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Feedback systems and methods utilizing two or more sites along denervation catheter

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Publication number
WO2014149550A2
WO2014149550A2 PCT/US2014/019488 US2014019488W WO2014149550A2 WO 2014149550 A2 WO2014149550 A2 WO 2014149550A2 US 2014019488 W US2014019488 W US 2014019488W WO 2014149550 A2 WO2014149550 A2 WO 2014149550A2
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WO
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Application
Patent type
Prior art keywords
renal
denervation
flow
blood
artery
Prior art date
Application number
PCT/US2014/019488
Other languages
French (fr)
Other versions
WO2014149550A3 (en )
Inventor
Yelena Nabutovsky
Edward Karst
Xiaoyi Min
Stuart Rosenberg
Kritika Gupta
Original Assignee
St. Jude Medical, Cardiology Division, 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

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Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B18/04Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating
    • A61B18/12Surgical 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
    • A61B18/14Probes or electrodes therefor
    • A61B18/1492Probes or electrodes therefor having a flexible, catheter-like structure, e.g. for heart ablation
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Detecting, measuring or recording for diagnostic purposes; Identification of persons
    • A61B5/05Detecting, measuring or recording for diagnosis by means of electric currents or magnetic fields; Measuring using microwaves or radiowaves
    • A61B5/053Measuring electrical impedance or conductance of a portion of the body
    • A61B5/0538Measuring electrical impedance or conductance of a portion of the body invasively, e.g. using a catheter
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Detecting, measuring or recording for diagnostic purposes; Identification of persons
    • A61B5/48Other medical applications
    • A61B5/4848Monitoring or testing the effects of treatment, e.g. of medication
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B2018/00636Sensing and controlling the application of energy
    • A61B2018/00773Sensed parameters
    • A61B2018/00863Fluid flow
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Detecting, measuring or recording for diagnostic purposes; Identification of persons
    • A61B5/02Detecting, measuring or recording pulse, heart rate, blood pressure or blood flow; Combined pulse/heart-rate/blood pressure determination; Evaluating a cardiovascular condition not otherwise provided for, e.g. using combinations of techniques provided for in this group with electrocardiography or electroauscultation; Heart catheters for measuring blood pressure
    • A61B5/026Measuring blood flow
    • A61B5/0261Measuring blood flow using optical means, e.g. infra-red light
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Detecting, measuring or recording for diagnostic purposes; Identification of persons
    • A61B5/20Detecting, measuring or recording for diagnostic purposes; Identification of persons for measuring urological functions restricted to the evaluation of the urinary system
    • A61B5/201Assessing renal or kidney functions
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B8/00Diagnosis using ultrasonic, sonic or infrasonic waves
    • A61B8/06Measuring blood flow

Abstract

A renal denervation system includes a renal denervation catheter and a flow determining system. The renal denervation catheter includes a plurality of ablation members positioned at a distal end portion thereof. The renal denervation catheter is insertable into a renal artery. The flow determining system includes a processor and first and second flow determining members spaced apart on the renal denervation catheter. The processor is configured to determine a change in blood flow through the renal artery resulting from a renal denervation procedure using the renal denervation catheter in response to input from the first and second flow determining members.

Description

FEEDBACK SYSTEMS AND METHODS UTILIZING TWO OR MORE SITES ALONG

DENERVATION CATHETER

CROSS-REFERENCE TO RELATED APPLICATIONS

[0001] The present application claims the benefit of the filing date of U.S. Non- Provisional Patent Application No. 13/840,244 filed March 15, 2013, the disclosure of which is incorporated herein by reference.

TECHNICAL FIELD

[0002] The present disclosure relates generally to renal denervation system and methods, and more particularly, to systems and methods for assessing efficacy of a renal denervation procedure.

BACKGROUND

[0003] Renal denervation is a method whereby amplified sympathetic activities are suppressed. Amplified sympathetic activities and their associated systems are known to contribute to arterial hypertension. Thus, renal denervation is used to treat hypertension or other cardiovascular disorders and chronic renal diseases.

[0004] Renal denervation is achieved through destruction of afferent and efferent nerve fibers that run adjacent to the renal artery, which results in lower blood pressure in a patient. Renal denervation has also been shown to have benefits associated with treatment of heart failure, diabetes, obesity, sleep apnea, and ventricular tachycardia (VT). An established renal denervation procedure involves introducing a radiofrequency (RF) ablation catheter, which ablates renal nerves at 4 to 6 locations. The RF ablation catheter typically uses variable energy up to about 8 Watts. Usually, the operator's objective is to ablate at the lowest power possible for the least amount of time and at the fewest locations. Presently, no feedback mechanisms are available to provide the operator with insight about the efficacy of the renal denervation treatment during the treatment procedure. Thus, it is difficult for the operator to know whether further power and/or ablation locations are needed to accomplish adequate renal denervation.

SUMMARY

[0005] One aspect of the present disclosure relates to a renal denervation system having a renal denervation catheter and a flow determining system. The renal denervation catheter includes a plurality of ablation members positioned at a distal end portion thereof. The renal denervation catheter is insertable into a renal artery. The flow determining system includes a processor and first and second flow determining members spaced apart on the renal denervation catheter. The processor is configured to determine a change in blood flow through the renal artery resulting from a renal denervation procedure using the renal denervation catheter and in response to input from the first and second flow determining members.

[0006] The first flow determining member may include at least one fluid port configured to release a flow of fluid into the renal artery, the second flow determining member may include at least one sensor configured to detect the flow of fluid, and the processor may determine a time delay between releasing the flow of fluid and detecting the flow of fluid prior to and after treating the renal artery with the renal denervation catheter. A difference in the time delay prior to and after treating the renal artery with the renal denervation catheter may correspond to a change in blood flow.

[0007] The first flow determining member may include at least one first electrode and the second flow determining member may include at least one second electrode, and the processor may determine a change in impedance between the at least one first electrode and at least one second electrode, wherein the change in impedance corresponds to the blood flow. The at least one first electrode may include distal and proximal electrodes configured to deliver current, and the at least one second electrode may include at least two middle electrodes spaced between the distal and proximal electrodes and configured to measure voltage.

