Ablation catheter with inductive heating for treating aneurysms

Abstract

At least some embodiments of the present disclosure relate to a catheter for use in the treatment of aneurysms, including a handle, an elongate shaft connected to the handle, and a heating element disposed in the vicinity of the distal end of the shaft. In some embodiments, the heating element is formed from a magnetic material and includes a tubular conductor connected to the elongate shaft and an induction coil helically wound on the tubular conductor.

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 as opposed 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 delivering 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, a device for treating a venous aneurysm includes a catheter, the catheter including an elongate shaft having a proximal end and a distal end, and a heating element disposed in the vicinity of the distal end of the elongate shaft. The elongate shaft can be sized and configured such that the distal end can be inserted into a blood vessel, and the heating element is formed from a magnetic material and can include a tubular conductor connected to the elongate shaft, an induction coil helically wound around the tubular conductor, and a dielectric layer disposed between the tubular conductor and the induction coil.

[0006] In Example 2, in the device of Example 1, the induction coil is configured to generate an electromagnetic induction field around the tubular conductor, and the tubular conductor is configured to generate sufficient thermal energy for ablation.

[0007] In Example 3, in the device of either Example 1 or 2, the dielectric layer includes an insulating coating disposed on the induction coil. In Example 4, in the device of any one of Examples 1 to 3, the heating element includes a set of tubular conductors, the set of tubular conductors having a tubular conductor and one or more additional tubular conductors, and the set of tubular conductors being longitudinally spaced apart from each other along the shaft.

[0008] In Example 5, in the device of Example 4, the heating element further includes one or more non-conductive (non-conductive) tubular portions, and at least one non-conductive tubular portion is disposed between two adjacent tubular conductors of the set of tubular conductors.

[0009] In Example 6, in the device of Example 5, the one or more non-conductive tubular portions are flexible. In Example 7, in the device of Example 6, at least one of the one or more non-conductive tubular portions is configured to allow a bending angle greater than 30 degrees between two adjacent tubular conductors.

[0010] In Example 8, in the device of any one of Examples 1 to 7, the tubular conductor includes stainless steel or carbon steel. In Example 9, in the device of any one of Examples 1 to 8, the induction coil includes a conductive material.

[0011] In Example 10, in the device of any one of Examples 1 to 9, the induction coil includes varnished copper wire. In Example 11, in the device of any one of Examples 1 to 10, the dielectric layer is resistant to high temperatures and is configured to insulate the tubular conductor and the induction coil.

[0012] In Example 12, in any of the devices of Examples 1 to 11, the dielectric layer includes polyimide. In Example 13, a system for treating an aneurysm includes any of the devices of Examples 1 to 12, an energy generator connected to a long catheter and configured to generate an electrical signal, and a controller operably connected to the energy generator and configured to control the generation of the electrical signal.

[0013] In Example 14, in the system of Example 13, the induction coil of the heating element is electrically connected to the energy generator. In Example 15, in the system of Example 14, the heating element includes a set of tubular conductors longitudinally spaced apart from each other along the shaft, and the induction coil includes a plurality of coil segments individually connected to the energy generator, and each coil segment of the plurality of coil segments is individually controllable and addressable.

[0014] Although multiple 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

[0015]

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Mode for Carrying Out the Invention

[0016] Although the present invention is capable of following various modification forms and alternative forms, 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 include all modification forms, equivalents, and alternative forms included within the scope of the present invention defined by the appended claims.

[0017] The following detailed description is merely exemplary in nature and is not intended to limit the scope, applicability, or configuration of the invention in any way. Rather, the following description provides some practical illustrations for implementing exemplary embodiments of the 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 described examples.

[0018] Therapeutic heat treatment can be used to treat a variety of medical conditions, including chronic venous diseases such as varicose veins that can expand and / or serpentine due to one or more pathological conditions. By applying sufficient thermal energy via an intravascular device, varicose veins can be treated by contracting or occluding the target vein.

[0019] An exemplary catheter for use in treating varicose veins can 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 can receive an electric current (e.g., alternating current, direct current) supplied by an energy generator and generate and supply thermal ablation energy. In certain embodiments, the heating element can receive an electrical signal (e.g., high-frequency alternating current) generated by an energy generator and generate and supply high-frequency ablation energy.

