Ablation catheter equipped with a pressure sensor for treating venous aneurysms

Abstract

A catheter for use in treating aneurysms may include a handle, an elongate shaft connected to the handle, and a heating element disposed near the distal end of the shaft. In some embodiments, the heating element may include a plurality of pressure sensors that are circumferentially offset from each other, and each pressure sensor is configured to generate an output signal indicative of the pressure applied to each pressure sensor by the surface of the target blood vessel.

Description

Technical Field

[0001] The present disclosure relates to medical devices, systems, and methods for providing therapeutic heat treatment. More specifically, the present disclosure relates to medical devices, systems, and methods for providing therapeutic heat treatment for venous diseases.

Background Art

[0002] Therapeutic heat treatment can be used to treat a variety of medical conditions such as tumors, fungal growths, etc. Heat treatment can be used to treat medical conditions in parallel with other treatment methods or as a standalone treatment method. Since heat treatment performs local heating, it does not cause cumulative toxicity, in contrast to other treatment methods such as drug-based treatments.

[0003] One exemplary clinical application of therapeutic heat treatment is the treatment of chronic venous diseases such as venous aneurysms that can expand and / or serpentine due to one or more pathological conditions. By applying sufficient thermal energy through an intravascular device, the venous aneurysm can be treated by contracting or occluding the target vein.

[0004] There is a continuing need for improved devices and methods for providing intensively controlled thermal energy while minimizing or eliminating the impact on surrounding healthy tissue for thermally treating chronic venous conditions such as venous aneurysms.

Summary of the Invention

[0005] In Example 1, the device for treating an aneurysm includes a long catheter. The long catheter may include a long shaft having a proximal end and a distal end and defining a longitudinal axis, a heating element disposed in the vicinity of the distal end of the long shaft, and a plurality of pressure sensors disposed longitudinally spaced apart from each other along the shaft. The shaft may be sized and configured such that the distal end can be inserted into the target blood vessel. The heating element may include a coil member having a plurality of first windings wound around the shaft in a first direction, and a plurality of openings in the plurality of first windings are defined along the length of the heating element. Each of the plurality of pressure sensors may be disposed on the shaft within an individual one of the plurality of openings in the plurality of first windings, adjacent pressure sensors are circumferentially offset from each other, and each pressure sensor is configured to generate an output signal indicating the pressure applied to each pressure sensor by the surface of the target blood vessel.

[0006] In Example 2, in the device of Example 1, the coil member further includes a plurality of second windings wound around the shaft in a second direction different from the first direction, and at least some of the plurality of second windings intersect the plurality of first windings at a plurality of positions spaced apart along the length of the heating element, and at least some of the plurality of openings are defined between the plurality of first windings and the plurality of second windings.

[0007] In Example 3, in the device of either Example 1 or 2, the plurality of pressure sensors includes three pressure sensors, and two adjacent pressure sensors among the plurality of pressure sensors are circumferentially offset from each other by an offset degree related to N.

[0008] In Example 4, in the device of Example 1, the plurality of pressure sensors includes a first pair of pressure sensors and a second pair of sensors. The first pair of pressure sensors includes a first pressure sensor and a second pressure sensor adjacent to the first pressure sensor. The second pressure sensor is offset in the circumferential direction by a first offset angle with respect to the first pressure sensor. The second pair of sensors includes a third pressure sensor and a fourth pressure sensor adjacent to the third pressure sensor. The fourth pressure sensor is offset in the circumferential direction by a second offset angle with respect to the third pressure sensor, and the second offset angle is equal to the first offset angle.

[0009] In Example 5, in the device of Example 1, the first plurality of windings and the second plurality of windings are arranged to define a plurality of coil segments. Adjacent coil segments are longitudinally spaced apart from each other, and one or more segment gaps are defined between each adjacent coil segment along the length of the shaft. The device further includes a temperature sensor, and the temperature sensor is disposed in one of the one or more segment gaps. At least one of the plurality of pressure sensors is disposed in an opening within a coil segment.

[0010] In Example 6, in the device of Example 1, the plurality of pressure sensors includes six pressure sensors. In Example 7, in the device of Example 6, two adjacent pressure sensors among the plurality of pressure sensors are offset from each other by 60 degrees in the circumferential direction.

[0011] In Example 8, in the device of Example 6, two adjacent pressure sensors among the plurality of pressure sensors are offset from each other by 120 degrees in the circumferential direction. In Example 9, in the device of any one of Examples 1 to 8, the plurality of pressure sensors includes at least one selected from the group consisting of a piezoelectric pressure sensor, a capacitive pressure sensor, an inductive pressure sensor, a strain gauge pressure sensor, and a potentiometric pressure sensor.

[0012] In Example 10, in any of the devices of Examples 1 to 8, the heating element is controlled to supply ablation energy when an output signal indicating the pressure generated by one of the plurality of pressure sensors is greater than a predetermined threshold value.

[0013] In Example 11, a device for treating an aneurysm includes an energy generator configured to generate an electrical signal, a controller operably connected to the energy generator and controlling the generation of the electrical signal, and a long catheter connected to the energy generator. The long catheter includes a long shaft having a proximal end and a distal end and defining a longitudinal axis, the size and configuration of which are such that the distal end can be inserted into a target blood vessel, a heating element disposed in the vicinity of the distal end of the long shaft, and a plurality of pressure sensors disposed longitudinally spaced apart from each other along the shaft. The heating element includes a first coil member having a first plurality of windings wound around the shaft, one or more first openings in the first plurality of windings being defined along the length of the first coil member, and a second coil member having a second plurality of windings wound around the shaft, one or more second openings in the second plurality of windings being defined along the length of the second coil member. Each pressure sensor of the plurality of pressure sensors is disposed on the shaft within an individual opening of the first opening in the first plurality of windings or the second opening in the second plurality of windings, at least two adjacent pressure sensors being circumferentially offset from each other, and each pressure sensor is configured to generate an output signal indicating the pressure applied to each pressure sensor by the surface of the target blood vessel. In some embodiments, the first and second coil members are each operably connected to the energy generator and are configured to generate thermal energy when an electrical signal generated by the energy generator is delivered to the first and second coil members.

[0014] In Example 12, in the device of Example 11, the heating element further includes a third coil member having a third plurality of windings wound around the shaft, and one or more third openings in the third plurality of windings are defined along the length of the third coil member, and one or more of the plurality of pressure sensors are disposed on the shaft within one or more of the third openings.

[0015] In Example 13, in the device of Example 11, the controller is configured to adjust the current generated by the energy generator based on an output signal indicating the pressure applied to each pressure sensor, generated by each pressure sensor of the plurality of pressure sensors.

[0016] In Example 14, in the device of any one of Examples 11 to 13, the controller is configured to control the current generated by the energy generator to be selectively delivered to one or both of the first and second coil members.

[0017] In Example 15, the device of any one of Examples 11 to 14 further includes a temperature sensor disposed on the shaft within one of the first opening or the second opening, and the temperature sensor is longitudinally spaced from one of the plurality of pressure sensors along the shaft.

[0018] Although a plurality of embodiments are disclosed, further other embodiments of the present invention will become apparent to those skilled in the art from the following detailed description showing and describing exemplary embodiments of the present invention. Therefore, the drawings and the detailed description should be considered to be illustrative in nature and not restrictive.

Brief Description of the Drawings

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DETAILED DESCRIPTION OF THE INVENTION

[0020] The present invention is capable of following various modified forms and alternative forms. However, specific embodiments are shown in the drawings as examples and will be described in detail below. However, the intention is not to limit the present invention to the specific embodiments described. On the contrary, the present invention is intended to embrace all modified forms, equivalents, and alternative forms included within the scope of the present invention as defined by the appended claims.

