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WO2025022336A1 - Dispositif à maillage endovasculaire guidable et ses applications - Google Patents

Dispositif à maillage endovasculaire guidable et ses applications Download PDF

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Publication number
WO2025022336A1
WO2025022336A1 PCT/IB2024/057193 IB2024057193W WO2025022336A1 WO 2025022336 A1 WO2025022336 A1 WO 2025022336A1 IB 2024057193 W IB2024057193 W IB 2024057193W WO 2025022336 A1 WO2025022336 A1 WO 2025022336A1
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WO
WIPO (PCT)
Prior art keywords
endovascular device
mechanical treatment
control element
selectively bendable
treatment portion
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/IB2024/057193
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English (en)
Inventor
Giora Kornblau
Eyal KAUFMAN
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Rapid Medical Ltd
Original Assignee
Rapid Medical Ltd
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Filing date
Publication date
Application filed by Rapid Medical Ltd filed Critical Rapid Medical Ltd
Publication of WO2025022336A1 publication Critical patent/WO2025022336A1/fr
Pending legal-status Critical Current
Anticipated expiration legal-status Critical

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Classifications

    • 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
    • A61B17/221—Gripping devices in the form of loops or baskets for gripping calculi or similar types of obstructions
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/32—Surgical cutting instruments
    • A61B17/3205—Excision instruments
    • A61B17/3207—Atherectomy devices working by cutting or abrading; Similar devices specially adapted for non-vascular obstructions
    • A61B17/320725—Atherectomy devices working by cutting or abrading; Similar devices specially adapted for non-vascular obstructions with radially expandable cutting or abrading elements
    • 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
    • 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
    • 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
    • A61B2017/22045—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 fixed to the catheter; guiding 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
    • A61B17/221—Gripping devices in the form of loops or baskets for gripping calculi or similar types of obstructions
    • A61B2017/2212—Gripping devices in the form of loops or baskets for gripping calculi or similar types of obstructions having a closed distal end, e.g. a loop

Definitions

  • This disclosure relates to the field of endovascular medical devices. Specifically, this disclosure is related to endovascular devices intended to pass through a blood vessel of a patient, to navigate to a target area inside the patient’s vasculature, and to perform a medical procedure.
  • an endovascular treatment of the type relevant to this disclosure is the use of an endovascular device to treat narrowing, blockage, or hemorrhage in a blood vessel, including neurovascular, cardiovascular, and peripheral vasculatures.
  • treatment of an acute stroke caused by a blockage of a blood vessel in the brain typically comprises either the intra-arterial administration of thrombolytic drugs such as recombinant tissue plasminogen activator (rtPA), mechanical removal of the blockage, or a combination of the two.
  • rtPA tissue plasminogen activator
  • interventional treatments must occur within hours of the onset of symptoms.
  • IA thrombolytic therapy and interventional thrombectomy involve accessing the blocked cerebral artery via endovascular techniques and devices.
  • Mechanical treatment involves the physical manipulation of the relevant structure to relieve the cause of the symptoms.
  • mechanical treatment of a blood clot involves the physical removal of the blood clot by various means, such as capturing the blood clot mechanically by use of a mesh, balloons, snares, or coils, with or without the addition of supporting techniques like the use of suction to remove the clot or stents to support the blood vessel.
  • Another example of a mechanical treatment is the mechanical reshaping of blood vessels to improve blood flow, which is accomplished by the use of mechanical devices similar to those discussed above.
  • the device needs to be positioned as close as possible to the source of disruption, e.g., to a blood clot or a site of narrowing blood vessels.
  • This may be challenging in anatomical areas in which the blood vessels comprise tortuous anatomy, such as the brain.
  • the medical devices discussed above are often used in a nested fashion, namely, a guidewire inside a microcatheter inside an intermediate catheter are advanced as an assembly to the target site. Once the target site is reached, the guidewire is typically removed, and the treatment device is put in its place to carry out the medical procedure. Accordingly, the user needs to be highly skilled at manipulating several devices together.
  • an endovascular device in a first embodiment, includes a body comprising: a selectively bendable portion, a mechanical treatment portion, and a proximal portion; a control element disposed inside at least a portion of the body, the control element fixed to a portion of the selectively bendable portion or of the mechanical treatment portion and configured to slide with respect to the body; and an activation tube disposed around at least part of the body and configured to slide with respect to the body, wherein the activation tube is configured to slide to surround at least part of the mechanical treatment portion.
  • an endovascular device includes a body comprising: a selectively bendable portion, a mechanical treatment portion, and a proximal portion; a control element disposed inside at least a portion of the body, the control element fixed to a portion of the selectively bendable portion and configured to slide with respect to the body, wherein movement of the control element is configured to selectively bend the selectively bendable portion; and a second control element disposed inside at least a portion of the body, the second control element fixed to a portion of the mechanical treatment portion and configured to slide with respect to the body, wherein movement of the second control element in a proximal direction is configured to cause an axial compression of the mechanical treatment portion.
  • an endovascular device includes a body comprising: a selectively bendable portion capable of navigating the body of the endovascular device to a target region of a blood vessel; and a mechanical treatment portion capable of performing a mechanical treatment at the target region of the blood vessel.
  • the endovascular device further comprises an activation tube disposed around at least part of the body and configured to slide with respect to the body. Wherein the activation tube is configured to slide to cover or uncover at least part of the mechanical treatment portion, thereby enabling the navigation mode of action or mechanical mode of action of the endovascular device, respectively.
  • a method of using an endovascular device comprises inserting a distal end of a body of the endovascular device into a blood vessel; navigating the body of the endovascular device to a target region of the blood vessel; and performing a mechanical treatment at the target region using a mechanical treatment portion of the body of the endovascular device.
  • FIG. l is a perspective view of an endovascular device according to an embodiment.
  • FIG. 2 is a partial side view of an endovascular device according to an embodiment.
  • FIG. 3 is a partial side view of the endovascular device of FIG. 2 in an alternative configuration.
  • FIG. 4 is a cross-section of a selectively bendable portion of an endovascular device according to an embodiment.
  • FIG. 5 is top and side view of a control element according to an embodiment.
  • FIG. 6 is cross-section view of the control element of FIG. 5 in an endovascular device according to an embodiment.
  • FIG. 7 is cross-section view of the control element of FIG. 5 in an endovascular device according to an embodiment.
  • FIG. 8 is top and side view of a control element according to an embodiment.
  • FIG. 9 is a detail view of a portion of an endovascular device according to an embodiment.
  • FIG. 10 is a detail view of a portion of an endovascular device according to an embodiment.
  • FIG. 11 is a diagram of a flowchart showing a method of using an endovascular device according to an embodiment.
  • FIGS. 12A-12B are partial side views of an endovascular device according to an embodiment.
  • FIGS. 13A-13C are partial side views of an endovascular device according to an embodiment.
  • FIGS. 14A-14B are partial side views of an endovascular device according to an embodiment.
  • FIGS. 15A-15B are partial side views of an endovascular device according to an embodiment.
  • Endovascular devices used to perform mechanical intravascular medical treatments need to be able to navigate through a blood vessel to reach the treatment site to deliver the mechanical treatment to the relevant treatment site. This can be difficult in situations where the blood vessels in question comprise multiple turns because the typical endovascular device is not able to actively bend to navigate a twist or turn.
  • existing systems often require multiple devices to accomplish mechanical treatment. For example, a guidewire is first navigated to the target region through a microcatheter, when the target region is reached, the guidewire is removed and a mechanical treatment device is advanced in place of the guidewire to the treatment site. This increases system complexity and the potential for misplacements and mistakes, and thus requires the user to be highly skilled at manipulating several devices simultaneously.
  • an embodiment of the present disclosure is an endovascular device having a body with a selectively bendable portion, a mechanical treatment portion, and a proximal portion.
  • a control element disposed inside at least a portion of the body and configured to slide with respect to the body, is configured to control a curvature of the selectively bendable portion to enable navigation of the device through the blood vessel and/or to control activation of the mechanical treatment portion.
