Catheter structure

Abstract

Polymer tubing for a catheter or other medical device, where the polymer tubing may have regions of customized properties including, but not limited to, hardness, torque control, flexibility, axial strength, stiffness, etc. One variation of the device allows transitions between the regions to be configured such that there may be a graded or customized transition between the regions to selectively design structural characteristic differences between the regions. Additional variations include an outer layer having a plurality of material segments extending in a helical direction along an axial length to form a continuous wall of the outer layer. In some variations, structural characteristic differences are minimized or eliminated as compared to conventional catheters.

Description

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS

[0002] This application claims the benefit of U.S. Provisional Patent Application No. 63 / 369,947, filed on July 30, 2022, and this application claims the benefit of U.S. Provisional Patent Application No. 63 / 505,397, filed on May 31, 2023, the entire contents of both applications are incorporated by reference. Field of the Invention

[0003] Polymer tubing for use in catheters or other medical devices, wherein the polymer tubing can have length segments with customized properties, including but not limited to hardness, torque control, flexibility, axial strength, stiffness, etc. In one variation, transition regions between length segments can be configured so that there can be abrupt, gradual, or customized transition regions between various length segments, thereby selectively designing differences in structural properties between length segments and across transition regions. In some variations, structural property differences are minimized or eliminated compared to conventional catheters. Background of the Invention

[0005] Medical catheters allow physicians to apply a variety of different treatment methods in patients. Many catheters enter remote areas of the human body for delivery of diagnostic or therapeutic tools and / or agents to these sites. Optionally, the catheter may include a shaft or stent for treating a working end (e.g., a balloon, a filter retriever, an electrode, etc.). Some catheters, including but not limited to catheters for neurovascular use, are intended to enter small cerebral vessels from the aorta (e.g., the femoral artery or radial artery) through a tortuous anatomical structure. Therefore, due to the diverse regions of the anatomical structure through which the catheter passes, the catheter must be constructed to have diverse structural characteristics. Many times, the vascular path itself is circuitous into a multi-loop path, making it difficult for the catheter design to meet the requirements required for the tortuous anatomical structure. For example, the catheter must be quite hard at its proximal end to be able to push and manipulate the catheter when the catheter travels through the body, but must be sufficiently flexible at the distal end to allow the catheter end to pass through the ring and smaller blood vessels. In any case, the catheter must not cause significant trauma to the blood vessels or surrounding tissues.

[0006] Figure 1AA common catheter structure is shown, and a cross-sectional view of a catheter segment 10 is shown, which can be constructed on an internal mandrel or core 12 that can be removed at a later time. Common catheter structures include a layer 14 such as polytetrafluoroethylene (PTFE) that provides a smooth surface for the interior of the catheter while also supporting various structural components to provide the diverse segments 16 and 18 of the catheter 10. For example, the illustrated catheter 10 includes a reinforcement segment 16 in which a braid or coil 20 (or both) is wrapped around a second layer 14. Many catheters use a metal braid at the proximal end of the catheter and a metal coil (or one underneath the other) at the distal end of the catheter.

[0007] Many catheters intended to navigate through tortuous anatomy also include regions of variable durometer 18 where polymers 22, 24, and 26 of different durometers are placed adjacent to one another. Figure 1A Intended to illustrate the basic structure of a conventional catheter. For illustrative purposes, Figure 1A The catheter 10 of FIG. 1 shows that the polymer 22 terminates before the distal end 8 of the catheter 10, with only the underlying reinforcement section 16 being shown. In most conventional catheters, the entire distal end is encapsulated by the polymer.

[0008] like Figure 1A As shown, a series of adjacently placed polymer sheaths 22, 24, 26 are placed on the reinforcement layer and fused in place (e.g., by heating and reflowing the polymer onto the braid or coil). Different polymer hardnesses (i.e., "stiffness") are used for different segments, so each of these segments of the catheter will have unique structural properties / attributes, where the structural properties may include, but are not limited to, stiffness, resistance to twisting or torsion, flexibility, breaking strength, etc. The illustrated structure 10 provides varying structural properties over diverse regions of the catheter. However, in conventional devices, such catheter structures produce abrupt changes in properties at the transition or edge of each region 22, 24, 26.

[0009] In many conventional catheter devices, a higher durometer polymer is used in the proximal region, with a softer durometer polymer applied as the catheter progresses distally. More sophisticated catheters have more "segments" or transitions in stiffness (i.e., smaller extrusions with different durometers are used for the outer sheath). For example, Figure 1C The device manufactured by Microvention Termuo, Inc. (Aliso Viejo, CA) is shown. The end of the Plus distal access catheter 19 is shown, which is an example of a commercially available intracranial catheter described by Microvention as having an "exceptionally flexible distal tip" and a "twistable shaft" at the proximal length. The catheter includes an intermediate section 23 adjacent to the flexible distal tip 25. The proximal length of the catheter is not shown because Figure 1C It is intended to show that the intermediate length 23 is made of a relatively high durometer polymer and that there is an abrupt transition to a relatively soft distal tip 25. Typically, higher durometer polymers provide improved torque, rotational / axial stability, but are less flexible. Figure 1C As shown, a push force applied at the proximal end of a harder durometer polymer may cause buckling in region 38, approximately where the polymer changes. Buckling results in poorer push and travel.

[0010] Typically, harder durometers are more suitable for the proximal region of the catheter. Although polymers with higher durometers do not bend well around turns, polymers with higher durometers have better postural stability in the blood vessels and tend to transmit torque well. In contrast, softer durometers are suitable for the distal region of the catheter; because these polymers bend more easily and gently around the more delicate and tortuous distal turns. However, polymers with softer durometers do not transmit torque well and have poor postural stability. Therefore, conventional catheter designs adopt a "balancing approach" between mechanical properties, in which design elements (rigidity and stability, compared to, softness and less stability) are compromised. In addition, the change from one durometer to another has always been a source of mechanical challenges. These transitions are sources of discontinuity and are known in the art to cause challenges in torque transmission and to cause irregularities in bending stresses, which lead to poor navigation in anatomical structures. Therefore, engineers try to make transitions as long and gradual as possible, and to ease abrupt changes by using a large number of small transitions rather than fewer large transitions.

[0011] Regardless of the length of the transition, Figure 1A The common structure shown relies on a braid or coil 20 (or both) which is used to transmit torque when the catheter is traveling in a tortuous anatomical structure. However, due to polymers 22, 24, 26 (etc.), a greater degree of torque is applied to the polymer outside the braid / coil 20. Polymers with different physical properties will also have different torque resistance. For example, in a variation where polymers 22, 24 and 26 have reduced flexibility (22 is the most flexible, and 26 is the least flexible), the torque applied by the rotation of segment 26 will not be fully applied to segment 24. Therefore, segment 24 will not rotate as much as segment 26. Segment 22 will produce the same effect; it will not rotate as much as segment 24, and less than segment 26. This results in poor torque control or torque instability. In addition, when these segments contract, the transition between polymers will produce discontinuities in the response of the catheter to the contraction and bending of different segments.

[0012] Figure 1BAn illustration of a segment of the catheter body 10 (without the abrupt transition region) is provided with a curved profile to represent the segment of the catheter body 10 being pushed and thereby advanced through tortuous anatomy. Figure 1B A force 7 is shown applied to the proximal end 9 of the catheter body 10, which is resisted by the vessel wall, which is represented as force 6. In order to advance the catheter body 10, force 7 must be greater than force 6. When advancing through a tortuous path, the catheter body 10 is placed in a stretched state 32 at the outside of the bend and in a compressed state 34 inside the bend. However, polymers are suitable for compression or tension, and conventional catheter designs do not allow the selection of a single polymer to maximize the performance of both compression and tension. For example, a polymer that responds well to tension on the outside of the bend (e.g., a generally softer polymer) may not respond well to compression on the inside of the bend. Similarly, a polymer that responds well to compression on the inside of the bend (e.g., a relatively stiff polymer) does not respond well to tension on the outside of the bend. In addition, the polymer must also be selected to respond to torsion and axial compression. Otherwise, problems such as poor torque control or instability (e.g., known as "shaking") and axial instability (commonly known as catheter blockage) will result. As a compromise, ordinary catheter designs require balancing polymer properties, but cannot produce a device optimized for any given procedure. This compromise leads to undesirable effects. For example, Figure 1D An image of a React(TM) 071 catheter 36 provided by Medtronic is provided. The catheter 36 is held only at the end 37, allowing the catheter to assume its natural shape profile. As shown, the abrupt transition of the catheter 36 results in an irregular bend radius at point 38, rather than having a smooth bend radius or turn, which causes the catheter to buckle when pushed. The buckling of the catheter 36 reduces the transfer of thrust to areas outside the bend, as well as reduced traversability.

[0013] Undesirable abrupt transition regions are just one of the drawbacks of conventional catheter designs, which require a balancing act that compromises performance characteristics at any given segment of the catheter through the selection of less than ideal materials. Thus, there remains a need for improved catheter designs and catheter structures to produce catheters with highly customized properties. SUMMARY OF THE INVENTION

[0015] The catheter of the present invention allows for a customized designed catheter structure without compromising performance characteristics. This catheter structure is possible by being able to customize the properties and materials of any given segment of the catheter. This customized attribute includes, but is not limited to, hardness, torque control, flexibility, axial strength, stiffness, etc. The present disclosure also includes variations of improved catheters having a gradual or customized transition segment that can be selectively configured. For example, any segment of a polymer conduit (therefore, a finished catheter structure) can include polymers with low hardness, medium hardness, and high hardness in the same region. The ability to improve transitions is just an example of the benefits of a modified catheter constructed according to the teachings of this article.

[0016] To explain the features of the present invention, polymer strands / components represent material segments described herein before being formed into a tubular wall. As described herein, in some variations, a material segment can be formed of a first polymeric material and extend in a spiral pattern. At a certain point, the first polymeric material terminates at one end and is joined to one end of a second polymeric material, which still extends or continues in the spiral pattern of the material segment. In this case, the material segment is considered to have two different polymeric materials in different longitudinal regions. In another variation, the material segment includes a polymeric material and extends spirally in the longitudinal region of the pipe and then terminates so that adjacent material segments are joined together to maintain the continuity of the wall of the resulting pipe. It should also be noted that when referring to the joint structure of a single strand, the term tubular wall, polymer pipe, polymer layer, composite pipe, composite layer, etc., can include material segments composed of one or more of the following materials: metal, stainless steel, alloy, liquid crystal polymer (LCP), fiber, composite material or other similar structures.

[0017] It should be noted that transition segment should be used to describe the change of one or more material strands to different materials. The term transition region should describe the overall effect of one or more transition segments. In some variations, the transition region does not include any transition segments caused by the material simply terminating. Therefore, the catheter structure of the present disclosure can have a transition region that gradually changes material properties over the axial length, or, alternatively, the transition region can be a region where the material properties change abruptly.

[0018] The present disclosure includes multiple variations of catheters having an outer tubing layer formed of multiple materials to customize the properties of the longitudinal region of the catheter. Specific variations of the catheter may also include such a composite polymer layer on the inner layer of the catheter structure, but in many variations, the customized composite layer is on the outer layer.

[0019] A variation of this catheter conduit may include a tubular outer layer extending along the axial length of the tubular body; the tubular body includes a plurality of material segments extending helically along the axial length to form a wall of the tubular body, wherein each material segment is joined to an adjacent material segment to form the wall; wherein the plurality of material segments include at least a first material segment and a second material segment, the first material segment including a first structural property and the second material segment including a second structural property, wherein the first structural property is different from the second structural property; and wherein, along a transition region of the tubular body, a width of the first material segment increases while a width of the second material segment decreases, causing the structural properties of the transition region to vary along the transition region.

[0020] Another variation of the catheter may include an outer tubular body having a first segment and a second segment, the first segment and the second segment each extending along the axial length of the tubular body; wherein the outer tubular body includes a plurality of material segments extending helically along the axial length, wherein each material segment is sealingly joined to an adjacent material segment to form a composite wall of the outer tubular body, the composite wall surrounding an inner cavity extending along the axial length; wherein in the first segment, the plurality of material segments include at least a first material segment and a second material segment forming the composite wall, the first material segment including a first structural property, and the second material segment including a second structural property, wherein the first structural property is different from the second structural property; and a third material segment having a third structural property, wherein the third material segment is joined to an end of the first material segment at the second segment so that the third material segment replaces the first material segment in the second segment.

