Catheter with spine stiffener

Abstract

A clot retrieval catheter may have a customized, highly flexible body section capable of navigating in a tortuous path and an expandable tip for localized flow restriction / prevention. The catheter may include one or more spines that extend the length of the elongate shaft, which may be interwoven with the shaft braid. The distal portion of the spine may be formed as a spine hoop as part of the distal hoop of the tip section. Alternatively, the ridge may form a hoop around the axial braid. The ridges may be made of metal, polymer, or fiber strands. The polymer ridge may be formed using a lamination or co-extrusion manufacturing process. The support tube may also have a polymeric jacket or membrane disposed around at least a portion of the structure.

Description

Technical Field

[0001] The present invention generally relates to devices and methods for removing acute blockages from blood vessels during endovascular medical treatment. More specifically, the present disclosure relates to a retrieval aspiration catheter having a spine reinforcement. Background Art

[0002] Aspiration and clot retrieval catheters and devices are used in mechanical thrombectomy for endovascular interventions in patients with conditions such as acute ischemic stroke (AIS), myocardial infarction (MI), and pulmonary embolism (PE). Accessing neurovascular beds is particularly challenging using conventional techniques because the target vessels are small in diameter, distal relative to the insertion site, and highly tortuous.

[0003] Conventional catheters must try and balance many factors when delivering effective devices to the small and highly branched cerebral arterial system. The catheter must be flexible enough to navigate the vasculature and withstand high flexural strains, while also having axial stiffness to provide smooth and consistent advancement along the route. In addition, abrupt stiffness or geometry changes can hinder trackability, introduce significant stress concentrations, and increase the likelihood of device kinking or buckling.

[0004] The design for the suction catheter must balance the flexibility for delivery with sufficient radial force and atraumatic deployment. The catheter elements must withstand the severe mechanical strains imposed by the residence, and also generate sufficient radial force when expanded to prevent collapse under the extraction of the suction. Many highly flexible body designs have a reduced diameter that is unable to generate the required suction, and designs with expandable members or separate extraction extensions may lack the flexibility to navigate the neurovascular vessels. Some designs for clot retrieval catheters may have difficulties associated with insufficient tensile strength. In such scenarios, the catheter may stretch or stretch during use, causing usability and durability issues. Other designs have increased the tensile strength of the catheter, but at the expense of lateral flexibility, which makes the catheter more difficult to navigate. Summary of the invention

[0005] The present invention is designed to provide an improved retrieval catheter having an expandable tip that incorporates features to address the above-mentioned deficiencies.

[0006] The designs herein can be used for ridge reinforcements of catheters that can provide local flow restriction / blocking within a target vessel. The ridges of the catheter can increase the tensile strength of the catheter while maintaining lateral flexibility, which is particularly important. This allows the catheter to be flexible enough to be able to navigate highly tortuous areas of the anatomy (such as neurovascular vessels) to reach occlusive clots while also having increased tensile strength. The ridges can be metal or polymer. Some ridges can be interwoven with braids. Interweaving the ridges allows the ridge position to be maintained when the product is bent during use. In addition, this locks the ridges into the braid so that the ridges cannot be pulled through the liner or jacket.

[0007] The disclosed examples may include a catheter. The catheter may include a proximal elongated shaft, which may include a longitudinal axis, a distal end, and a shaft braid. The catheter may also include a distal terminal segment, which includes a terminal braid terminating in a distal hoop. In addition, the catheter may include a plurality of outer jackets disposed around the elongated shaft and the terminal segment. In addition, the catheter may include one or more metal ridges extending at least partially along the axial length of the catheter. The one or more metal ridges may inhibit tensile elongation of the catheter. The catheter may include a distal hoop of the terminal braid formed integrally with the wires of the shaft braid.

[0008] At least a portion of the one or more metal ridges may be a shape memory alloy.

[0009] At least a portion of the one or more metal ridges may be made of at least one of stainless steel, DFT, cobalt-chromium, titanium alloy, or tungsten.

[0010] At least one of the one or more metallic ridges may be interwoven with the shaft braid.

[0011] At least one of the one or more metal spines may have a proximal portion and a distal portion, and at least a portion of the proximal portion may include two or more adjacent parallel strands. The distal portion may form one or more distal hoops of the distal hoop of the end segment braid.

[0012] At least a portion of the one or more metallic ridges may extend the entire axial length of the conduit.

[0013] At least a portion of the one or more metal ridges may have a non-circular cross-section.

[0014] The one or more metal ridges may also include a first ridge and a second ridge spaced 180 degrees apart.

[0015] At least a portion of the shaft braid and at least a portion of the tip braid may comprise different materials.

[0016] At least one of the one or more metallic ridges may include sections of different thicknesses.

[0017] One or more metal ridges may be external to the shaft braid.

[0018] The one or more metallic ridges may also include a single ridge adhered to one of the shaft braid or the end braid at a termination point.

[0019] The disclosed examples may include a catheter. The catheter may include an elongated tube including a longitudinal axis and an axis braid, the axis braid may include a first set of spirals, the first set of spirals braided with a second set of spirals. The catheter may also include a distal end segment, the distal end segment including an end braid, the end braid having a distal hoop at the distal end. In addition, the catheter may include a plurality of outer jackets arranged around the elongated tube and the end segment. In addition, the catheter may include one or more polymer ridges, the one or more polymer ridges extending at least partially along the axial length of the catheter, wherein the polymer ridges inhibit tensile elongation of the catheter. The first set of spirals of the axis braid may be flipped toward the proximal side to form a second set of spirals of the axis braid. The distal hoop of the end braid may be formed integrally with the lines of the axis braid.

[0020] At least a portion of the one or more polymer ridges may include a combination of at least one of high density polyethylene, polyetherketone, ultra high molecular weight polyethylene, aramid, LCP liquid crystal polymer, nylon, or thermosetting liquid crystal polyoxazole.

[0021] At least a portion of the one or more polymeric spines may be laminated to the outer jacket.

[0022] At least a portion of the one or more polymeric spines may be coextruded with at least one of the outer jackets.

[0023] At least one of the one or more polymer spines may be interwoven with the shaft braid.

[0024] At least one of the one or more polymer spines may be turned over at the spine hoop through the shaft braid or the end braid to form two parallel strands.

[0025] At least a portion of one of the parallel strands may extend outside the shaft braid, and at least a portion of one of the parallel strands extends inside the shaft braid.

