WO2024257027A1 - Fil-guide présentant une extrémité distale conçue pour prendre plusieurs formes - Google Patents

Fil-guide présentant une extrémité distale conçue pour prendre plusieurs formes Download PDF

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Publication number
WO2024257027A1
WO2024257027A1 PCT/IB2024/055823 IB2024055823W WO2024257027A1 WO 2024257027 A1 WO2024257027 A1 WO 2024257027A1 IB 2024055823 W IB2024055823 W IB 2024055823W WO 2024257027 A1 WO2024257027 A1 WO 2024257027A1
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WO
WIPO (PCT)
Prior art keywords
coil
guide wire
distal end
core
braided
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/IB2024/055823
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English (en)
Inventor
Amos BRACHA
German Aleynikov
David ORION
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.)
Sheba Impact Ltd
Original Assignee
Sheba Impact Ltd
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Filing date
Publication date
Application filed by Sheba Impact Ltd filed Critical Sheba Impact Ltd
Priority to CN202480046950.XA priority Critical patent/CN121620407A/zh
Publication of WO2024257027A1 publication Critical patent/WO2024257027A1/fr
Anticipated expiration legal-status Critical
Pending legal-status Critical Current

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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
    • A61M25/09—Guide wires
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/22—Implements for squeezing-off ulcers or the like on inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; for invasive removal or destruction of calculus using mechanical vibrations; for removing obstructions in blood vessels, not otherwise provided for
    • A61B2017/22038—Implements for squeezing-off ulcers or the like on inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; for invasive removal or destruction of calculus using mechanical vibrations; for removing obstructions in blood vessels, not otherwise provided for with a guide wire
    • A61B2017/22042—Details of the tip of the guide wire
    • A61B2017/22044—Details of the tip of the guide wire with a pointed tip
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/22—Implements for squeezing-off ulcers or the like on inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; for invasive removal or destruction of calculus using mechanical vibrations; for removing obstructions in blood vessels, not otherwise provided for
    • A61B2017/22094—Implements for squeezing-off ulcers or the like on inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; for invasive removal or destruction of calculus using mechanical vibrations; for removing obstructions in blood vessels, not otherwise provided for for crossing total occlusions, i.e. piercing
    • 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
    • A61M25/09—Guide wires
    • A61M2025/09058—Basic structures of guide 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
    • A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
    • A61M25/09—Guide wires
    • A61M2025/09058—Basic structures of guide wires
    • A61M2025/09083—Basic structures of guide wires having a coil around a core
    • 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
    • A61M25/09—Guide wires
    • A61M2025/09058—Basic structures of guide wires
    • A61M2025/09083—Basic structures of guide wires having a coil around a core
    • A61M2025/09091—Basic structures of guide wires having a coil around a core where a sheath surrounds the coil at the distal part

Definitions

  • the invention is in the field of medical guidewires used for neurosurgery and cardiology.
  • a surgeon Guided by real-time imaging of the blood vessels, a surgeon must navigate a guide wire within the blood vessels up to the arteries in the brain. This procedure takes time and typically it does not even begin until about three hours after the patient discovers symptoms. The surgeon therefore has a limited amount of time to reach the blood vessel to perform a clinically effective intervention.
  • steerable and non-steerable guide wires There are steerable and non-steerable guide wires.
  • the steerable guide wires are typically of wider diameter.
  • a proximal mechanism for steering the guide wire This mechanism includes a hemostatic valve that prevents blood backflow.
  • steerable guidewires have complex construction which requires a larger outer diameters (often 2-5 or more mm).
  • a proximal mechanism for steering the guide wire In a steerable guide wire, there exists a proximal mechanism for steering the guide wire.
  • This mechanism includes a hemostatic valve that prevents blood backflow. Whenever it is necessary to turn the guide wire or to axially move the core of the guide wire, it is necessary to first release the core from the hemostatic valve somewhat. This step is repeated many times during the procedure of navigating the guide wire to the location of the problem in the blood vessels, which requires repeated effort and time. Applicant has discovered a structure for the guide wire which eliminates this step is certain embodiments. In some embodiments, the user is able to manipulate the shape and direction of the distal end of the coil and of the guide wire without having to take any step involving touching the or releasing the hemostatic valve.
  • the core may be axially moved to straighten out the distal end of the guide wire or the core may be rotated to change the direction of the bend (for example J-shape) in the distal end of the coil by simply rotating the core within the coil of the guide wire.
  • the core may be snugly fitted within the coil.
  • the guide wire In brain surgery for children where the diameter of the blood vessels, especially distant capillaries are tiny, it is necessary for the guide wire to be less than 0.05 mm. Applicant has discovered that it is possible to construct an effective guide wire whose outer diameter is about 0.27-0.29 mm with an inner core of about 0.11 mm.
  • Applicant has also determined that from the point of view of avoiding collateral damage to tissue from the insertion of the guide wire or from a microcatheter placed over the guide wire, it is advantageous to use a guide wire whose diameter is as narrow as possible.
  • the core of the guide wire may have a diameter of 0.11 mm and the outer diameter of the coil is 0.27-0.29 in some embodiments.
  • the distal end of the coil is braided in a tightly interlaced braid to increase the structural strength of the coil of the guide wire. Due to the structural integrity of the braided coil, the core of the guide wire would not inadvertently extend through a space in the braided coil since the tightly interlaced braided coil would not have such spaces (notwithstanding the illustration shown in Fig. 14).
  • the coil is a spring that is tightly wound together and in which the winds of the spring are adjacent to one another.
  • Applicant has configured the guide wire such that the change in shape at the distal end of the guide wire from a curved shape to a straight shape is effectuated by pushing the core through a central passageway within a braided coil (or spring coil) either such that the core enters the central passageway at the distal end to straighten the coil or such that the core that is already within the central passageway at the distal end is compressed within the central passageway at the distal portion end of the coil.
