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WO2025006303A2 - Cathéter de guidage orientable et procédés associés - Google Patents

Cathéter de guidage orientable et procédés associés Download PDF

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Publication number
WO2025006303A2
WO2025006303A2 PCT/US2024/034708 US2024034708W WO2025006303A2 WO 2025006303 A2 WO2025006303 A2 WO 2025006303A2 US 2024034708 W US2024034708 W US 2024034708W WO 2025006303 A2 WO2025006303 A2 WO 2025006303A2
Authority
WO
WIPO (PCT)
Prior art keywords
steerable
actuator
guide catheter
tip
moving
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/US2024/034708
Other languages
English (en)
Other versions
WO2025006303A3 (fr
Inventor
Scott Arp
Damian Tomlin
Victor Gamez
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.)
Proximal Inc
Original Assignee
Proximal Inc
Priority date (The priority date 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 date listed.)
Filing date
Publication date
Application filed by Proximal Inc filed Critical Proximal Inc
Publication of WO2025006303A2 publication Critical patent/WO2025006303A2/fr
Publication of WO2025006303A3 publication Critical patent/WO2025006303A3/fr
Anticipated expiration legal-status Critical
Pending legal-status Critical Current

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
    • A61M25/0105—Steering means as part of the catheter or advancing means; Markers for positioning
    • A61M25/0133—Tip steering devices
    • A61M25/0147—Tip steering devices with movable mechanical means, e.g. pull wires
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/0043—Catheters; Hollow probes characterised by structural features
    • A61M25/005—Catheters; Hollow probes characterised by structural features with embedded materials for reinforcement, e.g. wires, coils, braids
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
    • A61M25/0105—Steering means as part of the catheter or advancing means; Markers for positioning
    • A61M25/0133—Tip steering devices
    • A61M25/0136—Handles therefor
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B1/00—Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor
    • A61B1/005—Flexible endoscopes
    • A61B1/0051—Flexible endoscopes with controlled bending of insertion part
    • A61B1/0052—Constructional details of control elements, e.g. handles
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B1/00—Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor
    • A61B1/005—Flexible endoscopes
    • A61B1/009—Flexible endoscopes with bending or curvature detection of the insertion part
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/00234—Surgical instruments, devices or methods for minimally invasive surgery
    • A61B2017/00292—Surgical instruments, devices or methods for minimally invasive surgery mounted on or guided by flexible, e.g. catheter-like, means
    • A61B2017/003—Steerable
    • A61B2017/00318—Steering mechanisms
    • A61B2017/00323—Cables or rods
    • A61B2017/00327—Cables or rods with actuating members moving in opposite directions
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
    • A61M25/0105—Steering means as part of the catheter or advancing means; Markers for positioning
    • A61M25/0133—Tip steering devices
    • A61M25/0147—Tip steering devices with movable mechanical means, e.g. pull wires
    • A61M2025/015—Details of the distal fixation of the movable mechanical means

Definitions

  • the present disclosure generally relates to minimally invasive surgical devices and, more particularly, to steerable guide catheters for minimally invasive neurointerventional procedures, and related methods.
  • Trans-radial access (TRA) for neuro-interventional procedures is becoming more popular due to a lower incidence of major access site-related complications, reduced major bleeding, decreased length of hospitalization, reduced hospital costs, and enhanced patient satisfaction.
  • Guide catheters are used as conduits for neuro-interventional devices for neuro-interventional procedures.
  • Current guide catheters on the market for TRA for neuro-interventional procedures include essentially straight flexible tubes that are difficult to navigate, especially around tight bends.
  • Simmons catheters also known as a SIM catheters, are reverse-curve selective vascular catheters designed for catheterization and selection of brachiocephalic or visceral arteries, in order to secure access, advance, exchange devices, or deliver contrast in the target vessel.
  • SIM catheters were designed to approach tortuous and elongated aortic arch vessels. SIM catheters may be used for TRA for neuro-interventional procedures.
  • SIM catheters present challenges when navigating a guide catheter into desired position quickly for neuro-interventional procedures.
  • a steerable guide catheter includes an elongate shaft including a proximal end portion and a distal end portion.
  • a steerable tip is coupled to the distal end portion of the elongate shaft and at least a portion of the steerable tip is moveable in a first tip direction.
  • a handle is coupled to the proximal end portion of the elongate shaft.
  • the handle including a steering actuator coupled to the steerable tip and configured to direct the steerable tip. Moving the steering actuator in a first actuator direction moves at least a portion of the steerable tip in the first tip direction and moving the steering actuator in a second actuator direction moves at least a portion of the steerable tip in a second tip direction.
  • Moving the steering actuator in a third actuator direction increases a stiffness of at least a portion of at least one of the elongate shaft or the steerable tip.
  • Moving the steering actuator in a fourth actuator direction decreases the stiffness of at least a portion of at least one of the elongate shaft or the steerable tip.
  • the steerable tip may be generally aligned with a central axis of the elongate shaft before the steerable tip is moved in the first tip direction.
  • Moving the steerable tip in a second tip direction may realign the steerable tip with the central axis of the elongate shaft or may move the steerable tip into a position not aligned with the central axis of the elongate shaft.
  • moving the steering actuator in the first actuator direction and the second actuator direction may include rotating the steering actuator.