  • An activation tube is slidably disposed around at least part of the body, the activation tube is configured to selectively enable activation of the guidewire function of the device or deployment of the mechanical treatment portion.
  • This endovascular device has several benefits, including an improved ability to navigate through blood vessels, including torturous blood vessels, and the ability to selectively deploy a mechanical treatment combined in one device. Additional benefits are discussed below.
  • an endovascular device 1 is formed as an approximately tubular device.
  • Endovascular device 1 includes a distal end 2 and a proximal end 3 (also referred to as “distal tip” and “proximal tip”, respectively).
  • Proximal end 3 is the end of endovascular device 1 that generally remains outside of a patient and is manipulated by a user (e.g., a doctor or other medical professional).
  • Distal end 2 is the end of endovascular device 1 that is generally inserted into a blood vessel of the patient.
  • endovascular device 1 may have an overall length of between 1500 and 2500 millimeters (mm).
  • endovascular device 1 may have an overall length of about 1800-2200 mm.
  • endovascular device 1 may have an overall length of about 2000 mm.
  • a body 100 of endovascular device 1 is formed as a tubular shape with three main segments: a selectively bendable portion 110, a mechanical treatment portion 160, and a proximal portion 170. As seen in FIG. 1, in some embodiments, these three segments are located adjacent to each other, with selectively bendable portion 110 being the portion of body 100 closest to distal end 2, mechanical treatment portion 160 being the next proximal segment, and finally proximal portion 170 being the most proximal of the three segments. In other embodiments, there may be other segments of body 100 between these three segments. For example, a tubular element, a cable, a connector, a stopper, or any other element suitable to be placed between portions of a tubular device may be used. These three segments of body 100 can be joined through any suitable technique known in the art, including but not limited to, welding, soldering, brazing, adhesive, or mechanical connections such as intermediate sleeves, rings, fasteners, or splices.
  • selectively bendable portion 110 may be located proximally to the mechanical treatment portion 160. Furthermore, there may be additional selectively bendable portions 110 in endovascular device 1, such as for example, a selectively bendable portion 110 may be located distally with respect to bendable portion 110 and a second selectively bendable portion 110 may be located proximally with respect to mechanical treatment portion 160. Accordingly, device 1 may comprise one, two, three or more selectively bendable portions 110.
  • a control element 120 is disposed inside body 100 to control the bending of selectively bendable portion 110 and, in some embodiments, to enable expansion and retraction of mechanical treatment portion 160, as will be discussed in detail below.
  • An activation tube 180 is slidably disposed around body 100.
  • Activation tube 180 is sized to have a sliding fit with the outer surface of body 100.
  • Activation tube 180 functions to enable selective activation of selectively bendable portion 110 or mechanical treatment portion 160 by its sliding properties over body 100.
  • activation tube 180 functions to enable selective activation of mechanical treatment portion 160 by sliding towards proximal end 3 and uncovering (also referred to as “unsheathing”) mechanical treatment portion 160 (as shown in FIG. 2, for example).
  • activation tube 180 functions to enable selective activation of selectively bendable portion 110, and concomitantly deactivation of mechanical treatment portion 160 (as shown in FIG. 3) by sliding towards distal end 2 and covering (also referred to as “sheathing”) of mechanical treatment portion 160.
  • activation tube 180 may be used to control the bending of selectively bendable portion 110, as will be discussed herein below.
  • An actuation control 200 is formed around part of proximal portion 170 closest to proximal end 3. Actuation control 200 functions to control both selectively bendable portion 110 and activation tube 180. According to one embodiment, actuation control 200 functions to control one or more of selectively bendable portion 110, mechanical treatment portion 160, and activation tube 180. According to one embodiment, actuation control 200 functions to control both selectively bendable portion 110 and mechanical treatment portion 160. According to one embodiment, actuation control 200 functions to control both selectively bendable portion 110 and activation tube 180.
  • body 100 can be formed as a cylinder with a central opening.
  • Body 100 can be formed from any suitable material known in the art, such as metals or plastics, as discussed in detail below. As body 100 is intended to be at least partially inserted into a blood vessel, the material of body 100 should be biocompatible.
  • Examples of materials for body 100 are elastic and/or super-elastic polymers, super-elastic metals or various metals/alloys/oxides such, without being limited to, elastomers, silicon polymeric materials like Polydimethylsiloxane (PDMS), silicon adhesives, silicone rubbers, natural rubbers, thermoplastic elastomers, polyamide, polyimide, poly ethylene (PE), poly propylene (PP), poly ether etherketone (PEEK), Acrylonitrile butadiene styrene (ABS), epoxys, polytetrafluoroethylene (PTFE), polyurethane, thermoplastic polyurethanes (TPU), Nylon, Polyether block amide (PeBax), Kevlar, stainless titanium, steel or stainless steel, nickel titanium alloy (Nitino
  • body 100 Materials opaque to X-rays, such as platinum, gold, tungsten, tantalum or the like, may be incorporated into body 100, or portions thereof, to act as a fluoroscopic marker to aid in visualization of the device in a blood vessel.
  • selectively bendable portion 110 may be formed from stainless steel or nitinol
  • mechanical treatment portion 160 can be formed from nitinol
  • proximal portion 170 can be formed from stainless steel or nitinol.
  • body 100 is configured to be elastically deformable along at least portions of its length, as will be explained below.
  • body 100 may have an outer diameter (OD) of between about 0.10 mm and about 1.10 mm. In some embodiments, body 100 may have an OD of between about 0.15 mm and about 0.90 mm. In some embodiments, body 100 may have an OD of between about 0.20 mm and about 0.40 mm. In specific embodiments, body 100 may have an OD of about 0.15 mm, about 0.20 mm, about 0.25 mm, about 0.30 mm, about 0.35 mm, about 0.40 mm, about 0.45 mm, about 0.55 mm, about 0.65 mm, about 0.75 mm or about 0.80 mm. As mentioned above, body 100 can be formed as a cylinder with a central opening.
  • body 100 may have an inner diameter (ID) of between about 0.10 mm and about 0.90 mm. In some embodiments, body 100 may have an ID of between about 0.20 mm and about 0.70 mm. In specific embodiments, body 100 may have an inner diameter of about 0.20 mm, about 0.30 mm, about 0.40 mm, about 0.50 mm or about 0.60 mm.
  • ID inner diameter
  • body 100 may have an inner diameter of about 0.20 mm, about 0.30 mm, about 0.40 mm, about 0.50 mm or about 0.60 mm.
  • body 100 includes at least one selectively bendable portion 110 (shown in the straight configuration in FIG. 1, and in a partially bent configuration in FIGS. 2-3). As shown in FIG. 1, in some embodiments selectively bendable portion 110 is located at distal end 2. Selectively bendable portion 110 is controlled by actuation control 200 at proximal end 3. Thus, selectively bendable portion is a controllably bendable section being actuated by a control element (as further discussed hereinbelow). As will be explained in detail below, in some embodiments, the device can have multiple selectively bendable portions 110.
  • Selectively bendable portion 110 is a portion of body 100 that can be controllably bent with respect to the original axis of body 100. As will be discussed further below, selectively bendable portions 110 can be controlled by a user to improve navigation of endovascular device through the blood vessel of a patient. In some embodiments, selectively bendable portion 110 can extend between about 5 mm and about 50 mm in the axial direction along body 100. In some embodiments, selectively bendable portion 110 can extend between about 10 mm and about 30 mm in the axial direction along body 100.
  • selectively bendable portion 110 can extend about 10 mm, about 11 mm, about 12 mm, about 13 mm, about 14 mm, about 15 mm, about 16 mm, about 17 mm, about 18 mm, about 19 mm, about 20 mm or about 25 mm in the axial direction along body 100.
  • openings 102 are formed in a portion of body 100.
  • openings 102 may be formed in selectively bendable portion 110. Openings 102 may also be formed in proximal portion 170 (not shown).
