Systems and methods related to flexible antennas

Abstract

A flexible instrument includes an antenna having a distal tip portion, a proximal base, and an antenna body therebetween. The antenna body includes a patterned cylindrical structure having a proximal end coupled to the proximal base and a distal end coupled to the distal tip portion. The flexible instrument is configured to generate a radiation pattern from the antenna to ablate tissue.

Description

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS

[0002] This application claims the benefit of U.S. Provisional Application No. 62 / 649,974, filed March 29, 2018, which is incorporated herein by reference in its entirety. Technical Field

[0003] The present invention relates to systems and methods for improving tissue ablation using novel antenna configurations in a minimally invasive manner via a steerable, elongated device. Background Art

[0004] Minimally invasive medical techniques are intended to reduce the amount of tissue damaged during a medical procedure, thereby reducing patient recovery time, discomfort, and harmful side effects. Such minimally invasive techniques can be performed through natural orifices in the patient's anatomy or through one or more surgical incisions. Through these natural orifices or incisions, an operator can insert a minimally invasive medical instrument (including a surgical instrument, a diagnostic instrument, a therapeutic instrument, or a biopsy instrument) to reach the target tissue location. One type of minimally invasive technique is the use of a flexible and / or steerable elongated device, such as a flexible catheter, which can be inserted into an anatomical passage and navigated to an area of ​​interest within the patient's anatomy.

[0005] Currently, tissue ablation devices have few options for small form factors while maintaining flexibility to navigate tortuous anatomies. It would be advantageous to provide materials and designs that support flexible navigation of antennas for tissue ablation that maintain antenna shape, improve manufacturability, and / or facilitate control of tissue ablation parameters and are suitable for use in minimally invasive medical techniques. Summary of the invention

[0006] Embodiments of the invention are best summarized by the claims appended to the description.

[0007] In accordance with some embodiments, the systems and methods of the present invention include an ablation assembly including a patterned cylindrical structure including a proximal end and a distal end, the proximal end coupled to a conductive cable. The patterned cylindrical structure also includes a first material having a flexible plastic deformation limit, so that the strain of the patterned cylindrical structure when bent through a bend is maintained below the flexible plastic deformation limit. In addition, the patterned cylindrical structure includes a second material plated on the first material, the second material being more conductive than the first material and electrically coupled to the conductive cable to produce a radiation pattern for ablating tissue.

[0008] In accordance with some embodiments, a flexible instrument includes an antenna having a distal tip portion, a proximal base, and an antenna body therebetween. The antenna body includes a patterned cylindrical structure having a proximal end coupled to the proximal base and a distal end coupled to the distal tip portion. The flexible instrument is configured to generate a radiation pattern from the antenna to ablate tissue.

[0009] In accordance with some embodiments, a method includes identifying a desired ablation zone of a target tissue. The desired ablation zone has at least one ablation zone parameter. The method also includes determining physical parameters of a flexible instrument for generating ablation energy to create a desired ablation zone size for the target tissue. The flexible instrument includes an antenna having a distal tip portion, a proximal base, and an antenna body therebetween. The antenna body includes a patterned cylindrical structure having a proximal end coupled to the proximal base and a distal end coupled to the distal tip portion. The method also includes determining at least one ablation parameter of the flexible instrument to generate ablation energy for creating a desired ablation zone for the target tissue.

[0010] In accordance with some embodiments, a method includes identifying a desired ablation zone of a target tissue and adjusting physical parameters of a flexible instrument to generate ablation energy for creating the desired ablation zone for the target tissue. The flexible instrument includes an antenna having a distal tip portion, a proximal base, and an antenna body therebetween. The antenna body includes a patterned cylindrical structure having a proximal end coupled to the proximal base and a distal end coupled to the distal tip portion. The method also includes delivering ablation energy to create a desired ablation zone size for the target tissue.

[0011] It should be understood that the above general description and the following detailed description are exemplary and explanatory in nature, and are intended to provide an understanding of the present invention without limiting the scope of the present invention. In this regard, additional aspects, features and advantages of the present invention will be apparent to those skilled in the art based on the following detailed description. BRIEF DESCRIPTION OF THE DRAWINGS

[0012] Figure 1 is a simplified diagram of a flexible antenna system according to some embodiments.

[0013] Figure 2 is a simplified exploded view of a flexible antenna system according to some embodiments.

[0014] Figure 3A is a simplified diagram of a flexible antenna according to some embodiments.

[0015] Figure 3B is a simplified diagram of a flexible antenna system according to some embodiments.

[0016] Figure 3Cis a simplified diagram of a flexible antenna system according to some embodiments.

[0017] Figure 3D is a simplified diagram of a flexible antenna system according to some embodiments.

[0018] Figure 3E is a simplified diagram of a flexible antenna system according to some embodiments.

[0019] Figure 4A and Figure 4B is a side view of a simplified diagram of a flexible antenna tip according to some embodiments.

[0020] Figure 4C is a side view of a simplified diagram of a flexible antenna tip according to some embodiments.

[0021] Figure 4D is a side view of a simplified diagram of a flexible antenna tip according to some embodiments.

[0022] Figure 4E is a side view of a simplified diagram of a flexible antenna tip according to some embodiments.

[0023] Figure 5A is a simplified diagram of a flexible antenna system according to some embodiments.

[0024] Figure 5B is a simplified diagram of a flexible antenna system according to some embodiments.

[0025] Figure 5C is a simplified diagram of a flexible antenna system according to some embodiments.

[0026] Figure 5D is a simplified diagram of a flexible antenna system according to some embodiments.

[0027] Figure 6 is a simplified diagram of a flexible antenna system implemented around a bend in accordance with some embodiments.

[0028] Figure 7 is a simplified diagram of different ablation patterns for a flexible antenna system according to some embodiments.

[0029] Fig. 8A is a simplified diagram of a flexible tunable antenna system according to some embodiments.

[0030] Figure 8B is a simplified diagram of a flexible tunable antenna system according to some embodiments.

[0031] Fig.9A is a simplified diagram of a flexible tunable antenna system according to some embodiments.

[0032] Fig. 9Bis a simplified diagram of a flexible adjustable antenna system in a first configuration in accordance with some embodiments.

[0033] Fig. 9C is a simplified diagram of a flexible adjustable antenna system in a second configuration in accordance with some embodiments.

[0034] Fig. 10A and Fig. 10B is a diagram of a method for configuring a flexible antenna system according to some embodiments.

[0035] Fig. 10C is a diagram of a method for manufacturing a flexible antenna system according to some embodiments.

[0036] Fig.11 is a simplified diagram of a teleoperated medical system according to some embodiments.

[0037] Fig. 12A is a simplified diagram of a medical device system according to some embodiments.

[0038] Fig. 12B is a simplified diagram of a medical device with an expanded medical tool according to some embodiments.

[0039] Fig.13A and Fig. 13B is a simplified diagram of a side view of a patient coordinate space including a medical device mounted on an insertion assembly according to some embodiments.

[0040] Fig.14 is a method for adjusting parameters of ablation size and location according to some embodiments.

[0041] Fig.15 is a method for antenna component selection according to some embodiments.

[0042] Embodiments of the present invention and their advantages can be best understood by referring to the following detailed description. It should be understood that similar reference numerals are used to identify similar elements shown in one or more drawings, where the purpose of the drawings is to illustrate embodiments of the present invention, rather than to limit embodiments of the present invention. DETAILED DESCRIPTION

[0043] In order to promote the understanding of the principle of the present invention, the embodiment shown in the accompanying drawings will now be referenced and specific language will be used to describe the embodiment. However, it should be understood that this is not intended to limit the scope of disclosure. In the following detailed description of various aspects of the present invention, in order to provide a thorough understanding of the disclosed embodiments, many specific details are set forth. However, as will be appreciated by those skilled in the art, embodiments of the present invention may be implemented without these specific details. In other examples, known methods, processes, components and circuits are not described in detail to unnecessarily obscure aspects of embodiments of the present invention.

[0044] Any changes and further modifications to the described equipment, apparatus, methods, and any further applications of the principles of the present invention are generally expected by those skilled in the art to which the present invention relates. In particular, it is entirely contemplated that the features, components, and / or steps described with respect to one embodiment may be combined with the features, components, and / or steps described with respect to other embodiments of the present invention. In addition, the dimensions provided herein are for specific examples, and it is contemplated that different dimensions, sizes, and / or ratios may be utilized to implement the concepts of the present invention. In order to avoid unnecessary descriptive repetitions, one or more components or actions described with respect to an illustrative embodiment may be used or omitted according to the applicability of other illustrative embodiments. For the sake of brevity, multiple iterations of these combinations will not be described separately. For simplicity, in some cases, the same reference numerals are used throughout the drawings to represent the same or similar parts.

[0045] Minimally invasive techniques may include the use of tissue ablation devices. Tissue ablation can be accomplished by electrical energy ranging from extremely low frequencies to microwaves and even higher. However, difficulties may arise for applications that rely on antennas to transmit these frequencies into surrounding tissues (i.e., ablation is accomplished by dielectric heating). For example, microwave antennas may be formed by coaxial cables containing relatively inflexible conductive materials (e.g., copper), especially in small sizes for intracavitary applications. The rigidity of the conductive material may limit the utility of the antenna in anatomical regions where it is necessary to pass through one or more lumen bends to reach the region of interest. Although the antenna may be bent at the curve in the lumen, the rigidity of the material may prevent the antenna from recovering from the bent state when it is positioned at the target tissue to begin ablation. In other words, the antenna may not be able to straighten back to its pre-bend shape before ablation of the target tissue. In addition, most antennas are monopoles or dipoles, where the length of the antenna is determined by the frequency. It may be difficult to control the size of the ablation zone for tissue ablation and the minimum insertion depth of these antennas, because the length of the antenna and therefore the length of insertion (and the ablation size) are determined by the operating frequency selected for the antenna at the time of manufacture.

[0046] Additionally, wire length and configuration can affect axial stiffness and penetration difficulty. Figure 1 , which shows a simplified diagram of a flexible antenna system 100 according to some embodiments. The flexible antenna system 100 can be suitable for use in, for example, surgical procedures, diagnostic procedures, therapeutic procedures, or biopsy procedures. Although some embodiments of these procedures are provided herein, any reference to medical or surgical instruments and medical or surgical methods is non-limiting. The systems, instruments, and methods described herein can be used in animals, human cadavers, animal cadavers, portions of human or animal anatomy, non-surgical diagnostics, and industrial systems and general robotic or teleoperation systems.

[0047] like Figure 1 As shown, the flexible antenna system 100 includes an antenna assembly 103 located at the distal end of the antenna system 100 and a cable 102 (sometimes referred to as a conductive cable assembly) extending between the proximal end of the antenna system 100 and the antenna assembly 103. In some embodiments, the antenna assembly 103 is formed separately from the cable 102 and is coupled to a portion of the cable 102. The cable 102 can adopt various configurations capable of conducting current / electrical signals. The antenna assembly 103 includes an antenna tip portion 104 coupled to the distal end of the antenna body 108. The antenna base 106 of the antenna assembly 103 is coupled to the cable 102 or is formed integrally with the cable 102. The antenna body 108 can be formed of one or more of various generally cylindrical or tubular patterns, including a strip ring pattern, a cut pattern, a slotted pattern, and a helical pattern, which will be described in detail below. The jacket 110 surrounds the cable 102 and, in some embodiments, surrounds a portion of the antenna assembly 103. The jacket can be formed of, for example, a plastic material, an elastomer, or other flexible material.

[0048] Figure 2 The flexible antenna system 100 is shown exploded along a longitudinal axis A. In some embodiments, the cable 102 can be a coaxial cable that includes an inner conductor 120 surrounded by a dielectric insulator layer 122. An outer conductor 124 surrounds the dielectric insulator layer 122. A protective plastic jacket 126 surrounds the outer conductor 124. The inner conductor 120, dielectric insulator 122, outer conductor 124, and jacket 126 can all be coaxial with the axis A. Other coaxial cable configurations having different configurations, shapes, etc. of the inner conductor, dielectric, and outer conductor can also be used.

