similar pairs of reinforcement strips 910 d and 910 e are provided on each of the transversely angled attachment tabs 906 c and 906 d. In the illustrated embodiment, all attachment tabs will be provided on one side of the base, preferably emanating from adjacent corners of the rectangular electrode-carrying surface 904.
  • The structure of electrode assembly 900 permits the surgeon to implant the electrode assembly so that the electrodes 920 (which are preferably stretchable, flat-coil electrodes as described in detail above), are located at a preferred location relative to the target baroreceptors. The preferred location may be determined, for example, as described in copending application Ser. No. 09/963,991, filed on Sep. 26, 2001, the full disclosure of which incorporated herein by reference.
  • Once the preferred location for the electrodes 920 of the electrode assembly 900 is determined, the surgeon may position the base 902 so that the electrodes 920 are located appropriately relative to the underlying baroreceptors. Thus, the electrodes 920 may be positioned over the common carotid artery CC as shown in FIG. 28, or over the internal carotid artery IC, as shown in FIGS. 29 and 30. In FIG. 28, the assembly 900 may be attached by stretching the base 902 and attachment tabs 906 a and 906 b over the exterior of the common carotid artery. The reinforcement tabs 906 a or 906 b may then be secured to the reinforcement strip 910 a, either by suturing, stapling, fastening, gluing, welding, or other well-known means. Usually, the reinforcement tabs 906 c and 906 d will be cut off at their bases, as shown at 922 and 924, respectively.
  • In other cases, the bulge of the carotid sinus and the baroreceptors may be located differently with respect to the carotid bifurcation. For example, as shown in FIG. 29, the receptors may be located further up the internal carotid artery IC so that the placement of electrode assembly 900 as shown in FIG. 28 will not work. The assembly 900, however, may still be successfully attached by utilizing the transversely angled attachment tabs 906 c and 906 d rather than the central or axial tabs 906 a and 906 b. As shown in FIG. 29, the lower tab 906 d is wrapped around the common carotid artery CC, while the upper attachment tab 906 c is wrapped around the internal carotid artery IC. The axial attachment tabs 906 a and 906 b will usually be cut off (at locations 926), although neither of them could in some instances also be wrapped around the internal carotid artery IC. Again, the tabs which are used may be stretched and attached to reinforcement strip 910 a, as generally described above.
  • Referring to FIG. 30, in instances where the carotid bifurcation has less of an angle, the assembly 900 may be attached using the upper axial attachment tab 906 a and be lower transversely angled attachment tab 906 d. Attachment tabs 906 b and 906 c may be cut off, as shown at locations 928 and 930, respectively. In all instances, the elastic nature of the base 902 and the stretchable nature of the electrodes 920 permit the desired conformance and secure mounting of the electrode assembly over the carotid sinus. It would be appreciated that these or similar structures would also be useful for mounting electrode structures at other locations in the vascular system.
  • In most activation device embodiments described herein, it may be desirable to incorporate anti-inflammatory agents (e.g., steroid eluting electrodes) such as described in U.S. Pat. No. 4,711,251 to Stokes, U.S. Pat. No. 5,522,874 to Gates and U.S. Pat. No. 4,972,848 to Di Domenico et al., the entire disclosures of which are incorporated herein by reference. Such agents reduce tissue inflammation at the chronic interface between the device (e.g., electrodes) and the vascular wall tissue, to thereby increase the efficiency of stimulus transfer, reduce power consumption, and maintain activation efficiency, for example.
  • Those skilled in the art will recognize that the present invention may be manifested in a variety of forms other than the specific embodiments described and contemplated herein. Accordingly, departures in form and detail may be made without departing from the scope and spirit of the present invention as described in the appended claims.

Claims (16)

1. An electrode assembly for an implantable medical device, comprising: a spine; and a plurality of electrodes protruding from the spine, wherein at least two electrodes protrude from the spine in opposing directions and define a nerve-receiving channel; wherein, when said electrode assembly is not coupled to a nerve and said electrodes are in a relaxed state position, said nerve receiving channel comprises a cross-sectional area that is substantially less than a cross-sectional area of a nerve to which the electrode assembly is adapted to be coupled; and wherein, when coupled to said nerve, each electrode wraps around and directly contacts at least 60% of the circumference of the nerve.
2. The electrode assembly of claim 1 wherein, when said electrode assembly is not coupled to a nerve and said electrodes are in a relaxed state position, the cross-sectional area of the nerve receiving channel is less than 80% of the cross-sectional area of the nerve.
3. The electrode assembly of claim 2 wherein, when said electrode assembly is not coupled to a nerve and said electrodes are in a relaxed state position, the cross-sectional area of the nerve receiving channel is less than 60% of the cross-sectional area of the nerve.
4. The electrode assembly of claim 1 wherein said plurality of electrodes comprises at least three electrodes and at least two electrodes adjacent one another along the spine protrude from the spine in a common direction.
5. The electrode assembly of claim 1 wherein said spine includes a plurality of electrical conductors, and wherein each conductor is coupled to at least one electrode, and is electrically insulated from all other of said electrical conductors.
6. An implantable medical device, comprising: a pulse generator; a lead assembly coupled to said pulse generator; and an electrode assembly coupled to said lead assembly, wherein the electrode assembly comprises a spine and a plurality of electrodes protruding from the spine, and wherein at least two electrodes protrude from the spine in opposing directions and define a nerve-receiving channel; wherein, when said electrode assembly is not coupled to a nerve and said electrodes are in a relaxed state position, said nerve receiving channel comprises a cross-sectional area that is substantially less than a cross-sectional area of a nerve to which the electrode assembly is adapted to be coupled; and wherein, when coupled to said nerve, each electrode wraps around and directly contacts at least 70% of the circumference of the nerve.
7. The implantable medical device of claim 6 wherein, when said electrode assembly is not coupled to a nerve and said electrodes are in a relaxed state position, the cross-sectional area of the nerve receiving channel is less than 80% of the cross-sectional area of the nerve.
8. The implantable medical device of claim 7 wherein, when said electrode assembly is not coupled to a nerve and said electrodes are in a relaxed state position, the cross-sectional area of the nerve receiving channel is less than 60% of the cross-sectional area of the nerve.
9. The implantable medical device of claim 6 wherein said plurality of electrodes comprises at least three electrodes and at least two electrodes adjacent one another along the spine protrude from the spine in a common direction.
10. The implantable medical device of claim 6 wherein said spine includes a plurality of electrical conductors, and wherein each conductor is coupled to at least one electrode, and is electrically insulated from all other of said electrical conductors.
11. An electrode assembly usable with an implantable medical device, comprising: a spine; and a plurality of curved fingers protruding from said spine, wherein at least two fingers protrude from the spine in opposing directions and define a nerve-receiving channel, and wherein at least one of said fingers comprises an electrode that is adapted to electrically contact a nerve; wherein, when said electrode assembly is not coupled to the nerve and said fingers are in a relaxed state position, said nerve-receiving channel comprises a cross-sectional area that is substantially less than a cross-sectional area of a nerve to which the electrode assembly is adapted to be coupled; and wherein, when coupled to said nerve, all of said fingers contact the nerve on a partial outer surface of the nerve, said partial outer surface extending circumferentially at least approximately 40% of the circumference of the nerve.
12. The electrode assembly of claim 11 wherein each finger wraps around and directly contacts at least 70% of the circumference of the nerve.
13. The electrode assembly of claim 11 wherein at least two fingers comprise an electrode.
14. The electrode assembly of claim 11 wherein, when said electrode assembly is not coupled to a nerve and said fingers are in a relaxed state position, the cross-sectional area of the nerve receiving channel is less than 80% of the cross-sectional area of the nerve.
15. The electrode assembly of claim 14 wherein, when said electrode assembly is not coupled to a nerve and said fingers are in a relaxed state position, the cross-sectional area of the nerve receiving channel is less than 60% of the cross-sectional area of the nerve.
16. An electrode assembly for an implantable medical device, comprising: a spine; and a plurality of electrodes protruding from the spine, wherein at least two electrodes protrude from the spine in opposing directions and define a nerve-receiving channel; wherein, when said electrode assembly is not coupled to a nerve and said electrodes are in a relaxed state position, said nerve receiving channel comprises a cross-sectional area that is less than 80% of the cross-sectional area of a nerve to which the electrode assembly is adapted to be coupled.
US11/933,313 2000-09-27 2007-10-31 Self-locking electrode assembly usable with an implantable medical device Abandoned US20080177364A1 (en)

Priority Applications (1)

Application Number Priority Date Filing Date Title
US11/933,313 US20080177364A1 (en) 2000-09-27 2007-10-31 Self-locking electrode assembly usable with an implantable medical device

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US09/671,850 US6522926B1 (en) 2000-09-27 2000-09-27 Devices and methods for cardiovascular reflex control
US09/963,777 US7158832B2 (en) 2000-09-27 2001-09-26 Electrode designs and methods of use for cardiovascular reflex control devices
US11/933,313 US20080177364A1 (en) 2000-09-27 2007-10-31 Self-locking electrode assembly usable with an implantable medical device

Related Parent Applications (1)

Application Number Title Priority Date Filing Date
US09/963,777 Continuation US7158832B2 (en) 2000-09-27 2001-09-26 Electrode designs and methods of use for cardiovascular reflex control devices

Publications (1)

Publication Number Publication Date
US20080177364A1 true US20080177364A1 (en) 2008-07-24

Family

ID=25507692

Family Applications (5)

Application Number Title Priority Date Filing Date
US09/963,777 Expired - Lifetime US7158832B2 (en) 2000-09-27 2001-09-26 Electrode designs and methods of use for cardiovascular reflex control devices
US11/933,283 Abandoned US20080172101A1 (en) 2000-09-27 2007-10-31 Non-linear electrode array
US11/933,302 Abandoned US20080171923A1 (en) 2000-09-27 2007-10-31 Assessing autonomic activity using baroreflex analysis
US11/933,320 Abandoned US20080177339A1 (en) 2000-09-27 2007-10-31 Electrode contact configurations for cuff leads
US11/933,313 Abandoned US20080177364A1 (en) 2000-09-27 2007-10-31 Self-locking electrode assembly usable with an implantable medical device

Family Applications Before (4)

Application Number Title Priority Date Filing Date
US09/963,777 Expired - Lifetime US7158832B2 (en) 2000-09-27 2001-09-26 Electrode designs and methods of use for cardiovascular reflex control devices
US11/933,283 Abandoned US20080172101A1 (en) 2000-09-27 2007-10-31 Non-linear electrode array
US11/933,302 Abandoned US20080171923A1 (en) 2000-09-27 2007-10-31 Assessing autonomic activity using baroreflex analysis
US11/933,320 Abandoned US20080177339A1 (en) 2000-09-27 2007-10-31 Electrode contact configurations for cuff leads

Country Status (1)

Country Link
US (5) US7158832B2 (en)

Cited By (28)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US7813812B2 (en) 2000-09-27 2010-10-12 Cvrx, Inc. Baroreflex stimulator with integrated pressure sensor
US7822486B2 (en) 2005-08-17 2010-10-26 Enteromedics Inc. Custom sized neural electrodes
US7840271B2 (en) 2000-09-27 2010-11-23 Cvrx, Inc. Stimulus regimens for cardiovascular reflex control
US7949400B2 (en) 2000-09-27 2011-05-24 Cvrx, Inc. Devices and methods for cardiovascular reflex control via coupled electrodes
US8086314B1 (en) 2000-09-27 2011-12-27 Cvrx, Inc. Devices and methods for cardiovascular reflex control
WO2012017437A1 (en) * 2010-08-05 2012-02-09 Rainbow Medical Ltd. Enhancing perfusion by contraction
US20120059437A1 (en) * 2009-05-14 2012-03-08 Samson Neurosciences Ltd. Endovascular Electrostimulation Near a Carotid Bifurcation in Treating Cerebrovascular Conditions
US8594794B2 (en) 2007-07-24 2013-11-26 Cvrx, Inc. Baroreflex activation therapy with incrementally changing intensity
US8606359B2 (en) 2000-09-27 2013-12-10 Cvrx, Inc. System and method for sustained baroreflex stimulation
US8626290B2 (en) 2008-01-31 2014-01-07 Enopace Biomedical Ltd. Acute myocardial infarction treatment by electrical stimulation of the thoracic aorta
US8626299B2 (en) 2008-01-31 2014-01-07 Enopace Biomedical Ltd. Thoracic aorta and vagus nerve stimulation
US8649863B2 (en) 2010-12-20 2014-02-11 Rainbow Medical Ltd. Pacemaker with no production
US8740825B2 (en) 2011-10-19 2014-06-03 Sympara Medical, Inc. Methods and devices for treating hypertension
US8855783B2 (en) 2011-09-09 2014-10-07 Enopace Biomedical Ltd. Detector-based arterial stimulation
US8862243B2 (en) 2005-07-25 2014-10-14 Rainbow Medical Ltd. Electrical stimulation of blood vessels
US8954165B2 (en) 2012-01-25 2015-02-10 Nevro Corporation Lead anchors and associated systems and methods
US9005106B2 (en) 2008-01-31 2015-04-14 Enopace Biomedical Ltd Intra-aortic electrical counterpulsation
US20160038736A1 (en) * 2011-12-05 2016-02-11 Neurimpluse Srl Electro catheter for neurostimulation
US9265935B2 (en) 2013-06-28 2016-02-23 Nevro Corporation Neurological stimulation lead anchors and associated systems and methods
US9386991B2 (en) 2012-02-02 2016-07-12 Rainbow Medical Ltd. Pressure-enhanced blood flow treatment
US9526637B2 (en) 2011-09-09 2016-12-27 Enopace Biomedical Ltd. Wireless endovascular stent-based electrodes
US10368761B2 (en) 2011-12-22 2019-08-06 Modular Bionics Inc. Neural interface device and insertion tools
US10674914B1 (en) 2015-06-24 2020-06-09 Modular Bionics Inc. Wireless neural interface system
US10779965B2 (en) 2013-11-06 2020-09-22 Enopace Biomedical Ltd. Posts with compliant junctions
US10874847B2 (en) 2016-07-07 2020-12-29 Modular Bionics Inc. Neural interface insertion and retraction tools
US11065439B1 (en) 2017-12-11 2021-07-20 Modular Bionics Inc. Conforming modular neural interface system
US11285315B2 (en) 2011-09-01 2022-03-29 Inspire Medical Systems, Inc. Nerve cuff
US11400299B1 (en) 2021-09-14 2022-08-02 Rainbow Medical Ltd. Flexible antenna for stimulator

