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WO2025131958A1 - Boîtier de capteur intraluminal muni de différentes régions présentant une flexibilité pour une transition de rigidité lisse le long d'un dispositif intraluminal - Google Patents

Boîtier de capteur intraluminal muni de différentes régions présentant une flexibilité pour une transition de rigidité lisse le long d'un dispositif intraluminal Download PDF

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Publication number
WO2025131958A1
WO2025131958A1 PCT/EP2024/085812 EP2024085812W WO2025131958A1 WO 2025131958 A1 WO2025131958 A1 WO 2025131958A1 EP 2024085812 W EP2024085812 W EP 2024085812W WO 2025131958 A1 WO2025131958 A1 WO 2025131958A1
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WO
WIPO (PCT)
Prior art keywords
section
sensor housing
layers
sensor
aspects
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Pending
Application number
PCT/EP2024/085812
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English (en)
Inventor
Blake CORNELL
Steven Patrick PARKER
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Koninklijke Philips NV
Original Assignee
Koninklijke Philips NV
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Filing date
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Application filed by Koninklijke Philips NV filed Critical Koninklijke Philips NV
Publication of WO2025131958A1 publication Critical patent/WO2025131958A1/fr
Pending legal-status Critical Current
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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/68—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient
    • A61B5/6846—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be brought in contact with an internal body part, i.e. invasive
    • A61B5/6847—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be brought in contact with an internal body part, i.e. invasive mounted on an invasive device
    • A61B5/6851—Guide wires
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/68—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient
    • A61B5/6846—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be brought in contact with an internal body part, i.e. invasive
    • A61B5/6847—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be brought in contact with an internal body part, i.e. invasive mounted on an invasive device
    • A61B5/6852—Catheters
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B2560/00—Constructional details of operational features of apparatus; Accessories for medical measuring apparatus
    • A61B2560/04—Constructional details of apparatus
    • A61B2560/0406—Constructional details of apparatus specially shaped apparatus housings

Definitions

  • the subject matter described herein relates, in general, to intraluminal physiology sensing devices (e.g., an intravascular pressure sensing and/or flow sensing guidewire), and in particular to sensor housings that provide smoother stiffness transitions and limit kink points using multiple durometers and/or strain relief features.
  • intraluminal physiology sensing devices e.g., an intravascular pressure sensing and/or flow sensing guidewire
  • sensor housings that provide smoother stiffness transitions and limit kink points using multiple durometers and/or strain relief features.
  • 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.
  • 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.
  • 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.
  • restenosis can occur at the same place, it is difficult to check the condition inside the vessels after surgery with X-ray.
  • 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 sensor housing inside which is positioned pressure sensors, flow sensor, and/or other obtain the data related to the blood vessel.
  • a structural weak point, kink point, or hinge point is located at the distal portion of the core member adjacent to the one or more components. These hinge points reduce mechanical performance and are weak spots for electrical and mechanical stress. Therefore, the hinge point may cause the intravascular device to unintentionally bend, kink, or break at the hinge point.
  • the present disclosure provides an improvement for intraluminal devices such as intravascular catheters and/or guidewires by creating a sensor housing with varying levels of hardness along its length and/or providing strain relief (e.g., with openings in a wall of the sensor housing).
  • the varying levels of hardness and/or strain relief features provide a smooth transition in stiffness along the length of the intraluminal device.
  • sensor housing with multiple levels of hardness (also known as durometer) and/or the strain relief can be manufactured by three-dimensional (3D) printing. Different amounts of curing times are used along a length of the sensor housing to create the sensor housing with varying levels of hardness for the intraluminal device. Less cure time is used on portions of the sensor housing that abut a portion of the core member to make a relatively softer hardness section of the sensor housing, which provides for a smooth stiffness transition and avoids a kink point.
  • More cure time is used on portions of the sensor housing that do not abut a portion of the core member to make a relatively harder hardness section in comparison to the relatively softer hardness section.
  • the openings in the wall of the sensor housing, created via three-dimensional printing, are added to a portion of the sensor housing that abut a portion of the core member to provide for a smooth stiffness transition and to avoid a kink point.
  • Fig. l is a diagrammatic top view of an intravascular device, according to aspects of the present disclosure.
  • FIG. 2 is a diagrammatic side view of an intravascular sensing system that includes an intravascular device, according to aspects of the present disclosure.
  • Fig. 3 is a perspective view of at least some components of an example sensor assembly, according to aspects of the present disclosure.
  • Fig. 4A is a diagrammatic side view of a sensor housing at a stage of manufacturing, in accordance with at least one aspect of the present disclosure.
  • Fig. 4B is a diagrammatic side view of the sensor housing at a later stage of manufacturing, in accordance with at least one aspect of the present disclosure.
  • Fig. 4C is a diagrammatic side view of the sensor housing at a later stage of manufacturing, in accordance with one or more aspects of the present disclosure.
  • Fig. 4D is a diagrammatic side view of the sensor housing at a later stage of manufacturing, in accordance with one or more aspects of the present disclosure.
  • Fig. 5 A is a cross-sectional view of the sensor housing of Fig. 4D along section line 5A-5A, in accordance with at least one aspect of the present disclosure.
  • Fig. 5B is a cross-sectional view of the sensor housing of Fig. 4D along section line 5B-5B, in accordance with at least one aspect of the present disclosure.
  • Fig. 6 is a diagrammatic cross-sectional side view of a sensor assembly including the sensor housing of Fig. 4D, in accordance with at least one aspect of the present disclosure.
  • Fig. 7 is a diagrammatic side view of a sensor housing with strain relief features, in accordance with at least one aspect of the present disclosure.
  • Fig. 8 is a diagrammatic side view of a multi -durometer sensor housing with strain relief features, in accordance with at least one aspect of the present disclosure.
  • Fig. 9 is a diagrammatic side view of a multi -durometer sensor housing, in accordance with at least one aspect of the present disclosure.
  • Fig. 10 is a diagrammatic side view of a sensor housing with strain relief features on both ends of the sensor housing, in accordance with at least one aspect of the present disclosure.
  • Fig. 11 is a diagrammatic side view of a multi-durometer sensor housing with strain relief features on both ends, in accordance with at least one aspect of the present disclosure.
  • Fig. 12 is a diagrammatic side view of an intravascular device including a multidurometer sensor housing, in accordance with at least one aspect of the present disclosure.
  • Fig. 13A is a cross-sectional view of the sensor housing of Fig. 12 along the 13A line, in accordance with at least one aspect of the present disclosure.
  • Fig. 13B is a cross-sectional view of the sensor housing of Fig. 12 along the 13B line, in accordance with at least one aspect of the present disclosure.
  • 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.
  • 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.
  • 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.
  • the example aspects described below recognize that it may be desirable to have a method of manufacturing that includes manufacturing (such as three-dimensional (3D) printing) a sensor housing having at least two, different durometer values to create smooth transitions between the sensor housing and the remainder of the intraluminal device.
  • the aspects described below provide a method for printing and curing a sensor housing using different cure times to create a sensor housing with various durometer values.
  • the method of printing provides a way to create a multi-durometer sensor housing having a relatively lower durometer value at one or more ends of the sensor housing to create a smooth transition and prevent kink points. Therefore, the method of manufacturing provides an improvement by creating a multi-durometer sensor housing, using a single material with various cure times, and by placing a lower durometer value near the hinge points.
  • One or more aspects described below provide apparatuses related to forming strain relief features for a sensor housing for an intravascular device. For example, in some instances, a method is provided for 3D printing strain relief features into a sensor housing. The strain relief features are adjacent to a hinge point of the intravascular device. Therefore, the method of manufacturing provides an improvement by placing strain relief features in a sensor housing in order to reduce mechanical and electrical strain of the intraluminal device. [0030] One or more illustrative aspects described below provide apparatuses related to multi-durometer sensor housing with strain relief features, which smooth out abrupt transitions and reduce kink points caused by the sensor housing and wire features on an intraluminal device. Mechanical handling is reduced by abrupt transitions caused by sensor housing and wire features necessary for electrical performance.
  • 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.
  • 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.
  • the conductive portions 132, 134, 136 may be conductive ink that is printed and/or deposited around the flexible elongate member 106.
  • 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.
  • the intravascular device 102 in Fig. 1 includes 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • the proximal subassembly and the distal subassembly may be separately manufactured.
  • proximal subassembly and the distal subassembly may be electrically and mechanically joined together.
  • 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.).
  • the intravascular device 102 may include one, two, three, or more core wires extending along its length.
  • a single core wire may extend substantially along the entire length of the flexible elongate member 106.
  • 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.
  • 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).
  • the conductive members 230 may be one or more electrical wires that are directly in communication with the sensor 112.
  • the conductive members 230 are electrically and mechanically coupled to the sensor 112 by, e.g., soldering.
  • the conductive members 230 comprise 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.
  • 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.
  • the conductive members 230 are electrically and mechanically coupled to the sensor 112 by, e.g., soldering.
  • 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.
  • 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.
  • the conductive portions 132, 134, 136 may be in electrically communication with the sensor 112.
  • intravascular device 102 includes the locking section 118 and the knob or retention section 120.
  • 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.
  • 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.
  • an insulation layer 158 is formed over the proximal end portion of the connection portion 114 to insulate the exposed conductive ribbons.
  • 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.
  • the sensor 113 may be a pressure sensor and/or flow sensor configured 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 more than one property.
  • 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.
  • 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. [0039] 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.
  • 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.
  • 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.
  • the distal core 210 and the proximal core 220 are made of the same material.
  • 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.
  • 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.
  • flow data obtained by the sensor 113 may be transmitted to the conductive portions 132, 134.
  • 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.
  • Control signals from a processing system 306 may be transmitted to the sensor 113 via 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.
  • 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.
  • the proximal subassembly and the distal subassembly are separately manufactured.
  • the proximal subassembly and the distal subassembly may be electrically and mechanically joined together.
  • 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.
  • the intravascular device 102 may include one, two, three, or more core wires extending along its length.
  • a single core wire may extend substantially along the entire length of the flexible elongate member 106.
  • 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.
  • 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 secured 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.
  • the conductive members 230 may be one or more electrical wires that are directly in communication with the sensor 113.
  • the conductive members 230 are electrically and mechanically coupled to the sensor 113 by, e.g., soldering.
  • 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.
  • 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 the conductive portions 132 and/or 134.
  • a multi -filar conductor bundle 230 is electrically and mechanically coupled to the sensor 113 by, e.g., soldering.
  • 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.
  • 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.
  • the conductive portions 132, 134 may be in electrical communication with the sensor 113.
  • the intravascular device 102 includes a locking section 118 and knob or retention section 120.
  • 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.
  • 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.
  • an insulation layer 158 is formed over the proximal end portion of the connection portion 114 to insulate the exposed conductive ribbons 260.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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 protocols may 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).
  • WAN wide area network
  • 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.
  • the processor may execute computer readable instructions stored on the non-transitory tangible computer readable medium.
  • 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.
  • the PIM 304 performs preliminary processing of data prior to relaying the data to the processing system 306.
  • the PIM 304 performs amplification, filtering, and/or aggregating of the data.
  • the PIM 304 also supplies high- and low-voltage DC power to support operation of the intraluminal device 102 via the conductive members 230.
  • 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.
  • 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.
  • 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.
  • the display 308 may be used to provide a procedure-specific workflow to a user to complete an intraluminal imaging procedure.