[0049] Figure 3A-3E Various embodiments for coupling the cable 102 to the antenna assembly 103 are shown. Figure 3AAn antenna assembly 300 is shown in accordance with some embodiments. Antenna assembly 300 can be substantially similar to antenna assembly 103, but with differences as described. Antenna assembly 300 includes an antenna body 302 coupled to or integrally formed with an antenna tip portion 304. Antenna body 302 includes an antenna base 306 and an antenna body distal end 312. Antenna assembly 300 is coupled to a cable 320, which can be substantially similar to cable 102. Cable 320 includes a jacket 322 and an outer conductor 324. In Figure 3A In an embodiment of the present invention, the antenna assembly 300 is coupled to the cable 320 via the outer conductor 324 and is electrically connected to the cable 320. The coupling between the antenna body 302 and the outer conductor 324 can be achieved by crimping, welding, soldering, or other connection means to produce an electrical connection. Alternatively, the outer conductor 324 can be formed to fit within the antenna base 306, wherein the antenna base 306 is placed around the distal end of the outer conductor 324. In another embodiment, the antenna body can be cut directly from the coaxial cable. In such an embodiment, the inner conductor of the cable can remain unconnected to the antenna body 302, or can be connected at the antenna tip portion 304.

[0050] Figure 3B An antenna assembly 330 is shown in accordance with some embodiments. Antenna assembly 330 can be substantially similar to antenna assemblies 103, 300, but with differences as described. As previously described, antenna assembly 330 includes antenna body 302, antenna tip portion 304, antenna base 306, and antenna body distal end 312. Antenna assembly 330 is coupled to cable 340, which can be substantially similar to cables 102, 320. Cable 340 includes jacket 322, outer conductor 324, and inner conductor 326. Figure 3B In the embodiment of the present invention, the distal section of the antenna assembly 330 is coupled to the cable 340 via the inner conductor 326 and is electrically connected to the cable 340. The coupling between the antenna body 302 and the inner conductor 326 can be achieved by crimping, welding, soldering, or other connection means to produce an electrical connection. The inner conductor 326 extends through the central lumen 327 of the antenna body 302 and is connected to the distal end of the antenna assembly 330 (for example, at the antenna tip 304). In this configuration, the inner conductor 326 can provide axial strength to the antenna assembly 350.

[0051] Figure 3CAn antenna assembly 350 and a cable 360 ​​are shown according to some embodiments. The antenna assembly 350 is substantially similar to the antenna assembly 330, and the cable 360 ​​is substantially similar to the cable 340. The cable 360 ​​includes a jacket 322, an outer conductor 324, and an inner conductor 326. In this embodiment, the inner conductor 326 can extend partially through the central lumen 327 of the antenna body 302 and can be attached to the inner surface of the antenna body 302. The coupling between the antenna body 302 and the inner conductor 326 can be achieved by crimping, welding, soldering, or other connection means to produce an electrical connection. In this embodiment, the inner conductor 326 is connected to the antenna body 302 near the antenna base 306. As shown in this embodiment, the inner conductor 326 can be bent about 90 degrees to connect with the antenna assembly 350. Alternatively, the inner conductor can be unbent. In this configuration, if the inner conductor 326 is connected toward the distal end of the antenna body, it can provide axial strength to the antenna assembly 350. In other embodiments, the inner conductor 326 can be connected to any location along the length of the antenna body 302. Figure 3A As described, the outer conductor 324 may remain unconnected to the antenna assembly 350, or may be coupled to the antenna assembly 350. In the case where the outer conductor is not electrically connected to the antenna body, an insulator may be required to provide mechanical coupling rather than electrical coupling.

[0052] Figure 3D An antenna assembly 370 is shown in accordance with some embodiments. Antenna assembly 370 can be substantially similar to antenna assembly 350, but with differences as described. In this embodiment, a coupling strut 336 extends proximally from antenna base 306. Antenna assembly 330 is coupled to cable 360, which can be substantially similar to cable 340. Cable 340 includes a jacket 322, an outer conductor 324, a dielectric insulator layer 325, and an inner conductor 326. In this embodiment, coupling strut 336 is electrically connected to inner conductor 326 via a weld joint 334 (or alternatively, a solder, an adhesive, or a combination of solder, an adhesive, and / or welding (e.g., laser welding)). Weld joint 334 is illustrated as a butt joint, but other types of joints may also be suitable.

[0053] Figure 3E An antenna assembly 370 is shown in accordance with some embodiments. In this embodiment, the coupling strut 336 is coupled to the inner conductor 326 via the sleeve 342. The sleeve 342 can be conductive (i.e., formed of a conductive material) such that the inner conductor 326 is separated from the coupling strut 336. In some embodiments, the inner conductor 326 and the antenna base 306 are in physical contact with each other and are encapsulated within the sleeve 342. If the inner conductor 326 and the coupling strut 336 remain in physical contact with each other, the sleeve 342 can be non-conductive. Despite the above Figure 3D-Figure 3EThe antenna base 306 is shown connected to the inner conductor 326, but the same coupling mechanism (eg, a weld joint or sleeve) may alternatively be applied to connect the antenna base 306 to the outer conductor 324.

[0054] Figure 4A-4E Various embodiments of antenna tip portions are shown that may be used as antenna tip portion 104, 304. In some embodiments, the antenna tip portion is formed of the same material as antenna body 108, 302. In other embodiments, the antenna tip portion may be formed separately and attached to antenna body 108, 302. Figure 4A A side view of an antenna tip portion 502 according to some embodiments is shown. The antenna tip portion 502 includes a base portion 504 and a plurality of tabs or tip segments 506. The antenna tip portion 502 includes six tip segments 506, but alternative embodiments may include more or fewer tip segments. In various embodiments, the antenna tip portion may be integral with the antenna body. For example, the antenna tip portion may be formed from a distal segment of the antenna body by cutting away some areas of the antenna body to form the tip segments. Figure 4B A side view of the antenna tip portion 502 is shown, with the tip segment 506 drawn together. The tip segment 506 can be curled or folded so that the distal portion of each tip segment 506 is substantially in contact with the distal portion of other tip segments 506 to form a cone. In some embodiments, the tip segment 506 can be further maintained as a cone, such as by adhesive, welding (e.g., laser welding), solder or other mechanisms to maintain the cone shape and structure. The resulting antenna tip portion 502 can be used, for example, to pierce or separate tissue. The antenna tip portion 502 can be used with any antenna body previously described. In various alternatives, the antenna tip portion can be blunt rather than pointed, such as having a rounded or square tip to pass through tissue when sent with a needle. The tip portion can also be made entirely of the same material or made of two materials. In one example, the very distal tip is formed of stainless steel or other types of materials that can be sharpened to facilitate penetration of tissue. The distal end of the tip can be made of plastic to isolate it from the antenna body. Different materials may be glued, molded, welded, screwed, etc., or combined in any other manner.

[0055] A tongue segment may also be used or alternatively applied to the antenna base 106, 306 or the support 336 for crimping. In these embodiments, the tongue segment may be crimped until the tongue segment contacts a portion of the cable, such as the inner conductor or the outer conductor. Figure 3AIn an embodiment of the present invention, the tongue segments at the proximal end 306 of the antenna can be crimped onto the outer conductor 324 to form an electrical connection between at least some of the crimped tongue segments and the conductor 324. The coupling can be further secured in place by, for example, solder joints, solder, adhesives, or other types of securing techniques.

[0056] Figure 4C A side cross-sectional view of an antenna tip portion 512 according to some embodiments is shown. The antenna tip portion 512 includes a tapered section 510 and an insertion section 514. The insertion section 514 can be disposed within a distal end 517 of an antenna body (e.g., antenna body 108, 302). The insertion section 514 engages with an inner surface 518 of the receiving distal end 517. According to some embodiments, the insertion section 514 is fixed to select some portions of the inner surface of the receiving distal end 517 at a welding point 516 (e.g., one or more welding points around the perimeter of the insertion section 514). Alternatively, the welding point 516 can be a solder point or bonding point using some other material / fixing method. In some embodiments, the antenna body can be clamped between an insert and a portion of the tip extending concentrically around the outer diameter of the antenna body. After heating, the two sections will melt together to form a good bond. In order to allow material to flow through, it may be necessary to form a hole in the antenna body.

[0057] Figure 4D A side cross-sectional view of an antenna tip portion 520 is shown according to some embodiments. The antenna tip portion 520 includes a tapered section 510 and a coupling section 522. The coupling section 522 includes an internal thread 524 around the inner perimeter of the antenna tip portion 520, which is fixed to a threaded distal end 527 of an antenna body (e.g., antenna body 108, 302). The distal end 527 of the antenna body includes an external thread 525 around the perimeter of the distal end. The antenna tip portion 520 can be fixed to the antenna body by screwing the internal thread 524 onto the external thread 525. The threaded connection can provide a fixed lock between the antenna tip portion and the antenna body. In addition, the coupling can be further fixed by welding, brazing, or bonding with an adhesive. The structure can be additionally heated to further melt the plastic and enhance the bond.

[0058] Figure 4E An antenna tip portion 530 is shown having a tapered section 531 that is insertable into a receiving distal end 538 of an antenna body. The tapered section 531 includes a tab 532 attached to an insert 534. The insert 534 includes two distinct bars extending from the proximal end of the tapered section 531 toward the receiving distal end 538 of the antenna body. Alternatively, the insert 534 can be a single piece extending from the tapered section 531 (e.g., a circular "pin") having one or more tabs 532 at various points around the perimeter of the insert 534 (e.g., equidistant points, etc.).

[0059] The receiving distal end 538 of the antenna body includes one or more receiving slots 536 having a shape corresponding to the shape of the tongue 532. For example, if each tongue 532 is circular, the corresponding receiving slot 536 is also circular with a radius just larger than the radius of the tongue 532 to allow the tongue 532 to enter the receiving slot 536 and remain there. Although described as circular, the receiving slot 536 (and the corresponding tongue 532) can take a variety of shapes as long as the shapes correspond to each other (e.g., round tongue to round slot, square tongue to square hole, etc.).

[0060] In use, the insert 534 is inserted into the receiving distal end 538 until the tabs 532 releasably engage with the corresponding receiving slots 536. This is facilitated by having an insert 534 having a size (e.g., radius) just smaller than the radius of the corresponding receiving distal end 538, so that once the tabs 532 reach the corresponding receiving slots 536, their height allows them to "snap" into place. After releasably engaging with the corresponding receiving slots 536, they can be further secured in place by adhesive or some other mechanism (such as heating and melting plastic), or simply held in place by friction between the tabs 532 and the walls of the corresponding receiving slots 536.

[0061] Figure 5A-Figure 5C Various embodiments of cylindrical patterned antenna bodies that can be used as antenna bodies 108, 302 are shown. The antenna body is produced as Figure 7 Radiating structure of the radiation pattern shown. In the absence of shielding around the antenna body or other obstructions to the radiation pattern, the radiation pattern transverse to the longitudinal axis of the antenna can extend farther than the radiation pattern away from the antenna tip. The antenna body can be formed of steel or other suitable conductive material, or can be coated with a conductive material. Figure 5A A double-strip annular antenna body 400 is shown according to some embodiments. The antenna body 400 is generally cylindrical and axially aligned along the axis A1. The central lumen 403 extends longitudinally through the antenna body 400. The antenna body 400 can be manufactured by cutting some parts from the tube to form longitudinal strips 402 and radial rings 401. In this embodiment, the rings 401 are arranged around the axis A1 and along the axis A1. Each ring 401 is separated from another ring 401 by a pair of strips 402 arranged in parallel on opposite sides of the axis A1. The paired strips 402 at the level L1 can be rotated about 90 degrees relative to the paired strips 402 at the adjacent level L2. Various configurations of paired strip antenna bodies may be suitable. For example, the length D1 of the paired strips can be longer, shorter or the same as the height D2 of the ring. The antenna body may further include additional cutouts, fillets or changes between structures at adjacent levels to achieve desired flexibility, antenna performance or ease of manufacturing.

[0062] Figure 5B A single strip annular antenna body 405 is shown in accordance with some embodiments. The antenna body 405 is generally cylindrical and axially aligned along an axis A2. A central lumen 413 extends longitudinally through the antenna body 405. The antenna body 405 can be manufactured by cutting slots in a tube to form longitudinal strips 415 and radial rings 416. In this embodiment, the rings 416 are arranged around and along the axis A2. Each ring 416 is separated from another ring 401 by a single strip 415. The strips 415 at level L1 can be rotated approximately 180 degrees relative to the strips 415 at the adjacent level L2. Each ring 416 defines a ring edge 408, and each strip 415 defines a strip edge 410. The angles of the intersecting edges 408, 410 can be selected to reduce stress under bending conditions. For example, as Figure 5B As shown, each angle can be about 90 degrees. In other embodiments, the angle can be larger or smaller, or the angle can be different at different levels. In some embodiments, the edges 408, 410 are rounded rather than squared to further reduce stress under bending conditions, thereby increasing the elasticity of the material of the patterned columnar structure. Sections of the pipe can also be thinned or shaped in some way to allow material space to move and enhance flexibility.