[0020] As described above, there is a continuing need for improved devices and methods for delivering intensively controlled thermal energy while minimizing or eliminating the impact on surrounding healthy tissue for the thermal treatment of chronic venous conditions such as varicose veins. For example, catheters used to treat target blood vessels are desired to have improved flexibility to minimize potential undesirable damage to the vessel wall during treatment. Alternative methods of delivering thermal energy for treatment are also desired for improving and diversifying treatment methods. In some cases, methods for increasing the rate of heat generation are desired.

[0021] Some embodiments of the present disclosure will be described with respect to a catheter having an elongate shaft with a proximal end and a distal end, and a heating element disposed in the vicinity of the distal end of the shaft. In some embodiments, the heating element is formed from a magnetic material and includes a tubular conductor connected to the elongate shaft, an induction coil spirally wound around the tubular conductor, and a dielectric layer disposed between the tubular conductor and the induction coil. In some embodiments, the heating element includes a plurality of tubular conductors formed from a magnetic material that are longitudinally spaced apart from each other along the shaft and connected to the elongate shaft, an induction coil spirally wound around the tubular conductor, and a dielectric layer disposed between the tubular conductor and the induction coil.

[0022] Figure 1 is a schematic view of an exemplary ablation device 100 for treating chronic venous diseases, such as venous aneurysms, according to an embodiment of the present disclosure. The ablation device 100 includes an ablation catheter 102 that includes a handle 104, an elongate shaft 106 having a distal end portion 110 that terminates 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 elongate shaft 106. The shaft 106 is sized and configured such that the distal end 112 can be inserted into a target blood vessel. The heating element 114 is configured to supply ablation energy (e.g., radiofrequency energy, thermal energy) to the wall of the target blood vessel.

[0023] The ablation device 100 may include an energy generator 116 that is electrically coupled to the handle 104 via a connector 118 and is configured to generate energy by supplying an electrical signal (e.g., current, high-frequency alternating current). A controller 120 is operably connected to the energy generator 116 and controls the generation of the electrical signal. The controller 120 may be implemented using firmware, integrated circuits, and / or software modules that interact with each other or are combined together. For example, the 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.

[0024] In certain embodiments, the heating element 114 employs structural features and / or components to improve the clinical performance of the ablation catheter 102 and enhance manufacturability. In some embodiments, the heating element 114 may include a tubular conductor formed from a magnetic material and connected to a elongate shaft 106, an induction coil helically wound on the tubular conductor, and a dielectric layer disposed between the tubular conductor and the induction coil. In some embodiments, the heating element 114 may include a plurality of tubular conductors formed from a magnetic material that are longitudinally spaced apart from each other along the shaft 106, with at least one of the plurality of tubular conductors extending from the shaft 106, a plurality of tubular conductors, an induction coil helically wound on the tubular conductor, and a dielectric layer disposed between the tubular conductor and the induction coil. In certain embodiments, there is a non-conductive tubular portion between two adjacent tubular conductors. In some embodiments, the induction coil includes a plurality of coil segments, and each coil segment is proximate to a corresponding tubular conductor.

[0025] In some embodiments, the heating element 114 may include one or more non-conductive tubular portions, and at least one non-conductive tubular portion is disposed between two adjacent tubular conductors of the plurality of tubular conductors. In some embodiments, the heating element 114 includes non-conductive tubular portions disposed between each pair of adjacent tubular conductors of the plurality of tubular conductors. In certain embodiments, the dielectric layer is disposed on the tubular conductor to provide electrical insulation. In some embodiments, the dielectric layer includes a material having a relatively high thermal conductivity. In certain embodiments, the dielectric layer is disposed on the induction coil.

[0026] In embodiments, the induction coil may be connected to the energy generator 116 by the handle 104 and the cable 105. In some embodiments, the controller 120 may be configured to communicate with various components of the device 100 and generate a graphical user interface (GUI) displayed via the display 128.

[0027] The controller 120 may include any type of computing device suitable for implementing 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.

