Structure usable for robotic catheter for endovascular interventions and minimally invasive surgery

Abstract

The present invention discloses a configurable tube for a guiding sheath for intrabody use. Additionally, the present invention discloses a distally controllable distal end of an endoluminal device.

Description

[0001] STRUCTURE USABLE FOR ROBOTIC CATHETER FOR ENDOVASCULAR INTERVENTIONS AND MINIMALLY INVASIVE SURGERY

[0002] RELATED APPLICATION / S

[0003] This application claims the benefit of priority of U.S. Provisional Patent Application No. 63 / 560,949 filed on 4 March 2024, the contents of which are incorporated herein by reference in their entirety.

[0004] This application is also related to International Patent Application No. PCT / IL2022 / 051186. The contents of the above applications are all incorporated by reference as if fully set forth herein in their entirety.

[0005] FIELD AND BACKGROUND

[0006] The present invention, in some embodiments thereof, relates to a configurable tube and, more particularly, but not exclusively, to a configurable guide sheath for intrabody use. Additionally, the present invention, in some embodiments thereof, relates to a distal end of an endoluminal device and, more particularly, but not exclusively, to a distally controllable distal end of an endoluminal device.

[0007] One way of guiding a catheter in the body is to provide a guide sheath and guide a catheter inside the guide sheath.

[0008] Additional background art includes U.S. patent application No. US20180161547A1 disclosing guide extension catheters and related methods. A guide extension catheter can comprise an elongate tube member and a lumenless push member. The push member can be eccentrically coupled to the tube member for slidably positioning the tube member within and partially beyond a distal end of a guide catheter. At least a proximal end portion of the push member can include a cross-section defined by an arcuate first surface and an opposing second surface. The first surface can engage an inner wall surface of the guide catheter along an arc length, and the second surface can be spaced furthest from the first surface at its center point. The first surface can have the same or substantially the same radius of curvature as the guide catheter's inner wall surface, and the second surface can be flat or substantially flat. This configuration of the push member can provide an advantageous blend of stiffness and flexibility, as well as space conservation through the guide catheter.

[0009] U.S. patent application No. US20140052097A1 disclosing medical devices and methods for making and using medical devices. An example medical device may include a guide extension catheter. The guide extension catheter may include an elongate tubular member having a proximal region, a distal region, and a slot formed in the tubular member between the proximal region and the distal region. The proximal region of the tubular member may be configured to shift between a first configuration and a collapsed configuration. The guide extension catheter may also include an elongate shaft for shifting the proximal region between the first configuration and the collapsed configuration.

[0010] U.S. patent application No. US2016249900A1 disclosing an expansible elastic tube in which gas is encapsulated, a medical instrument (an endoscopic camera) secured to the tip of the elastic tube, a non-expansive tube that is connected to the other end of the elastic tube in such a way as to communicate therewith, the non-expansive tube in which gas is encapsulated, an inextensible body having flexibility, the inextensible body fixed to the elastic tube in a longitudinal direction, a connecting tube having the shape of a hollow circular cylinder and having flexibility and a non-expansive property, the connecting tube connected to the non-expansive tube, and a control device which performs variable control of the air pressure inside the elastic tube are provided, and the air pressure is controlled by the control device, whereby the elastic tube is made to expand and contract on the side opposite to the inextensible body and the elastic tube is curved at an arbitrary angle.

[0011] U.S. patent application No. US20200188635A1 disclosing user interface devices, systems, and methods can be used for selectively bending of, altering the bend characteristics of, and / or altering the lengths of catheter bodies, guidewires, steerable trocars, and other flexible structures inserted into a patient during use. Optionally, a housing is coupled to a proximal end of a catheter, and movement of the housing by a hand of a system user is sensed and used as a movement command for articulation of the catheter. Alternatively, a sensor can be coupled to an elongate flexible body flexing outside of the patient so as to alter bending of a catheter within the patient. Movements generated through a combination of manual manipulation and powered articulations are facilitated.

[0012] U.S. patent application No. US20030163154A1 disclosing a balloon catheter capable of expanding a narrowed site of a blood vessel in the vicinity of a curved part of the blood vessel, and of easily adapting the shape of the balloon to the shape of the curved part of the blood vessel. The balloon has a shape with a curved part, and the outer portion of the curved part (the shaded area) formed so as to have a smaller film thickness as compared with the remaining portion of the balloon is stretched by an amount larger than the remaining portion of the balloon. The difference in stretch amount between the outer portion of the curved part of the balloon and the remaining portion of the balloon becomes larger as the internal pressure of the balloon is increased. Accordingly, the extent of curve of the balloon can be controlled arbitrarily by controlling the internal pressure of the balloon.

[0013] U.S. patent application No. US2015352339A1 disclosing a contact-limiting side balloon double-hole urinary catheter, pertaining to the field of medical auxiliary devices; wherein a catheter body is made from a polymer blend, a side balloon is provided at one side of the catheter body close to a tip, the other side is provided with an excretion cavity drainage lower hole and an upper hole, and a flushing lumen liquid flow outlet is provided at the tip. After the urinary catheter is placed in the bladder, the side balloon automatically tilts in a water or gas injection state, the balloon wall and the catheter body do not press the trigone of the bladder and the orificium ureteris, the excretion cavity drainage lower hole is adjacent to the orificium ureteris to completely empty the bladder, and there is no residual urine. The tip, the side balloon, the excretion cavity drainage lower hole and upper hole, the excretion cavity, a water or gas injection lumen, the flushing lumen, the flushing lumen liquid flow outlet, an anti-reflux valve, an excretion cavity conical interface, a flushing cavity conical interface and a flushing cavity clipping switch of the urinary catheter are connected into an integral piece via the catheter body, and have a significant effect in clinical application.

[0014] U.S. patent No. US10456563B2 disclosing a steerable, conformable, drug eluting balloon catheter device may include a catheter stem with one or more balloon element(s), themselves comprised of one or more segment(s) arranged radially or axially along the length of the present catheter device may allow precise deployment of vascular interventional devices, including coring devices and / or placement of stents, and may also allow targeted, specific placement of selected diagnostic or therapeutic materials on the walls of a vascular structure during a cardiovascular intervention procedure.

[0015] U.S. patent No. US9095374B2 disclosing a catheter having a distal balloon and a deformable guidewire shaft of the catheter. The deformable guidewire shaft is adjacent to and external to the balloon. Inflation of the balloon bends the deformable guidewire shaft in order to orient or deflect a distal tip of the deformable guidewire shaft in a desired direction to guide and direct a guidewire extending through the deformable guidewire shaft towards a specific endovascular region. For example, it may be desired to orient the distal tip of the guidewire shaft towards a target vessel of a bifurcation or the balloon catheter may be used to bypass a Chronic Total Occlusion (CTO). U.S. patent No. US10688276B2 disclosing length- adjustable catheters and methods that employ length-adjustable catheters to treat malformations, constrictions, obstructions, lesions, and blockages within patients' blood vessels. The length of the shaft of a length-adjustable catheter, to which the current application is directed, can be adjusted over a range of lengths prior to and during medical procedures. In many implementations, length adjustment is accompanied by indications, to the medical provider, of the extent of a length adjustment. The indications may include one or more of visual markings, haptic feedback, radio-opaque markings, and / or other types of indications. In many implementations, the variable-length mechanism of the length-adjustable catheter is mechanically lockable following length adjustment.

[0016] International patent application No. W02008073126A1 disclosing a distal end of a flexible catheter that can be selectively deflected in a desired direction by actuating one or more actuators that extend outwardly of an exterior surface of the catheter. Each actuator can be a balloon disposed within a non- extendible balloon or sheath. Inflation of one (or both) of the balloons and the nonextendible balloon with a pressurized fluid can deflect the distal tip of the catheter. Another actuator embodiment comprises a strip of a bimorph material that bends outwardly when actuated, e.g., by heat, applying a force against adjacent tissue to deflect the distal tip. Yet another embodiment includes a strip of material that shortens when heated and can be coupled to a balloon that is inflated outwardly to increase a radial moment arm of the force applied thereby, relative to a neutral axis of the catheter, to more readily deflect the distal tip.

[0017] SUMMARY OF THE INVENTION

[0018] Following is a non-exclusive list including some examples of embodiments of the invention. The invention also includes embodiments which include fewer than all the features in an example and embodiments using features from multiple examples, also if not expressly listed below.

[0019] Example 1. A tube with a longitudinal axis and selectively deformable along a folding pattern which extends both circumferentially and axially, comprising a tubular body with a first crease and at least one second crease; wherein said first crease extends towards a first direction at a certain angle and said at least one second crease does not extend towards said certain angle.

[0020] Example 2. The tube according to example 1, wherein said second crease extends circumferentially a length of from a 1 / 16 to 2 / 3 of a total length of a circumference of said tube. Example 3. The tube according to example 1 or example 2, wherein said tube comprises more than one of said at least one second crease on a same circumferential location.

[0021] Example 4. The tube according to any one of examples 1-3, wherein said tube comprises a proximal end and a distal end, and wherein said first direction is from said proximal end to said distal end.

[0022] Example 5. The tube according to any one of examples 1-4, wherein said tube comprises a proximal end and a distal end, and wherein said first direction is from said distal end to said proximal end.

[0023] Example 6. The tube according to any one of examples 1-5, wherein said at least one second crease does not extend towards said first direction.

[0024] Example 7. The tube according to any one of examples 1-6, wherein said second crease extends in an opposite direction of said first crease.

[0025] Example 8. The tube according to any one of examples 1-7, wherein said second crease extends at an angle of from 5 degrees to 170 degrees in relation to said certain angle.

[0026] Example 9. The tube according to any one of examples 1-8, wherein said second crease extends at an angle of from 30 degrees to 170 degrees in relation to said certain angle.

[0027] Example 10. The tube according to any one of examples 1-9, wherein a passage from said first crease to said second crease is gradual.

[0028] Example 11. The tube according to any one of examples 1-10, wherein said second crease extends axially in a helical manner in relation to said longitudinal axis of said tube.

[0029] Example 12. The tube according to any one of examples 1-11, wherein said second crease axially extends more than said first crease during a deflection movement.

[0030] Example 13. The tube according to any one of examples 1-12, wherein said tube is configured to deflect an angle from 1 degree to 270 degrees in relation to said longitudinal axis.

[0031] Example 14. The tube according to any one of examples 1-13, wherein said first crease is conical.

[0032] Example 15. The tube according to any one of examples 1-14, wherein said conical crease has an angle relative to a plane perpendicular to said longitudinal axis of between 1 and 30 degrees.

[0033] Example 16. The tube according to any one of examples 1-15, wherein said second crease is non-conical. Example 17. The tube according to any one of examples 1-16, wherein said first crease and said second crease are all outside of a body geometry defined by the increased parts of said body.

[0034] Example 18. The tube according to any one of examples 1-17, wherein said first crease is formed by plastically deforming said tube against a form and said second crease is form by plastically deforming said first crease.

[0035] Example 19. The tube according to any one of examples 1-18, wherein said first crease is formed by molding.

[0036] Example 20. The tube according to any one of examples 1-19, wherein at least 80% of a thickness of said tube is formed of a single layer of material, over at least 50% of a length of a creased part of said tube.

[0037] Example 21. The tube according to any one of examples 1-20, wherein said tube is formed of metal or a polymer.

[0038] Example 22. The tube according to any one of examples 1-21, wherein said tube is elastically deformable under forces which contract said first crease and expand said second crease.

[0039] Example 23. The tube according to any one of examples 1-22, wherein said second crease expands more than said first crease.

[0040] Example 24. The tube according to any one of examples 1-23, comprising a membrane which seals said first crease and said second crease for allowing expansion of said first crease and said second crease by injection of fluid therein.

[0041] Example 25. The tube according to any one of examples 1-24, comprising a membrane configured to expand into said first crease and said second crease for causing expansion of said crease by entry therein.

[0042] Example 26. The tube according to any one of examples 1-25, comprising a membrane which seals said tube for allowing expansion of said first crease and said second crease by injection of fluid therein.

[0043] Example 27. The tube according to any one of examples 1-26, formed as an intrabody tube with bio-compatibility suitable at least for acute procedures.

[0044] Example 28. The tube according to any one of examples 1-27, wherein said tube is arranged as a guide sheath.

[0045] Example 29. The tube according to any one of examples 1-28, configured to include a creased section with a geometry suitable to cause deflection movement, rotation movement and / or extension movement of a more distal part of said tube. Example 30. The tube according to any one of examples 1-29, wherein said second crease section provides deflection movement to said tube.

[0046] Example 31. The tube according to any one of examples 1-30, configured for use as a trans-vascular guide sheath in an adult human heart or in coronary vessel and to resist plastic deformation by passage of tools there through including one or more of a valve and a stent.

[0047] Example 32. The tube according to any one of examples 1-31, formed as a robotic guide sheath.

[0048] Example 33. The tube according to any one of examples 1-32, comprising an electronically controlled pump for expanding said first crease and said second crease, including a controller with an accuracy of better than 1 degree in deflecting of said tube.

[0049] Example 34. The tube according to any one of examples 1-33, configured to deflect in at least two planes.

[0050] Example 35. A medical tube or robotically controlled sheath tube comprising a tube according to example 1.

[0051] Example 36. A method of providing deflection movement to a tube, comprising expanding a second crease more than a first crease in said tube.

[0052] Example 37. The method according to xample 36, wherein said tube is inserted into a human body.

[0053] Example 38. A guiding sheath, comprising: a. a handle, located at a proximal end of said guiding sheath; b. an elongated body, comprising proximal end interconnected to said handle and a distal end; c. an operational distal end interconnected to said distal end of said elongated body; said operational distal end comprising one or more segments configured to perform a movement selected from the group consisting of: axial movement, rotation movement and deflection movement; wherein said one or more segments are each characterized by comprising a folded tube (FT) comprising a fold type that enables said movement.

[0054] Example 39. The guiding sheath according to example 38, wherein said axial movement is performed by a conically folded tube (CFT).

[0055] Example 40. The guiding sheath according to example 38 or example 39, wherein said rotational movement is performed by a helically folded tube (HFT). Example 41. The guiding sheath according to any one of examples 38-40, wherein said deflection movement is performed by a mixed folded tube (MFT).

[0056] Example 42. The guiding sheath according to any one of examples 38-41, further comprising a microfluidic system configured to actuate said FT thereby performing said movement.

[0057] Example 43. The guiding sheath according to any one of examples 38-42, wherein said guide sheath is characterized by being a multi-layer sheath comprising a plurality of concentric tubes.

[0058] Example 44. The guiding sheath according to any one of examples 38-43, wherein fluids are configured to be injected between said plurality of concentric tubes to independently actuate said one or more segments.

[0059] Example 45. The guiding sheath according to any one of examples 38-44, wherein said guide sheath is characterized by being a mono-layer sheath comprising a plurality of micro tubes.

[0060] Example 46. The guiding sheath according to any one of examples 38-45, wherein fluids are configured to be injected in said micro tubes to independently actuate said one or more segments.

[0061] Example 47. The guiding sheath according to any one of examples 38-46, further comprising a wire reinforcing said FT.

[0062] Example 48. The guiding sheath according to any one of examples 38-47, wherein said microfluidic system is intrinsic to said guide sheath.

[0063] Example 49. The guiding sheath according to any one of examples 38-48, wherein said microfluidic system is intrinsic to said guide sheath inside said handle.

[0064] Example 50. The guiding sheath according to any one of examples 38-49, wherein said microfluidic system is an external system connected to said guide sheath.

[0065] Example 51. The guiding sheath according to any one of examples 38-50, further comprising an integrated cable connecting between said external microfluidic system and said guide sheath.

[0066] Example 52. The guiding sheath according to any one of examples 38-51, wherein said integrated cable comprises one or more of a plurality of lumens to provide fluids and electric wires for actuating said guide sheath.

[0067] Example 53. The guiding sheath according to any one of examples 38-52, wherein each of said one or more segments comprise an inner tube adapted to facilitate said movement. Example 54. The guiding sheath according to any one of examples 38-53, wherein said guide sheath is characterized by being a hybrid mono-layer and multi-layer.

[0068] Example 55. The guiding sheath according to any one of examples 38-54, further comprising an elastic liner covering said elongated body and said operational distal end.

[0069] Example 56. The guiding sheath according to any one of examples 38-55, further comprising an atraumatic distal end.

[0070] Example 101. A tube with a longitudinal axis and selectively deformable along a pattern which extends both circumferentially and axially, comprising a tubular body with a crease extending both axially and circumferentially, wherein the crease is bistable in at least two configurations, one configuration with a greater axial extent and a greater circumferential extent than the other configuration.

[0071] Example 102. The tube according to example 101, wherein said crease is continuous over at least 4 turns around said body.

[0072] Example 103. The tube according to example 101 or example 102, wherein said crease extends over at least 4 turns around said body and includes at least one portion which is not bistable or a non-creased section.

[0073] Example 104. The tube according to any of examples 101-103, wherein said tube is stable at at least 50 different deformation states.

[0074] Example 105. The tube according to any of examples 101-104, wherein said crease is helical.

[0075] Example 106. The tube according to any of examples 101-105, wherein said crease comprises multiple helical creases.

[0076] Example 107. The tube according to any of examples 101-106, wherein at least two of said creases overlap axially.

[0077] Example 108. The tube according to any of examples 101-107, wherein at least two of said creases do not overlap axially.

[0078] Example 109. The tube according to any of examples 101-108, wherein at least two of said creases have a same chirality.

[0079] Example 110. The tube according to any of examples 101-109, wherein at least two of said creases define a multi-start helix.

[0080] Example 111. The tube according to any of examples 101-110, wherein at least two of said creases have a different chirality. Example 112. The tube of any of examples 101-111, wherein said helical crease has a constant pitch.

[0081] Example 113. The tube of any of examples 101-112, wherein said helical crease has a nonconstant pitch.

[0082] Example 114. The tube of any of examples 101-113, wherein said crease has a pitch of between 0.1 and 5 tube diameters, optionally between 0.3 and 2 or 3 diameters.

[0083] Example 115. The tube of any of examples 101-114, wherein said crease has an angle relative to a plane perpendicular to said axis of between 1 and 30 degrees, optionally between 20 and 75 or 80 degrees.

[0084] Example 116. The tube according to any of examples 101-115, wherein said crease is nonhelical.

[0085] Example 117. The tube according to any of examples 101-116, wherein said crease includes at least one section with a negative pitch relative to other sections of said crease.

