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EP3052040A1 - Dispositif de neuromodulation intravasculaire présentant une piste en spirale et procédés associés - Google Patents

Dispositif de neuromodulation intravasculaire présentant une piste en spirale et procédés associés

Info

Publication number
EP3052040A1
EP3052040A1 EP14780700.2A EP14780700A EP3052040A1 EP 3052040 A1 EP3052040 A1 EP 3052040A1 EP 14780700 A EP14780700 A EP 14780700A EP 3052040 A1 EP3052040 A1 EP 3052040A1
Authority
EP
European Patent Office
Prior art keywords
track element
track
treatment
neuromodulation
renal
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.)
Withdrawn
Application number
EP14780700.2A
Other languages
German (de)
English (en)
Inventor
Barry O'connell
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.)
Medtronic Ardian Luxembourg SARL
Original Assignee
Medtronic Ardian Luxembourg SARL
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 US14/041,270 external-priority patent/US20150066118A1/en
Application filed by Medtronic Ardian Luxembourg SARL filed Critical Medtronic Ardian Luxembourg SARL
Publication of EP3052040A1 publication Critical patent/EP3052040A1/fr
Withdrawn legal-status Critical Current

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00—Electrotherapy; Circuits therefor
    • A61N1/02—Details
    • A61N1/04—Electrodes
    • A61N1/05—Electrodes for implantation or insertion into the body, e.g. heart electrode
    • A61N1/0507—Electrodes for the digestive system
    • A61N1/0514—Electrodes for the urinary tract
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B18/04—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating
    • A61B18/12—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating by passing a current through the tissue to be heated, e.g. high-frequency current
    • A61B18/14—Probes or electrodes therefor
    • A61B18/1492—Probes or electrodes therefor having a flexible, catheter-like structure, e.g. for heart ablation
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B2018/00053—Mechanical features of the instrument of device
    • A61B2018/00214—Expandable means emitting energy, e.g. by elements carried thereon
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B2018/00315—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body for treatment of particular body parts
    • A61B2018/00345—Vascular system
    • A61B2018/00404—Blood vessels other than those in or around the heart
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B2018/00315—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body for treatment of particular body parts
    • A61B2018/00434—Neural system
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B2018/00315—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body for treatment of particular body parts
    • A61B2018/00505—Urinary tract
    • A61B2018/00511—Kidney
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B18/04—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating
    • A61B18/12—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating by passing a current through the tissue to be heated, e.g. high-frequency current
    • A61B18/14—Probes or electrodes therefor
    • A61B2018/1405—Electrodes having a specific shape
    • A61B2018/1435—Spiral

Definitions

  • the present technology relates generally to intravascular neuromodulation and associated methods.
  • several embodiments are directed to devices positionable along spiral tracks for intravascular renal neuromodulation and associated methods.
  • the sympathetic nervous system is a primarily involuntary bodily control system typically associated with stress responses. Fibers of the SNS innervate tissue in almost every organ system of the human body and can affect characteristics suc as pupil diameter, gut motility, and urinary output. Such regulation can have adaptive utility in maintaining homeostasis or preparing the body for rapid response to environmental factors. Chronic activation of the SNS, however, is a common maladaptive response that can drive the progression of many disease states. Excessive activation of the renal SNS in particular has been identified experimentally and in humans as a likely contributor to the complex pathophysiology of hypertension, states of volume overload (such as heart failure), and progressive renal disease. For example, radiotracer dilution has demonstrated increased renal norepinephrine ("NE”) spillover rates in patients with essential hypertension.
  • NE renal norepinephrine
  • Cardio-renal sympathetic nerve hyperactivity can be particularly pronounced in patients with heart failure. For example, an exaggerated NE overflow from the heart and kidneys of plasma is often found in these patients. Heightened SNS activation commonly characterizes bot chronic and end stage renal disease. In patients with end stage renal disease, NE plasma levels above the median have been demonstrated to be predictive of cardiovascular diseases and several causes of death. This is also true for patients suffering from diabetic or contrast nephropathy. Evidence suggests that sensory afferent signals originating from diseased kidneys are major contributors to initiating and sustaining elevated central sympathetic outflow.
  • Sympathetic nerves innervating the kidneys terminate in the blood vessels, the juxtaglomerular apparatus, and the renal tubules. Stimulation of the renal sympathetic ner es can cause increased renin release, increased sodium (Na+) reabsorption, and a reduction of renal blood flow. These neural regulation components of renal function are considerably stimulated in disease states characterized by heightened sympathetic tone and likely contribute to increased blood pressure in hypertensive patients. The reduction of renal blood flow and glomerular fi ltration rate as a result of renal sympathetic efferent stimulation is likely a cornerstone of the loss of renal function in cardio-renal syndrome (i.e., renal dysfunction as a progressive complication of chronic heart failure).
  • Pharmacologic strategies to thwart the consequences of renal efferent sympathetic stimulation include centrally acting sympatholytic drugs, beta blockers (intended to reduce renin release), angiotensin converting enzyme mhibitors and receptor blockers (intended to block the action of angiotensin II and aldosterone activation consequent to renin release), and diuretics (intended to counter the renal sympathetic mediated sodium and water retention).
  • These pharmacologic strategies have significant limitations including limited efficacy, compliance issues, side effects, and others.
  • intravascular devices that reduce sympathetic n rv activity by applying an energy field to a target site in the renal blood vessel e.g., via radio frequency ablation
  • FIG. 1 is a partially schematic diagram of a neuromodulation system configured in accordance with an embodiment of the present technology.
  • FIG. 2 is a longitudinal cross-sectional view of an intravascular therapeutic assembly in a delivery state (e.g., low-profile or collapsed configuration) and carried within a delivery element in accordance with an embodiment of the present technology.
