Catheter Structure

Abstract

The goal is to improve catheter design and catheter construction. [Solution] Polymeric tubing for use with catheters or other medical devices, which can have regions with customized properties, including, but not limited to, durometer, torque control, flexibility, axial strength, stiffness, etc. One variation of the device allows for transitions between regions to be configured such that there can be gradual or customized transitions between various regions, so that differences in structural properties between regions can be selectively engineered. A further variation includes an outer layer having multiple material sections, which extend in a helical direction along the axial length to form a continuous wall of the outer layer. In certain variations, differences in structural properties are minimized or eliminated compared to conventional catheters.

Description

[Technical Field]

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS

[0001] This application claims the benefit of U.S. Provisional Patent Application No. 63 / 369,947, filed July 30, 2022, and this application claims the benefit of U.S. Provisional Patent Application No. 63 / 505,397, filed May 31, 2023, both of which are incorporated by reference in their entireties.

[0002]

[0002] Polymeric tubing for use with catheters or other medical devices, wherein the polymeric tubing can have lengths with customized properties, including, but not limited to, durometer, torque control, flexibility, axial strength, stiffness, etc. In one variation, the transition regions between the lengths can be configured such that there can be abrupt, gradual, or customized transition regions between various lengths, such that differences in structural properties between the lengths and across the transition regions can be selectively designed. In certain variations, differences in structural properties are minimized or eliminated compared to conventional catheters. [Background technology]

[0003] Medical catheters allow physicians to apply a variety of different treatments within a patient's body. Many catheters access remote regions of the body and deliver diagnostic or therapeutic tools and / or agents to those sites. Alternatively, catheters may include a shaft or support for a therapeutic working end (e.g., a balloon, filter retriever, electrode, etc.). Some catheters, including but not limited to catheters for neurovascular use, are intended to be advanced from the aorta (e.g., the femoral or radial artery) through tortuous anatomy into the small vessels of the brain. Therefore, catheters must be constructed with different structural characteristics due to the various regions of the anatomy through which they pass. Often, vascular pathways revolve around themselves in a multi-loop path, making it difficult for catheter designs to meet the requirements dictated by the tortuous anatomy. For example, a catheter must have a fair amount of stiffness at its proximal end to allow it to be pushed and manipulated as it advances through the body, yet be sufficiently flexible at its distal end to allow the catheter tip to pass through loops and smaller vessels, yet still not cause significant trauma to the vessels or surrounding tissue.

[0004] 1A illustrates a conventional catheter construction and shows a side view of a catheter section 10 that may be fabricated on an inner mandrel or core 12 that is later removed. The conventional catheter construction includes a layer 14 of PTFE or the like that provides a smooth surface for the interior of the catheter while also supporting various structural components to provide the various sections 16 and 18 of the catheter 10. For example, the catheter 10 shown includes a reinforced section 16 in which a braid or a coil 20 (or both) is wrapped around the second layer 14. Many catheters use a metal braid at the proximal end of the catheter and a metal coil at the distal end of the catheter (or one above the other).

[0005] Many catheters intended to navigate through tortuous structures also include a region 18 having varying durometers, where polymers 22, 24, and 26 of different durometers are placed next to each other. FIG. 1A is for illustrative purposes to show the basic structure of a conventional catheter. The catheter 10 of FIG. 1A shows the polymer 22 terminating before the distal end 8 of the catheter 10 for illustrative purposes showing only the underlying reinforced section 16. In most conventional catheters, the entire distal end is encapsulated by the polymer.

[0006] As shown in FIG. 1A, a series of adjacently positioned polymer jackets 22, 24, 26 are placed over the reinforcing layer and fused in place (such as by heating the polymer to reflow onto the braid or coil). Different polymer durometers (i.e., "stiffness") are used for the different sections. As a result, each of these sections of the catheter will have unique structural properties / properties, which may include, but are not limited to, stiffness, resistance to twisting or kinking, flexibility, column strength, etc. The illustrated structure 10 provides different structural properties across the various regions of the catheter. However, in conventional devices, such catheter structures result in abrupt changes in properties at the transitions or edges of each region 22, 24, 26.

[0007] In many conventional catheter devices, a higher durometer polymer is used in the proximal region, with softer durometers being established as the catheter progresses toward the distal end. More sophisticated catheters have more "sections," or rigidity transitions (i.e., more discreet extrusions of varying durometers are used for the outer jacket). For example, FIG. 1C shows an end view of the Sofia® Plus Digital Access Catheter 19 manufactured by Microvention Termuo (Aliso Viejo, CA), an example of a commercially available intracranial catheter described by Microvention as having a "highly flexible distal tip" and a "torqueable shaft" in the proximal length. This catheter includes a midsection 23 adjacent to a flexible distal tip 25. The proximal length of the catheter is not shown in FIG. 1C because the midsection 23 is intended to illustrate that it is made from a relatively high durometer polymer and has an abrupt transition to the relatively flexible distal tip 25. Typically, higher durometer polymers offer improved torque and rotational / axial stability, but are less flexible. As shown in FIG. 1C, a pushing force applied to the proximal end of a harder durometer polymer can cause area 38, approximately where the polymer changes, to buckle. Buckling results in even more severe pushing and guiding.

[0008] Typically, stiffer durometers are more suitable for the proximal region of a catheter. Stiffer durometer polymers tend to bend less well around curves, but have better positional stability within the vessel and transmit torque better. In contrast, softer durometers are more suitable for the distal region of a catheter because the polymer bends more easily and gently around more delicate and tortuous distal curves. However, softer durometer polymers do not transmit torque well and have poorer positional stability. Thus, traditional catheter designs use a "tradeoff" between mechanical properties, compromising design elements (stiff and stable versus flexible and less stable). Furthermore, transitions from one durometer to another have long been a source of mechanical challenges. These transitions are known in the art to cause discontinuities, creating challenges in torque transmission, and can lead to irregularities in bending stresses that lead to poor guidance in the anatomy. Therefore, engineers try to make the transitions as long and gradual as possible and to soften the abrupt changes by having many small transitions as opposed to fewer, longer transitions.

[0009] Regardless of the length of the transition section, conventional designs rely on a braid or coil 20 (or both) to transmit torque as the catheter navigates through a tortuous structure, as shown in FIG. 1A. However, because polymers 22, 24, 26 (etc.) are external to braid / coil 20, a greater degree of torque is applied to the polymer. Polymers with different physical properties also have different resistances to torque. For example, in a variation where polymers 22, 24, and 26 have reduced flexibility (22 being the most flexible and 26 being the least flexible), the torque applied by the rotation of section 26 is not fully applied to section 24. Therefore, section 24 does not rotate as much as section 26. The same effect occurs with section 22, which rotates less than section 24 and even less than section 26. This results in poor torque control or torque instability. Furthermore, when these sections are bent, the transitions between the polymers create discontinuities in the way the catheter responds to bending or flexing across the various sections.

[0010] FIG. 1B provides a diagram of a section of the catheter body 10 in a curved profile (not including abrupt transition regions) to represent the section of the catheter body 10 being pushed to advance through a tortuous structure. FIG. 1B shows force 7 applied to the proximal end 9 of the catheter body 10, which is resisted by the vessel wall, represented as force 6. In order to advance the catheter body 10, force 7 must be greater than force 6. As the catheter body 10 is advanced through a tortuous path, it is placed in tension 32 at the outer portion of the bend and in compression 34 at the inner portion of the bend. However, polymers are suited to either compression or tension, and conventional catheter designs do not allow for the selection of a single polymer to maximize performance against both compression and tension. For example, a polymer that responds well to tension on the outer side of a curve (e.g., a generally more flexible polymer) will not respond well to compression on the inner side of the curve. Similarly, a polymer that responds well to compression on the inside of a curve (e.g., a relatively stiffer polymer) will not respond well to tension on the outside of the curve. Furthermore, the polymer must also be selected to respond to torsion and axial compression. Otherwise, problems of poor torque control or instability (e.g., referred to as "snagging") and axial instability (commonly referred to as catheter backup) can occur. As a compromise, traditional catheter designs require balancing polymer properties, but fail to create a device optimized for any given procedure—such a compromise leads to undesirable effects. For example, Figure 1D provides an image of the React™ 071 catheter 36 supplied by Medtronic. The catheter 36 is held only at end 37, allowing the catheter to assume its naturally formed shape. As shown, instead of having a smooth bend radius or curve, the abrupt transition in the catheter 36 causes the bend radius to become irregular at point 38, which results in the catheter buckling when pushed. Buckling of the catheter 36 not only reduces the transmission of pushing forces to the area beyond the buckle, but also reduces steerability. Summary of the Invention [Problem to be solved by the invention]

[0011]

[0011] The undesirability of abrupt transition regions is just one of the shortcomings of conventional catheter designs, which require a balancing act that compromises performance characteristics over any given section of the catheter by selecting less than desirable materials. Thus, there remains a need for improved catheter designs and catheter constructions to create catheters with highly customized properties. [Means for solving the problem]

[0012] The catheters of the present invention allow for custom-designed catheter structures without the need to compromise performance characteristics. Such catheter structures are made possible by the ability to customize the properties and materials of any given section of the catheter. Such customized properties include, but are not limited to, durometer, torque control, flexibility, axial strength, stiffness, etc. The present disclosure also includes improved catheter variations with gradual or customized transition sections that can be selectively configured. For example, any section of polymeric tubing (and therefore the finished catheter structure) can include polymers having low, medium, and even high durometers in the same region. The ability to improve transitions is just one example of the benefits of improved catheters made in accordance with the teachings herein.

[0013] For purposes of describing features of the present invention, a polymeric strand / component refers to a material section described herein before being formed into a tubular wall. As noted herein, in some variations, the material section may be formed from a first polymeric material and extend in a helical pattern. At some point, the first polymeric material terminates at an end and is joined to an end of a second polymeric material, which still extends or continues in the helical pattern of the material section. In such cases, the material section is considered to have two different polymeric materials in different longitudinal regions. In a further variation, the material section includes a polymeric material and extends helically across a longitudinal region of the tubing, then terminates such that adjacent material sections are joined to each other to maintain the continuity of the resulting tubing wall. It should also be noted that when referring to the bonded structure of individual strands, terms such as tubular wall, polymer tubing, polymer layer, composite tubing, composite layer, etc., can include material sections composed of one or more types of material, i.e., metal, stainless steel, alloy, liquid crystal polymer (LCP), fiber, composite material, or other similar structures.

[0014] It should be noted that the term transition section is used to describe the change of one or more strands of material to a different material. The term transition region describes the overall effect of one or more transition sections. In some variations, the transition region does not include any transition sections, as the material simply terminates. Thus, catheter structures of the present disclosure can have transition regions that gradually change material properties over their axial length, or the transition region can be a region where the material properties change abruptly.

[0015]

[0015] The present disclosure includes numerous variations of catheters having an outer tubing layer formed from multiple materials to customize the properties of longitudinal regions of the catheter. While certain variations of catheters may include this composite polymeric layer as being on an inner layer of the catheter structure, in many variations the custom composite layer is on the outer layer.

[0016]

[0016] Variations of such catheter tubing may include a tubular outer layer extending along the axial length of the tubular body, the tubular body comprising a plurality of material sections extending helically along the axial direction to form the wall of the tubular body, each material section being joined to an adjacent material section to form the wall, the plurality of material sections comprising at least a first material section and a second material section, the first material section having a first structural property and the second material section having a second structural property, the first structural property being different from the second structural property, the width of the first material section increasing along a transition region of the tubular body while the width of the second material section decreasing to change the structural property of the transition region along the transition region.

[0017]

[0017] Another variation of the catheter may include an outer tubular body having a first section and a second section each extending along the axial length of the tubular body, the outer tubular body comprising a plurality of material sections extending helically along the axial length, each material section being sealingly bonded to an adjacent material section to form a composite wall of the outer tubular body surrounding a lumen extending along the axial length, in the first section the plurality of material sections including at least a first material section and a second material section forming the composite wall, the first material section having a first structural property and the second material section having a second structural property, the first structural property being different from the second structural property, the plurality of material sections also including a third material section having a third structural property, the third material section being bonded to an end of the first material section in the second section such that the third material section replaces the first material section in the second section.

[0018]

[0018] A further variation of the catheter includes catheter tubing comprising a tubular body having a first section and a second section each extending along the axial length of the tubular body, and a plurality of material sections extending helically along the axial length to form the first section, each material section being sealingly bonded to an adjacent material section to form a composite wall of the tubular body surrounding a lumen extending along the axial length, each of the plurality of material sections having respective structural properties, the structural properties of at least two of the material sections being different, the first section comprising a first arrangement of material sections and the second section comprising a second arrangement of material sections such that the material sections in the first arrangement are different from the material sections in the second arrangement, causing the structural properties of the first section to be different from the structural properties of the second section.