[0086] Example 118. The tube according to any of examples 101-117, wherein said crease includes at least two changes in axial orientation in a single turn-around said body.

[0087] Example 119. The tube according to any of examples 101-118, wherein said crease is all outside of a body geometry defined by the increased parts of said body.

[0088] Example 120. The tube according to any of examples 101-119, comprising a wire or a lumen embedded in or adjacent and extending along said crease.

[0089] Example 121. The tube according to any of examples 101-120, wherein said tube is inflatable to expand said crease.

[0090] Example 122. The tube according to any of examples 101-121, wherein said wire provides elastic recoil to said crease.

[0091] Example 123. The tube according to any of examples 101-122, wherein said crease is formed by plastically deforming said tube against a form.

[0092] Example 124. The tube according to any of examples 101-123, wherein said crease is formed by molding.

[0093] Example 125. The tube according to any of examples 101-124, wherein at least 80% of a thickness of said tube is formed of a single layer of material, over at least 50% of a length of a creased part of said tube.

[0094] Example 126. The tube according to any of examples 101-125, wherein said tube is formed of metal or a polymer. Example 127. The tube according to any of examples 101-126, wherein said tube is elastically deformable under forces which expand said crease.

[0095] Example 128. The tube according to any of examples 101-127, wherein said tube crease at at least 10% of a length thereof comprises at least one distal side wall extending from said tube at a distal point and at least one proximal sidewall that extends from said tube at a proximal point and which sidewalls meet a peak.

[0096] Example 129. The tube according to any of examples 101-128, wherein said peak overhangs at least one of said distal point and said proximal point when said crease is in an axially contracted state.

[0097] Example 130. The tube according to any of examples 101-129, wherein an angle of one of said sidewalls and said body is acute and an angle of the other of said sidewalls to said body is obtuse when said crease is in an axially contracted state.

[0098] Example 131. The tube according to any of examples 101-130, wherein said sidewalls are, on the average over area, thinner than a thickness of said body adjacent said crease.

[0099] Example 132. The tube according to any of examples 101-131, wherein a meeting of said sidewalls and said body and said peak are thinner, on the average over area, than a thickness of said body adjacent said crease and said sidewalls.

[0100] Example 133. The tube according to any of examples 101-132, provided with a removable shaper which expands to engage and / or deform said crease.

[0101] Example 134. The tube according to any of examples 101-133, comprising a membrane which seals said crease for allowing expansion of said crease by injection of fluid therein.

[0102] Example 135. The tube according to any of examples 101-134, comprising a membrane configured to expand into said crease for causing expansion of said crease by entry therein.

[0103] Example 136. The tube according to any of examples 101-135, comprising a conical-frusta section in the form of a sequence of circumferentially extending creases.

[0104] Example 137. The tube according to any of examples 101-136, formed as an intrabody tube with bio-compatibility suitable at least for acute procedures.

[0105] Example 138. The tube according to any of examples 101-137, wherein said tube is arranged as a guide sheath

[0106] Example 139. The tube according to any of examples 101-138, configured to include a creased section with a geometry suitable to cause curling, twisting and / or extension of a more distal part of said tube. Example 140. The tube according to any of examples 101-139, wherein said crease section applies twisting torque which twists a more distal part of said tube, without requiring a more proximal part of said tube to be twisted.

[0107] Example 141. The tube according to any of examples 101-140, wherein said more distal part is configured to be deformed using zero or more of each of helically extending creases and / or a series of circumferentially extending creases.

[0108] Example 142. The tube according to any of examples 101-141, configured foruse as a trans vascular guide sheath in an adult human heart or in coronary vessel and to resist plastic deformation by passage of tools there through including one or more of a valve and a stent.

[0109] Example 143. The tube according to any of examples 101-142, formed as a robotic sheath.

[0110] Example 144. The tube according to any of examples 101-143, comprising an electronically controlled pump for expanding said crease, including a controller with an accuracy of better than 5 degrees in bending or twisting of said tube, optionally better than 1 or 0.1 or optionally intermediate values.

[0111] Example 145. The tube according to any of examples 101-144, configured to bend in at least two planes.

[0112] Example 146. The tube according to any of examples 101-145, wherein said tube has a diameter over 50% of a length of a creased part thereof of 0.5 and 8 mm, optionally between 1 and 5 mm, optionally about 4 mm.

[0113] Example 147. A medical tube or robotically controlled sheath tube with a longitudinal axis and selectively deformable along a pattern which extends both circumferentially and axially, comprising a tubular body with a crease extending both axially and circumferentially, wherein the crease has at least two configurations, one configuration with a greater axial extent and a greater circumferential extent than the other configuration.

[0114] Example 148. The tube according to example 147, wherein said crease moves elastically between said configurations.

[0115] Example 149. The tube according to example 147 or example 148, wherein said crease moves stably between said configurations.

[0116] Example 150. A method of transferring torque along a bent axis, comprising: stabilizing a more proximal side of a tube; and expanding a crease which extends axially and circumferentially along said tube in an amount sufficient to twist a part of said tube distal to said expanded crease. Example 151. The method according to example 150, wherein said expanding comprises bi- stably expanding.

[0117] Example 152. The method according to example 150 or example 151, wherein said tube is inserted into a human body.

[0118] Example 153. The method according to any of examples 150-152, wherein said tube lies in a three-dimensional space, unsupported along at least a part of its length distal to said expanded crease.

[0119] Example 154. The method according to any of examples 150-153, wherein said torque is transferred past a bend in said tube which is distal to said expanded crease, substantially without generating any parasite deflections along the bent axis other than torque.

[0120] Example 155. A method of manufacturing creased tube, comprising: mounting a tube on a fitted mandrel; and axially compressing said tube to form a circumferentially extending crease.

[0121] Example 156. The method according to example 155, wherein said crease extends axially

[0122] Example 157. The method according to example 155 or example 156 comprising repeating said axially compressing at multiple locations along said tube.

[0123] Example 158. The method according to any of examples 155-157, comprising twisting said tube while said compressing.

[0124] Example 159. The method according to any of examples 155-158, comprising twisting said tube while said compressing.

[0125] Example 160. The method according to any of examples 155-159, comprising prior to said axial compression, pre-disposing the tube to deform along said crease.

[0126] Example 161. The method according to any of examples 155-160, wherein said predisposing comprises forming an inwards crease along a line for said circumferentially extending crease.

[0127] Example 162. The method according to any of examples 155-160, wherein said forming an inwards crease comprises compressing said tube against a non-uniform mandrel.

[0128] BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWINGS

[0129] Some embodiments of the invention are herein described, by way of example only, with reference to the accompanying drawings and images. With specific reference now to the drawings and images in detail, it is stressed that the particulars shown are by way of example and for purposes of illustrative discussion of embodiments of the invention. In this regard, the description taken with the drawings makes apparent to those skilled in the art how embodiments of the invention may be practiced.

[0130] In the drawings:

[0131] Figure 1 is a schematic representation of an exemplary system for endoluminal navigation, according to some embodiments of the invention;

[0132] Figure 2a is schematic representation of an exemplary guide sheath, according to some embodiments of the invention;

[0133] Figure 2b is a schematic representation of an exemplary guide sheath comprising a handle, an elongated body and an operational distal end, according to some embodiments of the invention;

[0134] Figure 2c is a schematic zoom in representation of an exemplary operational distal end, according to some embodiments of the invention;

[0135] Figure 2d is a schematic zoom in representation of a handle according to some embodiments of the invention;

[0136] Figure 2e is a schematic representation of an exemplary segment, according to some embodiments of the invention;

[0137] Figure 2f is a schematic representation of an exemplary multi-layer sheath in a cross- sectional view, according to some embodiments of the invention;

[0138] Figure 2g is a schematic representation of an exemplary mono-layer with micro tubes sheath, according to some embodiments of the invention;

[0139] Figure 2h is a schematic representation of an exemplary mono-layer with micro tubes sheath, according to some embodiments of the invention;

[0140] Figure 2i is a schematic representation of an exemplary multi-layer sheath, according to some embodiments of the invention;

[0141] Figure 2j is a schematic representation of an exemplary multi-layer sheath, according to some embodiments of the invention;

[0142] Figures 3a-f are photographs of exemplary Folded Tubes (FTs), according to some embodiments of the invention;

[0143] Figure 4a is a schematic representation including schematic illustrations showing an exterior view of a Helically Folded Tube (HFT), according to some exemplary embodiments of the invention;

[0144] Figure 4b is a schematic representation of an interior view of the HFT structure, according to some exemplary embodiments of the invention; Figure 4c is a schematic representation of a robotic control sheath for vascular interventions, according to some exemplary embodiments of the invention;

[0145] Figure 4d is a schematic representation of a HFT based robotic catheter distal portion, according to some exemplary embodiments of the invention;

[0146] Figure 4e is a schematic representation of a cross-sectional view of the sheath middle portion (elongated body), according to some exemplary embodiments of the invention;

[0147] Figure 4f is a schematic representation of a cross-sectional view of a transition between the sheath’s middle portion and distal portion, according to some exemplary embodiments of the invention;

[0148] Figure 4g is a schematic representation of a cross-sectional view of a helically folded tube segment of the distal portion, according to some exemplary embodiments of the invention;

[0149] Figure 4h is a schematic representation of a cross-sectional view of an axial Cross-sectional view of the conically folded tube segment of the distal portion, according to some exemplary embodiments of the invention;

[0150] Figure 5 shows an empirical investigation of the dynamics of a folded tube comprising a layer in an exemplary sheath segment;

[0151] Figure 6 shows schematic illustrations and images of a fabrication process of a HFT, according to some exemplary embodiments of the invention;

[0152] Figure 7 shows images of different types and sizes of HFTs, according to some exemplary embodiments of the invention;

[0153] Figure 8 shows experimental measurements of stability thresholds for elongation and rotation of helical folds with different pitch between bi-stable elements;

[0154] Figure 9 shows schematic illustrations of a hydraulically actuated robotic sheath device, according to some exemplary embodiments of the invention;

[0155] Figure 10 shows schematic illustrations of a sheath conveying a cardiac ablation catheter, according to some exemplary embodiments of the invention;

[0156] Figure 11 shows schematic illustrations of a sheath in an undeflected state conveying a cardiac ablation catheter, according to some exemplary embodiments of the invention;

[0157] Figure 12 shows schematic illustrations of a sheath in a deflected state conveying a cardiac ablation catheter, according to some exemplary embodiments of the invention;

[0158] Figure 13 shows schematic illustrations of a sheath in a rotated state conveying a cardiac ablation catheter, according to some exemplary embodiments of the invention; Figure 14 shows images of exemplary actuations of the operational distal end, according to some embodiments of the invention;

[0159] Figure 15 shows an exemplary GUI with real-time readings and real-time images, according to some embodiments of the invention;

[0160] Figure 16 shows a schematic representation of a robotic Transseptal puncture procedure with the sheath, according to some embodiments of the invention;

[0161] Figure 17 shows a schematic representation of a Left Ventricle (LV) access for delivery of Ablation therapy with the sheath, according to some embodiments of the invention;

[0162] Figure 18 shows a schematic representation of a Right ventricle (RV) access for delivery of Ablation therapy with the sheath, according to some embodiments of the invention;

[0163] Figure 19 shows a schematic representation of a Pulmonary vein (PV) isolation procedure with the sheath, according to some embodiments of the invention;

[0164] Figure 20 is a schematic illustration of a general description of an HFT, according to some embodiments of the invention;

[0165] Figure 21 are exemplary calculations to characterize an HFT, according to some embodiments of the invention;

[0166] Figure 22 shows a comparison between A9G (°) versus C, (in mm) obtained by using eq. (35) (denoted by continuous blue curves) and experimentally measured results (denoted by red marks), for various pitches between bi-stable elements; and

[0167] Figure 23 shows the qualitative agreement between theoretical and experimental results.

[0168] DESCRIPTION OF SPECIFIC EMBODIMENTS OF THE INVENTION

[0169] The present invention, in some embodiments thereof, relates to a configurable tube and, more particularly, but not exclusively, to a configurable guide sheath for intrabody use. Additionally, the present invention, in some embodiments thereof, relates to a distal end of an endoluminal device and, more particularly, but not exclusively, to a distally controllable distal end of an endoluminal device.

[0170] Introduction to catheters and uses thereof

[0171] Catheters are interventional tools used by clinicians in over 10 million vascular catheterization procedures performed each year, world-wide. They are the important means of transferring life-saving therapies to remote locations within the body, sometimes the only means. As more and more therapies are becoming available via catheter-based edge-to-edge techniques (e.g. transcatheter edge-to-edge valve repair or replacement therapies), much of our ability to administer them lies in the essential control capabilities we have at the tips of the catheters used to convey them.

[0172] According to some exemplary embodiments, the current invention relates to the percutaneous insertion of diagnostic and therapeutic catheters into the cardiovascular system and the cardiac space. Manual steerable catheters, also referred to as steerable sheaths and / or endoluminal devices, are used for guiding therapeutic and diagnostic devices within the heart, these include, but are not limited to, electrophysiological devices such as: cardiac ablation catheters, pulmonary vein isolation (PVI) catheters including “single-shot” or “large-footprint” PVI catheters, cardiac mapping catheters and cardiac pacing catheters. Manual steerable sheaths are also an integral part of many intracardiac therapeutic delivery systems such as: Transcatheter heart valve repair and replacement devices, Occlusion or closure devices (ASD, PFO, LAA), Interatrial shunt delivery devices and other structural heart therapy devices and implant delivery systems.

[0173] According to some exemplary embodiments, a manual steerable sheath is a deflectable tube which optionally includes three manual control modalities for placing the distal end of the tube in a specific position and orientation within the three-dimensional space of the heart. In some embodiments, the control modalities are axial advancement and retraction (optionally achieved by pushing and pulling on the handle), rotation, i.e. the action of torquing the sheath (achieved by rotating the handle about its axis) and deflection of the sheath’s tip, i.e. pointing the axis of the distal segment of the sheath in a particular orientation, optionally achieved typically by varying the tension on one or several pull- wires which are threaded from the sheath’s distal end to its hub, or pulling or pushing on one of two concentric tubes within the sheath’s shaft which are connected distally. In some embodiments, in both cases the distal segment of the shaft which is deflectable includes a softened laser-cut hypotube segment, or laser-cut tubular structure to accommodate the deflection or dedicated braided or coiled tube segment (or a combination of both).

[0174] Torque transfer is a control signal transferred along catheter shafts in many intravascular applications. In some embodiments, transferring torque along slender tubes or catheters plays an important role in interventional cardiology and in radiology. Optionally, torque performance dictates not only catheter steering capability but also the ability to advance the catheter along the axis, cross heavily classified lesions and / or deliver therapies. Optimal torque performance of all catheter structures - torque-ability may be a subject to a careful balance between other desired handling functions, namely track- ability, the ability to track along an inner railing wire, and push- ability, the ability to transfer force along the length of the shaft without buckling, all clearly mechanically opposing functions.

[0175] One example reflecting the tradeoff between these functions is when navigating in a tortuous vascular anatomy. Typically, a low bending stiffness may be required of the catheter, for example in order to avoid buckling of the shaft along highly angled curves. A low bending stiffness (despite the use of metal braiding in the shaft) may result in low torque transmission from hub to tip preventing proximally transmitted torque to reach the catheter’s tip (shaft might twist or kink in a torsional manner). Catheter shaft design evolved over the years to optimize this delicate functional tradeoff and balance the physical properties of flexural rigidity, buckling resistance and torque performance. Despite this evolution, catheter shaft design peaked nearly two decades ago, while challenges relating to torque transfer have persisted across the interventional framework and are still eminent.

[0176] One of the fundamental limitations of mechanical torque transfer along a slender shaft is the inability to directly control the catheter's tip actions: in conventional shaft design the physician’s may control signals exerted on the catheter hub dictate the proximal forces at the base of the shaft - namely how much push / pull or torque force will begin to relay across the shaft from the base to its tip (the functional steerable segment). The physician in this setting may have difficulty to control the actual torque transmitted to the tip of the catheter, let alone the tip's rotational angles which provide steering.

[0177] In addition, the transfer of torque along the shaft may contribute to the creation of elastic potential energy, which is stored along the shaft and can hinder catheter tip steering and also cause serious injury if released suddenly, for example in the setting of a steerable sheath for interventional cardiology, known as the shaft “Whipping effect”. This whipping effect is one example of many coupled tip-shaft movements which may hinder catheter steering and the interventional process. Other optional considerations regarding indirect catheter tip steering are that once inserted into the body the catheter is subject to many intravascular unknowns, such as intraluminal forces exerted on the shaft of the catheter along the vascular path, dynamic effects such as patient respiration or heartbeat, antegrade or retrograde hemodynamic flow regimes and off-course the inevitable human operator error. All these make conventional mechanical relay steering challenging and subject to randomness, and also reliant on visual feedback from the imaging system.

[0178] Electrophysiology (EP) procedures and electrophysiology studies are a combination of diagnostic and / or therapeutic intracardiac interventions for cardiac rhythm management. In these procedures, therapeutic EP catheters (e.g. Ablation catheters) are used to transfer heat or cold energy (e.g. radiofrequency or cryogenic), for example to ablate cardiomyocyte cells for atrial fibrillation therapy or other cardiac arrhythmia condition therapies. Access to the left atrial region of the heart is optionally gained via the femoral vein and interatrial septal puncture; a therapeutic or diagnostic EP catheter is optionally guided and controlled via a manual steerable sheath as well as manual control of the therapeutic / diagnostic catheter itself which may also optionally include the three standard control modalities applied along its shaft, as discussed above. The manual control of the sheath and therapeutic / diagnostic EP catheter inside the heart, each based on the aforementioned control modalities may be a difficult task, even for an experienced operator and may require a long learning curve.

[0179] Furthermore, the precise positioning of the therapeutic / diagnostic EP catheter in the left atrium in a specific location and the millimeter scale motion control from point-to-point locations, for example in focal pulmonary vein isolation of the left atrial vein antra, may be difficult for handheld operation. The positioning process of the therapeutic / diagnostic EP catheter optionally includes dual and simultaneous manual handling of both guide sheath and therapeutic / diagnostic EP catheter, each in all three control modalities (therapeutic / diagnostic EP catheters are typically pull- wire deflectable as well), which may contribute to the complexity of the process.