  • Moving the steering actuator in the third actuator direction may include moving the steering actuator in a proximal direction.
  • Moving the steering actuator in the fourth actuator direction may include moving the steering actuator in a distal direction.
  • the steerable guide catheter may include a first elongate tensile member and a second elongate tensile member coupling the steerable tip and the steering actuator.
  • Moving the steering actuator in the first actuator direction may tension the first elongate tensile member.
  • Moving the steering actuator in the second actuator direction may tension the second elongate tensile member.
  • Moving the steering actuator in the first actuator direction may reduce tension on the second elongate tensile member.
  • Moving the steering actuator in the second actuator direction may reduce tension on the first elongate tensile member.
  • Moving the steering actuator in the third actuator direction may tension the first elongate tensile member and the second elongate tensile member.
  • Moving the steering actuator in the fourth actuator direction may reduce the tension of the first elongate tensile member and the second elongate tensile member. Alternately tensioning the first and second elongate tensile members and reducing the tension of the first and second elongate tensile members may aid the movement of the steerable tip in a distal direction.
  • the elongate shaft may include a braided structure. Tensioning the first and second elongate tensile members may compress the braided structure, reducing a length of the elongate shaft, and increasing a diameter of the elongate shaft. Reducing the tension of the first and second elongate tensile members may relax the braided structure, allowing the length of the elongate shaft to increase, and allowing the diameter of the elongate shaft to decrease. Moving the steering actuator in the third actuator direction may maintain an orientation of the steerable tip. The steering actuator may be configured to be locked to prevent movement of the steerable tip in the first and second tip directions.
  • the steerable guide catheter may include a dilator configured to pass through the steerable guide catheter.
  • the steerable guide catheter may include a guidewire configured to pass through the steerable guide catheter.
  • the elongate shaft may be generally flexible. A stiffness of the elongate shaft may vary over a length of the elongate shaft between the proximal end portion and the distal end portion. The stiffness of the elongate shaft may vary in discrete intervals over the length of the elongate shaft. The stiffness of the elongate shaft may be greater proximate the proximal end portion than proximate the distal end portion.
  • the steerable tip may include a radiopaque material.
  • a steerable guide catheter in another embodiment, includes an elongate shaft including a proximal end portion and a distal end portion.
  • a steerable tip is coupled to the distal end portion of the elongate shaft. At least a portion of the steerable tip is moveable in a first tip direction and a second tip direction.
  • a handle is coupled to the proximal end portion of the elongate shaft.
  • the handle includes a steering actuator coupled to the steerable tip and configured to direct the steerable tip. Moving the steering actuator in a first actuator direction moves at least a portion of the steerable tip in the first tip direction. Moving the steering actuator in a second actuator direction moves at least a portion of the steerable tip in the second tip direction.
  • Moving the steering actuator in a third actuator direction increases a stiffness of at least a portion of at least one of the elongate shaft or the steerable tip.
  • Moving the steering actuator in a fourth actuator direction decreases the stiffness of at least a portion of at least one of the elongate shaft or the steerable tip.
  • moving the steering actuator in the first actuator direction and the second actuator direction may include rotating the steering actuator.
  • Moving the steering actuator in the third actuator direction may include moving the steering actuator in a proximal direction.
  • Moving the steering actuator in the fourth actuator direction may include moving the steering actuator in a distal direction.
  • At least a portion of the steerable tip may be configured to move between 150° and 180° in the first tip direction.
  • At least a portion of the steerable tip may be configured to move between 150° and 180° in the second tip direction.
  • the second tip direction may be generally opposite the first tip direction.
  • the steerable guide catheter may include a first elongate tensile member and a second elongate tensile member coupling the steerable tip and the steering actuator.
  • Moving the steering actuator in the first actuator direction may tension the first elongate tensile member.
  • Moving the steering actuator in the second actuator direction may tension the second elongate tensile member.
  • Moving the steering actuator in the first actuator direction may reduce tension on the second elongate tensile member.
  • Moving the steering actuator in the second actuator direction may reduce tension on the first elongate tensile member.
  • Moving the steering actuator in the third actuator direction may tension the first elongate tensile member and the second elongate tensile member.
  • Moving the steering actuator in the fourth actuator direction may reduce the tension of the first elongate tensile member and the second elongate tensile member. Alternately tensioning the first and second elongate tensile members and reducing the tension of the first and second elongate tensile members may aid the movement of the steerable tip in a distal direction.
  • the elongate shaft may include a braided structure. Tensioning the first and second elongate tensile members may compress the braided structure, reducing a length of the elongate shaft, and increasing a diameter of the elongate shaft. Reducing the tension of the first and second elongate tensile members may relax the braided structure, allowing the length of the elongate shaft to increase, and allowing the diameter of the elongate shaft to decrease. Moving the steering actuator in the third actuator direction may maintain an orientation of the steerable tip. The steering actuator may be configured to be locked to prevent movement of the steerable tip in the first and second tip directions.
  • the steerable guide catheter may include a dilator configured to pass through the steerable guide catheter.
  • the steerable guide catheter may include a guidewire configured to pass through the steerable guide catheter.
  • the elongate shaft may be generally flexible. A stiffness of the elongate shaft may vary over a length of the elongate shaft between the proximal end portion and the distal end portion. The stiffness of the elongate shaft may vary in discrete intervals over the length of the elongate shaft. The stiffness of the elongate shaft may be greater proximate the proximal end portion than proximate the distal end portion.
