Source: https://patents.google.com/patent/US20140188103A1/en
Timestamp: 2019-10-24 00:47:51
Document Index: 21420579

Matched Legal Cases: ['Application No. 61', 'art 390', 'art 395', 'art 390', 'art 390', 'art 395', 'art 390', 'art 395', 'art 395', 'arts 930', 'art 395', 'arts 980', 'arts 985', 'arts 990']

US20140188103A1 - Methods and Apparatus for Neuromodulation Utilizing Optical-Acoustic Sensors - Google Patents
Methods and Apparatus for Neuromodulation Utilizing Optical-Acoustic Sensors Download PDF
US20140188103A1
US20140188103A1 US14/139,523 US201314139523A US2014188103A1 US 20140188103 A1 US20140188103 A1 US 20140188103A1 US 201314139523 A US201314139523 A US 201314139523A US 2014188103 A1 US2014188103 A1 US 2014188103A1
US14/139,523
2012-12-31 Priority to US201261747939P priority Critical
2013-12-23 Application filed by Volcano Corp filed Critical Volcano Corp
2013-12-23 Priority to US14/139,523 priority patent/US20140188103A1/en
2013-12-26 Assigned to VOLCANO CORPORATION reassignment VOLCANO CORPORATION ASSIGNMENT OF ASSIGNORS INTEREST (SEE DOCUMENT FOR DETAILS). Assignors: MILLETT, Bret C.
2014-07-03 Publication of US20140188103A1 publication Critical patent/US20140188103A1/en
206010007558 Cardiac failure chronic Diseases 0 description 5
208000004990 Cardio-Renal Syndrome Diseases 0 description 1
206010007654 Cardiovascular injuries Diseases 0 description 1
206010020772 Hypertension Diseases 0 description 24
206010022489 Insulin resistance Diseases 0 description 2
210000003734 Kidney Anatomy 0 description 47
102100000775 REN Human genes 0 description 7
210000002254 Renal Artery Anatomy 0 description 49
206010038444 Renal failure chronic Diseases 0 description 7
206010061481 Renal injury Diseases 0 description 1
206010063897 Renal ischaemia Diseases 0 description 2
108090000783 Renin Proteins 0 description 7
206010041277 Sodium retention Diseases 0 description 4
210000002820 Sympathetic Nervous System Anatomy 0 description 20
239000000219 Sympatholytics Substances 0 description 1
230000002638 denervation Effects 0 description 10
238000002608 intravascular ultrasound Methods 0 description 14
230000035766 natriuresis Effects 0 description 1
230000004007 neuromodulation Effects 0 abstract claims description title 40
230000012495 positive regulation of renal sodium excretion Effects 0 description 1
230000029865 regulation of blood pressure Effects 0 description 2
230000036454 renin-angiotensin system Effects 0 description 6
230000000268 renotropic Effects 0 abstract claims description 77
230000002889 sympathetic Effects 0 description 32
231100000827 tissue damage Toxicity 0 claims 2
230000000451 tissue damage Effects 0 claims 2
The present application claims priority to and the benefit of U.S. Provisional Patent Application No. 61/747,939, filed Dec. 31, 2012, which is hereby incorporated by reference in its entirety.
In one exemplary embodiment, the present disclosure describes an apparatus for intravascular thermal neuromodulation, comprising an elongate, hollow body, and expandable structure, at least one electrode and at least one imaging component. The elongate, hollow body includes a proximal portion and a distal portion including a distal tip. The body is configured to have an unexpanded condition wherein the distal portion and the distal tip are in contact with each other and an expanded condition wherein the distal portion and the distal tip are spaced apart from each other. The expandable structure is configured to have an expanded condition and an unexpanded condition, and the expandable structure is disposed in an unexpanded condition within the distal portion and proximal to the distal tip. The expandable structure includes at least one support arm. The at least one electrode and the at least one imaging component are positioned on the at least one support arm of the expandable structure. In a further aspect, the imaging component is an optical-acoustic sensor and the arm includes at least one optical fiber.
