Braided Catheter Assemblies

Abstract

The present invention relates to a braided catheter assembly, and more particularly to a catheter assembly, which comprises a catheter body extending from a catheter proximal portion to a catheter distal portion. The catheter body comprises an inner liner and an outer sleeve. The braid assembly is in the catheter body and between the inner liner and the outer sleeve. The braid assembly comprises a first wire array, which comprises one or more first wires extending spirally around the catheter body in a first direction. The braid assembly also comprises a second wire array, which comprises one or more second wires extending spirally around the catheter body in a second direction opposite to the first direction.

Description

[0001] This application is a divisional application of the Chinese patent application with the application date of May 18, 2017, application number 201780041148.1, and invention name “Braided Catheter Assembly”.

[0002] Priority claim

[0003] This patent application claims the benefit of priority to U.S. Provisional Patent Application Serial No. 62 / 338,491, filed May 18, 2016, and entitled “BRIDGED CATHETER ASSEMBLY,” the entire contents of which are hereby incorporated by reference herein.

[0004] This patent application is a continuation of and claims the benefit of priority to U.S. patent application 15 / 598,114, filed May 17, 2017, entitled “BRIDGED CATHETER ASSEMBLY,” the entire contents of which are hereby incorporated by reference. Technical Field

[0005] This document relates generally, but not in a limiting manner, to catheters containing instruments for use in diagnostic or therapeutic procedures. Background Art

[0006] Guide sheaths, guide catheters, etc. are used for diagnostic and therapeutic procedures. Sheaths and guide catheters are used to guide other instruments including catheters into the vascular system and to guide through the vascular system to one or more locations of interest. The catheter is delivered through one or more of the sheath or guide catheter, and the catheter is optionally navigated through the vascular system beyond the distal end of the sheath or guide catheter together with a probe, a guide wire, etc. Sheaths and guide catheters are navigated through the vascular system in a similar manner (e.g., together with a guide wire) in some instances.

[0007] Various features of delivery through the vasculature, including blood vessels, thrombi, plaques, etc., are performed by manipulating one or more of these catheters, including one of an introducer sheath, a guide catheter, a catheter, etc. Manipulation includes one or more of the following: axially pushing the catheter, such as axially pushing the catheter from the proximal catheter end toward the distal catheter end; lateral bending of the catheter (e.g., perpendicular to the longitudinal axis of the catheter) to navigate the bend in the vasculature or other passageway; and rotating the catheter, such as rotating the proximal catheter end to correspondingly rotate the distal catheter end. Summary of the invention

[0008] Among other things, the inventor has recognized that the problem to be solved may include minimizing the kinking of the catheter while enhancing the handling characteristics of the catheter, including one or more of pushability, torsion and flexibility. Because the traditional catheter is made more flexible (e.g., can bend and navigate the turning part in the channel or blood vessel), the catheter usually becomes easier to kink. In addition, in some instances, the traditional catheter includes a braid (e.g., polymer, nickel-titanium alloy, stainless steel, etc.) to enhance torsion. Adding the braid in these instances usually reduces the kink resistance of the catheter. In some instances, the catheter is made more kink-resistant by including one or more wires (e.g., one or more of nickel-titanium alloy, stainless steel wires, etc.) in the catheter. The one or more wires increase the kink resistance of the catheter, but the braid is not provided with available torsion. Further, the wire and braid are combined to increase the size of the catheter and accordingly consume the precious space (e.g., luminal space) that can be used to deliver fluids, catheters, instruments, etc. through the catheter or arrange conductors, instruments or other features in the catheter.

[0009] The present subject matter can help provide solutions to these problems, such as by changing one or more characteristics in the structural features of the catheter, the changes include: pairing of braided wires in various ratios, specifications and pitches (the inverse of the number of picks per inch), including one or more winding wires in the braid, etc. In one example, the braid includes a first array (X) of wires braided in a left-hand direction and a second array (Y) of wires braided in a right-hand direction. The number of wires is changed (for example, X:Y is 15:1, 14:2, 12:4, 10:6, 8:8, 6:10, 12:4, 14:2, 15:1, etc. in an example based on the number of 16 wires) to provide the catheter with a desired degree of twist. In other examples, the size of the wires used for the first array of wires and the second array of wires is changed. For example, the size of the wires in the first wire array (X) (one or more of the width and height) is smaller than the size of the wires in the second wire array (Y). In one example, the size of the wires used for the wire array with a smaller number of wires is relatively larger than the size of the wires used for the wire array with a larger number of wires. For example, increasing the size for a smaller number of filaments may provide increased torsional properties in one direction (eg, a left-handed rotational direction), while a larger number of filaments may provide increased torsional properties in the opposite direction (eg, a right-handed rotational direction).

[0010] In addition, the proposed arrangement increases the kink resistance of the catheter. As discussed above, conventional braided catheters (in some instances) are relatively easy to kink relative to catheters including wire wraps. The catheters comprising braided wires described herein are also kink-resistant. In one example, the braid includes a smaller number of wires in the second wire array, wherein the wires of the array have a relatively larger size (e.g., width) relative to the size of the second wire array. In some instances, the wires of the second wire array at least include a width that is one order of magnitude larger than the wires of the first wire array. Therefore, the second wire array provides a braided stent that extends above and below the first wire array including a larger number of wires. The braided stent is anchored in the catheter, for example, by a reflowed outer sleeve. The braided stent (which is anchored in place in the catheter) structurally supports the first wire array and the braided stent also enhances the retention of the first wire array in the winding configuration of the braided stent even when the catheter is deflected, for example, in a tortuous vascular system. In other words, the braided stent (e.g., the second wire array) anchors the first wire array in place in the catheter and provides structural support for the braid to resist kinking. That is, the braided stent provides a support framework (cage, framework, etc.) within the catheter body that is interwoven with the first array of wires to minimize (eg, eliminate or reduce) kinks that would otherwise exist with the first array of wires.

[0011] Optionally, the second wire array includes one or more wires, the size of the one or more wires being close to or equal to the size of the wire wrap. That is, the braid includes one or more braided wire wraps that are part of at least one of the wire arrays. The braided wire wraps are another example of a braided stent that provides support for at least one of the wire arrays to enhance kink resistance, while the relative wire arrays enhance torsion. In addition, combining wires of similar size to the wire wraps (e.g., at least one of the wire arrays includes the wire wraps) minimizes the profile of the braid relative to the following assembly: the assembly includes a braid with wire wraps that are individually wound around the braid or positioned below the braid.

[0012] Because the second wire array anchors the first wire array and the second wire array provides structural support in one example due to the larger size of the wires of the second wire array (e.g., forming a braided stent), the pitch of the braid (or the inverse of the number of picks per inch or PPI) is easily adjusted to a level that otherwise makes the catheter more prone to kinking. For example, by increasing the pitch of the first wire array (e.g., increasing to 45 degrees or greater), the torsion of the catheter increases. On the contrary, the first wire array with a higher pitch (e.g., a reduced PPI) has poor kink resistance. The second wire array braided together with the first wire array structurally supports the first wire array and enhances the kink resistance that is otherwise minimized by the first wire array. In effect, for the braid, the first wire array enhances kink resistance, while the second wire array helps to enhance torsion.

[0013] In another example, one or more supplementary wires are included in the braid. As previously mentioned, in some examples, the inclusion of wires undesirably consumes space in the catheter, or requires the catheter to have a larger outer diameter to accommodate the supplementary components. The present subject matter can also help provide a solution to this problem by utilizing a guide recess provided by the braid, such as a spiral track formed by one of the first wire array or the second wire array along the braid. In one example, the second wire array comprises a smaller number of wires relative to the first wire array. Optionally, the second wire array comprises a larger size to provide additional structural support to the braid, while simultaneously improving torsion along the "weak" direction of the braid (e.g., the winding direction for a limited number of wires in the first wire array). The spiral track of the second wire array provides the following guide recess: the guide recess extends along the second wire array and is configured to receive the wire (at least a portion of the wire) therein. Positioning the wire in the guide recess minimizes the overall profile of the wire and provides additional kink resistance to the catheter. In one example, a catheter including a second wire array provides structural support for the first wire array, and additional wire wraps cooperate with the second wire array to sandwich the first wire array between the additional wire wraps and the second wire array and further enhance the catheter's kink resistance.