  • body 100 may be made of any suitable material, including medical grade stainless steel or nitinol. Openings 102 are portions removed from the material (e.g., cutouts). In some embodiments, these openings 102 are formed as slots in body 100 that penetrate at least partially around a circumference of body 100 from an exterior of body 100 to an interior of body 100. In some embodiments, openings 102 penetrate from the exterior of body 100 to the interior of body 100.
  • openings 102 when endovascular device 1 is inserted into a patient’s blood vessel, fluid may penetrate through openings 102.
  • openings 102 do not extend around the entire circumference of body 100. Openings 102 can extend, for example, from between ten percent to ninety percent of the circumference of body 100.
  • openings 102 can be formed as a regular, rectangular shape projected onto the surface of body 100.
  • openings 102 can have a width in the axial direction of between about 0.01 mm and about 0.1 mm.
  • openings 102 can have a width in the axial direction of between about 0.02 mm and about 0.06 mm.
  • Openings 102 can also be formed from different shapes projected onto the surface of body 100, such as slits, circles, ovals, triangles, or any other desired polygonal shape.
  • Openings 102 may be etched from body 100, for example, using any manufacturing methods known in the art, such as by cutting or grinding, for example, with a disc, with a semiconductor dicing blade or using laser cutting. [0044] By removing material from body 100, openings 102 reduce the stiffness or resistance to bending of body 100. Thus, openings 102 can be used to create more flexible or bendable portions of body 100. These are portions of body 100 that are more susceptible to being controllably bent, as will be discussed below. Changing the extent of openings 102 can therefore be used to control flexibility or softness of body 100. For example, increasing the extent, by increasing size, number, shape, or density of openings 102 will reduce the stiffness of body 100, or increase the tendency to bend.
  • openings 102 increases the stiffness of body 100, or decreases the tendency to bend.
  • selectively bendable portion 110 of body 100 has openings 102, while proximal portion 170 may not have any openings 102.
  • selectively bendable portion 110 may have openings 102, and proximal portion 170 may have openings 102 but of reduced size, number, or density as compared to the selectively bendable portion 110.
  • Openings 102 on the selectively bendable portion may be asymmetric, in that openings 102 may be deeper, more frequent, larger in size and/or of a favorable shape on the side in the direction where the tip is bent.
  • openings 102 on the selectively bendable portion may be symmetric, in that case, openings 102 may be equal in depth, frequency, size and/or shape, on both sides of the tube. In areas where the tube is not meant to bend when tension is applied, openings 102 may only serve to increase flexibility or softness of the tube.
  • openings 102 have identical dimensions, but have variable spacing between them.
  • openings 102 disposed in selectively bendable portion 110 may have a spacing of about 0.03 mm to about 0.2 mm (e.g., pitch of about 0.06 mm to about 0.3 mm).
  • openings 102 disposed in selectively bendable portion 110 may have a spacing of about 0.08 mm to about 0.06 mm (e.g., pitch of about 0.12 mm to about 0.16 mm).
  • Openings 102 in a separate, more proximal portion of body 100 may be smaller and may be spaced further apart, and may have a spacing of between about 0.03 mm to about 3 mm.
  • openings 102 Another example of changing the extent of openings 102 is changes in spacing between openings 102. Larger spacing between openings 102 would increase the stiffness of body 100, while smaller spacing between openings 102 decreases the stiffness of body 100.
  • This technique can be used to create variable gradients of stiffness to tailor the stiffness of body 100 as desired.
  • the spacing or pitch of openings 102 in selectively bendable portion 110 is smaller at the end of selectively bendable portion 110 that is closest to distal end 2. In these embodiments, the spacing increases towards the end of selectively bendable portion 110 that is closer to proximal end 3. In this way, selectively bendable portion 110 is biased to be more flexible nearer distal end 2, which is the end that is inserted into the blood vessel first.
  • the rate of change in spacing can be constant or can be variable to tailor the stiffness change as needed.
  • This portion of body 100 may also be the portion of body 100 intended to remain outside of the patient during an endovascular procedure.
  • the design or material of body 100 can also be used to adjust flexibility of body 100.
  • the cross-section dimensions or shape of body 100 may be altered to increase or decrease flexibility.
  • Changing the material of body 100 can also change flexibility.
  • a stiffer material will make the corresponding portion of body 100 less flexible, for example. This can be useful when flexibility changes are desired without changing external dimensions of body 100.
  • the connection can be, for example, any suitable connection technique including, but not limited to, adhesives, welding, or use of a mechanical connector such as a ring or sleeve (used alone or in combination with other connecting techniques). As seen in FIGS.
  • selectively bendable portion 110 disposed at distal end 2 of body 100. This enables a portion of body 100 at distal end 2 to be more flexible, and thus selectively bendable. Selectively bendable portion 110 may also be disposed at various other points along body 100 as needed to increase flexibility and control. Accordingly, selectively bendable portion 110 may be disposed at a distal portion of endovascular device 1 which is not the distal end 2, such as up to about 150 mm from the distal end 2. As seen in FIGS. 4 and 6, in some embodiments this distally located, selectively bendable portion 110 is terminated at distal end 2 with a plug 112. Plug 112 acts to finish or seal distal end 2.
  • Plug 112 is generally an atraumatic and non-sharp tip which typically has a rounded, oval, or similar shape to improve the ability of body 100 to transit inside a blood vessel in an atraumatic manner.
  • a washer 114 is disposed between selectively bendable portion 110 and plug 112.
  • Plug 112 and washer 114 can be fixedly connected to body 100 by any suitable method, including but not limited to, welding, soldering, brazing, adhesive, or mechanical connections such as fasteners or crimping. Both plug 112 and washer 114 can be made from any suitable biocompatible material, including for example metals, metal alloys/oxides, adhesives, silicones, and plastics, or any combination thereof.
  • endovascular device 1 can include a control element 120 (also referred to as an actuator) disposed inside body 100.
  • Control element 120 can take the form of any suitably stiff element that can freely slide inside body 100. Sufficient stiffness is needed to prevent control element 120 from buckling excessively when it is put in compression (during the straightening of selectively bendable portion 110). However, control element 120 must also be sufficiently flexible such that it does not render body 100 too inflexible.
  • control element 120 also affects the flexibility of selectively bendable portion 110, and thus the portion of control element 120 that transitions through selectively bendable portion 110 must be designed to allow for selectively bendable portion 110 to bend as desired.
  • Control element 120 can be made of any suitable biocompatible material, including metals, metal alloys and plastics, or any combination thereof.
  • control element 120 can be a solid wire, a multi-filament wire, a string, or a thread.
  • control element 120 can be a solid wire formed from any material known in the art, such as but not limited to, nitinol alloy, stainless steel, and a plastic material, or any combination thereof.
  • control element 120 can be formed as a solid wire that is sized to fit inside body 100. Control element 120 can also take the form of a tube.
  • control element 120 The function of control element 120 is to transmit force to selectively bend or straighten selectively bendable portion 110. As explained below, this also has the effect of controlling mechanical treatment portion 160. This is accomplished by fixing the distal end of control element 120 to the distal end of the selectively bendable portion 110 (or to a different attachment point of the selectively bendable portion 110 depending on the needs and circumstances of the device). According to one embodiment, the distal end of control element 120 is fixed to plug 112. According to one embodiment, the distal end of control element 120 is fixed to washer 114. According to one embodiment, washer 114 is in turn fixed to an end of selectively bendable portion 110.
  • washer 114 may be located at different locations along body 100 depending on where selectively bendable portion 110 begins and ends.
  • control element 120 passes through an opening in washer 114 and curves to fit into a groove 115 in washer 114.
  • control element 120 extends through washer 114 traveling in an axial direction, and then curves approximately 180 degrees back to fit into groove 115, forming a u-shaped curve. In this way, control element 120 is fixed both axially and rotationally to washer 114 at distal end 2 of endovascular device 1. Examples of these types of curves are shown in FIGS. 4 and 6.