[0008] The renal denervation catheter may include a basket construction having a plurality of arms, and the plurality of ablation members may be positioned on separate ones of the plurality of arms. The first and second flow determining members may each include at least one pressure sensor, and the first and second flow determining members may be spaced apart along a length of the renal denervation catheter and configured to measure flow pressure within the renal artery. The first and second flow determining members may measure a pressure wave advanced through the renal artery in a first direction and reflected through the renal artery in an opposite second direction. The processor may determine a change in amplitude of the pressure wave reflected through the renal artery.

[0009] The first and second flow determining members may each include at least one wire coil, the first flow determining member may be configured to generate an electromagnetic field to orient dipoles of red blood cells in the blood flow passing through the at least one wire coil of the first flow determining member, and the red blood cells may induce current in the at least one wire coil of the second flow determining member. The renal denervation catheter may operate using one of radiofrequency and ultrasound.

[0010] Another aspect of the present disclosure relates to a method of determining the efficacy of a denervation procedure in a renal artery. The method includes providing a renal denervation catheter and a flow determining system, determining a preliminary flow characteristic of blood flow through the renal artery, ablating the renal artery with the renal denervation catheter as part of a renal denervation procedure, determining a subsequent flow characteristic of blood flow through the renal artery after ablating, and comparing the preliminary flow characteristic with the subsequent flow characteristic to determine a change in blood flow, which corresponds to the efficacy of the renal denervation procedure.

[0011] Determining the preliminary and subsequent flow characteristics may include injecting a flow of fluid into the blood flow at a first location and determining the presence of the flow of fluid at an axially spaced apart second location. Determining the preliminary and subsequent flow characteristics may include determining a change in impedance between at least first and second electrodes of the flow determining system, wherein the change in impedance corresponds to the change in blood flow. Determining the preliminary and subsequent flow characteristics may include determining a change in voltage between at least first and second electrodes of the flow determining system, wherein the change in voltage corresponds to the change in blood flow. Determining the preliminary and subsequent flow characteristics may include sensing with the flow determining system a pressure wave in the blood flow in a first direction and in an opposite second direction. Sensing the pressure wave may include determining an amplitude of the pressure wave. The flow determining system may include first and second coils, wherein the first coil is configured to generate an electromagnetic field that orients dipoles of red blood cells in the blood flow passing through the first coil, and the red blood cells induce a current in the second coil upon passing through the second coil downstream of the first coil.

[0012] Another aspect of the present disclosure relates to a method of determining blood flow in a renal artery during a renal denervation procedure. The method includes performing denervation on the renal artery, determining a blood flow characteristic prior to and after performing renal denervation, comparing the blood flow characteristic determined prior to and after performing renal denervation to determine whether blood flow has increased above a threshold level.

[0013] Determining the blood flow characteristic may include injecting a flow of fluid into the renal artery at a first location and determining the presence of the flow of fluid at a second location downstream of the first location. Determining the blood flow characteristic may include determining a change in impedance between at least first and second electrodes positioned on a renal denervation catheter. Determining the blood flow characteristic may include sensing an amplitude of a pressure wave in the blood flow in a first direction and in an opposite second direction. Determining the blood flow characteristic may include orienting dipoles of red blood cells in the blood flow at a first location, and passing the red blood cells through a coil at a downstream location to induce a current. Determining the blood flow characteristic may occur while a renal denervation catheter, which is used to perform the renal denervation procedure, is positioned in the renal artery.

[0014] The foregoing and other features, utilities, and advantages of the invention will be apparent from the following detailed description of the invention with reference to the accompanying drawings.

BRIEF DESCRIPTION OF THE DRAWINGS

[0015] The accompanying drawings illustrate various embodiments of the present disclosure and are a part of the specification. The illustrated embodiments are merely examples of the present disclosure and do not limit the scope of the invention.

[0016] FIG. 1 is a perspective view of an example renal denervation catheter in accordance with the present disclosure.

[0017] FIG. 2 shows the renal denervation catheter of FIG. 1 positioned in a renal artery. [0018] FIG. 3 is a cross-sectional view of the renal denervation catheter and renal artery of FIG. 2 taken along cross-section indicators 3-3 prior to ablating the renal artery.

[0019] FIG. 4 is a cross-sectional of the renal denervation catheter and renal artery of FIG. 2 taken along cross-section indicators 4-4 after ablating the renal artery.

[0020] FIG. 5 is a perspective view of another example renal denervation catheter in accordance with the present disclosure.

[0021] FIG. 6 shows the renal denervation catheter of FIG. 5 positioned in a renal artery.

[0022] FIG. 7 shows the renal denervation catheter of FIG. 5 positioned in a renal artery and a detectable fluid being injected into the renal artery.

[0023] FIG. 8 shows another example renal denervation catheter in accordance with the present disclosure and positioned within a renal artery with a forward pressure wave present.

[0024] FIG. 9 shows the renal denervation catheter of FIG. 8 positioned in a renal artery with a reflected pressure wave present.

[0025] FIG. 10 is a graph showing a pressure waveform measured at a proximal arterial location, decomposed into forward and reflected pressure waves.

[0026] FIG. 1 1 is a graph showing a pressure waveform measured in a renal artery prior to ablation, decomposed into forward and reflected pressure waves.

[0027] FIG. 12 is a graph showing a pressure waveform measured in a renal artery after ablation, decomposed into forward and reflected pressure waves.

[0028] FIG. 13 shows an example blood alignment member in accordance with the present disclosure.

[0029] FIG. 14 shows the blood alignment member of FIG. 13 retained in a carrier tube. [0030] FIG. 15 shows another example blood alignment member positioned in a carrier tube in accordance with the present disclosure.

[0031] FIG. 16 shows the blood alignment member of FIG. 15 removed from the carrier tube and having a pair of expandable coils in an unexpanded position.