[0021] The following detailed description is essentially exemplary in nature and is in no way intended to limit the scope, applicability, or configuration of the present invention. Rather, the following description provides some practical exemplifications for implementing exemplary embodiments of the present invention. Examples of configurations, materials, and / or dimensions are provided for the selected elements. Those skilled in the art will recognize that there are various suitable alternative means for many of the examples described.

[0022] Therapeutic heat treatment can be used to treat a wide variety of medical conditions, including chronic venous diseases such as venous aneurysms that can expand and / or serpentine due to one or more pathological conditions. By applying sufficient thermal energy via an intravascular device, the target vein can be contracted or occluded to treat the venous aneurysm.

[0023] Exemplary catheters for use in treating aneurysms may include a handle, a long shaft connected to the handle, and a heating element disposed near the distal end of the shaft. In some embodiments, the heating element may include a coil that receives a current (e.g., alternating current, direct current) supplied by an energy generator to generate and supply thermal ablation energy. In certain embodiments, the heating element may include a coil that receives an electrical signal (e.g., high-frequency alternating current) generated by an energy generator to generate and supply high-frequency ablation energy.

[0024] As described above, there is a continuing need for improved devices and methods for providing intensively controlled thermal energy while minimizing or eliminating the impact on surrounding healthy tissue for the thermal treatment of chronic venous conditions such as aneurysms. For example, a physician needs to confirm that a shaft including a heating element fits into the vein and makes good contact with the target treatment site within the vein. Insufficient contact between the vein wall and the heating element can result in a decrease in efficiency and an extension of the treatment time when treating the disease, or an ineffective treatment result. Thus, a physician can more appropriately determine treatment conditions (e.g., temperature, time, etc.) for obtaining better treatment results and efficiency by locally measuring the pressure within the target blood vessel in real time.

[0025] Some embodiments of the present disclosure describe a catheter having an elongated shaft with a proximal end and a distal end defining a longitudinal axis, and a heating element disposed in the vicinity of the distal end of the shaft. In some embodiments, the heating element may include a coil member having a plurality of first windings wound in a first direction around the shaft, and a plurality of openings in the plurality of first windings are defined along the length of the heating element. In an exemplary embodiment, the catheter may further include a plurality of pressure sensors disposed longitudinally spaced apart from each other along the shaft, each of the pressure sensors being disposed on the shaft within an individual one of the plurality of openings in the plurality of first windings, adjacent pressure sensors being circumferentially offset from each other, and each pressure sensor being configured to generate an output signal indicative of the pressure applied to each pressure sensor by the surface of the target blood vessel.

[0026] FIG. 1 is a schematic diagram of an exemplary ablation device 100 for treating chronic venous diseases, such as varicose veins, according to an embodiment of the present disclosure. The ablation device 100 includes an ablation catheter 102 including a handle 104, an elongated shaft 106 having a distal end portion 110 terminating at a proximal end 108 and a distal end 112, and a heating element 114 disposed in the vicinity of the distal end 112 of the elongated shaft 106. The shaft 106 is sized and configured such that the distal end 112 can be inserted into the target blood vessel. The heating element 114 is configured to supply ablation energy (e.g., high-frequency energy, thermal energy) to the wall of the target blood vessel.

[0027] Device 100 may include an energy generator 116 that is electrically coupled to handle 104 via connector 118 and is configured to generate energy by supplying an electrical signal (e.g., current, high frequency alternating current). Controller 120 is operably connected to energy generator 116 and controls the generation of the electrical signal. Controller 120 may be implemented using firmware, integrated circuits, and / or software modules that interact with each other or are combined together. For example, controller 120 may include a memory 122 that stores computer-readable instructions / code 124 for execution by a processor 126 (e.g., a microprocessor) to implement aspects of the method embodiments described herein.

[0028] In certain embodiments, heating element 114 employs structural features and / or components to improve the clinical performance of ablation catheter 102 and enhance manufacturability. In some embodiments, heating element 114 may include two or more coils having windings wound in different directions around shaft 106, and the two or more coils intersect each other at multiple positions along shaft 106, such that, for example, the diameter of heating element 114 is larger. In certain embodiments, the two or more coils may be made from individual conductor wires, and controller 120 is configured to adjust the power of the treatment by selectively supplying current and / or by supplying specific currents (e.g., different currents) generated by energy generator 116 to the two or more conductor wires. In some embodiments, heating element 114 includes a plurality of coil segments, and one or more of the coil segments are configured to be individually controlled and / or addressed. In certain embodiments, one or more of the coil segments include two or more coils having windings wound in one or more directions. In some embodiments, one or more of the coil segments include two or more coils that intersect each other at one or more positions.

[0029] In some embodiments, the controller 120 can be configured to communicate with various components of the device 100 and generate a graphical user interface (GUI) displayed via the display 128. The controller 120 can include any type of computing device suitable for implementing the embodiments of the present disclosure. Examples of computing devices include workstations, servers, laptops, portable devices, desktops, tablet computers, handheld devices, dedicated computing devices such as general-purpose graphics processing units (GPGPUs), or general-purpose computing devices, all of which are contemplated within the scope of FIG. 1 with reference to the various components of the device 100.

[0030] In some embodiments, the controller 120 includes a bus that directly and / or indirectly couples devices such as a processor, memory, input / output (I / O) ports, I / O components, and a power supply. Any number of additional components, different components, and / or combinations of components can also be included in the computing device. The bus represents one or more buses (e.g., an address bus, a data bus, or a combination thereof). Similarly, in some embodiments, the computing device can include multiple processors, multiple memory components, multiple I / O ports, multiple I / O components, and / or multiple power supplies. Additionally, any number of these components, or combinations thereof, can be distributed and / or replicated across multiple computing devices.

[0031] In some embodiments, the memory 122 includes computer-readable media in the form of volatile and / or non-volatile memory, temporary and / or non-temporary storage media, and can be removable, non-removable, or a combination thereof. Examples of media include random access memory (RAM), read-only memory (ROM), electrically erasable programmable read-only memory (EEPROM), flash memory, optical or holographic media, magnetic cassettes, magnetic tapes, magnetic disk storage devices or other magnetic storage devices, data transmission, and / or any other media that can be used to store information and can be accessed by a computing device, such as a quantum state memory, and / or the like. In some embodiments, the memory 122 stores computer-executable instructions for causing a processor (e.g., the controller 120) to implement aspects of the embodiments of the system components described herein and / or to execute aspects of the embodiments of the methods and procedures described herein.

[0032] The computer-executable instructions 124 can include, for example, computer code, machine-usable instructions, and program components executable by one or more processors associated with a computing device, such as. The program components can be programmed using any number of different programming environments, including various languages, development kits, frameworks, and / or the like. Some or all of the functions contemplated herein can also or alternatively be implemented in hardware and / or firmware.

[0033] In some embodiments, memory 122 may include a data repository implemented using any one of the configurations described below. The data repository may include a random access memory, a flat file, an XML file, and / or one or more database management systems (DBMSs) running on one or more database servers or data centers. The database management system may be a relational (RDBMS), hierarchical (HDBMS), multidimensional (MDBMS), object-oriented (ODBMS or OODBMS), or object-relational (ORDBMS) database management system, etc. The data repository may be, for example, a single relational database. In some cases, the data repository may include multiple databases that can exchange and aggregate data by a data integration process or software application. In an exemplary embodiment, at least a portion of the data repository may be hosted in a cloud data center. In some cases, the data repository may be hosted on a single computer, server, storage device, cloud server, or the like. In some other cases, the data repository may be hosted on a series of network-connected computers, servers, or devices. In some cases, the data repository may be hosted on a hierarchical data storage device including local, regional, and central.