[0019] Another catheter construction comprises a catheter shaft having an axial length and comprising a tubular outer layer comprising a plurality of material sections each having a respective width measured along the axial length, the plurality of material sections extending helically along the axial length to form walls of the tubular outer layer, the tubular outer layer having a first lengthwise region, a second lengthwise region and a transition region therebetween, in the first lengthwise region the plurality of material sections including the first material section and the second material section, The catheter structure includes a catheter structure in which the structural properties of a first material section are different from the structural properties of a second material section, such that the first longitudinal region has first structural properties, a transition region in which the second material section terminates at an end and a third material section is joined to the end of the second material section, such that the structural properties of the second material section are different from the structural properties of the third material section, and the first material section and the third material section extend helically from the transition region to the second longitudinal region, such that the structural properties of the second longitudinal region are different from the structural properties of the first longitudinal region.

[0020]

[0020] Yet 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 sections each having a respective width measured along the axial length, the plurality of material sections extending helically along the axial length to form walls of the tubular outer layer, the tubular outer layer having a first longitudinal region, a second longitudinal region, in the first longitudinal region the plurality of material sections including a first material section having a first structural property in the first longitudinal region, in the second longitudinal region at least a portion of the first material section terminating at an end and a second material section bonded to the end of the first material section, the structural properties of the first material section being different from the structural properties of the second material section such that the second longitudinal region has second structural properties different from the first structural properties.

[0021]

[0021] Another variation of the catheter structure includes a tubular outer layer comprising a plurality of material sections each having a respective width measured along the axial length, the plurality of material sections extending helically along the axial length to form a continuous wall of the tubular outer layer, the plurality of material sections including a first material section and a second material section adjacent to the first material section, the structural properties of the first material section being different from the structural properties of the second material section.

[0022]

[0022] Another variation includes a catheter shaft having an axial length comprising an inner liner, a reinforcing structure external to the inner liner, and a tubular outer layer extending over the reinforcing structure, the tubular outer layer comprising a plurality of material sections each having a respective width measured along the axial length, the plurality of material sections extending helically along the axial length to form a continuous wall of the tubular outer layer, the plurality of material sections including a first material section, a second material section, and a third material section, the first material section, the second material section, and the third material section each having different structural properties, the tubular outer layer having a first transition region, the width of at least one of the first material section, the second material section, or the third material section varying across the first transition region to result in a change in the structural properties of the first transition section.

[0023]

[0023] Still further variations include medical tubing comprising a tubular layer having a plurality of material sections each having a respective width measured along the axial length, the plurality of material sections extending helically along the axial length to form a continuous wall of the tubular outer layer, the plurality of material sections including a first material section and a second material section adjacent the first material section, the structural properties of the first material section being different from the structural properties of the second material section; 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 to cause the structural properties to vary across the first longitudinal region.

[0024]

[0024] The medical tube may also include a tubular outer layer having a plurality of material sections each having a respective width measured along the axial length, the plurality of material sections extending helically along the axial length to form a continuous wall of the tubular outer layer, the plurality of material sections including a first material section, a second material section, and a third material section, the first material section, the second material section, and the third material section each having different structural properties, the tubular outer layer having a first longitudinal region, and the width of at least one of the first material section, the second material section, or the third material section varying across the first longitudinal region to result in a change in the structural properties of the first longitudinal region.

[0025]

[0025] Another variation of a medical tube is a catheter shaft having an axial length, comprising an inner liner, a reinforcing structure exterior to the inner liner, and a tubular outer layer extending over the reinforcing structure, the tubular outer layer comprising a plurality of material sections each having a respective width measured along the axial length, the plurality of material sections extending helically along the axial length to form a wall of the tubular outer layer, the tubular outer layer having a first lengthwise region, a second lengthwise region and a transition region therebetween, and in the first lengthwise region the plurality of material sections are separated by a transition region between the first material section and the second material section. a catheter shaft including a first longitudinal region having first structural properties such that the structural properties of the first material section are different from the structural properties of the second material section, a transition region in which the second material section terminates at an end and a third material section is joined to the end of the second material section, the structural properties of the second material section being different from the structural properties of the third material section, and the first material section and the third material section extend helically from the transition region to the second longitudinal region, causing the structural properties of the second longitudinal region to be different from the structural properties of the first longitudinal region.

[0026] The present disclosure also includes one or more methods of forming a polymer tube. For example, such methods may include winding a plurality of polymer strands in a helical configuration to form a polymer tube, wherein at least two of the polymer strands have different structural properties, the plurality of polymer strands forming a first arrangement in a first section of the polymer tube, altering the arrangement of the polymer strands to form a second arrangement in a second section of the polymer tube, and fusing each polymer strand to an adjacent polymer strand to form a continuous wall in the polymer tube, the continuous wall defining a lumen therethrough, and wherein the structural properties of the first section differ from the structural properties of the second section due to the difference between the first arrangement and the second arrangement.

[0027]

[0027] Another catheter included in the present disclosure includes an inner liner and an outer layer comprising a plurality of polymer strands wound in a helical configuration, at least two of the polymer strands having different structural properties, wherein in a first section of the outer layer, the plurality of polymer strands form a first arrangement and in a second section of the polymer tube, the polymer strands form a second arrangement, each polymer strand fused or bonded to an adjacent polymer strand such that the plurality of polymer strands form a continuous wall defining a lumen through the polymer tube, and wherein due to the difference between the first arrangement and the second arrangement, the structural properties of the first section differ from the structural properties of the second section.

[0028]

[0028] Another variation of the catheter includes an inner liner, an outer layer comprising a first polymeric material having a tubular shape, and at least one second polymeric strand wound in a helical configuration around the tubular shape and fused to the first polymeric material, wherein at least a portion of the wall of the tubular shape comprises the first polymeric material and the second polymeric material, the first polymeric material and the second polymeric material having different structural properties, wherein in a first section of the outer layer the first polymeric material and the second polymeric material form a first pattern, wherein in the first section of the outer layer the first polymeric material and the second polymeric material form the first pattern, each polymeric strand is fused or bonded to an adjacent polymeric strand such that the plurality of polymeric strands form a continuous wall defining a lumen through the polymer tube, and wherein due to the difference between the first arrangement and the second arrangement the structural properties of the first section differ from the structural properties of the second section.

[0029]

[0029] The catheter and tubing configurations of the present disclosure allow for numerous combinations and permutations of the various catheter variations, as well as combinations of aspects of their construction. It is contemplated that any of the following requirements and elements may be combined with any independent claim where the requirements of the independent claim do not contradict the various elements.

[0030]

[0030] Any of the structures herein may include a tubular outer layer having a plurality of material sections each having a respective width measured along the axial length, the plurality of material sections extending in a spiral direction along the axial length to form a continuous wall of the tubular outer layer.

[0031] Any variation of the device / method may further comprise an inner liner within the tubular outer layer and a reinforcing structure external to the inner liner and within the tubular outer layer.

[0032] The variations can include the width of the first material section and the width of the second material section varying along the first transition region.

[0033]

[0033] A variant can include a tubular outer layer having a proximal longitudinal region proximal to the first transition region, the proximal longitudinal region being formed entirely from the first material section.

[0034]

[0034] Variations can include a third section of material extending over the majority of the axial length of the catheter tubular body.

[0035]

[0035] Variations can include the width of the first material section exceeding the width of the second material in at least the first section of the tubular wall.

[0036]

[0036] Variations may include tapering the end of the second material section.

[0037]

[0037] The catheters and structures described herein can have material sections that have a right-handed helix, a left-handed helix, or both.

[0038]

[0038] Any device or method variation herein can include at least one of the material sections comprising a non-fusible material. Further, such a non-fusible material may be used only for fabrication, after which the non-fusible material is removed to impart a groove cavity or other design feature on any surface of the device.

[0039]

[0039] The devices herein may also include an inner liner within the tubular outer layer and a reinforcing structure external to the inner liner and within the tubular outer layer.

[0040]

[0040] Variations of the device structure herein may further include a tubular outer wall further having a second longitudinal region, a third longitudinal region, and a transition region therebetween, the second longitudinal region including a first material section and a second material section defining structural properties of the second longitudinal region, in the transition region the second material section having an end and the third material section being joined to that end of the second material section, the structural properties of the second material section being different from the structural properties of the third material section, and the first material section and the third material section extending helically from the transition region to the third longitudinal region making the structural properties of the third longitudinal region different from the structural properties of the second longitudinal region.

[0041]

[0041] The catheter or catheter structure of any of the example procedures can include a tubular outer layer comprising a plurality of material sections each having a respective width measured along the axial length, the plurality of material sections extending helically along the axial length to form a continuous wall of the tubular outer layer. Further, the change in any material section can be gradual or continuously varying.

[0042] This application is related to U.S. Patent Application No. 17 / 173,003, filed February 10, 2021, which is a divisional application of U.S. Patent Application No. 16 / 902,154, filed June 15, 2020, which is a regular application of U.S. Provisional Application No. 62 / 862,035, filed June 15, 2019. This application is also related to PCT Application No. PCT / US2020 / 037808, filed June 15, 2020, each of which is incorporated by reference in its entirety. [Brief explanation of the drawings]

[0043] [Figure 1A]

[0043] FIG. 1 is a diagram of a conventional catheter construction showing a cross-sectional view of a catheter section fabricated on an inner extruded tube. [Figure 1B]

[0044] FIG. 1 is a view of a catheter body in a curved profile. [Figure 1C]

[0045] FIG. 1 is a diagram of a conventional catheter having multiple durometer regions. [Figure 1D]

[0046] FIG. 10 shows a photograph of a catheter having an abrupt change in structural properties between regions and being held in a bent or curved profile, resulting in the abrupt change in the catheter causing an irregular bend radius. [Figure 2A]

[0047] FIG. 1 is a partial cross-sectional view of an improved catheter incorporating the improved polymeric outer layer described herein. [Figure 2B] FIG. 1 is a partial cross-sectional view of an improved catheter incorporating the improved polymeric outer layer described herein. [Figure 2C] FIG. 1 is a partial cross-sectional view of an improved catheter incorporating the improved polymeric outer layer described herein. [Figure 2D]

[0048] 1 is a conceptual diagram of a catheter shaft intended to illustrate features of a catheter design according to the present disclosure. FIG. [Figure 2E]

[0049] 10A-10C are diagrams of various pathways through which variations of the catheter section of the present invention are specifically designed to pass. [Figure 2F]

[0050] FIG. 10 is a diagram of three catheters having left- and right-handed wound sections of material. [Figure 2G]

[0051] 1 is a diagram of various cerebral vessels including a catheter being advanced through one of the carotid arteries. [Figure 2H]

[0052] 1 is a diagram of a conventional catheter including various sections with abrupt transitions between sections as it is advanced through a carotid artery. FIG. [Figure 2I]

[0053] FIG. 2I is a diagram of the shape of the improved catheter as it advances through the vessel of FIG. 2I and assumes the shape of that vessel. [Figure 2J] FIG. 2I is a diagram of the shape of the improved catheter as it advances through the vessel of FIG. 2I and assumes the shape of that vessel. [Figure 2K]

[0054] FIG. 1 is a diagram of one possible design configuration for creating a catheter structure using composite tubing that includes material sections with different materials that each provide various mechanical advantages / benefits all within a single area of the finished catheter. [Figure 3A]

[0055] 1A-1C illustrate an example of a fabrication process for creating a catheter section according to the present disclosure. [Figure 3B] 1A-1C illustrate an example of a fabrication process for creating a catheter section according to the present disclosure. [Figure 3C]

[0056] FIG. 1 is a diagram of a catheter section comprising multiple individual polymeric strands of material wrapped around a mandrel or tube. [Figure 3D]

[0057] FIG. 10 is a diagram showing an example of a winding process. [Figure 3E]

[0058] FIG. 1 shows a structure in which polymer strands are secured to each other before being helically wound. [Figure 3F]

[0059] 10A-10C show three further variations of polymer strands arranged with different properties. [Figure 3G]

[0060] 10A-10C show further variations in which polymer strands are bonded together lengthwise end-to-end before being helically wound to form a tubular body. [Figure 3H]10A-10C show further variations in which polymer strands are bonded together lengthwise end-to-end before being helically wound to form a tubular body. [Figure 3I]

[0061] 10A-10C show further variations in which non-uniform strands are bonded together prior to forming tubing for use in catheter construction. [Figure 3J] 10A-10C show further variations in which non-uniform strands are bonded together prior to forming tubing for use in catheter construction. [Figure 4A]

