WO2024059572A1 - Dispositifs de traitement vasculaire ainsi que systèmes associés et méthodes d'utilisation - Google Patents

Dispositifs de traitement vasculaire ainsi que systèmes associés et méthodes d'utilisation Download PDF

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Publication number
WO2024059572A1
WO2024059572A1 PCT/US2023/073987 US2023073987W WO2024059572A1 WO 2024059572 A1 WO2024059572 A1 WO 2024059572A1 US 2023073987 W US2023073987 W US 2023073987W WO 2024059572 A1 WO2024059572 A1 WO 2024059572A1
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Prior art keywords
cross
artery
expanded
lumen
wall
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PCT/US2023/073987
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English (en)
Inventor
Hanson S. Gifford Iii
Mary Louise FOX
Katrina Marie MARCELO
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The Foundry, Llc
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Publication of WO2024059572A1 publication Critical patent/WO2024059572A1/fr

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/82—Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/86—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure
    • A61F2/90—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61D—VETERINARY INSTRUMENTS, IMPLEMENTS, TOOLS, OR METHODS
    • A61D1/00—Surgical instruments for veterinary use
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/04—Hollow or tubular parts of organs, e.g. bladders, tracheae, bronchi or bile ducts
    • A61F2/06—Blood vessels
    • A61F2/07—Stent-grafts
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/04—Hollow or tubular parts of organs, e.g. bladders, tracheae, bronchi or bile ducts
    • A61F2/06—Blood vessels
    • A61F2002/068—Modifying the blood flow model, e.g. by diffuser or deflector
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2220/00—Fixations or connections for prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2220/0025—Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements
    • A61F2220/0091—Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements connected by a hinged linkage mechanism, e.g. of the single-bar or multi-bar linkage type
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2230/00—Geometry of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2230/0002—Two-dimensional shapes, e.g. cross-sections
    • A61F2230/0004—Rounded shapes, e.g. with rounded corners
    • A61F2230/0008—Rounded shapes, e.g. with rounded corners elliptical or oval
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2230/00—Geometry of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2230/0002—Two-dimensional shapes, e.g. cross-sections
    • A61F2230/0004—Rounded shapes, e.g. with rounded corners
    • A61F2230/001—Figure-8-shaped, e.g. hourglass-shaped
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2230/00—Geometry of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2230/0002—Two-dimensional shapes, e.g. cross-sections
    • A61F2230/0017—Angular shapes
    • A61F2230/0023—Angular shapes triangular
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2250/00—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2250/0014—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof having different values of a given property or geometrical feature, e.g. mechanical property or material property, at different locations within the same prosthesis
    • A61F2250/0018—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof having different values of a given property or geometrical feature, e.g. mechanical property or material property, at different locations within the same prosthesis differing in elasticity, stiffness or compressibility
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2250/00—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2250/0014—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof having different values of a given property or geometrical feature, e.g. mechanical property or material property, at different locations within the same prosthesis
    • A61F2250/0029—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof having different values of a given property or geometrical feature, e.g. mechanical property or material property, at different locations within the same prosthesis differing in bending or flexure capacity
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2250/00—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2250/0014—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof having different values of a given property or geometrical feature, e.g. mechanical property or material property, at different locations within the same prosthesis
    • A61F2250/0036—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof having different values of a given property or geometrical feature, e.g. mechanical property or material property, at different locations within the same prosthesis differing in thickness
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2250/00—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2250/0014—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof having different values of a given property or geometrical feature, e.g. mechanical property or material property, at different locations within the same prosthesis
    • A61F2250/0037—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof having different values of a given property or geometrical feature, e.g. mechanical property or material property, at different locations within the same prosthesis differing in height or in length

Definitions

  • the present technology relates to devices for treating blood vessels and associated systems and methods of use.
  • the present technology is directed to devices for treating arteries.
  • Aortic and pulmonary artery elasticity are essential to the healthy function of the heart, lungs, and circulatory system.
  • healthy large arteries stretch and recoil with the pumping action of the heart, thus serving as elastic reservoirs that enable the arterial tree to undergo large volume changes with little change in pressure.
  • the aorta and some of the proximal large vessels store about 50% of the left ventncular stroke volume during systole. In diastole, the elastic forces of the aortic wall forward this 50% of the volume to the peripheral circulation, thus creating a nearly continuous peripheral blood flow.
  • This systolic-diastolic interplay represents the Windkessel function, which has an influence not only on the peripheral circulation but also on the heart, resulting in a reduction of left ventncular afterload and improvement in coronary blood flow and left ventricular relaxation.
  • the pulmonary arteries carry deoxygenated blood from the right side of the heart to the lungs to be oxygenated and then distributed to the rest of the body.
  • the normal pulmonary circulation is a low-pressure, high-compliance system.
  • the present technology is directed to devices for increasing vascular compliance and associated systems and methods.
  • the device comprises an expandable structure configured to be positioned within the lumen of a blood vessel, such as an artery', to influence the cross-sectional shape of the vessel wall during the cardiac cycle.
  • the expandable structure enables the blood vessel to move between a non-circular cross-sectional shape in diastole and a circular (or more circular) cross-sectional shape in systole.
  • the expandable structure enables an increase in the cross-sectional area of the blood vessel in response to systolic pressure, thereby providing increased compliance.
  • the expandable structures of the present technology may be particularly beneficial for treating vessel wall stiffness, including aortic stiffness and/or pulmonary artery stiffness.
  • the expandable structures of the present technology may be positioned within a substantially inelastic region of the blood vessel to restore and/or improve the Windkessel function of the blood vessel during the cardiac cycle. Even without any stretching of the vessel wall itself, the change in volume of the blood vessel enabled by the present technology provides significant compliance to the vascular system.
  • the subject technology is illustrated, for example, according to various aspects described below, including with reference to FIGS. 2A-39. Various examples of aspects of the subject technology are described as numbered clauses (1, 2, 3, etc.) for convenience. These are provided as examples and do not limit the subject technology.
  • a device for treating an artery, the artery having a circular cross-sectional shape comprising: an expandable, generally tubular mesh configured to be intravascularly positioned within a lumen of the artery at a treatment site, the mesh being transformable between a low-profile state for delivery to the treatment site and an expanded state in which the mesh has a non-circular cross-sectional shape, wherein the mesh is configured to expand into apposition with the arterial wall at the treatment site, thereby increasing the radius of curvature of opposing portions of the wall such that the wall assumes the non-circular cross-sectional shape of the mesh, wherein (a) under diastolic pressure, the mesh holds the arterial wall in the non-circular cross-sectional shape, (b) the mesh allows the wall to deform in response to systolic pressure such that the wall assumes a second cross-sectional shape in which a distance between the opposing portions of the wall increases relative to the distance when the wall is in the non-circular cross-sectional shape,
  • a cross-sectional area of the cross- sectional shape is defined by a major diameter and a minor diameter.
  • a sidewall of the mesh has generally straight portions connected by curved portions, and wherein the mesh preferentially flexes at the curved portions during systole such that the generally straight portions remain straight during systole.
  • the device when implanted within the arterial lumen, the device is configured to decrease systolic pressure and increase diastolic pressure.
  • the device when implanted within the arterial lumen, the device is configured to increase a compliance of the artery without substantially stretching the arterial wall.
  • a device for treating an artery, the artery having a generally circular cross-sectional shape comprising: a device configured to be intravascularly positioned within a lumen of the artery at a treatment site, the device being transformable between a low-profile state for delivery' to the treatment site and an expanded state after delivery, wherein the device is configured to expand into apposition with the arterial wall at the treatment site and change the cross-sectional shape of the artery' to decrease a cross- sectional area of the artery in diastole relative to a cross-sectional area of the artery in diastole without the device positioned therein, wherein the device elastically deforms under systolic pressure to allow an increase in the cross-sectional area of the artery, thereby increasing compliance of the artery.
  • the mesh comprises a generally tubular sidewall defining a lumen therethrough, wherein the sidewall comprises a plurality of strut sections and a plurality of bridge sections, wherein: (a) each of the strut sections extends circumferentially about the mesh and comprises a plurality of struts, and (b) each of the bridge sections extends between adjacent strut sections and comprises at least one bridge.
  • the artery is a portion of the aorta.
  • the device is configured to be positioned at a treatment site within at least one of a left common carotid artery, a right common carotid artery, and a brachiocephalic artery.
  • the device includes first and second radiopaque markers at distinct first and second locations along the mesh, and wherein the first and second locations represent portions of the mesh configured to be positioned at anterior and posterior positions, respectively, when the device is implanted.
  • all or a portion of the mesh includes an anti-proliferative coating.
  • the mesh comprises a stent cut from a tube of superelastic material such as Nitinol.
  • the mesh comprises a stent formed from stainless steel or cobalt-chromium wires which allow elastic deformation from a low-profile shape for delivery to an expanded shape after delivery.
  • a device for treating an artery, the artery having a circular cross-sectional shape comprising: an expandable mesh configured to be intravascularly positioned within a lumen of the artery at a treatment site, the mesh comprising a tubular sidewall transformable between a low-profile state for delivery to the treatment site and an expanded state in which the sidewall has (a) a non-circular cross-sectional shape, and (b) alternating first and second portions about its circumference, wherein each of the first portions have a first radius of curvature and each of the second portions have a second radius of curvature smaller than the first radius of curvature, wherein, when deployed with the arterial lumen, the arterial wall conforms to the shape of the mesh, and wherein the mesh has (a) a chronic outward force great enough to hold the arterial wall in the non-circular cross-sectional shape under diastolic pressure, and (b) a radial resistive force low enough such that, during systole, the forces applied to the
  • the sidewall comprises a plurality of strut sections and a plurality of bridge sections, wherein: (a) each of the strut sections extend circumferentially about the mesh and comprise a plurality of struts, and (b) each of the bridge sections extend between adjacent strut sections and comprise at least one bridge.
  • the device is configured to be positioned at a treatment site within at least one of a left common carotid artery, a right common carotid artery, and a brachiocephalic artery.
  • the device includes first and second radiopaque markers at distinct first and second locations along the mesh, and wherein the first and second locations represent portions of the mesh configured to be positioned at anterior and posterior positions, respectively, when the device is implanted.
  • the mesh is configured absorb energy transmitted by a pulse wave, thereby reducing stress on the arterial wall relative to a stress on the arterial wall without the mesh implanted within the artery.
  • a method for treating heart failure comprising: positioning a device within an artery. the device imparting a non-circular cross-sectional shape to that artery in diastole to reduce its cross-sectional area, wherein during systole, the force of blood pressure within that artery overcomes the shape change imparted by the device and allows the artery to assume a second, more circular cross-sectional shape with greater cross-sectional area, thereby increasing the compliance of the arterial system.