[0063] Figure 5C A helical antenna body 420 is shown according to some embodiments. The antenna body 420 is generally cylindrical and axially aligned along the axis A3. A central lumen 423 extends longitudinally through the antenna body 420. The antenna body 420 can have end surfaces 422, 428 that are manufactured by cutting a helical slot 425 in a tube to form a helical coiled ribbon structure 426. In some embodiments, the helical ribbon structure 426 is formed by laser cutting the tube. Alternatively, the helical ribbon structure can be formed by injection molding rather than laser cutting.

[0064] Figure 5D A slotted antenna body 430 is shown according to some embodiments. The antenna body 430 is generally cylindrical and axially aligned along axis A4. The antenna body 430 may include spiral slots 432 extending less than 360 degrees around the body. In alternative embodiments, the antenna body may be formed from a tube with symmetrical or asymmetrical cutouts (including asymmetrical slot patterns).

[0065] Ring bar structures may have advantages over other structures due to the trade-off between bending and axial stiffness. These bars have good axial stiffness while the cutouts have bending flexibility. In the case of a helix, such an antenna may not be able to penetrate tissue easily as there is not much axial support. A single bar structure or any other slotted structure will have performance between the ring bar structure and the helix. However, the helix shows better radiation distribution than the ring bar and single ring bar configurations. The need for certain mechanical properties may need to be weighed against the radiation pattern results.

[0066] Figure 1 The overall antenna assembly 103 can be designed in materials and structure to allow for greater flexibility than the rigid conductive materials used in traditional antennas, which have a small form factor for entering different locations of the target tissue. For example, the antenna assembly 103 may need to bend through a bend of 10mm to 15mm and as low as 5mm and be able to recover for insertion straight into the target tissue. In other words, certain materials in certain patterned columns (such as copper) reach a soft plastic deformation limit, and when the material is placed in a tight bend through tissue, the material undergoes plastic deformation, causing the antenna assembly to bend and cannot recover. This makes it difficult to align the antenna assembly with the target tissue.

[0067] Thus, the materials used for the structure of antenna assembly 103 and any antenna assembly or antenna body described herein may be selected to increase the plastic deformation limit of the antenna assembly and the ability to recover its shape and re-straighten after passing through a particularly tight bend. This may be achieved through material selection for antenna assembly 103. In some embodiments, the antenna body may be composed of a highly elastic first material plated with a conductive second material. The first material may be more elastic than the second material. The second material may be plated onto the first material on the outer surface of the antenna body, i.e., the surface facing away from the longitudinal axis of the antenna assembly.

[0068] The first material can be selected from a material having high elastic properties relative to a less elastic material (e.g., copper). For example, the first material can be beryllium copper alloy (BeCu), nickel titanium alloy (NiTi), or other similar plastic materials (e.g., steel). It is noteworthy that the first material does not need to be conductive in order to emit radiation of any wavelength. This is achieved by plating the second material onto the first material. The second material can be a conductive material so that the antenna assembly can operate as a radiating antenna for ablating tissue. For example, the second material can be silver or gold plated on a material selected as the first material. The relative thickness of the coating of the second material can depend on one or more operating frequencies of the flexible antenna system 100. In some examples, the frequency can be in the order of megahertz to gigahertz, such as about 900MHz to about 8GHz. For example, it can be selected to operate at about 2.45GHz. At such a frequency, the epidermis depth of the second material may be small enough, such as in the order of micrometers, so the coating does not have to be very thick. Therefore, from the characteristics of the first material, the flexibility of the antenna assembly 103 remains unchanged.

[0069] Due to the material selection and selection of appropriate structural patterns, the antenna assembly 103 and any antenna assembly or antenna body described herein maintains a flexible plastic deformation limit that exceeds the strain imposed on the material of the antenna assembly when operating through a tight bend in a lumen. Therefore, the antenna assembly, and in particular the antenna body 108, is able to recover its original profile / shape after exiting such a lumen bend, compared to existing copper or other materials that would remain deformed due to the lower plastic deformation limit of such materials. As described above, the antenna tip (e.g., the antenna tip portion 104) can be formed of the same or different material as the antenna body 108.

[0070] The patterned structures formed in the tubular antenna body according to the various methods described herein can also contribute to the flexibility of the antenna body. Figure 6 The elasticity and flexibility of the antenna body are illustrated in the illustration of , which provides a simplified illustration of a flexible antenna system 600 (eg, similar to system 100 ) in successive unbent, bent, and restored states.

[0071] As shown, the antenna assembly 600 includes an antenna body 602 coupled to an antenna tip portion 604 and an antenna base 606 coupled to an outer conductor 610 having a jacket 612. Figure 6 , the antenna assembly 600 starts in a non-bent state in a straight configuration along the longitudinal axis A4 (e.g., its default configuration). The antenna assembly 600 can be inserted into an anatomical passage in a patient via a flexible and / or steerable elongated device (e.g., a flexible catheter) and navigated toward an area of ​​interest within the patient's anatomy.

[0072] exist Figure 6 In the example shown, as the antenna assembly 600 navigates toward the region of interest, it may be subjected to forces that cause it to bend. As shown, the antenna assembly 600 bends about a curve having a radius R 616. The radius R 616 of the curve may be on the order of 5 mm to 20 mm, or as small as 5 mm, and the antenna assembly 600 is able to bend about the radius R 616 because it is formed of a first material that is selected due to its relatively high elastic properties. The patterned structure of the antenna body may also contribute to the elasticity of the antenna assembly.

[0073] After the antenna assembly, and in particular the antenna body 602, passes through the bend of radius R 616, the antenna assembly straightens, recovers, and re-straightens so that it roughly returns to the original shape of the antenna body. This recovered state allows the antenna assembly to approach the target tissue with a predictable trajectory. In some embodiments, the original body shape is a substantially straight shape. In other embodiments, the original body shape is a curved shape to allow a curved insertion trajectory. This is also possible due to the selection of the material as the first material, and due to the conductive second material coating the flexible first material, the antenna assembly is able to ablate tissue with the energy emitted by the antenna body 602. Once in the tissue, power is applied at a specific frequency in CW or pulse mode to perform ablation.

[0074] In addition to the flexible aspects of the present invention, embodiments of the present invention also provide for controlling tissue ablation parameters by controlling one or more parameters of the antenna body. Different parameters can affect the resonant frequency of the antenna, including the length of the antenna body, the number of repetitions within the pattern, the angle of the cuts in the pattern, the material, the diameter of the tube, and the wall thickness, etc. These parameters can be used to affect the size of the ablation zone produced by the flexible antenna system during operation. For example, the length of the antenna body can be referred to as the effective length, and can include or be defined by the length of the patterned section of the patterned cylindrical structure of the antenna body (e.g., antenna body 108 or any alternative described herein). The patterned section of the antenna body is where most of the energy for tissue ablation is dissipated, although some energy will also be dissipated from the corresponding ends of the antenna structure. Therefore, changing the effective length can change the resonant frequency of the antenna assembly, change the delivery of the ablation energy, and thus change the size of the ablation zone during treatment. As another example, the number of repetitions of the pattern of the patterned cylindrical structure describes the spacing between the portions of the antenna body. This can generally be referred to as the pitch between the antenna body elements, i.e., the cut space between the material of the antenna body (resulting in the total number of antenna body elements within the entire effective length). Furthermore, the wall thickness refers to the thickness of the first material and the second material of the patterned columnar structure as viewed from a cross-sectional end view.

[0075] For example, refer to Figure 5AIn the illustrated dual strip ring embodiment, as the length of strip 402 increases (e.g., length D1 increases), the center frequency decreases. Furthermore, as ring 401 becomes longer (i.e., length D2 increases), the center frequency decreases again. The span of strip 402 is the circumference of the strip. For example, if the strip is viewed in a cross section perpendicular to axis A1, a strip with a span of 90 degrees will span one-quarter of the distance around axis A1. As the span of each strip increases, the center frequency decreases. Finally, reducing the wall thickness of the antenna body will reduce the center frequency. Conversely, it will increase the center frequency of each parameter. More generally, changing different parameters of the antenna assembly may have different effects, depending on the specific antenna structure, i.e., dual strip ring, single strip ring, helix, etc.

[0076] Thus, according to embodiments of the present invention, pitch, effective current path length, wall thickness, and cut pattern are different interrelated dimensions of the antenna body that provide additional degrees of freedom to control one or more parameters including resonant frequency, maximum allowable strain on the antenna assembly, and ablation size. Figure 5C In the case of a helical antenna body, the effective current path length 440 is directly determined by the selected center frequency; it is typically chosen to be one quarter wavelength. The structure length SL will define the size of the ablation zone. The pitch P and the cut pattern also affect the center frequency insofar as they affect the effective current path length 440, and should be chosen to produce the necessary current path length and the appropriate structure length. For example, in Figure 5C In a helical antenna of FIG. 5 , the pitch P, the number of turns, and the radius R of the turns can be used to adjust the maximum strain on the antenna when bent, and can also be set so that the ablation zone has a desired size.

[0077] For example, the maximum strain on the antenna can be adjusted by increasing the diameter of the patterned cylindrical structure. Due to the size limitations of the delivery device working channel (e.g., a delivery device (e.g., a flexible and / or steerable elongated device, such as a flexible catheter) that is inserted into an anatomical channel and navigated to an area of ​​interest in the patient's anatomy), there is often a practical limit to the extent to which the diameter can be increased. Alternatively, the maximum strain can be reduced by reducing the pitch between the turns of the antenna body. This will also affect the ablation zone size, which can be mitigated by, for example, increasing the effective current path length in increments of λ / 2 while adjusting the pitch.

[0078] Figure 7 Some exemplary effects of the mode and its parameters that may affect the size of the ablated zone are described. Figure 7, a flexible antenna system 700 includes a cable 702, an antenna body 710 (e.g., substantially similar to antenna body 108 or any other antenna body described herein). An antenna base 706 of antenna body 710 is coupled to a distal end 704 of cable 702. An antenna tip portion 712 is also shown, and a varying pitch 714 (generally referring to the spacing between elements of antenna body 710) is identified.

[0079] For the purpose of discussion, several different radiation patterns 716, 718, and 720 are illustrated. Looking at the various parameters associated with the antenna assembly, the current path length of the antenna body 710 has a relatively large impact on the resonant frequency and bandwidth of the antenna's radiation pattern compared to other parameters. In the case of a helical configuration, the current path length is the length of the unfolded spiral and has the greatest impact on the resonant frequency.

[0080] Compared to the effective current path length, the structural length, i.e., the total length of the patterned portion of the antenna body 710 (i.e., the helix length in the case of a helix), has a relatively small effect on the resonant frequency. By adjusting the pitch of the repeating elements (i.e., the spiral), different antenna effective current path lengths can be achieved at the same resonant frequency.

[0081] In general, the longer the length of the antenna body 710, the longer the ablation lesion length in the target tissue (e.g., the length in a plane parallel to the axis along which the antenna assembly extends from the proximal end to the distal end), while the ablation lesion width (in a plane orthogonal to the extension direction parallel to the antenna assembly) remains substantially unchanged. Therefore, by increasing the pitch 714, the length of the ablation zone size changes. For example, at a given starting pitch 714, a radiation pattern 718 will be obtained (and therefore an ablation zone size corresponding to the radiation pattern 718). By increasing the pitch 714 (making it larger), the radiation pattern changes to a radiation pattern 720, which is longer in parallel axes and is generally the same width in the transverse axis. Conversely, by decreasing the pitch 714 (making it smaller), the radiation pattern changes to a radiation pattern 716, which is shorter in parallel axes (but generally still the same width in the transverse axis) than the radiation pattern 718.

[0082] Through the construction of the flexible antenna system discussed herein, embodiments of the present invention thus provide the ability to tailor the size of the ablation zone in the target tissue during ablation. This is different from a monopole antenna, where the wire length and corresponding ablation size in the tissue are set by the operating frequency.

[0083] Several different examples are discussed in more detail below that provide for adjusting one or more parameters of the antenna to affect (ie, size) the ablation zone size, the maximum strain on the antenna, a combination of both, and / or other parameters.