[0026] The disclosed examples may include a method for constructing a catheter. The method may include arranging a liner around an application mandrel. The method may also include positioning one or more axial ridges substantially parallel to the longitudinal axis outside the outer surface of the liner. In addition, the method may include arranging a braided member around at least a portion of the liner on the application mandrel, the braided member including a proximal portion and a distal portion terminating in a plurality of distal hoops. In addition, the method may include reflowing a series of proximal outer jackets to engage the catheter assembly. The method may also include loading a polymer distal inner jacket around a reflow tool. In addition, the method may include removing the application mandrel and inserting the reflow tool and the polymer distal inner jacket into the distal end of the catheter assembly. The method may include positioning a polymer distal outer jacket around at least the distal portion of the catheter assembly on the reflow tool. The method may also include reflowing the polymer distal inner jacket and the polymer distal outer jacket to the distal portion of the catheter assembly. Finally, the method may include removing the reflow tool.

[0027] The method may further include applying an inner hydrophilic coating at least on the interior of the distal portion of the catheter assembly.

[0028] The method may also include utilizing a polymer in at least a portion of the one or more ridges that has a melting temperature within a range of about ±17 degrees of the melting temperature of the distal-most outer jacket of the catheter. The method may also include laminating at least a portion of the one or more ridges with the outer jacket. The method may also include coextruding at least a portion of the one or more ridges into at least a portion of the outer jacket to form a layered structure.

[0029] The method may include inverting at least one of the one or more ridges to loop through an opening in the braided member.

[0030] The method may include utilizing a flashback tool having a flared distal end.

[0031] The method may include utilizing a polymer in at least a portion of the one or more ridges, the polymer having a melting temperature within about ±6 degrees of a melting temperature of a distal-most outer jacket of the catheter.

[0032] The method may include everting a distal portion of one or more of the axial ridges to form one or more of the distal hoops of the end segment braid.

[0033] An example catheter may have an elongated tube comprising a longitudinal axis and an axis braid comprising a first set of helices braided with a second set of helices. The catheter may also have a distal end segment comprising an end braid having a distal hoop at the distal end. The catheter may also have a plurality of outer jackets disposed around the elongated tube and the end segment. Extending at least partially along the axial length of the catheter, one or more polymer ridges may be present. These polymer ridges may inhibit tensile elongation of the catheter. The first set of helices of the axis braid may be flipped proximally to form a second set of helices of the axis braid. The distal hoop of the end braid may be formed integrally with the wires of the axis braid.

[0034] An example method for constructing a catheter may include arranging the liner around an application mandrel. The method may also include positioning one or more axial ridges parallel to the longitudinal axis outside the outer surface of the liner. In addition, this may include arranging a braided member around at least a portion of the liner on the application mandrel, the braided member including a proximal portion and a distal portion terminating in a plurality of distal hoops. In addition, this may include reflowing a series of proximal outer jackets to engage the catheter assembly. This may additionally include loading a polymer distal inner jacket around a reflow tool. Additional steps may include removing the application mandrel and inserting the reflow tool and the polymer distal inner jacket into the distal end of the catheter assembly. In addition, the method may include positioning a polymer distal outer jacket around at least the distal portion of the catheter assembly on the reflow tool. This may include reflowing the polymer distal inner jacket and the polymer distal outer jacket to the distal portion of the catheter assembly. In addition, this may include removing the reflow tool. Finally, this may include applying an inner hydrophilic coating at least inside the distal portion of the catheter assembly. BRIEF DESCRIPTION OF THE DRAWINGS

[0035] The above aspects and additional aspects of the present invention will be further discussed with reference to the following description and in conjunction with the accompanying drawings, in which like numbers indicate similar structural elements and features in the various figures. The accompanying drawings are not necessarily drawn to scale, but instead, emphasis is placed on illustrating the principles of the present invention. The accompanying drawings depict one or more specific implementations of the present invention by way of example only and not by way of limitation.

[0036] Figure 1 is a side view of a catheter having a spine reinforcement according to aspects of the present invention, wherein the distal portion of the spine forms a distal hoop of the tip section braid.

[0037] Figure 2 is a side view of a catheter having a spine reinforcement wherein one of the metal spines is interwoven with the shaft braid according to aspects of the present invention.

[0038] Figure 3 yes Figure 2sectional view of a catheter showing the position of axial strands relative to the shaft braid according to aspects of the present invention.

[0039] Figure 4 yes Figure 2 0026] A cross-sectional view of a catheter illustrating the position of axial strands relative to the shaft braid according to aspects of the present invention.

[0040] Figure 5 is a side view of a catheter having a spine stiffener including a spine hoop according to aspects of the present invention.

[0041] Figure 6 yes Figure 5 0026] A cross-sectional view of a catheter illustrating the position of axial strands relative to the shaft braid according to aspects of the present invention.

[0042] Figure 7 is a side view of a catheter having a spine stiffener including two spine hoops spaced 180 degrees apart in accordance with aspects of the present invention.

[0043] Figure 8 is a side view of a catheter having a spine stiffener including a single spline attached to a shaft braid according to aspects of the present invention.

[0044] Fig. 9 is an isometric view of a catheter with a spine hoop having a self-expanding collapsible super-aperture (CSB) tip according to aspects of the present invention.

[0045] Fig.10 is an isometric view of a catheter with a spine hoop having a clot-expanding low shear tip (LST) tip in accordance with aspects of the present invention.

[0046] Fig.11 is a diagram showing the manufacture of a catheter having a ridge stiffener by lamination according to aspects of the present invention.

[0047] Fig.12 is a diagram illustrating the manufacture of a catheter having a ridge stiffener by coextrusion according to aspects of the present invention.

[0048] Fig.13A is a front side view of an application mandrel assembly for assembling a catheter having a spine stiffener and a distal marker band in accordance with aspects of the present invention.

[0049] Fig. 13B is a side view illustrating the use of an application mandrel to assemble a catheter having a spine stiffener and a distal marker band in accordance with aspects of the present invention.

[0050] Fig. 13Cis an isometric view showing the use of an application mandrel to assemble a catheter having a spine hoop and a distal marker band in accordance with aspects of the present invention.

[0051] Fig.13D is an isometric view showing the use of an application mandrel to assemble a catheter having a spine hoop in accordance with aspects of the present invention.

[0052] Fig.13E is an isometric view of a flashback tool for making a catheter having a spine stiffener in accordance with aspects of the present invention.

[0053] Fig.13F is an isometric cross-sectional view of a flashback tool inserting a distal inner jacket into a catheter having a spine stiffener in accordance with aspects of the present invention.

[0054] Figure 13G is an isometric view of a flashback tool for heating a distal inner jacket into a catheter having a spine stiffener in accordance with aspects of the present invention.

[0055] Fig.13H is an isometric view of a flashback tool removed from a catheter having a spine stiffener in accordance with aspects of the present invention.

[0056] Fig.13I is a side cross-sectional view of a complete catheter with a spine stiffener according to aspects of the present invention.