[0180] Part of the reason for this laborious and difficult process can be explained from a mechanical stand-point since all control signals aimed at changing position and orientation of the distal end of the sheath or the distal end of a catheter which is delivered through the sheath to the cardiac space, are optionally transferred via physical force through the shaft of the sheath or shaft of the delivered catheter, and thus may cause parasitic movements and inadvertent movements of the sheath’s tip and consequently the delivered catheter’s tip.

[0181] For example, when examining manual control actions affecting the guiding sheath: the deflection caused by the pull-wire(s) of the sheath is optionally achieved in the weakened lasercut (or softened by using softer elastic material) segment, but the pull-wire also optionally generates tension in the shaft’s mid- section, which is generally stiffer, but not too stiff so as not to deflect. Thus, this tension causes parasitic curving and shortening of the shaft’s mid-section, which both displaces the position of the tip of the sheath and causes strain on the surrounding vascular environment through which the sheath is inserted. To accommodate these movement shifts the operator may be required to provide an axial push / pull force from the hub which further complicates the manipulation of the sheath inside the vasculature. Secondly, when examining the torquing action performed from the hub, conventional sheath shafts store energy during this torquing action which causes the tip to move at certain deflection angles, this movement also causes spontaneous deflections of the tip, despite pull-wire tension. This inadvertent motion causes the tip to change position suddenly and optionally forces the operator to reposition the system.

[0182] Lastly, when examining the axial control modality, the push / pull action, pushing the shaft forward fundamentally does not generate advancement along the local distal axis, i.e. moving tip position in a desired increment along its axis, but a combination of axial and translational motion.

[0183] To conclude, any action of the operator in a certain control modality may be accommodated by corrections in the other control modalities. These in-tum optionally warrants even further corrections thus forcing an iterative process which may be very difficult to converge. This is especially the case when both sets of control modalities of guiding sheath and delivered catheter are to be controlled simultaneously by the operator.

[0184] In addition, since the entire middle section of the guiding sheath’s shaft is forced by its surroundings, e.g., vascular lumen, the interatrial septal wall, and any anchoring locations along it, any control action transferred along the shaft is subject first to these forces which may affect the outcome of the control action in an unknown way. The control of the sheath may be complicated even further due to the dynamic cardiac environment which is affected by heart rate motion (in many cases irregular) and patient breathing motions. The mastery of the hand-held technique takes years of experience and even when achieved at its very best results in a lengthy and laborious process for the operator which consumes extensive EP lab time during procedures.

[0185] Considering the above, the hand-held technique for pulmonary vein isolation (PVI), in which cardiac ablation tissue lesions are generated around the pulmonary vein antra in order to isolate electrical rhythm disturbances originating from the pulmonary veins, was examined. PVIs are performed using a focal ablation catheter positioned via a conventional steerable sheath in the left atrium. In this process the operator seeks to generate continuous lesions surrounding one or two pulmonary vein antra via a point-by-point ablation process. Due to the limitations described above, the operator cannot move freely, or continuously from point to point, but he may need to perform a repositioning of the system for every subsequent ablation location.

[0186] In addition, in light of the manual catheter navigation limitations described above, the precision at which these locations can be attained by the manual combination of steerable sheath and steerable ablation catheter is at least one order of magnitude larger than the positioning feedback registered by the cardiac mapping system (e.g., Bio-sense, Abbot, etc.). Thus, in order to achieve continuous isolating lesions operators may need to overlap the ablation points on average by 30%-50% which means there is an excess of unnecessary radio -frequency (RF) ablation time per PVI performed. In some cases, the resulting ablation points are even clustered together in a certain region instead of forming a continuous line.

[0187] When examining many clinical studies of PVI ablation it appears that the total RF time is on average less than 20% of the total time taken to perform the PVI procedure. The operator may spend more than half of the ablation procedural time navigating, positioning and repositioning the sheath and ablation catheter system. And again, the RF time itself may be significantly longer than could be achieved if continuous non-overlapping or minimally overlapping lesions could be performed.

[0188] Overview

[0189] An aspect of some embodiments of the invention relates to a creased tube with an axially and circumferentially extending and expandable crease (where, when the crease is helical may be termed a Helically Folded Tube (HFT)) which is optionally a dedicated inflatable multi- stable twisting micro-structure, that allows for example to control an angle of rotation of a tip of a catheter about its longitudinal axis optionally without transferring mechanical forces (e.g. mechanical torque) along the shaft of the catheter, but hydraulic actuation instead. In some embodiments, during this actuation, the simple transfer of pressurized fluids (e.g. saline) along the shaft, using various methods which will be specified, is enough to directly control the angle of rotation with very high accuracy. Some aspects of the invention relate to a combination of the HFT structure, a method for fabricating the HFT structure, and a method for actuating the HFT structure.

[0190] WO2023 / 079566 Al incorporated herein as a reference in its entirety, describes tubes with folded creases, for example the Conical-Frusta Tip (CFT), or the Conically Folded Tube (also CFT) structure. In some embodiments of the invention, a helical pitch, as it approaches a zero angle, may be considered as acting and / or be difficult to be visually distinguished from a CFT formed of rings.

[0191] An additional relevant folded tube pattern is an MFT - mixed folded tube pattern, which is defined by a repeated folding pattern along the axis of the tube where each circumferential crease in the pattern can be partially conically folded and partially non-conically folded along the circumference of the crease. The sector of the circumference which is non-conically folded can be optionally geometrically defined by alterations of a conical crease which have secondary folds as seen in figures 3c-f. These secondary folds can form a variety of patterns along the axis of the tube which are derived by the shape and pattern of the secondary folds along the circumference of the non-conically folded sector and their variation between circumferential elements. The axial pattern of the resulting non-conically folded face of the tube can be symmetrical about the non-conically folded sector’s center- line as seen in figure 3d or non- symmetrical about the non-conically folded sector’s centerline as seen in figures 3c and figures 3e-f.

[0192] Figure 3e shows an example where a side-view shows both the non-conically folded sector (top) as well as the conically folded sector (bottom), in addition in figure 3e roughly half of the circumferential segments are folded in closed position (left) and half are open folds (right). The open fold pattern in this case forms a wavy crest pattern as seen in the image.

[0193] Figure 3c shows a non- symmetrical (about non-conically folded center-line) MFT pattern where the left image is a curved state of the tube, as for example would be achieved by actuation of the supporting internal structure, middle image right image shows two straight states of the tube which vary in their radial vantage point.

[0194] As will be shown herein, in some embodiments, a functional robotic catheter tip is composed of a variable pitch helical fold at its distal segment optionally used to achieve a wide range of deflections, in-turn used to steer interventional therapeutic devices in the cardiovascular space.

[0195] According to some exemplary embodiments, a Helically Folded Tube (HFT) is a tube which has a helically running rotational crease (continuous or not) along its length. In some embodiments, the crease is viewed as a helix which surrounds the tubular structure - this helix is a material and continuous fold of the tube wall in the direction perpendicular to the local directional vector tangent to the helix line. In some embodiments, the helical fold has a multi-stable nature, in similar fashion to a conically folded tube (for example as described in WO2023 / 079566A1 incorporated herein as a reference in its entirety), or be of elastic nature - i.e. the fold can be actuated continuously to generate change in geometry - namely twisting of the tube (i.e. rotation of the tube about its longitudinal axis). In some embodiments, the twisting effect generated by closing or opening of the folds is a plastic deformation effect local to the HFT segment and optionally does not store or release any potential energy along any segment of the shaft which is proximal to the HFT. This means that transferring a twist signal to the HFT at the tip of the catheter optionally dictates no functional requirement on the wall of the proximal shaft - no coil or braiding reinforcements, and in-fact in many interventional settings, a very soft proximal shaft can be used, if necessary, while optionally retaining full twist control functionality at the catheter’s tip. Additionally, assuming twist angle control is achieved with hydraulic actuation of the HFT, then it does not depend on the path of the proximal shaft or any forces exerted on it by the vasculature along this path.

[0196] A potential advantage of the HFT structure may be that all the energetically stable deflection states that can be achieved by reconfiguring or actuating its folds are all stored in its wall. In some embodiments, the actuation of the folds can be segmental, i.e. via thin circumferential saline pressure layers interfacing each segment (direct global injection), and thus optionally the wall thickness of the overall catheter structure can be kept to a desirable minimum.

[0197] According to some exemplary embodiments, another method of actuation of the HFT tip structure is via saline injection of a thin-walled elastic tube which is threaded along the HFT’s helical crease (local helix injection). In some embodiments, this thin- walled tube takes on the shape of a coil as it is lined along the HFT’s helical crease. It can be inserted into the HFT’s helical crease with a metal mandrel in its lumen (a metal coil) and pressurized by saline pressure along its lumen (or in the annular gap between the internal metal coil and its wall). In some embodiments, as this thin-walled tube is pressurized, it is displaced radially (due to hoop stress) and thus creates an opening motion of the HFT’s helical fold, this opening motion in-turn actuates the HFT which is designed to create deflection of the catheter’s tip structure (this process can also be done dynamically along the Helix of the embedded actuation tube). Optionally, this is particularly useful in cardiovascular applications where the outer diameter of the catheter or access sheath must be kept minimal as it dictates the size of the arterial / venous access site and its invasiveness.

[0198] On the other hand, the catheter’s capability to deliver a large range of therapeutic devices is directly related to its lumen size or inner diameter required to be maximal.

[0199] According to some exemplary embodiments, the manufactured HFT has a thin wall and / or is controlled. In some embodiments, the HFT is manufactured or comprises at least one thin- walled tube, optionally in a micron scale, with optionally lumen ratios that are below a 10% loss of lumens to the walls.

[0200] According to some exemplary embodiments, diameters in French of robotic sheath devices: outer diameter (OD)=25, 24, 23, 22, 21, 20, 19, 18, 17, 16, 15, 14, 13, 12, 11, 10, 9, 8, 7, 6, 5, 4, 3, 2 Fr, for example from about 2Fr to about 25Fr. An inner diameter (ID) =18, 17, 16, 15, 14, 13, 12, 11, 10, 9, 8, 7, 6, 5, 4, 3, 2, 1, 0.9, 0.8, 0.7, 0.6, 0.5, 0.4, 0.3 Fr, for example from about 0.3Fr to about 20Fr. Or any physically viable combination of OD and ID. According to some exemplary embodiments, the HFT design allows direct control of the twist deflection and / or direct torque transfer to the tip. In some embodiments, the HFT designs allow twisting about the axis.

[0201] According to some exemplary embodiments, the HFT, for example spiral HFT is configured to ride on a bent inner shaft or a middle shaft, and still transfer torque, which is optionally particularly useful in a left-heart access setting).

[0202] Before explaining 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 the arrangement of the components and / or methods set forth in the following description and / or illustrated in the drawings and / or the Examples. The invention is capable of other embodiments or of being practiced or carried out in various ways.

[0203] Exemplary system

[0204] Referring now to Figure 1, showing a schematic representation of an exemplary system 100 for endoluminal navigation, according to some embodiments of the invention. In some embodiments, an exemplary endoluminal navigation system 100 comprises a guide sheath or catheter 102 (referred hereinafter just as “guide sheath” or “sheath”) configured to be inserted into a patient 104. In some embodiments, the system optionally comprises an external unit 106 configured for actuating, optionally in an automatic manner, one or more components in the guide sheath 102, as will be further explained below.

[0205] In some embodiments, the guide sheath (or catheter) 102 comprises one or more of: a handle, a shaft, a printed circuit board assembly (PCBA) and an operational distal end - see below for further explanations. In some embodiments, the optional external unit 106 is a robotic system that comprises one or more of dedicated software and hardware to operate the external unit, a user interface, one or more pumps and at least one pump controller configured for actuating the one or more pumps.

[0206] In some embodiments, the system comprises an integrated cable, which is a single cable comprising a plurality of lumens through which fluids are delivered to the sheath, and also electrical wiring is passed through the integrated cable. In some embodiments, the integrated cable is disposable. In some embodiments, electric wires and fluid tubes are separated.

[0207] In some embodiments, the system comprises a cartridge, optionally disposable, comprising a plurality of pistons for the actuation of segments (see below). Exemplary guide sheath 102

[0208] Referring now to Figure 2a, showing a schematic representation of an exemplary guide sheath 102, according to some embodiments of the invention. In some embodiments, an exemplary guide sheath 102 comprises one or more of the following parts:

[0209] 1. a handle 202 located at a most proximal end of the sheath 102;

[0210] 2. an elongated body 204, extending distally from the handle 202 over a medial area of the sheath 102; and

[0211] 3. an operational distal end 206 located at a most distal end of the sheath 102 and interconnected with the elongated body 204.

[0212] In some embodiments, as mentioned above, the guide sheath 102 is configured to be inserted into a body of a patient. In some embodiments, the guide sheath 102 is configured to be navigated inside the body of the patient in order to arrive at a desired location, for example in vascular applications, and more specifically in structural heart applications. In some embodiments, the navigation is permitted by actuating the operational distal end 206 while advancing the sheath as a whole inside the body. In some embodiments, once arrived at the desired location, the operational distal end is further actuated to direct an opening located at the most distal end of the operational distal end towards a specific location, thereby allowing for an interventional device to be brought precisely to the desired location.

[0213] Figure 2b shows a schematic representation of an exemplary guide sheath 102 comprising a handle 202, an elongated body 204 and an operational distal end 206, while Figure 2c shows a zoom in of an exemplary operational distal end 206 and Figure 2d shows a zoom in of a handle 202.

[0214] Exemplary actuation of the operational distal end 206

[0215] In some embodiments, the operational distal end 206 is configured to be actuated (to perform movements) in at least one of the following manners:

[0216] 1. Axial advancement and retraction (referred hereinafter as axial movement) of at least part of the operational distal end 206;

[0217] 2. Rotation (referred hereinafter as rotation movement) along a longitudinal axis of a specific location (segment - see below) in the operational distal end 206;

[0218] 3. Deflection (referred hereinafter as deflection movement) of at least part of the operational distal end 206. In some embodiments, the operational distal end 206 comprises a plurality of segments, each segment being capable of performing at least one of the above-mentioned movements (see below).

[0219] In some embodiments, the dedicated segments in the operational distal end 206 are configured to perform a unique movement. For example, a segment is configured to perform axial movement - which will be referred to as axial-movement-segment; a segment is configured to perform rotation movement - which will be referred to as rotation-movement-segment; and a segment is configured to perform deflection movement - which will be referred to as deflection- movement- segment.

[0220] In some embodiments, the operational distal end 206 comprises at least a deflection- movement- segment. In some embodiments, the operational distal end 206 comprises a plurality of each type of segments. In some embodiments, the operational distal end 206 comprises at least one of each type of segment.

[0221] In some embodiments, each type of segment comprises a dedicated configuration comprising several functional layers of the sheath’s wall that allows for the performance of the specific movement. In some embodiments, the different configurations differ from each other in the folding configuration of the tube used in the segment.

[0222] Exemplary folded tubes (FT)

[0223] In some embodiments, segments of the operational distal end are charactered by having a tube having unique fold types which confer dedicated motion characteristics to the segments. In some embodiments, exemplary folds types are one or more of:

[0224] 1. Conically Folded Tube (CFT) - configured to provide axial movement - as shown in Figure 3a and Figure 14.

[0225] 2. Helically Folded Tube (HFT) - configured to provide rotational movement - as shown in Figure 3b and Figure 14.

[0226] 3. Mixed Folded Tube (MFT) - configured to provide deflection movement - as shown in Figures 3c-f.

[0227] Non-canonical FT movement

[0228] In some embodiments, FTs can be configured to be actuated outside the canonical movements as described above. This can be done by either slightly modifying their folding patterns or by imposing restrictions on their folds. In some embodiments, CFT structures, which can provide deflection movement and other types of mixed plane movements are covered in WO2023079566A1. In some embodiments, an HFT fold can be configured to provide combined rotation and extension movement by varying the pitch of its fold. The limit of zero pitch corresponds to a conical fold representing a CFT structure with pure extension and no rotation, whereas the limit of infinite pitch corresponds to a longitudinal crease line along the axis offering pure rotation with no extension. For practical purposes depending on the required functionality of an HFT its pitch can be adapted to support the desired motion. A relevant medical application in which the extension rate of an HFT structure needs to be considered is in peripheral artery lesion crossing. In the context of peripheral vascular access, the HFT structure can provide the means for controlling the rotational position of the tip of a catheter in similar fashion to structural heart applications. In addition, it can provide the means for crossing calcified artery lesions as it can be actuated continuously in a rotational screw-like motion inside the vasculature.

[0229] In some embodiments, segments of the operational distal end 206 are actuated by injecting a liquid, for example saline, gas or other biocompatible fluids, generally less viscous than saline, from the proximal end (the handle 202) to the operational distal end 206, for example via concentrically lined annular channels which extend along the elongated body 204 and / or for example via microchannels which extend along the elongated body 204 (see for example Figure 2h). In some embodiments, the actuation is performed manually, for example by actuating one or more injectors and / or syringes. In some embodiments, the actuation is performed semi- automatically by a robot (for example, the optional external unit 106) for example by actuating a robotic microfluidic pump. In some embodiments, the actuation is fully automated by means of a robot, configured to maneuver the guide sheath towards the desired location, while receiving realtime feedback about the location of the device, by automatically actuating the different segments operating a microfluidic pump.

[0230] In some embodiments, any movement performed by a segment of the operational distal end, can be either a continuous movement or a movement characterized by increments.

[0231] In some embodiments, axial movements are in increments / decrements of from about 0.1mm to about 10mm - with an extension length of from about 30mm to about 60mm.

[0232] In some embodiments, rotational movements are in increments / decrements of from about 0. Idegrees to about lOdegrees - with a rotation angle of 360 degrees in either direction. In addition, long axial segments of rotational movement are also possible where continuous rotational movement or distal torque transfer is desired in which case continuous rotational motion can be achieved, for example rotating N times about the axis (N signifying a 360 deg rotation), N=l-100. In some embodiments, deflection movements are in increments / decrements of from about 0.1 degrees to about 10 degrees - with a deflection angle of up to 270 degrees (in relation to the straight configuration).

[0233] In some embodiments, the system is configured to perform small increments / decrements when necessary, and to perform large increments / decrements when necessary.