  • control element 120 may also be secured by adhesives and mechanical techniques such as a friction fit or the formation of additional bends/angles in control element 120. This manner of connecting control element 120 to washer 114 also improves the connection between body 100 and control element 120 because washer 114 substantially reduces the possibility of control element 120 separating from its fixed position with respect to body 100.
  • Control element 120 can otherwise slide freely inside body 100 to transmit force from actuation control 200 to washer 114 at distal end 2. From the straightened position shown in FIG. 1, retraction of control element 120 with respect to body 100 towards proximal end 3 will result in selectively bendable portion 110 bending to accommodate the shortened length of control element 120 (as seen in FIGS. 2-3). Conversely, extension of control element 120 towards distal end 2 will result in straightening of selectively bendable portion 110. The movement of control element 120 with respect to body 100 can be achieved by actuation control 200.
  • control element 120 can be configured to increase the tendency for selectively bendable portion 110 to bend in a desired direction or directions. This is accomplished by altering the shape of control element 120 to increase its tendency to bend in a given direction or directions.
  • control element 120 can have any lateral cross-section (perpendicular to the longitudinal axis) such as round, elliptic, square, rectangular, and the like.
  • control element 120 is formed from a solid wire with a varying cross section. Closer to proximal end 3, this embodiment of control element 120 has a circular cross section. As control element 120 continues in the distal direction, control element 120 flattens and has a rectangular cross section. The rectangular cross section tends to bend in the direction perpendicular to the long sides of the rectangle, creating a preferred or biased bending direction for selectively bendable portion 110 that control element 120 is disposed within.
  • control element 120 can maintain the same cross section, but change in size to alter bending tendencies.
  • control element 120 may maintain a circular cross section, but may increase or decrease in diameter to increase or reduce stiffness, respectively.
  • This type of control element 120 would not have a biased bending direction because the cross-sectional shape is maintained but would instead have lesser or greater bending tendencies depending on the dimensions of control element 120.
  • the dimensions of these changed areas of control element 120 can be varied to achieve the desired resistance to bending when combined with the properties of body 100.
  • an embodiment of this type of control element 120 can have different first, second, and third diameters at different locations along the length of control element 120.
  • control element 120 is shown in FIG. 5, which shows a side view and top view of control element 120.
  • control element 120 has a constant diameter portion 120a, a tapered portion 120b, and a flattened portion 120c.
  • Constant diameter portion 120a has a cross-section of a predetermined diameter, which may correspond to parts of control element 120 that are closer to proximal end 3 of body 100 when assembled into endovascular device 1.
  • Tapered portion 120b has a diameter that constantly decreases as distance from constant diameter portion 120a increases.
  • Flattened portion 120c has a rectangular cross-section (thus, it is flattened when compared to other parts of control element 120) that increases in width when viewed from the top as distance from tapered portion 120b increases.
  • Flattened portion 120c can correspond to the selectively bendable portion 110, and thus can correspond to distal end 2 of body 100.
  • flexibility of control element 120 will increase in all bending directions in tapered portion 120b as distance from constant diameter portion 120a increases because of the reduction in diameter. Bending in flattened portion 120c is biased towards bending in the direction in and out of the drawing with respect to the top view because of the flattened cross section shape.
  • This embodiment of control element 120 is shown in body 100 in FIG. 6, and a cross-section of FIG. 5 is shown in FIG. 7.
  • control element 120 can be fixed to a portion of a mechanical treatment portion 160, which is another portion of endovascular device 1 discussed in detail below.
  • a mechanical treatment portion 160 which is another portion of endovascular device 1 discussed in detail below.
  • the control element 120 is typically fixed to the distal end 162 of mechanical treatment portion 160, e.g., to the distal portion thereof.
  • different control elements 120 may be used to actuate different portions of the device, for example, one control element 120 may be fixed to mechanical treatment portion 160 and a second control element may be fixed to selectively bendable section 110.
  • control element 120 may be fixed to mechanical treatment portion 160 using any method known in the art, e.g., via a connector, plug or washer (as discussed above).
  • constant diameter portion 120a ranges between about 0.1 and about 0.45, e.g., about 0.140 and about 0.180 mm in diameter.
  • tapered portion 120b At its most proximal end, tapered portion 120b has the same diameter as constant diameter portion 120a.
  • Tapered portion 120b can taper down to a diameter of between about 0.065 mm and about 0.2 mm. The taper may be evenly distributed (a linear taper) along the axial length of tapered portion 120b or can be unevenly distributed.
  • Flattened portion 120c may have a width dimension that begins at the smallest diameter of tapered portion 120b and increases up to the diameter of constant diameter portion 120a. As seen in FIG.
  • the width dimension is being defined as the dimension in the top to bottom direction of FIG. 5 with respect to the lower top view. It should be understood that there can be more or less steps in flattened portion 120c as needed or desired to adjust flexibility. Flattened portion 120c can also be flatted and expand in width in a gradual, nonstepwise fashion, as shown in FIG. 5.
  • Biased bending as discussed above can also be achieved by distributing the open areas caused by openings 102 unevenly with respect to the circumference of body 100.
  • having asymmetric slots having openings with a greater extent (more open area) facing in a first radial direction and slots with a smaller extent (less open area) facing in a second radial direction (e.g., direction opposite the first radial direction) biases the bending of the selectively bendable portion 110 in the first direction when the control element 120 is moved by actuator control 200.
  • making openings 102 larger on one side of body 100 would bias body 100 to bend in the direction of that side.
  • any combination of these methods to bias the bending of body 100 has the advantages of providing predictable bending for the user of endovascular device 1. This is particularly helpful when distal end 2 of body 100 has been inserted into a blood vessel and is not visible. The orientation of the remainder of body 100 (present outside of the blood vessel) allows the user to understand the direction that the distal end of body 100 with such a bias will bend with respect to the blood vessel.
  • These selectively bendable portions of body 100 may include biased bending region accomplished by having an asymmetrical distribution of openings 102 as discussed above.
  • the same body 100 having asymmetrical distribution of openings 102 at the one or more selectively bendable portions of body 100 can also have a symmetrical set of openings disposed in a different portion of body 100. These symmetrical openings 102 improve flexibility of body 100 without introducing any directional bias. For example, some or all of proximal portion 170 may have symmetrical opening 102. Finally, the same body 100 may have a portion without any openings 102, for example, on the portion of body 100 intended to remain outside of the patient during the procedure. This has the effect of gradually increasing stiffness of body 100 in the proximal direction (towards proximal end 3).
  • a portion of body 100 that is proximal to non-bending portion 118 has no openings 102.
  • the symmetrical openings 102 are formed as a rectangular slot that is projected or wrapped around some portion of the circumference of tube 100. In these embodiments, this portion may be anywhere between 0° and 350° of the circumference of tube 100.
  • the slot that is projected can be between 0.01 mm and 0.1 mm in width, and the pitch or spacing between slots (openings 102) can be between 0.04 mm and 50 mm.
  • the orientation of the openings 102 can also be varied in different ways.
  • the ends of the openings 102 can be located at varying positions in terms of rotation about the axis of tube 100. This means that the solid portion of tube 100 between the ends of each opening 102 can be offset rotationally with respect to adjacent openings 102. In some embodiments, this results in openings 102 being interleaved rotationally.
  • this offset can be arranged in a pattern such that each opening 102 is rotated a specific predetermined angular amount with respect to adjacent openings 102. For example, each opening 102 may be rotated 90 degrees with respect to the adjacent openings 102, which means that the openings 102 would form a repeating pattern in terms of their rotational alignment. Any desirable symmetrical or asymmetrical rotational alignment of openings 102 is possible. That is, the predetermined amount of rotational offset can be the same or can vary as desired between adjacent openings 102.
  • opening 102 can be inclined with respect to the axis of tube 100 at an angle between zero and ninety degrees. This inclination may be easier to manufacture than strictly perpendicular opening.