  • a delivery state e.g., low-profile or collapsed configuration
  • FIG. 3A is a perspective view of the intravascular therapeutic assembly of FIG. 2 having a spiral-shaped track in a deployed state (e.g., expanded configuration) within a renal artery of a patient in accordance with a further embodiment of the present technology.
  • FIG. 3B is a transverse cross-sectional view of the intravascular therapeutic assembly taken along line 3B -3B of FIG. 3A.
  • FIG. 4A is a transverse cross-sectional view of an intravascular therapeutic assembly configured in accordance with an embodiment of the present technology.
  • FIG. 4B is a transverse cross-sectional view of an intravascular therapeutic assembly configured in accordance with another embodiment of the present technology.
  • FIG. 5 schematically illustrates modulating renal nerves with an intravascular therapeutic assembly configured in accordance with an embodiment of the present technology.
  • FIG. 6A is a longitudinal cross-sectional view of an intravascular therapeutic assembly and guidewire in a deliver ⁇ ' state (e.g., low-profile or collapsed configuration) in accordance with another embodiment of the present technology.
  • a deliver ⁇ ' state e.g., low-profile or collapsed configuration
  • FIG. 6B is a perspective view of the intravascular therapeutic assembly of FIG. 6A with the guidewire partially withdrawn and showing the therapeutic assembly in a deployed state (e.g., expanded configuration) within a renal arter of a patient in accordance with a further embodiment of the present technology.
  • a deployed state e.g., expanded configuration
  • FIG. 7 is a flowchart of a method for delivering and deploying an intravascular therapeutic assembly in accordance wi th an embodiment of the present technology.
  • FIG. 8 is a flowchart of another method for delivering and deploying an intravascular therapeutic assembly in accordance with an embodiment of the present technology.
  • the present technology is directed to apparatuses, and methods for achieving electrically- and/or thermally-induced renal neuromodulation (i.e., rendering neural fibers that inner aic the kidney inert or inactive or otherwise completely or partially reduced in function) by percutaneous transluminal intravascular access.
  • embodiments of the present technology relate to therapeutic assemblies having track elements and treatment devices (e.g., treatment catheters) slidably engaged with the track elements.
  • the therapeutic assemblies include at least one neuromodulation element (e.g., at least one electrode) that can be located, for example, at a distal portion of the treatment device.
  • a distal portion of the track element is transformable between a delivery or low-profile state (e.g., a generally straightened shape) to a deployed state (e.g., a radially expanded, generally spiral helical shape) such that the track element defines a spiral- shaped track in apposition with an inner wall of the target blood vessel (e.g., renal artery).
  • a delivery or low-profile state e.g., a generally straightened shape
  • a deployed state e.g., a radially expanded, generally spiral helical shape
  • the treatment device can include a treatment catheter or another elongate member that slidably engages the track element such that movement of the of the treatment device relative to the track element translates the neuromodulation element(s) along the track element to position the neuromodulation element(s) at various treatment positions within the target blood vessel.
  • the track element can be a wire (e.g., nitinol wire) that is accommodated within a lumen of the treatment device (e.g., treatment catheter, microcatheter, tubular sheath, etc.) and has an expandable, pre-formed, helical shape at a distal portion thereof. Accordingly, movement of the treatment device proximally or distaliy along the deployed and stationary track element can displace the neuromodulation element both angularly or circumferentially and longitudinally relative to a longitudinal axis of the target blood vessel.
  • a wire e.g., nitinol wire
  • the neuromodulation element(s) are in electrical communication with an energy source or energy generator external to the patient such that energy is delivered via the neuromodulation element(s) to portions of a renal artery after being advanced thereto along a percutaneous transluminal path (e.g., a femoral artery puncture, an iliac artery and the aorta, a radial artery, or another suitable intravascular path).
  • a percutaneous transluminal path e.g., a femoral artery puncture, an iliac artery and the aorta, a radial artery, or another suitable intravascular path.
  • Suitable energy modalities include, for example, electrical energy, radio frequency (RF) energy, pulsed electrical energy, or thermal energy.
  • RF radio frequency
  • the treatment device carrying the neuromodulation element(s) can be sized, shaped and have suitable flexibility such that the neuromodulation element(s) are in constant apposition with the interior wall of the renal artery when the track element is in the deployed (e.g., spiral/helical) state.
  • the pre-formed spiral/helical shape of the deployed portion of the track element carrying the treatment device allows blood to flow through the assembly during therapy, which is expected to help prevent occlusion of the renal artery during activation of the neuromodulation element(s).
  • Previous energy-delivery catheter systems for inducing neuromodulation that include arrays of electrodes can be expensive to manufacture. For example, multiple electrodes require separate wiring of each electrode as well as complex algorithms and design of the energy generator. Additionally, repositioning and specific lesion placement on the interior wall of the renal artery are challenging and time consuming when using conventional energy-deliver ⁇ ' catheter systems. In contrast, a self-expanding spiral frame over which an elongate member (e.g., sheath, treatment catheter, microcatheter, etc.) can travel provides a simple design that is easy to deploy and use compared to the conventional catheter devices.
  • an elongate member e.g., sheath, treatment catheter, microcatheter, etc.
  • the neuromodulation element can, in some embodiments, include a single electrode that can be moved proximally or distally along the track element while the track element remains in situ. The movement can be achieved via a pull or push mechanism that slides the neuromodulation element along the spiral-shaped track to easily select and access new ablation or treatment locations. Additionally, because movement of the neuromodulation element along the track element is achievable to access a plurality of treatment locations (both circumferential ly and longitudinally displaced from each other), a single neuromodulation element can be deployed on the treatment device. This design aspect avoids the separate wiring that multiple electrodes would require, which is expected to reduce manufacturing time and material costs associated with additional separate electrodes and wiring, as well as reduce the complexity of the control algorithm typically necessary to operate more than one independent electrode or energy delivery elements.