[0234] Exemplary Saline (or other fluid) Pressure Microfluidic Pump

[0235] In some embodiments, pressure signals directed at actuating the operational distal end 206 are generated by a dedicated micro-fluidic syringe pump device, as shown for example in Figure 2b. In some embodiments, control of the various pressure inputs is administered by the operator (semi-automatic actuation) in several embodiments to be specified herein. An exemplary graphical user interface (GUI) is shown for example in Figure 15, showing in addition the sheath in the patient in real-time. In some embodiments, the micro-fluidic syringe pump device is an intrinsic part of the sheath, for example, located at the handle. In some embodiments, the micro-fluidic syringe pump device is an external device (optional external unit 106), which is connected to the sheath.

[0236] In some embodiments, the micro-fluidic syringe pump device is configured to be a clinical level actuator, comprising replaceable sterile syringes (as seen in figure 2b). In some embodiments, the micro-fluidic syringe pump device comprises hardware / software that complies with medical device manufacturing standards. In some embodiments, the micro-fluidic syringe pump device comprises a unique integral connector conveying both electrical signals from the operator (handle) to the pump and pressure signals (for the various operational segments) from pump to tip (as schematically shown in Figure 1). In some embodiments, the micro-fluidic syringe pump device comprises unique features (modes) relating to the operation of the device, for example degassing of air from the lumens. In some embodiments, the micro-fluidic syringe pump device is designed to infuse very small amounts of liquid to each segment (average of 1 ml or less) so that its syringes are very small, and the forces required to move them are small too (small electrical stepper motors). In some embodiments, the micro-fluidic syringe pump device is configured to provide important information to the operator, for example it measures continuously the volume and pressure input into each operational segment at the tip and thus can provide feedback to the operator as to the 3D shape of the sheath inside the heart (this is just based on measuring the pressure and volume infused into the channels). In some embodiments, the microfluidic pump, in the context of intracardiac navigation, enables the operator to control several segments of the sheath simultaneously which otherwise cannot be done via manual controls. In some embodiments, the operator controls (250 in Figure 2J) can be mounted onto the handle 202 of the sheath or optionally controlled remotely, off handle. There exist several options for operator controls which can provide simultaneous movement control of two or more distal segments of the sheath. For example, a two-way joystick can provide an input based on its planar position and provide simultaneous operator control for a distal deflection position and a proximal rotational position as in the case of a 2 DOF (degree-of- freedom) sheath with 2 functional distal segments (as seen for example in Figure 2j). In another example this two-way joystick can be mounted on to a linear slider (linear potentiometer) which can for example feed another control for proximal segment extension or deflection, as in the case of a 3 DOF sheath as shown for example in Figure 2i.

[0237] Providing the operator with simultaneous segmental control can be beneficial in access and navigation inside the heart where dynamic control of complex distal shaft shapes is required, as seen for example in Figures 17, 18, 19.

[0238] In some embodiments, optionally, electromagnetic sensors are incorporated into the sheath, and these can also return data to the unit to help build the shape of the distal end of the sheath.

[0239] Exemplary architecture of the segments of the operational distal end

[0240] In some embodiments, each segment is independently actuated by injecting liquids to each specific segment in order to perform a certain movement. In some embodiments, each segment in the sheath is independently connected to the micro-fluidic syringe pump device (or to manually actuated syringes, either as part of the handle or as part of an external device). In some embodiments, the micro-fluidic syringe pump device comprises a number of microfluidic channels (one or more microfluidic channels to single segment) as the number of segments in the sheath. For example, if the sheath comprises one axial-movement- segment, one rotation-movement- segment and one deflection-movement- segment, the micro-fluidic syringe pump device will have at least three independent channels (each may comprises more than one microfluidic channel).

[0241] In some embodiments, a very small quantity of liquid is required for the actuation of the segments. For example, the required amount of liquid to actuate a segment is from about 0.1ml to about 1ml.

[0242] Referring now to Figure 2e, showing a schematic representation of a segment, according to some embodiments of the invention. In some embodiments, a single segment comprises a tube defined by an outer wall 208, an inner space 210 and an inner wall 212. In some embodiments, the most inner space 214 generated by the segment is configured to allow the insertion of an interventional device. In some embodiments, the distal side of the inner space of the tube is closed by a ring 216 (shown separated to facilitate the explanations). In some embodiments, the ring is configured to seal the inner space 210 to allow for the insertion and removal of fluids during the actuation of the segment. In some embodiments, both sides of the inner space are closed by rings. In some embodiments, the rings, in the case of a mono-shaft allow the passage of micro-tubes in their wall. In some embodiments, the rings are not individuals separated parts attached to segments, but rather intrinsic separators generated during the manufacturing process.

[0243] In some embodiments, an exemplary segment comprises different layers:

[0244] 1. an outer layer: which comprises the FTs; In some embodiments, the outer layer is made of reinforced nylon. In some embodiments, the outer layer is coated with one or more elastic layers configured to increase the lubricity of the device while being maneuvered inside the body. In some embodiments, the reinforced nylon is fabricated as such with the addition of metal braids and / or coils fused into the material, or could just be added to the structure, without the need of fusing the two. In some embodiments, similarly to a coil-embedded Nylon HFT, other metal structures can be embedded onto the MFT. In some embodiments, the FTs can be made of one or more of Nylon 12, Nylon 11, PEEK, Nylon 6 / 6, ETFE, ECTFE, EFEP, PVDF and other thermoplastic elastomers. In some embodiments, the elastic layers have several functions: for example (not an exhaustive list) as lubricious coating, improves / modifies the elastic response of the operational segments to fluid inputs, smooths-out corrugations in some FTs (e.g., MFT to avoid blood clots).

[0245] 2. an inner layer: comprising for example an hypotube with one or more slits or cuts that enable the hypotube to be actuated according to the type of movement, for example for the deflection movement, the hypotube will comprise slits that enable the deflection to one direction or deflection in a single plane, while blocking the movement in perpendicular directions. In some embodiments, the inner layer can be a local layered catheter type construction that, according to its fused reinforcement, supports appropriate FT motion. In some embodiments, optionally, the inner layer is coated (internally and / or externally) to seal pressure, and in some embodiments, the inner layer is not coated to allow actuation fluid to pass through.

[0246] 3. an optional reinforcement wire: which extends between the outer layer and the inner layer, for example within the fold of the FT, and configured to provide the FTs with an increase stability (see Figure 3b). In some embodiments, a coil can be embedded on either side of the fold of an FT, externally or internally to the FT material. It can be heat bonded, fused or neither. In some embodiments, the metal reinforcement improves / modifies the elastic response of the operational segments to fluid inputs - for example a coil-embedded HFT improves the response of the structure to negative pressure gradient actuation.

[0247] In some embodiments, a sheath is defined by the architecture of its parts (handle, elongated body and operational distal end), which affect also the architectures of segments. In some embodiments, possible architectures of the sheath are:

[0248] 1. Multi-layer;

[0249] 2. Mono-layer with micro tubes;

[0250] 3. Hybrid multi-lay er / mono-lay er.

[0251] In some embodiments, a multi-layer device is a device where each segment independently receives fluid from a tube (shaft layer) that extends from the handle 202, via the elongated body 204 until reaching the dedicated segment at the operational distal end 206. This means, for example, if there are 3 distinct segments, then there will be 4 layers of tubes 218a-c, as schematically shown in Figure 2f. In this case, at the most distal end of each tube there will be a ring 216 that defines the end of the segment at the operational distal end 206.

[0252] In some embodiments, a mono-layer device is a device where each segment comprises a certain length and the inner space 210 is closed on both sides by rings 216. In some embodiments, in this case, the rings comprise dedicated orifices for the distinct micro-tubes that need to feed the distal segments. In some embodiments, a plurality of segments 220a-c are attached to each other, one after another, separated by rings 216, as schematically shown in Figure 2g. Figure 2g also shows a distal part of the elongated body 204, which is connected to the most proximal segment 220a. In some embodiments, each segment is provided with a dedicated micro tube 222a-c, schematically shown as dotted lines to facilitate the understanding. In some embodiments, more than one micro tube can feed a single segment. For example, 2, 3, 4, or 5 microtubes can feed a single segment. In some embodiments, the geometry of the micro tubes can be one or more of circular, oval, rectangular, or any other geometrical form, optionally with round edges. In some embodiments, a dedicated form can be chosen to improve the movement or reduce the viscous resistance of the fluid within the micro tube. In some embodiments, the micro tubes extend from the handle 202, along the elongated body 204 and until reaching a single inner space 210 of a dedicated segment. Since each segment is hermetically closed on both sides by rings 216, the only entry / exit into and from the inner space 210 is via the micro tube 222. In some embodiments, the micro tubes extend within the walls on the device thereby leaving the most inner space 214 free for the insertion of the interventional device. In some embodiments, the micro tubes can run straight within the walls and / or in a spiral manner (see below). In some embodiments, the micro tubes are an integral part of the tube and / or can be fused into the tube. In some embodiments, micro tubes are configured to pass through orifices in the rings 216 and inner spaces 210 to reach a dedicated distal segment.

[0253] In some embodiments, a hybrid multi-layer / mono-layer device is a device where both architectures are used within a same device, for example, some segments are arranged as multilayer and they extend from the handle until the operational distal end, while some segments are limited only to the operational distal end and micro tubes extend along the device until reaching those specific segments.

[0254] Exemplary handle 202

[0255] In some embodiments, the handle 202, as shown for example in Figure 2 J, functions similarly to a conventional deflectable sheath handle, providing the means for manual insertion of the sheath into the body (see manual work-flow below). In some embodiments, the handle 202 includes one or more hemostasis valves (see also Figure 2j) and manual irrigation ports for the insertion of therapeutic and diagnostic interventional devices through the sheath and for which the sheath can provide (optionally robotic) precision access and guidance inside the vasculature. Optionally, it also includes an internal system, which provides supportive motion and saline pressure-tight sealing for the fluid pressure channels leading to the operational distal end 206. In some embodiments, the channel inputs are inserted into the handle 202 via a saline pressure port which can have 1-8 independent pressure inputs, depending on the embodiment of the sheath (i.e., types of segmental degrees of freedom used at the distal portion).

[0256] In some embodiments, the micro-fluidic syringe pump device is mounted on the handle 202. In some embodiments, the micro-fluidic syringe pump device is separated from the handle and dedicated tubes (or a single tube comprising a plurality of lumens) connect between the microfluidic syringe pump device and the handle. In some embodiments, a potential advantage of having a micro-fluidic syringe pump device separated, meaning not incorporated within the handle, is that it allows to have a single micro-fluidic syringe pump device that can be used and reused with different sheaths, and also it allows to manufacture a simple and economical handle.

[0257] In some embodiments, the handle comprises one or more mechanism configured to support the rotational movement performed in the operational distal end. In some embodiments, in the multi-layer architecture, an inner tube, positioned within an outer tube (for example as shown in Figures 2c, 2i, 2j and 9) is allowed to rotate along the longitudinal axis of the device and within the outer tube in order to support the rotational movement. Additionally, liquids need to be transported from the handle to the operational distal end to actuate the inner tube. It can be understood that a way to allow rotation is by not fixating the proximal end of the inner tube at the handle. In some embodiments, in order to allow rotation of the inner tube while keeping the liquids from exiting proximally the inner space (for example into the handle), a mechanism is provided at the handle that, on one hand, the liquids that actuate the segment are kept inside the inner space and, on the other hand, rotation of the inner tube is permitted.

[0258] In some embodiments, an exemplary mechanism to keep the liquids within the inner space in the handle is the use of one or more viscous fluids (see also Figure 2j) in Figure 2j, 242 refers to a dedicated viscous damper which allows rotation of the inner tube while sealing the pressurized lumen formed in the annular space between the inner and outer tubes, the damping viscous liquid does not interact with the actuation fluid optionally due to a membrane lying in the annular space in between them. In some embodiments, viscous fluids are kept within the inner space in the handle due to their higher superficial tension. In some embodiments, the viscous liquids block the passage of the liquids in the handle used in the actuation of the device from exiting the inner space at the handle. In some embodiments, the viscous liquids help attenuate the movement of the inner tube using lubricious friction, thereby increasing the control of the movement.

[0259] In some embodiments, another exemplary mechanism is the use of an O-ring configured to allow rotation while providing friction, and also block the exit of liquids proximally from the inner space into the handle or outside of the handle.

[0260] In some embodiments, additional electrical components can be connected to the handle to allow automated actuation of the systems without the need to incorporate the electric components within the handle itself.

[0261] In some embodiments, the handle comprises dedicated ports (entries) for the microfluidic actuation system. In some embodiments, the number of the ports is equal to the number of segments in the sheath.

[0262] Exemplary general sizes of the device

[0263] In some embodiments, parts of an exemplary guide sheath 102 comprises the following exemplary sizes:

[0264] An inner diameter of about 0.01 inch - for example as small as a small guidewire - to about 20 Fr, the size of the inner lumen of a transcatheter valve delivery system. For example, an inner diameter of about 8.5 Fr. An outer diameter of 2 Fr - for example as small as a small micro-catheter to about 25 Fr, the size of a transcatheter delivery system, for example an outer diameter of about 11.5 Fr.

[0265] In some embodiments, optionally, the folded tube mechanisms presented herein and supportive internal structures can also be integrated into interventional devices with no working lumen or internally translated payload. For example, the smallest relevant application in this embodiment can be a steerable guide wire. In which case the actuation fluid runs internally in the center of the cross-section and actuates the steering at the distal end of the guide-wire. Another application could be integrated onto a lumen-less therapeutic device such as an ablation or diagnostic catheter, where full segmental steering capabilities, are provided in the catheter, optionally without the need for supported external sheath steering.

[0266] Referring now to Figures 2h-j showing schematic representations of exemplary sheaths, their components and their architectures, according to some embodiments of the invention. Same parts are kept with the same reference numbers. Following the above explanations, multiple elements as disclosed herein are provided in a single sheath to allow a person having skills in the art to understand the invention. It should be understood that these are provided just as examples, and these are not meant to limit the scope of the invention in any manner.

[0267] Referring to Figure 2h, showing an exemplary _mono-layer with micro tubes sheath, according to some embodiments of the invention. In Figure 2h, the distal part of the elongated body 204 and the operational distal end 206 are shown. The operational distal end is shown with four segments 220a-d (from proximal to distal).

[0268] The elongated body 204 shows an outer shaft 224 extending distally until meeting a first ring 216a. In some embodiments, the elongated body 204 comprises an inner shaft 226, for example made of LCHT - laser cut hypotube coated internally and / or externally or any other suitable construction.

[0269] Additional rings 216b-e between segments are also shown.

[0270] In this embodiment, the micro tubes 222a-d (four shown) are helically arranged around the shaft, as schematically shown for example in detail balloon A. It can be seen that the most distal micro tube 222d feeds the proximal segment 220a (see arrow 228). Then, micro tube 222c feeds the segment 220b (see arrow 230), micro tube 222b feeds the segment 220c (see arrow 232), and finally micro tube 222a feeds the distal segment 220d (see arrow 234).

[0271] In this embodiment, the four segments shown are: two rotational movement segments (220a / 220c) and two axial movement segments (220b / 220d). It can be seen from detail balloon D, that the axial movement segments, having CFTs can be replaced with deflection movement segments, having MFTs. In fact, any segment can be replaced with any other type of segment. Detail balloon B shows an external view of the rotational movement segment having an HFT and an internal view of the rotational movement segment showing an internal tube (for example a hypotube having a cut pattern supporting rotation) and the microtubes 222a-c. Detail balloon C shows an external view of the axial movement segment having an CFT and an internal view of the axial movement segment showing an internal tube (for example a hypotube having a cut pattern that supports axial movement or deflection movement in the case of deflection movement segments) and the microtubes 222a-b.

[0272] Figure 2h also shows an atraumatic distal end 236 of the sheath itself.

[0273] Figure 2h also shows an exemplary elastic liner 238 that covers the entire elongated body 204 and the operational distal end 206.

[0274] Referring now to Figure 2i, showing an exemplary multi-layer sheath, according to some embodiments of the invention. In Figure 2i, the distal part of the elongated body 204 and the operational distal end 206 are shown. The operational distal end is shown with three segments 220a-c (from proximal to distal). Three rings 216a-c are also shown.

[0275] A plurality of concentric tubes is shown, each independently reaching each one of the segments. Fluid is injected between the tubes in order to actuate the segments, as explained herein elsewhere. For example, fluid 1 is injected to actuate segment 220c, fluid 2 is injected to actuate segment 220b, while fluid 3 is injected to actuate segment 220a.

[0276] In Figure 2i, segment 220a is an axial movement segment comprising a CFT (detailed balloon E), while segment 220b is a rotational movement segment having a HFT (detailed balloon F), and segment 220c is a deflection movement segment with a MFT (detailed balloon G). Same as above, either segment can be replaced with any type of segment.

[0277] Similar to what was explained above, each segment comprises an inner tube 226 (for example a hypotube) that support the specific movement each segment is designed to perform. In some embodiments, there is no inner tube. In some embodiments, the inner tube is sealed by a coating internally and / or externally - as schematically shown in detailed balloon H. In some embodiments, the inner tube does not comprise a coating and the fluids are allowed to pass through the inner tube - as schematically shown in detailed balloon G. The inner tube shown in detailed balloon G supports axial movement.

[0278] Figure 2i also shows an atraumatic distal end 236 of the sheath itself. Figure 2i also shows an exemplary elastic liner 238 that covers the entire elongated body 204 and the operational distal end 206.

[0279] Referring now to Figure 2j, showing an exemplary multi-layer sheath, according to some embodiments of the invention. In Figure 2j, the distal part of the elongated body 204 and the operational distal end 206 are shown. The operational distal end is shown with two segments 220a- b (from proximal to distal). Two rings 216a-b are also shown.

[0280] A plurality of concentric tubes is shown, each independently reaching each one of the segments. Fluid is injected between the tubes in order to actuate the segments, as explained herein elsewhere. For example, fluid 1 is injected to actuate segment 220a and fluid 2 is injected to actuate segment 220b.

[0281] In Figure 2j, segment 220a is a rotational movement segment having a HFT (detailed balloon I), and segment 220b is a deflection movement segment with a MFT (detailed balloon J). Same as above, either segment can be replaced with any type of segment.

[0282] Figure 2j also shows a schematic representation of a handle 102 showing how fluid 1 and fluid 2 are injected into specific tubes in the handle to then reach their specific segments. Additionally, Figure 2j shows an entry 240 for the viscous liquid which fills the viscous damper 242, as explained herein elsewhere.

