Woven fiber hypotube for intraluminal sensing devices

Abstract

An apparatus includes an intravascular guidewire. The intravascular guidewire includes a flexible elongate member that can be positioned inside a blood vessel and a tubular member extending along a length of the flexible elongate member. The tubular member includes fibers that are woven together and in a tensioned state. The fibers can define a lumen. The intravascular guidewire includes a cured matrix material and / or clamp(s) that maintain the plurality of fibers in the tensioned state.

Description

WOVEN FIBER HYPOTUBE FOR INTRALUMINAL SENSING DEVICESTECHNICAL FIELD

[0001] The subject matter described herein relates, in general, to intraluminal physiology sensing devices (e.g., an intravascular pressure sensing and / or flow sensing guidewire). In particular, the intraluminal device includes a woven fiber hypotube that is maintained in a tensioned / contracted state by a cured matrix material (e.g., adhesive) or clamp(s).BACKGROUND

[0002] Heart disease is very serious and often requires emergency operations to save lives. A main cause of heart disease is the accumulation of plaque inside the blood vessels, which eventually occludes the blood vessels. Common treatment options available to open up the occluded vessel include balloon angioplasty, rotational atherectomy, and intravascular stents. Traditionally, surgeons have relied on X-ray fluoroscopic images that are planar images showing the external shape of the silhouette of the lumen of blood vessels to guide treatment. Unfortunately, with X-ray fluoroscopic images, there is a great deal of uncertainty about the exact extent and orientation of the stenosis responsible for the occlusion, making it difficult to find the exact location of the stenosis. In addition, though it is known that restenosis can occur at the same place, it is difficult to check the condition inside the vessels after surgery with X-ray.

[0003] One solution is to use intravascular devices such as catheters and guide wires to measure the pressure within the blood vessel, visualize the inner lumen of the blood vessel, and / or otherwise obtain data related to the blood vessel. Conventionally, intravascular catheters and guide wires include a stiff proximal portion that transitions into a soft distal portion. The proximal portion may be stiffer in order to maximize trackability and to allow for the intravascular device to be pushed. The distal portion is softer in order to prevent damage to the vasculature of a patient. The intravascular device can include a core member that is generally formed of an elastic and durable material, which allows the guide wire to traverse the tortuous anatomy, such as the patient’s blood vessels. The core member generally extends along the length of the guide wire. The intravascular device often includes one or more rigid components disposed near the distal portion. The one or more components can include a hypotube which may surround a joint between a distal core and a proximal core.

[0004] Solid hypotubes may be rigid, opaque, and of a fixed length and diameter. Solid hypotubes present manufacturability challenges with respect to positioning and packaging other components within the hypotube, add to the minimum possible diameter of the device, and create hinge points at either end of the hypotube, where the device stiffness changes along its length, which increases the risk of kink points. These hinge points reduce mechanical performance and are weakspots for electrical and mechanical stress. Therefore, the hinge point may cause the intravascular device to unintentionally bend, kink, or break at the hinge point.

[0005] The information included in this Background section of the specification, including any references cited herein and any description or discussion thereof, is included for technical reference purposes only and is not to be regarded as subject matter by which the scope of the disclosure is to be bound.SUMMARY

[0006] The present disclosure is an improvement for intraluminal devices such as intravascular catheters and / or guidewires by providing a woven fiber hypotube. The woven fiber hypotube can, for example, be located at a joint or junction between a proximal subassembly and a distal subassembly of the intraluminal device, which may be separately assembled and joined together to form the intraluminal device. The woven fiber hypotube has an expanded state in which the diameter of the hypotube is increased and the length of the hypotube is decreased. One or more components of the intraluminal device may be placed within the hypotube in its expanded state (e.g., proximal core, distal core, electrical wires, etc.). Under longitudinal tension, the woven fiber hypotube changes from its expanded state to its contracted state. The hypotube, in its contracted state, conforms to the shape of the one or more components placed within the hypotube because the hypotube is made of woven fibers. An adhesive or other matrix material can be positioned inside, outside, and / or between the fibers of the woven fiber hypotube. Curing the adhesive while the woven fiber hypotube is in the contracted state allows for the woven fiber hypotube to maintain its longitudinal tension. The woven fiber hypotube and the adhesive hold / join the proximal and distal subassemblies together and prevent the intraluminal device from separating at the joint / j unction. Clamps at either end of the woven fiber hypotube can also be used to maintain the longitudinal tension of the woven fiber hypotube.

[0007] This Summary is provided to introduce a selection of concepts in a simplified form that are further described below in the Detailed Description. This Summary is not intended to identify all key features or essential features of the claimed subject matter, nor is it intended to limit the scope of the claimed subject matter. A more extensive presentation of features, details, utilities, and advantages of the woven fiber hypotube, as defined in the claims, is provided in the following written description of various aspects of the disclosure and illustrated in the accompanying drawings.BRIEF DESCRIPTION OF THE DRAWINGS

[0008] Illustrative aspects of the present disclosure will be described with reference to the accompanying drawings, of which:

[0009] Fig. 1 is a diagrammatic top view of an intravascular device, according to aspects of the present disclosure.

[0010] Fig. 2 is a diagrammatic side view of an intravascular sensing system that includes an intravascular device, according to aspects of the present disclosure.

[0011] Fig. 3A is a perspective view of an example woven fiber hypotube in an expanded / relaxed / un-tensioned state, according to aspects of the present disclosure.

[0012] Fig. 3B is a perspective view of an example woven fiber hypotube in a contracted / tensioned state, according to aspects of the present disclosure.

[0013] Fig. 4 A is a diagrammatic cross-sectional side view of the woven fiber hypotube of Fig. 3 at a stage of manufacturing, in accordance with at least one aspect of the present disclosure.

[0014] Fig. 4B is a diagrammatic cross-sectional side view of the woven fiber hypotube at a later stage of manufacturing, in accordance with at least one aspect of the present disclosure.

[0015] Fig. 4C is a diagrammatic cross-sectional side view the woven fiber hypotube at a later stage of manufacturing, in accordance with one or more aspects of the present disclosure.

[0016] Fig. 4D is a diagrammatic cross-sectional side view of the woven fiber hypotube at a later stage of manufacturing, in accordance with one or more aspects of the present disclosure.

[0017] Fig. 5 is a diagrammatic cross-sectional view of a woven fiber hypotube, in accordance with at least one aspect of the present disclosure.

[0018] Fig. 6 is a diagrammatic side view of a woven fiber hypotube, in accordance with at least one aspect of the present disclosure.

[0019] Fig. 7 is a diagrammatic cross-sectional view of the woven fiber hypotube of Fig. 6, in accordance with at least one aspect of the present disclosure.

[0020] Fig. 8 is a diagrammatic side view of a woven fiber hypotube, in accordance with at least one aspect of the present disclosure.

[0021] Fig. 9 is a diagrammatic side view of a woven fiber hypotube, in accordance with at least one aspect of the present disclosure.

[0022] Fig. 10 is a diagrammatic side view of a woven fiber hypotube, in accordance with at least one aspect of the present disclosure.

[0023] Fig. 11 is a diagrammatic cross-sectional view of the woven fiber hypotube of Fig. 10, in accordance with at least one aspect of the present disclosure.

[0024] Fig. 12 is a diagrammatic cross-sectional side view of a portion of an intraluminal device including a woven fiber hypotube, in accordance with at least one aspect of the present disclosure.

[0025] Fig. 13 is a diagrammatic side view of a portion of an intraluminal device including a woven fiber hypotube, in accordance with at least one aspect of the present disclosure.

[0026] Fig. 14 is a diagrammatic side view of a portion of an intraluminal device including a woven fiber hypotube, in accordance with at least one aspect of the present disclosure.DETAILED DESCRIPTION

[0027] For the purposes of promoting an understanding of the principles of the present disclosure, reference will now be made to the aspects illustrated in the drawings, and specific language will be used to describe the same. It is nevertheless understood that no limitation to the scope of the disclosure is intended. Any alterations and further modifications to the described devices, systems, and methods, and any further application of the principles of the present disclosure are fully contemplated and included within the present disclosure as would normally occur to one skilled in the art to which the disclosure relates. In particular, it is fully contemplated that the features, components, and / or steps described with respect to one aspect may be combined with the features, components, and / or steps described with respect to other aspects of the present disclosure. Further, while the aspects of the present disclosure may be described with respect to a blood vessel, it will be understood that the devices, systems, and methods described herein may be configured for use in any suitable anatomical structure or body lumen including a blood vessel, blood vessel lumen, an esophagus, eustachian tube, urethra, fallopian tube, intestine, colon, and / or any other suitable anatomical structure or body lumen. In other aspects, the devices, systems, and methods described herein may be used to examine any number of anatomical locations and tissue types, including without limitation, organs including the liver, heart, kidneys, gall bladder, pancreas, lungs; ducts; intestines; nervous system structures including the brain, dural sac, spinal cord and peripheral nerves; the urinary tract; as well as valves within the blood vessels, chambers or other parts of the heart, and / or other systems of the body. In addition to natural structures, the intraluminal devices, described herein, may be used to examine man-made structures such as, but without limitation, heart valves, stents, shunts, filters, and other devices. For the sake of brevity, however, the numerous iterations of these combinations will not be described separately.

[0028] The example aspects described below recognize that it may be desirable to have a method of manufacturing that includes manufacturing a woven fiber hypotube having at least two states or two configurations. The hypotube may be formed using a machine to weave fibers creating a hypotube in a relaxed configuration. One or more components are placed in the woven fiber hypotube in the relaxed configuration. The hypotube in the relaxed configuration has a greater diameter and a shorter length than the hypotube in the constricted (contracted) configuration, which has a smaller diameter and a longer length. When the hypotube is in its relaxed configuration, tension is longitudinally applied to the hypotube to transform the hypotube from a relaxed configuration to a constricted configuration. In the constricted configuration, a matrix material such as an adhesive is applied at least in between individual fibers of the woven fiber hypotubes. The matrix material is cured to maintain the woven hypotube in the constricted configuration permanently and / or when the hypotube is assembled with the remainder of the intraluminal device.

[0029] One or more aspects described below provide apparatuses related to preventing kink points along a length of an intraluminal device such as intravascular device. For example, the woven fibers and matrix material forming the hypotube may be more flexible and create a smoother transition between the hypotube and the remainder of the intraluminal device in comparison to a solid, rigid hypotube. In some aspects, a matrix material is added along the length of the hypotube and around the edges of the hypotube to create a smooth outer surface for the hypotube and create a smooth surface profile.

[0030] One or more example aspects below provides apparatuses related to increasing flexibility of hypotubes. For example, rather than using a solid metal hypotube, which is very rigid, a hypotube may be made using a plurality of woven fibers which are very flexible. A matrix material may be added around and / or between the plurality of woven fibers and cured to set the hypotube in a tensioned state. Although the hypotube is cured, the hypotube is still more flexible than a solid metal hypotube and / or a solid metal hypotube having one or more slits or cuts that add flexibility to only a portion of the hypotube.

[0031] One or more illustrative aspects described below provide apparatuses related to hypotubes that conform to the shape of the one or more components such as one or more core wires and conductive wires within the hypotube. The hypotube, having an expanded configuration, may allow for more room to put one or more components within the hypotube and may provide for a greater number of configurations of the one or more components within the hypotube due to the increase in diameter. The hypotube, having a constricted configuration, may allow for the hypotube under tension to conform to the shape of the one or more components placed within the hypotube.

[0032] Fig. 1 is a diagrammatic top view of an intravascular device 102, according to aspects of the present disclosure. The intravascular device 102 may be an intravascular, intraluminal, or endoluminal guidewire, catheter, or guide catheter sized and shaped for positioning within a blood vessel of a patient. The intravascular device 102 may include a sensor 112. For example, the sensor 112 may be a pressure sensor configured to measure a pressure of blood flow within the vessel of the patient. The intravascular device 102 includes the flexible elongate member 106. The sensor 112 is disposed at the distal portion 107 of the flexible elongate member 106. The sensor 112 may be mounted at the distal portion 107 within a housing 280 in some aspects. A flexible tip coil 290 extends between the housing 280 and the distal end 108. The connection portion 114 is disposed at the proximal portion 109 of the flexible elongate member 106. The connection portion includes the conductive portions 132, 134, 136. In various aspects, the conductive portions 132, 134, 136 may be conductive ink that is printed and / or deposited around the flexible elongate member 106. In some aspects, the conductive portions 132, 134, 136 may be conductive, metallic rings that are positioned around the flexible elongate member. The locking section 118 and knob or retention section 120 are disposed at the proximal portion 109 of the flexible elongate member 106.

[0033] The intravascular device 102 in Fig. 1 includes a distal core 210 and a proximal core 220. A joint between the distal core 210 and proximal core 220 is surrounded and contained by a hypotube 215. The distal core 210 and the proximal core 220 are metallic components forming part of the body of the intravascular device 102. For example, the distal core 210 and the proximal core 220 are flexible metallic rods that provide structure for the flexible elongate member 106. The diameter of the distal core 210 and the proximal core 220 may vary along its length.

[0034] In some various, the intravascular device 102 comprises a distal assembly and a proximal assembly that are electrically and mechanically joined together, which results in electrical communication between the sensor 112 and the conductive portions 132, 134, 136. For example, pressure data obtained by the sensor 112 (in this example, sensor 112 is a pressure sensor) may be transmitted to the conductive portions 132, 134, 136. Control signals from a computer in communication with the intravascular device 102 may be transmitted to the sensor 112 via the conductive portions 132, 134, 136. The distal subassembly may include the distal core 210. The distal subassembly may also include the sensor 112, conductive members 230, and / or one or more layers of polymer / plastic 240 surrounding the conductive members 230 and the core 210. For example, the polymer / plastic layer(s) may protect the conductive members 230. The proximal subassembly may include the proximal core 220. The proximal subassembly may also include one or more layers of polymer layer(s) 250 (hereinafter polymer layer 250) surrounding the proximal core 220 and / or conductive ribbons 260 embedded within the one or more layers of polymer layer(s) 250. In some aspects, the proximal subassembly and the distal subassembly may be separately manufactured.During the assembly process for the intravascular device 102, the proximal subassembly and the distal subassembly may be electrically and mechanically joined together. As used herein, flexible elongate member may refer to one or more components along the entire length of the intravascular device 102, one or more components of the proximal subassembly (e g., including the proximal core 220, etc.), and / or one or more components the distal subassembly 210 (e.g., including the distal core 210, etc.).