[0084] Fig. 8A is a simplified diagram of a flexible adjustable antenna system 800 according to some embodiments. Fig. 8A The illustrated adjustable antenna system 800 includes many elements substantially similar to those discussed above with respect to the flexible antenna system 100 or other embodiments disclosed herein, but with the differences described. Fig. 8A 8, the cable 801 is a coaxial cable having a jacket 812, an outer conductor 814, a dielectric insulator 816, and an inner conductor 818. The antenna system 800 includes an antenna base 808, an antenna body 802, and an antenna tip portion 804.

[0085] The push / pull element 806 extends through the cable 801, for example through a channel formed in the dielectric insulator 816 that extends generally parallel to (but not in contact with) the inner conductor 818. The cable can be a hollow coaxial cable for accommodating the push / pull element 806, or alternatively, the push / pull element 806 can be located off-center from the inner conductor 818.

[0086] In the illustrated embodiment, the antenna assembly including the antenna body 802 and the antenna tip portion 804 can be electrically attached (and mechanically attached) to the inner conductor 818 or the outer conductor 814, while the push / pull element 806 extends through the center of the antenna body 802 and connects with the antenna tip 804 at the distal end of the antenna assembly. This mechanical connection at the antenna tip 804 allows the push / pull element 806 to apply a push and / or pull force to the antenna tip 804, such as a push and / or pull force provided by a user of a flexible antenna system according to embodiments of the present invention.

[0087] In some embodiments, the push / pull element 806 extends along the entire length of the cable and, along with other aspects of the flexible and / or steerable elongated device, is mechanically controlled (e.g., manually or robotically controlled using a motor or other actuator) at the proximal end of the cable. Thus, when a user pushes on the push / pull element 806 at the proximal end (e.g., by physically pushing or pulling the proximal end of the push / pull element 806 at a location external to the proximal end of the cable), it is mechanically transferred along the length of the cable to the distal portion of the antenna assembly and the connection to the antenna tip 804.

[0088] In an alternative embodiment, the push / pull element 806 does not extend along the entire length of the cable. Instead, a small motor or other actuator or electrical interface can be placed in or on the cable near the distal end of the antenna assembly at a location where the push / pull element 806 extends the rest of the way to the antenna tip 804. For example, the small interface can be electrically coupled to a controller at the proximal end of the cable and actuated in response to a command signal sent from the controller to push the push / pull element 806 or pull the push / pull element 806, depending on the command signal received. In other embodiments, the push / pull element 806 can be formed of a shape memory alloy (e.g., nitinol) so that it can change shape when an electric current is applied (e.g., according to a command signal from a controller).

[0089] By actuating the push / pull element 806, the length of the antenna body 802 can be changed by extending the antenna body 802 (when the push / pull element 806 is pushed in the distal direction) or compressing the antenna body 802 (when the push / pull element 806 is pulled in the proximal direction). This changes the pitch between the turns of the antenna body 802 and the overall length of the patterned cylindrical structure. This in turn dynamically changes the delivery of energy, thereby changing the ablation zone size. In the process of changing the pitch length, the center operating frequency also changes. This change in the center operating frequency can be addressed by shifting the operating frequency to reduce the reflected power caused by the impedance mismatch.

[0090] Figure 8B is a simplified diagram of a flexible adjustable antenna system 828 according to some alternative embodiments. Figure 8B The adjustable antenna system shown includes many elements that are substantially similar to those discussed above with respect to the flexible antenna system. Figure 8B In the embodiment, a coaxial cable 801 is used. The antenna assembly system 828 includes an antenna base 808, an antenna body 810 and an antenna tip portion 832.

[0091] This embodiment also includes an outer sheath 830. The outer sheath 830 surrounds the remainder of the cable and the antenna assembly and is able to slide longitudinally relative to the cable (generally parallel to the axis of the cable) and the antenna assembly. Figure 8B As can be seen in FIG. 8 , the antenna assembly has a blunt antenna tip portion 832 (e.g., a square end with or without rounded edges, an oval end, etc.) that has sufficient area to contact the sheath tip 836 at the distal end of the assembly.

[0092] The outer sheath 830 can enclose the entire length of the cable and thus extend from the proximal section of the cable to the distal end where the antenna assembly is located along with other aspects of the flexible and / or steerable elongated device. The outer sheath 830 can be controlled to move in response to a push or pull action. In these embodiments, the push or pull action can be applied at the proximal end and translated along the length of the cable until it is applied to the antenna tip portion 832 by the sheath tip 836.

[0093] In some alternative embodiments, the outer sheath 830 does not extend the entire length of the cable, but can be controlled by a small motor or other electrical interface placed on or in the cable at a location near the distal end of the antenna assembly. For example, the small interface can be electrically coupled to a controller at the proximal end of the cable and actuated in response to a command signal sent from the controller to push the outer sheath 830 away from the antenna tip portion 832, or to pull the outer sheath 830 toward the antenna tip portion 832, depending on the command signal received.

[0094] In operation, pulling the outer sheath 830 in a proximal direction will cause the sheath tip 836 to press against some or most of the surface of the antenna tip portion 832. This, in turn, applies a compressive force to the antenna tip portion 832 (e.g., because movement of the outer sheath 830 does not occur with any corresponding movement of the cable within the outer sheath 830), which reduces the pitch of the helical antenna body 802, thereby reducing the size of the ablation zone (e.g., smaller length).

[0095] In another example, pushing the outer sheath 830 in a distal direction away from the antenna tip portion 832 causes the sheath tip 836 to relax the force applied to the antenna tip portion 832. In some embodiments, the sheath tip 836 and the antenna tip distal end 832 are not mechanically coupled together, but are in physical contact with each other solely by the amount of force applied by the sheath tip 836. Thus, as the sheath tip 836 extends distally, this reduces the amount of force applied by the sheath tip 836 to the antenna tip portion 832, which can allow the antenna body 810 to expand, thereby increasing the pitch 714 between the cuts, and correspondingly changing the energy delivery to increase the ablation size.

[0096] In some other embodiments, the sheath tip 836 and the antenna tip portion 832 are mechanically bonded together, such as by an adhesive. Therefore, when the sheath tip 836 extends distally, rather than simply releasing some of the force previously applied to the antenna tip portion 832, the movement of the sheath tip 836 applies a force in the distal direction, pulling the antenna tip portion 832 in the distal direction. This again increases the pitch 902 to change the pitch length, modifying the center operating frequency, and thus modifying the ablation zone size. If too much power is reflected at the interface between the conductors (inner conductor or outer conductor) that are electrically connected to the antenna assembly, the change in the center operating frequency can be addressed by shifting the operating frequency.

[0097] In some embodiments, movement of the outer sheath 830 may be remotely controlled by coupling the sheath to an actuator positioned along the length of the antenna system or at the proximal end of the antenna system.

[0098] Figure 9A-9C 9 shows a simplified diagram of a flexible adjustable antenna system 900 according to some embodiments. Fig.9A As shown, the antenna assembly 905 includes a distal end 903 and an antenna body 905 formed of two distinct parts, an inner tube 902 and an outer tube 904. These tubes 902, 904 can slide relative to each other, as will be discussed in more detail below. Each of the inner tube 802 and the outer tube 804 can be formed of a non-conductive, flexible, elastic material having a plastic deformation limit greater than the amount of strain imposed on the material when traversing, for example, a 5 mm bend in a tortuous path. For example, one or both of the inner tube 802 and the outer tube 804 can be formed of materials such as BeCu, NiTi, or steel, to name a few. The inner tube 902 can include conductive traces along the outer surface of the inner tube 902, and the outer tube 904 can include corresponding conductive traces along the inner surface of the outer tube 904. Therefore, when the relative positioning of the inner tube and the outer tube aligns the conductive traces, an electrical connection can occur between the inner tube 902 and the outer tube 904.

[0099] The conductive traces are depicted as a first pattern 908a on the outer surface of the inner tube 902, and in particular, etched, engraved, printed, adhered or otherwise affixed to the outer surface of the inner tube 902. The first pattern 908a is depicted as a spiral around the outer surface of the inner tube 902, extending from a first inner contact 906a at the distal end of the inner tube 902 to a second inner contact 906b at the proximal end of the inner tube 902.

[0100] Likewise, for the outer tube 904, a conductive trace is etched / engraved / printed / adhered, etc., on the inner surface of the outer tube 904 as a second pattern 908b. The second pattern 908b is depicted as a spiral around the inner surface of the outer tube 904, extending from a first outer contact 910a at the distal end of the outer tube 904 to a second outer contact 910b at the proximal end of the outer tube 904, where the flexible adjustable antenna system 900 is connected to the cable 901.

[0101] According to some embodiments, by default, the first pattern 908a or the second pattern 908b is electrically connected to the conductor of the cable to receive electrical energy to generate a radiation pattern for tissue ablation ( Figure 7 ). Thus, the connected pattern receives electrical energy and generates a radiation pattern to cause the ablation zone size set by the pitch of the pattern. For example, if the second pattern 908b on the outer tube 904 is the default connected pattern, a radiation pattern is generated according to the parameters of the second pattern 908b.

[0102] like Fig. 9B As shown, according to some embodiments, the flexible adjustable antenna system 900 is in a first configuration 900a. The inner tube 902 shown in the figure is located inside the hollow outer tube 904, but its configuration is such that the first inner contact 906a is not in electrical contact with the first outer contact 910a, and similarly the second inner contact 906b is not in electrical contact with the second outer contact 910b. Therefore, only the tube that is electrically connected to the energy source by default will produce a radiation pattern, thereby generating the ablation zone size through the pattern. The default connection is to connect to the second pattern 908b on the outer tube 904. Therefore, the generated radiation pattern is generated according to the parameters such as the pitch and length of the second pattern 908b.

[0103] like Fig. 9C As shown, if the user wishes to control / adjust the ablation zone size, the user may adjust the flexible adjustable antenna system 900 to the second configuration 900b. Fig. 9C In the example shown, the inner tube 902 has been rotated relative to the outer tube 904 so that the contacts now overlap each other to some extent, thereby providing an electrical connection between the corresponding contacts on the inner tube 902 and the outer tube 904. In alternative embodiments, the relative positioning of the inner tube 902 to the outer tube 904 can be changed by changing the relative longitudinal positioning of the inner tube 902 to the outer tube 904 or by changing a combination of the relative longitudinal positioning and the relative rotational positioning of the inner tube 902 to the outer tube 904.

[0104] When adjusted to the second configuration 900b, the first inner contact 906a now overlaps at least a portion of the first outer contact 910a, and the contacts are close enough to each other to make electrical and physical contact with each other. Similarly, the second inner contact 906b now overlaps at least a portion of the second outer contact 910b, and the contacts are close enough to each other to make electrical and physical contact with each other. Therefore, the first pattern 908a, which was previously not in electrical contact with the energy source as with the default connection of the second pattern 908b, is now in contact with the energy source.

[0105] Thus, the first pattern 908a now conducts energy by connecting the first inner contact 906a and the second inner contact 906b to the corresponding first outer contact 910a and the second outer contact 910b. Thus, electrical energy can now flow between the first inner contact 906a and the second inner contact 906b via the first pattern 908a. As shown, since both the inner pattern 908a and the outer pattern 908b are now conducting, both contribute to the radiation pattern of the antenna assembly. Since both the first pattern 908a and the second pattern 908b contribute to the radiation pattern, this effectively reduces the pitch of the radiating antenna and increases the length of the radiating antenna.

[0106] Although only two patterns on the inner and outer tubes are shown, embodiments of the present invention are also applicable to any number of different patterns and configurations, such that the tubes can be moved relative to each other to more than two different configurations to obtain more unique parameter combinations to change the radiation pattern that contributes to the size of the tissue ablation zone.

[0107] The inner tube 902 adjusts relative to the outer tube 904, the outer tube 904 adjusts relative to the inner tube 902, or the two tubes adjust relative to each other. The tubes can be manually adjusted from the proximal end or actuated by a robot. For example, the tubes can have a set track on which they can twist between a first position and a second position, with a guide (e.g., by some form of tactile or electronic feedback) to indicate that the first position or the second position has been reached.

[0108] For example, about Figures 8A-9C The above examples describe dynamic control / adjustment of parameters that contribute to the size of the tissue ablation zone for ablation. In other embodiments, the control / adjustment can be performed statically, for example, a set of antennas with variable parameters (e.g., antenna body length, pattern, pitch, radius, wire diameter, and material) can be used and delivered for ablation, depending on the desired ablation zone size.