  • This angle can be measured with slots that have at least one elongated or linear side, such as slots that are formed from projected rectangles. That is, the angle is taken as the angle between the elongated side and the axis of tube 100.
  • Openings 102 can be formed at a desired angle instead of being perpendicular to the axis of tube 100. Any desired angle can be used to slant openings 102, and the same discussion above with respect to staggering the solid portions of tube 100 applies here.
  • this portion may be anywhere between 0° and 350° of the circumference of tube 100.
  • the slot that is projected can be between 0.01 mm and 0.1 mm in width, and the pitch or spacing between slots (openings 102) can be between 0.04 mm and 50 mm.
  • openings 102 can include both inclined and perpendicular orientations in different sections of tube 100.
  • At least a portion of body 100 includes a cable formed of a plurality of wound wires.
  • the cable may include a proximal segment, at least one transition segment, and a distal segment.
  • the distal segment of the cable may include selectively bendable portion 110.
  • the distal segment includes a different number of wires compared to the proximal section.
  • the proximal segment may include a first number of wires
  • the distal segment may include a second number of wires, the second number of wires being less than the first number of wires.
  • the proximal segment may include a first number of wires (e.g., in a range of 2-20 wires, e.g., 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12 wires) and the distal segment may include a second number of wires (e.g., in a range of 1-11 wires, e.g., 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, or 11 wires).
  • the transition segment being the point of reduction in the number of wires in the cable.
  • the second number of wires may comprise more wires than the first number of wires.
  • the proximal segment may include a first number of wires (e.g., in a range of 1- 11 wires, e.g., 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, or 11 wires) and the distal segment may include a second number of wires (e.g., in a range of 2-20 wires, e.g., 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12 wires).
  • the transition segment being the point of increase in the number of wires in the cable.
  • selectively bendable portion 110 of body 100 can be fabricated from a plurality of wires twisted to form a cable.
  • a cable is configured to exhibit sufficient pliability to enable flexibility and control of selectively bendable portion 110.
  • the plurality of wires twisted to form the cable comprise one or more of the wires used to fabricate the mesh (as discussed in detail below).
  • the plurality of wires twisted to form the cable comprise all of the wires used to fabricate the mesh (as discussed in detail below).
  • the plurality of wires twisted to form the cable comprise some of the wires used to fabricate the mesh, e.g., 1, 2, 3, 4, 5, 6, 7, 8, 9, or 10 wires used to fabricate the mesh (as discussed in detail below).
  • selectively bendable portion 110 of body 100 is fabricated from a plurality of wires twisted to form a cable, while a proximal portion 170 of body 100 may not have any openings 102.
  • selectively bendable portion 110 is fabricated from a plurality of wires twisted to form a cable, while proximal portion 170 may have openings 102 but of size, number, or density to enable sufficient stiffness to body 100.
  • selectively bendable portion 110 of body 100 may comprise slots as discussed in detail herein above, while proximal portion 170 of body 100 may be fabricated from a plurality of wires twisted to form a cable.
  • Such a cable is configured to exhibit sufficient stiffness to enable torque of device 1 and control of selectively bendable portion 110 and mechanical treatment portion 160.
  • the plurality of wires twisted to form the cable comprise one or more of the wires used to fabricate the mesh (as discussed for the selectively bendable portion 110 above).
  • control element 120 can be coated to reduce friction.
  • Suitable coatings for control element 120 include polymers and elastomers.
  • PTFE polytetrafluoroethylene
  • TFE tetrafluoroethylene
  • nylon may be used to coat control element 120 to reduce friction when control element 120 moves with respect to tube 100.
  • Suitable coatings can be formed by any method known in the art, as discussed above.
  • Movement of control element 120 within body 100 can cause friction.
  • control element 120 can be coated to reduce friction.
  • Suitable coatings for control element 120 include polymers and elastomers.
  • endovascular device 100 may include a spacer 130.
  • spacer 130 can be disposed between control element 120 and the inside of body 100.
  • Spacer 130 acts as a spacer and guide that confines the movement of control element 120 inside body 100.
  • spacer 130 is described as a solid material.
  • spacer 130 may also include a liquid lubrication element, or may only be a liquid lubrication.
  • an oil can be added to the interior of body 100 (e.g., near distal end 2). This oil can reduce friction between control element 120 and body 100.
  • suitable oils can include, without limitation, a silicone oil.
  • Spacer 130 is fixed with respect to the interior of body 100. Suitable means for fixing spacer 130 to body 100 include, but are not limited to, welding, soldering, brazing, using adhesives, and mechanical connections.
  • a connector 132 fixes spacer 130 to body 100.
  • spacer 130 can be fixed to washer 114 using any method known in the art, such as with an adhesive, which in turn means spacer 130 is fixed to body 100 because washer 114 is fixed to body 100.
  • spacer 130 is fixed to tube 100 in a location closer to distal end 2. Accordingly, spacer 130 may be fixed at any location along tube 100 so as to enable longitudinal movement of control element 120. According to one embodiment, spacer 130 can completely surround control element 120 circumferentially.
  • spacer 130 can only partially surround control element 120 circumferentially. In some embodiments, spacer 130 extends the entire length of body 100. In other embodiments, spacer 130 extends only a portion of the axial length of body 100. In other embodiments, spacer 130 extends the portion of the selectively bendable portion of body 100. In some embodiments, spacer 130 extends 1 to 50 percent of the axial length of tube 100. In other embodiments, spacer 130 extends 5 to 30 percent of the axial length of tube 100. In other embodiments, spacer 130 extends 10 to 30 percent of the axial length of tube 100. Furthermore, spacer 130 may be placed at any section along the tube, e.g.
  • spacer 130 can extend about 10 mm to 500 mm in the axial direction along tube 100. According to a specific embodiment, spacer 130 can extend about 10 mm, 25 mm, 50 mm, 75 mm, 100 mm, 150 mm, 200 mm, 250 mm, 300 mm, 350 mm, 400 mm, 450 mm or 500 mm in the axial direction along tube 100. Furthermore, spacer 130 may be placed at any section along the tube, e.g. at the distal end of the tube, proximal end of the tube, or anywhere in between.
  • spacer 130 can be formed as a continuous tube of material. In other embodiments, spacer 130 can be formed from a strip or wire that is wrapped in a spiral or coil inside body 100. In other embodiments, spacer 130 can be formed from several strips of material or wires that are wrapped in a spiral or coil inside body 100. Other possible forms of spacer 130 include separate strips of material running the length of body 100, or discrete rings of material separated from each other. Spacer 130 may be formed from a biocompatible material that allows control element 120 to slide with respect to spacer 130. For example, but not limited to, spacer 130 can be made from a metal, a metal alloy/oxide, a silicone, and a plastic material, or any combination thereof. Exemplary materials of spacer 130 include nitinol, platinum, iridium, polytetrafluoroethylene (PTFE), a fluoropolymer, such as polytetrafluoroethylene.
  • PTFE polytetrafluoroethylene
  • a coil-type spacer 130 is formed from a single wire shaped into a coil.
  • the wire forming the coil has a diameter of between 0.020 mm to 0.200 mm.
  • the coil of spacer 130 has a diameter of between 0.20 mm to 1.20 mm.
  • the coil of spacer 130 has a pitch, which is the linear distance it takes the coil to complete a single rotation about its central axis and which can be measured by finding the linear distance between the same or common angular point on adjacent coils. This pitch can range from 1.5 to 20 times the wire diameter.
  • coil-type spacers 130 may maintain the same dimensions (e.g., wire diameter, coil diameter, and pitch) throughout, or may vary these dimensions to achieve different effects, such as increased or decreased resistance to bending.
  • the material selected for spacer 130 is radiopaque, which means spacer 130 is visible on an x-ray scan, or similar types of medical imaging, when placed in the body. This can be achieved by material selection, or by the addition of an additive or coating to spacer 130.
  • materials such as gold, platinum, tungsten, tantalum or the like, may be incorporated into spacer 130, to act as a fluoroscopic marker to aid in visualization.