[0057] Fig.14A and Fig. 14B Collectively, is a flow chart illustrating steps for making a catheter having a polymeric spine stiffener according to aspects of the present invention.

[0058] Fig.15A is a side view showing a flat spine end of a catheter with a spine stiffener according to aspects of the present invention.

[0059] Fig. 15B is a side view showing a cable spine end portion of a catheter having a spine stiffener according to aspects of the present invention.

[0060] Fig.16 is a close-up view showing how the cable spine ends of a catheter having spine reinforcements in accordance with aspects of the present invention interact with the braid at a braid intersection.

[0061] Fig.17A is a side view of a catheter having a spine stiffener showing the spines attached by adhesive fixation according to aspects of the present invention.

[0062] Fig. 17B is a side view of a catheter having a spine reinforcement showing the spine fixedly attached by an outer jacket in accordance with aspects of the present invention.

[0063] Fig.18 is a side view of a catheter having a spine stiffener with a marker band used to attach the spine according to aspects of the present invention. DETAILED DESCRIPTION

[0064] As used herein, the term "about" or "approximately" for any numerical value or range indicates a suitable dimensional tolerance that allows a part or collection of components to achieve its intended purpose as described herein. More specifically, "about" or "approximately" may refer to a range of ±20% of the value of the recited value, for example, "about 90%" may refer to a range of values ​​from 71% to 99%.

[0065] As used herein, the terms "tubular" and "tube" should be understood broadly and are not limited to structures that are perfect cylinders or have a completely circular cross section or a uniform cross section throughout their length. For example, tubular structures or systems are often shown as structures that are substantially perfect cylinders. However, tubular systems may have tapered or curved outer surfaces without departing from the scope of the present disclosure.

[0066] The purpose of at least some of the disclosed designs is to produce a spine reinforcement for a catheter that can provide both local flow restriction / blocking and high flexibility, thereby enabling navigation through tortuous areas of the vascular system within an external catheter to reach an occluding clot. In the case of stroke interventional surgery, where the blood vessels in the neurovascular bed are particularly small, tortuous and fragile, such advantages may also be particularly beneficial. Therefore, the customized axial and bending stiffness distribution of the expandable tube head end can inhibit kinking and binding while tracking through these blood vessels. The end may have a collapsed state so that the clot retrieval catheter can be compatible with a relatively low-profile entry sheath and external catheter, so that the puncture wound in the patient's groin (in the case of femoral entry) can be easily and reliably closed. The expandable tube head may also have internal and / or external low-friction lining features, as well as an outer polymer jacket or membrane set around the support structure. These improvements can lead to safe and faster entry of catheters and other devices into complex areas to more reliably remove obstructions and shorten surgical time.

[0067] Another advantage of using a clot retrieval catheter delivered through an external catheter and having the clot retrieval catheter delivered through an external catheter is that once the clot has entered the distal end of the clot retrieval catheter, the clot retrieval catheter can be retracted through the external catheter so that the external catheter remains in place to maintain access at the target treatment location. Although it should be understood that some clots may also require the external catheter to be retracted together with the clot and the internal clot retrieval catheter, most clots may be removed by the internal clot retrieval catheter. With this combination, the lumen of the external catheter will be cleared of debris with greater confidence to reduce the risk that potential thrombus residues may fall out of the catheter during contrast injection. With conventional catheters, the user may typically have to remove the external catheter before injecting contrast to flush any thrombus residues out of the body at the expense of losing access to the target treatment location. At least some examples of the present invention may provide a device that minimizes the number of catheter advancements required to treat a patient, thereby reducing the possibility of vascular injury and the associated vascular dissection risk when multiple passes are required.

[0068] Specific examples of the present invention are now described in detail with reference to the accompanying drawings. Access to various blood vessels within the blood vessel (whether coronary, pulmonary or cerebral) involves well-known surgical steps and the use of many conventional commercially available accessory products. These products such as angiographic materials, rotary hemostatic valves and guidewires are widely used in laboratories and medical manufacturers. When these products or similar products are used in conjunction with the systems and methods of the present invention described below, their function and exact construction are not described in detail. The design may typically have a polymer film cover / encapsulation and / or a polymer liner, which is typically not shown for clarity of the framework. Although this specification is in many cases in the context of mechanical thrombectomy treatment, the design may also be applicable to other surgeries and other body passages.

[0069] The example catheters disclosed herein may include spine reinforcements. Generally, there are many types of catheters with spine reinforcements. The methods described herein can be applied to many different types of catheters (e.g., funnel-shaped catheters or tubular suction catheters). The end sections of the catheters can be of various shapes and sizes and have a variety of configurations.

[0070] The flexibility of the catheter can enable the physician to use a standard sheath or external access catheter (not shown) of a smaller diameter to quickly form a path and obtain access to the vicinity of the obstruction. The example catheter disclosed herein may include an expandable tip. The expandable tip of the example catheter can be contracted by pushing the tip into the guide catheter under the support of a tubular loading tool. Then, when the tip leaves the guide catheter at a certain distance from the clot, the tip can be expanded. Then, the tip can be advanced toward the clot location. Alternatively, the expandable tip can be expanded at the treatment location to avoid having to advance the expanded tip through the vascular system, thereby allowing the length of the elongated shaft to be relatively short.

[0071] Some example catheters disclosed herein may have an expanded, deployed form of the end section 210 at the distal end 214 of the clot retrieval catheter, which may be flared or funnel-shaped. By incorporating a funnel shape into the expandable end, the clot may be gradually compressed to a smaller diameter clot during retrieval so that the clot can be completely aspirated through the catheter into an aspiration syringe or canister. Due to this compression, a solid, fibrin-rich clot is less likely to accumulate in the tubular section of the clot retrieval catheter. If a clot does accumulate in the tube head at the end, the expanded tube head will protect the clot and prevent it from falling out while maintaining suction extraction and retracting the catheter into a sheath or outer catheter.

[0072] The funnel-shaped design of the expandable tip of the disclosed example can be a direct and integrally meshed laser cut with the elongated shaft of the catheter shaft. Alternatively, the expandable tip mesh can be injection molded as a single piece and attached to the elongated shaft by heat welding, adhesive or similar means. The end section of the clot retrieval catheter can be designed to expand to a wide range of target vessel diameters, such as the end of the carotid artery (3.2mm-5.2mm), the horizontal MI segment of the middle cerebral artery (1.6mm-3.5mm) and / or the internal carotid artery (ICA, 2.7mm-7.5mm). Some example catheters can be configured so that if the catheter is subsequently retracted from the MI segment to the ICA (or another path with a proximally increased vessel inner diameter), the expandable tip may continue to seal the vessel over a range of vessel sizes. In addition, the tip that can accommodate a variety of target vessel diameters can also be sealed at a vessel bifurcation, which can have a wider cross-sectional area than the vessel proximal to the bifurcation and the vessel distal to the bifurcation. The tip section of the catheter may be expanded prior to reaching the treatment site or at the treatment site to avoid having to advance the expanded tip through the vasculature.