[0283] Similar to what was explained above, each segment comprises an inner tube (for example a hypotube) that support the specific movement each segment is designed to perform. In some embodiments, the inner tube is sealed by a coating internally and / or externally - as schematically shown in detailed balloon H. In some embodiments, the inner tube does not comprise a coating and the fluids are allowed to pass through the inner tube - as schematically shown in detailed balloon G.

[0284] Figure 2j also shows an atraumatic distal end 236 of the sheath itself.

[0285] Figure 2j also shows an exemplary elastic liner 238 that covers the entire elongated body 204 and the operational distal end 206.

[0286] Figure 2i also shows an exemplary embodiment of a handle 202 used by the operator to actuate the sheath. In this embodiment the handle takes on fluid pressure signals from an external micro-fluidic actuator [number of the new actuator] as input into the fluid ports of the handle.

[0287] Figure 2i also shows a control unit 250 configured to allow a user to operate the sheath. In some embodiments, the control unit 250 can have one or more joysticks, a PCBA, a screen or any other dedicate electronic required for the control of the device. Figure 2i also shows a rotating homeostatic valve 252, which is allowed to rotate to conform the rotational movements performed at the operational distal end.

[0288] Exemplary additional information and examples

[0289] In some embodiments, as mentioned above, the operational distal end 206 includes an outer layer of several Helically, Conically and mixed folded tube segments. In some embodiments, these segments are designed in accordance with a set theory to achieve certain functional properties. Optionally segmental motion control is achieved in any desired degree of freedom as per segment. For example, in segments which include a non-zero-helix pitch, torsional and deflection motion of the distal portion can be achieved. Optionally, in segments which include a zero-helix pitch (conical fold) but not limited to, deflection and extension motion of the distal portion can be achieved. In some embodiments, segments comprising a non-zero-helix pitch with mixed folds provide deflection of the distal portion.

[0290] In some embodiments, as shown in Figure 4a, the HFT shows a line that is a material line which runs along the tube wall (top) in folded formation, parallel to the tube’s centerline. The tube is unfolded to an open state (bottom) and the material line is shown to move continuously in a rotational manner about the tube’s centerline. This is one of the movement modes that the tube possesses - a pure twist along its longitudinal axis. This mode is responsible for the direct distal torque capabilities of sheaths which are composed of Helically, Conically and Mixed folded tubes.

[0291] Figure 4b shows a Helically Folded Tube - HFT, an interior computer aided design (CAD) view of the structure. Top Panel - Side view of the Helical fold structure (actual folds can vary in the crease angle, crease depth, pitch and other properties). Middle Panel - radial cross-sectional view of the HFT structure. Bottom panel - Eeft: Isometric view of a radial half-section (internal view of the structure), Right: Zoom-in on the geometry of the helical fold in the radial cross-section. As shown in the Figure the wall thickness of the fold varies.

[0292] Referring now to Figure 4c, showing a schematic representation of an exemplary guide sheath 102, according to some embodiments of the invention. In Figure 4c, a schematic representation of the handle 202 at the proximal end is shown, a schematic representation of the operational distal end 206 at the distal end is shown, and a cross section of the operational distal end is also shown.

[0293] Referring now to Figure 4d, depicting an HFT based sheath distal portion (left), conveying an exemplary dilatator and guidewire in the context of left-heart access (right), according to some embodiments of the invention. In some embodiments, the sheath’s mid-shaft can include a coil or braid or any type of desired construction reinforced jacket as seen in the figure. The distal portion includes a varying pitch helically folded tube structure which provides torsional motion control at its proximal segments and deflection motion control at its distal segments, Optionally, the helically folded tube may be configured to a reference actuation position where its creases are partially open and partially closed along the axis. From this reference point both positive rotational angle- via an increasing pressure / volume input, and negative rotational angle- via a decreasing pressure / volume input, can be achieved, thereby providing the operator freedom of motion in both directions of rotation about the local axis of the HFT segment.

[0294] Referring now to Figure 4e, showing a cross section of an exemplary elongated body, according to some embodiments of the invention. In some embodiments, the elongated body relays the input pressure signals from the handle 202 to the operational distal end 206. An exemplary elongated body structure is shown in a cross-sectional view in Figure 2f.

[0295] Referring now to Figure 4f, showing a cross-sectional view of the transition between the sheaths middle portion and distal portion, Section B-B, according to some exemplary embodiments of the invention.

[0296] Referring now to Figure 4g, showing a cross-sectional view of the Helically folded tube segment of the distal portion, Section C-C, according to some exemplary embodiments of the invention.

[0297] Referring now to Figure 4h, showing an axial cross-sectional view of the conically folded tube segment of the distal portion, Section D-D, according to some exemplary embodiments of the invention.

[0298] Exemplary fabrication of Conically folded tube (CFT)

[0299] In some embodiments, CFTs are generated by folding the tube in a repetitive consecutive manner along the axis of the tube.

[0300] Exemplary fabrication of Helically folded tube (HFT)

[0301] In some embodiments, a HFT is an inflatable multi-stable twisting structure based on helical folds of an elastic tube. In some embodiments, the structure can be produced by using the same fabrication process for variety of materials, tubes’ walls thicknesses, and radii, spanning wide range of material and / or geometrical properties. In some embodiments, the fabrication process is simple and affordable, optionally lasting less than 30 seconds, for example less than 20 seconds, less than 10 seconds, less than 5 seconds, or any intermediate, shorter or longer time duration. Additionally, the process is repeatable, as long as the external forces which are applied during the pre-stress process are the same. In some embodiments, the resulting HFT structure can optionally endure thousands of loading cycles without malfunction. In some embodiments, a theoretical model is proposed, we propose herein a theoretical model (see section entitled: Theoretical model for the deformation of HFTs and comparison with experiments, given below) corresponding to a bistable helical element, that yields good agreement with experimental results (also presented herein), and thus may optionally serve as a predictive tool for the mechanical properties.

[0302] Referring now to Figure 5 showing empirical investigation of the dynamics. Picture (A) shows intermediate frame from the movie of the HFT captured by a high-speed camera, where in (Al) the black dots represent the (grid) points which were tracked by using an image processing algorithm and in (A2) the same frame is presented where the curves represent the trajectories of the grid points in (Al) during 5ms. Graphs (B) shown the typical dynamics of two adjacent grid points along the X-axis extracted from the tracking process, where in (B 1) it is shown the position of the two grid points along the X-axis versus time, in (B2) it is shown the rotation of the grid points versus time, and in (B3) it is shown the non-linear dependence in the spinodal region between the rotation and the elongation of one grid point relative to another one. The scale bar corresponds to 1 cm.

[0303] In addition, a snap-through dynamics was examined with a high-speed camera (for example as shown in Figure 5), which confirmed the non-linearity between elongation and twist, that was obtained both, in the experiments and by using the theoretical model.

[0304] In some embodiments, the fabrication approach of Helically folded tubes (HFTs) utilizes directed mechanical instability as a method for a rapid fabrication, which is readily implemented at various length scales and is particularly scalable to micro-dimensions. In some embodiments, a theoretical model for the deformation of the bistable helical elements comprising the twisting tubular structure is used, and was compared to experimental data of various fabricated HFTs. Additionally, the fabrication methodology was used with a variety of polymer tubes, including medical grade tubes, ranging from 5mm to 44pm in radius and with a wall thickness ranging from 250pm to 19pm.

[0305] In some embodiments, the formed helical folds are interconnected bi-stable elements of an elastic tube. In some embodiments, the structure is fabricated using a pre-stress process that optionally enables controlled collapse of the tube into a pre-defined helical pathway. In some embodiments, this results in a structure with tunable mechanical properties.

[0306] In some embodiments, an experimental setup and / or a theoretical model were used to investigate the behavior and performance of helical folds under various conditions. In some embodiments, the theoretical model provides insight into the underlying mechanics of helical fold behavior and optionally enables prediction of performance in different situations. In some embodiments, the structure is fabricated in various radii (ranging at least from millimeters to micrometers) and from different polymers, optionally making the structure a promising candidate for various intrabody applications and for direct distal control of sheath devices.

[0307] Referring now to Figure 6, showing a demonstration of the fabrication process of HFTs, according to some embodiments of the invention. Pictures (A) shown an exemplary production process of the multi-stable helical folds which consists of four steps: (Al) placing the elastic tube on the mandrel, (A2) engraving with the engraving shaft to achieve the pre-stressed helical pattern, (A3) twisting the elastic tube along with pressing it, and (A4) obtaining the desirable multi-stable helical folds. Pictures (B) show a series of 4 images extracted from a video of the buckling process of the HFT after the external pressurization process was finished. The first frame shown in (B l) corresponds to (A3) and the last frame shown in (B4) corresponds to (A4). Pictures (C) show a cross-sectional view of a closed and opened HFT and a cross-sectional enlarged view of the boundary of the bistable part (the lower part of the panel). Pictures (D) show a closed HFT (DI) and an opened HFT (D2) with 26 bistable elements (with two helical inlets, each composed of 13 bistable elements) illustrate the rotation ability. The blue line emphasizes the 360° rotation of the HFT. The scale bars correspond to 1 cm (panel A and B) and 100pm (panel C).

[0308] In some embodiments, the multi- stable twisting structure comprises a series of rotating bistable elements. In some embodiments, different HFTs with their corresponding mandrels and engraving shafts are fabricated, for example as shown in Figure 6, and in multi-scale dimensions. In some embodiments, the multi-stable helically folded tube (HFT) is fabricated by first creating a helical pre-stress line on an elastic tube. In some embodiments, this is achieved by inserting a mandrel (with the desired helical groove and pitch) into the elastic tube (for example as shown in Figure 6(A1)) and optionally applying external pressure with an engraving shaft (for example as shown in Figure 6(A2)). In some embodiments, the pressurization results in plastic deformation on the unsupported grooves along the mandrel. Additionally, a buckling pattern is created along the elastic tube by optionally applying rotation torque and compression forces on the elastic tube (for example as shown in Figure 6(A3)) and thus the desired multi-stable helical folds (for example as shown in Figure 6(A4)) are fabricated via a mechanism of elastic instability.

[0309] In some embodiments, the entire fabrication process of the structure takes no longer than 30 seconds on average, for example no longer than 20 seconds on average, no longer than 10 sec on average, or any intermediate, shorter or longer time duration.

[0310] In some embodiments, Figure 6(B), shows a series of four frames (captured in a Digital Microscope) of the buckling process, where the first frame shown in (B 1) corresponds to (A3) and the last frame shown in (B4) corresponds to (A4). Figure 6(C) shows a cross-sectional view of an HFT, and the enlarged view of the cross-section boundary of the bistable element. Figure 6(D) shows a closed HFT (in Figure 6(D1)) and an opened HFT (in Figure 6(D2)) with optionally 26 bistable elements (with two helical inlets, each composed of 13 bistable elements) illustrate the rotation-ability, by performing a 360-degree rotation angle.

[0311] Reference is now made to Figure 7, showing a variety of fabricated HFTs, which differ in: Material, Thickness and Radius, according to some exemplary embodiments of the invention. Each HFT is labelled with its material name, inner radius, and thickness. The top-left panel provides an isometric comparison of different HFT variations. The top-right panel displays the smallest HFT that we fabricated, with an enlarged view of the HFT, where a human finger gives a scale reference. The scale bars correspond to 0.5cm, 2mm, 1mm, 500pm, 200pm, 150pm, 100pm, and 50pm. In some embodiments, HFTs are made from at least one of, Polypropylene, Polyolefin, and medical grade polymers: Polyimide, Nylon Grilamid, as well as different Pebax (5533, 6333, and 7233), for example as shown in Figure 7. In some embodiments, the tubes’ wall thicknesses range from 250 to 20 pm, and the range of inner radii is from 5mm to 44pm.

[0312] According to some exemplary embodiments, the HFTs are made from 4-6 mm (OD), for example 6 mm (OD) Polypropylene tubes (Young’s modulus of E = 1.3 GPa). In some embodiments, the mandrels were printed by using an SLA 3D printer (Form 3B+). In some embodiments, the HFTs are fabricated with four different pitches of 5, 6, 7, and 8mm. In some embodiments, the number of the bistable elements in each HFT was in the range of 5-13 elements. In the experiments, the HFT was directly connected with an elastic tube to a pressure controller (ELVEFLOW OBI MK3+), which in turn was connected to a compressor (CompAir L07). In the experiments, the pressure controller was adjusted to l±0.01 atm and the temperature was kept at room temperature. The other side of the HFT was sealed with hot glue. All videos were captured in 4K resolution and 60 fps. Panels (A) and (C) of Figure 6 were captured with iPhone 12pro camera, whereas panels (B) and (D) of Figure 6 were captured with a Digital Microscope (LCD ATFWEL). Figure 5 was captured with a Phantom v2640 high speed camera in 20,000 fps.

[0313] In some embodiments, the pre-stress process allows, for example, to achieve multi- stability during the fabrication process. In some embodiments, the pre-stress process induces overcurvature in the structure. To verify that geometry and material selection have only a marginal impact on the multi-stability of the structure, the HFT were fabricated using the same process with various polymers, thicknesses, and radii, spanning a wide range of material and geometric properties. Among these, medical-grade polymers and small radii tubes were employed, which can be utilized as sheath devices, offering a vital degree of freedom: direct (front-drive) rotational control of the distal shaft. This rotation is often challenging to achieve mechanically or in some cardiovascular intervention settings not possible.

[0314] Figure 7 and the analysis results show several examples of the fabricated HFTs, where the used materials include Polyimide, PTFE, Polypropylene, Polyolefin, and Pebax (5533,6333,7233), the inner radii of the tubes ranged from 5mm to 44pm, and the thicknesses of the tube walls ranged from 19pm to 250pm. A fabrication in example of a multi-layer HFT, based on a double layer extruded tube, where an inner layer is comprised of Pebax 6333 and an outer layer is comprised of Pebax 7233.

[0315] Exemplary theoretical model for the deformation of HFTs and comparison with experiments

[0316] The bi-stable relationship between tension, length, and the rotation angle was examined. To propose a qualitative model, an approximation of the expected behavior of the uniaxial stress problem was made by a perturbation on the solution obtained in the case of a uniaxial strain problem. To achieve this by using geometrical considerations, it was assumed that the pre-stress in the helical fibers is sufficiently small, so that the rotation of the helicodial plate is approximately rigid around the neutral axis. The full derivation of the model is available in the analysis section below. The analysis allowed to derive an expression for AS;?- which denotes the difference between the polar angle of the initial and the current configurations at the inner radius as a function of ('and0, which represent the average translation along the axial direction in the deformed and the initial configurations, respectively, relative to the reference configuration. was defined as the polar rotation angle measured at the experiment’s left (closed) stability point, . Using the continuity assumption, branches of the two stability points we connected and were expressed as a function of the HFT length, denoted by L, where for brevity we use the notation denoting the HFT length at the left stability point and This yields the relation of Equation 1 below:

[0317] Equation 1

[0318] In Equation 1 ?0is the helical angle, are constants that depend on the geometry of the HFT. Deriving the potential energy and by using the Euler-Lagrange equation, yields a relation between the inner pressure and elongation

[0319] Equation 2

[0320] Where cpdepends on the geometry of the HFT. Moreover, in Equation 2 h denotes the thickness of the helicoidal plate and Myis the Young’s modulus of the helicoidal plate. For more details see analysis below, sometimes referred to as Appendix A / Analysis.

[0321] Referring now to Figure 8, showing experimental measurements of stability thresholds for elongation and rotation of helical folds with different pitch between bi-stable elements. Experimental measurements of the pressure, P, (in atm) vs the length of one helical loop, L, (in mm) are denoted by blue circles, squares, and triangles and plotted relative to the left y- axis. Experimental measurements of the rotation angle, 0, (in degrees) vs. length of one helical loop are denoted by red circles, squares, and triangles, and plotted relative to the right y-axis. Each panel contains three different experimental measurements, denoted by different mark types, and corresponding to helical folds of different pitch between bi-stable elements of: (A) 8 mm, (B) 7 mm, (C) 6 mm, and (D) 5 mm. The solid black lines represent the corresponding theoretical results obtained by using equation (1) for the rotation angle versus elongation and equation (2) for the pressure versus elongation.

[0322] Figure 8 shows four plots corresponding to four different HFT pitches, where in each panel the left y-axis represents the pressure, P, (and the corresponding experimental data is marked in blue) and the right y-axis represents the angle, 0, (and the corresponding experimental data is marked in red). Both, P and 0, are plotted versus the experimentally measured values of the HFT elongation, L, in one HFT element, extracted by dividing the overall HFTs length by the number of HFTs elements, where each element is one loop of 360 degrees.

[0323] The upward and the downward snapping pressures, which are the same for elongation and 0.5, 0.95 atm and -0.7, -0.65, -0.6, and -0.7 atm obtained for the pitches of 8, 7, 6, and 5 mm, respectively.

[0324] All of the experiments were repeated three times. In all measurements, the standard deviation of the snapping pressure measurements is below 0.01 atm. More repeatable mechanical properties of the HFT can be achieved by using machinery process instead of manual fabrication as performed in our experiments.

[0325] It was shown that the rotation and elongation of the HFT depend on the pitch. Specifically, as the pitch increases the rotation angle increases as well, whereas the elongation decreases. Moreover, the experiments showed a good agreement (both for elongation and rotation) with a tri-

[0326] In order to validate the non-linear relation between elongation and rotation in the spinodal region (obtained both experimentally and analytically) an additional experiment of HFT opening dynamics which was captured by high-speed camera (20KHz, image processing algorithm via in Matlab), was performed. Figure 5(A) shows an intermediate frame of the opening process where the points of interest, which were denoted for brevity as grid point, are marked by black dots in panel (Al) and their trajectories are denoted by curves in (A2). Among these points, two representative grid points were chosen which are adjacent along the %-axis and Figure 5(B) shows their position versus time (see panel (B l)), their rotation versus time (see panel (B2)), and the rotation versus elongation of one grid point relative to another one (see panel (B3)). Looking at panels (B l) and (B2) it can be seen that both grid points move together with a constant rotation angle until the opening dynamics reach the position of the first grid point. Starting this moment, a sudden change in the motion occurs, which is reflected by stopping the propagation of the first grid point in the X-direction, at the expense of its rotation.

[0327] This dynamic occurs until the opening dynamics reach also to the second grid point, and then both points continue to move together with a constant distance and a constant rotation angle between them. Note that the opening process of an element creates a rotation on the right side of the HFT (which occurs due to the experimental setup constraints), while the left side continues to move forward only, this dynamic can be observed in Figure 5(A2) by the curves which represent the trajectories of the grid points in the last 5ms. Moreover, as it can be observed in Figure 5(B3), there is a non-linear dependence in the spinodal region between the rotation and the elongation of one grid point relative to another one, which confirms our expectations.