[0032] FIG. 17 shows the blood alignment member of FIG. 16 with the pair of expandable coils in an expanded position.

[0033] FIG. 18 schematically shows a plurality of red blood cells flowing through a renal artery and coils of one of the blood alignment members of FIGS. 13-17.

[0034] FIG. 1 shows the blood alignment member of FIG. 13 and a renal denervation catheter positioned in a vessel in a renal artery.

[0035] FIG. 20 shows the blood alignment member of FIG. 19 in a coiled position in the renal artery.

[0036] FIG. 21 shows the blood alignment member of FIG. 20 retracted into the carrier tube and the renal denervation catheter expanded to provide ablation of the renal artery.

[0037] FIG. 22 shows the renal denervation catheter withdrawn and the blood alignment member in a coiled position.

[0038] FIG. 23 shows an integrated renal denervation catheter and blood alignment member in accordance with the present disclosure.

[0039] Throughout the drawings, identical reference numbers designate similar, but not necessarily identical, elements.

DETAILED DESCRIPTION

[0040] The systems and methods disclosed herein are directed to aspects of renal denervation in a patient. The principles disclosed herein may be applicable to other systems and methods used for treating other aspects of the body, including, for example, any portion of the gastrointestinal, cardiovascular, nervous, hormonal, respiratory, excretory and reproductive systems of the body.

[0041] Renal denervation includes ablation of the renal artery using an ablation catheter. The systems and methods disclosed herein are used to provide feedback to an operator concerning the efficacy of the renal denervation procedure. The feedback may be given during the procedure, such as after ablating the renal artery while the ablation catheter is still positioned within the renal artery. It will be appreciated that the systems and methods disclosed herein may be applicable to other procedures involving ablation and other types of renal denervation procedures.

[0042] The general structure and function of renal denervation catheters used for ablating tissue in the renal artery are well known in the art. The principles disclosed herein may be useful in conjunction with various renal denervation catheters and methods of conducting renal denervation procedures. One procedure for renal denervation includes introducing a radio frequency ablation catheter into the renal artery and ablating renal nerves at several locations using variable energy up to, for example, about 8 Watts. The locations may be determined by a plurality of pre-positioned ablation members arranged in contact with an interior surface of the renal artery at various axially and circumferentially spaced apart locations. The ablation catheter may be repositioned axially and circumferentially at various locations in the renal artery to perform multiple ablations. In other examples, a single ablation member is moved to a plurality of axial and circumferential positions within the renal artery to ablate the renal nerves. Multiple series of stimulating, measuring and ablating may be used to confirm efficacy of the denervation procedure. Further, there may not be direct communication between any specific electrodes. [0043] The renal denervation catheters of the present disclosure may provide feedback mechanisms for determining the efficacy of the procedure while the procedure is ongoing (i.e. , feedback in real time), or at least while the renal denervation device is positioned within the patient. The devices and methods disclosed herein provide for measuring the effect of renal denervation using two or more sites along a length of the renal artery (e.g., along the length of a renal denervation catheter or renal denervation system component). The systems and methods may be used to determine flow characteristics in blood flow through the renal artery pre-ablation and post-ablation, and compare those flow characteristics to determine the efficacy of the renal denervation procedure.

[0044] In a first example, described with reference to FIGS. 1-4, a plurality of electrodes may be placed along the length of a renal denervation catheter, and impedance is measured between the electrodes before and after a denervation procedure during which the renal artery is ablated. Since vasodilation should occur due to the ablation, the impedance should decrease after the ablation occurs. In one example, four electrodes are spaced apart along a length of the renal denervation catheter. The distal-most and proximal-most electrodes may be used to deliver current, and the middle electrodes, which are positioned axially between the distal-most and proximal-most electrodes, may be used to measure voltage for the impedance measurement. As the renal artery dilates in response to a renal denervation procedure, more blood surrounds the electrodes and the electrodes have reduced contact with the inner surface of the renal artery, thereby causing a decrease in impedance.

[0045] FIG. 1 shows an example renal denervation catheter 10 having a catheter shaft 12, a deployable basket 14, ablation electrodes 16A,B, impedance electrodes 18A-C, a controller 20, and a hub 22. The deployable basket 14 may be operable between retracted and expanded positions. When in the expanded position, the deployable basket 14 positions the ablation electrodes 16A,B and impedance electrodes 18A-C in contact with an inner surface of a renal artery. The controller 20 may control the ablation electrodes 16A,B and impedance electrodes 18A-C to perform a renal denervation procedure by ablating renal nerves associated with the renal artery, and determine efficacy of the renal denervation procedure using a change in impedance. The controller 20 may be referred to as or include a processor or microprocessor. The ablation electrodes 16A,B may include radio frequency (RP) electrodes. In other embodiments, the ablation electrodes 16 may include other types of energy sources such as, for example, ultrasound electrodes, laser, cryothermal, and microwave energy sources.

[0046] The catheter shaft 12 may include distal and proximal ends 30, 32. A deployable basket 14 may include a plurality of splines 40A-D, distal and proximal ends 42, 44, and a pull wire 46. The deployable basket 14 may be operable between a retracted position and the expanded position shown in FIG. 1 by applying a tension force in the pull wire 46 while maintaining the proximal end 44 fixed relative to the catheter shaft 12. The ablation electrodes 16A,B and impedance electrodes 18A-C may be mounted to the splines 40A-D. In one example, one ablation electrode and one impedance electrode are mounted to each of the splines 40A-D. The ablation electrodes 16A,B may be positioned at spaced apart locations along a length of the deployable basket 14 and at circumferentially spaced apart locations. Likewise, the impedance electrodes 18A-C may be positioned at axially spaced apart locations along the length of the deployable basket 14 and at circumferentially spaced apart locations.

[0047] The ablation electrodes 16A,B may operate to deliver energy in the form of, for example, heat to a sidewall of the renal artery and renal nerves positioned within a sidewall and along an exterior surface of the renal artery. Varying an amount of energy delivered to the ablation electrode 16A,B and repositioning the deployable basket 14 at various locations axially and circumferentially within the renal artery may provide customized denervation of the renal artery and associated renal nerves.