[0073] In some example catheters disclosed herein, the distal section of the suction clot retrieval catheter has good propulsion and trackability characteristics to help propel it to the target location. The catheter can therefore have multiple designs or be made of multiple materials to impart a profile with reduced stiffness along the length, thereby minimizing insertion and retraction forces. In one example, the elongated shaft can be laser cut from a hypotube and integrally formed with the expansion frame portion of the end section. In another example, the elongated shaft can be an injection molded polymer or metal braid or braided support structure. Features that bias the bends around certain planes or encourage torsion to reduce the applied strain can also be combined. In this way, the catheter will maintain excellent lateral flexibility, but will not tend to kink when expanded or compressed.

[0074] The example catheter may also have a cover or membrane disposed around or encapsulating the elongated shaft and the terminal segment. In the disclosed examples shown in the figures herein, the jacket or membrane is generally not shown in order to clearly show the underlying support structure, and the configuration and appearance of such a membrane will be understood by those skilled in the art. Suitable membrane materials may include elastic polyurethanes, such as polyurethanes, which may have a Shore hardness of 40A (using, for example, the ASTM D2240 A scale) or less. Or silicone elastomer. The end segment may include an elastomeric polyurethane with a certain percentage of silicone, such as Neusoft 42A, 52A, 62A or 72A. Other suitable materials may include ReZalloy 40A, 50A, 60A or 70A, Rezithane 60A or 70A or Engage 50A. The shaft may include a distal soft segment and a more proximal harder segment, which may include a non-elastomeric material, such as Pebax 25D, 35D, 45D, 55D, 63D, 72D or 74D, or Rilasmid Nylon 12 or Rilasmid ML21. A single or variable stiffness cover may be extruded or post-molded over the elongated shaft. The cover may also be laminated or heat welded to the structure.

[0075] Alternatively, the cover may also be formed by a series of polymer jackets. Different jackets or jacket groups may be arranged in discrete lengths along the axis of the elongated shaft to provide different sections of the tubular portion of the catheter with different pushability and flexibility characteristics. By constructing the jackets axially in series, the overall stiffness of the catheter can be transitioned from a harder proximal end to a very flexible distal end. Alternatively, the polymer jacket of the cover may be a radial series arranged around the elongated shaft to customize material properties throughout the thickness. In another example, the transition between the jackets may be tapered or slotted to provide a more seamless transition between the flexible profiles of adjacent jackets in the longitudinal series.

[0076] In order to allow smooth delivery of the clot retrieval catheter through the external catheter, the outer surface of the membrane or outer jacket may be coated with a low friction material such as PTFE or FEP, or a lubricating material such as provided by BioCoat, Surmodics, Harland, Covalon or other companies. In another example, a low friction liner may also be applied to the inner circumference of the elongated shaft. Alternatively, a lubricant (such as silicone oil or molybdenum disulfide), or a coating such as a hydrophilic coating may also be used. In another example, the inner or outer surface of the membrane, or the tubular section of the catheter body (if formed by a polymer extrudate) may be impregnated with a low friction component that migrates to the surface so that a low friction liner does not need to be applied.

[0077] The elongated shaft structure of the clot retrieval catheter can have many different configurations and include spines of different configurations. The spines can have a tubular or linear configuration so that they have good axial stiffness for advancing and retracting the catheter and sufficient lateral flexibility for navigating within a blood vessel. The use of multiple spines promotes bending along a defined plane and at the same time reduces the likelihood of the elongated shaft extending under tensile loads, such as when the expandable tip is withdrawn into the tip of an external catheter.

[0078] The spines can be made of a variety of materials including metals or polymers. The metal spines can be interwoven during the manufacture of the braid (which is typically made of Nitinol) and can withstand the heat setting temperatures of the frame. Interweaving the spines allows the spine position to be maintained when the product is bent during use. The spines are locked into the braid and cannot be pulled through the liner (compared to if they were placed between the liner and the braid) or the jacket (compared to if they were placed between the jacket and the braid). When the spines are placed between the liner and the braid, a liner with a pre-plated layer can be beneficial. The PTFE liner does not melt during reflow, and therefore, the spines can prevent the outer jacket from bonding to the liner. If a pre-plated layer is used (e.g., a thin 0.00025" layer of Pebax 55D), the pre-plated layer will also melt with the outer jacket, allowing better adhesion under the spine. Interweaving can also make assembly easier because the spine has a stable position. As non-limiting examples, the metal spines can be made of Nitinol, stainless steel, cobalt-chromium, titanium alloy, tungsten, or drawn filler tubing. The tungsten ridge will provide the added benefit of radiopacity. The metal ridge may comprise a shape memory alloy. The ridge may extend the entire axial length of the catheter or only a portion of the length of the catheter. Preferably, the ridge extends a majority of the length of the catheter. The ridge may have a non-circular cross-section and have sections of varying thickness.

[0079] Polymer ridges or fiber ridges may also be used. Polymer ridges may be interwoven. When the braid needs to be heat set, metal ridges may be better than polymer ridges because polymer ridges may be damaged at the heat setting temperature. The polymer ridges may melt and reflow to form an excellent bond with the jacket and the braid. As a non-limiting example, the polymer spline may be made of high-density polyethylene, polyether ketone, ultra-high molecular weight polyethylene, aromatic polyamide, LCP liquid crystal polymer, nylon or thermosetting liquid crystal polyoxazole. The polymer ridges may be laminated or coextruded with the outer jacket. The fiber ridges may be placed below or above the braid, but will not melt / flow into the braid during reflow.

[0080] refer to Figure 1 , catheter 100 is a clot retrieval catheter for retrieving a clot or obstruction from a patient's blood vessel. Catheter 100 includes an elongated shaft 110. The elongated shaft 110 is disposed along a longitudinal axis 111. The elongated shaft 110 includes an inner liner 115 and an axis braid 120. At the proximal end (towards the right side of the drawing), the axis braid 120 is wrapped around the inner liner 115. At the distal end is a distal tip segment 210 (towards the left side of the drawing) that is sized and configured to radially expand to atraumatically contact the inner vessel wall when deployed at a target site to provide flow restriction and prevention to prevent undesirable aspiration of blood proximal to the tip and a large opening for aspirating and receiving a clot.