[0028] In some embodiments, the controller 120 includes a bus that directly and / or indirectly couples devices such as a processor, a memory, input / output (I / O) ports, I / O components, and a power source. Any number of additional components, different components, and / or combinations of components may also be included in the computing device. The bus represents one or more buses (such as an address bus, a data bus, or a combination thereof). Similarly, in some embodiments, the computing device may include multiple processors, multiple memory components, multiple I / O ports, multiple I / O components, and / or multiple power sources. Additionally, any number of these components, or combinations thereof, may be distributed and / or replicated across multiple computing devices.

[0029] In some embodiments, the memory 122 includes computer-readable media in the form of volatile and / or non-volatile memory, temporary storage media 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 media 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, for example, quantum state memory, and / or the like. In some embodiments, the memory 122 stores computer-executable instructions for causing a processor (such as 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.

[0030] 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. 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 functionality contemplated herein can also or alternatively be implemented in hardware and / or firmware.

[0031] In some embodiments, memory 122 can include a data repository implemented using any one of the configurations described below. The data repository can include random access memory, flat files, XML files, and / or one or more database management systems (DBMSs) running on one or more database servers or data centers. The database management system can be a relational (RDBMS), hierarchical (HDBMS), multidimensional (MDBMS), object-oriented (ODBMS or OODBMS), or object-relational (ORDBMS) database management system, among others. The data repository can be, for example, a single relational database. In some cases, the data repository can include multiple databases that can exchange and aggregate data by way of a data integration process or software application. In an exemplary embodiment, at least a portion of the data repository can be hosted in a cloud data center. In some cases, the data repository can be hosted on a single computer, server, storage device, cloud server, or the like. In some other cases, the data repository can be hosted on a series of network-connected computers, servers, or devices. In some cases, the data repository can be hosted on a tiered data storage device including local, regional, and central.

[0032] The various components of device 100 can communicate via a communication interface, such as a wired or wireless interface, or can be coupled to the communication interface. The communication interface includes, but is not limited to, wired or wireless short - and long - distance communication interfaces. For the wired interface, cables, umbilicals, and the like can be used. The short - distance 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 similar specifications (e.g., those based on the IEEE 702.15.4 standard), or other public or proprietary wireless protocols. The long - distance communication interface can be, for example, a wide area network (WAN), a cellular network interface, a satellite communication interface, etc. The communication interface can be within a private computer network such as an intranet or on a public computer network such as the Internet.

[0033] FIG. 2A is a schematic view of an exemplary ablation catheter 200 including a connector 218 (similar to connector 118 as shown in FIG. 1) for treating chronic venous diseases, such as varicose veins. 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.

[0034] As shown, the ablation catheter 200 includes a handle 204, an 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.

[0035] 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 may include thermocouple signals or pressure signals. The pins 244 are relatively larger compared to the pins 242 and may be configured to pass a 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 may 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., a plurality of coil segments), the ground pin may be used as a common ground pin by the plurality of heating segments.

[0036] FIGS. 3A and 3B are, respectively, a schematic front view and a partial cross-sectional view of a distal end portion of an ablation catheter according to an embodiment of the present disclosure. As shown, the distal end portion 300 includes a portion of an elongated shaft 302 that terminates at a distal end 304 and a heating element 306 disposed in the vicinity of the distal end 304 of the elongated shaft 302. The shaft 302 is sized and configured such that the distal end 304 can be inserted into a target blood vessel.

[0037] The heating element 306 is formed from a magnetic material and includes a tubular conductor 308 connected to the elongated shaft 302, an induction coil 310 spirally wound around the tubular conductor 308, and a dielectric layer 312 disposed between the tubular conductor 308 and the induction coil 310.

[0038] In some embodiments, the induction coil 310 is operably connected to an energy generator (e.g., the energy generator 116 of FIG. 1) and is configured to generate thermal energy in the tubular conductor by electromagnetic induction. As will be understood by those skilled in the art, induction heating is a process of heating a conductive object (e.g., the tubular conductor 308) by electromagnetic induction through the heat generated in the conductive object by eddy currents. Induction heating occurs when an electromagnetic field generates an electric current in a metal part (e.g., the tubular conductor 308) and the surface of the metal part is heated due to the resistance to the flow of the current. In an embodiment, the induction generator or induction heater (e.g., the induction coil 310) is shaped to contour the metal part (e.g., the tubular conductor 308).