[0062] 4C shows another variation of the joined strands prior to forming the tubular section shown in FIG. 4B. [Figure 4B]

[0063] FIG. 4B shows a catheter section formed from the strand shown in FIG. 4A. [Figure 5]

[0064] FIG. 10 is a diagram of a catheter section showing the spacing of dissimilar strands. [Figure 6A]

[0065] 10A-10C show variations of strands with reinforcing structures. [Figure 6B] 10A-10C show variations of strands with reinforcing structures. [Figure 6C] 10A-10C show variations of strands with reinforcing structures. [Figure 7A]

[0066] 1A-1C show examples of catheter sections formed from various polymers. [Figure 7B] 1A-1C show examples of catheter sections formed from various polymers. [Figure 7C] 1A-1C show examples of catheter sections formed from various polymers. [Figure 7D] 1A-1C show examples of catheter sections formed from various polymers. [Figure 7E] 1A-1C show examples of catheter sections formed from various polymers. [Figure 7F] 1A-1C show examples of catheter sections formed from various polymers. [Figure 8A]

[0067] FIG. 10 is a diagram of multiple strands extending next to a scale showing the strand configuration for one variation of catheter construction. [Figure 8B] FIG. 10 is a diagram of multiple strands extending next to a scale showing the strand configuration for one variation of catheter construction. [Figure 9A]

[0068] 1A-1C show examples of sections of catheters having outer layers that can be incorporated onto the catheter or used as stand-alone devices. [Figure 9B] 1A-1C show examples of sections of catheters having outer layers that can be incorporated onto the catheter or used as stand-alone devices. [Figure 10A]

[0069] FIG. 10 is a diagram of another variation of the device in which the polymer is additionally modified to create a wound catheter with gradated transition regions between various sections of the finished polymer tube. [Figure 10B] FIG. 10 is a diagram of another variation of the device in which the polymer is additionally modified to create a wound catheter with gradated transition regions between various sections of the finished polymer tube. [Figure 10C] FIG. 10 is a diagram of another variation of the device in which the polymer is additionally modified to create a wound catheter with gradated transition regions between various sections of the finished polymer tube. [Figure 10D] FIG. 10 is a diagram of another variation of the device in which the polymer is additionally modified to create a wound catheter with gradated transition regions between various sections of the finished polymer tube. [Figure 11A]

[0070] 1 is a graph of bending stiffness versus shaft position useful for understanding the ability of catheters of the present disclosure to create a significantly improved transition region over currently available catheters. [Figure 11B]

[0071] 1D shows an image of a section of a catheter made in accordance with the present disclosure, with the catheter section held in a position similar to that of the catheter shown in FIG. 1C. [Figure 12A]

[0072] 10A-10C show images of a catheter to illustrate the variations in patterns that can be formed in the bonded polymer strands to create features and / or patterns in the catheter section. [Figure 12F] 10A-10C show images of a catheter to illustrate the variations in patterns that can be formed in the bonded polymer strands to create features and / or patterns in the catheter section. [Figure 13A]

[0073] FIG. 10 illustrates multiple material sections in which additional individual materials are formed. [Figure 13B] FIG. 10 illustrates multiple material sections in which additional individual materials are formed. [Figure 14A]

[0074] FIG. 10 illustrates another variation of a composite polymer tube having multiple sections of material, where the sections of material are embedded in the polymer tube. [Figure 14B] FIG. 10 illustrates another variation of a composite polymer tube having multiple sections of material, where the sections of material are embedded in the polymer tube. [Figure 14C] FIG. 10 illustrates another variation of a composite polymer tube having multiple sections of material, where the sections of material are embedded in the polymer tube. [Figure 15A]

[0075] 10A-10C show variations of catheters having blended regions. [Figure 15B]

[0076] FIG. 15B is an enlarged view of the blood vessels in region 15B of FIG. 15A. [Figure 15C]

[0077] FIG. 15B is an enlarged view of the portion of the catheter in FIG. 15A traversing a sharp bend in the artery. [Figure 15D]

[0078] FIG. 15B illustrates several non-exhaustive design configurations for creating hybrid regions such as those shown in FIGS. 15A and 15C. [Figure 16A]

[0079] 10A-10C show further examples of various configurations of tubular members for use with the devices described herein. [Figure 16B] 10A-10C show further examples of various configurations of tubular members for use with the devices described herein. [Figure 16C] 10A-10C show further examples of various configurations of tubular members for use with the devices described herein. [Figure 16D] 10A-10C show further examples of various configurations of tubular members for use with the devices described herein. [Figure 16E] 10A-10C show further examples of various configurations of tubular members for use with the devices described herein. [Figure 16F] 10A-10C show further examples of various configurations of tubular members for use with the devices described herein. [Figure 17A]

[0080] 10A-10C illustrate another example of customizing material sections using transition material sections of decreasing width. [Figure 17B] 10A-10C illustrate examples of customizing material sections using transition material sections of decreasing width. [Figure 18A]

[0081] FIG. 1 illustrates a conventional catheter structure in which polymer chains are aligned along the axis or axial length of the tube. [Figure 18B]

[0082] FIG. 10 illustrates further design variations for use in high modulus / stiffness composite tubing sections. [Figure 18C] FIG. 10 illustrates further design variations for use in high modulus / stiffness composite tubing sections. [Figure 18D]FIG. 10 illustrates further design variations for use in high modulus / stiffness composite tubing sections. [Figure 18E] FIG. 10 illustrates further design variations for use in high modulus / stiffness composite tubing sections. [Figure 19A]

[0083] FIG. 10 shows another variation of a composite tube. [Figure 19B] FIG. 10 shows another variation of a composite tube. [Figure 19C] FIG. 10 shows another variation of a composite tube. [Figure 19D] FIG. 10 shows another variation of a composite tube. [Figure 20A]

[0084] FIG. 10 shows another embodiment of an improved catheter incorporating a composite layer at the tip of the catheter. [Figure 20B]

[0085] FIG. 10 shows a directional tip at the distal end of the catheter body. [Figure 20C]

[0086] 10A-10C show another variation of a directional tip located at the distal end of the catheter body. [Figure 20D] 10A-10C show another variation of a directional tip located at the distal end of the catheter body. [Figure 21A]

[0087] FIG. 10 shows another example of a catheter with a directional tip. [Figure 21B] FIG. 10 shows another example of a catheter with a directional tip. [Figure 22A]

[0088] 10A-10C illustrate the configuration of a section of material that forms a directional tip at the end of a catheter body. [Figure 22B] 10A-10C illustrate the configuration of a section of material that forms a directional tip at the end of a catheter body. [Figure 22C] 10A-10C illustrate the configuration of a section of material that forms a directional tip at the end of a catheter body. [Figure 22D]10A-10C illustrate the configuration of a section of material that forms a directional tip at the end of a catheter body. [Figure 23A]

[0089] 10A-10C show another variant of the manufacture of a composite tube. [Figure 23B] 10A-10C show another variant of the manufacture of a composite tube. [Figure 23C] 10A-10C show another variant of the manufacture of a composite tube. [Figure 23D] 10A-10C show another variant of the manufacture of a composite tube. [Figure 23E] 10A-10C show another variant of the manufacture of a composite tube. [Figure 23F] 10A-10C show another variant of the manufacture of a composite tube. [Figure 24]

[0090] 10A-10C illustrate another variation of a composite tube formed with non-overlapping sections of material. [Figure 25]

[0091] FIG. 10 shows another variation of composite tubing. DETAILED DESCRIPTION OF THE INVENTION

[0044]

[0092] The catheter configurations discussed herein can be used in a variety of devices, with different regions selected for customized properties. The configurations described herein can be incorporated into various medical devices or used as catheter shafts. Furthermore, in some variations, the structural features of the present disclosure are not limited to indwelling medical devices, but can be used in any device requiring tubing.

[0045]

[0093] The polymeric tubing described herein can be made by any method that allows for the material section configurations (and hybrid regions) disclosed below, including, but not limited to, forming the polymeric tube by winding directly onto 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 ribbons / strands onto a mandrel or support structure, then fusing the material into a tube and transferring it onto the catheter assembly.

[0046]

[0094] 2A-2C show partial cross-sectional views of an improved catheter 100 incorporating the improved composite outer layer 103 discussed herein. The catheter structure discussed herein can incorporate any number of features of catheter structures known by those skilled in the art. Such features are omitted herein to allow for a clear focus on the improved catheter composite outer layer 103. Furthermore, the improved catheter structure disclosed herein can be incorporated into any number of catheters that can benefit from the customization of 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 access catheters, central venous catheters, pulmonary artery catheters, coronary and cardiac catheters, and peripheral catheters.

[0047]

[0095] Further variations of the improved structure can be used in any polymeric tubular structure. It should be noted that none of the catheter structures or polymeric tubing described herein are limited to a single, uniform outer diameter throughout the catheter. As disclosed below, the catheters and polymeric tubing of the present disclosure can have contoured outer diameters. Alternatively, or in combination, the outer diameter may vary across various longitudinal regions of the catheter. The term longitudinal region is intended to refer to any length of a region along the axis 105 of the tubular structure. The catheter structures and tubular structures disclosed herein can have any number of conventional cross-sectional shapes. For example, device variations can include catheters with different diameters and / or cross-sectional shapes in various regions. Some sections of the catheters and tubular structures can include a circular cross-sectional shape that transitions to a non-circular shape.

[0048]

[0096] As shown in FIG. 2A , in one variation of the device, the tubular structure or shaft of the catheter 100 extends from the hub 101 and may be formed by an improved outer composite layer 103, discussed below, which covers a braid 20, coil, or other support structure commonly used with catheters. The braid 20 is positioned around a tubular inner liner 14 (typically made from PTFE, although other materials are within the scope of this disclosure). As shown in FIG. 2A , the improved composite layer 103 is the outermost component of the catheter tubing. As discussed below, the improved composite layer 103 can include any number of longitudinal regions better suited to transmitting torque through the catheter 100. Positioning these polymeric torque-transmission regions on the exterior of the catheter enhances the effectiveness of the torque-transmission regions compared to conventional catheters that primarily rely on a braid 20 positioned within the catheter shaft.

[0049]

[0097] FIG. 2B shows a variation similar to that shown in FIG. 2A in which the catheter 100 includes a distal tip 15 coupled to the end of the tubing 103. In some variations, the distal tip 15 can include a flexible polymeric or other material. FIG. 2C shows a device 100 similar to that shown in FIGS. 2A and 2B with the addition of an outer layer 13 positioned over the tubular member 103. The outer layer 13 includes a transparent or translucent material. In most cases, the performance and characteristics of the device 100 are controlled by the selection of materials forming the tubular member 103, the incorporation of braids / coils, or other support structures 20. In further variations, the outer layer 13 does not affect the performance and / or characteristics of the device 100.

[0050]

[0098] FIG. 2D illustrates a concept of a catheter layer 103 intended to characterize a catheter design according to the present disclosure. Layer 103 may be incorporated into a catheter structure such as that shown in FIG. 2A or any variation of such a structure (e.g., a catheter that does not include reinforcing structure 20 and / or a catheter that does not include liner 14). As shown, catheter layer 103 may include any number of regions 102, 104, 106, and 108, and the structural properties of each region may be customized based on the intended purpose for the catheter or as otherwise required. For example, layer 103 shown in FIG. 2D may be optimized or adapted for use in a catheter intended to be advanced through vasculature having various tortuosities. In the illustrated example, referring to FIG. 2E, region 102 may be designed to navigate tortuous region 52, while regions 104, 106, and 108 may be designed for respective regions 54, 56, and 58. 2D shows the catheter layer 103 as having at least one material section extending in a spiral or helical pattern with a pitch that varies along the length of the completed layer 103. In one variation, the various longitudinal regions 102, 104, 106, 108 may be adapted to particular regions of the vasculature 52, 54, 56, 58, each with a different degree of tortuosity. As described herein, the layer 103 may comprise any number of material sections. Additionally, the actual material of any material section (e.g., 110, 112) may vary over the length of the layer 103, which may result in new regions.

[0051]

[0099] 2D also shows that material section 110 comprises a helical region of polymer extending adjacent to second material section 112 comprising a second polymer (or alternative catheter material) to create regions (102, 104, 106, 108) having desired properties extending along catheter 100. For example, the pitch of first material section 110 may be different in each region 102, 104, 106, and 108. Alternatively, or in combination, the width of any of the material sections may vary from region to region. For example, material section 110 can comprise a reinforced polymer (e.g., PEBAX72D or a similar material).