[0081] At the distal end section 210, the shaft braid 120 expands to become the end braid 220 and terminates in the distal hoop 230. The end braid 220 may have a portion made of a different material than the shaft braid 120. The cross section of the braid forms a unit 226. At the distal end of the end section 214, a braid flip 238 occurs, and the distal hoop 230 forms the most distal unit 228. The ridge 130 extends in the direction of the longitudinal axis 111 between the layers of the shaft braid. The ridge 130 is preferably metallic or polymeric. The ridge 130 may be positioned at the intersection of the shaft braid 120. The two strands of the ridge 130 may be interwoven with the shaft braid 120, or have one strand interwoven with the shaft braid 120 and another strand placed on top of the shaft braid 120. This can be formed by converting one of the braid hoops into a double ridge at the shaft section. Alternatively, both strands may be positioned below the shaft braid or above the shaft braid. In addition, one strand may be interwoven and the other strand may be positioned above or below the braid. The spine 130 includes a proximal portion 143 and a distal portion 144 that are separated by a transition point 135. The transition point 135 need not occur at the beginning of the liner 115. The transition point 135 may be closer to the proximal end of the catheter, which may form a more flexible section of the shaft between the end and the spine 130. The distal portion 144 of the spine forms a spine hoop 231. The spine hoop 231 may be positioned between the distal hoops 230 of the end braid 220 so that the spine hoop 231 adds a hoop to the end braid.

[0082] Figure 2 Similar to Figure 1 , except that the spine hoop 231 is positioned adjacent to the distal hoop 230 of the terminal braid, such that the spine hoop 231 does not add an additional loop to the terminal braid, but rather reinforces one of the distal hoop 230. Figure 2 , the spine 130 has a proximal portion 143 and a distal portion 144. The two strands of the spine separate at a transition point 135. The spine distal portion 144 can be interwoven with the shaft braid 120 so that the spine hoop 231 is wrapped around the distal hoop 230 of the end braid 220. This can be formed by adding an additional braid hoop next to one of the existing hoop hoops.

[0083] Figure 3 The ridge 130 is shown in Figure 2The ridge 143 is positioned within the shaft braid 120 of the catheter. The ridge may have two or more adjacent parallel strands (131, 132). The proximal portion of the ridge 143 extends longitudinally and includes an axial first strand 131 and an axial second strand 132. The axial first strand 131 is positioned horizontally adjacent to the axial second strand 132, for example at a similar radius from the longitudinal axis 111 (not shown), but may be placed in a different configuration. The upper braided strand 134 of the shaft braid 120 extends above the ridge 130. The lower braided strand 133 extends below the ridge 130. The ridge 130 may be positioned near the intersection of the braided strands 133, 134.

[0084] Figure 4 Shown include Figure 2 130. A cross-sectional view of the elongated shaft 110 of the catheter of FIG. 130. The interior of the catheter is referred to as the inner lumen 116. The inner liner 115 surrounds the inner lumen and is below the shaft braid 120. The shaft braid 120 includes an under-braided strand below the axial first strand 131 and the axial second strand 132 of the spine 130. The over-braided strand 134 is above the axial first strand 131 and the axial second strand 132. The outer jacket 180 surrounds the over-braided strand 134.

[0085] Figure 5 Similar to Figure 2 ,Apart from Figure 2 The spine hoop 231 shown is replaced by a spine hoop 229 that bends approximately 360 degrees near the distal end of the elongated shaft 110 and does not extend into the distal tip section 210. Figure 5 , the spine 130 forms a spine hoop 229 around the shaft braid and extends only through the proximal portion of the catheter 100. The strands of the spine 130 may be interwoven through the shaft segment. Alternatively, one strand may be interwoven and the other strand may be looped over the braid. The hoop may extend around one or more of the braids. As shown, the hoop 229 is positioned at the intersection of two braids of the shaft braid 120. Alternatively, the spine hoop may float freely and may not be looped around any of the braided structures. In some embodiments, the stretch on the proximal elongated shaft 110 may cause the hoop 229 to engage the braid of the shaft braid 120 at the intersection to inhibit the elongation of the proximal elongated shaft 110. This example may also potentially be used with fiber strands for the spine 130. The spine may extend the entire length of the elongated shaft 110 or only a portion of the length. The two formed strands 131, 132 may be parallel and one of the parallel strands may be inside the shaft braid 120. Additionally, one of the parallel strands may be outside the shaft braid 120. The hoop 229 may be placed at a variety of locations on the shaft braid 120.

[0086] Figure 6A cross section of shaft 110 is shown, showing Figure 5 The inner lumen 116 is contained by the liner 115. The axial second strand 132 is positioned below the shaft braid 120. The axial first strand 131 is positioned above the shaft braid 120. The outer jacket 180 surrounds the shaft braid 120 and the axial second strand 132. The axial first strand 131 and the axial second strand 132 can be positioned to be vertically aligned at a location (e.g., a crossover point) in the shaft braid where the diameter of the braid is minimized.

[0087] Figure 7 Additional configurations of catheters having spine stiffeners are shown. Figure 7 A catheter is shown having a first spine 136 wherein the axial first strand 131 and the axial second strand 132 form a spine hoop 229. The spine hoop 229 is positioned where the proximal shaft 110 transitions into the distal tip 210. Figure 7 A second ridge 138 is also included that is positioned 180 degrees from the first ridge 136. The second ridge 138 extends just beyond the distal end 119 of the liner 115 so that the ridge hoop 229 of the second ridge 138 is positioned proximate to the distal end 119 of the liner 115. One, two, three or more ridges may be applied above the braid, below the braid or interwoven with the braid. These ridges may be 180 degrees apart. The addition of two ridges will prevent the support tube from extending under tensile loads and impart a preferred bending plane on the tube. If aligned parallel to the longitudinal axis, two ridges spaced 180 degrees apart will change the preferred bending position of the tube, enabling the support tube to self-adjust as it is advanced through a tortuous vessel.

[0088] Figure 8 Similar to Figure 5 , except that the spine 130 has only a single strand. The spine 130 is positioned below the shaft braid 120 and above the liner 115. The spine 130 includes only a single strand that terminates at a termination point 141. The termination point 141 may be located at the intersection of the shaft braid. The termination point 141 may be located in the proximal direction relative to the distal end 119 of the liner 115. Alternatively, the single strands may be interwoven. The distal end of the spine may be welded to one or a group of axial braids. The distal end may also be tied around one of the braids. Alternatively, the distal end of the spine may be held on the braid using braiding or an adhesive. Any of these fixing methods prevents the strands from penetrating the outer jacket.