  • FIGS. 1-7 Specific details of several embodiments of the technology are described below with reference to FIGS. 1-7. Although many of the embodiments are described below with respect to devices, systems, and methods for intravascular modulation of renal nerves using spiral-shaped track elements, other applications and other embodiments in addition to those described herein are within the scope of the technology. Additionally, several other embodiments of the technology can have different configurations, components, or procedures than those described herein. A person of ordinary skill in the art, therefore, will accordingly understand that the technology can have other embodiments with additional elements, or the technology can have other embodiments without several of the features shown and described below with reference to FIGS. 1-7.
  • distal and proximal define a position or direction with respect to the treating clinician or clinician's control device (e.g., a handle assembly).
  • distal or disally are a position distant from or in a direction away from the clinician or clinician's control device.
  • Proximal and proximally are a position near or in a direction toward the clinician or clinician's control device.
  • FIG. 1 is a partially schematic illustration of a renal neuromodulation system 10 (“system 10") configured in accordance with an embodiment of the present technology.
  • the system 10 includes an intravascular catheter 12 operably coupled to an energy source or energy generator 30 (e.g., a RF energy generator).
  • the catheter 12 can include an elongated shaft 14 having a proximal portion 16 and a distal portion 20.
  • the catheter 12 also includes a handle 18 at the proximal portion 16.
  • the catheter 12 can further include a therapeutic assembly or treatment section 100 (shown schematically) at the distal portion 20 (e.g., attached to the distal portion 20, defining a section of the distal portion 20, etc.).
  • the therapeutic assembly 100 can include a treatment device 120 slidably engaging a distal portion of track element 110,
  • the proximal end of track element 110 extends from an exit port 15 in handle 18.
  • the treatment device 120 can be an elongate member (e.g., a sheath, a treatment catheter, etc.) with one or more neuromodulation elements or energy delivery elements 122 disposed at a distal end thereof.
  • the neuromodulation or energy delivery element 122 can be an electrode for delivering energy at a target treatment site and providing therapeutically-effective electrically- and/or thermally-induced renal neuromodulation.
  • the therapeutic assembly 100 is configured to be intravascular! y delivered to a target blood vessel (e.g., a renal blood vessel) of a human patient in a low-profile configuration.
  • a target blood vessel e.g., a renal blood vessel
  • the therapeutic assembly 100 is further configured to be transformed into an expanded state (e.g., the distal portion of track element 1 10 is deployed into a generally spiral/helical configuration as shown schematically in FIG. 1) to place the track element 1 10 into apposition with an inner wall of the blood vessel.
  • the deployed state may be non-spiral provided that the deployed state places the track element and specifically one or more energy deliver ⁇ ' elements 122 in vessel wall apposition for delivering the energy to the treatment site.
  • the treatment device 120 can then be slidably moved along the track element 110 to position the neuromodulation or energy delivery element 122 at desired location(s) for modulating target nerves proximate to the inner wall of the blood vessel, thereby providing therapeutically- effective electrically- and/or thermally-induced renal neuromodulation.
  • the therapeutic assembly 100 may be transformed between the deliver ⁇ ' and deployed states using a variety of suitable mechanisms or techniques (e.g., self-expansion).
  • the distal portion of track element 110 can be a pre-formed, self- expanding wire that will transform into the deployed state or arrangement when unrestricted (e.g., by retracting a guide catheter, straightening sheath, etc.).
  • the proximal end of the treatment device 120 is carried by or affixed to the distal portion 20 of the elongated shaft 14.
  • a distal end of the track element 110 may include an atraumatic tip 112.
  • the distal end of the catheter 12 may include an atraumatic tip for preventing intravascular trauma during delivery of the therapeutic assembly 100 to the treatment site.
  • the distal end of the catheter 12 may also be configured to engage another element of the system 10 or catheter 12,
  • the distal end of the catheter 12 may define a passageway for receiving a guidewire for delivery of the treatment device using OTW or rapid exchange ("RX") techniques. Further details regarding such arrangements are described below with reference to FIGS. 6A and 6B.
  • the neuromodulation element(s) 122 can be electrically coupled to the energy source 30 via a cable 32, and the energy source 30 (e.g., a RF energy generator) can be configured to produce a selected modality and magnitude of energy for delivery to the treatment site via the neuromodulation element 122 carried by the treatment device 120.
  • the energy source 30 e.g., a RF energy generator
  • one or more supply wires can extend along the elongated shaft 14 or through a lumen in the shaft 14 to the therapeutic assembly 100 and supply the treatment energy to the neuromodulation element 122.
  • a control mechanism 40 such as foot pedal or handheld remote control device, may be connected to the energy source 30 to allow the clinician to initiate, terminate and, optionally, adjust various operational characteristics of the energy source 30, including, but not limited to, power delivery.
  • the remote control device can be positioned in a sterile field and operably coupled to the therapeutic assembly 100, and specifically to the neuromodulation element 122, and can be configured to allow the clinician to activate and deactivate the energy delivery to the neuromodulation element 122. In other embodiments, the remote control device may be built into the handle assembly 18.
  • the energy source or energy generator 30 can be configured to deliver the treatment energy via an automated control algorithm 34 and/or under the control of a clinician.
  • the energy source 30 can include computing devices (e.g., personal computers, server computers, tablets, etc.) having processing circuitry (e.g., a microprocessor) that is configured to execute stored instructions relating to the control algorithm 34.
  • the processing circuitry may be configured to execute one or more evaluation/feedback algorithms 35, which can be communicated to the clinician.
  • the energy source 30 can include a monitor or display 36 and/or associated features that are configured to provide visual, audio, or other indications of power levels, sensor data, and/or other feedback.
  • the energy source 30 can also be configured to communicate the feedback and other information to another device, such as a monitor in a catheterization laboratory.
  • the system 10 can also include one or more additional sensors (not shown) located proximate to or within the neuromoduiation element 122.