[0035] In various aspects, the intravascular device 102 may include one, two, three, or more core wires extending along its length. For example, a single core wire may extend substantially along the entire length of the flexible elongate member 106. In such aspects, the locking section 118 and the knob or retention section 120 may be integrally formed at the proximal portion of the single core wire. The sensor 112 may be secured at the distal portion of the single core wire. In other aspects, such as the aspect illustrated in Fig. 1, the locking section 118 and the knob or retention section 120 may be integrally formed at the proximal portion of the proximal core 220. The sensor 112 may be secured at the distal portion of the distal core 210. The intravascular device 102 includes one or more conductive members 230 in communication with the electronic component (sensor 112). For example, the conductive members 230 may be one or more electrical wires that are directly in communication with the sensor 112. In some instances, the conductive members 230 are electrically and mechanicallycoupled to the sensor 112 by, e.g., soldering. In some instances, the conductive members 230 comprise two or three electrical wires (e.g., abifilar cable or a trifilar cable). An individual electrical wire may include a bare metallic conductor surrounded by one or more insulating layers. The conductive members 230 may extend along the length of the distal core 210. For example, at least a portion of the conductive members 230 may be spirally wrapped around the distal core 210.

[0036] The intravascular device 102 includes one or more conductive ribbons 260 at the proximal portion of the flexible elongate member 106. The conductive ribbons 260 are embedded within polymer layer(s) 250. The conductive ribbons 260 are directly in communication with the conductive portions 132, 134, and / or 136. In some instances, the conductive members 230 are electrically and mechanically coupled to the sensor 112 by, e.g., soldering. In some instances, the conductive portions 132, 134, and / or 136 comprise conductive ink (e.g., metallic nano-ink, such as silver or gold nano-ink) that is deposited or printed directed over the conductive ribbons 260.

[0037] As described herein, electrical communication between the conductive members 230 and the conductive ribbons 260 may be established at the connection region 270 of the flexible elongate member 106. By establishing electrical communication between the conductive members 230 and the conductive ribbons 260, the conductive portions 132, 134, 136 may be in electrically communication with the sensor 112.

[0038] In some instances, represented by Fig. 1, intravascular device 102 includes the locking section 118 and the knob or retention section 120. To form the locking section 118, a machining process is necessary to remove the polymer layer 250 and the conductive ribbons 260 in the locking section 118 and to shape proximal core 220 in the locking section 118 to the desired shape. As shown in Fig. 1, the locking section 118 includes a reduced diameter while the knob or retention section 120 has a diameter substantially similar to that of proximal core 220 in the connection portion 114. In some instances, because the machining process removes conductive ribbons in locking section 118, proximal ends of the conductive ribbons 260 would be exposed to moisture and / or liquids, such as blood, saline solutions, disinfectants, and / or enzyme cleaner solutions, an insulation layer 158 is formed over the proximal end portion of the connection portion 114 to insulate the exposed conductive ribbons.

[0039] Fig. 2 is a diagrammatic side view of an intraluminal (e.g., intravascular) sensing system 100 that includes an intravascular device 102 comprising conductive members 230 (e.g., a multi-filar electrical conductor bundle) and conductive ribbons 260, according to aspects of the present disclosure. The intravascular device 102 may be an intravascular guidewire sized and shaped for positioning within a blood vessel of a patient. The intravascular device 102 includes a distal tip 108 and a sensor 113. For example, the sensor 113 may be a pressure sensor and / or flow sensor configmed to measure a pressure of blood flow within the vessel of the patient, or another type of sensor including but not limited to a temperature or imaging sensor, or combination sensor measuring morethan one property. For example, the flow data obtained by a flow sensor may be used to calculate physiological variables such as coronary flow reserve (CFR). The intravascular device 102 includes a flexible elongate member 106. The sensor 113 is disposed at a distal portion 107 of the flexible elongate member 106. The sensor 113 may be mounted at the distal portion 107 within a housing 282 in some aspects. A flexible tip coil 290 extends distally from the housing 282 at the distal portion 107 of the flexible elongate member 106. A connection portion 114 located at a proximal end of the flexible elongate member 106 includes conductive portions 132, 134. In some aspects, the conductive portions 132, 134 may be conductive ink that is printed and / or deposited around the connection portion 114 of the flexible elongate member 106. In some aspects, the conductive portions 132, 134 are conductive, may be metallic bands or rings that are positioned around the flexible elongate member. A locking area is formed by a collar or locking section 118 and knob or retention section 120 are disposed at the proximal portion 109 of the flexible elongate member 106.

[0040] The intravascular device 102 in Fig. 2 includes core wire comprising a distal core 210 and a proximal core 220. The distal core 210 and the proximal core 220 are metallic components forming part of the body of the intravascular device 102. For example, the distal core 210 and the proximal core 220 may be flexible metallic rods that provide structure for the flexible elongate member 106. The distal core 210 and / or the proximal core 220 may be made of a metal or metal alloy. For example, the distal core 210 and / or the proximal core 220 may be made of stainless steel, Nitinol, nickel-cobalt- chromium-molybdenum alloy (e.g., MP35N), and / or other suitable materials. In some aspects, the distal core 210 and the proximal core 220 are made of the same material. In other aspects, the distal core 210 and the proximal core 220 are made of different materials. The diameter of the distal core 210 and the proximal core 220 may vary along their respective lengths. A joint between the distal core 210 and proximal core 220 is surrounded and contained by a hypotube 215. The sensor 113 may in some cases be positioned at a distal end of the distal core 210.

[0041] In some aspects, the intravascular device 102 comprises a distal subassembly and a proximal subassembly that are electrically and mechanically joined together, which creates an electrical communication between the sensor 113 and the conductive portions 132, 134. For example, flow data obtained by the sensor 113 (in this example, sensor 113 is a flow sensor) may be transmitted to the conductive portions 132, 134. In an exemplary aspect, the sensor 113 is a single ultrasound transducer element. The transducer element emits ultrasound signals and receives echoes. The transducer element generates electrical signals representative of the echoes. The signal carrying filars carry this electrical signal from the sensor at the distal portion to the connector at the proximal portion. The processing system 306 processes the electrical signals to extract the flow velocity of the fluid.

[0042] Control signals from a processing system 306 (e.g., a processor circuit of the processing system 306) in communication with the intravascular device 102 may be transmitted to the sensor 113via a connector 314 that is attached to the conductive portions 132, 134. The distal subassembly may include the distal core 210. The distal subassembly may also include the sensor 113, the conductive members 230, and / or one or more layers of insulative polymer / plastic 240 surrounding the conductive members 230 and the core 210. For example, the polymer / plastic layer(s) may insulate and protect the conductive members of the multi-filar cable or conductor bundle 230. The proximal subassembly may include the proximal core 220. The proximal subassembly may also include one or more polymer layers 250 (hereinafter polymer layer 250) surrounding the proximal core 220 and / or conductive ribbons 260 embedded within the one or more insulative and / or protective polymer layer 250. In some aspects, the proximal subassembly and the distal subassembly are separately manufactured. During the assembly process for the intravascular device 102, the proximal subassembly and the distal subassembly may be electrically and mechanically joined together. As used herein, flexible elongate member 106 may refer to one or more components along the entire length of the intravascular device 102, one or more components of the proximal subassembly (e.g., including the proximal core 220, etc.), and / or one or more components the distal subassembly (e.g., including the distal core 210, etc.). Accordingly, flexible elongate member 106 may refer to the combined proximal and distal subassemblies described above. The joint between the proximal core 220 and distal core 210 is surrounded by the hypotube 215.

[0043] In various aspects, the intravascular device 102 may include one, two, three, or more core wires extending along its length. For example, a single core wire may extend substantially along the entire length of the flexible elongate member 106. In such aspects, a locking section 118 and a section 120 may be integrally formed at the proximal portion of the single core wire. The sensor 113 may be secured at the distal portion of the single core wire. In other aspects, such as the aspect illustrated in Fig. 2, the locking section 118 and the section 120 may be integrally formed at the proximal portion of the proximal core 220. The sensor 113 may be seemed at the distal portion of the distal core 210. The intravascular device 102 includes one or more conductive members 230 (e.g., a multi-filar conductor bundle or cable) in communication with the sensor 113. For example, the conductive members 230 may be one or more electrical wires that are directly in communication with the sensor 113. In some instances, the conductive members 230 are electrically and mechanically coupled to the sensor 113 by, e.g., soldering. In some instances, the conductor bundle 230 comprises two or three electrical wires (e.g., a bifilar cable or a trifilar cable). An individual electrical wire may include a bare metallic conductor surrounded by one or more insulating layers. The conductive members 230 may extend along the length of the distal core 210. For example, at least a portion of the conductive members 230 may be spirally wrapped around the distal core 210, minimizing or eliminating whipping of the distal core within tortuous anatomy.

[0044] The intravascular device 102 includes one or more conductive ribbons 260 at the proximal portion of the flexible elongate member 106. The conductive ribbons 260 are embedded within polymer layer 250. The conductive ribbons 260 are directly in communication with theconductive portions 132 and / or 134. In some instances, a multi-filar conductor bundle 230 is electrically and mechanically coupled to the sensor 113 by, e.g., soldering. In some instances, the conductive portions 132 and / or 134 comprise conductive ink (e.g., metallic nano-ink, such as copper, silver, gold, or aluminum nano-ink) that is deposited or printed directed over the conductive ribbons 260.

[0045] As described herein, electrical communication between the conductive members 230 and the conductive ribbons 260 may be established at the connection portion 114 of the flexible elongate member 106. By establishing electrical communication between the conductor bundle 230 and the conductive ribbons 260, the conductive portions 132, 134 may be in electrical communication with the sensor 113.

[0046] In some aspects represented by Fig. 1, the intravascular device 102 includes a locking section 118 and knob or retention section 120. To form locking section 118, a machining process is used to remove polymer layer 250 and conductive ribbons 260 in locking section 118 and to shape proximal core 220 in locking section 118 to the desired shape. As shown in Fig. 1, locking section 118 includes a reduced diameter while knob or retention has a diameter substantially similar to that of proximal core 220 in the connection portion 114. In some instances, because the machining process removes conductive ribbons in locking section 118, proximal ends of the conductive ribbons 260 would be exposed to moisture and / or liquids, such as blood, saline solutions, disinfectants, and / or enzyme cleaner solutions, an insulation layer 158 is formed over the proximal end portion of the connection portion 114 to insulate the exposed conductive ribbons 260.

[0047] In some aspects, a connector 314 provides electrical connectivity between the conductive portions 132, 134 and a patient interface monitor 304. The Patient Interface Monitor (PIM) 304 may in some cases connect to a console or processing system 306, which includes or is in communication with a display 308.

[0048] The system 100 may be deployed in a catheterization laboratory having a control room. The processing system 306 may be located in the control room. Optionally, the processing system 306 may be located elsewhere, such as in the catheterization laboratory itself. The catheterization laboratory may include a sterile field while its associated control room may or may not be sterile depending on the procedure to be performed and / or on the health care facility. In some aspects, device 102 may be controlled from a remote location such as the control room, such that an operator is not required to be in close proximity to the patient.

[0049] The intraluminal device 102, PIM 304, and display 308 may be communicatively coupled directly or indirectly to the processing system 306. These elements may be communicatively coupled to the medical processing system 306 via a wired connection such as a standard copper multi-filar conductor bundle 230. The processing system 306 may be communicatively coupled to one or more data networks, e g., a TCP / IP -based local area network (LAN). In other aspects, different protocolsmay be utilized such as Synchronous Optical Networking (SONET). In some cases, the processing system 306 may be communicatively coupled to a wide area network (WAN).

[0050] The PIM 304 transfers the received signals to the processing system 306 where the information is processed and displayed (e.g., as physiology data in graphical, symbolic, or alphanumeric form) on the display 308. The console or processing system 306 may include a processor and a memory. The processing system 306 may be operable to facilitate the features of the intravascular sensing system 100 described herein. For example, the processor may execute computer readable instructions stored on the non-transitory tangible computer readable medium.

[0051] The PIM 304 facilitates communication of signals between the processing system 306 and the intraluminal device 102. The PIM 304 may be communicatively positioned between the processing system 306 and the intraluminal device 102. In some aspects, the PIM 304 performs preliminary processing of data prior to relaying the data to the processing system 306. In examples of such aspects, the PIM 304 performs amplification, filtering, and / or aggregating of the data. In an aspect, the PIM 304 also supplies high- and low-voltage DC power to support operation of the intraluminal device 102 via the conductive members 230.

[0052] A multi-filar cable or transmission line bundle 230 may include a plurality of conductors, including one, two, three, four, five, six, seven, or more conductors. In the example shown in Fig. 2, the multi-filar conductor bundle 230 includes two straight portions 232 and 236, where the multi-filar conductor bundle 230 lies parallel to a longitudinal axis of the flexible elongate member 106, and a spiral portion 234, where the multi -filar conductor bundle 230 is wrapped around the exterior of the flexible elongate member 106 and then overcoated with an insulative and / or protective polymer 240. Communication, if any, along the multi-filar conductor bundle 230 may be through numerous methods or protocols, including serial, parallel, and otherwise, where one or more filars of the bundle 230 carry signals. One or more filars of the multi-filar conductor bundle 230 may also carry direct current (DC) power, alternating current (AC) power, or serve as a ground connection.