[0089] Fig. 9 Additional configurations of catheters having spine stiffeners are disclosed. Fig. 9A self-expanding collapsible super-aperture (CSB) tip 310 is included with an expanded inner diameter 215. A spine hoop 229 extends through the middle of the body. The spine hoop 229 may extend halfway along the funnel-shaped cone or may extend at the beginning of the funnel-shaped cone. The collapsible super-aperture catheter may be able to include an inner catheter with a low shear tip (LST).

[0090] Fig.10 Additional configurations of catheters having spine stiffeners are disclosed. Fig.10 A clot expansion LST tip 311 having an inner diameter 217 is included. The spine 130 extends a majority of the liner distance 145. The spine 130 is a single strand at the proximal end of the catheter and has a termination point 141 at which the spine forms a hoop 229. The spine hoop 229 has a rollover length 142 that extends along the length of the liner. The spine hoop 229 extends upward from below the shaft braid around the top of the shaft braid to reconnect at the termination point 141. The spine hoop 229 can transition from below the shaft braid to above the shaft braid distally of the intersection of the two distal hoops 230. This positioning can be helpful in preventing extension of the LST tip. The spine hoop 229 can optionally not reconnect to the underlying strand at the termination point 141.

[0091] Fig.11 A lamination (or reflow) manufacturing method is illustrated which can be used to add polymer spines during the lamination process with minimal impact on flexibility. The polymer spines 130 can have a higher hardness than the soft outer jacket 180. The inner liner 115 is located inside the shaft braid 120. The spines 130 are placed on top of the shaft braid 120 inside the outer jacket 180. When heated, the outer jacket 180 melts into the shaft braid along with the spines 130. This reflow through the braid allows the braid to bond with the inner liner, which can be made of PTFE. The spines can be made of 40D to 90D or another material, which can be used to increase the soft outer jacket 180 (which can be made of, for example 42A, 52A, 62A, 72A, The force at which tensile elongation occurs (e.g., ReZalloy 20A to 80A, ReZalloy 40A to 80A, or ReZithane 40A to 80A). It may be advantageous for the spine to have a low elongation relative to the elastomeric outer jacket 180. The polymer spine should have a melting temperature similar to the polymer jacket to improve bonding. The melting temperature of the spine material may differ from the jacket material melting temperature by ±40 degrees Celsius, ±17 degrees Celsius, ±10 degrees Celsius, or ±6 degrees Celsius. Ideally, where multiple jackets are used, the melting temperature of the spine most closely matches the melting temperature of the softer jacket as this section will benefit most from the tensile strength of the spine. For example, nylon may be used for A good spine material for 42A jackets because they have similar melting temperatures. Nylon also has 42A's higher hardness and tensile strength make it the preferred combination.

[0092] Fig.12 A co-extrusion manufacturing method is illustrated that can be used to add polymer spines. The spines 130 are co-extruded into a soft outer jacket 180. The shaft braid 120 and inner liner 115 are inserted inside the outer jacket 180 and spines 130. A reflow is then performed over the braid and liner to bond the outer jacket 180 and splines 130 to the shaft braid 120 and inner liner 115. The spines can be made of 60D to 90D or another elastomer, these materials can be used to increase the soft outer jacket 180 (which can be made of, for example, 42A, 62A, 72A or 20A to 80A) force at which tensile elongation occurs. This has minimal effect on flexibility.

[0093] FIG. 13A to FIG. 13I The configuration of a catheter having a funnel-shaped tip 322 is shown. Fig.13A As shown, the configuration of the catheter can involve using an application mandrel 350 to fit the ridge 317 and liner 315 to the braided member 320. The application mandrel 350 includes the liner 315 above the application mandrel 350. The ridge 317 is positioned above the liner 315. At the liner distal end 319, a distal marker band 321 is positioned above the top of the liner 315 and ridge 317.

[0094] exist Fig. 13B In the embodiment shown in FIG. 3 , the application mandrel 350 and the spine 317 , the liner 315 and the distal marker band 321 are placed inside the braided member 320 . Fig. 13C and Fig.13D Subsequent construction steps are shown for two different ridge 130 configurations. Fig. 13C shows a fold back to form a similar Figure 5 The ridge 317 of the ridge hoop 329 is shown. Fig.13D A ridge 317 is shown having a proximal portion 343 and a distal portion 344 separated by a transition point 335 and forming a similar Figure 2 The ridge hoop 331 shown. Alternatively, Fig. 13C and Fig.13D At the step shown, the spine 317 can be formed as disclosed elsewhere herein, or as understood by one skilled in the relevant art based on the teachings herein. In this step, the outer body jacket 382 is added. In this step, the funnel-shaped end 322 is made by forming the braided member 320 into the distal hoop 330.

[0095] Fig.13EA flashback tool for a funnel tip catheter is shown. The catheter may have a CSB tip. The flashback tool 352 includes a distal inner jacket 384. Fig.13F In FIG. 3 , the backflow tool 352 is inserted into the catheter, which is shown as having a ridged collar 331, but may also have a ridged collar. The distal inner jacket 384 is inserted in the direction of arrow 390 over the interior of the distal collar 330 the length of the funnel tip 322 and up to the liner 315. Figure 13G In the embodiment, the backflow tool 352 is heated and the distal inner jacket 384 is coupled to the distal hoop 330. The distal outer jacket 385 is also placed on the distal end of the catheter. The backflow tool 352 can then be removed in the direction of arrow 392 (eg, Fig.13H shown). Fig.13I is a side view of the completed catheter with tube head 349.

[0096] Fig.14A and Fig. 14B A method 14000 for constructing a catheter with a spine reinforcement is shown. In step 14010, a liner is arranged around an application mandrel. The mandrel can be used to provide structure during manufacturing and define the inner lumen of the catheter. For example, a nominal 6Fr specification catheter shaft can use an application mandrel with an outer diameter of approximately 0.071 inches, and the liner can have a thickness of approximately 0.005 inches. The mandrel can be silver-plated copper (SPC) or other commonly used materials, and its size is set to have a certain outer diameter so that the caliber of the resulting catheter is larger than many existing suction catheters (at least 0.070 inches). The liner can be etched PTFE or a similar low friction material. A pre-plating layer may also be included to better adhere the liner to subsequent layers of the catheter shaft.

[0097] In step 14020, one or more axial ridges are positioned outside the outer surface of the liner and parallel to the longitudinal axis. In optional step 14030, the polymer used for at least a portion of the one or more ridges has a melting temperature within the range of ±17 degrees Celsius of the melting temperature of the distal-most outer jacket of the catheter. The polymer ridge may have a melting temperature similar to that of the polymer jacket to improve bonding. Ideally, where multiple jackets are used, the melting temperature of the ridge most closely matches the melting temperature of the softer jacket, because this section will benefit most from the tensile strength of the ridge. In optional step 14040, the polymer used for at least a portion of the one or more splines has a melting temperature within the range of ±6 degrees Celsius of the melting temperature of the distal-most outer jacket of the catheter. For ridges that do not melt or only partially melt, looping the distal end may be advantageous because the ridge will attach to the braid, which will prevent the ridge from sliding if the end of the tip is pulled away from the proximal portion of the shaft. This additional benefit from looping the distal end may not exist or be needed in fully melted ridges.