  • spacer 130 is at least partially formed from a material selected from the group consisting of a metal alloy and a fluoropolymer material to ensure spacer 130 is sufficiently radiopaque.
  • body 100 can be radiopaque, either by material selection (as discussed above) or by the addition of an additive or coating (discussed below).
  • mechanical treatment portion 160 is formed as a selectively expandable segment of body 100 with respect to a radial direction of body 100.
  • the selective expansion of body 100 enables mechanical treatment of a blood vessel by physically contacting the relevant obstruction(s) in the blood vessel and capturing, dispersing, or entangling the obstruction while also allowing for navigation of endovascular device 1 through a blood vessel.
  • Mechanical treatment can also include re-shaping of the blood vessel that can address blood flow issues not directly related to obstructions, such as narrowing of the blood vessels.
  • Mechanical treatment can also include support of a blood vessel during treatment at a specific location, such as during treatment of an aneurysm, e.g. by coiling or insertion of other treatment material.
  • an expanded mechanical treatment portion 160 may contact a blood clot and either disperse it by mechanically rupturing the clot or may entangle the clot for removal by retracting body 100.
  • mechanical treatment portion 160 is formed as a mesh of interlocking strands of material.
  • This mesh may be formed from a variety of weaves and filaments of material, such as a 2x1 weave (where certain strands are more than one filament wound or braided together, and these multi -filament strands then are woven together), or a 2x2 weave (where all strands are formed from multiple filaments).
  • Exemplary weaving patterns include 1x2, 2x1, 2x2, 2x3, 3x3. Example drawings of these meshes are shown in FIGS. 9-10. Braiding includes interweaving wires such that one wire passes between two other wires.
  • any number of total filaments may be used, for example, a plurality of wires between 6 and 16 separate wires (which may be multi -filament), e.g., 6-14 wires, 6-12 wires, 6-10 wires, 6-8 wires, 8-10 wires, 10-12 wires (such as e.g., 6, 7, 8, 9, 10, 11 or 12 wires), can be braided together.
  • the junctions between each wire that form the mesh can be reinforced with suitable techniques (such as by mechanical connections like crimping or being woven together, welding, or adhesives).
  • the mesh may further include twists of wires to prevent slippage of the wires (e.g. during mesh expansion and contraction).
  • windows of different sizes may be formed in the mesh, particularly during mesh expansion, these depend on the location of the opening within the mesh, and the degree of expansion of the mesh. The windows formed may function in clot capture or as filter/s to catch blood clots.
  • the plurality of wires comprised in mechanical treatment portion 160 may comprise wires of different material or of different diameter.
  • the wires in a mechanical treatment portion 160 may comprise identical properties.
  • at least one wire of the plurality of wires has a diameter between 40 microns and 200 microns.
  • the at least one wire can have a diameter that is at least one of: 40 microns, 45 microns, 50 microns, 55 microns, 60 microns, 65 microns, 70 microns, 75 microns, 80 microns, 85 microns, 90 microns, 95 microns, 100 microns, 105 microns, 110 microns, 115 microns, 120 microns, 125 microns, 130 microns, 135 microns, 140 microns, 145 microns, 150 microns, 155 microns, 160 microns, 165 microns, 170 microns, 175 microns, 180 microns, 185 microns, 190 microns, 195 microns, and 200 microns, or a range thereof.
  • at least one wire of the plurality of wires can have a diameter in a range between 50 microns and 75 microns.
  • the plurality of wires of mechanical treatment portion 160 may be constructed of any suitable flexible material known to those skilled in the art. Suitable flexible materials can include, but are not limited to, polymers, metals, metal alloys, and combinations therefore. In some embodiments, for example, the wires may be constructed from super elastic metals such as Nitinol. In order to visualize the mechanical treatment portion 160 with angiographic imaging, the wires may further include a radio-opaque marker and/or material.
  • mechanical treatment portion 160 may include a plurality of Nitinol wires with a core made of Tantalum or Platinum metals. The radiopaque core can be 20% to 50% by volume (e.g. 30% or 40%).
  • the wires can be made to be radiopaque by deposition of a thin layer of radiopaque metal such as Platinum.
  • radiopaque features may be positioned at the proximal and distal ends of mechanical treatment portion 160, as discussed below.
  • the mesh of mechanical treatment portion 160 may be cut from suitable material instead of braided together.
  • the open nature of the mesh enables mechanical treatment because it allows fluid to pass through the mesh, while solid obstructions such as blood clots are captured by the mesh.
  • the proximal end 161 and distal end 162 of mechanical treatment portion 160 can be marked with markers 163 that are radiopaque. This allows for use of imaging techniques to determine the precise position of mechanical treatment portion 160 inside the blood vessel.
  • markers 163 also act as the connection points between mechanical treatment portion 160 and selectively bendable portion 110 and proximal portion 170. Any suitable connection type may be used, including mechanical connections, welding, or adhesives.
  • the mesh form of mechanical treatment portion 160 can be closed at both ends because the filaments and wires all terminate at markers 163.
  • mechanical treatment portion 160 may be formed as a mesh that is open at distal end 162 (the wires do not terminate at the corresponding distal marker 163).
  • mechanical treatment portion 160 may be woven from wires (or at least some of the wires) that are continuum of wires that form proximal portion 170.
  • selectively bendable portion 110 may comprise at least some of the wires that are part of mechanical treatment portion 160.
  • activation tube 180 is used to contain and protect mechanical treatment portion 160 as endovascular device 1 is advanced through the body to the treatment site.
  • Activation tube 180 can slide towards proximal end 3 of endovascular device 1 to expose mechanical treatment portion 160 for deployment (as shown by the arrows in FIG. 2).
  • Activation tube 180 may be made of any suitable material, including for example metals such as a metal alloy, stainless steel or a polymeric material (e.g., polyethylene block amide), or a combination thereof.
  • activation tube 180 can include openings that are similar to openings 102 discussed above with respect to body 100. The discussion above with respect to the variations of openings 102 applies equally to any openings on activation tube 180. Openings in activation tube 180 can perform the same flexibility altering function as openings 102 perform for body 100.
  • Deployment of mechanical treatment portion 160 involves the expansion of mechanical treatment portion 160. This can be accomplished by different mechanisms.
  • control element 120 can be used to expand mechanical treatment portion 160. This can be accomplished by moving control element 120 proximally.
  • control element 120 may be fixed to a portion of selectively bendable portion 110 that is located distally with respect to mechanical treatment portion 160.
  • the stiffness of mechanical treatment portion 160 is engineered to be less than that of selectively bendable portion 110 and proximal portion 170 with activation tube 180 retracted proximally and providing no support.
  • An additional or alternative technique for controlling mechanical treatment portion 160 is the use of a separate control element 120 fixed to mechanical treatment portion 160. Movement of this control element 120 deploys and retracts mechanical treatment portion 160 by providing axial compression (deployment) or tension (retraction) as needed. The independent movement of this second control element 120 can be accomplished by actuation control 200 as discussed above. These embodiments have some benefits, for example, the benefit of providing a separate, dedicated control for mechanical treatment portion 160. It should be understood that this duplication of control element 120 can be accomplished as many times as needed in embodiments of body 100 with multiple selectively bendable portions 120 and mechanical treatment portions 160. According to one embodiment, control element 120 actuates mechanical treatment portion 160, while activation tube 180 or proximal portion 170 is used to actuate selectively bendable section 110.
  • An additional or alternative technique is the use of a self-expanding mesh as mechanical treatment portion 160.
  • Self-expanding meshes are configured to have a natural resting state that is expanded when unsheathed. The retraction of activation tube 180 can therefore serve to deploy the mesh alone, without any need for additional inputs from control element 120.
  • both of these techniques can be combined.
  • only portions of mechanical treatment portion 160 may comprise selfexpanding mesh, with other portions of the mesh being non-expanding as discussed above.