  • the system 10 can include temperature sensors (e.g., additional thermocouples, thermistors, etc.), impedance sensors, pressure sensors, optical sensors, flow sensors, and/or other suitable sensors connected to one or more supply wires (not shown) that transmit signals from the sensors and/or convey energy to the therapeutic assembly 100.
  • FIG. 2 is an longitudinal cross-sectional view of a portion of the intravascular therapeutic assembly 100 in a deliver ⁇ ' state (e.g., a low-profile or collapsed configuration) in accordance with an embodiment of the present technology
  • FIG. 3A is a perspective view of the therapeutic assembly 100 of FIG . 2 in a deployed state or expanded configuration within a renal artery RA (or other target blood vessel) of a patient.
  • the therapeutic assembly 100 can be transformed or actuated between the delivery state (FIG. 2) and the deployed state (e.g., a radially expanded, generally spiral/helical configuration, FIG. 3A).
  • the therapeutic assembly 100 includes the treatment device 120 carried by and siidably engaged with the distal portion of track element 110.
  • the treatment device 120 includes the neuromoduiation element 122 positioned at or near a distal portion 124 thereof for delivering therapeutically effective energy to target tissue (e.g., one or more nerves) of the patient.
  • target tissue e.g., one or more nerves
  • the therapeutic assembly 100 is configured to place the distal portion of track element 110 and neuromoduiation element 122 in apposition with an interior wall of the renal artery RA,
  • the treatment device 120 comprises a treatment catheter, a microcatheter, or other elongate member (e.g., a sheath) having a lumen 126 therethrough defining a passageway for receiving the track element 110.
  • the track element 1 10 accordingly provides a guide for the treatment device 120 as it moves over the track element 110.
  • the therapeutic assembly 100 may be restrained in the delivery state (e.g., a generally straight or collapsed configuration) within the lumen of a tubular sheath or delivery element 130.
  • the delivery element 130 can have a suitable radial and bending stiffness for restraining the distal portion of track element 1 10 in the low-profile and generally straight or non-spiral configuration (e.g., the delivery state).
  • the delivery element 130 may comprise a guide catheter or a straightening sheath sized and shaped to restrain one or more components of the therapeutic assembly 100 in the low-profile state for delivery to the target treatment site within the renal artery RA.
  • the geometry of the therapeutic assembly 100 is configured to facilitate movement through the delivery element 130 to the treatment site.
  • delivery element 130 if it is a guide catheter, will typically have a pre-formed curved region (not shown) near the distal end.
  • the delivery state of the therapeutic assembly 100 will be reduced, i.e. "low” in transverse profile, but not necessarily straight as it passes through the curved region of the guide catheter.
  • Therapeutic assembly 100 in the low-profile configuration is sufficiently flexible to pass through the guide catheter, including the curved region.
  • the delivery element 130 may be 8 Fr or smaller (e.g., a 6 Fr guide catheter) to accommodate small renal arteries during delivery of the therapeutic assembly 100 to the treatment site. In other embodiments, however, the delivery element 130 may have a different size.
  • the intravascular catheter 12 may be delivered and deployed over a guidewire 50 (shown in FIG. 5), rather than with a delivery element 130.
  • the guidewire 50 can then be exchanged within lumen 126 for the track element 110, the pre-formed distal portion of which will tend to take its helical shape in the treatment site, thereby deforming the treatment device 120 into a similar helical shape such that at least the neuromoduiation element 122 is placed in apposition with an interior wall of the renal artery RA.
  • the track element 110 may be partially or folly withdrawn or exchanged within lumen 126 for guidewire 50 to allow treatment device 120 to relax to a straighter configuration for removal from the patient.
  • One of ordinary skill in the art will recognize a plurality of delivery protocols for delivering and deploying the therapeutic assembly 100 at the target treatment site, several of which are described further below and with respect to FIGS. 7 and 8.
  • the distal portion of track element 110 of the therapeutic assembly 100 may be deployed to its expanded, spiral-shaped configuration.
  • the distal portion of track element 110 may be deployed by moving the delivery element 130 (e.g., sheath; FIG. 2) and therapeutic assembly 100 relative to each other such that the therapeutic assembly 100 including the distal portion of track element 110 is exposed distally beyond the delivery element 130.
  • the distal portion of track element 1 10 can he configured to assume the expanded configuration when in an unbiased (e.g., unrestrained) condition.
  • the delivery element 130 FIG.
  • the therapeutic assembly 100 can be pulled proximally while the therapeutic assembly 100 is held stationary with respect to the treatment site.
  • the therapeutic assembly 100 can be pushed distally beyond a distal end 134 of the deliver element 130 while the delivery element 130 is held stationary with respect to the treatment site.
  • FIG. 3B is a transverse cross-sectional view of the therapeutic assembly 100 along the line 3B-3B of FIG. 3 A.
  • the distal portion of track element 1 10 defines a spiral track tending to contact the interior wail of the renal artery RA.
  • the distal portion of track element 1 10 can have a pre-set spiral/helical configuration such that the distal portion of track element 1 10 self-expands to a deployed geometiy within the renal artery RA.
  • the helix of track element 1 10 has a transverse dimension about its central axis CA that is at least approximately equal to a renal artery inner diameter Dj . (FIGS. 3A and 3B) and a maximum length in the direction of the central axis CA that is preferably less than or can be accommodated by the renal artery length (not shown). In other embodiments, however, the track element 1 10 may have a different arrangement and/or d liferent d imensions .
  • the track element 1 10 may be formed from suitable shape memory material, such as nitinol (nickel-titanium alloy) wire. In other embodiments, however, the track element 1 10 can be composed of different materials and/or have a different arrangement.
  • the track element 110 may be formed from other suitable materials such as metal wire (e.g., stainless steel), shape memory polymers, electro-active polymers, etc., that are pre-formed or pre-shaped into the desired deployed state (FIGS. 3A and 3B).