[0052]

[0100] In another variation, material section 110 can comprise a first polymeric material (e.g., PEBAX 35D) within second material section 112 comprising a relatively stiffer material (e.g., PEBAX 40D-70D), with the helical pitch of the material section selected such that first region 102 is relatively stiffer than the remaining regions, with adjacent region 104 having a decreasing stiffness relative to region 102. This variation in stiffness can continue until region 108 becomes the softest / least stiff region and serves as the distal portion of material layer 103, which in turn affects the distal portion of a catheter incorporating material layer 103.

[0053]

[0101] The structure of layer 103 of the present disclosure allows for any number of engineered catheters with customized properties. Figure 2F shows two layers 103 and 107 to demonstrate that the novel layers of the present disclosure provide the ability to create catheter structures with left-handed (layer 103) or right-handed (layer 107) winding directions for material sections 110, 112 to create unidirectionally biased catheters with opposite winding characteristics between the distal region 122 and the proximal region 124. In a first variation shown in Figure 2F, layer 103 can be used with catheters requiring various regions 102, 104, 106, and 108. However, in this variation, region 108 has a looser pitch wound in a right-hand direction and includes material section 110 with stiff polymer strands to create a flexible region that can be used to form the distal region of the catheter. Adjacent region 106 includes material section 110 with a gentler pitch so that it is not as flexible as region 108. The pitch of material section 110 may be increased in sections 104 and 102, providing enhanced support. While the diagram in FIG. 2F shows only two material sections 110 and 112, any number of material sections formed from polymeric materials may be used to create the various sections of outer layer 103 that form the catheter. As noted above, the structural characteristics of various regions may be tailored to the characteristics of the target anatomy. Furthermore, winding material sections 110 and / or 112 (or specific material sections), such as those shown in layers 103 or 107, can create a specific, unidirectionally wound catheter (i.e., a catheter that is better able to follow the curves of a specific region of the anatomy). Specifically, the winding direction may be tailored to the directional twist of a vessel (i.e., a left-handed catheter for the left internal carotid artery and vessels, a right-handed catheter for the right internal carotid artery and vessels, etc.). For example, a person's left carotid artery may twist left-handed, while that person's right carotid artery twists right-handed. Catheter structures using the disclosed catheter layers (eg, 103, 107) make the catheter particularly suited to following the tortuousity of certain internal carotid arteries or any other arteries or body passageways.In general, the orientation of the reinforcing strands, as discussed herein, can make the catheter more likely to bend or navigate in a particular rotational direction within the anatomy. As noted herein, the present disclosure allows for customization of any region of the catheter structure with specific material properties. Additionally, catheter layer 114 includes a single tubing having a right-handed winding adjacent the distal end of layer 114 and a left-handed winding adjacent the proximal end of layer 114. As will be apparent, the present disclosure includes winding of material sections in a single direction or in multiple directions along the length of any tubing.

[0054]

[0102] Figures 2G, 2I, and 2J further illustrate the benefits of catheters using the configurations disclosed herein. Figure 2G shows various cerebral vessels with catheter 10 advanced through one of the carotid arteries 4, which are typically used to access the brain. Carotid artery 4 has various tortuous regions, decreasing in diameter as the vessel advances further into the brain. Figure 2H shows a conventional catheter advanced through and assuming the shape of vessel 4 of Figure 2G. This catheter 10 resembles the structure shown in Figure 1A, where the catheter includes regions 21, 22, 24, 26, and 27 of various discrete stiffness. As discussed above, conventional catheters are designed with various regions, each with individual polymeric variations (or other features, such as removal of the inner liner, altered braid / coil structure, etc.), and therefore catheter 10 experiences abrupt changes in structural properties at the intersections of each region 21, 22, 24, 26, and 27. One of the problems with such a design is that torque losses are applied evenly across the various sections. In other words, the torque 40 applied to the proximal, stiffer section 27 will be greater than the torque 42 in the distal-most section 21, which is generally the most flexible section. In addition to the torque difference, the rotational deflection of the proximal section 27 will be greater than the rotational deflection of the distal-most section 21.

[0055]

[0103] 2I and 2J show the improved catheter 100 as it advances through the blood vessel 4 of FIG. 2G and assumes the shape of that vessel. FIG. 2I shows a variation of the catheter 100 design, but for purposes of illustration, only shows the first material section 110 helically wound with the second material section 112. As described herein and as shown in FIG. 2J, any number of material sections may be used in the catheter 100. For purposes of illustration, the material section 110 comprises a single polymer having a stiff material property (e.g., 72D). This example shows the first material section 110 comprising a polymer that extends the length of the catheter 100. Thus, the helically formed polymer strand material section 110 helps transmit the application of torque 44 along the length of the material section 110 along the catheter 100, such that torque 46 at the distal end more closely matches torque 44 at the proximal end, unlike conventional catheters.

[0056]

[0104] FIG. 2J shows a further variation of the catheter 100 having multiple material sections 110, 130, 132, 134, 136, 138, 140, 142 extending helically along the length of the catheter 100. The material sections shown in FIG. 2J are for illustrative purposes only; any number of polymers can extend helically around the catheter 100, with some polymers ending or tapering off and different polymers beginning in different regions, such that various regions of the catheter may contain different polymers to impart unique structural properties to each region of the catheter. FIG. 2J is intended to demonstrate the ability to position a combination of materials along any section of the catheter 100. For purposes of illustrating one variation of the catheter 100, the catheter's material section 110 forms the majority of the wall of the material layer (e.g., see 103 in FIG. 2A) at the proximal end 122 of the catheter 100. 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 changes material or terminates the material section before it abuts the distal end 124 of the catheter 100, such that the material section at the distal end 124 comprises different material sections 130, 132 or different polymers. As discussed herein, the material sections may be terminated such that the polymer changes within the same material section, or the polymer within a material section may be bonded to the end of a different polymer within the material section.

[0057]

[0105] FIG. 2K illustrates one possible design configuration for creating a catheter structure using composite tubing 103 with material sections containing different materials, each offering different mechanical advantages / benefits, all contained within a single region of the finished catheter. As a result, the finished catheter section achieves a blend of mechanical characteristics within one region of the catheter. Such a configuration is simply not possible with conventional catheter designs. For example, FIG. 2K illustrates a composite layer or tube 103 with multiple material sections 280, 282, 284, 286, and 288. Each of these material sections can provide unique benefits. Material section 280 includes a low-durometer, ultra-soft material for high flexibility. Material section 282 includes a medium-durometer material that provides axial stability as well as some flexibility. Material section 284 includes a high-durometer material that provides rotational and axial stability as well as enhanced torque control. Material sections 286 and 288 are shown to illustrate that composite tube 103 may include any number of additional layers of material.

[0058]

[0106] The various polymer strands used to fabricate the catheter (or outer layer) can be selected to provide desired properties for the catheter 100 based on the catheter's desired use and / or depending on the target's intended path within the body. This construction allows the varying properties of any given polymer to be extended throughout a section of the catheter 100 or throughout the entire catheter 100 so that the catheter does not contain any areas of abrupt changes in structural properties / properties that affect bending, torquing, flexure, rotational stability, and axial stability, etc.

[0059]

[0107] 3A and 3B illustrate an example of a fabrication process for creating catheter sections according to the present disclosure. Any manufacturing process that produces a catheter or catheter layer including multiple material sections is intended to fall within the scope of the present disclosure. For example, such manufacturing processes may include wrapping polymer strands (as shown), 3D printing, extrusion, etc. As shown in FIG. 3A, multiple polymer strands or ribbons may be arranged in a pattern to match material sections 130, 132, 134, 136 and wrapped around structure 116. The structure may include a mandrel, a tube, or a braid / liner of a catheter structure. Once the polymer strands are wrapped, they are fused or otherwise bonded to each other to form layers described herein (e.g., see layer 103 in FIG. 2A). In one variation, the wrapped and bonded polymer ribbons form the wall layers of the catheter after being fused to each other. Alternatively, the polymer ribbon can form an outer layer on a tube, braid, and / or coil 116 to form a portion of the catheter section. For convenience, polymer strands / ribbons / extrusions will be referred to as polymer strands. The present invention includes polymer sections as having any shape necessary to complete a catheter section. As shown, the cross section of the polymer strands can be rectangular. Alternatively, the polymer strands may be oval, circular, or have any other shape. In a further variation, polymer strands of various shapes and sizes can be combined to form layers. Furthermore, the polymer strands can comprise single lumen extrusions / tubes that are collapsed and melted / dissolved. Alternatively, the strands may be extruded or otherwise fabricated to be solid. In another variation, the lumen of each polymeric strand is left intact. In a typical variation, the strands are wound (as discussed above) onto a braid or coil.In a further variation, the polymer strand structures discussed herein may be used to form the inner layer of the catheter (instead of or in addition to a polymeric liner), with a separate structure being used for the outer layer of the catheter. In a further variation, although the disclosure herein discusses strands and material sections as including polymers, the strands or material sections may comprise non-polymeric materials (e.g., metal, stainless steel, alloy, liquid crystal polymer (LCP), fiber, composite material, or other similar structures). The strands may be of different materials, different shapes, different sizes, and mixed, or may be installed and removed to leave voids. The strands may also be of different materials, different shapes, different sizes, and mixed, or may be installed and removed to leave voids.

[0060]

[0108] For purposes of describing features of the present invention, a polymeric strand / component refers to a material section described herein before it is formed into a tubular wall. As noted herein, in some variations, the material section may be formed from a first polymeric material and extend in a helical pattern. The first polymeric material terminates at an end at some point and is joined to an end of a second polymeric material, with the second polymeric material still extending or continuing in the helical pattern of the material section. In such cases, the material section is considered to have two different polymeric materials in different longitudinal regions. In a further variation, the material section comprises a polymeric material, extends helically across a longitudinal region of the tubing, and then terminates such that adjacent material sections are joined to each other to maintain the continuity of the resulting tubing wall.

[0061]

[0109] Regardless of the fabrication process, the polymer strands in each of the material sections 130-136 can include polymers of various compositions. In one example, the polymer can be a common material (e.g., PEBAX), in which case each strand in each of the material sections 130-136 has a different durometer. For example, the strands can have the following associated durometers: 130-72D, 132-63D, 134-35D, and 136-45D. Obviously, any number of variations are within the scope of this disclosure.

[0062]

[0110] Figure 3A also shows multiple material sections 130, 132, 134, 136, each having a respective width W1, W2, W3, and W4 measured along the axial length 105 of the tube. In this illustration, axial length 105 is the axial length of the core or tube, which is generally similar, if not the same, as the axial length of the finished tube or catheter having layers formed by material sections 130, 132, 134, 136. For material not yet formed into a tubular structure, the width is measured in a plane perpendicular to the length of the strand. As shown in Figure 3B, the material sections extend helically along axial length 105 to form a continuous wall as discussed herein.

[0063]

[0111] 3C shows wall section 103 after multiple individual polymeric strands of material in material sections 130, 134, 132, 136 have been bonded together to support structure 116. Section 103 may be incorporated into medical catheters, medical devices, and / or other tubing.

[0064]

[0112] 3D shows an image of an example winding process in which strands of polymer are wound directly onto the catheter reinforcing braid 116, forming material sections 138, 140, and 142. (Alternatively, as in conventional catheter construction, the strands are wound onto a mandrel, fused or partially fused, and then transferred onto the catheter braid.) In this variation, the strands 138-142 are separate and are wound so that the strands touch and bond to form a sealed connection, such as by heat fusion, between adjacent materials. However, any process that results in bonding of adjacent materials may be used.

[0065]

[0113] It should be noted that although the variations disclosed herein show a single layer of various material sections forming the walls of the tubing, the tubing may be formed from multiple layers, each layer comprising multiple material sections, and each layer may have an arrangement of the same or different material sections.

[0066]

[0114] 3E shows a configuration in which the polymeric strands 130-134 are secured together before being helically wound to form the material sections 130-134. For example, the strands may be fused or stitched together before being wound.

[0067]

[0115] Figure 3F shows three additional variations of polymer strands arranged with varying properties. In the examples shown, the durometer of the strands is shown. However, the polymer strands may vary other properties as desired. As shown in the bottom two variations, two strands of similar composition may be placed adjacent to a dissimilar strand. When formed into a tubular member, the central material section will be bounded by material sections having the same polymer.