[0034] The various components of device 100 can communicate or be coupled to a communication interface, such as a wired interface or a wireless interface, for example. The communication interface can include, but is not limited to, wired or wireless short-range and long-range communication interfaces. For the wired interface, cables, umbilicals, and the like can be used. The short-range communication interface can be an interface compliant with known communication standards such as, for example, a local area network (LAN), the Bluetooth® standard, the IEEE 702 standard (e.g., IEEE 702.11), the ZigBee® or a similar specification (e.g., based on the IEEE 702.15.4 standard), or other public or proprietary wireless protocols. The long-range communication interface can be, for example, a wide area network (WAN), a cellular network interface, a satellite communication interface, and the like. The communication interface can be within a private computer network such as an intranet or on a public computer network such as the Internet.

[0035] FIG. 2A is a schematic view of an exemplary ablation catheter 200 that includes a connector 218 (similar to connector 118 as shown in FIG. 1) for treating chronic venous diseases, such as venous aneurysms. FIG. 2B is a schematic cross-sectional view of the connector 218 of the exemplary ablation catheter 200 along the cross-section indication line 2B-2B of FIG. 2A according to an embodiment of the present disclosure.

[0036] As shown, the ablation catheter 200 includes a handle 204, a elongate shaft 206 having a distal end portion 210 that terminates at a proximal end 208 and a distal end 212, and a heating element 214 disposed in the vicinity of the distal end 212 of the elongate shaft 206. The shaft 206 is sized and configured such that the distal end 212 can be inserted into a target blood vessel. The heating element 214 is configured to supply ablation energy (e.g., high-frequency energy, thermal energy) to the wall of the target blood vessel.

[0037] In some embodiments, the connector 218 includes pins 242 of different sizes (e.g., including pins 242a, 242b) and pins 244 (e.g., including pins 244a, 244b). The pins 242 are relatively smaller than the pins 244 and are configured to transmit electrical signals (e.g., the electrical signals generated by the energy generator 116 of FIG. 1). Exemplary electrical signals can include thermocouple signals or pressure signals. The pins 244 are relatively larger compared to the pins 242 and can be configured to pass an electric current from an energy generator (e.g., the energy generator 116 of FIG. 1) to generate heat in the heating element 214. One of the pins 244 can be used as a pin connected to ground (i.e., a ground pin). In some embodiments where the heating element includes a plurality of heating segments (e.g., coil segments), the ground pin can be used as a common ground pin by the plurality of heating segments.

[0038] Figures 3A - 3C respectively include a schematic front view, a partially enlarged view, and a partial cross - sectional view of an example of the distal end portion 300 of an ablation catheter according to an embodiment of the present disclosure. In some embodiments, the distal end portion 300 of an ablation catheter (e.g., the ablation catheter 102 of FIG. 1, the ablation catheter 200 of FIG. 2A) includes a portion of an elongate shaft 302 that terminates at a distal end 304, also referred to as the distal end portion of the shaft 302, and a heating element 306 disposed in the vicinity of the distal end 304 of the elongate shaft 302. The shaft 302 is sized and configured such that the distal end 304 can be inserted into a target blood vessel.

[0039] The heating element 306 includes a first heating coil 308 having a plurality of first windings 310 wound in a first direction 312 (indicated by the arrow around reference point A), and a second heating coil 314 having a plurality of second windings 316 wound in a second direction 318 (indicated by the arrow around reference point A). As shown, the first direction 312 is different from the second direction 318, and the second winding 316 intersects the first winding 310 at a plurality of positions spaced along the length (L) of the distal end portion 300 of the shaft 302. In some embodiments, the length (L) can be a length of about 2 cm to about 10 cm. In some embodiments, the length (L) can be a length of about 3 cm to about 8 cm. In an exemplary embodiment, the length L can be a length of about 5 cm to about 7 cm. The windings 310 and 316 can be wound around the shaft 302 using a winding machine to achieve a more tightly wound and smoother heating coils 308 and 314 around the shaft 302.

[0040] Figure 3B is a partial enlarged view of an example of the distal end portion 300 of the ablation catheter shown by the circle 3B in Figure 3A. As shown, the coil 308 can include a conductor wire 320, and the coil 314 can include a conductor wire 322. In some embodiments, the conductor wires 320 and 322 can be the same wire. In certain embodiments, the conductor wires 320 and 322 can be different wires. The conductor wires 320 and 322 can be single-filament or (not shown) multi-filament. In an embodiment, the conductor wires 320 and 322 each have an insulating cover, and the conductor wire 320 is electrically insulated from the conductor wire 322 during use of the catheter. In an exemplary embodiment, the insulating cover can be polyurethane or polyimide. In some embodiments, the conductor wires 320 and 322 can include single-filament wires that are symmetrically folded back and wound on the elongate shaft 302.

[0041] In some cases, the pitch between wires 320 and 322 (i.e., the distance between the midpoints of two adjacent wires) can be the same. In some cases, the pitch between wires 320 and 322 can be different. In some embodiments, wires 320 and 322 can be wound in the same direction (i.e., both clockwise or both counterclockwise). In some embodiments, wires 320 and 322 can be wound in opposite directions.

[0042] Figure 3C is a partial cross-sectional view of an example of the distal end portion 300 of the ablation catheter shown by arrow 3C in Figure 3A. Due to the intersection between coils 308 and 314, as shown in Figure 3C, the diameter of the heating element 306 increases from d1 to d2. The difference between d1 and d2 is greater than or equal to the thickness of the second heating coil 314. In some embodiments, the resulting diameter of the heating element 306 can be from about 1 mm to about 4 mm. In an exemplary embodiment, the resulting diameter of the heating element 306 can be from about 2 mm to about 3 mm. In some embodiments, coils 308 and 314 are operably connected to an energy generator (e.g., energy generator 116 of Figure 1) and are configured to generate thermal energy in response to receiving an electrical signal (e.g., a high-frequency current) from the energy generator.

[0043] In some embodiments, as shown in Figures 3A - 3C, conductor wires 320 and 322 can be single-filament. In some embodiments, conductor wires 320 and 322 can be multi-filament (not shown). In an exemplary embodiment, conductor wire 320 can include one filament folded and wound symmetrically on the elongate shaft 302, and conductor wire 322 can include one filament folded and wound symmetrically on the elongate shaft 302. The number of filaments in conductor wires 320 and 322 can be the same or different depending on the desired diameter for a particular treatment site and can be adjusted by including more or fewer filaments in the first heating coil 308 and / or the second heating coil 314.

[0044] By means of the cross design, it becomes possible to achieve any desired diameter of the heating element 306 simply by adjusting the number of fillers in each of the conductor wires. This enables ease of manufacturing by eliminating the need to produce shafts of different sizes (e.g., the elongated shafts 302 in FIGS. 3A - 3B). Since veins can meander due to chronic venous disease, it is not easy for an operator to insert the distal end portion 300 of the ablation catheter into the target vein. If the catheter is too rigid, it may become increasingly difficult to place the heating element 306 on the distal end portion 300 at a specific treatment site. As the flexibility of the catheter increases, it becomes easier for the distal end portion 300 to pass through the meandering vein and reach the target treatment site, and the surgical time can also be shortened. In addition, the cross design can increase the diameter of the catheter without increasing the diameter of the flexible elongated shaft 302.

[0045] In addition, the conductor wires 320, 322 are electrically insulated from each other and can be respectively controlled by a controller (e.g., the controller 120 in FIG. 1) to generate heat individually or simultaneously. Therefore, the physician and / or the controller can have the flexibility to adjust the amount of heat used in the treatment according to the patient's needs and the progress of the treatment.