[0053] The display or monitor 308 may be a display device such as a computer monitor or other type of screen. The display or monitor 308 may be used to display selectable prompts, instructions, and visualizations of imaging data to a user. In some aspects, the display 308 may be used to provide a procedure-specific workflow to a user to complete an intraluminal imaging procedure.

[0054] Before continuing, it should be noted that the examples described above are provided for purposes of illustration and are not intended to be limiting. Other devices and / or device configurations may be utilized to carry out the operations described herein.

[0055] Fig. 3A and Fig. 3B are perspective views of at least some components of an example woven fiber hypotube, in accordance with at least one embodiment of the present disclosure. Visible are the hypotube 215 including a plurality of woven fibers 300 and a central lumen 302. The plurality of woven fibers 300 extend around a circumference of the hypotube 215 having the central lumen 302extending within the hypotube 215 along the longitudinal axis 303. Fig. 3A illustrates the woven fiber hypotube 215 in a relaxed or expanded state (without the application of tension). Fig. 3A illustrates the woven fiber hypotube 215 in a contracted or tensioned state (because of the application of tension 320, 322 in opposite directions along the axis 303). The overall shape / profile of the hypotube 215 is the same in Figs. 3 A and 3B, but the dimensions are different. In particular, the length of the hypotube (along axis 303) is shorter in Fig. 3A than in Fig. 3B. Application of tension 320, 322 increases the length of the hypotube (along axis 303) such that the length in Fig. 3B is longer than in Fig. 3 A. The height or diameter (in the direction perpendicular to the axis 303) is larger in Fig. 3A than in Fig. 3B. Application of tension 320, 322 decreases the height or diameter of the hypotube (in the direction perpendicular to the axis 303) such that the height or diameter in Fig. 3B is smaller than in Fig. 3A. As described below, the overall shape / profile of the hypotube 215 will be different in the contracted / tensioned state vs. the relaxed / expanded / un-tensioned state. This is because hypotube 215 will be tensioned with components inside the lumen 302, so that the shape / profile hypotube 215, in the contracted / tensioned state, will follow the shape / profile of the components inside the hypotube 215 (see, e.g., radial cross-sectional views in Figs. 7 and 11). Longitudinal cross-sectional views of the hypotube 314 (e g., along section line 4-4) in the expanded / relaxed state are shown in, e g., Figs. 4A and 4B. Longitudinal cross-sectional views of the hypotube 314 (e.g., along section line 4-4) in the contracted / tensioned state are shown in, e.g., Figs. 4C, 4D, 5, and 12.

[0056] In one or more instances, the hypotube 215 is a tubular member that extends along a length of a flexible elongate member. In some instances, the plurality of woven fibers 300 may be made of a composite material, carbon fiber, aramid, and / or any other stranded fiber material. In various aspects, the plurality of woven fibers 300 have a variety of patterns, densities (strands per inch along the length), and materials. In some aspects, the plurality of woven fibers 300 includes a matrix material 315 such as an adhesive, polymer, potting compound, or the like. The matrix material may be configured to keep the shape of the hypotube in a tensioned state, as described herein. The matrix material may be configured to prevent the hypotube from returning to the un-tensioned state, as described herein. In various aspects, the lumen 302 is an opening that extends along the longitudinal axis 303 and is surrounded by the plurality of woven fibers 300. In one or more aspects, the plurality of woven fibers 300 define the lumen 302.

[0057] Figs. 3A and 3B may illustrate portions of an intraluminal device, such as the intravascular device 102 including the flexible elongate member 106 depicted as a pressure-sensing guidewire in Fig. 1 or the flow-sensing intraluminal device 102 of Fig. 2. The hypotube of Figs. 3 A and 3B may include other features of the intraluminal devices shown in Figs. 1 and 2. The hypotube 215 can include other features of other hypotubes described herein.

[0058] In some aspects, the intravascular devices described herein can include an already-woven woven fiber hypotube 215. For example, before the proximal and distal subassemblies are joinedtogether using the woven fiber hypotube 215 (during manufacturing of the intravascular device), the woven fiber hypotube 215 can be already be woven into the cylindrical shape shown in Figs. 3A and 3B. Thus, the weaving / winding of the fibers 300 into the woven fiber hypotube 215 can be separate from manufacturing the intravascular device (e.g., joining the proximal and distal subassemblies together using the woven fiber hypotube 215).

[0059] In other aspects, the woven fiber hypotube 215 is not already woven. For example, the weaving / winding the fibers 300 of the woven fiber hypotube 215 occurs while the proximal and distal subassemblies are being joined together using the woven fiber hypotube 215. The fibers 300 can be weaved / winded over the workpiece (e.g., proximal core, distal core, electrical wires, etc.) directly such that the proximal core, distal core, and / or electrical wires act as the mandrel for the woven fiber hypotube 215.

[0060] Collectively, Figs. 4A-4D illustrate aspects of a woven fiber hypotube for an intravascular device according to the present disclosure In particular, Figures 4A-4D illustrate the woven fiber hypotube of the intravascular device at different stages of manufacturing according to one or more aspects.

[0061] Referring to Fig. 4A, shown therein is a diagrammatic, cross-sectional side view of the hypotube 215 along the 4-4 line, according to an aspect of the present disclosure, according to an example aspect. As shown, a plurality of woven fibers 300 of the hypotube 215 include a first fiber 300a, a second fiber 300b, and athird fiber 300c. The hypotube 215 includes a plurality of openings 305 interleaving between the plurality of woven fibers 300. For example, the opening 305a extends between the first fiber 300a and the third fiber 300c. An inner diameter “inner DI” 307 is the diameter of the lumen 302 of the hypotube 215. The inner DI 307 is the same or approximate to the distance between two fibers such as the first fiber 300a and the second fiber 300b. In some instances, the first fiber 300a, the second fiber 300b, and / or the third fiber 300c are the same fiber wrapped around different portions of the hypotube 215. In other instances, the first fiber 300a, the second fiber 300b, and / or the third fiber 300c are distinct and separate fibers. The outer diameter “outer DI 310” is the dimension from top to bottom as shown in the cross-sectional view of Fig. 4A of the hypotube 215, inclusive of the plurality of woven fibers 300. The outer DI 310 is greater than the inner DI 307. The hypotube 215 extends along a length (“LI”) 312. The lumen 302 extending within hypotube 215 is shown in dotted lines.

[0062] In manufacturing, individual fibers of the plurality of woven fibers 300 are woven via a machine to form a hypotube having a diameter (inner DI 307 and outer diameter 310) and a length (LI 312). The machine may create a variety of weave patterns for the plurality of woven fiber 300. The machine may vary the size, shape, and number of the plurality of openings 305, the density of the weave, the angle(s) by which the weave is distributed (such as 45 degrees along LI 312), the number of fibers of the plurality of woven fibers 300, and the like.

[0063] In some instances, the hypotube 215 is woven in situ around one or more individual components (not shown). In other aspects, the hypotube 215 is woven separately. In some aspects, the plurality of woven fibers 300 is woven and then cut into discrete lengths forming the hypotube 215. In some aspects, the plurality of woven fibers 300 are spooled for later cutting to size (for forming the hypotube 215).

[0064] Referring to Fig. 4B, shown therein is a diagrammatic, cross-sectional side view of the hypotube 215 in accordance with an example aspect. Fig. 4B can depict an intermediate stage of manufacturing of the intraluminal device, such as when the proximal subassembly and distal subassembly are being joined together. The hypotube 215 includes a proximal end 211 of distal core 210, a distal end 221 of proximal core 220, and conductive members 230 disposed within the lumen 302. Within the hypotube 215, the proximal end 211 of the distal core 210 extends from a distal end 316 along a portion of LI 312. Within the hypotube 215, the distal end 221 of proximal core 220 extends from the proximal end 318 along another portion of LI 312. The distal end 221 of the proximal core 220 is adjacent to and / or in direct contact with a proximal end 211 of the distal core 210. The conductive members 230 are disposed above the proximal end 211 of the distal core 210 and the distal end 221 of proximal core 220 and extend along the entire length of LI 312. The plurality of openings 305 of Fig. 4A has been filled with the matrix material 315. The matrix material 315 is also within the lumen 302. The matrix material 315 fills the remainder of empty space within the hypotube 215. The matrix material 315 is in direct contact with and / or adjacent to the proximal end 211 of the distal core 210, the distal end 221 of proximal core 220, the conductive members 230, and the plurality of woven fibers 300. The matrix material 315 may be an adhesive material.

[0065] In manufacturing, one or more components such as the proximal end 211 of the distal core 210, the distal end 221 of proximal core 220, and conductive members 230 are inserted within the hypotube 215. The one or more components are then positioned in their respective desired locations within the hypotube 215. A matrix material 315 (e.g., in liquid or otherwise uncured form) is then inserted within the hypotube 215 to fill in gaps, openings (such as the plurality of openings 305 in Fig. 4a), and recesses. The matrix material 315 may be applied in a variety of ways such as, but not limited to, vacuum sealing the hypotube 215 and pumping in the matrix material 315 to fill the gaps or the matrix material 315, the matrix material 315 may be directly applied over the hypotube 215, or use a pre-impregnated material to heat cure the matrix material 315 in to fix the one or more components and the plurality of woven fibers 300 in place.

[0066] In some aspects, adding a liquid / uncured matrix material 315 is a separate step compared to, e.g., positioning the woven fiber hypotube 215 around the distal core 210, the proximal core 220, and / or the conductive members 230. For example, the woven fiber hypotube 215 is distinct from the matrix material 315. The matrix material 315 can be applied in over the top of the fibers after the woven fiber hypotube 215 is in the desired position (e.g., longitudinal location at junction betweenproximal and distal subassemblies, such as at junction between the distal core 210, the proximal core 220). The matrix material 315 can also be applied to the distal core 210, the proximal core 220, and / or the conductive members 230, and then after that, the woven fiber hypotube can be tensioned around matrix material 315 (and other components). This could advantageously aid in guaranteeing the fibers are completely saturated with the matrix material 315.

[0067] In some aspects, the woven fiber hypotube 215 is impregnated / pre -impregnated with the matrix material 315, such as before positioning the woven fiber hypotube 215 around the distal core 210, the proximal core 220, and / or the conductive members 230. The woven fiber hypotube 215 can be impregnated / pre-impregnated with the matrix material 315 such that the matrix material 315 is positioned between, inside, radially aligned with, and / or outside the fibers of the woven fiber hypotube 215. In such instances, adding the matrix material 315 can be the same step compared to, e.g., positioning the woven fiber hypotube 215 around the distal core 210, the proximal core 220, and / or the conductive members 230.

[0068] Referring to Fig. 4C, shown therein is a diagrammatic, cross-sectional side view of the hypotube 215, in accordance with an example aspect. Fig. 4C can depict an intermediate stage of manufacturing of the intraluminal device (e.g., occurring after the stage shown in Fig. 4B) such as when the proximal subassembly and distal subassembly are being joined together. The hypotube 215 includes the proximal end 211 of the distal core 210, the distal end 221 of proximal core 220, the conductive members 230 disposed above the proximal end 211 of the distal core 210 and the distal end 221 of the proximal core 220, the matrix material 315, and the plurality of woven fibers 300. Tension 320 and tension 322 are applied to the hypotube 215. The matrix material 315 extends past the plurality of woven fibers 300 at a distance 324 in a radial direction and at a distances 326 in the longitudinal direction along the length (“L2”) 328. The outer diameter (“outer D2”) 330 of the hypotube 215 is the dimension from top to bottom as shown in the cross-sectional view of Fig. 4C of the hypotube 215 along L2. The inner diameter (“inner D2”) 332 of the hypotube 215 is the diameter of the lumen 302.

[0069] In manufacturing, the tension 320 applies a force on the hypotube 215 along the longitudinal axis 303 in a distal direction. Tension 322 applies a force on the hypotube 215 along the longitudinal axis 303 in a proximal direction. In one example, one end of the hypotube 215 is held in place during manufacturing, while tension is applied (e.g., by a fiber weaving machine or a different machine) to the opposite end, which results in tension 320, 322 being applied in opposite directions (along the axis 303 in Figs. 3A, 3B). The tensions 320 and 322 cause the outer diameter to decrease from outer DI 310 to outer D2 330, the inner diameter to decrease from inner DI 307 to inner D2 332, and the length to increase from LI 312 to L2 328. Applying the tensions 320 and 322 also cause the matrix material 315 to conform to the shape of the one or more components such as the conductive members 230, the proximal end 211 of the distal core 210, and the distal end 221 ofproximal core 220. The matrix material 315 conforms to an outer profile of the one or more components. Applying the tensions 320 and 322 also cause the matrix material 315 to seep out past the plurality of woven fibers 300 in the radial direction by a distance such as the distance 324 and seep out past the one or more components and the plurality of woven fibers 300 in the longitudinal direction by a distance such as distance 326. Applying the tensions 320 and 322 cause the hypotube 215 to conform to the shape of the one or more components (e.g., the outer profile) such as the matrix material 315, the conductive members 230, the proximal end 211 of the distal core 210, and the distal end 221 of proximal core 220.

[0070] Referring to Fig. 4D, shown therein is a diagrammatic, cross-sectional side view of the hypotube 215, according to one example aspect. Fig. 4C can depict a late stage of manufacturing of the intraluminal device (after the stages shown in Figs. 4B and 4C) or when the manufacturing of the intraluminal device is complete, and the proximal subassembly and distal subassembly have been joined together. The hypotube 215 includes the proximal end 211 of the distal core 210, the distal end 221 of proximal core 220, the conductive members 230 disposed above the proximal end 211 of the distal core 210 and the distal end 221 of the proximal core 220, the matrix material 315, the plurality of woven fibers 300, and a hydrophilic coating 334. The hydrophilic coating 334 is an optional outermost layer of the hypotube 215 in the radial direction. The hydrophilic coating 334 extends around the plurality of woven fibers 300 and the matrix material 315 along a length (“L3”) 336 of the hypotube 215. In such instances, the hydrophilic coating 334 can be in contact with both the matrix material 315 and the woven fibers 300 because the woven fibers 300 and the matrix material 315 alternate along the length (“L3”) 336 of the hypotube 215. The outer diameter (“outer D3”) 338 of the hypotube 215 is the dimension from top to bottom as shown in the cross-sectional view of Fig. 4D of the hypotube 215 along L3. The inner diameter (“inner D3”) 340 of the hypotube 215 is the diameter of the lumen 302.