[0021] Another variation of the catheter includes a catheter conduit comprising: a tubular body having a first segment and a second segment, the first segment and the second segment each extending along the axial length of the tubular body; and a plurality of material segments extending spirally along the axial length to form a first segment, wherein each material segment is sealingly joined to an adjacent material segment to form a composite wall of the tubular body, the composite wall surrounding an inner cavity extending along the axial length; wherein each of the plurality of material segments respectively includes structural properties, and wherein the structural properties of at least two material segments are different; wherein the first segment includes a first sequence of material segments, and wherein the second segment includes a second sequence of material segments, such that the material segments in the first sequence are different from the material segments in the second sequence, resulting in the structural properties of the first segment being different from the structural properties of the second segment.

[0022] Another catheter structure includes the following catheter structure, which includes: a catheter shaft having an axial length, the catheter shaft including a tubular outer layer, the tubular outer layer including a plurality of material segments, each material segment having a corresponding width measured along the axial length, the plurality of material segments extending in a spiral direction along the axial length to form a wall of the tubular outer layer, the tubular outer layer having a first longitudinal region, a second longitudinal region and a transition region between the first longitudinal region and the second longitudinal region; wherein in the first longitudinal region, the plurality of material segments include a first material segment and a second material segment, wherein the structural properties of the first material segment are different from the structural properties of the second material segment, so that the first longitudinal region has a first structural characteristic; wherein in the transition region, the second material segment terminates at an end, and a third material segment is joined to the end of the second material segment, wherein the structural properties of the second material segment are different from the structural properties of the third material segment; and wherein the first material segment and the third material segment extend spirally from the transition region to the second longitudinal region, so that the structural properties of the second longitudinal region are different from the structural properties of the first longitudinal region.

[0023] Another variation of the catheter structure includes a catheter shaft having a tubular outer layer extending over at least a portion of the axial length of the catheter structure, the tubular outer layer comprising a plurality of material segments, each material segment having a corresponding width measured along the axial length, the plurality of material segments extending in a spiral direction along the axial length to form a wall of the tubular outer layer, the tubular outer layer having a first longitudinal region, a second longitudinal region; and wherein, in the first longitudinal region, the plurality of material segments include a first material segment located in the first longitudinal region having a first structural characteristic; wherein, in the second longitudinal region, at least a portion of the first material segment terminates at an end, and the second material segment is joined to the end of the first material segment, wherein the structural properties of the first material segment are different from the structural properties of the second material segment, so that the second longitudinal region has a second structural characteristic different from the first structural characteristic.

[0024] Another variation of the catheter structure includes a tubular outer layer, which includes a plurality of material segments, each material segment having a corresponding width measured along an axial length, and the plurality of material segments extend in a spiral direction along the axial length to form a continuous wall of the tubular outer layer; wherein the plurality of material segments include a first material segment and a second material segment adjacent to the first material segment, wherein the structural properties of the first material segment are different from the structural properties of the second material segment.

[0025] Another variation includes a catheter shaft having an axial length, the catheter shaft comprising an inner liner, a reinforcing structure located outside the inner liner, and a tubular outer layer extending over the reinforcing structure; the tubular outer layer comprises a plurality of material segments, each material segment having a corresponding width measured along the axial length, the plurality of material segments extending in a helical direction along the axial length to form a continuous wall of the tubular outer layer; wherein the plurality of material segments comprise a first material segment, a second material segment, and a third material segment, wherein the structural properties of each of the first material segment, the second material segment, and the third material segment are different; and the tubular outer layer has a first transition region, wherein the width of at least one of the first material segment, the second material segment, or the third material segment varies over the first transition region, resulting in a change in the structural properties of the first transition segment.

[0026] Additional variations include medical tubing, comprising: a tubular layer, the tubular layer comprising a plurality of material segments, each material segment having a corresponding width measured along an axial length, the plurality of material segments extending in a spiral direction along the axial length to form a continuous wall of the tubular outer layer; wherein the plurality of material segments include a first material segment and a second material segment adjacent to the first material segment, wherein the structural properties of the first material segment are different from the structural properties of the second material segment; and a first longitudinal region of the tubular outer layer, wherein both the width of the first material and the width of the second material vary along the first longitudinal region, causing the structural properties to vary in the first longitudinal region.

[0027] The medical tube may also include a tubular outer layer, the tubular outer layer including a plurality of material segments, each material segment having a corresponding width measured along an axial length, the plurality of material segments extending in a spiral direction along the axial length to form a continuous wall of the tubular outer layer; wherein the plurality of material segments include a first material segment, a second material segment, and a third material segment, wherein the structural properties of each of the first material segment, the second material segment, and the third material segment are different; and the tubular outer layer has a first longitudinal region, wherein the width of at least one of the first material segment, the second material segment, or the third material segment varies in the first longitudinal region, resulting in a change in the structural properties of the first longitudinal segment.

[0028] Another variation of a medical tube includes: a catheter shaft having an axial length, the catheter shaft including an inner liner, a reinforcing structure located outside the inner liner, and a tubular outer layer extending over the reinforcing structure; the tubular outer layer includes a plurality of material segments, each material segment having a corresponding width measured along the axial length, the plurality of material segments extending in a helical direction along the axial length to form a wall of the tubular outer layer, the tubular outer layer having a first longitudinal region, a second longitudinal region, and a transition region between the first longitudinal region and the second longitudinal region; wherein in the first longitudinal region, the plurality of material segments include a first material segment and a second material segment, wherein the structural properties of the first material segment are different from the structural properties of the second material segment, so that the first longitudinal region has a first structural characteristic; wherein in the transition region, the second material segment terminates at an end, and a third material segment is joined to the end of the second material segment, wherein the structural properties of the second material segment are different from the structural properties of the third material segment; and wherein the first material segment and the third material segment extend helically from the transition region to the second longitudinal region, so that the structural properties of the second longitudinal region are different from the structural properties of the first longitudinal region.

[0029] The present disclosure also includes one or more methods of forming a polymer tube. For example, such a method may include winding a plurality of polymer strands into a spiral configuration to form a polymer tube, wherein at least two of the polymer strands include different structural attributes; wherein in a first segment of the polymer tube, the plurality of polymer strands form a first sequence; changing the sequence of the polymer strands to form a second sequence in a second segment of the polymer tube; and fusing each polymer strand to an adjacent polymer strand to form a continuous wall in the polymer tube, wherein the continuous wall defines a lumen therethrough, and wherein due to the difference between the first sequence and the second sequence, the structural attributes of the first segment are different from the structural attributes of the second segment.

[0030] Another catheter according to the present disclosure includes: an inner lining; an outer layer, the outer layer including a plurality of polymer strands wound into a spiral configuration, wherein at least two of the polymer strands include different structural properties; wherein in a first segment of the outer layer, the plurality of polymer strands form a first sequence; wherein in a second segment of the polymer tube, the polymer strands form a second sequence; and wherein each polymer strand is fused or joined to adjacent polymer strands so that the plurality of polymer strands form a continuous wall that defines an inner cavity through the polymer tube, and wherein, due to the difference between the first sequence and the second sequence, the structural properties of the first segment are different from the structural properties of the second segment.

[0031] Another variation of the catheter includes: an inner lining; an outer layer, the outer layer including a first polymer material having a tubular shape, at least a second polymer strand, the second polymer strand being wound into a spiral configuration around the tubular shape and fused into the first polymer material so that at least a portion of the wall of the tubular shape includes the first polymer material and the second polymer material, wherein the first polymer material and the second polymer material include different structural properties; wherein in a first segment of the outer layer, the first polymer material and the second polymer material form a first pattern; wherein in a first segment of the outer layer, the first polymer material and the second polymer material form a first pattern; and wherein each polymer strand is fused or joined to adjacent polymer strands so that multiple polymer strands form a continuous wall, which defines an inner cavity through the polymer tube, and wherein, due to the difference between the first sequence and the second sequence, the structural properties of the first segment are different from the structural properties of the second segment.

[0032] The conduit and tubing configurations of the present disclosure allow for a considerable number of combinations and permutations of different variations of conduits, as well as combinations of various aspects of these configurations. It is contemplated that any of the following claims and elements may be combined with any independent claim, provided that the claims of the independent claims do not conflict with the various elements.

[0033] Any of the structures herein may include a tubular outer layer comprising a plurality of material segments, each material segment having a respective width measured along an axial length, the plurality of material segments extending in a helical direction along the axial length to form a continuous wall of the tubular outer layer.

[0034] Any of the variations of the apparatus / method may also include an inner liner positioned within the tubular outer layer, and a reinforcing structure positioned external to the inner liner and within the tubular outer layer.

[0035] Variations may include the width of the first material segment and the width of the second material segment varying along the first transition region.

[0036] Variations may include that the tubular outer layer has a proximal longitudinal region proximal to the first transition region, wherein the proximal longitudinal region is formed entirely from the first material segment.

[0037] Variations may include a third material segment extending over a majority of the axial length of the tubular body of the catheter.

[0038] Variations may include that in at least a first section of the wall of the tubular body, the width of the first material section is greater than the width of the second material.

[0039] Variations may include tapering of the ends of the second material segment.

[0040] The catheters and structures described herein can have segments of material that have right-handed windings, left-handed windings, or both.

[0041] Variations of any device or method herein may include at least one material segment that includes a non-fusible material. In addition, such non-fusible material may be used only for manufacturing, so removing the non-fusible material will impart a recessed cavity or other design feature on any surface of the device.

[0042] The device herein may also include an inner liner positioned within the tubular outer layer, and a reinforcing structure positioned external to the inner liner and within the tubular outer layer.

[0043] A variation of the device structure of the present invention may also include a tubular outer layer, which also has a second longitudinal region, a third longitudinal region, and a transition region between the second longitudinal region and the third longitudinal region; wherein the second longitudinal region includes a first material segment and a second material segment that define the structural properties of the second longitudinal region; wherein in the transition region, the second material segment has an end, and the third material segment is joined to the end of the second material segment, wherein the structural properties of the second material segment are different from the structural properties of the third material segment; and wherein the first material segment and the third material segment spirally extend from the transition region to the third longitudinal region, resulting in the structural properties of the third longitudinal region being different from the structural properties of the second longitudinal region.

[0044] Any of the aforementioned examples of catheters or catheter structures may include a tubular outer layer, the tubular outer layer comprising a plurality of material segments, each material segment having a corresponding width measured along an axial length, the plurality of material segments extending in a spiral direction along the axial length to form a continuous wall of the tubular outer layer. In addition, the change of any material segment can be incremental or continuous.

[0045] This application is related to U.S. Patent Application No. 17 / 173,003, filed on February 10, 2021, which is a divisional of U.S. Patent Application No. 16 / 902,154, filed on June 15, 2020, which is a non-provisional application of U.S. Provisional Application No. 62 / 862,035, filed on June 15, 2019. This application is also related to PCT Application No. PCT / US2020 / 037808, filed on June 15, 2020, the entire contents of each of which are incorporated by reference. BRIEF DESCRIPTION OF THE DRAWINGS

[0047] Figure 1A A common catheter structure is shown, and a cross-sectional view of a catheter segment constructed on an inner extruded tube is shown.

[0048] Figure 1B An illustration of a catheter body exhibiting a curved profile is provided.

[0049] Figure 1C A conventional catheter having multiple durometer regions is shown.

[0050] Figure 1D A representation of a photograph of a catheter having abrupt changes in structural properties between regions and being maintained to present a bent or curved profile such that the abrupt changes in the catheter result in an irregular bend radius.

[0051] FIG. 2A to FIG. 2C Shown is a partial cross-sectional view of an improved catheter comprising an improved polymeric outer layer as described herein.

[0052] Figure 2D The concept of a catheter shaft is illustrated to illustrate features of a catheter design according to the present disclosure.

[0053] Figure 2E Various pathways are illustrated through which variations of the catheter segments of the present invention are specifically designed to traverse.

[0054] Figure 2F Three conduits are shown with material segments wound in left-hand and right-hand directions.

[0055] Figure 2G Various cerebral blood vessels are shown with a catheter advanced through one of the carotid arteries.

[0056] Figure 2H The diagram illustrates a conventional catheter being advanced through a carotid artery, wherein the conventional catheter comprises different segments with abrupt changes between the segments.

[0057] Fig.2I and Figure 2J The improved catheter is shown in Fig.2I The shape of the vessel as it advances through it and takes on the shape of that vessel.

[0058] Figure 2K One possible design configuration is illustrated that utilizes a composite tube having material segments to manufacture a catheter structure that includes different materials that each provide different mechanical advantages / benefits all within a single area of ​​the finished catheter.

[0059] Figure 3A and Figure 3B One example of a manufacturing process for constructing a catheter segment according to the present disclosure is illustrated.