Families Citing this family (306)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US7799337B2 (en) * 1997-07-21 2010-09-21 Levin Bruce H Method for directed intranasal administration of a composition
US6702811B2 (en) 1999-04-05 2004-03-09 Medtronic, Inc. Ablation catheter assembly with radially decreasing helix and method of use
US7158832B2 (en) * 2000-09-27 2007-01-02 Cvrx, Inc. Electrode designs and methods of use for cardiovascular reflex control devices
US20080167699A1 (en) * 2000-09-27 2008-07-10 Cvrx, Inc. Method and Apparatus for Providing Complex Tissue Stimulation Parameters
US20080177348A1 (en) * 2000-09-27 2008-07-24 Cvrx, Inc. Electrode contact configurations for an implantable stimulator
US20070185542A1 (en) * 2002-03-27 2007-08-09 Cvrx, Inc. Baroreflex therapy for disordered breathing
US7069070B2 (en) * 2003-05-12 2006-06-27 Cardiac Pacemakers, Inc. Statistical method for assessing autonomic balance
EP1476220A4 (en) * 2002-02-01 2009-12-16 Cleveland Clinic Foundation Delivery device for stimulating the sympathetic nerve chain
US8774913B2 (en) 2002-04-08 2014-07-08 Medtronic Ardian Luxembourg S.A.R.L. Methods and apparatus for intravasculary-induced neuromodulation
US7756583B2 (en) 2002-04-08 2010-07-13 Ardian, Inc. Methods and apparatus for intravascularly-induced neuromodulation
US8774922B2 (en) 2002-04-08 2014-07-08 Medtronic Ardian Luxembourg S.A.R.L. Catheter apparatuses having expandable balloons for renal neuromodulation and associated systems and methods
US8145316B2 (en) 2002-04-08 2012-03-27 Ardian, Inc. Methods and apparatus for renal neuromodulation
US7653438B2 (en) * 2002-04-08 2010-01-26 Ardian, Inc. Methods and apparatus for renal neuromodulation
US9636174B2 (en) 2002-04-08 2017-05-02 Medtronic Ardian Luxembourg S.A.R.L. Methods for therapeutic renal neuromodulation
US7853333B2 (en) * 2002-04-08 2010-12-14 Ardian, Inc. Methods and apparatus for multi-vessel renal neuromodulation
US7617005B2 (en) 2002-04-08 2009-11-10 Ardian, Inc. Methods and apparatus for thermally-induced renal neuromodulation
US9308043B2 (en) 2002-04-08 2016-04-12 Medtronic Ardian Luxembourg S.A.R.L. Methods for monopolar renal neuromodulation
US20080213331A1 (en) 2002-04-08 2008-09-04 Ardian, Inc. Methods and devices for renal nerve blocking
US7620451B2 (en) * 2005-12-29 2009-11-17 Ardian, Inc. Methods and apparatus for pulsed electric field neuromodulation via an intra-to-extravascular approach
US7162303B2 (en) * 2002-04-08 2007-01-09 Ardian, Inc. Renal nerve stimulation method and apparatus for treatment of patients
US8145317B2 (en) 2002-04-08 2012-03-27 Ardian, Inc. Methods for renal neuromodulation
US8131371B2 (en) 2002-04-08 2012-03-06 Ardian, Inc. Methods and apparatus for monopolar renal neuromodulation
US9308044B2 (en) 2002-04-08 2016-04-12 Medtronic Ardian Luxembourg S.A.R.L. Methods for therapeutic renal neuromodulation
US8150519B2 (en) 2002-04-08 2012-04-03 Ardian, Inc. Methods and apparatus for bilateral renal neuromodulation
US20070129761A1 (en) 2002-04-08 2007-06-07 Ardian, Inc. Methods for treating heart arrhythmia
US20070135875A1 (en) 2002-04-08 2007-06-14 Ardian, Inc. Methods and apparatus for thermally-induced renal neuromodulation
US8347891B2 (en) 2002-04-08 2013-01-08 Medtronic Ardian Luxembourg S.A.R.L. Methods and apparatus for performing a non-continuous circumferential treatment of a body lumen
US20140018880A1 (en) 2002-04-08 2014-01-16 Medtronic Ardian Luxembourg S.A.R.L. Methods for monopolar renal neuromodulation
US8175711B2 (en) 2002-04-08 2012-05-08 Ardian, Inc. Methods for treating a condition or disease associated with cardio-renal function
US6978174B2 (en) 2002-04-08 2005-12-20 Ardian, Inc. Methods and devices for renal nerve blocking
US20040039417A1 (en) * 2002-04-16 2004-02-26 Medtronic, Inc. Electrical stimulation and thrombolytic therapy
US20040082859A1 (en) 2002-07-01 2004-04-29 Alan Schaer Method and apparatus employing ultrasound energy to treat body sphincters
US7189204B2 (en) 2002-12-04 2007-03-13 Cardiac Pacemakers, Inc. Sleep detection using an adjustable threshold
US20060111626A1 (en) * 2003-03-27 2006-05-25 Cvrx, Inc. Electrode structures having anti-inflammatory properties and methods of use
JP4192040B2 (en) * 2003-06-11 2008-12-03 泉工医科工業株式会社 Balloon pump drive device
US7887493B2 (en) * 2003-09-18 2011-02-15 Cardiac Pacemakers, Inc. Implantable device employing movement sensing for detecting sleep-related disorders
US8606356B2 (en) 2003-09-18 2013-12-10 Cardiac Pacemakers, Inc. Autonomic arousal detection system and method
EP2008581B1 (en) 2003-08-18 2011-08-17 Cardiac Pacemakers, Inc. Patient monitoring, diagnosis, and/or therapy systems and methods
US8002553B2 (en) 2003-08-18 2011-08-23 Cardiac Pacemakers, Inc. Sleep quality data collection and evaluation
DE202004021943U1 (en) 2003-09-12 2013-05-13 Vessix Vascular, Inc. Selectable eccentric remodeling and / or ablation of atherosclerotic material
US7392084B2 (en) 2003-09-23 2008-06-24 Cardiac Pacemakers, Inc. Demand-based cardiac function therapy
US7480532B2 (en) * 2003-10-22 2009-01-20 Cvrx, Inc. Baroreflex activation for pain control, sedation and sleep
US7572226B2 (en) 2003-10-28 2009-08-11 Cardiac Pacemakers, Inc. System and method for monitoring autonomic balance and physical activity
US7657312B2 (en) * 2003-11-03 2010-02-02 Cardiac Pacemakers, Inc. Multi-site ventricular pacing therapy with parasympathetic stimulation
US20050165317A1 (en) * 2003-11-04 2005-07-28 Turner Nicholas M. Medical devices
US7783353B2 (en) 2003-12-24 2010-08-24 Cardiac Pacemakers, Inc. Automatic neural stimulation modulation based on activity and circadian rhythm
US7460906B2 (en) 2003-12-24 2008-12-02 Cardiac Pacemakers, Inc. Baroreflex stimulation to treat acute myocardial infarction
US20050149132A1 (en) 2003-12-24 2005-07-07 Imad Libbus Automatic baroreflex modulation based on cardiac activity
US7509166B2 (en) 2003-12-24 2009-03-24 Cardiac Pacemakers, Inc. Automatic baroreflex modulation responsive to adverse event
US20080015659A1 (en) * 2003-12-24 2008-01-17 Yi Zhang Neurostimulation systems and methods for cardiac conditions
US7647114B2 (en) 2003-12-24 2010-01-12 Cardiac Pacemakers, Inc. Baroreflex modulation based on monitored cardiovascular parameter
US8126560B2 (en) 2003-12-24 2012-02-28 Cardiac Pacemakers, Inc. Stimulation lead for stimulating the baroreceptors in the pulmonary artery
US7706884B2 (en) * 2003-12-24 2010-04-27 Cardiac Pacemakers, Inc. Baroreflex stimulation synchronized to circadian rhythm
US7869881B2 (en) * 2003-12-24 2011-01-11 Cardiac Pacemakers, Inc. Baroreflex stimulator with integrated pressure sensor
US8396560B2 (en) 2004-11-18 2013-03-12 Cardiac Pacemakers, Inc. System and method for closed-loop neural stimulation
US20050149129A1 (en) * 2003-12-24 2005-07-07 Imad Libbus Baropacing and cardiac pacing to control output
US7486991B2 (en) 2003-12-24 2009-02-03 Cardiac Pacemakers, Inc. Baroreflex modulation to gradually decrease blood pressure
US7769450B2 (en) * 2004-11-18 2010-08-03 Cardiac Pacemakers, Inc. Cardiac rhythm management device with neural sensor
US20050149133A1 (en) * 2003-12-24 2005-07-07 Imad Libbus Sensing with compensation for neural stimulator
US7643875B2 (en) * 2003-12-24 2010-01-05 Cardiac Pacemakers, Inc. Baroreflex stimulation system to reduce hypertension
US9020595B2 (en) * 2003-12-24 2015-04-28 Cardiac Pacemakers, Inc. Baroreflex activation therapy with conditional shut off
US8024050B2 (en) 2003-12-24 2011-09-20 Cardiac Pacemakers, Inc. Lead for stimulating the baroreceptors in the pulmonary artery
US7668594B2 (en) 2005-08-19 2010-02-23 Cardiac Pacemakers, Inc. Method and apparatus for delivering chronic and post-ischemia cardiac therapies
US7840263B2 (en) * 2004-02-27 2010-11-23 Cardiac Pacemakers, Inc. Method and apparatus for device controlled gene expression
US7260431B2 (en) 2004-05-20 2007-08-21 Cardiac Pacemakers, Inc. Combined remodeling control therapy and anti-remodeling therapy by implantable cardiac device
US7747323B2 (en) 2004-06-08 2010-06-29 Cardiac Pacemakers, Inc. Adaptive baroreflex stimulation therapy for disordered breathing
WO2006012033A2 (en) * 2004-06-30 2006-02-02 Cvrx, Inc. Lockout connector arrangement for implantable medical device
US20060004417A1 (en) * 2004-06-30 2006-01-05 Cvrx, Inc. Baroreflex activation for arrhythmia treatment
WO2006012050A2 (en) * 2004-06-30 2006-02-02 Cvrx, Inc. Connection structures for extra-vascular electrode lead body
JP4696067B2 (en) * 2004-07-23 2011-06-08 パナソニック株式会社 3D shape drawing apparatus and 3D shape drawing method
US8396548B2 (en) 2008-11-14 2013-03-12 Vessix Vascular, Inc. Selective drug delivery in a lumen
US9713730B2 (en) 2004-09-10 2017-07-25 Boston Scientific Scimed, Inc. Apparatus and method for treatment of in-stent restenosis
US20060074453A1 (en) * 2004-10-04 2006-04-06 Cvrx, Inc. Baroreflex activation and cardiac resychronization for heart failure treatment
US8175705B2 (en) 2004-10-12 2012-05-08 Cardiac Pacemakers, Inc. System and method for sustained baroreflex stimulation
US8676326B1 (en) 2004-10-21 2014-03-18 Pacesetter, Inc Implantable device with responsive vascular and cardiac controllers
US7937143B2 (en) * 2004-11-02 2011-05-03 Ardian, Inc. Methods and apparatus for inducing controlled renal neuromodulation
US20070083239A1 (en) * 2005-09-23 2007-04-12 Denise Demarais Methods and apparatus for inducing, monitoring and controlling renal neuromodulation
FR2877205A1 (en) * 2004-11-03 2006-05-05 Luc Quintin METHOD AND DEVICE FOR PREDICTING ABNORMAL MEDICAL EVENTS AND / OR ASSISTING DIAGNOSIS AND / OR MONITORING, ESPECIALLY FOR DETERMINING THE DEPTH OF ANESTHESIA
US8332047B2 (en) * 2004-11-18 2012-12-11 Cardiac Pacemakers, Inc. System and method for closed-loop neural stimulation
US8874204B2 (en) * 2004-12-20 2014-10-28 Cardiac Pacemakers, Inc. Implantable medical devices comprising isolated extracellular matrix
US8060219B2 (en) * 2004-12-20 2011-11-15 Cardiac Pacemakers, Inc. Epicardial patch including isolated extracellular matrix with pacing electrodes
US7981065B2 (en) * 2004-12-20 2011-07-19 Cardiac Pacemakers, Inc. Lead electrode incorporating extracellular matrix
US7587238B2 (en) * 2005-03-11 2009-09-08 Cardiac Pacemakers, Inc. Combined neural stimulation and cardiac resynchronization therapy
US7660628B2 (en) * 2005-03-23 2010-02-09 Cardiac Pacemakers, Inc. System to provide myocardial and neural stimulation
EP3045110B1 (en) 2005-03-28 2019-07-31 Vessix Vascular, Inc. Intraluminal electrical tissue characterization and tuned rf energy for selective treatment of atheroma and other target tissues
US8473049B2 (en) 2005-05-25 2013-06-25 Cardiac Pacemakers, Inc. Implantable neural stimulator with mode switching
US8406876B2 (en) 2005-04-05 2013-03-26 Cardiac Pacemakers, Inc. Closed loop neural stimulation synchronized to cardiac cycles
US7493161B2 (en) 2005-05-10 2009-02-17 Cardiac Pacemakers, Inc. System and method to deliver therapy in presence of another therapy
US7542800B2 (en) * 2005-04-05 2009-06-02 Cardiac Pacemakers, Inc. Method and apparatus for synchronizing neural stimulation to cardiac cycles
US7499748B2 (en) * 2005-04-11 2009-03-03 Cardiac Pacemakers, Inc. Transvascular neural stimulation device
US7881782B2 (en) * 2005-04-20 2011-02-01 Cardiac Pacemakers, Inc. Neural stimulation system to prevent simultaneous energy discharges
US9592136B2 (en) 2005-07-25 2017-03-14 Vascular Dynamics, Inc. Devices and methods for control of blood pressure
US9642726B2 (en) 2005-07-25 2017-05-09 Vascular Dynamics, Inc. Devices and methods for control of blood pressure
US9125732B2 (en) 2005-07-25 2015-09-08 Vascular Dynamics, Inc. Devices and methods for control of blood pressure
US8923972B2 (en) 2005-07-25 2014-12-30 Vascular Dynamics, Inc. Elliptical element for blood pressure reduction
US20110077729A1 (en) * 2009-09-29 2011-03-31 Vascular Dynamics Inc. Devices and methods for control of blood pressure
US20110118773A1 (en) * 2005-07-25 2011-05-19 Rainbow Medical Ltd. Elliptical device for treating afterload
US7616990B2 (en) 2005-10-24 2009-11-10 Cardiac Pacemakers, Inc. Implantable and rechargeable neural stimulator
US7570999B2 (en) * 2005-12-20 2009-08-04 Cardiac Pacemakers, Inc. Implantable device for treating epilepsy and cardiac rhythm disorders
US8109879B2 (en) * 2006-01-10 2012-02-07 Cardiac Pacemakers, Inc. Assessing autonomic activity using baroreflex analysis
CA2637787A1 (en) * 2006-02-03 2007-08-16 Synecor, Llc Intravascular device for neuromodulation
US20070191904A1 (en) * 2006-02-14 2007-08-16 Imad Libbus Expandable stimulation electrode with integrated pressure sensor and methods related thereto
US20080004673A1 (en) * 2006-04-03 2008-01-03 Cvrx, Inc. Implantable extravascular electrostimulation system having a resilient cuff
US8019435B2 (en) 2006-05-02 2011-09-13 Boston Scientific Scimed, Inc. Control of arterial smooth muscle tone
US8968204B2 (en) * 2006-06-12 2015-03-03 Transonic Systems, Inc. System and method of perivascular pressure and flow measurement