[0014] Optionally, the first wire wrap is disposed on the proximal face of the first wire array (e.g., disposed within a first guide recess) and the second wire wrap is disposed on the distal face of the first wire array (e.g., disposed within a second guide recess). Reflow soldering the sleeve over the braid and wire wrap assembly anchors the at least one wire wrap in place within the guide recess. In addition, because the guide recess minimizes the profile of the wire wrap, the sleeve easily covers the wire wrap and combines the wire wrap with the catheter without requiring a relatively thicker sleeve.

[0015] This summary is intended to provide an overview of some of the subject matter of this patent application. This is not intended to provide an exclusive or exhaustive description of the disclosure. The detailed description is included to provide additional information about this patent application. BRIEF DESCRIPTION OF THE DRAWINGS

[0016] In the accompanying drawings, which are not necessarily drawn to scale, like numbers may describe similar components in different views. Like numbers with different letter suffixes may represent different examples of similar components. The accompanying drawings generally illustrate various embodiments discussed in this document by way of example and not by way of limitation.

[0017] Figure 1 is a front view of a catheter according to one embodiment.

[0018] Figure 2 is a rear view of a catheter according to one embodiment.

[0019] Figure 3 is a cross-sectional view of a catheter according to one embodiment.

[0020] Figure 4 is a cross-sectional view of a portion of a catheter according to one embodiment.

[0021] Figure 5 is a cross-sectional view of a portion of a catheter according to one embodiment.

[0022] Figure 6 is a cross-sectional view of a portion of a catheter according to one embodiment.

[0023] Figure 7 is a cross-sectional view of a portion of a catheter according to one embodiment.

[0024] Figure 8 is a cross-sectional view of a portion of a catheter according to one embodiment.

[0025] Fig. 9 is a cross-sectional view of a portion of a catheter according to one embodiment.

[0026] Fig.10 is a front view of a catheter according to one embodiment.

[0027] Fig.11 are composite cross-sectional views of an example catheter taken along a longitudinal axis (right view) and an orthogonal axis (left view).

[0028] Fig.12 is a composite cross-sectional view of another example catheter having a partial cutaway view along a longitudinal axis (right view) and a cross-section along an orthogonal axis (left view).

[0029] Although the present technology is susceptible to various modifications and alternative forms, the specific details of the present technology have been shown by way of examples and drawings, and will be described in detail. However, it should be understood that the present application is not limited to the specific embodiments described. On the contrary, the present application is intended to cover modifications, equivalents and substitutes that fall within the spirit and scope of the present technology. DETAILED DESCRIPTION

[0030] The embodiments of the present disclosure described herein are not intended to be exhaustive or to limit the present disclosure to the precise forms disclosed in the following detailed description. Instead, the embodiments are selected and described to enable those skilled in the art to appreciate and understand the principles and practices of the present disclosure.

[0031] All publications and patents mentioned herein are incorporated herein by reference. The publications and patents disclosed herein are provided only for their disclosures. Anything herein should not be construed as admitting that the inventor has no right to publish any publication and / or patent in advance, including any publication and / or patent cited herein.

[0032] As described herein, catheter example can solve the problems associated with current catheter technology by providing novel design, structure and material.Catheter described herein is optionally used in interventional therapy, and described interventional therapy comprises entering one or more blood vessels or passages (for example, artery, vein, blood vessel, body passage or body cavity etc.).In addition, catheter described herein helps to strengthen the deflection, torsion and other mechanical properties of catheter during navigation, and simultaneously kink is minimized.For example, in the case where such as obese patients adopt radial artery access or femoral artery approach to encounter obvious arterial tortuosity, catheter described herein is configured to be used for navigation through such blood vessel.Catheter described herein includes but is not limited to guide sheath, guide catheter, delivery catheter or other conventional tubular devices (for example, comprising instrument, fluid delivery channel, balloon etc.) used in diagnosis or treatment process.

[0033] In various embodiments, conduit comprises composite structure pipe, and this composite structure pipe utilizes the metal inner layer (braid assembly) of winding to manufacture and this composite structure pipe is respectively inside and outside---for example, in liner and outer sleeve---covered with polymer layer.The metal inner layer is spirally wound with multiple silk (6 to 30 silks) structure of braided structure member.In some embodiments, silk is forged, so that the cross section of one or more silks in described silk is partially flat or oblong (ovular) (for example, including rectangle), to realize close silk matrix.In other examples, braid assembly is made with one or more non-forged circular, square or rectangular silks (optionally combined with other silks with forged configuration).As described herein, braid assembly comprises silk array, for example, spirally wound and interwoven first silk array and second silk array.

[0034] In various embodiments, the wall thickness of the braid assembly ranges from about 0.0005 inches thick to 0.020 inches thick. Such as compared with current guide catheters, the braid assembly improves the mechanical integrity of the catheter in terms of kinking, buckling, flexibility, radial strength, and maintaining the annularity of the catheter lumen cross section. This improvement is achieved in an example by changing the number of silk in each silk array (for example, changing the number of silk with a variety of ratios, the ratio includes but is not limited to 15: 1, 14: 2, 13: 3, 12: 4, 11: 5, 10: 6, 9: 7, 8: 8, 7: 9, 6: 10, 5: 11, 4: 12, 3: 13, 2: 14, 1: 15 when the total number of silk is 16 silks).

[0035] In another example, the improved mechanical properties are achieved by changing the size (e.g., cross-sectional dimensions) of one or more wires in one or more arrays. For example, in an array with a ratio of 14:2, the cross-section of the first wire (14 wires) includes a first wire size that is smaller than the corresponding size of the second wire (2 wires), such as one or more of diameter, thickness, or width. In other words, relative to the first wire, the second wire number is less and larger in at least one cross-sectional dimension. As described herein, the second wire structurally supports the narrower first wire in the manner of a braided stent, and therefore, the second wire plays the role of a framework, skeleton, cage, etc. that keeps the first wire in an expected configuration (e.g., will not be kinked or buckled during deflection). Optionally, the second wire includes one or more wires interwoven with the first wire, such as a wire wrap. The wire wrap is similar to the second wire described above, serving as a braided stent of the first wire. The first wire (and the second wire comprising the braided stent) provides improved torsion for the catheter, while the braided stent structurally supports the braid assembly and provides at least enhanced kink resistance. Inclusion of a braided stent incorporates the contours of the stent into the braid component and, therefore, avoids the need to couple additional support structures above or below the braid component and the attendant loss of space (or enlargement of the catheter) is avoided.

[0036] In another example, the catheter described herein includes a wire wrap, which is wound along the braid assembly, for example, in the guide recess provided by one of the wire arrays. The wire wrap enhances the mechanical properties of the catheter. Optionally, the wire wrap extends helically along one or more wires in the wire that includes, for example, a braided stent. The wire wrap and the braided stent cooperate to capture the first wire (described above) in the catheter and keep it in place. In addition, an outer sleeve (for example, a reflow soldering or shrink sleeve) is infiltrated into the braid assembly and the optional wire wrap so that each of the braided stent and the wire wrap (optionally) is fixed in place. The outer sleeve and the braided stent capture the first wire and keep the first wire in place, and minimize the kink of the catheter (for example, eliminate or reduce). In the case where the wire wrap is included along the braid assembly, the wire wrap and the braided stent are captured in the outer sleeve (for example, a reflow soldering outer sleeve) and the first wire is sandwiched between the wire wrap and the braided stent. Therefore, the kink, buckling, etc. of the first wire are resisted by combining one or more of the braided stent or the wire wrap with the outer sleeve.

[0037] In at least some instances, the catheter of the present disclosure also includes an outer sleeve such as an outer polymer layer and an inner liner such as an inner polymer layer. In one embodiment, the outer polymer layer and the inner polymer layer include one or more polymers, such as PTFE, Pebax or Polyurethane. The polymer layer is attached to the braid assembly by heat shrinking or reflowing the thermopolymer. For each layer, the wall thickness of the polymer layer is one thousandth of an inch to three thousandths of an inch.

[0038] In various embodiments, the catheter comprises a preformed bend, such as a curved distal end region. The catheter obtains a preformed bend configuration by, for example, heat setting a metal portion of the catheter that indicates a curved configuration position. The bend maintains its shape at body temperature and does not soften significantly over time (e.g., to change shape unexpectedly). The guide catheter optionally comprises a soft (low hardness) polymer distal tip, various distal curved shapes, a radiopaque distal marker band, a proximal Luer adapter, etc.