  • a method for treating an artery of a patient comprising: positioning a generally tubular mesh in apposition with the wall of the artery, the mesh having a non-circular cross-sectional shape, wherein during diastole, the mesh holds the artery in the non-circular shape; and during systole, the mesh allows the artery to be urged into a second cross-sectional shape in response to systolic pressure, wherein the second cross-sectional shape is generally more circular and has a greater cross-sectional area, thereby increasing a compliance of the artery.
  • a method for treating an artery of a patient comprising: positioning a generally tubular mesh in apposition with the wall of the artery, the mesh having (a) a non-circular cross-sectional shape, and (b) alternating first and second portions about its circumference, wherein each of the first portions have a first radius of curvature and each of the second portions have a second radius of curvature greater than the first radius of curvature, during diastole, holding the artery in the non-circular shape of the mesh while maintaining apposition between the arterial wall and the mesh; during systole, allowing the mesh to be urged into a second cross-sectional shape by the artery in response to systolic pressure, wherein the forces applied to the mesh by the arterial wall urge the first portions of a mesh sidewall away from one another and the second portions of the sidewall towards one another; and increasing a compliance of the artery.
  • intravascularly positioning a mesh includes intravascularly positioning the mesh within the ascending aorta.
  • intravascularly positioning a mesh includes intravascularly positioning the mesh within the thoracic aorta.
  • intravascularly positioning a mesh includes intravascularly positioning the mesh within the abdominal aorta.
  • intravascularly positioning a mesh includes intravascularly positioning the mesh within an iliac artery.
  • intravascularly positioning a mesh includes intravascularly positioning the mesh within at least one of a left common carotid artery, a right common carotid artery at a treatment site.
  • positioning the mesh in apposition with the wall of the artery includes withdrawing a sheath to expose the mesh to allow the mesh to self-expand.
  • the mesh is a first mesh
  • the first mesh is intravascularly positioned at a first arterial location
  • the method further comprises intravascularly positioning a second mesh at a second arterial location different than the first arterial location.
  • the method of any one of the preceding Clauses further comprising increasing a diastolic pressure of the patient.
  • a device for treating an artery of a human patient comprising: an expandable structure configured to be intravascularly positioned within a lumen of the artery at a treatment site, wherein the artery has a substantially circular cross- sectional shape at the treatment site prior to deployment of the expandable structure therein, and wherein, when the expandable structure is in an expanded state and positioned in apposition with the arterial wall at the treatment site under diastolic pressure, the expandable structure forces the artery into a non-circular cross- sectional shape, wherein a cross-sectional area of the artery in the non-circular cross-sectional shape is less than a cross-sectional area of the artery in the substantially circular cross-sectional shape.
  • the expandable structure comprises a stent formed of a plurality of interconnected struts forming a plurality of cells therebetween.
  • a device for treating an artery comprising: an expandable structure configured to be intravascularly positioned wi thin a lumen of the artery at a treatment site, the expandable structure being generally tubular and movable between a low-profile state for delivery to the treatment site and an expanded state in which the expandable structure has a first cross-sectional shape, the first cross-sectional shape having a long dimension and a short dimension orthogonal to the long dimension, wherein the expandable structure comprises first portions at either side of the long dimension and second portions at either side of the short dimension, wherein — when the expandable structure is deployed within the arterial lumen, the arterial wall conforms to a shape of the expandable structure, and under diastolic pressure, the expandable structure assumes the first cross-sectional shape and forces the artery into the first cross-sectional shape, wherein a cross-sectional area of the artery in the first cross-sectional shape is less than a cross-sectional area of the artery prior to deployment of the expandable structure therein.
  • any one of Clauses 142 to 150 further comprising a first support proximate one of the first portions and a second support proximate the other one of the first portions, wherein the first and second supports are configured to engage an opposing portion of the sidewall and/or a support extending from the opposing portion of the sidewall to prevent the short dimension of the expandable structure from falling below a minimum distance.
  • a device for treating an artery of a human patient comprising: an expandable structure configured to be intravascularly positioned within a lumen of the artery at a treatment site, the expandable structure comprising a tubular sidewall defining a lumen therethrough, the sidewall forming a non-circular cross-sectional shape when the expandable structure is in a relaxed state, wherein the sidewall comprises: a long dimension and a short dimension orthogonal to the long dimension, first and second resilient bend regions at either side of the short dimension, and wherein, when the expandable structure is in the relaxed state, each of the first and second bend regions are biased towards the lumen such that each of the first and second bend regions exert a spring force that is generally constant when the sidewall is compressed along the long dimension.
  • Clause 160 The device of Clause 158 or Clause 159, further comprising third and fourth resilient bend regions at either side of the long dimension, wherein the third and fourth bend regions are concave towards the lumen.
  • the expandable structure comprises a stent formed of a plurality of interconnected struts forming a plurality of cells therebetween.
  • a device for treating an artery of a human patient comprising: an expandable structure configured to be intravascularly positioned wi thin a lumen of the artery at a treatment site, the expandable structure comprising a tubular sidewall defining a lumen therethrough, the sidewall forming a non-circular cross-sectional shape when the expandable structure is in a relaxed state, and wherein the cross- sectional shape comprises: a long dimension and a short dimension orthogonal to the long dimension, first, second, third, and fourth resilient bend regions spaced apart along a circumference of the cross-sectional shape, wherein the first and third bend regions are disposed at either side of the short dimension and the second and fourth bend regions are disposed at either side of the long dimension, the second and fourth bend regions forming respective second and fourth internal angles, and wherein, when the expandable structure is in the relaxed state, each of the first and third bend regions are preloaded such that, as the second and fourth angles increase, the first and third bend regions have an initial force resisting moving away from
  • the device is configured to be positioned at a treatment site within at least one of a left common carotid artery, a right common carotid artery, and a brachiocephalic artery.
  • a device for treating an artery of a human patient comprising: a first buffer configured to engage a first portion of a wall of the artery; a second buffer configured to engage a second portion of the wall of the artery opposite the first portion of the wall of the artery along a radial dimension of the artery ; and a spring comprising a first end at the first buffer and a second end at the second buffer such that the spring is configured to extend across a lumen of the artery when the first and second buffers engage the first and second portions of the wall of the artery, respectively, wherein, when the device is positioned within the lumen of the artery under diastolic pressure, the spring exerts a first force on the wall of the artery via the first and second buffers to cause the artery to assume a non-circular cross-sectional shape with a first cross-sectional area and, when the device is positioned within the lumen of the artery under systolic pressure, the systolic pressure causes the
  • each of the first, second, third, and fourth bends comprises a torsion spring.
  • a device for treating an artery of a human patient comprising: first and second buffers each comprising a first end portion, a second end portion opposite the first end portion along a longitudinal dimension of the respective buffer, and an intermediate portion therebetween; and a spring extending between the first and second buffers, the spring comprising: a bend, a first arm extending from the bend to the first buffer, and a second arm from the bend to the second buffer, wherein the second arm is disposed at an angle to the first arm, wherein the device is configured to be positioned within a lumen of the artery such that: the first and second buffers engage opposing portions of a wall of the artery, the bend of the spring is located within the lumen of the artery and radially spaced apart from the first and second buffers, as pressure increases within the lumen of the artery, the angle between the first and second arms decreases and the device applies a decreasing force to the wall of the artery , and as pressure decreases within the lumen of the artery, the angle between the first and second arms
  • a device for treating an artery of a human patient comprising: first and second elongate members each comprising a first end portion, a second end portion opposite the first end portion along a longitudinal dimension of the respective elongate member, and an intermediate portion therebetween; and a spring extending between the first and second elongate members, the spring comprising: a first bend at the intermediate portion of the first elongate member; a first arm extending from the first bend to a second bend located between the first and second elongate members; a second arm extending from the second bend to a third bend at the intermediate portion of the second elongate member such that the second arm is disposed at a first angle to the first arm; a third arm extending from the third bend to a fourth bend located between the first and second elongate members such that the third arm is disposed at a second angle to the second arm; and a fourth arm extending from the fourth bend to the first bend such that the fourth arm is disposed at a third angle to the third angle to the third angle
  • each of the second bend and the fourth bend comprises a torsion spring.
  • each of the first bend, the second bend, the third bend, and the fourth bend comprises a torsion spring.
  • each of the first and second elongate members is concave towards the spring.
  • a device for treating an artery of a human patient comprising: first and second elongate members each comprising a first end portion, a second end portion opposite the first end portion along a longitudinal dimension of the respective elongate member, and an intermediate portion therebetween; and a spring extending between the first and second elongate members, the spring comprising: a first end at the intermediate portion of the first elongate member; a first arm extending from the first end to a bend located between the first and second elongate members; a second arm extending from the bend to a second end at the intermediate portion of the second elongate member such that the second arm is disposed at an angle to the first arm; wherein the device is configured to be positioned within a lumen of the artery such that: the first and second elongate members engage opposing radial portions of a wall of the artery and the longitudinal dimension of each of the first and second elongate members is substantially aligned with a longitudinal dimension of the artery, the first and
  • each of the first and second elongate members is concave towards the spring.
  • the device defines one or more lumens, and wherein the lumens are configured to transport blood away from a space between the device and the wall of the artery while implanting the device.
  • the device includes a pump configured to remove blood from a space between the device and the wall of the artery.
  • a device for treating a blood vessel comprising: an expandable mesh configured to transition between a low-profile configuration for delivery to a treatment site within the blood vessel to an expanded configuration, the expandable mesh comprising a sidewall having an outer surface, an inner surface opposite the outer surface along a thickness of the sidewall, and a lumen defined by the inner surface, wherein the sidewall comprises first bend regions and second bend regions alternating about a circumference of the expandable mesh, wherein, when the expandable mesh is in the expanded state within the blood vessel, a wall of the blood vessel conforms to the outer surface of the expandable mesh and the expandable mesh is configured to transition between (i) an expanded diastolic state in which the first bend regions are convex towards the lumen and the second bend regions are concave towards the lumen such that a cross- sectional shape of the expandable mesh is substantially non-circular and has a first cross-sectional area, and (ii) an expanded systolic state in which the first bend regions are concave towards the
  • the sidewall carries one or more securing members configured to secure the sidewall to the wall of the blood vessel.
  • the device is configured to be positioned within a lumen of a blood vessel having an aneurysm such that the device extends across an opening to the aneurysm and prevents or limits blood flow from the lumen of the blood vessel into the aneurysm via the opening of the aneurysm.
  • FIGS. 1 A and IB are conceptual diagrams demonstrating arterial compliance during the cardiac cycle.
  • FIGS. 2A and 2B schematically depict a test setup for estimating the forces required to change the cross-sectional shape of an aorta from a circle to an ellipse.