  • the steerable tip may include a radiopaque material.
  • a steerable guide catheter in another embodiment, includes an elongate shaft including a proximal end portion and a distal end portion.
  • a steerable tip is coupled to the distal end portion of the elongate shaft. At least a portion of the steerable tip is moveable in a first tip direction.
  • a handle is coupled to the proximal end portion of the elongate shaft.
  • the handle includes a steering actuator coupled to the steerable tip and configured to direct the steerable tip. Moving the steering actuator in a first actuator direction moves at least a portion of the steerable tip in the first tip direction. Moving the steering actuator in a second actuator direction moves at least a portion of the steerable tip in a second tip direction.
  • the steering actuator is configured to be locked to prevent movement of the steerable tip in the first and second tip directions.
  • the steerable tip may be generally aligned with a central axis of the elongate shaft before the steerable tip is moved in the first tip direction. Moving the steerable tip in a second tip direction may realign the steerable tip with the central axis of the elongate shaft or may move the steerable tip into a position not aligned with the central axis of the elongate shaft. In some embodiments, at least a portion of the steerable tip may be configured to move between 150° and 180° in the first tip direction.
  • the handle may include a handle toothed portion.
  • the steering actuator may include an actuator toothed portion configured to engage the handle toothed portion. Engaging the actuator toothed portion with the handle toothed portion may lock the steering actuator.
  • the steering actuator may include an actuator biasing member configured to bias the actuator toothed portion to engage with the handle toothed portion. Overcoming the bias of the actuator biasing member may unlock the steering actuator.
  • the steerable guide catheter may include a first elongate tensile member and a second elongate tensile member coupling the steerable tip and the steering actuator. Moving the steering actuator in the first actuator direction tensions the first elongate tensile member, and wherein moving the steering actuator in the second actuator direction tensions the second elongate tensile member. Moving the steering actuator in the first actuator direction may reduce tension on the second elongate tensile member. Moving the steering actuator in the second actuator direction may reduce tension on the first elongate tensile member.
  • Moving the steering actuator in a third actuator direction may tension the first elongate tensile member and the second elongate tensile member.
  • Moving the steering actuator in a fourth actuator direction may reduce the tension of the first elongate tensile member and the second elongate tensile member. Alternately tensioning the first and second elongate tensile members and reducing the tension of the first and second elongate tensile members may aid the movement of the steerable tip in a distal direction.
  • Moving the steering actuator in the first actuator direction may include moving the steering actuator in a proximal direction.
  • Moving the steering actuator in the second actuator direction may include moving the actuator in a distal direction.
  • the elongate shaft may include a braided structure. Tensioning the first and second elongate tensile members may compress the braided structure, reducing a length of the elongate shaft, and increasing a diameter of the elongate shaft. Reducing the tension of the first and second elongate tensile members may relax the braided structure, allowing the length of the elongate shaft to increase, and allowing the diameter of the elongate shaft to decrease. Moving the steering actuator in the third actuator direction may maintain an orientation of the steerable tip.
  • the steerable guide catheter may include a dilator configured to pass through the steerable guide catheter.
  • the steerable guide catheter may include a guidewire configured to pass through the steerable guide catheter.
  • the elongate shaft may be generally flexible. A stiffness of the elongate shaft may vary over a length of the elongate shaft between the proximal end portion and the distal end portion. The stiffness of the elongate shaft may vary in discrete intervals over the length of the elongate shaft. The stiffness of the elongate shaft may be greater proximate the proximal end portion than proximate the distal end portion.
  • the steerable tip may include a radiopaque material.
  • a steerable guide catheter in another embodiment, includes an elongate shaft including a proximal end portion and a distal end portion.
  • a steerable tip is coupled to the distal end portion of the elongate shaft. At least a portion of the steerable tip is moveable in a first tip direction and a second tip direction.
  • a handle is coupled to the proximal end portion of the elongate shaft.
  • the handle includes a steering actuator coupled to the steerable tip and configured to direct the steerable tip. Moving the steering actuator in a first actuator direction moves at least a portion of the steerable tip in the first tip direction. Moving the steering actuator in a second actuator direction moves at least a portion of the steerable tip in the second tip direction.
  • the steering actuator is configured to be locked to prevent movement of the steerable tip in the first and second tip directions.
  • At least a portion of the steerable tip may be configured to move between 150° and 180° in the first tip direction. At least a portion of the steerable tip may be configured to move between 150° and 180° in the second tip direction.
  • the handle may include a toothed portion.
  • the steering actuator may include a toothed portion configured to engage the toothed portion of the handle. Engaging the toothed portion of the steering actuator with the toothed portion of the handle may lock the steering actuator.
  • the steering actuator may include an actuator biasing member configured to bias the actuator toothed portion to engage with the handle toothed portion. Overcoming the bias of the actuator biasing member may unlock the steering actuator.
  • the steerable guide catheter may include a first elongate tensile member and a second elongate tensile member coupling the steerable tip and the steering actuator. Moving the steering actuator in the first actuator direction may tension the first elongate tensile member. Moving the steering actuator in the second actuator direction may tension the second elongate tensile member. Moving the steering actuator in the first actuator direction may reduce tension on the second elongate tensile member. Moving the steering actuator in the second actuator direction reduces tension on the first elongate tensile member.