  • a braided coil or spring coil
  • One embodiment is a medical guide wire for improved blood vessel navigation, comprising: a shaft defining a central passageway; a spring extending from a distal end of the shaft and attached to the shaft and defining a central passageway; a coil defining a main central passageway and having a distal end that is curved when no external force is applied to the coil, the coil including a distal tip; a stopper mechanism that limits proximal movement of the coil, the mechanism comprising either (i) a coupling ring between the spring and the coil or (ii) the coil having a central section of a first diameter and a distal section of a second diameter larger than the first diameter; a straight core traversing the central passageways of the shaft, the spring and the main central passageway of the coil, the core configured, when pulled from the main central passageway at the distal end of the coil to allow the distal end to assume a curved configuration, the shaft, when moved distally when the distal end is in the curved configuration, compressing the spring and forcing the
  • the rotation of the distal end of the coil is from a J-shape to a J-shape.
  • the rotation is to a substantially symmetrical shape.
  • the rotation of the distal end is up to 360 degrees.
  • the coil has a tightly wound straight portion and a tightly wound distal end.
  • the guide wire further comprises a flat wire positioned longitudinally between the core and the coil on one side of the guide wire.
  • the coil is a tightly braided coil.
  • the coil is a spring coil.
  • the stopper mechanism comprises a rigid hollow coupling ring between the spring and the coil.
  • the coil has the central section of the first diameter and the distal section of the second larger diameter and wherein the distal tip extends into the distal section.
  • the coil is welded to the shaft by a circumferential overlapping weld.
  • the longitudinal sleeve covers all of the coil proximal to the spring.
  • Another embodiment is a medical guide wire for improved blood vessel navigation, comprising: a braided coil defining a central passageway and a tightly braided distal end that is curved when no external force is applied to the coil; a straight core traversing the central passageway along at least a portion of the braided coil, the core having a rounded distal tip; the straight core, when pushed distally from a proximal end of the guide wire, configured to move through the central passageway of the tightly braided distal end so as to straighten the tightly braided distal end.
  • an outer diameter of the core does not exceed 0.13 mm.
  • an outer diameter of the coil is less than 0.3 mm.
  • the braided coil includes a tightly braided straight portion.
  • the braided distal end bends through an arc of at least 70 degrees when no external force is applied.
  • the braided distal end bends through an arc of at least 90 degrees when no external force is applied.
  • the rounded distal tip is larger in diameter than a diameter of the straight core proximal to the distal tip.
  • the braided coil alternates between flat portions and bulging radiopaque portions.
  • the guide wire further comprises a flat wire positioned longitudinally between the core and the braided coil on one side of the guide wire, the flat wire configured to increase a rigidity of the coil.
  • the guide wire further comprises a proximal mechanism for actuating the core, the mechanism including a hemostatic valve, wherein the core is free of the hemostatic value such that the core is both movable axially in a distal direction and rotatable without first releasing or adjusting the valve.
  • the guide wire further comprises a shaft surrounding part of the core.
  • the braid of the tightly braided distal end extend from an inner wall of the coil to an outer wall of the coil.
  • the braid of the tightly braided distal end extends throughout a length of the tightly braided distal end.
  • a further embodiment is a medical guide wire for improved blood vessel navigation, comprising: a spring coil defining a central passageway and having a distal end that is curved when no external force is applied to the coil; a straight core traversing the central passageway in an area outside of the distal end of the spring coil, the core having a rounded distal tip; a shaft covering at last part of the core, the straight core, when pushed distally from a proximal end of the guide wire, configured to move through the central passageway of the distal end of the coil so as to straighten the distal end of the coil.
  • a diameter of the coil does not exceed 0.3 mm.
  • the distal end is J-shaped.
  • the coil includes a tightly woven straight portion.
  • the distal end bends through an arc of at least 70 degrees when no external force is applied.
  • the distal end bends through an arc of at least 90 degrees when no external force is applied.
  • the rounded distal tip is larger in diameter than a diameter of the straight core proximal to the distal tip.
  • the spring coil alternates between flat portions and bulging radiopaque portions.
  • the guide wire further comprises a flat wire positioned longitudinally between the core and the spring coil on one side of the guide wire, the flat wire configured to increase a rigidity of the coil.
  • the guide wire further comprises a proximal mechanism for actuating the core, the mechanism including a hemostatic valve, wherein the core is free of the hemostatic value such that the core is both movable axially in a distal direction and rotatable without first releasing or adjusting the valve.
  • the guide wire further comprises a shaft surrounding part of the core.
  • a yet further embodiment is a medical guide wire for improved blood vessel navigation, comprising: a spring coil defining a central passageway and having a tightly woven coiled distal end that is curved when no external force is applied to the coil; a straight core traversing the central passageway along the curved distal end when no external force is applied, a tip of the core welded to a tip of the spring coil, the core having a distal portion that includes compressible spaced-apart windings; a shaft covering at last part of the core, the straight core, when pushed distally from a proximal end of the guide wire, configured to compress the spaced-apart windings so as to straighten the distal end of the coil.
  • the coil has a rounded distal tip.
  • the guide wire further comprises a flat wire positioned longitudinally between the core and the coil on one side of the guide wire.
  • the coil has a tightly woven straight portion.
  • a yet still further embodiment is a medical guide wire for improved blood vessel navigation, comprising: a braided coil defining a central passageway and having a tightly braided distal end that is curved when no external force is applied to the coil; a straight core comprising a wire traversing the central passageway along the curved distal end, a tip of the core welded to a tip of the braided coil, the core having a distal portion that includes compressible spaced-apart windings; a shaft covering at last part of the core, the straight core, when pushed distally from a proximal end of the guide wire, configured to compress the spaced-apart windings so as to straighten the distal end of the braided coil.