[0328] Exemplary Types of HFTs

[0329] According to some exemplary embodiments, several types of HFTs can be fabricated using the methods outlined above:

[0330] In some embodiments, multiple start HFT is fabricated: for example, a tube having two 8mm pitch folds which start from different rotational positions of the base of the tube. Such a tube would have different deflection dynamics relative to a single start fold with a 4 mm pitch.

[0331] In some embodiments, CFT limit HFT is fabricated: an HFT with a very small pitch between the folds which resembles a CFT structure (WO2023 / 079566A1) and is geared mainly to have bending and extension characteristics rather than twist characteristics. The advantage of this structure is that contrary to the CFT (Conically folded tube) it can be embedded continuously with a coil.

[0332] In some embodiments, a variable pitch HFT is fabricated: an HFT where the pitch of the fold varies along the axis. For example, starting from 8 mm at the base of the tube and ending with 4 mm at the other end of the tube. Or for example, having larger pitches of from about 12mm to about 18mm. Another example is a fold which starts at a certain non-zero pitch at its base and ends at a near zero pitch, converging into a CFT structure towards the distal most end.

[0333] In some embodiments, a coil embedded HFT is fabricated: a metal coil wire is embedded along the helical fold or several helical folds of the HFT. The coil can be embedded on either side of the crease (see figures 3b, 4a and 4b), i.e. by accessing the crease from the inner lumen of the tube or by accessing the crease from the outer side of the tube wall, in both cases the coil can be embedded and fixed (fused) to the tube wall as in a reflow process or remained freely suspended along the fold.

[0334] Potential advantages of coil embedding an HFT may be: Resulting structure has a higher axial and lateral buckling resistance than a non-embedded HFT; Similarly to coil embedding a tube wall for sheath applications, the resulting structure retains its lumen cross-section better than just a tube and is more kink resistant; Resulting structure can take on higher actuation pressures without failure in all forms of actuation: direct global injection, interfacing membrane injection, local helix injection; and Coil embedding an HFT provides a method for modifying and controlling the elasticity of the folds and their response to hydraulic actuation. These modifications in many cases cannot be achieved by controlling fold geometry alone.

[0335] Another example of an application of using coil embedded HFTs in catheter shaft construction, besides a form of distal shaft steering, is also in controlling proximal shaft stiffness. In this example the outer layer of the elongated body shaft of the catheter is composed of a long coil embedded HFT structure with interfacing injected fluidic layer. At rest, there is ambient (for example atmospheric) pressure in the fluid layer and the elongated body shaft has relatively low stiffness since the folds significantly reduce the overall elastic bending stiffness of the structure. When the elongated HFT segment is actuated and fluidic pressure is raised in the layer, the overall structure attains a significantly higher bending stiffness due to the rise in tension of the folds (similarly to a coil reinforced shaft for example). This method of controlling shaft stiffness is relevant to many vascular applications and often time interventional devices are exchanged or replaced during catheter-based procedures in order to adapt to the procedural requirements in terms of: navigation, artery or chamber canulation and lesion crossing. This example also applies to the cardiac space.

[0336] Following this example, it should be mentioned that the folds of an HFT can be configured to provide no rotational movement along the axis (for example with alternating positive and negative fold pitch).

[0337] Exemplary HFT as a generalized CFT structure

[0338] In some embodiments, for example as mentioned previously, the HFT is a CFT structure, with a non-zero pitch of the fold pattern. In some embodiments, when the pitch of the fold approaches zero the helical rotations tend to rings. Optionally, the CFT structure is used for deflection and extension deflections and the HFT structure is optionally used for twist deflections (rotation about the axis). Optionally, HFTs are constructed to favor deflection or extension deflections as well since they optionally inherently have these modes of deflection configured into their geometrical structure. In some embodiments, CFTs are not used for twist deflection. In some embodiments, the deflection angle of an HFT is dependent on its pitch whereas the deflection angle of a CFT is dependent on the axial spacing between the conical folds. Optionally, using HFTs for deflection is advantageous since coil embedding is an easy and fast fabrication process.

[0339] Methods of fold actuation of an HFT / CFT

[0340] There are several methods to actuate the folds via saline injection as shown in the figures herein:

[0341] In some embodiments, direct global injection (fluid-to-material) is performed: the annular space between the shaft layers is pressurized with saline and fluid fills the HFT creases directly from the internal side of the tube as shown for example in Figure 9.

[0342] In some embodiments, the operational distal end portion includes an inner shaft 902 which interfaces a therapeutic tool 904 to be inserted into the vasculature and forms the an inner working lumen of the sheath, a middle shaft 906 which interfaces pressurized saline on either side of its wall, the saline in-tum actuates the sheath and an outer shaft 908 which comprises the deflectable segments which are folded tube patterns, proximally to the folded tube patterns the proximal outer shaft can be embedded with a metal coil or braid and modified to a desired stiffness.

[0343] In some embodiments, interfacing membrane 910 injection (material-to-material) is performed: same as above only that the fluid fills a space encapsulated by an elastic membrane (circumferentially) and the membrane interacts with the HFT creases internally actuating them. Unique to this method: the membranes do not have to span the entire circumference of the HFT but can actuate only a predefined sector of the HFT circumference, especially when curl-type actuation is desired.

[0344] In some embodiments, local helix injection (material-to-material) is performed: the injected actuation fluid runs helically along the crease and actuates the folds locally and sequentially. In some embodiments, the fluid can be pressurized while running over a coated coil wire (between the coil and its coating) which is embedded into the fold, or via an embedded coiltube which forms a helix and is embedded in the HFTs fold.

[0345] Manual work- flow - hybrid robotic approach vs. conventional robotic approach In some embodiments, intracardiac procedures which require the placement of percutaneous devices inside the heart via a femoral approach include two types of hand-held operation phases. In some embodiments, the first is an access or insertion phase, and the second is a precision manipulatory phase. In some embodiments, the access phase is relatively easy to perform via the hand-held approach, it relies on fluoroscopy during insertion and direct tactile feedback and takes-up very little procedural time (typically seconds), it is an inherent part of the standard manual operation workflow. In some embodiments, the manipulatory phase is a phase where therapeutic or diagnostic devices are inserted via the access route to perform tissue manipulation which requires a high degree of precision and is challenging for hand-held operation requiring skill and longer procedural time.

[0346] In some embodiments, examples of the intracardiac access phase include: placement of a steerable sheath inside the right atrium via the femoral vein route, placement of a steerable sheath inside the left atrium via the trans-septal route over a preceding wire, placement of a steerable sheath via the femoral artery in the region of the aortic valve.

[0347] In some embodiments, examples of the manipulatory phase: performing a transseptal puncture for left atrial access: depending on the desired target location of interest inside the left atrium, the puncture is to be performed at a different location of the fossa ovalis (e.g. for a PVI procedure - the puncture is performed posteriorly and inferiorly, for a left atrial appendage closure procedure - the puncture is performed at the center of the fossa ovalis, for a Mitral valve clip implantation procedure - the puncture is performed posteriorly and superiorly) precise control of the puncture location can be challenging in many cases and requires precise placement and stability of the tip of the steerable sheath. Further examples of the precision manipulation phase are performing focal ablation inside the heart (e.g. Cavotricuspid isthmus ablation, AVNRT ablation, PVI ablation, VT ablation, SVT ablation and any focal ablation inside the heart). Additional manipulatory phases include manipulation of stent graft segments in abdominal aortic aneurysm repair (AAA, FEVAR), where the initial stage of positioning the graft can be relatively easy but anchoring additional legs of the graft can be challenging and require high precision guidance of a steerable sheath.

[0348] Standard manual workflow typically supports the first access phase with relative ease, requiring a relatively basic skill level from the operator. However, performing of the manipulatory phase as described above, can be challenging in the manual approach even for experienced operators. Different robotic solutions have previously been proposed in order to tackle the shortcomings of hand-held devices during the manipulatory phase (examples of robotic ablation catheters are provided in US10537713B2, US20180326181A1, US10052121B2, incorporated herein as a reference in their entirety), these devices optionally comprised complex mechanical actuators and an abundance of moving parts, in many cases mechanizing the hand-held approach in order to achieve precision and repeatability at the distal end. As a result, their design included a robotic control unit, i.e. robotic arm mounted with a drive system which was installed in the cath- lab or EP-lab. The disadvantage of these devices was that they solved many of the shortcomings of the manual approach when it comes to the manipulatory phase but they significantly extended and complicated the access phase. Secondly, they hindered the surrounding and existent manual work-flow environment which must co-exist with the robotic platform as part of the whole procedure. For example, having a bulky robotic arm on one side of the patient hinders the insertion of other manual devices on that side of the patient alongside the robotic device. Thirdly, due to the nature of the associated drive systems, the amount of parts in the robotic assembly and number of actuators, their associated capital costs were very high and their associated cost of disposables was also significantly higher than existing manual devices, in many cases requiring costly disposables on the robotic platform itself (accessory disposables) which do not enter directly into the body.

[0349] A potential advantage of some embodiments described herein may be that they offer precision robotic control of the manipulatory phase of the procedure without having to compromise the access phase or the surrounding existing manual workflow environment. The access phase is optionally performed exactly the same as it would be with a standard hand-held device. The current device does not require any change of existing work-flow and functions as a standard manual device inserted into the patient body as any manual device would be. In addition, the proposed device requires minimal capital investment (e.g. simple bed-side infusion system) and no accessory disposables but the robotic control sheath itself.

[0350] Exemplary view of the exemplary sheath during interventions

[0351] Referring now to Figure 10, showing an exemplary control sheath for vascular interventions, according to some exemplary embodiments of the invention. The sheath is shown conveying a focal cardiac ablation catheter in the context of an Electrophysiology study and Ablation. The Figures show the actuation process of the sheath’s distal segments (from left to right). Top Panels show the orientation of the tip of the sheath, its deflected and torsional states. Bottom panels show Radial Cross-sectional views of the Middle portion (mid-shaft) and distal portion (Helically folded tube structures) of the sheath as it is deflected and twisted. Referring now to Figure 11, showing an exemplary control sheath for vascular interventions, according to some exemplary embodiments of the invention. The sheath is shown conveying a focal cardiac ablation catheter in the context of an Electrophysiology study and Ablation. The Figure shows the undeflected state of the sheath. Top Panel - top view of the sheath conveying a focal ablation catheter. Bottom Panel - Radial Cross-sectional view of the Middle portion (mid-shaft) and distal portion (Helically folded tube structures) of the sheath.

[0352] Referring now to Figure 12, showing an exemplary control sheath for vascular interventions, according to some exemplary embodiments of the invention. The sheath is shown conveying a focal cardiac ablation catheter in the context of an Electrophysiology study and Ablation. The Figure shows a deflected state of the sheath in which the distal-most conical folded tube structure is actuated via saline pressure to form an in-plane curve. Top Panel - top view of the sheath as its tip is curved. Bottom Panel - Radial Cross-sectional view of the Middle portion (midshaft) and distal portion (Helically folded tube structures) of the sheath as it is curved.

[0353] Referring now to Figure 13, showing an exemplary control sheath for vascular interventions, according to some exemplary embodiments of the invention. The sheath is shown conveying a focal cardiac ablation catheter in the context of an Electrophysiology study and Ablation. The Figure shows a twisted state of the sheath in which the middle-distal helical folded tube structure is actuated via saline pressure to form torsional actuation of the distal-most deflected portion. Top Panel - top view of the sheath as its tip is twisted clockwise. Bottom Panel - Radial Cross-sectional view of the Middle portion (mid-shaft) and distal portion (Helically folded tube structures) of the sheath as it is twisted.

[0354] Exemplary medical applications

[0355] In some embodiments, the sheath described herein is adapted to be used in a plurality of different medical applications. For example:

[0356] Transseptal puncture (TSP) application - the medical device (referred hereinafter as payload) is a transseptal needle (Radio frequency (RF) or BRK™) depicted in Figure 16

[0357] Manual TSP

[0358] The sheath of the present invention is compatible with the common practice workflow of cardiac transeptal with the current equipment (manual and RF) and a standard manual transseptal puncture setup (including a fixed dilatator and needle). To perform a manual TSP with the sheath of the present invention, the sheath’s distal curve segment will be guided to a fixed angle corresponding to the desired trajectory angle e.g., SL 0, 1, 2, 3, 4 (also corresponding to the dilatator and needle of the kit, and 0.032” wire). Then, the workflow will be similar to a fixed curve sheath and no actuation of the sheath of the present invention will take place during the puncture. Regarding the type of the sheath of the present invention for the TSP, any sheath with multiple DOF segments that has a distal curve segment can be used, so long as the proximal segments are kept at neutral position and not actuated during the process

[0359] Workflow for Manual TSP (not depicted in the figures) based on the robotic sheath of the present invention:

[0360] A. Advancing to the Right Atrium

[0361] 1. Advance a guidewire through the venous sheath into the superior vena cava (SVC).

[0362] 2. Insert the transseptal sheath and dilator over the wire.

[0363] 3. Position the transseptal sheath in the SVC (provides a controlled approach).

[0364] B. Locating the Fossa Ovalis

[0365] 4. Withdraw the sheath-dilator system into the right atrium (RA) while maintaining fluoroscopic or echocardiographic visualization.

[0366] 5. Use ICE to identify the fossa ovalis:

[0367] 6. Ideal TSP site - the sheath’s distal curve segment will be guided by fluidic pressure actuation to a fixed angle corresponding to the desired trajectory angle Confirm correct positioning by: o Fluoroscopic “tenting” of the septum. o ICE tenting of the fossa ovalis.

[0368] C. Performing the Transseptal Puncture

[0369] 7. Advance the needle into the transseptal sheath.

[0370] 8. Ensure proper orientation: o Fluoroscopy:

[0371] ■ AP view: Needle should be midline.

[0372] ■ LAO view (45°): Needle should be slightly posterior. o ICE: Needle tip should indent (tent) fossa ovalis.

[0373] 9. Apply gentle forward pressure to puncture the septum. o If resistance is encountered:

[0374] ■ Rotate the needle slightly. ■ Use RF energy-assisted needle if septum is thick.

[0375] 10. Confirm entry into the left atrium: o Insert wire after retracting the needle (in cases of Cryo ablation / PFA ) o Contrast injection in LA (fluoroscopy). o Some centers use pressure waveform shift (higher pressure confirms LA access). o ICE confirmation.

[0376] D. Advancing the Sheath into the Left Atrium

[0377] 11. Advance the dilator and sheath into the LA.

[0378] 12. Remove the dilator, leaving the sheath in LA.

[0379] 13. Flush the sheath with heparinized saline.

[0380] Common practice TSP for Pulmonary Vein Isolation (PVI)

[0381] Limitations:

[0382] • Suboptimal TSP Site Can Lead to Poor Catheter Maneuverability — Ideally, the puncture should be posterior and inferior to allow for easy access to all veins.

[0383] • Thick Interatrial Septum in Elderly Patients — May require force or RF-assisted puncture.

[0384] • Risk of Pericardial Effusion — Due to excessive force or a misplaced puncture.

[0385] Mitigation:

[0386] • ICE or TEE guidance to confirm ideal puncture location.

[0387] • Use of dilators and RF energy for fibrotic septa.

[0388] Robotic TSP (as shown in figure 16)

[0389] Background: conventional TSP sheaths lack the ability to perform precise navigation on the fossa ovalis 1602 in order to choose the appropriate puncture site and puncture trajectory. Different puncture sites are required for different left heart procedures such as: left atrial appendage occlusion (center position), pulmonary vein isolation (inferior-posterior position), mitral valve repair or replacement (superior-posterior), paravalvular leak closure, SVT ablation etc. A wrong puncture site necessitates re-puncture of the fossa and may result in procedural complications, in addition an inadequate or suboptimal puncture site in mitral repair or replacement procedures can lead to an inadequate trajectory of the delivery system and complications in valve repair or delivery.

[0390] The sheath of the present invention can be used to perform a robotic TSP puncture where it provides full control of the trajectory of the puncture into the left atrium (LA) 1604 and the location of the puncture on the fossa-ovalis 1602. The TSP workflow includes 3 stages where motion control of the sheath is paramount (schematically shown on the right side of Figure 16): (1) a first jump where the sheath translates along the junction of the superior vena cava (SVC) 1606 and right atrium (RA) 1608 (Figure 16[left] ), (2) a second (more subtle jump) where the sheath translates along the superior muscular rim of the fossa ovalis (FO) 1602 (limbus) and finally (3) onto the FO 1602 (figure 16[right]) (robotic motion control of these jumps can lead to favorable positioning on the FO). The third stage, where motion control is important, is on the FO 1602 itself where motion control can be advantageous in choosing the appropriate position of the puncture (see figure 16 middle zoom-in), in this case variation of the sheaths rotational and extendible segments can provide the means for navigating on the fossa in the anterior-posterior and inferior- superior manners, respectively.

[0391] Motion control is achieved via the use of a 3 degree of freedom sheath (similar to the one shown in figure 2i), like the one described herein, including a distal curve segment 1610, a medial rotational segment 1612 and a proximal extension segment 1614 (roll and extension can be optionally interchanged). Optionally, the distal curve segment can be replaced by a fixed curve segment with no use of fluid control signals. The axial advancement is used to position the tip of the dilatator on the FO and perform the two controlled jumps as prescribed above in the superiorinferior manner (as shown in Figure 16[left] ), in addition the axial advancement provides superiorinferior motion control on the fossa-ovalis as mentioned above, the roll segment is used to provide motion control on the fossa ovalis also in a combined medial-lateral and anterior-posterior plane. The deflection movement is used to choose an appropriate trajectory for the curve (as seen in figure 16[right] ) or to vary tension on the FO (vary the tenting degree for the puncture). In the case of a robotic TSP, a dedicated dilator and needle (BRK or RF) can be used to perform the puncture and are supplied with the device as described herein.

[0392] 2. Left Ventricle (LV) access for delivery of Ablation therapy - depicted in Figure 17 - the pay load is an ablation catheter or diagnostic catheter (ablation catheter is generally focal, but can be also large foot-print).