  • Moving the steering actuator in a third actuator direction may tension the first elongate tensile member and the second elongate tensile member.
  • Moving the steering actuator in a fourth actuator direction may reduce the tension of the first elongate tensile member and the second elongate tensile member. Alternately tensioning the first and second elongate tensile members and reducing the tension of the first and second elongate tensile members may aid the movement of the steerable tip in a distal direction.
  • the elongate shaft may include a braided structure. Tensioning the first and second elongate tensile members may compress the braided structure, reducing a length of the elongate shaft, and increasing a diameter of the elongate shaft. Reducing the tension of the first and second elongate tensile members may relax the braided structure, allowing the length of the elongate shaft to increase, and allowing the diameter of the elongate shaft to decrease. Moving the steering actuator in the third actuator direction may maintain an orientation of the steerable tip.
  • the steerable guide catheter may include a dilator configured to pass through the steerable guide catheter.
  • the steerable guide catheter may include a guidewire configured to pass through the steerable guide catheter.
  • the elongate shaft may be generally flexible. A stiffness of the elongate shaft may vary over a length of the elongate shaft between the proximal end portion and the distal end portion. The stiffness of the elongate shaft may vary in discrete intervals over the length of the elongate shaft. The stiffness of the elongate shaft may be greater proximate the proximal end portion than proximate the distal end portion.
  • the steerable tip may include a radiopaque material. [0018] A method of accessing a carotid artery is provided.
  • the method includes accessing an artery with a hollow needle, advancing a guidewire into the artery through a lumen of the needle, and withdrawing the needle from the artery and the guidewire.
  • the method also includes guiding a dilator over the guidewire and into the artery, guiding a steerable guide catheter over the dilator and into the artery, and advancing the guidewire, dilator, and steerable guide catheter to the aortic arch.
  • the method includes actuating a steerable tip of the steerable guide catheter such that the steerable tip is directed toward a carotid artery, advancing the guidewire into the carotid artery, advancing the dilator over the guidewire and into the carotid artery, and advancing the steerable guide catheter over the dilator and into the carotid artery.
  • the method may include accessing the artery with an introducer sheath.
  • the steerable guide catheter may be introduced into the artery through the introducer sheath.
  • Actuating the steerable tip of the steerable guide catheter may include turning the steerable tip between 150° and 180°.
  • Directing the steerable tip toward a carotid artery may include rotating the steerable guide catheter around a central axis of an elongate shaft.
  • the method may include tensioning and releasing elongate tensile members to advance the steerable guide catheter.
  • the method may include compressing and relaxing a braided structure to advance the steerable guide catheter.
  • the method may include tensioning elongate tensile members to increase a stiffness of the steerable guide catheter and relaxing the elongate tensile members to decrease the stiffness of the steerable guide catheter.
  • the method may include tensioning catheter elongate tensile members to increase a stiffness of the steerable guide catheter to prevent prolapse into the descending aorta.
  • the method may include holding an orientation of the steerable guide catheter while the dilator is advanced into the carotid artery.
  • FIG. 1 is a perspective view of an illustrative steerable guide catheter.
  • FIG. 2 is a section view of the shaft of the steerable guide catheter of FIG.
  • FIGS. 3A, 3B, 3C, 3D, and 3E are cutaway views of the steerable guide catheter of FIG. 1 .
  • FIG. 4 is a perspective view of the handle of the steerable guide catheter of FIG. 1.
  • FIGS. 5, 6, and 7 are cutaway views of the catheter handle of FIG. 4.
  • FIG. 8 illustrates a portion of the human blood circulatory system.
  • FIGS. 9A, 9B, 9C, 9D, 9E, 9F, 9G, 9H, and 9I progressively illustrate the steerable guide catheter of FIG. 1 being used in an illustrative procedure.
  • FIG. 10 is a perspective view of an alternative illustrative catheter handle.
  • FIG. 11 is a cutaway view of the catheter handle of FIG. 10.
  • FIG. 12 is a perspective view of an alternative illustrative catheter handle.
  • FIG. 13 is a cutaway view of the catheter handle of FIG. 12.
  • FIG. 14 is a perspective view of an alternative illustrative steerable guide catheter and catheter handle.
  • FIG. 15 and 16 are cutaway views of the catheter handle of FIG. 14 showing at least portions of a steering actuator.
  • FIG. 16A is a perspective view of the steering actuator of FIGS. 15 and 16.
  • FIGS. 17A, 17B, 17C, and 17D are cutaway views of the illustrative steerable guide catheter and catheter handle of FIGS. 14-16.
  • the disclosure herein describes a steerable guide catheter configured to be used to navigate and steer through the vasculature to access a target treatment site.
  • the device disclosed herein generally allows for accessing blood vessels via a minimally invasive percutaneous approach.
  • the terms “vessel”, “blood vessel”, “arteries”, “veins”, and similar forms of these terms mean any component of the circulatory system that transports blood throughout the human body.
  • the devices, systems, and methods described herein may be used during other therapies or surgical procedures as well.
  • the various non-limiting aspects of the devices, systems, and methods described herein may be used alone or in any desired combination.
  • FIG. 1 is a perspective view of an illustrative steerable guide catheter 100.