  • the coil has a rounded distal tip.
  • the guide wire further comprises a flat wire positioned longitudinally between the core and the coil on one side of the guide wire.
  • the braided coil has a tightly braided straight portion.
  • Another embodiment is a method of inserting a guide wire into a blood vessel that contains a difficult-to-navigate portion, the method comprising: inserting the guide wire of claim 1 into the blood vessel while the distal tip of the core is extended into the distal end of the guide wire, while the guide wire is in the blood vessel, pulling or releasing the core to remove the coil from the distal end of the coil and generate the curved shape of the distal end of the coil; and pushing the shaft to rotate the distal end of the guide wire while the distal end is in the curved shape.
  • the coil is a braided coil and the curved distal end is a curved braided distal end.
  • the method further comprises using a rounded distal tip of the core to smoothly navigate through the curved distal end of the coil to straighten the coil.
  • the proximal actuating mechanism includes a hemostatic valve and further comprising pushing the core through the distal end of the braided coil to straighten the braided coil without having to first release the hemostatic valve.
  • the coil includes a straight portion.
  • Fig. 1 A is a schematic view of a guide wire including a coil in the form of a spring before an external force is applied, in accordance with one embodiment
  • Fig. IB is a schematic view of a guide wire including a coil in the form of a spring after an external force is applied to the coil, in accordance with one embodiment
  • Fig. 1C is a schematic view of a guide wire including a coil in the form of a spring before an external force is applied, in accordance with one embodiment
  • Fig. ID is a schematic view of a guide wire including a differently shaped coil in the form of a spring after an external force is applied to the coil, in accordance with one embodiment
  • Fig. 2A is a cross-section of a substantially round wire of a spring coil, in accordance with one embodiment
  • Fig. 2B is a cross-section of a substantially rectangular wire of a spring coil, in accordance with one embodiment
  • Fig. 2C is a cross-section of a substantially rectangular wire of a spring coil having radiopaque sections, in accordance with one embodiment
  • Fig. 3 is a schematic cross-sectional view of a braided coil or spring coil of a guide wire, including a flat wire insert within the central passageway of the coil to strengthen the guide wire, in accordance with one embodiment;
  • Fig. 4 is a cross-sectional view of part of the guide wire showing the braided coil in a closed configuration, in accordance with one embodiment
  • Fig. 5 is a cross-sectional view of part of the guide wire showing the braided coil in an open configuration, in accordance with one embodiment
  • Fig. 6 is a cross-sectional view of part of the guide wire showing the coil as a spring in an open configuration, in accordance with one embodiment
  • Fig. 7 is a cross-sectional view of part of the guide wire using a hybrid coil having alternating flat sections and round radiopaque sections in an open configuration of the coil, in accordance with one embodiment
  • Fig. 8 is a schematic view of a coil, after heat treatment, which can be a braided coil or a spring coil, in accordance with one embodiment
  • Fig. 9 is a schematic view of a core of a guide wire, after heat treatment, having an open spring-like or zigzag section, in accordance with one embodiment
  • Fig. 10 is a schematic view of part of a guide wire showing in a closed configuration the core of Fig. 9 inside the passageway defined by the coil of Fig. 8 with the tip of the core laser welded to the tip of the coil and before an external force is applied to the guide wire, in accordance with one embodiment;
  • Fig. 11 is a schematic view of the part of the guide wire shown in Fig. 10 after the coil has been pushed so as to tighten the open spring-like portion thereof and thereby straighten the distal portion of the guide wire, in accordance with one embodiment;
  • Fig. 12 is a schematic and partial cross-sectional view of a guide wire including a shaft and a hemostatic valve and including a different embodiment of the core, in accordance with one embodiment;
  • Fig. 13 is a schematic view of a coil having three different wires of different diameter, in accordance with one embodiment
  • Fig. 14 is a schematic view of a braid to illustrate the braid of a tightly braided coil of a guide wire, in accordance with one embodiment
  • Fig. 15A is a schematic side view of a guide wire after a pulling force has been exerted on the core but before a pushing force has been exerted on the shaft, in accordance with one embodiment
  • Fig. 15B is a schematic side view of a guide wire as shown in Fig. 15A but before the pulling force has been exerted on the core, in accordance with one embodiment
  • Fig. 15C is a schematic view of the shaft of Fig. 15A with the walls of the shaft shown in broken lines, in accordance with one embodiment;
  • Fig. 15D1 is a schematic view of another embodiment of a guide wire with a spring 60 and an alternative stopping mechanism relative to the stopping mechanism of the guide wire of Fig. 15A-15B and shown after the pulling force has been exerted on the core, in accordance with one embodiment;
  • Fig. 15D2 is a schematic view of a guide wire as in Fig. 15D1 before the pulling force has been exerted on the core, in accordance with one embodiment
  • Fig. 15E1 is a schematic view of another embodiment of a guide wire similar to Fig. 15D1 except with an overlapping attachment configuration, in accordance with one embodiment;
  • Fig. 15E2 is a schematic view as in Fig. 15E1 before the pulling force has been exerted on the core, in accordance with one embodiment
  • Fig. 15F1 is a schematic view of a guide wire of the type shown in Fig. 1A and Fig. IB (without spring 60) with a sleeve 51C shown after the pulling force has been exerted on the core, in accordance with one embodiment;
  • Fig. 15F2 is a schematic view of a guide wire as in Fig. 15F1 shown before the pulling force has been exerted on the core, in accordance with one embodiment
  • Fig. 15G1 is a schematic view of a guide wire similar to Fig. 15F1 except with an overlapping attachment configuration and shown after the pulling force has been exerted on the core, in accordance with one embodiment;
  • Fig. 15G2 is a schematic view as in Fig. 15G1 before the pulling force has been exerted on the core, in accordance with one embodiment
  • Fig. 16A is a schematic view of the progression of a guide wire as it penetrates a blood clot, in accordance with one embodiment
  • Fig. 16B is a schematic view of a prior art guide wire as it approaches a blood clot.