[0048] The impedance electrodes 18A-C may be used to determine a change in impedance prior to and after denervation using the ablation electrodes 16A,B. In one example, one distal impedance electrode 18A and one proximal impedance electrode 18B are positioned at proximal and distal ends of the dep lovable basket 14, and a pair of middle impedance electrodes 18C may be positioned axially between the distal and proximal impedance electrodes 18A,B. IN other embodiments, multiple distal impedance electrodes 18 A, multiple proximal impedance electrodes 18B, and any number of middle impedance electrodes 18C (e.g., only a single middle electrode 16C) may be used. The impedance electrodes 18A-C may be positioned on any one of the plurality of splines 40A-D, such as being positioned on separate ones of the splines 40A-D or consolidated on only some of the splines 40A-D. The distal and proximal impedance electrodes 18A,B may have a current delivered to them, and the middle impedance electrodes 18C may be used to measure voltage for an impedance measurement.

[0049] In other examples, the ablation electrodes 16A,B may also be used to deliver the current and measure voltage used for the impedance measurement. In some examples, four electrodes may be used to generate an impedance measurement. However, in other examples, any number of electrodes may be used, such as, for example, the four impedance electrodes 18A-C shown in FIGS. 1-4, eight electrodes {e.g., a combination of the ablation electrodes 16A,B and impedance electrodes 18A-C), or any other number of electrodes.

[0050] FIG. 2 shows the renal denervation catheter 10 advanced through the aorta 90 and into the renal artery 92. The deployable basket 14 may be positioned in the renal artery 92 upstream from the kidney 94 and downstream of an ostium 98 of the renal artery 92. A plurality of renal nerves 96 may extend along an exterior surface of the renal artery 92 and may be positioned at least partially within the sidewall of the renal artery 92. The deployable basket 14 may be expanded to contact the ablation electrodes 16A,B and impedance electrodes 18A-C against an inner surface 99 of the renal artery 92. Current may be delivered to some of the impedance electrodes 18A-C while other of the impedance electrodes 18A-C may be used to measure voltage for calculating an impedance measurement. The impedance measurement may be stored (e.g. , using the controller 20) and compared to future calculated impedance measurements.

[0051] The operator may operate the ablation electrodes 16A,B to ablate the renal artery 92 and associated renal nerves 96. The ablation may be part of a renal denervation procedure. The ablation electrodes 16A,B may be controlled using the controller 20. Operating the ablation electrodes 16A,B may include, for example, controlling an amount of energy delivered to the electrodes, controlling a duration of application of energy, and determining a temperature of the electrode.

[00521 After the renal denervation using ablation electrodes 16A,B, current is again delivered to some of the impedance electrodes 18A-C while other of the impedance electrodes 18A-C measure voltage, which is used for determining a second impedance measurement. The second impedance measurement is compared to the first impedance measurement, which was determined prior to ablating. If the change in impedance falls within a certain range, or the absolute value of the second impedance measurement meets a threshold value, the renal denervation procedure may be considered successful. If the change in impedance or absolute value of the second impedance measurement does not meet predetermined values, the operator may choose to deliver additional energy to the ablation electrodes 16 A,B for a second ablation. The second ablation may occur in the same position as the first ablation, or the operator may move the ablation electrodes 16A,B into different axial or circumferential positions within the renal artery 92 and then conduct further ablation with the ablation electrodes 16A,B. Further impedance measurements may be made using the impedance electrodes 18A-C after the second ablation to determine whether the renal denervation procedure has been successful. The success or efficacy of the renal denervation procedure may be determined during the denervation procedure generally, such as when the renal denervation catheter 10 is positioned within the renal artery 92.

[0053] FIG. 3 shows the impedance electrodes 18A-C prior to ablation. The impedance electrodes 18A-C may be in contact with the inner surface 99 of the renal artery 92. After ablation and successful renal denervation, there may be increased blood flow around the impedance electrodes 18A-C resulting from, for example, the impedance electrodes 18 A-C moving out of contact with the inner surface 99 of the renal artery 92 or an increased volume of blood flow through the renal artery 92. The separation of the impedance electrodes 18A-C from the inner surface 99 after successful renal denervation may reduce impedance between the impedance electrodes 18 A-C. The reduced impedance may also result from increased blood flow through the renal artery 92. Increased blood flow may result from reduced sympathetic tone and increased vasodilation in the renal artery and the glomerular capillaries and adjacent arterials associated with the kidney.

[0054] Other steps associated with the renal denervation procedure described with reference to FIG. 2 may include stimulating the renal nerves 96 prior to determining an impedance measurement and ablating the renal artery 92. The stimulation may be achieved by positioning the deployable basket 14 within the renal artery 92 adjacent to the ostium 98. The deployable basket 14 may be expanded to position the ablation electrodes 16A,B in contact with the inner surface 99 of the renal artery 92. Energy is supplied via the ablation electrode 16A,B to stimulate the renal nerves 96 without ablating. This electrode stimulation may generate a physiological response in the kidney 94 such as, for example, the increased production of rennin. After the operator determines that a successful renal denervation procedure has occurred using a change of impedance before and after ablating the renal artery 92 (e.g., as described above with reference to FIG. 2), the operator may again stimulate the renal nerves 96 by positioning the expanded deployable basket 14 at the ostium 98 and supplying an electrical stimulation to the renal nerves 96. If the renal denervation procedure was successful, there may be little or no physiological response from the kidneys resulting from the electrical stimulation.

[0055] The impedance-related devices and methods described with reference to FIGS. 1-4 may be extended into an approach of using two separate sites. In this example, a pulsatile impedance waveform may be used to decide the propagation of velocity pre-ablation and post-ablation. For example, the time delay of dZ/dtmax at the two sites (e.g., distal and proximal ends on the deployable basket 14 where Z is an impedance measurement) pre- ablation and post-ablation may be used to assess flow velocity pre-renal denervation and post-renal denervation. The flow velocity may be used to measure the ablation outcome together with other parameters.