  • the steerable guide catheter 100 includes an elongate shaft 120 including a proximal end portion 122 and distal end portion a 124, a catheter handle 200 coupled to the proximal end portion 122, and a steerable tip 150 coupled to the distal end portion 124.
  • proximal may refer to a direction generally towards the user of the device
  • distal may refer to a direction generally away from the user of the device.
  • arrow 10 points generally in the proximal direction and arrow 12 points generally in the distal direction.
  • FIG. 2 is a section view of the elongate shaft 120 of the steerable guide catheter 100.
  • FIGS. 3A, 3B, 3C, 3D, and 3E are cutaway views of the illustrative steerable guide catheter 100.
  • the elongate shaft 120 is configured to be compatible with both trans-femoral and trans-radial procedures.
  • the elongate shaft 120 includes a central lumen 126, and first and second steering line lumens 128, 130 with first and second steering lines 132, 134 members running therethrough.
  • the first and second steering lines 132, 134 are elongate tensile members and may include suture, fiber, wire, cable, or any other material or construction configured to transmit a force while in tension.
  • the elongate shaft 120 includes an inner core 136, a braided structure 138, and an outer layer 140.
  • the braided structure 138 helps to reinforce the elongate shaft 120 for torque transmission, and kink and prolapse resistance.
  • the elongate shaft 120 may be reinforced with a cut or perforated hypotube structure or coiled structure instead of a braided structure.
  • the outer layer 140 of the elongate shaft 120 includes a hydrophilic coating along its entire length for lubricity allowing the elongate shaft 120 to be advanced within a vessel without excessive friction between the elongate shaft 120 and the interior of the vessel thereby preventing injury to the vessel wall.
  • the elongate shaft 120 is generally flexible, and the stiffness of the elongate shaft 120 varies over a length of the elongate shaft 120 between the proximal end portion 122 and the distal end portion 124. In this illustrative embodiment, the stiffness of the elongate shaft 120 is greater proximate the proximal end portion 122 and the elongate shaft 120 is more flexible near the distal end portion 124. In some embodiments, the stiffness of the elongate shaft 120 varies in discrete intervals over the length of the elongate shaft 120.
  • the elongate shaft 120 is configured to enable a user to rotate the catheter handle 200 thereby rotating the distal end portion 124 of the elongate shaft 120 around its central axis without excessive twist occurring over the length of the elongate shaft 120.
  • the steerable tip 150 includes a steerable portion 152 located at the proximal end of the steerable tip 150, a soft portion 154, and a radiopaque marker 156 located at the distal end of the steerable tip 150.
  • the steerable tip 150 is configured for bi-directional steering and to be directed by turning or bending the steerable portion 152. At least a portion of the steerable tip 150 may be turned between 150° and 180° in a first tip direction indicated by arrow 14, see FIGS. 3A and 3D, and between 150° and 180° in a second tip direction indicated by arrow 16, see FIG. 3A.
  • the first and second tip directions are generally opposite each other and are generally in a tip steering plane.
  • the steerable guide catheter 100 can make a 150°-180° turn while eliminating the need for a Simmons catheter, for example.
  • the elongate shaft 120 may be rotated around its central axis thereby rotating the steerable tip 150 allowing for a plurality of directions that the steerable tip 150, and thereby the steerable guide catheter 100, can be directed.
  • the soft portion 154 is configured to be atraumatic, thereby preventing injury if it comes into contact with a vessel wall, for example.
  • the radiopaque marker 156 is configured to assist a user with navigation and guidance of the guide catheter 100 when used in conjunction with non-invasive imaging methods.
  • FIG. 4 is perspective view of the distal end of the illustrative ergonomic catheter handle 200 of the steerable guide catheter 100.
  • FIGS. 5, 6, and 7 are cutaway views of the catheter handle 200.
  • the catheter handle 200 includes a handle body 202, a strain relief 204 coupling the proximal end portion 122 of the elongate shaft 120 to the catheter handle 200, and a steering actuator 220.
  • the catheter handle 200 includes a through hole 208 which is aligned with the central lumen 126 of the elongate shaft 120.
  • the catheter handle 200 includes an actuator latch 210.
  • the steering actuator 220 is configured to enable a user to direct the steerable tip 150, see FIG. 1 .
  • the steering actuator 220 includes an actuator handle 222, actuator gears 224, 226, 228, an upper actuator rack 230, and a lower actuator rack 232.
  • the upper and lower actuator racks 230, 232 include upper and lower rack gears 234, 236 respectively.
  • the upper and lower actuator racks 230, 232 include semi-circular recesses 238, 240 which align with hole 208 and the elongate shaft 120.
  • An actuator shaft 242 passes through the elongate slot 206 in the handle body 202 and couples the actuator handle 222 to the actuator gear 224.
  • the actuator gear 224 engages with actuator gear 226 which engages with actuator gear 228 which engages with the upper and lower rack gears 234, 236.
  • the steering actuator 220 is coupled to the steerable tip 150 by the first and second steering lines 132,134.
  • the first and second steering lines 132, 134 are coupled to the upper and lower actuator racks 230, 232 respectively.
  • a user may move the steering actuator handle 222 in the first actuator direction to move at least a portion of the steerable tip 150 in the first tip direction and move the steering actuator handle 222 in the second actuator direction to move at least a portion of the steerable tip 150 in the second tip direction, for example.