[0098] In step 14050, a braided member is disposed around at least a portion of the liner on the application mandrel. The braided member has a proximal portion and a distal portion. The distal portion terminates at the pole of the distal hoop. The braided member may be a reinforcing structure for a large portion of the catheter shaft. The pattern may utilize 16 lines for the end, a half diamond pattern with one line below and one line above, because it is balanced during the end expansion. Alternative patterns may include a double herringbone pattern with one line above and two lines below to enhance column stiffness and kink resistance. Other patterns may also be envisioned to meet different requirements of catheter design (e.g., a full diamond pattern). In optional step 14060, at least one of the one or more ridges looped through the opening in the braided member is flipped. In optional step 14070, the distal portion of one or more of the axial ridges is flipped to form one or more distal hoops in the distal hoop of the end segment braid.

[0099] In step 14080, a series of outer jackets are reflowed to join the catheter assembly. The jackets may preferably be in an axial series, but some combination of axial and radial series may be used. The flow of the jacket materials may allow them to encapsulate the braid of the elongated body and bond with the liner. In optional step 14090, at least a portion of the one or more ridges are laminated with the outer jacket. In optional step 14100, at least a portion of the one or more ridges are coextruded into at least a portion of the outer jacket to form a layered structure.

[0100] In step 14110, a polymer distal inner jacket is loaded around the reflux tool. The support braided framework of the distal end section braid can allow the use of very soft jacket materials to achieve their anti-damage properties, such as Neusoft with a hardness of 40A to 80A. The inner jacket can be thinner (e.g., approximately 0.001 inches to 0.004 inches) and is used to obtain a more uniform wall thickness of the terminal section, and ensures that the braid is fully encapsulated, so the lumen is smooth and unobstructed. In optional step 14120, a reflux tool with a flared distal end is utilized. In step 14130, the application mandrel is removed, and the reflux tool with a polymer distal inner jacket is inserted into the distal end of the catheter assembly. The inner jacket may include a low friction filler, such as Mobilise or Propell, to facilitate removal from the reflux tool, and also give the ID low friction for smooth passage of the auxiliary device or more effective retraction of the clot.

[0101] In step 14140, a polymer distal outer jacket is positioned around at least the distal portion of the catheter assembly on a backflow tool. Like the distal inner jacket, the distal outer jacket may be a thin Neusoft layer that can be laminated or backflowed to fuse with the inner jacket so that the final wall thickness of the combined distal polymer jacket is approximately 0.004 inches to 0.010 inches, retaining at least 0.0005 inches of jacket material above and below the braid surface. The jacket may extend proximally to the distal edge of the proximal outer jacket of the elongated body and protrude distally beyond the distal end of the braid hoop of the distal end braid by at least several millimeters. In step 14150, the polymer distal inner jacket and the polymer distal outer jacket are backflowed to the distal portion of the catheter assembly. In step 14160, the backflow tool is removed.

[0102] In optional step 14170, an inner hydrophilic coating is applied to at least the interior of the distal portion of the catheter assembly. After removing the flared mandrel, the coating can be applied to both the inner and outer surfaces using processes such as dip coating. In most cases, the coating can cover at least the farthest 20 cm of the catheter. In some cases, the hydrophilic coating can also be applied to the inner surface of the end without a PTFE liner. Further post-processing (such as reflux and compression / injection molding steps) can also be used to apply additional materials or continue to process existing materials to add features to the expandable end. The feature can be, for example, a feathery edge, a disc-shaped extension, a polymer lip, or an axial rib, etc.

[0103] refer to Fig.15A , catheter 400 includes an elongated body 410, a spine 412, a distal outer jacket 430, and a distal inner jacket 434. The spine 412 has a flat spine end 414 that extends beyond the liner 411. The spine 412 is placed below the braid 413 and above the liner 411. Alternatively, one end of the spine can be tied to the braid to create a distal fixation point. The liner 411 can be made of polytetrafluoroethylene (PTFE). The spine material should have sufficient strength to reduce the stretching of the shaft. The spine material can have a strength greater than 5N. The spine material can have a strength greater than 15N. The spine can be metal or polymer or can be a multifilament polymer.

[0104] Fig. 15B Similar to Fig.15A However, the spine 412 has a cable spine end 416 that extends outward to the distal outer jacket 430. The spine 412 is placed below the braid 413 and above the liner 411, and has a distal hoop 416. The distal hoop 416 is pulled through the braid opening and around the outer diameter of the braid. Alternatively, a cable knot (such as Fig.164 (shown) tying the distal hoop 416 of the spine 412 to the braided wire. The cable spine end can be tied to the braid 413 at the braid intersection 420. Attaching the spine to the braid with a lasso or cable will prevent the braid from stretching and overcome the adhesion between the polymer jacket and the spine.

[0105] Fig.17A Similar to Fig.15A .exist Fig.17A In the embodiment of the present invention, a small amount of adhesive 440 is used to secure the distal end of the spine to the braid and liner. Fig. 17B Also similar to Fig.15A .exist Fig. 17B In FIG. 17C , a short length of higher durometer outer jacket polymer 450 is used to secure the distal end of the spine to the braid and liner. FIG. 17C is also similar to FIG. Fig.15A In FIG. 17C , a marker tape 460 is placed over the braid and ridge 412. The marker tape 460 can be crimped to secure the ridge 412 to the braid, ridge, and marker tape together. Alternatively, an adhesive can be applied under the marker tape 460 to secure the braid, ridge, and marker tape together.

[0106] Fig.18 is similar to Fig.17A and Fig. 17B A side view of a catheter with a spine stiffener 312 is shown with a marker band 460 used to attach the spine and the marker band 460 is above the braid.

[0107] Any of the support tubes for clot retrieval catheter designs disclosed herein can be used in conjunction with a mechanical thrombectomy device. The combination of mechanical thrombectomy and suction through a funnel-shaped end segment can increase the likelihood of first-pass success in removing a clot. During thrombectomy, the funnel-shaped shape of the end segment can reduce clot shear upon entry into the catheter, block flow to protect distal vessels from new regional embolization, and also direct the suction vacuum to the clot face while the mechanical thrombectomy device holds the composite clot (composed of a friable region and a fibrin-rich region) together, thereby preventing embolism and aiding in the dislodging of the clot from the vessel wall. The shape of the end can also help prevent fragmentation if the clot enters the tip of the catheter at an offset position.