[0046] In some embodiments, the conductor wires 320 and 322 are electrically connected in series and receive the same current from an energy generator (e.g., the energy generator 116 in FIG. 1) passing through them. In some embodiments, the conductor wires 320 and 322 are electrically insulated from each other and are respectively individually addressable by an energy generator (e.g., the energy generator 116 in FIG. 1). When the wires 320 and 322 are electrically insulated from each other, the controller (e.g., the controller 120 in FIG. 1) can be configured to selectively supply the current generated by the energy generator to one or both of the first and second conductor wires.

[0047] In some embodiments, the heating element 306 includes a plurality of coil segments that are longitudinally spaced apart from each other along the length of the distal end portion, and each coil segment includes a portion of the first heating coil and a portion of the second heating coil. In some embodiments, the heating coils 308 and 314 are resistive heating coils.

[0048] In some embodiments, the electrical signal generated by an energy generator (e.g., the energy generator 116 of FIG. 1) can be a high-frequency alternating current, and the heating coils 308 and 314 are configured to supply high-frequency ablation energy to the target tissue. In certain embodiments, one or more ground pads are used in conjunction with the heating coils 308 and 314 to supply high-frequency ablation energy to the target blood vessel. In some embodiments, the heating coils 308 and 314 are configured to form bipolar electrodes for supplying high-frequency ablation energy to the target tissue or blood vessel. For example, the heating coils 308 and 314 include two or more coil segments, and two of the coil segments form an electrode pair.

[0049] In some embodiments, the opening 326 can be formed along the length of the heating element 306, and the temperature sensor 328 can be disposed in the opening 326. Based on the temperature measured by the temperature sensor 328 or a signal indicative of the temperature, the controller (e.g., the controller 120 of FIG. 1) can be configured to adjust the respective currents to the conductor wires 320, 322 or selectively supply current to one or both of the conductor wires 320, 322. In some examples, if the measured temperature is too high, the controller can reduce the current generated by the energy generator. In a particular example, if the measured temperature is too high, the controller can supply the current generated by the energy generator to only one of the conductor wires 320, 322. In some examples, if the measured temperature is too low, the controller can increase the current generated by the energy generator. In a particular example, if the measured temperature is too low, the controller can supply the current generated by the energy generator to both of the conductor wires 320, 322.

[0050] FIG. 4 is a schematic view of a distal end portion of the ablation catheter of FIG. 1, according to an embodiment of the present disclosure. As shown, the distal end portion 400 includes a portion of an elongate shaft 402 that terminates at a distal end 404 and a heating element 406 disposed in the vicinity of the distal end 404 of the elongate shaft 402. The shaft 402 is sized and configured such that the distal end 404 can be inserted into a target blood vessel.

[0051] The heating element 406 includes a first heating coil 408 having a plurality of first windings 410 wound in one direction 412 (indicated by the arrow around reference point A), and a second heating coil 414 having a plurality of second windings 416 wound around the shaft 402 in that direction 412 and in the same radial direction as the first heating coil 408. In some embodiments, coils 408 and 414 are operably connected to an energy generator (e.g., energy generator 116 of FIG. 1) and are configured to generate thermal energy when current supplied by the energy generator is delivered to coils 408 and 414. In some embodiments, coils 408 and 414 are electrically insulated from each other and individually addressable by the energy generator.

[0052] In some embodiments, each of coils 408 and 414 may include a single-filament conductor wire. In some embodiments, each of coils 408 and 414 may include a multi-filament conductor wire. In certain embodiments, the first and second heating coils 408, 414 may include single-filament wires that are symmetrically folded and wound on the elongate shaft 402. In some embodiments, a controller (e.g., controller 120 of FIG. 1) may be configured to selectively supply current generated by the energy generator to one or both of the first and second conductor wires.

[0053] In some embodiments, the opening 426 may be formed along the length of the heating element 406, and the temperature sensor 428 may be disposed in the opening 426. Based on the temperature measured by the temperature sensor 428 or a signal indicative of the temperature, a controller (e.g., controller 120 of FIG. 1) may be configured to adjust the respective currents to the conductor wires of coils 408 and 414 or selectively supply current to one or both of the conductor wires of coils 408 and 414. In some examples, if the measured temperature is too high, the controller may reduce the current generated by the energy generator. In a particular example, if the measured temperature is too high, the controller may supply the current generated by the energy generator to only one of the conductor wires of coils 408 and 414. In some examples, if the measured temperature is too low, the controller may increase the current generated by the energy generator. In a particular example, if the measured temperature is too low, the controller may deliver the current generated by the energy generator to both of the conductor wires of coils 408 and 414.

[0054] In some embodiments, the first and second heating coils 408 and 414 are resistive heating coils. In some embodiments, the electrical signal generated by an energy generator (e.g., energy generator 116 of FIG. 1) may be a high-frequency alternating current, and the first and second heating coils 408 and 414 are configured to supply high-frequency ablation energy to the target tissue.

[0055] FIG. 5 is a schematic view of a distal end portion 500 of an ablation catheter according to an embodiment of the present disclosure. As shown, the distal end portion 500 includes a portion of an elongate shaft 502 that terminates at a distal end 504 and a heating element 506 disposed in the vicinity of the distal end 504 of the elongate shaft 502. The shaft 502 is sized and configured such that the distal end 504 can be inserted into a target blood vessel.

[0056] As shown, the heating element 506 can include one or more coils 508a-d, each of which has a plurality of windings 510a-d wound around the shaft 502. Each of the plurality of windings 510 defines a coil segment (e.g., 512a-d) and one or more segment gaps 514a-c between each of the adjacent coil segments 512a-d. The windings 510 can be wound around the shaft 502 using a winding machine to achieve a more compact and smoother coil 508 around the shaft 502. Using a winding machine can also help ensure the position of each coil segment (e.g., 512a-d).

[0057] Due to the segmented design, one or more segment gaps 514a-c are created, increasing the flexibility of the ablation catheter (e.g., ablation catheter 102 of FIG. 1, ablation catheter 200 of FIG. 2A) and minimizing potential undesirable damage to the blood vessel wall during the procedure. Each of the coil segments 512a-d can be of the same length. In some embodiments, the coil segments 512a-d can be wound by the same wire. In some embodiments, each of the coil segments 512a-d can be wound by different separate wires. In some embodiments, when each of the coil segments 512a-d is wound by a different wire, some or all of the coil segments 512a-d can be individually addressable by an energy generator (e.g., energy generator 116 of FIG. 1) and / or controllable by a controller (e.g., controller 120 of FIG. 1). For example, an ablation current is supplied to coil segment 512a and no ablation current is supplied to coil segment 512b. By making some or all of the coil segments 512a-d individually addressable and controllable, a current can be selectively applied to each of the coil segments 512a-d to form electrical paths of different lengths and selectively change the effective length of the heat treatment.

[0058] In some embodiments, coils 508a-d are operably connected to an energy generator (e.g., energy generator 116 of FIG. 1) and are configured to generate thermal energy when current supplied by the energy generator is delivered to coils 508a-d. In some embodiments, coils 508a-d are individually addressable by the energy generator. In some embodiments, each of coils 508a-d may include a single-filament conductor wire. In some embodiments, each of coils 508a-d may include a multi-filament conductor wire. In some embodiments, a controller (e.g., controller 120 of FIG. 1) may be configured to selectively supply current generated by the energy generator to one or more of the conductor wires of coils 508a-d.

[0059] In some embodiments, as shown, the plurality of windings 510a-d forming each of coil segments 512a-d may include openings 516a-d within each of coil segments 512a-d. In certain embodiments, one or more temperature sensors (e.g., temperature sensor 328 or 428 of FIGS. 3A-3B and 4) may be disposed within openings 516a-d.