  • the track element 1 10 may be formed from multiple materials such as a composite of one or more polymers and metals.
  • the treatment device 120 is disposed over the distal portion of track element 1 10 such that, when the distal portion of track element 1 10 assumes its pre-set spiral/helical shape, the treatment device 120 is sufficiently flexible to conform to the helical shape of track element 1 10 such that at least neuromodulation element 122 can be placed in apposition with the interior w r all of the renal artery RA.
  • Treatment device 120 is moveable over the relatively stationary track element 1 10 for positioning or re -positioning element 122 at one or more treatment locations along the interior wall of the renal artery RA.
  • the treatment device 120 can include a flexible tube 128 and at least the pre-shaped spiral/helical distal portion of track element 110 can be received within the lumen 126 of tube 128.
  • the flexible tube 128 may be composed of a polymer material such as polyamide, polyimide, polyether block amide copolymer sold under the trademark PEBAX, polyethylene terephtha!ate (PET), polypropylene, an aliphatic, polycarbonate-based thermoplastic polyurethane sold under the trademark CARBQTilANE, or a polyether ether ketone (PEEK) polymer.
  • the material properties and dimensions of the tube 128 are selected to provide the necessary flexibility for the tube 128 to readily deform between a relaxed, substantially straight shape and a shape that conforms to the helical deployed shape of the distal portion of track element 110.
  • the tube 128 is more flexible than the track element 110 such that the shape of the combined components is defined by the shape of the track element 110.
  • the lumen 126 is sized to provide sufficient clearance with the track element 110 to reduce friction between the catheter 12 and the track element 110.
  • a lubricant or lubricious coating can be included on either or both of the sliding surfaces, or may be applied between the track element 1 10 and the catheter 12 to facilitate relative movement therebetween.
  • the catheter 12 may include an operative wire (not shown) to facilitate pushing or pulling the treatment device 120 relative to the track element 1 10.
  • the operative wire can extend proximally from the treatment device 120 (e.g. as an alternative to the shaft 14) to be accessible, for example, to a clinician outside the patient when the therapeutic assembly 100 is being delivered and deployed.
  • the treatment device 120 may have a different arrangement and/or different features.
  • the neuromodulation element 122 can be an electrode configured to deliver energy (e.g., electrical energy, RF energy, pulsed electrical energy, non- pulsed electrical energy, thermal energy, etc.) across the wall of the renal artery RA.
  • energy e.g., electrical energy, RF energy, pulsed electrical energy, non- pulsed electrical energy, thermal energy, etc.
  • the neuromodulation element 122 can deliver a thermal RF field to targeted renal nerves adjacent the wall of the renal artery RA.
  • the neuromodulation element 122 can include a band electrode surrounding the distal end 124 of the treatment device 120 such as at the distal end of the flexible tube 128.
  • the neuromodulation element 122 can be a band electrode bonded to the tube 128 using an adhesive.
  • the treatment device 120 can include more than one neuromodulation element 122.
  • the device 120 may include 2 or 3 electrodes (not shown) or, in yet another embodiment, an array of electrodes such as a series of separate band electrodes spaced along the treatment device 120 and bonded to the flexible tube 128.
  • band or tubular electrodes are illustrated, in other embodiments disc or flat electrodes may also be employed.
  • electrodes having a spiral or coil shape may be utilized.
  • the neuromodulation element 122 may be formed from any suitable metallic material (e.g., gold, platinum, an alloy of platinum and iridium, etc.). In other embodiments, however, the number, arrangement, and/or composition of the neuromodulation element(s) 122 may vary.
  • the neuromodulation element 122 may be placed on the treatment de vice 120 at another location proximal to the distal portion 124 of the treatment device 120.
  • the neuromodulation element 122 is electrically connected to an external energy source (such as energy source 30, FIG. 1) by a conductor or bifilar wire (not shown) extending through catheter 12.
  • the neuromodulation element 122 may be welded or otherwise electrically coupled to its energy supply wire, and the wire can extend the entire length of the catheter 12 (e.g. inside, outside or within a wall of the treatment device 120 and shaft 14) such that a proximal end thereof is coupled to the energy source 30 (FIG. 1).
  • the therapeutic assembly 100 may also include an insulating layer (e.g., a layer of PET or another suitable material) over the track element 110 to further electrically isolate the material (e.g., nitinol wire) of the track element 110 from the wires (not shown).
  • an insulating layer e.g., a layer of PET or another suitable material
  • the material e.g., nitinol wire
  • the therapeutic assembly 100 can include radiopaque markers 140 or other indicia for facilitating navigation of the assembly 100 through the vasculature as well as positioning of the neuromodulation element 122 at one or more desired treatment locations within the renal artery RA using x-ray imaging techniques known in the art.
  • FIG. 3 A illustrates an embodiment where radiopaque markers 140 are mounted to an outer surface of the distal portion 124 of the treatment device 120.
  • the track element 110 can also include radiopaque markers 140 (e.g., made with radiopaque ink).
  • at least a portion of the track element 110 and/or the treatment device 120 can be made from platinum and/or other radiopaque materials (e.g., platinum/iridium alloy metal coil wrapped around the elongate member).
  • the treatment device 120 can be slid in either a proximal or distal direction along the relatively stationary track element 110 to position the neuromodulation element 122 at a desired treatment location.
  • Therapeutically-effective energy can then be delivered via the neuromodulation element 122 across the wall of the renal artery RA to targeted renal nerves (not shown) at one or more treatment locations.
  • neuromodulatory energy can be delivered at a first treatment location followed by sliding the treatment device 120 in either a proximal or distal direction along the track element 110 to place the neuromodnlation element 122 at a second treatment location transposed circumferentially and longitudinally offset from the first treatment location along the renal artery RA.
  • This step can be followed by delivering energy via the neuromodulation element 122 across the wail of the renal artery RA to targeted renal nerves at the second treatment location.