[0068]

[0116] 3G and 3H show a further variation in which polymer strands 130, 132, 134, 130-134, are bonded end-to-end longitudinally before being formed into the wall, with strand 134 ultimately forming sections of material on either side of the section of material formed by strands 130 and 132. In this variation, strands 130 and 132 are bonded end-to-end at transition sections 120 to allow for a longitudinal material transition along the axial direction of the finished catheter. This means that when formed into the tubular member / wall, the central section of material includes material 130 bonded to material 132 at edges 120. The bond or transition section 120 between strands 130 and 132 can be an abrupt transition section 120, as shown in FIG. 3G, or an angled or tapered transition section 120, as shown in FIG. 3H.

[0069]

[0117] 3I and 3J illustrate additional, non-exhaustive variations of the interlocking strands 130, 132, 134, and 136, where the strands are not uniform. For example, FIG. 3I illustrates strand 134 as having a circular cross-sectional shape. As noted above, any type of cross-sectional shape may be used. In such cases, the width W3 of strand 134 may be considered the maximum width of strand 134 along its axis. In some variations, the size of strand 134 causes the resulting material section to protrude slightly from the surface of the tube. FIG. 3J illustrates such an instance, where a particular strand 134 of height H1 is interlocked with a strand 132 having a greater height H2. FIG. 3J also illustrates strand widths W5 and W6 as being nonuniform. Again, any permutation of shapes, sizes, widths, heights, etc. may be combined to create a polymeric layer. It should be noted that strands of any material incorporated into a composite polymeric layer may include strands of material having a different melting temperature than one or more adjacent strands. It should also be noted that in some variations, one or more strands may be infusible (i.e., thermosetting material, or metal, Teflon, etc.) that are mechanically held by adjacent strands but do not melt. In a further variation, the infusible strands are used during the formation of the tubing to create voids or patterns and are then removed.

[0070]

[0118] FIG. 4A shows another variation of a group of joined strands 130-138 prior to forming the tubular section shown in FIG. 4B. As shown, the strands have different properties that result in the different sections 102, 106, and 108 for the catheter. As shown in FIG. 4B, when wound, the varying composition of material sections 130-138 form the different axial sections 102, 106, and 108 extending lengthwise along the tubular layer 103. In both variations shown in FIGS. 4A and 4B, the strand / tubular layer 103 includes a single strand 130 that extends continuously as material section 130 for the entire length of the finished tube 103. In this example, the strand 130 includes 72D material and may ultimately be used as reinforcement for the finished catheter (used primarily to transmit torque and provide stability through the typically soft and flexible distal region, which typically does not transmit torque well and typically provides less stability).

[0071]

[0119] FIG. 5 shows a section 102 of tubing in which strands 152 and 154 are joined to form a tube. The figure shows the spacing of dissimilar strands 152 and 154. In an example, strand 152 may be separated by a second strand 154, which comprises a segment having the same width as strand 152, or the second strand 154 has a greater width than the first strand 152. As noted 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 lower durometer material. In an alternative 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 may range from 35D to 45D, while the high durometer material may range from 63D to 72D. Obviously, further variations in materials are within the scope of this disclosure.

[0072]

[0120] FIG. 6A shows a further variation of the catheter structure described herein, in which a polymer strand 130 includes a support member 156 extending therethrough, which reinforces the strand 130 or provides alternative structural properties. The support member 156 may extend the entire length of the strand 130 or extend partially through the strand. Additionally, variations of the reinforced strand 130 can include multiple support members extending therethrough. FIG. 6B shows a cross-sectional view of the strand 130 to illustrate several cross-sectional shapes of the reinforcement members. As shown, the reinforcement members can have a circular cross-section 158 or an oval cross-section, the support members can have a rectangular or square cross-section 160, or the support members can have a D-shaped cross-section 162. The support members can comprise a metal, alloy, or polymer. For example, the support member can include SS wire, shape memory wire, drawn-filled tubing, or composite fiber material. The support member may be in the form of a cable, braid, coil, strand, etc., or any shape / structure / material used to provide support. FIG. 6C illustrates various complex cross-sectional shapes 164 for the support member in strand 130. In certain variations, the catheter section can have different cross-sectional shapes in different sections of the catheter. For example, it has been found that strands having a circular or oval cross-sectional shape are better suited for the distal region of the catheter, while strands having D-shaped support members are useful in the intermediate or proximal region of the catheter.

[0073]

[0121] 7A through 7F show several examples of tubular sections 203 formed from various polymers with multiple material sections extending in a helical pattern along the tubing 203. For illustrative purposes, in 7A through 7F, material properties are shown in association with the following element numbering: 35D-235, 45D-245, 55D-255, 63D-263, and 72D-272. However, this association is intended to clarify variations in tubing 203. Any variations in material may be used in the catheter structures described herein. Furthermore, as discussed herein, any tubing section 203 may be used in any segment of a completed catheter. The illustrations in FIGS. 7A through 7F are intended to show non-exhaustive combinations of segments. In each illustration, the pattern shown by each material section 235, 245, 255, 263, and 272 repeats to impart unique properties to that segment of tubing 203. For example, FIG. 7B shows a pattern in which a 55D material section 255 resides directly between two 45D material sections 245, with the assembly then residing between two 35D material sections 235. This configuration can provide properties that allow for a “shock absorber” effect. In FIGS. 7C, 7D, 7E, and 7F, certain strands are doubled during the construction of tubing 203 to provide wider material sections for the structure. For example, material section 235 in FIG. 7D is shown to be approximately twice the width of material sections 245, 255, and 263. FIG. 7E shows material section 255 as approximately twice the width of sections 263 and 270. FIG. 7F shows material sections 245 and 255 as approximately twice the width of section 263. Again, the variations shown are intended to provide a non-exhaustive sample of variations for feasible catheter structures.

[0074]

[0122] 8A and 8B show example strands 130 and 132 extending adjacent to scale 30 to illustrate one example aspect of strands 130 and 132 that ultimately form the tubular member described above, where the overlap or offset of the polymer end bond locations results in a finished polymer tube / catheter structure with a transition region 129 that is a significant improvement over conventional catheter structures. FIGS. 8A and 8B also demonstrate the degree of polymer overlap or offset in the individual transition sections 120 (where the material has respective butt bond locations) that, when the end of 130 is adjacent to and wrapped around the end of 134, results in a transition region 120 that is a significant improvement over the conventional catheter described above. As shown, the configuration of FIG. 8A includes offset transition sections 120 that create a transition region 129 similar to that shown in FIG. 9A. As described herein, when strands 130 and 132 are formed into a tubular member, strand 130 collectively forms a material section that changes from a first material over region 129 to a second material, with the material of strand 132. FIG. 8B shows a variation similar to the example of FIG. 8A , including strand 134 bonded / joined end-to-end with strand 130. However, strand 136 remains continuous. When processed into a tubular member, strand 134 forms a material section that changes material, as described with respect to FIG. 8A , while the tube section formed by FIG. 8B includes a material section formed by strand 136 that remains constant.

[0075]

[0123] 9A and 9B show two examples of catheter sections having an outer layer 103 that can be incorporated onto a catheter or used as a stand-alone device / structure. FIG. 9A shows a material section 130 formed from a first polymer and a material section 132 formed from a second polymer. The outer layer 103 includes a tubular layer longitudinal region 129, with the widths of the first material section 130 and the second material section 129 both varying along the longitudinal region 129 to vary the structural properties across the first longitudinal region 129. As shown, the right side of FIG. 9A includes a tubular member formed entirely from material section 130 and a left side of material section 132 formed entirely from material section 132. In the transition region 129, the widths of the respective material sections vary in opposite directions along the longitudinal region 129, such that the width of the first material section 130 decreases toward the left while the width of the second material section increases. These transition regions can be made as long and progressive as desired by adjusting the length of section 129 and by adjusting the number of strands / ribbons used to provide a superior transition region that is a significant improvement over conventional catheters.

[0076]

[0124] 9B shows a variation of tubing 103 in which multiple sections of material 130, 132, 136 are helically wound to form tubing 103, which includes a joint 120 where material section 130 changes to a different material 134, which continues in the helical pattern of material 130. This end-to-end material joint allows the material section to continue changing materials.

[0077]

[0125] Figures 10A through 10D show another example of a strand arrangement to form a tubular member for use in a catheter. Figures 10A and 10C show a group of bonded strands, respectively, that can be altered to create the configurations shown in Figures 10B and 10D. Figure 10A shows a five-strand structure in which one end of the bonded strand includes a strand of a first polymer 204. The strands of the first polymer 204 are each replaced in individual transition sections 120, which are staggered to progressively replace the strands 204 with strands of a second polymer 206 over the transition regions comprising lengths 172, 174, 176, and 178. This structure allows for a gradual change across transition regions 172, 174, 176, and 178 along the completed tubular assembly 103 (as shown in FIG. 10B), where the completed tubular assembly 103 has the properties of a first polymer in the first longitudinal region 170 and gradually changes to the properties of a second polymer across transition regions 172, 174, 176, and 178 until longitudinal region 180 is composed entirely of the second polymer. The material transitions in longitudinal regions 172, 174, 176, and 178 represent examples of gradual transitions in material properties across the longitudinal transition regions of the tubular assembly 103 or the completed catheter structure. Obviously, any number of material sections, or widths of material sections, can be used to increase or decrease the proportion of the transitioning material properties. Additionally, the device variations described herein do not require offsetting of the transition sections 120. Although offsetting is usually desirable to obtain a gradual transition, the transition region can comprise an abrupt change in material if desired.

[0078]

[0126] It should be noted that the term transition section is used to describe the change of one or more strands of material with a different material. The term transition region describes the overall effect of one or more transition sections. In some variations, the transition region does not include any transition sections, as the material simply terminates. Thus, catheter structures of the present disclosure can have transition regions that gradually change material properties over their axial length, or the transition region can be a region where the material properties change abruptly.

[0079]

[0127] Figure 10B also shows that each longitudinal region 172, 174, 176, 178 comprises at least two sections of material 204 and 206, where the width of section 204 or 206 of material increases or decreases while the width of the other section 206 or 204 decreases or increases, respectively. Variations of tube 103 shown in Figure 10B also include longitudinal regions 170 and 180 formed entirely from a single section of material. Again, any of the tube structures 103 discussed herein may be incorporated into a catheter structure, as shown in Figure 2A, or such tube structures 103 may be incorporated into any medical or non-medical device.

[0080]

[0128] As shown, the catheter section can comprise various sections: section 170 comprises five strands of a first polymer (5-0), section 172 comprises four strands of a first polymer and one strand of a second polymer (4-1), section 174 comprises three strands of a first polymer and two strands of a second polymer (3-2), section 176 comprises two strands of a first polymer and three strands of a second polymer (2-3), section 178 comprises one strand of a first polymer and four strands of a second polymer (1-4), and section 180 comprises five strands of a second polymer (0-5). The structure of Figure 10A, after the strands are helically formed and fused into the catheter section, results in the catheter shown in Figure 10B.

[0081]

[0129] FIG. 10C shows multiple bonded strands, where section 190 comprises four strands 208 of a first polymer and a single strand 210 of a second polymer (4-1). As shown, at the transition to region 192, one strand 208 is tapered to leave only four strands (3-1). In the next section 194, another strand 208 is tapered to leave only three strands (2-1). This process continues through section 196 (1-1) until only a strand 210 of the second polymer remains. The wrapping of the bonded strands is adjusted (e.g., the pitch is changed) so that the reduction in strand count does not leave any openings or gaps between the strands. This structure results in a tube structure 103 similar to FIG. 10D. As shown, tubular structure 103 includes two material sections within longitudinal region 109, with the width of material section 210 increasing in section 192 relative to section 190, while the width of material section 208 decreasing in section 192 relative to section 190. The widths of material sections 208 and 210 continue to change in opposite directions throughout longitudinal regions 194 and 196 until region 198 includes a single material section 210. The structure shown in FIG. 10D illustrates tubular section 103 with transition regions 192, 294, 196, where the material sections change but there is no transition section of material 208 because the material just terminates as shown in FIG. 10C. While the structures in FIGS. 10A / 10B and 10C / 10D are different, both designs create a shaft that transitions from a first material property to a second material property using a very gradual basis. This smoothing and uniformity significantly exceeds what can be achieved using conventional catheter technology. One example of a material property is stiffness / flexibility. For example, the catheters of Figures 10B and 10D can transition from a relatively stiff material property, e.g., at 170 in Figure 10C and 190 in Figure 10D, to a much more flexible material property, e.g., at 180 in Figure 10B and 198 in Figure 10D.The transition regions (e.g., 172-178 in FIG. 10B and 192-196 in FIG. 10D) can be customized through selection of polymers, transition lengths, etc. to create transitions simply not found in currently available commercial catheters. Note also that the lengths of regions 170-180 and regions 190-198 (as well as lengths throughout this disclosure) are intended to convey the principles of the design. Lengths are not required to be the same and are not to scale unless otherwise stated.