[0060] In some embodiments, coils 508a-d are resistive heating coils. In some embodiments, the electrical signal generated by the energy generator (e.g., energy generator 116 of FIG. 1) may be a high-frequency alternating current, and coils 508a-d are configured to supply high-frequency ablation energy to the target tissue.

[0061] FIG. 6 is a schematic view of a distal end portion 600 of an ablation catheter according to an embodiment of the present disclosure. As shown, distal end portion 600 includes a portion of an elongate shaft 602 terminating at a distal end 604 and a heating element 606 disposed in the vicinity of distal end 604 of elongate shaft 602. Shaft 602 is sized and configured such that distal end 604 can be inserted into a target blood vessel.

[0062] As shown, the heating element 606 may include one or more coils 608a - c, and each coil has a plurality of windings 610a - c wound around the shaft 602. Each of the plurality of windings 610 defines a coil segment 612a - c and one or more segment gaps 614a - b between each of the adjacent coil segments 612a - d. The segmented design forms one or more segment gaps 614a - b. In certain embodiments, the shaft 602 includes a flexible material, and the one or more segment gaps 614a - b enhance the flexibility of the heating element 606 and the distal end portion 600 of the ablation catheter to minimize potential unwanted damage to the blood vessel wall during treatment, for example. Each of the coil segments 612a - c can have a different length. For example, coil segment 612a has a length different from that of coil segment 612b. As an example, coil segment 612b has a length different from that of coil segment 612c.

[0063] In some embodiments, the plurality of windings can form 2 - 8 coil segments, and each coil segment can be about 1 cm to about 5 cm in length. In some embodiments, the plurality of windings can form 3 - 6 coil segments, and each coil segment can be about 1 cm to about 3 cm in length. In an exemplary embodiment, as shown in FIG. 5 for example, the lengths of the coil segments can be the same, and the plurality of windings 510a - d include 4 coil segments 512a - d, and each coil segment can be about 1.4 cm to about 2.3 cm in length. In an exemplary embodiment, as shown in FIG. 6 for example, the lengths of the coil segments can be different, and the plurality of windings 610a - c include 3 coil segments 612a - c, and each coil segment can be about 1 cm to about 4 cm in length.

[0064] In some embodiments, coils 608a-c are operably connected to an energy generator (e.g., energy generator 116 of FIG. 1) and are configured to generate thermal energy when current supplied by the energy generator is delivered to coils 608a-c. In some embodiments, coils 608a-c are individually addressable by the energy generator. In some embodiments, each of coils 608a-c may include a single-filament conductor wire. In some embodiments, each of coils 608a-c may include a multi-filament conductor wire. In some embodiments, a controller (e.g., controller 120 of FIG. 1) may be configured to selectively supply current generated by the energy generator to one or more of the conductor wires of coils 608a-c.

[0065] In some embodiments, as shown, the plurality of windings 610a-c forming each of coil segments 612a-c may include openings 616a-c within each of coil segments 612a-c. In some embodiments, one or more temperature sensors (e.g., temperature sensor 328 or 428 of FIGS. 3A-3B and 4) may be disposed in openings 616a-c. In certain embodiments, coils 608a-c are resistive heating coils. In some embodiments, the electrical signal generated by the energy generator (e.g., energy generator 116 of FIG. 1) may be a high-frequency alternating current, and coils 608a-c are configured to supply high-frequency ablation energy to the target tissue.

[0066] FIG. 7 is a schematic view of a distal end portion of an ablation catheter according to an embodiment of the present disclosure. As shown, the distal end portion 700 includes a portion of an elongate shaft 702 that terminates at a distal end 704, and a heating element 706 disposed in the vicinity of the distal end 704 of the elongate shaft 702. The shaft 702 is sized and configured such that the distal end 704 can be inserted into a target blood vessel. In some examples, the distal end 704 has a diameter of 2 millimeters to 3 millimeters. In a particular example, the distal end 704 has a diameter of 1 millimeter to 5 millimeters. The heating element 706 may include one or more coil segments 712a-c. In a particular embodiment, within a particular diameter range, the distal end 704 and / or the heating element 706 are configured to be inserted into a blood vessel for ablation.

[0067] In some embodiments, the heating element 706 includes a first heating coil 708 having a plurality of first windings 710 wound in a first direction, and a second heating coil 714 having a plurality of second windings 716 wound in a second direction. In some embodiments, the first direction may be different from the second direction, and the second winding 716 intersects the first winding 710 within the length range of each of the coils 712a-c. Due to the intersection between the coils 708 and 714, as shown in FIG. 3B, the diameter of each of the coil segments 712a-c of the heating element 706 increases from d1 to d2. The difference between d1 and d2 is greater than or equal to the thickness of the second heating coil 714.

[0068] In some embodiments, the coils 708 and 714 are operably connected to an energy generator (e.g., the energy generator 116 of FIG. 1) and are configured to generate thermal energy in response to receiving an electrical signal (e.g., current) from the energy generator. In some embodiments, the coil 708 is individually addressable by the energy generator.

[0069] In some embodiments, one or more of the coil segments 712 (e.g., coil segment 712c) may include an opening 718c within the coil segment 712c. In some embodiments, one or more temperature sensors (e.g., temperature sensors 328 or 428 of FIGS. 3A-3B and 4) may be disposed within the opening 718c. In certain embodiments, coils 712a-c are resistive heating coils. In some embodiments, the electrical signal generated by an energy generator (e.g., energy generator 116 of FIG. 1) may be a high-frequency alternating current, and coils 712a-c are configured to supply high-frequency ablation energy to a target tissue.

[0070] In some embodiments, the first and second pluralities of windings 710, 716 are arranged to define a plurality of coil segments 712a-c, and adjacent coil segments (e.g., 712a-b or 712b-c) are longitudinally spaced from each other, defining one or more segment gaps 720 between each adjacent coil segment along the length of the shaft 702. In certain embodiments, the heating element 706 is configured as a plurality of coil segments 712a-c that are longitudinally spaced from each other along the length of the heating element 706, and each coil segment 712a-c includes a portion of the first heating coil 708 and a portion of the second heating coil 714.

[0071] FIGS. 8A-8C are, respectively, a schematic front view, a partial cross-sectional view, and a projection view of a distal end portion of an ablation catheter according to an embodiment of the present disclosure. As shown, the distal end portion 800 includes a portion of an elongate shaft 802 that terminates at a distal end 804, and a heating element 806 disposed in the vicinity of the distal end 804 of the elongate shaft 802. The shaft 802 is sized and configured such that the distal end 804 can be inserted into a target blood vessel.

[0072] The heating element 806 includes a coil member 808 that includes a plurality of windings 810 wound around a shaft 802, and a plurality of openings 812a-d are defined in the plurality of windings 810 along the length of the heating element 806. In some embodiments, the coil member 808 is operatively connected to an energy generator (e.g., energy generator 116 of FIG. 1) and is configured to generate thermal energy when current supplied by the energy generator is delivered to the coil member 808.

[0073] In some embodiments, a plurality of pressure sensors 814a-d are longitudinally spaced from each other along the shaft, each of the pressure sensors 814a-d is disposed on the shaft within an individual one of the openings 812a-d in the plurality of first windings, adjacent pressure sensors are circumferentially offset from each other, and each pressure sensor 814a-d is configured to generate an output signal indicative of the pressure applied to each pressure sensor 814a-d by the surface of the target blood vessel. In certain embodiments, two adjacent pressure sensors have a circumferential offset angle between them. In some examples, adjacent pressure sensors 814a and 814b include an offset angle 815a, adjacent pressure sensors 814b and 814c include an offset angle 815b, adjacent pressure sensors 814c and 814d include an offset angle 815c, and adjacent pressure sensors 814d and 814a include an offset angle 815d.