  • FIG. 3 is a plot of major diameter versus force per linear inch obtained using the test setup of FIGS. 2A and 2B.
  • FIGS. 4 A and 4B schematically depict a test setup for estimating the forces exerted by an ovular stent on the surrounding aorta when the stent is compressed along its major axis.
  • FIG. 5 is a plot of major diameter versus force per linear inch obtained using the test setup of FIGS. 4A and 4B. In FIG. 5, the plot is shown superimposed on the plot of FIG. 3.
  • FIG. 6 is a plot of major diameter versus force per linear inch obtained using the test setup of FIGS. 2A and 2B. In FIG. 6, the plot is shown superimposed on the plot of FIG. 3.
  • FIG. 7A is a side view of a device configured in accordance with several embodiments of the present technology.
  • FIG. 7B is a cross-sectional end view of the device shown in FIG. 7A, taken along line 7B-7B.
  • FIG. 7C is an enlarged, isolated view of a strut of the device shown in FIG. 7A.
  • FIG. 7D is an enlarged, isolated view of a strut of the device shown in FIG. 7B.
  • FIGS. 8A-8C show the device of FIGS. 7A and 7B positioned within an artery during systole and diastole, respectively, in accordance with several embodiments of the present technology.
  • FIGS. 9A and 9B depict a method for forming a preloaded device in accordance with several embodiments of the present technology.
  • FIGS. 10A-10D depict a method for forming a preloaded device in accordance with several embodiments of the present technology.
  • FIGS. 11A and 11B depict a method for forming a preloaded device in accordance with several embodiments of the present technology.
  • FIGS. 12A-12F are end views of several devices of the present technology that have different cross-sectional shapes.
  • FIGS. 13 A and 13B are an end view and a side view, respectively, of a device configured in accordance with several embodiments of the present technology.
  • FIGS. 14A-14E are end views of several devices of the present technology having different supports.
  • FIG. 15 A is a side view of a device configured in accordance with several embodiments of the present technology.
  • FIG. 15B is an axial cross-sectional view of the device shown in FIG. 15 A taken along line 15B-15B.
  • FIG. 15C is an axial cross-sectional view of the device shown in FIG. 15A taken along line 15B-15B.
  • FIG. 15D is an axial cross-sectional view of the device shown in FIG. 15A taken along line 15B-15B.
  • FIG. 16 is an isometric view of a device configured in accordance with several embodiments of the present technology.
  • FIGS. 17A-17D show examples of different cross-sectional shapes for the device of FIG. 16.
  • FIG. 18A-18E show examples of different cross-sectional shapes for a non- circumferential device configured to apply force to two opposing walls of the aorta.
  • FIG. 19 is an isometric view of a non-circumferential device configured in accordance with several embodiments of the present technology.
  • FIGS. 20A-20C depict a portion of a device comprising a continuous wire configured in accordance with several embodiments of the present technology.
  • FIGS. 21A and 21B are cross-sectional shapes of a device at different blood pressures configured in accordance with several embodiments of the present technology.
  • FIGS. 22A and 22B show cross-sectional views of delivery' balloons configured in accordance with several embodiments of the present technology.
  • FIGS. 23. 1 and 23.2 are side and end views, respectively, of a device configured in accordance with several embodiments of the present technology'.
  • FIG. 23.3 is a side view of a device configured in accordance with several embodiments of the present technology.
  • FIGS. 23 A and 23B show side and axial cross-sectional views, respectively, of the device of FIGS. 23. 1 and 23.2 positioned within a blood vessel during diastole in accordance with several embodiments of the present technology.
  • FIGS. 23C and 23D show side and axial cross-sectional views, respectively, of the device of FIGS. 23.1 and 23.2 positioned within a blood vessel during systole in accordance with several embodiments of the present technology.
  • FIG. 24 is a plot of arterial pressure and spring force exerted by a device configured in accordance with several embodiments of the present technology on a surrounding artery over time.
  • FIGS. 25A and 25B show side cross-sectional views of a blood vessel with a device configured in accordance with several embodiments of the present technology positioned therein during systole immediately after deployment of the device and after a predetennined duration of time has passed after deployment of the device, respectively.
  • FIGS. 26A and 26B show side cross-sectional views of a blood vessel with a device configured in accordance with several embodiments of the present technology positioned therein during systole and diastole, respectively, in accordance with several embodiments of the present technology.
  • FIG. 27 shows an axial cross-sectional view of a blood vessel with a device configured in accordance with several embodiments of the present technology positioned therein.
  • FIG. 28 shows an axial cross-sectional view of a blood vessel with a device configured in accordance with several embodiments of the present technology positioned therein.
  • FIG. 29 illustrates the pulmonary vasculature.
  • FIG. 30A is a perspective view of a device configured in accordance with several embodiments of the present technology.
  • FIGS. 30B and 30C are axial cross-sectional views of the device of FIG. 30A, taken along lines 30B-30B and 30C-30C, respectively.
  • FIGS. 31 A and 31B are axial cross-sectional views of the device of FIGS. 30A-30C positioned within a blood vessel in an expanded diastolic state and an expanded systolic state, respectively, in accordance with several embodiments of the present technology.
  • FIG. 32 illustrates a forming assembly for setting a shape of the device of FIGS. 30A-30C.
  • FIG. 33 is an axial cross-sectional view of a device in an expanded diastolic state configured in accordance with several embodiments of the present technology.
  • FIG. 34 is an axial cross-sectional view of a device in an expanded diastolic state configured in accordance with several embodiments of the present technology.
  • FIG. 35 is an axial cross-sectional view of a device in an expanded diastolic state configured in accordance with several embodiments of the present technology.
  • FIG. 36 is an axial cross-sectional view of a device in an expanded diastolic state configured in accordance with several embodiments of the present technology.
  • FIGS. 37A-37C illustrate a method of deploying a device within a vessel in accordance with several embodiments of the present technology.
  • FIGS. 38A and 38B are axial cross-sectional views of a device in expanded diastolic and expanded systolic states, respectively, in accordance with several embodiments of the present technology.
  • FIG. 39 illustrates an example calculation of cross-sectional area of the intermediate portion of the device of FIGS. 30A-30C. DETAILED DESCRIPTION
  • the present technology relates to devices, systems, and methods for treating blood vessels.
  • the device comprises an expandable structure configured to be positioned within the lumen of an artery to influence the cross-sectional shape of the arterial wall during the cardiac cycle.
  • the expandable structure exerts an elongating force on the arterial wall sufficient to deform the arterial wall into a cross-sectional shape having a cross-sectional area that is less than the natural cross-sectional area of the artery during diastole.
  • the elongating force exerted by the expandable structure may be low enough such that under systolic pressure, the expandable structure allows the artery to deform into a more circular cross-sectional shape.
  • the inventors of the present application conducted an experiment to better understand the forces required for a device (such as a stent) positioned within the aortic lumen to change the cross-sectional shape of the aorta from substantially circular to elongated under systolic and diastolic pressures.
  • the aorta was approximated by a substantially cylindrical tube having a 1-inch diameter, which is similar to that of the aorta.
  • two pairs of rigid rods were positioned at opposing sides of the tube.
  • FIG. 2A two pairs of rigid rods were positioned at opposing sides of the tube.
  • the pairs of rods were pulled in opposite directions to simulate forces exerted on the aortic wall by a stent having an elongated cross-sectional shape positioned within the aorta. While the force was applied, water was pumped through the tube at two pressures — 88 mmHg (1.7 psi) to simulate diastolic pressure, and 120 mmHg (2.3 psi) to simulate systolic pressure. Force applied versus major diameter was recorded for both pressures as graphically depicted in FIG. 3.
  • the hypothesis was based on the premise that the greater the change in cross- sectional shape of the aorta between diastole and systole, the greater the change in cross-sectional area, and hence the greater the system compliance.
  • the aorta may take the ovular cross-sectional shape in diastole but may not be able to achieve a cross-sectional shape in systole that is sufficiently circular to provide the change in volume necessary to meaningfully improve compliance.
  • the aorta will take a circular cross-sectional shape in systole, but may not be able to achieve a cross-sectional shape in diastole that is ovular enough to provide the change in volume necessary to meaningfully improve compliance.
  • the optimal stent characteristics such that the stent would exhibit a lateral force of A (see FIG. 3B) at the given diameter and a force of B (see FIG. 3B) at the other given diameter.
  • the expandable structures of the present technology may have preloaded bend regions that exert a spring force that is generally constant when the expandable structure is compressed along the long dimension. Such a configuration enables the expandable structures of the present technology to follow curve D shown in FIG. 6, thereby providing a greater change in major diameter between diastole and systole and thus improved compliance.
  • FIG. 7 A is a side view of an expandable, generally tubular structure 100 configured in accordance with several embodiments of the present technology and having preloaded bend regions A and C.
  • FIGS. 8 A and 8B show' the device of FIGS. 7A and 7B positioned within an artery during systole and diastole, respectively, in accordance with several embodiments of the present technology.
  • the device 100 may be configured to be intravascularly delivered in a low-profile state to a treatment site within the lumen of an artery.
  • the device 100 may be expanded at the treatment site, thereby assuming a pre-set, non-circular shape.
  • the device may comprise an expandable structure configured to be intravascularly positioned within the artery to improve arterial compliance.
  • the artery may have a substantially circular cross-sectional shape at the treatment site prior to deployment of the expandable structure.
  • the expandable structure When the expandable structure is in an expanded state and positioned in apposition with the arterial wall at the treatment site under diastolic pressure, the expandable structure forces the artery into a non-circular cross-sectional shape, wherein a cross-sectional area of the artery' in the noncircular cross-sectional shape is less than a cross-sectional area of the artery in the substantially circular cross-sectional shape.
  • the device 100 can comprise a plurality of interconnected struts 104, each having a length, a width, and a thickness.
  • the thickness T can be measured as a dimension that is orthogonal to a central axis when the device 100 is considered in a tubular shape, or as a dimension that is orthogonal to a plane of the device 100 when represented as laid-flat.
  • the length can be measured as a distance extending between ends of a strut, where the ends connect to another structure.
  • the minor diameter of the expandable structure may be as small as possible to maximize the volume change as it becomes round.
  • the ends of the major diameter should not be sharp enough to cause damage to the arterial walls, and the minor diameter should be large enough that flow through the artery is not impeded and there is no chance of thrombosis or other occlusion of the artery. Therefore, the average minor diameter might be in the range of 6mm- 12mm, and more preferably in the range of 8-10mm.
  • the expandable structure may increase compliance by 25-50 mL.