FIG. 4 a is a schematic diagram illustrating a perspective view of a portion of the renal nerve plexus overlying a segment of a renal artery.
FIG. 4 b is a schematic diagram illustrating a perspective view of a portion of the renal nerve plexus overlying a segment of an atherosclerotic renal artery.
FIG. 4 c is a schematic diagram illustrating a perspective view of a portion of the renal nerve plexus overlying a segment of a renal artery.
FIGS. 6 and 7 are illustrations of a side view of a portion of an optical-acoustic sensor in a first mode and a second mode.
FIG. 8 is an illustration of a single optical fiber having multiple optical-acoustic sensing regions.
FIGS. 9 a and 9 b are illustrations of a partial cross-sectional side view of the expandable structure in a non-deployed and unexpanded condition and a deployed, expanded condition according to one embodiment of the present disclosure.
FIG. 10 a is an illustration of a perspective side view of a thermal basket according to one aspect, along with FIG. 10 b showing a cross-section of one of the arms of the basket.
FIG. 11 is an illustration of a partially cross-sectional perspective view of a portion of the thermal basket catheter pictured in FIG. 18 a in an expanded condition positioned within a vessel according to one embodiment of the present disclosure.
FIG. 12 is an illustration of a partially cross-sectional perspective view of a portion of a thermal basket catheter in an expanded condition positioned within a vessel according to one embodiment of the present disclosure.
Although the following description is provided in relation to neuromodulation of the renal nerves, it is contemplated that the disclosed devices and methods have application in many different systems of the body. As an additional example, the disclosed systems can be utilized in carotid body baroreceptor ablation or aortic baroreceptor ablation to achieve neuromodulation. Still further, sensor data for the following described system can be utilized to provide tissue characterization information to the user. Further details of using a sensing systems in this manner is disclosed in co-pending application entitled “Device, System and Method for Imaging and Tissue Characterization of Ablated Tissue,” Ser. No. 61/745,476 filed Dec. 12, 2012, as well as co-pending application entitled “Methods and Apparatus for Renal Neuromodulation,” Ser. No. 13/458,856 filed Apr. 27, 2012, each of which is incorporated by reference in their entirety herein.
FIG. 2 illustrates a portion of a thermal basket catheter 210 in an expanded condition positioned within the human renal anatomy. The human renal anatomy includes kidneys 10 that are supplied with oxygenated blood by right and left renal arteries 80, which branch off an abdominal aorta 90 at the renal ostia 92 to enter the hilum 95 of the kidney 10. The abdominal aorta 90 connects the renal arteries 80 to the heart (not shown). Deoxygenated blood flows from the kidneys 10 to the heart via renal veins 100 and an inferior vena cava 110. Specifically, the thermal basket catheter 210 is shown extending through the abdominal aorta and into the left renal artery 80. In alternate embodiments, the thermal basket catheter may be sized and configured to travel through the inferior renal vessels 115 as well. The thermal basket catheter 210 will be described in more detail below with respect to FIGS. 9-12.
FIGS. 4 a, 4 b, and 4 c illustrate the portions 141, 143, 142, respectively, of the renal artery 80 in perspective view, showing the sympathetic renal nerves 120 that line the renal artery 80. FIG. 4 a illustrates the portion 141 of the renal artery 80 including the renal nerves 120, which are shown schematically as a branching network attached to the external surface of the renal artery 80. The renal nerves 120 extend generally lengthwise along the longitudinal axis LA of renal artery 80. In the case of hypertension, the sympathetic nerves that run from the spinal cord to the kidneys 10 signal the body to produce norepinephrine, which leads to a cascade of signals ultimately causing a rise in blood pressure. Neuromodulation of the renal nerves 120 (or renal denervation) removes or diminishes this response and facilitates a return to normal blood pressure.