[0074] In some embodiments, the coil member 808 further includes a plurality of second windings (not shown) wound around the shaft 802 in a second direction different from the first direction, and at least some of the plurality of second windings intersect the plurality of first windings 810 at a plurality of positions spaced along the length of the heating element 806. In some embodiments, at least some of the openings 812a-d are defined between the plurality of first windings 810 and the plurality of second windings. In a particular embodiment, the pressure sensors are circumferentially distributed along the shaft at equal offset angles (e.g., angles 815a-d) between two adjacent pressure sensors. For example, although not shown, in some embodiments, the plurality of pressure sensors includes three pressure sensors, and each of two adjacent pressure sensors among the three pressure sensors is offset circumferentially from each other by 120 degrees.

[0075] In an exemplary embodiment, as shown in FIGS. 8A-8C, the plurality of pressure sensors includes four pressure sensors 814a-d, and each of two adjacent pressure sensors among the four pressure sensors 814a-d is offset circumferentially from each other by 90 degrees. Although not shown, in some embodiments, the plurality of pressure sensors includes six pressure sensors, and each of two adjacent pressure sensors among the six pressure sensors is offset circumferentially from each other by 60 degrees. In some embodiments, the plurality of pressure sensors includes six pressure sensors, and each of two adjacent pressure sensors among the six pressure sensors is offset circumferentially from each other by 120 degrees.

[0076] In some embodiments, the heating element 806 may further include a temperature sensor (not shown) disposed on the shaft 802. In some embodiments, the plurality of pressure sensors includes at least one selected from the group consisting of a piezoelectric pressure sensor, a capacitive pressure sensor (i.e., a sensor that measures a change in electrode impedance when the electrode contacts the vein wall), an inductive pressure sensor, a strain gauge pressure sensor, an optical fiber pressure sensor, and a potentiometric pressure sensor. As will be appreciated by those skilled in the art, any type of sensor that can indicate the contact pressure between the sensor (e.g., sensors 814a-d) and the vein wall may be used herein.

[0077] During the procedure, the heating element 806 is controlled to supply ablation energy when an output signal indicating the pressure generated by one of the plurality of pressure sensors is greater than a predetermined threshold. In some embodiments, the heating element 806 is controlled to supply ablation energy when an output signal indicating the pressure generated by two of the plurality of pressure sensors is greater than a predetermined threshold. In some embodiments, the heating element 806 is controlled to supply ablation energy when an output signal indicating the pressure generated by two adjacent pressure sensors of the plurality of pressure sensors is greater than a predetermined threshold. In some embodiments, the heating element 806 is controlled to supply ablation energy when an output signal indicating the pressure generated by all of the plurality of pressure sensors is greater than a predetermined threshold. The pressure sensors (e.g., 814a-d) are configured to monitor the pressure of the heating element 806 along the elongate shaft 802 such that an operator or a controller (e.g., controller 120 in FIG. 1) can estimate the degree of vein wall sealing (i.e., vein constriction) during the procedure, more accurately determine the course of the procedure, and adjust the treatment plan accordingly.

[0078] FIG. 9 is a schematic view of a distal end portion of an ablation catheter according to an embodiment of the present disclosure. As shown, the distal end portion 900 includes a portion of an elongate shaft 902 that terminates at a distal end 904, and a heating element 906 disposed in the vicinity of the distal end 904 of the elongate shaft 902. The shaft 902 is sized and configured such that the distal end 904 can be inserted into a target blood vessel.

[0079] As shown, the heating element 906 can include one or more coils 908a-d, each of which has a plurality of windings 910a-d wound around the shaft 902. Each of the plurality of windings 910 defines a coil segment 912a-d and one or more segment gaps 914a-c between each of the adjacent coil segments 912a-d. The segmented design creates one or more segment gaps 914a-c, increasing the flexibility of the distal end portion 900 of the ablation catheter and minimizing potential unwanted damage to the vessel wall during treatment. Each of the coil segments 912a-d can be of the same length. In certain embodiments, some or all of the coil segments 912a-d are individually addressable and / or controllable. For example, an ablation current is supplied to coil segment 912a and not to coil segment 912b.

[0080] In some embodiments, the coils 908a-d are operably connected to an energy generator (e.g., energy generator 116 of FIG. 1) and are configured to generate thermal energy when current supplied by the energy generator is delivered to the coils 908a-d. In some embodiments, the coils 908a-d are individually addressable by the energy generator.

[0081] In some embodiments, each of coils 908a - d may include a single - filament conductor wire. In some embodiments, each of coils 908a - d may include a multi - filament conductor wire. In some embodiments, a controller (e.g., controller 120 of FIG. 1) may be configured to selectively supply current generated by an energy generator to one or more of the conductor wires of coils 908a - d.

[0082] In some embodiments, as shown, the plurality of windings 910a - d forming each of coil segments 912a - d may include openings 916a - d within each of coil segments 912a - d. In certain embodiments, one or more temperature sensors (e.g., temperature sensors 328 or 428 of FIGS. 3A - 3B and 4) may be disposed in openings 916a - d.

[0083] In some embodiments, coils 908a - d are resistive heating coils. In some embodiments, the electrical signal generated by an energy generator (e.g., energy generator 116 of FIG. 1) may be a high - frequency alternating current, and coils 908a - d are configured to supply high - frequency ablation energy to a target tissue or blood vessel.

[0084] In some embodiments, the heating element 906 may include a plurality of sets of coil segments 912a - d having a corresponding plurality of sets of pressure sensors 918a - d (pressure sensor 918d is not shown in FIG. 9), and a set of pressure sensors (e.g., a set of 3 pressure sensors, a set of 4 pressure sensors) may cover the entire circumference with a set of coil segments (e.g., a set of 3 coil segments). In some examples, the sum of the offset angles (e.g., four offset angles of 90 degrees each, a set of offset angles of (90, 120, 90, 60)) between adjacent pressure sensors in a set of pressure sensors is equal to 360 degrees. In some examples, the first set of pressure sensors and the second set of pressure sensors have the same adjacent offset angle pattern with respect to each other. In some examples, when an output signal indicating the pressure generated by at least one pressure sensor in a set of pressure sensors is greater than a predetermined threshold, the set of coil segments is activated (e.g., a current (single or plural) is supplied). In some examples, when none of the output signals indicating the pressure generated by a set of pressure sensors is greater than a predetermined threshold, the set of coil segments is deactivated (e.g., a current (single or plural) is not supplied).

[0085] In an exemplary embodiment, at least one pressure sensor among the plurality of pressure sensors 918a - d is disposed in an opening (e.g., opening 916a, 916b, 916c, or 916d) within a coil segment (e.g., coil segments 912a, 912b, 912c, or 912d). In some embodiments, the heating element may further include a temperature sensor (e.g., temperature sensor 328 or 428 in FIGS. 3A - 3B and 4) disposed in one of the one or more segment gaps 914a - c. The temperature sensor may be longitudinally spaced from one of the plurality of pressure sensors 918a - d and may be circumferentially offset from one of the plurality of pressure sensors 918a - d.

[0086] FIG. 10 is a schematic view of a distal end portion of an ablation catheter according to an embodiment of the present disclosure. As shown, the distal end portion 1000 includes a portion of an elongate shaft 1002 that terminates at a distal end 1004, and a heating element 1006 disposed in the vicinity of the distal end 1004 of the elongate shaft 1002. The shaft 1002 is sized and configured such that the distal end 1004 can be inserted into a target blood vessel.

