Patent Application
20220192743
The present disclosure relates to integrating imaging in an ablation catheter.
Atrial fibrillation (AF) is a common sustained arrhythmia throughout much of the world. Because most AF is initiated by aberrant electrical activity originating within the pulmonary veins (PVs), PV isolation (PVI) using radiofrequency ablation (RFA) has become a common curative procedure to treat AF. During PVI, lines of RFA lesions are created around the PVs to electrically isolate them from the left atrium (LA). The efficacy of this procedure greatly relies on transmurality of individual lesions. However, current PVI lesion formation is guided only with indirect information (e.g. temperature, impedance, contact force), which may lead to non-transmural lesions, and contribute to AF recurrence. Therefore, direct lesion transmurality feedback to guide PVI procedures may potentially improve its efficacy.
In an example, an ablation catheter includes an elongate tubular body having spaced apart proximal and distal ends and a lumen extending through the elongate tubular body. An ablation electrode extends from the distal end of the elongate tubular body to terminate in a distal end thereof. An elongate optical imaging probe extends through the lumen of the elongate tubular body and terminates in a distal end that is spaced a distance from the distal end of the ablation electrode. A flexible tubing extends over a length of the probe and configured to permit at least rotational movement of the probe within the flexible tubing. A distal end portion of the flexible tubing can be held at an axial position relative to the elongate tubular body to fix the distance between the distal end of the probe and the distal end of the ablation electrode.
A system can include a catheter, a pulse generator and a controller. The catheter includes an elongate tubular body having spaced apart proximal and distal ends and a lumen extending through the elongate tubular body. The catheter also includes an ablation electrode extending from the distal end of the elongate tubular body to terminate in a respective distal end of the electrode. The catheter also includes an elongate optical imaging probe extending through the lumen. The catheter also includes flexible tubing extending over a length of the probe and configured to permit at least rotational movement of the probe within the flexible tubing, in which a distal end portion of the flexible tubing being held at an axial position relative to the elongate tubular body to fix the distance between the distal end of the probe and the distal end of the ablation electrode. The controller is configured to control the pulse generator to supply electrical energy to the electrode to implement ablation.
An integrated imaging-ablation catheter includes an optical imaging probe and an ablation electrode. For example, the imaging probe is an optical coherence tomography (OCT) imaging probe. The catheter may also include a temperature sensor (e.g., thermocouple) and one or more electrodes configured for electrogram recording and 3D mapping.
As described herein, the integrated catheter device is configured to mitigate OCT probe back-out and non-uniform rotation distortion (NURD) that might occur during probe scanning and catheter steering. For example, to reduce NURD, the catheter includes a rotation-protect tubing between the OCT probe and the catheter sheath. The tubing may be a flexible material configured to lubricate the surrounding surface of the OCT probe or otherwise reduce friction during rotation and bending. To reduce (or eliminate) back-out of the OCT probe, such as during bending, the catheter includes a position limiting joint to fix a relative position of the rotation-protect tubing with respect to the catheter sheath.
In some examples the OCT probe is configured to implement polarization sensitive OCT (PSOCT), which provides high resolution (e.g., about 10-20 μm) in-depth (e.g., about 1-2 mm) noninvasive real-time imaging. The PSOCT probe thus can provide images and other data to guide RFA in the left atrium as well as to other target sites of patients.
As described herein, the integrated imaging-ablation catheter guidance of PVI in the LA through the use of imaging, including PSOCT. For example, PS OCT (or other) images generated by the imaging probe, which may be combined with other localized measurements (e.g., temperature and/or electrograms), provide direct lesion transmurality feedback to guide PVI procedures and thereby improve its efficacy.
The catheter 100 includes an ablation electrode 112 extending from the distal end of the elongate tubular body to terminate in a distal end 114 of the catheter. For example, as shown in
Additionally, the ablation electrode 112 includes another lumen (e.g., a slot) 124 formed in the sidewall of the ablation electrode spaced radially apart from and parallel to the larger center lumen 116. The lumen 124 has a diameter to house a temperature sensor that is located adjacent the ablation electrode distal end 114. For example, the temperature sensor is implemented as a thermocouple (e.g., a type K or other type of thermocouple) is mounted in the lumen 124 adjacent to the ablation electrode distal end 114. A distal end of the lumen 124 can be closed so as to position the temperature sensor nearly at the end but not exposed on the distal end from the outside of the catheter 100. The temperature sensor 126 thus is configured to measure the temperature at tissue surface during ablation of the tissue by the electrode 112. The distal end of temperature sensor may be protected with a coating to ensure desired performance characteristics.