In FIG. 4 a, the first portion 141 of the renal artery 80 includes a lumen 140 that extends lengthwise through the renal artery along the longitudinal axis LA. The lumen 140 is a generally cylindrical passage that allows the flow of oxygenated blood from the abdominal aorta to the kidney. The lumen 140 includes a luminal wall 150 that forms the blood-contacting surface of the renal artery 80. The distance D1 corresponds to the luminal diameter of lumen 140 and defines the diameter or perimeter of the blood flow lumen. A distance D2, corresponding to the wall thickness, exists between the luminal wall 150 and the renal nerves 120. The relatively healthy renal artery 80 may have an almost uniform distance D2 or wall thickness with respect to the lumen 140. The relatively healthy renal artery 80 may decrease substantially regularly in cross-sectional area and volume per unit length, from a proximal portion near the aorta to a distal portion near the kidney.
FIG. 4 b illustrates the third portion 143 of the renal artery 80 including a lumen 140′ that extends lengthwise through the renal artery along the longitudinal axis LA. The lumen 140′ includes a luminal wall 150′ which forms the blood-contacting surface of the renal artery 80′. In some patients, the smooth muscle wall of the renal artery is thicker than in other patients, and consequently, as illustrated in FIG. 3 b, the lumen of the third portion 143 of the renal artery 80 possesses a smaller diameter relative to the renal arteries of other patients. The lumen 140′, which is smaller in diameter and cross-sectional area than the lumen 140 pictured in FIG. 4 a, is a generally cylindrical passage that allows the flow of oxygenated blood from the abdominal aorta to the kidney. A distance D2′ exists between the luminal wall 150′ and the renal nerves 120 that is greater than the distance D2 pictured in FIG. 4 a.
FIG. 4 c illustrates the diseased second portion 142 of the renal artery 80 including atherosclerotic changes. The second portion 142 includes a lumen 140″ that extends lengthwise through the renal artery along the longitudinal axis LA. Unlike the renal artery of a patient without atherosclerotic changes, as is pictured in FIGS. 4 a and 4 b, the lumen 140″ is an irregularly-shaped passage that may allow the flow of oxygenated blood from the abdominal aorta to the kidney at a reduced rate because the narrowed lumen creates a reduced cross-sectional area for blood flow. The lumen 140″ includes a luminal wall 150″ which forms the blood-contacting surface of the renal artery 80. The luminal wall 150″ is irregularly shaped by the presence of two atherosclerotic plaques 160, 170. A distance D3 exists between the luminal wall 150″ and the renal nerves 120 that is greater than the distance D2 pictured in FIG. 4 a.
Earlier stages of atherosclerotic plaque formation are manifested as “fatty or lipid streaks” on luminal walls. These fatty streaks contain lipid-laden foam cells located in the subendothelial layer of the arterial intima. Additional intracellular and extracellular lipids accumulate at the site of the plaque during later plaque formation stages to cause raised lesions, such as the plaques 160, 170. In addition, smooth muscle and connective tissue cells may migrate into the plaque and proliferate within the plaque. Plaques damage the luminal surface of the artery, thereby weakening the artery and decreasing its elasticity. Luminal damage may also attract additional cells and extracellular materials to accumulate at or near the plaque. Over time, a plaque may calcify. As cells and extracellular materials accumulate, the luminal surface of the artery becomes irregular, as pictured in FIG. 4 c, which may lead to the accumulation of blood platelets and thrombus formation. The American Heart Association has recognized several different stages of plaque formation starting from flat lipid streaks, through the visible raised lesions, and ending in a fully occluded artery. As such, atherosclerotic plaque formation is a continuum of events. As the plaques mature, the thickness of the arterial wall, and therefore the distance from the luminal wall to the nerves surrounding the artery, may expand.