[0087] As shown, the heating element 1006 can include one or more coils 1008a-c, each having a plurality of windings 1010a-c wound around the shaft 1002. Each of the plurality of windings 1010 defines a coil segment 1012a-c and one or more segment gaps 1014a-b between each of the adjacent coil segments 1012a-c. The segmented design forms one or more segment gaps 1014a-b. In certain embodiments, the shaft 1002 includes a flexible material, and the one or more segment gaps 1014a-b enhance the flexibility of the heating element 1006 and the distal end portion 1000 of the ablation catheter, for example, to minimize potential unwanted damage to the vessel wall during a procedure. Each of the coil segments 1012a-c can have a different length. For example, coil segment 1012a has a length different from that of coil segment 1012b. As an example, coil segment 1012b has a length different from that of coil segment 1012c.

[0088] In some embodiments, coils 1008a - c are operably connected to an energy generator (e.g., energy generator 116 of FIG. 1) and are configured to generate thermal energy when current supplied by the energy generator is delivered to coils 1008a - c. In some embodiments, coils 1008a - c are individually addressable by the energy generator. In some embodiments, each of coils 1008a - c may include a single - filar conductor wire. In some embodiments, each of coils 1008a - c may include a multi - filar conductor wire. In some embodiments, a controller (e.g., controller 120 of FIG. 1) may be configured to selectively supply the current generated by the energy generator to one or more of the conductor wires of coils 1008a - c.

[0089] In some embodiments, as shown, each of the plurality of windings 1010a - c forming each of coil segments 1012a - c may include openings 1016a - c within each of coil segments 1012a - c. In certain embodiments, coils 1008a - c are resistive heating coils. In some embodiments, the electrical signal generated by an energy generator (e.g., energy generator 116 of FIG. 1) may be a high - frequency alternating current, and coils 1008a - c are configured to supply high - frequency ablation energy to a target tissue or blood vessel.

[0090] In certain embodiments, the heating element 1006 may include a plurality of sets of coil segments 1012a - c having corresponding plural sets of pressure sensors 1018a - c, and one set of pressure sensors (e.g., a set of three pressure sensors) covers the entire circumference with one set of coil segments (e.g., a set of three coil segments). In some examples, the sum of the offset angles between adjacent pressure sensors of one set of pressure sensors (e.g., three offset angles of 120 degrees each, a set of offset angles of (180, 120, 60)) is equal to 360 degrees. In some examples, when an output signal indicating the pressure generated by at least one pressure sensor of one set of pressure sensors is greater than a predetermined threshold, the set of coil segments is activated (e.g., current(s) is / are supplied). In some examples, when none of the output signals indicating the pressure generated by a set of pressure sensors is greater than a predetermined threshold, the set of coil segments is deactivated (e.g., current(s) is / are not supplied).

[0091] In an exemplary embodiment, at least one of the plurality of pressure sensors 1018a - c is disposed within an opening (e.g., opening 1016a, 1016b, or 1016c) in a coil segment (e.g., coil segment 1012a, 1012b, or 1012c). In some embodiments, the heating element 1006 may further include a temperature sensor (e.g., temperature sensor 328 or 428 in FIGS. 3A - 3B and 4) disposed in one of the one or more segment gaps 1014a - b. The temperature sensor may be longitudinally spaced from one of the plurality of pressure sensors 1018a - c and may be circumferentially offset from one of the plurality of pressure sensors 1018a - c. In some embodiments, one or more temperature sensors (e.g., temperature sensor 328 or 428 in FIGS. 3A - 3B and 4) may be disposed in the openings 1016a - c.

[0092] In some embodiments (e.g., as shown in FIG. 7), the heating element (e.g., heating element 114 of FIG. 1) may include first and second pluralities of windings arranged to define a plurality of coil segments, at least some of the second plurality of windings intersect the first windings along the length of the heating element, adjacent coil segments are longitudinally spaced from each other, and one or more segment gaps are defined between each adjacent coil segment along the length of the shaft. In an exemplary embodiment, one or more openings are formed in one or more of the plurality of coil segments, and at least one of the plurality of pressure sensors is disposed in an opening within a coil segment. In some embodiments, the heating element may further include a temperature sensor disposed in one of the one or more segment gaps. The temperature sensor may be longitudinally spaced from one of the plurality of pressure sensors and circumferentially offset from one of the plurality of pressure sensors.

[0093] FIGS. 11A-11B are schematic views of a portion of an ablation catheter for use within a target vessel of a patient for the treatment of an aneurysm, according to an embodiment of the present disclosure. In some embodiments, during an endovenous thermal ablation procedure, an introducer sheath may be placed within a target vein of a patient using ultrasound guidance and standard vascular techniques. The ablation catheter (e.g., ablation catheter 102 in FIG. 1) may then be inserted through the introducer sheath into the target vein. In some situations, under ultrasound guidance, an infiltrating anesthetic solution or saline may be injected into the target vein segment to function as a heat sink to protect the tissue from thermal damage and to improve the thermal conductivity between the wall of the target vein and the ablation catheter.

[0094] As shown in FIG. 11A, the distal end portion 1100 of an ablation catheter (e.g., ablation catheter 102 of FIG. 1) is disposed within the target blood vessel 1102a. The ablation catheter can be introduced and positioned by an introducer sheath using ultrasonic guidance. As will be understood by those skilled in the art, any standard vascular technique may be used herein to introduce and position the distal end portion 1100 of the ablation catheter within the target vein segment. The distal end portion 1100 may include a heating element 1106 having heating coils 1108 and 1114.

[0095] In some embodiments, during the procedure, an electric current can be applied to heating coils 1108 and 1114 by a generator (e.g., energy generator 116 of FIG. 1). The generator can include a high-frequency generator that generates a high-frequency electric current to heat heating coils 1108 and 1114. In some implementations, the ablation catheter can include a temperature sensor disposed along the length of the catheter shaft, and the power supply to the coils can be automatically adjusted by a controller (e.g., controller 120 of FIG. 1) based on the temperature measured by the temperature sensor or a signal indicative of the temperature. In some embodiments, the power supply to heating coils 1108 and 1114 can heat heating coils 1108 and 1114 to about 80° C. to about 140° C. to treat the venous aneurysm. In some embodiments, the power supply to heating coils 1108 and 1114 can heat heating coils 1108 and 1114 to about 100° C. to about 130° C. to treat the venous aneurysm. In some embodiments, the power supply to heating coils 1108 and 1114 can heat heating coils 1108 and 1114 to about 120° C. to treat the venous aneurysm.

[0096] Segments of the target vessel 1102a to be treated adjacent to the heating coils 1108 and 1114 will close (e.g., contract, reduce in diameter) as the coils are heated, as shown as 1102b in FIG. 11B. During the treatment, external pressure can be applied as needed. After a particular section has been treated (i.e., the section of the vein has closed), the catheter can be moved toward the venous access, as indicated by arrow 1116, and this process is repeated until the entire vein is closed. The catheter and introducer sheath can then be removed after the treatment has been performed. In some use cases, the diameter of the heating element 1106 is smaller than the diameter of the vessel 1102a, and during the treatment, the heating element 1106 can be moved closer to the vessel wall.

[0097] In some embodiments, a device for treating an aneurysm may include an energy generator configured to generate an electric current, a controller operably connected to the energy generator to control the generation of the electric current, and a catheter connected to the energy generator. The catheter is a long shaft connected to the handle, having a handle and a distal end portion terminated at a proximal end and a distal end, the size of the distal end being determined and configured such that it can be inserted into the target blood vessel, and may include a heating element disposed near the distal end of the long shaft, the heating element comprising a first heating coil having a plurality of first windings wound in a first direction around the shaft, and a second heating coil having a plurality of second windings wound in the first direction in the same radial direction as the first heating coil around the shaft, the first and second heating coils being each operably connected to the energy generator and configured to generate thermal energy when an electric current supplied by the energy generator is delivered to the first and second heating coils, the first and second heating coils being electrically insulated from each other and individually addressable by the energy generator. In some embodiments, the first and second heating coils may each comprise a single-filament conductor wire. In some embodiments, the first and second heating coils may each comprise a multi-filament conductor wire. In some embodiments, the first and second heating coils may be resistive heating coils, the electrical signal may be a high-frequency alternating current, and the first and second heating coils are configured to supply high-frequency ablation energy to the target tissue.