  • Further steps can include sliding the treatment device 120 along the track element 110 to one or more additional treatment locations and again delivering energy to target nerves.
  • the second treatment location can be longitudinally spaced away from the first treatment location along the renal artery RA in either a proximal or distal direction. Sliding the treatment device 120 between first and second treatment locations can also translate the second treatment location circumferentially about the interior wall of the blood vessel with respect to the first treatment location. For example, as the treatment device 120 slides along the spiral-shaped track provided by the distal portion of the track element 110 (FIG. 3 A), the neuromodulation element 122 is transposed circumferentially and longitudinally on the interior wall of the renal artery RA. Accordingly, energy can be delivered at one or more discrete treatment locations to form a helical pattern of lesions or treatment zones along the interior wall of the renal artery.
  • the treatment zones may overlap. In other embodiments, however, the lesions may be spaced sufficiently such that they do not overlap. In still further embodiments, energy can be delivered while sliding the treatment device 120 along the spiral- shaped track element 110 to form a continuous or approximately continuous helical lesion.
  • FIGS. 4 A and 4B are transverse cross-sectional views of the therapeutic assembly 100 illustrating various arrangements of the treatment device 120 surrounding the track element 110
  • the track element 110 can be a wire having a generally circular cross-sectional shape
  • the treatment device 120 can be an elongate member with a generally circular cross-sectional shape and having the lumen 126 for accommodating the track element 1 10
  • the treatment device 120 may be a treatment catheter or other microcatheter having the flexible tube 128 that is configured to slidably engage the track element 110.
  • FIG, 4B shows an alternative arrangement wherein the track element 110 has a generally rectangular cross-sectional shape.
  • FIGS. 4A and 4B also depicts an embodiment of the treatment device 120 that does not include a tube 128, but instead incorporates a non-circumferential sleeve 428 that only partially encloses the track element 110.
  • a track or rail configured to be placed in apposition with the interior wall of the target blood vessel and a treatment device configured to engage and slidably move along the track or rail to position a neuromodulation element coupled thereto at a plurality of treatment locations.
  • the track element 1 10 may be delivered to the treatment site through or within a guide catheter or straightening sheath (e.g., the delivery element 130 shown in FIG. 2).
  • the sheath may be pre -placed across the treatment site with or without use of a guidewire, and the track element 1 10, with or without catheter 12 mounted thereabout, can then be passed through the sheath.
  • track element 1 10 with or without catheter 12 mounted thereabout can be pre-loaded into the sheath such that the assembled components can be advanced simultaneously through the patient's vasculature.
  • the straightening sheath can partially or fully restrain the distal portion of track element 110 in the delivery configuration,.
  • the straightening sheath may be at least partially withdrawn or retracted to permit the distal portion of track element 110 to transform into the deployed configuration.
  • FIG. 5 illustrates at least one step of modulating renal nerves with an embodiment of the system 10.
  • the therapeutic assembly 100 is shown positioned within the renal plexus RP and catheter 12 is shown in an intravascular path P extending from a percutaneous access site in a femoral (illustrated), brachial, radial, or axillary artery to a targeted treatment site within a respective renal artery RA.
  • a section of the proximal portion 16 of the catheter shaft 14 is exposed externally of the patient even as the therapeutic assembly 100 has been advanced fully to the targeted treatment site in the patient.
  • the clinician may advance the shaft 14 through the sometimes tortuous intravascular path P and remotely manipulate the distal portion 20 of the shaft 14.
  • the therapeutic assembly 100 extends intravascularly to the treatment site over a guidewire 50 using an OTW technique.
  • the guidewire 50 may comprise any suitable medical guidewire sized to siidably fit within the lumen 126 of catheter 12. In one particular embodiment, for example, the guidewire 50 may have a diameter of 0.356 mm (0.014 inch).
  • deployment of the track element 110 can be accomplished by exchanging the guidewire 50 for the track element 1 10 within the lumen 126 of the catheter 12. This exchange can be accomplished through the open proximal end of lumen 126 at exit port 15 in handle 18 (See FIG. 1).
  • the exposed element is labeled as either guidewire 50 or track element 110.
  • FIG. 6A illustrates a transverse cross-sectional view of a portion of the intravascular therapeutic assembly 100 wherein both a guidewire 50 and track element 110 are disposed within treatment device 120.
  • FIG. 6B is a perspective view of the therapeutic assembly 100 of FIG. 6A in a deployed state (e.g., expanded configuration) within a renal artery RA (or other target blood vessel ) of a patient.
  • both guidewire 50 and track element 110 are siidably disposed in lumen 126, which will necessarily be somewhat larger than the earlier embodiment wiierein only one of guidewire 50 or track element 110 are present in lumen 126.
  • guidewire 50 and track element 110 can be siidably disposed in separate, dedicated lumens.
  • the guidewire 50 may be sufficiently stiff to keep treatment device 120 relatively straight and thereby restrain the track element 110 in the deliver state. It will be understood that, without additional bending stiffness provided by either guidewire 50 or delivery element 130 (of the previous method), treatment device 120 will tend to conform to the shape of track element 110.
  • the track element 110 provides a shape-recovery force sufficient to overcome the straightening force provided by a distalmost portion 52 of the guidewire 50 such that the track element 110 can deploy into its spiral/helical shaped configuration and deforrn treatment device 120 along with it.
  • the guidewire 50 can impart additional structural integrity to the positioning of the spiral-shaped portion during treatment. This feature is expected to help mitigate or reduce problems associated with keeping the therapeutic assembly 100 in place during treatment (e.g., help with vasoconstriction).
  • the guidewire 50 including the distalmost portion 52 may be withdrawn completely from the therapeutic assembiy 100 while remaining within the shaft 14 (not shown) to permit the transformation of therapeutic assembly 100.
  • the guidewire 50 may be withdrawn completely from the shaft 14.