One or more sensor wires (e.g., twisted pair, pigtail conductors) 128 are coupled to the temperature sensor 126 and extend through the catheter 100 to carry electrical signals to and/or from the sensor. For example, the sensor wire 128 may extend through a corresponding lumen 130 of the tubular body 102 of the catheter 100 and out the proximal end 104 of the catheter for connection to a connector of associated circuitry (not shown). The temperature sensor 126 may be mounted adjacent the distal end of the ablation electrode, a conductor coupled with the temperature sensor to carry a temperature signal from the temperature sensor toward the proximal end of the elongate tubular body. As may be understood by those skilled in the art, other sensors (e.g. pressure sensors) or electrodes (e.g. bipolar electrode pairs) may be adapted to be mounted adjacent to the distal end of the ablation catheter in a similar fashion. In some examples the sensor wires may be configured to have a dielectric strength sufficient to withstand DC voltages in excess of 100 V to 1000 V, or 250-750 V, or about 500 V.
An elongate distal hypotube 154 is positioned within and extends through a distal portion of the lumen 108 of the elongate tubular body 102. The distal hypotube 154 terminates in a distal end 132 that is sized and configured to receive the ablation electrode 112 on an outer surface thereof, such as shown in
The imaging probe 118 is mounted within the proximal hypotube 154. The imaging probe 118 is configured to acquire optical images through the window 122 (e.g., through the window. For example, as best shown in the example of
In an example, the imaging probe 118 is an OCT probe coupled to an OCT scanning system by one or more optical fibers that extend from the probe through the catheter 100. In the catheter 100, the OCT probe may be implemented as a forward scanning probe with its viewing angle aligned to image through the window 122 mounted at the end 114 of the ablation electrode. The scanning system includes a controller and a light source configured to send a laser beam through the probe and onto an object (e.g., tissue). The OCT probe collects back-reflected light that is sent through an optical fiber, extending through the probe and catheter 100, to the optical scanning system. The scanning system is configured to generate an OCT image based on the back-reflected light. The probe 118 may be rotated about its central longitudinal axis during scanning through the window 122. In other examples, the probe may be kept stationary relative to the catheter body 102 during scanning Additionally, because the OCT probe is integrated in the catheter with the ablation electrode 112, the OCT probe 118 may be activated for scanning during ablation, which may involve stationary or rotational scanning to collect images or reflectometry signals of subject tissue.
As one example, the scanning system may be configured to perform polarization sensitive OCT, such as disclosed in U.S. Pat. No. 7,826,059, entitled Method and apparatus for polarization-sensitive optical coherence tomography, which is incorporated herein by reference. Other scanning systems may be used in other examples.
The catheter 100 also includes a flexible tubing 140 extending over a length of the imaging probe 118 and configured to permit at least rotational movement of the probe within the flexible tubing 140. The flexible tubing is further configured to limit the rotation of the imaging probe and to inhibit axial movement of the probe. In an example, a distal end portion 142 of the flexible tubing 140 holds the probe 136 at an axial position relative to the elongate tubular body 102. Additionally, the inner surface of the flexible tubing 140 is configured to hold the probe concentric with the central axis of rotation and thereby reduce NURD during rotation of the probe (e.g., when bending to traverse a curved path). Additionally, the inner surface of the flexible tubing 140 may be implemented to have low friction (e.g., by applying lubricant or other friction reducing coating) to reduce frictional forces during rotation between the probe and inner surface during rotation and bending of the probe 118.