[0071] In manufacturing, the excess matrix material 315 (shown in Fig. 4c) is removed to create a relatively smooth, even outer surface of the hypotube. The removal of the excess matrix material 315 reduces the outer diameter from outer D2 330 to outer D3 338, the inner diameter stays relatively the same from inner D2 332 to inner D3 340 and reduces the length from L2 328 to L3 336. The matrix material 315 is cured for a set amount of time in order to harden the matrix material 315. Hardening the matrix material 315 allows for the effects of the applied tensions 320 and 322 (described in Fig. 4c) to be maintained such as conforming the matrix material 315 and the plurality of woven fibers 300 around the one or more components. Additionally curing the matrix material 315 provides for a smooth outer diameter between the plurality of woven fibers 300 and the matrix material 315. In some instances, due to the flexibility of the plurality of woven fibers 300, even after curing the hypotube 215 remains flexible. After removal of the excess matrix material 315 and after curing, the hydrophilic coating 334 is applied around the outer circumference of the hypotube 215.

[0072] In some instances, the excess matrix material 315 is removed after curing. In some instances, the hydrophilic coating 334 is also applied on at least a portion of the distal end 316 and the proximal end 318.

[0073] With continuing reference to Figs. 4A-D, in one or more instances, the plurality of woven fibers 300 is one fiber wrapped around the length 312 forming a hypotube 215. In other aspects, the plurality of woven fibers 300 is two, three, four, or more individual fibers wrapped around the length 312 of the hypotube 215. In various aspects, the plurality of woven fibers 300 include a plurality of materials forming the woven fibers such as carbon and aramid. In some aspects the plurality of woven fibers 300 include a first layer of a first material of a first size and a second layer of a second material of a second size, and the first layer may differ from the second layer in size, composition, and / or shape. In one or more aspects, a plurality of woven fibers 300 includes a plurality of sections of a single fiber. The plurality of sections of a single fiber are woven around itself. The plurality of woven fibers 300 may be made of at least one of: carbon, aramid, stranded metallic fiber, or fiber glass. Carbon provides the highest relative tensile strength, aramid is more flexible than carbon, and the stranded metallic fiber and fiber glass have lower relative tensile strength and are less resilient than carbon and aramid. In other instances, another material is used for the plurality of woven fibers 300 that has sufficient tensile strength and resiliency to form a hypotube 215. The size of individual fibers of the plurality of woven fibers 300 may vary in length, thickness, and width.

[0074] In several aspects, the first fiber 300a and the second fiber 300b are the same fiber wrapped around the circumference of the hypotube 215. In one or more instances, the first fiber 300a is a different fiber than the second fiber 300b. In several aspects, the first fiber 300a and the third fiber 300c are the same fiber wrapped around the perimeter of the hypotube 215. In one or more instances, the third fiber 300c is a different fiber than the first fiber 300a. In several aspects, the third fiber 300c and the second fiber 300b are the same fiber wrapped around the perimeter of the hypotube 215. In one or more instances, the third fiber 300c is a different fiber than the second fiber 300b. In some aspects, two fibers of the plurality of woven fibers 300 may be directly adjacent from one another along the longitudinal axis 303. In one or more aspects, a single fiber of the plurality of woven fibers 300 may be on either side of the lumen 302 at the same location along the longitudinal axis 303. In one or more aspects, two or more individual fibers of the plurality of woven fibers 300 may be on either side of the lumen 302 at the same location along the longitudinal axis 303. In some aspects, two fibers of the plurality of woven fibers 300 may be directly adjacent from one another along the longitudinal axis 303.

[0075] In one or more aspects, the plurality of openings 305 may vary in size, shape, orientation, and / or number from what is shown in Fig. 4A. In some aspects, two openings of the plurality of openings 305 may be directly adjacent from one another along the longitudinal axis 303. In one ormore aspects, a single opening of the plurality of openings 305 may be on either side of the lumen 302 at the same location along the longitudinal axis 303.

[0076] In some aspects, the inner DI 307 is consistent along the LI 312 of the hypotube 215. In several instances, the outer DI 310 is inconsistent along the LI 312 of the hypotube 215 due to the openings 305 and the plurality of woven fibers 300. In some aspects, the inner DI 307 is varying along the LI 312.

[0077] In some aspects, the inner D2 332 is consistent along the L2 328 of the hypotube 215. In several instances, the outer D2 330 is inconsistent along the L2 328 of the hypotube 215 due to excess matrix material 315 seeping out due to the application of the tension 320 and the tension 322. In some aspects, the inner D2 332 is varying along the L2 324.

[0078] In some aspects, the inner D3 340 is consistent along the L3 336 of the hypotube 215. In several instances, the outer D3 338 is inconsistent along the L2 328 of the hypotube 215 due to the shape of the plurality of woven fibers 300. In other instances, the outer D3 338 is consistent along the L2 328 of the hypotube 215 due by applying the matrix material 315 to smooth out the shape of individual fibers of the plurality of woven fibers 300. In some aspects, the inner D3 340 is varying along the L3 336.

[0079] In some aspects, the matrix material 315 is an adhesive such as epoxy resin or another similar resin. In several instances, the matrix material 315 includes a material capable of laminating together individual fibers of the plurality of woven fibers 300. The matrix material 315 may be, in some instances, in direct contact with each individual fiber of the plurality of woven fibers 300. In some instances, the matrix material 315 is placed over the plurality of woven fibers 300, and therefore the matrix material 315 may radially extend around the plurality of woven fibers 300. In other instances, the matrix material 315 does not radially extend around the plurality of woven fibers 300, but may be directly adjacent to the plurality of fibers in a longitudinal direction and / or a radial direction. In some aspects, the matrix material 315 must be cured in order to harden or set the matrix material 315. In some aspects, the matrix material 315 is in direct contact with one or more components in the hypotube 215. In some aspects, the matrix material 315 is configured to couple the distal end 221 of the proximal core 220 and the proximal end 211 of the distal core 210. In one or more aspects, the matrix material 315 fills every void within the hypotube 215. In some aspects, when tensioned, the matrix material 315 seeps out of top, bottom, and sides of the hypotube 215. In some aspects, the hypotube 215 is cleaned to remove the excess matrix material 315 that seeps out of the top, bottom, and sides of the hypotube 215. The matrix material 315, in several aspects, seeps out of the hypotube 215 in a radial direction. The distance the matrix material 315 seeps may be the distance 324. In some aspects, the distance 324 includes only one side of the hypotube along a location on L2 328 (as shown in Fig. 4C). In other aspects, the distances 324 includes the radial distance along every side of the hypotube along a location on L2 328. In some aspects, the matrix material 315 seeps atvarying distances and / or rates along L2 328. In one or more aspects, the matrix material 315 seeps out of the hypotube 215 in the longitudinal direction at a distance 326. The distance 326 may be the same on both the proximal and distal ends of the hypotube 215, in some aspects. In other aspects, the amount of excess matrix material 315on the proximal and distal ends of the hypotube 215 varies.

[0080] In some aspects, only tension 322 is applied. For example, the hypotube 215 may be clamped or held at the proximal end 318 and pulled (tension 322). In other aspects, only tension 320 is applied. In some aspects, tension 320 and tension 322 are equal and opposite forces pulling the hypotube 214 along the longitudinal direction. In other aspects, the hypotube 215 is pressed along the length such as L2 328 to squeeze out the excess matrix material 315 and have the remainder of the matrix material 315 conform to the shape of the one or more components within the hypotube 215.

[0081] In some aspects, the hydrophilic coating 334 is applied to the exterior of the hypotube 215. The hydrophilic coating 334 in some instances is omitted.

[0082] In some aspects, the conductive members 230 may include one or more wires or optical fibers extending within the lumen 302 of the hypotube 215. In other aspects, the conductive members 230 extend outside of the hypotube 215 along an outer diameter of the hypotube 215. In several aspects, the conductive members 230 may include three wires extending within the hypotube 215. In other embodiments, the conductive members 230 are a conductive wire bundle. In some instances, the conductive members 230 directly contact the distal end 221 of the proximal core 220 and / or the proximal end 211 of the distal core 210. In one or more aspects, the conductive members 230 are proximate at least one of the plurality of woven fibers 300. In some aspects, the conductive members 230 directly contact one or more fibers of the plurality of woven fibers 300. In some instances, the plurality of woven fibers 300 is conformed to the conductive members 230 such that the shape or profile of the plurality of woven fibers 300 corresponds to the shape or profile of the conductive members 300.

[0083] In several aspects, the proximal end 211 of the distal core 210 and the distal end 221 of proximal core 220 have varying shapes. In some aspects, the proximal end 211 of the distal core 210 and the distal end 221 of the proximal core 220 are in the shape of a circle, oval, polygon, or the like. In one or more instances, the proximal end 211 of the distal core 210 and the distal end 221 of the proximal core 220 are in contact with each other. In some instances, the proximal end 211 of distal core 210 and the distal end 211 of the proximal core 220 are coupled together. In several instances, the distal core 210 and the proximal core 220 are different sizes. In some aspects, the proximal end 211 of the distal core 210 directly contacts one or more fibers of the plurality of woven fibers 300. In some aspects, the distal end 221 of proximal core 220 directly contacts one or more fibers of the plurality of woven fibers 300. In one or more aspects, the plurality of woven fibers 300, in the tensioned state, conform to the distal end 221 of the proximal core 220 and the proximal end 211 of the distal core 210.

[0084] In some instances, different components (such as additional wires or a sensor) are inserted into the hypotube 215 than the components shown in Figs. 4A-4D.

[0085] In some aspects, Figs. 4A-4B show the hypotube 215 in an expanded state or configuration. The expanded configuration is shown with the outer DI 310 and the inner DI 307 being greater than the outer D2 330 and D3 338 and the inner D2 332 and D3 340. In one or more aspects, the one or more components such as the proximal end 211 of the distal core 210, the distal end 221 of proximal core 220, and the conductive members 230 are inserted and positioned within the hypotube 215 in the expanded configuration.

[0086] In some aspects, Fig. 4C shows the hypotube 215 in a transition state or configuration. In other aspects, Fig.4C shows the hypotube 215 in a contracted stated. In some aspects, the length L2 328 is increased from LI 312.

[0087] In various instances, Fig. 4D shows the hypotube in a contracted state or configuration. In some instances, Fig. 4D is the final state of manufacturing for the hypotube. In some instances, L3 336 is less than L2 328 and greater than LI 312. In one or more instances, the inner D3 340 is the same as the inner D2 332. In other aspects, the inner D3 varies either greater or smaller than D2 332. In some aspects, the inner D3 340 is smaller than inner DI 307. In one or more aspects, the outer D3 338 is smaller than outer DI 310 and outer D2 330. In some aspects, the conductive members 230 are spaced closer to the distal end 221 of proximal core 220 and the proximal end 211 of the distal core 210 in the contracted state than in the expanded state. In one or more instances, the conductive members 230 are spaced closer to a first portion of the plurality of woven fibers 300 in the contracted state than the expanded state. In various aspects, the distal end 221 of the proximal core 220 and the proximal end 211 of the distal core 210 are positioned closer to the conductive members 230 in the contracted state than in the expanded state. In one or more instances, the distal end 221 of the proximal core 220 and the proximal end 211 of the distal core 210 are spaced closer to a second portion of the plurality of woven fibers 300 (opposite to the first portion) in the contracted state than in the expanded state. In various aspects, less matrix material 315 is present in the hypotube 215 in the contracted state (as shown in Fig. 4D), than in the transition state (as shown in Fig. 4C) or the expanded state (as shown in Fig. 4B).

[0088] In some instances, the matrix material 315 can completely surround the outside of the woven fibers 300 of the hypotube 215. For example, a layer of the matrix material 315 can be positioned between the woven fibers 300 and the hydrophilic coating 334, along an entire length of the woven fiber hypotube 215. In such instances, the hydrophilic coating 334 is in contact with the matrix material 315 and not the woven fibers 300 because the woven fibers 300 are spaced from the hydrophilic coating 334 by the matrix material 315. TO provide the matrix material 315 on the outside of the hypotube 315, the excess matrix material 315 (Fig. 4C) can be spread or distributed along the outside of the hypotube 315 and / or additional matrix material 315 can be added to the outside of thehypotube 315. Thus, the matrix material 31 can be positioned on the inside of the hypotube 315 and / or the outside of the hypotube 315.

[0089] Figs. 4A-D may illustrate portions of an intraluminal device, such as the intravascular device 102 including the flexible elongate member 106 depicted as a pressure-sensing guidewire in Fig. 1 or the flow-sensing intraluminal device 102 of Fig. 2 The hypotube 215 of Figs. 4-5 may include other features of the intraluminal devices shown in Figs. 1 and 2. The hypotube 215 can include other features of other hypotubes described herein, such as hypotube 215 of Fig. 3.

[0090] Referring to Fig. 5, shown therein is a diagrammatic, cross-sectional side view of the hypotube 215 according to one example aspect. Fig. 5 can depict a late stage of manufacturing of the intraluminal device (after the stages shown in Figs. 4B and 4C) or when the manufacturing of the intraluminal device is complete, and the proximal subassembly and distal subassembly have been joined together. The hypotube 215 includes the proximal end 211 of the distal core 210, the distal end 221 of proximal core 220, the conductive members 230 disposed above both the proximal end 211 of the distal core 210 and the distal end 221 of proximal core 220, the plurality of woven fibers 300, and a hydrophilic coating 334. The hypotube 215 includes a first matrix material 342 and a second matrix material 344. The first matrix material 342 is interleaved between the plurality of woven fibers 300. The hydrophilic coating 334 disposed radially around the plurality of woven fibers 300 and the interleaved first matrix material 342. The hydrophilic coating 334 is the outermost layer of the hypotube 215 in the radial direction. The second matrix material 344 is disposed within the lumen 302. The second matrix material 344 is in contact with the proximal end 211 of the distal core 210, the distal end 221 of proximal core 220, and the conductors 230.