In FIG. 4 c, the atherosclerotic plaque 160 is a predominantly fatty plaque in the earlier stages of plaque formation. The atherosclerotic plaque 170 is a hardened, calcified plaque in the later stages of plaque formation. The distance D3 extending from the luminal wall 150″ to the renal nerves ranges in thickness along the circumferential and longitudinal span of the plaques 160, 170. Different types of plaques may possess different conductive and impedance properties, thereby affecting the amount, type, and duration of thermal energy that may be required to effectively modulate the nerves overlying the vessels in the region of the plaques.
The interface 240 may also be configured to include a plurality of electrical connections and optical connections, each electrically coupled to an electrode on the expandable structure 300 via a dedicated conductor and/or optical fibers extending to optical-acoustic or optical only sensors, respectively, running through the body 220 as described in more detail below with respect to FIG. 11. Such a configuration allows for a specific group or subset of electrodes on the expandable structure 300 to be easily energized with either monopolar or bipolar energy, for example. Similarly, the optical-acoustic sensors positioned on the expandable basket can be energized to interrogate the adjacent tissue structures during the ablation. Such a configuration may also allow the expandable structure 300 to transmit data from any of a variety of sensors via the controller 310 to data display modules such as the GUI 315 and/or the processor 320. The interface 240 may be coupled to the thermal electric field generator 325 via the controller 310, with the controller 310 allowing energy to be selectively directed to the portion of a luminal wall of the renal artery that is engaged by the expandable structure 300 while in an expanded condition.
The controller 310 may be configured to couple the imaging apparatus 280 to an imaging energy generator 322. In embodiments where the imaging apparatus 280 is an IVUS, the imaging energy generator comprises an light generator, such as a controllable laser source. Under the user-directed operation of the controller 310, the imaging energy generator 322 may generate a selected form and magnitude of energy (e.g., a particular energy or light based frequency) best suited to a particular application and best suited to activate a designated optical-acoustic sensor. At least one supply wire (not shown) passing through the body 220 and the interface 240 connects the imaging apparatus 280 to the imaging energy generator 322. The user may use the controller 130 to initiate, terminate, and adjust various operational characteristics of the imaging energy generator 318.
In the pictured embodiment, the imaging apparatus 280 is an intravascular ultrasound (IVUS) apparatus. More specifically, the imaging apparatus 280 pictured in FIG. 5 represents an ultrasound transducer array formed from a plurality of optical-acoustic sensing elements. In one embodiment, the transducer array includes 32 elements, while in others it can include 64, 96 or 128 sensing elements. A bundle of optical fibers interconnects the transducer array with the optical source positioned outside of the body. The entire IVUS apparatus may extend through the body 220 and include all the components associated with an IVUS module. The imaging apparatus 280 of the pictured embodiment may utilize any IVUS configuration that allows at least a portion of the body 220 to be introduced over a guidewire. For example, in some instances, the imaging apparatus 280 utilizes an array of transducers (e.g., 32, 64, 128, or other number transducers) disposed circumferentially about the central lumen 225 of the body 220 in a fixed orientation. In other embodiments, the IVUS portion 280 is a rotational IVUS system having only a single optical-acoustic ultrasonic transducer assembly. In some instances, the imaging apparatus 280 includes components such as transmitters and receivers similar or identical to those found in U.S. Pat. Nos. 7,245,789; 6,659,957 and U.S. application Ser. No. 12/571,724, each of which is hereby incorporated by reference in its entirety. Still further, in some embodiments, the sensors include optical pressure sensors. U.S. Pat. Nos. 7,689,071; 8,151,648 and U.S. application Ser. No. 13/415,514, disclose optical pressure sensors in detail and are herein incorporated by reference in their entirety.
