Modular vascular catheter

Abstract

To provide catheter modules each having different physical properties.SOLUTION: A catheter comprises proximal tubular modules 110 and distal tubular modules 120. Each of the tubular modules having at least one section with spiral cuts. Each pair of adjacent tubular modules is coupled together by a joint. The joint comprises (a) at least one snap-fit connector 140 on a first tubular module, and a snap-fit acceptor 150 positioned on an adjacent tubular module, the snap-fit connector being elastically deformable when engaged, and (b) at least one stabilizing element, including a tongue element positioned on the first tubular module or the adjacent tubular module, and a groove element positioned on the opposite, first tubular module or the opposite, adjacent tubular module.SELECTED DRAWING: Figure 1(a)-(b)

Description

[Technical field]

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS This application is a continuation of U.S. Provisional Patent Application No. 62 / 404,552, filed October 5, 2016. This document claims the benefit of and priority to the following technical issues: [Background technology]

[0002] Currently, there are a number of different catheters, each designed to allow access to different anatomical sites within the vascular system. There are many different types of vascular catheters and microcatheters. A key problem facing the catheter meter is how to control pushability and flexibility over the length of the catheter. The aim is to allow physicians to treat a variety of complex disorders that are often found in the cardiovascular or neurovascular systems. To allow access through the often tortuous anatomical vasculature, It is important to control the compressibility and flexibility. One way to adjust the flexibility is However, different types of materials, e.g. stainless steel and / or The catheter body is made from a layered polymer or polymers. The wires are assembled into a tubular structure via a coiled or braided wire pattern disposed within the composition. Another method is to vary the cylindrical diameter and wall thickness of the catheter. Alternatively, a variety of different spiral cuts can be introduced into the wall of the catheter, thereby increasing flexibility. These spiral cuts can be continuous or discontinuous in nature. However, different cutting patterns can be used with different types of materials in modules that are easy to assemble. There are currently no catheters with multiple turns. Each is made of a different material. Assembling a catheter from a plurality of modules having these materials presents a problem with the physical properties of these materials in that a functional combination is an issue, i.e., directly fusing a stainless steel tube to a nitinol tube can be difficult because it cannot be done. However, if a catheter is assembled from different modules each having different properties it will be possible to adjust the catheter to meet the specific requirements of the anatomical structures of various types of blood vessels will be possible.

SUMMARY OF THE INVENTION

PROBLEMS TO BE SOLVED BY THE INVENTION

[0003] The present invention provides a method for assembling catheter modules each having different physical properties. The properties of the catheter can be directly adjusted to meet specific anatomical requirements. Thus, it is possible to specifically control the flexibility, resistance to plastic deformation of the catheter, axial torque transmission, and column strength in an anatomically specific manner. The modular catheter of the present invention supports a guide wire and / or is particularly useful for delivering drugs through vascular stenoses or tortuous anatomical structures such as are often encountered in the cardiovascular system or the neurovascular system. is particularly useful for delivering drugs.

MEANS FOR SOLVING THE PROBLEMS

[0004] Embodiments of the present invention provide a catheter comprising at least one proximal tubular module and a distal tubular module wherein each tubular module has at least one portion having a helical cut, and each pair of adjacent tubular modules is connected by a joint, the joint comprising (a) at least one snap-fit connection on a first tubular module and an adjacent tubular module one tubular module and, on the adjacent tubular module and a snap - fitting receiving portion disposed in the loop, where the snap - fitting connection portion is elastically deformable upon engagement, and further, (b) at least one stabilizing element including a tongue element disposed in the first tubular module or an adjacent tubular module, and a groove element disposed in the opposite first tubular module or an opposite adjacent tubular module.

[0005] In some embodiments, the helical cut has a plurality of segmented helical cuts.

[0006] The snap - fitting connection portion may form a cantilever joint. In a further embodiment, the snap - fitting connection portion has a stem structure and a locking structure, and the width of the locking structure at the widest point measured between opposite sides of the locking structure is greater than the width of the stem structure. The snap - fitting receiving portion has a stem cavity and a locking cavity, and the width of the locking cavity at the widest point measured between opposite sides of the locking cavity is greater than the width of the stem cavity. In a particular embodiment, the locking structure can be formed in an elliptical shape, and the snap - fitting receiving portion has a locking cavity formed in a circular shape. The snap - fitting connection portion can bend as a cantilever at an angle in the range of about

[0007] 0.1° to about 90° with respect to a line parallel to the longitudinal axis extending parallel to one of at least one proximal tubular module or distal tubular module. In some embodiments, the snap - fitting connection portion forms a return structure that remains parallel to a line parallel to the longitudinal axis of one of at least one proximal comprises a sagittal structure formed from

[0008] In some embodiments, the distal tubular module is formed from nitinol. Alternatively , the distal module can be formed from SAE grade stainless steels of 304, 316, 402 and 440, 17-7 precipitation hardening stainless steel (PH) or nickel cobalt alloy (MP35N).

[0009] To protect the joints between adjacent tubular modules, the joints can be at least partially surrounded by a tubular cover.

[0010] The catheter can comprise at least two cutout openings which are first and second cutout openings disposed in at least one proximal tubular module or distal tubular module. In some embodiments, both cutout openings are disposed in the distal tubular module. In other embodiments, one cutout opening is disposed in the distal tubular module and the second cutout opening is disposed in one of the at least one proximal tubular module. In some embodiments, a filament is helically screwed around the outside of the tubular module. One end of the filament is disposed in the first cutout opening and the other end of the filament is disposed in the second cutout opening.

[0011] The filament can be fixed in position at the first and second openings. Also, the filament can be screwed around the one or more tubular modules contained therein in a clockwise or counterclockwise configuration. The filament can be held in place by at least one ring. It can be fixed to one or more of the proximal tubular module or the distal tubular module . Further, the cross-sectional area of the filament can be circular, square, triangular, rectangular, semi-circular or trapezoidal .

[0012] In some embodiments, the catheter comprises 2 to 20 tubular modules

[0013] In some embodiments, a polymer forming the jacket is used to cover at least a part of one or more of at least one of the proximal tubular modules or the distal tubular modules. In some embodiments, the polymer jacket is nylon, polyether block amide, PTFE (polytetrafluoroethylene), FEP (fluorinated ethylene propylene), PFA (perfluoroalkoxy alkane), PET (polyethylene terephthalate) or PEEK (polyether ether ketone) may be formed . . .

[0014] In some embodiments of the catheter according to the present invention, at least one proximal tubular module and the distal tubular module include an inner lumen, and at least a part of the inner lumen of the proximal or distal tubular module is covered by an inner lining. In some embodiments , the inner lining may be formed of nylon, polyether block amide, PTFE (polytetrafluoroethylene), FEP (fluorinated ethylene propylene), PFA (perfluoroalkoxy alkane), PET (polyethylene terephthalate) or PEEK (polyether ether ketone). . . . .

[0015] Fix the snap-fit connection part and the snap-fit receiving part to between adjacent tubular modules There are several ways to ensure a secure connection. For example, a snap-fit connection and a snap receptacle can be adhered to each other, welded to each other, or soldered to each other.

[0016] At least one proximal tubular module and a distal tubular module can be formed from the same material, or from different materials. In certain embodiments, one or more of the at least one proximal tubular modules are formed from stainless steel and the distal tubular module is formed from nitinol. In some embodiments, one or more of the at least one tubular module and the distal tubular module are formed from a polymer. In some embodiments, one or more of the at least one proximal tubular module and the distal tubular module are formed from a braided composite of metal and polymer.

[0017] In some embodiments, the outer diameter of the proximal tubular module adjacent to the distal tubular body is the same as the outer diameter of the distal tubular module. In an alternative embodiment, the outer diameter of the adjacent proximal tubular module is larger than the outer diameter of the distal tubular module.

[0018] In some embodiments, the inner diameter of the distal tubular module is smaller than the inner diameter of the adjacent proximal tubular module. Alternatively, the inner diameter of the adjacent proximal tubular module may be equal to the inner diameter of the distal tubular module.

[0019] One or more of the at least one proximal tubular module can have the same flexibility as the distal tubular module. Alternatively, the distal tubular module can have a higher flexibility than one or more of the at least one proximal tubular module.

[0020] In some embodiments, the distal end of the distal tubular module has a crown. In some embodiments, the crown comprises a plurality of curved elements. In certain embodiments, the crown comprises 5 to 20 curved elements. The curved elements may be sinusoidal in shape.

[0021] In an embodiment of the catheter of the present invention, the catheter further comprises a tip attached to the crown of the distal tubular module. In some embodiments, the tip is tapered and further comprises a radiopaque material impregnated within the tip material. The tip may be obtained from a metal such as gold, but is not limited thereto. The tip can be implemented as a hollow tubular body that is tapered conically. A filament may be wound helically around the distal portion of the distal tubular module and the tip, and the filament and the tip can both be covered by a jacket.

[0022] In some embodiments, the catheter is coated with a hydrophilic lubricating polymer.

[0023] Embodiments of the catheter of the present invention also provide a catheter comprising at least one proximal tubular module and a distal tubular module, each tubular module having at least one portion with a helical cut, each pair of adjacent tubular modules being connected by a joint, the joint having a connection shape with a plurality of protrusions and a receiving portion that mates with the protrusions, each of a pair of adjacent tubular modules having one or more of the plurality of protrusions and the plurality of receiving portions.

[0024] In some embodiments, the connection shape of the joint comprises a zigzag pattern. Alternatively, The connection shape of the joint has a waveform. The catheter joint may be covered by a jacket. Yes.

[0025] In some embodiments of the catheter of the present invention, the distal tubular module comprises at least one portion having a helical cut, the distal tubular module is formed from a shape memory metal, sections or portions of the distal tubular module are set in a curved shape along the central lumen axis of the tubular module, and when the distal tubular module takes a curved shape, a constant cross-sectional lumen is maintained around the central lumen axis. In some embodiments, at least a part of the distal tubular module may be formed from nitinol. In other embodiments, the distal tubular module is formed from a stainless steel material selected from the group consisting of SAE grades of stainless steel selected from 304, 316, 402 and 440, 17-7 precipitation hardening stainless steel (PH), nickel cobalt alloy (MP35 N) and mixtures thereof. Alternatively, the distal tubular module can be formed from a polymer. In some embodiments, the portion of the distal tubular module set in a curved shape maintains an angle in the range of about 0° to about 90° with respect to the section of the distal tubular module not set in a curved shape. In other embodiments, the portion of the distal tubular module set in a curved shape maintains an angle in the range of about 0° to about 180° with respect to the section of the distal tubular module not set in a curved shape. The curved portion is straightened using a guide wire. In some embodiments, the guide wire used is tapered. In some embodiments, the portion of the distal tubular module preset in a curved shape, when the guide wire is withdrawn from the tubular module, returns to a straight state. In some embodiments, the portion of the distal tubular module set in a curved shape maintains an angle in the range of about 0° to about 180° with respect to the section of the distal tubular module not set in a curved shape. The curved portion is straightened using a guide wire. In some embodiments, the guide wire used is tapered. In some embodiments, the portion of the distal tubular module preset in a curved shape, when the guide wire is withdrawn from the tubular module, returns to a straight state. returns to a straight state when the guide wire is withdrawn from the tubular module. transition at an angle of approximately 45° with respect to a section of the distal tubular module that is not set to a curved shape occurs. In other embodiments, the portion of the distal tubular module preset to a curved shape transitions at an angle of approximately 180° with respect to a section of the distal tubular module that is not set to a curved shape when the guide wire is withdrawn from the tubular module. BRIEF DESCRIPTION OF THE DRAWINGS

[0026]

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DETAILED DESCRIPTION OF THE INVENTION

[0027] Referring to FIGS. 1(a) and 1(b), catheter 100 generally comprises at least two tubular modules 110, 1 20 called proximal 110 and distal 120 tubular modules. Each tubular module has at least one portion that can have at least one helical cutout. The helical cutout may extend along the entire length of the tubular module or may be disposed only along one or more portions of the tubular module and It may be. The spiral cut may be continuous or form a segmented spiral pattern. It may be. In certain embodiments, more than two tubular modules, e.g., 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20~, or up to n tubular modules may be connected to each other. When there are multiple tubular modules, e.g., more than two tubular modules, the additional tubular modules function or act as an extension of the proximal tubular module. The tubular module may be formed from a hypodermic tube, and the hypodermic tube may include a patterned cut disposed at one end of the tubular module in certain embodiments. The tubular module may be formed from the same or different materials and may have the same or different outer or inner diameters. For example, the tubular module can be made from similar metals (metals with similar physical properties, e.g., maximum tensile strength (UTS), % elongation or modulus of elasticity), two types of metals, a polymer or a combination of a polymer and a metal.

[0028] In one embodiment, the tubular modules are joined to each other by a plurality of snap - fit connections and snap - fit receivers disposed at one end of the same or different adjacent tubular modules.

[0029] The structure of the snap - fit connection may vary. For example, in one embodiment, the snap - fit connection includes a stem structure and a locking structure. The width of the locking structure at its widest point, when measured between opposite sides of the locking structure, is greater than the width of the stem structure at its widest point, when measured between opposite sides of the stem. The shape of the locking structure may vary. In one embodiment, the locking The locking structure is elliptical, but in the second embodiment, its shape is circular or semi-circular. Other shapes of the locking structure including square, rectangular, trapezoidal, rhomboidal or triangular are also encompassed by the present invention. .

[0030] The snap-fit receiving portion includes a stem cavity and a locking cavity and is disposed on the opposite side of the snap-fit connection portion on the opposite or adjacent tubular module. The structure of the snap-fit receiving portion is a cut-out image corresponding to the geometric structure of the snap-fit connection portion.