[0060] Figure 3C A catheter segment is illustrated that includes a plurality of discrete strands of polymeric material wrapped around a mandrel or tube.

[0061] Figure 3D An image illustrating an example of a winding process.

[0062] Figure 3EThe diagram shows a configuration where polymer strands are secured together prior to helical winding.

[0063] Figure 3F Three additional variations of polymer strands arranged to have diverse properties are illustrated.

[0064] Figure 3G and Figure 3H Additional variations of polymer strands being joined together end-to-end and longitudinally prior to being helically wound and formed into a tubular body are shown.

[0065] Fig. 3I and Figure 3J Additional variations of non-uniform strands that are joined together prior to forming a conduit for a catheter structure are depicted.

[0066] Figure 4A The diagram shows the formation Figure 4B Another variation of a set of joined strands preceding a tubular segment is shown.

[0067] Figure 4B The diagram shows Figure 4A The strands shown form a catheter segment.

[0068] Figure 5 A catheter segment is shown illustrating the separation of dissimilar strands.

[0069] FIG. 6A to FIG. 6C A variation of a strand with a reinforcing structure is shown.

[0070] 7A to 7F Some examples of catheter segments formed from various polymers are illustrated.

[0071] Fig. 8A and Figure 8B A picture of multiple strands extending about a ruler is shown to illustrate a perspective view of the strands for one variation of a catheter structure.

[0072] Fig. 9A and Fig. 9B Two examples of catheter segments with an outer layer are shown that can be incorporated into the catheter or used as a stand-alone device.

[0073] FIG. 10A to FIG. 10D Another variation of the device is illustrated which incrementally changes polymer to construct a coiled conduit having gradually changing transition regions between different sections of the finished polymer tube.

[0074] Fig.11A A graph of bending stiffness versus shaft position is illustrated to help understand the ability of the catheters of the present disclosure to create a transition region that is a significant improvement over currently available catheters.

[0075] Fig. 11B An image of a catheter segment constructed in accordance with the present disclosure is shown, wherein the catheter segment is held in place with Figure 1C The catheter posture shown is similar to the posture.

[0076] Fig. 12A and Fig.12F Images of various catheters are shown to illustrate variations in patterns that may be formed by joining polymer strands to create features and / or patterns in a catheter segment.

[0077] Fig.13A and Fig. 13B A plurality of material segments are shown in which additional discrete materials are formed.

[0078] FIG. 14A to FIG. 14C Another variation of a composite polymer tube having a plurality of material segments is illustrated, wherein the material segments are embedded in the polymer tube.

[0079] Fig.15A A variation of a catheter having a mixing region is shown.

[0080] Fig. 15B Shows Fig.15A 15B is an enlarged view of the blood vessels in the area.

[0081] Fig. 15C Picture shows Fig.15A Magnified view of the catheter passing through an acute bend in the artery.

[0082] Fig.15D It shows that the Fig.15A and Fig. 15C Several non-exhaustive design configurations of mixing regions are shown.

[0083] FIG. 16A to FIG. 16F Additional examples of various configurations of tubular members for use with the devices described herein are shown.

[0084] Fig.17A and Fig. 17B Another example of customizing material segments using transition material segments of reduced width is shown.

[0085] Fig.18A A conventional catheter configuration is shown, wherein the polymer chains are aligned with the axis or axial length of the tube.

[0086] FIG. 18B to FIG. 18E Additional design variations for composite pipe segments having high elastic modulus / stiffness are shown.

[0087] FIG. 19A to FIG. 19D Another variation of a composite tube is shown.

[0088] Fig. 20AAnother aspect of an improved catheter incorporating a composite layer at the distal end of the catheter is shown.

[0089] Fig. 20B The directional tip at the distal end of the catheter body is shown.

[0090] Fig. 20C and Fig.20D Another variation of a directional tip at the distal end of the catheter body is shown.

[0091] Fig.21A and Fig.21B Another example of a catheter with a directional tip is shown.

[0092] FIG. 22A to FIG. 22D Various configurations of the segments of material that form the directional tips at the end of the catheter body are shown.

[0093] FIG. 23A to FIG. 23F Another variant of the production of the composite tube is shown.

[0094] Fig.24 Another variation of a composite tube formed from non-overlapping material segments is shown.

[0095] Fig.25 Another variation of a composite pipe is shown.

[0096] Detailed Description

[0097] The catheter configurations discussed herein can be used in a variety of devices, where different regions are selected for customized properties. The configurations described herein can be incorporated into a variety of medical devices, or can be used as catheter shafts. In addition, in some variations, the construction features of the present disclosure are not limited to in vivo medical devices, and can be used in any device requiring a conduit.

[0098] The polymer conduits described herein can be constructed in any manner that allows for the material segment configurations (and hybrid regions) disclosed below. Such manufacturing methods include, but are not limited to: forming a polymer tube by direct winding on a catheter shaft; forming the strands into a composite sheet and then winding the sheet onto a structure to complete the catheter shaft; and / or first winding the strips / strands onto a mandrel or support structure and then fusing the material into the tube and then transferring to the catheter assembly.

[0099] FIG. 2A to FIG. 2CA partial cross-sectional view of an improved catheter 100 is shown, and the improved catheter 100 includes an improved composite outer layer 103 as described herein. The catheter structures discussed herein can be combined with any number of features known to those skilled in the art of catheter structures. Such features are omitted herein so that the focus can be on explaining the composite outer layer 103 of the improved catheter. In addition, the improved catheter structures disclosed herein can be incorporated into any number of catheters that can benefit from the customization of the features provided by the improved polymer outer layer 103. For example, such catheters include, but are not limited to, distal access catheters, sheaths, guide catheters, balloon catheters, intracranial support catheters, microcatheters, arterial catheters, central venous catheters, pulmonary artery catheters, coronary and cardiac catheters, and peripheral catheters, etc.

[0100] Other variations of the improved structure can be used for any polymer tubular structure. It should be noted that any catheter structure or polymer conduit disclosed herein is not limited to a single uniform outer diameter over the entire catheter. As described below, the catheter and polymer conduit of the present disclosure can have a wavy outer diameter. Alternatively or in combination, the outer diameter can vary in each longitudinal region of the catheter. The term longitudinal region means a region of any length along the axis 105 of the tubular structure. The catheter structure and tubular structure disclosed herein can have any number of conventional cross-sectional shapes. For example, a variation of the device can include a catheter having different diameters and / or cross-sectional shapes in different regions. Some segments of the catheter and tubular structure can include a circular cross-sectional shape that becomes a non-circular shape.

[0101] like Figure 2A As shown, in one variation of the device, the tubular structure or shaft of the catheter 100 extends from a hub 101 and may be formed of a modified outer composite layer 103, as described below, which covers a braid 20, coil, or other support structure commonly used for catheters. The braid 20 is positioned around the tubular liner 14 (typically composed of PTFE, but other materials are also within the scope of the present disclosure). Figure 2A As shown, the improved composite layer 103 is the outermost component of the catheter tubing. As described below, the improved composite layer 103 can include any number of longitudinal regions that are better suited to transmitting torque through the catheter 100. Positioning these torque-transmitting polymer regions on the exterior of the catheter increases the effectiveness of the torque-transmitting regions compared to conventional catheters that rely primarily on the braid 20 located within the catheter shaft.

[0102] Figure 2B Shows something like Figure 2A The illustrated variation in which catheter 100 includes a distal tip 15 coupled to the end of tubing 103. In some variations, distal tip 15 may comprise a soft polymer or other material. Figure 2C Shows something like Figure 2A and Figure 2B 100, wherein an outer layer 13 positioned above the tubular member 103 is added. The outer layer 13 may include a transparent or translucent material. In most cases, the performance and characteristics of the device 100 will be controlled by the selection of the material forming the tubular member 103, the combination of the braid / coil or other support structure 20. In other variations, the outer layer 13 will not affect the performance and / or characteristics of the device 100.

[0103] Figure 2D The concept of catheter layer 103 is described, which is intended to illustrate the features of the catheter design according to the present disclosure. Layer 103 can be incorporated into Figure 2A The catheter structure shown, or incorporated into any variation of such a structure (e.g., a catheter without reinforcing structure 20 and / or a catheter without liner 14). As shown, the catheter layer 103 may include any number of regions 102, 104, 106, and 108, wherein the structural properties of each region may be customized based on the intended purpose of the catheter or as otherwise desired. For example, Figure 2D The layer 103 shown in FIG. 1 may be optimized or matched for use in a catheter that is intended to be advanced through a vascular system having a variety of tortuosity. Figure 2E , region 102 may be designed to pass through the tortuous region 52 , while regions 104 , 106 , and 108 may be designed for the corresponding regions 54 , 56 , and 58 . Figure 2D The catheter layer 103 is shown to have at least one material segment extending in a spiral or helical pattern, the pitch of which varies along the length of the finished layer 103. In one variation, the various longitudinal regions 102, 104, 106, 108 can be matched to specific regions of the vascular system 52, 54, 56, 58, each of which has a different degree of tortuosity. As described herein, the layer 103 can include any number of material segments. In addition, the actual material of any material segment (e.g., 110, 112) over the length of the layer 103 can vary, which can create new regions.

[0104] Figure 2D Also shown is a material segment 110 comprising a polymer helical region extending adjacent to a second material segment 112, the second material segment 112 comprising a second polymer (or alternative conduit material) to produce regions (102, 104, 106, 108) to obtain desired properties extending along the conduit 100. For example, the pitch of the first material segment 110 can be varied in each region 102, 104, 106, and 108. Alternatively, or in combination, the width of any material segment can vary according to the region. For example, the material segment 110 can include a reinforced polymer (e.g., PEBAX 72D or similar material).

[0105] In another variation, material segment 110 may include a first polymer material (e.g., PEBAX 35D) within a second material segment 112, which includes a relatively stiffer material (e.g., PEBAX 40D-70D), wherein the helical pitch of the material segments is selected such that a first region 102 is relatively stiff compared to the remaining regions, and the stiffness of an adjacent region 104 is reduced relative to region 102. This change in stiffness may continue until region 108 is the softest / least stiff region and serves as the distal portion of material layer 103, which in turn similarly affects the distal portion of the catheter incorporating material layer 103.

[0106] The structure of layer 103 of the present disclosure allows for any number of engineered conduits with customized properties. Figure 2F Two layers 103 and 107 are shown to illustrate that the novel layers of the present disclosure provide the ability to manufacture a catheter structure having a left-handed winding (layer 103) or a right-handed winding (layer 107) of the material segments 110, 112 to produce a directionally biased catheter having opposite winding characteristics between the distal region 122 and the proximal region 124. Figure 2FIn the first variation shown, layer 103 can be used for a catheter that requires diverse regions 102, 104, 106, 108. However, in this variation, region 108 includes material segments 110 having a loose pitch wound in a right-hand direction and including rigid polymer strands to create a soft region that can be used to form the distal region of the catheter. The adjacent region 106 includes a more moderate pitch of material segments 110, so that region 106 is not as soft as region 108. The pitch of material segments 110 can be increased in segments 104 and 102, which allows for increased support. Although the figure of 2F shows only two material segments 110 and 112, any number of material segments formed of polymeric materials can be used to manufacture diverse segments that form the outer layer 103 of the catheter. As described above, the structural properties of the various regions can be matched to the properties of the target anatomical structure. In addition, the winding (or specific material selection) of the material segments 110 and / or 112 shown in the layer 103 or 107 can produce a catheter that is wound in a specific direction (i.e., a catheter that is pre-set to follow the winding of a specific area of ​​the anatomical structure). Specifically, the directionality of the winding can match the directional twist of the blood vessel (i.e., a left-handed winding catheter for the left internal carotid artery and blood vessels, and a right-handed winding catheter for the right internal carotid artery and blood vessels, etc.). For example, the left carotid artery of an individual is wound in a left-hand direction, while the right carotid artery of the individual is wound in a right-hand direction. The catheter structure using the disclosed catheter layer (e.g., 103, 107) produces a catheter that is suitable for specifically following the bends of a specific internal carotid artery or any other artery or body passage. In general, as described herein, the direction of the reinforcing strand can be pre-set so that the catheter bends or travels along a specific rotational direction within the anatomical structure. As described herein, the present disclosure allows any area of ​​the catheter structure to be customized with specific material properties. Furthermore, the conduit layer 114 comprises a single tube having a right-handed coil adjacent the distal end of the layer 114 and a left-handed coil adjacent the proximal end of the layer 114. Obviously, the present disclosure includes sections of material coiled in a single direction or multiple directions along the length of any tube.

