Reconfigurable steerable catheter

Abstract

The present disclosure presents, among other things, a steerable catheter and method for controlling the precise tip deflection of a compliant catheter mechanism with plastic and / or elastic deformation capabilities. The catheter tip deflection is optionally controlled by a dedicated hydroforming device inserted over a wire in the catheter lumen. The hydroforming device can be retracted as needed. Activating the hydroforming device deflects the tip along its axis to a desired location, and this process can be repeated at multiple locations, allowing the catheter tip to be shaped into a desired three-dimensional curve. The deflection can stably maintain a desired shape after the hydroforming device is retracted due to the multistability of the tip structure. In this way, a 3D path can be shaped while inside the vasculature or other human body structure, and this 3D path can be maintained and held in place while other transcatheter devices are passed along the 3D path.

Description

[Technical field]

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS This application claims the benefit of priority to U.S. Provisional Patent Application No. 63 / 276,727, filed November 8, 2021, the contents of which are incorporated by reference in their entirety herein. [Background technology]

[0002] The present invention, in some embodiments thereof, relates to a configurable tube, and more particularly, but not exclusively, to a configurable guiding sheath for use within the body.

[0003] One method of guiding a catheter within the body is to provide a guiding sheath and guide the catheter within the guiding sheath.

[0004] Further background art includes U.S. Patent Application Publication Nos. US20180161547A1, US20140052097A1, US2016249900, US2020 / 0188635, US20030163154, and US2015352339, U.S. Patent Nos. US10456563, US9095374, US10688276, and PCT Publication No. WO2008073126(A1), the disclosures of all of which are incorporated herein by reference. Summary of the Invention

[0005] Below is a non-exhaustive list including some example embodiments of the present invention. The present invention also includes embodiments including less than all of the features of an example, and embodiments that use features from more than one example, even if not explicitly listed below.

[0006] Example 1. A kit comprising: a multistable guide defining an inner lumen; a former sized to fit with the lumen; The guide is transformable from a first stable state to a second stable state by the shaper when the shaper is within the lumen.

[0007] Example 2. The kit of example 1, wherein the former is removable.

[0008] Example 3. The kit of any of Examples 1-2, wherein the second stable state defines a bending of the guide that is different from the first stable state.

[0009] Example 4. The kit of any of Examples 1-3, wherein the second stable state defines an extension of the guide that is different from the first stable state.

[0010] Example 5. The kit of any of the preceding examples, wherein the former is hydraulic.

[0011] Example 6. The kit of any of the preceding examples, wherein the former deforms away from axial symmetry when expanded.

[0012] Example 7. The kit of any of the preceding examples, wherein the former has an outer surface configured to frictionally engage with an inner surface of the lumen.

[0013] Example 8. The kit of any of the preceding examples, wherein the guide comprises a resilient section.

[0014] Example 9. The kit of any of the preceding examples, wherein the guide comprises a flexible section.

[0015] Example 10. The kit of any of the preceding examples, wherein the guide includes a multistable section arranged to interact with the former.

[0016] Example 11. The kit of example 10, wherein the multistable section comprises an axial arrangement of frustoconical pairs, each pair defining at least two stable states at different deformations.

[0017] Example 12. The kit of example 11, wherein the sections define at least 30 different stable deformation shapes.

[0018] Example 13. The kit of Example 12, wherein the stable deformed shape includes a range of bending of at least 60 degrees between one state and a second state, the bending being measured relative to a longitudinal axis of the sheath.

[0019] Example 14. The kit of any of the preceding examples, wherein the cross-sectional area of ​​the lumen is at least 50% of the area defined by the outer cross-section of the guide.

[0020] Example 15. The kit of any of the preceding examples, wherein the cross-sectional area of ​​the lumen is at least 70% of the area defined by the outer cross-section of the guide.

[0021] Example 16. The kit of any of the preceding examples, wherein the cross-sectional area of ​​the lumen is at least 80% of the area defined by the outer cross-section of the guide.

[0022] Example 17. The kit of any of Examples 1-11, wherein the guide defines a second lumen suitable for use as a working channel.

[0023] Example 18. The kit of any of Examples 1-11, wherein the former defines a lumen extending to and from a distal end of the former.

[0024] Example 19. The kit of any of the preceding examples, wherein the guide is of a size and material suitable for use within the human body.

[0025] Example 20. The kit of any of the preceding examples, wherein the guide is less than 30 mm in diameter over a length of 1 meter.

[0026] Example 21. The kit of any of the preceding examples, wherein the guide is less than 20 mm in diameter over a length of 1 meter.

[0027] Example 22. The kit of any of the preceding examples, wherein the guide is less than 10 mm in diameter over a length of 1 meter.

[0028] Example 23. The kit of any of the preceding examples, wherein the guide is pre-bent.

[0029] Example 24. The kit of any of the preceding examples, wherein the guide includes a section configured to remain outside the human body during use.

[0030] Example 25. A method for controlling a guide sheath, comprising: (a) using an insert to deform a portion of the guide sheath and apply a force; (b) manipulating the insert to remove the force; and (c) delivering one or both of a tool and a treatment agent through the modified guide sheath.

[0031] Example 26. The method of example 25, wherein the deforming includes expanding the former and the manipulating includes at least partially contracting the former.

[0032] Example 27. The method of example 25, wherein the manipulating includes removing the former, thereby clearing a cross section of the guide sheath.

[0033] Example 28. (b1) advancing the sheath after (b); (b2) then repeating (a) and (b) and (b1).

[0034] Example 29. The method of Example 28, comprising passing a stented lesion by said advancement.

[0035] Example 30 The method of example 28 or example 29, comprising reaching a distal lesion without exchanging the guide catheter.

[0036] Example 31. The method of any of Examples 25-30, wherein the deforming includes forming a compound curve in the sheath.

[0037] Example 32. The method of any of Examples 25-31, wherein the deformation secures the sheath within the surrounding body lumen.

[0038] Example 33. The method of example 32, comprising axially shortening a portion of the bendable section after said fixation to advance a proximal portion of the sheath.

[0039] Example 34. The method of any of Examples 25-33, wherein the delivering step includes orienting the guidewire in a desired three-dimensional direction established by the deforming.

[0040] Example 35. The method of any of Examples 25-34, comprising cannulating the artery through its ostium and extending the sheath axially beyond the ostium, thereby potentially reducing retraction of the delivered tool.

[0041] Example 36. The method of any of Examples 25-35, wherein the deforming provides support for delivery of a device through the sheath by controlling bending and / or axial forces exerted by the sheath.

[0042] Example 37. The method of any of Examples 25-36, wherein the deforming provides support for delivery of a device through the sheath by controlling bending and / or axial forces exerted by the sheath.

[0043] Example 38. A method according to any of Examples 25 to 37, wherein the deforming includes controlling one or both of an axial force applied by localized stretching of the sheath and a bending force applied by bending and / or three-dimensional curvature of the sheath.

[0044] Example 39. A method for controlling a guide sheath, comprising: (a) applying a force to an internal portion of the frustum sheath using an insert; (b) delivering one or both of a tool and a treatment agent through the modified guide sheath.

[0045] Example 40. The method of Example 39, wherein the deforming step includes guiding the tip of the guide sheath to a target location.

[0046] Example 41. The method of Example 40, wherein the location is the heart.

[0047] Example 42. The method of Example 41, wherein the location comprises the LV or RV outflow area.

[0048] Example 43 The method of Example 41, wherein the delivering comprises transseptal delivery.

[0049] Example 44. The method of any of Examples 39-43, wherein the sheath is stably deformed to include at least two curved portions with different bending radii or directions.

[0050] Example 45. The method of any of Examples 39 to 44, wherein the deforming includes stretching the tip of the guide sheath.

[0051] Example 46. The method of any of Examples 39-45, wherein the stretching includes stretching a distal portion of a stable bend in the guide sheath.

[0052] Example 47. The method of Example 46, wherein the delivering step includes altering the location of the tip to treat an adjacent location after the delivering step.

[0053] Example 48. The method of any of Examples 39-47, wherein the deforming includes forming a bend that does not lean on body tissue.

[0054] Example 49. The method of any one of Examples 39 to 48, wherein the insert is integrally attached to the inner surface of the sheath.

[0055] Example 50. The method of any of Examples 39-49, wherein the deforming comprises selectively deforming by bending decoupled from axial deformation.

[0056] Example 51. A method for controlling a guide sheath, comprising: (a) selecting a desired bend in the sheath; (b) applying pressure to a deformer associated with the sheath, thereby directly setting the bend.

[0057] Example 52. A method for controlling a guide sheath, comprising: (a) selecting a desired bend and a desired axial extension of the distal end of the sheath; (b) bending and axially stretching a portion of the tip distal to the bend in a separate manner, whereby the bend does not affect the axial stretch, and vice versa.

[0058] Example 53. A multi-stable guide sheath, The body includes: Lumens and a bendable section surrounding a portion of the lumen; The bendable section is deformable over a range of positions, each of the positions having an associated bending resistance, and a second of the plurality of positions has a bending resistance based on deformation, the resistance being discrete.

[0059] Example 54. The multistable guide sheath of example 53, wherein each of a plurality of axially separated points along the bendable section defines at least two minima of bending resistance.

[0060] Example 55. The multistable guide sheath of example 54, wherein the point is defined by a pair of frusto-conical elements.

[0061] Example 56. A multistable guide sheath according to any one of Examples 53 to 55, wherein the sheath is stable in the second of the plurality of positions.

[0062] Example 57. A multistable guide sheath as described in any of Examples 53 to 56, wherein the second plurality of positions of the plurality of positions includes at least 20 positions.

[0063] Example 58. A multistable guide sheath according to any one of Examples 53 to 55, wherein the body is elastic.

[0064] Example 59. A multistable guide sheath according to any of Examples 53-58, including an outer elastomeric layer covering a multistable underlayer.

[0065] Example 60. The multistable guide sheath of any of Examples 53-59, including at least one integral hydraulically expandable chamber configured to deform the bendable section when expanded.

[0066] Example 61. A multistable guide sheath as described in any of Examples 53 to 60, wherein the body defines a guidewire lumen.

[0067] Example 62. The multistable guide sheath of any of Examples 53-59, comprising at least one removable hydraulically expandable chamber.

[0068] Example 63. The multistable guide sheath of Example 62, wherein the former has an outer surface configured to frictionally and / or geometrically mate with the wall of the lumen.

[0069] Example 64. A multistable guide sheath as described in Example 62 or Example 63, wherein the former has a leading edge configured to advance along the lumen and avoid geometrically locking with the lumen.

[0070] Example 65. A multistable guide sheath according to any one of Examples 62 to 64, wherein the former has a predefined axially asymmetric shape.

[0071] Example 66. A multistable guide sheath as described in any of Examples 53 to 62, wherein the bendable section has at least one limiter that non-uniformly limits deformation of the bendable section.

[0072] Example 67. The multistable guide sheath of any of Examples 53-60, wherein the restrictor defines a compound curve within the bendable section.

[0073] Example 68. A multistable guide sheath as described in any of Examples 53 to 60, wherein the restrictor defines a radially expanding shape within the bendable section and is adapted to anchor the bendable section within a surrounding body lumen.

[0074] Example 69. A multistable guide sheath according to any one of Examples 66 to 68, wherein the restrictor is elongated.

[0075] Example 70. The multistable guide sheath of example 69, wherein the restrictor has a helical shape.

[0076] As will be appreciated by those skilled in the art, some embodiments of the present invention (e.g., a self-propelled forward-moving robot) may be embodied as a system, a method, or a computer program product. Accordingly, some embodiments of the present invention may take the form of an entirely hardware embodiment, an entirely software embodiment (including firmware, resident software, microcode, etc.), or an embodiment combining software and hardware aspects, all of which may be generally referred to herein as a "circuit," "module," or "system." Furthermore, some embodiments of the present invention may take the form of a computer program product embodied in one or more computer readable medium(s) having computer readable program code embodied therein. Implementation of the method and / or system of some embodiments of the present invention may include performing and / or completing selected tasks manually, automatically, or a combination thereof. Furthermore, depending on the actual instrumentation and implementation of some embodiments of the method and / or system of the present invention, some selected tasks may be implemented by hardware, software, or firmware, and / or a combination thereof, for example, using an operating system.

[0077] For example, hardware for performing selected tasks according to some embodiments of the invention may be implemented as a chip or circuit. Software, selected tasks according to some embodiments of the invention may be implemented as a number of software instructions executed by a computer using any suitable operating system. In an exemplary embodiment of the invention, one or more tasks according to some exemplary embodiments of the methods and / or systems described herein are performed by a data processor, such as a computing platform for executing a number of instructions. Optionally, the data processor includes volatile memory for storing instructions and / or data, and / or non-volatile storage, such as a magnetic hard disk and / or removable media, for storing instructions and / or data. Optionally, a network connection is also provided. A display and / or a user input device, such as a keyboard or mouse, are also optionally provided.

[0078] Any combination of one or more computer readable medium(s) may be utilized for some embodiments of the present invention. The computer readable medium may be a computer readable signal medium or a computer readable storage medium. The computer readable storage medium may be, for example, without limitation, an electronic, magnetic, optical, electromagnetic, infrared, or semiconductor system, apparatus, or device, or any suitable combination of the foregoing. More specific examples (non-exhaustive list) of computer readable storage media include: an electrical connection having one or more wires, a portable computer diskette, a hard disk, a random access memory (RAM), a read-only memory (ROM), an erasable programmable read-only memory (EPROM or flash memory), an optical fiber, a portable compact disk, a read-only memory (CD-ROM), an optical storage device, a magnetic storage device, or any suitable combination of the foregoing. In the context of this document, a computer readable storage medium may be any tangible medium of expression that can contain or store a program used by or in connection with an instruction execution system, apparatus, or device.

[0079] A computer-readable signal medium may include a propagated data signal in which computer-readable program code is embodied, for example, in baseband or as part of a carrier wave. Such a propagated signal may take any of a variety of forms, including, without limitation, electromagnetic, optical, or any suitable combination thereof. A computer-readable signal medium may be any computer-readable medium that is not a computer-readable storage medium and that can communicate, propagate, or transport a program for use by or in connection with an instruction execution system, apparatus, or device.

[0080] The program code embodied on the computer readable medium and / or data used thereby may be transmitted using any suitable medium, such as, but not limited to, wireless, wired, fiber optic cable, RF, etc., or any suitable combination of the foregoing.

[0081] Computer program code for carrying out operations for some embodiments of the present invention may be written in any combination of one or more programming languages, such as object-oriented programming languages, such as Java, Smalltalk, C++, etc., and traditional procedural programming languages, such as the "C" programming language, or similar programming languages. The program code may run entirely on the user's computer, partially on the user's computer, as a standalone software package, partially on the user's computer and partially on a remote computer, or entirely on a remote computer or server. In the latter scenario, the remote computer may be connected to the user's computer via any type of network, such as a local area network (LAN) or wide area network (WAN), or the connection may be to an external computer (e.g., via the Internet using an Internet Service Provider).

[0082] Some embodiments of the present invention may be described below with reference to flowchart illustrations and / or block diagrams of methods, apparatus (systems) and computer program products according to embodiments of the present invention. It will be understood that each block of the flowchart illustrations and / or block diagrams, and combinations of blocks in the flowchart illustrations and / or block diagrams, can be implemented by computer program instructions. These computer program instructions may be provided to a processor of a general purpose computer, a special purpose computer, or other programmable data processing apparatus to manufacture a machine, and the instructions executing on the processor of the computer or other programmable data processing apparatus create means for performing the function / acts specified in the block or blocks of the flowchart illustrations and / or block diagrams.

[0083] These computer program instructions may also be stored in a computer-readable medium that can instruct a computer, other programmable data processing apparatus, or other device to function in a particular manner, such that the instructions stored in the computer-readable medium produce an article of manufacture that includes instructions that implement the function / acts specified in the block or blocks of the flowcharts and / or block diagrams.

[0084] The computer program instructions may also be loaded onto a computer, other programmable data processing apparatus, or other device to cause a series of operational steps to be executed on the computer, other programmable apparatus, or other device to generate a computer-implemented process, the instructions executing on the computer or other programmable apparatus providing a process for performing the function / acts specified in the block or blocks of the flowcharts and / or block diagrams.

[0085] Some of the methods described herein are generally designed for computational use only and may not be feasible or practical to be performed entirely manually by a human expert. If a human expert wanted to manually perform a similar task, such as guiding a catheter or defining a bend in a guide sheath, they would be expected to use an entirely different method, e.g., utilizing specialized knowledge and / or the pattern recognition capabilities of the human brain, which would be much more efficient than performing the steps of the methods described herein manually.