  • Fig. 17 is a flow chart showing a method, in accordance with one embodiment. Detailed Description of the Embodiments
  • Certain embodiments generally provide a guide wire for navigating difficult to navigate blood vessels.
  • the guide wire is for use in navigating difficult to navigate blood vessels, for example looped, bent or bifurcated blood vessels, to reach a blood clot or an aneurism or a hemorrhagic stroke in preparation for the clinical intervention. It normally takes a lot of time for the neurosurgeon to navigate the blood vessels with the guide wire. But the outcome of the clinical intervention depends in significant part on the time that it takes the neurosurgeon to perform the clinical intervention. It is therefore critical to minimize the time it takes before the neurosurgeon can even begin the procedure of removing the blood clot or repairing the aneurism or performing another clinical intervention. The sooner the portion of the blood vessel is reached, the sooner the guide wire can be positioned. Precious time is lost in the arduous process of reaching the desired blood vessel location because of the tedious process of navigating through tortuous blood vessels.
  • a medical guide wire for improved blood vessel navigation comprises a braided coil or a spring coil defining a central passageway and having a tightly braided straight portion (or a spring coil that includes a straight portion) and a tightly braided distal end - or a distal end of a spring coil - that is curved when no external force is applied to the coil.
  • a straight core for example comprising a wire occupies (in some embodiments snugly) the central passageway at least along the straight portion of the braided coil such that when a user rotates the core the coil rotates, the core having a rounded distal tip.
  • the core extends into the distal end of the coil even before external force is applied the distal tip of the core is welded to the distal tip of the coil. In that case the coil may have a closed configuration.
  • a tightly braided coil 20A has no openings or has openings smaller than 0.05 mm.
  • the core When an external force is applied to the guide wire, for example manually or robotically pushing the core distally from a proximal portion of the guide wire, the core is configured to move through the central passageway of the tightly braided distal end so as to straighten the tightly braided distal end.
  • the open spring-like windings of the core at the distal portion of the core are compressed and this straightens out the distal end of the coil and the distal end of the guide wire.
  • the distal portion of the core is considered the portion of the core that is situated in the distal end of the central passageway within the distal end of the coil.
  • the core extends into the curved distal end of the coil before any external force is applied to the guide wire.
  • the core includes a compressible zigzagged section with spaced apart or zigzagged windings. When an external axial force is applied to the core in a distal direction the spaced apart windings are compressed and this causes the distal end of the coil to straighten.
  • the entire procedure of using the guide wire is guided by a robot in some embodiments.
  • a medical guide wire 10 for improved blood vessel navigation may comprise a coil 20.
  • Coil 20 may take one of several forms including a braided coil 20A and a spring coil 20B (or a multicoil 20C as shown in Fig. 13).
  • the various embodiments described below can be implemented with a braided coil 20A or with a spring coil 20B (or a multicoil).
  • the term "multicoil” refers to a coil 20 comprising wires of different diameter, as shown in Fig. 13 (wires of three different diameters shown).
  • the entire guide wire 10 is made of Nitinol, although this is not a requirement. Other materials that can perform the functions required may be used in any of the elements.
  • the "proximal" end of the guide wire 10 is the end where the shaft 50 and hemostatic valve 70 are situated.
  • the “distal” end of the guide wire 10 is the end having the end of the coil 20 that changes shape when subjected to an external force. For example, in Fig. 1 A the distal end 24 of coil 20 is already in curved configuration. This is accomplished through heat treatment. In certain embodiments, distal end 24 is even more curved (than that shown in Fig. 1 A) so as to be in a J-shaped configuration.
  • Fig. 1 A and Fig. IB and Fig. 1C and Fig. ID the other figures are merely illustrative of an arcuate distal end 24 of coil 20 of guide wire 10.
  • Fig. 1 A, Fig. IB, Fig. 1C and Fig. ID seem to depict the coil 20 as a spring coil
  • the guide wire 10 of these figures may well utilize the braided coil 20A shown in Fig. 14 and schematically shown in Fig. 4 and Fig. 5.
  • Fig. 2A, Fig. 2B and Fig. 2C depict cross-sectional views of examples of differently shaped coils 20 - circular, rectangular (flat) or rectangular (flat) with rounded bulging sections.
  • the shapes depicted in Figs. 2A-2C are the cross-sectional shapes of the wires 23 (for example individual wires) of the coil 20. As such these cross-sectional shapes are applicable to both a braided coil 20 A and a spring coil 20B.
  • coil 20 defines a central passageway 30 that is radially inward of the coil 20.
  • coil 20 In the version of coil 20 shown in Fig. 1 A and Fig. IB, coil 20 generally includes a straight portion 22 and a distal end 24. In contrast, in the version of coil 20 shown in Fig. 1C and Fig. ID, coil 20 is entirely curved when no external force is applied to it.
  • distal end 24 may assume multiple shapes or configurations. Distal end 24 may be curved when no external force is applied, as in Fig. 1 A. This may be achieved by heat treatment of the coil 20 (for example using Nitinol or another material that coil 20 is made of). Distal end 24 may be straight after external force is applied axially and distally on the core of the guide wire 10, as in Fig. IB.
  • braided coil 20A may have at least a tightly braided distal end 24A (Fig. 14) and may have a tightly braided straight portion 22A (Fig. 4 and Fig. 5) and a tightly braided distal end 24A (Fig. 14).
  • the straight portion 22A is braided throughout its length, in some embodiments.
  • the braided coil 20A is braided throughout the full thickness (from outer wall to inner wall) of the braided coil 20A (in some embodiments along the braid of the tightly braided straight portion and the braid of the tightly braided distal end).