US20080046054A1 (en) * 2006-06-23 2008-02-21 Cvrx, Inc. Implantable electrode assembly utilizing a belt mechanism for sutureless attachment
US8170668B2 (en) 2006-07-14 2012-05-01 Cardiac Pacemakers, Inc. Baroreflex sensitivity monitoring and trending for tachyarrhythmia detection and therapy
US8457734B2 (en) 2006-08-29 2013-06-04 Cardiac Pacemakers, Inc. System and method for neural stimulation
US8175712B2 (en) * 2006-09-05 2012-05-08 The Penn State Research Foundation Homotopic conditioning of the brain stem baroreflex of a subject
US8620422B2 (en) * 2006-09-28 2013-12-31 Cvrx, Inc. Electrode array structures and methods of use for cardiovascular reflex control
EP2954868A1 (en) 2006-10-18 2015-12-16 Vessix Vascular, Inc. Tuned rf energy and electrical tissue characterization for selective treatment of target tissues
WO2008049087A2 (en) 2006-10-18 2008-04-24 Minnow Medical, Inc. System for inducing desirable temperature effects on body tissue
WO2008049082A2 (en) 2006-10-18 2008-04-24 Minnow Medical, Inc. Inducing desirable temperature effects on body tissue
WO2008070189A2 (en) 2006-12-06 2008-06-12 The Cleveland Clinic Foundation Method and system for treating acute heart failure by neuromodulation
US20080161865A1 (en) * 2006-12-28 2008-07-03 Cvrx, Inc. Implantable vessel stimulation device coating
US20080167690A1 (en) * 2007-01-05 2008-07-10 Cvrx, Inc. Treatment of peripheral vascular disease by baroreflex activation
US8150521B2 (en) * 2007-03-15 2012-04-03 Cvrx, Inc. Methods and devices for controlling battery life in an implantable pulse generator
US8496653B2 (en) * 2007-04-23 2013-07-30 Boston Scientific Scimed, Inc. Thrombus removal
US20090132002A1 (en) * 2007-05-11 2009-05-21 Cvrx, Inc. Baroreflex activation therapy with conditional shut off
EP1998054B1 (en) * 2007-05-24 2014-08-13 Parker Origa Holding AG Pneumatic cylinder with self-adjusting cushioning at the end of stroke and corresponding method
EP2211775A4 (en) * 2007-10-11 2017-03-15 Kirk Promotion LTD. A device for treatment of aneurysm
EP2214775B1 (en) * 2007-10-11 2021-07-21 Implantica Patent Ltd. A system for treating a sexual dysfunctional female patient
EP3973923A1 (en) * 2007-10-11 2022-03-30 Implantica Patent Ltd. A device for the treatment of aneurysm
US8731665B1 (en) 2007-10-24 2014-05-20 Pacesetter, Inc. Posture detection using pressure and other physiologic sensors
US20090112962A1 (en) * 2007-10-31 2009-04-30 Research In Motion Limited Modular squaring in binary field arithmetic
US20110009692A1 (en) * 2007-12-26 2011-01-13 Yossi Gross Nitric oxide generation to treat female sexual dysfunction
US8214050B2 (en) 2007-12-31 2012-07-03 Cvrx, Inc. Method for monitoring physiological cycles of a patient to optimize patient therapy
US8140155B2 (en) * 2008-03-11 2012-03-20 Cardiac Pacemakers, Inc. Intermittent pacing therapy delivery statistics
US7925352B2 (en) * 2008-03-27 2011-04-12 Synecor Llc System and method for transvascularly stimulating contents of the carotid sheath
US20100211131A1 (en) * 2008-04-07 2010-08-19 Williams Michael S Intravascular system and method for blood pressure control
US8473062B2 (en) * 2008-05-01 2013-06-25 Autonomic Technologies, Inc. Method and device for the treatment of headache
CN102112177A (en) * 2008-05-02 2011-06-29 梅德特龙尼克有限公司 Self expanding electrode cuff
US8340785B2 (en) * 2008-05-02 2012-12-25 Medtronic, Inc. Self expanding electrode cuff
US8768469B2 (en) 2008-08-08 2014-07-01 Enteromedics Inc. Systems for regulation of blood pressure and heart rate
CN102209497A (en) * 2008-09-22 2011-10-05 明诺医学股份有限公司 Inducing desirable temperature effects on body tissue using alternate energy sources
ES2725524T3 (en) * 2008-09-26 2019-09-24 Vascular Dynamics Inc Devices and methods to control blood pressure
WO2010054116A1 (en) 2008-11-10 2010-05-14 Cardiac Pacemakers, Inc. Distal end converter for a medical device lead
EP2355737B1 (en) 2008-11-17 2021-08-11 Boston Scientific Scimed, Inc. Selective accumulation of energy without knowledge of tissue topography
EP2385860B1 (en) 2008-11-21 2021-01-06 Implantica Patent Ltd. System for supplying energy to an implantable medical device
US8515520B2 (en) * 2008-12-08 2013-08-20 Medtronic Xomed, Inc. Nerve electrode
US8412336B2 (en) 2008-12-29 2013-04-02 Autonomic Technologies, Inc. Integrated delivery and visualization tool for a neuromodulation system
US8652129B2 (en) 2008-12-31 2014-02-18 Medtronic Ardian Luxembourg S.A.R.L. Apparatus, systems, and methods for achieving intravascular, thermally-induced renal neuromodulation
WO2010080886A1 (en) * 2009-01-09 2010-07-15 Recor Medical, Inc. Methods and apparatus for treatment of mitral valve in insufficiency
US8494641B2 (en) 2009-04-22 2013-07-23 Autonomic Technologies, Inc. Implantable neurostimulator with integral hermetic electronic enclosure, circuit substrate, monolithic feed-through, lead assembly and anchoring mechanism
US9320908B2 (en) * 2009-01-15 2016-04-26 Autonomic Technologies, Inc. Approval per use implanted neurostimulator
US20100185249A1 (en) * 2009-01-22 2010-07-22 Wingeier Brett M Method and Devices for Adrenal Stimulation
US8551096B2 (en) 2009-05-13 2013-10-08 Boston Scientific Scimed, Inc. Directional delivery of energy and bioactives
EP2435129B1 (en) 2009-05-26 2015-07-01 Cardiac Pacemakers, Inc. Helically formed coil for a neural cuff electrode
US8958873B2 (en) * 2009-05-28 2015-02-17 Cardiac Pacemakers, Inc. Method and apparatus for safe and efficient delivery of cardiac stress augmentation pacing
US8224449B2 (en) * 2009-06-29 2012-07-17 Boston Scientific Neuromodulation Corporation Microstimulator with flap electrodes
US8812104B2 (en) * 2009-09-23 2014-08-19 Cardiac Pacemakers, Inc. Method and apparatus for automated control of pacing post-conditioning
WO2012082961A2 (en) 2010-12-14 2012-06-21 The Regents Of The University Of California Extracranial implantable devices, systems and methods for the treatment of medical disorders
AU2010303583B2 (en) * 2009-10-05 2015-08-06 The Regents Of The University Of California Systems, devices and methods for the treatment of neurological disorders and conditions
US8548585B2 (en) 2009-12-08 2013-10-01 Cardiac Pacemakers, Inc. Concurrent therapy detection in implantable medical devices
EP3381366A1 (en) 2010-03-12 2018-10-03 Inspire Medical Systems, Inc. System for identifying a location for nerve stimulation
JP2013523318A (en) 2010-04-09 2013-06-17 べシックス・バスキュラー・インコーポレイテッド Power generation and control equipment for tissue treatment
US9192790B2 (en) 2010-04-14 2015-11-24 Boston Scientific Scimed, Inc. Focused ultrasonic renal denervation
US8639327B2 (en) 2010-04-29 2014-01-28 Medtronic, Inc. Nerve signal differentiation in cardiac therapy
US8620425B2 (en) 2010-04-29 2013-12-31 Medtronic, Inc. Nerve signal differentiation in cardiac therapy
US8888699B2 (en) 2010-04-29 2014-11-18 Medtronic, Inc. Therapy using perturbation and effect of physiological systems
US8473067B2 (en) 2010-06-11 2013-06-25 Boston Scientific Scimed, Inc. Renal denervation and stimulation employing wireless vascular energy transfer arrangement
US9408661B2 (en) 2010-07-30 2016-08-09 Patrick A. Haverkost RF electrodes on multiple flexible wires for renal nerve ablation
US9463062B2 (en) 2010-07-30 2016-10-11 Boston Scientific Scimed, Inc. Cooled conductive balloon RF catheter for renal nerve ablation
US9084609B2 (en) 2010-07-30 2015-07-21 Boston Scientific Scime, Inc. Spiral balloon catheter for renal nerve ablation
US9358365B2 (en) 2010-07-30 2016-06-07 Boston Scientific Scimed, Inc. Precision electrode movement control for renal nerve ablation
US9155589B2 (en) 2010-07-30 2015-10-13 Boston Scientific Scimed, Inc. Sequential activation RF electrode set for renal nerve ablation
US20120188042A1 (en) * 2010-08-20 2012-07-26 Claude Timothy J Implantable medical device electrical lead body
WO2012036883A1 (en) 2010-09-15 2012-03-22 Cardiac Pacemakers, Inc. Automatic selection of lead configuration for a neural stimulation lead
US8805519B2 (en) 2010-09-30 2014-08-12 Nevro Corporation Systems and methods for detecting intrathecal penetration
EP2632373B1 (en) 2010-10-25 2018-07-18 Medtronic Ardian Luxembourg S.à.r.l. System for evaluation and feedback of neuromodulation treatment
US8974451B2 (en) 2010-10-25 2015-03-10 Boston Scientific Scimed, Inc. Renal nerve ablation using conductive fluid jet and RF energy
BR112013010007A2 (en) 2010-10-25 2017-10-24 Medtronic Ardian Luxembourg catheter apparatus
US9220558B2 (en) 2010-10-27 2015-12-29 Boston Scientific Scimed, Inc. RF renal denervation catheter with multiple independent electrodes
US10569083B2 (en) * 2010-11-11 2020-02-25 IINN, Inc. Motor devices for motor nerve root stimulation
US9028485B2 (en) 2010-11-15 2015-05-12 Boston Scientific Scimed, Inc. Self-expanding cooling electrode for renal nerve ablation
US9668811B2 (en) 2010-11-16 2017-06-06 Boston Scientific Scimed, Inc. Minimally invasive access for renal nerve ablation
US9089350B2 (en) 2010-11-16 2015-07-28 Boston Scientific Scimed, Inc. Renal denervation catheter with RF electrode and integral contrast dye injection arrangement
US9326751B2 (en) 2010-11-17 2016-05-03 Boston Scientific Scimed, Inc. Catheter guidance of external energy for renal denervation
US9060761B2 (en) 2010-11-18 2015-06-23 Boston Scientific Scime, Inc. Catheter-focused magnetic field induced renal nerve ablation
US9192435B2 (en) 2010-11-22 2015-11-24 Boston Scientific Scimed, Inc. Renal denervation catheter with cooled RF electrode
US9023034B2 (en) 2010-11-22 2015-05-05 Boston Scientific Scimed, Inc. Renal ablation electrode with force-activatable conduction apparatus
CA2819346C (en) 2010-11-30 2020-01-21 Ian A. Cook Pulse generator for cranial nerve stimulation
KR20140037803A (en) 2010-12-14 2014-03-27 더 리젠트스 오브 더 유니이버시티 오브 캘리포니아 Device, system and methods for the treatment of medical disorders
US20120157993A1 (en) 2010-12-15 2012-06-21 Jenson Mark L Bipolar Off-Wall Electrode Device for Renal Nerve Ablation
US8781583B2 (en) 2011-01-19 2014-07-15 Medtronic, Inc. Vagal stimulation
US8781582B2 (en) 2011-01-19 2014-07-15 Medtronic, Inc. Vagal stimulation
US8706223B2 (en) 2011-01-19 2014-04-22 Medtronic, Inc. Preventative vagal stimulation
US8718763B2 (en) 2011-01-19 2014-05-06 Medtronic, Inc. Vagal stimulation
WO2012100095A1 (en) 2011-01-19 2012-07-26 Boston Scientific Scimed, Inc. Guide-compatible large-electrode catheter for renal nerve ablation with reduced arterial injury
US8725259B2 (en) 2011-01-19 2014-05-13 Medtronic, Inc. Vagal stimulation
KR20130131471A (en) 2011-04-08 2013-12-03 코비디엔 엘피 Iontophoresis drug delivery system and method for denervation of the renal sympathetic nerve and iontophoretic drug delivery
EP2701623B1 (en) 2011-04-25 2016-08-17 Medtronic Ardian Luxembourg S.à.r.l. Apparatus related to constrained deployment of cryogenic balloons for limited cryogenic ablation of vessel walls
AU2012275666B2 (en) 2011-06-28 2015-06-11 Cardiac Pacemakers, Inc. Strain relief feature for an implantable medical device lead
EP2729213B1 (en) 2011-07-07 2019-05-01 Cardiac Pacemakers, Inc. Insulation and stability features for an implantable medical device lead
US9579030B2 (en) 2011-07-20 2017-02-28 Boston Scientific Scimed, Inc. Percutaneous devices and methods to visualize, target and ablate nerves
CN103813829B (en) 2011-07-22 2016-05-18 波士顿科学西美德公司 There is the neuromodulation system of the neuromodulation element that can be positioned in spiral guiding piece
US9186210B2 (en) 2011-10-10 2015-11-17 Boston Scientific Scimed, Inc. Medical devices including ablation electrodes
US9420955B2 (en) 2011-10-11 2016-08-23 Boston Scientific Scimed, Inc. Intravascular temperature monitoring system and method
US10085799B2 (en) 2011-10-11 2018-10-02 Boston Scientific Scimed, Inc. Off-wall electrode device and methods for nerve modulation
US9364284B2 (en) 2011-10-12 2016-06-14 Boston Scientific Scimed, Inc. Method of making an off-wall spacer cage
US9162046B2 (en) 2011-10-18 2015-10-20 Boston Scientific Scimed, Inc. Deflectable medical devices
WO2013059202A1 (en) 2011-10-18 2013-04-25 Boston Scientific Scimed, Inc. Integrated crossing balloon catheter
EP3366250A1 (en) 2011-11-08 2018-08-29 Boston Scientific Scimed, Inc. Ostial renal nerve ablation
US9119600B2 (en) 2011-11-15 2015-09-01 Boston Scientific Scimed, Inc. Device and methods for renal nerve modulation monitoring
US9119632B2 (en) 2011-11-21 2015-09-01 Boston Scientific Scimed, Inc. Deflectable renal nerve ablation catheter
US10188856B1 (en) 2011-12-07 2019-01-29 Cyberonics, Inc. Implantable device for providing electrical stimulation of cervical vagus nerves for treatment of chronic cardiac dysfunction
US8600505B2 (en) 2011-12-07 2013-12-03 Cyberonics, Inc. Implantable device for facilitating control of electrical stimulation of cervical vagus nerves for treatment of chronic cardiac dysfunction
US8630709B2 (en) 2011-12-07 2014-01-14 Cyberonics, Inc. Computer-implemented system and method for selecting therapy profiles of electrical stimulation of cervical vagus nerves for treatment of chronic cardiac dysfunction