[0086] Some embodiments of the present invention are herein described, by way of example only, with reference to the accompanying drawings, in which: - With specific reference now to the drawings in detail, it is stressed that the particulars shown are by way of example and are for the purpose of illustrating embodiments of the invention, - In this connection, the description given with the drawings will make apparent to those skilled in the art how embodiments of the invention may be practiced, [Brief description of the drawings]

[0087] [Figure 1(a)] FIG. 1 illustrates a CFT (frustum tip) tool, e.g., a sheath / catheter, and optionally, an OTW (over the wire) (e.g., dual lumen) bend former microcatheter used to shape curves within the CFT, according to some embodiments of the present invention. [Figure 1(b)] FIG. 1 illustrates a CFT (frustum tip) tool, e.g., a sheath / catheter, and optionally, an OTW (over the wire) (e.g., dual lumen) bend former microcatheter used to shape curves within the CFT, according to some embodiments of the present invention. [Figure 1(c)] FIG. 1 illustrates a CFT (frustum tip) tool, e.g., a sheath / catheter, and optionally, an OTW (over the wire) (e.g., dual lumen) bend former microcatheter used to shape curves within the CFT, according to some embodiments of the present invention. [Figure 1(d)]FIG. 1 illustrates a CFT (frustum tip) tool, e.g., a sheath / catheter, and optionally, an OTW (over the wire) (e.g., dual lumen) bend former microcatheter used to shape curves within the CFT, according to some embodiments of the present invention. [Figure 1(e)] FIG. 1 illustrates a CFT (frustum tip) tool, e.g., a sheath / catheter, and optionally, an OTW (over the wire) (e.g., dual lumen) bend former microcatheter used to shape curves within the CFT, according to some embodiments of the present invention. [Figure 1(f)] FIG. 1 illustrates a CFT (frustum tip) tool, e.g., a sheath / catheter, and optionally, an OTW (over the wire) (e.g., dual lumen) bend former microcatheter used to shape curves within the CFT, according to some embodiments of the present invention. [Figure 1(g)] FIG. 1 illustrates a CFT (frustum tip) tool, e.g., a sheath / catheter, and optionally, an OTW (over the wire) (e.g., dual lumen) bend former microcatheter used to shape curves within the CFT, according to some embodiments of the present invention. [Figure 1(h)] FIG. 1 illustrates a CFT (frustum tip) tool, e.g., a sheath / catheter, and optionally, an OTW (over the wire) (e.g., dual lumen) bend former microcatheter used to shape curves within the CFT, according to some embodiments of the present invention. [Figure 1(i)] FIG. 1 illustrates a CFT (frustum tip) tool, e.g., a sheath / catheter, and optionally, an OTW (over the wire) (e.g., dual lumen) bend former microcatheter used to shape curves within the CFT, according to some embodiments of the present invention. [Figure 1(j)] FIG. 1 illustrates a CFT (frustum tip) tool, e.g., a sheath / catheter, and optionally, an OTW (over the wire) (e.g., dual lumen) bend former microcatheter used to shape curves within the CFT, according to some embodiments of the present invention. [Figure 2(a)] FIG. 1 illustrates a CFT tool and, optionally, an OTW (dual lumen) elongated shaper microcatheter, according to some embodiments of the present invention. [Figure 2(a1)] FIG. 1 illustrates a CFT tool and, optionally, an OTW (dual lumen) elongated shaper microcatheter, according to some embodiments of the present invention. [Figure 2(b)] FIG. 1 illustrates a CFT tool and, optionally, an OTW (dual lumen) elongated shaper microcatheter, according to some embodiments of the present invention. [Figure 2(c)] FIG. 1 illustrates a CFT tool and, optionally, an OTW (dual lumen) elongated shaper microcatheter, according to some embodiments of the present invention. [Figure 2(d)] FIG. 1 illustrates a CFT tool and, optionally, an OTW (dual lumen) elongated shaper microcatheter, according to some embodiments of the present invention. [Figure 2(e)] FIG. 1 illustrates a CFT tool and, optionally, an OTW (dual lumen) elongated shaper microcatheter, according to some embodiments of the present invention. [Figure 2(f)] FIG. 1 illustrates a CFT tool and, optionally, an OTW (dual lumen) elongated shaper microcatheter, according to some embodiments of the present invention. [Figure 2(g)] FIG. 1 illustrates a CFT tool and, optionally, an OTW (dual lumen) elongated shaper microcatheter, according to some embodiments of the present invention. [Figure 2(h)] FIG. 1 illustrates a CFT tool and, optionally, an OTW (dual lumen) elongated shaper microcatheter, according to some embodiments of the present invention. [Figure 2(i)] FIG. 1 illustrates a CFT tool and, optionally, an OTW (dual lumen) elongated shaper microcatheter, according to some embodiments of the present invention. [Figure 2(j)] FIG. 1 illustrates a CFT tool and, optionally, an OTW (dual lumen) elongated shaper microcatheter, according to some embodiments of the present invention. [Figure 2(k)]FIG. 1 illustrates a CFT tool and, optionally, an OTW (dual lumen) elongated shaper microcatheter, according to some embodiments of the present invention. [Figure 2(l)] FIG. 1 illustrates a CFT tool and, optionally, an OTW (dual lumen) elongated shaper microcatheter, according to some embodiments of the present invention. [Figure 2(m)] FIG. 1 illustrates a CFT tool and, optionally, an OTW (dual lumen) elongated shaper microcatheter, according to some embodiments of the present invention. [Figure 3(a)] 1A-1D show a CFT tool and, optionally, an OTW (dual lumen) bend former microcatheter and partial shaping of a double curve within the CFT, according to some embodiments of the present invention. [Figure 3(b)] 1A-1D show a CFT tool and, optionally, an OTW (dual lumen) bend former microcatheter and partial shaping of a double curve within the CFT, according to some embodiments of the present invention. [Figure 3(c)] 1A-1D show a CFT tool and, optionally, an OTW (dual lumen) bend former microcatheter and partial shaping of a double curve within the CFT, according to some embodiments of the present invention. [Figure 3(d)] 1A-1D show a CFT tool and, optionally, an OTW (dual lumen) bend former microcatheter and partial shaping of a double curve within the CFT, according to some embodiments of the present invention. [Figure 3(e)] 1A-1D show a CFT tool and, optionally, an OTW (dual lumen) bend former microcatheter and partial shaping of a double curve within the CFT, according to some embodiments of the present invention. [Figure 3(f)] 1A-1D show a CFT tool and, optionally, an OTW (dual lumen) bend former microcatheter and partial shaping of a double curve within the CFT, according to some embodiments of the present invention. [Figure 3(g)] 1A-1D show a CFT tool and, optionally, an OTW (dual lumen) bend former microcatheter and partial shaping of a double curve within the CFT, according to some embodiments of the present invention. [Figure 3(h)] 1A-1D show a CFT tool and, optionally, an OTW (dual lumen) bend former microcatheter and partial shaping of a double curve within the CFT, according to some embodiments of the present invention. [Figure 3(i)] 1A-1D show a CFT tool and, optionally, an OTW (dual lumen) bend former microcatheter and partial shaping of a double curve within the CFT, according to some embodiments of the present invention. [Figure 3(j)] 1A-1D show a CFT tool and, optionally, an OTW (dual lumen) bend former microcatheter and partial shaping of a double curve within the CFT, according to some embodiments of the present invention. [Figure 3(k)] 1A-1D show a CFT tool and, optionally, an OTW (dual lumen) bend former microcatheter and partial shaping of a double curve within the CFT, according to some embodiments of the present invention. [Figure 3(l)] 1A-1D show a CFT tool and, optionally, an OTW (dual lumen) bend former microcatheter and partial shaping of a double curve within the CFT, according to some embodiments of the present invention. [Figure 3(m)] 1A-1D show a CFT tool and, optionally, an OTW (dual lumen) bend former microcatheter and partial shaping of a double curve within the CFT, according to some embodiments of the present invention. [Figure 4(a)] 1A-1C illustrate a constrained CFT tool, and optionally an OTW (dual lumen) high elongation ratio shaper microcatheter, and integral shaping of complex curves within the CFT, according to some embodiments of the present invention. [Figure 4(b)] 1A-1C illustrate a constrained CFT tool, and optionally an OTW (dual lumen) high elongation ratio shaper microcatheter, and integral shaping of complex curves within the CFT, according to some embodiments of the present invention. [Figure 4(c)] 1A-1C illustrate a constrained CFT tool, and optionally an OTW (dual lumen) high elongation ratio shaper microcatheter, and integral shaping of complex curves within the CFT, according to some embodiments of the present invention. [Figure 4(d)]1A-1C illustrate a constrained CFT tool, and optionally an OTW (dual lumen) high elongation ratio shaper microcatheter, and integral shaping of complex curves within the CFT, according to some embodiments of the present invention. [Figure 4(e)] 1A-1C illustrate a constrained CFT tool, and optionally an OTW (dual lumen) high elongation ratio shaper microcatheter, and integral shaping of complex curves within the CFT, according to some embodiments of the present invention. [Figure 4(f)] 1A-1C illustrate a constrained CFT tool, and optionally an OTW (dual lumen) high elongation ratio shaper microcatheter, and integral shaping of complex curves within the CFT, according to some embodiments of the present invention. [Figure 4(g)] 1A-1C illustrate a constrained CFT tool, and optionally an OTW (dual lumen) high elongation ratio shaper microcatheter, and integral shaping of complex curves within the CFT, according to some embodiments of the present invention. [Figure 4(h)] 1A-1C illustrate a constrained CFT tool, and optionally an OTW (dual lumen) high elongation ratio shaper microcatheter, and integral shaping of complex curves within the CFT, according to some embodiments of the present invention. [Figure 4(i)] 1A-1C illustrate a constrained CFT tool, and optionally an OTW (dual lumen) high elongation ratio shaper microcatheter, and integral shaping of complex curves within the CFT, according to some embodiments of the present invention. [Figure 4(j)] 1A-1C illustrate a constrained CFT tool, and optionally an OTW (dual lumen) high elongation ratio shaper microcatheter, and integral shaping of complex curves within the CFT, according to some embodiments of the present invention. [Figure 4(k)] 1A-1C illustrate a constrained CFT tool, and optionally an OTW (dual lumen) high elongation ratio shaper microcatheter, and integral shaping of complex curves within the CFT, according to some embodiments of the present invention. [Figure 4(l)] 1A-1C illustrate a constrained CFT tool, and optionally an OTW (dual lumen) high elongation ratio shaper microcatheter, and integral shaping of complex curves within the CFT, according to some embodiments of the present invention. [Figure 4(m)] 1A-1C illustrate a constrained CFT tool, and optionally an OTW (dual lumen) high elongation ratio shaper microcatheter, and integral shaping of complex curves within the CFT, according to some embodiments of the present invention. [Figure 4(n)] 1A-1C illustrate a constrained CFT tool, and optionally an OTW (dual lumen) high elongation ratio shaper microcatheter, and integral shaping of complex curves within the CFT, according to some embodiments of the present invention. [Figure 5(a)] FIG. 1 illustrates a CFT tool and, optionally, an OTW (dual lumen) bend shaper microcatheter with a unique curvature and / or a spherical shape with a hole at the tip, which is optionally used to shape curves within the CFT, according to some embodiments of the present invention. [Figure 5(b)] FIG. 1 illustrates a CFT tool and, optionally, an OTW (dual lumen) bend shaper microcatheter with a unique curvature and / or a spherical shape with a hole at the tip, which is optionally used to shape curves within the CFT, according to some embodiments of the present invention. [Figure 5(c)] FIG. 1 illustrates a CFT tool and, optionally, an OTW (dual lumen) bend shaper microcatheter with a unique curvature and / or a spherical shape with a hole at the tip, which is optionally used to shape curves within the CFT, according to some embodiments of the present invention. [Figure 5(d)] FIG. 1 illustrates a CFT tool and, optionally, an OTW (dual lumen) bend shaper microcatheter with a unique curvature and / or a spherical shape with a hole at the tip, which is optionally used to shape curves within the CFT, according to some embodiments of the present invention. [Figure 5(e)] FIG. 1 illustrates a CFT tool and, optionally, an OTW (dual lumen) bend shaper microcatheter with a unique curvature and / or a spherical shape with a hole at the tip, which is optionally used to shape curves within the CFT, according to some embodiments of the present invention. [Figure 5(f)]FIG. 1 illustrates a CFT tool and, optionally, an OTW (dual lumen) bend shaper microcatheter with a unique curvature and / or a spherical shape with a hole at the tip, which is optionally used to shape curves within the CFT, according to some embodiments of the present invention. [Figure 5(g)] FIG. 1 illustrates a CFT tool and, optionally, an OTW (dual lumen) bend shaper microcatheter with a unique curvature and / or a spherical shape with a hole at the tip, which is optionally used to shape curves within the CFT, according to some embodiments of the present invention. [Figure 5(h)] FIG. 1 illustrates a CFT tool and, optionally, an OTW (dual lumen) bend shaper microcatheter with a unique curvature and / or a spherical shape with a hole at the tip, which is optionally used to shape curves within the CFT, according to some embodiments of the present invention. [Figure 5(i)] FIG. 1 illustrates a CFT tool and, optionally, an OTW (dual lumen) bend shaper microcatheter with a unique curvature and / or a spherical shape with a hole at the tip, which is optionally used to shape curves within the CFT, according to some embodiments of the present invention. [Figure 6(a)] FIG. 1 shows a CFT tool and, optionally, an OTW (dual lumen) bend shaper microcatheter with a fixed antenna-like wire and / or a bulbous shape at its tip, which is optionally used to shape curves within the CFT, according to some embodiments of the present invention. [Figure 6(b)] FIG. 1 shows a CFT tool and, optionally, an OTW (dual lumen) bend shaper microcatheter with a fixed antenna-like wire and / or a bulbous shape at its tip, which is optionally used to shape curves within the CFT, according to some embodiments of the present invention. [Figure 6(c)] FIG. 1 shows a CFT tool and, optionally, an OTW (dual lumen) bend shaper microcatheter with a fixed antenna-like wire and / or a bulbous shape at its tip, which is optionally used to shape curves within the CFT, according to some embodiments of the present invention. [Figure 6(d)] FIG. 1 shows a CFT tool and, optionally, an OTW (dual lumen) bend shaper microcatheter with a fixed antenna-like wire and / or a bulbous shape at its tip, which is optionally used to shape curves within the CFT, according to some embodiments of the present invention. [Figure 6(e)] FIG. 1 shows a CFT tool and, optionally, an OTW (dual lumen) bend shaper microcatheter with a fixed antenna-like wire and / or a bulbous shape at its tip, which is optionally used to shape curves within the CFT, according to some embodiments of the present invention. [Figure 6(f)] FIG. 1 shows a CFT tool and, optionally, an OTW (dual lumen) bend shaper microcatheter with a fixed antenna-like wire and / or a bulbous shape at its tip, which is optionally used to shape curves within the CFT, according to some embodiments of the present invention. [Figure 6(g)] FIG. 1 shows a CFT tool and, optionally, an OTW (dual lumen) bend shaper microcatheter with a fixed antenna-like wire and / or a bulbous shape at its tip, which is optionally used to shape curves within the CFT, according to some embodiments of the present invention. [Figure 6(h)] FIG. 1 shows a CFT tool and, optionally, an OTW (dual lumen) bend shaper microcatheter with a fixed antenna-like wire and / or a bulbous shape at its tip, which is optionally used to shape curves within the CFT, according to some embodiments of the present invention. [Figure 6(i)] FIG. 1 shows a CFT tool and, optionally, an OTW (dual lumen) bend shaper microcatheter with a fixed antenna-like wire and / or a bulbous shape at its tip, which is optionally used to shape curves within the CFT, according to some embodiments of the present invention. [Figure 7(a)] 1A-1D show schematic layouts of a catheter tip and top and cross-sectional views of a constituent multistable cell consisting of two elastic truncated cones, according to some embodiments of the present invention. [Figure 7(b)]1A-1D show schematic layouts of a catheter tip and top and cross-sectional views of a constituent multistable cell consisting of two elastic truncated cones, according to some embodiments of the present invention. [Figure 7(c)] 1A-1D show schematic layouts of a catheter tip and top and cross-sectional views of a constituent multistable cell consisting of two elastic truncated cones, according to some embodiments of the present invention. [Figure 7(d)] 1A-1D show schematic layouts of a catheter tip and top and cross-sectional views of a constituent multistable cell consisting of two elastic truncated cones, according to some embodiments of the present invention. [Figure 8] 1(a)-(c) show the theoretical potential energy of a single elastic frustum under zero gauge pressure, according to some embodiments of the present invention, and a comparison between theoretical and numerically calculated values ​​of the potential energy. [Figure 9] 1(a)-(c) are three projections describing the dependence of the equilibrium state of a single elastic frustum on the pressure applied directly to the elastic frustum, according to some embodiments of the present invention. [Figure 10(a)] 1 is a schematic diagram of a CFT-based search and rescue robot, navigation capabilities and gait according to some embodiments of the present invention. [Figure 10(b)] 1 is a schematic diagram of a CFT-based search and rescue robot, navigation capabilities and gait according to some embodiments of the present invention. [Figure 11(a)] 1A-1D show a CFT tool and optionally an OTW (dual lumen) high elongation ratio shaper microcatheter, designed to optionally perform intraluminal hydraulic crawling when, for example, the tip of the CFT guide catheter pulls the shaft distally when driven by the shaper microcatheter, without the need to push proximally from the hub, in accordance with some embodiments of the present invention. [Figure 11(b)]1A-1D show a CFT tool and optionally an OTW (dual lumen) high elongation ratio shaper microcatheter designed to optionally perform intraluminal hydraulic crawling when, for example, the tip of the CFT guide catheter pulls the shaft distally when actuated by the shaper microcatheter, without the need to push proximally from the hub, in accordance with some embodiments of the present invention. [Figure 11(c)] 1A-1D show a CFT tool and optionally an OTW (dual lumen) high elongation ratio shaper microcatheter designed to optionally perform intraluminal hydraulic crawling when, for example, the tip of the CFT guide catheter pulls the shaft distally when actuated by the shaper microcatheter, without the need to push proximally from the hub, in accordance with some embodiments of the present invention. [Figure 11(d)] 1A-1D show a CFT tool and optionally an OTW (dual lumen) high elongation ratio shaper microcatheter designed to optionally perform intraluminal hydraulic crawling when, for example, the tip of the CFT guide catheter pulls the shaft distally when actuated by the shaper microcatheter, without the need to push proximally from the hub, in accordance with some embodiments of the present invention. [Figure 11(e)] 1A-1D show a CFT tool and optionally an OTW (dual lumen) high elongation ratio shaper microcatheter designed to optionally perform intraluminal hydraulic crawling when, for example, the tip of the CFT guide catheter pulls the shaft distally when actuated by the shaper microcatheter, without the need to push proximally from the hub, in accordance with some embodiments of the present invention. [Figure 11(f)] 1A-1D show a CFT tool and optionally an OTW (dual lumen) high elongation ratio shaper microcatheter designed to optionally perform intraluminal hydraulic crawling when, for example, the tip of the CFT guide catheter pulls the shaft distally when actuated by the shaper microcatheter, without the need to push proximally from the hub, in accordance with some embodiments of the present invention. [Figure 11(g)] 1A-1D show a CFT tool and optionally an OTW (dual lumen) high elongation ratio shaper microcatheter designed to optionally perform intraluminal hydraulic crawling when, for example, the tip of the CFT guide catheter pulls the shaft distally when actuated by the shaper microcatheter, without the need to push proximally from the hub, in accordance with some embodiments of the present invention. [Figure 11(h)] 1A-1D show a CFT tool and optionally an OTW (dual lumen) high elongation ratio shaper microcatheter designed to optionally perform intraluminal hydraulic crawling when, for example, the tip of the CFT guide catheter pulls the shaft distally when actuated by the shaper microcatheter, without the need to push proximally from the hub, in accordance with some embodiments of the present invention. [Figure 11(i)] 1A-1D show a CFT tool and optionally an OTW (dual lumen) high elongation ratio shaper microcatheter designed to optionally perform intraluminal hydraulic crawling when, for example, the tip of the CFT guide catheter pulls the shaft distally when actuated by the shaper microcatheter, without the need to push proximally from the hub, in accordance with some embodiments of the present invention. [Figure 11(j)] 1A-1D show a CFT tool and optionally an OTW (dual lumen) high elongation ratio shaper microcatheter designed to optionally perform intraluminal hydraulic crawling when, for example, the tip of the CFT guide catheter pulls the shaft distally when actuated by the shaper microcatheter, without the need to push proximally from the hub, in accordance with some embodiments of the present invention. [Figure 11(k)]1A-1D show a CFT tool and optionally an OTW (dual lumen) high elongation ratio shaper microcatheter designed to optionally perform intraluminal hydraulic crawling when, for example, the tip of the CFT guide catheter pulls the shaft distally when actuated by the shaper microcatheter, without the need to push proximally from the hub, in accordance with some embodiments of the present invention. [Figure 11(l)] 1A-1D show a CFT tool and optionally an OTW (dual lumen) high elongation ratio shaper microcatheter designed to optionally perform intraluminal hydraulic crawling when, for example, the tip of the CFT guide catheter pulls the shaft distally when actuated by the shaper microcatheter, without the need to push proximally from the hub, in accordance with some embodiments of the present invention. [Figure 11(m)] 1A-1D show a CFT tool and optionally an OTW (dual lumen) high elongation ratio shaper microcatheter designed to optionally perform intraluminal hydraulic crawling when, for example, the tip of the CFT guide catheter pulls the shaft distally when actuated by the shaper microcatheter, without the need to push proximally from the hub, in accordance with some embodiments of the present invention. [Figure 11(n)] 1A-1D show a CFT tool and optionally an OTW (dual lumen) high elongation ratio shaper microcatheter designed to optionally perform intraluminal hydraulic crawling when, for example, the tip of the CFT guide catheter pulls the shaft distally when actuated by the shaper microcatheter, without the need to push proximally from the hub, in accordance with some embodiments of the present invention. [Figure 11(o)] 1A-1D show a CFT tool and optionally an OTW (dual lumen) high elongation ratio shaper microcatheter designed to optionally perform intraluminal hydraulic crawling when, for example, the tip of the CFT guide catheter pulls the shaft distally when actuated by the shaper microcatheter, without the need to push proximally from the hub, in accordance with some embodiments of the present invention. [Figure 11(p)] 1A-1D show a CFT tool and optionally an OTW (dual lumen) high elongation ratio shaper microcatheter designed to optionally perform intraluminal hydraulic crawling when, for example, the tip of the CFT guide catheter pulls the shaft distally when actuated by the shaper microcatheter, without the need to push proximally from the hub, in accordance with some embodiments of the present invention. [Figure 12] 9(a)-(b) are diagrams illustrating ideal and realistic deformations of an active frustum along (a) vertical and (b) horizontal cross sections of FIG. 8, according to some embodiments of the present invention. [Figure 13] 1A-1D are cross-sectional views of an integrated device including a sheath having CFT-like properties and one or more integrated hydraulic compartments for shaping the sheath, according to some embodiments of the present invention. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0088] The present invention, in some embodiments thereof, relates to configurable tubes, and more particularly, but not exclusively, to configurable guiding sheaths or catheters for use within the body.