As a further example, with reference to
As shown in the examples of
As a further example the joint 150 is in the form of a single ring that circumscribes the distal end of the flexible tubing. In another example, the joint includes a plurality of joint portions spaced axially apart distributed along the circumference of the flexible tubing 140. The joint 150 thus is configured to stabilize (e.g., maintain or fix) the relative distance of between the end 132 of the probe 118 and the inner surface of the window 122. For example, the distance between the distal end 132 (the lens 134) and the window 122 may be set to provide a desired fixed imaging distance from the probe to the subject tissue. In one example, the joint comprises an adhesive to hold the distal end 142 of the flexible tubing 140 at a fixed axial position within the hypotube 154 and body 102. Other type of joints can be used in other examples, including a heat joint, friction fit joint, crimp joint, swage, threading, weld, or any other joint to stabilize the axial position of the probe 118, as described herein.
The catheter 100 also may include steering cables 160, 161 having distal ends coupled (e.g., welded or otherwise coupled) to a steering cable anchor (e.g., a ring structure) 162 that is fixed along a circumferential outside surface of the distal end of catheter body 102. For example, the steering cables 160, 161 may extend through the tubular body 102 within respective channels on diametrically opposed sides of the catheter sheath and be attached to the anchor 162. In some examples steering cables 160 and 161 connect to the distal most end 114 of the catheter 100. Other ends of the cables may extend through respective channels and exit the body 102 through apertures 166, 168 formed in the tubular body 102, as shown in
In some examples, the catheter 100 also includes one or more electrodes 170, 172 and 174 mounted on a radially outer surface of the body portion 102. In the example of
In some examples, the electrodes 170, 172 and 174 may also be configured to form bipolar pairs amongst one another and/or the ablation electrode 112. Such bipolar pairs may be configured to deliver RF electricity or high voltage electrical pulses, such as those utilized in irreversible electroporation (IEP). In one example of IEP with bipolar pairs of electrodes, monophasic electrical impulses are employed. In another example of IEP with bipolar pairs of electrodes, biphasic electrical impulses are employed. In an example of IEP employing biphasic electrical impulses there are 1-6 pulse trains consisting of 10-60 pulses. Such pulse trains may be delivered over 1-6 seconds at frequencies of 1 Hz and may have amplitudes of 200-700 V and current range of 8-25 Amps.
As a further example, the thickness (e.g., 2 mm versus 4 mm) and/or character (e.g. fat versus muscle) of the tissue to be ablated may be evaluated via OCT, and the energy to be delivered titrated appropriately. In an example of OCT guided IEP, 2 mm-4 mm thick muscle or another target site having desired tissue characteristics is identified optically based on OCT image data acquired via the OCT probe. Responsive to the OCT data, the voltage, number of pulses, and/or pulse width can be titrated to deliver the desired current density to create a transmural lesion while reducing excessive heat generation. In another example of OCT guided IEP, 2 mm-4 mm thick muscle (or a site having other desired tissue characteristics) is targeted for ablation and the voltage, number of pulses, or pulse width is automatically adjusted in real time as the lesion depth increases (one or more of the parameters is reduced as lesion depth increases). In another example of OCT guided IEP, fatty tissue is identified optically and targeted for ablation by reducing the duration of pulses (e.g. 1 nanosecond-200 microseconds). In a related example both OCT and impedance measurements may be used to titrate electrical energy during ablation.
As described herein, the integrated imaging-ablation catheter 100 thus is configured to perform a variety of functions. For example, the catheter 100 can accurately record electrograms, determine 3D catheter location, monitor temperature change, as well as directly guide catheter-tissue apposition and monitor lesion formation in the LA (or other locations) directly in real-time.
The system 200 includes hardware and software arranged and configured to control the ablation catheter 100 and to generate images as described herein. In the example of
The system 200 also can include a computing system 206 to which one or more output devices 208 can be coupled. For example, the output device 208 can include a display, such as configured to display images acquired by an imaging probe (e.g., OCT imaging probe) that is implemented in the catheter 100. For example, the one or more OCT images can be displayed on the output device 208, such as generated by an OCT device 210.
The OCT device 210 can include a light source and an arrangement of optical components to send incident light and detect scattered and reflected light from an object (e.g., in vivo or in vitro). The OCT device 210 can supply OCT data to the computer system 206, which can construct one or more respective images (e.g., two-dimensional or three-dimensional images) of the object based on the OCT data, which can be displayed on output device 208. Examples of apparatus that can be used to implement the OCT device 210, including polarization sensitive OCT devices, are disclosed in U.S. Pat. Nos. 10,591,275 and 7,826,059 and U.S. Pat. No. 6,615,072, each of which is incorporated herein by reference.