[0109] Fig.14A method 1400 for adjusting parameters of ablation size and location is shown in accordance with some embodiments. It will be appreciated that additional processes may be provided before, during, and after the process of method 1400, and that some of the processes described may be replaced or eliminated from method 1400. Method 1400 may be manual or may be controlled by a processor of a control system (e.g., control system 1112). In process 1402, a desired ablation zone size and / or shape is determined, for example, by using: an external imaging technique such as MRI, CT, ultrasound, or fluoroscopy; an internal imaging technique such as endobronchial ultrasound (EBUS), intravascular ultrasound (IVUS), optical coherence tomography (OCT); or user input. In process 1404, adjustments to the configuration of the antenna system based on the desired ablation zone size and / or shape may be directed manually by a user or remotely by the control system 1112 of the adjustment mechanism to treat tissue. The configuration of the antenna system can be adjusted by adjusting the following parameters: one or more antenna parameters, including antenna body length, pattern, pitch, radius, wire diameter and material; and / or system parameters, including cooling flow, ablation time, power, duty cycle, frequency, maximum temperature and other energy characteristics; and / or the position / orientation of the antenna. In some embodiments, the adjustment can be controlled remotely by the control system 1112. In other embodiments, the control system 1112 can provide instructions (e.g., via a display system or an audio system) to guide the user to adjust the antenna system, including replacing antenna system components. In process 1406, ablative energy is delivered to the tissue through the antenna system with the adjusted configuration. In process 1408, the size and / or shape of the ablation zone produced by the delivered ablation energy is evaluated. This evaluation can be performed using external imaging techniques (such as MRI, CT, ultrasound or fluoroscopy); or internal imaging techniques (such as EBUS, IVUS or OCT). Alternatively, the impedance or other electrical properties of the measured tissue can be used for this evaluation. In process 1410, it is determined whether further tissue ablation is required based on the evaluation. If further ablation is required, processes 1404-1410 can be repeated with the antenna system repositioned or reoriented as needed. If further ablation is not required, no further ablation energy can be provided in process 1412.

[0110] In some embodiments, impedance mismatch and undesired reflections may occur at the interface between the cable and the antenna assembly. To avoid these problems, a matching network may be applied. For example, a quarter wave transformer may be formed by changing the diameter of the inner conductor or dielectric. For example, a 30 ohm cable may be used for impedance matching. A quarter wave segment may be formed by cutting back the inner conductor 326 by means of ablation, necking, or joining another section of coaxial cable with a corresponding inner conductor 326 of a different size. Alternatively, the outer diameter of the cable may be increased or decreased to form a quarter wave transformer, although this also reaches size limitations due to size limitations of the working channel.

[0111] In some embodiments, given the challenges that may exist in cutting the inner conductor 326 to the appropriate diameter at the interface, a high dielectric constant material (e.g., highly doped titanium dioxide (TiO 2 )) to create a quarter wave transformer.

[0112] For unwanted currents that propagate along the outside of the coaxial shaft, a choke or balun can be used to attenuate the electric field without burning unwanted tissue. Such chokes include a bazooka balun or other sections of conductive tubing concentric with the outer conductor of the cable, which are either floating or connected to the outer conductor at the proximal or distal ends. A double balun or choke can also be used; this structure consists of the two structures described previously to achieve greater current suppression. The dielectric between the choke / balun and the outer conductor can be plastic, water, ceramic, or any insulating material.

[0113] A second option for attenuating unwanted current is to use a high resistance surface coating on the outer conductor surface. Individual sections of the outer conductor can be painted, deposited or otherwise treated. Additionally, lower conductivity materials can be spliced ​​onto the outer conductor at appropriate locations to achieve a similar effect, such as graphene or colloidal graphite (aquadag).

[0114] Now go to Fig. 10A , which illustrates a method diagram 1000a for designing a flexible helical antenna system according to some embodiments. Specifically, method 1000a illustrates some aspects of configuring (e.g., including optimizing) a flexible antenna system 100 according to some embodiments of the present invention. This discussion is also applicable to various antenna body configurations. It is understood that additional steps may be provided before, during, and after the steps of method 1000a, and some of the steps described may be replaced or eliminated from method 1000a.

[0115] At block 1002a, an ablation zone size desired for tissue ablation is identified or selected. Where an ablation zone size is identified / selected, a structure length that produces a radiation pattern is selected to be just below the identified ablation zone size.

[0116] At block 1004a, an operating frequency is selected, which tells the appropriate current path length. In the example of a helix, this corresponds to the unfolded length of the helix. For example, the length will be some multiple of a quarter wavelength or a half wavelength, depending on whether operation is performed at the first resonant frequency or the second resonant frequency (either of which is permitted according to embodiments of the present invention).

[0117] At block 1006a, based on the antenna body 108 (e.g., Figure 1 ) The diameter of the antenna body 108 is fixed by the determined mechanical dimensions of the working channel through which it will pass during use. For example, the working channel can pass through a flexible and / or steerable elongated device (e.g., a flexible catheter) that is inserted into an anatomical passage and navigated to an area of ​​interest within the patient's anatomy.

[0118] At block 1008a, other parameters of the device are selected, as well as the pitch and number of repetitions, to correspond to the selected ablation length. For example, in the case of a helix, it will be confirmed that the windings of the selected helix length are not too short for convenient conventional operation as an antenna for tissue ablation.

[0119] At decision block 1010a, if the pitch is available and meets the necessary mechanical strain requirements, the method 1000a proceeds to block 1014a.

[0120] At block 1014a, the pitch is set to the value determined at block 1008a, and all parameters are fixed.

[0121] Returning to decision block 1010a, if the pitch is not usable (eg, too short for practical purposes), method 1000a proceeds to block 1012a instead. At block 1012a, the length used at block 1004a is changed to a multiple of the wavelength of the operating frequency previously selected at block 1004a.

[0122] From here, method 1000a returns to block 1006a and proceeds again as described above. Thus, the antenna may be optimized according to embodiments of the present invention, including by selecting a flexible material (plated with a conductive material) for the coil substrate, and including adjustability of the parameters of the flexible antenna system 100 to achieve different radiation patterns ( Figure 7 ).

[0123] Fig. 10BA method diagram 1000b for designing a flexible antenna system is shown. Method 1000b can be similar to method 1000a, but is used to design a differently patterned antenna body, such as a loop antenna body. In particular, method 1000b illustrates some aspects of configuring (e.g., including optimizing) a flexible antenna system 100 according to some embodiments of the present invention. This discussion also applies to various antenna body configurations. It will be appreciated that additional steps may be provided before, during, and after the steps of method 1000b, and some of the steps described may be replaced or eliminated from method 1000b.

[0124] At block 1002b, an ablation zone size desired for tissue ablation is identified or selected. Where an ablation zone size is identified / selected, a structure length that produces a radiation pattern is selected to be just below the identified ablation zone size.

[0125] At block 1004b, an operating frequency is selected which informs the appropriate current path length.

[0126] At block 1006b, the maximum diameter of the antenna body is fixed based on the determined mechanical dimensions of a working channel through which the antenna body will pass in use. For example, the working channel may pass through a flexible and / or steerable elongated device (e.g., a flexible catheter) that is inserted into an anatomical passage and navigated to an area of ​​interest within a patient's anatomy.

[0127] At block 1008b, the ring height, radius, strip height, strip width, and tube thickness are selected to meet resonance at the operating frequency.

[0128] At decision block 1010b, if the ring dimensions and strip dimensions are available and meet the necessary mechanical strain requirements, method 1000b proceeds to block 1014b. For example, if the strain is still below plastic deformation, method 1006 proceeds to block 1014b; otherwise, adjust the antenna parameters and repeat the process.

[0129] At block 1014b, the scale is set to the value determined at block 1008b, and all parameters are fixed.

[0130] Returning to decision block 1010b, if the metric is not available, the method 1000b returns to block 1010b.

[0131] Thus, the antenna may be optimized according to embodiments of the present invention, including the selection of a flexible material for the substrate (on which a conductive material is plated), and including adjustability of parameters of the flexible antenna system 100 to achieve different radiation patterns ( Figure 7 ).

[0132] Now go to Fig. 10C, which illustrates a method diagram for configuring a flexible antenna system according to some embodiments. In particular, method 1020 illustrates some aspects of manufacturing (e.g., assembling) a flexible antenna system 100 according to embodiments of the present invention. This discussion is applicable to various antenna body configurations. It should be understood that additional steps may be provided before, during, and after the steps of method 1020, and some of the steps described may be replaced or eliminated from method 1020.

[0133] At block 1022, the pattern is cut (e.g., laser cut) into hollow cylinders. This will form patterned columnar structures such as those described above. The hollow cylinders can be composed of a material with relatively low electrical conductivity, such as beryllium copper (BeCu), nickel titanium (NiTi), or other similar plastic materials (e.g., steel).

[0134] At block 1024, the patterned pillar structure is plated with a conductive material to enable the antenna assembly 103 to operate as a radiating antenna for ablating tissue. For example, the plating may be a silver plating or a gold plating. The relative thickness of the plating may depend on one or more operating frequencies of the flexible antenna system 100. Although discussed as occurring after the pattern is cut, in some embodiments, the pillar is plated prior to cutting the pattern.

[0135] At block 1026, a tip is formed for the distal end of the patterned cylindrical structure (optional). For example, the tip can be formed from the material at the end of the patterned cylindrical structure, such as by cutting the end of an open tube into a plurality of tip segments, which are then crimped (e.g., bent at their interface with the remaining material of the flexible antenna system 100 (e.g., the material of the antenna body 108)) so that the distal portion of each tip segment is substantially in contact with the distal portions of the other tip segments to form a cone as the antenna tip, such as about Figure 4A and Figure 4B Alternatively, the tip may be a separate component welded to the distal end of the patterned pillar structure ( Figure 4C ), through the tongue ( Figure 4E ) are fixed in place or tightened together ( Figure 4D ). These are just some examples. Block 1026 may be optional in method 1020.

[0136] At block 1028, the proximal end of the patterned pillar structure (because it is plated, it can also be based on Figure 1The antenna assembly 103 is coupled to the distal end of the cable. As part of this coupling, the base of the antenna can be electrically coupled to the inner conductor or outer conductor of the cable (in the example where the cable 102 is a coaxial cable). In some embodiments, only one conductor is coupled to the antenna; in other embodiments, one of the conductors is coupled to the proximal end of the antenna, while another conductor (e.g., the inner conductor) is also coupled to the distal end.

[0137] In some embodiments, block 1030 occurs next (i.e., this is an optional part of method 1020). At block 1030, an adjustment device is coupled to the patterned cylindrical structure (which is used in operation to change the ablation size of the device by adjusting the pitch and / or other parameters of the antenna). Fig. 10B , is shown as optional to recognize that some devices may include this element while other devices may not. The adjustment device can take a variety of forms / methods, such as Figures 8A-9C As a result of the above-described manufacturing method, a flexible antenna system is provided, as discussed with respect to embodiments of the present invention. Blocks 1024, 1026, and 1030 and the processes described therein may occur in a different order.

[0138] Fig.15 A method 1500 for antenna component selection according to some embodiments is shown. It can be appreciated that additional processes can be provided before, during, and after the process of method 1500, and some of the processes described can be replaced or eliminated from method 1500. Method 1500 can be controlled by a processor of a control system (e.g., control system 1112).

[0139] In process 1502, a desired ablation zone size and / or shape is determined, for example, by using an external imaging technique (e.g., MRI, CT, ultrasound, or fluoroscopy), an internal imaging technique (e.g., endobronchial ultrasound (EBUS), intravascular ultrasound (IVUS), optical coherence tomography (OCT)), or user input. The process may include receiving information about the location of the lesion, for example, by user input or by an imaging technique. Additionally or alternatively, the process may include receiving information about surrounding anatomical structures, such as blood vessels, by user input or by an imaging technique. In process 1504, information about the type of tissue to be ablated is received. The tissue type may include, for example, lung, stomach, intestine, liver, kidney, kidney stone, bladder, prostate, uterus, ovary, or other types of anatomical tissue. The tissue type may be provided by the user (e.g., by entering a target organ or intended medical procedure) as input, or may be automatically identified using imaging technology (e.g., automatically identifying an organ in a scan of an MRI, CT, ultrasound, fluoroscopy, OCT, etc.).