  • the stent should be designed so that once deployed in the artery, an arterial pressure somewhere between diastolic and systolic pressures is enough to distend the artery from a flattened shape to a rounded shape. This will maximize the effect of the stent in increasing arterial compliance. Therefore with the stent in place, an aorta should preferably deform between an aortic pressure of 60 and 150 mmHg, and more preferably between 90 and 120 mmHg.
  • a stent configured to be positioned in a pulmonary artery should preferably deform between a pressure of 5 mmHg and 60 mmHg, and more preferably between 10 mmHg and 25 mmHg.
  • the typical stroke volume of the heart is 70 ml. Roughly 1/3 of that volume flows through the distal capillaries and organs in systole, leaving 2/3 or about 50 mL to flow during diastole.
  • a net change in cross-sectional area from diastole to systole would be about 3 cm 2 .
  • this would generate up to 10 mL of volume change, which is enough to make a significant impact on pulmonary hypertension by dramatically reducing the peak systolic pressure and increasing the diastolic pressure, which increases the flow through the lungs in diastole.
  • FIGS. 9A-1 IB depict a method for forming a preloaded device in accordance with several embodiments of the present technology.
  • a stent with pre-loaded bend regions can be formed from a plurality of stmt regions 902-908.
  • FIG. 9A shows an axial cross-sectional view of the plurality of strut regions 902-908.
  • the plurality of strut regions can comprise a strut region 902 corresponding to a bend region A, a stmt region 904 corresponding to a bend region B, a stmt region 906 corresponding to a bend region C, and/or a strut region 908 corresponding to a bend region D.
  • Each of the strut regions can include two ends and a bend region having a curvature therebetween.
  • strut region 902 can comprise a first end 1 and a second end 8 with bend region A therebetween.
  • the strut regions 902 and 906 can be oriented such that the bend regions A and C extend toward each other and the apices of strut region 902 extends away from the ends of strut region 906.
  • Strut regions 904 and 908 can be oriented such that the bend regions B and D extend away from each other and the ends of strut region 904 extend toward the ends of strut region 908.
  • a strut region can be heat treated to form the curvature of the strut region.
  • strut regions 902 and 906 have equivalent curvatures and strut regions 904 and 908 have equivalent curvatures.
  • the stent can be formed from the plurality of strut regions by joining adjacent apices of neighboring strut regions, such as the stent depicted in FIG. 9B.
  • end 1 can be joined to end 2
  • end 3 can be joined to end 4
  • end 5 can be joined to end 6, and/or end 7 can be joined to end 8.
  • the adjacent ends can be joined by laser- welding, resistancewelding, or another suitable method.
  • FIG. 9B shows an end view of an example stent 900 formed from a plurality of strut regions 902-908.
  • Each bend region can comprise an angle defining the degree of biasing of the bend region.
  • bend regions A and C can comprise an angle cp.
  • Bend regions B and D can comprise an angle 9.
  • a thickness of the struts in a strut region can be based at least in part on a corresponding angle of the strut region.
  • struts in strut regions 904 and 908 can be narrower and/or thinner than stmts in strut regions 902 and 906 because the angle q> of strut regions 904 and 908 is greater than the angle 0 of strut regions 902 and 906.
  • FIGS. 10A-10D depict a method for forming a preloaded device through heat treatment in accordance with several embodiments of the present technology.
  • FIG. 10A shows an end view of a stent 1000 with a first cross-sectional shape having a long dimension and a short dimension that is orthogonal to the long dimension.
  • the first cross-sectional shape can be set by a heat treatment process.
  • the stent 1000 can comprise strut regions with corresponding bend regions (e.g., bend region A, B, C, and/or D).
  • one or more portions of the stent 1000 can be heat treated to create preloaded bend regions. For example, as depicted in FIG.
  • the stent 1000’ can be attached to a heat treatment fixture 1002 such that a portion of the stent corresponding to bend region A 1004 is configured to be exposed to heat and a portion of the stent corresponding to bend region C 1006 is insulated.
  • a heat treatment process can be used to set a preloaded shape of bend region A.
  • FIG. 10C depicts the stent 1000” attached to the heat treatment fixture 1002 such that a portion of the stent corresponding to bend region A 1004 is insulated and a portion of the stent corresponding to bend region C 1006 is configured to be heat treated.
  • one or more portions of the stent can be heat treated in the same process step.
  • portions of the stent can be heat treated individually and/or sequentially.
  • the stent 1000”’ can comprise a cross-sectional shape that is different from first cross- sectional shape of the stent 1000 before heat treatment (see FIG. 10A).
  • the stent 1000 can comprise a generally ovular cross-sectional shape before heat treatment, as depicted in FIG. 10 A.
  • the stent 1000’” can comprise a generally hourglass cross-sectional shape with preloaded bend regions A and C after heat treatment, as depicted in FIG. 10D.
  • a stent can be configured to have one cross-sectional shape in an initial state and another cross-sectional shape in an inverted state.
  • FIG. 11A shows an end view of a stent 1100 in an initial state with an inner surface 1102, and an outer surface 1104.
  • the stent 1100 can comprise bend regions A, B, C, and D and an angle can be defined for each bend region.
  • FIG. 11 A shows the stent 1100 with preloaded bend regions B and D.
  • the stent 1100 can be inverted to bend the initial angles of each bend region by about 180 degrees and obtain a stent 1100 in an inverted state, as depicted in FIG. 11B.
  • the stent 1100 in the inverted state can comprise different preloaded bend regions from the stent 1100 in the initial state.
  • the stent 1100 in the inverted state can comprise preloaded bend regions A and C.
  • a cross-sectional shape of a stent as described herein can be defined by a perimeter of the stent.
  • a cross-sectional shape can have a long dimension and a short dimension orthogonal to the long dimension.
  • the stent can comprise first portions at either side of the long dimension and second portions at either side of the short dimension.
  • Each of the first portions and the second portions can have a radius of curvature.
  • a radius of curvature of one first portion is the same as a radius of curvature of the other first portion.
  • a radius of curvature of one second portion can be the same as a radius of curvature of the other second portion.
  • FIGS. 12A-12F show end views of several devices of the present technology with different cross-sectional shapes.
  • FIG. 12A depicts an end view of a stent 1200 with a perimeter 1202 that defines a generally ovular cross-sectional shape with a long dimension 1204 and a short dimension 1206.
  • the stent 1200 can comprise first portions 1208a and 1208b that are generally parallel to a long dimension of the stent and second portions 1210a and 1210b.
  • First portions 1208a and 1208b can each be connected to opposite ends of second portions 1210a and 1210b to form the generally ovular cross-sectional shape.
  • first portions 1208a and 1208b can comprise preloaded bend regions that are biased toward a lumen of the stent (see FIG. 12B).
  • the preloaded bend regions can be convex towards the lumen according to some aspects of the present technology.
  • the preloaded bend regions of first portions 1208a and 1208b are concave to the lumen, as shown in FIG. 12D.
  • a radius of curvature of one or more portions can be adjusted based on a desired cross-sectional shape of a stent. For example, FIG.
  • first portions 1208a and 1208b and second portions 1210a and 1210b can have preloaded bend regions biased towards the lumen of the stent 1200.
  • second portions 1210a and 1210b can have preloaded bend regions biased towards the lumen of the stent 1200 and first portions 1208a and 1208b can have preloaded bend regions biased away from the lumen of the stent 1200 (see FIG. 12F).
  • a stent 1300 can be configured to include one or more torsion springs to facilitate a change in cross-sectional shape of the stent 1300 in response to a change in blood pressure, as depicted in FIGS. 13A and 13B.
  • a torsion spring 1304 can have at least end portion 1306 positioned proximate to a first portion and/or a second portion of the stent 1300.
  • torsion springs 1304 are positioned proximate to the first portions of the stent 1300 corresponding to bend regions B and D in FIG. 13 A.
  • an intermediate portion 1308 of the torsion spring 1304 can be configured to receive a force when an arterial wall exerts a force on the stent 1300 during systole.
  • the force can be transferred from the intermediate portion 1308 to the end portion 1306 and the end portion 1306 can be configured to apply the force to a portion of the stent 1300 to facilitate a change in cross-sectional shape of the stent 1300 in response to the force exerted by the arterial wall.
  • the torsion springs 1304 proximate to bend regions B and D in FIG. 13A can facilitate second portions moving away from one another along a short dimension of the stent during systole.
  • Torsion springs 1304 can be positioned along a length of a stent 1300 as depicted in FIG. 13B.
  • a stent in accordance with several embodiments of the present technology can include one or more supports within a lumen of the stent.
  • FIG. 14A shows an end view of a stent 1400 with a first support 1402a proximate to one first portion of the stent corresponding to bend region A and a second support 1402b proximate to another first portion of the stent corresponding to bend region C.
  • a first support 1402a can be configured to engage a second support 1402b to prevent a short dimension of the stent 1400 from decreasing below a minimum distance.
  • FIG. 14A shows an end view of a stent 1400 with a first support 1402a proximate to one first portion of the stent corresponding to bend region A and a second support 1402b proximate to another first portion of the stent corresponding to bend region C.
  • a first support 1402a can be configured to engage a second support 1402b to prevent a short dimension of the stent 1400
  • a stent can comprise first supports 1402a proximate one second portion of the stent corresponding to bend region D and a second support 1402b proximate another second portion of the stent corresponding to bend region B.
  • the first and second supports 1402a and 1402b can be configured to extend into the lumen of the stent 1400.
  • a stent 1400 can comprise supports 1402a and 1402b proximate first portions of the stent and supports 1402c and 1402d proximate second portions of the stent, as shown in FIG. 14C.
  • first and second supports 1402a and 1402b can comprise a first end portion attached to the stent and a second end portion spaced apart from an opposing portion of the stent, as depicted in FIG. 14D.
  • FIG. 14E shows an axial cross-sectional view of a stent 1400 with C- shaped first and second supports 1402a and 1402b positioned proximate to second portions of the stent 1400.
  • the first and second supports 1402a and 1402b can include a projection 1404 positioned at an apex of the support configured to attach to the stent 1400.
  • the projection 1404 can permit a radius of curvature of bend regions B and D of the stent 1400 to increase in response to forces exerted by the arterial wall, while the first and second supports 1402a and 1402b prevent a short dimension of the stent from decreasing below a minimum distance.
  • a stent 1500 can comprise end portions 15B and 15D with one cross-sectional shape and an intermediate portion 15C with another cross-sectional shape.
  • the end portions can compnse a generally ovular cross-sectional shape while the intermediate portion can comprise a generally hourglass cross-sectional shape.
  • one or more portions of a stent can comprise one cross-sectional shape and one or more remaining portions can comprise another cross-sectional shape.
  • all portions of a stent can comprise the same cross-sectional shape and/or all portions of a stent can comprise different cross-sectional shapes.