[0031] Figures 1(a) and (b) show an overview of the structure of the catheter 100. In the illustrated embodiment, there are two tubular modules, a proximal tubular module 110 and a distal tubular module 120. As used herein, the terms "proximal" and "distal" refer to the proximity to the hub 190 of the tubular module or the proximity to the cardiovascular system. In other words, the proximal tubular module is relatively close to the hub 190 and relatively far from the heart when measured along the length of the catheter, while the distal module is relatively close to the heart and thus to the coronary arteries. However, these terms only indicate relative positions and do not limit with respect to the structure, length, shape or number of the tubular modules.

[0032] The proximal and distal tubular modules can be made from similar metals, different metals, polymers, or combinations of polymers and metals. Examples of materials that can be used include stainless steel (SST), nickel titanium (nitinol) or polymers. Examples of other metals that can be used include superelastic nickel titanium, shape memory nickel titanium, Ti-Ni, nickel -titanium alloys, cobalt-chromium alloys, platinum-iridium alloys, and combinations thereof. -titanium alloys, cobalt-chromium alloys, platinum-iridium alloys, and combinations thereof. Other examples of polymers that can be used include polyethylene, polypropylene, polytetrafluoroethylene (PTFE), Nickel titanium, about 55 to 60 wt% Ni, Ni-Ti-Hf, Ni-Ti-Pd, Ni -Mn-Ga, 300 - 400 series, such as 304, 316, 402, 440 SA E grade stainless steel (SST), MP35N and 17-7 precipitation hardening (PH) st ainless steel, other spring steels or other high-tensile materials or other biocompatible metallic materials may be mentioned . In a preferred embodiment, the material is superelastic or shape memory nickel titanium, and in another preferred embodiment, the material is stainless steel.

[0033] The proximal and distal modules of the present invention can generally include superelastic alloys generally referred to as "shape memory alloys", either in whole or limited to selected portions . Elements made of such shape memory alloys have the ability to recover their original shape after being deformed to an extent that they would permanently deform if they were made of ordinary metals . Superelastic alloys useful in the present invention include Elgiloy® and Phynox® spring alloys (Elgiloy® alloy is available from Carpenter Technology Corporation of Reading, Pennsylvania, Phynox® alloy is available from Metal Imphy of Anney, France), SAE grade 316 stainless steel and MP35N (nickel cobalt) alloy available from Carpenter Technology corporation and Latrobe Steel Company of Latrobe, Pennsylvania (Elgiloy® alloy is available from Carpenter Technology Corporation of Reading, Pennsylvania, Phynox® alloy is available from Metal Imphy of Anney, France), SAE grade 316 stainless steel and MP35N (nickel cobalt) alloy available from Carpenter Technology corporation and Latrobe Steel Company of Latrobe, Pennsylvania ), and shape memory alloys available from Shape Memory Applications of Santa Clara, California ​​​​Possible examples of superelastic nitinol are given. Details regarding one or more of these alloys are disclosed in U.S. Patent No. 5,891,191.

[0034] The term "superelastic" refers to an alloy having superelastic properties that include at least two phases: a martensite phase with a relatively low tensile strength and stable at relatively low temperatures, and an austenite phase with a relatively high tensile strength and stable at a higher temperature than the martensite phase. The superelastic properties generally enable the metal to be deformed by applying a force that compresses and deforms the metal, causing the nitinol to change to the martensite phase. More precisely, when a stress is applied to a test piece of a metal such as nitinol that exhibits superelastic properties at a temperature above the temperature at which the transformation from the martensite phase to the austenite phase is complete, the test piece deforms elastically until it reaches a specific stress level at which stress-induced phase transformation from the austenite phase to the martensite phase occurs in the alloy. As the phase transformation progresses, the strain in the alloy increases significantly, but there is little or no accompanying increase in the corresponding stress. Until the transformation from the austenite phase to the martensite phase is complete, the stress remains essentially constant while the strain increases. Thereafter, to cause further deformation, additional stress needs to be increased. The martensite metal first yields elastically when further stress is applied, and then plastically yields with permanent residual deformation. If the load applied to the test piece is removed before permanent deformation occurs, the martensite test piece elastically recovers and returns to the austenite phase. The decrease in stress first reduces the strain. When the decrease in stress reaches the level at which the martensite phase returns to the austenite phase, the test ​​​​​​​​​​​​​​​​The stress level of the test piece remains essentially constant (however, until it completely returns to the austenite phase, there is a certain stress level at which the austenite crystal structure transforms into the martensite crystal structure lower than that). That is, when the corresponding stress decreases slightly, the strain significantly recovers . After completely returning to austenite, further stress reduction causes the elastic strain to decrease . When a load is applied, significant strain occurs at a relatively constant stress, and when the load is removed, the ability to recover from deformation is generally called superelasticity. As described above, suitable superelastic alloys include nitinol essentially composed of 49 - 53 atomic % Ni

[0035] , Cu-Zn alloy essentially composed of 38.5 - 41.5 wt% Zn , Cu-Zn-X alloy containing 1 - 10 wt% X (X = Be, Si, Sn, Al or Ga) , and Ni-Al alloy essentially composed of 36 - 38 atomic % Al . Nitinol is particularly preferred. The mechanical properties of nitinol can be changed as desired by replacing a part of the Ti-Ni alloy with 0.01 - 30.0 atomic % of another element X (X = Cu, Pd or Zr) , or by selecting the cold working reduction rate and / or the final heat treatment conditions . The buckling strength (yield stress when the load increases) of the superelastic alloy used is 5 - 200 kg / mm (22 °C), preferably 8 - 150 kg / mm , and the recovery stress (yield stress when the load decreases) is 3 - 180 kg / mm 2 (22 °C), preferably 5 - 130 kg / mm 2 . Alternatively, the tubular module may be formed from a polymer . Examples of polymers include polyimide, PEEK, nylon, polyurethane, poly 2 preferably 5 - 130 kg / mm 2 . Or, the tubular module may be formed from a polymer . Examples of polymers include polyimide, PEEK, nylon, polyurethane, poly Ethylene terephthalate (PET), latex, HDHMWPE (high density high molecular weight polyethylene), and thermoplastic elastomers may be mentioned.

[0036] The tubular module may be made, for example, by forming a pipe of superelastic metal and then removing the part of the pipe where notches or holes are to be formed. Notches, holes or incisions can be formed in the pipe by using a laser (e.g., YAG laser), discharge, chemical etching, mechanical cutting, or any combination of these techniques. See U.S. Patent No. 5,879,381 to Moriuchi et al., which is hereby incorporated by reference in its entirety. After deformation by heating and deformation to a predetermined shape, such as a curved shape, the tubular module can be cooled. The tubular module is then constrained in the deformed state within the delivery system to facilitate intravascular insertion. The superelastic tubular module can return to its original undeformed shape, i.e., a curve, when the physical constraint on the tubular module is removed. In one embodiment, the proximal tubular module 110 is made of 316SST and the distal tubular module 120 is made of 17-7SST. In another embodiment, the proximal tubular module 110 is made of 17-7SST and the distal tubular module 120 is made of nitinol. Either the proximal tubular module 110 or the distal tubular module 120 may similarly be made of a braided composition of materials. In other embodiments, the proximal tubular module 11

[0037]

[0038] ​​​​​​​​​​​​Either 0 or the distal tubular module 120 may be made from a cable or braided wire. It may be.

[0039] Each tubular module 110, 120 may have several different types of helical cut patterns, including both continuous and discontinuous helical cut patterns. Different helical cut patterns may be distributed on the same or different tubular modules. Both continuous and discontinuous helical cut patterns may be included. Different helical cut patterns may be distributed on the same or different tubular modules. On the same or different tubular modules, different helical cut patterns may be distributed.

[0040] The helical cut portion provides an axial torque transmission for pushability, kink resistance, rotational responsiveness, and / or a gradual transition of bending flexibility when measured by torque to breakage. For example, the helical cut pattern may have a pitch that varies to increase the flexibility of one or more regions of the tubular module. The pitch of the helical cut can be measured by the distance between points at the same radial position of two adjacent threads. In one embodiment, the pitch may increase as the helical cut progresses from the proximal position to the distal end of the catheter. In another embodiment, the pitch may decrease as the helical cut progresses from the proximal position on the catheter to the distal end of the catheter. In this case, the distal end of the catheter may be relatively flexible. By adjusting the pitch of the helical cut and the cut and uncut paths, the pushability, kink resistance, torque, flexibility, and compression resistance of the catheter, i.e., the tubular module, may be adjusted. Thus, tubular modules with different rigidities or flexibilities can be combined. For example, a relatively rigid tubular module and a relatively flexible tubular module can be combined. And / or a gradual transition of bending flexibility when measured by torque to breakage. For example, the helical cut pattern may have a pitch that varies to increase the flexibility of one or more regions of the tubular module. The pitch of the helical cut may increase as the helical cut progresses from the proximal position to the distal end of the catheter. The pitch of the helical cut can be measured by the distance between points at the same radial position of two adjacent threads. In one embodiment, the pitch may increase as the helical cut progresses from the proximal position to the distal end of the catheter. In another embodiment, the pitch may decrease as the helical cut progresses from the proximal position on the catheter to the distal end of the catheter. In this case, the distal end of the catheter may be relatively flexible. By adjusting the pitch of the helical cut and the cut and uncut paths, the pushability, kink resistance, torque, flexibility, and compression resistance of the catheter, i.e., the tubular module, may be adjusted. Thus, tubular modules with different rigidities or flexibilities can be combined. For example, a relatively rigid tubular module and a relatively flexible tubular module can be combined. By adjusting the pitch of the helical cut and the cut and uncut paths, the pushability, kink resistance, torque, flexibility, and compression resistance of the catheter, i.e., the tubular module, may be adjusted. Thus, different rigid or flexible tubular modules can be combined. For example, a relatively rigid tubular module and a relatively flexible tubular module can be combined. For example, a relatively rigid tubular module and a relatively flexible tubular module can be combined. For example, a relatively rigid tubular module and a relatively flexible tubular module can be combined. This combination can be further combined with a tubular module that is relatively rigid or relatively flexible. This can be done.

[0041] By combining tubular modules with various rigidities (conversely, flexibilities), particularly when the anatomical structure of the blood vessel is tortuous, or in cases such as chronic total occlusion (CTO), where the lumen of the blood vessel system is partially or completely damaged or blocked, the catheter can travel through a wide variety of blood vessel systems. The modular structure also provides the ability to effectively transmit torque along the length of the catheter without accompanying kinking, stenosis, or collapse of the lumen of the tubular module. This combination of tubular modules with various rigidities or flexibilities allows the flexibility of the catheter to be adjusted along its length. Specifically, when the anatomical structure of the blood vessel is tortuous, or in cases such as chronic total occlusion (CTO), where the lumen of the blood vessel system is partially or completely damaged or blocked. Furthermore, it becomes possible to change the flexibility of the modular part from more rigid to more flexible and then back to rigid again by virtue of the various rigidities. By adjusting the flexibility / rigidity in this way along the length of the catheter, the catheter can advance into and across lumen occlusions within various anatomical lumens and function. This combination of tubular modules with various rigidities or flexibilities allows the flexibility of the catheter to be adjusted along its length. Furthermore, it becomes possible to change the flexibility of the modular part from more rigid to more flexible and then back to rigid again by virtue of the various rigidities. By adjusting the flexibility / rigidity in this way along the length of the catheter, the catheter can advance into and across lumen occlusions within various anatomical lumens and function. This combination of tubular modules with various rigidities or flexibilities allows the flexibility of the catheter to be adjusted along its length. Furthermore, it becomes possible to change the flexibility of the modular part from more rigid to more flexible and then back to rigid again by virtue of the various rigidities. By adjusting the flexibility / rigidity in this way along the length of the catheter, the catheter can advance into and across lumen occlusions within various anatomical lumens and function. Furthermore, it becomes possible to change the flexibility of the modular part from more rigid to more flexible and then back to rigid again by virtue of the various rigidities. By adjusting the flexibility / rigidity in this way along the length of the catheter, the catheter can advance into and across lumen occlusions within various anatomical lumens and function. Furthermore, it becomes possible to change the flexibility of the modular part from more rigid to more flexible and then back to rigid again by virtue of the various rigidities. By adjusting the flexibility / rigidity in this way along the length of the catheter, the catheter can advance into and across lumen occlusions within various anatomical lumens and function. Furthermore, it becomes possible to change the flexibility of the modular part from more rigid to more flexible and then back to rigid again by virtue of the various rigidities. By adjusting the flexibility / rigidity in this way along the length of the catheter, the catheter can advance into and across lumen occlusions within various anatomical lumens and function. Furthermore, it becomes possible to change the flexibility of the modular part from more rigid to more flexible and then back to rigid again by virtue of the various rigidities. By adjusting the flexibility / rigidity in this way along the length of the catheter, the catheter can advance into and across lumen occlusions within various anatomical lumens and function.