In alternate embodiments, the imaging apparatus 280 may be or include, by way of non-limiting example, any of grey-scale IVUS, forward-looking IVUS, rotational IVUS, phased array IVUS, solid state IVUS, optical-acoustic IVUS, optical coherence tomography, or virtual histology. It is understood that, in some instances, wires and optical fibers associated with the imaging apparatus 280 extend along the length of the elongated tubular body 220 through the handle 230 and along electrical connection 245 to the interface 240 such that signals from the imaging apparatus 280 can be communicated to the controller 310. In some instances, the imaging apparatus 280 communicates wirelessly with the controller 310 and/or the processor 320.
The proximal portion 250 of the body 220 connects to the handle 230, which is sized and configured to be securely held and manipulated by a user outside a patient's body. By manipulating the handle 230 outside the patient's body, the user may advance the body 220 of the catheter 210 through an intravascular path (as illustrated, for example, in FIG. 2) and remotely manipulate or actuate the distal portion 260. In the pictured embodiment, the handle 230 includes an elongated, slidable body actuator 360 positioned within an actuator recess 370. The body actuator 360 may be configured as any of a variety of elements, including by way of non-limiting example, a knob, a pin, or a lever, capable of manipulating or actuating the distal portion 260 to reveal the expandable structure 300. The operation of the body actuator 360 will be further described below with respect to FIGS. 6 b and 7.
FIGS. 6 and 7 illustrate an optical-acoustic sensor formed on an optical fiber. As indicated in FIG. 6, a high energy pulsed laser is transmitted down the fiber and reflected outward by the 45 degree Bragg Grating. The reflected light heats the overlying material to cause an ultrasonic pulse to be generated. In FIG. 7, interference from reflected ultrasonic pulses causes interference in a continuous interrogation beam of a different frequency. Based on the interference, the ultrasonic echo can be detected. By using different frequencies for the high energy pulse and selective Bragg Gratings, a plurality of optical-acoustic sensors can be formed along a single fiber as shown in FIG. 8. As shown in the drawings for illustration purposes, the gratings could be responsive to different wavelengths or colors within the spectrum. While different colors are indicated, it is likely that different frequencies in or near the infrared spectrum would be the likely choice for the high energy pulses. As will be explained more fully below, the multi-sensor fibers can be embedded within moveable components of the system.
FIG. 9 a illustrates at least a segment of the distal portion 260 of the thermal basket catheter 210 in an unexpanded condition according to one embodiment of the present disclosure. In some instances, the thermal basket catheter 210 includes components or features similar or identical to those disclosed in U.S. Patent Application Publication No. US2004/0176699, which is hereby incorporated by reference in its entirety. In the pictured embodiment, the distal tip 290 is positioned against the remainder of the body along the longitudinal axis CA, and the expandable structure 300 is compressed within the lumen in an unexpanded condition. The distal portion 260 includes a distal connection part 390, which is the proximal-most part of the distal tip 290, and a proximal connection part 395, which abuts the distal connection part 390 when the catheter 210 is in an unexpanded condition. In the pictured embodiment, the imaging apparatus 280 is positioned distal to the distal connection part 390. As discussed above, in one form, the imaging apparatus 280 comprising an array of optical-acoustic elements. In another form, the imaging apparatus 280 can comprises a single optical-acoustic element that is rotationally moved to generate an image. Additionally or alternatively, the imaging apparatus may be positioned proximal to the proximal connection part 395.