  • FIG. 16 shows a device comprising an expandable structure 1600 having a low- profile state for delivery to a treatment site within an artery and/or an expanded, deployed.
  • the expandable structure 1600 can comprise a first end portion 1600a, a second end portion 1 00b, an intermediate portion between the first and second end portions 1600a, 1600b, and a length extending between the first and second end portions 1600a, 1600b along a longitudinal axis L of the expandable structure 1600.
  • the expandable structure 1600 has a non-circular cross-sectional shape when at rest in an unconstrained configuration.
  • the expandable structure 1600 can comprise a plurality of strut regions 1602 (only one labeled) extending circumferentially about the expandable structure 1600.
  • Each strut region 1602 can comprise a plurality of struts 1604 and a plurality of apices 1608.
  • the expandable structure 1600 comprises a plurality of bridge struts 1606, each extending between adjacent strut regions 1602.
  • a lumen 1612 of the expandable structure 1600 can be defined by the struts 1604.
  • the strut regions 1602 can comprise continuous circumferential rings as depicted in FIG. 16.
  • the struts 1604 of a stmt region 1602 can be connected at apices 1608 such that the struts 1604 are disposed in a zig-zag pattern to facilitate radial compression and expansion of the expandable structure 1600.
  • the stmts 1604 of a strut region 1602 can be connected in a pattern to enhance longitudinal flexibility of the expandable structure 1600.
  • the stent may have radiopaque markers positioned at the first end portion, at the second end portions, and/or therebetween, as shown in FIG. 16.
  • Radiopaque markers 1610 can be positioned on the expandable structure 1600 to facilitate visualization of the device during delivery.
  • the expandable structure 1600 can include radiopaque markers located on anterior and posterior portions of the stent to visualize the device with a direct anterior-posterior fluoroscopy view.
  • the expandable structure 1600 can have a non-circular cross-sectional shape.
  • the cross-sectional shape can have a long dimension 1702 and a short dimension 1704.
  • the short dimension 1704 can be between about 6 mm and 12 mm and the long dimension 1702 can be between about 15 mm and 40 mm.
  • the non-circular cross-sectional shape can have parallel major walls as shown in FIG. 17 A, slightly curved walls as shown in FIG. 17B, a generally oval shape as shown in FIG. 17C, a generally rhomboidal shape as shown in FIG. 17D, or a variation of these shapes.
  • the cross-sectional shape of the expandable structure 1600 can be configured such that a wall of an artery conforming to the cross-sectional shape of the expandable structure 1600 has the same cross-sectional shape as the expandable structure 1600.
  • the cross-sectional shape of the expandable structure 1600 can be configured to flatten a cross- sectional shape of an artery in an anterior-posterior direction, a lateral direction, and/or at an oblique angle.
  • An angle can be selected to minimize any impact on surrounding organs, structures, and/or branch vessels.
  • the angle varies over a length of the stent.
  • an end portion of the expandable structure 1600 comprises a generally circular cross-sectional shape and an intermediate portion of the stent between the end portions comprises a generally non-circular cross-sectional shape, as shown in FIG. 16.
  • a generally circular cross- sectional shape of end portions of the expandable structure 1600 can facilitate a smooth transition in cross-sectional shape between a portion of an artery conforming to the expandable structure 1600 and a portion of the artery without the expandable structure 1600.
  • a stiffness of the end portions of the expandable structure 1600 can be less than a stiffness of the intermediate portion of the expandable structure 1600 to facilitate a smooth transition between various portions of the artery.
  • the expandable structure 1600 can be configured to be positioned in apposition with an arterial wall at the treatment site. Under diastolic pressure, the expandable structure 1600 can cause the arterial wall to conform to the non-circular cross- sectional shape of the expandable structure 1600.
  • a cross-sectional area based on the non-circular cross-sectional shape of the artery can be less than a cross-sectional area of a circular cross- sectional shape of the artery .
  • the expandable structure 1600 can comprise a long dimension and a short dimension, and the expandable structure 1600 can comprise first portions at either end of the long dimension and second portions at either end of the short dimension.
  • the expandable structure 1600 When positioned within the artery' in the expanded state, the expandable structure 1600 can cause a radius of curvature of portions of the arterial wall proximate to the second portions of the expandable structure 1600 to increase.
  • the artery' By decreasing the cross-sectional area of the artery during diastole, the artery' can undergo a greater change in volume throughout a cardiac cycle. Reducing the cross- sectional area of the artery can thereby increase a compliance of the arterial system without stretching the arterial wall.
  • Such increase in compliance can be advantageous in arteries with reduced capacity to stretch (e.g., arteries with calcification).
  • the expandable structure 1600 and artery can assume a second cross-sectional shape and a second cross-sectional area.
  • the second cross- sectional shape is generally circular, and the second cross-sectional area is generally greater than a cross-sectional area of the first cross-sectional shape.
  • the change in cross-sectional shape can thereby absorb and reduce energy transmitted to the arterial system from the left ventricle during sy stolen.
  • a circumference of the artery and/or the expandable structure 1600 does not change during systole.
  • the expandable structure 1600 may be configured to assume a second cross-sectional shape different from a first cross-sectional shape at a predetermined pressure or range of pressures.
  • a device configured to be placed in an aorta can be configured to expand at an aortic pressure between diastolic and systolic pressure to increase the compliance of the aorta.
  • the expandable structure 1600 can be configured to deform between an aortic pressure of about 60 and about 150 mmHg. In some embodiments, the expandable structure 1600 can be configured to deform between an aortic pressure of about 90 and about 120 mmHg.
  • a device configured to be placed in a pulmonary artery can be configured to expand at a pulmonary artery' pressure between diastolic and systolic pressure to increase compliance of the pulmonary artery.
  • the expandable structure 1600 can be configured to deform between a pulmonary artery pressure of about 5 mmHg and about 60 mmHg. In some embodiments, the expandable structure 1600 can be configured to deform between a pulmonary artery' pressure of about 10 mmHg and about 25 mmHg.
  • the device is configured to be positioned in a portion of the aorta such as the ascending aorta, the aortic arch, the descending thoracic aorta, the abdominal aorta, or even the iliac arteries.
  • One or more devices can be deployed in multiple sections of the aorta. A size, shape, or taper of the device can be determined based on the portion of the aorta that the device is configured to be positioned within.
  • the device can be configured to be positioned within a portion of a pulmonary artery, such as the main pulmonary artery, the left pulmonary artery, the right pulmonary artery, etc.
  • the expandable structure 1600 of the device includes long struts to permit fluid flow to a branching artery such as a celiac artery, a renal artery, a mesenteric artery, a vertebral artery, a brachiocephalic artery, a carotid artery, and/or a subclavian artery.
  • a branching artery such as a celiac artery, a renal artery, a mesenteric artery, a vertebral artery, a brachiocephalic artery, a carotid artery, and/or a subclavian artery.
  • an expandable structure is configured to maintain a non-circular cross-sectional shape of an artery during diastole and expand to assume a circular cross-sectional shape during systole.
  • the expandable structure can have a non-circumferential design.
  • Alternative, non-circumferential cross-sectional shapes are shown in FIGS. 18A-18E.
  • the expandable structure can comprise a C- shaped cross-sectional shape 1800 and 1802, an hourglass cross-sectional shape 1804, a dog-bone cross-sectional shape 1806 and/or a cross-sectional shape comprised of multiple round strut regions 1808.
  • an expandable structure 1900 can have multiple curved sections 1902 configured to engage an arterial wall and one or more support struts 1904 configured to maintain a distance between the curved sections 1902, as shown in FIG. 19.
  • an expandable structure may be formed by laser-cutting a desired pattern into a tubular sheet of material.
  • the expandable structure may be initially formed as a flat sheet of material having a pattern of struts.
  • the struts may be formed by depositing a thin film on a flat surface in the desired pattern, or by laser-cutting a desired pattern into the flat sheet of material.
  • the flat pattern may then be curled up into a generally tube-like shape such that the longitudinal edges of the flat pattern are positioned adjacent to or in contact with one another.
  • the longitudinal edges can be joined (e.g., via laser welding) along all or a portion of their respective lengths.
  • the struts may be formed by depositing a thin film on the surface of a tubular frame in a desired pattern (e.g., via thin film deposition, vapor deposition, or combinations thereof.
  • an expandable structure can comprise strut regions 2000 formed of a single, continuous wire.
  • the strut regions 2000 can comprise a plurality of struts and a plurality of apices 2002 and 2004. Apices of one strut region 2000 can be connected to apices of another adjacent strut region 2000 (e.g., via laser welding) to form an expandable structure comprising multiple strut regions 2000.
  • an expandable structure may be configured to remain in direct contact with a portion of an arterial wall throughout a full cardiac cycle.
  • the expandable structure has resilient bend regions configured to expand under systolic blood pressure such that a cross-sectional area of the expandable structure changes throughout the expansion and compression of a circumference of the stent is minimized (see FIGS. 21A and 21B).
  • an expandable structure 2100 can have a first cross-sectional area associated with a first, non-circular cross-sectional shape of the expandable structure 2100 (see FIG.
  • an expandable structure 2100 can have a generally rhomboidal cross-sectional shape with resilient bend regions A at either side of a short dimension of the cross-sectional shape and/or either side of a long dimension of the cross-sectional shape.
  • Generally straight regions B can extend between neighboring bend regions A.
  • a stiffness of a straight and/or bend region can be based on a width, a thickness, a length, and/or a material property of struts of the region.
  • the generally straight regions B can be configured to be stiffer than the generally bent regions A by using wider, thicker, and/or shorter struts.
  • the generally bent regions A can be configured to be less stiff than the generally straight regions B by using, less wide, thinner, and/or longer stmts.
  • a material the struts are formed of can be selected based on a desired stiffness of the portions. Based on relative stiffnesses of the bent and straight regions A and B, the bent regions A can bend under systolic pressure in response to forces exerted on the expandable structure 2100 by the arterial wall.
  • a pattern of strut regions can be selected to prevent crack formation at the bent regions A.
  • a flexible delivery catheter and/or catheter system can be used to deliver the device to an artery.
  • the delivery catheter can be inserted into a patient’s femoral artery, carotid artery, and/or any other vessel suitable for percutaneous or vascular surgical techniques.
  • the delivery catheter can include a guidewire lumen and can be configured to be advanced over a guidewire.
  • the delivery catheter can have a tapered distal end to mitigate traumatic injury to a vessel from advancement of the catheter.
  • An expandable structure of a device of the present technology' can be compressed to assume a low-profile state by a cover sleeve.
  • the cover sleeve can be withdrawn to allow the expandable structure to expand from the low-profile state to the expanded state.