[0039] The catheters described herein have a range of sizes from 3F to 34F and a range of lengths from at least 15 cm or greater to 205 cm or less. As previously described, the features, elements, and functions described herein and their equivalents are used in a variety of catheters, including but not limited to guide sheaths, guide catheters, catheters containing one or more of an instrument or delivery lumen, etc. That is, each of the enhancements in torsion, pushability, flexibility, kink resistance, etc. is easily applied to a variety of catheter styles and types.

[0040] Referring now to the accompanying drawings, Figure 1 A front view of a guide catheter 100 is shown according to one embodiment. Figure 2 A rear view of guide catheter 100 is shown. Figure 3 Shows Figure 1 and Figure 2 A cross-sectional view of guide catheter 100 is shown in FIG. In one embodiment, guide catheter 100 can be configured for introducing an interventional catheter into the vasculature of a patient.

[0041] In one embodiment, the catheter 100 includes a catheter body 102 (e.g., a main tubular shaft with an optional lumen), which has a distal end portion (which includes a distal tip 104) and a proximal end portion (which includes a proximal end 106). The distal tip 104 is on the end of the tubular shaft 102 opposite to the proximal end 106. The distal tip 104 includes at least one layer of polymer. In another example, the distal tip 104 includes at least two layers of polymer. Optionally, the distal tip 104 includes an inner layer and an outer layer. In one example, the inner layer of the distal tip 104 includes PTFE. In another example, the outer layer of the distal tip 104 includes Pebax. In one embodiment, the distal tip 104 has a length of at least 0.05 inches. In another embodiment, the distal tip 104 has a length of at least 0.02 inches long. In yet another embodiment, the distal tip 104 is 0.2 inches long or shorter. In yet another embodiment, the distal tip 104 may be 0.5 inches long or less.

[0042] In various embodiments, the catheter body (e.g., a catheter body comprising a tubular shaft 102) comprises a primary internal structural layer, such as one or more of a braid assembly, discontinuous wire wrapping, or a combination thereof as described herein. The primary internal structural layer comprises a helically interwoven braid assembly, which extends between the proximal end portion and the distal end portion (e.g., along the entire length or partial length of the catheter body). In various embodiments, the braid assembly covers at least a portion of the catheter liner. An outer sleeve such as a shrink tube, a reflow soldering polymer, etc. surrounds the braid assembly and in at least some instances immerses the interstitial space of the braid assembly (e.g., between the relative helical wires of the wire, the wire wrapping, the braid, etc.).

[0043] As described herein, the catheter body including the main tubular shaft 102 includes an outer layer (e.g., a sheath, such as an outer sleeve). The outer layer optionally includes a polymer. The outer layer surrounds the braid component (e.g., a sheath, a coating, a covering, etc.). The outer layer is fixed (e.g., fixedly coupled) to the braid component and is optionally fixed to the liner by one or more of the following methods: shrinking the outer layer (shrink tube), or infiltrating the braid component, and optionally contacting the liner (by reflow soldering).

[0044] In various embodiments, the inner liner of the catheter (e.g., a catheter body including the main tubular shaft 102) comprises a polymer. The inner layer (e.g., an inner liner) extends along the inner surface of the braid component (e.g., a sheath, a coating, or a covering, etc.) and is coupled to it. The inner layer is coupled (e.g., fixedly coupled) to the main internal structural layer by one or more of the following: the braid component is compressed onto the liner (e.g., compressed onto the liner by an outer sleeve including a shrink tube), compressed onto the liner during the braiding of the braid component, and infiltrated into the braid component by a reflowable outer sleeve (including contact and coupling of a reflowed polymer to the liner).

[0045] The main tubular shaft 102 may optionally include a bend, such as at or near the distal end including the distal tip 104. Fig.10 ). The shape of the bend is configured for anatomical consistency. The shape is optionally formed in the main tubular shaft 102, such as in a braid component or another metal portion and heat treated into the main tubular shaft 102. In one example, the braid component terminates at the distal end before the bend of the distal end portion.

[0046] In various embodiments, the braid component is laminated between the inner layer (liner) and the outer layer (outer sleeve) such that the lamination does not fuse the outer sleeve and the liner together.

[0047] In one embodiment, the catheter is at least 60 cm long and no longer than 200 cm. In another embodiment, the main tubular shaft 102 is at least 10 cm long and no longer than 300 cm. In yet another embodiment, the main tubular shaft 102 is at least 30 cm long and no longer than 250 cm. In another embodiment, the main tubular shaft 102 is at least 50 cm long and no longer than 225 cm.

[0048] In one embodiment, the outer diameter of the main tube-shaped shaft 102 is at least 0.060 inches and at most 0.115 inches (e.g., the outer diameter of the outer sleeve when connected to the rest of the catheter body). In another embodiment, the outer diameter of the main tube-shaped shaft 102 is at least 0.060 inches. In another embodiment, the outer diameter of the main tube-shaped shaft 102 is at least 0.040 inches. In yet another embodiment, the outer diameter of the main tube-shaped shaft 102 is at least 0.050 inches. In other embodiments, the outer diameter of the main tube-shaped shaft 102 is at least 0.070 inches, at least 0.080 inches, etc. In yet another embodiment, the outer diameter of the main tube-shaped shaft 102 is at most 0.115 inches. In other examples, the outer diameter of the main tube-shaped shaft 102 includes, but is not limited to, at most 0.095 inches, at most 0.105 inches, at most 0.125 inches, at most 0.135 inches.

[0049] Figure 4 and Figure 5 A cross-sectional view of a portion of a catheter 100 is shown according to various embodiments. In the example shown, the catheter 100 includes an internal lumen 400. In other examples, the catheter does not have an open internal lumen. Figure 5 A cross section of a portion of the distal tip 104 is shown. Figure 5 As seen in FIG. 1 , the guide catheter 100 in one example includes one or more apertures 506. In various embodiments, the catheter body including the main tubular shaft 102 includes an aperture 506 extending from the inside of the catheter 100 to the outside of the catheter. In one embodiment, the distal tip 104 includes an aperture 506.

[0050] Figure 6 A cross-sectional view of a portion of the main tubular shaft 102 along the longitudinal axis of the catheter 100 is shown according to one embodiment. Figure 7The cross-sectional view observed from the end of the main tube-shaped shaft 102 (e.g., orthogonal to the longitudinal axis of the catheter 100) is shown. In one embodiment, the catheter body comprising the main tube-shaped shaft 102 comprises a braid assembly 608. The braid assembly 608 comprises two or more wire arrays interwoven around the catheter body in opposite (left and right) directions. As described herein, each wire array comprises one or more wires, and the wires include but are not limited to flat or oblong (e.g., forged) wires, wire wraps (round wires) etc. In various embodiments, the braid assembly comprises one or more wires constructed by but not limited to metal (stainless steel, nickel-titanium alloy, etc.), polymers, composites, or comprises a combination of wires constructed by two or more of the materials described herein.

[0051] In various embodiments, the wire of braid component 608 is forged. In various embodiments, the wire of the composition of the braid component comprises at least 2 to 30 wires with a weft number per inch (the inverse of the pitch) of 30 to 180. In various embodiments, the braid component comprises at least 4 wires and 24 wires at most. In other embodiments, the braid component comprises at least 8 wires and 16 wires at most. In various embodiments, the metal wire of the braid component 608 comprises including but not limited to the following cross-sectional shapes: rectangular cross section, circular cross section, oblong cross section, elliptical cross section (another example of elliptical) etc. In various embodiments, the wire of the braid component 608 is coated with, for example, PTFE before being woven into the interlaced configuration of the braid.

[0052] In one embodiment, the braid assembly 608 comprises soldered terminals. In one embodiment, the braid assembly 608 comprises a distal end having a gold coating. In various embodiments, the gold coating is approximately 0.5 mm to 2 mm thick. In certain embodiments, the gold coating is approximately 0.4 mm to 2.5 mm thick. In other embodiments, the gold coating is approximately 0.25 mm to 3 mm thick.

[0053] In one embodiment, the thickness of braid component 608 is about 0.0015 inch to 0.010 inch (e.g., from the braid component outside to the braid component inside). In another embodiment, the thickness of braid component 608 is at least 0.0010 inch. In yet another embodiment, the thickness of braid component 608 is at least 0.0005 inch. In other embodiments, the thickness of main internal braid component 608 is at most 0.015 inch. In other embodiments, the thickness of braid component 608 is at most 0.020 inch.