[0082]

[0130] As will be apparent, the lengths of each section shown in Figures 10A and 10C are for illustrative purposes only. Additionally, any number of polymer strands may be used with any number of polymers. Furthermore, note that in Figure 10A, the material sections may be considered all of the separate elements 204 of the same material. Thus, region 170 includes a material section that changes width gradually into region 172, and so on. The width change may be gradual, as shown, or incremental. Alternatively, the change may be graded so that the width change is continuous, as shown by the region in Figure 10C where the end of material 208 tapers.

[0083]

[0131] Figure 11A shows a graph of bending stiffness versus shaft position to aid in understanding the ability of the catheters of the present disclosure to provide a significantly improved transition region over currently available catheters. Figure 11A shows the results of a test, commonly known as a three-point bending test, in which the force required to displace a catheter a given distance is measured. The catheter is supported at two points so that the gap between the two points is deflected a given distance. The force required to cause this deflection is measured and graphed as a function of distance from the distal end of the catheter. For example, the left side of the graph shows the amount of force required to move the catheter section at the point closest to the distal end of the catheter (i.e., the distal end). The right side of the force graph shows the amount of force required to move the catheter section at the point closest to the proximal end of the catheter. Three catheters tested in this manner included catheter 300 made in accordance with the present disclosure, commercially available catheter 302 (React 071) manufactured by Medtronic, and commercially available catheter 304 (ACE 068) manufactured by Penumbra. The graph shows the improved catheter 300 as having a gradual increase in bending stiffness without any abrupt or irregular increases in bending stiffness. In contrast, the graphed data for bending stiffness of the Medtronic catheter 302 shows two significant regions 306 of abrupt changes in property. The graphed data for bending stiffness of the Penumbra catheter 304 shows three significant regions 306 of abrupt changes.

[0084]

[0132] FIG. 11B depicts a section of a catheter constructed in accordance with the disclosure herein, with the catheter section held in a position similar to that of the catheter shown in FIG. 1D. However, 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 catheter 310 across various longitudinal regions 312, 314, 316, and 318 to avoid any areas of abrupt transition that would otherwise result in irregular bending. FIG. 11B shows just one example of catheter 310 using materials 134, 206, 208, and 210. Clearly, any number of combinations are within the scope of the present disclosure, as described herein. As shown, longitudinal region 312 includes three material sections: materials 134, 206, and 210. Longitudinal region 314 includes two material sections: materials 206 and 210. Longitudinal section 316 includes three sections of material: materials 206, 208, and 210. This section also exhibits sections of material that vary in width such that the thickness of material / material section 206 decreases and the thickness of material / material section 208 increases in a direction toward longitudinal section 318. Longitudinal section 318 includes two sections of material: materials 208 and 210. The net result of creating catheter 310 is that longitudinal sections 312 and 314 have significantly different structural properties compared to longitudinal section 318, but the changes are gradual enough to avoid significant discontinuities in bending stiffness.

[0085]

[0133] 12A through 12D are grayscale images of exemplary catheter structures according to the present disclosure. FIG. 12A shows three different catheter sections 320, 322, and 324, each having a different helical pitch angle (i.e., the angle that material sections 134, 132 make with respect to the axis of the catheter). Catheter 320 exhibits a nearly radial angle (i.e., the angle is nearly perpendicular to the axis). The structure for this catheter section included two strands: one strand of material 134 and one strand of material 132. Catheter 322 exhibits an intermediate pitch angle. The structure for this catheter section included four strands: one strand of material 134, one strand of material 132, one strand of material 134, and one strand of material 132. Catheter 324 exhibits an increased pitch angle relative to catheters 320 or 322. The construction for this catheter section included six strands: one strand of material 134 repeated three times and one strand of material 132. More strands used during construction allows for a greater increase in pitch angle.

[0086]

[0134] FIG. 12B shows another grayscale image of another variation of a constructed catheter section, with a material section 130 having a larger width and two material sections of the same material on either side of the material section having flexible material 134. Such a configuration can provide a “bumper” if material 132 is a stiffer material. FIGS. 12C and 12D show a catheter constructed in accordance with the present invention with a contoured outer surface. FIG. 12C shows a grayscale image of another example of a constructed catheter section, similarly constructed in a manner similar to the structure shown in FIG. 3J. In this variation, the height of material 132 exceeds the height of adjacent material 134, and the width of material 132 is less than the height of adjacent material 134. Despite the height difference, the materials were able to fuse together to form a polymer layer. FIG. 12D shows another catheter in which material section 134 has a diameter greater than the adjacent materials 132 and 130. In another variation, the contoured surface can be formed using one or more materials along with a non-fusible material (e.g., a high melting temperature polymer such as PTFE, a metal alloy, etc.) on the strands during the fusing process (e.g., as illustrated in Figure 3A), such that the non-fusible material is removed, leaving voids in the finished polymer layer.

[0087]

[0135] 12E and 12F show illustrations of variations of tubing 330-348 that can be incorporated into a catheter or used as a tube device without a catheter structure. FIGS. 12E and 12F show two material sections 230, 232, which can include any variation of material. In one example, FIG. 12E shows section 230 constructed of a stiff 72D durometer ribbon (used as a torque coil) embedded in section 232 comprising a softer 60A durometer ribbon. The pitch (i.e., spacing) of material 230 increases from 330 to 340 by increasing the number of material sections in each unit; i.e., tubing 330 has a single material section 230 along with material section 232. In contrast, structure 340 is formed from a structure including multiple strands of material 230 and multiple strands of material 232.

[0088]

[0136] FIG. 12F shows a diagram of four tubings 342, 344, 346, and 348, in which the angles of material sections 230 and material sections 232 vary in each tube. In each of these units, the spacing (i.e., pitch) of material sections 230 of the white 72D coil does not change (i.e., the width of material sections 232 between material sections 230 is the same dimension in each unit). However, the angles of material sections 230 vary in each unit. For example, tube 342 exhibits the most radial material section 230 angle (i.e., extending radially from the tube), while the bottom tube 348 has the most axial or linear material section 230. Tube 342 has three strands: one strand 230 and two strands 232 to create material sections 230 and 232. Tube 344 was made using six strands: 230x1 + 232x2 + 230x1 + 232x2. Tube 346 was made from nine strands, and tube 346 was made from twelve strands using the same arrangement.

[0089]

[0137] 13A and 13B illustrate another feature of catheter structures in which multiple strands (of similar or different polymers) are bonded together as described above. However, in these variations, various individual materials (i.e., polymers, metals, composites, alloys, etc.) can be patterned on the bonded strands 130. In FIG. 13A, the polymer is patterned into the shown shape 214. The base strand 130 may be removed, or a polymer 214 may be positioned on the base strand. Similarly, multiple polymers 214 and 216 may be positioned on the polymer base strand 130. In an alternative variation, the base polymer strand 130 may be removed so that the patterned polymer 214 or 216 can be positioned in the space left by the removed base strand 130. The completed assembly 130 can be processed into a tubular structure for incorporation as the shaft of a catheter or other medical device.

[0090]

[0138] 14A-14C illustrate another variation for creating a composite polymer tube 294 having multiple material sections according to the present disclosure. As shown in FIG. 14A, the initial structure can comprise a conventional polymer tube 290 around which one or more strands 292 are wrapped. The tube 290 and strands 292 are then heat-fused together to create a composite polymer layer 294, where the strands 292 become at least partially embedded in the tube 290, resulting in the polymer layer 294 comprising a first material section comprising the tube material 290 and a second material section comprising the strand material 292. Obviously, variations in the number of strands (as described above) can be embedded in the tube. Additionally, the outer diameter of the polymer layer 294 can include undulations. FIG. 14C illustrates the polymer tube 294 with a portion removed to highlight the cross-sectional area of the polymer layer. In a further variation, the structure of Figures 14A-14C can replace the conventional polymer tube 290 with a composite polymer tube including various material sections made as described herein.

[0091]

[0139] FIG. 15A shows a partial view of a patient's anatomy to demonstrate one feature of the catheter 100 of the present disclosure. FIG. 15A shows the catheter 100 being inserted using a radial access procedure. Clearly, the catheter structure (and polymer layer) described herein can be incorporated into any device where material selection for specific performance characteristics is desired. Radial access procedures are becoming a desirable access point for interventional procedures. Radial access is the primary mode for cardiac surgery and is becoming increasingly commonplace for neurovascular procedures. However, sharp bends, especially when attempting neurovascular access, pose significant challenges for conventional catheters. The catheter structure described herein is well suited to address the challenges of the sharp anatomy faced by conventional catheters.

[0092]

[0140] FIG. 15A shows a catheter 100 of the present disclosure being placed into the radial artery 50, navigated into the right subclavian artery 51, navigated into the internal carotid artery 53, and finally navigated into a neurovasculature 60. The catheter 100 shown in FIG. 15A includes regions of various material sections, as described above. However, a variation of this catheter 100 includes a hybrid region 220 that allows for multiple catheter performance characteristics in that region. Such a configuration not only allows navigation through tortuous bends, but does not suffer from the same drawbacks as catheters simply made from flexible polymers. The present disclosure contemplates catheters having any number of hybrid regions with any permutation of material properties. FIG. 15B shows the area from FIG. 15A and also illustrates the sharp bend between the right subclavian artery 51 and the right internal carotid artery 53. The catheter has been removed from FIG. 15B for purposes of illustrating the bend. Conventional catheters encounter problems when advanced through such tight bends because stiffer / more rigid polymers have difficulty navigating the tortuous curves of the anatomy. While softer polymers may be able to navigate such tight bends, the softer section will not transmit sufficient pushing force and torque to the bend and the region of the catheter distal to the soft polymer.

[0093]

[0141] FIG. 15C shows an enlarged view of a portion of catheter 100 traversing a sharp bend between the right subclavian artery 51 and the right internal carotid artery 53. Catheter 100 is designed so that hybrid section 220 (or a sufficient length thereof) is positioned so that hybrid section 220 is located within the bend when the distal end of catheter 100 is positioned at or near its intended target. FIG. 15C shows catheter 100 as having multiple material sections 134, 206, etc. However, in this variation, hybrid section 220 includes material section 210, which is stiffer and enables torque and force transmission of catheter 100. Hybrid section 220 can also include one or more individual sections of material 208 that provide desired material properties different from those of base material section 210. In this example, the individual sections of material 208 comprise a flexible material. Such a structure allows the catheter to make sharp bends due to the flexible individual material sections 208. Meanwhile, the harder durometer base section 210 transmits the pushing force and torque to the distal region of the catheter.

[0094]

[0142] 15A and 15C. The hybrid region of the catheter / finished tubing is formed from multiple materials 130 bonded together, where a base material 210 is interrupted by discrete sections of a second material 208 having different properties than the base. For example, in one variation of this design, material 210 can include a stiffer / harder durometer material or polymer, while material 208 includes a flexible / soft material or polymer. Obviously, any material properties other than stiff / soft materials can be selected and configured into the hybrid region.

[0095]

[0143] 16A and 16B show additional examples of tube 103 configurations for use with the devices described herein. FIG. 16A is a cross-sectional view of multiple strands 358, 362, 364, and 366 joined to form a tubular section as shown in FIG. 16B. In FIG. 16B, tubular section 103 includes multiple material sections extending in a continuous spiral across tube section 103, where one material section 360 extending from region 350 through regions 352 and 354 changes material in each region. In one example, material section 360 includes a reinforced material section as it extends in a continuous spiral across multiple regions. Furthermore, the structural properties of each region can be selectively designed based on the individual materials 362, 364, and 366. For example, to increase the flexibility of the device in the proximal to distal direction, the first region 350 may include a material 362 having a greater hardness / durometer than a material 364 in the adjacent / second region 352.

[0096]

[0144] In further variations, third region 354 can include material 366 having a durometer / hardness less than the hardness / durometer of material 364. Note that material sections (e.g., 358) adjacent material section 360 can include any number of materials as discussed herein. However, in some variations of the devices described herein, material section 360 comprises a hardness / durometer that exceeds the hardness / durometer of each adjacent material section 358 in the respective region. For example, in first region 350, material section 360 can include material 362 having a durometer / hardness that exceeds the material of each adjacent material section 358 in that same region (i.e., region 350).