[0056] Referring now to FIGS. 5-7, another example system and method for renal denervation is shown and described. The renal denervation catheter 100 shown in FIGS. 5-7 includes at least one port for injecting a substance into a blood flow B in the renal artery 92, and a sensor positioned downstream of the port to determine the presence of the substance in the blood flow B. The sensor may include, for example, one of an optical sensor, a chemical sensor, and a Doppler sensor. The substance may include, for example, a contrast agent or fluid having certain physical or chemical properties that are detectable within the blood flow. Prior to ablating the renal artery as part of a renal denervation procedure, the substance may be injected into the blood stream, with the downstream sensor detecting the presence of the substance within a measureable time period after the injection. After ablating the renal artery, the substance is again injected into the blood flow, with the sensor again detecting the presence of the substance within a measureable time period after the injection. The time period before and after ablation are compared. If the change in time or an absolute value of the amount of time after ablation meets a threshold value, the operator may determine whether the ablation and associated denervation is sufficient.

[0057] Referring to FIG. 5, a renal denervation catheter 100 includes a catheter shaft 1 12, a deployable basket 1 14, a plurality of ablation electrodes 1 16A,B, a controller 120 and a hub 122. The catheter shaft 112 includes distal and proximal ends 130, 132, and a lumen 134. The deployable basket 1 14 includes a plurality of splines 140A-D, distal and proximal ends 142, 144, and a pull wire 146. The renal denervation catheter 100 may include a sensor 150 positioned downstream of the distal opening of the lumen 134 {e.g., at the distal end 130). The sensor 150 may include any of a number of different types of sensors including, for example, an optical sensor, a chemical sensor, and a Doppler sensor. The sensor 150 may operate to determine presence of a substance that is injected into the blood flow from the lumen 134 of catheter shaft 1 12. The lumen 134 may be in flow communication with a port 124 on hub 122. The lumen 134 may include a distal port near the distal end 130 of catheter shaft 1 12. The substance may include, for example, a contrast agent or other fluid that is detectable by the sensor 150.

[0058] The sensor 150 may be positioned at any desirable location. In one example, the sensor 150 is positioned at the distal end 142 of the deployable basket 1 14. The sensor may be positioned at other locations such as, for example, on one or more of the splines 140A-D or the pull wire 146. The sensor may be positioned on the catheter shaft and an outlet port for the substance S to be injected into the renal artery is positioned upstream of the sensor. The sensor may communicate its measurements back to the controller (e.g., controller 20) or directly to the operator. The sensor may be connected using, for example, a hardwire connection or a wireless communication such as radio frequency (RF).

[0059] Referring to FIG. 6, the renal denervation catheter 100 is positioned in a renal artery 92 as part of a renal denervation procedure. The substance S is injected into the renal artery 92 and flows downstream with the blood flow B as shown in FIG. 7. The sensor 150 detects the presence of substance S. A time period Tj for the substance S to travel from the port in lumen 134 to the sensor 150 is determined and stored for comparison to future determined time periods. Thereafter, the ablation electrodes 116A,B are operated to ablate the renal artery 92 and associated renal nerves. The substance S is again injected into the blood flow B and detected downstream with the sensor 150. A second time period T2 is determined for travel of the substance S from the point of injection until being sensed by the sensor 150. The times T] and T2 are compared to determine a ΔΤ. If ΔΤ meets a threshold value, the renal denervation may be considered successful. Alternatively, if T2 meets a certain predetermined absolute value, the renal denervation procedure may be considered successful. Thereafter, the operator may remove the renal denervation catheter 100 from the renal artery 92. If ΔΤ or T2 do not meet threshold values, the operator may choose to conduct further ablation of the renal artery 92 followed by additional measurements of ΔΤ and T.

[0060] The time period between injecting the substance S and detecting the substance S with sensor 150 may be based at least in part on a time at which the substance S is initially injected into lumen 134 at port 124 as opposed to when the substance S is injected out of the lumen 134 into the blood flow B. The distance between the sensor 150 and a distal port of the lumen 134 where the substance is injected may have a distance X as shown in FIG. 5. The distance X may vary depending on, for example, the sensitivity of the sensor 150 or the type of substance S being used. The distal port for lumen 134 may be positioned at the distal end 130, or may be positioned along a portion of the catheter shaft 112 that is positioned within the renal artery 92 during the renal denervation procedure.

[0061] It is expected that there will be an increase in blood flow after the renal denervation procedure, which results in an increase in mean or peak velocity of blood flow. Therefore, the time T for detecting the substance S should decrease by a certain amount after ablation. There may be a threshold by which ΔΤ or T2 decreases in order for the ablation to be considered effective. In one example, the sensor is a near-infrared spectroscopy (NIRS) optical sensor, and the substance S includes incyanine green (ICG) or another contrast agent such as SIDAG (1 ,l (')-bis-(4-sulfobutyl) indotricarbocyanine-5,5(')-dicarboxylic acid diglucamide monosodium salt).

[0062] Prior to renal denervation, the substance is injected {e.g., as a contrast agent) through the distal port of lumen 134 at a time A. The substance is then detected by the sensor 150 at a time B. The time T\ for the substance to travel from the port to the sensor 150 is the time B minus the time A. After renal denervation, the substance may be injected and a time T2 determined using the sensor 150. The times Ti and T2 are compared to determine ΔΤ as described above.