[0054] As described herein, the catheter body comprising the main tube-shaped shaft 102 comprises an outer layer 610, such as an outer sleeve. The outer layer 610 comprises a polymer in at least one instance. The outer layer 610 extends around at least a portion (e.g., sheath, coating, coating, etc.) of the braid assembly 608. In one embodiment, the outer layer 610 is at least about 0.001 inches thick and at most about 0.005 inches thick. In another embodiment, the outer layer 610 is at least about 0.0005 inches thick. In yet another embodiment, the outer layer 610 is at most about 0.007 inches thick. In other embodiments, the outer layer is at most about 0.01 inches thick.

[0055] Optionally, the outer layer 610 comprises one or more of a polymer, a shrink tube, etc., and the polymer includes but is not limited to Pebax, PTFE. In another example, the outer layer 610 comprises nylon. In one embodiment, the outer layer 610 is coated with a hydrophilic polymer. In another embodiment, the outer layer 610 comprises at least two layers. Optionally, each of the two layers comprises Pebax, or comprises one or more of the polymers described herein. In another example, the outer layer 610 can be heat-shrunk to form the outer layer 610 tightly connected to the braid component 608. In yet another example, the outer layer 610 comprises a reflowable polymer that is heated and reflowed around the braid component 608. Optionally, the outer layer 610 that has been reflowed penetrates and captures one or more of the silk (comprising the braided stent) in the outer layer 610. As described herein, the outer layer 610 and optional discontinuous wire wraps in conjunction with a braided support (e.g., a wire wrap, a wire as described herein, etc.) maintain the braid assembly 608 in a particular (unkinked) configuration even when the catheter 100 is significantly deflected (relative to a braid assembly without the structural support described herein).

[0056] In one embodiment, the catheter body including the main tubular shaft 102 includes an inner lining, such as the inner layer 612. The inner layer 612 includes a polymer, including but not limited to a lubricious polymer such as PTFE (e.g., to provide strength and facilitate the passage of instruments such as in Figure 6 and Figure 7 ). Inner layer 612 extends along at least an interior portion of braid component 608.

[0057] In one embodiment, the inner layer 612 is at least about 0.001 inches thick and at most about 0.005 inches thick. In another embodiment, the inner layer 612 is at least about 0.0007 inches thick. In yet another embodiment, the inner layer 612 is at least about 0.0005 inches thick. In another example, the inner layer 612 is at most about 0.007 inches thick. In yet another example, the inner layer is at most about 0.01 inches thick. Optionally, the inner layer 612 comprises one or more polymers including, but not limited to, PTFE (as described above), nylon, and a coated polymer (e.g., a polymer coated with a hydrophilic polymer).

[0058] In one embodiment, the outer layer 610 (outer sleeve) and the inner layer 612 (inner liner) are connected, for example, by a braid component 608 (which is Figure 6 and Figure 8 ) and are fused together. Figure 8 A cross-sectional view of a portion of a main tubular shaft 802 (a portion of a catheter body) is shown according to one embodiment. Fig. 9 The cross-sectional view observed from the end of the main tube-shaped shaft 802 is shown. In various embodiments, the main tube-shaped shaft 802 includes a braid assembly 814. The braid assembly 814 is arranged between an optional inner braid assembly 808 (or other structural support layers) and an outer layer 810. In another example, the braid assembly 814 is between an outer sleeve (e.g., outer layer 810) and an inner liner (e.g., inner layer 812). In yet another example, the braid assembly 814 is arranged in a part of the outer layer 810. In another example, the braid assembly 814 covers at least a portion of the optional inner braid assembly 808.

[0059] In one embodiment, the wire of braid component 814 comprises metal or polymer, including but not limited to stainless steel, titanium nickel alloy etc.In one embodiment, braid component 814 is at least about 0.0005 inch thick and at most about 0.010 inch thick.In another embodiment, braid component 814 is at least about 0.005 inch thick and at most about 0.010 inch thick.In yet another embodiment, braid component 814 is at least about 0.0004 inch thick.In another embodiment, braid component 814 is at least about 0.0003 inch thick.In other embodiments, braid component 814 is at most about 0.015 inch thick, at most about 0.020 inch thick etc.

[0060] Fig.10A front view of an example guide catheter 1000 according to one embodiment is shown. The guide catheter 1000 includes a distal end bend 1016. The distal end bend 1016 is constructed for anatomical consistency in one example. As described herein, the distal end bend 1016 is heat treated and formed by a formable portion of the catheter 1000, a separate metal feature, etc., the formable portion, for example, in an area containing one or more braid components described herein. The distal end bend 1016 maintains its shape at body temperature and does not soften significantly over time, and therefore, unspecified shape changes of the bend are prevented.

[0061] Catheter as herein described comprises a catheter body, and this catheter body comprises a braid assembly with at least first and second interwoven silk arrays, wherein each silk array comprises one or more corresponding first silk and second silk extending along opposite helical lines.The braid assembly is between liner and outer sleeve.In at least one example, the braid assembly comprising interstitial space between silk, silk array etc. is infiltrated by means of outer sleeve.

[0062] The braid component is constructed with multiple wires (e.g., 6 to 30 wires) spirally wound on an interwoven braided structure. In some embodiments, the wire is forged so that the cross-section of one or more wires is partially flat or oblong (including, for example, rectangular and elliptical) to achieve a tight wire matrix. In other examples, the braid component is made of one or more non-forged round, square or rectangular wires (optionally combined with other wires having a forged configuration). In one example, one or more wires in one or both of the first wire array and the second wire array include wires with dimensions and properties (e.g., circular or oblong cross-sections, material properties such as Young's modulus, flexural modulus, etc.) close to the dimensions and properties of the winding wire. An example of a braided stent 1102 is Fig.11 A round (wrap) wire is shown as part of the braid assembly 1100 (and is shown in a right side cross-sectional view taken along the longitudinal axis of the catheter).

[0063] In various embodiments, the wall thickness of the braid component 1100 is about 0.0005 inches to 0.020 inches thick. The braid component 1100 improves the mechanical properties of the catheter 1101 compared to current guide catheters, such as kinking, buckling, flexibility, radial strength, and maintaining the annularity of the cross-section of the catheter lumen 1109. The braid component 1100 of the catheter also improves one or more of the following properties of the catheter, including but not limited to: torsion, flexibility, pushability, or kink resistance. This improvement is achieved in one example by varying the number of filaments (e.g., filaments, windings, etc.) in each of the filament arrays 1104, 1106 (e.g., in various ratios, including but not limited to 15:1, 14:2, 13:3, 12:4, 11:5, 10:6, 9:7, 8:8, 7:9, 6:10, 5:11, 4:12, 3:13, 2:14, 1:15 for a total of 16 filaments). An example of a braided fabric component 1200 including an unbalanced ratio is Fig.12 , which includes the following 16-wire example braid: the 16-wire example braid has 14 first wires in the first wire array 1202 and 2 second wires in the second wire array 1204. For the purpose of illustration, the interlacing portion is removed (but the interlacing portion exists in the braid component).

[0064] In another example, the one or more improved mechanical properties are achieved by changing the size (e.g., cross-sectional size) of one or more wires in one or more arrays. For example, in an array with a ratio of 14:2, a first wire (14 wires of the first wire array) has a cross-sectional size that is smaller than a corresponding size of a second wire (2 wires of the second wire array), the first wire size being one or more of diameter, thickness, or width. In other words, relative to the first wire, the second wires are fewer in number and larger in at least one cross-sectional dimension. The second wires structurally support the narrower first wires in the manner of a braided stent, and thus, the second wires provide a framework, skeleton, cage, etc. that holds the first wires in a desired configuration (e.g., without kinking or buckling during deflection). An example of a braided fabric assembly 1200 having wires of different sizes between a first wire array 1202 and a second wire array 1204 is shown in FIG. Fig.12 As shown, the second wires (e.g., winding wires, wires, etc.) of the second wire array 1204 have at least one larger dimension relative to the first wires of the first wire array 1202. In one example, the second wires have a dimension, such as width, that is at least one order of magnitude larger than the first wires.