  • the clinician can withdraw the guidewire 50 sufficiently to observe transformation of the therapeutic assembly 100 to the deployed configuration and/or until an X-ray image shows that the distal tip of the guidewire 50 is at a desired location relative to the therapeutic assembly 100 (e.g., at least partially withdrawn from the therapeutic assembly 100, or completely withdrawn from the therapeutic assembly 100, etc.).
  • the extent of withdrawal of the guidewire 50 can be based, at least in part, on the clinician's judgment with respect to the selected guidewire and the extent of withdrawal necessary to achi eve deployment of the therapeutic assembly 100.
  • the therapeutic assembiy 100 may be transformed back to the low-profile deliver ⁇ ' configuration by axially advancing the guidewire 50 relative to the therapeutic assembiy 100 (e.g., within the lumen 126 of the treatment device 120).
  • the track element 1 10 can be withdrawn from the renal artery RA, or in another embodiment, the guidewire 50 can be exchanged for the track element 110 in lumen 126 of the treatment device 120 (FIG. 6).
  • the treatment device 120 can be pulled back with or over the guidewire 50.
  • a guide catheter or straightening sheath (e.g., shown as delivery element 130 in FIG. 2) can be axially advanced relative to the therapeutic assembly 100 to transform the track element 1 10 back to the delivery configuration.
  • the guide catheter or straightening sheath may be advanced until the distal tip of the catheter or sheath is generally aligned with the distal end of the track element 110.
  • the distalmost portion of the catheter or sheath may be advanced to a different location relative to the therapeutic assembly 100 to achieve transformation of the track element 1 10 back to a low-profile configuration.
  • Image guidance e.g., computed tomography (CT), fluoroscopy, intravascular ultrasound (IVUS), optical coherence tomography (OCT), intracardiac echocardiography (ICE), or another suitable guidance modality, or combinations thereof, may be used to aid the clinician's positioning and manipulation of the therapeutic assembly 100.
  • CT computed tomography
  • IVUS intravascular ultrasound
  • OCT optical coherence tomography
  • ICE intracardiac echocardiography
  • another suitable guidance modality e.g., computed tomography (CT), fluoroscopy, intravascular ultrasound (IVUS), optical coherence tomography (OCT), intracardiac echocardiography (ICE), or another suitable guidance modality, or combinations thereof, may be used to aid the clinician's positioning and manipulation of the therapeutic assembly 100.
  • a fluoroscopy system e.g., including a flat-panel detector, x-ray, or c-arm
  • the treatment site can be determined using IVUS, OCT, and/or other suitable image mapping modalities that can correlate the target treatment site with an identifiable anatomical structure (e.g., a spinal feature) and/or a radiopaque ruler (e.g., positioned under or on the patient) before delivering the catheter 12 and/or the therapeutic assembly 100.
  • image guidance components e.g., IVUS, OCT
  • image guidance components e.g., IVUS or OCT
  • IVUS intravascular medical apparatus
  • OCT optical coherence tomography
  • FIG. 7 is a block diagram illustrating a method 700 of delivering and deploying the therapeutic assembly 100 described above with reference to FIGS. 1-6 at a target treatment site for modulating renal nerves.
  • the method 700 can include transluminally delivering a catheter in a low-profile delivery configuration within a renal artery of a human patient (block 702).
  • the catheter can comprise a therapeutic assembly that includes a track element and a treatment device carried by the track element.
  • the treatment device can include a iieuromodulation element at a distal portion thereof.
  • the method 700 can also include transforming the catheter from the delivery configuration to a deployed configuration (block 704).
  • the track element has a radially expanded, generally helical shape configured to place the treatment device and at least the neuromoduiation element carried thereon proximate to a renal nerve.
  • the treatment device can include a sleeve with a lumen for receiving the track element therethrough.
  • the sleeve is configured to slide over the stationary track to position the neuromoduiation element at one or more treatment locations along the renal artery.
  • the catheter can include a guide catheter or straightening sheath configured to hold the track element in the delivery configuration.
  • the step of transforming the catheter can include a step of at least partially withdrawing the guide catheter (or the straightening sheath) to expose the track element within an interior lumen of the renal artery.
  • the therapeutic device components as illustrated in FIGS. 1-4B and 6 above can be configured to fit within an 8 Fr guide catheter or smaller (e.g., 7 Fr, 6 Fr, etc.) to access small peripheral vessels.
  • the method 700 can optionally include delivering the catheter to the renal artery over a guidewire (not shown).
  • delivering the catheter over a guidewire can also include exchanging the guidewire for the therapeutic assembly within the catheter.
  • the method 700 can further include modulating the renal nerve (block 706).
  • energy can be delivered to the renal nerve via the neuromodulation element at a first treatment location along the renal artery.
  • the treatment device can then be moved along the relatively stationary track element to position the neuromodulation element at a second treatment location along the renal artery, and energy can be delivered to the renal nerve via the neuromodulation element at the second treatment location.
  • the treatment device can slide along the relatively stationary track element having the generally helical shape to position the neuromodulation element at the one or more treatment locations along an inner wall of the renal artery. Moving the treatment device transposes the neuromodulation element circumfe e tialiy and longitudinally relative to a longitudinal axis of the renal artery.
  • the neuromodulation element can emit RF energy for modulating the renal nerve adjacent the inner wall of the renal artery at the targeted treatment locations. Delivering energy at the first and second treatment locations can form an interrupted lesion along the inner wall of the renal artery. In other embodiments, however, energy can be delivered during movement of the treatment device to form a continuous lesion along the inner wall. In certain other embodiments, modulation of the renal nerve can occur by delivering energy via the neuromodulation element at a single treatment location,
  • FIG. 8 is a block diagram illustrating another method 800 of delivering and deploying the therapeutic assembly 100 described above with reference to FIGS. 1-6 at a target treatment site for modulating renal nerves.