  • FIGs. 3A-3C illustrate aspects of a multi-durometer polymer jacket for an intravascular device according to the present disclosure.
  • Figures 3A-3C illustrate the multi-durometer polymer jacket of the intravascular device at different stages of manufacturing according to one or more aspects.
  • Figures 3A-3C may illustrate a distal portion of an intraluminal device (e.g., intravascular guidewire), such as the distal portion 107 of the pressure-sensing guidewire (intravascular device 102) in Fig.l, and/or the distal portion 107 of the flow sensing guidewire (intravascular device 102) in Fig. 2.
  • intraluminal device e.g., intravascular guidewire
  • Fig. 3 is a perspective view of at least some components of an example sensor assembly, in accordance with at least one embodiment of the present disclosure. Visible are the sensor housing 282 and a sensor electrical subassembly 440.
  • the sensor housing 282 is formed from a hypotube 410 that includes a central lumen 420.
  • the sensor housing 282 also includes a sensor cavity 412 that connects to the central lumen 420 by a tapered region 430.
  • the sensor electrical subassembly (which may in some cases be referred to colloquially as a “tadpole”) includes the electrical conductors 310, 320, and 330, along with the sensor or transducer 112.
  • the wire 320 extends through the sensor central lumen 340 to form a distal connection 350 with the distal face of the sensor or transducer 112.
  • an assembly technician may, for example, place a polymer material 460 (e.g., an adhesive or potting material) on the proximal face of the sensor 112 and/or in the sensor cavity 412 of the sensor housing 282. The assembly technician may then pull the wires 310, 320, and 330 through the sensor cavity 412, tapered region 430, and the central lumen 420 of the housing 282 until the sensor 112 is seated within the sensor cavity 412.
  • the sensor housing 282 includes a first portion 470 and a second portion 472. The first portion 470 and the second portion 472 are integrally formed. The first portion 470 has a different durometer than the second portion 472.
  • the first portion 470 has a relatively lower durometer value or harness compared to the second portion 472.
  • the second portion 472 in various aspects, has a harder durometer value relative to the first portion 470.
  • one or more transition regions extend between the first portion 470 and the second portion 472.
  • the one or more transition regions may have a durometer value or a varying durometer that is in between the low durometer values of the first portion 470 and the high durometer values of the second portion 472.
  • the first portion 470 extends along a smaller length of the hypotube 410 than the second portion 472.
  • a length of the first portion 470 is between, e.g., l%-30%, 5%-25%, 5%-l 5% of the total length of the sensor housing 282, including values such as 5%, 10%, 15%, 20%, and/or other values both larger and smaller.
  • a length of second section 472 is between, e.g., 70%-99%, 75%-95%, 85%-95% of the total length of the sensor housing 282, including values such as 80%, 85%, 90%, 95%, and/or other values both larger and smaller.
  • Fig. 3 may illustrate portions of an intraluminal device (e.g., intravascular guidewire), such as the flow-sensing intravascular device 102 depicted as in Fig. 2.
  • a sensor housing 474 shown therein is a diagrammatic, schematic side view of a sensor housing 474 positioned on a surface 476 according to an aspect of the present disclosure. As shown, a plurality of layers 478 of the sensor housing 474 are stacked on top of the surface 476. The plurality of layers 478 of the sensor housing 474 includes a first portion 480. The first portion 480 of the plurality of layers 478 include a diameter 482 and a first length (“LI”) 484.
  • LI first length
  • the plurality of layers 478 includes a representative first layer 486 and a representative second layer 488.
  • the second layer 488 is stacked or printed upon the first layer 486.
  • the first layer 486 and the second layer 488 each have the diameter 482 and together form a portion of the LI 484.
  • the plurality of layers 478, including the first layer 486 and the second layer 488, are all composed of a material source 490.
  • the material source 490 in the first portion 480 of the plurality of layers 478 are cured at a setting of 100% light source for curing 492.
  • a lumen 494 extending within the first portion 480 of the plurality of layers 478 is shown in dotted lines.
  • an individual layer of the plurality of layers 478 is printed by a 3D printer onto the surface 476. Another layer of the plurality of layers 478 is printed by a 3D printer on top of the individual layer. The 3D printer continues to print layers on top of other layers (including printing the representative first layer 486 and the printing the representative second layer 488 on top of the first layer 486).
  • the first portion 480 of the plurality of layers 478 along LI 484 are, e.g., light-cured at a specific setting and a specific time.
  • the first portion 480 of the plurality of layers 478 along LI 484 are cured at a setting of 100% light source for curing 492.
  • the first portion 480 of the plurality of layers 478 are cured for a time period that fully cures the material source 490 along LI 484.
  • the first portion 480 of the plurality of layers 478 may have a hollow portion or opening defining the lumen 494.
  • any suitable example of additive manufacturing can be used the manufacture the housing 474.
  • additive manufacturing include stereolithography (SLA), selective laser sintering (SLS), fused deposition modeling (FDM), digital light process (DLP), multi jet fusion (MJF), polyjet, direct metal laser sintering (DMLS), and electron beam melting (EBM).
  • SLA stereolithography
  • SLS selective laser sintering
  • FDM fused deposition modeling
  • DLP digital light process
  • MJF multi jet fusion
  • polyjet direct metal laser sintering
  • EBM electron beam melting
  • One example of additive manufacturing and/or curing is 2-photon polymerization. Curing can be done using laser light.
  • the light source 492 is a source of laser light. Different amounts/degrees of curing can be achieved attenuating (or not attenuating) the laser power. For example, 100% can refer no attenuation of the laser power.
  • the sensor housing 474 includes the first portion 480 of the plurality of layers 478 formed on top of the surface 476, a second portion 496 of the plurality of layers 478 formed on top of the first portion 480, and a third portion 498 of the plurality of layers 478 formed on top of the second portion 496.
  • the second portion 496 includes the plurality of layers 478 along a second length (“L2”) 500, having the diameter 482.
  • the second portion 496 of the plurality of layers 478 may have a hollow portion or opening defining the lumen 494.
  • the lumen 494 may change diameter in the second portion 496.
  • the second portion 496 is proximal to the first portion 480.
  • an individual layer of the plurality of layers 478 is printed by a 3D printer onto the second layer 488 of the first portion 480.
  • Another layer of the plurality of layers 478 is printed by a 3D printer on top of the individual layer.
  • the 3D printer continues to print layers on top of other layers along L2 500.
  • the second portion 496 of the plurality of layers 478 along L2 500 are cured at a specific setting and a specific time.
  • the second portion 496 of the plurality of layers 478 along L2 500 are cured at the same settings and time as the first portion 480: a setting of 100% light source for curing 492.
  • the second portion 496 of the plurality of layers 478 are cured for a time period that fully cures the material source 490 along L2 500.
  • the third portion 498 includes the plurality of layers 478 along the third length (“L3”) 502, having the diameter 482.
  • the third portion 498 may have less layers of the plurality of layers 478 in comparison to the first portion 480 and/or the second portion 496.
  • the third portion 498 of the plurality of layers 478 may have a hollow portion or opening defining the lumen 494.
  • the lumen 494 may have a constant diameter in the third portion 498.
  • the third portion 498 is proximal to the second portion 496.
  • an individual layer of the plurality of layers 478 of the third portion 498 is printed by a 3D printer onto an individual layer of the plurality of layers 478 of the second portion 496. Another layer of the plurality of layers 478 of the third portion 498 is printed by a 3D printer on top of the individual layer. The 3D printer continues to print layers on top of other layers along L3 502.
  • the third portion 498 of the plurality of layers 478 along L3 502 are cured at a specific setting and a specific time.
  • the third portion 498 of the plurality of layers 478 along L3 502 are cured at a setting of 95% light source for curing 504.
  • the third portion 498 of the plurality of layers 478 are cured for a time period that cures the material source 490 along L3 502 less than the material source 490 is cured along LI 484 and/or L2 500.
  • the sensor housing 474 includes the first portion 480 of the plurality of layers 478 formed on top of the surface 476, the second portion 496 of the plurality of layers 478 formed on top of the first portion 480, the third portion 498 of the plurality of layers 478 formed on top of the second portion 496, and a fourth portion 506 of the plurality of layers 478 formed on top of the third portion 498.
  • the fourth portion 506 includes the plurality of layers 478 along a fourth length (“L4”) 508, having the diameter 482.
  • the fourth portion 506 of the plurality of layers 478 may have a hollow portion or opening defining the lumen 494.
  • the lumen 494 may have a constant diameter in the fourth portion 506.
  • the fourth portion 506 is proximal to the third portion 498.
  • an individual layer of the plurality of layers 478 is printed by a 3D printer onto an individual layer of the third portion 498.
  • Another layer of the plurality of layers 478 of the fourth portion 506 is printed by a 3D printer on top of the individual layer.
  • the fourth portion 506 of the plurality of layers 478 along L4 508 are cured at a specific setting and a specific time.
  • the fourth portion 506 of the plurality of layers 478 along L4 508 are cured at different settings than the first portion 480, the second portion 496, and the third portion 498.
  • the fourth portion 506 of the plurality of layers 478 are cured at a setting of 90% light source for curing 510.
  • the fourth portion 506 of the plurality of layers 478 are cured for a time period or power setting that cures the material source 490 along L4 508 less than the material source 490 is cured along LI 484, L2 500, and/or L3 502.
  • the sensor housing 474 includes the first portion 480 of the plurality of layers 478 formed on top of the surface 476, the second portion 496 of the plurality of layers 478 formed on top of the first portion 480, the third portion 498 of the plurality of layers 478 formed on top of the second portion 496, the fourth portion 506 of the plurality of layers 478 formed on top of the third portion 498, a fifth portion 511 of the plurality of layers 478, and a sixth portion 512 of the plurality of layers 478.
  • the fifth portion 511 includes the plurality of layers 478 along a fifth length (“L5”) 513, having the diameter 482.
  • the fifth portion 511 of the plurality of layers 478 may have a hollow portion or opening defining the lumen 494.
  • the lumen 494 may have a constant diameter in the fifth portion 511.
  • the fifth portion 512 is proximal to the fourth portion 506.
  • the sixth portion 512 includes the plurality of layers 478 along a sixth length (“L6”) 514, having the diameter 482.
  • the sixth portion 512 of the plurality of layers 478 may have a hollow portion or opening defining the lumen 494.
  • the lumen 494 may have a constant diameter in the sixth portion 512.
  • the sixth portion 512 is proximal to the fifth portion 511.
  • an individual layer of the plurality of layers 478 of the fifth portion 511 is printed by a 3D printer onto an individual layer of the plurality of layers 478 of the fourth portion 506.
  • Another layer of the plurality of layers 478 of the fifth portion 511 is printed by a 3D printer on top of the individual layer of the fifth portion 511.
  • the process repeats.
  • the fifth portion 511 of the plurality of layers 478 along L5 513 are cured at a specific setting and a specific time.
  • the fifth portion 51 lof the plurality of layers 478 along L5 513 are cured at different settings than the first portion 480, the second portion 496, the third portion 498, and the fourth portion 506.
  • the fifth portion 511 of the plurality of layers 478 are cured at a setting of 85% light source for curing.
  • the sixth portion 512 is printed by a 3D printer on top of the individual layer of the sixth portion 512.
  • the process repeats.
  • the sixth portion 512 of the plurality of layers 478 along L6 513 are cured at a specific setting and a specific time.