US8918191B2 (en) 2011-12-07 2014-12-23 Cyberonics, Inc. Implantable device for providing electrical stimulation of cervical vagus nerves for treatment of chronic cardiac dysfunction with bounded titration
US8577458B1 (en) 2011-12-07 2013-11-05 Cyberonics, Inc. Implantable device for providing electrical stimulation of cervical vagus nerves for treatment of chronic cardiac dysfunction with leadless heart rate monitoring
US8918190B2 (en) 2011-12-07 2014-12-23 Cyberonics, Inc. Implantable device for evaluating autonomic cardiovascular drive in a patient suffering from chronic cardiac dysfunction
US9265969B2 (en) 2011-12-21 2016-02-23 Cardiac Pacemakers, Inc. Methods for modulating cell function
JP6130397B2 (en) 2011-12-23 2017-05-17 べシックス・バスキュラー・インコーポレイテッド Device for remodeling tissue in or adjacent to a body passage
WO2013101452A1 (en) 2011-12-28 2013-07-04 Boston Scientific Scimed, Inc. Device and methods for nerve modulation using a novel ablation catheter with polymeric ablative elements
US9050106B2 (en) 2011-12-29 2015-06-09 Boston Scientific Scimed, Inc. Off-wall electrode device and methods for nerve modulation
US8571654B2 (en) 2012-01-17 2013-10-29 Cyberonics, Inc. Vagus nerve neurostimulator with multiple patient-selectable modes for treating chronic cardiac dysfunction
US8700150B2 (en) 2012-01-17 2014-04-15 Cyberonics, Inc. Implantable neurostimulator for providing electrical stimulation of cervical vagus nerves for treatment of chronic cardiac dysfunction with bounded titration
WO2013134548A2 (en) 2012-03-08 2013-09-12 Medtronic Ardian Luxembourg S.A.R.L. Ovarian neuromodulation and associated systems and methods
JP6195856B2 (en) 2012-03-08 2017-09-13 メドトロニック アーディアン ルクセンブルク ソシエテ ア レスポンサビリテ リミテ Biomarker sampling and related systems and methods for neuromodulators
US8903509B2 (en) 2012-03-21 2014-12-02 Cardiac Pacemakers Inc. Systems and methods for stimulation of vagus nerve
WO2013169927A1 (en) 2012-05-08 2013-11-14 Boston Scientific Scimed, Inc. Renal nerve modulation devices
EP2846724B1 (en) 2012-05-11 2016-11-09 Medtronic Ardian Luxembourg S.à.r.l. Multi-electrode catheter assemblies for renal neuromodulation and associated systems
US9403007B2 (en) 2012-06-14 2016-08-02 Cardiac Pacemakers, Inc. Systems and methods to reduce syncope risk during neural stimulation therapy
US8688212B2 (en) 2012-07-20 2014-04-01 Cyberonics, Inc. Implantable neurostimulator-implemented method for managing bradycardia through vagus nerve stimulation
WO2014032016A1 (en) 2012-08-24 2014-02-27 Boston Scientific Scimed, Inc. Intravascular catheter with a balloon comprising separate microporous regions
WO2014043687A2 (en) 2012-09-17 2014-03-20 Boston Scientific Scimed, Inc. Self-positioning electrode system and method for renal nerve modulation
US10398464B2 (en) 2012-09-21 2019-09-03 Boston Scientific Scimed, Inc. System for nerve modulation and innocuous thermal gradient nerve block
WO2014047454A2 (en) 2012-09-21 2014-03-27 Boston Scientific Scimed, Inc. Self-cooling ultrasound ablation catheter
JP6096300B2 (en) 2012-10-02 2017-03-15 カーディアック ペースメイカーズ, インコーポレイテッド Cuff electrode assembly and lead assembly
US9283379B2 (en) 2012-10-02 2016-03-15 Cardiac Pacemakers, Inc. Pinch to open cuff electrode
EP2906135A2 (en) 2012-10-10 2015-08-19 Boston Scientific Scimed, Inc. Renal nerve modulation devices and methods
US20140110296A1 (en) 2012-10-19 2014-04-24 Medtronic Ardian Luxembourg S.A.R.L. Packaging for Catheter Treatment Devices and Associated Devices, Systems, and Methods
US9643008B2 (en) 2012-11-09 2017-05-09 Cyberonics, Inc. Implantable neurostimulator-implemented method for enhancing post-exercise recovery through vagus nerve stimulation
US9452290B2 (en) 2012-11-09 2016-09-27 Cyberonics, Inc. Implantable neurostimulator-implemented method for managing tachyarrhythmia through vagus nerve stimulation
US8923964B2 (en) 2012-11-09 2014-12-30 Cyberonics, Inc. Implantable neurostimulator-implemented method for enhancing heart failure patient awakening through vagus nerve stimulation
US11056233B2 (en) 2012-11-14 2021-07-06 Victor M. Pedro Controller-based apparatus and method for diagnosis and treatment of acquired brain injury and dysfunction
US10888274B2 (en) * 2012-11-14 2021-01-12 Victor M. Pedro Method for diagnosis of and therapy for a subject having a central nervous system disorder
JP6026674B2 (en) 2012-12-28 2016-11-16 カーディアック ペースメイカーズ, インコーポレイテッド Stimulation cuff and implantable device
JP6069523B2 (en) 2013-02-13 2017-02-01 カーディアック ペースメイカーズ, インコーポレイテッド Cuff electrode with integral vine
US9693821B2 (en) 2013-03-11 2017-07-04 Boston Scientific Scimed, Inc. Medical devices for modulating nerves
WO2014163987A1 (en) 2013-03-11 2014-10-09 Boston Scientific Scimed, Inc. Medical devices for modulating nerves
US9808311B2 (en) 2013-03-13 2017-11-07 Boston Scientific Scimed, Inc. Deflectable medical devices
US9643011B2 (en) 2013-03-14 2017-05-09 Cyberonics, Inc. Implantable neurostimulator-implemented method for managing tachyarrhythmic risk during sleep through vagus nerve stimulation
WO2014149690A2 (en) 2013-03-15 2014-09-25 Boston Scientific Scimed, Inc. Medical devices and methods for treatment of hypertension that utilize impedance compensation
US10265122B2 (en) 2013-03-15 2019-04-23 Boston Scientific Scimed, Inc. Nerve ablation devices and related methods of use
US9610444B2 (en) 2013-03-15 2017-04-04 Pacesetter, Inc. Erythropoeitin production by electrical stimulation
US9179974B2 (en) 2013-03-15 2015-11-10 Medtronic Ardian Luxembourg S.A.R.L. Helical push wire electrode
JP6220044B2 (en) 2013-03-15 2017-10-25 ボストン サイエンティフィック サイムド,インコーポレイテッドBoston Scientific Scimed,Inc. Medical device for renal nerve ablation
CN105473091B (en) 2013-06-21 2020-01-21 波士顿科学国际有限公司 Renal denervation balloon catheter with co-movable electrode supports
US10022182B2 (en) 2013-06-21 2018-07-17 Boston Scientific Scimed, Inc. Medical devices for renal nerve ablation having rotatable shafts
US9707036B2 (en) 2013-06-25 2017-07-18 Boston Scientific Scimed, Inc. Devices and methods for nerve modulation using localized indifferent electrodes
EP3013285A1 (en) * 2013-06-26 2016-05-04 Christopher G. Kunis Implant device with spine and c-ring
WO2015002787A1 (en) 2013-07-01 2015-01-08 Boston Scientific Scimed, Inc. Medical devices for renal nerve ablation
WO2015006573A1 (en) 2013-07-11 2015-01-15 Boston Scientific Scimed, Inc. Medical device with stretchable electrode assemblies
US10660698B2 (en) 2013-07-11 2020-05-26 Boston Scientific Scimed, Inc. Devices and methods for nerve modulation
US9925001B2 (en) 2013-07-19 2018-03-27 Boston Scientific Scimed, Inc. Spiral bipolar electrode renal denervation balloon
US10342609B2 (en) 2013-07-22 2019-07-09 Boston Scientific Scimed, Inc. Medical devices for renal nerve ablation
CN105392435B (en) 2013-07-22 2018-11-09 波士顿科学国际有限公司 Renal nerve ablation catheter with twisting sacculus
EP4049605A1 (en) 2013-08-22 2022-08-31 Boston Scientific Scimed Inc. Flexible circuit having improved adhesion to a renal nerve modulation balloon
WO2015035047A1 (en) 2013-09-04 2015-03-12 Boston Scientific Scimed, Inc. Radio frequency (rf) balloon catheter having flushing and cooling capability
US20150073515A1 (en) 2013-09-09 2015-03-12 Medtronic Ardian Luxembourg S.a.r.I. Neuromodulation Catheter Devices and Systems Having Energy Delivering Thermocouple Assemblies and Associated Methods
EP3043733A1 (en) 2013-09-13 2016-07-20 Boston Scientific Scimed, Inc. Ablation balloon with vapor deposited cover layer
US11246654B2 (en) 2013-10-14 2022-02-15 Boston Scientific Scimed, Inc. Flexible renal nerve ablation devices and related methods of use and manufacture
US9687166B2 (en) 2013-10-14 2017-06-27 Boston Scientific Scimed, Inc. High resolution cardiac mapping electrode array catheter
WO2015057584A1 (en) 2013-10-15 2015-04-23 Boston Scientific Scimed, Inc. Medical device balloon
US9770606B2 (en) 2013-10-15 2017-09-26 Boston Scientific Scimed, Inc. Ultrasound ablation catheter with cooling infusion and centering basket
EP3057521B1 (en) 2013-10-18 2020-03-25 Boston Scientific Scimed, Inc. Balloon catheters with flexible conducting wires
EP3060153A1 (en) 2013-10-25 2016-08-31 Boston Scientific Scimed, Inc. Embedded thermocouple in denervation flex circuit
US9999773B2 (en) 2013-10-30 2018-06-19 Cyberonics, Inc. Implantable neurostimulator-implemented method utilizing multi-modal stimulation parameters
CN105899157B (en) 2014-01-06 2019-08-09 波士顿科学国际有限公司 Tear-proof flexible circuit assembly
US9511228B2 (en) 2014-01-14 2016-12-06 Cyberonics, Inc. Implantable neurostimulator-implemented method for managing hypertension through renal denervation and vagus nerve stimulation
EP3102136B1 (en) 2014-02-04 2018-06-27 Boston Scientific Scimed, Inc. Alternative placement of thermal sensors on bipolar electrode
US11000679B2 (en) 2014-02-04 2021-05-11 Boston Scientific Scimed, Inc. Balloon protection and rewrapping devices and related methods of use
US9415224B2 (en) 2014-04-25 2016-08-16 Cyberonics, Inc. Neurostimulation and recording of physiological response for the treatment of chronic cardiac dysfunction
US9950169B2 (en) 2014-04-25 2018-04-24 Cyberonics, Inc. Dynamic stimulation adjustment for identification of a neural fulcrum
US9272143B2 (en) 2014-05-07 2016-03-01 Cyberonics, Inc. Responsive neurostimulation for the treatment of chronic cardiac dysfunction
US9713719B2 (en) 2014-04-17 2017-07-25 Cyberonics, Inc. Fine resolution identification of a neural fulcrum for the treatment of chronic cardiac dysfunction
US9409024B2 (en) 2014-03-25 2016-08-09 Cyberonics, Inc. Neurostimulation in a neural fulcrum zone for the treatment of chronic cardiac dysfunction
US10194980B1 (en) 2014-03-28 2019-02-05 Medtronic Ardian Luxembourg S.A.R.L. Methods for catheter-based renal neuromodulation
US10194979B1 (en) 2014-03-28 2019-02-05 Medtronic Ardian Luxembourg S.A.R.L. Methods for catheter-based renal neuromodulation
US9980766B1 (en) 2014-03-28 2018-05-29 Medtronic Ardian Luxembourg S.A.R.L. Methods and systems for renal neuromodulation
WO2015164280A1 (en) 2014-04-24 2015-10-29 Medtronic Ardian Luxembourg S.A.R.L. Neuromodulation catheters having braided shafts and associated systems and methods
US10709490B2 (en) 2014-05-07 2020-07-14 Medtronic Ardian Luxembourg S.A.R.L. Catheter assemblies comprising a direct heating element for renal neuromodulation and associated systems and methods
CN106456975B (en) 2014-05-22 2020-09-04 卡迪诺米克公司 Catheter and catheter system for electrical neuromodulation
EP3169251A4 (en) * 2014-07-20 2018-03-14 Elchanan Bruckheimer Pulmonary artery implant apparatus and methods of use thereof
US9533153B2 (en) 2014-08-12 2017-01-03 Cyberonics, Inc. Neurostimulation titration process
US9770599B2 (en) 2014-08-12 2017-09-26 Cyberonics, Inc. Vagus nerve stimulation and subcutaneous defibrillation system
US9737716B2 (en) 2014-08-12 2017-08-22 Cyberonics, Inc. Vagus nerve and carotid baroreceptor stimulation system
EP3194017A1 (en) 2014-09-08 2017-07-26 Cardionomic, Inc. Methods for electrical neuromodulation of the heart
EP3194007B1 (en) 2014-09-08 2018-07-04 Cardionomic, Inc. Catheter and electrode systems for electrical neuromodulation
US9504832B2 (en) 2014-11-12 2016-11-29 Cyberonics, Inc. Neurostimulation titration process via adaptive parametric modification
EP3610917A1 (en) 2015-01-05 2020-02-19 Cardionomic, Inc. Cardiac modulation facilitation methods and systems
DE102015106810A1 (en) * 2015-04-30 2016-11-03 Infineon Technologies Ag Implantable device and implantable system with this
US11110270B2 (en) * 2015-05-31 2021-09-07 Closed Loop Medical Pty Ltd Brain neurostimulator electrode fitting
WO2017156039A1 (en) 2016-03-09 2017-09-14 CARDIONOMIC, Inc. Cardiac contractility neurostimulation systems and methods
US11771434B2 (en) 2016-09-28 2023-10-03 Restore Medical Ltd. Artery medical apparatus and methods of use thereof
WO2018165391A1 (en) 2017-03-09 2018-09-13 Nevro Corp. Paddle leads and delivery tools, and associated systems and methods
US11364132B2 (en) 2017-06-05 2022-06-21 Restore Medical Ltd. Double walled fixed length stent like apparatus and methods of use thereof
DE102017209773A1 (en) * 2017-06-09 2018-12-13 Neuroloop GmbH Implantable electrical connection structure
US11298540B2 (en) 2017-08-11 2022-04-12 Inspire Medical Systems, Inc. Cuff electrode
EP3664703A4 (en) 2017-09-13 2021-05-12 Cardionomic, Inc. Neurostimulation systems and methods for affecting cardiac contractility
US11253189B2 (en) 2018-01-24 2022-02-22 Medtronic Ardian Luxembourg S.A.R.L. Systems, devices, and methods for evaluating neuromodulation therapy via detection of magnetic fields
US10674924B2 (en) * 2018-02-22 2020-06-09 Seoul National University Hospital Mapping cavernous nerves during surgery
US11420045B2 (en) 2018-03-29 2022-08-23 Nevro Corp. Leads having sidewall openings, and associated systems and methods
JP2021535776A (en) 2018-08-13 2021-12-23 カーディオノミック,インク. Systems and methods that act on systole and / or relaxation
CN114040704A (en) 2019-05-06 2022-02-11 卡迪诺米克公司 System and method for denoising physiological signals during electrical neuromodulation