[0089] Aspects of some embodiments of the invention relate to a multi-stable tool, optionally a sheath tool used to deliver other tools (e.g., elongated tools with working channels such as guide sheaths, guide catheters, and / or endoscopes), optionally for medical applications (e.g., sterile packaging). In some embodiments of the invention, the tool (using a guide sheath as an example) can stably maintain multiple deformation states (e.g., including one, two, three or more bends in one or two planes). One or more radiopaque markers may be provided at the deformable points to better see the deformed shape under X-ray. In some embodiments of the invention, the deformable part of the tool is a series of frustoconical elements, and without loss of generality (because the elements may not extend to the actual distal end of the tool and may be located at other points along the distal part of the tool), the term CFT (frustoconical tip) is used. It is noted that the designs described herein may also (or instead of) be applied to the mid-section and / or proximal part of the tool.

[0090] Although the term "guide sheath" is used herein, it should be noted that the same device can function as both a guide sheath and a guide catheter, with the functionality optionally depending on the outer and inner diameters of the device and / or the target location and route thereto. In particular, the tools described herein are optionally guided to locations within the body through which other tools may pass and / or be contained within the tools themselves. Some typical tool sizes for medical applications include, for example, 7F (French) to 12F ID (inner diameter) for the guide sheath, optionally further 1 to 3F for the outer diameter (OD), 4F=7F for the guide catheter outer diameter, and 2.5F to 4F for the unexpanded former outer diameter. The CFT section may be, for example, 5 to 500 mm long, for example, 10 to 200 mm long, for example, 20 to 150 mm long. The device may include multiple CFT sections, for example, 2, 3, 4 or more CFT sections separated by non-CFT sections. Overall, the device may include, for example, 2 to 1000 CFT cells, such as 10 to 800, such as 20 to 100 cells. The cells may be unconstrained, but in some embodiments 10% to 90%, such as 20% to 70% of the cells are constrained or asymmetric in operation.

[0091] In some embodiments of the invention, the sheath is provided as a kit with an internal shaper, optionally a hydraulically deformable shaper (e.g., deformation by expansion), although in some embodiments other shape changes (e.g., stretching and bending) may be provided by deformation. Optionally, a shaper is inserted into the sheath at the desired bend location and expanded to cause deformation of the sheath. In some embodiments of the invention, the shaper is in the form of an asymmetrically expanding balloon, such as a balloon that bends when expanded and / or expands differently at different axial locations and / or a balloon that expands to different amounts at different radial locations (e.g., has different compliance at different axial portions thereof) and / or a balloon formed of multiple independent inflatable compartments, optionally controlled in parallel or series.

[0092] In some embodiments of the invention, the former is designed using calculations (e.g., as shown herein) to achieve a desired effect on the surrounding CFT. Optionally or additionally, the former is capable of a wide range of deformations, some of which are sufficient for CFT operation, e.g., given suitable inflation pressures.

[0093] In some embodiments of the invention, the deformation includes stretching of the sheath. Optionally, the shaper is designed to frictionally fit inside the sheath, and optionally includes two portions that move axially when expanded. In some embodiments of the invention, the shaper includes a surface texture that frictionally fits and / or geometrically interlocks with the inner surface of the CFT. In one example, multiple serrations and / or protrusions are provided on one or both of the outer shaper surface and the inner CFT surface. In some embodiments of the invention, a first compartment (or section) of the shaper, which has a lower resistance to expansion, expands first to fit with the inner CFT surface, allowing the shaper to stretch and / or otherwise change shape to modify the shape of the CFT. A potential advantage of such engagement is that the force applied to the CFT can be localized, rather than provided from a remote location, such as outside the body (e.g., by pushing). This can have the effect of pulling a portion of the CFT forward, rather than pushing it from its proximal side. Optionally or additionally, such elongation may be useful to allow manipulation of the sheath tip without affecting more proximal deformation.

[0094] In some embodiments of the present invention, the sheath is deformed but maintains a stable configuration when deformed. This may be useful, for example, to allow the sheath to maintain its natural elasticity and bounce back after deformation caused by body tissue movement or other forces. In a sense, the geometric deformation of the CF (frustum cone) element is plastic, and the element switches between two stable states. This type of deformation is referred to herein as a "bistable" deformation. Note that once in such a stable state, the element does not exert any force or experience any significant strain. Optionally, the CFT material itself can be elastic, in the sense that when the element is not in a stable state, such a portion of the CFT can deform elastically and bounce back when such a deformation force is removed.

[0095] A potential advantage of a CFT-like structure over a simple elastic wall is that it can provide a stiffer wall. A potential advantage over a wall with embedded coils or braids is that the CFT has a more structured deformation process. This prevents uncontrolled deformation that can occur with coils, for example. Another potential advantage of a CFT-like structure is that the CFT structure is stiff rather than flexible when bent. This stiffness and / or reduced degrees of freedom can result in more predictable and stable bending configurations. Additionally, the CFT structure may be thinner and / or require less force to deform than would be the case with a stiff, thick wall.

[0096] A potential advantage of CFT-like structures with respect to bending is that circumferentially related portions of the CFT structure may be bonded, and bending may be provided by isolating points on one side while the other circumferentially opposite side is compressed. Thus, to bend a coil-based flexible catheter, a unidirectional balloon may not be sufficient; multiple circumferentially spaced balloons may be required.

[0097] In some embodiments of the invention, the CFT segments define multiple stable positions (stretching and / or bending), e.g., 2, 10, 40, 50, 100, or smaller, intermediate, or larger numbers. In such stable positions, the forces exerted by the frustum sections in various states are balanced (e.g., optionally with some frictional or plastic deformation forces), so that no net force is exerted on the sheath. Furthermore, due to the nature of the frustum design, each frustum element is at a local minimum, so that changing the shape of the CFT requires input of forces to move the frustum element away from such minimum, thereby providing stability and resistance to deformation (e.g., until sufficient force is applied to further deform the CFT).

[0098] In a practical design, the stable states of such a CFT may effectively form a continuum of positions at which the CFT is stable and at rest.

[0099] In some embodiments of the invention, the sheath is pre-formed to be asymmetric, e.g., bending in a certain direction when in a resting state, bending more on one (lateral) side of the CFT as the CF element changes state, and / or defining a non-planar and / or multi-bend shape.

[0100] A potential advantage of using a CFT is that forces (axial and / or torque) can be applied locally (at the deformation region) rather than proximally.

[0101] In some embodiments of the invention, the deformable portion of the sheath (e.g., CFT) is formed from an array of frustums (e.g., 4, 10, 20, 30, or an intermediate or greater number), optionally circumferentially symmetric, arranged in pairs, each pair together defining a number of stable states (e.g., 2). Optionally, the sheath deformation includes deforming one or more such pairs. Note that the overall deformation options can be continuous, by allowing a successive set of positions, each with a pair of frustums having slightly different deformations.

[0102] In some embodiments of the invention, different mechanisms are used: for example, the sheath may contain one or more plastically deformable elements, such as wires, braids, ribbons, and / or other structures within its wall, which are deformed using an internal former.

[0103] In some embodiments of the invention, the CFT as a whole (or an axial section thereof) is elastic. Optionally, this functionality is provided by an elastic layer (e.g., an elastic wire or coating or sheath). In some embodiments of the invention, this elastic layer is selected to apply an elastic force greater than the force required to change between bistable states (e.g., the local minimum force required to keep the frustum cells open). Optionally, this allows the structure to deform instantaneously in a bistable manner under the application of force by a shaper, but to statically bounce back to its original form. This may be useful for navigation to select bending and / or stretching points along the CFT using a shaper.

[0104] Note that in this and other embodiments, the CFT may surround a guidewire, and the guidewire may be used to maintain a path to the target as the CFT deforms.

[0105] In some embodiments of the invention, such sheaths are used to deliver tools into the heart or gastrointestinal tract. A potential advantage of such use is that a stable, easily traversable path is defined. Another potential advantage of such use is that the deformed sheath potentially does not apply significant additional force to tissue as the tool passes through and / or during use. Another potential advantage of such use is that the path can be set incrementally, such that once a particular anatomical structure has been traversed, no further manipulation of the sheath or another tool is required to pass through that anatomical structure. As with other sheaths, the use of the sheath can protect tissue from inadvertent engagement by a tool passing through the sheath.

[0106] An aspect of some embodiments of the invention relates to using hydraulic techniques to set the shape (e.g., bend(s) and / or axial length) of an elongated medical tool, such that the shape of the tool remains stable even when the hydraulic pressure used to set the shape is discontinued. In some embodiments of the invention, the tool includes a bendable section comprising a truncated cone or an array of plastically deformable elements and an axially adjacent shaped section that is hydraulically deformable (e.g., expandable) by expansion thereof, thereby stably setting the shape of the deformable section.

[0107] In some embodiments of the invention, the shape is set using a hydroformer, and the former can be removed to increase the available working lumen of the medical tool. Optionally or additionally, the former (e.g., when not inflated) can be used as a microcatheter over a guidewire.

[0108] An aspect of some embodiments of the invention relates to a multi-joint device controllable by an internally inserted shaper that selectively bends one or more of the joints. In some embodiments of the invention, the device is resiliently biased such that when the shaper is removed or otherwise ceases its molding action, at least a portion of the joint bends back to its resting state. In some embodiments of the invention, the joint is a multi-stable structure.

[0109] A potential advantage of some embodiments of the present invention relates to providing greater and / or active control of the axial and / or bending forces exerted by the guide sheath (eg, its bending and / or extension).

[0110] A potential advantage of some embodiments of the present invention relates to passing through narrow and / or other obstructions, such as through stents or other implanted devices.

[0111] A potential advantage of some embodiments of the present invention relates to more precise aiming of a guidewire or tool exiting a guide sheath. Optionally, greater control and stability of the 3D deformation of the sheath is used to improve such precision.

[0112] A potential advantage of some embodiments of the invention relates to prevention of backout: Optionally, better, more stable and / or geometrically correct placement and / or shape of the guide sheath according to some embodiments of the invention at the port prevents deformation and / or retrograde movement of the sheath away from the port.

[0113] A potential advantage of some embodiments of the present invention relates to delivery of tools and / or implants, optionally using the sheath as a stable and / or precise aiming platform, with options for realignment.

[0114] A potential advantage of some embodiments of the invention relates to reaching distal lesions (e.g., more than 5-10 cm past the LM or RCA ostium and / or past at least two bifurcations / bends from the LM or RCA). Optionally, the methods described herein are used to steer the sheath so that the guidewire is pointed in the correct direction as the sheath is advanced. In some embodiments of the invention, a potential advantage is that the guide sheath is not exchanged during progression to the lesion.

[0115] Aspects of some embodiments of the invention relate to treating the heart using a stable deformable sheath, for example as described herein. In some embodiments of the invention, a sheath is used to set a path to a target lesion, and the advancement of the tool does not apply force and / or damage to the body because the sheath is rigid after deployment. Optionally or additionally, the target area is beyond at least one, and optionally two or more, different bends in the sheath. In some embodiments of the invention, the tip of the sheath advances axially, but the previous bend remains in place by axial extension of the CFT portion, for example as described herein. Optionally or additionally, the tip bends without moving the previous bend. A potential advantage is that once navigation of the sheath to the target is at least roughly completed, fine adjustments may only require application of force to the tip.

[0116] An aspect of some embodiments of the invention relates to decoupling axial stretching and bending of tubular devices. In some embodiments of the invention, axial stretching is provided by CFT type stretching of the tip section or other parts of the catheter or sheath device. As described herein, no mechanical tension or push is required along the shaft body of the device. In contrast, standard catheters are bent using pull wires that apply tension along the entire shaft, and / or axial advancement tends to change the support point of the catheter on the body part, causing bending changes.

[0117] In some embodiments of the invention, bending is provided by CFT-like bending at a location. Desirably, such bending uses a locally applied force that can be transmitted by a pressurized fluid. Preferably, this does not apply tension, compression, or bending forces to any other part of the device, thereby isolating bending from extension (or contraction).

[0118] An aspect of some embodiments of the present invention relates to a device with an integrated pressure forming mechanism and a multi-stable structure such as a CFT. In some embodiments of the present invention, one or more expansion chambers are provided under the CFT-like structure. Selective expansion of one or more chambers can result in bending and / or stretching, for example, as described herein, but it is noted that radial expansion is not required to obtain friction, since the expansion chambers are intrinsically bonded to the CFT layer by manufacturing. Optionally, the expansion chambers are evacuated after use to reduce the amount of occupied internal volume of the device. Optionally or additionally, for example in elastic return devices, the chambers are limited in radial extension into the device lumen, for example, by an internal non-expanding layer or a radially elastic layer.

[0119] An aspect of some embodiments of the invention relates to using pressure to set the bend angle of the device. In some embodiments of the invention, pressure is provided using hydraulic fluid. In some embodiments, pressure is provided using gas. In some embodiments of the invention, pressure is provided by a separate expandable former inserted into the device. In some embodiments, a pressurizable chamber is incorporated into the device. Generally, this disclosure describes hydraulic actuators, but pneumatic actuators may be substituted. Generally, pneumatic actuators have the potential advantage of being more resilient, while hydraulic actuators have the potential advantage of being more precise.

[0120] A potential advantage of using pressure is the option to avoid applying forces to parts of the device other than the part that is being intentionally deformed, allowing parts of the device to be deformed while other parts remain stable. Specifically, in some embodiments, there are no pulling forces, pushing forces, rotational torques, and / or length-changing forces.

[0121] An aspect of some embodiments of the invention relates to catheters that have a bend radius less than 150% (or less than 120% or less than 100%) of the catheter diameter. In one example, the bend radius is 3-5 mm or less, e.g., for catheter diameters of 3-5 mm. In some embodiments of the invention, such bend radii for rigid and / or elastic catheters are achieved using structures such as CFTs, ​​which optionally provide support to avoid crimping of any catheter lumen.

[0122] Before describing at least one embodiment of the invention in detail, it is to be understood that the invention is not necessarily limited in its application to the details of construction and arrangement of components and / or methods set forth in the following description and / or illustrated in the drawings and / or examples. The invention is capable of other embodiments or of being practiced or carried out in various ways.

[0123] Description of Some Embodiments of the Invention One proposed steerable catheter mechanism is based on a combination of component devices: a truncated cone tip (abbreviated CFT) structure that forms the distal portion of the steerable catheter, and a hydraulic device (e.g., either a monorail configuration or over the guidewire (OTW)) that is inserted into the lumen of the steerable catheter. Each device separately, the truncated cone tip or the hydraulic device (also referred to as a "former") are optionally relatively simple mechanisms, but the two combined can potentially provide precise steering with various shape-changing capabilities as described herein. The catheter shaft is optionally wire-free and does not require any special features or specifications (e.g., threaded or other embedded mechanisms for pull wires) according to some embodiments of the present invention, and thus can potentially be designed for optimal torque transmission. The resulting wall thickness of the catheter distal portion can potentially be significantly smaller than conventional steerable catheters or sheaths that incorporate pull wires. Furthermore, tip control is optionally independent of shaft structure, length, or material. In some embodiments of the invention, control of the tip is achieved by pressurization of an internal lumen retractable hydraulic device connected to the hub of the catheter.

[0124] Typical truncated cone tip In some embodiments of the invention, the frustum tip comprises the deflected (optionally distal) portion of the catheter, in some embodiments of the invention. The design parameters of the frustum (e.g., geometric definitions such as the angle and height of the cone element, material definitions such as wall thickness and stiffness, and further parameters described herein) and the resulting functionality of the catheter are optionally linked together, as described herein.

[0125] In conventional non-steerable catheters and in some steerable catheters, the distal portion of the catheter may be pre-shaped to provide a certain function (e.g., arterial support). Generally, in some embodiments of the invention, the distal portion of the catheter is not pre-shaped, but can be pre-shaped. The frustum tip can undergo dynamic shaping within the vasculature as it is actuated by a hydroformer catheter (see, e.g., figure caption above).

[0126] In this document, shaping is defined as a permanent or instantaneous change in the local 2- or 3-dimensional orientation of the tip segment axis along any point of the tip segment axis. For example, both the curvature and deflection of the axis can be controlled in 3-dimensional space to form a desired 3-dimensional curve. Instantaneous pressure actuation dependent shaping of the CFT can be achieved by incorporating an elastically deformable lining within the CFT, for example, on either the inner or outer wall. Alternatively, instantaneous pressure dependent shaping of the CFT can be achieved, for example, with the CFT design shown in FIG. 7 and a dedicated shaping device with an elastic spring layer on the concave arc of the single lumen shaper.

[0127] The pre-actuated axial length of the cone tip is

number

number

number

[0128] FIG. 7( c ) shows a schematic layout of the catheter tip 700 and an inner lumen hydraulic system 702 with a hydraulic pressure source 704 .

[0129] Figures 7(a) and 7(b) show top and cross-sectional views of a constituent multistable cell consisting of two elastic frustums (710, 712). Figure 7(a) shows the upper frustum surface 706 and CFT lumen 708 according to some exemplary embodiments of the present invention. Figure 7(d) shows a cross-sectional view of hydraulic device 702 with corresponding static thickness and radial functions.