[0065] Optionally, the second filament comprises one or more filaments interwoven with the first filament, such as a twisted filament. Fig.11An example of a second wire comprising a wire wrap (which comprises a wire having a wire wrap shape and size) is provided in. Fig.11 1106, but other examples include multiple arrays of second wires interwoven with corresponding number of first wire arrays 1104. One or more interwoven wire wraps are another example of a braided support for the first wire. The first wire (and the second wire comprising the braided support 1102) provide improved torsional properties for the conduit, and the braided support 1102 structurally supports the braid assembly 1100 and provides enhanced anti-kinking properties (and optionally provides other improved properties, including pushability and torsional properties). The profile of the support including the braided support 1102 is incorporated into the braid assembly, and therefore, the introduction of additional support structures (such as wire wraps) above or below the braid assembly is minimized, and the resulting space consumption (or expansion of the conduit) is avoided.

[0066] In yet another example, the catheter described herein includes a wire wrap 1206 that is wound along the braid component 1200, for example, in a guide recess 1208 provided by one of the wire arrays 1202, 1204. An example of a discontinuous wire wrap is Fig.12 1204 is shown by one or more wire wraps 1206 extending along the second wire array 1204. The wire wraps 1206 enhance the mechanical properties of the catheter 1201. Optionally, the wire wraps 1206 extend helically along one or more wires including, for example, a braided support 1210. The wire wraps 1206 and the braided support 1210 cooperate to capture the first wire (described above) 1202 in the catheter 1201 and hold it in place. In addition, an outer sleeve 1212 (e.g., a reflow soldering or shrink sleeve) is infiltrated into the braid assembly 1200 and the optional wire wraps 1206 to fix each of the braided support 1210 and the wire wraps 1206 (optionally) in place. The outer sleeve 1212 and the braided support 1210 capture and hold the first wire 1202 in place and minimize (e.g., eliminate or reduce) the kink of the catheter 1201. In the case where the wire wrap 1206 is included along the braid component 1200, the wire wrap and the braided support are captured within an outer sleeve 1212 (e.g., a reflowed outer sleeve) and sandwich the first wire 1202. Thus, kinking, buckling, etc. of the first wire are resisted by combining one or more of the braided support 1210 or the wire wrap 1206 with the outer sleeve 1212.

[0067] As in Fig.12 As further shown in FIG. 1 , the catheter 1201 further includes one or more guide recesses 1208 adjacent to the second wire array 1204. One or more faces 1214, 1216 of the second wire array 1204 form the guide recesses 1208. For example, as shown in FIG. Fig.12, the second wire array 1204 includes a proximal face 1214 and a distal face 1216. The one or more guide recesses 1208 follow the spiral track of one of the wire arrays 1202, 1204 (in the example shown in the second array 1204), and optionally include two guide recesses: one guide recess along the proximal face 1214 of the second wire array 1204 and another along the distal face 1216 of the second wire array 1204. Because the second wire array 1204 is interwoven with the first wire array 1202 to form the braid component 1200, the proximal face 1214 and the distal face 1216 exist at the location where the second wire array 1204 is located on the outside of the braid component (e.g., between the channels of the first wires of the first wire array 1202). In at least those areas, the wire 1206 is partially contained within the braid assembly 1200, so as to minimize the space (e.g., the thickness of the outer sleeve 1212) used to accommodate the wire 1206 in the outer sleeve. In one example, the braid assembly 1200 helps to contain the discontinuous wire 1206 and helps to provide benefits related to mechanical properties (e.g., kink resistance, etc.), while minimizing the space required to keep the wire 1206 in the catheter 1201. At least a portion of the profile of the wire 1206 is hidden in the guide recess 1208, while the rest is located in the outer layer 1212. In one example, the outer layer 1212 is made thinner by having the outer side of the outer layer 1212 adjacent to the outer surface of the (recessed) wire.

[0068] As described above herein, the ratio of silk, the size of silk, one or more of the parts contained in braid assembly 1100, 1200 and along the braid assembly are changed to provide specific mechanical properties for conduit 1101, 1201. For example, multiple silk ratios and sizes are used to provide specific torsion for conduit 1101, 1201 and enhance kink resistance simultaneously. One or more optional discontinuous winding wires 1206 are optionally arranged in the guide recess 1208 of, for example, braid assembly 1200 along braid assembly 1100, 1200, to further enhance the mechanical properties of conduit. Table 1, table 2 and table 3 provided herein describe each feature in the multiple features of example braid assembly, and the features include but are not limited to the ratio of silk between the first silk array and the second silk array, silk size, silk shape, discontinuous winding wire and positioning thereof. These features are selected and implemented in conduit to provide specific characteristics for treatment or diagnostic process.

[0069] Table 1 (below) provides an example of a braid assembly comprising a total of 16 silk numbers. As shown, the ratio between the first silk array and the second silk array and the cross-sectional shape of the first silk array and the second silk array in some instances are changed with each in the example braiding configuration. Although fewer silk arrays (e.g., 6 and less than 6) include the selection for round silk (e.g., winding wire, etc.), round silk is also included in the silk array with a larger silk number, e.g., greater than 6 silks, in some instances.

[0070] Table 1: Structural braid configuration (using 16 wires between arrays as an example, but the total wire count is higher or lower in the examples, such as the total wire count is 6, 8, 10, 12, 14, 18, 20, 22, 24, 26, 28, 30, etc.)

[0071]

[0072] Table 2 describes the silk configuration of the size of each of the first silk array and the second silk array. In some instances, a larger silk size (e.g., the larger silk size of the second silk array) is paired with a smaller silk size of other silk arrays (e.g., the first silk array). An example of a silk with a circular cross section is also provided, which comprises a size of about 0.001 inches to 0.01 inches. Table 2 also qualitatively shows the relative difference between the size of the first silk array and the size of the second silk array in the column of order of magnitude, as shown, at least some silk configurations provide one or more silks in an array, which are at least one order of magnitude larger than the corresponding size of other silks in other (e.g., second) silk arrays in size, such as width or diameter.

[0073]

[0074] Table 3 describes the arrangement of one or more discontinuous wires and braid components. In addition, the table describes the options for positioning the wires in the guide recess, such as along the front in the Fig.12 One or more guide recesses 1208 are shown in the figure and disposed next to one of the wire arrays, such as a second wire array 1204 having a larger size and correspondingly a larger recess (e.g., having a depth corresponding to the thickness or diameter of the second wire). In various examples, one or more wire wraps are positioned within a proximal or distal guide recess 1208 (e.g., along a proximal face 1214 or a distal face 1216 of a wire assembly, such as a second wire assembly).

[0075]

[0076] A variety of foreseeable example catheter configurations are provided herein. The configurations are drawn by assembling one or more of the configurations provided in Table 1, Table 2, and Table 3, and provide variations in mechanical properties based on the selected configuration (e.g., inclusion of a braided stent, such as a larger wire in one of the arrays, a wire wrap, etc., improves kink resistance).

[0077] The catheter of Example 1 includes a braid assembly disposed on a PTFE liner, wherein an intermediate tie layer is disposed between the PTFE and the braid assembly (e.g., to facilitate coupling of the braid assembly to the liner and optionally to facilitate coupling of the outer sleeve to the liner). The outer diameter of the liner is about 0.255 to 0.256 inches; the outer diameter of the tie layer (on the liner) is about 0.260 to 0.2605 inches; and the outer diameter of the braid assembly (on the tie layer) is about 0.270 to 0.271 inches. An outer sleeve, such as Pebax, is disposed along the catheter and disposed on the braid assembly.

[0078] The catheter of Example 2 includes a braid assembly with discontinuous windings, which extend along the outside of the braid assembly. The braid assembly includes a ratio of 8:8 of a first wire and a second wire. In one example, the cross-sectional dimensions of the first wire are approximately 0.002 inches (thickness) multiplied by approximately 0.015 inches (width). The second wire has the same size. In another example, the second wire has the size described above (e.g., 0.002 inches × 0.015 inches), and the cross-sectional dimensions of the first wire are approximately 0.0005 inches multiplied by 0.003 inches. In this example, the size of the second wire is an order of magnitude larger than the first wire. The braid assembly is arranged on the PTFE liner by an intermediate tie layer. The outer diameter of the liner is about 0.2555 inch to 0.2565 inch; the outer diameter of the tie layer (on the liner) is about 0.2585 inch to 0.259 inch; and the outer diameter of the braid assembly (on the tie layer) is about 0.261 inch to 0.2615 inch. The wire winding is mounted on the braid assembly and is kept together with the outer sleeve along the braid assembly, such as Pebax, etc. In one example, the hardness of the outer sleeve is 55D and the outer diameter is about 0.280 inch to 0.285 inch. Optionally, one end of the wire winding is fixed near the corresponding end of the braid assembly and the wire winding is wound around the braid assembly in the same direction (for example, from the proximal end to the distal end). In another example, the wire winding is wound along one or more guide recesses of one of the silk arrays as described herein.