[0108] The mechanical thrombectomy device can be configured to support the lumen of the blood vessel during aspiration so that the lumen is less likely to collapse under negative pressure and if the clot includes a series of hard and soft portions that would otherwise break apart, the mechanical thrombectomy device will hold the clot together. The mechanical thrombectomy device may also allow the user to pinch a clot that will not fully enter the lumen of the clot retrieval catheter, thereby ensuring that the clot will not fall out of the clot retrieval catheter as the clot retrieval catheter, clot, and mechanical thrombectomy device are retracted as a whole through the vasculature, through the external catheter, and outside the patient's body. The interaction between the external catheter and the dilating tube head may help to gradually compress the clot so that it can be pulled through the external catheter together with the clot retrieval catheter and the mechanical thrombectomy device. If the clot is still too large to enter the external catheter, the clot retrieval catheter and the mechanical thrombectomy device can be retracted proximally through the blood vessel and into a second larger external catheter, such as a balloon guide. If the clot is still too hard to be retrieved by the second external catheter, all devices can be retracted together through the vasculature and outside the body. The clot retrieval catheter can be designed to be advanced through an external catheter, such as a 7Fr, 8Fr, 9Fr or 10Fr guide catheter or a balloon guide catheter. Alternatively, the clot retrieval catheter can be designed as a 4Fr, 5Fr, 6Fr intermediate catheter. In another embodiment, the funnel-shaped feature can also be set on a 7Fr, 8Fr, 9Fr or 10Fr guide sheath to provide a seal in larger blood vessels instead of a balloon guide sheath.

[0109] The descriptions contained herein are examples of embodiments of the present invention and are not intended to limit the scope of the present invention in any way. As described herein, the present invention contemplates many variations and modifications of the catheter, including funnel-shaped catheters and tubular suction catheters. Modifications and variations that are obvious to those skilled in the relevant art in light of the teachings of this disclosure are intended to fall within the scope of the appended claims.

Claims

1. A catheter, comprising: a proximal elongated shaft comprising a longitudinal axis, a distal end, and a shaft braid; a distal tip segment including a terminal braid terminating in a distal hoop; a plurality of outer jackets disposed about the elongated shaft and the end section; one or more metallic ridges extending at least partially along an axial length of the conduit, the one or more metallic ridges inhibiting tensile elongation of the conduit; and The distal hoop of the end braid is integrally formed with the wires of the shaft braid. 2 . The catheter of claim 1 , at least a portion of the one or more metal ridges comprising a shape memory alloy. 3 . The catheter of claim 1 , at least a portion of the one or more metal ridges comprising at least one of stainless steel, DFT, cobalt-chromium, a titanium alloy, or tungsten. 4 . The catheter of claim 1 , at least one of the one or more metal ridges being interwoven with the shaft braid.

5. The catheter of claim 1, at least one of the one or more metal spines comprising a proximal portion and a distal portion, at least a portion of the proximal portion comprising two or more adjacent parallel strands. 6 . The catheter of claim 5 , the distal portion forming one or more of the distal hoops of the tip segment braid.

7. The catheter of claim 1, at least a portion of the one or more metal ridges extending the entire axial length of the catheter and comprising a non-circular cross-section.

8. The catheter of claim 1, the one or more metal ridges further comprising a first ridge and a second ridge spaced 180 degrees apart.

9. The catheter of claim 1, at least one of the one or more metal ridges comprising sections of varying thicknesses, and the one or more metal ridges being external to the shaft braid.

10. The catheter of claim 1, the one or more metallic ridges further comprising a single ridge adhered to one of the shaft braid or the tip braid at a termination point.

11. A catheter, comprising: an elongated tube comprising a longitudinal axis and a shaft braid, the shaft braid comprising a first set of helical wires braided with a second set of helical wires; a distal tip segment including a tip braid having a distal hoop at a distal end; a plurality of outer jackets disposed around the elongated tube and the end segment; and one or more polymer ridges extending at least partially along an axial length of the catheter, the one or more polymer ridges inhibiting tensile elongation of the catheter; the first set of helices of the shaft braid, the first set of helices flipped proximally to form the second set of helices of the shaft braid; and The distal hoop of the end braid is integrally formed with the wires of the shaft braid.

12. The catheter of claim 11, at least a portion of the one or more polymer spines comprising a combination of at least one of high density polyethylene, polyetherketone, ultra high molecular weight polyethylene, aramid, LCP liquid crystal polymer, nylon, or thermosetting liquid crystal polyoxazole.

13. The catheter of claim 11, at least a portion of the one or more polymer spines being laminated to the outer jacket.

14. The catheter of claim 11, at least a portion of the one or more polymer spines being coextruded with at least one of the outer jackets.

15. The catheter of claim 11, at least one of the one or more polymer spines being interwoven with the shaft braid.

16. The catheter of claim 11, at least one of the one or more polymer spines flipping through the shaft braid or the tip braid at a spine hoop to form two parallel strands.

17. The catheter of claim 16, at least a portion of one of the parallel strands extending outside of the shaft braid; and At least a portion of one of the parallel strands extends within the shaft braid.

18. A method for constructing a catheter, the method comprising: arranging the liner around the application mandrel; positioning one or more axial ridges exteriorly of an outer surface of the liner substantially parallel to the longitudinal axis; disposing a braided member around at least a portion of the liner on the application mandrel to form a catheter assembly, the braided member including a proximal portion and a distal portion terminating in a plurality of distal hoops; reflowing a series of proximal outer jackets to engage the catheter assembly; loading a polymer distal inner jacket around the reflux tool; removing the application mandrel and inserting the flashback tool and the polymeric distal inner jacket into the distal end of the catheter assembly; positioning a polymeric distal outer jacket on the flashback tool around at least the distal portion of the catheter assembly; refluxing the polymeric distal inner jacket and the polymeric distal outer jacket to the distal portion of the catheter assembly; as well as The reflow tool is removed.

19. The method of claim 18, further comprising the step of utilizing a polymer in at least a portion of the one or more ridges, the polymer having a melting temperature within a range of approximately ±17 degrees of the melting temperature of the distal-most outer jacket of the catheter.

20. The method according to claim 19, further comprising the steps of: flipping at least one of the one or more ridges to loop through an opening in the braided member; inverting a distal portion of one or more of the axial ridges to form one or more of the distal hoops of the end segment braid; laminating at least a portion of the one or more ridges with the outer jacket; coextruding at least a portion of the one or more ridges into at least a portion of the outer jacket to form a layered structure; utilizing a backflow tool having a flared distal end; as well as An inner hydrophilic coating is applied at least inside the distal portion of the catheter assembly.

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