[0091] In manufacturing, in some aspects, the second matrix material 344 is used to hold in place the proximal end 211 of the distal core 210, the distal end 221 of the proximal core 220, and the conductive members 230. The second matrix material 344 may be cured to set the second matrix material 344. The proximal end 211 of the distal core 210, the distal core 221 of the proximal core 220, and the conductive members 230 cured in the second matrix material 344 may be inserted into the hypotube 215. The first matrix material 342 may be in a form of a dry sheet placed over the hypotube 215 and rolled out so that the first matrix material 342 seeps into openings (such as the plurality of openings 305). The first matrix material 342 may then be cured so that the hypotube 215 is maintained in its contracted state, as described herein.

[0092] In some instances, the first matrix material 342 is the matrix material 315. In other instances, the first matrix material 342 is a polymer, adhesive or the like. In several instances, the first matrix material 342 is applied to the hypotube 215 in a different manner such as, but not limited to, by being inserted into the openings between the plurality of woven fibers 300. In some instances, the first matrix material 342 is cured and / or set after the second matrix material 344. In some instances, the proximal end 211 of the distal core 210, the distal end 221 of the proximal core 220, and theconductive members 230 are set in the second matrix material 344 and inserted into the hypotube; then, the plurality of woven fibers 300 are tensioned to contact the set second matrix material 344; and then the first matrix material 342 is applied and cured. In other instances, the first matrix material 342 is set at the same time as the second matrix material 344.

[0093] In various aspects, the second matrix material 344 is the matrix material 315. In other instances, the second matrix material 344 is a polymer, adhesive such as epoxy resin, or the like. In several instances, the second matrix material 344 is applied when the conductive members 230, the proximal end 211 of the distal core 210, and the distal end 221 of proximal core 220 are disposed within the hypotube 215. In other instances, the second matrix material is applied over the proximal end 211 of the distal core 210 and the distal end 221 of the proximal core 220 prior to insertion into the hypotube 215. In some instances, the set second matrix material 344 includes the proximal end 211 of the distal core 210, the distal end 221 of the proximal core 220, and the conductive members 230 and is inserted into the hypotube 215 in its expanded state. In some instances, the second matrix material 344 is cured and / or set before the first matrix material 342. In some instances, the first matrix material 342 differs in composition from the second matrix material 344. In one or more aspects, the first matrix material 342 is cured for a different period of time than the second matrix material. In some instances, the second matrix material 344 is configured to couple the distal end 221 of the proximal core 220 with the proximal end 211 of the distal core 210.

[0094] Fig. 5 may illustrate portions of an intraluminal device, such as the intravascular device 102 including the flexible elongate member 106 depicted as a pressure-sensing guidewire in Fig. 1 or the flow-sensing intraluminal device 102 of Fig. 2 The hypotube 215 of Fig. 5 may include other features of the intraluminal devices shown in Figs. 1 and 2. The hypotube 215 can include other features of other hypotubes described herein, such as hypotube 215 of Figs. 3-4D.

[0095] Fig. 6 is a diagrammatic side view of an example hypotube 346. The hypotube 346 includes a distal end 348 and a proximal end 350. The distal end 348 and the proximal end 350 are separated by a length 352. The hypotube 346 includes a plurality of fibers 354 wound along the length 352 and a matrix material 356 interleaved with one or more fibers of the plurality of fibers 354. For example, a first fiber 354a is wrapped around at least a portion of the length 352 in a first direction and a second fiber 354b wrapped around at least a portion of the length 352 in a second direction. The first fiber 354a may contact the second fiber 354b in one or more locations. Between a portion of the first fiber 354a and a portion of the second fiber 354b is a portion of the matrix material 356a.

[0096] In several instances, an outermost diameter and / or perimeter of the hypotube 346 may vary along radial direction. In some instances, an outermost diameter and / or perimeter of the hypotube 346 may vary along the length 352.

[0097] In some instances, the matrix material 356 extends the length 352. In several instances, the matrix material 356 extends over the plurality of fibers 354. In other instances, the matrix material356 extends between individual fibers of the plurality of fibers 354 such as the portion of the matrix material 356a extending between the first fiber 354a and the second fiber 354b. In some aspects, the matrix material 356 may be composed of one or more of: an adhesive, polymer, or similar material. In various instances, the matrix material 356 may be the radially outermost layer of the hypotube 346 to create a smooth outermost layer of the hypotube 346. In some aspects, a hydrophilic coating is the radially outermost layer of the hypotube 346. The matrix material 356 and the plurality of fibers 354, in other instances, are both the radially outermost layer of the hypotube 346.

[0098] In several instances, the plurality of fibers 354 are woven by a machine. In some instances, the plurality of fibers 354 are replaced with a single fiber wound around the length 352. In some instances, the single fiber is wound around the length 352 in a first direction and around the length 352 in a second direction, different from the first. In other aspects, the plurality of fibers 354 include two, three, four, or more woven fibers. In one or more aspects, the plurality of fibers 354 may be composed of carbon, carbon-aramid composition, aramid, stranded metallic fiber, fiber glass, or a similar material. In some aspects, the first fiber 354a is composed of a first material, and the second fiber 354b is composed of a second different material. In some aspects, the individual fibers such as the first fiber 354a of the plurality of fibers 354 each have the same diameter. In several aspects, the individual fibers such as the first fiber 354a of the plurality of fibers 354 each have the same length. In other aspects, the first fiber 354a and the second fiber 354b is composed of the same material. For example, by keeping the first fiber 354a and the second fiber 354b the same material provides for the same outermost perimeter and / or circumference for the hypotube 346 along the length 352. In some aspects, the plurality of fibers 354 are wound around the length 352 at a 45 -degree angle from the proximal end 350 to the distal end 348. In various aspects, the plurality of fibers 354 are wound around the length 352 at a 45-degree angle from the distal end 348 to the proximal end 350. In some aspects, the plurality of fibers 354 are at 90-degree angle with respect to one another. For example, the first fiber 354a may be at a 90-degree angle with respect to the second fiber 354b. In various aspects, individual fibers of the plurality of fibers 354 are 45 degrees to one another and 45 degrees along the length 352 to provide the most flexibility to the hypotube 346. In other aspects, the plurality of fibers 354 are at 45-degree angle with respect to one another. In various aspects, the plurality of fibers 354 are at one or more angles such as but not limited to 45, 50, 60, 75, 90-degree angle with respect to one another. In various aspects, the plurality of fibers 354 are at one or more angles such as but not limited to 45, 50, 60, 75, 90, 180 degree angle with respect to the length 352. In some instances, a portion of the plurality of fibers 354 are wrapped along the length 352 of the hypotube 346 at a first angle and another portion of the plurality of fibers 354 are wrapped along the length 352 at a second angle.

[0099] Fig. 6 may illustrate portions of an intraluminal device, such as the intravascular device 102 including the flexible elongate member 106 depicted as a pressure-sensing guidewire in Fig. 1 or the flow-sensing intraluminal device 102 of Fig. 2 The hypotube 346 of Fig. 6 may include otherfeatures of the intraluminal devices shown in Figs. 1 and 2. The hypotube 346 can include other features of other hypotubes described herein, such as hypotube 215 of Figs. 3-5.

[0100] Fig. 7 is a diagrammatic cross-sectional view of the example hypotube 346 of Fig. 6 along the 7-7 line. The hypotube 346 includes the plurality of fibers 354 and the matrix material 356 disposed around the distal end 221 of proximal core 220 and the conductive members 230. The matrix material 356 extends between the conductive member 230 and the distal end 221 of the proximal core 220. The matrix material 356 may be interleaved between one or more fibers of the plurality of woven fibers 300.

[0101] In some instances, curing the matrix material 356, when the plurality of woven fibers 300 are in the tensioned (contracted state) as described herein, may cause the plurality of fibers 354 to grip portions of the distal end 221 of the proximal core 220 and the proximal end 211 of the distal core 210 (not shown in Fig. 7), and the conductive members 230. In various instances, a portion of the conductive members 230 contacts the distal end 221 of the proximal core 220. In some aspects, at least a portion of the plurality of fibers 354 contacts directly the conductive members 230, the distal end 221 of the proximal core 220, and / or the proximal end 211 of the distal core 210 (not shown). In several aspects, at least a portion of the matrix material 356 contacts directly the conductive members 230, the distal end 221 of the proximal core 220, and / or the proximal end 211 of distal core 210 (not shown). In some aspects, the matrix material 356 is disposed between two individual fibers of the plurality of fibers 354. In one or more aspects, the matrix material 356 is disposed between the plurality of fibers 354 and the conductive members 230 and / or the distal end 221 of the proximal core 220.

[0102] Fig. 7 may illustrate portions of an intraluminal device, such as the intravascular device 102 including the flexible elongate member 106 depicted as a pressure-sensing guidewire in Fig. 1 or the flow-sensing intraluminal device 102 of Fig. 2 The hypotube 346 of Fig. 7 may include other features of the intraluminal devices shown in Figs. 1 and 2. The hypotube 346 can include other features of other hypotubes described herein, such as hypotube 215 of Figs. 3-5 and the hypotube 346 of Fig. 6.

[0103] Fig. 8 is a diagrammatic side view of an example hypotube 358. The hypotube 358 includes a distal end 360 and a proximal end 362. The distal end 360 and the proximal end 362 are separated by a length 364. The hypotube 358 includes a plurality of fibers 366 wound along the length 364 and a matrix material 368 interleaved with one or more fibers of the plurality of fibers 366. The plurality of fibers 366 along the length 364 are a denser weave than for example, the plurality of fibers 354 along the length 352. The denser weave of hypotube 358 includes more fibers per inch creating a stronger and more rigid hypotube than the hypotube 346.

[0104] In several instances, an outermost diameter and / or perimeter of the hypotube 358 may vary along radial direction. In some instances, an outermost diameter and / or perimeter of the hypotube 358 may vary along the length 364.

[0105] In some instances, the matrix material 368 extends the length 364. In several instances, the matrix material 368 extends over the plurality of fibers 366. In other instances, the matrix material 368 extends between individual fibers of the plurality of fibers 366. In some aspects, the matrix material 368 may be composed of one or more of: an adhesive, polymer, or similar material. In various instances, the matrix material 368 may be the radially outermost layer of the hypotube 358 to create a smooth outermost layer of the hypotube 346. In some aspects, a hydrophilic coating is the radially outermost layer of the hypotube 358. The matrix material 368 and the plurality of fibers 366, in other instances, are both the radially outermost layer of the hypotube 358.

[0106] In several instances, the plurality of fibers 366 are woven by a machine. In some instances, the plurality of fibers 366 are replaced with a single fiber wound around the length 364. In some instances, the single fiber is wound around the length 364 in a first direction twice and around the length 352 in a second direction only once, the second direction different than the first. In other aspects, the plurality of fibers 366 include two, three, four, or more woven fibers. In one or more aspects, the plurality of fibers 366 may be composed of carbon, carbon-aramid composition, aramid, stranded metallic fiber, fiber glass, or a similar material. In some aspects, the individual fibers of the plurality of fibers 366 each have the same diameter. In some aspects, the plurality of fibers 366 are wound around the length 364 at a 45-degree angle from the proximal end 362 to the distal end 360. In various aspects, the plurality of fibers 366 are wound around the length 364 at a 45-degree angle from the distal end 360 to the proximal end 362. In some aspects, the plurality of fibers 366 may be wound around the length 364 at a different angle with respect to the length 364 and / or each other to change the mechanical properties of the hypotube 358. In one or more instances, the plurality of fibers 366 are wound multiple times around the length 364 to create a denser weave. A denser weave, for example, may provide rigidity and more structural support by having more fibers of the plurality of fibers 366 and less of the matrix material 368 along the length 364.

[0107] Fig. 8 may illustrate portions of an intraluminal device, such as the intravascular device 102 including the flexible elongate member 106 depicted as a pressure-sensing guidewire in Fig. 1 or the flow-sensing intraluminal device 102 of Fig. 2 The hypotube 358 of Fig. 8 may include other features of the intraluminal devices shown in Figs. 1 and 2. The hypotube 358 can include other features of other hypotubes described herein, such as hypotube 215 of Figs. 3-5 and the hypotube 346 of Figs. 6-7.

[0108] Fig. 9 is a diagrammatic side view of an example hypotube 370. The hypotube 370 includes a distal end 372 and a proximal end 374. The distal end 372 and the proximal end 374 are separated by a length 376. The hypotube 370 includes a plurality of fibers 378 wound along the length376 and a matrix material 380 in between one or more fibers of the plurality of fibers 366. The plurality of fibers 366 are at a 90-degree angle with respect to the length 376. The plurality of fibers 366 are at a 90-degree angle with respect to one another. For example, the plurality of fibers 378 along the length 376 are at a different angle along the length 376 than the plurality of fibers 336 along the length 364 of Fig. 8.

[0109] In several instances, an outermost diameter and / or perimeter of the hypotube 370 may vary along radial direction. In some instances, an outermost diameter and / or perimeter of the hypotube 370 may vary along the length 376.

[0110] In some instances, the matrix material 380 extends the length 376. In several instances, the matrix material 380 is in direct contact and / or adjacent to the plurality of fibers 378. In one or more instances, the matrix material 380 extends over the plurality of fibers 378. In other instances, the matrix material 380 extends between individual fibers of the plurality of fibers 378. In some aspects, the matrix material 380 may be composed of one or more of: an adhesive, polymer, or similar material. In various instances, the matrix material 380 may be the radially outermost layer of the hypotube 370 to create a smooth outermost layer of the hypotube 370. In some aspects, a hydrophilic coating is the radially outermost layer of the hypotube 370. The matrix material 380 and the plurality of fibers 378, in other instances, are both the radially outermost layer of the hypotube 370.