[0079] The catheter of Example 3 includes a braid assembly having an 8:8 ratio of eight wires for the first wire array to eight wires for the second wire array. The braid assembly is disposed on a PTFE liner and an intermediate tie layer is disposed between the PTFE and the braid assembly (e.g., to facilitate coupling of the braid assembly to the liner and optionally to facilitate coupling of the outer sleeve to the liner). The outer diameter of the liner is approximately 0.255 inches to 0.266 inches; the outer diameter of the tie layer is approximately 0.258 inches to 0.259 inches; and the outer diameter of the braid assembly is approximately 0.263 inches to 0.264 inches. The cross-sectional dimensions of the first wire are 0.0005 inches (thickness) by 0.003 inches (width). The cross-sectional dimensions of the second wire are 0.002 inches (thickness) by 0.015 inches (width). The size of the second wire is one order of magnitude larger than the first wire. The braid assembly was braided at 50 picks per inch and encapsulated with a polymer having a durometer of 55D and an outer diameter of approximately 0.280 inches to 0.285 inches.

[0080] In other examples (related to Example 3), the braid component has a ratio of 14:2 or 12:4, and the first wire has the same size. In this example, the number of picks per inch is optionally increased (e.g., increased to greater than 50, such as increased to 180 PPI). In another example, the braid component has a ratio of 15:1 of the first wire to the second wire. Each of the first wire and the second wire includes the same size as the 8:8 example provided above.

[0081] In any of the examples (e.g., ratios of 8:8, 14:2, 12:4, 15:1), the catheter optionally includes a discontinuous wire wrap. For example, in the last example including a 15:1 ratio, the wire wrap is positioned within a guide recess formed along a second wire array (e.g., which includes a single second wire). The guide recess is presented in an example as one or more internal thread grooves extending along the braid assembly. In addition to providing increased kink resistance, the inclusion of the wire wrap also enhances the radial strength (resistance to folding) of the catheter.

[0082] The catheter of Example 4 includes a braid assembly having a 14:2 ratio of fourteen first wires for the first wire array to two second wires for the second wire array. In a manner similar to the previous examples, the braid assembly is disposed on a PTFE liner (e.g., Fig.11 The inner sleeve 1107 and the Fig.12The inner sleeve 1203 in the conduit and the intermediate tie layer (e.g., intermediate tie layer 1103, intermediate tie layer 1205, respectively) is disposed between the PTFE and the braid assembly. The outer diameter of the liner is about 0.255 inches to 0.256 inches; the outer diameter of the tie layer is about 0.258 inches to 0.259 inches; and the outer diameter of the braid assembly is about 0.263 inches to 0.2635 inches. The cross-sectional dimensions of the first wire are 0.0005 inches (thickness) by 0.003 inches (width). The cross-sectional dimensions of the second wire are 0.002 inches (thickness) by 0.015 inches (width), and the second wire is one order of magnitude larger than the first wire. Optionally, the two wires of the second wire array are staggered 180 degrees (e.g., on opposite sides of the catheter) to form a double helix. The braid component is braided at 90 PPI and encapsulated with a polymer (eg, outer sleeve 1105) having a durometer of 55D and an outer diameter of approximately 0.280 inches to 0.285 inches.

[0083] The catheter of Example 5 includes a braid assembly having a 15:1 ratio of fifteen first wires for the first wire array to one second wire for the second wire array. The wires are arranged at 160 PPI. In a manner similar to the previous examples, the braid assembly is arranged on a PTFE liner and an intermediate tie layer is arranged between the PTFE and the braid assembly. The outer diameter of the liner is about 0.2555 inches to 0.256 inches; the outer diameter of the tie layer is about 0.258 inches to 0.259 inches; and the outer diameter of the braid assembly is about 0.2625 inches to 0.2635 inches. The cross-sectional dimensions of the first wire are 0.0005 inches (thickness) by 0.003 inches (width). The cross-sectional dimensions of the second wire are 0.002 inches (thickness) by 0.015 inches (width), and the second wire is one order of magnitude larger than the first wire.

[0084] The second wire array in this example provides at least one guide recess (e.g., at least one guide recess along the proximal or distal face of the wire array), and the wire is wound along the wire array and positioned in the guide recess (the guide recess serves as a guide for arranging the wire). The wire is at least partially contained in the guide recess, and thus the profile of the wire is reduced because the wire is partially absorbed by the wire array and the guide recess of the wire array. In one example, when the wire is wound along a specific direction (e.g., a left-hand direction), the second wire array is also wound around the left-hand direction (and the first wire array is wound around the right-hand direction) to ensure that the wire is arranged in the guide recess.

[0085] The braid assembly and the wire wrap are encapsulated in a polymer (outer sleeve) having a hardness of 55D and an outer diameter of about 0.280 inches to 0.285 inches. Optionally, the outer sleeve is reflowed multiple times (e.g., at least twice) to remove bubbles in the sleeve. The catheter of Example 5 has enhanced radial strength and flexibility relative to at least some of the other examples.

[0086] Example 6 includes a selected catheter comprising a braid assembly having a ratio of 15:1, 14:2, 12:4, etc. The braid assembly comprises a second wire having a size close to or equal to the size of the wire wrap. For example, the wire (wire wrap) diameter is about 0.003 inches to 0.005 inches (e.g., greater than the 0.002×0.015 wire described herein). The second wires of the second wire array are interwoven with the first wire array. In one example, the second wires are interlaced around the catheter body, for example, according to the number of the second wires (4 second wires at 90 degree intervals, 3 second wires at 120 degree intervals, 2 second wires at 180 degree intervals, etc.). Optionally, the second wire array in these catheters and each catheter is paired with a discontinuous wire wrap positioned in one or more guide recesses of the second wire array.

[0087] It should be noted that, as used in this specification and the appended claims, the singular forms "a," "an," and "the" include plural referents unless the content clearly dictates otherwise. Thus, for example, reference to a composition containing "a compound" includes a mixture of two or more compounds. It should also be noted that the term "or" is generally employed in its sense including "and / or" unless the content clearly dictates otherwise.

[0088] It should also be noted that the term "configured" as used in this specification and the appended claims describes a system, device, or other structure that is constructed or configured to perform a specific task or adopt a specific configuration. The term "configured" may be used interchangeably with other similar terms such as arrange and configure, build and arrange, construct, manufacture and arrange, etc.

[0089] All publications and patent applications in this specification are indicative of the levels of ordinary skill in the art to which this technology belongs. All publications and patent applications are herein incorporated by reference to the same extent as if each individual publication or patent application was specifically and individually indicated by reference.

[0090] The present technology has been described with reference to a variety of specific and preferred embodiments and techniques. However, it should be understood that various modifications and improvements can be made while remaining within the spirit and scope of the present technology.

[0091] Various notes and examples

[0092] Example 1 may include a subject matter, such as a catheter assembly, comprising: a catheter body, the catheter body extending from a proximal portion of the catheter to a distal portion of the catheter, the catheter body comprising an inner liner and an outer sleeve; and a braid assembly, the braid assembly being within the catheter body and between the inner liner and the outer sleeve, the braid assembly comprising: a first wire array, the first wire array comprising one or more first wires extending helically around the catheter body in a first direction; and a braided stent, the braided stent being interwoven with the first wire array, the braided stent extending around the catheter body in a second direction opposite to the first direction, wherein the braided stent anchors and supports the first wire array.

[0093] Example 2 may include the subject matter of Example 1 or may optionally be combined with the subject matter of Example 1 to optionally include: wherein the braided stent comprises a second wire array comprising one or more second wires.

[0094] Example 3 may include the subject matter described in one or any combination of Example 1 or Example 2 or may be optionally combined with the subject matter described in one or any combination of Example 1 or Example 2 to optionally include: wherein the second wire width of the one or more second wires is greater than the first wire width of the one or more first wires.

[0095] Example 4 may include the subject matter described in one or any combination of Examples 1 to 3 or may optionally be combined with the subject matter described in one or any combination of Examples 1 to 3 to optionally include: wherein the second wire width is at least an order of magnitude greater than the first wire width.