[0140] In process 1506, information about the type of delivery device (e.g., a flexible, elongated delivery device) can be received by the control system for determining the size (e.g., maximum size) of a customizable component of an antenna system to be delivered within a working channel of the delivery device. In one embodiment, the delivery device information can be determined by the control system based on a determination of the type of tissue to be ablated (e.g., an organ and a passage to the organ). For example, the control system can identify the maximum size of the delivery device based on the type of target organ to be approached (e.g., lung, liver, kidney, etc.) and the size of the passage providing access to the target organ (e.g., airway, rectum, esophagus, etc.). The control system can then determine the maximum size of the antenna system that can be received within the working channel of the delivery device. In process 1508, a determination can be made regarding selecting an antenna component from a plurality of available antenna components. The determination can be made by a control system (e.g., control system 1112). The antenna component can include, for example, a plurality of antenna bodies 108 that vary based on physical parameters (e.g., helical pitch, wire length, and pattern (e.g., stripe height, stripe width, loop height, and cut pattern)). In some embodiments, a visual or audible indicator can provide instructions to the user for selecting the determined antenna component. In some embodiments, as with a robotic system, the antenna component can be selected automatically. In process 1510, a determination is made regarding treatment parameters such as the ablation power, time, and / or frequency required to generate the desired ablation zone size and / or shape using the selected antenna component. The determination can be made by a control system (e.g., control system 1112) and can be based on any received or determined information including tissue type and the selected antenna component. In process 1512, the size of the predicted or actual ablation zone can optionally be stored. This process can be performed after the ablation energy is delivered to the anatomical tissue. The stored ablation zone can be used to guide a secondary ablation.

[0141] In an alternative embodiment, after power is delivered using the selected antenna, ablation can be evaluated and the processes 1508, 1510, 1512 can be repeated and further ablations can be performed at the target anatomical site.

[0142] Flexible antenna systems (including flexible adjustable antenna systems) according to embodiments of the present invention can be operated in any manner (including manual and automatic) to ablate target tissue (e.g., using microwave ablation, which is only one example of radio frequency application of these embodiments). For automated methods, robotic systems can be used for precise positioning and surgical manipulation of tissue.

[0143] To this end, the present invention describes various instruments and some parts of instruments according to their state in three-dimensional space. As used herein, the term "position" refers to the orientation of an object or a portion of an object in three-dimensional space (e.g., three translational degrees of freedom along Cartesian x, y, and z coordinates). As used herein, the term "orientation" refers to the rotational placement of an object or a portion of an object (three rotational degrees of freedom-e.g., roll, pitch, and yaw). As used herein, the term "pose" refers to the position of an object or a portion of an object in at least one translational degree of freedom and the orientation of the object or a portion of an object in at least one rotational degree of freedom (up to six total degrees of freedom). As used herein, the term "shape" refers to a set of poses, positions, or orientations measured along an object.

[0144] Fig.11 is a simplified diagram of a teleoperated medical system 1100 according to some embodiments. In some embodiments, the teleoperated medical system 1100 may be suitable for use in, for example, surgical, diagnostic, therapeutic, or biopsy procedures, including tissue ablation (e.g., tumor tissue ablation). Although some embodiments of these procedures are provided herein, any reference to medical or surgical instruments and medical or surgical methods is non-limiting. The systems, instruments, and methods described herein may be used in animals, human cadavers, animal cadavers, human or animal anatomical parts, non-surgical diagnostics, as well as industrial systems and general robotic or teleoperated systems.

[0145] like Fig.11 As shown, medical system 1100 generally includes a manipulator assembly 1102 for operating a medical device 1104 when performing various procedures on a patient P (e.g., tissue ablation using flexible antenna system 100 according to an embodiment of the present invention). Manipulator assembly 1102 can be a teleoperated, non-teleoperated, or a hybrid teleoperated and non-teleoperated assembly having selected degrees of freedom of movement that can be electrically and / or teleoperated and selected degrees of freedom of movement that can be non-electrically and / or non-teleoperated. Manipulator assembly 1102 is mounted on or near operating table T. Master control assembly 1106 allows an operator (e.g., Fig.11 The surgeon, clinician, or physician (shown) views the intervention site and controls the manipulator assembly 1102.

[0146] The master control assembly 1106 can be located at an operator console that is typically located in the same room as the operating table T, for example, on one side of the operating table where the patient P is located. However, it should be understood that the operator O can be located in a different room from the patient P or in a completely different building. The master control assembly 1106 typically includes one or more control devices for controlling the manipulator assembly 1102. The control device can include any number of various input devices, such as a joystick, trackball, data glove, trigger gun, manual controller, voice recognition device, body movement or presence sensor, etc. In order to provide the operator O with a strong sense of directly controlling the instrument 1104, the control device can be provided with the same degrees of freedom as the associated medical device 1104. In this way, the control device provides the operator O with a sense of presence or a sense that the control device and the medical device 1104 are integrated.

[0147] In some embodiments, the control device may have more or fewer degrees of freedom than the associated medical instrument 1104 and still provide a sense of presence to the operator O. In some embodiments, the control device may optionally be a manual input device that moves with six degrees of freedom, and may also include an actuatable handle for driving the instrument (e.g., for closing grasping jaws, applying potentials to electrodes and / or antennas, delivering drug therapy, etc.).

[0148] The manipulator assembly 1102 supports the medical device 1104 and can include one or more non-servo controlled links (e.g., one or more links that can be manually positioned and locked in place, often referred to as setup structures) and / or one or more servo controlled links (e.g., multiple links that can be controlled in response to commands from a control system) and a motion structure of the manipulator. The manipulator assembly 1102 can optionally include multiple actuators or motors that drive inputs on the medical device 1104 in response to commands from a control system (e.g., control system 1112). The actuators can optionally include drive systems that, when coupled to the medical device 1104, can advance the medical device 1104 into a natural or surgically created anatomical hole. Other drive systems can move the distal end of the medical device 1104 in multiple degrees of freedom, which can include three degrees of freedom for linear motion (e.g., linear motion along the X, Y, Z Cartesian axes) and three degrees of freedom for rotational motion (e.g., rotation about the X, Y, Z Cartesian axes). Additionally, these actuators can be used to actuate an articulated end effector of medical device 1104 for grasping tissue in the jaws of a biopsy device and / or similar device. Actuator position sensors (e.g., resolvers, encoders, potentiometers, and other mechanisms) can provide sensor data describing the rotation and orientation of the motor shaft to medical system 1100. This position sensor data can be used to determine the motion of an object manipulated by the actuator.

[0149] The teleoperated medical system 1100 may include a sensor system 1108 having one or more subsystems for receiving information about the instrument of the manipulator assembly 1102. Such subsystems may include: a position / orientation sensor system (e.g., an electromagnetic (EM) sensor system); a shape sensor system for determining the position, orientation, speed, velocity, posture, and / or shape of the distal end and / or along one or more segments of the flexible body that may comprise the medical instrument 1104; and / or a visualization system for acquiring images from the distal end of the medical instrument 1104.

[0150] The telemedicine system 1100 also includes a display system 1110 for displaying images or representations of the surgical site and medical device 1104 generated by the subsystems of the sensor system 1108. The display system 1110 and the main control assembly 1106 can be oriented so that the operator O can control the medical device 1104 (e.g., including tissue ablation via RF (e.g., microwave frequencies)) and the main control assembly 1106 with a sense of telepresence.

[0151] In some embodiments, the medical device 1104 can have a visualization system (discussed in more detail below) that can include a scope assembly that records concurrent or real-time images of the surgical site and provides the images to an operator or operator O via one or more displays of the medical system 1100 (e.g., one or more displays of the display system 1110). The concurrent images can be, for example, two-dimensional or three-dimensional images taken by an endoscope positioned within the surgical site. In some embodiments, the visualization system includes an endoscope component that can be integrally or removably coupled to the medical device 1104. However, in some embodiments, a separate endoscope attached to a separate manipulator assembly can be used with the medical device 1104 to image the surgical site. The visualization system can be implemented as hardware, firmware, software, or a combination thereof that interacts with or is otherwise executed by one or more computer processors, which can include a processor of the control system 1112.

[0152] The display system 1110 can also display images of the surgical site and medical instruments captured by the visualization system. In some examples, the teleoperation medical system 1100 can configure the controls of the medical instruments 1104 and the master control assembly 1106 so that the relative positions of the medical instruments are similar to the relative positions of the eyes and hands of the operator O. In this way, the operator O can manipulate the medical instruments 1104 and the manual control devices as if actually viewing the workspace. By real presence, it is meant that the appearance of the image is a real perspective image that simulates the viewpoint of the doctor who is physically manipulating the medical instrument 1104.

[0153] In some examples, display system 1110 can present an image of a surgical site recorded preoperatively or intraoperatively using image data from an imaging technique (e.g., computed tomography (CT), magnetic resonance imaging (MRI), fluoroscopy, thermal imaging, ultrasound, optical coherence tomography (OCT), thermography, impedance imaging, laser imaging, nanotube x-ray imaging, etc.). The preoperative or intraoperative image data can be presented as a two-dimensional, three-dimensional, or four-dimensional (including, for example, time-based or velocity-based information) image, and / or as an image from a model generated from a preoperative or intraoperative image data set.

[0154] In some embodiments, the display system 1110 may display a virtual navigation image in which the actual position of the medical device 1104 is registered (i.e., dynamically referenced) with a preoperative or concurrent image / model, typically for the purpose of an imaging-guided surgical procedure. This may be done to present a virtual image of the internal surgical site to the operator O from the perspective of the medical device 1104. In some examples, the perspective may be from the tip of the medical device 1104. An image of the tip of the medical device 1104 and / or other graphical or alphanumeric indicators may be superimposed on the virtual image to assist the operator O in controlling the medical device 1104. In some examples, the medical device 1104 may not be visible in the virtual image.

[0155] In some embodiments, the display system 1110 can display a virtual navigation image in which the actual position of the medical device 1104 is registered with the preoperative image or concurrent image to present a virtual image of the medical device 1104 within the surgical site to the operator O from an external perspective. An image of a portion of the medical device 1104 or other graphical or alphanumeric indicators can be superimposed on the virtual image to help the operator O control the medical device 1104. As described herein, a visual representation of the data points can be rendered to the display system 1110. For example, measured data points, moved data points, registered data points, and other data points described herein can be displayed on the display system 1110 in a visual representation. These data points can be visually represented on the user interface by a plurality of points or dots on the display system 1110 or as a rendered model (e.g., a grid or wire model created based on a set of data points). In some examples, these data points can be color-coded according to the data they represent. In some embodiments, the visual representation can be refreshed in the display system 1110 after each processing operation has been implemented to change the data points.

[0156] The remotely operated medical system 1100 may also include a control system 1112. The control system 1112 includes at least one memory and at least one computer processor (not shown) for implementing control between the medical device 1104, the main control component 1106, the sensor system 1108, and the display system 1110. The control system 1112 also includes programmed instructions (e.g., a non-transitory machine-readable medium storing these instructions) to implement some or all of the methods described according to the various aspects disclosed herein, including instructions for providing information to the display system 1110. Although the control system 1112 is Fig.11 1102 is shown as a single box in the simplified diagram of , but the system may include two or more data processing circuits, wherein a portion of the processing is optionally performed on or adjacent to the manipulator component 1102, another portion of the processing is performed at the main control component 1106, and / or the like. The processor of the control system 1112 can execute instructions corresponding to the processing disclosed herein, such as controlling the dynamic adjustment of antenna parameters according to the above-mentioned embodiments. Any of a variety of centralized or distributed data processing architectures can be utilized. Similarly, the programmed instructions can be implemented as several independent programs or subroutines, or they can be integrated into several other aspects of the remote operation system described herein. In one embodiment, the control system 1112 supports wireless communication protocols such as Bluetooth, IrDA, HomeRF, IEEE802.11, DECT, and wireless telemetry.

[0157] In some embodiments, the control system 1112 can receive force and / or torque feedback from the medical device 1104. In response to the feedback, the control system 1112 can transmit a signal to the master control assembly 1106. In some examples, the control system 1112 can transmit a signal instructing one or more actuators of the manipulator assembly 1102 to move the medical device 1104. The medical device 1104 can extend to an internal surgical site within the body of the patient P via an opening in the body of the patient P. Any suitable conventional and / or specialized actuator can be used. In some examples, one or more actuators can be separate from the manipulator assembly 1102, or integrated with the manipulator assembly 1102. In some embodiments, one or more actuators and the manipulator assembly 1102 are provided as part of a remotely operated cart positioned adjacent to the patient P and the operating table T.