  • a user may also move the steering actuator handle 222 in the first actuator direction to move at least a portion of the steerable tip 150 in the first tip direction and move the steering actuator handle 222 in the second actuator direction to move at least a portion of the steerable tip 150 in the second tip direction to realign the steerable tip 150 with a central axis of the elongate shaft 120 or some other orientation relative to the elongate shaft 120, for example.
  • moving the steering actuator handle 222 in the third actuator direction moves the shaft 226 in the proximal direction in the slot 206 which moves the upper and lower actuator racks 230, 232 in the proximal direction.
  • Moving the steering actuator handle 222 in the third actuator direction tensions the first and second steering lines 132, 134, see FIG. 3E. Simultaneously tensioning the first and second steering lines 132, 134 compresses the braided structure 138, reduces the length of the elongate shaft 120, and increases the diameter of the elongate shaft 120.
  • Tensioning the first and second steering lines 132, 134 increases the stiffness of the elongate shaft 120 and/or the steerable tip 150. Tensioning the first and second steering lines 132, 134 simultaneously allows a user to maintain an orientation of the elongate shaft 120 and/or the steerable tip 150.
  • the steering actuator 220 can be locked in position with the shaft 226 in the proximal end of the slot 206 by engaging the actuator latch 210 thereby locking the stiffness and/or orientation of the elongate shaft 120 and or the steerable tip 150. Disengaging the actuator latch 210 unlocks the steering actuator 220.
  • Moving the steering actuator handle 222 in the fourth actuator direction moves the shaft 226 in the distal direction in the slot 206 which moves the upper and lower actuator racks 230, 232 in the distal direction.
  • Moving the steering actuator handle 222 in the fourth actuator direction reduces the tension of the first and second steering lines 132, 134. Simultaneously reducing the tension of the first and second steering lines 132, 134 relaxes the braided structure 138, allows the length of the elongate shaft 120 to increase, and allows the diameter of the elongate shaft 120 decrease. Reducing the tension of the first and second steering lines 132, 134 decreases the stiffness of the elongate shaft 120 and/or the steerable tip 150.
  • FIG. 8 illustrates a portion of the human blood circulatory system.
  • FIGS. 9A, 9B, 9C, 9D, 9E, 9F, 9G, 9H, and 9I progressively illustrate the steerable guide catheter 100 being used in an illustrative procedure.
  • the steerable guide catheter 100 may be part of a system that includes the steerable guide catheter 100, a dilator 160, and a guidewire 170, for example.
  • the dilator 160 and/or guidewire 170 may be directed through the hole 208 and the central lumen 126 of the elongate shaft 120 during a procedure, for example.
  • Other instruments may be advanced through the steerable guide catheter 100 by guiding the instruments through the hole 208 and the central lumen 126 of the elongate shaft 120.
  • a dilator 160 is inserted into the steerable guide catheter 100 by guiding the dilator 160 through the hole 208 and the central lumen 126 of the elongate shaft 120.
  • an introducer sheath 30 and guidewire 170 is inserted into a patient’s radial artery 50 using a Seidinger technique, for example, see FIGS. 9A and 9B. With the distal end of the introducer sheath 30 positioned in the radial artery 50, the steerable guide catheter 100 and dilator 160 are directed over the guidewire 170 and through the introducer sheath 30 into the radial artery 50.
  • the guidewire 170, dilator 160, and steerable guide catheter 100 are advanced along the radial artery 50, the brachial artery 52, the axillar artery 54, the subclavian artery 56, and the brachiocephalic artery to the aortic arch 60, see FIGS. 8, 9C, and 9D.
  • the steerable guide catheter 100, dilator 160, and guidewire 170 may be alternately advanced.
  • the guidewire 170 may be advanced within the vessels and then the dilator 160 and steerable guide catheter 100 advanced over the guidewire 170.
  • the steerable guide catheter 100, dilator 160, and guidewire 170 may be advanced simultaneously.
  • the guidewire 170, dilator 160, and steerable guide catheter 100 reach the aortic arch 60, the guidewire 170 and dilator 160 are retracted within the distal end of the steerable guide catheter 100, see FIG. 9E.
  • the steerable tip 150 is actuated to direct the steerable tip 150 toward the right common carotid artery 62 or the left common carotid artery 64, see FIGS. 8 and 9F.
  • Actuation of the steerable tip 150 includes steering the steerable tip 150 in the first or second direction in the steering plane using the steering actuator 220.
  • the catheter handle 200 is also rotated as needed to rotate the elongate shaft 120 to align the steerable tip 150 with the desired vessel.
  • the actuator handle 222 is moved in the third actuator direction and locked in place to maintain the orientation of the elongate shaft 120 and the steerable tip 150 and the guidewire 170 is advanced into the vessel, see FIGS. 9G, 9H, and 9I.
  • the dilator 160 is soft and flexible allowing the dilator 160 to be advanced over the guidewire 170, thereby following the guidewire 170 inside the vessel. While the dilator 160 is being advanced, the shape and orientation of the elongate shaft 120 and the steerable tip 150 of the steerable guide catheter 100 is maintained by holding the steering actuator handle 222 in the third actuator direction and/or keeping the steering actuator handle 222 in the locked position.
  • the steerable guide catheter 100 is then advanced over the dilator 160.