[0096] Example 5 may include the subject matter described in one or any combination of Examples 1 to 4 or may optionally be combined with the subject matter described in one or any combination of Examples 1 to 4 to optionally include: wherein the second filament array includes fewer second filaments than the first filament array.

[0097] Example 6 can include or can optionally be combined with the subject matter of Examples 1 to 5 to optionally include: wherein the braided stent comprises wire wraps interwoven with the first wire array.

[0098] Example 7 may include or may optionally be combined with the subject matter of Examples 1 to 6 to optionally include: wherein the wire wrap comprises a circular cross-section.

[0099] Example 8 may include the subject matter described in Examples 1 to 7 or may optionally be combined with the subject matter described in Examples 1 to 7 to optionally include: wherein the outer sleeve is reflowed on the braid component, and the reflowed outer sleeve anchors the braided stent in the catheter body, and the reflowed outer sleeve and the braided stent cooperate to structurally support the first wire array.

[0100] Example 9 may include the subject matter described in Examples 1 to 8 or may optionally be combined with the subject matter described in Examples 1 to 8 to optionally include: wherein the fabric component comprises a twistable and kink-resistant fabric component, the first wire array comprises a first torsion property and a first kink resistance, and the braided support comprises a second kink resistance greater than the first kink resistance.

[0101] Example 10 may include or may optionally be combined with the subject matter of Examples 1 to 9 to optionally include: wherein the braided stent includes a second torsional property that is less than the first torsional property of the first wire array.

[0102] Example 11 can include or can optionally be combined with the subject matter of Examples 1-10 to optionally include a wire wrap extending helically along the outside of the braid component.

[0103] Example 12 may include the subject matter described in Examples 1 to 11 or may optionally be combined with the subject matter described in Examples 1 to 11 to optionally include: wherein the braided stent includes at least one guide recess extending helically around the catheter body, and the wire wrap is accommodated in the at least one guide recess.

[0104] Example 13 may include the subject matter of Examples 1 to 12 or may optionally be combined with the subject matter of Examples 1 to 12 to optionally include: wherein the at least one guide recess extends along one of the proximal surface or the distal surface of the braided stent.

[0105] Example 14 may include or may optionally be combined with the subject matter of Examples 1 to 13 to optionally include: wherein the wire wrap and the braided support sandwich the braid component between the wire wrap and the braided support.

[0106] Example 15 may include the subject matter described in Examples 1 to 14 or may optionally be combined with the subject matter described in Examples 1 to 14 to optionally include a catheter assembly, the catheter assembly comprising: a catheter body, the catheter body extending from the proximal portion of the catheter to the distal portion of the catheter, the catheter body comprising an inner liner and an outer sleeve; a fabric assembly, the fabric assembly being within the catheter body and between the inner liner and the outer sleeve, the fabric assembly comprising: a first wire array, the first wire array comprising one or more first wires extending helically around the catheter body in a first direction; a second wire array, the second wire array comprising one or more second wires extending helically around the catheter body in a second direction opposite to the first direction, and wherein at least one of the first wire array or the second wire array comprises at least one guide recess extending helically with the first wire or the second wire; and a wire wrap, the wire wrap being accommodated in the at least one guide recess and the wire wrap extending helically around the catheter body with the first wire or the second wire.

[0107] Example 16 may include the subject matter described in Examples 1 to 15 or may optionally be combined with the subject matter described in Examples 1 to 15 to optionally include: wherein the one or more second wires of the second wire array have a larger dimension across the wire cross-section compared to the smaller dimension of the one or more first wires of the first wire array.

[0108] Example 17 may include the subject matter described in Examples 1 to 16 or may optionally be combined with the subject matter described in Examples 1 to 16 to optionally include: wherein the at least one guide recess extends along the second wire array comprising the larger dimension, and the at least one guide recess includes a recess depth that varies proportionally with the larger dimension.

[0109] Example 18 may include the subject matter of Examples 1 to 17 or may optionally be combined with the subject matter of Examples 1 to 17 to optionally include: wherein the one or more second filaments comprise flat or oblong filaments and the larger dimension comprises one or more of a width and a thickness of the flat or oblong filaments.

[0110] Example 19 may include or may optionally be combined with the subject matter of Examples 1 to 18 to optionally include: wherein the one or more second filaments comprise round filaments and the larger dimension comprises a diameter of the round filaments.

[0111] Example 20 may include the subject matter of Examples 1 to 19 or may optionally be combined with the subject matter of Examples 1 to 19 to optionally include: wherein the wire wrap includes a wire wrap profile, and at least a first portion of the wire wrap profile is contained within the at least one guide recess.

[0112] Example 21 may include the subject matter described in Examples 1 to 20 or may optionally be combined with the subject matter described in Examples 1 to 20 to optionally include: wherein the wire winding profile includes a second portion of the wire winding profile, and the second portion of the wire winding profile is accommodated in the outer sleeve.

[0113] Example 22 may include the subject matter described in Examples 1 to 21 or may optionally be combined with the subject matter described in Examples 1 to 21 to optionally include: wherein the wire wrap includes a wire wrap profile, and at least a portion of the wire wrap profile is contained within the at least one guide recess and extends together with the fabric profile of the fabric assembly.

[0114] Example 23 may include or may optionally be combined with the subject matter of Examples 1 to 22 to optionally include: wherein the wire wrap comprises a diameter of approximately 0.001 inches to 0.010 inches.

[0115] Example 24 may include the subject matter described in Examples 1 to 23 or may optionally be combined with the subject matter described in Examples 1 to 23 to optionally include: wherein at least one of the first wire array or the second wire array includes: a proximal guide recess, which extends along the proximal surface of the first wire array or the second wire array; and a distal guide recess, which extends along the distal surface of the first wire array or the second wire array.

[0116] Example 25 may include the subject matter of Examples 1 to 24 or may optionally be combined with the subject matter of Examples 1 to 24 to optionally include: wherein the wire wrap is received in one of the proximal guide recess or the distal guide recess.

[0117] Example 26 may include the subject matter described in Examples 1 to 25 or may optionally be combined with the subject matter described in Examples 1 to 25 to optionally include: wherein the wire wrap includes a first wire wrap and a second wire wrap, and the first wire wrap is accommodated in the proximal guide recess and the second wire wrap is accommodated in the distal guide recess.

[0118] Example 27 may include or may optionally be combined with the subject matter of Examples 1-26 to optionally include: wherein the wire wrap extends on an outer side of the braid component.

[0119] Example 28 can include or can optionally be combined with the subject matter of Examples 1-27 to optionally include: wherein the wire wrap extends on an inner side of the braid component.

[0120] Example 29 may include the subject matter described in Examples 1 to 28 or may optionally be combined with the subject matter described in Examples 1 to 28 to optionally include a catheter assembly, the catheter assembly comprising: a catheter body, the catheter body extending from the proximal portion of the catheter to the distal portion of the catheter, the catheter body comprising an inner lining and an outer sleeve; and a fabric assembly, the fabric assembly being within the catheter body and between the inner lining and the outer sleeve, the fabric assembly comprising: a first wire array, the first wire array comprising one or more first wires extending helically around the catheter body in a first direction; and a second wire array, the second wire array comprising one or more second wires extending helically around the catheter body in a second direction opposite to the first direction.

[0121] Example 30 may include the subject matter described in Examples 1 to 29 or may optionally be combined with the subject matter described in Examples 1 to 29 to optionally include: wherein the number of first filaments of the one or more first filaments is greater than the number of second filaments of the one or more second filaments.

[0122] Example 31 may include the subject matter described in Examples 1 to 30 or may optionally be combined with the subject matter described in Examples 1 to 30 to optionally include: wherein based on the difference between the first number of filaments and the second number of filaments, at least the second filament width of the one or more second filaments is greater than the first filament width of the one or more first filaments.

[0123] Example 32 may include the subject matter described in Examples 1 to 31 or may optionally be combined with the subject matter described in Examples 1 to 31 to optionally include: wherein when the first number of filaments is greater than the second number of filaments, at least the second filament width of the one or more second filaments is greater than the first filament width of the one or more first filaments.

[0124] Example 33 may include the subject matter described in Examples 1 to 32 or may optionally be combined with the subject matter described in Examples 1 to 32 to optionally include: wherein the number of first filaments of the one or more first filaments and the number of second filaments of the one or more second filaments are in a ratio including the following: 15:1, 14:2, 13:3, 12:4, 11:5, 10:6, 9:7, 8:8, 7:9, 6:10, 5:11, 4:12, 3:13, 2:14, 1:15.