FIG. 9 b illustrates at least a segment of the distal portion 260 of the thermal basket catheter 210 in an expanded condition according to one embodiment of the present disclosure. In the pictured embodiment, the distal tip 290 is moved distally away from the remainder of the body along the longitudinal axis CA to allow the expandable structure 300 to emerge from the lumen and assume an expanded condition. Specifically, the distal connection part 390 is separated axially away from the proximal connection part 395 along the axis CA. As further described below, the user may transition the catheter 210 from an unexpanded condition to an expanded condition by manipulating the body actuator 360 within the actuator recess 370 to cause the distal tip 290 to move distally away from the remainder of the body 220. In the pictured embodiment, the expandable structure 300 is shown in a deployed and expanded condition wherein at least one support arm 400 has expanded outwardly. The expandable structure 300 includes six flexible support arms 400. In other embodiments, the expandable structure may include any number of support arms 400. At least one electrode 410 and at least one optical-acoustic sensor 420 may be positioned on at least one of the support arms 400. The at least one electrode 410 and at least one sensor 420 will be described in further detail below with reference to FIGS. 10 a and 10 b. FIG. 9 c shows a cross-section of the shaft illustrating the optical fiber bundle 419 that has fibers extending to the array assembly 280 as well as individual fibers that may extend onto the flexible arms 400 to define optical-acoustic sensors thereon.
The support arms 400 may be manufactured from a variety of biocompatible materials, including, by way of non-limiting example, superelastic or shape memory alloys such as Nitinol, and other metals such as titanium, Elgiloy®, and/or stainless steel. The support arms 400 could also be made of, by way of non-limiting example, polymers or polymer composites that include thermoplastics, resins, carbon fiber, and like materials. In the illustrated embodiment, the support arms 400 are secured to a deployment support member 430, which may be secured to an interior component of the body 220 in a variety of ways, including by way of non-limiting example, adhesively bonded, laser welded, mechanically coupled, or integrally formed. In alternate embodiments, the support arms 400 may be secured to an interior component of the body 220 directly, thereby eliminating the need for a deployment support member 430.
FIG. 10 a illustrates the thermal basket catheter 210 in an expanded condition according to one embodiment of the present disclosure wherein the distal tip 290 has been moved axially away from the remainder of the distal portion 260 and at least one of the support arms 400 has expanded outwardly. The support arms 400 may be manufactured in any of a variety of shapes, including by way of non-limiting example, arcuate shapes, bell shapes, smooth shapes, and step-transition shapes. The support arms include a proximal section 545, a medial section 550, and a distal section 555. The proximal section 545 may be capable of coupling the expandable structure 300 to the body 220 or the inner body 490. The medial section 550 is configured to be positioned proximate to or in contact with a vessel luminal wall. The distal section 555 couples each arm 400 to a support arm retainer 540 positioned on an exterior of the inner body 490.
In one embodiment, the proximal sections 545 of the support arms 400 may be coupled to the deployment support member 430 using an adhesive, such as, by way of non-limiting example, Loctite 3311 adhesive or any other biologically compatible adhesive. In an alternate embodiment, the expandable structure 300 may be manufactured by laser cutting or forming the at least one support arm 50 from a substrate. For example, any number of support arms 400 may be laser cut within a Nitinol tube or cylinder, thereby providing a slotted expandable body. The support arms 400 may be fabricated from a self-expanding material biased such that the medial section 550 expands into contact with the vessel luminal wall upon expanding the catheter 210. In some embodiments, the one or more support arms 400 may be formed in a deployed state as shown in FIG. 10 a wherein at least one support arm 400 is flared outwardly from the longitudinal axis CA of the catheter 210.
In the illustrated embodiment, the guidewire lumen 510, capable of receiving the guidewire 460 therein, longitudinally traverses the expandable structure 300. The guidewire lumen 510 is in communication with the guidewire port 450 on the distal portion 260 and guidewire exit slot 265 located on the elongated body 220. In an alternate embodiment, the guidewire lumen 510 may be in communication with the guidewire port 450 on the distal tip 290 and/or a proximal port located on the handle 230 (shown in FIGS. 4 and 5). In the illustrated embodiment, a retainer sleeve 530 is positioned over a distal section of the support arms 400 to provide a transition between the distal tip 290 and the support arms 400. As shown, the retainer sleeve 530 is positioned over the support arm retainers 540, thereby preventing the support arm retainers 540 from contacting the vessel wall 90 and causing trauma to the vessel luminal wall (not shown), damaging the support arm retainers 540, or both. Other embodiments may lack a retainer sleeve.