[0107] Figure 2G , Fig.2I and Figure 2J The benefits of using a catheter of the configuration disclosed herein are further illustrated. Figure 2G Various cerebral blood vessels are illustrated with a catheter 10 being advanced through one of the carotid arteries 4, which are commonly used to access the brain. The carotid arteries 4 have various tortuosity regions and decrease in diameter as the vessel further enters the brain. Figure 2H The diagram shows the Figure 2G The catheter 10 is similar to a conventional catheter that advances through the blood vessel 4 and assumes the shape of the blood vessel 4. Figure 1AThe structure shown, wherein the catheter includes discrete regions 21, 22, 24, 26, 27 of varying stiffness. As described above, although conventional catheters are designed to have different regions, each region has a discontinuous change in polymer (or other features, such as removing the liner, changing the braid / coil structure, etc.), and therefore the catheter 10 has a sudden change in structural properties at the intersection of each region 21, 22, 24, 26, 27. One problem with this design is the loss of torque applied uniformly to each segment. In other words, the torque 40 applied to the harder proximal segment 27 will be greater than the torque 42 of the distalmost segment 21, which is generally the most flexible segment. In addition to the difference in torque, the rotational deflection of the proximal segment 27 will be greater than the rotational deflection of the distalmost segment 21.

[0108] Fig.2I and Figure 2J The improved catheter 100 is shown in FIG. Figure 2G The situation when it advances in the blood vessel 4 and takes the shape of the blood vessel. Fig.2I Variations of the catheter 100 of the present design are shown, but for purposes of illustration, only a first material segment 110 helically wound with a second material segment 112 is shown. Figure 2J As shown, any number of material segments may be used in the catheter 100. For purposes of illustration, the material segment 110 comprises a single polymer having a rigid material property (e.g., 72D). The example shows a first material segment 110 having a polymer extending the length of the catheter 100. Thus, the helically formed polymer strand material segment 110 helps to transfer the applied torque 44 along the length of the catheter 100 through the material segment 110, so that the torque 46 at the distal end is closer to the torque 44 at the proximal end, which is different from conventional catheters.

[0109] Figure 2J Another variation of a catheter 100 is shown having a plurality of material segments 110 , 130 , 132 , 134 , 136 , 138 , 140 , 142 extending helically along the length of the catheter 100 . Figure 2J The material segments shown in are for illustrative purposes only, and any number of polymers may extend helically around the catheter 100, with some polymers stopping or tapering at different regions and different polymers starting, such that different regions of the catheter may include different polymers to impart unique structural properties to each region of the catheter. Figure 2J This is intended to illustrate the ability to position a material combination along any segment of the catheter 100. To illustrate one variation of the catheter 100, the material segment 110 of the catheter forms a majority of the wall of the material layer at the proximal end 122 of the catheter 100 (see, for example, Figure 2A103 in). The polymer forming the material layer 110 at the proximal end 122 of the catheter 100 extends helically along the length of the catheter 110, and the material or changes or the material segment ends before the distal end 124 adjacent the catheter 100, so that the material segment at the distal end 124 includes different material segments 130, 132 or different polymers. As described herein, the material segment can be terminated, or the polymer in the material segment can be joined to the end of a different polymer in the material segment, so that the polymer in the same material segment changes.

[0110] Figure 2K One possible design configuration is illustrated that utilizes a composite pipe 103 having material segments to manufacture a conduit structure that includes different materials, each of which provides different mechanical advantages / benefits all within a single region of the finished conduit. The result is that the finished conduit segment will have mixed mechanical characteristics within one region of the conduit. This configuration is simply not possible with conventional conduit designs. For example, Figure 2K A composite layer or tube 103 is shown having multiple material segments 280, 282, 284, 286, and 288. These material segments can each provide unique benefits: material segment 280 includes a low-durometer ultra-soft material for high flexibility; material segment 282 includes a medium-durometer material that provides some flexibility as well as axial stability; material segment 284 includes a high-durometer material that provides enhanced torque control and rotational stability and axial stability. Material segments 286 and 288 are shown to represent that the composite tube 103 can include any number of additional material layers.

[0111] The various polymer strands used to make the catheter (or outer layer) can be selected based on the intended use of the catheter and / or according to the expected path of the target in the body to impart desired properties to the catheter 100. This structure allows the various properties of any polymer to extend to various segments of the catheter 100 or the entire catheter 100, so that the catheter does not contain any abrupt changes in structural characteristics / properties that affect rotational stability and axial stability such as bending, torsion, contraction, etc.

[0112] Figure 3A and Figure 3B An example of a manufacturing process for constructing a catheter segment according to the present disclosure is illustrated. It is contemplated that any manufacturing process for manufacturing a catheter or catheter layer having multiple material segments is within the scope of the present disclosure. For example, such a manufacturing process may include winding polymer strands (as shown), 3D printing, extrusion, etc. Figure 3AAs shown, multiple polymer strands or ribbons are placed in a pattern to correspond to material segments 130, 132, 134, 136 and can be wrapped around structure 116. The structure can include a braid / liner of a mandrel, tube, or catheter structure. Once the polymer strands are wrapped, they are fused or otherwise joined together to form layers as described herein (e.g., see Figure 2A Layer 103). In one variation, the polymer bands that are wound and joined form the wall layer of the catheter after they are fused together. Alternatively, the polymer bands can form an outer layer on a tube, braid and / or coil 116 and form a part of a catheter segment. For convenience, polymer strands / bands / extrusions should be referred to as polymer strands. The present invention includes polymer segments of any shape required to complete the catheter segment. As shown, the cross-section of the polymer strand can be rectangular. Alternatively, the polymer strand can be oval, circular or any other shape. In another variation, polymer strands of different shapes and sizes can be combined to form a layer. In addition, the polymer strand can include a single-lumen extrudate / tube that shrinks and melts / fuses. Alternatively, the strand can be extruded or otherwise made solid. In another variation, the lumen of each polymer strand remains intact. In a typical variation, the strand is wound around a braid or coil (as described above). In other variations, the polymer strand structures discussed herein can be used to form the inner layer of a catheter (instead of or in addition to a polymer liner), with a separate structure being used for the outer layer of the catheter. In other variations, although the disclosure herein discusses strands and material segments comprising polymers. Strands or material segments can include non-polymeric materials (e.g., metals, stainless steel, alloys, liquid crystal polymers (LCP), fibers, composite materials, or other similar structures). Strands can be different materials, shapes, sizes, and mixed together, or can be placed and removed to leave gaps. Strands can also be different materials, shapes, sizes, and mixed together, or can be placed and removed to leave gaps.

[0113] For the purpose of explaining the features of the present invention, polymer strands / components represent material segments described herein before being formed into a tubular wall. As described herein, in some variations, a material segment can be formed of a first polymeric material and extend in a spiral pattern. At a certain point, the first polymeric material terminates at one end and is joined to one end of a second polymeric material, which still extends or continues in the spiral pattern of the material segment. In this case, the material segment is considered to have two different polymeric materials in different longitudinal regions. In other variations, the material segment includes polymeric materials and extends spirally within the longitudinal region of the pipe and then terminates so that adjacent material segments are joined together to maintain the continuity of the wall of the resulting pipe.

[0114] Regardless of the manufacturing process, the polymer strands in each material segment 130-136 can include polymers of different compositions. In one example, the polymer can be a common material (e.g., PEBAX), wherein each strand in the corresponding material segment 130-136 includes a different hardness. For example, the strands can have the following relative hardnesses: 130-72D, 132-63D, 134-35D, and 136-45D. Obviously, any number of variations are within the scope of the present disclosure.

[0115] Figure 3A Also shown are a plurality of material segments 130, 132, 134, 136, each having a respective width W1, W2, W3 and W4, which are measured along the axial length 105 of the tube. In this illustration, the axial length 105 is the axial length of the core or tube and is substantially similar if not the same as the axial length of a finished tube or conduit having layers formed from the material segments 130, 132, 134, 136. In the case where the material has not yet been formed into a tube structure, the width is measured in a plane perpendicular to the strand length. As shown in FIG. Figure 3B As shown, the material segment extends in a helical direction along the axial length 105 to form a continuous wall as described herein.

[0116] Figure 3C The wall segment 103 and support structure 116 are shown after the plurality of discrete polymeric material strands in the material segments 130, 134, 132, 136 have been joined together. The segment 103 may be incorporated into a medical catheter, medical device, and / or other conduit.

[0117] Figure 3D An image of one example of a winding process is shown, in which polymer strands are formed into material segments 138, 140, 142 and are wound directly onto the catheter reinforcement braid 116. (Alternatively, the strands may be wound onto a mandrel, fused or partially fused together, and then transferred to the catheter braid as a conventional catheter structure.) In this variation, the strands 138-142 are separate and wound so that the strands are in contact for joining to form a sealed connection between adjacent materials, such as by heat fusion. However, any process that results in joining of adjacent materials may be used.

[0118] Although the variations disclosed herein show a single layer of various material segments forming the wall of the conduit, it should be noted that the conduit may be formed from multiple layers, each layer comprising multiple material segments. Each layer may have the same or different order of material segments.

[0119] Figure 3EA configuration is shown in which polymer strands 130-134 are secured together prior to being helically wound to form material segments 130-134. For example, the strands may be fused together or stapled together prior to winding.

[0120] Figure 3F Three additional variations of polymer strands arranged to have diverse properties are illustrated. In the illustrated example, the stiffness of the strands is shown. However, the polymer strands may vary in other properties as desired. As shown in the bottom two variations, two strands with similar configurations may be placed adjacent to dissimilar strands. When formed into a tubular member, the central material segment will be bounded by material segments having the same polymer.

[0121] Figure 3G and Figure 3H An additional variation of polymer strands 130, 132, 134, 130-134 is shown that are joined together end-to-end and longitudinally prior to forming the wall, wherein strand 134 will ultimately form a material segment on either side of the material segment formed by strands 130 and 132. In this variation, strands 130 and 132 are joined end-to-end at transition segment 120 to allow for a longitudinal transition of material in the axial direction of the finished conduit. This means that when the tubular member / wall is formed, the central material segment includes material 130 joined to material 132 at edge 120. The joint or transition segment 120 between strands 130 and 132 may be as shown in FIG. Figure 3G The abrupt transition segment 120 shown, or Figure 3H An inclined or tapered transition segment 120 is shown.

[0122] Fig. 3I and Figure 3J Additional but non-exhaustive variations of strands 130, 132, 134, 136 being joined together where the strands are not uniform are depicted. For example, Fig. 3I A strand 134 having a circular cross-sectional shape is shown. As described above, any type of cross-sectional shape may be used. In this case, the width W3 of the strand 134 may be considered to be its widest dimension along the axis. In some variations, the size of the strand 134 will result in the resulting material segment protruding slightly from the surface of the tube. Figure 3J This is shown in which certain strands 134 of height H1 are joined to strands 132 having a greater height H2. Figure 3JAlso shown are strands that are not uniform in width, W5 and W6. Likewise, any arrangement of shapes, sizes, widths, heights, etc., may be combined to form a polymer layer. It should be noted that strands of any material incorporated into a composite polymer layer may include strands of material having a melting temperature different from one or more adjacent strands. It should also be noted that in some variations, one or more strands may be non-meltable (i.e., thermosets, or metals, Teflon, etc.), such strands being mechanically secured by adjacent strands, but not melted. In other variations, non-meltable strands are used during pipe formation and then removed to create voids or patterns.

[0123] Figure 4A The diagram shows the formation Figure 4B Another variation of a set of joined strands 130-138 before the tubular segment is shown. As shown, the strands include different properties, which in turn produce different segments 102, 106 and 108 for the catheter. Figure 4B As shown, when coiled, the changes in composition of the material segments 130-138 form different axial segments 102, 106, 108 extending longitudinally along the tubular layer 103. Figure 4A and Figure 4B In both variations shown, the strand / tubing layer 103 comprises a single strand 130 that will extend continuously as a material segment 130 throughout the length of the finished tube 103. In this example, the strand 130 comprises a 72D material and may ultimately serve as a reinforcement for the finished catheter (primarily to transmit torque and provide stability through the generally soft and pliable distal region, which generally does not transmit torque well and generally has poor stability).