  • a braided distal end 24A which is usually larger than that shown in Fig. 14 and may be 70 or 80 or 90 or 100 or 110 or 120 or 130 or 140 or 150 or 160 or 170 or 180 degrees or more.
  • Tightly braided distal end 24A may be arcuate or curved when no external force is applied to the guide wire 10. In some embodiments, braided distal end 24A may bend through an arc of at least 70 degrees, or in another version through an arc of at least 90 degrees, when no external force is applied to the guide wire 10. In some embodiments, braided distal end 24A bend through an arc of 70 degrees or 80 degrees or 90 degrees or 100 degrees or 110 degrees or 120 degrees (or 130 or 140 or 150 or 160 or 170 or 180 or 190 or 200 or 210 degrees) or any number in between 70 degrees and 210 degrees or any range between 70 degrees and 210 degrees such as 70-90 or 70-100 or 90-120 or 70-150 or 70-180 or 90-180 degrees or any other range.
  • guide wire 10 may also comprise a straight core 40.
  • Core 40 may be made of a wire.
  • Core 40 may traverse the central passageway 30 at least along the straight portion of the coil 20.
  • core 40 snugly occupies (in a friction fit for example) at least the straight portion of the coil 20 and is attached tightly enough (in a friction fit) to the core 20 inner wall 21 or otherwise attached to the coil 20 such that when a user rotates the core 20, for example along a plane orthogonal to a longitudinal axis of the core 40, the coil 20 immediately rotates.
  • This provides an advantage in some embodiments in that the surgeon only needs to manipulate one component of the guide wire - namely the core 20 - in order to effectuate both a straightening motion (or an un-straightening motion to restore the curvature of the distal end 24 of the coil 20) and a rotating motion of the distal end of the guide wire 10 (i.e. the distal end 24 of the coil 20).
  • Core 40 may have a distal portion 41.
  • the distal portion 41 of the core 40 is the portion of the core 40 that occupies the central passageway 30 of the coil 20 at the distal end 24 of the coil 20.
  • this happens when an external force has been applied to the core 40 for example an axial force in the distal direction.
  • this configuration - where the distal portion 41 of core 40 traverse or occupies the central passageway 30 at the distal end 24 of the coil 20 - exists even before an external force has been applied to core 40 and in effect exists both before and after an external force has been applied (i.e. the configuration is in effect at all times).
  • the distal portion 41 of core 40 may include a distal tip 42.
  • the distal tip 42 of the core 40 is a rounded distal tip 42A that reduces friction to facilitate the ability of the distal portion 41 of core 40 to move to penetrate the central passageway 30 of coil at the distal end 24 of coil 20 in embodiments in which the core 40 does not extend into the central passageway 30 of the distal end 24 of coil 20 until an axial force (in a distal direction) is applied to core 40.
  • the rounded distal tip 42A reduces friction between core 40 and the distal end 24 of coil 20 as the distal portion 41 of the core 40 moves distally to traverse the distal portion of the central passageway 30 at the distal end 24 of the coil 20.
  • the straight core 40 when pushed distally from a proximal portion of the guide wire 10, may be configured to move through the central passageway 30 of the coil 20, including through the central passageway of distal end 24 of coil 20 so as to straighten the distal end 24 of coil 20 and thereby straighten the distal end 15 of guide wire 10.
  • coil 20 is a braided coil 20A
  • the straight core 40 moves through the central passageway 30 of tightly braided coil 20A
  • the tightly braided distal end 24A of braided coil 20A is straightened and guide wire 10 is straightened.
  • Fig. 14 illustrates a braided configuration of coil 40 that seems to have spaces
  • braided coil 20A is tightly enough woven such that there would not be spaces in the walls of the braided coil 20A of guide wire 10 at least in certain embodiments.
  • a flat wire 29 is positioned longitudinally between the core 40 (within passageway 30) and the inner wall 21 of the coil 20, for example within passageway 30 of braided coil 20A.
  • the flat wire 29 is configured to increase a rigidity of the coil 20.
  • the coil 20 may be open or closed at its distal tip.
  • Fig. 4 is a cross-sectional view of part of the guide wire 10 showing a braided coil 20A in a closed configuration whereas Fig. 5 shows the braided coil in an open configuration.
  • Fig. 6 is a cross-sectional view of part of the guide wire 10 showing the coil 20 as a spring coil 20B in an open configuration but can also be in the closed configuration shown in Fig. 4.
  • Fig. 4 is a cross-sectional view of part of the guide wire 10 showing a braided coil 20A in a closed configuration whereas Fig. 5 shows the braided coil in an open configuration.
  • Fig. 6 is a cross-sectional view of part of the guide wire 10 showing the coil 20 as a spring coil 20B in an open configuration but can also be in the closed configuration shown in Fig. 4.
  • Fig. 4 is a cross-sectional view of part of the guide wire 10 showing a braided coil 20A in a closed configuration
  • FIG. 7 is a cross-sectional view of part of the guide wire 10 using a hybrid coil having alternating flat sections and round radiopaque sections in an open configuration of the coil 20, although this is also applicable to a closed configuration of the coil shown in Fig. 4. All dimensions in Figs. 4-7 are merely illustrative of one example.
  • an outer diameter of the core 40 does not exceed 0.13 mm.
  • the outer diameter of core 40 is 0.11 mm or 0.10- 0.12 mm or less than 0.13 mm or less than 0.12 mm or less than 0.11 mm.
  • core 40 has a rounded distal tip 42A, as shown in Fig. 1 A and Fig. IB.
  • the outer diameter of the coil is less than 0.3 mm.
  • the outer diameter of the coil is 0.27-0.29 mm.
  • the outer diameter of the coil is 0.27 mm but this is merely one example of a non-limiting dimension.