[0158] The control system 1112 may optionally further include a virtual visualization system to provide navigation assistance to the operator O when controlling the medical device 1104 during an image-guided surgical procedure. Virtual navigation using the virtual visualization system can be based on a reference to a preoperative or intraoperative data set of an anatomical pathway that has been acquired. The virtual visualization system processes images of the surgical site imaged using imaging techniques (e.g., computed tomography (CT), magnetic resonance imaging (MRI), fluoroscopy, thermal imaging, ultrasound, optical coherence tomography (OCT), thermal imaging, impedance imaging, laser imaging, nanotube X-ray imaging, etc.). Software that can be used in conjunction with manual input is used to convert the recorded images into a segmented two-dimensional or three-dimensional composite representation of a local or global anatomical organ or anatomical region. The image data set is associated with the composite representation. The composite representation and the image data set describe various orientations and shapes of pathways and their connectivity. The images used to generate the composite representation can be recorded preoperatively or intraoperatively during a clinical procedure. In some embodiments, the virtual visualization system can use a standard representation (i.e., not patient-specific) or a mixture of a standard representation and patient-specific data. The composite representation and any virtual images generated from the composite representation may represent the static pose of the deformable anatomical region during one or more phases of motion (eg, during the inspiration / expiration cycle of the lungs).

[0159] During the virtual navigation procedure, the sensor system 1108 can be used to calculate the approximate position of the medical device 1104 relative to the anatomical structure of the patient P. The position can be used to generate a macro-level (external) tracking image of the anatomical structure of the patient P and a virtual internal image of the anatomical structure of the patient P. The system can implement one or more electromagnetic (EM) sensors, fiber optic sensors, and / or other sensors to align and display surgical images of medical practice and preoperative records, such as those from the virtual visualization system. For example, U.S. Patent Application No. 13 / 107,562 (filed on May 13, 2011) (disclosing "Medical System Providing Dynamic Registration of a Model of an Anatomical Structure for Image-Guided Surgery") discloses such a system, which is incorporated herein by reference in its entirety. The remotely operated medical system 1100 may further include optional operating and support systems (not shown), such as lighting systems, steering control systems, irrigation systems, and / or suction systems. In some embodiments, the remotely operated medical system 1100 may include more than one manipulator assembly and / or more than one master control assembly. The exact number of teleoperated manipulator assemblies will depend on the surgical procedure and the space constraints in the operating room, among other factors. The master control assemblies 1106 may be collocated, or they may be positioned in separate locations. Multiple master control assemblies allow more than one operator to control one or more teleoperated manipulator assemblies in various combinations.

[0160] Fig. 12A 1 is a simplified diagram of a medical device system 1200 according to some embodiments. In some embodiments, the medical device system 1200 can be used as a medical device 1104 in an image-guided medical procedure performed using the teleoperated medical system 1100. In some examples, the medical device system 1200 can be used for non-teleoperated exploratory procedures or in procedures involving traditional manually operated medical devices (e.g., endoscopes and radiofrequency tissue ablation). Optionally, the medical device system 1200 can be used to collect (i.e., measure) a set of data points corresponding to locations within an anatomical pathway of a patient (e.g., patient P).

[0161] Medical device system 1200 includes an elongated device 1202 (e.g., a flexible catheter) coupled to a drive unit 1204. Elongated device 1202 includes a flexible body 1216 having a proximal end 1217 and a distal end or tip portion 1218. In some embodiments, flexible body 1216 has an outer diameter of approximately 3 mm. Other flexible body outer diameters may be larger or smaller.

[0162] The medical device system 1200 further includes a tracking system 1230, as described in further detail below, for determining the position, orientation, speed, velocity, posture, and / or shape of the distal end 1218 and / or one or more segments 1224 along the flexible body 1216 using one or more sensors and / or imaging devices. The entire length of the flexible body 1216 between the distal end 1218 and the proximal end 1217 can be effectively divided into a plurality of segments 1224. The tracking system 1230 can optionally be implemented as hardware, firmware, software, or a combination thereof interacting with or executed by one or more computer processors, which can include Fig.11 A processor of the control system 1112 in the system.

[0163] The tracking system 1230 may optionally use a shape sensor 1222 to track the distal end 1218 and / or one or more segments 1224. The shape sensor 1222 may optionally include an optical fiber aligned with the flexible body 1216 (e.g., provided in an internal channel (not shown) or mounted externally). In one embodiment, the optical fiber has a diameter of approximately 200 μm. In other embodiments, the size may be larger or smaller. The optical fiber of the shape sensor 1222 forms a fiber optic bend sensor for determining the shape of the flexible body 1216. In an alternative, an optical fiber including a fiber Bragg grating (FBG) is used to provide strain measurement in the structure in one or more dimensions. Various systems and methods for monitoring the shape and relative position of an optical fiber in three dimensions are described in U.S. Patent Application No. 11 / 180,389 (filed July 13, 2005) (disclosing "Fiber optic position and shape sensing device and method relating thereto"); U.S. Patent Application No. 12 / 047,056 (filed July 16, 2004) (disclosing "Fiber-optic shape and relative position sensing"); and U.S. Patent No. 6,389,187 (filed June 17, 1998) (disclosing "Optical Fiber Bend Sensor"), which are incorporated herein by reference in their entirety. In some embodiments, the sensor may employ other suitable strain sensing techniques, such as Rayleigh scattering, Raman scattering, Brillouin scattering, and fluorescence scattering. In some embodiments, the shape of the elongated device may be determined using other techniques. For example, the history of the distal posture of the flexible body 1216 can be used to reconstruct the shape of the flexible body 1216 over the period of time. In some embodiments, tracking system 1230 may optionally and / or additionally use position sensor system 1220 to track distal end 1218. Position sensor system 1220 may be a component of an EM sensor system having position sensor system 1220, wherein position sensor system 1220 includes one or more conductive coils that can be subjected to an externally generated electromagnetic field. Each coil of the electromagnetic sensor system then generates an induced electrical signal, the characteristics of which depend on the position and orientation of the coil relative to the externally generated electromagnetic field. In some embodiments, position sensor system 1220 may be configured and positioned to measure six degrees of freedom (e.g., three position coordinates X, Y, Z and three orientation angles of pitch, yaw and roll indicating a base point) or five degrees of freedom (e.g., three position coordinates X, Y, Z and two orientation angles of pitch and yaw indicating a base point).Further description of position sensor systems is provided in U.S. Pat. No. 6,380,732 (filed Aug. 11, 1999) (disclosing “Six-Degree of Freedom Tracking System Having a Passive Transponder on the Object Being Tracked”), which is incorporated herein by reference in its entirety.

[0164] In some embodiments, tracking system 1230 may alternatively and / or additionally rely on historical posture, position, or orientation data stored for known points of the instrument system along cycles of alternating motion (e.g., breathing). This stored data may be used to develop shape information about flexible body 1216. In some examples, a series of position sensors (not shown) (e.g., electromagnetic (EM) sensors similar to those in position sensors 1220) may be positioned along flexible body 1216 and then used for shape sensing, in some embodiments, at a sufficient distance from medical device 1104 (e.g., flexible antenna system 100 according to an embodiment). In some examples, a history of data from one or more of these sensors acquired during a procedure may be used to represent the shape of elongated device 1202, particularly where the anatomical pathway is substantially static.

[0165] Flexible body 1216 includes a channel 1221 sized and shaped to receive a medical device 1226 . Fig. 12B1 is a simplified diagram of the flexible body 1216 with a medical device 1226, such as an ablation tool (e.g., microwave ablation), extended, according to some embodiments. In some embodiments, the medical device 1226 can be used for procedures such as surgery, biopsy, ablation, irradiation, perfusion, or aspiration. The medical device 1226 can be deployed through the channel 1221 of the flexible body 1216 and used at a target location within the anatomical structure. The medical device 1226 can include, for example, an image acquisition probe, a biopsy instrument, a laser ablation fiber, and / or other surgical, diagnostic, or therapeutic tools. In addition to, for example, an ablation antenna of the flexible antenna system 100, the medical tool can also include an end effector having a single working member, such as a scalpel, a blunt blade, an optical fiber, an electrode, etc. The medical device 1226 can also be used with an image capture probe that is also located within the flexible body 1216. In various embodiments, the medical device 1226 can be an image capture probe that includes a distal portion having a stereo camera or a monoscopic camera at or near the distal end 1218 of the flexible body 1216 for acquiring images (including video images) that are processed by the visualization system 1231 for display and / or provided to the tracking system 1230 to support tracking of the distal end 1218 and / or one or more of the segments 1224. The image capture probe can include a cable coupled to the camera for transmitting the acquired image data. In some examples, the image capture instrument can be a fiber optic bundle coupled to the visualization system 1231, such as a fiberscope. The image capture instrument can be single-spectrum or multi-spectrum, such as capturing image data in one or more of the visible, infrared, and / or ultraviolet spectra. Alternatively, the medical device 1226 itself can be an image capture probe. The medical device 1226 can be advanced from the opening of the channel 1221 to perform a procedure and then retracted into the channel when the procedure is completed. The medical device 1226 may be removed from the proximal end 1217 of the flexible body 1216 or from another optional instrument port (not shown) along the flexible body 1216 .

[0166] The medical device 1226 may additionally house cables, linkages, or other actuation control devices (not shown) extending between its proximal and distal ends to controllably bend the distal end of the medical device 1226. Steerable instruments are described in detail in U.S. Patent No. 7,316,681 (filed October 4, 2005) (disclosing "Articulated Surgical Instrument for Performing Minimally Invasive Surgery with Enhanced Dexterity and Sensitivity") and U.S. Patent Application No. 12 / 286,644 (filed September 30, 2008) (disclosing "Passive Preload and Capstan Drive for Surgical Instruments"), which are incorporated herein by reference in their entirety.

[0167] The flexible body 1216 may also house cables, linkages, or other steering control devices (not shown) extending between the drive unit 1204 and the distal end 1218 to controllably bend the distal end 1218 as shown, for example, by a dashed line depiction 1219 of the distal end 1218. In some examples, at least four cables are used to provide independent "up and down" steering to control the pitch of the distal end 1218, and to provide "side to side" steering to control the yaw of the distal end 1281. Steerable elongated devices are described in detail in U.S. Patent Application No. 13 / 274,208 (filed on October 14, 2011) (disclosing "Catheter with Removable Vision Probe"), which is incorporated herein by reference in its entirety. In embodiments where the medical device system 1200 is actuated by a remotely operated assembly, the drive unit 1204 may include a drive input device that is removably coupled to a drive element (e.g., an actuator) of the remotely operated assembly and receives power from the drive element. In some embodiments, the medical device system 1200 may include clamping features, manual actuators, or other components for manually controlling the movement of the medical device system 1200. The elongated device 1202 may be steerable, or alternatively, the system may be non-steerable without an integrated mechanism for operator-controlled bending of the distal end 1218. In some examples, one or more lumens are defined in the wall of the flexible body 1216 through which a medical device can be deployed at a target surgical site and used.

[0168] In some embodiments, the medical device system 1200 may include a flexible bronchial instrument, such as a bronchoscope or bronchial catheter for use in the inspection, diagnosis, biopsy or treatment of the lungs. The medical device system 1200 is also suitable for navigating and treating other tissues via natural or surgically established connection channels in any of various anatomical systems (including the colon, intestines, kidneys and calyces, brain, heart, circulatory system including vascular system, etc.). The medical device system 1200 can provide a working cavity to, for example, diagnostic equipment and / or treatment tools (including biopsy needles), ablation tools (including antenna systems, such as flexible antenna system 100) and / or the like. Alternatively, the medical device system 1200 may include an integrated biopsy and / or treatment tool, including, for example, an integrated antenna system of the flexible antenna system 100.

[0169] Information from tracking system 1230 can be sent to navigation system 1232 where it is combined with information from visualization system 1231 and / or preoperatively acquired models to provide real-time position information to a physician or other operator. In some examples, the real-time position information can be displayed on a Fig.11 In some examples, Fig.11 The control system 1112 can use the position information as feedback to position the medical instrument system 1200. Various systems for utilizing fiber optic sensors to align and display surgical instruments with surgical images are provided in U.S. patent application Ser. No. 13 / 107,562, filed on May 13, 2011, and disclosing “Medical System Providing Dynamic Registration of a Model of an Anatomic Structure for Image-Guided Surgery,” which is incorporated herein by reference in its entirety.