[0125] Example 34 may include the subject matter of Examples 1 to 33 or may optionally be combined with the subject matter of Examples 1 to 33 to optionally include: wherein at least a second wire width of the one or more second wires is greater than a first wire width of the one or more first wires.

[0126] Example 35 may include or may optionally be combined with the subject matter of Examples 1 to 34 to optionally include: wherein the second filament width is at least an order of magnitude greater than the first filament width.

[0127] Example 36 may include the subject matter of Examples 1 to 35 or may optionally be combined with the subject matter of Examples 1 to 35 to optionally include: wherein at least one of the first filament and the second filament comprises a flat or oblong cross-section.

[0128] Example 37 may include the subject matter described in Examples 1 to 36 or may optionally be combined with the subject matter described in Examples 1 to 36 to optionally include: wherein at least one of the first filament and the second filament comprises a thickness dimension of approximately 0.0005 inches to 0.005 inches and a width dimension of approximately 0.001 inches to 0.030 inches.

[0129] Example 38 may include the subject matter described in Examples 1 to 37 or may optionally be combined with the subject matter described in Examples 1 to 37 to optionally include: wherein the fabric component includes at least one guide recess extending along one of the first wire array or the second wire array, and the fabric component includes a wire wrap that is accommodated in the at least one guide recess.

[0130] Example 39 may include the subject matter described in Examples 1 to 38 or may optionally be combined with the subject matter described in Examples 1 to 38 to optionally include: wherein the wire wrap follows the helix of either the first wire array or the second wire array according to the at least one guide recess extending along either the first wire array or the second wire array.

[0131] Example 40 may include the subject matter of Examples 1 to 39 or may optionally be combined with the subject matter of Examples 1 to 39 to optionally include: wherein the wire wrap includes a wire wrap profile, and at least a portion of the wire wrap profile is positioned in the at least one guide recess.

[0132] Example 41 may include the subject matter described in Examples 1 to 40 or may optionally be combined with the subject matter described in Examples 1 to 40 to optionally include: wherein the wire wrap includes a wire wrap profile, and at least a portion of the wire wrap profile extends together with the fabric profile of the fabric component.

[0133] Example 42 may include or may optionally be combined with the subject matter of Examples 1-41 to optionally include: wherein the wire wrap comprises a diameter of approximately 0.001 inches to 0.010 inches.

[0134] Example 43 may include the subject matter described in Examples 1 to 42 or may optionally be combined with the subject matter described in Examples 1 to 42 to optionally include: wherein at least one of the first wires of the first wire array or the second wires of the second wire array is a winding wire interwoven with another one of the second wire array or the first wire array.

[0135] Example 44 may include or may optionally be combined with the subject matter of Examples 1 to 43 to optionally include: wherein the wire wrap comprises a diameter of approximately 0.001 inches to 0.010 inches.

[0136] Example 45 may include the subject matter described in Examples 1 to 44 or may optionally be combined with the subject matter described in Examples 1 to 44 to optionally include: wherein at least one of the first wire array or the second wire array includes a braided stent interwoven with another of the second wire array or the first wire array.

[0137] Example 46 may include the subject matter described in Examples 1 to 45 or may optionally be combined with the subject matter described in Examples 1 to 45 to optionally include: wherein the outer sleeve is reflowed on the braid component, and the reflowed outer sleeve anchors the braided stent in the catheter body, and the reflowed outer sleeve and the braided stent of the first wire array or the second wire array cooperate to structurally support the second wire array or the other of the first wire arrays.

[0138] Example 47 may include the subject matter of Examples 1 to 46 or may optionally be combined with the subject matter of Examples 1 to 46 to optionally include: wherein the one or more first filaments and the one or more second filaments have a pick count per inch (PPI) of 30 to 180.

[0139] Each of these non-limiting examples may stand on its own and may be combined with one or more of the other examples in various permutations or combinations.

[0140] The above detailed description includes reference to the accompanying drawings, which form a part of the detailed description. The accompanying drawings show, in an illustrative manner, specific embodiments in which the present disclosure can be practiced. These embodiments are also referred to as "examples" in this article. Such examples may include elements other than the elements shown or described. However, the inventors also contemplate the following examples: in the examples, only those elements shown or described are provided. In addition, the inventors also contemplate examples using any combination or arrangement of those elements shown or described (or one or more aspects thereof) related to a specific example (or one or more aspects thereof) or related to other examples (or one or more aspects thereof) shown or described in this article.

[0141] In the event of inconsistent usage between this document and any document incorporated by reference, the usage of this document controls.

[0142] In this document, the term "one" or "an" is used to include one or more than one as commonly used in patent documents, regardless of any other examples or usages of "at least one" or "one or more". In this document, the term "or" is used to refer to non-exclusive, or, so that "A or B" includes "A but not B", "B but not A", and "A and B", unless otherwise specified. In this document, the terms "including" and "wherein" are used as the plain English equivalents of the corresponding terms "including" and "wherein". In addition, in the appended claims, the terms "including" and "comprising" are open-ended, that is, systems, devices, articles, compositions, preparations or processes containing elements other than the elements listed after such terms in a claim are still considered to fall within the scope of the claim. In addition, in the appended claims, the terms "first", "second", and "third", etc. are used only as markers and are not intended to impose numerical requirements on the objects of the terms.

[0143] The above description is intended to be illustrative rather than restrictive. For example, the above examples (or one or more aspects thereof) can be used in combination with each other. For example, other embodiments may be used by a person of ordinary skill in the art when reviewing the above description. An abstract is provided to comply with 37 CFR § 1.72 (b) to allow the reader to quickly determine the nature of the technical disclosure. The disclosure is submitted with the understanding that the disclosure will not be used to interpret or limit the scope or meaning of the claims. In addition, in the above-mentioned specific embodiments, various features can be combined together to simplify the disclosure. This should not be interpreted as intending that the disclosed features that are not claimed for protection are necessary for any claim. On the contrary, the subject matter of the invention may be less than all the features of the specific disclosed embodiments. Therefore, the attached claims are incorporated herein into the specific embodiments as examples or embodiments, wherein each claim exists independently as a separate embodiment, and it is contemplated that these embodiments can be combined with each other in various combinations or arrangements. The scope of the disclosure should be determined with reference to the attached claims together with the full scope of equivalents enjoyed by the claims.

Claims

1. A catheter assembly, comprising: A catheter body extending from a proximal portion of the catheter to a distal portion of the catheter, the catheter body comprising: Lining; and an outer sleeve; and A braid assembly, the braid assembly being within the catheter body and between the inner liner and the outer sleeve, the braid assembly comprising: a first wire array extending helically about the catheter body in a first direction, the first wire array comprising one or more first wires having a first dimension, the first dimension comprising one or more of a width or a height of each of the one or more first wires; and and a second wire array extending helically about the catheter body in a second direction opposite to the first direction, the second wire array comprising two or more second wires interwoven with the first wire array, wherein at least one of the two or more second wires comprises a second dimension, one or more of a width or a height of the second dimension being greater than a corresponding width or height of the first dimension, and wherein at least another wire of the two or more second wires comprises the first dimension.

2. The catheter assembly of claim 1, wherein the braid assembly is laid over the inner liner and the outer sleeve is laid over the braid assembly.

3. The catheter assembly of claim 1, wherein the cross-sectional width of the second dimension is greater than the cross-sectional width of the first dimension.

4. The catheter assembly of claim 3, wherein the second dimension cross-sectional width is at least one order of magnitude greater than the first dimension cross-sectional width.

5. The catheter assembly of claim 1, wherein the second array of wires comprises fewer second wires than the first wires of the first array of wires.

6. The catheter assembly of claim 1, wherein the first wire array comprises a first kink resistance, and The second array of filaments comprises a second kink resistance that is greater than the first kink resistance.

7. The catheter assembly of claim 1, comprising a wire wrap extending helically along an outside of the braid assembly.

8. The catheter assembly of claim 7, wherein one or more of the first or second wire arrays comprises at least one guide recess extending helically around the catheter body, and the wire wrap is received in the at least one guide recess.

9. The catheter assembly of claim 1, wherein the two or more second wires in the second wire array comprise wire wraps.

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