[0042] The adjustment of the flexibility / rigidity along the length of the catheter can be achieved in several ways. For example, the flexibility / rigidity of the tubular module can be controlled by changing the helical cut pattern variables (pitch, segmentation) and transitioning between helical cut patterns. Furthermore, the helical cut pattern allows the cross-sectional diameter of the lumen to be maintained when the tubular module is bent or curved. The flexibility / rigidity of the tubular module can be controlled by changing the helical cut pattern variables (pitch, segmentation) and transitioning between helical cut patterns. Furthermore, the helical cut pattern allows the cross-sectional diameter of the lumen to be maintained when the tubular module is bent or curved. The helical cut pattern allows the cross-sectional diameter of the lumen to be maintained when the tubular module is bent or curved. The indented portions may be distributed along the length of the tubular module. The spiral indentation pattern may be continuous or discontinuous along the length of the module. For example, there may be 1, 2, 3, 4, 5, 6, 7 to n spiral indented portions along the length of the module. The spiral indented portions may be continuous or segmented. A certain indentation pattern may exist within each portion but the indentation pattern may vary, for example with respect to pitch, across various portions within the tubular module. Each portion may also include a variable pitch pattern within a particular portion as well. Each spiral indented portion may have a constant pitch, for example, within the range of about 0.05 mm to about 10 mm, for example 0.1 mm, 0.2 mm, 0.3 mm, 0.4 mm, 0.5 mm, 0.6 mm, 0. 7 mm, 0.8 mm, 0.9 mm, 1.0 mm, 1.5 mm, 2.0 mm, 2.5 mm, 3.0 mm, 3.5 mm, 4.0 mm, etc. The pitch may also vary within each portion. The pitches of different spiral indented portions may be the same or different . Alternatively, the catheter may be formed from a tubular module having a spiral indentation pattern that varies continuously along the length of the catheter. The orientation or winding of the spiral indented portions within the module may also vary within the spiral indented portions . The width of the spiral indentation can be varied, for example, in the range of about 1 micron to about 100 microns.

[0043] In the case of segmented spiral indented portions, each turn or rotation of the spiral includes a specific number of indentations (Nc )(e.g., 1.5, 2.5, 3.5, 4.5, 5.5, etc.) such that the segmented

[0044] A spiral pattern can be designed. Nc can be an integer such as 2, 3, 4, 5~n, or it can also be other real numbers such as 2.2, 2.4, 2.7, 3.1, 3.3. For a given Nc, each rotation has Nc repeated patterns each with a cut portion in range β adjacent to a non-cut portion in range α, such that the non-cut range α and the cut range β can be selected as α = (360-(β×Nc)) / Nc. For example, for Nc = 1.5, 2.5, and 3.5, the following table shows examples of selections for various embodiments of α and β. For Nc = 1.5, 2.5, and 3.5, the following table shows examples of selections for various embodiments of α and β. are shown.

Table 1

[0045] FIG. 1(a) shows an embodiment of a catheter in which two tubular modules, namely a proximal tubular module 110 and a distal tubular module 120, are joined to each other. In the illustrated embodiment, the tip 170 is attached to a crown 160 at the distal end of the distal tubular module 120. The two tubular modules are connected to each other by a joint 130. The joint 130 is formed by a snap-fit connection portion 140 and a snap-fit receiving portion 150 as shown in FIG. 1(b), and the snap-fit connection portion 140 is locked or snap-fitted within the snap-fit receiving portion 150. The tubular modules are hollow and have an inner lumen and an outer wall. A hub 190 can be disposed at one end of the catheter 100, and an intermediate tubular portion 180 connects the hub 190 and the proximal tubular module 110. Any type of hub can be used with the catheter. A hub 190 can be disposed at one end of the catheter 100, and an intermediate tubular portion 180 connects the hub 190 and the proximal tubular module 110. Any type of hub can be used with the catheter. can be used.

[0046] FIGS. 2(b)~(i) show various portions of the proximal and distal tubular modules shown in FIG. 2(a). Shows an embodiment of the helical cut portion of the tubular module that can be used in. The distal tubular module 120 includes segmented helical cut portions 210 (shown enlarged in FIG. 2(b)), 220 (shown enlarged in FIG. 2(c)) and 230 (shown enlarged in FIG. 2(d)). The proximal tubular module 110 includes segmented helical cut portions 240 (shown enlarged in FIG. 2(f)) , 250 (shown enlarged in FIG. 2(g)), 260 (shown enlarged in FIG. 2(h)) and 270 (shown enlarged in FIG. 2(i)). The joint 130 between the proximal tubular module and the distal tubular module is shown in FIG. 2(e). In the illustrated embodiment, the snap-fit connection portion and the span-fit receiving portion are flush with the outer surface of the tubular module, that is, the outer portion of the snap-fit connection portion and the receiving portion does not protrude beyond the outer diameter of the tubular module Note that.

[0047] In the embodiments shown in FIGS. 2(a) to 2(i), the segmented helical cuts are represented as discontinuous ones. A detailed view of one embodiment of these helical cuts is shown in FIG. 3, and FIG. 3 shows an expanded (or flattened ) part of a tubular module having a segmented helical cut pattern. The helical cut tube portion of the tubular module is substantially defined by the segmented helical cut path width 330 and separated adjacent turns 310 , 320 having a single helical ribbon portion. The helical cut path width 330 includes open or cut portions 340 and non-cut portions 350 alternately. The helical path width 330 is alternately composed of cut portions 340 and non-cut portions 350 and is angled with respect to the circumference of the tubular portion (in other words, the pitch angle φ shown in FIG. 3 is less than 90° is alternately composed of cut portions 340 and non-cut portions 350 and is angled with respect to the circumference of the tubular portion (in other words, the pitch angle φ shown in FIG. 3 is less than 90° )

[0048] As shown in FIG. 3, the non-cut portions 350 oriented spirally each have an arcuate range “α”, and the cut portions oriented spirally each have an arcuate range “β”. The angles α and β can be expressed in degrees (each complete spiral turn is 360°). The non-cut portions can be distributed so that adjacent non-cut portions 350 are not axially aligned with each other along a direction parallel to the longitudinal axis L (or “alternately”). As shown in FIG. 3, the non-cut portions 350 every other turn of the segmented spiral cut width 330 can be axially aligned.

[0049] The spiral cut pattern of each tubular module can be formed from continuous spiral cut portions, segmented spiral cut portions, or a mixture of both types of spiral cut patterns, and various patterns are arranged in any order. The segmented cut spiral modules have the ability to maintain a concentric lumen region even with sharp bends of small radius while in a bent configuration. The ability to maintain a concentric lumen allows smooth wire movement in any direction within the tubular lumen without deforming the lumen. Further, by using a superelastic material such as nitinol in the spiral cut compartments, the compartments can bend in sharp curves through various

[0050] vascular paths without permanently deforming the lumen. The lengths of the respective tubular modules may vary. For example, the length It may be in the range of 35 cm or about 50 cm to 100 cm. The distal tubular module 120 has a length in the range of about 15 cm to about 35 cm, about 10 cm to about 25 cm, about 20 cm to about 45 cm , about 30 cm to about 50 cm, about 5 cm to about 15 cm or about 1 - 5 cm .

[0051] In certain embodiments, the distal tubular module may be formed as a microcatheter. The microcatheter can be navigated to the remote vasculature via a guide wire . The microcatheter crosses the lesion and delivers the guide wire and / or contrast agent across the lesion, and subsequently, for example, deploys an interventional treatment element across the lesion to immediately restore blood flow. The interventional treatment element may be a stent, coil, flow diverter , blood flow restoration element, thrombus removal element, retrieval element, aspirator or snare.

[0052] Figures 4(a)-(b) and Figures 5(a)-(b) show two different preferred embodiments of a snap - fit connection and a snap - fit receptacle that can be used to connect tubular modules according to the present invention. The embodiments are shown in a two - dimensional display where the tubular modules are planar and flattened. In Figure 4(a), the proximal tubular module 110, which is formed of SST in this embodiment, is connected by a joint 130 to an adjacent distal tubular module formed of nitinol in this embodiment, by a snap - fit connection 140 and a snap - fit receptacle 150. In addition to the snap - fit connection 140 and the snap - fit receptacle 150, on both sides of the snap - fit connection / snap - fit receptacle 140, 150 . ​Two stabilizing elements 450, 451 may be arranged. In the illustrated embodiment, the stabilizing element is rectangular in shape, but the shape of the stabilizing element is not limited to a rectangular shape (for example, trapezoidal , square or triangular).

[0053] A plurality of snap - fit connections and snap - fit receivers for connecting two adjacent tubular modules may be present in the range of 1, 2, 3, 4, 5, 6, 7, 8, 9, 10 to n. The snap - fit connection and / or the snap - fit receiver can be arranged on either the proximal and / or distal tubular module. For example, the snap - fit connection can be on the distal tubular module, and the snap - fit receiver can be on the proximal tubular module, or the snap - fit connection can be on the proximal tubular module, and the snap - fit receiver can be on the distal tubular module. The snap - fit connection and the snap - fit receiver form a pair on adjacent tubular modules. The stabilizing element can prevent the independent rotation of the tubular module, maintain concentric alignment, and enable the transmission of torque across the proximal and distal modules along the length of the catheter

[0054] . Thereby, the management of the torsion and shear stress of the modular catheter is improved . The ratio of the shear stress to the strain of the material is the elastic constant (G) of the module. When the applied torque is balanced by the internal stress of the material, the torque on the cross - section resulting from the shear stress is as follows. The shear stress and strain ratio of the material is the elastic constant (G) of the module. When the applied torque is balanced by the internal stress of the material, the torque on the cross - section resulting from the shear stress is as follows. The torque on the cross - section resulting from the shear stress is as follows.

[0055] Torque (T)=Gθ / L×J where θ is the angle of rotation, L is the length of the part, and J is the "polar moment of inertia of the cross - section (po known as the "polar second moment of area".

[0056] For a hollow shaft such as a catheter, the formula for J is as follows.

[0057] J = π(D 4 - d 4 ) / 32 Where D and d are the outer diameter and inner diameter of the catheter (i.e., the tubular module). These equations provide an indication of the amount of torque that can be safely transmitted along the catheter to prevent excessive torsion.

[0058] The stabilizing elements can be implemented as tongue elements 450, 451 that fit into corresponding grooves 460, 461 on the opposite tubular module. Also in this embodiment, the snap - fit connection 140 forms a cantilever joint formed on the distal tubular module 120. In the illustrated embodiment, the snap - fit connection 140 includes a circular locking portion 410 connected to the body of the proximal tubular module by a stem portion 420. The proximal tubular module 110 includes a circular portion 430 for receiving the circular portion 410 and a corresponding snap - fit receptacle 150 which is a space or receptacle including a rectangular 440 portion for receiving the stem portion 420. Figure 4(b) shows an exploded view of the two tubular modules 110, 120 and the joint 130 of Figure 4(a). The tubular modules are joined together by inserting the snap - fit connection 140 into the snap - fit receptacle 150. Figures 5(a) and (b) show another embodiment of the snap - fit joint. In this embodiment, the snap - fit connection 510 has two arms 530, 540, and each arm 530,

[0059] ​​​​​​540 has heads 550, 560 each having a triangular or trapezoidal shape (also called arrow or return shape) disposed at one end. Arms 530, 540 are elastic and have a margin to pivot laterally with respect to the longitudinal axis 570 of the tubular module. In Fig. 5(b), the snap - fit connection 510 is shown in an open position where the arms 530, 540 are displaced laterally with respect to the longitudinal axis 57 0 of the tubular module. When the arms 530, 540 are inserted into the snap - fit receiving part 520, they pivot inwards, and the angle between the arms and the longitudinal axis of the tubular module decreases. After insertion, the triangular heads 550, 560 move outwards again or flex as shown in Fig. 5(a), and snap - fit the snap - fit connection 510 to the snap - fit receiving part 520. In other embodiments, other designs of snap - fit joints including twist joints and annular snap joints can be used. Figs. 6(a) - 6(j) show various perspective views of the embodiment shown in Figs. 4(a) and (b), where the proximal tubular module 110 and the distal tubular module 120 are connected to each other using the snap - fit connection 140 and the snap - fit receiving part 150 together with the stabilizing tongue and groove elements 450, 460. In the embodiments shown in Figs. 6(a) - 6(j), the stabilizing element 450 and the snap - fit connection 140 are disposed at one end of a single tubular module 120. In other embodiments, the snap - fit connection 140 and the stabilizing element 450 are disposed and used on a plurality of tubular modules. Alternatively, each tubular module

[0060] can include various different snap - fit connections. For example, the snap - fit shown in Fig. 4(a) connection 140 and the stabilizing tongue 450 are disposed at one end of a single tubular module 120. In other embodiments, the snap - fit connection 140 and the stabilizing element 450 are disposed and used on a plurality of tubular modules. Alternatively, each tubular module can include various different snap - fit connections. For example, the snap - fit shown in Fig. 4(a) connection 140 and the stabilizing element 450 are disposed at one end of a single tubular module 120. In other embodiments, the snap - fit connection 140 and the stabilizing element 450 are disposed on a plurality of tubular modules. Or, each tubular module can include various different snap - fit connections. For example, the snap - fit shown in Fig. 4(a) connection 140 and the stabilizing element 450 are disposed at one end of a single tubular module 120. In other embodiments, the snap - fit connection 140 and the stabilizing element The snap connection portion 140 can be combined with the snap connection portion 510 shown in FIG. 5(b). Furthermore, the embodiment shown in FIG. 6(g) shows a tubular cover 445 for the whole or only a part of the joint 130, and the tubular cover 445 can be made of a polymer or other material, such as metal.

[0061] As described above, the snap - fit connection portion 140 that can be disposed in either the distal or proximal tubular module 110, 120 may be formed from a stem structure 420 (FIG. 6(c)) that can be attached to one end of either the proximal or distal tubular module with a cantilever joint 610. The attachment portion forms an elastically deformable cantilever joint 610, and as shown further in FIG. 6(l), around it, the stem structure 420 and the locking structure 410 can bend at an angle θ in the range of about 0° to about 90° with respect to a line parallel to the longitudinal axis 620 of the first or second tubular module. FIGS. 6(l)-(o) show a plan view of the snap - fit connection portion 410 of the cantilever joint 610 in the lifted position (the tubular module is cut, spread out, and laid flat). FIG. 6(l) is a side view or a sagittal view of the lifted cantilever joint. FIG. 6(m) shows the joint as seen obliquely from the outer surface of the tubular module. FIG. 6(n) shows the joint as seen from the outside of the upper surface, and FIG. 6(o) shows the joint as seen from the inner surface of the tubular module. FIGS. 6(p)-(s) show perspective views of the cantilever joint 610 with the snap - fit connection portion 140 in the lifted position.