[0124] Figure 5 A segment 102 of a pipe is shown in which strands 152 and 154 are joined together to form a tube. The figure shows the separation of dissimilar strands 152 and 154. In this example, strand 152 can be separated by a second strand 154, wherein the second strand either includes a segment having the same width as strand 152, or the second strand 154 has a greater width than the first strand 152. As described above, the width is measured along the axial length of the tube. For example, strand 152 can include a high durometer material, while strand 154 includes a relatively low durometer material. In another variation, strand 152 includes a low durometer material, while strand 154 includes a high durometer material. For example, in one variation of the device, the low durometer material can range between 35D and 45D, while the high durometer material can range between 63D and 72D. Obviously, additional changes in materials are within the scope of the present disclosure.

[0125] Fig. 6AAnother variation of the catheter structures described herein is shown in which a polymeric strand 130 includes a support member 156 extending therethrough that reinforces the strand 130 or provides alternative structure and properties. The support member 156 may extend through the entire length of the strand 130 or partially through the strand. Furthermore, variations of the reinforced strand 130 may include multiple support members extending through the strand. Figure 6B A cross-sectional view of strand 130 is shown to illustrate some cross-sectional shapes of the reinforcing member. As shown, the reinforcing member can have a circular 158 or elliptical cross section, the support member can have a rectangular or square 160 cross section, or the support member can include a D-shaped 162 cross section. The support member can include a metal, alloy, or polymer. For example, the support member can include SS wire, shape memory wire, drawn filling tube, or composite fiber material. It can be a cable, braid, coil, strand, etc., or any shape / structure / material for providing support. Figure 6C Various complex cross-sectional shapes 164 are shown for support members within strands 130. In some variations, the catheter segments may include different cross-sectional shapes in different segments of the catheter. For example, it has been found that strands with round or oval cross-sectional shapes are more suitable for the distal region of the catheter, while strands with D-shaped support members are useful in the middle or proximal region of the catheter.

[0126] 7A to 7F Some examples of tubular segments 203 formed of various polymers are shown to have multiple material segments extending in a spiral pattern along the pipe 203. For illustration in 7A to 7F, material properties are shown in association with the following element numbers: 35D-235, 45D-245, 55D-255, 63D-263, 72D-272. However, this association is intended to show variations of the pipe 203. Any material changes can be used in the catheter structures described herein. In addition, as described herein, any pipe segment 203 can be used in any section of a complete catheter. 7A to 7F The illustrations of are intended to illustrate non-exhaustive combinations of sections. In each figure, the pattern illustrated by the corresponding material segment 235, 245, 255, 263, 272 is repeated to provide unique properties to that section of the pipe 203. For example, Figure 7B A version is shown where a 55D material segment 255 is located directly between two 45D material segments 245, and the assembly is located between two 35D material segments 235. This configuration can provide properties that allow for a "shock absorber" effect. Figure 7C , Fig.7D , Fig. 7E and Figure 7F In the process of constructing the pipe 203, some of the strands are doubled to provide a wider material section having this configuration. For example, Fig.7DMaterial segment 235 in FIG. 2 is shown as being nearly twice as wide as material segments 245 , 255 , and 263 . Fig. 7E Display material segment 255 is almost twice as wide as segments 263 and 270 . Figure 7F Material segments 245 and 255 are shown to be nearly twice as wide as segment 263. Again, the illustrated variations are intended to provide a non-exhaustive sample of variations for possible catheter structures.

[0127] Fig. 8A and Figure 8B An example of strands 130 and 132 extending adjacent to scale 30 is shown to illustrate a perspective view of an example of strands 130 and 132 that ultimately form a tubular member as described above, wherein the overlapping or staggering of the end joint locations of the polymers produces a finished polymer tube / catheter structure having a transition region 129 that is a significant improvement over conventional catheter structures. Fig. 8A and Figure 8B The overlapping or staggering of polymers at a single transition segment 120 (where the materials each have a butt joint) is shown so that the end of 130 abuts the end of 134 and when wound, will result in a significantly improved transition region 120 over the conventional catheter described above. As shown, Fig. 8A The configuration includes staggered transition segments 120, which produces a similar Fig. 9A Transition region 129 is shown. As described herein, when strands 130 and 132 are formed into a tubular member, strands 130 collectively form a material segment that transitions from a first material to a second material having the material of strand 132 at region 129 . Figure 8B Shows something like Fig. 8A , wherein strand 134 is joined / spliced ​​end-to-end with strand 130. However, strand 136 remains continuous. When manufactured into a tubular member, strand 134 is formed as in reference Fig. 8A The material changes of the material segment, but by Figure 8B The formed tube segment includes a segment of material formed from strands 136 that remain unchanged.

[0128] Fig. 9A and Fig. 9B Two examples of catheter segments are shown having an outer layer 103 that can be incorporated onto the catheter or used as a standalone device / structure. Fig. 9A A material segment 130 formed from a first polymer and a material segment 132 formed from a second polymer are shown. The outer layer 103 includes a longitudinal region 129 of a tubular layer, wherein both the width of the first material segment 130 and the width of the second material segment 129 change width along the longitudinal region 129, resulting in structural properties changing across the first longitudinal region 129. As shown, Fig. 9AThe right side of the catheter comprises a tubular member formed entirely of material segments 130, and the left side comprises a tubular member formed entirely of material segments 132. In the transition region 129, the width of the various material segments varies inversely along the longitudinal region 129, such that as the width of the first material 130 decreases toward the left, the width of the second material segment increases. By adjusting the length of the segments 129, and by adjusting the number of strands / ribbons used, these transition regions can be made as long and more gradual as desired, thereby providing a significantly improved and better transition region than conventional catheters.

[0129] Fig. 9B A variation of a pipe 103 is shown having a plurality of material segments 130, 132, 136 that are helically wound to form the pipe 103, wherein the pipe 103 includes a joint 120 where the material segment 130 changes to a different material 134 that continues in the helical pattern of the material 130. This end-to-end joining of materials allows the material segments to continue while changing materials.

[0130] FIG. 10A to FIG. 10D Another example of an arrangement of strands forming a tubular member for a catheter is shown. Fig. 10A and Fig. 10C A set of bonded strands are shown which can be varied to produce Fig. 10B and Fig. 10D Configuration shown. Fig. 10A A 5-strand structure is shown, wherein one end of the joined strand includes a first polymer strand 204. The first polymer strands 204 are each replaced at a separate transition segment 120, which is staggered to gradually replace the strands 204 with second polymer strands 206 over the transition region including the lengths 172, 174, 176, and 178. This structure allows the transition regions 172, 174, 176, and 178 to be formed along the finished tubular assembly 103 (e.g., Fig. 10B The finished tubular component 103 has the properties of a first polymer in a first longitudinal region 170 and gradually changes to the properties of a second polymer over transition regions 172, 174, 176, and 178 until longitudinal region 180 includes all of the second polymer. The material transitions in longitudinal regions 172, 174, 176, 178 represent examples of gradual transitions of material properties over the longitudinal transition regions of the tubular component 103 or finished catheter structure. Obviously, any number of material segments or widths of material segments can be used to increase or decrease the rate of material property transitions. In addition, variations of the devices described herein do not require staggered transition segments 120. Although staggering is generally desired to obtain a gradual transition, the transition region can include an abrupt change in material when desired.

[0131] It should be noted that transition segment should be used to describe the change of one or more material strands to different materials. The term transition region should describe the overall effect of one or more transition segments. In some variations, the transition region does not include any transition segments caused by the material simply terminating. Therefore, the catheter structure of the present disclosure can have a transition region that gradually changes material properties over the axial length, or, alternatively, the transition region can be a region where the material properties change abruptly.

[0132] Fig. 10B It is also shown that each longitudinal region 172, 174, 176, 178 includes at least two material segments 204 and 206, wherein the width of one material segment 204 or 206 increases or decreases while the width of the other material segment 206 or 204 decreases or increases accordingly. Fig. 10B The variation of the tube 103 shown also includes longitudinal regions 170 and 180 formed entirely from a single material segment. Likewise, any tube structure 103 discussed herein may be incorporated into a Figure 2A The catheter structure shown, or such a tube structure 103 can be incorporated into any medical or non-medical device.

[0133] As shown, the catheter segments may include various segments: segment 170 is composed of 5 strands of the first polymer (5 and 0); segment 172 is composed of 4 strands of the first polymer and 1 strand of the second polymer (4 and 1); segment 174 includes 3 strands of the first polymer and 2 strands of the second polymer (3 and 2); segment 176 includes 2 strands of the first polymer and 3 strands of the second polymer (2 and 3); segment 178 includes 1 strand of the first polymer and 4 strands of the second polymer (1 and 4); and segment 180 includes 5 strands of the second polymer (0 and 5). Fig. 10A The structure is produced after the strands are formed and melted into the catheter segment. Fig. 10B The catheter is shown.

[0134] Fig. 10C A plurality of joined strands are shown, wherein segment 190 includes four strands 208 of a first polymer and a single strand 210 of a second polymer (4 and 1). As shown, in the variation in region 192, one strand 208 tapers off, leaving only four strands (3 and 1). Next, segment 194, another strand 208 tapers off, leaving only three strands (2 and 1). The process continues to segment 196 (1 and 1), until only a strand 210 of the second polymer remains. The winding of the joined strands is adjusted (e.g., the pitch is changed) so that the reduction in the number of strands does not leave any openings or gaps between the strands. This structure produces a structure similar to Fig. 10DAs shown, tubular structure 103 includes two material segments in longitudinal region 109, with material segment 210 increasing in width in segment 192 relative to segment 190, and material segment 208 decreasing in width in segment 192 relative to segment 190. The widths of material segments 208 and 210 continue to vary inversely over longitudinal regions 194 and 196 until region 198 includes a single material segment 210. Fig. 10D The illustrated structure shows a tubular segment 103 with transition regions 192, 294, 196 where the material segment changes, but there is no transition segment of material 208 because the material is only as shown. Fig. 10C terminated as shown. Fig. 10A / Fig. 10B and Fig. 10C / Fig. 10D The structures of the catheters are different, but both designs utilize a very gradual basis to create a shaft that transitions from a first material property to a second material property. This division and uniformity is significantly better than what can be produced by conventional catheter technology. An example of a material property is stiffness / softness. For example, Fig. 10B and Fig. 10D The catheter can be from e.g. Fig. 10C 170 and Fig. 10D The relatively stiff material properties at 190° transition to, for example Fig. 10B 180 and Fig. 10D 198 of the softer material properties. Transition regions (e.g. Fig. 10B 172-178 and Fig. 10D 192-196) can be customized by selecting polymers, transition lengths, etc. to create transitions that are not present in current commercially available catheters. It should also be noted that the lengths of regions 170-180 and 190-198 (and the lengths throughout this disclosure) are intended to convey the principles of the present design. Unless otherwise required, there is no requirement to be identical to these lengths, nor to be proportional.

[0135] Obviously, Fig. 10A and Fig. 10C The length of each segment shown is for illustration purposes only. Furthermore, any number of polymer strands may be used with any number of polymers. Also, note that Fig. 10A In FIG. 2 , the material segments can all be considered as separate elements 204 of the same material. Thus, region 170 includes material segments whose width gradually changes toward region 172, etc. The change in width can be gradual or incremental, as shown. Alternatively, the change can be tapered so that the change in width is continuous, as shown. Fig. 10C The tapered area at the end of material 208 is shown.

[0136] Fig.11AA graph of bending stiffness versus shaft position is illustrated to help understand the ability of the catheters of the present disclosure to produce a significantly improved transition region over currently available catheters. Fig.11A The results of the test are shown, in which the force to move the catheter a given distance is measured, commonly known as a 3-point bending test. The catheter is supported at two points so that the gap between the two points will deflect at a given distance. The force required to produce this deflection is measured and plotted as a distance corresponding to the distal end of the catheter. For example, the left side of the figure shows the magnitude of the force required to move the catheter segment at the point closest to the distal end of the catheter (i.e., the distal end). The right side of the force diagram shows the magnitude of the force required to move the catheter segment at the point closest to the proximal end of the catheter. The three catheters tested in this way include a catheter 300 constructed according to the present disclosure, a commercially available catheter 302 (React 071) manufactured by Medtronic, and a commercially available catheter 304 (ACE 068) manufactured by Penumbra. The figure shows that the improved catheter 300 has a gradually increasing bending stiffness, and the bending stiffness does not have a sudden or irregular increase. In contrast, the chart data of the bending stiffness of the Medtronic catheter 302 shows two significant areas 306 of sudden changes in the property. The graphical data of the bending stiffness of the Penumbra catheter 304 shows three regions 306 of significant abrupt changes.