The at least one electrode 410 may be positioned on the medial section 550 of at least one of the support arms 400, thereby enabling the electrode 410 and the sensor 420 to contact or approximate the vessel luminal wall. At least one electrode cable 560 connects each electrode 410 to the interface 240 and/or the thermal electric field generator 325. The at least one electrode 410 will be described in further detail below in reference to FIG. 13.
The at least one sensor 420 may be positioned on the medial section 550 of at least one of the support arms 400, thereby enabling the sensor to contact or approximate the vessel luminal wall. In the illustrated embodiment, the sensor is an optical-acoustic sensor as described above. As shown in the FIG. 10 b showing a cross-section of arm 400, an optical fiber 421 is embedded within the material 423 forming the arm. An aperture 425 is formed through the material 423 to allow the sensor component to be exposed to the surrounding environment. Although the fiber and sensor are shown embedded within the material, it is contemplated that the fiber and/or sensor may be on the exterior surface of the arm 400 or only partially embedded. In the illustrated embodiment, the fiber 421 can be embedded in a polymer material as the arm 400 is being formed. When the arm is formed of a metal, it may be easier to adhere the optical fiber to the surface of the arm. Still further, while the illustrated sensor is an ultrasound sensor, it is contemplated that other sensors such as optical pressure sensors or light based imaging fibers could be combined with or substituted for the ultrasound sensor.
Referring now to FIGS. 11 and 12, there are shown alternative embodiments of the expandable therapy devices including heating electrodes 410 and sensing devices 420. With respect to FIG. 11, the plurality of sensing locations 420 formed on each arm can be formed by a single fiber having multiple differential frequency Bragg Gratings as discussed above with respect to FIG. 8. In this manner, a single optical fiber can provide a low profile sensing string along the expandable arm 400.
The expandable structure 300 may include at least one ancillary sensor 575 thereon. As shown in FIG. 12, the ancillary sensor 575 a may be positioned on an exterior surface of the inner body 490. In the alternative, at least one ancillary sensor 575 b may be positioned on at least one support arm 400. Exemplary ancillary sensors 575 include, without limitation, ultrasonic sensors, flow sensors, thermal sensors, blood temperature sensors, electrical contact sensors, conductivity sensors, electromagnetic detectors, pressure sensors, chemical or hormonal sensors, pH sensors, and infrared sensors. For example, in one embodiment the ancillary sensor 575 a may comprise a blood sensor positioned on the guidewire lumen 510 in the bloodstream as shown in FIG. 12, thereby permitting the sensors 420 located on the support arms 400 to measure the vessel wall temperature while simultaneously the ancillary sensor 575 a measures blood temperature within the vessel. In another embodiment, the ancillary sensor 575 b may comprise a pressure sensor positioned on the support arm 400 proximate to the electrode 410 and/or encircling the electrode 410. The ancillary pressure sensor 575 b may detect the pressure with which the proximate electrode 410 is contacting the vessel wall, thereby allowing the user to determine whether the electrode 410 is effectively contacting the vessel wall to ensure adequate energy transfer and neuromodulation.
FIG. 11 illustrates the elongated expandable structure 910 in an expanded condition after emerging from the proximal connection part 395 of the distal portion 260. In the pictured embodiment, the intermediate parts 930 of the support arms 400 of the expandable structure 910 have expanded outwardly from the longitudinal axis CA, thereby permitting a majority of the electrodes 410 and the sensors 420 located on the support arms 400 to contact the internal luminal surface 820 of the vessel 810. Using a thermal basket catheter including an elongated expandable structure allows the user to simultaneously apply thermal energy to multiple positions spaced longitudinally along the vessel wall, thereby potentially shortening the duration of the thermal neuromodulation procedure. For example, in the pictured embodiment, the expandable structure 910 may simultaneously apply thermal energy to the vessel wall at a circumferential position 840 and a circumferential position 850, which are spaced longitudinally from each other along the vessel wall of vessel 810. In addition, the spaced optical-acoustic sensors 420 can be utilized to image and characterize adjacent tissue to monitor the ablation process. Thus, each heating electrode can be monitored individually if desired by the user to customize the delivered therapy to correspond to the sensed tissue type, depth or density adjacent the electrode.