[0062] In addition to the snap - fit connection portion 140, at least one stabilizing element comprises a tongue - like element 450 in one of the tubular modules and a groove - like element 460 in the connection module. ​​​​​​​​​​​​​​​ . The stabilizing element 450 may be disposed laterally with respect to the snap connection around the circumference of the end of the proximal or distal tubular module 110, 120 (a second stabilizing element including tongue element 451 and groove element 461 is also shown in some figures, e.g., FIG. 6(s)). The stabilizing element may take a variety of different shapes including, but not limited to, rectangular, trapezoidal, square, circular or triangular. Functionally, the role of the stabilizing element 450 is shown in FIGS. 6(d)-(j). When the snap fit connection and snap fit receiver 140, 150 are joined to each other, the shape of the stabilizing element functions to prevent the proximal and distal tubular modules 110, 120 from rotating circumferentially at the joint 130 where the tubular modules are connected. There may be one stabilizing element (FIG. 6(e)), or two or more stabilizing elements (FIG. 6(j)), e.g., 3, 4, 5, 6, 7, 8, 9, 10 - n stabilizing elements may be present. The stabilizing element enables the transmission of forces (torque) along the longitudinal length of the catheter.

[0063] The shape of the snap fit connection used to fix two tubular modules to each other may vary. For example, in one embodiment, the snap fit connection 150 of the proximal tubular module 110 has a receiver 430 in the form of an ellipse together with a stem structure 440, and the snap fit connection 140 has a complementary shape 410 in the form of an ellipse and a stem structure 420 that fits directly into the snap fit receiver 150. This joining is shown in FIGS. 6(d)-(j) where the tubular modules 110, 120 are connected to each other, and in FIGS. 6(a)-(b) where the two tubular modules are shown disassembled or separated from each other. FIG. ​​​​​​​​​​​​​​​​​ 6(d) to (j) show snap - fit joints from several different figures. In FIGS. 6(d) to (j), the stabilization element 450 and the snap connection 140 are arranged transversely to each other around the distal tubular member.

[0064] Other shapes for the snap - fit connection may be included herein, either individually or in combination with other shapes, including semi - circular, oval, triangular, trapezoidal or irregular. In these designs, the maximum width of the locking structure 410 measured between opposite sides is greater than the width of the stem structure 420. This configuration fixes the snap - fit connection 140 within the snap - fit receiver and prevents them from being pulled apart from each other without first removing the snap - fit connection.

[0065] The edges of the snap - fit connection 140 of the distal tubular module 120 and the edges of the snap - fit receiver 150 of the proximal tubular module 110 may be chamfered so that, as shown in FIG. 6(t), the snap - fit connection and the snap - fit receiver are securely connected and do not separate or come apart after being inserted into the patient. The chamfer angle θ may be in the range of about 0° to about 90° with respect to a line formed along the longitudinal axis of the proximal and distal tubular modules. The angle θ may be in the range of about 5° to about 90°, about 20° to about 70° or 40° to about 60°. The snap - fit connection and the snap - fit receiver may also be joined by an adhesive, soldering, laser welding, welding or encapsulation within a ring, or fixing of a jacket (tubular) covering the joint. These modifications prevent the snap - fit from lifting out of the plane.

[0066] ​​​​​​​​Micrograph of the joint between the snap - fit connection part and the snap - fit receiving part according to an embodiment of the present invention As shown in FIGS. 7(a) - (f) showing micrographs, the joint between the snap - fit connection part 140 and the snap - fit receiving part 150 may be flush, that is, the surface of the snap - fit connection part does not protrude above the outer surface (outer diameter) of the snap - fit receiving part and is at the same height as the outer surface of the tubular module

[0067] FIGS. 8(a) - (h) show other embodiments of the type of joint between the proximal tubular module 110 and the distal tubular module 120 In these embodiments, the proximal and distal tubular modules 110, 120 have a connection shape including protrusions 810, 830 and receiving parts 820, 840 that are connected to each other by a joint 135 In the embodiments shown in FIGS. 8(a) - (d), the protrusions 810, 830 and the receiving parts 820, 840 are in the form of waves, sine waves, serpentines or curved elements In another embodiment, FIGS. 8(e) - (h), the connection shape 137 comprises protrusions 815, 835 and receiving parts 825, 845 in the form of a triangular or zigzag pattern The connection shapes of the protrusions and receiving parts used may all be the same, or there may be multiple types of protrusions and receiving parts on the proximal and / or distal tubular modules Generally, an embodiment can include one or more, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10 - n protrusions and receiving parts. For example, in the embodiments shown in FIGS. 8(a) - (h), there are three protrusions and corresponding receiving parts

[0068] functionally, the protrusions, for example 810, 830 and the receiving parts, for example 820, 840, connect the proximal and distal tubular modules 110, 120 ​​​120 prevents the tubular module-connected joint from rotating circumferentially. The tubular jacket can cover the connecting-shaped joint and help fix the joint.

[0069] As shown in the cross-sectional views of FIGS. 9(a) to (c), the proximal and distal tubular modules 110, 1 20 may have the same or different inner or outer diameters. The outer diameter of the proximal tubular module 110 or the distal tubular module 120 may range from about 0.5 mm to about 1 mm. The inner diameter of the proximal tubular module 110 or the distal tubular module 120 may range from about 0.10 mm to about 3.5 mm.

[0070] As shown in FIG. 9(a), the inner diameter 910 of the proximal tubular module 110 and the inner diameter 920 of the distal tubular module 120 may be the same or substantially the same. Further, the outer diameter 930 of the proximal tubular module 1 10 and the outer diameter 940 of the distal tubular module 120 may be the same or substantially the same.

[0071] Alternatively, as shown in FIG. 9(b), the proximal tubular module 110 and the distal tubular module 120 may have the same inner diameters 911, 921, but different outer diameters 931, 941 (FIG. 9(b)). In this particular embodiment, the proximal tubular module 110 has an outer diameter 931 that is larger than the outer diameter 941 of the distal tubular module 120. This is further explained in the embodiments shown in FIGS. 10(a) and 10(b). In this embodiment , in the joint between the proximal tubular member 110 and the distal tubular member 120, the proximal tubular member 110 and the distal tubular member 120 are 90° relative to each other due to the difference in their outer diameters 931, 941. ​forms an angle. FIG. 10(a) shows the difference in outer diameter 931 of the proximal tubular module 110 compared to the outer diameter 941 of the distal tubular module 120. FIG. 10(b) shows a cross-sectional view of FIG. 10(a). In the embodiment shown herein, the inner diameters of both the proximal capillary 911 and the distal tubular module 92 1 are the same.

[0072] In yet another embodiment, the proximal tubular module 110 can have both an inner diameter 912 and an outer diameter 932 that are greater than the inner diameter 922 and outer diameter 942, respectively, of the distal tubular module 120 (FIG. 9(c)). This difference is further shown in FIGS. 10(c) and 10(d), which show a partial and enlarged cross-sectional view of the embodiment shown in FIG. 9(c). In this embodiment, at the joint 130 between the proximal tubular member 110 and the distal tubular member 120, the inner diameter 922 and outer diameter 942 of the distal tubular module 120 at the joint 130 are initially the same as the inner diameter 912 and outer diameter 932 of the proximal tubular module 110. At the joint, the inner diameter 922 and outer diameter 942 of the distal tubular module 120 decrease until they are less than the inner diameter 9 12 and outer diameter 932 of the proximal tubular module 110. The decrease in the size of the inner diameter 922 and outer diameter 942 can be linear or non-linear. The proximal tubular module 110 or the distal tubular module 120 can have a varying diameter, such as a tapered configuration, over its length. It can be tapered in any direction, or there may be a taper only along a portion of the tubular module.

[0073]

[0074] The wall thicknesses of the proximal tubular module 110 and the distal tubular module 120 may vary, for example, to increase flexibility toward the distal tip end. In the embodiment shown in FIG. 9(a), the wall thickness 950 of the proximal tubular module 110 may be the same as the wall thickness 960 of the distal tubular module 120. In the embodiments shown in FIGS. 9(b) and 10(b), the wall thickness 951 of the proximal tubular module 110 is greater than the wall thickness 961 of the distal tubular module 120. However, in this embodiment, while the inner diameters 911, 921 of the proximal and distal tubular modules 110, 120 remain the same, the outer diameters 93 1, 941 of the proximal and distal tubular modules 110, 120 are different. In FIGS. 9(c), 10(c) and 10(d), the wall thickness 952 of the proximal tubular module is tapered at the joint with the distal tubular module. Similarly, the wall thickness 962 of the distal module is tapered at the joint with the proximal tubular module and may be tapered. For example, the wall thicknesses 952, 962 may increase as they move away from the joint 130 and may be the same or different from each other. Any change in the inner or outer diameter from one tubular module may incorporate a tapered transition from one tubular module to the next tubular module.

[0075] Depending on the material and the structural requirements regarding flexibility, the wall thickness of the tubular module at any point may be, for example, from about 0.05 mm to 2 mm, such as 0.05 mm to about 1 mm, about 0.1 mm , 0.2 mm, 0.3 mm, 0.4 mm, 0.5 mm, 0.6 mm, 0.7 mm, 0.8 mm, 0.9 mm, 1.0 mm, etc., and may vary. The inner diameter of the tubular module may be, for example from about 0.1 mm to about 2 mm, or from about 0.25 mm to about 1 mm, such as about 0.2 mm , about 0.3 mm, about 0.4 mm, about 0.5 mm, about 0.6 mm, about 0.7 mm, about 0.8 mm, about 0.9 mm, about 1 mm, about 2 mm, about 2.5 mm, about 3 mm in thickness, etc., can be various and acceptable. The outer diameter of the tubular module can also be, for example, about 0.2 mm to about 3 mm, for example, about 0.2 mm, about 0.3 mm, about 0.4 mm, about 0.5 mm, about 0.6 mm, about 0.7 m m, about 0.8 mm, about 0.9 mm, about 1 mm, about 1.1 mm, about 1.2 mm, about 1.3 m m, about 1.4 mm, about 1.5 mm, about 1.6 mm, about 1.7 mm, about 1.8 mm, about 1. 9 mm, about 2.0 mm, about 2.5 mm, about 3 mm in thickness, including, can be various. The tubular module wall thickness, inner diameter and outer diameter can each be constant over the length of the tubular module or may vary along the length of the tubular module.

[0076] The joint between the tubular modules may be covered or coated by a jacket or sleeve such as a polymer or the like. FIGS. 10(a) - 10(d) show an embodiment comprising a coating 1010 that covers two separate parts, the distal end of the proximal tubular module 110, and the joint 130, and a second coating 1020 that covers or coats the distal portion of the distal tubular module 120. The coatings 1010, 1020 may be the same or different. In other embodiments, a single coating (i.e., a jacket coating or a spray coating) can be used. This jacket or sleeve further joins the elements of the joint to each other and prevents the proximal tubular module 110 and the distal tubular module 1 20 from separating from each other. The entire catheter 100 or a portion of the catheter 100 ​​Only the portion, for example, can cover the proximal or distal tubular module. The coating or jacket can provide a conduit for fluid along the length of the catheter. The coating may also be limited to covering only the joint 130 where the two tubular modules are connected to each other. Alternatively, the joint can be covered by a ring to fix the joint 130. As schematically shown in FIGS. 10(e) and 10(f), the joint may also be covered by a crimping metal that tightly covers and joins the connected tubular modules. FIG. 10(e) shows the joint 135 covered by the crimping metal 1035, and FIG. 10(f) shows the joint 137 covered by the crimping metal 1036. FIG. 10(e) shows the joint 135 covered by the crimping metal 1035, and FIG. 10(f) shows the joint 137 covered by the crimping metal 1036. FIG. 10(e) shows the joint 135 covered by the crimping metal 1035, and FIG. 10(f) shows the joint 137 covered by the crimping metal 1036.

[0077] Furthermore, the inner walls of the proximal and distal tubular modules, i.e., the lumens, can be covered by an inner lining that protects the tubular modules and facilitates the conveyance of additional instrument devices such as guidewires and balloons through the catheter tube to the distal position. The inner lining can extend along a part of the proximal or distal tubular module or can extend over the entire length of the tubular module. Furthermore, the inner walls of the proximal and distal tubular modules, i.e., the lumens, can be covered by an inner lining that protects the tubular modules and facilitates the conveyance of additional instrument devices such as guidewires and balloons through the catheter tube to the distal position. The inner lining can extend along a part of the proximal or distal tubular module or can extend over the entire length of the tubular module. Furthermore, the inner walls of the proximal and distal tubular modules, i.e., the lumens, can be covered by an inner lining that protects the tubular modules and facilitates the conveyance of additional instrument devices such as guidewires and balloons through the catheter tube to the distal position. The inner lining can extend along a part of the proximal or distal tubular module or can extend over the entire length of the tubular module. Furthermore, the inner walls of the proximal and distal tubular modules, i.e., the lumens, can be covered by an inner lining that protects the tubular modules and facilitates the conveyance of additional instrument devices such as guidewires and balloons through the catheter tube to the distal position. The inner lining can extend along a part of the proximal or distal tubular module or can extend over the entire length of the tubular module. Furthermore, the inner walls of the proximal and distal tubular modules, i.e., the lumens, can be covered by an inner lining that protects the tubular modules and facilitates the conveyance of additional instrument devices such as guidewires and balloons through the catheter tube to the distal position. The inner lining can extend along a part of the proximal or distal tubular module or can extend over the entire length of the tubular module.