  • the outer diameter of the coil spring is 0.29 mm in some embodiments but this is merely illustrative.
  • the coil 20 has alternating sections wherein flat portions 26 and bulging radiopaque portions 27 alternate.
  • Radiopaque sections 27 may be made of an alloy that allows clear visibility of the coil 20 in x-rays and other imaging technologies.
  • At least part of core 40 is situated within a shaft 50.
  • the mechanism including a hemostatic valve 70 (Fig. 12) for example using a y-connector.
  • the core is free of the hemostatic value such that the core is both movable axially in a distal direction and rotatable without first releasing or adjusting the valve.
  • the spring coil 20 may be tightly woven, especially in the straight portion of the coil 20.
  • the distal end 24 may be curved when no external force is applied to the coil 20.
  • the straight core 40 may traverse (and in some embodiments snugly occupy as in a frictional fit) the central passageway 30 along the straight portion of the spring coil 20.
  • the core 40 may have a rounded distal tip 42.
  • a shaft 50 may cover at least part of the core 40.
  • the straight core 40 is configured to, when pushed distally from a proximal portion 11 of the guide wire, move through the central passageway 30 of the distal end so as to straighten the distal end 24 of the coil 20.
  • a radiopaque sleeve 51 A around shaft 50.
  • the sleeve 51A is approximately 50 microns or more.
  • shaft 50 may have a hydrophilic coating 5 IB (for example including a fluoride) or a hydrophobic coating to reduce friction.
  • a hydrophilic coating 5 IB for example including a fluoride
  • a hydrophobic coating to reduce friction.
  • another embodiment of the guide wire 10 for improved blood vessel navigation comprises a spring coil 20 defining a central passageway 30 and having a coiled straight portion (in some embodiments a tightly woven straight portion) and a distal end that is curved when no external force is applied to the coil.
  • the guide wire 10 may also include a straight core 40 (which may be a wire) that traverses and occupies the central passageway 30 along the straight portion of the spring coil and the curved distal end even before an external force is applied.
  • a tip 42 of the core 40 may be rigidly affixed, for example welded, to a tip 28 of the spring coil 20.
  • the core 40 has a distal portion 41 that includes compressible spaced-apart windings 44 (for example appearing as a zig-zag shape as in Fig. 9 and Fig. 10).
  • Fig. 10 shows the distal portion 41 of the core 40 and a distal end of shaft 50.
  • a shaft 50 may cover at least part of the core 40.
  • the straight core 40 may be configured to, when pushed distally from a proximal portion of the guide wire, compress the spaced-apart windings 44 of the core 40.
  • This tightening of the windings 44 increases the resistance of the tightened windings 44 in the distal portion 41 of the core 40 to being curved. This in turn has the effect of straightening the distal portion 41 of the core and straightening thereby the distal end 24 of the coil 20 so as to reach the configuration shown in Fig. 11.
  • Figs. 9-11 is applicable to a coil 20 that is braided (and any version thereof) as well as to a coil that is a spring coil (Fig. 8) (and any version thereof) as well as to the multicoil coil 20 of Fig. 13.
  • the coil 20 has a rounded distal tip and in some versions, the guide wire 10 further comprises a flat wire positioned longitudinally within the central passageway 30 of the coil 20 between the core 40 and the coil 20 typically on one side of the guide wire 10.
  • a medical guide wire 10 for improved blood vessel navigation comprising a shaft 50 defining a central passageway 55 (Fig. 15C), a spring 60 extending from a distal end 52 of the shaft 50 and attached to an external wall of the shaft the spring 60 defining a central passageway 65, a coil 20 (a spring coil or a braided coil) defining a main central passageway 30.
  • the coil 20 (spring coil or braided coil) may have a straight portion and a distal end 24 (or 24A) that is curved when no external force is applied to the coil 20 (or 20A).
  • Spring 60 may be referred to as a central spring 60 to distinguish it from the coil 20 when coil 20 comprises a spring coil 20.
  • Guide wire 10 may comprise a stopper mechanism that limits proximal movement of the coil 20 (or 20 A).
  • the stopper mechanism may comprise either (i) a coupling ring between the spring and the coil or (ii) that the coil having multiple diameters.
  • the guide wire 10 may also include a straight core 40 traversing the central passageways of the shaft 50, the spring and the coupling ring 99 and at least a proximal portion of the main central passageway 30 of the coil 20 (whether spring coil or braided coil). The guide wire 10 is placed at the desired position in the blood vessel in a configuration in which the core 20 traverses the main central passageway 30 at the distal end 24 of the coil 20 and the distal end 24 of the coil is straight, as shown in Fig.
  • Core 40 is configured, when pulled from the main central passageway 30 of coil 20, to allow the distal end 24 of the coil 20 (spring coil or braided coil) to assume its "natural" curved configuration. Then, it is possible to use shaft 50, which may be a proximal shaft 50 (such as a tube) as shown in Fig. 15A and Fig. 15B, to move the shaft 50 axially in a distal direction (when the distal end 24 of the coil 20 is in the curved configuration as in Fig. 15 A), to compress the spring 60 and exert force against the distal end 24 of the coil 20 (spring coil or braided coil) thereby forcing the distal end 24 of the coil 20 (which may be a braided distal end 24A) to rotate.
  • shaft 50 which may be a proximal shaft 50 (such as a tube) as shown in Fig. 15A and Fig. 15B, to move the shaft 50 axially in a distal direction (when the distal end 24 of the coil 20 is in the curved
  • this rotation is at least 90 degrees, or at least 180 degrees or at least 270 degrees or as much as 360 degrees around an axis A of rotation parallel to the length of the guide wire 10. This provides an important advantage in that the inserted guide wire 10 can both be bent at its distal end 24, 24A and also its distal end may be rotated as many degrees as necessary.