[0130] The frustum tip shown in FIG. 7 consists of a series interconnection of two sets of elastic frustums (diverging frustum 710 and converging frustum 712 aligned on opposite sides along an axis). In some embodiments of the invention, each set or substructure has both uniaxial and antisymmetric degrees of freedom. Under appropriate conditions, each set has four stable equilibrium states (see, for example, FIG. 8). This local multistability potentially gives the element the ability to remain stable in a multitude of complex equilibrium states, which may be useful for reconfiguring the shape of the catheter tip. Note that while the overall effect is a multistable deformability of shape (which appears to be plastic), the actual structure may be elastically deformable.

[0131] As illustrated in FIG. 7, a catheter (or guide sheath) tip 700 is optionally described as a serial interconnection of N cells 714, each consisting of two elastic frustums. The cells are optionally operatively connected to a pressurizable device 702 (hydraulic device) where pressure, denoted p as seen in FIG. 7(c), is located within the lumen 708 of the tip segment and controlled externally. Here, deflections of the tip and its constituent building blocks are expressed in terms of a global coordinate system

number

number

number

[0132] Typical coordinates of tip structure movement In some embodiments of the present invention, the horizontal and vertical coordinates of the centre of mass of the nth multistable cell relative to the global coordinate system are expressed as follows:

number

[0133]

number

number

number

number

[0134] The horizontal, vertical and rotational DOF of the distal exit of the tip can be given by:

number

[0135] Typical contributions of non-conservative forces applied to a system To account for the effects of non-conservative forces on the system, virtual work may be calculated. These forces include the distal radius of the catheter,

number

number

number

number

number

number

number

[0136] Typical closed-form expressions for externally applied axial forces and bending moments on a single frustum In some embodiments of the invention, the forces and moments exerted by the interface hydraulics 702 or adjacent frustum experienced by a single frustum are expressed by:

number

[0137] Where:

number

number

number

[0138] A typical solution for the final shape of the catheter under hydraulic pressure. In some embodiments of the present invention, equations (10) and (11) are

number

number

number

[0139] Here, we assume that all odd frustums are identical to all even frustums (although this is not necessary in some embodiments),

number

[0140] Optionally, the potential energy of the hydraulic compartment contributed by the nth cell is given by:

[0141]

number

number

number

[0142] The total energy of the CFT portion of the catheter is given by, optionally, summing the energies for all cells at the tip and adding the energy of the interface shaper catheter:

[0143]

number

[0144] One solution method involves applying Hamilton's principle to this sum. For example, in the present system of equations, the total energy sum (potential and virtual work) is differentiated with respect to each degree of freedom and equated to zero, resulting in a system of 4N ordinary differential equations governing the dynamics of the system under study. Their solution can result in a controlled deflection of the CFT under hydraulic actuation of the former. Furthermore, equations (10) and (11) can be used to calculate the local DOFs (degrees of freedom) of each frustum.

number

[0145] Typical solutions and analysis of governing equations Based on the theoretical formulation, the fundamental multistable behavior of the CFT section can be inferred by utilizing finite element analysis to investigate the elastic properties of a single frustum while not subjected to pressure (or forming) from a hydraulic device.

[0146] Figure 8 shows the strain energy function of a single active frustum based on equation (15) and the parameters calculated in the calibration process according to some embodiments of the present invention. The figure also presents the equilibrium states of the frustum achieved by forcing equations (10) and (11) to zero. The stability of each state is classified based on the eigenvalues ​​of the Jacobian of these equations at the examined states.

[0147] Figure 8 further shows several sections of the strain energy function where either the axial or tilt DOF is constant. Finally, for validation purposes, the corresponding sections obtained from a finite element scheme devised using the COMSOL Multiphysics software are also shown. In this scheme, the frustum is discretized by quadratic rectangular shell elements, uniformly distributed so that there are 15 elements in the radial direction and 100 elements along the perimeter. A number of static simulations utilizing this scheme were performed to determine the axial displacement of the small base of the frustum, while its large base was constrained to a plane in a way that allows rotation. The strain energy at each state was calculated by the built-in functions.

[0148] Figure 8 shows very good agreement between theoretical and numerically obtained results at reasonably small values ​​of DOF, while for significant values ​​of ζ and φ the correlation seems to weaken due to large values ​​of the base angle ψ, which is assumed to be small in the particular model derivation. Nevertheless, the range of validity seems sufficient to capture most reasonable deformations of the frustum, showing that it is possible to solve both the forward and inverse problems of the CFT shape based on the forces and the forces required to achieve the CFT shape.

[0149] Next, Figure 8 shows that when the frustum is unstressed, there are nine equilibrium states, four of which are stable and correspond to snap-up, snap-down, and two antisymmetric partial snap states. These stable states give an unpressurized (e.g., no internal fluid or other pressures) CFT the ability to remain stable in a large number of equilibrium states (e.g., due to the presence of a large number of frustums), including local folding, configurations, and bending. In realistic cases where the thickness of the frustum is not infinitesimally small, the strain energy function and its equilibrium states are not symmetric around ζ=0.

[0150] To complete the picture of typical static behavior of the frustum, in Fig. 9 we show analytically obtained equilibrium states of an active frustum achieved in conditions where the pressure of various external hydraulic devices is applied directly. The figure shows four bifurcating pressure values ​​that separate five regions with different numbers of stable states. The first region corresponds to small absolute pressure values ​​and is therefore qualitatively described by Fig. 8, i.e., in this region the frustum has four stable states. Conversely, at high positive pressure values ​​the frustum can only remain stable in the snap-up state, and at similarly high negative pressure values ​​the only equilibrium state is snap-down. Two complementary regions are achieved at intermediate pressure values ​​(positive or negative). In these regions the frustum has two stable equilibria corresponding to the snap-up and snap-down states. Thus, in agreement with Fig. 8, a relatively small pressure change inside the CFT (or the interface hydraulic compartment) results in an energetically favorable post-buckling behavior from the snap-up or snap-down state to a partial snap. However, at higher pressure values ​​each frustum instantly switches between the snap-up and snap-down states. One potential benefit is that the bent configuration can be straightened into an axially elongated configuration by increasing the pressure. This allows for continuous deformation of the same part of the CFT, but also of different parts of the CFT. The last analysis performed, dealing with the elastic properties of the system, examines the assumption that all odd frustums are considered rigid. In this analysis, we utilize a finite element scheme established in COMSOLM ultiphysics to describe a multistable cell consisting of two interconnected frustums of identical thickness with unstressed axisymmetric deflections ζ0,1 and ζ0,2.

[0151] Consistent with the model assumptions, the bases of both frustums are free to rotate about the tangential direction, but the large base of both frustums is forced to undergo equal translational motions, the axial displacement of the small base of the upper frustum is prescribed, and the small base of the lower frustum is fixed to the plane.Similar to the previously described scheme, each frustum is discretized by second-order rectangular shell elements and divided into 15 uniformly distributed radial and 100 tangential segments.

[0152] Based on this scheme, in Fig. 12 we compare the ideal deformation of the cell, represented only by the deformation of the upper frustum, with the deformation of this frustum in a more realistic case where the lower frustum is not considered to be rigid. The figure shows that for moderate values ​​of ζ and φ, appropriate for most practical deformations, the deviation between the realistic and ideal cases is small, implying that the simplification of the model to truncate half of the DOF is applicable in practice.

[0153] In summary, this high-energy stability map obtained from numerical simulations shows both stable and unstable equilibrium points. In FIG. 8, the extension DOF is zeta and the curvature DOF is phi. At zero phi, there are two stable axial extension points, meaning that the cell can be energetically stable when contracted and when open. Alternatively, at zero zeta, there are two stable curvature points, and since the analysis is two-dimensional, the structure can bend on both sides (e.g., without loss of generality, both sides means any azimuthal direction in three dimensions).

[0154] Typical Hydroformer Catheter In some embodiments of the invention, hydraulic actuation (e.g., shaper) is generated via a dedicated intralumen transcatheter (operating within the lumen of a frusto-conical catheter) device. The shaft structure of the hydraulic device can be implemented using an embodiment similar to the shaft portion of a PTCA balloon angioplasty catheter. For example, OTW (over the wire) (dual lumen shaft with guidewire lumen and inflation lumen), or monorail / rapid exchange (shaft with single central inflation lumen and distal guidewire entry port), or shaft with single central inflation lumen without wire incorporated. The tip of the shaper catheter optionally includes an elastically deformable compartment that assumes a pre-designed shape when pressurized (e.g., such shape is optionally a function of its elastic and geometric properties). Such compartment may have a radius and / or wall thickness, Young's modulus, Poisson's ratio, and / or other parameters that vary axially and / or tangentially. Optionally, the overall shape matches the cylindrical shape of the tip of the shaper catheter 702, as seen in FIG. 7.

[0155] The properties of the elastically deformable compartment (e.g., radial cross section, arc sector, length, and / or elastic material constants) optionally determine its function while pressurized inside the lumen of the CFT. The elastically deformable compartment is optionally made from, without limitation, a flexible superelastic material. Optionally, the stress-strain curve of such a material is designed according to its desired function (e.g., by appropriate selection of a specific material). In some embodiments of the invention, the design process is performed by closed-form simulation or numerical solution of the governing equations of the structure, for example, as described above. It is noted that for any given desired deflection of the CFT, there are often multiple different embodiments of hydroformer tips that thus produce the desired deflection of the CFT. It is also noted that the former tips may be pre-designed to expand and / or apply forces in a non-uniform manner in the axial and / or circumferential directions. Furthermore, the tips may be designed to apply different forces in the radial direction, for example, some may be flexible and some may not. As the pressure increases beyond a certain point, the flexible sections expand further, potentially further deforming the surrounding CFT, without significantly affecting the inflexible sections.

[0156] Typical navigation of the vasculature / heart chambers using an OTW hydroformer microcatheter and a cone-tipped catheter (CFT-tipped catheter) A set of hydraulic formers described herein can generate a wide range of deflections of the CFT. Optionally, one or both of two types of pressure signals are provided by such formers: a constant uniform pressure (such as that used in a PTCA balloon device) and a time-dependent pressure signal. The time-dependent pressure signal can create a corresponding desired transient response of the CFT, which may optionally be used to guide the catheter within the vasculature (e.g., when the sheath / catheter has not deformed to a new stable configuration). The mechanism by which the former generates either an elastic or plastic (reconfigurable) deflection of the CFT is a measured combination between local axial elastic strains generated within the elastic compartment of the former and local tangential (circumferential) strains that enforce contact forces along the CFT (e.g., as described herein for an elastic sheath covering the CFT).

[0157] Some typical operation modes There are several embodiments of hydraulic actuation. One of the main approaches that is viable, for example when the outer sheath or catheter diameter is larger than 4Fr, is a separate hydraulic former catheter. When the former and CFT are aligned and the former is twisted, the directionality of the curve changes without the need to twist the CFT sheath. The table below summarizes some typical former embodiments.

[0158] [Table 1]

[0159] In some embodiments of the invention, the hydroforming device described in Table 1 is positioned along the CFT as part of a retractable microcatheter device. This method may be particularly useful in limited diameter configurations where the former microcatheter can be exchanged for other transcatheter devices once the CFT catheter / sheath is in the desired configuration. This method is also consistent with some examples of peripheral radiology workflows where microcatheters (3-4 Fr) are typically used over the wire with 5-6 Fr catheters. However, it should be noted that the same method and design can also be used in catheter designs where the hydraulic device is not retractable but is fixed to (or within) the CFT wall. Such a permanent hydraulic device can be designed in larger diameter situations, such as cardiology / transseptally placed sheaths, as part of the CFT sheath. Optionally, such a compartment is embedded in the wall of the device and no separate balloon is provided.

[0160] In addition to the desired selection of materials and geometric properties for the CFT, several alternative designs are provided that may provide various functions, for example as described in the section entitled "Trusted Cone Tip." The following table summarizes several exemplary CFT embodiments (optionally coated and / or covered with various layers for smoothness, hydrophilic behavior, biocompatibility, waterproofing, and / or protection, etc.):

[0161] [Table 2-1] [Table 2-2]

[0162] In some embodiments of the invention, the sheath and / or catheter are manufactured to have a non-linear rest or starting position, e.g., the CFT is plastically bent along a set curve during manufacture, such that a static curve is generated by small local deviations of the frustum cells, as in the form of a pre-shaped guide catheter (e.g., Judkins-Left), which can also be understood as a slightly distorted cone section within each cell, integrally generating a pre-shaped curve.

[0163] After presenting Tables 1 and 2, it is emphasized that, based on the section entitled "Solution for the Final Shape of the Catheter Under Hydraulic Actuation", many CFT designs can be generated based on, for example, the design and computational methods described herein, such as using a simulation-driven parametric optimization process to select the exact hydraulic compartment diameter, the diameter and / or local cell shape of the CFT, and / or other design parameters.

[0164] In one example, an initial configuration for a particular task is inferred, e.g., a desired 3D curve is set, simulation parameters are prescribed, and after each simulation run, the parameters are updated until the simulation converges to a desired output (e.g., a desired curve). This allows for the construction of a shaper microcatheter with a dedicated diameter, elastic membrane shape, and material that upon actuation produces a desired curve in the CFT, where the tip angle may also depend on the amount of pressure input to the shaper by the surrounding tissue.

[0165] Typical CFT dimensions In some embodiments of the invention, the minimum wall thickness of the CFT is twice the thickness of the tubing material used to manufacture it. In general, the minimum achievable wall thickness of an extruded tube depends on its diameter. For example, in a 5 mm diameter tube with a 0.1 mm wall, the CFT thickness can be 0.2 mm (an extreme value). This suggests that the portion of the lumen cross-sectional diameter occupied by the CFT wall can be, for example, 4%. As mentioned, for example, smaller wall thicknesses can be provided with smaller thicknesses. In some embodiments of the invention, the percentage of the diameter occupied by the CFT (which also refers to the internal lumen diameter as a function of the external lumen) is, for example, 4% to 50%, for example, 10% to 30%, for example, 15 to 26%. In a particular example, the internal lumen of the CFT is 75% of the total external diameter.

[0166] In some of the figures herein, the axial length of the CFT cells is 0.16 units when retracted and 0.36 units when open. This gives an elongation ratio of 2.25. The distance is measured as the distance between the maximum boundaries of the upper and lower frustoconical surfaces that make up each cell (710 and 712 in FIG. 7(b)). It should be noted that higher elongation ratios, e.g., 1:3, 1:5, 1:10 or lower, or intermediate ratios, as well as smaller ratios, e.g., 1:1.5 to 1:2 and / or 1:2 to 1:3, can also be achieved. In some embodiments of the invention, the height of the retracted cells (measured radially) is, for example, 0.1 mm to 10 mm.

[0167] Exemplary Drawing Description Figure (Set) 1-CFT sheath / catheter and OTW (double lumen) bending molder Microcatheter-CFT internal curve molding This set of figures shows an exemplary process of molding a two-dimensional curve in a CFT by a dual-lumen microcatheter molding device (Type 5 former - see Table 1, Type 1 CFT - see Table 2) according to some embodiments of the present invention.

[0168] FIG1(a) - An exemplary two-dimensional side view of a dual lumen (OTW) former 100 (optionally a microcatheter). A wire 102 can be seen protruding from the tip 104 of the former.

[0169] Typical hydraulic system structure (see Figure 1(a)) In some embodiments of the invention, the hydraulic core compartment 106 includes an expandable elastic cylindrical tube or membrane 108 designed to form a curve within the CFT. A typical method of operation is by radially and asymmetrically latching the membrane 108 (e.g., using friction mechanisms and / or geometric interference mechanisms, e.g., based on protrusions) onto the CFT inner wall, simultaneously moving any two material points away from (or towards) each other along the longitudinal axis. As the membrane is pressurized, strain fields begin to form almost exclusively in those surfaces that are designed to yield first (optionally, membrane 108 is fabricated with a varying yield or thickness function (e.g., see FIG. 7(d)—regions with thinner walls yield first, regions with thicker walls yield later). With specific reference to FIG. 1(i), as membrane 108 expands radially, it contacts the inner surface of CFT bend section 134 at multiple points (e.g., points 137 and 139). This contact creates friction between membrane 108 and points 137, 139. In some embodiments, membrane 108 includes one or more protrusions or or forced by expansion to conform to the internal shape of section 134 (e.g., mechanically impeding relative axial movement therebetween). Further expansion is restricted radially by the CFT itself, and membrane 108 then expands axially. Points 137 and 139 are brought together by friction, increasing the distance between them (as membrane 108 also expands axially between points 137, 139). This exerts sufficient force on the CFT cell at section 134 (and between points 137, 139) to cause a state change. The effect is asymmetric, resulting in a net bending of CFT 130 at section 134.

[0170] Optionally, the side of the membrane 108 designed to yield first is hereinafter referred to as the "convex side" and the opposing side is hereinafter referred to as the "concave side". The membrane 108 expands to contact the inner wall of the CFT, and a mechanism that curves the CFT is put into effect. The design optionally includes one or more radiopaque markers 110 on the concave side of the membrane 108, which can provide imaging (e.g., x-ray) feedback regarding the location of the shaper along the CFT and / or the curvature of the membrane. Optionally or additionally, the CFT includes such markers. The shaft 112 of the shaper 100 is optionally coated with a hydrophilic layer.

[0171] FIG. 1(b)--shows axial and cross-sectional views of a former microcatheter 100 with two visible lumens 114 (guidewire lumen), 116 (inflation lumen) according to some embodiments of the present invention. The inflation lumen 116 (optionally defined by a hypotube 118) optionally includes one or more orifices 120 for supplying pressurized saline to the membrane 108, which is optionally elastic. Element 122 indicates a lock seal section of the catheter, which optionally serves to seal the membrane to the body of the catheter and limit the axial expansion range of the membrane 108. An axial cross-sectional view of the former structure is also seen to the right of the radial section describing the top cross-sectional view above.

[0172] FIG. 1(c) - A two-dimensional side view of CFT 130 after actuation, according to some embodiments of the present invention. This is the typical desired stable shape that a CFT will be formed into, and the process is described in the following steps (FIGS. 1(d)-1(j)). Section 132 represents an elongated non-CFT body portion that may be braided or transitioned into a braid or other body structure. The diameter of section 132 optionally corresponds roughly to the inner diameter of CFT 130. During the manufacturing process, CFT 130 is optionally mixed with desired shaft sections 132 (e.g., welded or machined from the same tube).

[0173] FIG. 1(d)--A two-dimensional side view (radial direction) of a CFT 130 in an unactuated state, according to some embodiments of the present invention. The illustrated CFT is a specific case of a CFT geometry. Its elongation ratio is 1:2.25.

[0174] FIG. 1( e )—A two-dimensional side view (radial) of a shaper microcatheter 100 positioned at the proximal end of the CFT 130 along with a radial cross-sectional view of the CFT 130 .

[0175] FIG. 1( f )—A radial cross-section of the CFT 130 along with a radial cross-section of the proximal end of the CFT 130 and the former microcatheter 100 positioned within the CFT 130 .

[0176] FIG. 1(g)--A two-dimensional side view (radial) of the shaper microcatheter 100 when it has been advanced axially into the CFT 130 and positioned at the desired location where shaping of the CFT 130 is desired (e.g., its membrane 108), along with a radial cross-sectional view of the CFT 130, in accordance with some embodiments of the present invention.