[0097]

[0145] Similarly, in a further variation, this structure may be repeated in regions 352 and 354, where material 364 has a greater durometer than the material in the adjacent material section within that region, and material 366 has a greater durometer than the material in the adjacent material section within that region. In such an example, material section 360 can effectively function as a continuous torque coil within tubular member 130 (across at least any two sections), but can have a varying or gradually decreasing hardness / durometer as required by the application. In situations requiring the catheter to reach a distal region, the catheter can be made through tubular member 103 to increase flexibility toward the distal region while still employing a continuous torque coil that also decreases in flexibility.

[0098]

[0146] In yet a further variation, the structure shown in Figures 16A and 16B can include a configuration in which material sections 360 have a durometer / hardness that is lower than adjacent material sections 358 and / or that decreases in each region (350, 352, 354).

[0099]

[0147] 16C and 16D show another example of a tube 103 structure for use with the devices described herein. FIG. 16C shows a cross-sectional view of multiple strands 358, 362, 364, 366 joined to form a tubular section as shown in FIG. 16D. However, the area forming region 350 includes two sections of material 362 having the same durometer / hardness. This structure is shown in FIG. 16D, where tubular section 103 includes multiple material sections extending in a continuous spiral across tube section 103, with one material section 360 extending from region 350 through regions 352 and 354 changing material in each region, while region 350 includes two helically wound material 362 having the same durometer / hardness. In such a configuration, first region 350, material section 360 includes material 362 having a durometer / hardness that is different from the material of each adjacent material section 358 in that same region (i.e., region 350) but equal to another material section material 362. As noted above, the durometer / hardness of material 362 may be greater than or less than the adjacent sections.

[0100]

[0148] 16E and 16F show another possible example of a tube 103 configuration for use with the devices described herein. FIG. 16E shows a cross-sectional view of multiple strands 358, 362, 364, 366 joined to form a tubular section as shown in FIGS. 16A and 16B above, along with an additional material section 370 including materials 372, 374, and 376 in respective sections 350, 352, and 354. FIG. 16E shows a tubular section 103 formed from the configuration of FIG. 16E, where multiple material sections extend in a continuous spiral across the tubular section 103, with one material section 360 acting as a reinforcing material section, and the hardness / durometer of the materials 362, 364, 366 in that material section extending beyond region 350 through regions 352 and 354, varying the material in each region. 16E and 16F also show material section 370 having materials 372, 374, and 376 that are less than or equal to the hardness / durometer of the adjacent materials in material section 358. In a further variation, the hardness / durometer of materials 372, 374, and 376 can decrease in sections 350, 352, and 354, respectively. While material section 360 is shown directly helically adjacent to material section 370, further variations include spacing between the highest and lowest durometer materials, as opposed to being directly adjacent.

[0101]

[0149] 17A and 17B illustrate another example of customizing material sections to adjust the structural properties of the tubular member 103 and / or device, as described above. FIG. 17A illustrates a series of material sections 358 adjacent to a transition material section 380. As described above, the material section 358 can include any variety of materials desired to adjust the properties of the device. FIGS. 17A and 17B illustrate the transition material section 380 in the first region 350, including a first width 385 corresponding to the width of the transition region 380. The transition material section in the second region includes a second width 386 corresponding to the width of the transition region 380. As discussed herein, not only can the width be varied, but the height / depth of the material may also be varied. Furthermore, while FIG. 17B illustrates that the material section 380 initially includes a first material 382 and then transitions to a second material 384, in a further variation, the material section can include a single material that changes from the first width 385 to the second width 386. A further variation of this design may include a transition region that changes from a smaller to a larger dimension distally along the tubing.

[0102]

[0150] As mentioned above, FIG. 17A shows the state of the tubular portion before the material sections are joined in a helical configuration. As shown in FIG. 17B , once joined to the tubular structure 103, the material on either side of the narrower region of the transition material section 380 fills in to form a completely sealed joint between the adjacent material sections. As shown, the first region 350 can include a section of consistent transition material section width, and at the beginning of the second region 352, the transition material section 380 tapers off in a tapered region 387. A variation of this configuration includes a length of the tapered region 387 that is less than the width of the larger transition material section. In another variation of this configuration, the transition material section 380 can include a first material 382 in the first region 350 and a second material 384 in the second region 352. As noted above, transition material section 380 can include a material that allows section 380 to function as a torque coil, for example, if the transition section has a greater hardness / durometer than the adjacent material sections. Alternatively, the transition material section can have a lesser hardness / durometer than the adjacent material sections. In yet a further variation, a single tubular structure 103 can include multiple tapered regions for various material sections. Alternatively, or in combination, section 380, or any material with a greater hardness / durometer than the adjacent materials, can function as a type of "push coil," where this increased hardness / durometer material is formed into a helical shape in the catheter tubing and strengthens the tubing when pushed from a proximal location.

[0103]

[0151] 18B through 18F show another design variation for use in composite tubing sections. In conventional catheter designs, the use of extruded material 98, as shown in FIG. 18A, aligns polymer chains 396 along the axial length of the tube, which coincides with the axis 126 of the material 98. Therefore, bending a conventional, rigid tube results in bending of the polymer chains 396 in a normal direction against the trunk. Excessive bending can lead to fracture of the polymer 98. One benefit of fabricating the tube 103 from one or more polymers with a high modulus / stiffness is that the polymer chains 396 are oriented in a helical direction around the tube structure 103. For example, in the variation shown in FIGS. 18C through 18E, the polymer chains 396 extend in a helical pattern, which allows for improved flexing of the polymer and reduces the risk of material fracture due to bending of the tube structure 103. Figure 18B shows one example of multiple material sections in which material 390 is bonded to materials 392 and 394. These materials are sealingly bonded to form the tube structure 103 of Figure 18C, where the material section extends helically along the axial length of the tube structure 103 to form a wall that may optionally be incorporated into one of the devices described herein. In this variation, the material section in a first region (designated in the direction shown by arrow 398) is formed from a first polymer 390 such that the polymer chains extend helically following the helix of the material section in that region when the material section is rolled to form the tube 103, as shown in Figure 18D. In the first region, multiple material sections have a structure as shown in FIG. 18C comprising a first polymer 390 having a high modulus / stiffness adjacent to a second region where each of the polymers 392, 394 has a lower modulus / stiffness than material 390, allowing for a device design that includes a proximal region that is stiff but more resistant to fracture.FIG. 18E shows another variation of structure 103 in which first region 398 extends in a spiral fashion and is formed from one or more sections of material including a single polymer 390 along with a similar polymer 399 having the same structural properties as first polymer 390 but that is distinguishable / distinguishable from first polymer 390 (e.g., via color, surface texture, marker, radiograph, etc.). In such a structure, although the material properties of sections 398 are the same, tubular structure 103 may be uniquely identifiable by a distinguishable (visually and / or mechanically) pattern resulting from materials 390 and 399, allowing a caregiver to distinguish one tubing from another. For example, when used in a catheter positioned within a patient via the femoral or radial artery, a caregiver can distinguish a catheter having the features shown in FIG. 18E from other catheters as region 398 extends from the patient's body. Section 398 comprises at least two distinct sections of material 390, 399 having similar or the same structural properties, although it is understood that the remaining regions of the catheter may have additional sections of material as discussed herein (e.g., as shown in FIG. 18C), or alternatively, the remaining portions of the catheter may have a conventional extruded construction.

[0104]

[0152] 19A through 19D show another variation of a composite tube 103 for use in the devices described herein. In this variation, FIG. 19A shows a first tube of material 388 that can be conventionally extruded as a common single-lumen tubing. As shown, the tube 388 is spaced apart from a second tube of material 389 that is conventionally formed. Each tube of material 388, 389 can have distinct properties, as described above. Additionally, the tubes 388, 389 can be cut (e.g., via laser cutting) to create helical or other spiral patterns 394, 395, respectively. FIG. 19B shows the tubes 388 and 389 of FIG. 19A sealingly joined so that the different properties of each material section provide a transition section 397 similar to that described above. FIG. 19C shows a variation in which the first tube of material 388 and the second tube of material 389 are continuous and then cut to form helical patterns 394, 395, which are finally joined to form a transition section 397 as shown in FIG. 19D.

[0105]

[0153] The ability to combine softer and relatively stiffer materials, as shown in the figures above, allows for improved customization of device properties. Furthermore, the ability to continuously transition the helical material section to different materials and controllably taper in width allows for significant improvements in catheter design. The ability to vary materials as described herein provides manufacturers with the ability to change many more catheter design elements and fine-tune catheter design to a degree not previously available with conventional catheter designs.

[0106]

[0154] 20A shows another embodiment of an improved catheter 100 incorporating a composite layer at the catheter tip 17. As shown, the catheter 100 can include any number of material sections 238, 240, 244, and 242 to form the directional tip 17 located at the distal end of the catheter body 103. Variations of the catheter 10 having a directional tip 17 can include a catheter body having a composite structure as described above. Alternatively, the catheter body can comprise a conventional catheter structure along with the directional composite tip 17.

[0107]

[0155] 20B shows the directional tip 17 at the distal end of the catheter body 103. As shown, material sections 238, 240, 244, and 242 can comprise polymers of various durometers, thicknesses, widths, etc. Additionally, material sections 238, 240, 244, and 242 can be helically wound around the tip 17 or can extend parallel to the axis 105 of the catheter 100 as shown.

[0108]

[0156] 20C and 20D show variations of the directional tip 17 located at the distal end of the catheter body 103. In this variation, material sections 238, 240, and 242 extend in a helical or spiral pattern to form the tip 17. Furthermore, as shown in FIG. 20D, the material sections can be designed to preferentially bend toward a particular direction when encountering resistance, such as a blood vessel wall. In the example shown in FIG. 20C, the directional tip 17 bends in the "y" direction. The directional tip 17 uses a combination of materials and material dimensions to control the preferential bending. Note that variations of the directional tip 17 can bend in multiple directions but are biased to bend toward a preferential direction. Furthermore, the preferential bending direction of the directional tip 17 can occur in multiple directions in three-dimensional space, not just along a single axis as shown.

[0109]

[0157] FIGS. 21A and 21B show an example of a catheter 100 having a directional tip 17. FIG. 21A shows the catheter 100 advanced through a blood vessel 2 into a branch vessel 5. As 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 in FIG. 21B. Note that FIG. 3B shows the tip member 17 deflected upward. Many conventional catheters rely on flexible distal tips to minimize the risk of trauma to the vessel, detaching plaque from the vessel wall, perforating the vessel, or introducing embolism into the bloodstream. When the square / flat tip of a conventional catheter engages the back wall of a branch vessel, the tip can often get stuck because it is not designed to deflect in the preferred direction. Having a directional tip 17 that bends in the preferred direction reduces the chance of the directional tip 17 getting stuck on the branch vessel wall.

[0110]

[0158] Figures 22A through 22D show various configurations of material sections 238, 240, 242 that form the directional tip 17 at the end of the catheter body 103. Figure 22A shows multiple material sections 238, 240, 242 that are spirally wound. Figures 22B and 22C show two material sections 238 and 240 with different widths, and Figure 22C shows a directional tip 17 with a conventional soft tip 15 at its end. Figure 22D shows material sections 238 and 240 that extend parallel to the axis of the tip 17. Like conventional soft tips, the directional tip 17 will typically comprise a flexible polymer with various reinforcement or other designs to allow preferential bending.

[0111]

[0159] 23A through 23F illustrate another variation for fabricating a composite tube. As shown, in FIG. 23A, a tube 400 can be formed (e.g., by extrusion, 3D printing, or any other fabrication process) from a base material 400. The tube 400 can be modified or formed to have a spiral groove (extending through the wall) or a slot (i.e., a notch that does not extend entirely through the wall). Then, as shown in FIG. 23B, a material such as a polymer or other material is bonded to the tube material 402 within the groove 404 to form a material section 410 that extends within the tube 400. FIG. 23C illustrates a second material positioned within the groove to form a second material section 412 that is bonded to the end of the first material section 410. Thus, FIG. 23C illustrates a tube structure 400 having three different materials 402, 410, and 412.

[0112]

[0160] Figure 23D shows a variation similar to that described above, but in which material sections 410 and 412 are adjacent to a different material section 414. Figure 23E shows two joined material sections 410 and 412, along with a spaced apart material section 414. Figure 23F shows another variation in which the tube structure 400 can be formed from multiple tubes having different materials 402, 406 with different structural or distinguishable properties. In such a case, a tube containing material 402 can be joined to a tube containing material 406 at a join point 408, and the composite tube 400 can be modified as described above in Figure 23A.