  • the steering actuator handle 222 is unlocked and/or moved in the fourth actuator direction allowing the steerable tip 150 of the steerable guide catheter 100 to the be advanced over the dilator 160.
  • the steering actuator handle 222 is held and/or locked in the third actuator direction to stiffen the elongate shaft 120 to prevent prolapse into the descending aorta 68.
  • the guidewire 170 and/or the dilator 160 may be removed from the steerable guide catheter 100 through the hole 208 in the catheter handle 200.
  • FIG. 10 is a perspective views of an alternative illustrative catheter handle 200’ and FIG 11 is a cutaway view of the catheter handle 200’.
  • the catheter handle 200’ is similar in construction and operation to the catheter handle 200 described above and the catheter handle 200’ may be substituted for other handles, or any feature of the catheter handle 200’ may be used, in various other exemplary embodiments according to the present disclosure.
  • Like reference numbers refer to like components.
  • the catheter handle 200’ includes a handle body 202’, a strain relief 204’ coupling the proximal end portion 122 of the elongate shaft 120 to the catheter handle 200’, and a steering actuator 220’.
  • the catheter handle 200’ includes a through hole 208’ which is aligned with the central lumen 126 of the elongate shaft 120.
  • the catheter handle 200’ includes an actuator latch 210’.
  • the steering actuator 220’ is configured to enable a user to direct the steerable tip 150.
  • the steering actuator 220’ includes an actuator handle 222’, an actuator gear 224’, an upper actuator rack 230’, and a lower actuator rack 232’.
  • the upper and lower actuator racks 230’, 232’ include upper and lower rack gears 234’, 236’ respectively.
  • the upper and lower actuator racks 230’, 232’ include semi-circular recesses 238’, 240’ which align with hole 208’ and the elongate shaft 120.
  • the actuator gear 224’ engages with the upper and lower rack gears 234’, 236’.
  • the steering actuator 220’ is coupled to the steerable tip 150, see FIG. 1 , by the first and second steering lines 132, 134.
  • the first and second steering lines 132, 134 are coupled to the upper and lower actuator racks 230’, 232’ respectively.
  • Moving the steering actuator handle 222’ in the third actuator direction tensions the first and second steering lines 132, 134.
  • the steering actuator 220’ can be locked in position with the shaft 226’ in the proximal end of the slot 206’ by engaging the actuator latch 210’. Disengaging the actuator latch 210’ unlocks the steering actuator 220’.
  • FIG. 12 is a perspective view of an alternative illustrative catheter handle 300.
  • FIG. 13 is a cutaway view of the catheter handle 300.
  • the catheter handle 300 is similar in construction and operation to the catheter handles 200 and 200’ described above and the catheter handle 300 may be substituted for other handles, or any feature of the catheter handle 300 may be used, in various other exemplary embodiments according to the present disclosure.
  • Like reference numbers refer to like components.
  • the catheter handle 300 includes a handle body 302, a strain relief 304 coupling the proximal end portion 122 of the elongate shaft 120 to the catheter handle 300, and a steering actuator 320.
  • the catheter handle 300 includes a through hole 308 which is aligned with the central lumen 126 of the elongate shaft 120.
  • the steering actuator 320 is configured to enable a user to direct the steerable tip 150.
  • the steering actuator 320 includes an actuator handle 322, an actuator gear 324, an upper actuator rack 330, and a lower actuator rack 332.
  • the upper and lower actuator racks 330, 332 include upper and lower rack gears 334, 336 respectively.
  • the upper and lower actuator racks 330, 332 include semi-circular recesses 338, 340 which align with hole 308 and the elongate shaft 120.
  • An actuator shaft 342 passes through the elongate slot 306 in the handle body 302 and couples the actuator handle 322 to the lower actuator rack 332.
  • the actuator gear 324 engages with the upper and lower rack gears 334, 336.
  • the steering actuator 320 is coupled to the steerable tip 150, see FIG. 1 , by the first and second steering lines 132, 134.
  • the first and second steering lines 132, 134 are coupled to the upper and lower actuator racks 330, 332 respectively.
  • FIG. 14 is a perspective view of an alternative illustrative steerable guide catheter 400 with a catheter handle 402.
  • FIGS. 15 and 16 are cutaway views of the catheter handle 402 showing at least portions of steering actuator 420.
  • FIG. 16A is a perspective view of the steering actuator 420.
  • the catheter handle 402 is similar in construction and operation to the catheter handles 200, 200’, and 300 described above and the catheter handle 402 may be substituted for other handles, or any feature of the catheter handle 402 may be used, in various other exemplary embodiments according to the present disclosure.
  • Like reference numbers refer to like components.
  • the catheter handle 402 includes a handle body 402, a strain relief 404 coupling the proximal end portion 122 of the elongate shaft 120 to the catheter handle 402, and a steering actuator 420.
  • the catheter handle 402 includes a through hole 408 which is aligned with the central lumen 126 of the elongate shaft 120.
  • the steering actuator 420 is configured to enable a user to direct the steerable tip 150, see FIG. 1 .
  • the steering actuator 420 includes an actuator handle 422, a slider 424, a first spur gear 428, and a second spur gear 430.
  • the slider 424 includes first and second upper rack gears 432, 434 and first and second lower rack gears 436, 438.
  • the actuator shaft 426 passes through an elongate slot 406 in the handle body 402 and couples the actuator handle 422 to the slider 424.