FIG. 12 shows a thermal basket catheter 960 including a helical expandable structure 970 positioned within a curved portion 810 of the renal artery 80 (similar to the portion 141 shown in FIG. 2) according to one embodiment of the present disclosure. FIG. 12 illustrates the elongated expandable structure 960 in an expanded condition after emerging from the proximal connection part 395 of the distal portion 260. The thermal basket catheter 970 is substantially identical to the thermal basket catheter 210 except for the differences noted herein. The expandable structure 970 is shaped and configured as an elongated basket comprising support arms 975 that include proximal parts 980, intermediate parts 985, and distal parts 990.
It should be appreciated that while several of the exemplary embodiments herein are described in terms of an ultrasonic device, or more particularly the use of IVUS data obtained via optical-acoustic sensors (or a transformation thereof) to render images of a vascular object, the present disclosure is not so limited. Thus, for example, an imaging device using backscattered data (or a transformation thereof) based on ultrasound waves or even electromagnetic radiation (e.g., light waves in non-visible ranges such as Optical Coherence Tomography, X-Ray CT, etc.) to render images of any tissue type or composition (not limited to vasculature, but including other human as well as non-human structures) is within the spirit and scope of the present disclosure.
an expandable structure configured to have an expanded condition and an unexpanded condition, the expandable structure disposed in an unexpanded condition within the distal portion and proximal to the distal tip, the expandable structure including at least one support arm;
at least one optical-acoustic sensor positioned adjacent the expandable structure.
11. A method for thermal modulation of nerves overlying a vessel, comprising:
positioning a thermal neuromodulation apparatus including at least one optical-acoustic sensor positioned adjacent the expandable structure and an expandable structure carrying at least one electrode within a lumen of the vessel;
positioning the thermal neuromodulation apparatus in the vessel;
expanding the expandable structure to enable the at least one electrode to contact a luminal wall proximate the nerves overlying the vessel;
imaging the luminal wall of the vessel and the nerves with the at least one optical-acoustic sensor to obtain image data reflective of the extent of tissue damage.
US14/139,523 2012-12-31 2013-12-23 Methods and Apparatus for Neuromodulation Utilizing Optical-Acoustic Sensors Abandoned US20140188103A1 (en)
US201261747939P true 2012-12-31 2012-12-31
US14/139,523 US20140188103A1 (en) 2012-12-31 2013-12-23 Methods and Apparatus for Neuromodulation Utilizing Optical-Acoustic Sensors
US20140188103A1 true US20140188103A1 (en) 2014-07-03
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US14/139,523 Abandoned US20140188103A1 (en) 2012-12-31 2013-12-23 Methods and Apparatus for Neuromodulation Utilizing Optical-Acoustic Sensors
US (1) US20140188103A1 (en)
WO2016019760A1 (en) * 2014-08-05 2016-02-11 上海魅丽纬叶医疗科技有限公司 Radiofrequency ablation catheter having petal-shaped stent structure and apparatus thereof
2013-12-23 US US14/139,523 patent/US20140188103A1/en not_active Abandoned
EP2632373B1 (en) 2018-07-18 System for evaluation and feedback of neuromodulation treatment
JP2012110748A (en) 2012-06-14 Apparatus for renal neuromodulation
JP2012525933A (en) 2012-10-25 Irrigated ablation catheter with multi-segment ablation electrode
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Free format text: ASSIGNMENT OF ASSIGNORS INTEREST;ASSIGNOR:MILLETT, BRET C.;REEL/FRAME:031850/0457