[0078] The jacket and the inner lining can be made of a polymer, for example, by surrounding the tube wall with a multi-layer single co-extruded polymer tubular structure, heat-shrinking the tubular structure, or coating the tube wall through a dip coating method. The material of the polymer jacket can be nylon, polyether block amide, PTFE (polytetrafluoroethylene), FEP (fluorinated ethylene propylene), PFA (perfluoroalkoxy alkane), PET (poly The jacket and the inner lining can be made of a polymer, for example, by surrounding the tube wall with a multi-layer single co-extruded polymer tubular structure, heat-shrinking the tubular structure, or coating the tube wall through a dip coating method. The material of the polymer jacket can be nylon, polyether block amide, PTFE (polytetrafluoroethylene), FEP (fluorinated ethylene propylene), PFA (perfluoroalkoxy alkane), PET (poly The jacket and the inner lining can be made of a polymer, for example, by surrounding the tube wall with a multi-layer single co-extruded polymer tubular structure, heat-shrinking the tubular structure, or coating the tube wall through a dip coating method. The material of the polymer jacket can be nylon, polyether block amide, PTFE (polytetrafluoroethylene), FEP (fluorinated ethylene propylene), PFA (perfluoroalkoxy alkane), PET (poly The jacket and the inner lining can be made of a polymer, for example, by surrounding the tube wall with a multi-layer single co-extruded polymer tubular structure, heat-shrinking the tubular structure, or coating the tube wall through a dip coating method. The material of the polymer jacket can be nylon, polyether block amide, PTFE (polytetrafluoroethylene), FEP (fluorinated ethylene propylene), PFA (perfluoroalkoxy alkane), PET (poly The jacket and the inner lining can be made of a polymer, for example, by surrounding the tube wall with a multi-layer single co-extruded polymer tubular structure, heat-shrinking the tubular structure, or coating the tube wall through a dip coating method. The material of the polymer jacket can be nylon, polyether block amide, PTFE (polytetrafluoroethylene), FEP (fluorinated ethylene propylene), PFA (perfluoroalkoxy alkane), PET (poly It may be ethylene terephthalate or PEEK (polyetheretherketone). . Further, the distal tube portion 120 (or the entire length of the catheter 100) may be coated by a hydrophilic polymer coating to improve lubricity and trackability. The hydrophilic polymer coating can include, but is not limited to, polyelectrolytes and / or nonionic hydrophilic polymers. The polyelectrolyte polymer can include poly(acrylamide-co-acrylic acid) salts, poly(methacrylamide-co-acrylic acid ) salts, poly(acrylamide-co-methacrylic acid) salts, etc. The nonionic hydrophilic polymer can be poly(lactam), for example, polyvinylpyrrolidone (PVP), poly urethane, homopolymers and copolymers of acrylic acid and methacrylic acid, polyvinyl alcohol, polyvinyl ether, snapic anhydride based copolymer, polyester, hydroxypropyl cellulose, heparin, dextran, polypeptide, etc. See, for example, U.S. Patent No. 6,458,867 and U.S. Patent No. 8,871,869. The coating can be applied by dipping coating method or by spraying the coating on the outer and inner surfaces of the tube . .

[0079] In the spray coating method, a nozzle device is used to apply a coating formulation to the surface of the device. This device has a chamber for containing the coating formulation and an opening in fluid communication with the chamber, through which the coating formulation can be dispensed and deposited on the surface. To apply a coating formulation to the surface of the tubular module of the catheter​​​​ Put the formulation into the chamber of the nozzle device and charge it using a high voltage with a conductor. When the coating formulation in the chamber becomes charged, it acquires the same charge as the conductor. As a result, the formulation and the conductor repel each other. This repulsive force causes the coating formulation to be discharged through the opening of the nozzle, creating a stream of droplets. An additional gas source can be used to spray the coating formulation. When the coating formulation in the chamber becomes charged, it acquires the same charge as the conductor. As a result, the formulation and the conductor repel each other. This repulsive force causes the coating formulation to be discharged through the opening of the nozzle, creating a stream of droplets. An additional gas source can be used to spray the coating formulation. This repulsive force causes the coating formulation to be discharged through the opening of the nozzle, creating a stream of droplets. An additional gas source can be used to spray the coating formulation. An additional gas source can be used to spray the coating formulation.

[0080] One or both of the tubular modules 110, 120 can further include a filament 1100. FIGS. 11(a) - 11(e) depict the filament 1100 wound around the distal tubular module 120. In FIGS. 11(a) - 11(c), the filament 1100 is wound helically around the distal tubular module 120. FIGS. 11(a) and 11(b) show the catheter, i.e., the tubular module, in a straight configuration, and FIG. 11(c) shows the catheter, i.e., the tubular module, in a curved configuration. Generally, the filament 1100 is disposed on the outer surface of the distal tubular module 120 and surrounds all or part of the distal tubular module 120. The filament 1100 advances helically around the distal tubular module 120, forming a helical structure on the outer surface of the tubular module. In certain embodiments, a helical filament can be wound around the proximal tubular module. The filament can be wound around the tubular module clockwise or counterclockwise. One or both of the tubular modules 110, 120 can further include a filament 1100. FIGS. 11(a) - 11(e) depict the filament 1100 wound around the distal tubular module 120. In FIGS. 11(a) - 11(c), the filament 1100 is wound helically around the distal tubular module 120. In FIGS. 11(a) - 11(c), the filament 1100 is wound helically around the distal tubular module 120. FIGS. 11(a) and 11(b) show the catheter, i.e., the tubular module, in a straight configuration, and FIG. 11(c) shows the catheter, i.e., the tubular module, in a curved configuration. FIGS. 11(a) and 11(b) show the catheter, i.e., the tubular module, in a straight configuration, and FIG. 11(c) shows the catheter, i.e., the tubular module, in a curved configuration. Generally, the filament 1100 is disposed on the outer surface of the distal tubular module 120 and surrounds all or part of the distal tubular module 120. Generally, the filament 1100 is disposed on the outer surface of the distal tubular module 120 and surrounds all or part of the distal tubular module 120. The filament 1100 advances helically around the distal tubular module 120, forming a helical structure on the outer surface of the tubular module. The filament 1100 advances helically around the distal tubular module 120, forming a helical structure on the outer surface of the tubular module. In certain embodiments, a helical filament can be wound around the proximal tubular module. The filament can be wound around the tubular module clockwise or counterclockwise.

[0081] The filament 1100 can be adhered to or attached to the tubular module in a variety of different ways. In one embodiment, the filament 1100 is firmly attached to the tubular module. In one embodiment, the filament 1100 is firmly attached to the tubular module. Connect and adapt one or more bands or covers around it to the tubular module. Other embodiments can include wedging, hooking, attaching, joining, or adhering a filament within or onto the tubular module. FIG. 11(a) shows bands 1102, 1104 that securely fix filament 1100 to distal tubular module 120. Furthermore, in some embodiments, a jacket covering one or more of the tubular modules also covers filament 1100. This cover securely fixes the filament in place relative to the tubular module. Add a smooth coating or film over the jacket to facilitate the movement of a catheter through a blood vessel. The smooth coating can be composed of, for example, silicone or a hydrogel polymer such as, for example, a vinyl polymer, a polyalkylene glycol, an alkoxysilane polyethylene glycol, or an uncrosslinked hydrogel such as a polymer network of polyethylene oxide (PEO). In other embodiments, such as FIGS. 11(d) and 11(e), filament 1100 is screwed into a coating 1020 of one or more of the tubular modules. FIGS. 11(d) and 11(e) show cross-sectional views of filaments attached to the outer surface of distal tubular module 120. As shown in FIGS. 11(d) and (e), the cross-sectional view of filament 1100 can be circular. Alternatively, the cross-section of filament 1100 can have a different shape, such as, for example, square, rectangular, triangular, hexagonal, semi-circular, or oval.

[0082]

[0083] ​​​​​​​​​​​​Torque 1100 can be screwed (or unscrewed) through, for example, narrow tapered diameter blood vessels, such as a nascent plaque region and a restenosis section of a target blood vessel, or an occluded section within the arterial wall. When the filament 1100 contacts the blood vessel and / or the occluded section and torque is applied to the catheter, the filament facilitates the forward movement of the catheter through the intermediate blood vessel and plaque to reach the target blood vessel. For example, when rotating the catheter system 100, the filament 1100 can be used to facilitate the perforation or drilling of calcified atherosclerotic plaques. The filament 1100 converts rotational motion into linear motion and converts torque into linear force, thereby further facilitating the advancement of the catheter through the blood vessel, particularly in regions where calcification has progressed substantially. The filament 110 0 can also be used as a fixing mechanism, such as creating a clamping force against the wall of the blood vessel to fix the catheter at a specific position within the blood vessel. To remove the catheter without peeling the wall of the blood vessel, the catheter must be retracted in the opposite direction using the same screw-like movement. The circular cross-section minimizes damage to the arterial wall due to its rounded surface. The pitch angle of the helical thread can remain constant. By adhering the helical thread section to the outside of the module, it is possible to maintain a constant pitch angle over the length of the helical section.

[0084] The filament may be of the same material as or different from the tubular modules 110, 120. Alternatively, in some embodiments, the filament 1100 may be made of a polymer.

[0085] ​​​​The proximal tubular module 110 and the distal tubular module 120 can include at least one additional cutout opening that penetrates the wall, as shown in FIGS. 12(a) through 12 (d) and FIG. 14. The cutout openings can be on the same or different tubular modules. The first cutout opening 1200 shown in FIGS. 12(a) - (d) can be arranged within a segmented helix. The first cutout opening 1200 can be oriented at a right angle to the longitudinal axis 1

[0086] 400 of the tubular module or can be arranged at an angle to the longitudinal axis 1400. As shown in FIG. 13, the filament 1100 can be attached to the tubular module at the first cutout opening 120 0. As shown in FIG. 14, the second cutout opening 1300 can generally be formed in an "L" shape and can be located near or adjacent to the crown 160 where the tip 170 is fixed to the tubular module 120, at the distal end of the tubular module 120. In one embodiment the first cutout opening 1200 and the second cutout opening 1300 are arranged on the same tubular module. As shown in FIGS. 15(a) - (c), the filament 1100 can be attached to the second cutout opening 1300.

[0087] The walls of the cutout openings 1200, 1300 can be chamfered or have their corners rounded. The chamfering angle θ can range from about 20° to about 70° or from about 40° to about 60° with respect to the long axis 1400 of the tubular module. The shapes of the cutout openings 1200, 1300 can be various, such as elliptical, square, L-shaped (see 1300 in FIG. 14), V-shaped, curved, or circular The first cutout opening 1200 and the second cutout opening 1300 are arranged on the same tubular module. As shown in FIGS. 15(a) - (c), the filament 1100 can be attached to the second cutout opening 1300. The walls of the cutout openings 1200, 1300 can be chamfered or have their corners rounded. The chamfering

[0088] angle θ can range from about 20° to about 70° or from about 40° to about 60° with respect to the long axis 1400 of the tubular module. The shapes of the cutout openings 1200, 1300 can be various, such as elliptical, square, L-shaped (see 1300 in FIG. 14), V-shaped, curved, or circular The walls of the cutout openings 1200, 1300 can be chamfered or have their corners rounded. The chamfering angle θ can range from about 20° to about 70° or from about 40° It may be.

[0089] Figures 14, 15(a) - 15(c), and 16(a) - 16(f) show an embodiment where the distal end of the distal tubular module 120 has a crown 160. The crown 160 may be made from a plurality of closed curve elements that can be in a sine wave shape or generally a wavy (serpentine) shape. In one embodiment, for example, there may be a plurality of curve elements in the range of 5 to 20. Figures 15(a) - (c) show an embodiment where the tip 170 is attached to the distal tubular module 120. The filament 1100 is attached to the cut - out opening 1300 at the distal end 160 of the distal tubular module 120. The distal tubular module 120 and also the tip 170 may be covered by a jacket 175. The jacket can act to fix the tip 170 to the distal end 160 of the distal tubular module 120. .

[0090] In one embodiment shown in Figures 16(a) - (d), the distal end 160 of the distal tubular module 12 0 can be attached to the tip 170. The tip may comprise a hollow tubular body and may be tapered conically as shown in Figures 16(a) and 16(b). Further, threads can be cut on the hollow tubular body of the tip. The tip 170 may be covered by a jacket 175. Figure 16(c) shows a view of a relatively elongated tip 171, and Figure 16 (d) shows a view of a relatively short tip 172. The tip may be configured to be different from the catheter or the proximal or distal tubular module in terms of taper, durometer, rigidity, shape, length, radiation non - permeability, profile, and composition. The tip may have shape memory. It can be made of a superelastic alloy. The shape of the tip can be set by heat treatment. For example, the tip may be made of a radiopaque material such as gold, or a radiopaque material may be incorporated.

[0091] As shown in FIGS. 16(e) and (f), due to the curved structure (e.g., protrusions) of the crown 160, the surface area (SA1) of the crown can be larger than the surface area (SA2 ) of the distal end of the distal tubular module. The relatively large surface area of the crown allows for a relatively large surface area contact, and thus bonding, between the crown 160 and the tip 1 70.

[0092] As shown in FIGS. 17(a)-(c), the filament 1100 can be spirally wound around both the proximal or distal tubular modules 110, 120 and can continue to be spirally wound around the tip 1 70. As shown in FIG. 17(b), in an embodiment where the tip is a hollow tube including threads, the filament can fit into the threads of the tip. The filament 1100 may proceed around all or only a part of the tip 170. The filament may be wound around the module in a clockwise or counterclockwise spiral. In other embodiments, a tip having its own thread structure may be manufactured. The filament at the tip may be covered by a jacket.