  • the cover sleeve can be advanced over the stent after having been previously withdrawn to compress the expandable structure to the low-profile state for repositioning and/or retrieval.
  • the device structure may be selfexpanding.
  • a self-expanding device can be formed of a shape memory' alloy such as nitinol, for example.
  • the device can be balloon-expandable and formed of a stainless- steel alloy, a cobalt-chromium alloy, and/or other similar materials.
  • Balloon catheters for expanding balloon-expandable devices typically have a circular volume w en inflated.
  • a balloon comprising an ovular inflated volume can comprise a plurality of tubular balloons 2202 joined by a balloon wall 2200 surrounding the plurality of tubular balloons 2202.
  • a balloon with an ovular inflated volume can comprise a balloon wall 2200 surrounding a plurality of chambers 2104 separated by chamber walls 2106.
  • a device in accordance with the present technology may be coated with an anti-proliferative and/or an anti-thrombotic coating to prevent thrombosis of the treatment site and/or a healing response that increases a stiffness of the artery being treated.
  • the device can include a coating, surface texture, and/or covering member disposed on a radially outer surface and/or a radially inner surface of the expandable structure.
  • a covering member comprising polyester fibers can be disposed on a radially outer surface of the expandable structure to promote ingrowth of arterial wall tissue into the expandable structure. Ingrow th can be advantageous to mitigate device fatigue and/or aneurysm formation in the arterial wall.
  • the device can be configured to promote ingrowth such that the device is incorporated into arterial and configured to reduce the stress experienced by the arterial wall throughout the cardiac cycle.
  • the device comprises a plurality of cells in the expandable structure to permit fluid flow in branch vessels.
  • a device can be sized to be slightly larger than an artery of the treatment site such that one or more portions of an arterial wall are in contact with the device for a desired portion of the cardiac cycle.
  • FIGS. 23.1 and 23.2 are side and end views, respectively, of a device 2300 configured to alter a cross-sectional shape of an artery in accordance with several embodiments of the present technology.
  • the device 2300 comprises a first buffer 2302, a second buffer 2304, and a spring 2306 positioned between the first and second buffers 2302, 2304.
  • the first and a second buffers 2302, 2304 are spaced apart along a height dimension of the device 2300 by a gap 2305, and the spring 2306 is positioned within the gap 2305.
  • the device 2300 is configured to be positioned within a lumen of an artery such that the first and second buffers 2302, 2304 are in contact with a wall of the artery.
  • the spring 2306 is configured to exert a force on the arterial wall via the first and second buffers 2302, 2304 to influence a cross-sectional shape of the artery and thereby improve arterial compliance.
  • the first and second buffers 2302, 2304 can be configured to distribute the forces exerted by the portions of the spring 2306 disposed proximate the arterial wall.
  • the first buffer 2302 can comprise a first end portion 2302a, a second end portion 2302b opposite the first end portion 2302a along a longitudinal dimension of the first buffer 2302, and an intermediate portion 2302c positioned between the first and second end portions 2302a, 2302b.
  • the second buffer 2304 comprises a first end portion 2304a, a second end portion 2304b opposite the first end portion 2304a along a longitudinal dimension of the second buffer 2304, and an intermediate portion 2304c positioned between the first and second end portions 2304a, 2304b.
  • Each of the first and second buffers 2302, 2304 can have a length that is greater than a width of the portion of the spring 2306 that is coupled to the respective buffer but no greater than a length of the section of the artery in which it is placed.
  • the length of the first buffer 2302 and/or the length of the second buffer 2304 can be no greater than about 1 cm, about 2 cm, about 3 cm, about 4 cm, about 5 cm, about 6 cm, or between about 1 cm and about 6 cm, between about 2 cm and about 5 cm, or between about 3 cm and about 4 cm.
  • the device 2300 may comprise multiple pairs of buffers (e.g., four buffers, six buffers, etc ).
  • one or both of the first end portions 2302a, 2304a and/or one or both of the second end portions 2302b, 2304b of the buffers can extend inwardly towards the gap 2305, which can prevent or limit the buffer(s) from causing stress concentrations in the arterial wall at the first end portion(s) and/or the second end portion(s).
  • first and/or second buffers 2302, 2304 can be sufficiently flexible such that one or both of the first end portions 2302a, 2304a and/or one or both of the second end portions 2302b, 2304b is configured to flex inwardly towards the gap 2305 to reduce or limit the stress imparted on the arterial wall at the first end portions 2302a, 2304a and/or the second end portions 2302b, 2304b.
  • one or both of the first end portions 2302a, 2304a and/or one or both of the second end portions 2302b, 2304b can be configured to flex inwardly when the spring is expanded and is applying a higher pressure to the vessel wall, as in diastole, and relax outwardly (towards the vessel wall) when the spring is compressed and is applying a lower pressure to the vessel wall, as in systole.
  • the first and/or second buffer 2302, 2304 can be curved along its width such that the respective buffer is concave towards the spring 2306 (and thus concave towards the arterial lumen when the device 2300 is positioned within the arterial lumen). Such concavity enables the buffer to smoothly distribute forces from the spring 2306 to the curved arterial wall without generating significant stress concentrations in the arterial wall.
  • the width of the first and/or second buffer 2302, 2304 can be sufficiently small, and/or the first and/or second buffer 2302, 2304 can be sufficiently flexible, to allow the artery to assume an elongated, non- circular cross-sectional shape without the edges of the buffer contacting or piercing the arterial wall.
  • the first and/or second buffer 2302, 2304 can have a width that is greater than a thickness of the portion of the spring 2306 coupled to the respective buffer.
  • the first and/or second buffer 2302, 2304 can have a width of about 1 mm, about 2 mm, about 3 mm, about 4 mm, or about 5 mm.
  • the first and/or second buffer 2302, 2304 can comprise a structure having a rigidity sufficient to efficiently transfer forces between the spring 2306 and the arterial wall but low enough to provide enough flexibility to prevent or limit damage to the arterial wall.
  • the first and/or second buffer 2302, 2304 comprises a woven, braided, and/or knitted material. Additionally or alternatively, the first and/or second buffer 2302, 2304 can comprise a laser-cut stent, a sheet of material, a wire, etc.
  • the first and/or second buffer 2302, 2304 can comprise a biocompatible material including, but not limited to, nitinol, stainless steel, cobalt chromium, platinum, nylon, polyurethane, polytetrafluoroethylene (PTFE), expanded polytetrafluoroethy lene EPTFE, and/or other suitable materials.
  • a biocompatible material including, but not limited to, nitinol, stainless steel, cobalt chromium, platinum, nylon, polyurethane, polytetrafluoroethylene (PTFE), expanded polytetrafluoroethy lene EPTFE, and/or other suitable materials.
  • the spring 2306 has a first end portion 2306a coupled to and disposed at the first buffer 2302 and a second end portion 2306b coupled to and disposed at the second buffer 2304.
  • the first end portion 2306a of the spring 2306 can be positioned at the intermediate portion 2302c of the first buffer 2302 and/or the second end portion 2306b of the spring 2306 can be positioned at the intermediate portion 2304c of the second buffer 2304.
  • the first end portion 2306a of the spring 2306 is positioned at the first end portion 2302a of the first buffer 2302 or at the second end portion 2302b of the first buffer 2302.
  • the second end portion 2306b of the spring 2306 is positioned at the first end portion 2304a of the second buffer 2304 or at the second end portion 2304b of the second buffer 2304.
  • FIGS. 23.1 and 23.2 depict the device 2300 including one spring 2306 any of the devices disclosed herein may include multiple springs 2306.
  • multiple springs 2306 may be positioned along the longitudinal dimension of the device 2300 such that each of the first and second buffers 2302, 2304 are coupled to multiple springs 2306.
  • the spring 2306 can comprise one or more bends.
  • the spring 2306 can comprise a quadrilateral having a first bend 2308a, a second bend 2308b, a third bend 2308c, and a fourth bend 2308d (collectively "bends 2308") disposed clockwise around a periphery of the spring 2306.
  • the first bend 2308a can be located at the first end portion 2306a of the spring 2306 (e.g., proximate and/or at the first buffer 2302) and the third bend 2308c can be located at the second end portion 2306b of the spring 2306 (e.g., proximate and/or at the second buffer 2304).
  • the second bend 2308b and the fourth bend 2308d can be positioned between the first bend 2308a and the third bend 2308c (e.g., between the first and second buffers 2302, 2304).
  • the first bend 2308a and the third bend 2308c are disposed at substantially the same location along a longitudinal dimension of the device 2300 with the second and fourth bends 2308b, 2308d on either side.
  • the second and fourth bends 2308b, 2308d can be disposed at substantially the same height.
  • the first and third bends 2308a, 2308c are offset from one another along the longitudinal dimension of the device 2300 and/or the second and fourth bends 2308b, 2308d are disposed at different heights.
  • the spring 2306 can comprise one or more arms extending between adjacent bends and forming the sides of the quadrilateral shape.
  • the spring 2306 can comprise a first arm 2310a extending from a first end at the first bend 2308a to a second end at the second bend 2308b, a second arm 2310b extending from a first end at the second bend 2308b to a second end at the third bend 2308c, a third arm 2310c extending from a first end at the third bend 2308c to a second end at the fourth bend 2308d, and a fourth arm 23 lOd extending from a first end at the fourth bend 2308d to a second end at the first bend 2308a (collectively "arms 2310").
  • the first arm 2310a can be disposed at a first angle 2312a to the second arm 2310b
  • the second arm 2310b can be disposed at a second angle 2312b to the third arm 2310c
  • the third arm 2310c can be disposed at a third angle 2312c to the fourth arm 2310d
  • the fourth arm 2310d can be disposed at a fourth angle 2312d to the first arm 2310a (collectively "angles 2312").
  • each of the arms 2310 can have substantially the same length. In some embodiments, two or more of the arms 2310 can have different lengths.
  • the first arm 2310a and the third arm 2310c can have substantially the same length and the second arm 2310b and the fourth arm 23 lOd can have substantially the same length, but the length of the first and third arms 2310a, 2310c may differ from the length of the second and fourth arms 2310b, 2310d such that the first and third bends 2308a, 2308c are offset from one another along the longitudinal dimension of the device 2300, which can advantageously prevent or limit the first and third bends 2308a, 2308c from contacting one another when the device 2300 is in a compressed configuration (e.g., during delivery through a catheter, etc.).
  • a distance between the first bend 2308a and the third bend 2308c along the height dimension of the device 2300 can define a height H of the spring 2306 and/or a distance between the second bend 2308b and the fourth bend 2308d along the longitudinal dimension of the device 2300 can define a width W of the spring 2306.
  • the height H of the spring 2306 can substantially correspond to and/or control the distance between the first and second buffers 2302, 2304 and thereby a height of the gap 2305.