[0039] In some embodiments, the induction coil 310 is electrically insulated from the tubular conductor 308 by an insulating coating disposed on the induction coil. In some embodiments, the tubular conductor 308 can be made of a magnetically conductive material (e.g., stainless steel or carbon steel). In some embodiments, the induction coil 310 can be made of a conductive material (e.g., varnished copper wire). In some embodiments, the dielectric layer 312 is configured to be resistant to high temperatures and to insulate the tubular conductor 308 and the induction coil 310. In an exemplary embodiment, the dielectric layer 312 can include polyimide.

[0040] In an exemplary embodiment, as shown, for example, in FIG. 3A, the first end 314 and the second end 316 of the induction coil 310 are both combined and can be connected to the output interface of the induction heater using wires 318 and 320. In some embodiments, the induction coil 310 can be operably connected to an energy generator (e.g., the energy generator 116 of FIG. 1) via a handle (e.g., the handle 104 of FIG. 1) and a cable (e.g., the cable 105 of FIG. 1). In an embodiment, the tubular conductor 308 is sized to be inserted into the target vessel while providing ablation efficiency (e.g., sufficient width, sufficient length, etc.). In some embodiments, the length (L) of the tubular conductor 308 can be a length of about 3 centimeters to about 7 centimeters. In some embodiments, the diameter (d) of the induction coil 310 surrounding the tubular conductor 308 can be from about 1.5 millimeters to about 18 millimeters. In a particular embodiment, the length of the tubular conductor 308 is greater than 2 centimeters. In some embodiments, the length of the tubular conductor is less than 10 centimeters. In a particular embodiment, the diameter of the tubular conductor 308 is greater than 1 millimeter. In some embodiments, the diameter of the tubular conductor 308 is less than 20 millimeters.

[0041] One or more pressure sensors (not shown) can be disposed proximate to the heating element 306 to measure a signal indicative of the pressure applied to the heating element 306 through the target tissue (e.g., the target vessel wall). In some embodiments, multiple pressure sensors (e.g., three sensors, four sensors, six sensors) are circumferentially disposed around the heating element (e.g., two adjacent pressure sensors are offset from each other by a certain angle in a projection view).

[0042] In some embodiments, the plurality of pressure sensors includes at least one selected from the group consisting of piezoelectric pressure sensors, capacitive pressure sensors, inductive pressure sensors, strain gauge pressure sensors, and potentiometric pressure sensors. In certain embodiments, during the procedure, the heating element 306 is controlled to supply ablation energy when an output signal indicative of the pressure generated by at least one of the plurality of pressure sensors is greater than a predetermined threshold. In certain embodiments, the heating element 306 is controlled to supply ablation energy when an output signal indicative of the pressure generated by some of all of the plurality of pressure sensors is greater than a predetermined threshold.

[0043] Figures 4A - 4D are, respectively, a schematic front view, a cross-sectional view, a partially enlarged view, and a front view of a distal end portion of an ablation catheter 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 and / or the heating element 406 are sized and configured such that the distal end 404 can be inserted into a target blood vessel.

[0044] The heating element 406 may be formed from a magnetic material and may include a plurality of tubular conductors 408 connected to the elongate shaft 402. The plurality of tubular conductors 408 are longitudinally spaced apart from each other along the shaft 402. The heating element 406 may further include an induction coil 410 spirally wound around the tubular conductors 408, and a dielectric layer 412 disposed between the tubular conductors 408 and the induction coil 410.

[0045] In an embodiment, the two ends of induction coils 410a and 410b are each connected to the output interface of the induction heater. In some embodiments, induction coils 410a and 410b are operably connected to an energy generator (e.g., energy generator 116 of FIG. 1) and are configured to generate thermal energy in a plurality of tubular conductors 408 by electromagnetic induction. In some embodiments, induction coil 410 is electrically insulated from a plurality of tubular conductors 408 by an insulating coating disposed on the induction coil.