  • Proximal portion 170 functions to deliver selectively bendable portion 110 and mechanical treatment portion 160 to the appropriate treatment site in a blood vessel.
  • Proximal portion 170 can therefore take any suitable form that can pass through a blood vessel and provide the needed support.
  • proximal portion 170 can be a tube, shaft, wire, or other structure.
  • proximal portion 170 is a hypotube.
  • proximal portion 170 is formed as a hollow tube with or without openings 102 as discussed above.
  • Proximal portion 170 must accommodate control element 120 that passes through selectively bendable portion 110 and/or through mechanical treatment portion 160.
  • proximal portion 170 is hollow to allow control element 120 to travel therein.
  • proximal portion 170 are not hollow, but are directly connected to control element 120 at the junction between proximal portion 170 and mechanical treatment portion 160.
  • proximal portion 170 of body 100 may also comprise a plurality of wires twisted to form a second cable, as discussed above.
  • Body 100 and activation tube 180 may be sized and configured to act with other endovascular devices, such as catheters, e.g., micro-catheters, guide catheters or aspiration catheters.
  • a micro-catheter 190 may be advanced along the outside of body 100 to assist in treatment.
  • activation tube 180 may itself be another device such as a catheter, e.g., a micro-catheter.
  • a catheter e.g., a micro-catheter.
  • the same type of nesting may allow for multiple other devices to be arranged around body 100.
  • there may be an additional guide catheter surrounding microcatheter 190. This nesting of devices may be desirable to provide additional support to body 100 and to improve navigation of the combined endovascular devices.
  • endovascular device 1 comprises a control element for controlling a pump of the aspiration catheter such that aspiration through the aspiration catheter, and retraction of the activation tube occur in a synchronized manner.
  • body 100 may include multiple selectively bendable portions 110, mechanical treatment portions 160, and proximal portions 170. These can be arranged in any suitable order. For example, the order discussed above may be repeated to provide multiple mechanical treatment portions 160 with a corresponding distally-adjacent selectively bendable portion 110. In other embodiments there may be different orders or combinations of the various segments. The length of the various segments may be varied as desired to accommodate specific design constraints. There may be additional activation tubes 180 associated with each additional mechanical treatment portion 160. These embodiments have additional benefits including providing multiple mechanical treatment areas and multiple selectively bendable portions, which improve treatment options and device flexibility and control for navigation.
  • selectively bendable portion 110, mechanical treatment portion 160 and proximal portion 170 may be fabricated as a single unitary structure.
  • the outer diameter of the selectively bendable portion 110 can be different than the outer diameter of activation tube 180.
  • the outer diameter of the selectively bendable portion 110 can be greater than the outer diameter of activation tube 180.
  • the outer diameter of the selectively bendable portion 110 can be less than the diameter of activation tube 180.
  • the outer diameter of the selectively bendable portion 110 can be equal to the outer diameter of activation tube 180.
  • body 100 may be coated with various substances to improve system performance.
  • an exterior surface of body 100 intended for insertion into a patient may be entirely or partially equipped with an elastic or otherwise compliant, biocompatible coating or sheath to provide a smooth outer surface hydrophobic or hydrophilic, depending on the needs and circumstances.
  • a coating material is selected to minimize sliding friction of the device during insertion and removal into a subject’s body, and is substantially chemically inert in the in vivo vascular environment.
  • the exterior surface of tube 100 may have a hydrophilic coating to reduce friction between body 100 and a blood vessel.
  • Suitable coatings include, but are not limited to, polytetrafluoroethylene (PTFE), tetrafluoroethylene (TFE), urethane, polyurethane, thermoplastic polyurethanes (TPU), silicone Polyether block amide (PeBax), Nylon or polyethylene (PE), other polymers, polyurethane polymers, and elastomers are also suitable for coating. Additionally or alternatively, the coating material may be selected for its hydrophilic properties thus improving gliding in blood and navigability. Typically, this kind of coating is applied at the distal end 2 of body 100 and extends up to 50-500 cm from the tip, e.g., 50 cm, 100 cm, 150 cm, 200 cm from the tip. Suitable coatings can be formed by any method known in the art, such as by dipping, spraying or wrapping and heat curing operations.
  • a method of using embodiments of endovascular device 1 begins at step 1102 by inserting distal end 2 of endovascular device 1 into a suitable blood vessel.
  • body 100 of endovascular device 1 is advanced through the blood vessel to the target region.
  • Selectively bendable portion 110 is actuated as necessary to navigate body 100 through the various blood vessels.
  • activation tube 180 is retracted to prepare for deployment of mechanical treatment portion 160.
  • mechanical treatment portion 160 is deployed either by actuating control element 120, by allowing mechanical treatment portion 160 to selfexpand, or both.
  • the position of mechanical treatment portion 160 at the target region in step 1104 may be verified by suitable imaging, which can be assisted by the radi opacity of markers 163, as well as by other radi opacity elements provided in the device, such as but not limited to, in selectively bendable portion 110, in mechanical treatment portion 160, or in activation tube 180.
  • FIGS. 12A-12B show cross-sections of parts of an embodiment of endovascular device 1 that differs from the above-described embodiments because the outer diameter of the distal selectively bendable portion 110 is equal to the outer diameter of activation tube 180.
  • FIG. 12A shows endovascular device 1 in a navigation configuration while FIG. 12B shows endovascular device 1 with mechanical treatment portion 160 deployed.
  • These embodiments can be thought of as essentially an endovascular device 1 having a selectively bendable portion 110 being joined in series with an endovascular device 1 having a mechanical treatment portion 160.
  • each lengthwise portion of this embodiment of endovascular device 1 can be any one of the separate devices discussed above. For example, here there are two lengthwise portions joined to each other.
  • the portion of endovascular device 1 that is located more proximally i.e., after mechanical treatment portion 160
  • FIGS. 13A-13C show cross-sections of parts of an embodiment of endovascular device 1 that differs from the above-described embodiment because activation tube 180 terminates at the proximal tip and is used to actuate the selectively bendable portion 110.
  • This configuration provides the entirety of body 100, including mechanical treatment portion 160, within activation tube 180.
  • activation tube 180 extends to plug 112 but is not attached thereto.
  • activation tube 180 is used to actuate selectively bendable portion 110, while control element 120 is used to actuate mechanical treatment portion 160.
  • activation tube 180 can be the same diameter as the proximal end of plug 112.
  • activation tube 180 is positioned proximally and forms a smooth continuous outer surface from plug 112.
  • endovascular device 1 is able to navigate and be selectively curved as discussed above.
  • activation tube 180 is retracted to result in the configuration shown in FIG. 13B.
  • Mechanical treatment portion 160 can then be deployed for treatment as discussed above.
  • FIG. 13C after unsheathing of mechanical treatment portion 160, control element 120 is pulled proximally, mechanical treatment portion 160 is moved closer to the distal end of endovascular device 1 (e.g. to plug 112), and control element 120 can be used to expand and retract mechanical treatment portion 160.
  • a coiled wire 182 can be positioned proximally of mechanical treatment portion 160 to provide torqueability, softness and/or support to proximal section 170 of body 100 as required for the functionality of endovascular device 1. Additionally or alternatively, coiled wire 182 can be utilized to reduce friction between mechanical treatment portion 160 and/or proximal section 170 and activation tube 180. Coiled wire 182 can be formed from one or more wires that form mechanical treatment portion 160, and thus coiled wire 182 may be manufactured as one piece as mechanical treatment portion 160 or may be mechanically linked to mechanical treatment portion 160 as discussed above. In some embodiments coiled wire 182 is more flexible than body 100. In some embodiments coiled wire 182 is configured to bend or collapse into a bent configuration upon actuation of control element 120 and to transmit rotational torque to the mechanical treatment portion 160 in the bent configuration when at least a portion of the actuator control 200 is rotated.