[0177] FIG. 1(h) - Radial cross section of a shaper microcatheter 100 along with a radial cross section of a CFT 130, according to some embodiments of the present invention, where the shaper microcatheter 100 is positioned at a desired location and rotated such that the membrane 108 is selectively axially stretched facing a section 134 of the CFT 130 to create a localized bend. In some embodiments of the present invention, the bending section 134 is 3-70 mm long, e.g., 10-40 mm long. This may be set by the length of the membrane 108 and / or the actual length of the portion that includes the CFT. Thus, for example, the length (e.g., when expanded) of the membrane 108 (or other membranes described herein) may be 10-300 mm, e.g., 20-100 mm.

[0178] 1(i) - A two-dimensional side view (radial) of a shaper microcatheter 100 as it is hydraulically actuated to expand the membrane 108, along with a radial cross-sectional view of the CFT 130, according to some embodiments of the present invention. Upon actuation, the CFT 130 optionally curves around the center of the membrane 130, creating a convex curve in section 134 of the CFT 130 and a concave curve in section 136 of the CFT 130. Optionally, an internal curved section 122 of the shaper 100 presses against section 136 to provide a counter force against the contact of the membrane 108 against the inner wall of section 134. This may help ensure friction between the membrane 108 and section 134 and / or ensure the transmission of radial forces to section 134.

[0179] FIG. 1(j) - Radial cross section of the shaper microcatheter 100 when hydraulically actuated, along with a radial cross section of the CFT 130, according to some embodiments of the present invention. An axial cross section is also shown in the figure (right), where the shaper membrane 108 can be seen during actuation. Optionally, an optional tapered (soft) section 104 at the distal end can be easily curved along with the CFT 130. Upon actuation, the CFT 130 optionally curves around the center of the membrane 108 (the center of curvature generally coincides with the axial center of the uniform membrane).

[0180] Figure (Set) 2-CFT sheath / catheter and OTW (double lumen) stretch molder microcatheter The figure set illustrates the process of molding two separate localized extensions in the CFT 230 according to some embodiments of the present invention. Using the mechanism shown in the figures, precise extensions can be formed with a single frustum resolution of the CFT 230 controlled by the saline pressure of the molding device 200. The former and CFT used here are optionally Type 3 formers - see Table 1 and Type 1 CFTs - see Table 2, respectively. It should be noted that such extension mechanisms need not be used only for steerable sheath / catheter applications, but may also be relevant for guide catheter shaft extensions such as Guideliner (manufactured by Teleflex, see US20180161547A1) or Guidezilla (manufactured by Boston scientific, see US20140052097A1). Reference numbers generally reflect components similar or corresponding to those in FIG. 1 and other figure sets, except that number prefixes are adjusted to be consistent with the figure numbers. Such elements may not be described again to reduce redundancy.

[0181] FIG. 2(a) - A two-dimensional side view of a dual lumen (OTW) former 200 and an axial cross-section of its shaft 212, according to some embodiments of the invention. An optional guidewire 202 can be seen protruding from the tip 204 of the former 200. In some embodiments of the invention, the former 200 includes at its distal end a membrane 208 (optionally elastic) designed to cause elongation of the CFT 230 by latching onto the inner wall of the CFT 230 while moving two material points away from each other. A strain field is optionally created that is uniform and axisymmetric along the circumference of the membrane 208, thereby correspondingly elongating the CFT. The design optionally includes one or more radiopaque markers 210 at the tip of the axisymmetric membrane, which can provide imaging feedback regarding the location of the former 200 (and its membrane segment 208) along the CFT 230 and / or the segment that is being elongated. The figure also shows an axial cross-sectional view of a former microcatheter including two visible lumens, wire lumen 214 and inflation lumen 216, according to some embodiments of the present invention. An inflation orifice between lumen 216 and space 209 optionally delivers pressurized saline to membrane 208.

[0182] Typical hydraulic system structure (see Figure 2(a)) In some embodiments of the invention, the hydraulic mechanism of the shaper 200 includes an internal stretchable elastic sleeve 215. This allows for stable passage of an optional guidewire, for example, as the sleeve curves through the CFT 230. The membrane 208 is optionally stretched axisymmetrically around the sleeve 215. Pressurizing the membrane 208 optionally undergoes a combination of radial strain, which may provide at least a portion of the latching force onto the inner wall of the CFT, and / or optional axial strain, which provides a stretching force for the CFT. Optionally, the shaper 100 is designed around two actuation pressures that can achieve single frustum resolution.

[0183] 2(a) - An exemplary two-dimensional side view of a dual lumen (OTW) former 200. The wire 202 can be seen protruding from the tip 204 of the former 200. The figure includes three axial cross-sectional views: AA taken at the proximal seal of the hydraulic compartment, BB taken in the middle of the hydraulic compartment 206, and CC taken just proximal to the distal seal 222 of the hydraulic compartment.

[0184] FIG. 2(a1)--A radial cross-sectional view of a shaper microcatheter 200 with two visible lumens, also showing an inflation orifice 220, according to some embodiments of the present invention.

[0185] 2(b)--A two-dimensional side view (radial direction) of a CFT 230 in an unactuated state, according to some embodiments of the present invention. The illustrated CFT is a specific case of a CFT geometry. Its elongation ratio is 1:2.25.

[0186] FIG. 2(c) - Radial cross section of CFT 230 - in an unactuated state.

[0187] FIG. 2( d )—A two-dimensional side view (radial) of a shaper microcatheter 200 positioned at the proximal end of the CFT 230 along with a radial cross-sectional view of the CFT 230 .

[0188] FIG. 2(e)--A two-dimensional side view (radial) of the shaper microcatheter 200 positioned distally such that its hydraulic actuator 206 is at a first point of interest 234 where actuation is desired, along with a radial cross-sectional view of the CFT 230, according to some embodiments of the present invention.

[0189] FIG. 2( f )—A radial cross-sectional view of the shaper microcatheter 200 positioned with the hydraulic actuator 206 disposed at a first point of interest 234 where actuation of the membrane 208 is desired, along with a radial cross-sectional view of the CFT 230, according to some embodiments of the present invention.

[0190] 2(g) - Radial cross section of distally positioned shaper microcatheter 200 along with a radial cross section of CFT 230, whose hydraulic compartment 206 is actuated at a first point of interest 234, causing membrane 208 to expand and exert a force on the inner wall at 234. The actuation optionally generates a response in CFT 230, illustratively shown at the axial opening of three frustums, which correspondingly advances distal portion 235 of CFT 230. This potential response may be provided as a result of a combination of radial and axial strains in shaper membrane 208.

[0191] 2(h)--A two-dimensional side view (radial) of the shaper microcatheter 200 positioned distally and actuated at a first point of interest 234, along with a radial cross-sectional view of the CFT 230, according to some embodiments of the present invention. An axial cross-sectional view of the shaper device while in the actuated state is shown on the right side of the figure.

[0192] Following actuation in Figures 2(i)-2(g) and 2(h), the shaping apparatus 200 is then depressurized at actuation point 234. The arrows on the right side of the figures indicate the directions in which the shaper microcatheter may be advanced.

[0193] FIG. 2(j) - According to some embodiments of the present invention, the shaper microcatheter is advanced to a second (distal) target point 238 where axial elongation is desired.

[0194] A similar process as described in Figures 2(k)-2(g) occurs at a second distal location 238. The distal portion 235 of the CFT 230 is optionally advanced further by the same increments as in Figure 2(g). The distal portion 235 of the CFT 230 is now elongated, for example by six frustums, compared to its initial state before actuation (Figure 2(f)).

[0195] 2(l)-2(k), the shaping apparatus 200 is then optionally depressurized at a secondary point of actuation 238. The blue arrow on the right side of the figure indicates the direction in which the shaper microcatheter 200 may be retracted.

[0196] FIG. 2(m)—A two-dimensional side view (radial) of a CFT 230 after being hydraulically actuated at two designated locations 234, 238, according to some embodiments of the present invention.

[0197] Figure (Set) 3-CFT sheath / catheter and OTW (dual lumen) bending molder Microcatheter-Partial molding of double curves within CFT Following on from Figure 1, this set of figures shows a typical process of forming a two-dimensional double curve in a CFT 330 by a two-step process of continuous single curve (as in Figure 1) and alternating twisting of the former MC (microcatheter) 300. Although the figures describe a two-dimensional curve (the former is twisted 180 degrees between the curves), multiple planar curves can be established with the same ease and by the same procedure without any loss of generality. As in Figure 1, a double lumen microcatheter forming device (Type 5 former - see Table 1, Type 1 CFT - see Table 2) is optionally used.

[0198] 3(a)--A side view of a dual lumen (OTW) former 300, according to some embodiments of the present invention. An optional wire 302 can be seen protruding from the tip 304 of the former 300.

[0199] Typical hydraulic system structure (see Figure 3(a)) The hydraulic system is optionally the same as that used in FIG.

[0200] Figure 3(b) - Follow Figure 1(b).

[0201] 3(c)-3(f) - According to some embodiments of the invention, a shaper microcatheter 300 is placed at the first curve location 334 (proximal) where a curve is desired. The process of shaping the curve at this location is optionally the same as that shown in Figures 1(e)-1(j).

[0202] 3(g) - Radial cross section of CFT 330, 2D side view of former MC 300. Twisted arrows at the base of CFT 330 indicate axial rotation of former MC 300.

[0203] 3(h) - Radial cross section of CFT 330, 2D side view of former MC 300. The former MC 300 has been rotated 180 degrees. The membrane element 308 of the hydraulic device is now on the concave surface 336 of the bend, while the optional radiopaque marker 310 is now optionally in the convex surface at the tip of the former 300. The arrows at the bottom of the former 300 indicate the directions in which the former may advance.

[0204] 3(i) - A radial cross-section of CFT 330, a 2D side view of shaper MC 300. According to some embodiments of the invention, shaper MC 300 has been advanced to a second distal location 338 where a curve is desired.

[0205] FIG. 3(j)-3(l)-the process of shaping the curve at point 338 can be the same as FIG. 1(e)-(j).

[0206] FIG. 3(m)--shows the CFT 330 in a new stable state after the double curve has been molded. The curves optionally have the same and opposite curvature so that the distal end 335 of the CFT is aligned with the axis of the proximal end of the CFT. By the same process, any arbitrary 3D curve (e.g., with more or fewer curve sections, same or different radii, and / or same or different distances between curve points) can be molded into the CFT.

[0207] Figure (Set) 4 - Constrained CFT sheath / catheter and OTW (dual lumen) high elongation ratio molder microcatheter - Integrated molding of (complex) curves within the CFT This set of figures illustrates the process of molding a pre-designed curve in a constrained CFT (e.g., Type 3 (Table 2)) using an integrated shaper microcatheter-Type 1 (Table 1), according to some embodiments of the present invention. Application of an increasing pressure signal to hydraulic device 406 may induce axial strain in membrane 408 (e.g., from proximal to distal end) to gradually advance membrane 408 (e.g., balloon) through CFT 430. In some embodiments of the present invention, an initial pressure increase establishes sufficient radial deformation in membrane 408 that is maintained throughout its advancement. Optionally, the incremental axial strain actuates CFT 430 cell by cell, and upon encountering a constrained segment, the CFT locally bends in accordance with the constraint, straining open all portions of the unconstrained cells. Optionally, CFT 430 is constructed with a higher stiffness than membrane 408, so that membrane 408 follows the curvature created during actuation of CFT 430.

[0208] FIG. 4(a)--A side view of a dual lumen (OTW) former 400, according to some embodiments of the invention. An optional wire 402 can be seen protruding from the tip of the former. At its distal end, a hydraulic stretching device 406 is made of an elastic membrane, optionally with a torus cross section, designed to create large stretches of the CFT 430 by latching any two material points to its inner wall while moving them away from each other. A strain field is optionally created uniformly and / or axisymmetrically along the circumference of the membrane 408, thereby correspondingly potentially stretching the CFT. In some embodiments of the invention, the CFT 430 has locked (or otherwise constrained) cells (e.g., type 3), and the locking is effective along an axis with a predefined locking azimuth angle (θ(z), θ being the azimuth angle and z being the axial coordinate). FIG. 4(c) shows a straight, two-dimensional locking line 450 that can be used to create two-dimensional deflections. The lock is optionally implemented inherently in the manufacturing process of the CFT 430.

[0209] Typical hydraulic system structure (see Figure 4(b)) In some embodiments of the invention, hydraulic mechanism 406 includes a stretchable torus membrane 408 that, when unactuated, remains fixed to tip 406 of former 400 below a tapered cross-sectional segment. The torus shape optionally allows for stable passage of guidewire 402, especially as the mechanism curves through CFT 430. In some embodiments of the invention, torus membrane 408 is stretched axisymmetrically around the microcatheter and, when pressurized, optionally undergoes a combination of radial strain, which may provide a latching force on the inner wall of CFT 430, and / or axial strain, which may provide an elongation force against CFT 430. In some embodiments of the invention, device 406 is configured to undergo significant axial stretching of up to 10 times its unactuated length.

[0210] 4(b) - A radial cross section of the shaper microcatheter 400 shows the catheter structure and the hydraulic device 406 structure. An axial cross section of a typical hydraulic device is also seen in view (AA) and includes two visible lumens (wire lumen and inflation lumen 414) and an inflation orifice 420 that supplies pressurized saline to the elastic membrane torus 408.

[0211] FIG. 4(c) - Side view of CFT 430 according to some embodiments of the present invention - Unactuated state. Its inner diameter can be ascertained based on the elongated shaft section 432 that extends proximally without the CF section. The steering mechanism is optionally completely independent of the structure of the shaft 432, whose properties can optionally be optimized independent of the function of the CFT 432. Two subsequent locked cell series, each with 27 locked cells, are implemented in this example of CFT 430. Other numbers may also be provided. Optionally, the locked segments alternate 180 degrees in azimuth of their locking lines, which in this example are straight and lie in plane. This design may be used to provide dynamic shaping of planar S-curves (progression from proximal to distal).

[0212] Note that there is a potential advantage to shaping the double curve, since one of the main challenges in conventional guide catheters is curving the distal curve in the opposite direction to the already existing traction of the proximal curve. When pushing from the hub, the catheter always tries to follow the proximal curve or other existing proximal traction. In many cases of tortuous anatomy (e.g., the abdomen), it is necessary to control the double curve, i.e., to change the traction along the tip in the opposite direction, and more importantly, to change it in 3D.

[0213] In addition, the CFT can be optionally designed to provide conformal progression along the vasculature, so that fixation against the arterial wall is not necessary, potentially reducing the risk of perforation and / or arrhythmia and / or slippage along the tissue. Such designs can also provide a combination of curved and shaft extension sections, so that they can navigate a wide range of anatomical structures. The shaft extension section can be used to extend the distal shaft into the anatomical structure after rotation has been made, thus providing additional fixation when the force of the hub cannot be transferred along the traction of the tip. This can be useful, for example, in a guide catheter situation, where a curve is established, but any movement of a subsequent device (e.g., a microcatheter, balloon catheter, or wire) changes the traction along the curve and pushes the guide catheter out of place. There are many relevant anatomical structures where these situations can occur, including (but not limited to):

[0214] Peripheral: abdominal aorta to kidney placement, abdominal aorta to celiac artery, splenic artery navigation.

[0215] Coronary Arteries: Any type of severe vessel tortuosity or angulation, especially extreme angulation of the side branches to the main vessel, or severe stenosis in both the main vessel and the side branches.

[0216] FIG. 4(d) - Radial cross-section of CFT 430 (radial cross-section of FIG. 4(c)).

[0217] FIG. 4( e )—A side view of a shaper microcatheter 400 inserted over a guidewire 402 and positioned distally prior to advancement into the CFT 430 , along with a radial cross-sectional view of the CFT 430 .

[0218] FIG. 4( f ) - A side view of a shaper microcatheter 400 inserted over a guidewire 400 and advanced to an actuation position 433 (optionally at a first bend point 434 ) along with a radial cross-sectional view of a CFT 430 .

[0219] FIG. 4(g) - Radial cross section of a shaper microcatheter 400 inserted over a guidewire 402, along with a radial cross section of a CFT 430. The hydraulic device 406 is actuated according to some embodiments of the invention and advanced into the first locked cell segment 434. As shown, the first 10 cells are curved at this point. The actuation and advancement of the hydraulic device 406 can be done on a soft (e.g., tapered) portion of the guidewire, so it does not resist the curve. Note that axial extension can be expected in some embodiments of the invention when activated on unconstrained cells. Also, although deployment is shown starting from a proximal position 433, it may start from a distal position, retracting the device 406 proximally and / or designing the membrane 408 to expand proximally (in addition to or instead of extending distally as shown).

[0220] 4(h) - A radial cross-sectional view of the shaper microcatheter 400 inserted over the guidewire along with a radial cross-sectional view of the CFT 430. The hydraulic device is advanced over the first locked cell segment 434 and curved 180 degrees away from the proximal shaft 432.

[0221] By comparing Figures 4(g) and 4(h), the mechanism of action of membrane 408 can be visualized. This mechanism also applies to other embodiments herein having axially expanding membranes. Starting with Figure 4(g). As membrane 408 first expands, it expands radially until points 437 and 439 (on the inner surface of the lumen of CFT 430) frictionally and / or geometrically engage. Point 441 (further axially along CFT 430) is not reached or engaged. As membrane 408 expands further, it is constrained from radial expansion by CFT 430 and must expand axially. An example of this is both its tip 443 and the membrane portion that contacts the wall, such as the section between points 437 and 439. Axial expansion of this membrane section causes points 437 and 439 to move apart, resulting in bending as shown. Axial expansion at 443 causes the radial engagement of membrane 408 to extend axially along CFT 430, for example, to engage point 441 (see FIG. 4(h)). Further expansion again results in separation between points 439 and 441, expanding more CFT cells and, in this example, causing more bending. Bending between points 437 and 439 may be constrained by the CFT deformation limits.

[0222] In some embodiments of the invention, membrane 408 has the shape of a thin-walled balloon, e.g., a diameter smaller than the inner diameter of the CFT (e.g., so that it does not exert a force on the wall when it collapses). Optionally, the wall includes one or more protrusions or serrations for a better fit and / or conformity with the inner wall of the CFT 430. Optionally, the diameter is not too small to allow sufficient expandability for axial expansion and / or to reduce axial expansion occurring before radial expansion is complete. Optionally, membrane 408 is designed to expand at least 3, 5, 7, 10, 15, 20 times or more, or by intermediate amounts.

[0223] In some embodiments of the invention, membrane 408 has non-linear expansion characteristics, e.g., expands more easily radially than axially, e.g., by including one or more axial threads that are more elastic than the body of membrane 408. Optionally, different axial locations along membrane 408 have different expansion characteristics, e.g., to control the relative amount of axial stretch between axially spaced points 437, 439, and 441.

[0224] 4(i) - A radial cross-sectional view of a shaper microcatheter 400 inserted over a guidewire 402, along with a radial cross-sectional view of a CFT 430. The hydraulic device 406 has been further advanced into an intermediate cell 437 located between the locked cell segments at 434 and 438. The CFT 430 has optionally been axially elongated in this region, such that the hydraulic device 406 has reached the second locked cell segment 438 but has not yet curved it.