[0393] Background: Current practice for mapping ventricular tachycardia (VT) requires precise access to the arrhythmogenic substrate, but several anatomical, technical, and procedural barriers limit successful mapping and ablation. Catheter ablation for ventricular tachycardia (VT), particularly in structural heart disease (e.g., post-MI scar-related VT, nonischemic cardiomyopathy), relies heavily in the common practice on electro-anatomical mapping (EAM) to identify and eliminate arrhythmogenic substrates. However, several limitations exist when mapping the left ventricle (LV) for VT ablation, which can affect procedural success and patient outcomes.

[0394] These limitations arise from vascular access, intracardiac navigation, anatomical constraints, and tissue characteristics.

[0395] 1. Vascular and Structural Access Limitations

[0396] A. Difficulty in Accessing the Left Ventricle (LV)

[0397] Limitation:

[0398] • Most VT ablations require left ventricular access, which is challenging due to the need for transaortic or transseptal entry.

[0399] • Transaortic Approach Risks: o Aortic atherosclerosis — Risk of embolic stroke. o Severe aortic stenosis or tortuosity — Limits catheter maneuverability.

[0400] • Transseptal Approach Risks: o Thick interatrial septum or previous atrial septal closure devices can hinder crossing. o Increased thromboembolic risk when crossing into systemic circulation.

[0401] Solutions:

[0402] • Transseptal approach with ICE guidance when aortic access is challenging.

[0403] • Use of robotic sheaths for better catheter stability.

[0404] • CT or MRI pre-procedural planning to assess vascular patency.

[0405] • Use of robotic sheath of the present invention

[0406] 2. Anatomical Limitations in VT Mapping

[0407] Limited Catheter Stability in Specific Regions

[0408] Limitation:

[0409] • Apical, basal, and papillary muscle VT sites poses a challenge for stable catheter positioning.

[0410] • Respiratory and cardiac motion can alter catheter position during mapping.

[0411] Solutions:

[0412] Contact-force sensing catheters (TactiCath, SmartTouch).

[0413] Long sheaths for catheter stability and specifically a Robotic sheath which provides deep sheath support positioning in the ventricle The ability to perform precise movements with a robotic system would eliminate all the existing current limitations. Figure 17 shows a robotically control access-navigation workflow with a proximal rotation movement segment 1702, medial-proximal deflection 1704, medial-distal rotation segment 1706 and distal deflection segment 1708. This capability enables safe crossing of the mitral valve 1710, after TSP and navigation / rovering inside the LV 1712 to reach any target point (the basal region, and apical region) as well as navigation in the LVOT (Aortic root) 1714 (see detailed balloon M) under the aortic valve and precision diagnostic and therapeutic procedures in these areas, including below aortic cusps.

[0414] Robotic navigation sheath system in VT mapping and ablation will improve precision, stability, and efficiency while reducing radiation exposure and operator fatigue. The system integrates advanced microfluidic sheath control, with real-time feedback to optimize outcomes in complex VT cases, including those requiring endocardial, and intramural access.

[0415] Advantages of using robotic sheath systemin the workflow:

[0416] • Robotic platforms maintain stable, constant contact force for better electrogram quality.

[0417] • Reduces catheter dislodgement, which is common during LV apex or basal septum mapping

[0418] • Automated, rapid mapping algorithms allow for faster substrate identification.

[0419] • Integration with high-density mapping systems (CARTO 3, Ensite Precision) improves scar characterization.

[0420] • Access to Difficult Anatomical Locations

[0421] Antegrade left ventricle (LV) access for ablation therapy is crucial in administering therapy for ventricular tachycardia, however current antegrade approaches have challenges in providing adequate control and stabilization of the therapeutic or diagnostic catheter inside the LV. The alternative access route - retro-aortic LV access - has limitations since the catheter has to cross the aortic valve putting the patient at risk of brain embolism. If a sheath is used in the retro-aortic route this could be even more dangerous to the patient since the sheath is a stiff tube which can also cause the release of emboli along the aortic arc or when crossing the aortic valve, thus this must be avoided. In the antegrade LV access route, in conventional catheter workflow, the sheath is typically positioned above the mitral valve and again as in the right ventricle (RV) case (below) navigation in the LV is performed sheath-less. Control of the catheter is limited in the LV and also specifically in the Left Ventricular Outflow Tract (LVOT) and below the aortic valve. 3. Right ventricle (RV) access for delivery of Ablation therapy depicted in Figure 18 - the exemplary payload is an ablation catheter or diagnostic catheter (ablation catheter is generally focal, but can be also large foot-print)

[0422] Background: Right ventricular (RV) mapping is essential for diagnosing and treating ventricular tachycardia (VT), premature ventricular contractions (PVCs), and arrhythmogenic right ventricular cardiomyopathy (ARVC). The workflow follows a structured approach to ensure precise substrate identification and successful ablation.

[0423] The current workflow for RV mapping presents several limitations. These limitations arise due to sheath design, anatomical constraints, and procedural challenges.

[0424] 1. Mechanical & Structural Limitations

[0425] A. Size & Flexibility Constraints in the RV

[0426] Limitation:

[0427] • The common practice sheath is relatively stiff, designed primarily for left- sided access.

[0428] • Right ventricular structures (RVOT, trabeculated RV walls, papillary muscles) require high flexibility, which the common practice sheath lacks.

[0429] Alternatives:

[0430] • Deflectable, soft-tipped catheters (e.g., HD Grid, Pentaray) work better in highly mobile RV regions.

[0431] • Use long sheaths or robotic sheaths with better flexibility (e.g., Destination, FlexCath Advance for better maneuverability).

[0432] B. Challenges in Navigating the RVOT

[0433] Limitation:

[0434] • The RV outflow tract (RVOT) is a curved, narrow space.

[0435] • The common practice sheath stiffness makes navigation challenging, increasing the risk of wall trauma or dislodgement.

[0436] Present Alternatives:

[0437] • Manual sheath-less catheter control (without sheath support) may be preferable in some RVOT cases based on current practice.

[0438] A. Poor Adaptation to the Highly Trabeculated RV Endocardium

[0439] Limitation:

[0440] The trabeculated RV wall, moderator band, and papillary muscles create multiple microreentrant circuits in VT cases. • The Common practice sheath large profile may not engage deeply into trabeculated regions, reducing mapping accuracy.

[0441] Current Alternatives:

[0442] • Smaller, flexible, deflectable sheaths allow better contact in trabeculated areas.

[0443] • Microelectrode mapping systems (e.g., HD Grid, Octaray) improve scar detection in trabeculated

[0444] 2. Functional Limitations in RV Mapping

[0445] A. Limited Catheter Stability in a Highly Mobile Chamber

[0446] Limitation:

[0447] • The RV is highly dynamic, especially in tachycardia or high-output states.

[0448] • The Common practice sheath lacks adaptive motion compensation, leading to catheter instability and signal inconsistency.

[0449] Current Alternatives:

[0450] • Active robotic stabilization (e.g., Stereotaxis Niobe, Hansen Sensei) improves catheter tracking in a mobile RV.

[0451] • Contact-force sensing catheters (TactiCath, SmartTouch) help maintain operator stability based on feedback.

[0452] Robotic sheath navigation has the potential to enhance precision, stability, and safety in right ventricular (RV) mapping and ablation for ventricular tachycardia (VT) treatment. The RV presents unique challenges, including its trabeculated anatomy, high mobility, and variable scar burden (e.g., ARVC, post-myocarditis VT, post-surgical VT). Robotic sheath navigation systems may offer several advantages in addressing these limitations, its trabeculated anatomy, high mobility, and variable scar burden (e.g., ARVC, post-myocarditis VT, post-surgical VT). Robotic systems offer several advantages in addressing these limitations.

[0453] Key Benefits of Robotic Navigation in RV Mapping & VT Ablation

[0454] • Enhanced Catheter Stability in a Dynamic Chamber o Automated, fine-tuned catheter control compensates for RV motion. o Real-time force sensing (e.g., Stereotaxis Niobe, Hansen Sensei) ensures stable tissue contact. o Adaptive algorithms adjust catheter position dynamically in response to RV motion.

[0455] • Improved Navigation in Complex RV Anatomy o Flexible, multi-directional catheter steering enables precise movement in the RVOT and septal areas. o Programmable trajectory tracking allows automated, reproducible catheter movement along trabeculated surfaces. o Integration with electroanatomic mapping (CARTO, Ensite, Rhythmia) improves regional coverage without excessive catheter repositioning.

[0456] • High-Resolution & Consistent Electroanatomic Mapping o Automated point collection (Hansen, Niobe) reduces operator-dependent variability. o High-density mapping with robotic precision ensures complete scar and isthmus identification.

[0457] • Improved Contact Force Control for Safer Ablation o Steerable robotic catheters can optimize transseptal or epicardial positioning. o More precise retrograde aortic access for deep septal circuits. o Reduced mechanical trauma in the pericardial space.

[0458] Robotics sheath system will enhance RV Mapping and VT Ablation

[0459] RV access for ablation therapy is typically done sheath-less, where the steerable sheath remains above the tri-cuspid valve and the ablation catheter is navigated inside the RV with no sheath. This method has various challenges: for example, control of the ablation catheter is limited, and contact generation of the ablation catheter and the tissue is limited especially below and above the pulmonic cusps. In addition, navigating and ablating near the heart’s conduction system, bundle of his and bundle branches requires precision control so as not to harm the conduction system when ablating.

[0460] Figure 18 shows a (optionally robotically) control access-navigation workflow with two rotational movement segments (1802 / 1806) intercalated with 2 deflection movement segments (1804 / 1808). It enables safe crossing of the tricuspid valve 1810 and navigation inside the RV 1812 to reach any target point as well as navigation in the Right Ventricular Outflow Tract (RVOT) 1814 under and above the pulmonic valve and precision pacing and ablation of these areas, including the pulmonic cusps (see detailed balloon L). In addition to what is shown in Figure 18, another important application is wire placement in the apex via the RV for subsequent tricuspid valve replacement therapy. Again, today’s workflow includes the use of a conventional steerable sheath which remains above the valve and does not provide the means for precision guidance of the wire to the apex. This results in time consuming iterations using conventional workflow.

[0461] 5. Left atrial appendage occlusion navigation: In the present invention the use of robotically controlled distal segments can provide the option of orienting a left-atrial appendage occluder inside the appendage. One of the main challenges with delivery of left atrial appendage occluders is that the currently available single degree of freedom delivery sheath can only direct its distal opening at a fixed trajectory relative to the atrial wall. In some anatomical cases, known as tough appendages, the sack of the appendage has a tortuous orientation relative to the atrial wall and for optimal delivery and post procedural performance, the left atrial plug must be oriented so as to properly seal off the appendage sack from the atrial chamber. Achieving this complex orientation requires a multi-degree of freedom sheath for optimal delivery.

[0462] 6. Pulmonary vein isolation

[0463] Pulmonary Vein Isolation (PVI) is the cornerstone of atrial fibrillation (AF) ablation, but several technical, anatomical, and procedural challenges limit its success and widespread standardization.

[0464] ♦♦♦ Operator-Dependent Variability

[0465] • Challenge:

[0466] • Manual PVI techniques vary between operators and centers, leading to inconsistent outcomes. • Success rates depend on experience, mapping strategy, and energy delivery techniques. Possible Solution - Microfluidic robotic system of the present invention

[0467] ♦♦♦ Challenges in Wide Antral Circumferential Ablation o Inconsistent lesion contiguity leading to incomplete isolation. o Difficulty maintaining stable catheter positioning, especially in thin atrial tissue (e.g., posterior wall, LAA ridge, carina region).

[0468] Possible Solution - Microfluidic robotic system of the present invention, with the ability to better maneuver and stabilize.

[0469] ♦♦♦ Transeptal puncture

[0470] An accurate puncture location is the corner stone for a successful puncture and subsequent PVI procedure. The Microfluidic robotic system of the present invention has the ability to better maneuver and give stability with accurate positioning in order to perform the puncture in the ideal location.

[0471] Pulmonary vein (PV) isolation workflow using the present invention is depicted in figure 19, there are a variety of possible payloads for the figure including: focal ablation catheter, large footprint ablation catheter and diagnostic catheter - depicted in Figure 19 - the system enables precision (optionally robotic) control of the pay load. As can be seen in Figure 19, the sheath comprises several segments (for example 2 rotation movement segments (1902 / 1906) intercalated with 2 deflection movement segments (1904 / 1908)), which allow for the easy movement of the sheath to reach the PVs 1910. In the case of a focal catheter - Navigating around the PVs with no gaps between steps to form a continuous lesion 1912 (see detailed balloon K). For the case of a large- footprint catheter (e.g., single shot Pulsed field ablation (PFA) catheter) the system enables precise positioning of the ablation catheter in the PV, controlling tissue contact in very small steps and controlling pulmonary vein concentricity (see detailed balloon K). These are very hard to achieve in a manual setup, both for focal and single-shot payloads. The transseptal crossing shown in the figure is shown in a dashed line. The length of the dashed line extends methodically across the septum for figurative purposes - practically there is no operational distal segment in this region (this comment applies to both the trans-atrial navigation scenarios shown in figures 17,19)

[0472] Other important applications of the present invention include transcatheter valve-delivery and additional occlusion device delivery such as interatrial shunts and plugs, also in the case of a paravalvular leak closures. Unless otherwise defined, all technical and / or scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which the invention pertains. Although methods and materials similar or equivalent to those described herein can be used in the practice or testing of embodiments of the invention, exemplary methods and / or materials are described below. In case of conflict, the patent specification, including definitions, will control. In addition, the materials, methods, and examples are illustrative only and are not intended to be necessarily limiting.

[0473] As used herein with reference to quantity or value, the term “about” means “within +-10%”.

[0474] The terms “comprises”, “comprising”, “includes”, “including”, “has”, “having” and their conjugates mean “including but not limited to .”

[0475] The term “consisting of’ means “including and limited to.”

[0476] The term “consisting essentially of’ means that the composition, method or structure may include additional ingredients, steps and / or parts, but only if the additional ingredients, steps and / or parts do not materially alter the basic and novel characteristics of the claimed composition, method or structure.

[0477] 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” may include a plurality of compounds, including mixtures thereof.

[0478] Throughout this application, embodiments of this 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. Accordingly, the description of a range should be considered to have specifically disclosed all the possible subranges as well as individual numerical values within that range. For example, description of a range such as “from 1 to 6” should be considered to have specifically disclosed subranges such as “from 1 to 3”, “from 1 to 4”, “from 1 to 5”, “from 2 to 4”, “from 2 to 6”, “from 3 to 6”, etc.; as well as individual numbers within that range, for example, 1, 2, 3, 4, 5, and 6. This applies regardless of the breadth of the range.

[0479] Whenever a numerical range is indicated herein (for example “10-15”, “10 to 15”, or any pair of numbers linked by these another such range indication), it is meant to include any number (fractional or integral) within the indicated range limits, including the range limits, unless the context clearly dictates otherwise. The phrases “range / ranging / ranges between” a first indicate number and a second indicate number and “range / ranging / ranges from” a first indicate number “to”, “up to”, “until” or “through” (or another such range-indicating term) a second indicate number are used herein interchangeably and are meant to include the first and second indicated numbers and all the fractional and integral numbers therebetween.

[0480] Unless otherwise indicated, numbers used herein and any number ranges based thereon are approximations within the accuracy of reasonable measurement and rounding errors as understood by persons skilled in the art.

[0481] As used herein the term “method” refers to manners, means, techniques and procedures for accomplishing a given task including, but not limited to, those manners, means, techniques and procedures either known to, or readily developed from known manners, means, techniques and procedures by practitioners of the chemical, pharmacological, biological, biochemical and medical arts.

[0482] As used herein, the term “treating” includes abrogating, substantially inhibiting, slowing or reversing the progression of a condition, substantially ameliorating clinical or aesthetical symptoms of a condition or substantially preventing the appearance of clinical or aesthetical symptoms of a condition.

[0483] It is appreciated that certain features of the invention, which 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, which are, for brevity, described in the context of a single embodiment, may also be provided separately or in any suitable subcombination or as suitable in any other described embodiment of the invention. Certain features described in the context of various embodiments are not to be considered essential features of those embodiments, unless the embodiment is inoperative without those elements.

[0484] Various embodiments and aspects of the present invention as delineated hereinabove and as claimed in the claims section below find experimental / calculated support in the following examples.

[0485] Examples

[0486] Reference is now made to the following examples, which together with the above descriptions illustrate some embodiments of the invention in a non-limiting fashion.

[0487] 1. Exemplary Kinematic Relations

[0488] 1.1 General Description

[0489] Let us consider a helical folded tube (HFT) that is made from a linear elastic and isotropic material (see Figure 20(a)). We adopt a Cartesian system of coordinates, as indicated in Figure 20(b), where the z-axis is the local longitudinal direction passing through the tube’s center- line and the local xy-plane is perpendicular to the z-axis, so that the origin is located on the lowest meridianal cross-section of the reference configuration, which will be defined in the sequel and is denoted with arrow 2002 in Figure 14(b). In this section we will concentrate on one element, which internal pressure, which is denoted by p. All of the external loads are applied quasi-statically and thus it is reasonable to assume that the system is in equilibrium, so that in particular, p is equal to Pin- where UE denotes the elastic energy and W is the work due to the pressure, p, within the helicoidal element. The elastic energy, UE, will be found via integrating the internal energy, denoted by UE, over the volume of the upper helicoidal plate. Moreover, UE for a linear elastic material will be derived from the strain tensor, denoted by £, and defined in the deformed configuration. The work, W, done by p will be obtained via the integration of p over the volume which is occupied by the upper part of the helicoidal plate between the sections where the subscript r indicate the reference configuration.

[0490] 1.2 Normalization

[0491] Let us denote by r(1)a correction of r with respect to ro, which is, according to our assumption of elastic deformations, of a lower order of magnitude relative to ro.

[0492] For convenience, we will denote a small general parameter by e, 0 < e « 1. To render the problem dimensionless with values of order 0(1) with respect to e, we use the following transformations,

[0493] We hereafter denote normalized variables by tildes and characteristic values by an asterisk superscript.

[0494] Let us denote by erthe ratio between the width, ro- , and the characteristic radius of the helical folds, ro, and by enthe ratio between the thickness, h. and the width, ro- ,

[0495] From geometrical considerations it is reasonable to assume that 0 < (n,cr « 1, and moreover we will restrict our consideration to the case that en,er= 0(e). Our approach is based on approximating the solution for the uniaxial stress problem by the results obtained for the uniaxial strain problem (rigid helicoidal plate). Hence, we assume a small normalization as derived from the known conical solution adapted to our problem, namely

[0496]

[0497] In what follows, in order to obtain analytic results, we shall assume the following asymptotic expansions,

[0498]

[0499] 1.3 Position vector

[0500]

[0501] Note that this is the same result for the neutral radius, as obtained by Almen and Laszlo [1], obtained in the case of the assumption that ro -ri = 0(e).