[0093] In another embodiment shown in FIGS. 19(a) and 19(b), a reentry tip can be connected to the distal end of the distal tubular module regardless of whether it directly engages the protrusion of the crown 160. A detailed description of catheter reentry is incorporated herein by reference in its entirety. ​​​​​​​"Vascular Re-entry Catheter" incorporated herein and entitled, found in U.S. Patent Application No. 14 / 854,242, jointly owned and assigned . When using a modular catheter with a re-entry tip, it can be used in procedures that include re-entering the true lumen after creating an incision plane.

[0094] Examples of re-entry tips are shown in FIGS. 18(a) - 18(d). FIG. 18(a) shows a re-entry tip 1810 having a smooth surface and two wings disposed on both sides of the re-entry tip. FIG. 18(b) shows a re-entry tip 1820 having a depression in its surface around the overall diameter of the tip. FIG. 18(c) shows a re-entry tip 1830 having a depression in its surface around the overall diameter of the tip and two wings disposed on both sides of the re-entry tip. FIG. 18(d) shows a re-entry tip 1840 having a smooth surface and no wings. As shown in FIGS. 19(b) - 19(c), the modular catheter system 100 can further include at least one side port 1900. As shown in FIGS. 19(a) and 19(d), some embodiments have two side ports 1900a,

[0095] 1900b. Three or more side ports can be used. In embodiments having multiple side ports, all side ports can be linearly aligned along the length of the catheter system 100. In other embodiments, the side ports can be aligned around the diameter of the catheter system 100. The side ports are part of the catheter system 100. As shown in FIGS. 19(a) and 19(d), some embodiments have two side ports 1900a, 1900b. Three or more side ports can be used. In embodiments having multiple side ports, all side ports can be linearly aligned along the length of the catheter system 100. In other embodiments, the side ports can be aligned around the diameter of the catheter system 100. The side ports are part of the catheter system 100. Can it be evenly spaced along the length of the Lucis system 100 or spaced at specific positions? In another embodiment, the side ports are disposed on the distal tubular module 120.

[0096] Referring to FIG. 19(a), the side ports 1900a and 1900b can be arranged radially offset from each other by approximately 1 80°, for example, approximately 180° (±10°). The reentry tip 1810 also includes wings 1811, 1 812 arranged at an interval of approximately 180°. Generally, the radial displacement of the side port with respect to the wing can be in the range of approximately 0° to 9 0°, for example, 10°, 20°, 30°, 50°, 70° and 80°. In one embodiment, the position of the side port may be radially offset from the wing by approximately 90°. In this way, when the two wings 1811 and 1812 are arranged in a stable configuration within the subintimal space of the artery, port 1900a may face or be opposite to the true lumen of the artery, and port 1900b may face the opposite side.

[0097] The side port may have a symmetric shape and may be circular, semi-circular, oval, semi-oval, rectangular or semi-rectangular. The side ports may have the same shape and size (i.e., surface area) or may be different from each other and are configured to allow a reentry wire or another medical device to pass through the port. The dimensions of the port are adjusted to accommodate various types of medical devices or wires having a diameter in the range of, for example, approximately 0 .05 mm to approximately 1.0 mm. Erglis et al., Eurointervention 2010:6,1-8. The distal tube portion 120 can be radially along its longitudinal direction as desired​​​​ Three or more outlet ports, such as 3, 4, 5, 6, 7, 8 to n ports distributed in the direction It can include.

[0098] The side ports may be chamfered. The chamfered configuration of the side ports is The reentry wire with the end is designed to smoothly exit the side port and facilitate retraction. The chamfer angle θ can be set to 10° to about 90°, about 20° to about 70°, or 40° to about 90°. The angle may range from about 0° to about 90°, including from about 0° to about 60°.

[0099] In one embodiment, the positioning of the catheter 100 within the lumen of the blood vessel is visualized by x-ray photography. At least two radiopaque markers are provided on the distal tubular portion 1 to aid in the identification of the The markers may be made of a radiopaque material, such as a wire coil or The bands are formed by evaporation deposition of metals such as platinum, platinum-iridium, tantalum, and gold, as well as by radiation. Radiopaque powders or fillers, e.g., embedded or encapsulated in a polymer matrix barium sulfate, bismuth trioxide, bismuth subcarbonate, etc., or The markers may be made from a radiopaque polymer, such as radiopaque polyurethane. The marker may be in the form of a band for surrounding the outer sheath of the distal tubular portion. That's fine.

[0100] The distal tube portion 120 is targeted using a radiopaque marker configured as a band. Facilitate determining the location of the side port while maneuvering within the anatomy of the The markers can also be used to provide a partial alignment with the corresponding side port. Can be configured as a band or patch. For example, one marker on the side pole can be axially aligned with the T1900a, and the second marker can be axially aligned with the side port 1900 b. Thus, similar to the configuration where the side ports 1900a and 19 00b face each other radially, the markers also face each other radially. In this way, the visualization of the markers can be used to determine the orientation of each side port. The markers can be configured in different shapes, for example, partially circumferential bands, or any other desired shape, to facilitate the determination of the port orientation.

[0101] The markers can also be configured as surface patches surrounding the respective side ports 1900a and 1900b. In such embodiments, the position of the marker that can be visualized directly corresponds to the position of the side port. In such embodiments, the position of the marker that can be visualized directly corresponds to the position of the side port. The position of the marker that can be visualized directly corresponds to the position of the side port.

[0102] The markers need to have sufficient size and suitable configuration / structure (e.g., type of radiation-impermeable material, filling amount of radiation-impermeable material, etc.) so that they can be visualized by appropriate X-ray imaging assistance. sufficient size and suitable configuration / structure (e.g., type of radiation-impermeable material, filling amount of radiation-impermeable material, etc.) so that they can be visualized by appropriate X-ray imaging assistance. sufficient size and suitable configuration / structure (e.g., type of radiation-impermeable material, filling amount of radiation-impermeable material, etc.) so that they can be visualized by appropriate X-ray imaging assistance.

[0103] The flexibility of the variability of the tubular module portion also facilitates surgical procedures that require side branch access or encounter tortuous vasculature in the central nervous system, etc. A wide variety of combinations from the mechanical properties of the bare tube material, tube dimensions (OD / ID), wall thickness, and the mechanical properties of the cut tube resulting from the cut pattern along the tube (material composition, UTS, % elongation, modulus of elasticity), and other combinations of material and mechanical properties (UTS, cut pitch angle, cut width, helical cut arc length, and formulas defining the uncut helical interval between the helical cut arc and the next helical cut arc) are used. formulas defining the uncut helical interval between the helical cut arc and the next helical cut arc) are used. formulas defining the uncut helical interval between the helical cut arc and the next helical cut arc) are used. formulas defining the uncut helical interval between the helical cut arc and the next helical cut arc) are used. formulas defining the uncut helical interval between the helical cut arc and the next helical cut arc) are used. Considering the capabilities for use, all of these enable the designer to adjust various mechanical properties defined over the travel length of the cut-in tube. Such properties obtained as a result of using rigidity, flexibility, and shape memory define a preset curve shape and are programmable and changeable.

[0104] Furthermore, such an induced shape memory form straightens or contracts along the cut and shape processing part of the distal tubular section through a resistive loading force, maintains, and orients the shape setting part of the tube, which will enable the catheter to be advanced to the vascular target. A greater force will be required to return it to the straight concentric coaxial configuration.

[0105] Variables such as those constructed together to create a wide variety of structural shape combinations of the tubular module. These structural shapes exhibit mechanical deformation characteristics that exceed the spring constant of the curved shape, such as wire following, for example, advancing the tubular module through a guide wire, and can be easily temporarily reduced in series. This temporary deformation enables the catheter (tubular module) to be advanced through the anatomical structure of the blood vessel via a guide wire. Simply put, the spring constant of the formed curve part is smaller than that of the wire section it follows. When the spring constant of the holding guide wire section becomes smaller than the spring constant of the preset curve shape, the cut-in shaped tube section returns to its predetermined shape unless affected by additional external forces or vascular constriction.

[0106] The distal module of the present invention, by applying shape memory, can bend or get caught. or can include a portion that is set at a fixed position in a curved shape. As described above Superelastic alloys containing nitinol have this property and can be deformed by heating as described. FIGS. 20(a) and 20(b) respectively show a side view and an end view of the distal end of a catheter according to the present invention including this feature. As shown in the side view, a part of the distal tubular module 2020 includes a curved portion 2030 that bends at its distal end. The bent portion can be at least one of a curve, sine curve, non-linear portion, angular, mountain, valley, wavy, curved and spiral The bent portion can have variable rigidity. The bent portion can have a rigidity coefficient greater than that of the remaining portion of the elongated member The curved portion can bend at about 0° to about 1 80° with respect to the longitudinal axis (L, FIG. 21(a)) of the tubular module. The curve shape of this portion can be various and can include flat, simple curve

[0107] , complex curve, reverse curve or double curve. The length of the curved portion can be various and can include only a part of the tubular module or the entire length. In the embodiment shown in FIG. 20(a), the curved portion 2030 takes 45° unless a force such as a guide wire is applied to straighten its configuration or otherwise change its configuration. Various means such as a guide wire inserted into the lumen of the tubular module and coaxial with the lumen of the tubular module can be used to apply a force. The end view of FIG. 20(b) shows the lumen 2050 of the distal tubular module. This cross-section of the lumen remains constant during the bending of the curved portion 2030 This constant cross-sectional lumen facilitates the passage of wires and other devices through the vascular system In the embodiment shown in FIG. 20(a), the curved portion 2030 takes 45° unless a force such as a guide wire is applied to straighten its configuration or otherwise change its configuration. Various means such as a guide wire inserted into the lumen of the tubular module and coaxial with the lumen of the tubular module can be used to apply a force. The end view of FIG. 20(b) shows the lumen 2050 of the distal tubular module. This cross-section of the lumen remains constant during the bending of the curved portion 2030 This constant cross-sectional lumen facilitates the passage of wires and other devices through the vascular system The force may be applied through various means such as a guide wire inserted into the lumen of the tubular module and coaxial with the lumen of the tubular module. The end view of FIG. 20(b) shows the lumen 2050 of the distal tubular module. This cross-section of the lumen remains constant during the bending of the curved portion 2030 The end view of FIG. 20(b) shows the lumen 2050 of the distal tubular module. This cross-section of the lumen remains constant during the bending of the curved portion 2030 The end view of FIG. 20(b) shows the lumen 2050 of the distal tubular module. This cross-section of the lumen remains constant during the bending of the curved portion 2030 This constant cross-sectional lumen facilitates the passage of wires and other devices through the vascular system .

[0108] The catheter includes a guidewire that can pass through the lumen of the tubular module. It can. The tubular module can be passed into the artery via the guidewire. The guidewire is typically relatively thin and has a diameter of about 0.254 mm to 0.457 mm. The guidewire can transmit rotation from the proximal end of the guidewire to the distal end of the guidewire. This transmission enables the physician to controllably maneuver the guidewire through the bifurcations of the patient's artery and manipulate the catheter to the target site of interest within the coronary artery. Furthermore, the distal end of the guidewire needs to be flexible enough to allow the distal portion of the guidewire to pass through the sharply curved and tortuous coronary anatomy. Among the common guidewire configurations used in angioplasty, there are guidewires of the type shown in U.S. Patent No. 4,545, 390. Such wires typically include an elongated flexible shaft formed of stainless steel having a tapered distal portion and a helical coil attached around the tapered distal portion.

[0109] The substantially tapered distal portion of the shaft serves as a core for the coil and is configured to still transmit rotation from the proximal end to the distal end of the guidewire while following the curves of the vascular anatomy so that the physician can controllably maneuver the guidewire through the patient's blood vessels. This results in a guidewire with increased flexibility at the distal portion. The characteristics of the guidewire are significantly affected by the details of the structure as the distal tip of the guidewire. For example, in certain types of tip structures, the tapered core wire passes through the helical coil to the distal tip of the coil. The distal tip of the coil. The distal tip of the coil. The distal tip of the coil. The distal tip of the coil. The distal tip of the coil. The characteristics of the guidewire are significantly affected by the details of the structure as the distal tip of the guidewire. For example, in certain types of tip structures, the tapered core wire passes through the helical coil to the distal tip of the coil. extends fully to and is directly attached to a tip weld that is smoothly rounded at the distal tip of the coil Such a structure typically results in a relatively stiff tip that is particularly suitable for use when attempting to push a guide wire through a narrow stenosis In addition to high column strength, such a tip also exhibits excellent torsional characteristics

[0110] In another type of tip structure, the tapered core wire terminates just before the tip weld In such a structure, it is common to attach a very thin metal ribbon to the core wire at one (proximal) end and to the tip weld at the other (distal) end The ribbon functions as a safety element to maintain the connection between the core wire and the distal tip weld in the event that the coil breaks The ribbon also serves to hold bends formed in the ribbon to maintain the tip in a bent configuration, as desired when manipulating and steering the guide wire Furthermore, by terminating the core wire before the tip weld, the section of the helical coil between the distal end of the core wire and the tip weld becomes extremely flexible and pliable A flexible tip is desirable in situations where the vasculature is highly tortuous and the guide wire must conform to and follow a tortuous anatomical structure while minimizing trauma to the blood vessel In another type of tip structure, the most distal section of the core wire is flattened (flattened out) so as to function as a single piece integral with the core wire and perform the same function as the formed ribbon The tip of the flattened section is attached to the tip weld

[0111] Guide wires are well known in the art and are guides for using the catheters of the present invention ​​​​​​The appropriate selection of the wire can be made by medical professionals such as interventional cardiologists or interventional radiologists. It can be performed accordingly.