[0225] FIG. 4(j) - A radial cross-sectional view of a shaper microcatheter 400 inserted over a guidewire 402, along with a radial cross-sectional view of a CFT 430. According to some embodiments of the invention, a hydraulic device 406 has advanced into the second locked cell segment 438 and begun to bend it.

[0226] FIG. 4(k) - A radial cross-sectional view of the shaper microcatheter 400 inserted over the guidewire 402 along with a radial cross-sectional view of the CFT 430. According to some embodiments of the invention, the hydraulic device 406 has advanced across the second locked cell segment 438, bending it 180 degrees and completing the formation of the S-shaped planar curve.

[0227] 4(l) - A radial cross-sectional view of a shaper microcatheter 400 inserted over a guidewire 402, along with a radial cross-sectional view of a CFT 430. The hydraulic device 406 is retracted from the CFT 430 and, optionally, returns to its original, unactuated state. According to some embodiments of the present invention, the CFT 430 retains a pre-designed double curve to remain stable.

[0228] 4(m)--A radial cross-sectional view of a shaper microcatheter 400 inserted over a guidewire 402, along with a radial cross-sectional view of a CFT 430, according to some embodiments of the present invention. Continuing with FIG. 4(l), the guidewire 402 is shown optionally advanced into the newly formed double curve. The guidewire may be longer than shown, e.g., extending from end 435.

[0229] 4(n) - A radial cross-sectional view of a shaper microcatheter 400 inserted over a guidewire 402, along with a radial cross-sectional view of a CFT 430. Assuming the target anatomy has been reached, the shaper microcatheter 400 is withdrawn from the catheter / sheath containing the CFT 430 in preparation for an optional subsequent procedure via such catheter / sheath.

[0230] Figure (Set) 5-CFT sheath / catheter and OTW (dual lumen) bend former microcatheter, with inherent curvature and spherical shape with a hole at the tip, purpose-to mold a curve within the CFT.

[0231] The figure set illustrates the process of forming a two-dimensional curve in the CFT 530 by a dual lumen microcatheter forming device 400 (Type 5 former - see Table 1, Type 1 CFT - see Table 2) according to some embodiments of the present invention. The former in this figure set optionally has the same design as the former described in FIG. 1, but optionally has one or more additional features that may improve its traversal ability to account for the possibly non-smooth surface of the CFT 530 (as follows, in bending scale and / or individual cell scale). The former is fabricated with an inherent curvature, and the figures optionally show such a curvature shape, which is a curvature similar to the shape of a "cobra" angiography catheter. When it needs to move forward through a straight segment in the CFT 530, its elasticity allows it to adopt a straight shape and slide forward. When it needs to move forward through a curved segment in the CFT 530, its inherent curvature helps it slide forward along the CFT. Another feature that may improve the traversability of the former is a perforated sphere or other rounded shape made of a rigid or semi-rigid material at its tip 504 (tip 504 hereafter referred to as a "perforated valve"), more distal from the asymmetrically expanding membrane 508. These features are designed to improve traversability through non-smooth CFTs, ​​and although shown for a bent former, are relevant and can be fabricated on or instead of any of the other shapes and types of formers, including extensional.

[0232] 5(a) - A two-dimensional side view of a typical dual lumen (OTW) former 500. You can see the inherent curvature and the perforated valve at the tip 504. A guidewire 502 can traverse along the former 500 and pass through the perforated valve 504.

[0233] Typical hydraulic system construction (see figure (5a)) Hydraulic device 506 optionally includes an inflated elastic cylindrical tube or membrane 508 (hereafter referred to as membrane), optionally designed to form a curve within CFT 530. Such curvature is optionally provided by radially asymmetrically latching (e.g., using a friction mechanism) to the inner wall of CFT 530, moving two material points away from each other. As the membrane 508 is pressurized, a strain field begins to form, optionally almost exclusively, in the surface designed to yield first (optionally the membrane 508 is fabricated to include areas of thin thickness to yield first and areas of thicker thickness to yield last (the surface of the membrane designed to yield first is hereinafter referred to as the "convex surface" and the opposite surface is hereinafter referred to as the "concave surface"), causing the membrane to expand and contact the inner wall of the CFT 530, activating a mechanism that curves the CFT 530. The design optionally includes one or more radiopaque markers 510 on the concave surface of the membrane 508, which can provide imaging feedback regarding the location of the shaper 500 along the CFT 530 and / or the curvature of the membrane 508.

[0234] 5(b) - A radial cross-sectional view of a shaper microcatheter 500 with two visible lumens, a wire lumen 514 and an inflation lumen 516, according to some embodiments of the present invention. An inflation orifice 520 delivers pressurized saline to a (optionally elastic) membrane 508. An axial cross-sectional view of the shaper structure is also seen to the right of the axial cross-sectional view describing the top cross-sectional view above.

[0235] 5(c)--A two-dimensional side view (radial direction) of a CFT 530 in an unactuated state, according to some embodiments of the present invention. The illustrated CFT is a specific case of a CFT shape. Its elongation ratio, for example, is 1:2.25.

[0236] FIG. 5(d) - Radial cross section of CFT 530.

[0237] FIG. 5( e )—A two-dimensional side view (radial) of a shaper microcatheter 500 positioned at the proximal end of a CFT 530 along with a radial cross-sectional view of the CFT 530 .

[0238] 5(f)--A two-dimensional side view (radial) of the shaper microcatheter 500 as it is advanced axially into the CFT 530 and positioned at the desired location 534 where shaping of the CFT 530 is desired, along with a radial cross-sectional view of the CFT 530, according to some embodiments of the invention. In this and other embodiments, "at the desired location" generally refers to the alignment of the active area and / or reach of the membrane 508 with respect to the portion of the CFT 530 that is to be (and can be) deformed. In some embodiments of the invention, it is the axial center of the membrane that is aligned (e.g., as an example of the point of maximum deformation).

[0239] In some embodiments of the invention, the membrane 508 is axially short and the curve is created by deforming a first section of the CFT 530 and then moving the shaper 500 to a nearby location to further deform it. This allows for curves of variable curvature to be created. For example, the shaper is sized to fit fewer than 50, fewer than 30, fewer than 20, fewer than 10, fewer than 5, and / or more than 2 CFT cells at a time. Figure 11 shows the reverse case where multiple CFT cells fit with a single balloon.

[0240] It can be seen how the inherent curvature of former 500 adopts a more linear shape in accordance with the linear alignment of CFT 530, and perforated spherical tip 504 is believed to slide along the zigzag inner surface of CFT 530 as the former advances axially. In some embodiments of the invention, former 500 is made soft enough so that it exerts a lower force (if not hydraulically actuated) than would be required to deform the CFT elements of CFT 530.

[0241] 5(g)--A two-dimensional side view (radial) of the shaper microcatheter 500 when hydraulically actuated, along with a radial cross-sectional view of the CFT 530, according to some embodiments of the present invention. Upon actuation, the CFT 530 optionally curves around the center of the elastic membrane 508.

[0242] FIG. 5(h)--A two-dimensional side view (radial) of the shaper microcatheter 500, along with a radial cross-sectional view of the CFT 530, according to some embodiments of the present invention, when the shaper microcatheter 500 has optionally been hydraulically contracted as a preparatory step for further axial advancement along the CFT 530.

[0243] 5(i)--A two-dimensional side view (radial) of a shaper microcatheter 500 as the shaper 500 advances past bend region 534 and optionally past distal end 535 of CFT 530, along with a radial cross-sectional view of CFT 530, according to some embodiments of the present invention. As can be seen, the intrinsic curve of the shaper 500 matches the actual curve (or lack thereof) of CFT 530, because the force applied by the non-actuated catheter is optionally not sufficient to deform any CFT cells within CFT 530.

[0244] Figure (Set) 6-CFT sheath / catheter and OTW (dual lumen) bend former microcatheter, with a fixed antenna-like wire and a bulbous tip shape to form a curve within the CFT.

[0245] This set of figures illustrates the process of shaping a two-dimensional curve in a CFT 630 with a dual lumen microcatheter shaping device 600 (e.g., Type 5 shaping device - see Table 1, Type 1 CFT - see Table 2) according to some embodiments of the present invention. The shaping device in this set of figures optionally has the same design as the shaping device described in FIG. 1, but may include one or more additional features that improve its traversal ability along the CFT 630, especially considering the potentially non-smooth topology of the inner surface of the CFT 630. The distal tip is provided with an elongated element 603 (which resembles an antenna and can be made of the same shape and material as a conventional Nitinol guidewire, hereafter referred to as an "antenna") at a point more distal from the (optionally) asymmetrically expanding membrane 608. Its tapered design is potentially advantageous but not required. Optionally, the antenna 603 is stiffer at its base than its distal end. At the distal tip of the antenna 603, a sphere or other rounded shape 604, optionally made of a rigid or semi-rigid material, is optionally provided (hereafter referred to as a "bulb"). The antenna 603 is optionally used to bypass the stiffer portion of the shaper 600 to which it is attached when the shaper 600 needs to slide forward along the CFT 630 in the same direction that the CFT 630 curves. Optionally, the antenna 603 can block the wire lumen so that the guidewire extends along the shaper 600 but does not protrude distally from the shaper 600. Such a wire (or stylet) may provide the shaper 600 with better kink resistance and / or better pushability. In some embodiments, such properties are not necessary and / or for other reasons, the guidewire and its lumen may be omitted from the design. This may allow for the production of a smaller diameter shaper. The aforementioned features, which potentially improve traversability through zigzag surfaces of the CFT, are shown in the illustration of a bend former, but are relevant and can be fabricated on a stretch former as well. Also, in some embodiments of the invention, valve 604 includes a port for a guidewire.

[0246] Figure 6(a) - A two-dimensional side view of a typical dual lumen (OTW) former 600. The fixed "antenna" 603 and the "bulb" 604 at the tip can be seen.

[0247] Typical hydraulic system structure (see Figure 6(a)) The distal end of the former 600 includes a hydraulic device 606. The hydraulic device 606 optionally includes an expandable (elastic) cylindrical tube or membrane 608 (hereafter referred to as membrane) designed to deform (axially and / or laterally) the CFT 630. The deformation is provided by radially asymmetrically latching (e.g., a friction mechanism) against the inner wall of the CFT 630 while moving two material points away from each other. As the membrane 608 is pressurized, a strain field begins to form, optionally almost exclusively, in the surface that is designed to yield first (optionally by producing areas of low thickness to yield first and areas of high thickness to yield last; the side of the membrane 608 that is designed to yield first is hereafter referred to as the "convex surface" and the opposite side is hereafter referred to as the "concave surface"). This pressure causes the membrane 608 to expand and contact the inner wall of the CFT 630, causing the action of curving or otherwise deforming the CFT 630. The shaper 600 optionally includes one or more radiopaque markers 610 on the concave surface of the membrane, which can provide imaging feedback regarding the location of the shaper 600 along the CFT 630 and / or the curvature of the membrane 608 and / or hydraulic device 606.

[0248] 6(b) - A radial cross-sectional view of a shaper microcatheter 600 having two visible lumens, a wire lumen 614 and an inflation lumen 616, according to some embodiments of the present invention, where an inflation orifice 620 delivers pressurized saline to an (optionally elastic) membrane 608. An axial cross-sectional view of the shaper 600 is also shown to the right of the axial cross-sectional view describing the top cross-sectional view above.

[0249] 6(c)--A two-dimensional side view (radial direction) of a CFT 630 in an unactuated state, according to some embodiments of the present invention. The illustrated CFT is a specific case of a CFT geometry. Its elongation ratio is 1:2.25.

[0250] FIG. 6(d) - Radial cross section of CFT 630.

[0251] FIG. 6( e )—A two-dimensional side view (radial) of a shaper microcatheter 600 positioned at the proximal end of a CFT 630 along with a radial cross-sectional view of the CFT 630 .

[0252] FIG. 6(f)--A two-dimensional side view (radial) of the shaper microcatheter 600 as it is advanced axially into the CFT 630 and positioned at the desired location 634 where shaping of the CFT 630 is desired, along with a radial cross-sectional view of the CFT 630, according to some embodiments of the present invention.

[0253] 6(g)--A two-dimensional side view (radial) of the shaper microcatheter 600 when hydraulically actuated, along with a radial cross-sectional view of the CFT 630, according to some embodiments of the present invention. Upon actuation, the CFT 630 optionally curves around the center of the elastic membrane 608.

[0254] FIG. 6(h)--A two-dimensional side view (radial) of the shaper microcatheter 600, along with a radial cross-sectional view of the CFT 630, according to some embodiments of the present invention, when the shaper microcatheter 600 has optionally been hydraulically contracted as a preparatory step for further axial advancement along the axis of the CFT 630.

[0255] FIG. 6(i)--A two-dimensional side view (radial) of the shaper microcatheter 600 as the shaper 600 advances further toward (and past) the distal end 635 of the CFT 630, along with a radial cross-sectional view of the CFT 630, according to some embodiments of the present invention.

[0256] Figure (set) 7 - Schematic layout of the tip of the catheter in the context of a mathematical model of the CFT motion, according to some embodiments of the present invention.

[0257] FIG. 7(a), (b) - Top view (axial) and cross-sectional view of a constitutive multistable cell consisting of two elastic truncated cones (710, 712).

[0258] Fig. 7(c) - Schematic layout of the distal section of the guide catheter (CFT) 700 with the hydraulic device (as part of the shaper microcatheter) 702 inserted. Diagram of the corresponding coordinate system.

[0259] FIG. 7(d) - Diagram of hydraulic system compartment 702 in a local coordinate system.

[0260] Figure (set) 8-(a) Stable and unstable equilibria along with theoretical potential energy of a single elastic frustum under zero gauge pressure according to equation (11).

[0261] 8(b) and (c) - Comparison between theoretical values ​​of potential energy (dashed curve) and numerically calculated values ​​(solid black curve) in the section indicated by the dashed line in panel (a), all according to some embodiments of the present invention.

[0262] The energy stability map in panel (a) is obtained from a numerical simulation, showing stable equilibrium points in blue and unstable equilibrium points in red (colors are shown as different shades). In the figure, the extension DOF is zeta and the curvature DOF is phi. At zero phi, there are two stable axial extension points, meaning that the cell can be energetically stable when contracted and when open. Alternatively, at zero zeta, there are two stable curvature points, and since the analysis is two-dimensional, the structure can bend on both sides; without loss of generality, both sides simply means any azimuthal direction in the three-dimensional case.

[0263] 12a-12b show ideal and realistic deformations of an active frustum along (a) vertical and (b) horizontal cross sections of FIG. 8, according to some embodiments of the present invention.

[0264] 9(a)-(c)-Three projections describing the dependence of the equilibrium state of a single elastic frustum on a directly applied pressure, according to some embodiments of the present invention. The red curve shows the unstable bifurcation, while the blue curve represents the stable bifurcation (colors shown as shades of grey).

[0265] 10-(a) Schematic layout of a CFT-based search and rescue robot 1001 including a CFT body 1030 and an inserted former 1000, according to some embodiments of the present invention. Note that the robot 1001 may be tethered (e.g., receiving hydraulics, computer communication, and / or oxygen (e.g., for trapped personnel)) or untethered (e.g., self-contained in terms of power, optionally receiving instructions and / or power wirelessly). Optionally, the robot 1001 includes a processing system for control of the CFT 1030, sensor processing (e.g., if the robot 1001 includes sensors such as an imager), and / or navigation decisions.

[0266] FIG. 10(b) illustrates a high level architecture of a navigation system for use in disaster areas, according to an exemplary embodiment of the present invention.

[0267] In some embodiments of the invention, the following method is used.

[0268] (a) A human or computer selects a desired target or transformation, for example based on a desired navigation goal.

[0269] (b) Once a target is selected, one or more sets of variants are selected that approximate the target, e.g., using automated methods.

[0270] (c) Running a series of simulations (eg, as described herein) to find a solution for a set / sequence of inflation pressures and / or former positions that provides the desired deformation.

[0271] (d) optionally generating a "fail" indication if no suitable set is found.

[0272] In some embodiments of the invention, one or more simulations are used to generate a set of achievable (optionally maximal) targets, which are displayed to the user and / or provided to the computer to define a working set from which to select the next command. For example, such a set may be displayed to the user as an overlay of an image showing possible targets.

[0273] Figure (Set) 11 - Constrained CFT sheath / catheter and OTW (dual lumen) high elongation ratio former microcatheter designed for hydraulic percutaneous crawling.

[0274] The diagram set illustrates a CFT former composite device 1105 designed to perform percutaneous hydraulic crawling, according to an exemplary embodiment of the present invention.

[0275] The figure (set) shows a single crawling stroke in which pressurization of the former 1100 advances the CFT 1100 distally along the axis of the housing lumen 1160 (e.g., artery). The pulling action of the device 1105 is based on elongation of the CFT 1130, e.g., similar to that shown in FIG. 4 of this document, followed by helical clamping of the distal CFT segment 1138 against the lumen wall 1160, e.g., at points 1162, 1164, and finally depressurization of the hydraulic device 1106 of the former 1100. The clamping action serves to contract the CFT cells towards the distal anchors (but not the other proximal anchors) via depressurization of the hydraulic device, thereby advancing them distally along the catheter shaft.

[0276] The contraction action upon decompression is provided in this embodiment, in contrast to some other hydraulic mechanisms shown in this document, by optionally incorporating a relatively thick hydraulic device wall (t(x, θ)) and a relatively large static radius (R(x, θ) of the hydraulic device. The specific selection of hydraulic device characteristics by the crawling process is optionally performed by convergence of the simulation on the desired crawling function. The process includes initially selecting an arbitrary wall thickness function and gradually increasing the thickness function during the simulation. As the thickness function increases, the actuation pressure increases accordingly. This process may ensure that the hydraulic device walls are maximally expanded into the folds of the CFT cells, so that upon decompression, contraction is first formed in the bulk section of the hydraulic compartment (concentrated along the central axis of the hydraulic device). During the first stage of decompression, the membrane contour of the optional serrations creates a frictional force along the CFT, which causes the CFT to contract. In the first stage, the frictional effect is relieved immediately after the CFT is contracted distally. Careful tuning of this process is optionally done by simulation. The CFT 1130 itself is optionally coated with an elastic layer that exerts a force greater than the CFT cells can resist, so that when the former 1100 is depressurized, the CFT shrinks.

[0277] 11(a) - A two-dimensional side view of a typical dual lumen (OTW) former 1100. An optional guidewire 1102 can be seen protruding from the tip of the former.

[0278] 11(b) - A radial cross-sectional view of a shaper microcatheter 1100 with two visible lumens, a wire lumen 1114 and an inflation lumen 1116, according to some embodiments of the present invention. An inflation orifice 1120 optionally delivers pressurized saline to the elastic membrane 1108. An axial cross-sectional view of the shaper structure is also seen to the right of the axial cross-sectional view describing the top cross-sectional view above.