  • the sixth portion 512 of the plurality of layers 478 along L5 514 are cured at different settings than the first portion 480, the second portion 496, the third portion 498, the fourth portion 506, and the fifth portion 511.
  • the sixth portion 512 of the plurality of layers 478 are cured at a setting of 80% light source for curing 516.
  • the sixth portion 512 of the plurality of layers 478 are cured for a time period or power setting that cures the material source 490 along L6 514 less than the material source 490 is cured along LI 484, L2 500, L3 502, L4 508, and/or L5 513.
  • the numerical values of the light cure settings are exemplary only. For example, higher values indicate a relatively greater amount of intensity for the laser light, and lower values indicates a relatively lower amount of intensity for the laser light. Any suitable numerical values for the light cure settings (e.g., attenuation of the laser light) can be used such that the proximal portion of the housing 474 is cured to a lesser degree (e.g., has a lower durometer hardness) than the distal portion of the housing 474 (which is cured to a higher degree and/or has a higher durometer hardness).
  • the sensor housing 474 is composed of a material source.
  • the material source 490 may be a material such as a plastic, polymer, or other similar material that may be printed by a 3D printer.
  • the material source 490 is a composition or a combination of materials.
  • the material source 490 may vary along the length of the sensor housing 474.
  • a first plastic material may be used in the first portion 480 and a second, differing plastic material may be used in the fifth portion 512.
  • the height of the individual layers of the plurality of layers 478 such as the height of the first layer 486 may vary from a height of another layer such as second layer 488.
  • each layer of the plurality of layers 478 is the same length or height along the longitudinal axis.
  • the longitudinal axis defined by the up-down orientation, illustrated in FIGS. 4A-4D.
  • the longitudinal axis extends down the lumen 494.
  • one or more layers of the plurality of layers 478 are different lengths or heights along the longitudinal axis.
  • the first portion 480 is the distal most portion of the sensor housing 474.
  • the material source 490 of the first portion 480 is cured the most and/or fully in comparison to the remainder portions (i.e., the second portion 496, the third portion 498, the fourth portion 506, the fifth portion 511, and the sixth portion 512).
  • the first portion 480 and the second portion 496 are considered a singular portion of the sensor housing 474 as both the first portion 480 and the second portion 496 are cured at 100% light source for curing 492.
  • the first portion 480 and the second portion 496 have the longest combined length of the sensor housing 474.
  • the first portion 480 includes the lumen 494 with a non-varying diameter. In other aspects, the first portion 480 includes the lumen 494 with a varying diameter. In one or more aspects, the first portion 480 includes the lumen 494 with the largest diameter in comparison to the remainder portions. In some instances, the number of layers of the plurality of layers 478 may vary (more or less) in the first portion 480.
  • the second portion 496 is directly adjacent to the first portion 480 and the third portion 498.
  • the material source 490 of the second portion 496 is cured the most and/or fully in comparison to the remainder portions (i.e., the third portion 498, the fourth portion 506, the fifth portion 511, and the sixth portion 512).
  • the material source 490 of the second portion 496 is cured more than the first portion 480.
  • the second portion 496 has the longest length (L2 500) of the sensor housing 474.
  • the second portion 496 includes the lumen 494 with a non-varying diameter. In other aspects, the second portion 496 includes the lumen 494 with a varying diameter.
  • the second portion 496 includes the lumen 494 which tapers and goes from a large diameter (as shown in the first portion 480) to a smaller diameter (as shown in the third portion 498).
  • the number of layers of the plurality of layers 478 may vary (more or less) in the second portion 496.
  • the third portion 498 is directly adjacent to the second portion 496 and the fourth portion 506.
  • the material source 490 of the third portion 498 is cured less than the first portion 480 and/or the second portion 496.
  • a setting other than 95% light source for curing 504 is used.
  • the 100% light source for curing 492 or the 90% light source for curing 510 settings are used.
  • the third portion 498 is cured for a smaller period of time than the first portion 480 and/or the second portion 496.
  • the third portion 498 is cured at a lower setting such as 95% light source for curing 504 in comparison to the first portion 480 and/or the second portion 496. In one or more aspects, the material source 490 of the second portion 496 is cured more than the third portion 498. In some aspects, L3 502 of the third portion 498 is the shortest length of the sensor housing 474. In some aspects, the third portion 498 includes the lumen 494 with a non-varying diameter. In several aspects, the third portion 498 includes the lumen 494 with a non-varying diameter that is smaller than a non-varying diameter of the lumen 494 in the first portion 480. In some instances, the number of layers of the plurality of layers 478 may vary (more or less) in the third portion 498.
  • the fourth portion 506 is directly adjacent to the third portion 498 and the fifth portion 511.
  • the material source 490 of the fourth portion 506 is cured less than the first portion 480, the second portion 496, and/or the third portion 498.
  • a setting other than 90% light source for curing 510 is used.
  • the light source may be from 95% to 85%.
  • the fourth portion 506 is cured for a smaller period of time than the first portion 480, the second portion 496, and/or the third portion 498.
  • the fourth portion 506 is cured at a lower setting such as 90% light source for curing 510 in comparison to the first portion 480 and/or the second portion 496. In one or more aspects, the material source 490 of the third portion 498 is cured more than the fourth portion 506. In some aspects, L4 508 of the fourth portion 506 is the shortest length of the sensor housing 474. In some aspects, L3 503 is equivalent to L4 508. In some aspects, the fourth portion 506 includes the lumen 494 with a non-varying diameter. In several aspects, the fourth portion 506 includes the lumen 494 with a non-varying diameter that is smaller than a non-varying diameter of the lumen 494 in the first portion 480. In some instances, the number of layers of the plurality of layers 478 may vary (more or less) in the fourth portion 506.
  • the fifth portion 511 is directly adjacent to the fourth portion 506 and/or the sixth portion 512.
  • the material source 490 of the fifth portion 511 is cured less than the first portion 480, the second portion 496, the third portion 498, and/or the fourth portion 506.
  • a setting other than 85% light source for is used on the fifth portion 511.
  • the light source may be from 90% to 75%.
  • the fifth portion 511 is cured for a smaller period of time than the first portion 480, the second portion 496, the third portion 498, and/or the fourth portion 506.
  • the fifth portion 511 is cured at a lower setting of the light source (e.g., 71%, 78%, 83%, etc.) for curing in comparison to the first portion 480, the second portion 496, the third portion 498, and/or the fourth portion 506.
  • the material source 490 of the fourth portion 506 is cured more than the fifth portion 511.
  • L5 513 of the fifth portion 511 is the shortest length of the sensor housing 474.
  • L5 513 is equivalent to L4 508 and/or L6 514.
  • L5 513 is equivalent to L3 502.
  • the fifth portion 511 includes the lumen 494 with a non-varying diameter.
  • the fifth portion 511 includes the lumen 494 with a non-varying diameter that is smaller than a non-varying diameter of the lumen 494 in the first portion 480.
  • the number of layers of the plurality of layers 478 may vary (more or less) in the fifth portion 511.
  • the sixth portion 512 is directly adjacent to the fourth portion 506 and the fifth portion 513 is omitted. In some aspects, the sixth portion 512 is directly adjacent to the fifth portion 513. In some aspects, the material source 490 of the sixth portion 512 is cured less than the first portion 480, the second portion 496, the third portion 498, the fourth portion 506, and/or the fifth portion 511. In some instances, a setting other than 80% light source for 516 is used on the sixth portion 512. In some aspects, the light source may be from 90% to 75%.
  • the sixth portion 512 is cured for a smaller period of time than the first portion 480, the second portion 496, the third portion 498, the fourth portion 506, and/or the fifth portion 511. In one or more aspects, the sixth portion 512 is cured at a lower setting of the light source (e.g., 71%, 78%, 83%, etc.) for curing in comparison to the first portion 480, the second portion 496, the third portion 498, the fourth portion 506 and/or the fifth portion 511. In one or more aspects, the material source 490 of the fifth portion 511 is cured more than the sixth portion 512. In some aspects, L6 514 of the sixth portion 512 is the shortest length of the sensor housing 474.
  • L6 514 is equivalent to L3 502, L4 508, and/or L5 513.
  • the sixth portion 512 includes the lumen 494 with a non-varying diameter.
  • the sixth portion 512 includes the lumen 494 with a non-varying diameter that is smaller than a non-varying diameter of the lumen 494 in the first portion 480.
  • the number of layers of the plurality of layers 478 may vary (more or less) in the sixth portion 512.
  • one or more of: the first portion 480, the second portion 496, the third portion 498, the fourth portion 506, the fifth portion 511, and the sixth portion 512 vary in the number layers of the plurality of layers 478. In some instances, one or more of: the first portion 480, the second portion 496, the third portion 498, the fourth portion 506, the fifth portion 511, and the sixth portion 512 include a same number of layers of the plurality of layers 478.
  • the light source for curing setting may be set in increments of 5%. In other aspects, the light source for curing setting may be set in smaller increments. In some aspects, the light source for curing setting is associated with the power of the light source. In one or more aspects, the light source for curing setting includes a time component (cure for 0.5 seconds, 1 second, 2 seconds, 10 seconds, etc.). The time for one layer of material to be deposited/cured at the relevant scale (layer thicknesses ⁇ lmm) would be in seconds for a single housing. In some instances, the proximal side of the sensor housing 474 is printed first and formed on top of the surface 476. In one or more aspects, the fifth portion 512 is printed or formed prior to the remainder portions.
  • the material source 490 may include two, three, four, or more different materials for a distal portion and a proximal portion of the proximal portion 474.
  • a first composition (or combination) of materials is used at the distal portion and a second, different composition (or combination) of materials is used at the proximal portion.
  • the first composition and the second composition include the same materials at different ratios.
  • the curing time for the first composition and the second composition is the same but due to the differing compositions, the proximal portion is still more flexible than the distal portion.
  • the curing time differs between the proximal portion and the distal portion.
  • a transition region extends along a length of the sensor housing 474 and is disposed between the distal portion and the proximal portion that acts a transition between the first composition and the second composition.
  • the transition region may have at least a third composition of materials. Examples of using multiple durometers are described in U.S. Provisional Application No. 63/543,532, filed October 11, 2023, and titled “Multi-Durometer Polymer Extrusions for Smooth Stiffness Transition in Intraluminal Guidewires and/or Catheters”, which is incorporated by reference in its entirety.
  • Fig. 5A shown therein is a diagrammatic, cross-sectional view of the sensor housing 474 shown in Fig. 4D along the 5A line according to an aspect of the present disclosure.
  • the sensor housing 474 includes a layer 524 of the material source 490 cured at 100% light source for curing 492.
  • a 3D printer prints the layer 524, including the sidewalls of the layer 524.
  • the layer 524 includes an outer sidewall 520, which is an outer surface, having a diameter of 482, and an inner sidewall 520, which is an inner surface having an inner diameter 522.
  • the inner sidewall 520 defines a portion of the lumen 494.
  • the diameter of the lumen is the same as the inner diameter 522.
  • the sensor housing 474 includes a cross- sectional view of a layer 524 of the plurality of layers 478.
  • the layer 524 is defined by the diameter 482.
  • Fig. 5B shown therein is a diagrammatic, cross-sectional view of the sensor housing 474 shown in Fig. 4D along the 5B line according to an aspect of the present disclosure.
  • the sensor housing 474 includes a layer 532 of material source 490 cured at 95% light source for curing 504.
  • a 3D printer prints the layer 532, including the sidewalls of the layer 532.