[0111] In several instances, the plurality of fibers 378 are woven by a machine. In some instances, the plurality of fibers 378 are replaced with a single fiber wound around the length 376. In some instances, one or more fibers of the plurality of fibers 378 is wound around the length 376 in a first direction and another one or more fibers around a width. In some aspects, the plurality of fibers 378 include two, three, four, or more woven fibers. In one or more aspects, the plurality of fibers 378 may be composed of carbon, carbon-aramid composition, aramid, stranded metallic fiber, fiber glass, or a similar material. In some aspects, the individual fibers of the plurality of fibers 378 each have the same diameter. In some aspects, a portion of the plurality of fibers 378 are wound around the length 376 at a 90-degree angle from the proximal end 374 to the distal end 372. In various aspects, at least a portion of the plurality of fibers 378 are wound around the length 376 at a 90-degree angle from the distal end 372 to the proximal end 374. In some aspects, the plurality of fibers 378 may be wound around the length 376 at a different angle than 90-degrees with respect to the length 376 and / or each other to change the mechanical properties of the hypotube 370. In various aspects, the individual fibers of the plurality of fibers 378 are at a 90-degree angle with respect to each other. A 90-degree angle with respect to the length and / or to each other, for example, may provide rigidity and more structural support than smaller angles such as a 45 degree angle described herein. In some instances, at least a portion of the plurality of fibers 378 are wrapped around a width of the hypotube 370 such that the portion of the plurality of fibers 378 extend along the length 376. In some aspects, at least a portion of the plurality of fibers 378 are parallel to the length 376 and another portion of the pluralityof fibers 378 are perpendicular to the length 376. In one or more instances, the plurality of fibers 378 are wound multiple times around the length 376 to create a denser weave. In various instances, the plurality of fibers 378 are wound multiple times around the width to create a denser weave A denser weave, for example, may provide rigidity and more structural support by having more fibers of the plurality of fibers 378 and less of the matrix material 380 along the length 376.

[0112] Fig. 9 may illustrate portions of an intraluminal device, such as the intravascular device 102 including the flexible elongate member 106 depicted as a pressure-sensing guidewire in Fig. 1 or the flow-sensing intraluminal device 102 of Fig. 2 The hypotube 370 of Fig. 9 may include other features of the intraluminal devices shown in Figs. 1 and 2. The hypotube 370 can include other features of other hypotubes described herein, such as hypotube 215 of Figs. 3-5, the hypotube 346 of Figs. 6-7, and the hypotube 358 of Fig. 8.

[0113] Fig. 10 is a diagrammatic side view of an example hypotube 382. The hypotube 382 includes a distal end 384 and a proximal end 386. The distal end 384 and the proximal end 386 are separated by a length 388. The hypotube 382 includes a first layer of a plurality of fibers 390 wound along the length 388 and a matrix material 394 in between one or more fibers of the first layer of the plurality of fibers 390. The hypotube 382 includes a second layer of a plurality of fibers 392 wound along the length 388, having the matrix material 394 in between one or more fibers of the second layer of the plurality of fibers 392. The second layer of the plurality of fibers 392 is disposed beneath the first layer of the plurality of fibers 390. The first layer of the plurality of fibers 390 is located radially outward from the second layer of the plurality of fibers 392. The first layer of the plurality of fibers 390 are at a 45 -degree angle with respect to the length 388. Individual fibers of the first layer of the plurality of fibers 390 are at a 45-degree angle with respect to each other. The second layer of the plurality of fibers 392 are at a 90-degree or a 180-degree angle with respect to the length 388.Individual fibers of the second layer of the plurality of fibers 392 are at a 90-degree angle with respect to each other.

[0114] In several instances, an outermost diameter and / or perimeter of the hypotube 382 may vary along radial direction. In some instances, an outermost diameter and / or perimeter of the hypotube 382 may vary along the length 388.

[0115] In some instances, the matrix material 394 extends the length 388. In several instances, the matrix material 394 is in direct contact and / or adjacent to the first layer of the plurality of fibers 390 and to the second layer of the plurality of fibers 392. In one or more instances, the matrix material 394 extends over the first layer of the plurality of fibers 390 and / or the second layer of the plurality of fibers 392. In other instances, the matrix material 394 extends between individual fibers of the first layer of the plurality of fibers 390 and to the second layer of the plurality of fibers 392 along the length 388. In some aspects, the matrix material 394 may be composed of one or more of: an adhesive, polymer, or similar material. In various instances, the matrix material 394 may be theradially outermost layer of the hypotube 382 to create a smooth outermost layer of the hypotube 382. In some aspects, a hydrophilic coating is the radially outermost layer of the hypotube 382. The matrix material 394 and the first layer of the plurality of fibers 390, in other instances, are both the radially outermost layer of the hypotube 382. In some instances, the composition of the matrix material 394 differs between the first layer of the plurality of fibers 390 and the second layer of the plurality of fibers 392. In some aspects, the amount of the matrix material 394 differs between the first layer of the plurality of fibers 390 and the second layer of the plurality of fibers 392. In various aspects, the matrix material 394 extends radially between the first layer of the plurality of fibers 390 and the second layer of the plurality of fibers 392.

[0116] In several instances, the second layer of the plurality of fibers 392 are woven by a machine, then the first layer of the plurality of fibers 390 are woven over the second layer of the plurality of fibers 392. In one or more instances, the second layer of the plurality of fibers 392 is woven; then the one or more components are added to the hypotube 382; then the matrix material 394 is added; then the second layer of the plurality of fibers 392 is tensioned to the contracted state; and the second layer of the plurality of fibers 392 is cured. In some instances, after the second layer of the plurality of fibers 392 is cured, then the first layer of the plurality of fibers 390 is woven and constricted into the contracted state, before applying and curing the matrix material 394. In other instances, the first layer of the plurality of fibers 390 and the second layer of the plurality of fibers 392 are woven prior to adding the matrix material 394. In several aspects, the first layer of the plurality of fibers 390 and the second layer of the plurality of fibers 392 are tensioned into the contracted state simultaneously. In several aspects, the density (e.g., fibers per inch along the length 388) varies along the length 388. In one or more aspects, the density between the first layer of the plurality of fibers 390 and the second layer of the plurality of fibers 392 is different In one or more instances, the second layer of the plurality of fibers 392 is denser than the first layer of the plurality of fibers 390. In other instances, the first layer of the plurality of fibers 390 is denser than the second layer of the plurality of fibers 392. In yet other instances, the first layer of the plurality of fibers 390 is the same density as the second layer of the plurality of fibers 392. In various aspects, the angles relative to individual fibers and / or to the length 388 of the first layer of the plurality of fibers 390 and of the second layer of the plurality of fibers 392 vary from what is shown in Fig. 10. For example, the angles relative to individual fibers and / or to the length may be the same in the first layer of the plurality of fibers 390 as the second layer of the plurality of fibers 392. In other aspects, the first layer of the plurality of fibers 390 is replaced by the second layer of the plurality of fibers 392. In yet other aspects, the first layer of the plurality of fibers 390 replaces the second layer of the plurality of fibers 392. In one or more aspects, the individual wires of the first layer of the plurality of fibers 390 and the individual fibers of second layer of the plurality of fibers 392 are the same size, shape, orientation, and / or number. In other aspects, the individual fibers of the first layer of the plurality of fibers 390 and the individual fibers second layer of the plurality of fibers 392 are different in size, shape,orientation, and / or number. For example, the second layer of the plurality of fibers 392 may have individual fibers that have less thickness than the individual fibers of the first layer of the plurality of fibers 390. In some aspects, the hypotube 382 includes additional layers of plurality of fibers around the first layer of the plurality of fibers 390. In several instances, a hydrophilic coating is applied to the exterior of the hypotube 382.

[0117] Fig. 10 may illustrate portions of an intraluminal device, such as the intravascular device 102 including the flexible elongate member 106 depicted as a pressure-sensing guidewire in Fig. 1 or the flow-sensing intraluminal device 102 of Fig. 2 The hypotube 382 of Fig. 10 may include other features of the intraluminal devices shown in Figs. 1 and 2. The hypotube 382 can include other features of other hypotubes described herein, such as hypotube 215 of Figs. 3-5, the hypotube 346 of Figs. 6-7, the hypotube 358 of Fig. 8, and the hypotube 370 of Fig. 9.

[0118] Fig. 11 is a diagrammatic cross-sectional view of the example hypotube 382 of Fig. 10 along the 11-11 line. The hypotube 382 includes the first layer of the plurality of fibers 390, the second layer of the plurality of fibers 392, and the matrix material 394. The matrix material 394 is disposed around the distal end 221 of proximal core 220 and the conductive members 230. The matrix material 394 extends between the conductive member 230 and the distal end 221 of the proximal core 220. The matrix material 394 may be interleaved between one or more fibers of the first layer of the plurality of fibers 390. The matrix material 394 may be interleaved between one or more fibers of the second layer of the plurality of fibers 392. The matrix material 394 may be disposed between the second layer of the plurality of fibers 392 and the first layer of the plurality of fibers 390.

[0119] In some instances, curing the matrix material 394, when the second layer of the plurality of fibers 392 are in the tensioned (contracted state) as described herein, may cause the individual fibers to grip portions of the proximal core 220, the distal core 210 (not shown in Fig. 7), and the conductive members 230. In some instances, curing the matrix material 394, when the first layer of the plurality of fibers 390 and the second layer of the plurality of fibers 392 are in the tensioned (contracted state) as described herein, may cause the individual fibers to grip portions of the proximal core 220, the distal core 210 (not shown in Fig. 7), and the conductive members 230. In various instances, a portion of the conductive members 230 contacts the distal end 221 of proximal core 220. In several aspects, the outer perimeter of the distal end 221 of proximal core 220 is shaped like a circle, oval, polygon or the like. In some aspects, at least a portion of the second layer of the plurality of fibers 392 contacts directly the conductive members 230, the distal end 221 of the proximal core 220, and / or the proximal end 211 of the distal core 210 (not shown). In several aspects, at least a portion of the matrix material 394 contacts directly the conductive members 230, the distal end 221 of the proximal core 220, and / or the proximal end 211 of the distal core 210 (not shown). In some aspects, the matrix material 394 is disposed between two individual fibers of the first layer of theplurality of fibers 390. In several aspects, the matrix material 394 is disposed between two individual fibers of the second layer of the plurality of fibers 392.

[0120] In some aspects, the amount of matrix material 394 disposed within the first layer of the plurality of fibers 390 is greater than the amount of the matrix material 394 disposed within the second layer of the plurality of fibers 392. In some aspects, a first matrix material is disposed within and / or between the first layer of the plurality of fibers 390, a second, differing matrix material is disposed within and / or between the second layer of the plurality of fibers 392, and / or a third, differing matrix material is disposed within and / or between the conductive members 230 and the distal end 221 of the proximal core 220. In one or more aspects, the matrix material 394 is disposed between the second layer of the plurality of fibers 392 and the conductive members 230 and / or the distal end 221 of the proximal core 220. In several instances, the thickness of each individual fiber of the first layer of the plurality of fibers 390 is the same. In one or more instances, the thickness of each individual fiber of the second layer of the plurality of fibers 392 is the same. In one or more instances, the thickness of individual fibers of the first layer of the plurality of fibers 390 is greater than the thickness of the individual fibers of the second layer of the plurality of fibers 392. In other aspects, the thickness of individual fibers of the first layer of the plurality of fibers 390 is less than or equivalent to the thickness of the individual fibers of the second layer of the plurality of fibers 392.

[0121] Fig. 11 may illustrate portions of an intraluminal device, such as the intravascular device 102 including the flexible elongate member 106 depicted as a pressure-sensing guidewire in Fig. 1 or the flow-sensing intraluminal device 102 of Fig. 2 The hypotube 382 of Fig. 11 may include other features of the intraluminal devices shown in Figs. 1 and 2. The hypotube 382 can include other features of other hypotubes described herein, such as hypotube 215 of Figs. 3-5, the hypotube 346 of Figs. 6-7, the hypotube 358 of Fig. 8, the hypotube 370 of Fig. 9, and the hypotube 382 of Fig. 10.

[0122] Fig. 12 is a cross-sectional side view of a portion of an intraluminal device 396 including the woven fiber hypotube 215 of Fig. 4D. Fig. 12 can depict a late stage of manufacturing of the intraluminal device (after the stages shown in Figs. 4B and 4C) or when the manufacturing of the intraluminal device is complete, and the proximal subassembly and distal subassembly have been joined together. The hypotube 215 includes the distal core 210, the proximal core 220, the conductive members 230 disposed above the distal core 210 and the proximal core 220, the matrix material 315, the plurality of woven fibers 300, and a hydrophilic coating 334. The hydrophilic coating 334 is the outermost layer of the portion of the intraluminal device 396 including the outermost layer of the hypotube 215 in the radial direction. A width or outer diameter 398 remains substantially constant along a length 400 of the portion of the intraluminal device 396. The distal core 210 extends distally past a distal end 402 of the hypotube 215, and the proximal core 220 extends proximally past a proximal end of the hypotube 215. The matrix material 315 is disposed over portions of the distal core210, the conductive members 230, and the proximal core 220 that extend past the hypotube to help maintain a relatively consistent outer diameter 398 of the portion of the intraluminal device 396.

[0123] In various aspects, the portion of the intraluminal device 396 is configured to be insertable into a lumen of a subject’s body. In some aspects, the portion of the intraluminal device 396 is configured to be insertable into a vessel of a subject’s body. In one or more instances, the portion of the intraluminal device 396 includes a flexible elongate member configured to be positioned within a blood vessel, and the flexible elongate member includes: a proximal portion, a distal portion, and a longitudinal axis. In some aspects, the hypotube 215 is configured to couple the proximal portion and the distal portion of the flexible elongate member. In one or more aspects, the hypotube 215 extends between a distal end of the proximal portion and a proximal end of the distal portion. In various instances, the hypotube 215 is positioned between the proximal subassembly and distal subassembly (as described in U.S. Patent No. 10,772,564, titled “Intravascular devices, systems, and methods having separate sections with engaged core components”, which is incorporated by reference herein in its entirety).