[0279] FIG. 11(c,d) - 2D side view (radial) of a CFT 1130 prior to actuation, according to some embodiments of the present invention. Locally locked cells 1150 of the CFT 1130 are marked in black along the perimeter of each cell, if applicable. View (c) shows a side view, which view (d) complements with a view of the opposite side (180 degrees) of the CFT 1130. In this example, the locking pattern forms a spiral with a centerline that coincides with the centerline of the CFT axis. Other shapes can be provided, including non-uniform shapes and shapes that bend in other helical directions, or shapes that bend in other helical directions instead.

[0280] Figure 11(e) - A radial cross-section of the CFT 1130 prior to actuation, showing locked cell locations 1150, if applicable.

[0281] FIG. 11(f)—A radial cross-sectional view of the CFT 1130 prior to actuation, along with a side view of the shaper microcatheter 1100 positioned at the proximal end of the CFT prior to actuation.

[0282] Continuing with Figures 11(g)-11(f), hydraulic device 1106 is actuated along straight segment 1134 (before reaching the helical preformed segment). The CFT 1130 is seen in radial cross section, while hydraulic device 1106 is seen in side view.

[0283] 11(h,i)-(g) shown held in place. The CFT 1130 is now shown within a containment lumen 1160, such as a blood vessel lumen.

[0284] 11(j) - The hydraulic device 1106 is now actuated further from the point shown in view (g) (e.g., membrane 1108 is further expanded) to reach the helical segment. As the CFT 1130 is actuated cell by cell, each cell responds to the actuation by deforming in a pre-constrained direction dictated by the locking point to form a helix 1150 in the distal segment of the CFT 1130. In some embodiments of the invention, the CFT 1130 is secured by friction along the containment lumen 1160 (e.g., at points 1162, 1164). The CFT 1130 is shown in side view overlaid with the former 1100 and the activated and extended hydraulic compartment 1106.

[0285] 11(k)-(j) show the same diagram of the CFT 1130 in the actuated state, with the locking (restraining) perimeter 1150 shown in black.

[0286] The same views as in Figures 11(l) to (k) are shown rotated 180 degrees around the longitudinal axis.

[0287] 11(m) - The hydraulic compartment 1106 is now contracted. Contraction shortens the straight (proximal) cell segments 1134 as the structure is still fixed distally along the helical segments.

[0288] 11(n)-(m) show the outer view. The proximal shaft has been advanced according to the advancement ratio of the straight segment 1130.

[0289] FIG. 11(o) - Further depletion of hydraulic chamber 1106 is performed along fixed segment 1138. The former 1100 and CFT 1130 advance in a distal direction. The hydraulic compartment 1106 is retracted and positioned at the distal end of the CFT. In some embodiments of the invention, the distal end of the membrane 1108 is designed to retract after the proximal side. This can be provided, for example, by making the distal side more elastic (e.g., thicker walled) so that it radially retracts before (or faster than) the distal portion of the membrane 1108 radially retracts and / or before / faster than the intervening membrane axially contracts. Optionally or additionally, the CFT 1130 may include an elastic layer that is more elastic in the proximal direction than in the distal direction. Optionally or additionally, the inner surface of the CFT 1130 may have higher friction in the distal direction than in the proximal direction.

[0290] 11(p)-(o) show, in outer views, the catheter 1105 having been advanced distally along the lumen axis a distance 1170. This sequence ("stroke") may be repeated again to perform further crawling movements.

[0291] Typical all-in-one device 13 is a cross-sectional view of an integrated device 1300 including a sheath 1330 having CFT-like properties and one or more integrated hydraulic compartments 1306 for shaping the sheath, according to some embodiments of the present invention. It should be understood that the features described below may be provided in part or in whole in any of the other embodiments shown in the figures herein above.

[0292] In some embodiments of the invention, CFT sheath 1330 includes a set of CFT cells and an underlying compartment 1306. When compartment 1306 is pressurized, e.g., via inflation lumen 1316, compartment 1306 expands (e.g., defined between CFT wall 1360 and an internal elastic (optionally axially only or more elastic) layer 1362. Layer 1362 may also function as an inner layer for the lumen of CFT 1330.

[0293] In this embodiment, friction between compartment 1306 and CFT wall 1360 is typically not necessary due to the manufacturing of the integrated system.

[0294] The sheath 1330 is shown having an optional tip 1304 (optionally soft and / or otherwise atraumatic) and optionally a tool 1302 filling its lumen.

[0295] Distal to the CFT wall 1360, the sheath 1330 extends as a shaft 1329. Optionally, a coil or braid 1333 is provided embedded within at least a portion of the shaft, for example to obtain desired resilience and pushability characteristics. Optional outer layer 1331 is also shown. Optionally, layer 1331 is resilient and strong enough to return the deformed CFT cells thereunder to their resting state, at least in some places. Optionally or additionally, layer 1331 serves to limit deformation of at least some of the CFT cells, at least in some places. Optionally or additionally, resilience is provided by layer 1362 and / or another internal layer. In some embodiments of the invention, layer 1362 includes one or more surrounding elements (e.g., threads or wiring or bands, or attachment of layer 1362 to CFT wall 1360) that resist expansion of the 1306 chamber into the lumen of the CFT 1330.

[0296] Also of note in the figure is an optional design in which compartment 1306 also includes a resilient layer 1364 beneath wall 1360. Layer 1364 is shown extending into the fold defined by wall 1330. A potential benefit is that this allows chamber 1306 to be provided as an integral part of, rather than sealed to, CFT 1330. Optionally or additionally, one or more apertures can be formed in CFT wall 1360.

[0297] 13 is optionally used for medical access at the heart, where tool 1302 can be, for example, an ablation tool. In some embodiments of the invention, device 1300 extends to a handheld (or other) hub outside the body, which can include, for example, a pressure source and / or user controls for selecting sections of CFT 1330 to deform and / or the amount of deformation.

[0298] In some embodiments of the invention, multiple lumens 1316 are provided, one for each section to be expanded, e.g., one for the preset bending section, one for the universal bending section, and / or one for the axial extension section.

[0299] A potential advantage of the integral hydraulic compartment is that it eliminates the need to axially and / or rotationally align the former with respect to the CFT.

[0300] A potential advantage of an integrated device is that it allows for a simpler mode of operation since the former does not need to be retracted when the tool is to be used.

[0301] A potential advantage of the one-piece device is that it allows for elastic deformation using a tool.

[0302] Specific exemplary use cases according to some embodiments of the present invention will now be described.

[0303] Typical peripheral vascular catheter insertion The mechanisms, methods, and designs described thus far have laid the foundation for a steerable catheter device to be used in combination with a microcatheter and optionally a guidewire, which may be provided by some embodiments of the present invention. In a radiology situation, the microcatheter may have two functions as shown. First, the microcatheter may provide distal fixation and support for further navigation, guidewire placement, and treatment transfer (e.g., embolization) to the target, which is the traditional function of microcatheters in peripheral vascular catheterization. Second, the microcatheter may act as a CFT forming device that, upon receiving a functional pressure control signal, strains the hydraulic device / compartment at its tip, which then activates and steers the CFT. The functional role of the guidewire is optionally retrained in this design, making it suitable for a steerable peripheral vascular intervention situation. In some embodiments of the present invention, the target size of the CFT for this use case is 5-6 Fr, while the target size of the dual lumen microcatheter is 3-4 Fr. Various guidewires up to 0.035" in size can be fitted into the design. The proposed method can provide precise 3D shaping / steering of the CFT catheter for further microcatheter placement and / or transfer of the procedure to the target. The extension function can also serve as a navigation method when torque transmission becomes difficult. Note that when using a Type 2 hydraulic device (see Table 1) in combination with an unconstrained CFT catheter / sheath, steering is optionally achieved without the need for torque transmission at all. In some embodiments of the invention, steering involves selecting a sheath bend direction and applying the bend, rather than rotating the sheath to apply a preset bend direction.

[0304] Even in those embodiments where it is necessary to rotate the inner former, this generally does not require the same amount of torque transmission and / or precision as rotating the sheath itself, especially when the former is contracted and occupies a smaller diameter.

[0305] In some embodiments of the invention, the shape has three surrounding compartments, each of which extends less than 360 degrees, for example, each of which extends between 30 and 120 degrees. This can provide a universal bending mechanism. Selective expansion of one or two compartments expands the former and deforms the surrounding CFT along a direction dictated by the selection of those compartments and the degree of expansion.

[0306] In some embodiments of the invention, the CFT sections are shortened using a two-balloon system. The two balloons are expanded to mate with the CFT at different portions and spaced apart by a section that can be shortened and not mate with the wall. After inflation, the sections are shortened, thereby shortening the CFT. For example, shortening can be achieved by attaching each balloon to a different pull wire and then pulling the pull wire of the more distal balloon. This method can also be used with a single balloon former, whereby the balloons are inflated to mate with the CFT and then the former is pulled back while holding the CFT in place.

[0307] In addition, the use of constrained CFT designs (e.g., CFT types 3 and 6) with symmetric shapers (e.g., types 1, 3, 4) may also reduce the need for steering that relies on torque transmission. Finally, in the peripheral vascular context, a potentially significant advantage of the CFT shaper composite device is the control of local curvature of the distal shaft, which can minimize arterial support and fixation. For example, in conventional radiology, to turn, for example, from the aorta into the ostium, physicians typically use specialized catheter designs that are fixed to the aorta and rotated into the ostium. The CFT catheter can be curved into the ostium using a rotation of the proximal segment of the CFT (shaft) relative to the distal segment that is positioned in the ostium, optionally without fixing or pressing against the aorta or any sliding movement against the aortic wall.

[0308] Exemplary Manual Interface Steerable Catheter In some embodiments of the invention, the combination of a CFT catheter and a hydroforming catheter, for example as described above and herein and / or in Figures 1-4, together form a steerable catheter device. The device can be manually actuated, optionally by the equivalent of a PTCA balloon inflation device integrated into the CFT catheter and / or the former's hub. The hub can potentially facilitate axial and rotational alignment between the former and the CFT device. When using a single membrane compartment forming device (see Table 1), the former (micro)catheter can optionally be torqued to control the plane of the local curve. In some embodiments of the invention, the closed environment of the CFT catheter lumen optionally provides a basis for precise rotational alignment between the two catheters (CFT and forming catheter). The design of the CFT catheter's hub optionally includes dial-type controls for control of the rotational alignment of the former and CFT, and / or control of the saline pressure in the hydrodynamic device. The hub also optionally includes a locking mechanism for positioning and retraction of the former catheter.

[0309] Exemplary Robotic Interface Steerable Vascular Catheter Robotic vascular catheter insertion platforms have recently attracted increasing attention. Some of their potential advantages are low radiation exposure to staff and patients (due to radiation-protected control interfaces), the ability to perform procedures remotely (even via 5G wireless connections), possibly without the need for highly trained staff to be on-site, and improved overall clinical outcomes. Currently, robotic catheter insertion platforms can be classified into two main market segments: non-steerable technologies based on traditional manual catheter disposables (e.g., by Siemens Corindus and Robocath), and steerable technologies (each based on a dedicated catheter design compatible with a robotic interface) that are widespread in various vascular applications. The first segment has been the focus of recent advances in the field due to the relatively low procedure costs and the low cost of disposable catheters per procedure. However, this first segment is limited in scope, as it suffers from low maneuverability or equivalent to no maneuverability in the manually operated segment, and typically excludes PCI of complex lesions, cardiac catheterization, peripheral vascular catheterization and beyond. The second segment incurs high procedure costs and high costs of disposables, which can reach thousands of dollars for a single catheter. In some embodiments of the invention, precise robotic interface steering is potentially provided at a low cost per procedure while maintaining similar catheter modularity and catheter lab workflow as in the manual segment.

[0310] The combination of the CFT and hydroforming catheters described above and herein and for example in Figures 1-4 provides the basis for robotic controlled steering. A potential advantage of this control method is that the catheters (i.e., CFT catheters and forming catheters) may require only minor (if any) modifications of the traditional manual catheter (vascular) manufacturing process, such as modification of the tip of a traditional guide catheter (for use as a CFT device) and modification of the balloon of a PTCA catheter (for use as a forming catheter). Once this is accomplished, the robotic interface can provide precise actuation and steering of relatively inexpensive disposable catheters, which can be combined to form a steerable catheter device with multiple degrees of freedom. Another potential advantage when considering a robotic platform is that the combined CFT and former device can be actuated by a dedicated control algorithm (e.g., based on the solution of the CFT governing equations described above). In this algorithm, position feedback of the catheter tip is achieved by a combination of the catheter lab imaging resources and proprietary dynamic pressure readings. For example, a pressure-to-shape table may be provided, which is optionally related to the shape and strain field of the hydrodynamic device. Optionally or additionally, one or more rules are provided. For example, a high rise in pressure may indicate that the catheter is stuck. In another example, the internal pressure of the hydraulic device may vary not only as a function of actuation, but also as a function of stress exerted by the arterial wall. By continuously reading the hydraulic device pressure (p in the potential energy of the frustum (denoted Vn,k above)), a feedback mechanism and control algorithm can generate a more correct position and arc shape of the CFT. In some embodiments of the invention, the robotic control of the CFT former combination device can include one or more of the axial position of the CFT catheter, the torque and axial position of the former catheter (torque is not required for former types 2 and 4), pressure control of the membrane compartment of the hydraulic device (at the tip of the former catheter), and / or the torque and axial position of the guidewire, if applicable.

[0311] In some embodiments of the invention, a model is constructed that matches the sensed pressure signal with the actual deformation and / or force applied to the CFT. For example, a data set may be created with pressure and images (e.g., x-rays) or may be constructed using simulations. Once the actual signal is sensed, the model is used as a reference to determine the deformation or pressure. Such a model may be implemented, for example, as a look-up table, a neural network, or a machine learning model (e.g., a weighted parameter set model), among other methods. Links in both directions are possible - what pressure applied results in what deformation and, conversely, what pressure signal detected indicates what force. Analytical solutions can also be provided using mathematical equations that model the relationship between shape, deformation, pressure, and transients.

[0312] Typical Transseptal Access System In some embodiments of the present invention, a structural cardiac access / placement sheath is provided. The sheath can be actuated manually or robotically. For example, using a combination of hydraulic devices of types 2 and 4 (Table 1), actuation can be achieved without the need to apply rotational torque to the sheath and / or inner lumen hydraulic devices. Optionally, the local curvature of the CFT is controlled, keeping the structure stable both during and after actuation. The sheath can also be optionally locked in place (e.g., if necessary) via a constraining CFT mechanism once the shaping mechanism is retracted to provide additional support for the delivery of the transcatheter device. Once the hydraulic devices are retracted, the large delivery lumen can be cleared, resulting in a good inner diameter to outer diameter ratio of the sheath, e.g., greater than 70%, greater than 80%, greater than 85%, greater than 90%, or smaller or intermediate percentages. Combining the sheath's extendability with curvature control provides good coaxial alignment capabilities (e.g., to align the sheath axis with the valve axis) for mitral valve delivery and / or treatment. For example, when considering a comparable CFT mitral valve delivery device in direct comparison to a mitral clip system, it provides one or more of the following potential advantages: A single delivery CFT sheath can potentially provide all of the necessary navigation and placement capabilities in an easily operated robotically controlled (or single human) device, as opposed to a manually controlled device that requires two skilled physicians and several additional catheter lab technicians. The CFT's extendability potentially allows for delicate, precise, controlled corrections instead of or in addition to the physician's traditional push-pull action. In some cases, septal puncture is performed, and steering of the distal left atrial sheath is quite limited in the mitral situation. The ability to locally control the distal sheath via a shaping device after atrial puncture provides unique precision delivery capabilities. Retractable hydraulic devices provide a relatively large available delivery lumen relative to the outer diameter, potentially opening up additional markets for left atrial procedures, such as pediatric.Another potential benefit is that once a portion of the CFT has been formed, the formed configuration can be kept stable while the next section is formed, which could allow for sequential rather than parallel operations, which could be more accurate and / or require less expertise.

[0313] Typical Cardiac Uses In some embodiments of the invention, a cardiac access / placement sheath is provided. Optionally, the sheath is used to deliver a cardiac tool, such as a cardiac ablation tool, optionally a standard such tool, optionally without articulation capabilities (e.g., so that any required articulation can be provided by the sheath).

[0314] In one example, the sheath conforms to FIG. 4, although other designs, for example, other figures showing the sheath or otherwise described herein may be used.

[0315] In some embodiments of the invention, the sheath is used to access complex anatomical structures, such as structures with complex pathways to them. One example of a complex pathway includes a pathway through a heart valve (potentially two valves in total) that requires further stretches or curves. Note that in these delicate structures, pushing or advancing from the hub may be difficult or cause adverse events. Another example of a complex pathway is a pathway that includes an S-shaped curve or an S-shaped curve that requires further navigation afterwards (e.g., the right ventricular outflow tract (RVOT)).

[0316] For example, the sheath can be configured (and optionally includes the use of presets, such as in FIG. 4 ) by controlling several segments of the distal shaft (not just simple curves as in conventional steerable catheter designs) as shown in the previous figures. Such a configuration may allow the sheath to extend to the distal regions of the LVOT or RVOT (left ventricular outflow tract and right ventricular outflow tract, respectively) without compromising the delicate structures of the heart. After reaching these regions, further distal manipulation may still be available, which can be used to guide therapeutic tools through the sheath in these regions with high precision. Sheath access to these regions can be used to guide therapeutic tools to these locations, for example, for ablation, delivery of implants such as pacemakers or mitral valve clips, performing valvuloplasty, and / or electroanatomical mapping of the heart.

[0317] A potential benefit of using the controllable sheaths described herein is the stability of the sheath once shaped, thereby enabling stable access to targets, potentially without intruding on the target, even targets that are currently difficult or impossible to access with stability, or where it is impossible to provide a stable sheath. Once the target area is reached, the tip of the guide sheath can be moved to aid in accessing nearby locations, as described herein.

[0318] In a particular implementation, the sheath device includes a multi-stable guide sheath with an outer elastic layer, which is optionally configured as a soft sheath (without any braided or coiled metal reinforcement of the shaft). In one exemplary use, the sheath device is advanced to a complex anatomical region of the heart using hydroforming, potentially without endangering and / or damaging the delicate internal structures of the human heart and / or without deforming the heart or causing unintended arrhythmias. Once in place, the sheath device may be reinforced (e.g., using the hydroforming mechanisms described herein) to provide support for passing tools through and manipulating the heart.

[0319] In one use case, tip axial advancement is used to position the sheath after it is correctly positioned. For example, the sheath may be guided and curved as necessary, with the actual length set after navigation and curvature is complete. In contrast, standard catheters can only be advanced by pushing, so any curved section relies on pressure against the body surface, and the catheter must slide around the bend (applying friction and force to the anatomy) to complete tip advancement. Therapeutic tools (e.g., ablation catheters) may be positioned within the sheath during navigation or may be provided after navigation. In systems with a removable hydroformer, it is typically provided afterwards to reduce the overall diameter.

[0320] A potential advantage of the tip bending described herein is that any applied force is applied to the tip of the catheter and does not have to be transferred mechanically (by pushing or pulling) along the catheter / sheath. Such bending does not interfere with the layout of other parts of the catheter / sheath, since the sheath can be stiff except at the tip. Conversely, the actual layout of the catheter / sheath is not expected to affect bending, whereas in a typical pullwire-based catheter, friction and forces and bending of the catheter / sheath along its length may affect the quality and / or quantity of movement. Potentially, this allows for more precise, predictable and / or stable movement.