  • the method 800 can include intravascularly positioning a therapeutic assembly at a treatment site within a target blood vessel of a human patient (block 802),
  • the therapeutic assembly can comprise a track element in a low-profile delivery configuration and an elongate member over the track element.
  • the elongate member can comprise an electrode disposed a distal portion thereof.
  • the method 800 can also include transforming the track element from the delivery configuration to a deployed configuration, wherein, in the deployed configuration, the track element comprises a spiral track tending to be in apposition with an inner wall of the target blood vessel (block 804).
  • the track element can be maintained in the delivery configuration with a delivery element (e.g., guide catheter, straightening sheath, etc.), and the step of transitioning the track element can include at least partially withdrawing or retracting the deliver)' element.
  • the method 800 can further include sliding the elongate member over the track element to position the electrode at a treatment location along the spiral track (block 806).
  • the method 800 can also include delivering energy via the electrode to modulate target nerves proximate to the inner wall of the target blood vessel (block 808).
  • neuromodulation system 10 can provide delivery of any of the therapeutic assemblies 100 illustrated in FIGS. 2-4B, 6 A, and 6B using one or more additional deliver ⁇ ' elements such as guide catheters, straightening sheaths, and/or guidewires.
  • additional deliver ⁇ ' elements such as guide catheters, straightening sheaths, and/or guidewires.
  • the therapeutic assemblies described above and illustrated in FIGS. 1-3B, 6A and 6B showing only a single neuromodulation element can also include additional electrode elements, wires, and energy delivery features positioned along the treatment device.
  • Renal neuromodulation is the partial or complete incapacitation or other effective disruption of nerves innervating the kidneys.
  • renal neuromodulation comprises inhibiting, reducing, and/or blocking neural communication along neural fibers (i.e., efferent and/or afferent nerve fibers) innervating the kidneys.
  • neural fibers i.e., efferent and/or afferent nerve fibers
  • Such incapacitation can be long-term (e.g., permanent or for periods of months, years, or decades) or short-term (e.g., for periods of minutes, hours, days, or weeks).
  • Renal neuromodulation is expected to efficaciously treat several clinical conditions characterized by increased overall sympathetic activity, and in particular conditions associated with central sympathetic over-stimulation such as hypertension, heart failure, acute myocardial infarction, metabolic syndrome, insulin resistance, diabetes, left ventricular hypertrophy, chronic and end stage renal disease, inappropriate fluid retention in heart failure, cardio-renal syndrome, osteoporosis, and sudden death.
  • the reduction of afferent neural signals contributes to the systemic reduction of sympathetic tone/drive, and renal neuromodulation is expected to be useful in treating several conditions associated with systemic sympathetic over activity or hyperactivity. Renal neuromodulation can potentially benefit a vari ety of organs and bodily structures innervated by sympathetic nerves.
  • Various techniques can be used to partially or completely incapacitate neural pathways, such as those innervating the kidney.
  • energy e.g., electrical energy, thermal energy
  • the purposeful application of energy (e.g., electrical energy, thermal energy) to tissue by energy delivery element(s) or components such as those described in conjunction with the intravascular treatment assemblies above, can induce one or more desired thermal heating effects on localized regions of the renal artery and adjacent regions of the renal plexus, which lay intimately within or adjacent to the adventitia of the renal artery.
  • the purposeful application of the thermal heating effects can achieve neuromodulation along all or a portion of the renal plexus.
  • the thermal heating effects can include both thermal ablation and non-ablative thermal alteration or damage (e.g., via sustained heating and/or resistive heating). Desired thermal heating effects may include raising the temperature of target neural fibers above a desired threshold to achieve non-ablative thermal alteration, or above a higher temperature to achieve ablative thermal alteration.
  • the target temperature can be above body- temperature (e.g., approximately 37°C) but less than about 45°C for non-ablative thermal alteration, or the target temperature can be about 45°C or higher for the ablative thermal alteration.
  • thermal energy in excess of a body temperature of about 37°C, but below a temperature of about 45°C, may induce thermal alteration via moderate heating of the target neural fibers or of vascular structures that perfuse the target fibers.
  • the target neural fibers are denied perfusion resulting in necrosis of the neural tissue.
  • this may induce non- ablative thermal alteration in the fibers or structures.
  • Exposure to heat above a temperature of about 45°C, or above about 60°C may induce thermal alteration via substantial heating of the fibers or structures. For example, such higher temperatures may thermally ablate the target neural fibers or the vascular structures.
  • RSNA renal sympathetic nerve activity

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Abstract

La présente invention concerne des ensembles, des systèmes et des procédés destinés à la neuromodulation intravasculaire, qui comprennent un procédé de positionnement d'un dispositif de traitement et un élément de piste au niveau d'un site de traitement dans une artère d'un patient humain et de transformation de l'élément de piste à partir d'une configuration d'administration à une configuration déployée afin de former une piste en forme de spirale tendant à être en apposition avec une paroi intérieure de l'artère. Le dispositif de traitement présente un élément de neuromodulation situé de manière distale destiné à coulisser le long de la piste en forme de spirale. Le procédé peut comprendre également l'administration d'énergie par l'intermédiaire de l'élément de neuromodulation à travers la paroi intérieure d'une artère rénale pour chauffer ou autrement moduler électriquement les fibres neuronales qui contribuent à la fonction rénale.
EP14780700.2A 2013-09-30 2014-09-17 Dispositif de neuromodulation intravasculaire présentant une piste en spirale et procédés associés Withdrawn EP3052040A1 (fr)

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US14/041,270 US20150066118A1 (en) 2013-08-28 2013-09-30 Intravascular Neuromodulation Device Having a Spiral Track and Associated Methods
PCT/US2014/056040 WO2015047817A1 (fr) 2013-09-30 2014-09-17 Dispositif de neuromodulation intravasculaire présentant une piste en spirale et procédés associés

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