  • the layer 532 includes an outer sidewall 528, which is an outer surface, having a diameter of 530, and an inner sidewall 526, which is an inner surface having an inner diameter 531.
  • the inner sidewall 526 defines another portion of the lumen 494.
  • the diameter of the lumen is the same as the inner diameter 531.
  • the sensor housing 474 includes a cross- sectional view of a layer 532 of the plurality of layers 478.
  • the layer 532 is defined by the diameter 482.
  • the inner diameter 522 is the same size as the inner diameter 531.
  • the inner sidewall 518 and the inner sidewall 526 are the same size.
  • the inner sidewall 518 and the inner sidewall 526 are circumferential sidewalls defining the lumen 494 or opening, printed by a 3-D printer.
  • the outer diameter 482 and the outer diameter 530 are the same size.
  • the outer sidewall 520 and the outer sidewall 528 are the circumferential sidewalls printed by a 3-D printer.
  • the material source 490 in Fig. 5B is less hard and has a lower durometer value than the material source 490 in Fig.5 A due to curing settings.
  • Fig. 6 is a diagrammatic cross-sectional view of an example sensor assembly 534, which may for example be included in the intravascular device 102 of Fig. 2 and include the flexible elongate member 106. More specifically, Fig. 6 illustrates a sensor assembly 534 that includes a sensing component or sensor 536, a housing 474, and an acoustic matching layer 538. The sensor assembly 534 may be included in a distal portion of an intravascular device (such as intravascular device 102) such that a distal surface 540 of the sensing component 536 faces distally.
  • an intravascular device such as intravascular device 102
  • the sensing component 536 is positioned within the housing 474 and includes a proximal surface 542, the opposite, distal surface 540, and a side surface 544.
  • the sensing component 536 is configured to obtain medical data associated with the blood vessel.
  • one or more of the proximal surface 542, the distal surface 540, or the side surface 544 may be coated in an insulating layer 546.
  • the insulating layer 546 may be formed from parylene, which may be deposited on the one or more surfaces, for example.
  • the insulating layer 546 may additionally or alternatively be formed from any other suitable insulating material.
  • the insulating layer 546 may prevent a short (e.g., an electrical failure), which may otherwise be caused by contact between a conductive portion of the sensing component 536 and the housing 474, which may be formed with a metal or a plastic.
  • the distal surface 540 can include the insulating layer 546 in instances where a distal end of the sensing component 536 is covered by the insulating layer 546
  • the proximal surface 542 can include the insulating layer in instances where a proximal end of the sensing component 536 is covered by the insulating layer 546
  • the side surface 544 can include the insulating layer 546 in instances where the side of the sensing component 536 is covered by the insulating layer 546, as described in U.S. Provisional Application No. 63/414,017, filed October 7, 2022, and titled “Spacer For Sensor In Intraluminal Sensing Device”, which is incorporated by reference in its entirety.
  • the sensor spacer advantageously position the sensor 536 relative to the housing 474 so that the chances of shorting are minimized or eliminated.
  • the insulating layer 546 can be omitted as a result of using the sensor spacer described herein.
  • the sensing component or sensor 536 may include a transducer element, such as an ultrasound transducer element on the distal surface 540 such that the transducer element faces distally and may be used by the sensing component 536 to obtain sensor data corresponding to a structure distal of the sensing component 536.
  • the sensing component 536 may additionally or alternatively include a transducer element on the proximal surface 542 such that the transducer faces proximally and may be used to obtain sensor data corresponding to a structure proximal of the sensing component.
  • a transducer element may additionally or alternatively be positioned on a side surface 544 (e.g., on a perimeter or circumference) of the sensing component 536 in some instances.
  • a transducer and its associated electrodes and electrical connection points may form the entire sensing component 536, such that all surfaces of the sensing component 536 comprise the transducer.
  • a core member 547 extends along a portion of the distal portion.
  • the core member 547 is configured to provide structural support.
  • the core member 547 is adjacent to the sensor housing 474. In some aspects, the core member 547 is in direct contact with the sensor housing 474.
  • the sensing component 536 is coupled to a wires 548, and at least a portion (e.g., a distal portion) of the wires 548 are extends through the housing 474.
  • the wires 548 are directly adjacent to the core member 547.
  • the wires 548 and the sensing component 536 may be physically (e.g., mechanically) coupled.
  • the wires 548 are a multi-filar conductor bundle.
  • one or more filars (e.g., conductive members) of the multi -filar conductor bundle 548 may electrically couple to (e.g., be in electrical communication) with the sensing component 536.
  • one or more filars of the multi-filar conductor bundle 548 may couple to an element, such as a transducer (e.g., an ultrasound transducer), of the sensing component 536 and may provide power, control signals, an electrical ground or signal return, and/or the like to the element.
  • an element such as a transducer (e.g., an ultrasound transducer), of the sensing component 536 and may provide power, control signals, an electrical ground or signal return, and/or the like to the element.
  • an element may be positioned on the distal surface 540 of the sensor.
  • one or more filars of the multi-filar conductor bundle 548 may extend through a cutout or hole in the sensing component 536 (e.g., in at least the proximal surface 542) to establish electrical communication with an element on the distal surface 540 of the sensor.
  • Filars may additionally or alternatively wrap around the side surface 544 to establish electrical communication with the element on the distal surface 540.
  • filars of the multi-filar conductor bundle 548 may terminate at and/or electrically couple to the proximal surface 542 (e.g., to an element on the proximal surface 542) of the sensing component 536.
  • a subset of the filars of the multi-filar conductor bundle 548 may extend to the distal surface 540 and/or electrically couple to an element at the distal surface 540, while a different subset of the filars may electrically couple to an element at the proximal surface 542, for example.
  • the wires 548 may be coated in the insulating layer 546.
  • the wires548 and the sensing component 536 may be coupled together in a sub-assembly before being positioned in the housing 474.
  • the insulating layer 546 may be applied (e.g., coated and/or deposited) onto the entire subassembly, resulting in an insulating layer 546 on both the sensing component 536 and the wires 548.
  • the acoustic matching layer 538 may be positioned on (e.g., over) the distal surface 540 of the sensing component 536.
  • the acoustic matching layer 538 may be disposed directly on the sensing component 536, or the acoustic matching layer 538 may be disposed on the insulating layer 546 coating the sensing component 536.
  • the acoustic matching layer 538 may be disposed on a transducer element (e.g., an ultrasound transducer element) positioned on the sensing component (e.g., the distal surface 272) and/or at least a portion of a conductive filar of the wires548 that is in communication with the transducer element, such as a filar extending through a hole or along a side of the sensing component 112.
  • the acoustic matching layer 538 may contact and/or at least partially surround the portion of the conductive filar and/or the transducer element.
  • the acoustic matching layer 538 may provide acoustic matching to the sensing component 536 (e.g., to an ultrasound transducer of the sensing component 112). For instance, the acoustic matching layer 538 may minimize acoustic impedance mismatch between the ultrasound transducer and a sensed medium, such as a fluid and/or a lumen that the intraluminal device (such as the intravascular device 102) is positioned within.
  • the acoustic matching layer 538 may be formed from any suitable material, such as a polymer or an adhesive, to provide acoustic matching with the sensing component 536.
  • the portion of the acoustic matching layer 538 positioned on the distal surface 540 may include and/or be formed from the same material as a portion of the acoustic matching layer positioned on the side surface 544 and/or the proximal surface 542. Further, the acoustic matching layer 538 may be applied to the sensing component 536 before or after the sensing component 536 is positioned within the sensor housing 474 during assembly of the sensor assembly 534. In this regard, the portion of the acoustic matching layer 538 positioned on the distal surface 540 and the portion of the acoustic matching layer 538 positioned on the side surface 544 and/or the proximal surface 542 may be included in the sensor assembly 534 in the same or different steps.
  • the acoustic matching layer 538 may provide acoustic matching with the sensing component 536 via one or more dimensions of the acoustic matching layer 538.
  • the sensor assembly 534 may include an atraumatic tip, such as the distal tip 108 illustrated in Fig. 2.
  • the distal tip 108 may include the same material as the acoustic matching layer 538.
  • the distal tip may include a different material than the acoustic matching layer 538.
  • the distal tip 108 may be formed from one or more layers of materials. The layers may include different materials and/or different configurations (e.g., shape and/or profile, thickness, and/or the like). Further, the distal tip 108 may be arranged to cover the distal surface 540 of the sensing component 536.
  • the distal tip 108 may also cover a distal end 550 of the housing 282. Moreover, while the distal tip 108 is illustrated as having a domed shape, instances are not limited thereto. In this regard, the distal tip 108 may include a flattened profile or any suitable shape. In some instances, the entire sensing component 536 may be positioned within (e.g., surrounded by the continuous surface of) the housing 474.
  • a polymer jacket 551 may be disposed directly adjacent to a coil 552.
  • the polymer jacket 551 extends circumferentially around the core member 547 and the wires 548. In some instances, the polymer jacket 551 extends over a portion of the coils 552. In one or more instances, the coil 552 is replaced with the polymer jacket 551.
  • the polymer jacket 551, in some instances, is directly adjacent to the sensor housing 474.
  • a coil 552 is disposed adjacent to the sensor housing 474 at the distal portion of an intraluminal device (such as intravascular device 102 in Fig. 2).
  • the coil 552 is secured to the core member 547 and/or the polymer jacket 551 with adhesive 553.
  • the polymer jacket 551 is disposed adjacent to the coil 552.
  • the coil 552 and the polymer jacket 551 extend circumferentially around the core member 547 and the wires 548. In some aspects, the coil
  • the adhesive 552 is in direct contact with the sensor housing 474. In one or more instances, the adhesive
  • the less cured portions of the sensor housing 474 are located adjacent to the coil 552. In one or more instances, the less cured portions of the sensor housing 474 are in direct contact with and or directly adjacent to the coil 552.
  • the sensor housing 474 has varying durometer values, where the greater relative durometer values are located distally, and the lesser relative durometer values are located proximally. In one or more aspects, the sensor housing 474 has a greater portion of higher relative durometer values than lower relative durometer values along the length of the sensor housing, as described herein.
  • Figs.4A-6 may illustrate portions of an intraluminal device (e.g., intravascular guidewire), such as the housing 282 of the flow-sensing intravascular device 102 depicted as in Fig. 2.
  • the sensor housing 474, in Figs. 4A-6, can include other features described herein with the same reference numeral and housing 282 in Fig. 3.
  • a plurality of layers 556 are stacked or formed on top of one another to form the sensor housing 554.
  • the plurality of layers 556 of the sensor housing 554 includes a first portion 558.
  • the first portion 558 of the plurality of layers 556 include a plurality of strain relief features 560.
  • the plurality of strain relief features 560 include an opening 560a and an opening 560b, circumferentially offset from the opening 560a.
  • the opening 560a and the opening 560b may be radial openings.
  • the plurality of layers 556 includes a representative first layer 562 and a representative second layer 564.
  • the first layer 562 may be stacked or printed upon the second layer 564. In some instances, the second layer 564 may be formed upon the first layer 562.
  • the second layer 564 includes the opening 560a and the opening 560b of the strain relief features 560.
  • the first layer 561 does not include a strain relief feature of the plurality of strain relief features 560.
  • the first layer 562 is contiguous and solid around a perimeter or circumference of the sensor housing 554.
  • the second layer 564 is non-contiguous.