[0113]

[0161] FIG. 24 shows another variation of a composite tube 420 formed with non-overlapping material sections 432, 434, 436, and 438, such that the material or polymer of the tube 430 separates the material sections. As shown, the material sections can be axially spaced apart (e.g., 434 is axially spaced apart from 432 and 436). Additionally, the ends of the material sections can overlap (e.g., 434, 432, and 436), or the ends may be spaced apart (e.g., 438). The structure 420 shown in FIG. 24 may be fabricated entirely through the use of material sections in which material 430 is wrapped with the remaining material sections. Alternatively, the composite tube 420 may comprise a polymeric tube (formed from an extrusion) or other tube that includes material 430 and is mechanically modified to have slots or grooves to allow for the insertion of material sections 432, 434, 436, and 438.

[0114]

[0162] FIG. 25 shows another variation of composite tubing 450, which can be formed using any process described herein or used in tubing manufacturing. FIG. 25 shows tubing 450 having a first region comprising a single material 470, where first region 452 is adjacent to second region 454, where material section 472 comprising the second material begins in a spiral pattern. In second region 452, the first material forms first material section 470 of decreasing width (as measured axially), while second material section 472 increases in width until third region 456, which is formed entirely from second material 472. The composite tubing continues to fourth region 458, where third material section 472 results in the formation of material section 472, which decreases in width as third material section 474 increases in width. As discussed herein, each material 470, 472, 474 has different properties (e.g., different structural and / or visually distinguishable properties) allowing the overall properties of composite tube 450 to be customized. FIG. 25 also shows that third material 474 persists in fifth region 460, which is formed entirely from third material 474. Note that the widths, spacing, and helical winding of material sections shown in FIG. 25 are for illustrative purposes only and can be combined with any of the variations discussed herein. Additionally, regions 452, 456, and / or 460 in composite tube 450 can be formed from extruded tubing that is mechanically modified in second region 454 and fourth region 458. Alternatively, regions 452, 456, and / or 460 can be helically wound.

[0115]

[0163] It should be noted that the polymer strands disclosed herein can extend in a helical manner around the inner braid / coil or support structure. In a further variation, the polymer strands can be longitudinally aligned with the catheter axis and wrapped around the support structure to form the catheter section. Any number of manufacturing practices can be used to create the catheter structures of the present disclosure. For example, 1) the strands can be wrapped directly onto the liner / braid structure and then fused together to form the catheter structure; 2) the strands can be wrapped and fused onto a tube and then transferred to the remaining components to create the catheter structure; and / or 3) the strands can be created as a flat structure (fused together, extruded, cast, or otherwise formed), and then the ribbon assembly can be wrapped and fused onto the liner / braid. The devices described herein can also be created using a 3-D printing process.

[0116]

[0164] It is understood that any manufacturing process is within the scope of this disclosure and does not limit any claimed structure to any claims relating to composite polymer tubing or catheter structures.

[0117]

[0165] With respect to other details of the invention, materials and manufacturing techniques may be employed within the level of one skilled in the relevant art. The same may apply to method-based aspects of the invention in terms of further acts commonly or logically employed. Furthermore, while the invention has been described with reference to several examples optionally incorporating various features, the invention is not limited to what has been described or shown as intended for each variation of the invention.

[0118]

[0166] Various modifications may be made to the described invention, and equivalents (whether described herein or not included for a degree of brevity) may be substituted without departing from the true spirit and scope of the invention. Also, any optional features of the inventive alternatives may be described and claimed independently or in combination with any one or more of the features described herein. Thus, the present invention contemplates combinations of various aspects of the embodiments, or combinations of the embodiments themselves, where possible. Reference to a singular item includes the possibility that plurals of the same items are present. More specifically, as used in this specification and the appended claims, the singular forms "a," "and," "said," and "the" include plural references unless the context clearly dictates otherwise.

[0119]

[0167] It is important to note that, where possible, aspects of the various described embodiments or embodiments themselves may be combined, and such combinations are intended to be within the scope of the present disclosure.

Claims

1. A tubular body having a longitudinally extending axis, the tubular body having a first region and a second region, the first region and the second region both extending along the axis, and both having walls formed from a plurality of sections of material extending helically along the axis. Equipped with the plurality of material sections includes a reinforced material section extending in a continuous spiral across the first region and the second region; The medical tubing, wherein the reinforcement material section comprises a first hardness in the first region and a second hardness in the second region, the first hardness being different from the second hardness.

2. 10. The medical tubing of claim 1, wherein in the first region, the reinforcement material section comprises a first structural dimension and in the second region, the reinforcement material section comprises a second structural dimension that is different from the first structural dimension.

3. 2. The medical tubing of claim 1, wherein in the first region, the plurality of material sections includes the reinforced material section and a first plurality of adjacent material sections, and the first hardness exceeds a respective hardness of each of the first plurality of adjacent material sections.

4. 4. The medical tubing of claim 3, wherein in the second region, the plurality of material sections includes the reinforced material section and a second plurality of adjacent material sections, and the second hardness exceeds a respective hardness of each of the second plurality of adjacent material sections.

5. The medical tubing of claim 1 , further comprising an inner liner residing inside the tubular body.

6. The medical tubing of claim 5 , further comprising a reinforcing structure external to the inner liner.

7. The medical tubing of claim 6 , wherein the reinforcing structure is embedded in the wall.

8. The medical tubing of claim 1 , wherein the plurality of material sections extend in a right-handed direction in the first region.

9. The medical tubing of claim 1 , wherein the plurality of material sections extend in a left-handed direction in the first region.

10. The medical tubing of claim 1 , wherein at least one of the plurality of material sections comprises a non-fusible material.

11. The medical tubing of claim 1 , further comprising a flexible distal tip section.

12. The medical tubing of claim 11 , wherein the flexible distal tip section comprises a single material.

13. 10. The medical tubing of claim 1, wherein the tubular body comprises a proximal region located proximal to both the first region and the second region, the proximal region comprising a single material.

14. A tubular body having a longitudinally extending axis, the tubular body having a first region and a second region, the first region and the second region both extending along the axis, the first region and the second region both having walls formed from a plurality of material sections extending continuously and helically along the axis, the plurality of material sections including a first material section and a reinforcing material section. Equipped with In the first region, the first material section has a first hardness that is less than or equal to a respective hardness of each adjacent material section, and the reinforced material section has a first reinforced hardness that is greater than both the first hardness and the respective hardness of each adjacent material section in the first region; In the second region, the first material section has a second hardness different from the first hardness and less than the respective hardness of each adjacent material section in the second region.

15. 15. The medical tubing of claim 14, wherein in the second region, the reinforcement material section comprises a second reinforcement hardness that is less than the first reinforcement hardness.

16. 15. The medical tubing of claim 14, further comprising an inner liner residing inside the tubular body.

17. 17. The medical tubing of claim 16, further comprising a reinforcing structure on the exterior of the inner liner.

18. 18. The medical tubing of claim 17, wherein the reinforcing structure is embedded in the wall.

19. 15. The medical tubing of claim 14, wherein the plurality of material sections extend in a right-handed direction in the first region.

20. 15. The medical tubing of claim 14, wherein the plurality of material sections extend in a left-handed direction in the first region.

21. The medical tubing of claim 10 , wherein at least one of the plurality of material sections comprises a non-fusible material.

22. 15. The medical tubing of claim 14, further comprising a flexible distal tip section.

23. 23. The medical tubing of claim 22, wherein the flexible distal tip section comprises a single material.

24. 11. The medical tubing of claim 10, wherein the tubular body comprises a proximal region located proximal to both the first region and the second region, the proximal region comprising a single material.

25. A tubular body having an axis extending longitudinally, the tubular body having a wall formed from a plurality of sections of material extending helically along the axis, each of the plurality of sections of material including a width. Equipped with 1. The medical tubing of claim 1, wherein the plurality of material sections includes a transition material section that extends in a continuous spiral across both a first region and a second region, wherein a first width of the transition material section is consistent in the first region, and the transition material section narrows to a second width in a tapered region, and the second width is consistent in the second region.

26. 26. The medical tubing of claim 25, wherein in the first region, the transition material section comprises a first material and in the second region, the transition material section comprises a second material.

27. 26. The medical tubing of claim 25, wherein the length of the tapered region is less than the first width.

28. 26. The medical tubing of claim 25, further comprising an inner liner residing inside the tubular body.

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

30. 30. The medical tubing of claim 29, wherein the reinforcing structure is embedded in the wall.

31. 26. The medical tubing of claim 25, wherein the plurality of material sections extend in a right-handed direction in the first region.

32. 26. The medical tubing of claim 25, wherein the plurality of material sections extend in a left-handed direction in the first region.

33. 26. The medical tubing of claim 25, wherein at least one of the plurality of material sections comprises a non-fusible material.

34. 26. The medical tubing of claim 25, further comprising a flexible distal tip section.

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

36. 26. The medical tubing of claim 25, wherein the tubular body comprises a proximal region located proximal to both the first region and the second region, the proximal region comprising a single material.

37. a tubular body having a first region adjacent to a second region, each of the first region and the second region extending along an axial length of the tubular body; a plurality of sections of material extending helically along the axial length and at least partially forming walls of the first and second regions of the tubular body; Equipped with In the first region, the plurality of material sections extend helically around the axial length, and the plurality of material sections comprise one or more material sections including a first polymer such that polymer chains of the first polymer extend helically in the first region, the first polymer having a first hardness; The medical tubing, wherein in the second region, at least one of the plurality of material sections comprises one or more polymers having a second hardness less than the first hardness.

38. 38. The medical tubing of claim 37, further comprising an inner liner residing inside the tubular body.

39. 40. The medical tubing of claim 38, further comprising a reinforcing structure on the exterior of the inner liner.

40. 40. The medical tubing of claim 39, wherein the reinforcing structure is embedded in the wall.

41. 38. The medical tubing of claim 37, wherein the plurality of material sections extend in a right-handed direction in the first region.

42. 38. The medical tubing of claim 37, wherein the plurality of material sections extend in a left-handed direction in the first region.

43. 38. The medical tubing of claim 37, wherein at least one of the plurality of material sections comprises a non-fusible material.

44. 38. The medical tubing of claim 37, further comprising a flexible distal tip section.

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

46. 38. The medical tubing of claim 37, wherein the tubular body comprises a proximal region located proximal to both the first region and the second region, the proximal region comprising a single material.

47. 38. The medical tubing of claim 37, wherein, at least in the first region, the plurality of material sections includes at least one identifiable material section that is visually distinct from the remainder of the plurality of material sections, the at least one identifiable material section having the first hardness.

48. a tubular body having a first region, the first region extending at least along an axial length of the tubular body; a tip member at a distal end of the first region, the tip member being formed from a plurality of material sections joined together to form a wall of the tip member, a first material section of the plurality of material sections having a first material property that causes the tip member to bend in a preferential direction when the tip member encounters resistance during axial advancement of the tubular body; A catheter comprising:

49. 49. The catheter of claim 48, wherein the plurality of sections of material extend helically around the tip member.

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

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

52. 49. The catheter of claim 48, wherein the plurality of sections of material configure the tip member to be an atraumatic tip member.

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

54. 49. The catheter of claim 48, wherein at least one of the plurality of sections of material comprises a width that varies along the axial length of the tip member.

55. 49. The catheter of claim 48, wherein the first material property comprises a first stiffness that exceeds a stiffness of the plurality of material sections.

56. 1. Medical tubing, comprising: a tubular body having an axial length and including 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 section and a second material section extending in the second region and sharing structural properties, the first material section and the second material section being visually distinguishable from one another by an operator from outside the medical tubing; A medical tubing comprising:

57. 57. The medical tubing of claim 56, wherein the first section of material and the second section of material extend helically along the axial length of the second region.

58. 57. The medical tubing of claim 56, further comprising a plurality of sections of material within the first region.

59. 57. The medical tubing of claim 56, wherein the first section of material and the second section of material are visually distinguishable from one another.

60. 57. The medical tubing of claim 56, wherein the first section of material and the second section of material are mechanically distinguishable from one another.

61. a tubular body having an axial length, the tubular body including at least one base material having base material structural properties; a first material section extending helically within the wall of the tubular body along a first region of the axial length, the first material section having a first structural property, the first structural property and the base material structural property being different; a second material section extending helically within the wall of the tubular body along a second region of the axial length, the second material section having second structural properties, the second structural properties being different from the first structural properties; and Equipped with At the end of the first region, the first section of material terminates and is replaced by the second section of material.

62. 62. The catheter tubing of claim 61, wherein the tubular body comprises a second region having a second base material, the second base material being bonded to an end of the base material.

63. 63. The catheter tubing of claim 62, wherein at least the second section of material extends helically along the second region.

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

65. 63. The catheter tubing of claim 62, wherein the base material structural properties and the second base material structural properties are the same, and the base material is visually distinguishable from the second base material.

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