[0063] Referring now to FIGS. 8-12, another example system and method for renal denervation is described. In this example, a pressure wire or other pressure sensor is used to measure the morphology of a traveling pressure wave in the renal artery. The pressure wave at any given point along an artery may include a forward wave caused by the force of ejection from the left ventricle (LV) into a close system of tubes, along with a delayed reflection wave that results from the forward wave meeting a resistance of glomerular capillaries and adjacent arterioles. The arterial pressure wave form at any location may be represented as a superimposed sum of forward and reflected pressure waves. [0064] FIG. 8 shows a renal denervation catheter 200 positioned within a renal artery 92. The renal denervation catheter 200 includes a catheter shaft 212, a deployable basket 214, a plurality of ablation electrodes 216A,B and a pressure sensor 252. A forward pressure wave 254 advances through the renal artery 92 in the direction of blood flow B. FIG. 9 shows a reflected pressure wave 256 traveling in a direction opposite the blood flow B. The pressure sensor 252 may detect the forward pressure wave 254 and reflected pressure wave 256. A pressure wave form 250 may be determined as a sum of the absolute value of the forward and reflected pressure wave 254, 256.

[0065] FIG. 10 is a graph showing the forward and reflected pressure waves 254, 256 that are present at a proximal location in the aorta. The pressure wave form 258 in the aorta has a generally high value over time.

[0066] FIG. 11 is a graph showing the forward and reflected pressure waves 254, 256 and pressure wave form 258 in the renal artery 92 prior to renal denervation. The reflected pressure wave 256 has a relatively high value due to the resistance of blood flow through the renal artery and downstream blood flow paths in the kidney.

[0067] FIG. 12 is a graph showing the forward and reflected pressure waves 254, 256 and pressure wave form 258 in the renal artery 92 after renal denervation. The pressure wave form 258 is generally lower than what is shown in FIG. 11 because the reflected pressure wave 256 is generally smaller as compared to the reflected pressure present prior to the renal denervation. Successful renal denervation typically provides a decrease in sympathetic tone of the renal artery 92 and other downstream vessels. The decrease in sympathetic tone may provide dilation of the vessels and a decrease in resistance to blood flow, which correlate with a reduced amplitude reflected pressure wave 256.

[0068] A comparison of the pressure wave form 258 prior to and after renal denervation may provide an indication of the efficacy of the renal denervation procedure. An operator may determine based on a change in the pressure wave form 258 or an absolute value of the pressure wave form 258 at various points in time (e.g., at the peaks of reflected pressure wave 256) whether the renal denervation procedure is sufficient. Upon successful renal denervation, arteries, arterioles and capillaries will undergo vasodilation, thus diminishing the amplitude and abruptness of the reflected wave 256.

[0069] A comparison of the graphs in FIGS. 10 and 1 1 shows that the reflected pressure wave 256 reaches a proximal site in the aorta at a time ti, which is greater than the amount of time to reach a more distal side in the renal artery at a time t2. A comparison of FIGS. 11 and 12 also shows that the reflected pressure wave 256 has a greater peak pressure Pi prior to renal denervation than the peak pressure P2 after the renal denervation. In some examples, the peak pressure values Pi, P2 of the reflected pressure wave 256 for the times ti, t2 may be compared rather than comparing the pressure wave form 258 in order to determine the efficacy of the renal denervation procedure.

[0070] If the amplitude of the reflected pressure wave 256 drops by an absolute amount or a certain percentage of the initial amplitude Pi, renal denervation may be considered successful. Alternatively, the change may be quantified by assessing the morphology of the reflected wave using any non-morphology assessment method. In at least some examples, the pressure waveform and corresponding forward and reflected waves may be measured by a photoplethysmographic (PPG) sensor that calculates pressure using optical absorption at visible and near-infrared wavelengths or another pressure sensor.

[0071] Referring now to FIGS. 13-22, a further example system and related methods for renal denervation are disclosed. In this example, the renal denervation catheter includes at least two coils, spirals or loops (generally referred to as "coils" herein) positioned at spaced apart locations along the length of the catheter body. These coil features may be straightened or otherwise retained in a reduced profile shape during insertion of the catheter into the renal artery, and then may be deployed once the catheter is positioned within the renal artery. The proximal coil may be electrically charged to create an electromagnetic field, which aligns the dipoles of red blood cells (RBCs) within the blood flood B in the renal artery. Depending on the speed and turbulence of the blood flow B in a renal artery, some decay or randomness to the alignment of dipoles occurs. The net alignment of all the RBCs in the sample volume is detected as it passes through the distal coil by inducing a current that may be measurable. The amplitude of the measured current is adversely proportionate to the alignment of the RBC dipoles. Faster, and therefore more turbulent, renal artery blood flood B results in RBCs becoming less aligned and therefore capable of generating less current in the distal coil or loop. Since increases in renal blood flow may be considered a target of the renal denervation procedure, the absolute decrease or ratio metric decrease in current from pre-ablation to post-ablation may be used to determine the efficacy of the renal denervation procedure.

[0072] FIGS. 13 and 14 show a blood alignment member 360A for use in a renal denervation procedure. The blood alignment member 360 A may be referred to as a renal denervation catheter or a component of a renal denervation system. The blood alignment member 360A may include a distal tip 362, first and second loops 364, 366 (also referred to as coils— see FIG. 13), and a carrier tube 368 configured to hold the blood alignment member 360A in a straight, uncoiled orientation {i.e., without first and second loops 364, 366) during delivery into the renal artery. A controller or processor may be associated with the blood alignment member 360A.

[0073] Once the blood alignment member 360A is positioned within the renal artery, the carrier tube 368 may be withdrawn and the blood alignment member 360A may move into a coiled orientation to create the first and second loops 364, 366. In one example, the blood alignment member 360 A includes a shape memory material such as, for example, Nitonol. In other examples, the blood alignment member 360A includes a temperature- activated material. In such an example, the blood alignment member 360 A has a relatively straight orientation when in a cooled state (e.g., a temperature less than a threshold temperature), and moves into a preformed, shaped orientation after being heated above a threshold temperature. The heating of the blood alignment member 360 A may result from heat transfer from the blood or vessel wall. The operator may have a certain amount of time (e.g., three to four minutes) to insert the blood alignment member 360A through the aorta and into the renal artery, whereupon the blood alignment member 360 A is heated above the threshold temperature and automatically returned to an original form having the first and second loops 364, 366.