  • the plurality of layers 556 also includes a second portion 566 distal to the first portion 558.
  • a lumen 568 extends within the first portion 558 and the second portion 566 of the plurality of layers 556 and is shown in dotted lines.
  • the sensor housing 554 including the plurality of strain relief features is formed by 3D printing. In other instances, the sensor housing 554 including the plurality of strain relief features 560, is formed by machining. In this instance, the plurality of layers 556 may be replaced with a solid piece of material that is machined to form the plurality of strain relief features 560. In some instances, the sensor housing 554 is composed of a rigid material such as a metal, an alloy, or a plastic.
  • the number of the plurality of layers 556 vary from the number of layers shown in Fig. 7. In one or more instances, each layer of the plurality of layers 556 includes a thickness. In some aspects, the thickness of the layers varies. In some instances, the number of layers in the first portion 558 and the second portion 566 vary from the number of layers shown in Fig. 7. In some instances, there are less layers in the first portion 558 than in the second portion 566. In one or more instances, the sensor housing 554 includes a length along a longitudinal axis, the longitudinal axis extending through the center of the lumen 568. In some aspects, the first portion 558 of the plurality of layers 556 is shorter along the length than the second portion 566.
  • the first portion 558 of the plurality of layers 556 is more flexible than the second portion 566.
  • the second portion 566 may not any strain reliefs such as any radial openings.
  • the plurality of strain relief features 560 extend in a radial direction. In some instances, the plurality of strain relief feature 560 extend partially through a sidewall of the sensor housing 554. In one or more aspects, the plurality of strain relief features 560 extend completely through a sidewall. In some instances, the first portion 558 is the proximal portion of the sensor housing 554 and has a strain relief.
  • the strain reliefs may include one, two, three, four, or more openings, referred to as collectively as strain relief features 560. The openings, in some instances, extend from an outer surface of the sensor housing 554 and extend inwardly partially into sidewall.
  • the openings extend from an outer surface of the sensor housing 554 and extend inwardly completely through the sidewall into the lumen 568.
  • the openings in various instances, extend from an inner surface of the sensor housing 554 and extend outwardly partially through the sidewall into the lumen 568.
  • the openings are longitudinally offset from one another.
  • the openings are circumferentially offset from one another (such as opening 560a and opening 560b).
  • two or more openings of the plurality of strain relief features 560 are disposed along one longitudinal location that are on opposite sides of the sensor housing 554 such as opening 560a and opening 560b.
  • dimensions of the openings of the plurality of strain relief features 560 may vary in the proximal-distal direction or may vary in the up-down direction illustrated in Fig. 7. In several instances, the dimensions of the openings (such as openings 560a and 560b) may be the same size.
  • the strain relief features 560 include portions intentionally skipped when the sensor housing 554 was being printed.
  • the strain relief feature 560 form openings that provide the sensor housing 554 with strain relief, bending, flexibility, and/or help to smooth transitions when attached to the intraluminal device (such as the intravascular device 102 in Fig. 2).
  • the strain relief feature 560 may vary in size, number, or shape, so long as, the strain relief feature 560 help to provide a smooth transition from the sensor housing 554 to the remainder of the intravascular device 102.
  • a portion of the strain relief features 560 (such as opening 560a) are disposed at a proximal end of the sensor housing 554.
  • a portion of the strain relief features 560 (such as opening 560b) are disposed spaced from the proximal end as shown in Fig. 7.
  • a first set of the plurality of strain relief features 560 are disposed at a proximal end of the sensor housing 554 and a second set of the plurality of strain relief features 560 are spaced from the proximal end.
  • the strain relief features 560 include one or more cut-outs, openings, recess, or slits in the sensor housing 554.
  • the walls/structure of the housing 554 could be 3D printed as a mesh or lattice structure.
  • the walls/structure of the housing 554 that define/ surround the strain relieving features 560 can be cured completely or cured to a relatively greater degree.
  • the strain relieving features 560 themselves can be completely empty, so that the strain relieving features 560 are openings in the wall of the housing 554. In other instances, the strain relieving features 560 themselves (the spaces surrounded by the wall portions of the housing 554) are not completely empty.
  • any individual opening or pocket need not be completely empty, but could instead have the curing (and therefore hardness) modulated down to some degree (relatively less curing than surrounding wall portions of housing 554, relative lower durometer hardness).
  • the lumen 568 includes a varying diameter as shown in Fig. 7.
  • the lumen 568 may have a varying diameter in the second portion 566 and a constant diameter in the first portion 558.
  • the lumen 568 represents an internal opening to fit the conductive wires and sensor components, as described herein.
  • Fig. 7 may illustrate a sensor housing 554 of an intraluminal device (e.g., intravascular guidewire), such as the housing 282 of the flow-sensing intravascular device 102 depicted as in Fig. 2.
  • the sensor housing 554 can include other features of other sensor housings described herein such as sensor housing 474 in Figs. 4A-6 and housing 282 in Fig. 3.
  • FIG. 8 shown therein is a diagrammatic, schematic side view of a sensor housing 570 according to an aspect of the present disclosure.
  • a plurality of layers 572 are formed, via 3D printing, on top of one another to form the sensor housing 570.
  • the plurality of layers 572 of the sensor housing 570 includes a first portion 574, a second portion 576, a third portion 578, and a fourth portion 580.
  • the first portion 574 is proximal of the second portion 576.
  • the second portion 576 is proximal of the third portion 578.
  • the third portion 578 is proximal to the fourth portion 580.
  • the fourth portion 580 is the distal- most portion.
  • the first portion 574 is the proximal-most portion.
  • the first portion 574 includes a representative layer 582.
  • the second portion 576 includes a representative layer 584.
  • the third portion 578 includes a representative layer 586.
  • the fourth portion 580 includes a representative first layer 588.
  • the plurality of layers 572 include a plurality of strain relief feature 590.
  • the representative layer 582 of the first portion 574 includes a strain relief feature of the plurality of strain relief features 590.
  • the representative layer 584 of the second portion 576, the representative layer 586 of the third portion 578, and the representative layer 588 of the fourth portion 580 do not include a strain relief feature of the strain relief features 590.
  • the representative layer 584 of the second portion 576, and the representative layer 586 of the third portion 578 do include a strain relief feature of the strain relief features 590.
  • the representative layer 584 of the second portion 576, the representative layer 586 of the third portion 578, and the representative layer 588 of the fourth portion 580 are each continuous and circumferentially extending.
  • the representative layer 582 is non-contiguous.
  • a lumen 592 extends within the sensor housing 570 and is shown in dotted lines.
  • the representative layer 582 of the first portion 574, the representative layer 584 of the second portion 576, the representative layer 586 of the third portion 578, and the representative layer 588 of the fourth portion 580 are comprised of the same material.
  • the material is printed with a 3-D printer.
  • the material is comprised of a plastic, metal, alloy, polymer, or the like.
  • a plurality of materials are used and one portion may be comprised of a different material than another portion (e.g., the first portion 574 may be a different material than the fourth portion 580).
  • the representative layer 582 of the first portion 574, the representative layer 584 of the second portion 576, the representative layer 586 of the third portion 578, and the representative layer 588 of the fourth portion 580 are comprised of the same material at different curing settings and times, as described herein.
  • the first portion 574 of the plurality of layers 574 has a lower durometer value and is less hard relative to the second portion 576, the third portion 578, and the fourth portion 580.
  • the second portion 576 of the plurality of layers 574 has a lower durometer value and is less hard relative to the third portion 578 and the fourth portion 580.
  • the third portion 578 of the plurality of layers 574 has a lower durometer value and is less hard relative to only the fourth portion 580.
  • the fourth portion 580 of the plurality of layers 572 may be fully cured.
  • the first portion 574 may also be flexible in comparison to the fourth portion 580 due to the strain relief features 590.
  • the strain relief features 590 may be printed by a 3D printer by skipping portions of a layer within the plurality of layers, thus making the layer non-contiguous.
  • a variety of shapes and sizes for the strain relief features 90 may be used.
  • the strain relief features 590 may be formed on one or more sides of the sensor housing 570. Additionally, the strain relief features 590 may extend over one or more plurality of layers. In some instances, a strain relief feature of the strain relief features 590 is only in (only extends along) one layer of the plurality of layers.
  • the strain relief features in some aspects, may be combined with a multi-durometer plurality of layers to provide strain relief and smooth transitions for when the sensor housing 570 is placed in an intraluminal device such as the intravascular device 102 in Fig. 2.
  • the first portion 574 is adjacent to the second portion 576, the second portion 576 is adjacent to the third portion 578, the third portion 578 is adjacent to the fourth portion 580.
  • the first portion 574 is in direct contact with or directly adjacent to the second portion 576, the second portion 576 in direct contact with or directly adjacent to the third portion 578, the third portion 578 in direct contact with or directly adjacent to the fourth portion 580.
  • the number of the plurality of layers 572 vary from the number of layers shown in Fig. 8. In one or more instances, each layer of the plurality of layers 572 includes a thickness. In some aspects, the thickness of the layers vary and are not uniform unlike what is depicted in Fig. 8. In some instances, the number of layers in the first portion 574, the second portion 576, the third portion 578, and the fourth portion 580 vary from the number of layers shown in Fig. 8. In some instances, there are less layers in the first portion 574 than in the second portion 576 or the third portion 578. In some instances, the plurality of layers 572 may include few or more portions with varying durometer levels (altered by changing the curing settings of the material, as described herein).
  • the fourth portion 580 is the largest portion.
  • the second portion 576 is omitted and replaced with the first portion 574.
  • the third portion 578 is omitted and replaced with the first portion 574.
  • the sensor housing 554 includes a length along a longitudinal axis, the longitudinal axis extending through the center of the lumen 568.
  • the fourth portion 580 is the largest portion along the length.
  • the lumen 568 includes a varying diameter as shown in Fig. 8.
  • the lumen 592 may have a varying diameter in the fourth portion 580 and a constant diameter in the first portion 574, the second portion 576, and the third portion 578.
  • the lumen 592 represents an internal opening to fit the conductive wires and sensor components, as described herein.
  • Fig. 8 may illustrate a sensor housing 570 of an intraluminal device (e.g., intravascular guidewire), such as the housing 282 of the flow-sensing intravascular device 102 depicted as in Fig. 2.
  • the sensor housing 570 can include other features of other sensor housings described herein such as sensor housing 554 in Fig. 7, sensor housing 474 in Fig. 4A-6, and housing 282 in Fig. 3.
  • a diagrammatic, schematic side view of a sensor housing 594 according to an aspect of the present disclosure.
  • a plurality of layers 596 are formed, via 3D printing, on top of one another to form the sensor housing 594.
  • the plurality of layers 596 of the sensor housing 594 includes a first portion 598, a second portion 600, and a third portion 602.
  • the first portion 598 is proximal of the second portion 600.
  • the second portion 600 is between the first portion 598 and the third portion 602.
  • the third portion 602 is distal to the second portion 600.
  • the sensor housing 594 includes a proximal end 604 and an opposing distal end 606.
  • the first portion 598 extends from the proximal end 604 along a first length “LI” 608.
  • the second portion 600 extends between the first portion 598 and the third portion 602 along a second length “L2” 610.
  • the third portion 602 extends from the distal end 606 along the length “L3” 612.
  • a lumen 614 extends within the sensor housing 594 and is illustrated by two parallel dotted lines.
  • the lumen 614 includes a non-varying diameter along LI 608, L2 610, and L3 612.