[0137] Fig. 11B A catheter segment constructed according to the present disclosure is shown, wherein the catheter segment is held in contact with Figure 1D However, the improved catheter 310 is constructed in accordance with the present disclosure such that materials are actively selected to provide the desired properties and characteristics of the catheter 310 in the various longitudinal regions 312, 314, 316, and 318, thereby avoiding any abrupt change regions that would otherwise result in bending irregularities. Fig. 11B Only one example of a catheter 310 using materials 134, 206, 208, and 210 is shown. Obviously, any number of combinations as described herein are within the scope of the present disclosure. As shown, longitudinal region 312 includes three material segments of materials 134, 206, and 210. Longitudinal region 314 includes two material segments of materials 206 and 210. Longitudinal segment 316 includes three material segments of materials 206, 208, and 210. This segment also shows a material segment with a width change, so that the thickness of material / material segment 206 decreases and material / material segment 208 increases in the direction toward longitudinal segment 318. Longitudinal segment 318 includes two material segments of materials 208 and 210. The final result of the structure of catheter 310 is that longitudinal segments 312 and 314 include significantly different structural properties compared to longitudinal segment 318, but this change is gradual enough to avoid significant discontinuity in bending stiffness.

[0138] FIG. 12A to FIG. 12D is a grayscale image of an exemplary catheter structure according to the present disclosure. Fig. 12A Three different conduit segments 320, 322, and 324 are shown, each having a different helical pitch angle (i.e., the angle formed by the material segments 134, 132 with the conduit axis). Conduit 320 shows an angle that is close to radial (meaning that the angle is almost perpendicular to the axis). The structure of this conduit segment includes two strands: one strand of material 134 and one strand of material 132. Conduit 322 shows a medium pitch angle. The structure of this conduit segment includes 4 strands: one strand of material 134, one strand of material 132, one strand of material 134 and one strand of material 132. Conduit 324 shows an increased pitch angle relative to conduits 320 or 322. The structure of this conduit segment includes 6 strands: one strand of material 134 and one strand of material 132 are repeated three times. Using a greater number of strands during the construction process allows the pitch angle to be increased even more.

[0139] Fig. 12B Another grayscale image of another variation of a constructed catheter segment is shown having two material segments of the same material with material segment 130 having a greater width on either side of a material segment with flexible material 134. This configuration may include a "shock absorber" if material 132 is a stiffer material. Fig. 12C and Fig.12D A catheter having a contoured outer surface constructed in accordance with the present invention is shown. Fig. 12C A grayscale image of another example of a constructed catheter segment is shown with Figure 3J In this variation, the height of material 132 is greater than the height of adjacent material 134, and the width of material 132 is less than the width of adjacent material 134. Despite the difference in height, these materials are able to fuse together to form a polymer layer. Fig.12D Another catheter is shown in which the material segment 134 has a diameter greater than the diameter of the adjacent materials 132 and 130. In another variation, the wavy surface can be formed using one or more materials during the fusion process (e.g., as Figure 3A As described above, there is a non-fusible material (e.g., a high melting temperature polymer such as PTFE, a metal alloy, etc.) on the top of the strand, so that the non-fusible material is removed to leave a void in the finished polymer layer.

[0140] Fig.12E and Fig.12F Pictures showing variations of conduits 330 - 348 that may be incorporated into a catheter or used as a tube arrangement without a catheter structure. Fig.12E and Fig.12FTwo material segments 230, 232 are shown, which may include any variety of materials. In one example, Fig.12E Segment 230 is shown embedded within segment 232, which includes a hard 72D durometer band (used as a torque coil), and segment 232 includes a softer 60A durometer band. By increasing the number of material segments in each unit, the pitch (i.e., separation) of material 230 increases from 330 to 340. That is, pipe 330 has a single material segment 230 with material segment 232. In contrast, structure 340 is formed of a structure including multiple material strands 230 and multiple material strands 232.

[0141] Fig.12F A picture of four tubes 342, 344, 346, and 348 is shown, where the angles of material segments 230 and material segments 232 vary in each tube. In each of these units, the pitch (i.e., separation) of the material segments 230 white 72D coils is constant (i.e., the width of the material segments 232 between the material segments 230 is the same size in each unit). However, the angles of the material segments 230 vary in each unit. For example, tube 342 shows the most radial (i.e., extending radially from the tube) angles of the material segments 230, while the bottom tube 348 includes the most axial or linear material segments 230. Tube 342 includes three strands: one strand 230 and two strands 232 to produce material segments 230 and 232. Tube 344 is composed of 6 strands: 1 strand 230 + 2 strands 232 + 1 strand 230 + 2 strands 232. Tube 346 is constructed of nine strands, and tube 346 is constructed of 12 strands, using the same arrangement.

[0142] Fig.13A and Fig. 13B Another feature of the catheter structure is depicted in which multiple strands (similar polymers or different polymers) are joined together as described above. However, in these variations, various discrete materials (i.e., polymers, metals, composites, alloys, etc.) can be patterned on the joined strands 130. Fig.13A In the embodiment of the present invention, the polymer is patterned into the illustrated shape 214. The base strand 130 can be removed, or the polymer 214 can be placed on top of the base strand. Likewise, multiple polymers 214 and 216 can be located on the base strand 130 of polymer. In an optional variation, the base polymer strand 130 can be removed so that the patterned polymer 214 or 216 can be located in the space left by the removed base strand 130. The finished assembly 130 can be manufactured into a tubular structure to be incorporated into a catheter or other medical device shaft.

[0143] FIG. 14A to FIG. 14C Another variation of constructing a composite polymer tube 294 having multiple material segments in accordance with the present disclosure is shown. Fig.14AAs shown, the initial structure may include a conventional polymer tube 290 with one or more strands 292 wrapped around the tube 290. The tube 290 and strands 292 are then heated and fused together to produce a composite polymer layer 294, wherein the strands 292 become at least partially embedded within the tube 290, such that the polymer layer 294 includes a first material segment comprising the material of the tube 290 and a second material segment comprising the material of the strands 292. Obviously, any number of variations of strands (as described above) may be embedded in the tube. In addition, the outer diameter of the polymer layer 294 may include a wave shape. Fig. 14C A polymer tube 294 is shown with a portion removed to highlight a cross section of the polymer layer. FIG. 14A to FIG. 14C The structure can replace the conventional polymer tube 290 with a composite polymer tube having diversified material segments constructed as described herein.

[0144] Fig.15A A partial view of a patient's anatomy is shown to demonstrate one feature of the catheter 100 of the present disclosure. Fig.15A A catheter 100 is shown inserted using a radial artery access procedure. Obviously, the catheter structures (and polymer layers) described herein can be incorporated into any device where materials need to be selected for specific performance characteristics. Radial artery access procedures are increasingly becoming a desirable entry point for interventional procedures. Radial artery access is a staple in cardiac surgery and is increasingly common in neurovascular surgery. However, acute bends, especially when attempting to access neurovascular vessels, present considerable challenges to conventional catheters. The catheter structures described herein are well suited to address the sharp anatomical challenges faced by conventional catheters.

[0145] Fig.15A The catheter 100 of the present disclosure is shown advanced into the radial artery 50 , and traversed to the right subclavian artery 51 , and into the internal carotid artery 53 , and ultimately to the neurovascular vessel 60 . Fig.15A The catheter 100 shown includes regions of diverse material segments as described above. However, this variation of the catheter 100 includes a hybrid region 220 that allows for a variety of catheter performance characteristics in this region. This configuration not only allows for navigation through tortuous bends, but also does not suffer from the same disadvantages as catheters simply constructed of soft polymers. The present disclosure contemplates catheters having any number of hybrid regions with any arrangement of material properties. Fig. 15B Shown from Fig.15A The region of FIG. 5 is shown, and the acute bend between the right subclavian artery 51 and the right internal carotid artery 53 is shown. For the purpose of illustrating this bend, the catheter is guided from Fig. 15BConventional catheters have problems navigating such acute bends because the stiffer / stronger polymers have difficulty navigating the tortuous bends in the anatomy. Softer polymers are able to navigate such acute bends, but the softer segments do not transmit sufficient thrust and torque to the bend and the area of ​​the catheter distal to the soft polymer.

[0146] Fig. 15C An enlarged view of a portion of catheter 100 is shown, the catheter being passed through an acute bend between the right subclavian artery 51 and the right internal carotid artery 53. Catheter 100 is designed so that mixing segment 220 is positioned (or has sufficient length) so that when the distal end of catheter 100 is at or near its intended target, mixing segment 220 is located within the bend. Fig. 15C A catheter 100 is shown with multiple material segments 134, 206, etc. However, in this variation, a hybrid segment 220 includes a harder material segment 210 and allows the catheter 100 to perform torque and force transmission. The hybrid segment 220 may also include one or more discrete segments of material 208 that provide desired material properties different from the base material segment 210. In this example, the discrete segments of material 208 include a flexible material. This structure allows the catheter to bend acutely due to the discrete segments 208 of flexible material. At the same time, the harder base segment 210 transmits thrust and torque to the distal region of the catheter.

[0147] Fig.15D It shows that the Fig.15A and Fig. 15C Multiple non-exhaustive design configurations of hybrid regions are shown. The hybrid region of the catheter / finished tubing is formed from multiple materials 130 joined together, where a base material 210 is interrupted by discrete segments of a second material 208 having different properties than the base. For example, in one variation of the design, material 210 may include a more rigid / harder durometer material or polymer, while material 208 includes a pliable / soft material or polymer. Obviously, any material properties other than hard material / soft material may be selected and configured into the hybrid region.

[0148] Fig.16A and Fig. 16B Additional examples of configurations of tubes 103 for use with the devices described herein are shown. Fig.16A are joined together to form Fig. 16B A cross-sectional view of the plurality of strands 358, 362, 364, 366 of the tubular segment is shown. Fig. 16B, the tubular segment 103 includes multiple material segments extending in a continuous spiral on the tubular segment 103, wherein one material segment 360 extending from region 350 through regions 352 and 354 changes material at each region. In one example, the material segment 360 includes a reinforced material segment because it extends continuously and spirally over multiple regions. In addition, the structural properties of each region can be selectively designed based on the individual materials 362, 364, and 366. For example, in order to increase flexibility from the proximal to distal direction of the device, the first region 350 can include a material 362 having a greater hardness / durometer than the material 364 in the adjacent / second region 352.

[0149] In further variations, third region 354 may include material 366 having a Shore hardness / durometer less than the hardness / Shore hardness of material 364. It should be noted that material segments (e.g., 358) adjacent to material segment 360 may include any number of materials as discussed herein. However, in some variations of the devices described herein, material segment 360 includes a hardness / Shore hardness greater than the hardness / Shore hardness of each adjacent material segment 358 in the corresponding region. For example, in first region 350, material segment 360 may include material 362 having a Shore hardness / durometer greater than the material of each adjacent material segment 358 in the same region (i.e., region 350).

[0150] Similarly, in further variations, this configuration may be repeated in regions 352 and 354, wherein material 364 comprises a greater Shore durometer than the material in the adjacent material segments within the region, and material 366 comprises a greater Shore durometer than the material in the adjacent material segments within the region. In such examples, material segments 360 may effectively function as a continuous torque coil within tubular member 130 (at least across any two segments), but may have a hardness / Shore durometer that varies or tapers as required by the application. In those instances where it is desirable for the catheter to reach a distal region, the catheter may be configured via tubular member 103 to have increased flexibility toward the distal region while still employing a continuous torque coil that also decreases in flexibility.

[0151] In yet another variation, Fig.16A and Fig. 16B The structure shown in may include a configuration in which material segment 360 includes a lower Shore hardness / durometer than adjacent material segment 358 and / or decreases in each region ( 350 , 352 , 354 ).

[0152] Fig. 16C and Fig.16D Another example of a configuration of a tube 103 for use with the devices described herein is shown. Fig. 16C shows the joining together to form Fig.16D The cross-sectional view of the plurality of strands 358, 362, 364, 366 of the tubular segment is shown. However, the region forming region 350 includes two segments 362 of material having the same Shore hardness / hardness. This structure is Fig.16D , where the tubular segment 103 includes a plurality of material segments extending in a continuous spiral on the tubular segment 103, wherein one material segment 360 extending from region 350 through regions 352 and 354 changes material at each region, while region 350 includes two spirally wound materials 362 having the same Shore hardness / hardness. In this configuration, in a first region 350, the material segment 360 includes a material 362 having a Shore hardness / hardness that is different from the material of each adjacent material segment 358 in the same region (i.e., region 350), but is equal to the material 362 of another material segment. As described above, the Shore hardness / hardness of the material 362 can be greater or less than that of the adjacent segments.