  • the rotation of the distal end 24 of the coil 20 (20A, 20B) may be from one shape of the distal end 24 to a symmetrical or substantially symmetrical shape of the distal end 24.
  • the rotation of the distal end 24 of the coil 20 may be from a first J-shape to a second J-shape that is approximately 180 degrees rotationally from the first J-shape.
  • the coil 20 (20A or 20B) may have a rounded distal tip.
  • the coil 20 (spring coil or braided coil) may have a tightly wound straight portion and a tightly wound distal end 24.
  • the guide wire may also include a flat wire 29 (Fig. 3) positioned longitudinally between the core 40 and the coil 20 for example on one side of the guide wire.
  • this embodiment shown in Fig. 15A and Fig. 15B is applicable to a coil 20 that is a braided coil 20A as well as to a coil 20 that is a spring coil 20 as well as to a multicoil (Fig. 13). All versions of braided coils, spring coils and multicoil are included in this statement including all stated variations with respect to the tightness of the coil.
  • Fig. 15D1 and Fig. 15D2 shows a guide wire 10 generally similar to that shown in Fig. 15B in that it includes a (central) spring 60. However, instead of using a coupling ring 99 (see Fig. 15B) to limit proximal (backward) movement of distal tip 42A of core 40, a different (stopper) mechanism is employed to limit proximal movement of distal tip 42 A. As seen in Fig. 15D1 and Fig. 15D2, coil 20 is constructed of multiple sections 201, 202 (for example a first section 201 and a second section 202), each having different diameters.
  • a first section for example the distal section 201 of coil 20, has a larger diameter than a second section, for example the central section 202 of coil 20. Furthermore, the diameter of distal tip 42A exceeds the internal diameter of the central section 202 of coil 20 (or braided coil 20A) thereby limiting the proximal (backward) movement of core 40.
  • the distal tip 42, 42A of the coil may extend into the distal section 201 having the second (larger) diameter.
  • distal tip 42A of core 40 may comprise be spherical and may have a wider diameter than the part of core 40 immediately distal to it so as to form a spherical head. In some embodiments, this serves multiple functions. One is to limit proximal or backward movement of core 40. A second function is to prevent core 40 from penetrating coil 20 (20A, 20B) (although this purpose may also be accomplished by using a tightly braided coil 20A). The spherical head 42A also facilitates a tight fit with the coil 20 so as to act as a plunger and facilitates deforming the working element (i.e.
  • coil 20 may be connected (for example by welding) to shaft 50 by a butt-joint (for example a butt-weld) at point W where the proximal end of coil 20 (whether 20A or 20B) begins at the distal end of the shaft 50.
  • the coil 20 (whether 20A or 20B) may be attached (for example welded) to the shaft 50 using an overlap connection (at region WR) such as a circumferential overlapping weld. It is called "overlapping" since it overlaps with shaft 50.
  • Guide wire 10 of Fig. 15D1, Fig. 15D2, Fig. 15E1 and Fig. 15E2 may also have a sleeve 51C to add structural stability.
  • guide wire 10 is held within a sleeve 51C.
  • Sleeve 51C is designed to prevent the spring 60 from stretching and to ensure the connection between the spring 60 and the shaft/tube 50.
  • the sleeve 51C may be long enough to cover the junction between the spring 60 and the shaft 50 on the proximal side and in some embodiments to also cover a majority of the portion of the length of the coil 20 that is proximal to the spring 60. In one non-limiting implementation, however, the sleeve 51C leaves spring 60 free and does not cover it.
  • sleeve 51C covers guide wire 10 from the entire distal end 24, 24A of core 20 to the entire proximal end of the guide wire 10. In some embodiments, sleeve 51C allows a portion of the proximal end so of shaft 50 or of core 40 to jut out of the sleeve 51C so as to be held by a user).
  • Fig. 15F1 and Fig. 15F2 depict the guide wire 10 of the embodiment of Fig. 1 A and Fig. IB (without spring 60) with a sleeve 51C and utilize a butt-joint (such as a butt-weld) similar to the attachment method of Fig. 15D1 and Fig. 15D2.
  • Fig. 15G1 and Fig. 15G2 depict the guide wire 10 of Fig. 1A and Fig. IB with a sleeve 51C and utilizing an overlapping joint (such as an overlapping butt-weld).
  • sleeve 51C covers may extend up to the beginning of the distal end 24, 24 A of core 20 (whether 20 A or 20B), or alternatively sleeve 51C may extend to the very distal end of the guide wire 10 including the distal end 24, 24A. This largely depends on the material from which sleeve 51C is made. This ensures flexibility of the distal end 24, 24A (in the event the material from which sleeve 51C is made is not flexible or not flexible enough). All versions of braided coils, spring coils and multicoil discussed with respect to other embodiments are also applicable to the guide wire 10 of the versions shown in Figs. 15A through Fig. 15G2, including but not limited to dimensions.
  • Fig. 16B shows the progression of a guide wire 10 as it penetrates a blood clot 85 within a patient's blood vessel.
  • Fig. 16B shows the progression of a guide wire 10 as it penetrates a blood clot 85 within a patient's blood vessel.
  • Fig. 16B shows that since the distal end of the guide wire 10 that will first contact the blood clot 85 is now in a straight configuration only a diameter of about 0.2 to 0.3 mm meets the surface of the side of the blood clot 85. This makes it much easier to penetrate the blood clot 85. Contrast this with Fig. 16A of the prior art.
  • only a single brief action need be taken by the neurosurgeon to straighten out guide wire.
  • a proximal button 14A that controls the axial push movement of the core 40 straightens the distal end 24 of the coil 20 and therefore of the guide wire 10.
  • there is no need to release the hemostatic valve 70 no need to rotate a core or a coil to position the core for a straightening motion and no need to take anything more one simple brief action. This difference adds up when one considers the arduous but time-sensitive and oft-repeated tasks of the neurosurgeon in navigating the tortuous pathways of the brain's capillaries (or arteries) prior to implementing the clinical intervention.