[0124] In some instances, the distal core 210 and the proximal core 220 have varying diameters along the length 400. In some instances, the matrix material 315 is disposed only on a top portion of the distal core 210 and the proximal core 220, extending past the hypotube 215 to further set the conductive member 230 and / or to maintain a relatively constant outer diameter 398. In other instances, the matrix material 315 is disposed on a top and bottom portion of the distal core 210 and the proximal core 220 extending past hypotube 215 to further set the conductive members 230 and / or to maintain a relatively constant outer diameter 398. In some instances, an additional layer of the matrix material 315 is added to the portion of the intraluminal device 396 that directly abuts the proximal end 404 of the hypotube 215 and extends proximally over and / or around a portion of the proximal core 220. In several instances, an additional layer of the matrix material 315 is added to the portion of the intraluminal device 396 that directly abuts the distal end 402 of the hypotube 215 and extends distally over and / or around a portion of the distal core 210. In some aspects, the additional layer is a different composition of matrix material. In other aspects, the additional layer is cured for a different amount of time than the matrix material 315 was cured for the hypotube. In some aspects, the conductive members 230 follow a route defined by the outer diameters of the distal core 210 and the proximal core 220. In various aspects, the distal core 210 is bound together with the proximal core 220 using the matrix 314. In some aspects, the distal core 210 is a different shape or size than the proximal core 220. In some aspects. The distal core 210 contacts the proximal core 220.

[0125] In one or more instances, the outer diameter 398 is equivalent to outer D3 338. In some instances, the outer diameter 398 is the same along the length 400. In some instances, the plurality of woven fibers 300 create small deviations in the outer diameter 398 along the length 400. In otherembodiments, the matrix material 315 extends radially over the plurality of woven fibers 300 to smooth out the outer diameter. In some instances, the hydrophilic coating is omitted.

[0126] Fig. 12 may illustrate portions of an intraluminal device, such as the intravascular device 102 including the flexible elongate member 106 depicted as a pressure-sensing guidewire in Fig. 1 or the flow-sensing intraluminal device 102 of Fig. 2 The portion of the intraluminal device 396 of Fig. 12 may include other features of the intraluminal devices shown in Figs. 1 and 2. The hypotube 215 can include other features of other hypotubes described herein, such as hypotube 215 of Figs. 3-5, the hypotube 346 of Figs. 6-7, the hypotube 358 of Fig. 8, the hypotube 370 of Fig. 9, and the hypotube 382 of Figs. 10-11.

[0127] Fig. 13 is a diagrammatic side view of an intraluminal device 410 with the hypotube 215 in accordance with an example aspect. Fig. 13 can depict an intermediate stage of manufacturing of the intraluminal device, such as when the proximal subassembly and distal subassembly are being joined together. The intraluminal device 410 also includes a distal core wire 414, a proximal core wire 416, and one or multiple conductive members 230 (e.g., electrical wires or electrical filars) that are positioned inside the woven fiber hypotube 412.

[0128] The distal core wire 414 includes a raised feature or projection 418, and the proximal core wire 416 includes a raised feature or projection 420. The projection 418 and the projection 420 is a part of respective core wire 414, 416 that has a relatively larger diameter 438 relative to adjacent and / or otherwise proximate portions of the respective core wire 414, 416, which have a relatively smaller diameter 440. As illustrated in Fig. 13, the projection 418 and the projection 420 have the same diameter 438, and the core wire 414 and the core wire 416 have the same diameter 440. In some instances, the diameters of the projections 418, 420 can be different from one another. In some instances, the diameters of the core wires 414, 416 can be different from one another. In some instances, the diameters of the core wires 414, 416 can be different from one another, but the diameters of the projections 418, 420 can be the same.

[0129] The projection 418 and the projection 420 can be integrally formed parts of the respective core wire 414, 415, in some instances. In other instances, the projection 418 and the projection 420 are physically distinct / separate components that are mechanically attached or otherwise coupled (e.g., soldering, welding, etc.) to the respective core wire 414, 415. The projection 418 can be made of a same or similar material (e g., metal / metal alloy) as the core wire 414, and the projection 420 can be made of a same or similar material (e.g., metal / metal alloy) as the core wire 416. The projection 418 and the projection 420 can be made of different materials, such as when the core wire 414 and the core wire 416 are formed of different materials.

[0130] The projection 418 is located at a proximal portion of the distal core wire 414. The projection 420 is located at a distal portion of the proximal core wire 416. As illustrated in Fig. 13, the distance between the distal end 417 of the core wire 414 and the projection 420, and the distancebetween the proximal end 415 of the core wire 414 and the projection 420 can be equal. In other instances, the projection 418 and the projection 420 are unequally spaced from the respective distal ends 415, 417. The projection 418 and the projection 420 can be longitudinally located at any suitable location along the longitudinal axis (in the proximal / distal direction) of the respective core wire 414, 416 around which the woven fiber hypotube 412 is positioned. For example, the projection 420 can be longitudinally located at the distal end 417 of the core wire 416, and the projection 418 can be longitudinally located at the proximal end 415 of the core wire 414.

[0131] As illustrated, the projection 418 and the projection 420 can be circumferentially located at and / or extend around only part of the perimeter / circumference of the respective core wire 414, 416. For example, in the cross-sectional side view and the orientation of the intraluminal device 410 depicted in Fig. 13, the projection 418 and the projection 420 are on top relative to the majority of the respective core wire 414, 416, which are on the bottom. In other instances, the projection 418 and the projection 420 can be located at and / or extend around some, most, or all of the perimeter / circumference of the respective core wire 414, 416. For example, the projection 418 and the projection 420 can be on the top and the bottom relative to the majority of the respective core wire 414, 416, which would radially located in the middle.

[0132] The projection 418 and the projection 420 can have any suitable shape, outer profile, and / or cross-sectional profile. The shape or profile of the projection 418 shown in Fig. 13 includes a distal-facing surface / wall 422, a radially outward facing surface / wall 424, and proximal-facing surface / wall 426. The cross-sectional shape or profile of the projection 420 shown in Fig. 13 includes surfaces or walls 428, 430, and 432.

[0133] When the woven fiber hypotube 412 is tensioned and constricted around the core wires 414, 416, the fibers of the woven fiber hypotube 412 mechanically grip the core wires 414, 416. As described herein, one or more multiple matrix materials (e.g., adhesives) can be positioned inside and / or outside the woven fiber hypotube 412 and cured to maintain the woven fiber hypotube 412 in the tensioned / constricted state. Because of this mechanical gripping, the woven fiber hypotube 412 provides a force on the components inside the hypotube (e.g., the core wires 414, 416, the conductors 230), shown by the arrows 442. In general, the force of the mechanical gripping is applied in the direction perpendicular to the direction that the woven fiber hypotube 412 is laying against the core wires 414, 416 (and / or other components inside the woven fiber hypotube 412), e.g., the perpendicular to the outline / outer profile of the woven fiber hypotube 412. For example, when the woven fiber hypotube 412 extends longitudinally / horizontally in the same direction as the core wires extend, the force is in the radially inward direction show by the arrows 442. This force is applied along the entire length of the woven fiber hypotube 412, though the arrows 442 are explicitly shown only at two longitudinal locations. (The force 448, 450 and directions 434, 436 is described below.) As described herein, the woven fiber hypotube 412 can be used at the joint or junction between thedistal subassembly of the intraluminal device (including the distal core 414) and the proximal subassembly of the intraluminal device (including the proximal core 416). The mechanical gripping by the woven fiber hypotube can advantageously increase the strength / holding power of the joint / junction formed by the woven fiber hypotube 412, the core wire 414, the core wire 416, and / or other components inside or outside the woven fiber hypotube 412 (e.g., one or multiple matrix materials described herein). For example, the woven fiber hypotube 412 itself contributes to holding the joint together and / or preventing the components forming the joint from separating from one another. This contribution by woven fiber hypotube 412 is in addition to the one or multiple matrix materials (e.g., adhesives) holding the joint together and / or mechanical engagement between the proximal portion of the distal core wire 414 and the distal portion of the proximal core wire 416 holding the joint together (as described in, e.g., U.S. Patent No. 10,772,564, titled “Intravascular devices, systems, and methods having separate sections with engaged core components”, which is incorporated by reference herein in its entirety). This mechanical gripping by the woven fiber hypotube 412 in provided in all of the aspects described herein (regardless of whether the distal and proximal core wires have the projections 418, 420 or not).

[0134] This mechanical gripping by the woven fiber hypotube 412 is even more pronounced when the core wires 414, 416 have the projections 418, 420. For example, the woven fiber hypotube 412, in its tensioned state, mechanically grips the surfaces or walls 422, 424, and 426 (and / or the comers where they meet) and the surfaces or walls 428, 430, and 432 (and / or the comers where they meet). The force exerted by the woven fiber hypotube 412 at a given location can be perpendicular to the outline of the woven fiber hypotube 412. When the woven fiber hypotube is constricted around the projections 418, 420, the outline of the woven fiber hypotube 412 has sloped and / or partially / fully vertical portions. For example, the portion 444 of the woven fiber hypotube 412 is sloped and / or at least partially vertical, which contacts and / or exerts a force 448 towards the projection 418 that is at least partially in the proximal direction (because the force is perpendicular to the sloped and / or at least partially vertical portion 444). The force 448 can be, e.g., exerted on the surface / wall 422, the surface / wall 424, and / or the comer between these surfaces / walls 422, 424. For example, the portion 446 of the woven fiber hypotube 412 is sloped and / or at least partially vertical, which contacts and / or exerts a force 450 towards the projection 420 that is at least partially in the distal direction (because the force is perpendicular to the sloped and / or at least partially vertical portion 446). The force 450 can be, e.g., exerted on the surface / wall 432, the surface / wall 430, and / or the corner between these surfaces / walls 432, 430. This advantageous because, through the mechanical gripping, the woven fiber hypotube urges, joins, and / or otherwise brings the core wire 414, 416 towards one another in the directions 434, 436 (corresponding to the direction of the forces 448, 450). This advantageously increases the strength / holding power of the joint / junction formed by the woven fiber hypotube 412, the core wire 414, the core wire 416, and / or other components inside or outside the woven fiber hypotube 412 (e g., one or multiple matrix materials described herein). As described above, the wovenfiber hypotube 412 itself contributes to holding the joint together and / or preventing the components forming the joint from separating from one another, which is in in addition to the one or multiple matrix materials (e.g., adhesives) holding the joint together and / or mechanical engagement between the proximal portion of the distal core wire 414 and the distal portion of the proximal core wire 416 holding the joint together.

[0135] In existing devices, a metal hypotube is only serving to constrain the joint. For example, the lumen of the metal hypotube only defines the volume to receive the ends of the core wires and the adhesive to couple the core wires. The strength of that joint in existing devices relies on the joining method itself (e.g., the strength of the adhesives), and not the tensile strength of the hypotube. The metal hypotube in the existing devices does not itself contribute to holding the joint together.

[0136] In contrast, the woven fiber hypotube 412 is made to grip the core wires 414, 416, which advantageously contributes to the overall tensile strength of that section of the device, leveraging the tensile strength for which composite materials (forming the woven fiber hypotube 412) are well suited. In some instances, this means the sectional area of the core(s) could be reduced in this region proportional to the tensile strength of the woven tube, resulting in the ability to further eliminate kink / hinge points and / or change stiffness characteristics as desired, potentially with no decrease in tensile strength.

[0137] The intraluminal device 410 can include features of other intraluminal devices described herein. For example, the hypotube 412 can include other features of hypotubes described herein, such as hypotube 215 of Figs. 3-5, the hypotube 346 of Figs. 6-7, the hypotube 358 of Fig. 8, the hypotube 370 of Fig. 9, the hypotube 382 of Figs. 10-11, and / or the hypotube 215 of Fig. 12. For example, the intraluminal device 410 can include one or multiple matrix materials between, inside, radially aligned with, and / or outside the woven fiber hypotube 412. In some instances, such as described with respect to Fig. 12, the one or multiple matrix materials can provide the intraluminal device 410 a uniform diameter and / or cross-sectional shape along the length of the woven fiber hypotube 412. Thus, while Fig. 13 illustrate a non-uniform uniform diameter and / or cross-sectional shape along the length of the woven fiber hypotube 412, the one or multiple matrix materials can fill the spaces inside and / or outside the woven fiber hypotube 412 (e.g., between projections 418 and 420) to provide a uniform diameter and / or cross-sectional shape for the intraluminal device 410. The intraluminal device 410 can also include a hydrophilic coating on the outside.

[0138] Fig. 14 is a diagrammatic, side view of an intraluminal device 500 with the hypotube 215 in accordance with an example aspect. Fig. 14 can depict an intermediate stage of manufacturing of the intraluminal device, such as when the proximal subassembly and distal subassembly are being joined together. The intraluminal device 500 also includes the distal core wire 414 (including proximal end 415), the proximal core wire 416 (including distal end 417), and one or multipleconductive members 230 (e.g., electrical wires or electrical filars) that are positioned inside the woven fiber hypotube 412.

[0139] The intravascular device 500 includes one or more clamps (e.g., clamps 504 and 506) that partially or fully maintain the tension in the woven fiber hypotube 412. The clamps 504 and 506 can be positioned completely around the perimeter of the woven fiber hypotube 412, the distal core wire 414, and / or the proximal core wire 416. The clamps 504 and 506 apply radially inward force to the outer surface of the woven fiber hypotube 412, so that the inner surface of the woven fiber hypotube 4f2 is urged against the outer surfaces of the distal core wire 414 and proximal core wire 416. This fixes the position of the clamps 504, 506 and the woven fiber hypotube 412 relative to the distal core wire 414 and proximal core wire 416, thereby partially or fully maintaining the woven fiber hypotube 412 in the tensioned state.