Citations (97)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US3309924A (en) * 1964-06-22 1967-03-21 Universtity Of California Electromagnetic flow meter
US3645267A (en) * 1969-10-29 1972-02-29 Medtronic Inc Medical-electronic stimulator, particularly a carotid sinus nerve stimulator with controlled turn-on amplitude rate
US3650277A (en) * 1969-02-24 1972-03-21 Lkb Medical Ab Apparatus for influencing the systemic blood pressure in a patient by carotid sinus nerve stimulation
US3943936A (en) * 1970-09-21 1976-03-16 Rasor Associates, Inc. Self powered pacers and stimulators
US4014318A (en) * 1973-08-20 1977-03-29 Dockum James M Circulatory assist device and system
US4256094A (en) * 1979-06-18 1981-03-17 Kapp John P Arterial pressure control system
US4323073A (en) * 1978-09-11 1982-04-06 Cos Electronics Corporation Apparatus and method for controlling the application of therapeutic direct current to living tissue
US4331157A (en) * 1980-07-09 1982-05-25 Stimtech, Inc. Mutually noninterfering transcutaneous nerve stimulation and patient monitoring
US4525074A (en) * 1983-08-19 1985-06-25 Citizen Watch Co., Ltd. Apparatus for measuring the quantity of physical exercise
US4531943A (en) * 1983-08-08 1985-07-30 Angiomedics Corporation Catheter with soft deformable tip
US4573481A (en) * 1984-06-25 1986-03-04 Huntington Institute Of Applied Research Implantable electrode array
US4586501A (en) * 1982-10-21 1986-05-06 Michel Claracq Device for partly occluding a vessel in particular the inferior vena cava and inherent component of this device
US4590946A (en) * 1984-06-14 1986-05-27 Biomed Concepts, Inc. Surgically implantable electrode for nerve bundles
US4640286A (en) * 1984-11-02 1987-02-03 Staodynamics, Inc. Optimized nerve fiber stimulation
US4641664A (en) * 1984-04-13 1987-02-10 Siemens Aktiengesellschaft Endocardial electrode arrangement
US4664120A (en) * 1986-01-22 1987-05-12 Cordis Corporation Adjustable isodiametric atrial-ventricular pervenous lead
US4682583A (en) * 1984-04-13 1987-07-28 Burton John H Inflatable artificial sphincter
US4719921A (en) * 1985-08-28 1988-01-19 Raul Chirife Cardiac pacemaker adaptive to physiological requirements
US4739762A (en) * 1985-11-07 1988-04-26 Expandable Grafts Partnership Expandable intraluminal graft, and method and apparatus for implanting an expandable intraluminal graft
US4800882A (en) * 1987-03-13 1989-01-31 Cook Incorporated Endovascular stent and delivery system
US4813418A (en) * 1987-02-02 1989-03-21 Staodynamics, Inc. Nerve fiber stimulation using symmetrical biphasic waveform applied through plural equally active electrodes
US4825871A (en) * 1984-03-27 1989-05-02 Societe Anonyme Dite: Atesys Defibrillating or cardioverting electric shock system including electrodes
US4828544A (en) * 1984-09-05 1989-05-09 Quotidian No. 100 Pty Limited Control of blood flow
US4830003A (en) * 1988-06-17 1989-05-16 Wolff Rodney G Compressive stent and delivery system
US4915113A (en) * 1988-12-16 1990-04-10 Bio-Vascular, Inc. Method and apparatus for monitoring the patency of vascular grafts
US4917092A (en) * 1988-07-13 1990-04-17 Medical Designs, Inc. Transcutaneous nerve stimulator for treatment of sympathetic nerve dysfunction
US4926875A (en) * 1988-01-25 1990-05-22 Baylor College Of Medicine Implantable and extractable biological sensor probe
US4987897A (en) * 1989-09-18 1991-01-29 Medtronic, Inc. Body bus medical device communication system
US5025807A (en) * 1983-09-14 1991-06-25 Jacob Zabara Neurocybernetic prosthesis
US5078736A (en) * 1990-05-04 1992-01-07 Interventional Thermodynamics, Inc. Method and apparatus for maintaining patency in the body passages
US5113869A (en) * 1990-08-21 1992-05-19 Telectronics Pacing Systems, Inc. Implantable ambulatory electrocardiogram monitor
US5113859A (en) * 1988-09-19 1992-05-19 Medtronic, Inc. Acoustic body bus medical device communication system
US5117826A (en) * 1987-02-02 1992-06-02 Staodyn, Inc. Combined nerve fiber and body tissue stimulation apparatus and method
US5181911A (en) * 1991-04-22 1993-01-26 Shturman Technologies, Inc. Helical balloon perfusion angioplasty catheter
US5199428A (en) * 1991-03-22 1993-04-06 Medtronic, Inc. Implantable electrical nerve stimulator/pacemaker with ischemia for decreasing cardiac workload
US5215089A (en) * 1991-10-21 1993-06-01 Cyberonics, Inc. Electrode assembly for nerve stimulation
US5222971A (en) * 1990-10-09 1993-06-29 Scimed Life Systems, Inc. Temporary stent and methods for use and manufacture
US5224491A (en) * 1991-01-07 1993-07-06 Medtronic, Inc. Implantable electrode for location within a blood vessel
US5282468A (en) * 1990-06-07 1994-02-01 Medtronic, Inc. Implantable neural electrode
US5295959A (en) * 1992-03-13 1994-03-22 Medtronic, Inc. Autoperfusion dilatation catheter having a bonded channel
US5299569A (en) * 1991-05-03 1994-04-05 Cyberonics, Inc. Treatment of neuropsychiatric disorders by nerve stimulation
US5304206A (en) * 1991-11-18 1994-04-19 Cyberonics, Inc. Activation techniques for implantable medical device
US5305745A (en) * 1988-06-13 1994-04-26 Fred Zacouto Device for protection against blood-related disorders, notably thromboses, embolisms, vascular spasms, hemorrhages, hemopathies and the presence of abnormal elements in the blood
US5314453A (en) * 1991-12-06 1994-05-24 Spinal Cord Society Position sensitive power transfer antenna
US5318592A (en) * 1991-09-12 1994-06-07 BIOTRONIK, Mess- und Therapiegerate GmbH & Co., Ingenieurburo Berlin Cardiac therapy system
US5330507A (en) * 1992-04-24 1994-07-19 Medtronic, Inc. Implantable electrical vagal stimulation for prevention or interruption of life threatening arrhythmias
US5330515A (en) * 1992-06-17 1994-07-19 Cyberonics, Inc. Treatment of pain by vagal afferent stimulation
US5331966A (en) * 1991-04-05 1994-07-26 Medtronic, Inc. Subcutaneous multi-electrode sensing system, method and pacer
US5411540A (en) * 1993-06-03 1995-05-02 Massachusetts Institute Of Technology Method and apparatus for preferential neuron stimulation
US5509888A (en) * 1994-07-26 1996-04-23 Conceptek Corporation Controller valve device and method
US5522854A (en) * 1994-05-19 1996-06-04 Duke University Method and apparatus for the prevention of arrhythmia by nerve stimulation
US5529067A (en) * 1994-08-19 1996-06-25 Novoste Corporation Methods for procedures related to the electrophysiology of the heart
US5531779A (en) * 1992-10-01 1996-07-02 Cardiac Pacemakers, Inc. Stent-type defibrillation electrode structures
US5535752A (en) * 1995-02-27 1996-07-16 Medtronic, Inc. Implantable capacitive absolute pressure and temperature monitor system
US5540734A (en) * 1994-09-28 1996-07-30 Zabara; Jacob Cranial nerve stimulation treatments using neurocybernetic prosthesis
US5540735A (en) * 1994-12-12 1996-07-30 Rehabilicare, Inc. Apparatus for electro-stimulation of flexing body portions
US5634878A (en) * 1993-09-17 1997-06-03 Eska Medical Gmbh & Co. Implantable device for selectively opening and closing a tubular organ of the body
US5643330A (en) * 1994-01-24 1997-07-01 Medtronic, Inc. Multichannel apparatus for epidural spinal cord stimulation
US5651378A (en) * 1996-02-20 1997-07-29 Cardiothoracic Systems, Inc. Method of using vagal nerve stimulation in surgery
US5707400A (en) * 1995-09-19 1998-01-13 Cyberonics, Inc. Treating refractory hypertension by nerve stimulation
US5715837A (en) * 1996-08-29 1998-02-10 Light Sciences Limited Partnership Transcutaneous electromagnetic energy transfer
US5725471A (en) * 1994-11-28 1998-03-10 Neotonus, Inc. Magnetic nerve stimulator for exciting peripheral nerves
US5725563A (en) * 1993-04-21 1998-03-10 Klotz; Antoine Electronic device and method for adrenergically stimulating the sympathetic system with respect to the venous media
US5727558A (en) * 1996-02-14 1998-03-17 Hakki; A-Hamid Noninvasive blood pressure monitor and control device
US5741316A (en) * 1996-12-02 1998-04-21 Light Sciences Limited Partnership Electromagnetic coil configurations for power transmission through tissue
US5766236A (en) * 1996-04-19 1998-06-16 Detty; Gerald D. Electrical stimulation support braces
US5861015A (en) * 1997-05-05 1999-01-19 Benja-Athon; Anuthep Modulation of the nervous system for treatment of pain and related disorders
US5876422A (en) * 1998-07-07 1999-03-02 Vitatron Medical B.V. Pacemaker system with peltier cooling of A-V node for treating atrial fibrillation
US5891181A (en) * 1995-12-23 1999-04-06 Zhu; Qiang Blood pressure depressor
US5904708A (en) * 1998-03-19 1999-05-18 Medtronic, Inc. System and method for deriving relative physiologic signals
US5913876A (en) * 1996-02-20 1999-06-22 Cardiothoracic Systems, Inc. Method and apparatus for using vagus nerve stimulation in surgery
US5916239A (en) * 1996-03-29 1999-06-29 Purdue Research Foundation Method and apparatus using vagal stimulation for control of ventricular rate during atrial fibrillation
US5919220A (en) * 1994-09-16 1999-07-06 Fraunhofer Gesellschaft Zur Foerderung Der Angewandten Forschung E.V. Cuff electrode
US5928272A (en) * 1998-05-02 1999-07-27 Cyberonics, Inc. Automatic activation of a neurostimulator device using a detection algorithm based on cardiac activity
US6016449A (en) * 1997-10-27 2000-01-18 Neuropace, Inc. System for treatment of neurological disorders
US6023642A (en) * 1997-05-08 2000-02-08 Biogenics Ii, Llc Compact transcutaneous electrical nerve stimulator
US6052623A (en) * 1998-11-30 2000-04-18 Medtronic, Inc. Feedthrough assembly for implantable medical devices and methods for providing same
US6058331A (en) * 1998-04-27 2000-05-02 Medtronic, Inc. Apparatus and method for treating peripheral vascular disease and organ ischemia by electrical stimulation with closed loop feedback control
US6061596A (en) * 1995-11-24 2000-05-09 Advanced Bionics Corporation Method for conditioning pelvic musculature using an implanted microstimulator
US6073048A (en) * 1995-11-17 2000-06-06 Medtronic, Inc. Baroreflex modulation with carotid sinus nerve stimulation for the treatment of heart failure
US6077227A (en) * 1998-12-28 2000-06-20 Medtronic, Inc. Method for manufacture and implant of an implantable blood vessel cuff
US6077298A (en) * 1999-02-20 2000-06-20 Tu; Lily Chen Expandable/retractable stent and methods thereof
US6178349B1 (en) * 1999-04-15 2001-01-23 Medtronic, Inc. Drug delivery neural stimulation device for treatment of cardiovascular disorders
US6206914B1 (en) * 1998-04-30 2001-03-27 Medtronic, Inc. Implantable system with drug-eluting cells for on-demand local drug delivery
US6208894B1 (en) * 1997-02-26 2001-03-27 Alfred E. Mann Foundation For Scientific Research And Advanced Bionics System of implantable devices for monitoring and/or affecting body parameters
US6231516B1 (en) * 1997-10-14 2001-05-15 Vacusense, Inc. Endoluminal implant with therapeutic and diagnostic capability
US20020005982A1 (en) * 2000-07-17 2002-01-17 Rolf Borlinghaus Arrangement for spectrally sensitive reflected-light and transmitted-light microscopy
US6393324B2 (en) * 1999-05-07 2002-05-21 Woodside Biomedical, Inc. Method of blood pressure moderation
US6397109B1 (en) * 1998-12-23 2002-05-28 Avio Maria Perna Single pass multiple chamber implantable electro-catheter for multi-site electrical therapy of up to four cardiac chambers, indicated in the treatment of such pathologies as atrial fibrillation and congestive/dilate cardio myopathy
US6401129B1 (en) * 1997-11-07 2002-06-04 Telefonaktiebolaget Lm Ericsson (Publ) Routing functionality application in a data communications network with a number of hierarchical nodes
US6522926B1 (en) * 2000-09-27 2003-02-18 Cvrx, Inc. Devices and methods for cardiovascular reflex control
US6564101B1 (en) * 1998-02-02 2003-05-13 The Trustees Of Columbia University In The City Of New York Electrical system for weight loss and laparoscopic implanation thereof
US20040019364A1 (en) * 2000-09-27 2004-01-29 Cvrx, Inc. Devices and methods for cardiovascular reflex control via coupled electrodes
US6718212B2 (en) * 2001-10-12 2004-04-06 Medtronic, Inc. Implantable medical electrical lead with light-activated adhesive fixation
US6850801B2 (en) * 2001-09-26 2005-02-01 Cvrx, Inc. Mapping methods for cardiovascular reflex control devices
US6894204B2 (en) * 2001-05-02 2005-05-17 3M Innovative Properties Company Tapered stretch removable adhesive articles and methods
US6985774B2 (en) * 2000-09-27 2006-01-10 Cvrx, Inc. Stimulus regimens for cardiovascular reflex control