  • Method 100 may include a step 110 of inserting the guide wire 10 into the blood vessel, the guide wire 10 comprising a coil 20 (whether 20A or 20B) defining a central passageway.
  • Coil 20 (20Arome 20B) has a curved distal end and may include a straight portion.
  • Guide wire 10 may also include a straight core 40 traversing the central passageway 30 at least up to (and in some embodiments but not including) the curved distal end 24.
  • the core 40 may have a rounded distal tip 42.
  • the guide wire 10 may include any structural version described above.
  • the guide wire 10 may comprise a shaft 50 defining a central passageway and a spring 60 extending from a distal end of the shaft and attached to the shaft and defining a central passageway as shown in any version of Figs. 15A through 15G2.;
  • Method step 110 may include pushing the core 40 to traverse the central passageway and move into the distal end of the coil 20 A, 20B to straighten out the coil.
  • Method 100 may also include a step 120 of while the guide wire is in the blood vessel, pulling the core through the distal end of the coil to create the curved shape of the distal end of the of the coil.
  • the coil may be a braided coil 20 A or a spring coil 20B or a multicoil.
  • this step further includes pushing the whole guide wire 10 forward into a blood clot 85 with the distal tip of the guide wire 10 facing a side of the blood clot 85 (Fig. 16B). This is a much more effective way of having the guide wire 10 penetrate the blood clot 85 than certain guide wires of the prior art that have a curved distal end.
  • Method 100 may also include a step 130 of pulling the core 40, while the guide wire 10 is in the blood vessel, to move the core 40 out of the distal end 24 of the coil 20 and thereby restore the previous curved shape of the coil 20.
  • This may occur for example by releasing the pushing motion for example by pulling or by pressing a button (for example a proximal button 14A) that releases the pushing motion while the guide wire is in the blood vessel.
  • the movement of the core 40 out of the distal end 24 of the coil 20 has the effect of restoring the curved shape of the distal end 24, 24A of the coil 20, for example to a J-shape.
  • Method 100 may include a step 130 of pushing shaft 50 so as to rotate the distal end 24 A (by as much as 360 rotational degrees or in other versions by at least 90 degrees or by at least 180 degrees or by at least 270 degrees) along an axis A running along a length of the guide wire 10. This occurs while the guide wire is in the blood vessels. This allows the physician to navigate anywhere in the convoluted blood vessels of the brains where one needs to both bend and also rotate the distal end of the guide wire 10.
  • a further step is once again pushing, while the guide wire 10 is in the blood vessel, the core 40 through the distal end 24 of the coil 20 to straighten the coil 20 and pushing the whole guide wire 10 forward into a blood clot 85 with the distal tip of the guide wire facing a side of the blood clot 85 (Fig. 16B).
  • the coil is a braided coil and the curved distal end is a curved braided distal end.
  • method 100 includes a step of using a rounded distal tip 42 A of the core to smoothly navigate through the curved distal end 24 of the coil 20 to straighten the coil 20.
  • the proximal actuating mechanism includes a hemostatic valve 70 and further comprising pushing the core through the distal end of the braided coil to straighten the braided coil without having to first release the hemostatic valve 70.
  • the outer diameter of the coil 20 is 0.27 to 0.29 mm
  • the mechanism for manipulating the core is located at a proximal end 14 of the guide wire 10 which is part of the proximal portion 11 of the guide wire 10.
  • the core and the coil may be made of Nitinol, a metal alloy of nickel and titanium.
  • the thicker portion of the core is the proximal and central portions whereas the outer diameter of the core tapers downward are one gets closer to the distal end.
  • the core is 0.11 millimeters wide in diameter.

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  • Anesthesiology (AREA)
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  • Heart & Thoracic Surgery (AREA)
  • Hematology (AREA)
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Abstract

Fil-guide médical destiné à améliorer la navigation dans les vaisseaux sanguins présentant une bobine tressée serrée sur toute sa longueur, une bobine à ressort ou une bobine multiple. La bobine définit un passage central et présente une extrémité distale incurvée lorsqu'aucune force extérieure n'est appliquée, un arbre définissant un passage central et un ressort central. Un mécanisme d'arrêt comporte soit un anneau de couplage entre le ressort et la bobine, soit la bobine présente plusieurs diamètres. L'âme droite traverse les passages centraux de l'arbre, du ressort et du passage central principal de la bobine et, lorsqu'elle est tirée, permet à l'extrémité distale de prendre une configuration incurvée. L'arbre, lorsqu'il est déplacé de manière distale tandis que l'extrémité distale de la bobine est incurvée, comprime le ressort et force l'extrémité distale de la bobine à tourner. Un manchon longitudinal recouvre une partie de la bobine et une jonction entre l'arbre et la bobine.
PCT/IB2024/055823 2023-06-15 2024-06-14 Fil-guide présentant une extrémité distale conçue pour prendre plusieurs formes Pending WO2024257027A1 (fr)

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Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP0729765A1 (fr) * 1995-03-02 1996-09-04 Schneider (Europe) Ag Fil de guidage
US20030139689A1 (en) * 2001-11-19 2003-07-24 Leonid Shturman High torque, low profile intravascular guidewire system
WO2024018460A1 (fr) * 2022-07-19 2024-01-25 EndoWays LTD. Fil-guide et microcathéter

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP0729765A1 (fr) * 1995-03-02 1996-09-04 Schneider (Europe) Ag Fil de guidage
US20030139689A1 (en) * 2001-11-19 2003-07-24 Leonid Shturman High torque, low profile intravascular guidewire system
WO2024018460A1 (fr) * 2022-07-19 2024-01-25 EndoWays LTD. Fil-guide et microcathéter

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