[0140] The clamps 504, 506 can be swaged and / or otherwise coupled to the woven fiber hypotube 412, the distal core wire 414, and / or the proximal core wire 416. For example, the clamps can be pressed, press fit, fixed with adhesive, etc.

[0141] The clamps 504, 506 can be made of a metal, metal alloy, or a polymer. In some instances, the material of the clamps 504, 506 can be radiopaque.

[0142] The clamp 504 can be positioned at a distal portion 514 of the woven fiber hypotube 4f2 and the clamp 504 can be positioned at a proximal portion 516 of the woven fiber hypotube 412. The distal portion 514 terminates at a distal end 524 of the woven fiber hypotube 412. The proximal portion 516 terminates at a proximal end 526 of the woven fiber hypotube 412. The clamp 504 can be positioned at the distal end 524 or spaced proximally from the distal end 524. The clamp 506 can be positioned at the proximal end 526 or spaced distally from the proximal end 526.

[0143] In some aspects, the clamps 504, 506 are sufficiently strongly coupled the woven fiber hypotube 412, the distal core wire 414, and / or the proximal core wire 416 to fully maintain tension of the woven fiber hypotube 412. In these instances, the need for a matrix material to form a laminate with the woven fibers is eliminated or minimized. One or multiple matrix materials could still be to provided (e.g., between, inside, radially aligned with, and / or outside the woven fiber hypotube 412) to create a uniform diameter and / or cross-sectional shape for the intraluminal device 500. The intraluminal device 500 can also include a hydrophilic coating on the outside. However, the one or more matrix materials and / or hydrophilic coating may not contribute at all or only minimally contribute to maintaining the woven fiber hypotube 412 in the tensioned state. Rather, the woven fiber hypotube 412 provides all or most of the contribution to maintaining the woven fiber hypotube 412 in the tensioned state.

[0144] In some aspects, the clamps 504, 506 are used hold the woven fiber hypotube 412 in the tensioned stated while a polymer coating or polymer jacket (e.g., one or more matrix materials) is applied over the woven fiber hypotube 412, the distal core wire 414, and / or the proximal core wire416. An example of a polymer coating or polymer jacket is described in U.S. 11,219,748, titled “Intravascular devices, systems, and methods having a polymer jacket formed around communication lines wrapped around a core member”, which is incorporated by reference herein in its entirety. The polymer coating or polymer jacket (e.g., one or more matrix materials) can be provided between, inside, radially aligned with, and / or outside the woven fiber hypotube 412. The polymer coating or polymer jacket (e.g., one or more matrix materials) forms the laminate with the fibers of the woven fiber hypotube 412 and forms part of the body / structure of the intravascular device 500. Both the clamps 504, 506 and the polymer coating or polymer jacket (e.g., one or more matrix materials) can contribute to maintaining the woven fiber hypotube 412 in the tensioned state. This approach can result in fewer layers in cross section and advantageously allow further reduction of outer diameter (OD) of the intravascular device 500. The polymer coating or polymer jacket (e.g., one or more matrix materials) can provide a uniform diameter and / or cross-sectional shape for the intraluminal device 500. The intraluminal device 500 can also include a hydrophilic coating on the outside.

[0145] The intraluminal device 500 can include features of other intraluminal devices described herein. For example, the hypotube 412 can include other features of hypotubes described herein, such as hypotube 215 of Figs. 3-5, the hypotube 346 of Figs. 6-7, the hypotube 358 of Fig. 8, the hypotube 370 of Fig. 9, the hypotube 382 of Figs. 10-11, and / or the hypotube 215 of Fig. 12.

[0146] In an exemplary aspect, an apparatus is provided. The apparatus includes an intravascular guidewire comprising: a flexible elongate member configured to be positioned inside a blood vessel; and a tubular member extending along a length of the flexible elongate member and comprising a plurality of fibers that are woven together and in a tensioned state, wherein the plurality of fibers defines a lumen.

[0147] In some aspects, the flexible elongate member comprises a proximal portion and a distal portion, and the tubular member is configured to couple the proximal portion and the distal portion. In some aspects, the length of the flexible elongate member along which the tubular member extends comprises a distal end of the proximal portion and a proximal end of the distal portion. In some aspects, the proximal portion comprises a proximal core wire, the distal portion comprises a distal core wire, a distal end of the proximal core wire and a proximal end of the distal core wire are proximate to one another, and the distal end of the proximal core wire and the proximal end of the distal core wire are positioned inside the lumen. In some aspects, the plurality of fibers is conformed to the distal end of the proximal core wire and the proximal end of the distal core wire. In some aspects, the intravascular guidewire includes a matrix material positioned between the plurality of fibers and in a cured state that maintains the plurality of fibers in the tensioned state. In some aspects, the matrix material is in direct contact with at least one of the distal end of the proximal core wire and the proximal end of the distal core wire, and the matrix material is positioned inside the lumen. In some aspects, the matrix material comprises an adhesive configured to couple the distal end of theproximal core wire and the proximal end of the distal core wire. In some aspects, the intravascular guidewire further comprises an adhesive different than the matrix material, the adhesive is configured to couple the distal end of the proximal core wire and the proximal end of the distal core wire, the adhesive is positioned inside the lumen, and the adhesive is in direct contact with at least one of the plurality of fibers or the matrix material. In some aspects, the proximal core wire comprises a first projection and the distal core wire comprises a second projection, and, when the plurality of fibers are in the tensioned state, the plurality of fibers are configured to mechanically grip the first projection and the second projection, and thereby urge the proximal core wire and the distal core wire towards one another. In some aspects, when the plurality of fibers are in the tensioned state, the plurality of fibers are configured to mechanically grip at least one of the proximal core wire, the distal core wire, or the matrix material. In some aspects, the intravascular guidewire comprises: an intravascular sensor configured to obtain intravascular data associated with the blood vessel; and a plurality of communication lines coupled to the intravascular sensor and configured to carry the intravascular data, wherein the plurality of communication lines extends along the length of the flexible elongate member proximate to the at least one of the plurality of fibers or the matrix material. In some aspects, the plurality of communication lines is in direct contact with at least one of the plurality of fibers or the matrix material. In some aspects, the plurality of communication lines is positioned inside the lumen. In some aspects, the plurality of fibers is conformed to the plurality of communication lines. In some aspects, the plurality of fibers comprises at least one of a carbon fiber, an aramid fiber, fiber glass, or a metallic fiber. In some aspects, the plurality of fibers is arranged in a first fiber layer and a second fiber layer positioned around the second fiber layer. In some aspects, the plurality of fibers is arranged at a 45-degree angle with respect to the length or each other. In some aspects, 19. The apparatus of claim 1, the intravascular guidewire includes a first clamp positioned at a proximal portion of the tubular member and a second clamp positioned at a distal portion of the tubular member, where the first clamp and the second clamp maintain the plurality of fibers in the tensioned state.

[0148] In an exemplary aspect, an apparatus is provided. The apparatus includes an intravascular guidewire configured to positioned within a blood vessel of a patient and comprising: an intravascular sensor configured to obtain intravascular data associated with the blood vessel; a plurality of communication lines coupled to the intravascular sensor and configured to carry the intravascular data; a proximal core wire and a distal core wire configured to provide structural support; a woven fiber hypotube positioned around at least one a distal end of the proximal core wire, a proximal end of the distal core wire, or the plurality of communication lines, wherein the woven fiber hypotube comprises a tensioned stated such that the woven fiber hypotube conforms to an outer profile of at least one a distal end of the proximal core wire, a proximal end of the distal core wire, or the plurality of communication lines; and at least one of a cured matrix material or a clamp configured to maintain the woven fiber hypotube in the tensioned state.

[0149] The logical operations making up the aspects of the technology described herein are referred to variously as operations, steps, objects, elements, components, or modules. Furthermore, it should be understood that these may be arranged or performed in any order, unless explicitly claimed otherwise or a specific order is inherently necessitated by the claim language. It should further be understood that the described technology may be employed in single-use and multi-use electrical and electronic devices for medical or nonmedical use.

[0150] All directional references e.g., upper, lower, inner, outer, upward, downward, left, right, lateral, front, back, top, bottom, above, below, vertical, horizontal, clockwise, counterclockwise, proximal, and distal are only used for identification purposes to aid the reader’s understanding of the claimed subject matter, and do not create limitations, particularly as to the position, orientation, or use of the metal ink conductor assembly. Connection references, e.g., attached, coupled, connected, and joined are to be construed broadly and may include intermediate members between a collection of elements and relative movement between elements unless otherwise indicated. As such, connection references do not necessarily imply that two elements are directly connected and in fixed relation to each other. The term “or” shall be interpreted to mean “and / or” rather than “exclusive or.” The word "comprising” does not exclude other elements or steps, and the indefinite article “a” or “an” does not exclude a plurality. Unless otherwise noted in the claims, stated values shall be interpreted as illustrative only and shall not be taken to be limiting.

[0151] The above specification, examples and data provide a complete description of the structure and use of exemplary aspects of the metal ink conductor assembly as defined in the claims. Although various aspects of the claimed subject matter have been described above with a certain degree of particularity, or with reference to one or more individual aspects, those skilled in the art could make numerous alterations to the disclosed aspects without departing from the spirit or scope of the claimed subject matter.

[0152] Still other aspects are contemplated. It is intended that all matter contained in the above description and shown in the accompanying drawings shall be interpreted as illustrative only of particular aspects and not limiting. Changes in detail or structure may be made without departing from the basic elements of the subject matter as defined in the following claims.

Claims

CLAIMSWhat is claimed is:

1. An apparatus, comprising: an intravascular guidewire comprising: a flexible elongate member configmed to be positioned inside a blood vessel; and a tubular member extending along a length of the flexible elongate member and comprising a plurality of fibers that are woven together and in a tensioned state, wherein the plurality of fibers defines a lumen.

2. The apparatus of claim 1, wherein the flexible elongate member comprises a proximal portion and a distal portion, wherein the tubular member is configured to couple the proximal portion and the distal portion.

3. The apparatus of claim 2, wherein the length of the flexible elongate member along which the tubular member extends comprises a distal end of the proximal portion and a proximal end of the distal portion.

4. The apparatus of claim 2, wherein the proximal portion comprises a proximal core wire, wherein the distal portion comprises a distal core wire, wherein a distal end of the proximal core wire and a proximal end of the distal core wire are proximate to one another, and wherein the distal end of the proximal core wire and the proximal end of the distal core wire are positioned inside the lumen.

5. The apparatus of claim 4, wherein the plurality of fibers is conformed to the distal end of the proximal core wire and the proximal end of the distal core wire.

6. The apparatus of claim 4, wherein the intravascular guidewire further comprises a matrix material positioned between the plurality of fibers and in a cured state that maintains the plurality of fibers in the tensioned state.

7. The apparatus of claim 6, wherein the matrix material is in direct contact with at least one of the distal end of the proximal core wire and the proximal end of the distal core wire,wherein the matrix material is positioned inside the lumen.

8. The apparatus of claim 6, wherein the matrix material comprises an adhesive configured to couple the distal end of the proximal core wire and the proximal end of the distal core wire.

9. The apparatus of claim 6, wherein the intravascular guidewire further comprises an adhesive different than the matrix material, wherein the adhesive is configured to couple the distal end of the proximal core wire and the proximal end of the distal core wire, wherein the adhesive is positioned inside the lumen, wherein the adhesive is in direct contact with at least one of the plurality of fibers or the matrix material.

10. The apparatus of claim 6, wherein, when the plurality of fibers are in the tensioned state, the plurality of fibers are configured to mechanically grip at least one of the proximal core wire, the distal core wire, or the matrix material.

11. The apparatus of claim 6, wherein the intravascular guidewire comprises: an intravascular sensor configured to obtain intravascular data associated with the blood vessel; and a plurality of communication lines coupled to the intravascular sensor and configured to carry the intravascular data, wherein the plurality of communication lines extends along the length of the flexible elongate member proximate to the at least one of the plurality of fibers or the matrix material.

12. The apparatus of claim 11, wherein the plurality of communication lines is in direct contact with at least one of the plurality of fibers or the matrix material.

13. The apparatus of claim 11, wherein the plurality of communication lines is positioned inside the lumen.

14. The apparatus of claim 13, wherein the plurality of fibers is conformed to the plurality of communication lines.

15. The apparatus of claim 4,wherein the proximal core wire comprises a first projection and the distal core wire comprises a second projection, wherein, in the tensioned state, the plurality of fibers are configured to mechanically grip the first projection and the second projection, and thereby urge the proximal core wire and the distal core wire towards one another.

16. The apparatus of claim 1, wherein the plurality of fibers comprises at least one of a carbon fiber, an aramid fiber, fiber glass, or a metallic fiber.

17. The apparatus of claim 1, wherein the plurality of fibers is arranged in a first fiber layer and a second fiber layer positioned around the second fiber layer.

18. The apparatus of claim 1, wherein the plurality of fibers is arranged at a 45-degree angle with respect to the length or each other.

19. The apparatus of claim 1, wherein the intravascular guidewire further comprising a first clamp positioned at a proximal portion of the tubular member and a second clamp positioned at a distal portion of the tubular member, wherein the first clamp and the second clamp are configured to maintain the plurality of fibers in the tensioned state.

20. An apparatus, comprising: an intravascular guidewire configured to positioned within a blood vessel of a patient and comprising: an intravascular sensor configured to obtain intravascular data associated with the blood vessel; a plurality of communication lines coupled to the intravascular sensor and configured to carry the intravascular data; a proximal core wire and a distal core wire configured to provide structural support; a woven fiber hypotube positioned around at least one a distal end of the proximal core wire, a proximal end of the distal core wire, or the plurality of communication lines, wherein the woven fiber hypotube comprises a tensioned stated such that the woven fiber hypotube conforms to an outer profile of at least one a distal end of the proximal core wire, a proximal end of the distal core wire, or the plurality of communication lines; and at least one of a cured matrix material or a clamp configured to maintain the woven fiber hypotube in the tensioned state.

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