[0046] In some embodiments, the plurality of tubular conductors 408 can be fabricated from a magnetically conductive material (e.g., stainless steel or carbon steel). In some embodiments, induction coil 410 can be fabricated from a conductive material (e.g., varnished copper wire). In some embodiments, dielectric layer 412 includes a dielectric material for insulating the tubular conductors 408 and induction coil 410 and is resistant to high temperatures. In an exemplary embodiment, dielectric layer 412 can include polyimide. In certain embodiments, dielectric layer 412 includes a dielectric material having a relatively high thermal conductivity.

[0047] As shown, a plurality of tubular conductors 408 are longitudinally spaced from each other along the shaft 402. In embodiments, the heating element 406 may include one or more non-conductive tubular portions 414, and at least one non-conductive tubular portion 414 is disposed between two adjacent tubular conductors of a set of tubular conductors 408. In some embodiments, one or more non-conductive tubular portions 414 are flexible such that at least one of the one or more non-conductive tubular portions allows a bend angle 420 greater than 30 degrees between two adjacent tubular conductors. During treatment, for example, as shown in FIG. 4C, the elongate shaft 402 may bend at one of the one or more gaps or non-conductive tubular portions 414 while being inserted into the target vasculature to better conform to the contour of the blood vessel. In embodiments, the elongate shaft 402 may bend at a plurality of gaps or at one or more non-conductive tubular portions 414.

[0048] Due to the fact that veins can become tortuous due to chronic venous disease, it is not easy for an operator to insert the distal end portion 400 of the ablation catheter into the target vein. If the catheter is too rigid, it may become increasingly difficult to position the heating element 406 on the distal end portion 400 at a specific treatment site. As the flexibility of the catheter increases, it becomes easier for the distal end portion 400 to pass through the tortuous vein and reach the target treatment site, and the surgical time can also be shortened. Additionally, by using the induction coil 410 and the tubular conductor 408 instead of the heat-resistant coil, induction heating typically responds quickly to the input of the energy generator, so the heat generation rate can be improved.

[0049] In an embodiment, the heating element 406 and the tubular conductor 408 are sized (e.g., sufficient width, sufficient length, etc.) to be inserted into the target vessel while providing ablation efficiency. In some embodiments, the length (L) of the plurality of tubular conductors 408 can be a length from about 3 centimeters to about 7 centimeters. In some embodiments, the diameter (d) of the induction coil 410 surrounding the tubular conductor 408 can be from about 1.5 millimeters to about 18 millimeters. In a particular embodiment, the length of the plurality of tubular conductors is greater than 2 centimeters. In some embodiments, the length of the plurality of tubular conductors is less than 10 centimeters. In a particular embodiment, the diameter of the tubular conductor 408 is greater than 1 millimeter. In some embodiments, the diameter of the tubular conductor 408 is less than 20 millimeters.

[0050] In a particular embodiment, the induction coil 410 is an integrated part, and the plurality of tubular conductors can be heated simultaneously during the treatment. In some embodiments (not shown), the induction coil 410 includes a plurality of coil segments individually connected to an energy generator, and each coil segment is individually controllable and addressable. In a particular embodiment, during the treatment, at least one tubular conductor 408a is heated and at least one tubular conductor 408b is not heated.

[0051] A temperature sensor (not shown) can be disposed within one or more of the gaps or non-conductive tubular portions 414. Based on the signal indicating the temperature measured by the temperature sensor, a controller (e.g., the energy controller 120 of FIG. 1) or a physician can selectively adjust the power supply to the induction coil 410 and thus adjust the heat supplied to the target blood vessel.

[0052] One or more pressure sensors (not shown) may be disposed proximate to heating element 406 and / or the plurality of tubular conductors 408 to measure a signal indicative of the pressure applied to heating element 406 through a target tissue (e.g., a target vessel wall). In some embodiments, a plurality of pressure sensors (e.g., three sensors, four sensors, six sensors) are circumferentially disposed around the heating element (e.g., two adjacent pressure sensors are offset from each other by a certain angle in a projection view).

[0053] In some embodiments, the plurality of pressure sensors includes at least one selected from the group consisting of piezoelectric pressure sensors, capacitive pressure sensors, inductive pressure sensors, strain gauge pressure sensors, and potentiometric pressure sensors. In certain embodiments, during the procedure, heating element 406 and / or induction coil 410 are controlled to supply ablation energy when an output signal indicative of the pressure generated by at least one of the plurality of pressure sensors is greater than a predetermined threshold. In certain embodiments, heating element 406 and / or induction coil 410 are controlled to supply ablation energy when an output signal indicative of the pressure generated by some or all of the plurality of pressure sensors is greater than a predetermined threshold.