  • One or more portions of the spring 2306 can have different thicknesses T.
  • the spring 2306 can have a thickness at each of its bends that is greater than a thickness along the rest of the spring 2306.
  • the spring 2306 can have a small thickness T relative to its width W and/or height H so that, when the device 2300 is positioned within an arterial lumen, the spring 2306 does not substantially disrupt blood flow through the arterial lumen.
  • each of the bends 2308 comprises a torsion spring, which provides a substantially constant torsional bending force at each of the bends 2308 as the spring 2306 deforms under increasing arterial pressure.
  • the substantially constant torsional strength of the spring 2306 over its range of motion allows for the spring force exerted by the spring 2306 on an arterial wall to advantageously decrease as pressure within the arterial lumen increases and the spring is compressed.
  • Each of the torsion springs can comprise one or more closed windings of a coil, and each of the bends can have the same or a different number of windings.
  • Any of the torsion springs can comprise one winding, tw o windings, three windings, four windings, five windings, six windings, seven windings, eight windings, nine windings, or ten windings.
  • the number of windings can be based on a desired change (or lack thereof) of the spring force over the range of motion of the torsion spring, with more windings providing a more constant spring force over the range of motion.
  • the windings of the torsion springs are wound in the same direction.
  • the spring 2306 may comprise a continuous torsion spring in which a single, continuous material (e.g., a wire, a sheet, etc.) is wound into a desired shape with the one or more torsion springs at the one or more bends 2308. Additionally or alternatively, the spring 2306 can comprise two or more discrete elements secured to one another.
  • fewer than all of the bends comprise a torsion spring.
  • the first bend 2308a and the third bend 2308c or only the second bend 2308b and the fourth bend 2308d may comprise torsion springs.
  • one or more of the bends 2308 comprises a spring other than a torsion spring (e g., a tension spring, a compression spring, etc.).
  • the device 2300 may include a spring 2306 having a single bend 2308 and only two arms 2310a, 2310b, each on either side of the bend 2308.
  • One of the arms 2310a can extend between the bend 2308 and the first buffer 2302, and the other arm 2310b can extend between the bend 2308 and the second buffer 2304.
  • the spring 2306 can include a single torsion spring located at the bend 2308 between the two arms 2310a, 2310b.
  • FIGS. 23A and 23B illustrate the device 2300 positioned within a lumen AL of an artery A at a lower pressure, such as diastole
  • FIGS. 23C and 23D illustrate the device 2300 positioned within the lumen AL of the artery A at a higher pressure, such as systole.
  • the first buffer 2302 can be spaced apart from the second buffer 2304 along a radial dimension of the arterial lumen AL such that the first and second buffers 2302, 2304 are positioned proximate to and/or in contact with opposing circumferential portions of the arterial wall AW.
  • the spring 2306 has a first end portion 2306a at the first buffer 2302 and a second end portion 2306b at the second buffer 2304. Accordingly, when the device 2300 is positioned within the arterial lumen AL, the spring 2306 can extend across the arterial lumen AL.
  • a normal vector to a broad plane within which the arms 2310 lie can be substantially perpendicular to the longitudinal dimension of the artery A.
  • a thickness T of the spring 2306 can be substantially perpendicular to the longitudinal dimension of the artery A.
  • the width W of the spring 2306 can be substantially parallel to and/or aligned with the longitudinal dimension of the artery A and/or the height H of the spring 2306 can be substantially perpendicular to the longitudinal dimension of the artery A.
  • the spring 2306 is configured to pivot when deployed within the arterial lumen AL, so that the spring is at a skewed angle relative to the longitudinal dimension of the artery and the arms 2310 are positioned closer to the arterial wall AW, leaving the arterial lumen AL more open centrally, which could facilitate passing other devices through the artery A and/or the device 2300.
  • the spring 2306 is configured to exert a force on the arterial wall AW via the first buffer 2302 and the second buffer 2304.
  • the spnng 2306 can be configured to exert a radially outwardly directed force on the arterial wall AW at opposing radial portions of the arterial wall AW to deform the artery A.
  • FIGS. 23A and 23B depict the artery A and device 2300 when the pressure within the arterial lumen AL is low and FIGS. 23 C and 23D depict the artery A and device 2300 when the pressure within the arterial lumen AL is high.
  • Low pressure can comprise diastolic pressure and/or a pressure that is higher than diastolic pressure but lower than systolic pressure.
  • High pressure can comprise systolic pressure and/or a pressure that is lower than systolic pressure but higher than diastolic pressure.
  • the spring 2306 is elongated along the height dimension of the device 2300 (e g., the radial dimension of the arterial lumen AL) with the first angle 2312a and the third angle 2312c being obtuse and the second angle 2312b and the fourth angle 2312d being acute.
  • the height H of the spring 2306 is greater than a natural diameter of the artery' A and the spring 2306 applies a radially outward force to the arterial wall AW that causes the artery A to assume an elongated shape with a major diameter MA and a minor diameter MI less than the major diameter MA.
  • a cross-sectional area of the arterial lumen AL in this elongated shape can be less than a natural cross-sectional area of the arterial lumen AL.
  • the first angle 2312a and the third angle 2312c decrease as the pressure increases within the arterial lumen AL and the second angle 2312b and the fourth angle 2312d increase as the pressure within the arterial lumen AL increases.
  • the height H of the of the spring 2306 decreases and the width W of the spring 2306 increases such that the radial distance between the first buffer 2302 and the second buffer 2304 decreases and the major diameter MA of the arterial wall AW decreases, causing the artery A assumes a more circular cross-sectional shape.
  • a cross-sectional area of the arterial lumen AL with the more circular cross- sectional shape is greater than a cross-sectional area of the arterial lumen AL with the elongated, less circular cross-sectional shape (FIG. 23B).
  • the increase in cross-sectional area from diastole to systole also increases the volume change from diastole to systole, thereby increasing the compliance of the artery A.
  • FIG. 24 is a plot of pressure within an arterial lumen AL over one cardiac cycle and the corresponding force exerted on the arterial wall AW by the device 2300 over time.
  • pressure within the arterial lumen AL increases from a lower pressure during diastole to a higher pressure during systole.
  • the spring force that the device 2300 exerts on the arterial wall AW is greater than the force exerted by the arterial wall AW on the device 2300, so the device 2300 forces the artery A into a non-circular, elongated cross-sectional shape.
  • the force exerted by the arterial wall AW on the device 2300 approaches and exceeds the spring force exerted by the device 2300 on the arterial wall AW such that the arterial wall AW causes the spring 2306 to deform.
  • the first and third angles 2312a, 2312c of the spring 2306 decrease and the second and fourth angles 2312b, 2312d increase so that the height H of the spring 2306 decreases, the width W of the spring 2306 increases, and the first and second buffers 2302, 2304 move radially towards one another.
  • the major axis MA of the artery A and the minor axis MI of the artery A approach one another in size and thus, the artery A assumes a more circular cross-sectional shape and the cross-sectional area of the arterial lumen AL increases.
  • the spring force exerted by the spring 2306 on the arterial wall AW is inversely related to the sine of half of the fourth angle 2312d between the first arm 2310a and the fourth arm 2310d, and thus, the spring force decreases as the fourth angle 2312d increases (e.g., as pressure increases in the arterial lumen AL and the first and second buffers 2302, 2304 move towards one another).
  • the height H of the spring 2306 and thereby the radial distance between the first and second buffers 2302, 2304 has a larger range from diastole to systole (e.g., in contrast to the ovular stent described above with respect to FIGS.
  • the spring force in systole is about 25% less than the spring force in diastole, about 33% less than the spring force in diastole, about 50% less than the spring force in diastole, about 75% less than the spring force in diastole, about 80% less than the spring force in diastole, between about 25% and about 75% less than the spring force in diastole, between about 30% and about 80% less than the spring force in diastole, or between about 30% and about 70% less than the spring force in diastole.
  • the radial distance between the first and second buffers 2302, 2304 can increase by about 4 mm from systole to diastole, about 5 mm from systole to diastole, about 6 mm from systole to diastole, about 7 mm from systole to diastole, about 8 mm from systole to diastole, about 9 mm from systole to diastole, about 10 mm from systole to diastole, between about 4 mm and about 10 mm from systole to diastole, between about 5 mm and about 9 mm from systole to diastole, or between about 6 mm and about 8 mm from systole to diastole.
  • a difference between the cross-sectional area of the artery A in diastole and the cross-sectional area of the artery A in systole can be about 1 cm 2 , about 2 cm 2 , about 3 cm 2 , about 4 cm 2 , about 5 cm 2 , between about 1 cm 2 and about 5 cm 2 , or between about 2 cm 2 and about 4 cm 2 .
  • FIGS. 25 A and 25B illustrate an example of a device 2500 comprising a tether 2503 configured to limit expansion of the device 2500 for a predetermined duration after deployment of the device 2500 within the lumen AL of the artery A.
  • FIGS. 25 A and 25B illustrate an example of a device 2500 comprising a tether 2503 configured to limit expansion of the device 2500 for a predetermined duration after deployment of the device 2500 within the lumen AL of the artery A.
  • the tether 2503 can comprise a first end 2503a at or proximate a first end portion 2506a of the spring 2506 and a second end 2503b at or proximate a second end portion 2506b of the spring 2506. Additionally or alternatively, the first and second ends 2503 a, 2503b of the tether 2503 can be connected to and located at the first and second buffers 2502, 2504, respectively.
  • the tether 2503 can be configured to bioerode after the predetermined duration after deployment has passed.
  • 25B illustrates the device 2500 once the tether 2503 has eroded, broken, and/or separated from the device 2500 such that the spring 2506 is able to push first and second buffers 2502, 2504 of the device 2500 further apart and to cyclically deform the arterial wall AW as described herein.
  • a temporary limitation on expansion of the device during the healing period can be provided by bioabsorbable elements strategically located at points on the spring 2506 to limit the expansion of the spring 2506.
  • Any of the devices disclosed herein can comprise one or more tethers similar to the tether 2503 shown and described with reference to FIGS. 25 A and 25B.
  • FIGS. 26A and 26B show an example of such a device 2600 positioned within a lumen AL of an artery A.
  • the device 2600 comprises a permanent tether 2603 configured to limit maximum expansion of the device 2600 to prevent the device 2600 from deforming a wall AW of the artery A so greatly that it becomes aneurysmal or damaged.
  • the tether 2603 can be slack.
  • low pressure e.g., diastole, etc.
  • the tether 2603 can be taut and/or can have less slack such that the tether 2603 limits a height H of the spring 2606 and thereby a maximum radial distance between first and second buffers 2602, 2604.