[0112] Figures 21(a) and 21(b) show a side view and an end view of another embodiment of the distal end of the catheter according to the present invention. In this embodiment, the distal tubular module 2120 has a curved portion 2130 at its distal end that naturally bends 90° from the point where the curved portion 2130 connects to the rest of the distal tubular module (i.e., the horizontal axis) to the tip 2140. The curved portion bends 90° unless a force is applied to straighten its configuration or otherwise change it. The end view of Figure 21(b) shows the lumen 2150 of the distal tubular module. This lumen can maintain a constant cross-section within the distal tubular module, and the lumen is maintained within the curved portion 2130.

[0113] Figure 22 shows a side view of yet another embodiment of the distal end of the catheter according to the present invention. In this embodiment, the curved portion 2230 of the distal capillary module 2220 bends approximately 180° further so that the tip 2240 faces the distal tubular module and is aligned substantially parallel to the longitudinal axis L of the distal tubular module.

[0114] Figures 23 to 25 show three parts of a procedure in which the tubular module includes a curved portion together with a guide wire. Any conventional guide wire may be used with the present invention. For example, the central core of the guide wire may be formed of stainless steel, Durasteel (trademark), or nitinol / Lastinite (registered trademark). The guide wire may be covered with a polymeric sleeve or a coil spring tip and coated with a smooth coating. ​ Good.

[0115] Figure 23 is a cross-sectional view showing a distal tubular module having a curved portion 2330 that is straightened by passing a guide wire 2310 through a tubular module 2320 and a distal tip 2340. As shown, the guide wire 2310 passes through the end of the distal tubular module 2320, through the shape memory curved portion 2330, and beyond the distal tip 2340 of the tubular module. At this position, the guide wire 2310 aligns or keeps straight the curved portion 2330 with respect to the longitudinal axis (L) of the distal tubular module 2320, preventing the curved portion from bending according to its shape memory. In other words, the spring constant of the curved portion 2330 is less than that of the guide wire 2310 section that the distal tubular module 2320 follows. If the spring constant of the holding guide wire 2330 section is less than that of the curved portion 2330, the curved portion 2330 will return to its predetermined shape unless affected by additional external forces or vessel confinement. In Figure 24, the guide wire 2310 is withdrawn leftward (as indicated by the arrow) a distance (L1) within the preset curved portion 2330 of the distal tubular module 2320 from the distal tip 2340. As shown in Figure 24, when the guide wire 2310 is withdrawn, the preset curved portion 2330 begins to bend and takes its predetermined shape as described above. In Figure 25, the guide wire 2310 is further withdrawn (i.e., L2 > L1) from the position shown in Figure 24 within the curved portion 2330. As a result, the curved portion 2330 is at the tip

[0116]

[0117] ​​​​​​​​​​​The angle (Ψ) between the direction in which section 2340 faces and the longitudinal axis L of the distal tubular module 2320 continues to bend according to its shape memory so that it becomes greater than 90°. The range of bending is in the range of approximately 0° to approximately 180° with respect to the longitudinal axis L. In this embodiment, at this position the distal end of a certain distal tubular module is configured in the shape of a "shepherd's hook", and this configuration is well adapted to access the side branches of the arterial system or to access the tortuous vascular system as well.

[0118] FIG. 26 shows an example of a catheter and a distal tubular module having a shape memory curve portion that can be applied to collateral artery access and is shown together with the aortic bifurcation 26 02 and the collateral artery 2604 that joins and branches off from the aorta 2602. The distal end of the catheter including the distal tubular module 2620 is shown together with a preset curve portion 2630 and a tip portion 2640. In the figure, the guide wire 2610 has been withdrawn from the curve portion 26 30, enabling the curve portion to bend up to approximately 180° with respect to the longitudinal axis of the tubular module (see L in FIGS. 23 to 25 above). When the catheter including the distal tubular module 2620 is moved laterally within the artery, the curve portion 2630 can enter the collateral 2604. Note that torque force may be applied to the catheter by rotating the hub, thereby enabling the proximal and distal tubular modules to rotate around the central axis

[0119]

[0120] of the catheter.

[0120] FIG. 28(a) shows the main blood vessel 280 together with a single collateral artery (also called a side branch) 2804 A cross-sectional view of the arterial system including 2 is shown. In the illustrated example, the diameter of the aorta 2802 is larger than the diameter of the first collateral 2804. The distal tubular module 2820 is disposed within the artery 2802 as shown, where the distal tubular module extends beyond the collateral artery 2804. The guide wire 2810 extends beyond the end of the distal tubular module 2820 and the tip 2840 . The guide wire 2810 includes a tapered portion 2814. As described above, the guide wire 28 10 straightens the preset curved portion 2830 of the distal tubular module 2820 .

[0121] FIG. 28(b) shows that the guide wire 2810 is partially withdrawn from the distal tubular module 2820, allowing the curved portion 2830 to bend. The tip 2840 and the tapered end 2814 of the guide wire 2810 change position according to the bending of the curved portion 2830, and the tip 2 840 is positioned so as to enter the collateral of the artery 2804 or be able to enter the collateral 2804.

[0122] In FIG. 28(c), the guide wire 2810 has been further withdrawn from the distal tubular module 2820. The tip 2840 and the tapered end of the guide wire 2814 are aligned with the axis of the collateral 28 04.

[0123] In FIG. 28(d), the tapered end of the guide wire 2814 extends into the collateral 2804 beyond the tip 2840. Then, in FIG. 28(e), the distal tubular module 2820 is advanced downward through the collateral 2804 via the guide wire 2810.

[0124] FIG. 29(a) shows another method for enabling access to the arterial collateral. Shown As shown, a distal tubular module 2920 including a preset curved portion 2930 and a tip portion 2940 is disposed within the aorta 2902 with the guide wire withdrawn. The preset curved portion 2930 and the tip portion 2940 are disposed beyond (in the forward direction) the junction of the aorta 2902 and the side branch 2904. Due to the shape memory of the preset curved portion 2930, this portion and the tip portion are bent or shown in the Shepard's hook position. In the illustrated example, the tip portion is bent 180° in the reverse direction parallel to the longitudinal axis. The preset bend can also be at other angles (e.g., 45°, 90°, 120°, etc.). When the distal tubular module 2920 is withdrawn from this position, a torque force 2945 can be applied to rotate the distal tubular module 2920 clockwise or counterclockwise. Then, the distal tubular module 2920 can be inserted into the side branch 2904. 2920 is arranged in the aorta 2902 with the guide wire pulled out. The preset curved portion 2930 and the tip portion 2940 are arranged beyond (in the forward direction) the junction of the aorta 2902 and the side branch 2904. The preset curved portion 2930 and the tip portion 2940 are arranged beyond (in the forward direction) the junction of the aorta 2902 and the side branch 2904. Due to the shape memory of the preset curved portion 2930, this portion and the tip portion are bent or shown in the Shepard's hook position. In the illustrated example, the tip portion is bent 180° in the reverse direction parallel to the longitudinal axis. Due to the shape memory of the preset curved portion 2930, this portion and the tip portion are bent or shown in the Shepard's hook position. In the illustrated example, the tip portion is bent 180° in the reverse direction parallel to the longitudinal axis. In the illustrated example, the tip portion is bent 180° in the reverse direction parallel to the longitudinal axis. The preset bend can also be at other angles (e.g., 45°, 90°, 120°, etc.). When the distal tubular module 2920 is withdrawn from this position, a torque force 2945 can be applied to rotate the distal tubular module 2920 clockwise or counterclockwise. When the distal tubular module 2920 is withdrawn from this position, a torque force 2945 can be applied to rotate the distal tubular module 2920 clockwise or counterclockwise. Then, the distal tubular module 2920 can be inserted into the side branch 2904.

[0125] FIG. 29(c) shows the distal tubular module 2920 and the tip portion 2940 further advanced into the side branch 2904 from the position shown in FIG. 29(b). In FIG. 29(c), the tip portion approaches alignment with the axis of the side branch 2904. FIG. 29(c) shows the distal tubular module 2920 and the tip portion 2940 further advanced into the side branch 2904 from the position shown in FIG. 29(b). In FIG. 29(c), the tip portion approaches alignment with the axis of the side branch 2904. In FIG. 29(c), the tip portion approaches alignment with the axis of the side branch 2904.

[0126] FIG. 29(d) shows the continuous advancement of the distal tubular module 2920 through the first side branch 2904. The guide wire 2910 can be used to straighten the curved portion 2930 to enable the catheter to advance through the lumen of the side branch 2804. Due to the designed flexibility of the distal tubular module, the distal tubular module can bend to adapt to a sharp rotation angle 2924. FIG. 29(d) shows the continuous advancement of the distal tubular module 2920 through the first side branch 2904. The guide wire 2910 can be used to straighten the curved portion 2930 to enable the catheter to advance through the lumen of the side branch 2804. The guide wire 2910 can be used to straighten the curved portion 2930 to enable the catheter to advance through the lumen of the side branch 2804. Due to the designed flexibility of the distal tubular module, the distal tubular module can bend to adapt to a sharp rotation angle 2924. Due to the designed flexibility of the distal tubular module, the distal tubular module can bend to adapt to a sharp rotation angle 2924.

[0127] In short, in both single-side branch access methods, the preset curved section of the distal tubular module is used like a hook to create a secure fixation for advancing into the side branch, ultimately enabling the catheter to advance through multiple arterial blood vessels and side branches.

[0128] Figure 30(a) shows an arterial system including the aorta 3002, the collateral artery 3004, and the secondary collateral 3006 emerging from the collateral 3004. A path 3008 for advancing a catheter through the aorta 3002 and the two collaterals 3004, 30 06 is shown. Figure 30(b) shows the distal tubular module 3020 penetrating the collateral 3004 by the method described above with respect to FIGS. 28(a) - 28(e) and FIGS. 29(a) - 29(d). The tip 3040 and the tapered end of the guide wire 3014 extend substantially perpendicular to the axis of the second branch 3006. In Figure 30(c), the guide wire 3010 is partially withdrawn, and torque forces 3045, 3046 are applied to the distal tubular module 3020. Due to the structure of the catheter, torque is transmitted to the tip 3040 and the curved portion 3030 (as indicated by the curved arrow 3046). The torque force bends the tip 3040 in a direction away from the axis of the first branch 3004. As shown in Figure 30(d), the combination of the torque force and the lateral movement enables the tip 3040 to access the second collateral 3006. In Figure 3 0(e), the guide wire 3010 advances through the distal tubular module 3020 and the tip 304 0, enabling the distal tubular module 3020 to be transported through the path defined by the guide wire 3010.

[0129] Due to the modular structure of the catheter system according to the present invention, for use in various procedures By changing the distal tubular module of the catheter system, a group of micro-catheters can be created. A micro-catheter is typically a single-lumen device that can be attached to a guide wire to follow the guide wire to the target lesion . A typical outer diameter (OD) ranges from about 1.30 mm at the proximal portion of the shaft to about 0.70 mm at the distal portion or tip of the shaft . The inner diameter of the lumen of the distal tubular module can vary and, when used as a micro-catheter, can be tapered . The trackability and pushability of the distal tubular module can vary as described above . The distal tubular module can be designed to address specific anatomical challenges, such as use in antegrade or retrograde procedures, use in peripheral vascular access procedures, or use as a reentry catheter . The distal tubular module and the proximal tubular module can be pre-assembled with the proximal tubular module attached to one of the various distal tubular modules . Alternatively, the distal tubular module and the proximal tubular module can be separated and assembled immediately before use . The design of the distal tubular module can be changed, such as by using different materials in manufacturing . Also, by simply reducing the outer diameter in a serial stepwise manner while maintaining a constant inner diameter, machining or grinding the tubular module material to change the wall thickness along the length of the tubular module, or laser cutting, removing, machining, or grinding the tubular module material to create specific design features along the surface of the tubular module, such as at specific locations The distal tubular module and the proximal tubular module can be pre-assembled with the proximal tubular module attached to one of the various distal tubular modules . Alternatively, the distal tubular module and the proximal tubular module can be separated and assembled immediately before use .

[0130] The design of the distal tubular module can be changed, such as by using different materials in manufacturing . Also, by simply reducing the outer diameter in a serial stepwise manner while maintaining a constant inner diameter, machining or grinding the tubular module material to change the wall thickness along the length of the tubular module, or laser cutting, removing, machining, or grinding the tubular module material to create specific design features along the surface of the tubular module, such as at specific locations . By machining or grinding the tubular module material to change the wall thickness along the length of the tubular module, or by laser cutting, removing, machining, or grinding the tubular module material to create specific design features along the surface of the tubular module . For example, at specific locations . or create a thread design engraved from a tubular module material along a defined length By doing so, the variable wall thickness of the serially stacked distal tubular module 1 can be changed The design of 20 can also be changed by using segmented helical cuts stacked along the length of the tubular module These segmented helical cut patterns can be changed by using turns. These segmented helical cut patterns The turn variables can include, for example, the cut pitch angle, laser cut path width, or variable cut pattern stacked along the length of the tubular module, having a pattern of segmented cut and non-cut angles along the helical cut Another specific example of the use of the modular catheter system would be for making a microcatheter device. Such a microcatheter can include a base microcatheter as one of the tubular modules This base microcatheter can be used for an antegrade approach, access narrow lesions, and have support by a backup wire

[0131] The second tubular module can be one of various microcatheters. These devices can access peripheral and neurovascular arteries and can be used for many disease management applications and should not be limited to only the examples provided herein and have support by a backup wire. The second tubular module can be one of various microcatheters These devices can access peripheral and neurovascular arteries and can be used for many disease management applications and should not be limited to only the examples provided herein and have support by a backup wire. The second tubular module can be one of various microcatheters These devices can access peripheral and neurovascular arteries and can be used for many disease management applications and should not be limited to only the examples provided herein These devices can access peripheral and neurovascular arteries and can be used for many disease management applications and should not be limited to only the examples provided herein These devices can access peripheral and neurovascular arteries and can be used for many disease management applications and should not be limited to only the examples provided herein and should not be limited to only the examples provided herein

[0132] [Examples] Test methods The proximal tubular module and the distal tubular module can have various flexibility, kinkability, torque until breakage, torqueability, followability, pushability, passability, and rotational responsiveness. Flexibility, kinkability, break ability, torque until breakage, torqueability, followability, pushability, passability, and rotational responsiveness ability, torque until breakage, torqueability, followability, pushability, passability, and rotational responsiveness There are various tests for torque up to damage, torque property, followability, pushability, passability, and rotational responsiveness. Various standard tests regarding these properties known in the art are disclosed, for example, at http: / / www.protomedlabs.com / medical-device-testing / catheter-testing-functional-performance.