  • the sensor housing 594 includes an opening 616.
  • the first portion 598 of the plurality of layers 596 changes durometer values along LI 608.
  • the durometer values vary along LI 608 from a relatively soft durometer near the proximal end 604 to a relatively harder durometer at an opposite end of the first portion 598.
  • the first portion 598 of the plurality of layers 596 may be made of a single material that has been cured to different level of hardness (durometer values or hardness values) by altering the curing settings as described herein.
  • the softest layers of the first portion 598 of the plurality of layers 596 are near the proximal end 604.
  • the proximal end 604 may be attached to portions of an intraluminal device such as intravascular device 102 shown in Fig. 1.
  • the “relatively” soft layers near the proximal end 604 provide a smooth transition from the sensor housing 594 to the other components of the intraluminal device and prevent a kink point.
  • various cure settings are used on the material of the plurality of layers 596 of the first portion 598, which can range from fully cured to light source for curing set at 75%.
  • the light source for curing the first portion 598 ranges from 75%-90%.
  • the light source for curing the first portion 598 ranges from 80%-95%.
  • the light source is incrementally changed per one or more layers of the plurality of layers 596 of the first portion 598.
  • the third portion 602 includes only a single durometer value along L3 612, while, the first portion 598 includes a plurality of a durometer values along LI 608. In some aspects, the first portion 598 includes a plurality of hardness values and each individual value of the plurality of hardness values are less than of the hardness values in the second portion 600 600.
  • the second portion 600 of the plurality of layers 596 does not vary durometer values along L2 610.
  • the second portion 600 has the same level of hardness along L2 610.
  • the second portion 600 in some aspects, is relatively harder/has a higher durometer value than any layer of the plurality of layers 596 in the first portion 598 and/or in the third portion 602.
  • the second portion 600 may be directly adjacent to and/or in direct contact with the first portion 598 and the third portion 602.
  • the material of the plurality of layers 596 in the second portion 600 is fully cured.
  • the plurality of layer 596 in the third portion 602 is stiff or rigid to support one or more sensor components and wires.
  • L2 610 is greater than either LI 608 or L3 612. As shown in Fig. 9, a portion of the plurality of layers 596 of the second portion 600 are non-contiguous due to the opening 612.
  • the opening 612 may provide access to one or more sensing components.
  • the third portion 602 of the plurality of layers 596 changes durometer values along L3 612.
  • the durometer values vary along L3 612 from a relatively hard durometer to a relatively soft durometer at the distal end 606 of the third portion 602.
  • the third portion 602 of the plurality of layers 596 may be made of a single material that has been cured to different level of hardness (durometer values) by altering the curing settings as described herein. In some instances, the third portion 602 mirrors the first portion 598 in length and in cure settings. In other instances, the L3 612 is a different size than LI 608. The difference in size may be due to different strains or desired transitions for the sensor housing 594 when incorporated with an intraluminal device.
  • the softest layers of the third portion 602 of the plurality of layers 596 are near the distal end 606.
  • the distal end 606 may be attached to portions of an intraluminal device such as intravascular device 102 shown in Fig. 1.
  • the “relatively” soft layers near the distal end 606 provide a smooth transition from the sensor housing 594 to the other components of the intraluminal device and prevent a kink point.
  • various cure settings are used on the material of the plurality of layers 596 of the third portion 602, which can range from fully cured to light source for curing set at 75%.
  • the light source for curing the third portion 602 ranges from 75%-90%. In other aspects, the light source for curing the third portion 602 ranges from 80%-95%.
  • the light source is incrementally changed per one or more layers of the plurality of layers 596 of the third portion 602.
  • the third portion 602 includes a plurality of durometer values along L3 612, while, the first portion 598 includes only a single durometer value along LI 608.
  • the third portion 602 includes one or more durometer values along L3 612 that differ from the one or more durometer values of the second portion 600 along L2 610 and/or the one or more durometer values of the first portion 598 along LI 608.
  • the third portion 602 includes one or more durometer values along L3 612 that is the same as the one or more durometer values of the second portion 600 along L2 610 and/or the one or more durometer values of the first portion 598 along LI 608.
  • the third portion 602 includes a plurality of hardness values and each individual value of the plurality of hardness values are less than of the hardness values in the first portion 598 and/or the second portion 600.
  • the first portion 598 of the plurality of layers 596, the second portion 600 of the plurality of layers 596, and the third portion 602 of the plurality of layers 596 are comprised of the same material.
  • the material is printed with a 3-D printer.
  • the material is comprised of a plastic, metal, alloy, polymer, or the like.
  • a plurality of materials are used and one portion may be comprised of a different material than another portion (e.g., the first portion 574 may be a different material than the fourth portion 580).
  • the first portion 598 includes a first hardness value; the second portion 600 includes a second hardness value; and the third portion 602 includes a third hardness value.
  • the first hardness value is the same as the third hardness value.
  • the first hardness value and the second hardness value are less than the third hardness value.
  • the first hardness value is greater than the third hardness value, but less than the second hardness value.
  • the third hardness value is greater than the first hardness value, but less than the second hardness value.
  • the first portion 598 includes a plurality of hardness values including the first hardness value, but each of the plurality of hardness values is less than the second hardness value.
  • the first portion 598 includes a plurality of hardness values including the first hardness value, but each of the plurality of hardness values is less than the third hardness value.
  • the third portion 602 includes a plurality of hardness values including the third hardness value, but each of the plurality of hardness values is less than the second hardness value.
  • the first portion 598 includes a plurality of hardness values including the first hardness value, but each of the plurality of hardness values is less than the third hardness value.
  • the number of the plurality of layers 596 may vary from the number of layers shown in Fig. 9. In one or more instances, each layer of the plurality of layers 596 includes a thickness. In some aspects, the thickness of the layers varies and are not uniform unlike what is depicted in Fig. 9. In some instances, the number of layers in the first portion 598, the second portion 600, and the third portion 602 vary from the number of layers shown in Fig. 9. In some instances, there are less layers in the first portion 598 than in the second portion 600 or the third portion 602. In some aspects, there are less layers in the third portion 602 than in the first portion 598 or the second portion 600.
  • Fig. 9 may illustrate a sensor housing 594 of an intraluminal device (e.g., intravascular guidewire), such as the housing 280 of the intravascular device 102 depicted as a pressure-sensing guidewire in Fig. 1 and the portion of the intravascular device 670 described below in Figs. 12-13B.
  • the sensor housing 594 can include other features of other sensor housings described herein.
  • features of the sensor housing 594 can be used for a housing of the flow-sensing guidewire in, e.g., Fig. 2 and 3.
  • the distal-most third portion 602 (which has relatively lower hardness than the relatively more proximal portion 600) can be implemented in the sensor housing 282 (Fig.
  • the relatively most hard section (e.g., the portion 600 in Fig. 9) of the sensor housing can be the distal-most section or may not be the distal-most section.
  • the center section (e.g., the portion 600 in Fig. 9) of the sensor housing can be the relatively hardest, while a more proximal section (first portion 598 in Fig. 9) is relatively softer (less hard) than the center section and a more distal section (third portion 602 in Fig. 9) is relatively softer (less hard) than the center section.
  • a sensor housing 618 shown therein is a diagrammatic, schematic side view of a sensor housing 618 according to an aspect of the present disclosure.
  • a plurality of layers 620 are formed, via 3D printing, on top of one another to form the sensor housing 618.
  • the plurality of layers 620 of the sensor housing 618 includes a first portion 622, a second portion 624, and a third portion 626.
  • the first portion 622 is proximal of the second portion 624.
  • the second portion 624 is between the first portion 622 and the third portion 626.
  • the third portion 626 is distal to the second portion 624.
  • the sensor housing 618 includes a proximal end 628 and an opposing distal end 630.
  • the first portion 622 extends from the proximal end 628 along a first length “LI” 632.
  • the sensor housing 618 includes a plurality of strain relief features 634. A first subset of the plurality of strain relief features 634 is disposed within the first portion 622 of the plurality of layers 620.
  • the second portion 624 extends between the first portion 622 and the third portion 626 along a second length “L2” 636.
  • the third portion 626 extends from the distal end 630 along the length “L3” 638.
  • a second subset of the plurality of strain relief features 634 is disposed within the third portion 626 of the plurality of layers 620.
  • a lumen 640 extends within the sensor housing 618 and is illustrated by two parallel dotted lines. The lumen 640 includes a non-varying diameter along LI 632, L2 636, and L3 638.
  • the sensor housing 618 includes an opening 642 in the second portion 624.
  • the first portion 622 mirrors the third portion 626.
  • the first subset of strain relief features 634 in the first portion 622 is identical in at least number and size to the second subset of strain relief features 634 in the third portion 626.
  • the first subset of strain relief features 634 in the first portion 622 differs in quantity, size, or shape to the second subset of strain relief features 634 in the third portion 626. The difference between the first subset and the second subset of strain relief features 634 may be due to the stress and transition region of the sensor housing 618 and another component of an intraluminal device such as intravascular device 102 in Fig. 1.
  • the same curing time and light settings are used on the entirety of the plurality of layers 620.
  • the first portion 622 and/or the third portion 626 may be flexible in comparison to the second portion 624 due to the strain relief features 634.
  • the strain relief features 634 may be printed by a 3D printer by skipping portions of a layer within the plurality of layers 620, thus making the layer non-contiguous. A variety of shapes and sizes for the strain relief features 634 may be used. For example, in Fig.10, the strain relief features 634 may be formed on one or more sides of the sensor housing 618 in the first portion 622 and the third portion 626. Additionally, the strain relief features 636 may extend over one or more plurality of layers, as shown in Fig. 10.
  • a strain relief feature of the strain relief features 634 is only in (only extends along) one layer of the plurality of layers.
  • the third portion 626 includes a plurality of strain relief features 636 along L3 638, while the first portion 622 includes only a single strain relief feature along LI 632.
  • the third portion 626 includes a single strain-relief feature along L3 638, while the first portion 622 includes a plurality of strain relief features 636 along LI 632.
  • the third portion 626 includes a plurality of strain relief features 636 along L3 638, while the first portion 622 includes no strain relief feature along LI 632.
  • the third portion 626 includes no strain-relief feature along L3 638, while the first portion 622 includes a plurality of strain relief features 636 along LI 632.
  • L2 636 is greater than LI 632 and/or L2 638.
  • LI 632 equals L3 638.
  • the first portion 622 of the plurality of layers 620, the second portion 624 of the plurality of layers 620, and the third portion 626 of the plurality of layers 620 are comprised of the same material.
  • the material is printed with a 3-D printer.
  • the material is machined to form the strain relief features 634.
  • the material is comprised of a plastic, metal, alloy, polymer, or the like.
  • a plurality of materials are used and one portion may be comprised of a different material than another portion (e.g., the first portion 622 may be a different material than the second portion 624).
  • the number of the plurality of layers 620 may vary from the number of layers shown in Fig.10. In one or more instances, each layer of the plurality of layers 620 includes a thickness. In some aspects, the thickness of the layers varies and are not uniform unlike what is depicted in Fig. 10. In some instances, the number of layers in the first portion 622, the second portion 624, and the third portion 626 vary from the number of layers shown in Fig. 10. In some instances, there are less layers in the first portion 622 than in the second portion 624 or the third portion 626. In some aspects, there are less layers in the third portion 626 than in the first portion 622 or the second portion 624.