Family Cites Families (89)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US103510A (en) * 1870-05-24 sexton
US40785A (en) * 1863-12-01 greenotjgh
US151051A (en) * 1874-05-19 Improvement in miter-boxes
US5982A (en) * 1848-12-26 Corw-sheller
US1003518A (en) * 1910-06-13 1911-09-19 Moritz Schiller Lubricating device for mowing-machines.
US3421511A (en) * 1965-12-10 1969-01-14 Medtronic Inc Implantable electrode for nerve stimulation
US3522811A (en) * 1969-02-13 1970-08-04 Medtronic Inc Implantable nerve stimulator and method of use
USRE30366E (en) 1970-09-21 1980-08-12 Rasor Associates, Inc. Organ stimulator
GB1434524A (en) * 1972-04-27 1976-05-05 Nat Res Dev Urinary control apparatus
US4481953A (en) 1981-11-12 1984-11-13 Cordis Corporation Endocardial lead having helically wound ribbon electrode
US4551862A (en) 1982-12-15 1985-11-12 Haber Terry M Prosthetic sphincter
US4867164A (en) 1983-09-14 1989-09-19 Jacob Zabara Neurocybernetic prosthesis
US4702254A (en) 1983-09-14 1987-10-27 Jacob Zabara Neurocybernetic prosthesis
US4887608A (en) 1986-01-31 1989-12-19 Boston Scientific Corporation Method and apparatus for estimating tissue damage
US4860751A (en) 1985-02-04 1989-08-29 Cordis Corporation Activity sensor for pacemaker control
US4881939A (en) 1985-02-19 1989-11-21 The Johns Hopkins University Implantable helical cuff
US4770177A (en) 1986-02-18 1988-09-13 Telectronics N.V. Apparatus and method for adjusting heart/pacer relative to changes in venous diameter during exercise to obtain a required cardiac output.
US4762820A (en) 1986-03-03 1988-08-09 Trustees Of Boston University Therapeutic treatment for congestive heart failure
US4709690A (en) 1986-04-21 1987-12-01 Habley Medical Technology Corporation Implantable blood flow and occlusion pressure sensing sphincteric system
US5010893A (en) * 1987-01-15 1991-04-30 Siemens-Pacesetter, Inc. Motion sensor for implanted medical device
US4762130A (en) 1987-01-15 1988-08-09 Thomas J. Fogarty Catheter with corkscrew-like balloon
US4969458A (en) 1987-07-06 1990-11-13 Medtronic, Inc. Intracoronary stent and method of simultaneous angioplasty and stent implant
US4791931A (en) 1987-08-13 1988-12-20 Pacesetter Infusion, Ltd. Demand pacemaker using an artificial baroreceptor reflex
US4819662A (en) * 1987-10-26 1989-04-11 Cardiac Pacemakers, Inc. Cardiac electrode with drug delivery capabilities
US4960133A (en) 1988-11-21 1990-10-02 Brunswick Manufacturing Co., Inc. Esophageal electrode
US5031621A (en) * 1989-12-06 1991-07-16 Grandjean Pierre A Nerve electrode with biological substrate
US5086787A (en) * 1989-12-06 1992-02-11 Medtronic, Inc. Steroid eluting intramuscular lead
US5040533A (en) 1989-12-29 1991-08-20 Medical Engineering And Development Institute Incorporated Implantable cardiovascular treatment device container for sensing a physiological parameter
US5092332A (en) * 1990-02-22 1992-03-03 Medtronic, Inc. Steroid eluting cuff electrode for peripheral nerve stimulation
US5203348A (en) 1990-06-06 1993-04-20 Cardiac Pacemakers, Inc. Subcutaneous defibrillation electrodes
US5282844A (en) * 1990-06-15 1994-02-01 Medtronic, Inc. High impedance, low polarization, low threshold miniature steriod eluting pacing lead electrodes
FR2671010B1 (en) 1990-12-27 1993-07-09 Ela Medical Sa ENDOCARDIAC PROBE PROVIDED WITH AN ACTIVE FIXING MEMBER
US5170802A (en) 1991-01-07 1992-12-15 Medtronic, Inc. Implantable electrode for location within a blood vessel
US5251634A (en) 1991-05-03 1993-10-12 Cyberonics, Inc. Helical nerve electrode
US5295394A (en) * 1991-06-13 1994-03-22 Mks Japan Inc. Bypass unit for a flowmeter sensor
US5203326A (en) * 1991-12-18 1993-04-20 Telectronics Pacing Systems, Inc. Antiarrhythmia pacer using antiarrhythmia pacing and autonomic nerve stimulation therapy
US5387234A (en) * 1992-05-21 1995-02-07 Siemens-Elema Ab Medical electrode device
AU663948B2 (en) 1992-06-12 1995-10-26 Kabushiki Kaisha Advance Electrical stimulator
US5408744A (en) * 1993-04-30 1995-04-25 Medtronic, Inc. Substrate for a sintered electrode
US5411531A (en) * 1993-09-23 1995-05-02 Medtronic, Inc. Method and apparatus for control of A-V interval
US5527159A (en) 1993-11-10 1996-06-18 The United States Of America As Represented By The Administrator Of The National Aeronautics And Space Administration Rotary blood pump
US5545132A (en) 1993-12-21 1996-08-13 C. R. Bard, Inc. Helically grooved balloon for dilatation catheter and method of using
US5458626A (en) 1993-12-27 1995-10-17 Krause; Horst E. Method of electrical nerve stimulation for acceleration of tissue healing
JP3511668B2 (en) * 1994-02-25 2004-03-29 ソニー株式会社 Disc loading device
EP0688579B1 (en) 1994-06-24 2001-08-22 St. Jude Medical AB Device for heart therapy
US5601615A (en) * 1994-08-16 1997-02-11 Medtronic, Inc. Atrial and ventricular capture detection and threshold-seeking pacemaker
US5695468A (en) 1994-09-16 1997-12-09 Scimed Life Systems, Inc. Balloon catheter with improved pressure source
US5571150A (en) 1994-12-19 1996-11-05 Cyberonics, Inc. Treatment of patients in coma by nerve stimulation
US5593431A (en) * 1995-03-30 1997-01-14 Medtronic, Inc. Medical service employing multiple DC accelerometers for patient activity and posture sensing and method
US5700282A (en) 1995-10-13 1997-12-23 Zabara; Jacob Heart rhythm stabilization using a neurocybernetic prosthesis
US5786236A (en) * 1996-03-29 1998-07-28 Eastman Kodak Company Backside thinning using ion-beam figuring
US5824021A (en) 1996-04-25 1998-10-20 Medtronic Inc. Method and apparatus for providing feedback to spinal cord stimulation for angina
US5800464A (en) 1996-10-03 1998-09-01 Medtronic, Inc. System for providing hyperpolarization of cardiac to enhance cardiac function
US5814079A (en) 1996-10-04 1998-09-29 Medtronic, Inc. Cardiac arrhythmia management by application of adnodal stimulation for hyperpolarization of myocardial cells
US5895416A (en) * 1997-03-12 1999-04-20 Medtronic, Inc. Method and apparatus for controlling and steering an electric field
US5938596A (en) * 1997-03-17 1999-08-17 Medtronic, Inc. Medical electrical lead
US5851015A (en) * 1997-03-21 1998-12-22 Trw Inc. Rack and pinion steering system for four wheel drive vehicle
US5967986A (en) 1997-11-25 1999-10-19 Vascusense, Inc. Endoluminal implant with fluid flow sensing capability
US5807258A (en) 1997-10-14 1998-09-15 Cimochowski; George E. Ultrasonic sensors for monitoring the condition of a vascular graft
US6193996B1 (en) * 1998-04-02 2001-02-27 3M Innovative Properties Company Device for the transdermal delivery of diclofenac
US6205359B1 (en) * 1998-10-26 2001-03-20 Birinder Bob Boveja Apparatus and method for adjunct (add-on) therapy of partial complex epilepsy, generalized epilepsy and involuntary movement disorders utilizing an external stimulator
US9061139B2 (en) * 1998-11-04 2015-06-23 Greatbatch Ltd. Implantable lead with a band stop filter having a capacitor in parallel with an inductor embedded in a dielectric body
US6701176B1 (en) * 1998-11-04 2004-03-02 Johns Hopkins University School Of Medicine Magnetic-resonance-guided imaging, electrophysiology, and ablation
US6909917B2 (en) * 1999-01-07 2005-06-21 Advanced Bionics Corporation Implantable generator having current steering means
US6324421B1 (en) * 1999-03-29 2001-11-27 Medtronic, Inc. Axis shift analysis of electrocardiogram signal parameters especially applicable for multivector analysis by implantable medical devices, and use of same
US6341236B1 (en) * 1999-04-30 2002-01-22 Ivan Osorio Vagal nerve stimulation techniques for treatment of epileptic seizures
US6438428B1 (en) * 1999-10-27 2002-08-20 Axelgaard Manufacturing Co., Ltd. Electrical stimulation compress
EP1106202A3 (en) * 1999-11-30 2004-03-31 BIOTRONIK Mess- und Therapiegeräte GmbH & Co Ingenieurbüro Berlin Electrode for intravascular stimulation, cardioversion and /or defibrillation
US6371922B1 (en) * 2000-04-07 2002-04-16 Cardiac Pacemakers, Inc. Method for measuring baroreflex sensitivity and therapy optimization in heart failure patients
US6540735B1 (en) * 2000-05-12 2003-04-01 Sub-Q, Inc. System and method for facilitating hemostasis of blood vessel punctures with absorbable sponge
KR100411702B1 (en) * 2000-09-22 2003-12-18 금호석유화학 주식회사 Transgenic Plants and Plant Cells with Improved Growth Rate and Related Methods
US7158832B2 (en) * 2000-09-27 2007-01-02 Cvrx, Inc. Electrode designs and methods of use for cardiovascular reflex control devices
US7499742B2 (en) * 2001-09-26 2009-03-03 Cvrx, Inc. Electrode structures and methods for their use in cardiovascular reflex control
US8086314B1 (en) * 2000-09-27 2011-12-27 Cvrx, Inc. Devices and methods for cardiovascular reflex control
US7623926B2 (en) * 2000-09-27 2009-11-24 Cvrx, Inc. Stimulus regimens for cardiovascular reflex control
US6704598B2 (en) * 2001-05-23 2004-03-09 Cardiac Pacemakers, Inc. Cardiac rhythm management system selecting between multiple same-chamber electrodes for delivering cardiac therapy
US20050010263A1 (en) * 2001-07-27 2005-01-13 Patrick Schauerte Neurostimulation unit for immobilizing the heart during cardiosurgical operations
EP1460935A2 (en) * 2001-08-17 2004-09-29 Ted W. Russell Methods, apparatus and sensor for hemodynamic monitoring
US6600956B2 (en) * 2001-08-21 2003-07-29 Cyberonics, Inc. Circumneural electrode assembly
US6701186B2 (en) * 2001-09-13 2004-03-02 Cardiac Pacemakers, Inc. Atrial pacing and sensing in cardiac resynchronization therapy
US6859667B2 (en) * 2001-11-07 2005-02-22 Cardiac Pacemakers, Inc. Multiplexed medical device lead with standard header
TW524670B (en) * 2002-04-01 2003-03-21 Ind Tech Res Inst Non-invasive apparatus system for monitoring autonomic nervous system and uses thereof
US7321793B2 (en) * 2003-06-13 2008-01-22 Biocontrol Medical Ltd. Vagal stimulation for atrial fibrillation therapy
US6876881B2 (en) * 2002-08-16 2005-04-05 Cardiac Pacemakers, Inc. Cardiac rhythm management system with respiration synchronous optimization of cardiac performance using atrial cycle length
US7010337B2 (en) * 2002-10-24 2006-03-07 Furnary Anthony P Method and apparatus for monitoring blood condition and cardiopulmonary function
US7149574B2 (en) * 2003-06-09 2006-12-12 Palo Alto Investors Treatment of conditions through electrical modulation of the autonomic nervous system
WO2004110549A2 (en) * 2003-06-13 2004-12-23 Biocontrol Medical Ltd. Applications of vagal stimulation
US20060004417A1 (en) * 2004-06-30 2006-01-05 Cvrx, Inc. Baroreflex activation for arrhythmia treatment
US7930038B2 (en) * 2005-05-27 2011-04-19 Cardiac Pacemakers, Inc. Tubular lead electrodes and methods