  • the handle body 402 includes first and second handle gears 410, 412 located inside the handle body 302 and on opposite sides of slot 406.
  • the first and second upper rack gears 432, 434 engage with first and second handle gears 410, 412 preventing movement of the actuator handle 422 thereby locking the actuator 420 in one of a plurality of positions.
  • the lower rack gears 436, 438 engage with the first and second spur gears 428, 430 respectively.
  • the steering actuator 420 is coupled to the steerable tip 150, see FIG. 1 , by the first and second steering lines 132, 134.
  • the first and second steering lines 132, 134 are coupled to the first and second steering pulleys 440, 442 by first and second shafts 444, 446 respectively.
  • the first and second shafts 444, 446 are supported by inner spring mounts 448, 450 and outer spring mounts 452, 454.
  • the inner spring mounts 448, 450 and outer spring mounts 452, 454 include biasing members, such as springs, which bias the first and second upper rack gears 432, 434 against the first and second handle gears 410, 412.
  • the proximal ends of the first and second steering lines 132, 134 are at least partially wrapped around the first and second steering pulleys 440, 442.
  • FIGS. 17A, 17B, 17C, and 17D are cutaway views of the illustrative steerable guide catheter 400 with catheter handle 402.
  • Depressing actuator handle 422 in the direction indicated by arrow 32 disengages the first and second upper rack gears 432, 434 from the first and second handle gears 410, 412 enabling the actuator handle 422 to be moved.
  • Moving the steering actuator handle 422 in a proximal or first actuator direction, indicated by arrow 34 moves the lower rack gears 436, 438 which engage with and rotate the first and second spur gears 428, 430.
  • Rotating the first and second spur gears 428, 430 rotates the first and second steering pulleys 440, 442 respectively.
  • Rotating the first and second steering pulleys 440, 442 causes the proximal ends of the first and second steering lines 132, 134 to wind around and unwind from around the first and second steering pulleys 440, 442.
  • Moving the steering actuator handle 322 in the first actuator direction tensions the first steering line 132 while reducing tension on the second steering line 134 thereby moving the steerable tip 150 in the first tip direction, see FIG. 17C.
  • Moving the steering actuator handle 422 in a distal or second actuator direction, indicated by arrow 36 tensions the second steering line 134 while reducing tension on the first steering line 132 thereby moving the steerable tip 150 in the second tip direction indicated by arrow 16, see FIG. 3A.
  • the entire steering actuator 420 can be moved in the first and second actuator directions without rotating the first and second spur gears 428, 430 and the first and second steering pulleys 440, 442, see FIGS. 17B and 17D. Moving the entire steering actuator 420 in the first actuator direction tensions the first and second steering lines 132, 134 simultaneously. Moving the entire steering actuator 320 in the second actuator direction reduces the tension of the first and second steering lines 132, 134.

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Pulmonology (AREA)
  • Anesthesiology (AREA)
  • Biophysics (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Hematology (AREA)
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  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
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Abstract

Un cathéter de guidage orientable (100) comprend un arbre allongé (120), une pointe orientable (150) couplée à une partie d'extrémité distale (124) de l'arbre allongé (120), et une poignée (200) couplée à une partie d'extrémité proximale (122) de l'arbre allongé (120). La poignée (150) comprend un actionneur de direction (220) couplé à la pointe orientable (150) et conçu pour diriger la pointe orientable (150). Le déplacement de l'actionneur de direction (220) dans une première direction d'actionneur déplace au moins une partie de la pointe orientable (150) dans la première direction de pointe, et le déplacement de l'actionneur de direction (220) dans une seconde direction d'actionneur déplace au moins une partie de la pointe orientable (150) dans une seconde direction de pointe. Le déplacement de l'actionneur de direction (220) dans une troisième direction d'actionneur augmente une rigidité d'au moins une partie de l'arbre allongé (120) et/ou de la pointe orientable (150).
PCT/US2024/034708 2023-06-29 2024-06-20 Cathéter de guidage orientable et procédés associés Pending WO2025006303A2 (fr)

Applications Claiming Priority (2)

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US202363524053P 2023-06-29 2023-06-29
US63/524,053 2023-06-29

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* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20070167682A1 (en) * 2004-04-21 2007-07-19 Acclarent, Inc. Endoscopic methods and devices for transnasal procedures
US8777929B2 (en) * 2005-06-28 2014-07-15 St. Jude Medical, Atrial Fibrillation Division, Inc. Auto lock for catheter handle
US7771416B2 (en) * 2007-06-14 2010-08-10 Ethicon Endo-Surgery, Inc. Control mechanism for flexible endoscopic device and method of use
US9101733B2 (en) * 2009-09-29 2015-08-11 Biosense Webster, Inc. Catheter with biased planar deflection
US9272085B2 (en) * 2010-08-03 2016-03-01 Cook Medical Technologies Llc Method of introducing a catheter
WO2020214221A1 (fr) * 2019-04-17 2020-10-22 Neptune Medical Inc. Structures médicales composites à rigidification dynamique
CN118524870A (zh) * 2021-12-06 2024-08-20 瑞迪奥一有限公司 快速置换导管
WO2023114368A2 (fr) * 2021-12-17 2023-06-22 Deinde Medical Corp. Cathéters orientables et méthodes associées

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