[0054] Figures 5A and 5B are schematic views of a portion of an ablation catheter for use within a patient's target vessel for treatment of an aneurysm, according to embodiments of the present disclosure. In some embodiments, during an endovenous thermal ablation procedure, an introducer sheath may be placed within a patient's target vein using ultrasound guidance and standard vascular techniques. An 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 infiltration 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.

[0055] As shown in FIG. 5A, the distal end portion 500 of the ablation catheter (e.g., ablation catheter 102 in FIG. 1) is disposed within the target blood vessel 502a. 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 here to introduce and position the distal end portion 500 of the ablation catheter within the target vein segment. The distal end portion 500 may include a heating element 506 having an induction coil 510 spirally wound around a tubular conductor 508, and a dielectric layer 514 disposed between the tubular conductor 508 and the induction coil 510.

[0056] In some embodiments, during the procedure, a current can be applied to the induction coil 510 by a generator (e.g., energy generator 116 of FIG. 1), and a segment of the target blood vessel 502a is adjacent to the heating element 506. The generator may include a high-frequency generator that generates a high-frequency current to heat the tubular conductor 508 and the target blood vessel 502a adjacent to the tubular conductor 508. During the procedure, the tubular conductor 508 is heated by electromagnetic induction, and as shown as 502b in FIG. 5B, the target blood vessel begins to close or its diameter decreases.

[0057] In some embodiments, the ablation catheter may include a temperature sensor disposed along the length of the catheter shaft, and the power supply to the induction coil 510 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 the induction coil 510 can heat the induction coil 510 to about 80° C. to about 140° C. to treat the aneurysm. In some embodiments, the power supply to the induction coil 510 can heat the induction coil 510 to about 100° C. to about 130° C. to treat the aneurysm. In some embodiments, the power supply to the induction coil 510 can heat the induction coil 510 to about 120° C. to treat the aneurysm.

[0058] The segment of the target blood vessel 502a to be treated adjacent to the tubular conductor 508 will close (e.g., contract, decrease in diameter) as the conductor is heated, as shown as 502b 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 516, and this process is repeated until the entire vein is closed. Then, the catheter and the introducer sheath can be removed after the treatment has been performed. In some cases, the diameter of the heating element 506 is smaller than the diameter of the blood vessel 502a, and during the treatment, the heating element 506 can be moved closer to the vessel wall.

[0059] In Example 16, a device for treating a venous aneurysm includes an energy generator and a catheter connected to the energy generator. In some embodiments, the elongate catheter includes an elongate shaft having a proximal end and a distal end, sized and configured such that the distal end can be inserted into a blood vessel, and a heating element disposed in the vicinity of the distal end of the elongate shaft. In some embodiments, the heating element includes a plurality of tubular conductors formed from a magnetic material, longitudinally spaced apart from each other along the shaft and connected to the elongate shaft, an induction coil helically wound around the plurality of tubular conductors, a dielectric layer disposed between the plurality of tubular conductors and the induction coil, and one or more non-conductive tubular portions, with at least one non-conductive tubular portion disposed between two adjacent tubular conductors of a set of tubular conductors.

[0060] In Example 17, in the device of Example 16, the induction coil is electrically connected to the energy generator and configured to generate an electromagnetic induction field around the plurality of tubular conductors, and the plurality of tubular conductors are configured to generate sufficient thermal energy for ablation.

[0061] In Example 18, in the device of Example 16, the dielectric layer includes an insulating coating disposed on the induction coil. In Example 19, in the device of Example 16, one or more non-conductive tubular portions are flexible.

[0062] In Example 20, in the device of Example 19, at least one of the one or more non-conductive tubular portions is configured to allow a bending angle greater than 30 degrees between two adjacent tubular conductors.

[0063] In Example 21, in the device of Example 16, the plurality of tubular conductors includes stainless steel or carbon steel. In Example 22, in the device of Example 16, the induction coil includes a conductive material.