[0321] Another potential advantage of the designs described herein is that the catheter or sheath is free of coupled tip-shaft and tool-sheath motions that may be present in standard sheath / catheter designs. In some embodiments of the invention, hydraulic deflection and extension replaces pull wire tension (or coaxial shaft positioning) and push-pull motions (usually applied via a handle). This has the potential advantage of reducing the dependency of positioning, navigation, and stability on the hand motion and dexterity of the operator.

[0322] Typical Colonoscopic Access System In some embodiments of the invention, a basis for colonic diagnostic and / or procedural scopes (e.g., CFT colonoscopes) is provided. Potential advantages in this use case focus on significantly lower support and strain on the colon, which is considered a known drawback to patient outcomes in traditional colonoscopy and a potential cause of laceration or perforation, or other colonic trauma. Optionally or additionally, improved is fine control of tip location, a problem exacerbated in standard colonoscopy by the elasticity and mobility of the colon. Tip resistance can be reduced by local control of shaft curvature, minimizing lateral movement along the colon (especially around sigmoid loops). Additionally, the extension feature of the CFT scope provides the potential to gradually advance the distal shaft without the need to push on the proximal shaft at all, potentially reaching the target safely and minimizing perforation. In some embodiments of the invention, local control of the stiffness of the scope is obtained using intralumen hydraulic technology. In some embodiments of the invention, relatively large (e.g., relative to what is typically available in the heart) and permanent hydraulic devices can be used. Optionally, these are provided to give the physician access to all possible controls along the CFT colonoscope shaft. In the context of colonoscopy, a robotic interface could potentially benefit, among other things, hydroformer compartment feedback, which could also inform the algorithm whether the tip is advancing smoothly without lateral forces, or whether lateral forces are increasing and corrections should be made.

[0323] In some embodiments of the invention, where there is more lumen space available, a three compartment hydraulic device with omnidirectionality (e.g., Type 2 former, Table 1) can be used. Feedback is optionally provided by reading the proximal (hub) pressure of a particular lumen. Generally, in these cases, the control signal is saline flow rate and the controlled variable is saline pressure.

[0324] A typical search and rescue robot In the event of a major crisis, the primary task of fire and rescue services is to search for human survivors at the scene of the incident. This is a complex and dangerous task that often results in loss of life among the human emergency managers themselves. In this section of the document, we present unmanned search and rescue robot / device technology that is based on the mechanisms previously described for the steerable catheter device. However, the scale, design, and / or operation method may be adjusted to better suit the debris environment in which the robot / device is used. Such robots / devices may be equipped with one or more of the currently available miniature sensing technologies, e.g., high-resolution video cameras, thermal cameras, 2D and 3D laser range finders, spectrometers, chemical sensors, microphones, and / or other sensors, allowing them to locate casualties trapped underground and / or perform accurate and / or relatively fast mapping of the search area. For other purposes, such as pinpointing potential hazards, sensors can be used, such as to measure chemical, biological, and radioactive contamination. A potential advantage of using unmanned robots / devices is that they can keep human operators safe remotely.

[0325] In some embodiments of the invention, the search and rescue robot / device is designed to function primarily as a tool in the hands of human search and rescue workers on a mission to "tunnel through the rubble." In such missions, rescuers attempt to open a path through piles of rubble (e.g., collapsed buildings) and search for signs of life, searching for air-trapped cavities where a person might survive. The search and rescue robot / device is adapted to such types of environments and is able to navigate in uncertain media, follow three-dimensional mazes created by the rubble, often through narrow, branching and meandering tunnels, and advance and turn in open spaces that often have no support to lean on.

[0326] Note that the (optional) soft robotic mechanism described is optionally designed to penetrate into the rubble. Optionally, the head (distal tip) of the robotic mechanism guides the search and advances into the rubble, while the tail (proximal end) always remains outside the rubble, thus maintaining a path. Once located, aid supplies (e.g. oxygen, water, food, communication) can be delivered to the trapped survivors through lumens in the robot itself.

[0327] A potential advantage of this design is that such a robot / device can be steered to advance / grow in any direction along an axis and bend into any necessary 3D curve. In contrast to some snake-like mechanical robots and growing soft robots, some embodiments of the invention can recover their trajectory and change navigation route at any point along the path.

[0328] As with some embodiments of the steerable catheter device, the search and rescue robot / device is optionally manually actuated by hydraulically pressurizing an asymmetric and / or flexible balloon / membrane inside the CFT lumen. (See, e.g., FIG. 11.) Optionally, the CFT includes a hub that provides axial and / or rotational alignment between the molding device and the CFT, and can operate in the same manner as the steerable catheter device.

[0329] In some embodiments of the invention, guidewires are used in maneuvering search and rescue robots / devices. A wire is typically characterized by its pushability, steerability, and torque. Pushability is the amount of force required to advance the wire. Steerability is the ability and responsiveness of the wire tip to navigate a blood vessel. Torque is the response of the wire to rotation by an operator, for example, when moving through debris. Guidewires typically come in two basic configurations: solid steel or nitinol core wires and solid core wires wound into smaller wire coils or braids. Coiled or braided wires typically exhibit high flexibility, pushability, and kink resistance. Guidewires typically have a soft tip and a stiff body to facilitate navigation of the tip, and stiffer sections of the wire exhibit good pushability. Some wires are coated with polymers such as silicone or polytetrafluoroethylene (PTFE) to enhance lubricity. The tip of the wire is provided in various configurations, such as a "J" curve, various angles, or a straight tip to aid in navigating various 3D obstacles. When considering the diameter of the guidewire for search and rescue applications, it can optionally be scaled up from the size used in medical applications, for example to a diameter of approximately 10 mm, although shape, diameter, length, and stiffness considerations are optionally customized depending on the mission and application.

[0330] One way that a guidewire can be used in navigation is by introducing it into the CFT lumen to guide the CFT over complex debris / rubbish terrain or through obstacles when using a curved guidewire. Advance the wire, then advance the CFT along the wire using the wire as a rail, then advance the wire again, etc. At any point, a shaper can be inserted into the CFT lumen in place of the wire (or above or beside the wire) to create the desired bend or stretch. As shown herein, the CFT can be stable, at least in some parts, maintaining its curvature, for example after a bi-stable transition, and resist the force of the wire or shaper when introduced through it, so that the tip of the CFT is directed to the next destination of navigation where the wire is directed in the next step. In some embodiments, at least a portion of the CFT has an elastic element or layer associated therewith to reverse the deformation of the CFT by the shaper. When moving in an open space, the guide wire can only stand a limited distance under gravity without bending into the gland, in which case the CFT is optionally guided by the wire over the gland until it reaches a point where the CFT needs to be bent upwards. A former is then introduced along the CFT to the desired point and actuated to create the required bend in the CFT.

[0331] In some embodiments of the invention, a CFT (in this or any other embodiment) may include stable portions and elastically recoil portions, for example some portions of the CFT may have elastic layers and some portions may not, or may have thinner and / or otherwise less elastic layers.

[0332] Another way that a guidewire can be used in navigation is to introduce the guidewire into a designated lumen in a shaper and guide the shaper through the tortuous curves in the CFT and over the wavy surfaces that may characterize the inner surface CFT, in some embodiments the inner surface is coated to make it smoother, as is the case with medical tool inner surfaces.

[0333] The lumen of the CFT is optionally large for search and rescue applications compared to steerable catheter devices. Its diameter can be on the order of a few centimeters (usually 2-5 centimeters, but can be larger, e.g., 5-10 cm or 10-20 cm or more). With such lumen diameters, it can be advantageous to design a mechanical robot controller to actuate the CFT. Such a robot controller can either bend the CFT or extend it, or both. Such a robot controller can translate commands (e.g., given by a GUI or a joystick or knob) into inflate / deflate / advance / retract commands for the shaper. Optionally or additionally, no handheld controller is provided, but rather the user may indicate a target location or a general command (e.g., "search"), and the robot interface translates such commands into actions by the shaper and CFT, e.g., using planning systems known in the art.

[0334] An option for actuating the search and rescue robot / device is by a robotic interface. The CFT former and guidewire retain their original form and use a suitable control system to actuate them. From a mechanical perspective, actuation is the same way as a human. For example, the control system controls electronic gears to mechanically shift the CFT back and forth and set its axial position. Similarly, electronic gears attached to the former and / or guidewire can apply and / or sense torque and / or axial frictional forces to determine the axial and rotational positions of the former and / or guidewire. Other layout sensing methods may be used. In the case of a hydroformer, the pressure in the balloon / membrane compartment is optionally controlled to control the bending and / or stretching of the former. If a mechanical robot is actuating the CFT, the mechanism is optionally fully electronically controlled.

[0335] Actuation by the just-mentioned robotic interface can be performed by a human manipulating a joystick, with a different action to control each degree of freedom (e.g., pulling the stick once drives the CFT backwards by an axial position of 1 mm, pressing the button to move the joystick left rotates the former by 5 degrees counterclockwise, etc.). One way to actuate the robotic interface is by a dedicated control algorithm that receives as input the position of the catheter tip in a coordinate system (or on an image) optionally estimated by a 3D sensing means (e.g., a 3D laser distance sensor or stereo imaging).

[0336] FIG. 10(a) shows an exemplary diagram of a CFT-based search and rescue robot 1001, and chart 10(b) shows the navigation algorithm (including navigation function and gait) of the proposed search and rescue robot based on hydroforming, according to some embodiments of the present invention.

[0337] Such control methods may also be used in clinical practice, for example, in dedicated control algorithms (e.g., based on solutions of CFT governing equations as described herein) where position feedback of the catheter tip is achieved by a combination of catheter lab imaging resources and unique dynamic pressure readings associated with the geometry and strain field of the hydraulic device. For example, the internal pressure of the hydraulic device may vary not only as a function of actuation but also as a function of the stresses exerted by the arterial wall. The potential energy of the frustum (as mentioned in the section entitled "Typical Frustum Tip" above)

number

[0338] Exemplary specific designs arising from this disclosure and having specific interventional applications.

[0339] Below is a list of designs that may be provided by some embodiments of the present invention that correspond to specific interventional use cases based on the technology described herein. The size and force of the general mechanisms described above and / or other design elements may be optionally adjusted to match the following applications, particularly but not limited to, using features known in the art.

[0340] 1. Steerable guide sheath (with or without the use of a guidewire). In particular, it may be useful to decouple the bending setting (location and / or angle) from the axial stretch setting (location and / or amount).

[0341] 2. Steerable catheters (a guidewire goes inside the lumen and a former is advanced over the wire).

[0342] 3. Steerable ablation catheter (CFT actuation with pressurized integral lumen, non-retractable device).

[0343] 4. Steerable guidewire (CFT actuated by push wire).

[0344] 5. Steerable colonoscope.

[0345] 6. Steerable coronary delivery sheath (optionally similar to item 1, but with one or more optional specific features to match needs in the coronary system - local reordering of CFT (and pre-defined (e.g., during manufacturing) bend locations, orientations, contractions), e.g., to match known shapes to provide support without fixation, and move in 3D space using arbitrary 3D curves and extensions independent of proximal pushing or twisting).

[0346] 7. Decoupling shaft stiffness from the pushability and / or torqueability of the catheter (e.g., the shaper and CFT are aligned and twisting the shaper changes the directionality of the curve without having to twist the CFT sheath).

[0347] 8. Steerable transseptal catheters.

[0348] 9. Wired or wireless steerable snake-like robots for exploring rubble and other chaotic environments.

[0349] 10. Dynamic shaft extension, for example, allowing one to select a stable orientation and then advance the catheter tip to the desired location.

[0350] 11.Crawling former.

[0351] 12. Provides open loop accuracy - Due to the stability and restraint provided by the CFT geometry, the angle of bend has a direct relationship to pressure.

[0352] 13. Interventional Radiology Situation- The shaper MC functions as a conventional MC (microcatheter) while the CFT (e.g., 5F in diameter) provides precise steering.

[0353] 14. Transseptal delivery-Transmits higher torque independent of shaft and steering.

[0354] 15. Some internal size examples: 6Fr OD catheter-MC-3-4Fr, wire 0.018.

[0355] overview During the life of the patent which matures from this application, many related multistable designs will be developed, and the scope of the term multistable design is intended to include all such new technologies a priori.

[0356] As used herein in reference to an amount or value, the term "about" means "within ±10% thereof."

[0357] The terms "comprises," "comprising," "includes," "including," "has," "having" and their conjugations mean "including, but not limited to."

[0358] The term "consisting of" means "including and limited to."

[0359] The term "consisting essentially of" means that a composition, method, or structure may include additional ingredients, steps, and / or moieties, but only if the additional ingredients, steps, and / or moieties do not materially alter the basic and novel characteristics of the claimed composition, method, or structure.

[0360] As used herein, the singular forms "a," "an," and "the" include plural references unless the context clearly dictates otherwise. For example, the term "a compound" or "at least one compound" can include a plurality of compounds, including mixtures thereof.

[0361] Throughout this application, embodiments of the invention may be presented with reference to a range format. It should be understood that the description in range format is merely for convenience and brevity and should not be construed as an inflexible limitation on the scope of the invention. Thus, the description of a range should be considered to specifically disclose all possible subranges as well as individual numerical values ​​within that range. For example, a description of a range such as "1 to 6" should be considered to specifically disclose subranges such as "1 to 3", "1 to 4", "1 to 5", "2 to 4", "2 to 6", "3 to 6", etc., as well as individual numerical values ​​within that range, e.g., 1, 2, 3, 4, 5, and 6. This applies regardless of the breadth of the range.

[0362] Whenever a range of numerical values ​​is given herein (e.g., any pair of numerical values ​​joined by "10-15," "10 to 15," or another such range designator), it is meant to include any numerical value (fractional or integer) within the limits of the stated range, including the limits of the range, unless the context clearly dictates otherwise. The phrases "range / ranging / ranges between" a first designator and a second designator, and "range / ranging / ranges from" a first designator "to," "up to," "until," or "through" a second designator (or other such range designator terminology) are used interchangeably herein and are meant to include the first designator and the second designator, and all fractional and integer numerical values ​​therebetween.

[0363] Unless otherwise indicated, the numerical values ​​used herein and any numerical ranges based thereon are approximations within reasonable measurement precision and rounding errors that one of ordinary skill in the art would understand.

[0364] It is understood that certain features of the invention that are, for clarity, described in the context of separate embodiments, may also be provided in combination in a single embodiment. Conversely, various features of the invention that are, for brevity, described in the context of a single embodiment, may also be provided separately or in any suitable subcombination or as appropriate in any other described embodiment of the invention. Certain features described in the context of various embodiments are not to be construed as essential features of those embodiments, unless the embodiment is inoperable without those elements.

[0365] While the present invention has been described in conjunction with specific embodiments thereof, it is evident that many alternatives, modifications and variations will be apparent to those skilled in the art. Accordingly, it is intended to embrace all such alternatives, modifications and variations that fall within the spirit and broad scope of the appended claims.

[0366] All publications, patents, and patent applications mentioned in this specification are hereby incorporated by reference in their entirety to the same extent as if each individual publication, patent, or patent application was specifically and individually indicated to be incorporated by reference herein. Furthermore, citation or identification of any reference in this application should not be construed as an admission that such reference is available as prior art to the present invention. Section headings, if used, should not be construed as necessarily limiting. Additionally, any priority document(s) of this application are hereby incorporated by reference in their entirety herein. [Explanation of symbols]

[0367] l t -Non-working axial length of the cone frustum tip lr - Tip axial extension ratio r i -Inner frustum radius r o -Outer frustum radius E-Young's Modulus h-CFT wall thickness List of Abbreviations CFT - Cone truncated tip

Claims

1. 1. A multistable guide sheath, comprising: a body, the body comprising: Lumens and a bendable section surrounding a portion of the lumen, the bendable section having an axial extent and defining an array of a plurality of deformation points axially spaced apart along a side of the bendable section, each point defined by at least one fold; Including, Each deformation point is characterized by having a plurality of locally stable deformation states. Multi-stable guide sheath.

2. 2. The multistable guide sheath of claim 1, wherein the deformation at the point includes buckling at the fold.

3. The multistable guide sheath of claim 1 , wherein the plurality of deformation points axially spaced along the bendable section each define at least two minima of bending resistance.

4. the folds define a CFT-like structure in the wall; 4. The multistable guide sheath of claim 3, wherein the CFT-like structure is defined by a pair of radially converging and diverging surfaces of the wall at the point.

5. The CFT-like structure is a. It is defined by diverging and converging frustums meeting at folds, and b. Not symmetrical in the circumferential direction; 5. The multistable guide sheath of claim 4, wherein:

6. The multistable guide sheath of claim 1 , including one or more circumferentially extending wires.

7. The multistable guide sheath of claim 1 , wherein the body is elastic and / or includes an elastic layer.

8. at least one integral fluid-expandable chamber configured to deform the bendable section when expanded; 2. The multistable guiding sheath of claim 1, wherein the at least one integral fluid-expandable chamber includes a plurality of the chambers for selective expansion to obtain bending and / or elongation of the bendable section, the plurality of chambers being disposed below the bendable section.

9. The multistable guiding sheath of claim 8 , wherein the fluid is a gas or a liquid.

10. The multistable guiding sheath of claim 8 , wherein the chamber is defined by a membrane between the chamber and a wall of the body, the membrane being constrained from expanding into the lumen.

11. The multistable guiding sheath of claim 8 having a single central inflation lumen.

12. 10. A system comprising the multistable guide sheath of claim 8 and circuitry that calculates the resistance of a position of at least a portion of the sheath or surrounding structure based on the pressure in the chamber.

13. at least one removable former sized to fit with the lumen and to shape the bendable section, the former comprising: a. an outer surface configured to frictionally and / or geometrically fit against the inner wall of the lumen; and b. a predefined axially asymmetric shape; 10. The multistable guide sheath of claim 1, comprising one or more of:

14. The multistable guide sheath of claim 1 , wherein the bendable section has at least one limiter that non-uniformly limits deformation of the bendable section.

15. The multistable guide sheath of claim 1 , wherein the sheath is configured to bend forming a compound curve within the bendable section.

16. The multistable guide sheath of claim 1 , wherein a first deformation of the plurality of folds defines an axial extension of the guide sheath that is different from a second deformation of the plurality of folds.

17. 2. The multistable guide sheath of claim 1, wherein the folds are arranged to allow a range of bending of the bendable section of at least 60 degrees between a first position and a second position, the bending being measured relative to a longitudinal axis of the sheath.

18. 2. The multistable guide sheath of claim 1, wherein the folds are arranged to cause the body to bend with a proximal curve, an axially extensible section, and a more distal curve, wherein one or both of the proximal curve and the more distal curve are at least 180 degrees.

19. The multistable guide sheath of claim 1 , wherein the guide sheath is an intracorporeal guide sheath and the lumen has a cross-sectional area that is at least 80% of an area defined by an outer cross section of the guide.

20. 20. The multistable guide sheath of claim 19, wherein the guide sheath is a cardiac guide sheath.

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