The computer system 206 can include a processor (and/or the OCT device 210 can include a processor) programmed to perform interferometry and calculations on the detector signal and compute optical polarization properties of the sample that is illuminated. The processor can also compute other optical properties such as total reflective power, B polarization, net retardance or net extinction ratio based on processing of the OCT signals. The computer system can utilize the computations a corresponding OCT images that can be presented on the display and/or stored in memory.
The system 200 can also include an electrical pulse generator 212 and one or more sensor interfaces 214. For example, the electrical pulse generator 212 can be coupled to the ablation electrode 112 and configured to supply electrical pulses for ablating tissue. For example, the computer system 206 can provide instructions to the electrical pulse generator 212 to control application of ablative to the electrode 122 for ablating tissue, such as by configuring one or more parameters (e.g., frequency and power) of energy being applied. The OCT device 210 can acquire OCT data (e.g., before during and after the ablation) and the computer system can generate corresponding OCT images displayed in real-time or near real-time. The OCT images can be used to control the ablation (e.g., by setting respective parameters of the pulse generator 212) automatically or in response to a user input based on the OCT images that are generated. Thus, as described herein, the system 200, including the catheter 100 having an integrated OCT probe, can be used to produce OCT images and other information to help guide and monitor the RFA procedure in real-time, including direct monitoring of changes in tissue responsive to the ablation.
The computer system 206 can be configured to provide other information (e.g., text or graphical information) to the output device 210, which can also be used to guide the ablation. For example, the computer system 206 can output information to the device 210 representative of operating parameters of the ablation catheter 100 and/or other features sensed by one or more sensors of the catheter 100. For example, as described herein, the catheter can include a temperature sensor 126 and/or one or more sensing electrodes 162, 170, 172, 174. Each sensor can be coupled to the sensor interface 214, which can provide respective sensor data to the computer system 206. The computer system 206 can display information in the form of text and/or graphics on the output device 208 representative of the sensed condition(s). Such sensed information can (along with the OCT images) be used to control the ablation (e.g., by setting respective parameters of the pulse generator 212) automatically or in response to a user input based.
From the above description of the invention, those skilled in the art will perceive improvements, changes and modifications. Such improvements, changes and modifications within the skill of the art are intended to be covered by this application, including the appended claims. Accordingly, the invention is intended to embrace all such alterations, modifications, and variations that fall within the scope of this application, including the appended claims. Where the disclosure or claims recite “a,” “an,” “a first,” or “another” element, or the equivalent thereof, it should be interpreted to include one or more than one such element, neither requiring nor excluding two or more such elements.
Also, as used herein, the term “couple” or “couples” means either an indirect or direct connection. Thus, if a first device couples to a second device, that connection may be through a direct connection or through an indirect connection via other devices and connections. For example, if device A generates a signal to control device B to perform an action, in a first example device A is coupled to device B, or in a second example device A is coupled to device B through intervening component C if intervening component C does not substantially alter the functional relationship between device A and device B such that device B is controlled by device A via the control signal generated by device A.
Furthermore, a circuit or device that is said to include certain components may instead be configured to couple to those components to form the described circuitry or device. For example, a structure described as including one or more elements A, B and C may instead include only the A elements within a single physical device and may be configured to couple to at least some of the elements B and/or C to form the described structure, either at a time of manufacture or after a time of manufacture, for example, by an end-user and/or a third-party.
As used herein, the term “includes” means includes but not limited to, the term “including” means including but not limited to. The term “based on” means based at least in part on. All references, publications, and patents cited in the present application are herein incorporated by reference in their entirety.
This application claims the benefit of priority to U.S. Provisional Application No. 63/127,560, filed Dec. 18, 2020, which is incorporated herein by reference in its entirety.
This invention was made with government support under Grant Nos. R01HL149369 and UH54HL119810 awarded by the National Institutes of Health. The United States government has certain rights in the invention.
| Number | Date | Country | |
|---|---|---|---|
| 63127560 | Dec 2020 | US |