[0064] In Example 23, in the device of Example 22, the induction coil includes a varnished copper wire. In Example 24, in the device of Example 16, the dielectric layer is resistant to high temperatures and is configured to insulate the tubular conductors and the induction coil.

[0065] In Example 25, in the device of Example 16, the dielectric layer includes polyimide. As used herein, the terms “about” and “approximately” are used with respect to measurements (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 with each other. These “about” and “approximately” include the recited measurement values and also measurement values that are reasonably close to the recited measurement values, and are understood to include slight differences that can be readily determined by a person of ordinary skill in the relevant art due to measurement errors, differences in calibration of measurement or manufacturing equipment, human error in reading and / or setting measurement values, adjustments for optimization of performance and structural parameters taking into account other measurement values (e.g., measurement values related to other things), particular implementation scenarios, human, computing device, mechanical operation, setting, inaccurate adjustment and / or operation of measurement values, system tolerances, control loops, machine learning, predictable variations (e.g., statistically negligible variations, chaotic variations, instability of systems and / or models, etc.), preferences and / or the like.

[0066] Exemplary methods may be represented by one or more drawings (e.g., flow diagrams, 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 a particular step and / or a particular order between particular steps, as may be explicitly described herein and / or as may be 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.

[0067] Various modifications and additions can be made to the exemplary embodiments described without departing from the scope of the present invention. For example, while the above-described embodiments refer to certain features, the scope of the present 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 present invention is intended to embrace all such alternatives, modifications, and variations that fall within the scope of the claims, together with all equivalents thereof.

Claims

1. A device for treating an aneurysm, comprising a catheter, said catheter comprising a long shaft having a proximal end and a distal end, sized and configured such that the distal end can be inserted into a blood vessel, and said long shaft; a heating element disposed in the vicinity of the distal end of said long shaft, formed of a magnetic material and comprising a tubular conductor connected to said long shaft, an induction coil spirally wound around said tubular conductor, and a dielectric layer disposed between said tubular conductor and said induction coil. A device comprising said heating element.

2. The device according to claim 1, wherein said induction coil is configured to generate an electromagnetic induction field around said tubular conductor, and said tubular conductor is configured to generate sufficient thermal energy for ablation.

3. The device according to claim 1 or 2, wherein said dielectric layer includes an insulating coating disposed on said induction coil.

4. The device according to any one of claims 1 to 3, wherein said heating element includes a set of tubular conductors, said set of tubular conductors including said tubular conductor and one or more additional tubular conductors, and said set of tubular conductors being longitudinally spaced apart from each other along said long shaft.

5. The device according to claim 4, wherein said heating element further includes one or more non-conductive tubular portions, and at least one non-conductive tubular portion is disposed between two adjacent tubular conductors of said set of tubular conductors.

6. The device according to claim 5, wherein said one or more non-conductive tubular portions are flexible.

7. The device according to claim 6, wherein at least one non-conductive tubular portion of said one or more non-conductive tubular portions is configured to allow a bending angle greater than 30 degrees between two adjacent tubular conductors.

8. The device according to any one of claims 1 to 7, wherein said tubular conductor includes stainless steel or carbon steel.

9. The device according to any one of claims 1 to 8, wherein said induction coil includes a conductive material.

10. The device according to any one of claims 1 to 9, wherein said induction coil includes varnished copper wire.

11. The device according to any one of claims 1 to 10, wherein the dielectric layer has resistance to high temperatures and is configured to insulate the tubular conductor and the induction coil.

12. The device according to any one of claims 1 to 11, wherein the dielectric layer contains polyimide.

13. A system for treating an aneurysm, comprising: the device according to any one of claims 1 to 12; an energy generator connected to the elongate catheter and configured to generate an electrical signal; a controller operably connected to the energy generator and configured to control the generation of the electrical signal.

14. The system according to claim 13, wherein the induction coil of the heating element is electrically connected to the energy generator.

15. The system according to claim 14, wherein the heating element includes a set of tubular conductors longitudinally spaced apart from each other along the shaft, the induction coil includes a plurality of coil segments individually connected to the energy generator, and each coil segment of the plurality of coil segments is individually controllable and addressable.

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