[0502] 2. Kinetics Relations

[0503] 2.1 Potential energy

[0504] Finally, the normalized total potential energy, U~p, can be expressed by using eq. (1) with W~ and U~E, which are given in eqs. (28) and (29).

[0505] 2.2 Forces and Moments

[0506] The equilibrium equations for the axial force, F , and the torque, T , along the z -axis may be expressed as where A9~b is the change of the polar rotation angle between the initial and the deformed configurations at r = ri , which is obtained in eq. (61). Expressing (30) in dimensionless notation, we get that

[0507] Note that we have assumed that both, the axial force, F , and the torque, T , are applied, but they depend one on another via the geometry of the helicoidal element.

[0508] We solve eq. (31) for F~ and T~, where we use eqs. (1), (61) and (69), and get that 3. Qualitative Experimental Verification

[0509] For each HFT using a caliper we measured (at the opened condition state, at room temperature and pressure) the thickness, h, and the external diameters of the helicoidal plate which are equal to 2ro and 2ri + 2h. Moreover, the helical angle, po , was calculated according to where Az denotes the pitch of the outer helical fiber which is known from the manufacturing process. As described in the main paper, for each HFT, a pressure was applied using OB 1 MK3+ Elveflow controller to transform between the closed and the opened stability points, denoted by and +0, respectively, which allowed us to measure the elongation and the rotation angle relative to a reference point. Due to the symmetry of the problem with respect to the reference plane, the magnitude |^0| := |C±0| of the stability points, which are assumed to have the opposite signs, was calculated as the distance between the stability points divided by two.

[0510] Using the formula for A9~b which was derived in Section 4.3 (see equation (61)), transforming it back to a dimensional notation by using (3), (4), (6), (7), (9), (69), and expressing the result in degrees, we get that where the constants c91 and c92 depend on the geometry of the HFT and are given in Section 4.5. Note that in equation (34) the measurements correspond to the assumption of n = 0 which is the average between the upper and lower thickness coordinate of the helicoidal plate. In particular, the expression in (34) implies that A9b (CO) = 0. Eet us define A9G , as the generalized change of the polar rotation angle that contains the full range of C (with both stability points included), so that A9G obeys the continuity requirement at C = 0 at the limiting point of the two branches, which are obtained from (34) for -|5| - |£0| < C, < 0 and |5| + |£0| > C, > 0, where 6 represents a small region of order O(e2) around the stability point in which the derivation is valid. Specifically, since the convention is that A9G (£-) = 0 where the constant c90 is given in Section 4.5.

[0511] The values that were derived from the measurements for the thickness, h, the external radius, ro , the internal radius, ri , the helical angle, Po , and the magnitude of the average translations at the two different stability points, |^0|, are summarized in Table 1. Moreover, the values of ri which were obtained by using a least square fit to the experimental measurements of the rotation angle versus the length and are denoted by (ri )fit are presented in Table 2.

[0512] Using the formula for F~ which was derived in (32), isolating p~in and transforming it back, to a dimensional notation by using (3), (4), (6), (7), (15), (69), we get that where cp depends on the geometry of the HFT and is given in Section 4.5. Note that according to our assumption, there is no additional external force, except the applied pressure. Similarly to the symmetric part in [2], the expression in (37) implies that pin is linear in hMy . 4.4 Calculation of the Deformation Angle Although the 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

[0513] It is the intent of the applicant(s) that all publications, patents and patent applications referred to in this specification are to be incorporated in their entirety by reference into the specification, as if each individual publication, patent or patent application was specifically and individually noted when referenced that it is to be incorporated herein by reference. In addition, citation or identification of any reference in this application shall not be construed as an admission that such reference is available as prior art to the present invention. To the extent that section headings are used, they should not be construed as necessarily limiting. In addition, any priority document(s) of this application is / are hereby incorporated herein by reference in its / their entirety.

[0514] References

[0515]

[0001] J. O. Almen and A. Laszlo. The uniform-section disk spring. Transactions of the American Society of Mechanical Engineers, 58:309-310, 1936.

[0516] [2] Dotan Ilssar, Michael Pukshansky, Yizhar Or, and Amir D. Gat. Dynamics of reconfigurable strawlike elements. Phys. Rev. Applied, 18:034041, Sep 2022

[0517] [3] Yair Luxenburg and Sefi Givli. The static response of axisymmetric conical shells exhibiting bistable behavior. Journal of Applied Mechanics, 88:1-24, 06 2021.

Claims

WHAT IS CLAIMED IS:

1. A tube with a longitudinal axis and selectively deformable along a folding pattern which extends both circumferentially and axially, comprising a tubular body with a first crease and at least one second crease; wherein said first crease extends towards a first direction at a certain angle and said at least one second crease does not extend towards said certain angle.

2. The tube according to claim 1, wherein said second crease extends circumferentially a length of from a 1 / 16 to 2 / 3 of a total length of a circumference of said tube.

3. The tube according to claim 1, wherein said tube comprises more than one of said at least one second crease on a same circumferential location.

4. The tube according to claim 1, wherein said tube comprises a proximal end and a distal end, and wherein said first direction is from said proximal end to said distal end.

5. The tube according to claim 1, wherein said tube comprises a proximal end and a distal end, and wherein said first direction is from said distal end to said proximal end.

6. The tube according to claim 1, wherein said at least one second crease does not extend towards said first direction.

7. The tube according to claim 1, wherein said second crease extends in an opposite direction of said first crease.

8. The tube according to claim 1, wherein said second crease extends at an angle of from 5 degrees to 170 degrees in relation to said certain angle.

9. The tube according to claim 1, wherein said second crease extends at an angle of from 30 degrees to 170 degrees in relation to said certain angle.

10. The tube according to claim 1, wherein a passage from said first crease to said second crease is gradual.

11. The tube according to claim 1, wherein said second crease extends axially in a helical manner in relation to said longitudinal axis of said tube.

12. The tube according to claim 1, wherein said second crease axially extends more than said first crease during a deflection movement.

13. The tube according to claim 1, wherein said tube is configured to deflect an angle from 1 degree to 270 degrees in relation to said longitudinal axis.

14. The tube according to claim 1, wherein said first crease is conical.

15. The tube according to claim 14, wherein said conical crease has an angle relative to a plane perpendicular to said longitudinal axis of between 1 and 30 degrees.

16. The tube according to claim 1, wherein said second crease is non-conical.

17. The tube according to claim 1, wherein said first crease and said second crease are all outside of a body geometry defined by the increased parts of said body.

18. The tube according to claim 1, wherein said first crease is formed by plastically deforming said tube against a form and said second crease is form by plastically deforming said first crease.

19. The tube according to claim 1, wherein said first crease is formed by molding.

20. The tube according to claim 1, wherein at least 80% of a thickness of said tube is formed of a single layer of material, over at least 50% of a length of a creased part of said tube.

21. The tube according to claim 20, wherein said tube is formed of metal or a polymer.

22. The tube according to claim 1, wherein said tube is elastically deformable under forces which contract said first crease and expand said second crease.

23. The tube according to claim 22, wherein said second crease expands more than said first crease.

24. The tube according to claim 1, comprising a membrane which seals said first crease and said second crease for allowing expansion of said first crease and said second crease by injection of fluid therein.

25. The tube according to claim 1, comprising a membrane configured to expand into said first crease and said second crease for causing expansion of said crease by entry therein.

26. The tube according to claim 1, comprising a membrane which seals said tube for allowing expansion of said first crease and said second crease by injection of fluid therein.

27. The tube according to claim 1, formed as an intrabody tube with biocompatibility suitable at least for acute procedures.

28. The tube according to claim 27, wherein said tube is arranged as a guide sheath.

29. The tube according to claim 27, configured to include a creased section with a geometry suitable to cause deflection movement, rotation movement and / or extension movement of a more distal part of said tube.

30. The tube according to claim 29, wherein said second crease section provides deflection movement to said tube.

31. The tube according to claim 1, configured for use as a trans-vascular guide sheath in an adult human heart or in coronary vessel and to resist plastic deformation by passage of tools there through including one or more of a valve and a stent.

32. The tube according to claim 1, formed as a robotic guide sheath.

33. The tube according to claim 32, comprising an electronically controlled pump for expanding said first crease and said second crease, including a controller with an accuracy of better than 1 degree in deflecting of said tube.

34. The tube according to claim 1, configured to deflect in at least two planes.

35. A medical tube or robotically controlled sheath tube comprising a tube according to claim 1.

36. A method of providing deflection movement to a tube, comprising expanding a second crease more than a first crease in said tube.

37. The method according to claim 36, wherein said tube is inserted into a human body.

38. A guiding sheath, comprising: a. a handle, located at a proximal end of said guiding sheath; b. an elongated body, comprising proximal end interconnected to said handle and a distal end; c. an operational distal end interconnected to said distal end of said elongated body; said operational distal end comprising one or more segments configured to perform a movement selected from the group consisting of: axial movement, rotation movement and deflection movement; wherein said one or more segments are each characterized by comprising a folded tube (FT) comprising a fold type that enables said movement.

39. The guiding sheath according to claim 38, wherein said axial movement is performed by a conically folded tube (CFT).

40. The guiding sheath according to claim 38, wherein said rotational movement is performed by a helically folded tube (HFT).

41. The guiding sheath according to claim 38, wherein said deflection movement is performed by a mixed folded tube (MFT).

42. The guiding sheath according to claim 38, further comprising a micro fluidic system configured to actuate said FT thereby performing said movement.

43. The guiding sheath according to claim 38, wherein said guide sheath is characterized by being a multi-layer sheath comprising a plurality of concentric tubes.

44. The guiding sheath according to claim 43, wherein fluids are configured to be injected between said plurality of concentric tubes to independently actuate said one or more segments.

45. The guiding sheath according to claim 38, wherein said guide sheath is characterized by being a mono-layer sheath comprising a plurality of micro tubes.

46. The guiding sheath according to claim 45, wherein fluids are configured to be injected in said micro tubes to independently actuate said one or more segments.

47. The guiding sheath according to claim 38, further comprising a wire reinforcing said FT.

48. The guiding sheath according to claim 42, wherein said microfluidic system is intrinsic to said guide sheath.

49. The guiding sheath according to claim 42, wherein said microfluidic system is intrinsic to said guide sheath inside said handle.

50. The guiding sheath according to claim 42, wherein said microfluidic system is an external system connected to said guide sheath.

51. The guiding sheath according to claim 50, further comprising an integrated cable connecting between said external microfluidic system and said guide sheath.

52. The guiding sheath according to claim 51, wherein said integrated cable comprises one or more of a plurality of lumens to provide fluids and electric wires for actuating said guide sheath.

53. The guiding sheath according to claim 38, wherein each of said one or more segments comprise an inner tube adapted to facilitate said movement.

54. The guiding sheath according to claim 38, wherein said guide sheath is characterized by being a hybrid mono-layer and multi-layer.

55. The guiding sheath according to claim 38, further comprising an elastic liner covering said elongated body and said operational distal end.

56. The guiding sheath according to claim 38, further comprising an atraumatic distal end.

57. A tube with a longitudinal axis and selectively deformable along a pattern which extends both circumferentially and axially, comprising a tubular body with a crease extending both axially and circumferentially, wherein the crease is bistable in at least two configurations, one configuration with a greater axial extent and a greater circumferential extent than the other configuration.

58. The tube according to claim 57, wherein said crease is continuous over at least 4 turns around said body.

59. The tube according to claim 57, wherein said crease extends over at least 4 turns around said body and includes at least one portion which is not bistable or a non-creased section.

60. The tube according to claim 59, further comprising a wire and wherein said at least one portion not bistable comprises said wire.

61. The tube according to claim 57, wherein said tube is stable at at least 50 different deformation states.

62. The tube according to claim 57, wherein said crease is helical.

63. The tube according to claim 57, wherein said crease comprises multiple helical creases.

64. The tube according to claim 63, wherein at least two of said creases overlap axially.

65. The tube according to claim 64, wherein at least two of said creases do not overlap axially.

66. The tube according to claim 63, wherein at least two of said creases have a same chirality.

67. The tube according to claim 63, wherein at least two of said creases define a multi-start helix.

68. The tube according to claim 63, wherein at least two of said creases have a different chirality.

69. The tube according to claim 61 , wherein said helical crease has a constant pitch.

70. The tube according to claim 61, wherein said helical crease has a non-constant pitch.

71. The tube according to claim 61, wherein said crease has a pitch of between 0.1 and 5 tube diameters, optionally between 0.3 and 2 or 3 diameters.

72. The tube according to claim 61, wherein said crease has an angle relative to a plane perpendicular to said axis of between 1 and 30 degrees, optionally between 20 and 75 or 80 degrees.

73. The tube according to claim 57, wherein said crease is non-helical.

74. The tube according to claim 71 , wherein said crease includes at least one section with a negative pitch relative to other sections of said crease.

75. The tube according to claim 74, wherein said crease includes at least two changes in axial orientation in a single turn around said body.

76. The tube according to claim 57, wherein said crease is all outside of a body geometry defined by the increased parts of said body.

77. The tube according to claim 57, comprising a wire or a lumen embedded in or adjacent and extending along said crease.

78. The tube according to claim 77, wherein said tube is inflatable to expand said crease.

79. The tube according to claim 77, wherein said wire provides elastic recoil to said crease.

80. The tube according to claim 57, wherein said crease is formed by plastically deforming said tube against a form.

81. The tube according to claim 57, wherein said crease is formed by molding.

82. The tube according to claim 57, wherein at least 80% of a thickness of said tube is formed of a single layer of material, over at least 50% of a length of a creased part of said tube.

83. The tube according to claim 82, wherein said tube is formed of metal or a polymer.

84. The tube according to claim 57, wherein said tube is elastically deformable under forces which expand said crease.

85. The tube according to claim 57, wherein said tube crease at at least 10% of a length thereof comprises at least one distal side wall extending from said tube at a distal point and at least one proximal sidewall that extends from said tube at a proximal point and which sidewalls meet a peak.

86. The tube according to claim 85, wherein said peak overhangs at least one of said distal point and said proximal point when said crease is in an axially contracted state.

87. The tube according to claim 85, wherein an angle of one of said sidewalls and said body is acute and an angle of the other of said sidewalls to said body is obtuse when said crease is in an axially contracted state.

88. The tube according to claim 85, wherein said sidewalls are, on the average over area, thinner than a thickness of said body adjacent said crease.

89. The tube according to claim 85, wherein a meeting of said sidewalls and said body and said peak are thinner, on the average over area, than a thickness of said body adjacent said crease and said sidewalls.

90. The tube according to claim 57, provided with a removable shaper which expands to engage and / or deform said crease.

91. The tube according to claim 57, comprising a membrane which seals said crease for allowing expansion of said crease by injection of fluid therein.

92. The tube according to claim 57, comprising a membrane configured to expand into said crease for causing expansion of said crease by entry therein.

93. The tube according to claim 57, comprising a conical-frusta section in the form of a sequence of circumferentially extending creases.

94. The tube according to claim 57, formed as an intrabody tube with biocompatibility suitable at least for acute procedures.

95. The tube according to claim 94, wherein said tube is arranged as a guide sheath.

96. The tube according to claim 94, configured to include a creased section with a geometry suitable to cause curling, twisting and / or extension of a more distal part of said tube.

97. The tube according to claim 96, wherein said crease section applies twisting torque which twists a more distal part of said tube, without requiring a more proximal part of said tube to be twisted.

98. The tube according to claim 96, wherein said more distal part is configured to be deformed using zero or more of each of helically extending creases and / or a series of circumferentially extending creases.

99. The tube according to claim 57, configured for use as a trans vascular guide sheath in an adult human heart or in coronary vessel and to resist plastic deformation by passage of tools there through including one or more of a valve and a stent.

100. The tube according to claim 57, formed as a robotic sheath.

101. The tube according to claim 100, comprising an electronically controlled pump for expanding said crease, including controller with an accuracy of better than 5 degrees in bending or twisting of said tube, optionally better than 1 or 0.1 or optionally intermediate values.

102. The tube according to claim 57, configured to bend in at least two planes.

103. The tube according to claim 57, wherein said tube has a diameter over 50% of a length of a creased part thereof of 0.5 and 8 mm, optionally between 1 and 5 mm, optionally about 4 mm.

104. A medical tube or robotically controlled sheath tube with a longitudinal axis and selectively deformable along a pattern which extends both circumferentially and axially, comprising a tubular body with a crease extending both axially and circumferentially, wherein the crease has at least two configurations, one configuration with a greater axial extent and a greater circumferential extent than the other configuration.

105. The tube according to claim 104, wherein said crease moves elastically between said configurations.

106. The tube according to claim 104, wherein said crease moves stably between said configurations.

107. A method of transferring torque along a bent axis, comprising: stabilizing a more proximal side of a tube; and expanding a crease which extends axially and circumferentially along said tube in an amount sufficient to twist a part of said tube distal to said expanded crease.

108. The method according to claim 107, wherein said expanding comprises bi- stably expanding.

109. The method according to claim 107, wherein said tube is inserted into a human body.

110. The method according to claim 107, wherein said tube lies in a three dimensional space, unsupported along at least a part of its length distal to said expanded crease.

111. The method according to claim 107, wherein said torque is transferred past a bend in said tube which is distal to said expanded crease, substantially without generating any parasite deflections along the bent axis other than torque.

112. A method of manufacturing a creased tube, comprising: mounting a tube on a fitted mandrel; and axially compressing said tube to form a circumferentially extending crease.

113. The method according to claim 112, wherein said crease extends axially.

114. The method according to claim 112, comprising repeating said axially compressing at multiple locations along said tube.

115. The method according to claim 112, comprising twisting said tube while said compressing.

116. The method according to claim 112, comprising twisting said tube while said compressing.

117. The method according to claim 112, comprising prior to said axial compression, pre-disposing the tube to deform along said crease.

118. The method according to claim 117, wherein said predisposing comprises forming an inwards crease along a line for said circumferentially extending crease.

119. The method according to claim 118, wherein said forming an inwards crease comprises compressing said tube against a non-uniform mandrel.

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