  • FIGS. 14A-14B show cross-sections of parts of an embodiment of endovascular device 1 that is similar to the embodiment of FIGS. 13A-13C. This embodiment differs from the above-described embodiment in how selectively bendable portion 110 is actuated. While the embodiment in FIGS. 13A-C illustrate actuation of selectively bendable portion 110 by activation tube 180, the embodiment in FIGS. 14A-B illustrate actuation of selectively bendable portion 110 by proximal portion 170In this embodiment, similarly to FIGs. 13A-C, deployment of mechanical treatment portion 160 requires proximal movement of activation tube 180 followed by actuation of control element 120.
  • FIGS. 15A-15B show cross-sections of parts of an embodiment of endovascular device 1 that is similar to the embodiment of FIGS. 2-3.
  • This embodiment differs from the above-described embodiment because it includes a barrier 186 placed on body 100 between mechanical treatment portion 160 and selectively bendable portion 110.
  • Barrier 186 functions to provide a physical boundary between mechanical treatment portion 160 and selectively bendable portion 110 (may also be referred to as a stopper).
  • barrier 186 is an element that is fixed to body 100.
  • Exemplary barriers 186 which may be used include, for example but not limited to, a bead and a plug. Suitable means for fixing barrier 186 to body 100 include, but are not limited to, welding, soldering, brazing, using adhesives, and mechanical connections.
  • the selectively bendable portion 110 may comprise a pre-shaped tip 184 that extends forward (distally) from barrier 186.
  • Tip 184 is able to be pre-shaped before use to improve navigation of endovascular device 1.
  • Tip 184 can be constructed from any suitable flexible material, such as metal or plastic material (e.g., shape memory material).
  • Tip 184 is designed to be shaped manually by the user of endovascular device 1, e.g., by hand, prior to insertion into a patient’s body. Tip 184 cannot be actuated once endovascular device 1 has been inserted into the patient. While this type of arrangement is less controllable than selectively bendable portion 110, it may provide additional navigation benefits in specific circumstances.
  • Advantages of the embodiments and methods discussed above include providing a single, integrated endovascular device 1 that can smoothly and quickly navigate to a treatment site and can also provide mechanical treatment at the treatment site. This allows for reduced treatment time because only a single device needs to be used, and also reduces potential for error because it reduces the number of devices that need to be inserted in the patient.
  • an endovascular device includes a body comprising: a selectively bendable portion; a mechanical treatment portion; and a proximal portion; a control element disposed inside at least a portion of the body, the control element fixed to a portion of the selectively bendable portion or of the mechanical treatment portion and configured to slide with respect to the body; and an activation tube disposed around at least part of the body and configured to slide with respect to the body, wherein the activation tube is configured to slide to surround at least part of the mechanical treatment portion.
  • an endovascular device includes a body comprising: a selectively bendable portion; a mechanical treatment portion; and a proximal portion; a control element disposed inside at least a portion of the body, the control element fixed to a portion of the selectively bendable portion and configured to slide with respect to the body, wherein movement of the control element is configured to selectively bend the selectively bendable portion; and a second control element disposed inside at least a portion of the body, the second control element fixed to a portion of the mechanical treatment portion and configured to slide with respect to the body, wherein movement of the second control element in a proximal direction is configured to cause an axial compression of the mechanical treatment portion.
  • an endovascular device includes a body comprising: a selectively bendable portion capable of navigating the body of the endovascular device to a target region of a blood vessel; and a mechanical treatment portion capable of performing a mechanical treatment at the target region of the blood vessel.
  • the endovascular device of any of the preceding examples further comprising a plug disposed at a distal portion of the body, wherein the plug has a non-traumatic tip configured to be inserted into the blood vessel.
  • the endovascular device of any of the preceding examples further comprising a washer disposed between the plug and at least a portion of the body, the washer fixed with respect to the body.
  • Example 3E The endovascular device of any of the preceding examples, wherein movement of the proximal portion is configured to selectively bend the selectively bendable portion.
  • the endovascular device of any one of any of the preceding examples further comprising a second control element disposed inside at least a portion of the body, the control element fixed to a portion of the mechanical treatment portion.
  • the mechanical treatment portion comprises a mesh, wherein the mesh is configured to expand beyond an outer diameter of at least part of the body.
  • the tube comprises a plurality of slots.
  • the endovascular device of any one of any of the preceding examples further comprising at least one barrier.
  • the barrier is positioned between the selectively bendable portion and the mechanical treatment portion.
  • Example 16 The endovascular device of any of the preceding examples, wherein the radiopaque element is provided in at least one of the selectively bendable portion, the proximal end of the mechanical treatment portion, the distal end of the mechanical treatment portion, and the distal end of activation tube.
  • the endovascular device of any of the preceding examples further comprising a catheter disposed around at least a portion of the activation tube.
  • the catheter is disposed around at least a portion of the body (e.g., replaces activation tube).
  • the catheter comprises a microcatheter.
  • the catheter comprises an aspiration catheter.
  • the endovascular device comprises a control element for controlling a pump of the aspiration catheter such that aspiration through the aspiration catheter, and retraction of the activation tube occur in a synchronized manner.
  • a method of using an endovascular device comprises inserting a distal end of a body of the endovascular device into a blood vessel; navigating the body of the endovascular device to a target region of the blood vessel; and performing a mechanical treatment at the target region using a mechanical treatment portion of the body of the endovascular device.
  • Example 22 The method of using an endovascular device of any of the preceding examples, further comprising: retracting an activation tube slidably disposed around the body to expose the mechanical treatment portion before deploying the mechanical treatment portion.

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Abstract

Un dispositif endovasculaire pour le traitement mécanique d'un vaisseau sanguin comprend un corps ayant une partie pliable sélectivement, une partie de traitement mécanique et une partie proximale. Le dispositif endovasculaire comprend également un tube d'activation disposé coulissant autour du corps. Le tube d'activation peut coulisser de façon à recouvrir ou découvrir la partie de traitement mécanique. La partie pliable sélectivement peut être actionnée mécaniquement par l'intermédiaire d'une commande d'actionneur disposée au niveau de la partie proximale. La partie pliable sélectivement peut être actionnée pour améliorer la navigation du dispositif endovasculaire à travers des parties incurvées ou torsadées de vaisseaux sanguins. La partie de traitement mécanique peut être déployée d'un état rétracté à un état déployé afin d'appliquer un traitement mécanique.
PCT/IB2024/057193 2023-07-25 2024-07-25 Dispositif à maillage endovasculaire guidable et ses applications Pending WO2025022336A1 (fr)

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US202363528773P 2023-07-25 2023-07-25
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US202363529197P 2023-07-27 2023-07-27
US63/529,197 2023-07-27
US202363533276P 2023-08-17 2023-08-17
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Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2014139845A1 (fr) * 2013-03-14 2014-09-18 Neuravi Limited Dispositif de retrait d'un caillot occlusif dans un vaisseau sanguin
US20140343585A1 (en) * 2012-01-17 2014-11-20 Perflow Medical Ltd. Method and apparatus for occlusion removal
WO2018098045A1 (fr) * 2016-11-23 2018-05-31 Microvention, Inc. Système d'élimination d'obstruction
US20190224457A1 (en) * 2016-09-29 2019-07-25 Rapid Medical Ltd. Rotationally torquable endovascular device with actuatable working end
KR20200076406A (ko) * 2018-12-19 2020-06-29 서울대학교병원 스톤 바스켓

Patent Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20140343585A1 (en) * 2012-01-17 2014-11-20 Perflow Medical Ltd. Method and apparatus for occlusion removal
WO2014139845A1 (fr) * 2013-03-14 2014-09-18 Neuravi Limited Dispositif de retrait d'un caillot occlusif dans un vaisseau sanguin
US20190224457A1 (en) * 2016-09-29 2019-07-25 Rapid Medical Ltd. Rotationally torquable endovascular device with actuatable working end
WO2018098045A1 (fr) * 2016-11-23 2018-05-31 Microvention, Inc. Système d'élimination d'obstruction
KR20200076406A (ko) * 2018-12-19 2020-06-29 서울대학교병원 스톤 바스켓

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