[0153] Fig.16E and Fig.16F Another potential example of a configuration for a tube 103 for use with the devices described herein is shown. Fig.16E A cross-sectional view of a plurality of strands 358, 362, 364, 366 is shown, with the strands 358, 362, 364, 366 joined together to form the Fig.16A and 16B , wherein additional material segment 370 includes materials 372 , 374 , and 376 in respective segments 350 , 352 , and 354 . Fig.16E Shown by Fig.16E The tubular segment 103 is formed by a structure in which a plurality of material segments extending in a continuous spiral on the tubular segment 103 and a material segment 360 is used as a reinforcing material segment, wherein the hardness / Shore hardness materials 362, 364, 366 extend in the form of material segments across the region 350, through the regions 352 and 354, and change the material in each region. However, Fig.16E and Fig.16F The structure shown in also shows a material segment 370 having materials 372, 374, and 376 that are lower than or equal to the hardness / Shore hardness of adjacent materials in material segment 358. In further variations, the hardness / Shore hardness of materials 372, 374, and 376 may decrease in segments 350, 352, and 354, respectively. While material segment 360 is shown as being directly helically adjacent to material segment 370, further variations include having a spacing between the highest and lowest Shore hardness materials rather than being directly adjacent.

[0154] Fig.17A and Fig. 17BAnother example of tailoring material segments to adjust structural properties of the tube member 103 and / or the device as described above is shown. Fig.17A A series of material segments 358 are shown adjacent to a transition material segment 380. As described above, the material segments 358 may include any type of material required to adjust the characteristics of the device. Fig.17A and Fig. 17B A transition material segment 380 is shown that includes a first width 385 corresponding to the width of the transition region 380 in the first region 350. The transition material segment includes a second width 386 corresponding to the width of the transition region 380 in the second region. As discussed herein, not only can the width vary, but the height / depth of the material can also vary. In addition, Fig. 17B The material segment 380 is shown initially comprising a first material 382 and then transitioning to a second material 384, however, in further variations, the material segment may comprise a single material that changes from a first width 385 to a second width 386. Further variations of this design may include a transition region that changes from a smaller size to a larger size in a distal direction along the conduit.

[0155] As mentioned above, Fig.17A 1 shows the state of the tubular portion before the material segments are joined in a spiral configuration. Once joined into the tubular structure 103, as shown Fig. 17B As shown, the material on both sides of the thinner area of ​​the transition material segment 380 fills between the adjacent material segments to form a completely sealed joint. As shown, the first region 350 may include a segment of uniform width of the transition material segment, and at the beginning of the second region 352, the transition material segment 380 is stepped down at the step-down area 387. A variation of this configuration includes a length of the step-down area 387 that is less than the width of the larger transition material segment. In another variation of this configuration, the transition material segment 380 may include a first material 382 in the first region 350 and a second material 384 in the second region 352. As described above, the transition material segment 380 may include a material that allows the segment 380 to be used as a torque coil, for example, wherein the hardness / Shore hardness of the transition segment is greater than that of the adjacent material segment. Alternatively, the transition material segment may include a hardness / Shore hardness that is less than that of the adjacent material segment. In a further variation, a single tubular structure 103 may include multiple step-down areas for different material segments. Alternatively or in combination, segment 380 or any material having a greater durometer / Shore hardness than adjacent materials acts as a "pushing coil" wherein this increased durometer / Shore hardness material is helically formed into the catheter tubing and reinforces the tubing when pushed from a proximal position.

[0156] Fig.18BFIG. 18F shows another design variation for a composite conduit segment. In conventional conduit construction, such as Fig.18A As shown, the use of extruded material 98 aligns polymer chains 396 with the axis 126 of material 98 along the axial length of the tube. Thus, flexing of a conventional rigid tube results in a main body bending against the polymer chains 396 in the normal direction. Excessive bending can cause the polymer 98 to break. One benefit of constructing the tube 103 from one or more polymers having a high elastic modulus / stiffness is that the polymer chains 396 are oriented in a helical direction around the tube structure 103. For example, in a tube structure such as FIG. 18C to FIG. 18E In the variation shown, the polymer chains 396 extend in a helical pattern, which allows for increased flexibility of the polymer and reduces the risk of material fracture due to bending of the tube structure 103 . Fig.18B An example of multiple material segments is shown in which material 390 is joined to materials 392 and 394. These materials are sealingly joined to form Fig. 18C The tubular structure 103 of the present invention is a tubular structure 103 in which material segments extend helically along the axial length of the tubular structure 103 to form a wall that can optionally be incorporated into one of the devices described herein. In this variation, the material segments in the first region (designated in the direction indicated by arrow 398) are formed from a first polymer 390 such that when the material segments are wound to form the tube 103, the polymer chains in the region extend helically along the helix of the material segments, as shown in FIG. Fig.18D As shown. Fig. 18C The construction shown, in which in a first region, multiple material segments include a first polymer 390 having a high modulus / stiffness adjacent to a second region, wherein each of polymers 392, 394 includes a lower modulus / stiffness than material 390, allows for the design of a device having a proximal region that is stiffer but more resistant to fracture. Fig.18E Another variation of the construction 103 is shown in which the first region 398 is formed of one or more material segments extending helically and includes a single polymer 390 having the same structural properties as the first polymer 390, but is distinguishable / identifiable from the first polymer 390 (e.g., via color, surface texture, markings, radiography, etc.). In such a construction, the material properties of the segments 398 are the same, but the tubular structure 103 can be uniquely identified (visually and / or mechanically) by the distinguishable pattern created by the materials 390 and 399, so that a caregiver can identify the tubing relative to other tubing. For example, when used in a catheter positioned in a patient's body via the femoral artery or radial artery, when the region 398 extends from the patient's body, the caregiver can distinguish the tubing having the first region 398 relative to other tubing. Fig.18E It should be understood that the segment 398 will include at least two distinguishable material segments 390, 399 having similar or identical structural properties, while the remaining area of ​​the catheter (e.g., Fig. 18C ) may have additional material segments as discussed herein. Alternatively, the remainder of the catheter may also have a conventional extruded construction.

[0157] FIG. 19A to FIG. 19D Another variation of the composite tube 103 used in the devices described herein is shown. In this variation, Fig.19A A first material tube 388 is shown, which can be conventionally extruded into a common single lumen pipe. As shown, the tube 388 is spaced apart from a second conventionally formed material tube 389. Each material tube 388, 389 can have individual properties as described above. In addition, the tubes 388, 389 can be cut (e.g., via laser cutting) to produce spirals or other spiral patterns 394, 395, respectively. Fig.19B Shows the sealed joints Fig.19A The tubes 388 and 389 such that the different properties of each material segment provide a transition segment 397 similar to those discussed above. Fig.19C A variation is shown in which a first tube 388 and a second tube 389 of material are continuous and then cut to form spiral patterns 394, 395 which are ultimately joined together to form a spiral pattern 394, 395. Fig.19D Transition segment 397 is shown.

[0158] As shown in the figure above, the ability to combine softer materials with relatively harder materials allows for customized selection of improved device properties. In addition, the ability to transition a continuous spiral material segment to a different material and controllably step down the width allows for significant improvements in catheter design. The ability to change materials as described herein provides manufacturers with the ability to change a greater number of catheter design elements to fine-tune catheter construction to a degree previously unavailable with conventional catheter constructions.

[0159] Fig. 20A Another aspect of an improved catheter 100 incorporating a composite layer at the end 17 of the catheter is shown. As shown, the catheter 100 can include any number of material segments 238, 240, 244, and 242 to form a directional end 17 located at the distal end of the catheter body 103. A variation of the catheter 10 with a directional end 17 can include a catheter body having a composite structure as described above. Alternatively, the catheter body can include a conventional catheter construction with a directional composite end 17.

[0160] Fig. 20BThe directional tip 17 is shown at the distal end of the catheter body 103. As shown, the material segments 238, 240, 244 and 242 can include polymers of different durometers, thicknesses, widths, etc. In addition, the material segments 238, 240, 244 and 242 can be helically wrapped around the tip 17, or can extend parallel to the axis 105 of the catheter 100, as shown.

[0161] Fig. 20C and Fig.20D 1 shows a variation of the directional tip 17 at the distal end of the catheter body 103. In this variation, material segments 238, 240, and 242 extend helically or spirally to form the tip 17. In addition, as shown in FIG. Fig.20D As shown, material segments can be designed to preferentially bend in a particular direction when encountering resistance (such as a blood vessel wall). Fig. 20C In the illustration shown, the orienting tip 17 bends in the "y" direction. The orienting tip 17 uses a combination of materials and material dimensions to control preferential bending. It should be noted that variations of the orienting tip 17 can bend in multiple directions, but will be biased to bend toward a preferential direction. Furthermore, the preferential bending direction of the orienting tip 17 can occur in multiple directions in three-dimensional space, not just toward a single axis as depicted.

[0162] Fig.21A and Fig.21B An example of a catheter 100 having a directional tip 17 is shown. Fig.21A The catheter 100 is shown advanced through the blood vessel 2 into the branch vessel 5. Fig.21B In the embodiment of the present invention, when the catheter approaches the far wall of the branch vessel 5, the end of the directional tip 17 engages the wall and deflects toward the preferred direction. Figure 3B The tip member 17 is shown deflected upward. Many conventional catheters rely on a soft distal tip to minimize the risk of trauma to the vessel, releasing plaque from the vessel wall, puncturing the vessel, or creating an embolism in the bloodstream. When the square / flat tip of a conventional catheter engages the back wall of a branch vessel, it often gets stuck because it is not designed to deflect in a preferred direction. Having a directional tip 17 that bends in a preferred direction reduces the chance of the directional tip 17 getting stuck on the wall of a branch vessel.

[0163] FIG. 22A to FIG. 22D Various configurations of material segments 238 , 240 , 242 that form the orienting tip 17 at the end of the catheter body 103 are shown. Fig.22A A plurality of helically wound segments of material 238, 240, 242 are shown. Fig. 22B and Fig. 22C Two material segments 238 and 240 with different widths are shown, wherein Fig. 22CA directional tip 17 is shown with a conventional soft tip 15 at the end. Fig.22D Material segments 238 and 240 are shown extending parallel to the axis of the tip 17. As with conventional soft tips, the directional tip 17 generally comprises a soft polymer with various reinforcements or other designs to allow for preferential bending.

[0164] FIG. 23A to FIG. 23F Another variation of the manufacture of the composite tube is shown. Fig.23A As shown, tube 400 can be formed from base material 400 (e.g., by extrusion, 3D printing, or any other manufacturing process). Tube 400 can be modified or formed to have a spiral groove (extending through the wall) or a slot (i.e., a cut that does not extend through the entire wall). Next, as Fig. 23B As shown, a material such as a polymer or other material is joined to the tube material 402 within the groove 404 to form a segment of material 410 that extends within the tube 400 . Fig.23C A second material is shown forming a second material segment 412 that is positioned within the groove and joined to the end of the first material segment 410. Thus, Fig.23C A tube structure 400 having three different materials 402 , 410 , and 412 is shown.

[0165] Fig.23D A variation similar to that shown above is shown, but in which material segments 410 and 412 are adjacent to a different material segment 414 . Fig.23E Two joined material segments 410 and 412 are shown with a spaced-apart material segment 414 . Fig.23F Another variation is shown in which the tube structure 400 can be formed from multiple tubes having different materials 402, 406 with different structural properties or different distinguishable properties. In this case, the tube comprising material 402 can be joined to the tube comprising material 406 at the joint 408, and the composite tube 400 can be formed as above in Fig.23A was changed as discussed in .

[0166] Fig.24 Another variation of composite tube 420 is shown, which is formed with non-overlapping material segments 432, 434, 436, 438, such that the material or polymer of tube 430 separates the material segments. As shown, the material segments can be axially spaced apart (e.g., 434 is axially spaced apart from 432 and 436). In addition, the ends of the material segments can overlap (e.g., 434, 432, 436) or the ends can also be spaced apart (e.g., 438). Fig.24The structure 420 shown in the figure can be manufactured entirely by using material segments, wherein material 430 is coiled with the remaining material segments. Alternatively, the composite tube 420 may include a polymer or other tube (formed by extrusion) containing material 430 and mechanically altered to form a slot or groove to allow insertion of material segments 432, 434, 436, 438.