  • a portion of the plurality of strain relief features 634 are disposed at a distal end of the sensor housing 618. In some aspects, a portion of the plurality of strain relief features 634 are disposed spaced from the distal end. In various instances, a first set of the plurality of strain relief features 634 are disposed at a distal end of the sensor housing 554 and a second set of a portion of the plurality of strain relief features 634 are spaced from the distal end. In one or more instances, a portion of the plurality of strain relief features 634 are disposed at a proximal end of the sensor housing 618.
  • the portion of the plurality of strain relief features 634 are disposed spaced from the proximal end. In various instances, a first set of a portion of the plurality of strain relief features 634 are disposed at a proximal end of the sensor housing 554 and a second set of a portion of the plurality of strain relief features 634 are spaced from the proximal end.
  • Fig. 10 may illustrate a sensor housing 618 of an intraluminal device (e.g., intravascular guidewire), such as the housing 280 of the intravascular device 102 depicted as a pressure-sensing guidewire in Fig. 1 and the portion of the intravascular device 670 described below in Figs. 12-13B.
  • the sensor housing 618 can include other features of other sensor housings described herein such as sensor housing 594 in Fig. 9.
  • a diagrammatic, schematic side view of a sensor housing 644 according to an aspect of the present disclosure.
  • a plurality of layers 646 are formed, via 3D printing, on top of one another to form the sensor housing 644.
  • the plurality of layers 646 of the sensor housing 644 includes a first portion 648, a second portion 650, and a third portion 652.
  • the first portion 648 is proximal of the second portion 650.
  • the second portion 650 is between the first portion 648 and the third portion 652.
  • the third portion 652 is distal to the second portion 650.
  • the sensor housing 644 includes a proximal end 654 and an opposing distal end 656.
  • the first portion 648 extends from the proximal end 654 along a first length “LI” 658.
  • the sensor housing 644 includes a plurality of strain relief features 660. A first subset of the strain relief features 660 are located within the first portion 648.
  • the second portion 650 extends between the first portion 648 and the third portion 652 along a second length “L2” 662.
  • the third portion 652 extends from the distal end 656 along the length “L3” 664.
  • a lumen 666 extends within the sensor housing 644 and is illustrated by two parallel dotted lines.
  • the lumen 666 includes a non-varying diameter along LI 658, L2 662, and L3 664.
  • the sensor housing 644 includes an opening 668.
  • the first portion 648 of the plurality of layers 646 changes durometer values along LI 658.
  • the durometer values vary along LI 658 from a relatively soft durometer near the proximal end 654 to a relatively harder durometer at an opposite end of the first portion 648.
  • the first portion 648 of the plurality of layers 646 may be made of a single material that has been cured to different level of hardness (durometer values) by altering the curing settings as described herein.
  • the softest layers of the first portion 648 of the plurality of layers 646 are near the proximal end 654.
  • the proximal end 654 may be attached to portions of an intraluminal device such as intravascular device 102 shown in Fig. 1.
  • the “relatively” soft layers near the proximal end 654 provide a smooth transition from the sensor housing 644 to the other components of the intraluminal device and prevent a kink point.
  • various cure settings are used on the material of the plurality of layers 646 of the first portion 648, which can range from fully cured to light source for curing set at 75%.
  • the light source for curing the first portion 648 ranges from 75%-90%.
  • the light source for curing the first portion 648 ranges from 80%-95%.
  • the light source is incrementally changed per one or more layers of the plurality of layers 596 of the first portion 648.
  • the first portion 648 mirrors the third portion 652.
  • the first subset of strain relief features 660 in the first portion 648 is identical in at least number and size to the second subset of strain relief features 660 in the third portion 652. In other aspects, the first subset of strain relief features 660 in the first portion 648 differs in quantity, size, or shape to the second subset of strain relief features 660 in the third portion 652. The difference between the first subset and the second subset of strain relief features 660 may be due to the stress and transition region of the sensor housing 644 and another component of an intraluminal device such as intravascular device 102 in Fig. 1. In some aspects, the first portion 648 and/or the third portion 652 may be flexible in comparison to the second portion 650 due to the strain relief features 660.
  • the strain relief features 660 may be printed by a 3D printer by skipping portions of a layer within the plurality of layers 646, thus making the layer non-contiguous.
  • a variety of shapes and sizes for the strain relief features 660 may be used.
  • the strain relief features 660 may be formed on one or more sides of the sensor housing 644 in the first portion 648 and the third portion 652.
  • the strain relief features 660 may extend over one or more plurality of layers, as shown in Fig. 11. In some instances, a strain relief feature of the strain relief features 660 is only in (only extends along) one layer of the plurality of layers.
  • the third portion 652 includes a plurality of strain relief features 660 along L3 664, while the first portion 648 includes only a single strain relief feature along LI 658. In other instances, the third portion 652 includes a single strain-relief feature along L3 664, while the first portion 648 includes a plurality of strain relief features 660 along LI 658.
  • the third portion 652 includes a plurality of durometer values along L3 664, while the first portion 648 includes only a single durometer value along LI 658. In other instances, the third portion 652 includes a single durometer value along L3 664, while the first portion 648 includes a plurality of durometer values along LI 658. In some aspects, the first portion 648 includes a plurality of hardness values and each individual value of the plurality of hardness values are less than of the hardness values in the second portion 650.
  • the second portion 650 of the plurality of layers 646 does not vary durometer values along L2 662 or any of the strain relief features 660.
  • the second portion 650 has the same level of hardness along L2 662.
  • the second portion 650 in some aspects, is relatively harder/has a higher durometer value than any layer of the plurality of layers 646 in the first portion 648 and/or in the third portion 652.
  • the second portion 650 may be directly adjacent to and/or in direct contact with the first portion 648 and the third portion 652.
  • the material of the plurality of layers 646 in the second portion 650 is fully cured.
  • the plurality of layer 646 in the third portion 652 is stiff or rigid to support one or more sensor components and wires.
  • L2 662 is greater than either LI 658 or L3 664.
  • a portion of the plurality of layers 646 of the second portion 650 are noncontiguous due to the opening 668.
  • the opening 668 may provide access to one or more sensing components rather than to provide strain relief or create flexibility along the length of the sensing housing 644.
  • the first portion 648 includes a strain relief feature along a first length
  • the third portion 652 includes a strain relief feature along a second length.
  • the second portion 650 and the first portion 648 are directly adjacent to one another, in some aspects.
  • the strain relief feature along the first length and the strain relief feature along the second length are configured to add flexibility to the sensor housing.
  • the third portion 652 of the plurality of layers 646 changes durometer values along L3 664.
  • the durometer values vary along L3 664 from a relatively hard durometer to a relatively soft durometer at the distal end 656 of the third portion 652.
  • the third portion 652 of the plurality of layers 646 may be made of a single material that has been cured to different level of hardness (durometer values) by altering the curing settings as described herein. In some instances, the third portion 652 mirrors the first portion 648 in length and in cure settings. In other instances, the L3 664 is a different size than LI 662. The difference in size may be due to different strains or desired transitions for the sensor housing 644 when incorporated with an intraluminal device.
  • the softest layers of the third portion 652 of the plurality of layers 646 are near the distal end 656.
  • the distal end 656 may be attached to portions of an intraluminal device such as intravascular device 102 shown in Fig. 1.
  • the “relatively” soft layers near the distal end 656 provide a smooth transition from the sensor housing 644 to the other components of the intraluminal device and prevent a kink point.
  • various cure settings are used on the material of the plurality of layers 646 of the third portion 652, which can range from fully cured to light source for curing set at 75%. In some aspects, the light source for curing the third portion 652 ranges from 75%-90%.
  • the light source for curing the third portion 652 ranges from 80%-95%. In some aspects, the light source is incrementally changed per one or more layers of the plurality of layers 646 of the third portion 652.
  • the third portion 652 includes one or more durometer values along L3 664 that differ from the one or more durometer values of the second portion 650 along L2 662 and/or the one or more durometer values of the first portion 648 along LI 658.
  • the third 652 602 includes one or more durometer values along L3 664 that is the same as the one or more durometer values of the second portion 650 along L2 662 and/or the one or more durometer values of the first portion 648 along LI 658.
  • the third portion 652 includes a plurality of hardness values and each individual value of the plurality of hardness values are less than of the hardness values in the first portion 648 and/or the second portion 650.
  • the first portion 648 includes a first hardness value; the second portion 650 includes a second hardness value; and the third portion 652 includes a third hardness value.
  • the first hardness value is the same as the third hardness value.
  • the first hardness value and the second hardness value are less than the third hardness value.
  • the first hardness value is greater than the third hardness value, but less than the second hardness value.
  • the third hardness value is greater than the first hardness value, but less than the second hardness value.
  • the first portion 648 includes a plurality of hardness values including the first hardness value, but each of the plurality of hardness values is less than the second hardness value.
  • the first portion 648 includes a plurality of hardness values including the first hardness value, but each of the plurality of hardness values is less than the third hardness value.
  • the third portion 652 includes a plurality of hardness values including the third hardness value, but each of the plurality of hardness values is less than the second hardness value.
  • the first portion 648 includes a plurality of hardness values including the first hardness value, but each of the plurality of hardness values is less than the third hardness value.
  • the material is printed with a 3-D printer.
  • the material is comprised of a plastic, metal, alloy, polymer, or the like.
  • a plurality of materials are used and one portion may be comprised of a different material than another portion (e.g., the first portion 574 may be a different material than the fourth portion 580).
  • the number of the plurality of layers 596 may vary from the number of layers shown in Fig. 9. In one or more instances, each layer of the plurality of layers 596 includes a thickness. In some aspects, the thickness of the layers varies and are not uniform unlike what is depicted in Fig. 9. In some instances, the number of layers in the first portion 598, the second portion 600, and the third portion 602 vary from the number of layers shown in Fig. 9. In some instances, there are less layers in the first portion 598 than in the second portion 600 or the third portion 602. In some aspects, there are less layers in the third portion 602 than in the first portion 598 or the second portion 600.
  • the first portion 622 mirrors the third portion 626.
  • the first subset of strain relief features 634 in the first portion 622 is identical in at least number and size to the second subset of strain relief features 634 in the third portion 626.
  • the first subset of strain relief features 634 in the first portion 622 differs in quantity, size, or shape to the second subset of strain relief features 634 in the third portion 626. The difference between the first subset and the second subset of strain relief features 634 may be due to the stress and transition region of the sensor housing 618 and another component of an intraluminal device such as intravascular device 102 in Fig. 1.
  • the same curing time and light settings are used on the entirety of the plurality of layers 620.
  • the first portion 622 and/or the third portion 626 may be flexible in comparison to the second portion 624 due to the strain relief features 634.
  • the strain relief features 634 may be printed by a 3D printer by skipping portions of a layer within the plurality of layers 620, thus making the layer non-contiguous. A variety of shapes and sizes for the strain relief features 634 may be used. For example, in Fig.10, the strain relief features 634 may be formed on one or more sides of the sensor housing 618 in the first portion 622 and the third portion 626. Additionally, the strain relief features 636 may extend over one or more plurality of layers, as shown in Fig. 10.
  • a strain relief feature of the strain relief features 634 is only in (only extends along) one layer of the plurality of layers.
  • Fig. 11 may illustrate a sensor housing 644 of an intraluminal device (e.g., intravascular guidewire), such as the housing 280 of the intravascular device 102 depicted as a pressure-sensing guidewire in Fig. 1 and the portion of the intravascular device 670 described below in Figs. 12-13B.