Patent Citations (100)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US3309924A (en) * 1964-06-22 1967-03-21 Universtity Of California Electromagnetic flow meter
US3650277A (en) * 1969-02-24 1972-03-21 Lkb Medical Ab Apparatus for influencing the systemic blood pressure in a patient by carotid sinus nerve stimulation
US3645267A (en) * 1969-10-29 1972-02-29 Medtronic Inc Medical-electronic stimulator, particularly a carotid sinus nerve stimulator with controlled turn-on amplitude rate
US3943936A (en) * 1970-09-21 1976-03-16 Rasor Associates, Inc. Self powered pacers and stimulators
US4014318A (en) * 1973-08-20 1977-03-29 Dockum James M Circulatory assist device and system
US4323073A (en) * 1978-09-11 1982-04-06 Cos Electronics Corporation Apparatus and method for controlling the application of therapeutic direct current to living tissue
US4256094A (en) * 1979-06-18 1981-03-17 Kapp John P Arterial pressure control system
US4331157A (en) * 1980-07-09 1982-05-25 Stimtech, Inc. Mutually noninterfering transcutaneous nerve stimulation and patient monitoring
US4586501A (en) * 1982-10-21 1986-05-06 Michel Claracq Device for partly occluding a vessel in particular the inferior vena cava and inherent component of this device
US4531943A (en) * 1983-08-08 1985-07-30 Angiomedics Corporation Catheter with soft deformable tip
US4525074A (en) * 1983-08-19 1985-06-25 Citizen Watch Co., Ltd. Apparatus for measuring the quantity of physical exercise
US5025807A (en) * 1983-09-14 1991-06-25 Jacob Zabara Neurocybernetic prosthesis
US4825871A (en) * 1984-03-27 1989-05-02 Societe Anonyme Dite: Atesys Defibrillating or cardioverting electric shock system including electrodes
US4641664A (en) * 1984-04-13 1987-02-10 Siemens Aktiengesellschaft Endocardial electrode arrangement
US4682583A (en) * 1984-04-13 1987-07-28 Burton John H Inflatable artificial sphincter
US4590946A (en) * 1984-06-14 1986-05-27 Biomed Concepts, Inc. Surgically implantable electrode for nerve bundles
US4573481A (en) * 1984-06-25 1986-03-04 Huntington Institute Of Applied Research Implantable electrode array
US4828544A (en) * 1984-09-05 1989-05-09 Quotidian No. 100 Pty Limited Control of blood flow
US4640286A (en) * 1984-11-02 1987-02-03 Staodynamics, Inc. Optimized nerve fiber stimulation
US4803988A (en) * 1984-11-02 1989-02-14 Staodynamics, Inc. Nerve fiber stimulation using plural equally active electrodes
US4719921A (en) * 1985-08-28 1988-01-19 Raul Chirife Cardiac pacemaker adaptive to physiological requirements
US4739762A (en) * 1985-11-07 1988-04-26 Expandable Grafts Partnership Expandable intraluminal graft, and method and apparatus for implanting an expandable intraluminal graft
US4739762B1 (en) * 1985-11-07 1998-10-27 Expandable Grafts Partnership Expandable intraluminal graft and method and apparatus for implanting an expandable intraluminal graft
US4664120A (en) * 1986-01-22 1987-05-12 Cordis Corporation Adjustable isodiametric atrial-ventricular pervenous lead
US4813418A (en) * 1987-02-02 1989-03-21 Staodynamics, Inc. Nerve fiber stimulation using symmetrical biphasic waveform applied through plural equally active electrodes
US5117826A (en) * 1987-02-02 1992-06-02 Staodyn, Inc. Combined nerve fiber and body tissue stimulation apparatus and method
US4800882A (en) * 1987-03-13 1989-01-31 Cook Incorporated Endovascular stent and delivery system
US4926875A (en) * 1988-01-25 1990-05-22 Baylor College Of Medicine Implantable and extractable biological sensor probe
US5305745A (en) * 1988-06-13 1994-04-26 Fred Zacouto Device for protection against blood-related disorders, notably thromboses, embolisms, vascular spasms, hemorrhages, hemopathies and the presence of abnormal elements in the blood
US4830003A (en) * 1988-06-17 1989-05-16 Wolff Rodney G Compressive stent and delivery system
US4917092A (en) * 1988-07-13 1990-04-17 Medical Designs, Inc. Transcutaneous nerve stimulator for treatment of sympathetic nerve dysfunction
US5113859A (en) * 1988-09-19 1992-05-19 Medtronic, Inc. Acoustic body bus medical device communication system
US4915113A (en) * 1988-12-16 1990-04-10 Bio-Vascular, Inc. Method and apparatus for monitoring the patency of vascular grafts
US4987897A (en) * 1989-09-18 1991-01-29 Medtronic, Inc. Body bus medical device communication system
US5078736A (en) * 1990-05-04 1992-01-07 Interventional Thermodynamics, Inc. Method and apparatus for maintaining patency in the body passages
US5282468A (en) * 1990-06-07 1994-02-01 Medtronic, Inc. Implantable neural electrode
US5113869A (en) * 1990-08-21 1992-05-19 Telectronics Pacing Systems, Inc. Implantable ambulatory electrocardiogram monitor
US5222971A (en) * 1990-10-09 1993-06-29 Scimed Life Systems, Inc. Temporary stent and methods for use and manufacture
US5224491A (en) * 1991-01-07 1993-07-06 Medtronic, Inc. Implantable electrode for location within a blood vessel
US5199428A (en) * 1991-03-22 1993-04-06 Medtronic, Inc. Implantable electrical nerve stimulator/pacemaker with ischemia for decreasing cardiac workload
US5331966A (en) * 1991-04-05 1994-07-26 Medtronic, Inc. Subcutaneous multi-electrode sensing system, method and pacer
US5181911A (en) * 1991-04-22 1993-01-26 Shturman Technologies, Inc. Helical balloon perfusion angioplasty catheter
US5299569A (en) * 1991-05-03 1994-04-05 Cyberonics, Inc. Treatment of neuropsychiatric disorders by nerve stimulation
US5318592A (en) * 1991-09-12 1994-06-07 BIOTRONIK, Mess- und Therapiegerate GmbH & Co., Ingenieurburo Berlin Cardiac therapy system
US5215089A (en) * 1991-10-21 1993-06-01 Cyberonics, Inc. Electrode assembly for nerve stimulation
US5304206A (en) * 1991-11-18 1994-04-19 Cyberonics, Inc. Activation techniques for implantable medical device
US5314453A (en) * 1991-12-06 1994-05-24 Spinal Cord Society Position sensitive power transfer antenna
US5295959A (en) * 1992-03-13 1994-03-22 Medtronic, Inc. Autoperfusion dilatation catheter having a bonded channel
US5330507A (en) * 1992-04-24 1994-07-19 Medtronic, Inc. Implantable electrical vagal stimulation for prevention or interruption of life threatening arrhythmias
US5330515A (en) * 1992-06-17 1994-07-19 Cyberonics, Inc. Treatment of pain by vagal afferent stimulation
US5531779A (en) * 1992-10-01 1996-07-02 Cardiac Pacemakers, Inc. Stent-type defibrillation electrode structures
US5725563A (en) * 1993-04-21 1998-03-10 Klotz; Antoine Electronic device and method for adrenergically stimulating the sympathetic system with respect to the venous media
US5411540A (en) * 1993-06-03 1995-05-02 Massachusetts Institute Of Technology Method and apparatus for preferential neuron stimulation
US5634878A (en) * 1993-09-17 1997-06-03 Eska Medical Gmbh & Co. Implantable device for selectively opening and closing a tubular organ of the body
US5643330A (en) * 1994-01-24 1997-07-01 Medtronic, Inc. Multichannel apparatus for epidural spinal cord stimulation
US5522854A (en) * 1994-05-19 1996-06-04 Duke University Method and apparatus for the prevention of arrhythmia by nerve stimulation
US5509888A (en) * 1994-07-26 1996-04-23 Conceptek Corporation Controller valve device and method
US5529067A (en) * 1994-08-19 1996-06-25 Novoste Corporation Methods for procedures related to the electrophysiology of the heart
US5919220A (en) * 1994-09-16 1999-07-06 Fraunhofer Gesellschaft Zur Foerderung Der Angewandten Forschung E.V. Cuff electrode
US5540734A (en) * 1994-09-28 1996-07-30 Zabara; Jacob Cranial nerve stimulation treatments using neurocybernetic prosthesis
US5725471A (en) * 1994-11-28 1998-03-10 Neotonus, Inc. Magnetic nerve stimulator for exciting peripheral nerves
US5540735A (en) * 1994-12-12 1996-07-30 Rehabilicare, Inc. Apparatus for electro-stimulation of flexing body portions
US5535752A (en) * 1995-02-27 1996-07-16 Medtronic, Inc. Implantable capacitive absolute pressure and temperature monitor system
US5707400A (en) * 1995-09-19 1998-01-13 Cyberonics, Inc. Treating refractory hypertension by nerve stimulation
US6073048A (en) * 1995-11-17 2000-06-06 Medtronic, Inc. Baroreflex modulation with carotid sinus nerve stimulation for the treatment of heart failure
US6061596A (en) * 1995-11-24 2000-05-09 Advanced Bionics Corporation Method for conditioning pelvic musculature using an implanted microstimulator
US5891181A (en) * 1995-12-23 1999-04-06 Zhu; Qiang Blood pressure depressor
US6050952A (en) * 1996-02-14 2000-04-18 Hakki; A-Hamid Method for noninvasive monitoring and control of blood pressure
US5727558A (en) * 1996-02-14 1998-03-17 Hakki; A-Hamid Noninvasive blood pressure monitor and control device
US5913876A (en) * 1996-02-20 1999-06-22 Cardiothoracic Systems, Inc. Method and apparatus for using vagus nerve stimulation in surgery
US5651378A (en) * 1996-02-20 1997-07-29 Cardiothoracic Systems, Inc. Method of using vagal nerve stimulation in surgery
US5916239A (en) * 1996-03-29 1999-06-29 Purdue Research Foundation Method and apparatus using vagal stimulation for control of ventricular rate during atrial fibrillation
US5766236A (en) * 1996-04-19 1998-06-16 Detty; Gerald D. Electrical stimulation support braces
US5715837A (en) * 1996-08-29 1998-02-10 Light Sciences Limited Partnership Transcutaneous electromagnetic energy transfer
US5741316A (en) * 1996-12-02 1998-04-21 Light Sciences Limited Partnership Electromagnetic coil configurations for power transmission through tissue
US6208894B1 (en) * 1997-02-26 2001-03-27 Alfred E. Mann Foundation For Scientific Research And Advanced Bionics System of implantable devices for monitoring and/or affecting body parameters
US5861015A (en) * 1997-05-05 1999-01-19 Benja-Athon; Anuthep Modulation of the nervous system for treatment of pain and related disorders
US6023642A (en) * 1997-05-08 2000-02-08 Biogenics Ii, Llc Compact transcutaneous electrical nerve stimulator
US6231516B1 (en) * 1997-10-14 2001-05-15 Vacusense, Inc. Endoluminal implant with therapeutic and diagnostic capability
US6016449A (en) * 1997-10-27 2000-01-18 Neuropace, Inc. System for treatment of neurological disorders
US6401129B1 (en) * 1997-11-07 2002-06-04 Telefonaktiebolaget Lm Ericsson (Publ) Routing functionality application in a data communications network with a number of hierarchical nodes
US6564101B1 (en) * 1998-02-02 2003-05-13 The Trustees Of Columbia University In The City Of New York Electrical system for weight loss and laparoscopic implanation thereof
US5904708A (en) * 1998-03-19 1999-05-18 Medtronic, Inc. System and method for deriving relative physiologic signals
US6058331A (en) * 1998-04-27 2000-05-02 Medtronic, Inc. Apparatus and method for treating peripheral vascular disease and organ ischemia by electrical stimulation with closed loop feedback control
US6206914B1 (en) * 1998-04-30 2001-03-27 Medtronic, Inc. Implantable system with drug-eluting cells for on-demand local drug delivery
US5928272A (en) * 1998-05-02 1999-07-27 Cyberonics, Inc. Automatic activation of a neurostimulator device using a detection algorithm based on cardiac activity
US5876422A (en) * 1998-07-07 1999-03-02 Vitatron Medical B.V. Pacemaker system with peltier cooling of A-V node for treating atrial fibrillation
US6052623A (en) * 1998-11-30 2000-04-18 Medtronic, Inc. Feedthrough assembly for implantable medical devices and methods for providing same
US6397109B1 (en) * 1998-12-23 2002-05-28 Avio Maria Perna Single pass multiple chamber implantable electro-catheter for multi-site electrical therapy of up to four cardiac chambers, indicated in the treatment of such pathologies as atrial fibrillation and congestive/dilate cardio myopathy
US6077227A (en) * 1998-12-28 2000-06-20 Medtronic, Inc. Method for manufacture and implant of an implantable blood vessel cuff
US6077298A (en) * 1999-02-20 2000-06-20 Tu; Lily Chen Expandable/retractable stent and methods thereof
US6178349B1 (en) * 1999-04-15 2001-01-23 Medtronic, Inc. Drug delivery neural stimulation device for treatment of cardiovascular disorders
US6393324B2 (en) * 1999-05-07 2002-05-21 Woodside Biomedical, Inc. Method of blood pressure moderation
US20020005982A1 (en) * 2000-07-17 2002-01-17 Rolf Borlinghaus Arrangement for spectrally sensitive reflected-light and transmitted-light microscopy
US6522926B1 (en) * 2000-09-27 2003-02-18 Cvrx, Inc. Devices and methods for cardiovascular reflex control
US20040019364A1 (en) * 2000-09-27 2004-01-29 Cvrx, Inc. Devices and methods for cardiovascular reflex control via coupled electrodes
US6985774B2 (en) * 2000-09-27 2006-01-10 Cvrx, Inc. Stimulus regimens for cardiovascular reflex control
US6894204B2 (en) * 2001-05-02 2005-05-17 3M Innovative Properties Company Tapered stretch removable adhesive articles and methods
US6850801B2 (en) * 2001-09-26 2005-02-01 Cvrx, Inc. Mapping methods for cardiovascular reflex control devices
US6718212B2 (en) * 2001-10-12 2004-04-06 Medtronic, Inc. Implantable medical electrical lead with light-activated adhesive fixation