[0098] As used herein, the terms “about” and “approximately” are used with respect to measured values (e.g., dimensions, characteristics, attributes, components, etc.) and ranges thereof, specifically with respect to tangible things (e.g., products, inventories, etc.) and / or intangible things (e.g., data, electronic currency representations, accounts, information, ratios of things (e.g., percentages, fractions), calculations, data models, dynamic system models, algorithms, parameters, etc.), and may be used interchangeably. These “about” and “approximately” include the recited measured values and also measured values reasonably close to the recited measured values, and are understood to include minor differences that would be readily discernible to a person of ordinary skill in the relevant art due to measurement error, differences in calibration of measuring or manufacturing equipment, human error in reading and / or setting measured values, adjustments for optimization of performance and structural parameters in view of other measured values (e.g., measured values related to other things), particular implementation scenarios, human, computing device, mechanical operation, setting, inaccurate adjustment and / or operation of measured values, system tolerances, control loops, machine learning, predictable variations (e.g., statistically negligible variations, chaotic variations, system and / or model instabilities, etc.), preferences, and / or the like.

[0099] Exemplary methods may be represented by one or more drawings (e.g., flowcharts, communication flows, etc.), but the drawings should not be construed as implying requirements for the various steps disclosed herein or a particular order between steps. However, some specific embodiments may require specific steps and / or a particular order between specific steps, as may be explicitly described herein and / or understood from the nature of the steps themselves (e.g., the execution of some steps may depend on the result of a previous step). Further, a “set,” “subset,” or “group” of items (e.g., inputs, algorithms, data values, etc.) may include one or more items, and similarly, a subset or subgroup of items may include one or more items. “Plurality” means two or more.

[0100] Various modifications and additions can be made to the exemplary embodiments described without departing from the scope of the invention. For example, although the above embodiments refer to specific features, the scope of the invention also includes embodiments having different combinations of features and embodiments that do not include all of the described features. Accordingly, the scope of the invention is intended to embrace all such alternative, modified, and variant forms, together with all of their equivalents, that are included in the claims.

Claims

Claim 1 A device for treating an aneurysm, comprising a long catheter having a long shaft defining a longitudinal axis with a proximal end and a distal end, the distal end being sized and configured to be inserted into a target blood vessel, the long shaft; a heating element disposed near the distal end of the long shaft, the heating element comprising a coil member having a plurality of first windings wound in a first direction around the shaft, a plurality of openings in the plurality of first windings being defined along the length of the heating element, the heating element; a plurality of pressure sensors spaced longitudinally apart from each other along the shaft, each of the plurality of pressure sensors being disposed on the shaft within an individual one of the plurality of openings in the plurality of first windings, adjacent pressure sensors being circumferentially offset from each other, each pressure sensor being configured to generate an output signal indicative of the pressure applied to each pressure sensor by the surface of the target blood vessel, the plurality of pressure sensors, a device comprising. Claim 2 The coil member further comprises a plurality of second windings wound in a second direction different from the first direction around the shaft, at least some of the plurality of second windings intersecting the plurality of first windings at a plurality of positions spaced along the length of the heating element, at least some of the plurality of openings being defined between the plurality of first windings and the plurality of second windings, the device according to claim 1. Claim 3 The plurality of pressure sensors includes N pressure sensors, two adjacent pressure sensors of the plurality of pressure sensors being circumferentially offset from each other by an offset degree associated with N, the device according to any one of claims 1 or 2. Claim 4 ​ The plurality of pressure sensors includes a first pair of pressure sensors and a second pair of sensors. The first pair of pressure sensors includes a first pressure sensor and a second pressure sensor adjacent to the first pressure sensor. The second pressure sensor is offset in the circumferential direction by a first offset angle with respect to the first pressure sensor. The second pair of sensors includes a third pressure sensor and a fourth pressure sensor adjacent to the third pressure sensor. The fourth pressure sensor is offset in the circumferential direction by a second offset angle with respect to the third pressure sensor. The second offset angle is equal to the first offset angle. The device according to claim 1.

5. The plurality of first windings and the plurality of second windings are arranged to define a plurality of coil segments. Adjacent coil segments are longitudinally spaced apart from each other, and one or more segment gaps are defined between each adjacent coil segment along the length of the shaft. The device further includes a temperature sensor, and the temperature sensor is disposed in one of the one or more segment gaps. At least one of the plurality of pressure sensors is disposed in an opening within a coil segment. The device according to claim 1.

6. The plurality of pressure sensors includes six pressure sensors. The device according to claim 1.

7. Two adjacent pressure sensors among the plurality of pressure sensors are offset from each other by 60 degrees in the circumferential direction. The device according to claim 6.

8. Two adjacent pressure sensors among the plurality of pressure sensors are offset from each other by 120 degrees in the circumferential direction. The device according to claim 6.

9. The plurality of pressure sensors includes at least one selected from the group consisting of a piezoelectric pressure sensor, a capacitive pressure sensor, an inductive pressure sensor, a strain gauge pressure sensor, and a potentiometric pressure sensor. The device according to any one of claims 1 to 8.

10. The heating element is controlled to supply ablation energy when an output signal indicating the pressure generated by one of the plurality of pressure sensors is greater than a predetermined threshold. The device according to any one of claims 1 to 8.

11. A device for treating an aneurysm, comprising: an energy generator configured to generate an electrical signal; a controller operably connected to the energy generator and configured to control the generation of the electrical signal; a long catheter connected to the energy generator, the long catheter comprising: a long shaft having a proximal end and a distal end and defining a longitudinal axis, the distal end being sized and configured to be inserted into a target blood vessel; a heating element disposed near the distal end of the long shaft; a first coil member comprising a first plurality of windings wound around the shaft, one or more first openings in the first plurality of windings being defined along the length of the first coil member; a second coil member comprising a second plurality of windings wound around the shaft, one or more second openings in the second plurality of windings being defined along the length of the second coil member, the heating element including the second coil member; a plurality of pressure sensors disposed longitudinally spaced apart from each other along the shaft, each pressure sensor of the plurality of pressure sensors being disposed on the shaft within an individual opening of the first openings in the first plurality of windings or the second openings in the second plurality of windings, at least two adjacent pressure sensors being circumferentially offset from each other, each pressure sensor being configured to generate an output signal indicative of the pressure applied to the pressure sensor by the surface of the target blood vessel; wherein the first and second coil members are each operably connected to the energy generator and configured to generate thermal energy when the electrical signal generated by the energy generator is delivered to the first and second coil members. Claim 12 The heating element further includes a third coil member including a third plurality of windings wound around the shaft, and one or more third openings in the third plurality of windings are defined along the length of the third coil member, and one or more of the plurality of pressure sensors are disposed on the shaft within one or more of the third openings. The device according to claim 11.

13. The controller is configured to adjust the current generated by the energy generator based on the output signal indicating the pressure applied to each pressure sensor generated by each pressure sensor of the plurality of pressure sensors. The device according to claim 11.

14. The controller is configured to control the current generated by the energy generator to be selectively delivered to one or both of the first coil member and the second coil member. The device according to any one of claims 11 to 13.

15. The device further includes a temperature sensor disposed on the shaft within one of the first opening or the second opening, and the temperature sensor is longitudinally spaced from one of the plurality of pressure sensors along the shaft. The device according to any one of claims 11 to 14.

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