[0074] The second loop 366 may be configured to create an electromagnetic field within the renal artery. The second loop 366 may define an opening through which the blood flow B passes. The electromagnetic field may orient the dipoles of the RBCs in a certain direction (e.g., longitudinally). The blood flow B flows downstream and passed through an opening formed in the first loop 364. The first loop 364 may have a current induced therein upon passage of the oriented RBCs. The less oriented the RBCs are when passing through the first loop 364, the less current may be induced. Thus, the greater the velocity and turbulence of the blood flow B, the less current is induced in the first loop 364.

[0075] Referring to FIGS. 15-17, another example blood alignment member 360B is shown including first and second expandable coils 370, 372. The coils 370, 372 may be held in a restricted or contracted position using the carrier tube 368. Once the blood alignment member 360B is positioned within the renal artery, the carrier tube 368 may be withdrawn to expose the first and second expandable coils 370, 372 as shown in FIG. 16. The coils 370, 372 may expand automatically after withdrawing the carrier tube 368. Alternatively, the blood alignment member 360B may include other features (e.g., an expandable balloon) that expand the coils 370, 372 to an expanded or open position.

[0076] Once the first and second expandable coils 370, 372 are in an expanded position, an opening may be defined through the first and second expandable coils 370, 372 for passage of the blood flow B. The second coil 372 may be energized to create an electromagnetic field. Blood passing through the electromagnetic field may orient the dipoles of the RBCs in a predetermined orientation. The blood flow may pass through the first coil 370 and induce current therein due to the oriented RBCs. As described above, the more oriented the RBCs are in a common direction, the greater the current induced in first coil 370. The more turbulent the blood flow and the greater the velocity of the blood flow, the less the RBCs are oriented (e.g., are considered more random in their orientation) and thus less current is induced in first coil 370. A change in the amount of induced current in first coil 370 prior to and after the renal denervation procedure may help assess the efficacy of the renal denervation procedure.

[0077] The result of using the blood alignment members 360A, 360B in a renal artery 92 is shown schematically in FIG. 18. A plurality of randomly oriented blood cells Ri in the blood flow B pass through the second loop 366. The second loop 366 may produce an electromagnetic field that orients the RBCs to form a plurality of oriented blood cells R2. Depending on the speed and turbulence of the blood flow B between loops 366 and 364, the RBCs may change into a more random orientation as shown in the blood cells R3. The blood cells R3 pass first through first loop 364 to induce a current in the first loop 364.

[0078] Referring now to FIGS. 19-22, an example method of renal denervation in assessing the efficacy of renal denervation is described. FIG. 19 shows the blood alignment member 360 A positioned within a renal artery 92 downstream of a renal denervation catheter 300. The renal denervation catheter 300 may be operated to expand the deployable basket 314. The carrier tube 368 is withdrawn and the first and second loops 364, 366 are formed within the renal artery 92. Blood flow B passes through the second loop 366 to orient the RBCs, as shown in FIG. 20. The blood flow B passes through the first loop 364 to induce current in the first loop 364. The amount of induced current is measured and saved.

[0079] Referring to FIG. 21, the carrier tube 368 is advanced to remove the first and second loops 364, 366, and the blood alignment member 360A is positioned proximal of the renal denervation catheter 300. The renal denervation catheter 300 is operated to expand the deployable basket 314 thereby positioning the ablation electrodes 316A,B in contact with an inner surface 99 of the renal artery 92. The ablation electrodes 316A,B are operated to ablate the renal artery 92 and associated renal nerves as part of a renal denervation procedure.

[0080] FIG. 22 shows the deployable basket 314 contracted and the blood alignment member 360A positioned distal of the renal denervation catheter 300. The blood alignment member 360 A is withdrawn and the first and second loops 364, 366 are formed within the renal artery 92. The blood flow B again passes through the second loop 366 to orient the RBCs, as shown in FIG. 22. The blood flow B then passes through the first loop 364 to generate a current in the first loop 364. The current is measured and compared to the current generated in first loop 364 prior to ablation in the steps discussed above with reference to FIG. 20. A change in induced current or an absolute value of the current induced post-ablation may be compared to threshold values. If the values meet the threshold values, the renal denervation resulting from ablation described with reference to FIG. 21 may be considered sufficient. If further ablation is needed, the step described with reference to FIG. 21 may be repeated as needed, followed by again measuring the induced current in first loop 364 as described with reference to FIG. 22. The induced current in any subsequent steps may be compared to any of the previously induced currents to help determine the efficacy of the renal denervation procedure. [0081] While the renal denervation system described with reference to FIGS. 15- 22 includes a separate blood alignment member and a renal denervation catheter, other embodiments are possible in which the renal denervation catheter includes features of the blood alignment member. For example, the first and second loops 364, 366 may be formed in the catheter shaft 312 proximal of the deployable basket 314. In another example, the first and second expandable coils 370, 372 may be carried by the catheter shaft 312 at a location proximal of the deployable basket 314. FIG. 23 shows an example renal denervation catheter having features of the blood alignment member 360A.

[0082] The renal denervation catheter 400 shown in FIG. 23 includes a catheter shaft 412 having first and second loops 464, 466 formed therein, and a deployable basket 414 carrying a plurality of ablation electrodes 416A,B. The first and second loops 464, 466 may remain positioned in the renal artery 92 prior to, during and after operating the ablation members carried by the deployable basket 414 to provide renal denervation. A controller or processor (e.g., controller 20 described above) may be used with the renal denervation catheter 400.

[0083] The various systems and methods disclosed herein may provide feedback during a renal denervation procedure to help minimize the number of ablation sites, time and energy required for each ablation. The systems and methods may determine a change in blood flow rate using injection of contrast in renal arteries to determine efficacy of the ablation. An impedance measurement in a renal artery may provide indication of the degree of vessel distention. Decomposition of a pressure wave form into forward and reflected waves prior to and after renal denervation may be used to determine efficacy of the renal denervation procedure. The catheter designs in accordance with the present disclosure may allow for blood flow through the catheter while maintaining contact with the vessel wall, and characteristics of the blood flow may be used to help determine efficacy of the renal denervation. The devices and methods disclosed herein may provide alignment of RBCs as an indicator of turbulence in the blood flow, and thus changes in blood flow correlating to the efficacy of the renal denervation procedure.