[0170] In some examples, the medical device system 1200 may be Fig.11 The medical system 1100 is remotely operated. In some embodiments, Fig.11 The manipulator assembly 1102 of the instrument may be replaced by direct operator controls. In some examples, the direct operator controls may include various handles and operator interfaces for handheld operation of the instrument.

[0171] Fig.13A and Fig. 13B is a simplified diagram of a side view of a patient coordinate space including a medical device mounted on an insertion assembly according to some embodiments. Fig.13A and Fig. 13B As shown, surgical environment 1300 includes a patient P positioned in Fig.11 The patient P may be stationary in the surgical environment because the patient's movement is limited by sedation, restraints and / or other means. Unless the patient is asked to hold his breath to temporarily suspend respiratory movement, the cyclic anatomical movement of the patient P, including respiratory and cardiac movement, can continue. Therefore, in some embodiments, data can be collected at a specific phase in the breathing, and the phase is used to mark and identify. In some embodiments, the phase during which data is collected can be inferred based on the physiological information collected from the patient P. Within the surgical environment 1300, the point collection instrument 1304 is coupled to the instrument bracket 1306. In some embodiments, the point collection instrument 1304 can use EM sensors, shape sensors and / or other sensor modalities. The instrument bracket 1306 is mounted to an insertion table 1308 fixed in the surgical environment 1300. Alternatively, the insertion table 1308 can be movable, but has a known position in the surgical environment 1300 (e.g., known via a tracking sensor or other tracking device). The instrument bracket 1306 can be a component of a manipulator assembly (e.g., manipulator assembly 1102) that is coupled to the point collection instrument 1304 to control the insertion motion (i.e., motion along the A axis) and optionally control the motion of the distal end 1318 of the elongated device 1310 in multiple directions (including yaw, pitch, and roll). The instrument bracket 1306 or insertion stage 1308 may include an actuator (not shown), such as a servo motor, that controls the motion of the instrument bracket 1306 along the insertion stage 1308.

[0172] The elongated device 1310 is coupled to an instrument body 1312. The instrument body 1312 is coupled and fixed relative to the instrument bracket 1306. In some embodiments, a fiber optic shape sensor 1314 is fixed at a proximal point 1316 on the instrument body 1312. In some embodiments, the proximal point 1316 of the fiber optic shape sensor 1314 can be movable along with the instrument body 1312, but the position of the proximal point 1316 can be known (e.g., via a tracking sensor or other tracking device). The shape sensor 1314 measures the shape from the proximal point 1316 to another point (such as the distal end 1318 of the elongated device 1310). The point collection instrument 1304 can be substantially similar to the medical instrument system 1200.

[0173] As the instrument body 1312 moves along the insertion axis A on the insertion stage 1308, the position measurement device 1320 provides information about the position of the instrument body 1312. The position measurement device 1320 may include a rotary transformer, an encoder, a potentiometer, and / or other sensors that determine the rotation and / or orientation of the actuator that controls the movement of the instrument bracket 1306 and thus the movement of the instrument body 1312. In some embodiments, the insertion stage 1308 is linear. In some embodiments, the insertion stage 1308 may be arcuate or have a combination of arcuate and linear segments.

[0174] Fig.13A The instrument body 1312 and the instrument bracket 1306 are shown in a retracted position along the insertion station 1308. In this retracted position, the position L of the proximal point 1316 on the axis A 0 At this position along the insertion table 1308, the A component of the orientation of the proximal point 1316 can be set to zero and / or another reference value to provide a basic reference describing the position of the instrument bracket 306 and therefore the proximal point 1316 on the insertion table 1308. With the instrument body 1312 and the instrument bracket 1306 in this retracted position, the distal end 1318 of the slender device 1310 can be positioned just within the access orifice of the patient P. Also at this position, the position measurement device 1320 can be set to zero and / or another reference value (e.g., I=0). Fig. 13B , the instrument body 1312 and the instrument holder 1306 have been advanced along the linear track of the insertion table 1308, and the distal end 1318 of the elongated device 1310 has been advanced into the patient P. In this advanced position, the position L of the proximal point 1316 on the axis A is 1 In some examples, encoders and / or other position data from one or more actuators that control movement of the instrument holder 1306 along the insertion table 1308 and / or one or more position sensors associated with the instrument holder 1306 and / or the insertion table 1308 are used to determine the position of the proximal point 1316 relative to the position L. 0 Location L x In some examples, position Lx can further be used as an indicator of the distance or insertion depth of distal end 1318 of elongate device 1310 inserted into a passage of the anatomical structure of patient P.

[0175] Although certain exemplary embodiments of the present invention have been described and shown in the accompanying drawings, it should be understood that these embodiments are merely exemplary and not restrictive of the broad invention, and that the embodiments of the present invention are not limited to the specific structures and arrangements shown and described, since various other modifications will be readily apparent to those skilled in the art.

Claims

1. A flexible antenna system, comprising: Flexible medical devices, including: an antenna having a distal tip portion, a proximal base, and an antenna body therebetween, wherein the antenna body comprises a patterned cylindrical structure having antenna body elements spaced apart from one another, the antenna body having a proximal end coupled to the proximal base and a distal end coupled to the distal tip portion; and an adjustment device configured to adjust a pitch length between adjacent antenna body elements, wherein the flexible medical device is configured to generate a radiation pattern from the antenna that varies based on the pitch length between adjacent antenna body elements to ablate tissue; and A control system configured to shift an operating frequency of power applied to the antenna to adjust for changes in a center operating frequency of the antenna caused by adjusting the pitch length between adjacent antenna body elements.

2. The flexible antenna system according to claim 1, wherein the antenna body comprises: a first material having a flexible plastic deformation limit that allows the antenna body to be restored to an initial state after being formed into a tight bend; as well as A second material is plated on the first material, the second material being more conductive than the first material.

3. The flexible antenna system of claim 2, wherein the tightly curved member has a bending radius of less than 30 mm.

4. The flexible antenna system of claim 2, wherein the first material comprises at least one of stainless steel and nickel titanium (NiTi), BeCu, and the second material comprises at least one of gold and silver.

5. The flexible antenna system according to any one of claims 1-4, further comprising a conductive cable assembly comprising an inner conductor and an outer conductor, wherein the antenna is coupled to the conductive cable assembly.

6. The flexible antenna system of claim 5, wherein the proximal base is coupled to the outer conductor of the conductive cable assembly.

7. The flexible antenna system of claim 5, further comprising a spacer, wherein the proximal base of the antenna is coupled to the spacer proximate the outer conductor of the conductive cable.

8. The flexible antenna system of claim 1, further comprising a conductive cable comprising an inner conductor and an outer conductor, wherein the antenna is cut from the outer conductor of the conductive cable.

9. The flexible antenna system according to claim 8, wherein: The antenna body of the antenna is coupled to the inner conductor of the conductive cable.

10. The flexible antenna system of claim 9, wherein the proximal base of the antenna abuts the inner conductor.

11. The flexible antenna system of claim 9, wherein a lumen extends through the patterned cylindrical structure, and the inner conductor extends into the lumen and is coupled to the antenna body.

12. The flexible antenna system of claim 9, wherein a lumen extends through the patterned cylindrical structure, and the inner conductor extends through the lumen and is coupled to the distal tip portion.

13. The flexible antenna system of any of claims 1-4 or 8-12, wherein the antenna body comprises an asymmetric pattern of slots cut from the material.

14. The flexible antenna system of claim 1, wherein the distal tip portion comprises at least one of an electrically insulating material and a mechanically sharp material for piercing.

15. The flexible antenna system of claim 14, wherein the distal tip portion comprises at least one of plastic or metal.

16. The flexible antenna system of any one of claims 1-4 or 8-12, further comprising an impedance matching network coupled between the conductive cable assembly and the proximal base.

17. The flexible antenna system of claim 16, wherein the antenna body comprises a helical coil, and the adjustment device is coupled to the helical coil, and the adjustment device is configured to compress or expand the helical coil to respectively reduce or increase the pitch length, thereby changing the ablation size of the generated radiation pattern.

18. The flexible antenna system of claim 17, wherein the adjustment device comprises a wire coupled to the proximal base, and the wire is configured to retract in a proximal direction to increase the pitch and to extend in a distal direction to decrease the pitch.

19. The flexible antenna system of claim 17, wherein the adjustment device comprises a wire coupled to the distal tip portion, and the wire is configured to retract in a proximal direction to decrease the pitch and to extend in a distal direction to increase the pitch.

20. The flexible antenna system of claim 17, wherein: The adjustment device includes a sheath configured to surround the helical coil and to couple with the distal end, retraction of the sheath engages the distal end to compress the helical coil and reduce the pitch, and The expansion of the sheath pulls the distal end in a distal direction to increase the pitch.

21. The flexible antenna system of claim 17, wherein: The adjustment device comprises a first tube and a second tube surrounding the first tube, The helical coil includes a first combination of a first set of traces etched in an outer surface of the first tube facing an inner surface of the second tube and a second set of traces etched in the inner surface of the second tube, the first set of traces and the second set of traces being electrically coupled to each other, and The second tube is configured to move relative to the first tube to electrically couple a third set of traces etched in the inner surface of the second tube to the first set of traces, thereby changing the pitch of the helical coil.

22. A method of ablation using a flexible medical device, comprising: identifying a desired ablation zone of target tissue, the desired ablation zone having at least one ablation zone parameter; determining physical parameters of a flexible medical device for generating ablative energy to create the desired ablation zone size for the target tissue, the flexible medical device comprising: an antenna having a distal tip portion, a proximal base, and an antenna body therebetween, and wherein the antenna body comprises a patterned cylindrical structure having antenna body elements spaced apart from one another, the antenna body having a proximal end coupled to the proximal base and a distal end coupled to the distal tip portion; and an adjustment device configured to adjust a pitch length between adjacent antenna body elements; determining at least one ablation parameter of the flexible medical device so as to generate the ablation energy to create the desired ablation zone for the target tissue; and An operating frequency of power applied to the antenna is shifted to adjust for changes in a center operating frequency of the antenna caused by adjusting the pitch length between adjacent antenna body elements.

23. The method of claim 22, further comprising: Information about the target tissue is received, wherein a power output is determined based on at least one of the information about the target tissue or the at least one ablation parameter.

24. The method of claim 22, further comprising: A selected antenna element is determined from a plurality of antenna elements based on at least one of the information about the target tissue or the at least one ablation parameter.

25. The method of any one of claims 22-24, wherein the at least one ablation parameter is a size of the ablated zone or a shape of the ablated zone.

26. The method according to any one of claims 22-24, further comprising: A type of delivery device receiving the flexible medical device is determined, wherein the physical parameter of the flexible medical device is determined based at least in part on the determination of the type of delivery device.

27. The method of any one of claims 22-24, wherein the at least one ablation parameter comprises at least one of power output, duration of energy delivery, or energy frequency.

28. The method of any one of claims 22-24, further comprising storing a size of a predicted ablation zone or an actual ablation zone.

29. A method of ablation using a flexible medical device, comprising: identifying a desired ablation area of ​​target tissue; adjusting physical parameters of a flexible medical device for generating ablative energy to create the desired ablation zone for the target tissue, the flexible medical device comprising: an antenna having a distal tip portion, a proximal base, and an antenna body therebetween, and wherein the antenna body comprises a patterned cylindrical structure having antenna body elements spaced apart from one another, the antenna body having a proximal end coupled to the proximal base and a distal end coupled to the distal tip portion; and an adjustment device configured to adjust a pitch length between adjacent antenna body elements, shifting an operating frequency of power applied to the antenna to adjust for changes in a center operating frequency of the antenna caused by adjusting the pitch length between adjacent antenna body elements; and The ablation energy is delivered to create the desired ablation zone for the target tissue.

30. The method of claim 29, wherein adjusting the physical parameter of the flexible medical device comprises changing the pitch length, or providing instructions for changing the pitch length.

31. The method of claim 29, further comprising: evaluating the actual ablation zone size of the target tissue; as well as The actual ablation zone size of the target tissue is compared to a desired ablation zone size of the target tissue.

32. The method of claim 29, further comprising: evaluating the actual ablation zone shape of the target tissue; as well as The actual ablation zone shape of the target tissue is compared with a desired ablation zone shape of the target tissue.

33. The method according to any one of claims 31 or 32, further comprising: Based on the comparison, guidance is provided for repositioning the flexible medical device.

34. The method according to any one of claims 31 or 32, further comprising: Guidance is provided for readjusting the physical parameter of the flexible medical device, wherein the readjustment is based on the comparison.

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