[0133] The proximal tubular module and the distal tubular module can have the same flexibility or different flexibilities. Flexibility is the property of bending without breaking. The flexibility of the tubular module depends on the material used, the segmented helical pattern, the wall thickness, the inner diameter and the outer diameter, and other variables. Flexibility can be determined by one of the following test methods. One way to test flexibility is to use a proximal load cell to measure the ability of the device to advance and retreat over a specific bending angle without losing function or damaging the tortuous anatomical structure. Alternatively, a roller system can be used to determine the minimum radius of curvature that the device can withstand without kinking. Further, a cantilever beam can be used to conduct the test to measure the force and bending angle by calculating F = [M × (%SR)] / (S × 100) (where F = flexibility, M = total bending moment, %SR = scale reading average, and S = span length) at an inclination of 50°. Another way to test flexibility is to use one-point and four-point bending tests to detect the force F and the bending displacement f when one end of the device is fixed and the other end is pushed by a plate moving at a constant speed. ​​​​​​​​​​​​​​​It is to evaluate flexibility under displacement control using a ZWICK 005 testing machine. The most high measurement data is the flexibility determined by the equation E×I = (F×L 3 ) / (3×f) (Nmm 2 ), where I = moment of inertia, E = Young's modulus, L = bending length, f = bending displacement, and F = point force, and E× I = flexibility).

[0134] The proximal tubular member and the distal tubular member can have the same or different torques until breakage or torque at breakage. Torque until breakage is the amount of torsional or rotational force that a tubular member can withstand before plastic deformation, fracture, or breakage of the catheter component occurs. One way to test the torque until breakage is to rotate the device at a relatively proximal position and fix the distal end while the device is being guided through the tortuous anatomical structure, by using proximal and distal torque sensors that measure the amount of torque and the number of rotations until breakage of the device. Another test method for calculating the torque until breakage is to test the torque strength immediately after setting in water at 37 ± 2 °C for a period of immersion. With the guide wire positioned in place, the device is inserted into a conforming guiding catheter that is constrained in a two-dimensional shape, such that the most distal 10 cm of the catheter is exposed beyond the guide tip and attached to a torque gauge to prevent rotation, reproducing access to the coronary anatomical structure. The remaining portion of the catheter body is rotated 360° at a time until distortion, fracture, breakage, destruction, kinking, or other damage occurs along the catheter or at the catheter tip, or for a set number of rotations.

[0135] ​​​​​​​​​​The proximal tubular member and the distal tubular member can have the same or different torque properties. . Torque property refers to the amount of torque or rotation lost from one end of a tubular module to the other end of the tubular module when a rotational force is applied to one end. One method of testing torque property is to use proximal and distal torque sensors to rotate the device at a relatively proximal position and measure the amount of torque transmitted through the device by fixing the distal end while the device is guided through a tortuous anatomical structure. Another method of testing torque property is to use a PTCA trainer designed by Dr. Shinsuke Nanto, such as the arterial simulation device for PTCA training T / N: T001821-2, which simulates a clinical tortuous path. An indicator attached to the catheter tip and inserted through the dial hole. Connect the catheter body to a rotor, e.g., T / N : T001923, and rotate it clockwise by 90° increments up to 1080°. Use the angle measured by the dial attached to the indicator at the catheter tip to calculate the ratio of the rotation angle of the body to the rotation angle of the tip. This corresponds to the amount of torque lost during rotation.

[0136] The proximal tubular module and the distal tubular module can have the same or different followability. One method of testing followability is to use a proximal load cell to measure the force to advance the device through a tortuous anatomical structure with or without being supported by a guide accessory.

[0137] The proximal tubular module and the distal tubular module can have the same or different pushability. One method for testing pushability is to use proximal and distal load cells. to measure the amount of force experienced by the distal tip of the device when a known force is applied to the proximal end. This is what we should do.

[0138] The proximal and distal tubular modules may have the same or different transmissivities. One method of testing for passability is to use a proximal load cell to test for loss of function. Advance and target specific lesions without disrupting or damaging tortuous anatomy. The objective of the present invention is to measure the ability of the catheter device to move and retract. The worst disturbance that a device can withstand without damage can be determined.

[0139] The proximal and distal tubular modules may have the same or different rotational responses. One method to test the rotational response is to use proximal and distal rotational encoders. is used to rotate the device in a relatively proximal position to guide the device through tortuous anatomy. Measure the amount of rotation transmitted through the device by holding the distal end free while the device is inserted. That is the thing.

[0140] The scope of the present invention is not limited by what has been particularly shown and described above. that there are suitable alternatives to the illustrated examples of configuration, construction and dimensions, and materials; It will be recognized that citation and discussion of any reference in this application is solely indicative of the invention. Provided for clarity of explanation, any references to the inventions described herein are not intended to be limiting. No admission is made that the invention is prior art. All references are incorporated herein by reference in their entirety. Although embodiments have been shown and described, it will be apparent to those skilled in the art that changes and modifications can be made without departing from the spirit and scope of the invention. The foregoing description and the accompanying drawings are provided by way of example only and not by way of limitation.

Claims

1. A catheter comprising a first tubular module and a second tubular module connected to the first tubular module by a joint, The joint is (a) at least one snap-fit ​​connection on the first tubular module and a snap-fit ​​receiver disposed on the second tubular module; the snap-fit ​​connection comprises a circular locking portion connected to a body of the second tubular module by a stem portion; the snap-fit ​​receiver includes a circular portion for receiving the circular locking portion and a rectangular portion for receiving the stem portion; the snap-fit ​​connection is flush with the inner and outer diameters of the first tubular module, the snap-fit ​​receiver is flush with the inner and outer diameters of the second tubular module, and the inner surface of the first tubular module is flush with the inner surface of the second tubular module; when the snap-fit ​​connection and the snap-fit ​​receiver are coupled together, the snap-fit ​​connection and the snap-fit ​​receiver define a continuous lumen having the same diameter; and the snap-fit ​​connection comprises an elastically deformable cantilever joint disposed between the stem portion and the body of the second tubular module such that the circular locking portion and the stem portion can bend at the cantilever joint relative to a line parallel to a longitudinal axis of the first tubular module; and (b) at least one stabilizing element including a tongue element disposed on the first tubular module and a groove element disposed on the second tubular module; the tongue element fits into the groove element; the stabilization element does not include a cantilever joint and is not elastically deformable; the stabilizing element prevents the first and second tubular modules from rotating circumferentially at the joint; and the joint prevents the first and second tubular modules from rotating relative to one another. catheter.

2. The catheter of claim 1 , wherein at least one portion of the first or second tubular modules comprises a plurality of interrupted spiral cuts.

3. The catheter of claim 1 , wherein the first tubular module is formed from Nitinol.

4. 10. The catheter of claim 1, wherein the second tubular module is formed from an SAE grade stainless steel selected from 304, 316, 402 and 440, 17-7 precipitation hardened stainless steel (PH), or a nickel-cobalt alloy (MP35N).

5. The catheter of claim 1 , wherein at least a portion of the fitting is surrounded by a tubular covering.

6. 10. The catheter of claim 1, further comprising at least two cut openings, a first and a second cut opening, the cut openings being disposed in at least one of the first tubular module or the second tubular module.

7. 7. The catheter of claim 6, wherein a filament is helically threaded around one or more of the first tubular module or the second tubular module, one end of the filament being disposed in the first cut opening and the other end of the filament being disposed in the second cut opening.

8. The catheter of claim 7 , wherein the filament is threaded in a clockwise spiral.

9. The catheter of claim 8 , wherein the filament is secured to the first or second tubular module by at least one ring.

10. The catheter of claim 7 , wherein the filament is threaded in a counterclockwise spiral.

11. The catheter of claim 1 comprising between 2 and 20 tubular modules.

12. The catheter of claim 11 , wherein at least a portion of one or more of the tubular modules is covered by a polymer that forms a jacket.

13. 13. The catheter of claim 12, wherein the polymer jacket is formed from nylon, polyether block amide, PTFE (polytetrafluoroethylene), FEP (fluorinated ethylene propylene), PFA (perfluoroalkoxyalkane), PET (polyethylene terephthalate) or PEEK (polyether ether ketone).

14. The catheter of claim 1 , wherein at least a portion of the inner lumen of the first or second tubular module is covered by a lining.

15. 15. The catheter of claim 14, wherein the lining is formed from nylon, polyether block amide, PTFE (polytetrafluoroethylene), FEP (fluorinated ethylene propylene), PFA (perfluoroalkoxyalkane), PET (polyethylene terephthalate) or PEEK (polyether ether ketone).

16. The catheter of claim 11 , wherein the second tubular module is formed from stainless steel and the first tubular module is formed from Nitinol.

17. The catheter of claim 11, wherein at least one edge of the snap-fit ​​connection and the snap-fit ​​receiver is chamfered at an angle in the range of 5° to 90°.

18. The catheter of claim 1 , wherein at least one of the snap-fit ​​connections extends from the first tubular module and has the same wall thickness as the first tubular module.

19. The catheter of claim 1 , wherein the stabilizing element is flush with the inner and outer surfaces of the first and second tubular modules when coupled together.

20. The catheter of claim 1 , wherein the tongue element is rectangular in shape.

21. A catheter comprising a first tubular module and a second tubular module connected to the first tubular module by a joint, The joint is (a) at least one snap-fit ​​connection on the first tubular module and a snap-fit ​​receiver disposed on the second tubular module; the snap-fit ​​connection comprises a circular locking portion connected to a body of the second tubular module by a stem portion; the snap-fit ​​receiver includes a circular portion for receiving the circular locking portion and a rectangular portion for receiving the stem portion; the snap-fit ​​connection is flush with the inner and outer diameters of the first tubular module, the snap-fit ​​receiver is flush with the inner and outer diameters of the second tubular module, and the inner surface of the first tubular module is flush with the inner surface of the second tubular module; when the snap-fit ​​connection and the snap-fit ​​receiver are coupled together, the snap-fit ​​connection and the snap-fit ​​receiver define a continuous lumen having the same diameter; and the snap-fit ​​connection comprises an elastically deformable cantilever joint disposed between the stem portion and the body of the second tubular module such that the circular locking portion and the stem portion can bend at the cantilever joint relative to a line parallel to a longitudinal axis of the first tubular module; and (b) at least one stabilizing element including a tongue element disposed on the first tubular module and a groove element disposed on the second tubular module; the tongue element fits into the groove element; the stabilization element does not include a cantilever joint and is not elastically deformable; the stabilizing element prevents the first and second tubular modules from rotating circumferentially at the joint; the joint prevents the first and second tubular modules from rotating relative to one another; the first tubular module is formed from nitinol and the second tubular module is formed from stainless steel; catheter.

22. 22. The catheter of claim 21, wherein at least one edge of the snap-fit ​​connection and the snap-fit ​​receiver is chamfered at an angle in the range of 5 degrees to 90 degrees.

23. 22. The catheter of claim 21, wherein the continuous lumen diameter is maintained about a central lumen axis when the first or second tubular modules assume a curved shape.

24. A catheter comprising a first tubular module and a second tubular module connected to the first tubular module by a joint, The joint is (a) at least one snap-fit ​​connection on the first tubular module and a snap-fit ​​receiver disposed on the second tubular module; the snap-fit ​​connection comprises a circular locking portion connected to a body of the second tubular module by a stem portion; the snap-fit ​​receiver includes a circular portion for receiving the circular locking portion and a rectangular portion for receiving the stem portion; the snap-fit ​​connection is flush with the inner and outer diameters of the first tubular module, the snap-fit ​​receiver is flush with the inner and outer diameters of the second tubular module, and the inner surface of the first tubular module is flush with the inner surface of the second tubular module; when the snap-fit ​​connection and the snap-fit ​​receiver are coupled together, the snap-fit ​​connection and the snap-fit ​​receiver define a continuous lumen having the same diameter; and the snap-fit ​​connection comprises an elastically deformable cantilever joint disposed between the stem portion and the body of the second tubular module such that the circular locking portion and the stem portion can bend at the cantilever joint relative to a line parallel to a longitudinal axis of the first tubular module; and (b) at least one stabilizing element including a tongue element disposed on the first tubular module and a groove element disposed on the second tubular module; the tongue element fits into the groove element; said tongue element being rectangular in shape; the stabilization element does not include a cantilever joint and is not elastically deformable; the stabilizing element prevents the first and second tubular modules from rotating circumferentially at the joint; the joint prevents the first and second tubular modules from rotating relative to one another; the first tubular module is formed from nitinol and the second tubular module is formed from stainless steel; catheter.

25. 25. The catheter of claim 24, wherein the stabilizing element is flush with inner and outer surfaces of the first and second tubular modules when coupled together.

26. A catheter as described in claim 1, 21 or 24, wherein the outer diameter of the first tubular module is different from the outer diameter of the second tubular module.

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