[0084] As used in this specification and the appended claims, the terms "engage" and "cngagablc" are used broadly to mean interlock, mesh, or contact between two structures or devices. A "tube" is an elongated device with a passageway. A "lumen" refers to any open space or cavity in a bodily organ, especially in a blood vessel. The words "including" and "having," as well as their derivatives, as used in the specification, including the claims, have the same meaning as the word "comprising."

[0085] The preceding description has been presented only to illustrate and describe exemplary embodiments of the invention. It is not intended to be exhaustive or to limit the invention to any precise form disclosed. Many modifications and variations are possible in light of the above teaching. It is intended that the scope of the invention be defined by the following claims.

Claims

WHAT IS CLAIMED IS:
1. A renal denervation system, comprising:
a renal denervation catheter having a plurality of ablation members positioned at a distal end portion thereof and being insertable into a renal artery;
a flow detennining system, comprising:
first and second flow determining members spaced apart on the renal denervation catheter;
a processor configured to determine a change in blood flow through the renal artery resulting from a renal denervation procedure using the renal denervation catheter and in response to input from the first and second flow determining members.
2. The renal denervation system of claim 1, wherein the first flow determining member comprises at least one fluid port configured to release a flow of fluid into the renal artery, the second flow determining member comprises at least one sensor configured to detect the flow of fluid, and the processor determining a time delay between releasing the flow of fluid and detecting the flow of fluid prior to and after treating the renal artery with the renal denervation catheter.
3. The renal denervation system of claim 2, wherein a difference in the time delay prior to and after treating the renal artery with the renal denervation catheter corresponds to a change in blood flow.
4. The renal denervation system of claim 1, wherein the first flow determining member comprises at least one first electrode and the second flow determining member comprises at least one second electrode, and the processor determines a change in impedance between the at least one first electrode and the at least one second electrode, the change in impedance corresponding to the blood flow.
5. The renal denervation system of claim 4, wherein the at least one first electrode includes distal and proximal electrodes configured to deliver current, and the at least one second electrode includes at least two middle electrodes spaced between the distal and proximal electrodes and configured to measure voltage.
6. The renal denervation system of claim 1, wherein the renal denervation catheter comprises a basket construction having a plurality of arms, and the plurality of ablation members are positioned on separate ones of the plurality of arms.
7. The renal denervation system of claim 1, wherein the first and second flow determining members each comprising at least one pressure sensor, the first and second flow determining members being spaced apart along a length of the renal denervation catheter and configured to measure flow pressure within the renal artery.
8. The renal denervation system of claim 7, wherein the first and second flow determining members measure a pressure wave advanced through the renal artery in a first direction and reflected through the renal artery in an opposite second direction.
9. The renal denervation system of claim 8, wherein the processor determines a change in amplitude of the pressure wave reflected through the renal artery.
10. The renal denervation system of claim 1, wherein the first and second flow determining members each comprises at least one wire coil, the first flow determining member configured to generate an electromagnetic field to orient dipoles of red blood cells in the blood flow passing through the at least one wire coil of the first flow determining member, the red blood cells inducing current in the at least one wire coil of the second flow determining member.
11. The renal denervation system of claim 1, wherein the renal denervation catheter operates using one of radiofrequency and ultrasound.
12. A method of determining efficacy of a renal denervation procedure in a renal artery, comprising:
providing a renal denervation catheter and a flow determining system;
determining a preliminary flow characteristic of blood flow through the renal artery; ablating the renal artery with the renal denervation catheter as part of a renal denervation procedure;
determining a subsequent flow characteristic of blood flow through the renal artery after ablating;
comparing the preliminary flow characteristic with the subsequent flow characteristic to determine a change in blood flow, which corresponds to efficacy of the renal denervation procedure.
13. The method of claim 12, wherein determining the preliminary and subsequent flow characteristics includes injecting a flow of fluid into the blood flow at a first location and determining a presence of the flow of fluid at an axially spaced apart second location.
14. The method of claim 12, wherein determining the preliminary and subsequent flow characteristics includes determining a change in impedance between at least first and second electrodes of the flow determining system, the change in impedance corresponding to the change in blood flow.
15. The method of claim 12, wherein determining the preliminary and subsequent flow characteristics includes determining a change in voltage between at least first and second electrodes of the flow determining system, the change in voltage corresponding to the change in blood flow.
16. The method of claim 12, wherein determining the preliminary and subsequent flow characteristics includes sensing with the flow determining system a pressure wave in the blood flow in a first direction and in an opposite second direction.
17. The method of claim 16, wherein sensing the pressure wave includes determining an amplitude of the pressure wave.
18. The method of claim 12, wherein the flow determining system includes first and second coils, the first coil configured to generate an electromagnetic field that orients dipoles of red blood cells in the blood flow passing through the first coil, the red blood cells inducing a current in the second coil upon passing through the second coil downstream of the first coil.
19. A method of determining blood flow in a renal artery during a renal denervation procedure, the method comprising: performing renal denervation on the renal artery;
determining a blood flow characteristic prior to and after performing renal denervation;
comparing the blood flow characteristic determined prior to and after performing renal denervation to determine whether blood flow has increased above a threshold level.
20. The method of claim 1 , wherein determining the blood flow characteristic includes injecting a flow of fluid into the renal artery at a first location and determining a presence of the flow of fluid at a second location downstream of the first location.
21. The method of claim 19, wherein determining the blood flow characteristic includes determining a change in impedance between at least first and second electrodes positioned on a renal denervation catheter.
22. The method of claim 19, wherein determining the blood flow characteristic includes sensing an amplitude of a pressure wave in the blood flow in a first direction and in an opposite second direction.
23. The method of claim 19, wherein determining the blood flow characteristic includes orienting dipoles of red blood cells in the blood flow at a first location, and passing the red blood cells through a coil at a downstream location to induce a current.
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