Cited By (50)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US8290595B2 (en) 2000-09-27 2012-10-16 Cvrx, Inc. Method and apparatus for stimulation of baroreceptors in pulmonary artery
US8060206B2 (en) 2000-09-27 2011-11-15 Cvrx, Inc. Baroreflex modulation to gradually decrease blood pressure
US8712531B2 (en) 2000-09-27 2014-04-29 Cvrx, Inc. Automatic baroreflex modulation responsive to adverse event
US7949400B2 (en) 2000-09-27 2011-05-24 Cvrx, Inc. Devices and methods for cardiovascular reflex control via coupled electrodes
US9044609B2 (en) 2000-09-27 2015-06-02 Cvrx, Inc. Electrode structures and methods for their use in cardiovascular reflex control
US8086314B1 (en) 2000-09-27 2011-12-27 Cvrx, Inc. Devices and methods for cardiovascular reflex control
US8718789B2 (en) 2000-09-27 2014-05-06 Cvrx, Inc. Electrode structures and methods for their use in cardiovascular reflex control
US8583236B2 (en) 2000-09-27 2013-11-12 Cvrx, Inc. Devices and methods for cardiovascular reflex control
US7840271B2 (en) 2000-09-27 2010-11-23 Cvrx, Inc. Stimulus regimens for cardiovascular reflex control
US8838246B2 (en) 2000-09-27 2014-09-16 Cvrx, Inc. Devices and methods for cardiovascular reflex treatments
US9427583B2 (en) 2000-09-27 2016-08-30 Cvrx, Inc. Electrode structures and methods for their use in cardiovascular reflex control
US7813812B2 (en) 2000-09-27 2010-10-12 Cvrx, Inc. Baroreflex stimulator with integrated pressure sensor
US8606359B2 (en) 2000-09-27 2013-12-10 Cvrx, Inc. System and method for sustained baroreflex stimulation
US8880190B2 (en) 2000-09-27 2014-11-04 Cvrx, Inc. Electrode structures and methods for their use in cardiovascular reflex control
US8862243B2 (en) 2005-07-25 2014-10-14 Rainbow Medical Ltd. Electrical stimulation of blood vessels
US11197992B2 (en) 2005-07-25 2021-12-14 Enopace Biomedical Ltd. Electrical stimulation of blood vessels
US7822486B2 (en) 2005-08-17 2010-10-26 Enteromedics Inc. Custom sized neural electrodes
US8594794B2 (en) 2007-07-24 2013-11-26 Cvrx, Inc. Baroreflex activation therapy with incrementally changing intensity
US8626299B2 (en) 2008-01-31 2014-01-07 Enopace Biomedical Ltd. Thoracic aorta and vagus nerve stimulation
US9005106B2 (en) 2008-01-31 2015-04-14 Enopace Biomedical Ltd Intra-aortic electrical counterpulsation
US8626290B2 (en) 2008-01-31 2014-01-07 Enopace Biomedical Ltd. Acute myocardial infarction treatment by electrical stimulation of the thoracic aorta
US8694119B2 (en) * 2009-05-14 2014-04-08 Samson Neurosciences Ltd. Endovascular electrostimulation near a carotid bifurcation in treating cerebrovascular conditions
US20120059437A1 (en) * 2009-05-14 2012-03-08 Samson Neurosciences Ltd. Endovascular Electrostimulation Near a Carotid Bifurcation in Treating Cerebrovascular Conditions
US9649487B2 (en) 2010-08-05 2017-05-16 Enopace Biomedical Ltd. Enhancing perfusion by contraction
US8538535B2 (en) 2010-08-05 2013-09-17 Rainbow Medical Ltd. Enhancing perfusion by contraction
WO2012017437A1 (en) * 2010-08-05 2012-02-09 Rainbow Medical Ltd. Enhancing perfusion by contraction
US8649863B2 (en) 2010-12-20 2014-02-11 Rainbow Medical Ltd. Pacemaker with no production
US11806525B2 (en) 2011-09-01 2023-11-07 Inspire Medical Systems, Inc. Nerve cuff
US11285315B2 (en) 2011-09-01 2022-03-29 Inspire Medical Systems, Inc. Nerve cuff
US8855783B2 (en) 2011-09-09 2014-10-07 Enopace Biomedical Ltd. Detector-based arterial stimulation
US9526637B2 (en) 2011-09-09 2016-12-27 Enopace Biomedical Ltd. Wireless endovascular stent-based electrodes
US10828181B2 (en) 2011-09-09 2020-11-10 Enopace Biomedical Ltd. Annular antenna
US9011355B2 (en) 2011-10-19 2015-04-21 Sympara Medical, Inc. Methods and devices for treating hypertension
US8747338B2 (en) 2011-10-19 2014-06-10 Sympara Medical, Inc. Methods and devices for treating hypertension
US8740825B2 (en) 2011-10-19 2014-06-03 Sympara Medical, Inc. Methods and devices for treating hypertension
US20160038736A1 (en) * 2011-12-05 2016-02-11 Neurimpluse Srl Electro catheter for neurostimulation
US10368761B2 (en) 2011-12-22 2019-08-06 Modular Bionics Inc. Neural interface device and insertion tools
US11793437B2 (en) 2011-12-22 2023-10-24 Modular Bionics Inc. Neural interface device and insertion tools
US8954165B2 (en) 2012-01-25 2015-02-10 Nevro Corporation Lead anchors and associated systems and methods
US9386991B2 (en) 2012-02-02 2016-07-12 Rainbow Medical Ltd. Pressure-enhanced blood flow treatment
US9687649B2 (en) 2013-06-28 2017-06-27 Nevro Corp. Neurological stimulation lead anchors and associated systems and methods
US9265935B2 (en) 2013-06-28 2016-02-23 Nevro Corporation Neurological stimulation lead anchors and associated systems and methods
US11432949B2 (en) 2013-11-06 2022-09-06 Enopace Biomedical Ltd. Antenna posts
US10779965B2 (en) 2013-11-06 2020-09-22 Enopace Biomedical Ltd. Posts with compliant junctions
US11627878B2 (en) 2015-06-24 2023-04-18 Modular Bionics Inc. Wireless neural interface system
US10674914B1 (en) 2015-06-24 2020-06-09 Modular Bionics Inc. Wireless neural interface system
US11697018B2 (en) 2016-07-07 2023-07-11 Modular Bionics Inc. Neural interface insertion and retraction tools
US10874847B2 (en) 2016-07-07 2020-12-29 Modular Bionics Inc. Neural interface insertion and retraction tools
US11065439B1 (en) 2017-12-11 2021-07-20 Modular Bionics Inc. Conforming modular neural interface system
US11400299B1 (en) 2021-09-14 2022-08-02 Rainbow Medical Ltd. Flexible antenna for stimulator

Also Published As

Publication number Publication date
US20030060857A1 (en) 2003-03-27
US20080172101A1 (en) 2008-07-17
US7158832B2 (en) 2007-01-02
US20080177339A1 (en) 2008-07-24
US20080171923A1 (en) 2008-07-17

Similar Documents

Publication Publication Date Title
US20200114153A1 (en) Electrode structures and methods for their use in cardiovascular reflex control
EP1487535B1 (en) Electrode structures for use in cardiovascular reflex control
US20080177364A1 (en) Self-locking electrode assembly usable with an implantable medical device
US20080177366A1 (en) Cuff electrode arrangement for nerve stimulation and methods of treating disorders
US7499747B2 (en) External baroreflex activation
US20100249874A1 (en) Baroreflex therapy for disordered breathing

Legal Events

Date Code Title Description
STCB Information on status: application discontinuation

Free format text: ABANDONED -- FAILURE TO RESPOND TO AN OFFICE ACTION