[0167] Fig.25 Another variation of a composite pipe 450 is shown, which may be formed or used to manufacture a pipe using any of the processes described herein. Fig.25 A pipe 450 is shown having a first region including a single material 470, wherein the first region 452 is adjacent to a second region 454, wherein material segments 472 including a second material begin in a spiral pattern. In the second region 452, the first material forms a first material segment 470, the width of the first material segment 470 decreases (as measured axially) while the width of the second material segment 472 increases, until a third region 456 formed entirely of the second material 472. The composite pipe continues to a fourth region 458, wherein the third material segment 472 results in the formation of a material segment 472, the width of which decreases as the width of the third material segment 474 increases. As discussed herein, each material 470, 472, 474 will have different properties (e.g., different structural properties and / or visually distinguishable properties), thereby allowing the overall properties of the composite pipe 450 to be customized. Fig.25 It is also shown that the third material 474 continues in the fifth region 460 formed entirely of the third material 474. It should be noted that Fig.25 The width, spacing, and spiral winding of the material segments shown in are for illustrative purposes only and may be combined with any of the variations discussed herein. Additionally, regions 452, 456, and / or 460 in composite tube 450 may be formed from an extruded tube that is mechanically altered in second region 454 and fourth region 458. Alternatively, regions 452, 456, and / or 460 may be spirally wound.

[0168] Note that the polymer strands disclosed herein can extend in a spiral manner around an internal braid / coil or support structure. In another variation, the polymer strands can be aligned with the axis of the catheter in a longitudinal manner and wrapped around the support structure to form a catheter segment. Any number of manufacturing methods can be used to produce the catheter structure of the present disclosure. For example, the strands can be directly wrapped around the liner / braid structure and then fused together to form the catheter structure; 2) the strands can be wrapped around the tube and fused, and then transferred to the remaining components to produce the catheter structure; and / or 3) the strands can be manufactured into a flat structure (or fused together, extruded, molded or otherwise formed), and then the belt assembly is wrapped and fused to the liner / braid. The device described herein can also be constructed using a 3-d printing process.

[0169] It should be understood that any manufacturing process is within the scope of the present disclosure and should not limit any claimed structure to any claims related to composite polymer tube or catheter structures.

[0170] As for other details of the invention, the materials and manufacturing techniques employed may be within the level of a person skilled in the relevant art. This may also apply to the method-based aspects of the invention in terms of additional actions that are typically or logically employed. In addition, although the invention has been described with reference to several examples, optionally incorporating various features, the invention is not limited to what is described or shown as envisioned with respect to each variant of the invention.

[0171] Various changes may be made to the described invention, and equivalents (whether cited herein or not included herein for brevity) may be substituted without departing from the true spirit and scope of the invention. In addition, any optional features of the creative variations may be set forth and claimed independently or in combination with any one or more of the features described herein. Therefore, the present invention contemplates, where possible, combinations of multiple aspects of the embodiments or combinations of the embodiments themselves. References to single items include the possibility of multiple identical items. More specifically, as used herein and in the appended claims, the singular forms "a", "and", "said", and "the" include plural references unless the context clearly indicates otherwise.

[0172] It is important to note that, where possible, aspects of the various described embodiments or the embodiments themselves may be combined. All such combinations are intended to fall within the scope of the present disclosure.

Claims

1. A medical pipeline, comprising: a tubular body having an axis extending longitudinally, the tubular body having a first region and a second region, the first region and the second region each extending along the axis and each having a wall formed from a plurality of segments of material extending helically along the axis; The plurality of material segments include segments of reinforcing material extending in a continuous spiral over the first region and the second region; as well as Wherein the segment of reinforcement material comprises a first hardness in the first region and a second hardness in the second region, wherein the first hardness is different from the second hardness.

2. The medical tube according to claim 1, wherein: In the first region, the reinforcement material segment comprises a first structural dimension, and in the second region, the reinforcement material segment comprises a second structural dimension that is different from the first structural dimension.

3. The medical tube according to claim 1, wherein: In the first region, the plurality of material segments includes the reinforcing material segment and a first plurality of adjacent material segments, wherein the first stiffness is greater than a corresponding stiffness of each of the first plurality of adjacent material segments.

4. The medical tube according to claim 3, wherein: In the second region, the plurality of material segments includes the reinforcing material segment and a second plurality of adjacent material segments, wherein the second stiffness is greater than a corresponding stiffness of each of the second plurality of adjacent material segments.

5. The medical tubing of claim 1, further comprising a liner located within the interior of the tubular body.

6. The medical tubing of claim 5, further comprising a reinforcing structure located outside of the liner.

7. The medical tube according to claim 6, wherein: The reinforcement structure is embedded in the wall.

8. The medical tube according to claim 1, wherein: The plurality of material segments extend in a right-hand winding direction in the first region.

9. The medical tube according to claim 1, wherein: The plurality of material segments extend in a left-hand winding direction in the first region.

10. The medical tube according to claim 1, wherein: At least one of the plurality of material segments comprises a non-fusible material.

11. The medical tubing according to claim 1 further comprising a flexible distal tip segment.

12. The medical tube according to claim 11, wherein The flexible distal tip section comprises a single material.

13. The medical tubing according to claim 1, wherein: The tubular body includes a proximal region located proximal to both the first region and the second region, the proximal region including a single material.

14. A medical pipeline comprising: a tubular body having an axis extending longitudinally, the tubular body having a first region and a second region, the first region and the second region each extending along the axis and each having a wall formed by a plurality of material segments extending continuously and helically along the axis, wherein the plurality of material segments include a first material segment and a reinforcement material segment; wherein in the first region, the first material segment comprises a first hardness that is less than or equal to the respective hardness of each adjacent material segment, and wherein the reinforced material segment comprises a first reinforced hardness that is greater than both the first hardness and the respective hardness of each adjacent material segment in the first region; and Wherein, in the second region, the first material segment comprises a second hardness that is different from the first hardness and less than a corresponding hardness of each adjacent material segment in the second region.

15. The medical tubing according to claim 14, wherein: In the second region, the reinforcement material segment includes a second reinforcement hardness that is lower than the first reinforcement hardness.

16. The medical tubing of claim 14, further comprising a liner located within the interior of the tubular body.

17. The medical tubing of claim 16, further comprising a reinforcing structure external to the liner.

18. The medical tubing according to claim 17, wherein: The reinforcement structure is embedded in the wall.

19. The medical tubing according to claim 14, wherein: The plurality of material segments extend in a right-hand winding direction in the first region.

20. The medical tubing according to claim 14, wherein: The plurality of material segments extend in a left-hand winding direction in the first region.

21. The medical tubing according to claim 10, wherein: At least one of the plurality of material segments comprises a non-fusible material.

22. The medical tubing according to claim 14, further comprising a flexible distal tip segment.

23. The medical tubing according to claim 22, wherein: The flexible distal tip section comprises a single material.

24. The medical tubing according to claim 10, wherein: The tubular body includes a proximal region located proximal to both the first region and the second region, the proximal region including a single material.

25. A medical pipeline comprising: a tubular body having an axis extending longitudinally, the tubular body having a wall formed from a plurality of material segments extending helically along the axis, wherein each of the plurality of material segments comprises a width; and wherein the plurality of material segments include a transition material segment extending in a continuous spiral over both a first region and a second region, wherein a first width of the transition material segment is consistent at the first region, and wherein the transition material segment decreases to a second width at a step-down region, the second width being consistent at the second region.

26. The medical tubing according to claim 25, wherein In the first region, the transition material segment comprises a first material, and in the second region, the transition material segment comprises a second material.

27. The medical tubing according to claim 25, wherein: The length of the stepped descending area is smaller than the first width.

28. The medical tubing of claim 25, further comprising a liner located within the interior of the tubular body.

29. The medical tubing of claim 28, further comprising a reinforcing structure external to the liner.

30. The medical tubing according to claim 29, wherein The reinforcement structure is embedded in the wall.

31. The medical tubing according to claim 25, wherein: The plurality of material segments extend in a right-hand winding direction in the first region.

32. The medical tubing according to claim 25, wherein: The plurality of material segments extend in a left-hand winding direction in the first region.

33. The medical tubing according to claim 25, wherein: At least one of the plurality of material segments comprises a non-fusible material.

34. The medical tubing according to claim 25, further comprising a flexible distal tip segment.

35. The medical tubing according to claim 34, wherein The flexible distal tip section comprises a single material.

36. The medical tubing according to claim 25, wherein: The tubular body includes a proximal region located proximal to both the first region and the second region, the proximal region including a single material.

37. A medical pipeline comprising: a tubular body having a first region adjacent to a second region, the first region and the second region both extending along an axial length of the tubular body; as well as a plurality of material segments extending helically along the axial length and at least partially forming walls of the first and second regions of the tubular body; wherein in the first region, the plurality of material segments includes one or more material segments that extend helically about the axial length and include a first polymer such that polymer chains of the first polymer extend helically in the first region, and wherein the first polymer includes a first hardness; Wherein at the second region, at least one of the plurality of material segments comprises one or more polymers having a second hardness less than the first hardness.

38. The medical tubing of claim 37, further comprising a liner located within the interior of the tubular body.

39. The medical tubing of claim 38, further comprising a reinforcing structure external to the liner.

40. The medical tubing according to claim 39, wherein The reinforcement structure is embedded in the wall.

41. The medical tubing according to claim 37, wherein: The plurality of material segments extend in a right-hand winding direction in the first region.

42. The medical tubing according to claim 37, wherein: The plurality of material segments extend in a left-hand winding direction in the first region.

43. The medical tubing according to claim 37, wherein: At least one of the plurality of material segments comprises a non-fusible material.

44. The medical tubing according to claim 37 further comprising a flexible distal tip segment.

45. The medical tubing according to claim 44, wherein The flexible distal tip section comprises a single material.

46. ​​The medical tubing according to claim 37, wherein: The tubular body includes a proximal region located proximal to both the first region and the second region, the proximal region including a single material.

47. The medical tubing according to claim 37, wherein: At least in the first region, the plurality of material segments includes at least one identifiable material segment that is visually distinguishable from the remainder of the plurality of material segments, wherein the at least one identifiable material segment includes the first hardness.

48. A catheter comprising: a tubular body having a first region extending along at least an axial length of the tubular body; as well as and a terminal member at a distal end of the first region, wherein the terminal member is formed from a plurality of material segments joined together to form a wall of the terminal member, wherein a first material segment of the plurality of material segments includes a first material property that causes the terminal member to bend in a preferential direction when the terminal member encounters resistance during axial advancement of the tubular body.

49. A catheter as claimed in claim 48, wherein the plurality of material segments extend helically around the tip member.

50. The catheter of claim 48, wherein the plurality of material segments extend axially along the tip member.

51. The catheter of claim 48, wherein the plurality of material segments extend axially along the tip member.

52. The catheter of Claim 48, wherein the plurality of material segments configure the tip member as an atraumatic tip member.

53. The catheter of claim 48, wherein at least one of the plurality of material segments comprises a width greater than the remainder of the plurality of material segments.

54. The catheter of claim 48, wherein: At least one material segment of the plurality of material segments includes a width that varies along an axial length of the end member.

55. The catheter of claim 48, wherein the first material property comprises a first stiffness greater than a stiffness of the plurality of material segments.

56. A medical pipeline comprising: a tubular body having an axial length and comprising a first region and a second region axially spaced from the first region, wherein a first structural property of the first region is different from a second structural property of the second region; A first material segment and a second material segment extend in the second region and share structural properties, wherein the first material segment and the second material segment are visually distinguishable from one another by an operator from outside the medical tubing.

57. The medical tubing according to claim 56, wherein: The first material segment and the second material segment extend helically along an axial length of the second region.

58. The medical tubing of claim 56, further comprising a plurality of material segments in the first region.

59. The medical tubing of claim 56, wherein the first material segment and the second material segment are visually distinguishable from each other.

60. The medical tubing of claim 56, wherein the first material segment and the second material segment are mechanically distinguishable from each other.

61. A catheter conduit comprising: a tubular body having an axial length, the tubular body comprising at least a base material having the structural properties of the base material; a first material segment extending helically within a wall of the tubular body along a first region of the axial length, the first material segment comprising a first structural property, wherein the first structural property is different from the base material structural property; a second material segment extending helically within the wall of the tubular body along a second region of the axial length, the second material segment comprising a second structural property, wherein the second structural property is different from the first structural property; and Therein, at the end of the first region, the first material segment ends and is replaced by the second material segment.

62. The catheter conduit of claim 61, wherein: The tubular body includes a second region having a second base material, and wherein the second base material is joined to an end of the base material.

63. The catheter conduit of claim 62, wherein: At least the second material section extends helically along the second region.

64. The catheter conduit of claim 62, wherein: The base material structural property and the second base material structural property are different.

65. The catheter conduit of claim 62, wherein: The base material structural attribute and the second base material structural attribute are the same, and wherein the base material is visually distinguishable from the second base material.

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