  • the sensor housing 644 can include other features of other sensor housings described herein such as sensor housing 594 in Fig. 9 and sensor housing 618 in Fig. 10, for example, in some aspects, the plurality of strain relief features 634 of Fig. 10. [0135] Referring to Fig.
  • FIG. 12 shown therein is a diagrammatic side view of a portion of an intravascular device 670 including a multi -durometer sensor housing 594, in accordance with at least one aspect of the present disclosure.
  • the portion of the intravascular device 670 includes a polymer jacket 672 surrounding a set of conductors 674 and a portion of the core wire 676, the proximal end 604 of the sensor housing 594 is adjacent to the polymer jacket 672.
  • the sensor housing 594 includes a cantilevered sensor 680 placed on a sensor mount 682.
  • the sensor 680 may be accessible via the opening 616 and may be configured to obtain medical data associated with a blood vessel.
  • Coils 684 are adjacent to the distal end 606 of the sensor housing 594.
  • Shaping ribbon 686 extends in between the coils 684 and the sensor housing 594.
  • Adhesive 688 may be used to couple one or more components together (such as the shaping ribbon 686 to the sensor mount 682) and to smooth the circumference of the portion of the intravascular device 670 by the coils 684.
  • the core wire 676 extends the length of the portion of the intravascular device 670 and is configured to provide structural support.
  • the portion of the intravascular device 670 is configured to be positioned within a blood vessel.
  • the sensor mount 682 includes shaping ribbon 686, partially surrounded by a layer of adhesive 688. In some instances, the adhesive 688 is replaced with an insulating material.
  • the core wire 676 On a lower portion of the sensor mount 682 is the core wire 676 within a lumen (also describable as a trench, recess, depression, etc.) of the sensor mount 682. The core wire 676 is also disposed within the lumen 614 of the sensor housing 594, as is the sensor 680 and at least a portion of the sensor mount 682.
  • no wires or filars pass through the sensor housing 594 adjacent to the sensor mount 682 and may thus allow for a smaller sensor housing 594, a larger sensor mount 682, and/or a closer fit between the sensor housing 594 and the sensor mount 682.
  • the sensor mount 682 also includes a core wire lumen (which may also be described as a core wire recess, core wire region, core wire space, or core wire opening), and an optional solder or glue hole to facilitate attachment of the sensor mount 682 to the core wire and/or to a shaping ribbon that is coupled to the sensor mount 682 and extends distal of the sensor mount.
  • the shaping ribbon extends within the polymer jacket 672.
  • the housing and the mount are distinct components (e.g., that are coupled to one another), rather than an integral component.
  • Fig. 13A shown therein a cross-sectional view of the sensor housing of Fig. 12 along the 13A line, in accordance with at least one aspect of the present disclosure.
  • the sensor housing 594 forms an outermost surface of the portion of the intraluminal device 670.
  • sensor 680 Radially inward from the housing 594, is sensor 680, which includes a cantilever portion (shown in more detail in Fig.12), disposed above the sensor mount 682 and which is partially enclosed by the sensor housing 594 which includes the opening 616 above the sensor 680.
  • the sensor mount 682 is positioned radially inward from, and is partially enclosed by, the sensor housing 594.
  • the adhesive 688 is positioned radially inward from the sensor mount 682.
  • the adhesive 688 is disposed between the sensor mount 682 and the core wire 676.
  • the adhesive 688 acts to couple the core wire 676 to the sensor mount 682.
  • Fig. 13B shown therein is a cross-sectional view of the sensor housing of Fig. 12 along the 13B line, in accordance with at least one aspect of the present disclosure.
  • the sensor housing 594 forms an outermost surface of the portion of the intraluminal device 670.
  • the sensor housing 594 at the cross-section of the 13B line has a lower durometer value than that of the sensor housing 594 at the cross-section of the 13 A line.
  • the sensor housing 594 is more flexible along the cross-section of the 13B line than the 13 A line.
  • Radially inward from the housing 594 is a set of conductors 674, disposed above the sensor mount 682 and which is fully enclosed by the sensor housing 594.
  • the sensor mount 682 is positioned radially inward from, and is fully enclosed by, the sensor housing 594.
  • the adhesive 688 is positioned radially inward from the sensor mount 682.
  • the adhesive 688 is disposed between the sensor mount 682 and the core wire 676.
  • the adhesive 688 acts to couple the core wire 676 to the sensor mount 682.
  • the multi-durometer sensor housing 594 is beneficial to this portion of the intravascular device 670 because the harness (or durometer value) of the sensor housing is decreased at the respective distal and proximal portions of the sensor housings to create a smooth transition from the overall rigid sensor housing to the coils 684 and/or the polymer jacket 672.
  • the use of a multi-durometer sensor housing 594 prevents kinks, bends, and breaks that were caused by the rigidity of previous sensor housings. Additionally, having a higher durometer in the middle portion of the sensor housing 594 creates the rigidity needed to support the sensor 680 and the other components (such as the sensor mount 682).
  • the multi-durometer sensor housing 594 is an improvement to sensor housings for intraluminal devices.
  • Figs 12-13B may illustrate a portion of the intravascular device 102 including the flexible elongate member 106 depicted as a pressure-sensing guidewire in Fig. 1.
  • the portion of the intravascular device 670 of Figs. 12-13B can include other features of the intravascular device 102 in Fig. 1.
  • the sensor housing 594 can include other features of other sensor housings described herein such as sensor housing 644 in Fig. 11, for example, in some aspects, the plurality of strain relief features 660.
  • the apparatus includes an intravascular catheter or guidewire, which may include: a flexible elongate member configured to be positioned within a blood vessel and may include a proximal portion, a distal portion, and a longitudinal axis; a sensor housing positioned at the distal portion; and a sensor positioned within the sensor housing and configured to obtain medical data associated with the blood vessel.
  • the sensor housing may include a plurality of layers arranged along the longitudinal axis. The plurality of layers may include a first section with a first hardness value and a second section with a second hardness value. The first hardness value is greater than the second hardness value. The first section is distal to the second section.
  • Implementations may include one or more of the following features.
  • the plurality of layers in the first section and in the second section may include a same material.
  • the same material of the second section is cured for less time than the same material of the first section such that the first hardness value is larger than the second hardness value.
  • the sensor housing may include a lumen defined by the plurality of layers, and the sensor is positioned in the lumen.
  • the plurality of layers further may include a third section with a third hardness value, the third section is positioned between the first section and the second section, and the third hardness value is less than the first hardness value and greater than the second hardness value.
  • the sensor housing may include a proximal end and a distal end, the first section may include a first length of the sensor housing, the second section may include a second length of the sensor housing, and the second length of the sensor housing may include the proximal end.
  • the first section may include a first length of the sensor housing, the second section may include a second length of the sensor housing, and the first length is greater than the second length.
  • the second section may include a plurality of openings.
  • the plurality of layers may include a third section with a third hardness value, the third hardness value is less than the first hardness value, the sensor housing may include a proximal end and a distal end, the third section may include the distal end, the first section may include the proximal end, and the first section is positioned between the second section and the third section.
  • the second hardness value and the third hardness value are equivalent.
  • the apparatus includes an intravascular catheter or guidewire, which may include: a flexible elongate member configured to be positioned within a blood vessel and may include a proximal portion, a distal portion, and a longitudinal axis; a sensor housing positioned at the distal portion; and a sensor positioned within the sensor housing and configured to obtain medical data associated with the blood vessel.
  • the sensor housing may include a first section and a second section arranged along the longitudinal axis. The first section is distal of the second section. The second section may include a plurality of openings.
  • the sensor housing may include a proximal end and a distal end, and the second section may include the proximal end.
  • the first section may include a first plurality of layers
  • the second section may include a second plurality of layers
  • the second plurality of layers may include the plurality of openings.
  • the first plurality of layers may include a first hardness value
  • the second plurality of layers may include at least a second hardness value
  • the first hardness value is greater than the second hardness value.
  • the sensor housing may include a third section arranged along the longitudinal axis, the third section may include a further plurality of openings, and the first section is positioned between the second section and the third section.
  • the apparatus includes an intravascular guidewire, which may include: a flexible elongate member configured to be positioned within a blood vessel and may include a core wire configured to provide structural support; a sensor housing positioned at a distal portion and may include a lumen extending along a longitudinal axis of the intravascular guidewire; at least one of a flow sensor or pressure sensor positioned within the lumen and configured to obtain at least one of flow data or pressure data associated with blood flow within the blood vessel.
  • the sensor housing may include a first section and a second section arranged along the longitudinal axis. The first section is distal of the second section such that the second section is proximate to a distal end of the flexible elongate member.
  • the second section may include a plurality of radial openings and/or the second section may include a second hardness value that is less than a first hardness value of the first section, such that the second section is more flexible than the first section to provide a transition in stiffness between the sensor housing and the flexible elongate member.
  • a system of one or more computers can be configured to perform particular operations or actions by virtue of having software, firmware, hardware, or a combination of them installed on the system that in operation causes or cause the system to perform the actions.
  • One or more computer programs can be configured to perform particular operations or actions by virtue of including instructions that, when executed by data processing apparatus, cause the apparatus to perform the actions.
  • 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.

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Abstract

La présente invention concerne un appareil qui comprend un cathéter intravasculaire ou un fil-guide comportant un élément allongé flexible pouvant être positionné à l'intérieur d'un vaisseau sanguin et comprenant un fil central qui fournit un support structural, un boîtier de capteur comprenant une lumière s'étendant le long d'un axe longitudinal, un capteur d'écoulement et/ou un capteur de pression qui obtient des données d'écoulement et/ou des données de pression associées au flux sanguin à l'intérieur du vaisseau sanguin. Le boîtier de capteur comprend une première section et une seconde section disposées le long de l'axe longitudinal. La première section est distale par rapport à la seconde section de telle sorte que la seconde section soit à proximité d'une extrémité distale de l'élément allongé flexible. La seconde section comprend des ouvertures radiales et/ou la seconde section comprend une valeur de dureté qui est inférieure à une valeur de dureté de la première section. La seconde section est plus flexible que la première section pour fournir une transition de rigidité entre le boîtier de capteur et l'élément allongé flexible.
PCT/EP2024/085812 2023-12-22 2024-12-12 Boîtier de capteur intraluminal muni de différentes régions présentant une flexibilité pour une transition de rigidité lisse le long d'un dispositif intraluminal Pending WO2025131958A1 (fr)

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US63/613,909 2023-12-22

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Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20130296718A1 (en) * 2012-05-03 2013-11-07 St. Jude Medical Systems Ab Tube and sensor guide wire comprising tube
US20140276117A1 (en) * 2013-03-15 2014-09-18 Volcano Corporation Intravascular Devices, Systems, and Methods
WO2023194269A1 (fr) * 2022-04-07 2023-10-12 Koninklijke Philips N.V. Boîtier à composants multiples pour capteur dans un dispositif intraluminal

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20130296718A1 (en) * 2012-05-03 2013-11-07 St. Jude Medical Systems Ab Tube and sensor guide wire comprising tube
US20140276117A1 (en) * 2013-03-15 2014-09-18 Volcano Corporation Intravascular Devices, Systems, and Methods
WO2023194269A1 (fr) * 2022-04-07 2023-10-12 Koninklijke Philips N.V. Boîtier à composants multiples pour capteur dans un dispositif intraluminal

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