  • the tether 2603 can prevent the spring 2606 from expanding to such a great extent (e.g., with first and second buffers 2602, 2604 spaced far apart from one another, etc.) that the force that the arterial wall must exert to on the spring 2606 to compress the spring 2606 it is greater than the force generated by the arterial wall during systole.
  • a permanent limitation on expansion can be accomplished with stops or other motion limiters acting on the spring 2606.
  • any of the devices disclosed herein can comprise one or more tethers similar to the tether 2603 shown and described with reference to FIGS. 26A and 26B.
  • a device of the present technology may cause stress within the arterial wall by exerting forces on the arterial wall.
  • a device of the present technology can comprise a reinforcement material that is configured to reinforce the arterial wall and/or heal into the arterial wall.
  • the reinforcement material can prevent or limit stress concentrations from developing in the arterial wall and can reduce the risk of acute artenal rupture and/or arterial wall stretching as the artery acclimates to the cyclical shape changes caused by the device.
  • the reinforcement material can comprise a polymeric material, for example a woven or felted polyester, a porous expanded polytetrafluoroethylene (EPTFE), or other suitable material such as, but not limited to, vascular graft material.
  • the reinforcement material can be fixed to a first buffer and/or a second buffer of a device and/or may be positioned between a first buffer and/or a second buffer and an arterial wall.
  • FIGS. 27 and 28 are end views of example devices 2700, 2800 including such reinforcement 2701, 2801 and positioned within a lumen AL of an artery A.
  • the devices 2700, 2800 can include features similar to or the same as the features of any of the devices disclosed herein including, for example, the device 2300 show n in FIGS. 23A-23D.
  • each of the devices 2700, 2800 can comprise a first buffer 2702, 2802, a second buffer 2704, 2804 spaced apart from the first buffer 2702, 2802, and a spring 2706, 2806 extending between the first buffer 2702, 2802 and the second buffer 2704, 2804.
  • the reinforcement 2701, 2801 can be positioned between the first buffer 2702, 2802 and the arterial wall and/or the reinforcement 2701, 2801 can be positioned between the second buffer 2704, 2804 and the arterial wall.
  • the reinforcement 2701 can be circumferentially discontinuous as shown in FIG. 27, for example, or the reinforcement 2801 can be circumferentially continuous as shown in FIG. 28, for example.
  • the reinforcement 2701, 2801 can be secured to and/or monolithic with the first buffer 2702, 2082 and/or the second buffer 2704, 2804.
  • the reinforcement 2701, 2801 can be carried by a flexible stent configured to be positioned between the first buffer 2702, 2802 and/or the second buffer 2704, 2804 and the arterial wall.
  • a stent can hold the reinforcement 2701, 2801 gently against the arterial wall so that it can heal into the arterial wall and reinforce it, which can reduce the net stress experienced by the arterial wall and/or limit or prevent damage to the arterial wall as a result of repeated deformation of the arterial wall by the device 2700, 2800.
  • Such reinforcement may also prevent or limit stretching of the arterial wall over time in response to the increased circumferential stress applied to the arterial wall.
  • some devices of the present technology can have different, non-ovular cross-sectional shapes that enable the vessel to have a smaller cross- sectional area in the expanded diastolic state, and thereby a greater change in cross-sectional area from the expanded diastolic shape to the expanded systolic shape, without substantial stretching of the vessel wall (e.g., no more than a 10% increase in maximum cross-sectional dimension of the native vessel lumen).
  • the ovular devices disclosed herein are effective at improving vascular compliance, the lumens of such devices are relatively narrow in the expanded diastolic state (e.g., having a minor diameter no greater than 20% to 40% of the vessel lumen’s native cross- sectional dimension), which can limit blood flow. Moreover, the potential increase in force on the vessel wall caused by the ovular embodiments can impart significant stress on the vessel wall, although this can be ameliorated by configuring an ovular device heal to the wall of the vessel such that the device absorbs the stress.
  • the non-ovular devices disclosed herein are configured to reduce the cross-sectional area of the vessel during diastole while still providing a sufficiently large lumen for blood flow, and without substantially stretching and/or stressing the vessel wall.
  • the non-ovular devices reduce the amount of stress imparted on the vessel wall and reduce or eliminate disruption of blood flow.
  • the non-ovular devices may further be configured to adhere to the vessel wall, thereby further reducing stress on the vessel wall.
  • FIG. 30A shows an example non-ovular device 3000 in accordance with several embodiments of the present technology .
  • the device 3000 can comprise an expandable tubular structure having a low-profile configuration for delivery to a treatment site in a blood vessel lumen, and an expanded configuration for deployment within the vessel lumen.
  • the device 3000 is configured to assume a first expanded state during diastole (also referred to as the “expanded diastolic state”), shown in FIG. 30A, and a second expanded state during systole (also referred to as the “expanded systolic state”).
  • the device 3000 transforms between the first and second expanded states in response to changes in blood pressure to influence a cross-sectional shape of the vessel, thereby improving vascular compliance, as detailed herein.
  • the device 3000 can further be configured such that, when positioned within the vessel lumen in the expanded diastolic state, the vessel wall substantially conforms to the extenor of the device 3000 without the device 3000 causing substantial stretching of the vessel wall (e.g., no more than a 10% increase in maximum cross-sectional dimension of the native vessel lumen).
  • the device 3000 can include one or more adhering portions that enable efficient adherence of the device 3000 to the vessel wall, as described in greater detail below.
  • the device 3000 comprises a mesh structure that is configured to expand from the low-profile configuration for delivery (e.g., through a sheath, etc.) to the expanded configuration.
  • the mesh structure is configured to self-expand from the low-profile configuration to the expanded configuration.
  • the mesh structure may comprise a metal, such as a shape memory alloy and/or a superelastic material, such as nitinol, a cobalt chromium alloy, and others.
  • the mesh structure comprises a polymer rather than, or in addition to, a metal.
  • the device 3000 is nonporous.
  • the device 3000 can be self-expandable and/or plastically deformable from the low-profile configuration to the expanded configuration.
  • the device 3000 is expandable via mechanical actuation (which can be in addition to or in place of self-expansion), such as via inflation of a balloon and/or other expandable member (e.g., an expandable mesh, a stent, a spring, etc.) positioned within a lumen of the device 3000.
  • mechanical actuation which can be in addition to or in place of self-expansion
  • a balloon and/or other expandable member e.g., an expandable mesh, a stent, a spring, etc.
  • the device 3000 has a first end portion 3000a, a second end portion 3000b, a central longitudinal axis Lc extending between the first and second end portions 3000a, 3000b, and an intermediate portion 3000c extending between the first and second end portions 3000a, 3000b.
  • the central longitudinal axis Lc can extend through a centroid of a cross-sectional shape of the device 3000 when the device 3000 is in the expanded systolic state.
  • the device 3000 comprises a sidewall having an outer surface 3002 and an inner surface 3004 opposite the outer surface 3002 and defining a lumen 3006 of the device 3000.
  • the sidewall along at least the intermediate portion 3000c can have a non-circular, non-ovular cross-sectional shape comprising one or more regions that are convex towards the lumen 3006.
  • the intermediate portion 3000c of the device 3000 can comprise three first bend regions 3012 that are convex towards the device lumen 3006 and three second bend regions 3014 that are concave towards the lumen 3006.
  • Each of the first and second bend regions 3012, 3014 can extend longitudinally along the sidewall of the intermediate portion 3000c.
  • the first and second bend regions 3012, 3014 can alternate around a circumference of the device 3000.
  • the first bend regions 3012 are configured to flex radially outwardly in response to an increase in blood pressure to modify a cross-sectional shape of the vessel and increase a cross-sectional area of the vessel.
  • the intermediate portion 3000c of the device 3000 has a non-ovular and non-circular cross-sectional shape in the expanded diastolic state (best visualized in FIG. 30B).
  • the previously disclosed ovular devices have cross-sectional shapes in the expanded diastolic state comprising major and minor diameters defining two axes of symmetry
  • the cross-sectional shape of the intermediate portion 3000c shown in FIG. 30B has a single axis of symmetry and does not have major and minor axes.
  • the intermediate portion 3000c does not elongate portions of the vessel wall opposite one another about the circumference of the vessel. Instead, the intermediate portion 3000c causes the curvature of the vessel wall to be varied more consistently about the circumference of the vessel, which can place less stress on the vessel wall.
  • each of the first bend regions 3012 of the intermediate portion 3000c can include a first apex 3016.
  • the first apex 3016 can comprise a portion of the first bend region 3012 that is radially closest to the central longitudinal axis Lc of the device 3000.
  • the first apices 3016 of the first bend regions 3012 are radially spaced apart from the central longitudinal axis Lc by the same distance.
  • the first apices 3016 can be radially spaced apart from the central longitudinal axis Lc by different distances.
  • a size of the lumen 3006 of the intermediate portion 3000c can be based at least in part on the distances between the first apices 3016 and the central longitudinal axis Lc of the device 3000.
  • a circle Cl inscribed by the first apices 3016 can have a diameter dl sufficiently large such that the device 3000 does not substantially impede blood flow through the vessel.
  • the diameter dl of the circle C l can be between about 6 mm and about 12 mm or between about 8 mm and about 10 mm.
  • a luminal distance T defined between any two points facing one another on the inner surface 3004 of the device 3000 can be sufficiently large such that the device 3000 does not substantially impede or disrupt blood flow.
  • the luminal distance T can be at least 6 mm, at least 8 mm, or about 6 mm to 8 mm, for example. As shown in FIG. 30B, in some embodiments a minimum luminal distance T can occur between two points substantially corresponding to opposing ends 3014a, 3014b of a second bend region 3014.
  • the ends 3014a, 3014b of the second bend region 3014 can be defined by inflection points along the sidewall of the device 3000 where the sidewall transitions between being concave towards the lumen 3006 and being convex towards the lumen 3006.
  • the diameter dl and the minimum luminal distance T are sufficiently large to allow' blood to flow through the lumen 3006 of the device 3000
  • the total cross-sectional area of the lumen 3006 is also advantageous for the total cross-sectional area of the lumen 3006 to be sufficiently small in the expanded diastolic state such that a significant change in cross-sectional area occurs when the device 3000 deforms from the expanded diastolic state to the expanded systolic state.
  • the device 3000 In addition to having a reduced cross-sectional area in the expanded diastolic state while maintaining a sufficient lumen size for blood flow, it can be advantageous for the device 3000 to avoid substantially stretching the vessel wall during use.
  • the degree to which the device 3000 will stretch the vessel wall can be based at least in part on the geometry and dimensions of the second bend regions 3014.
  • Each of the second bend regions 3014 can include a second apex 3018 comprising a portion of the second bend region 3014 that is radially furthest from the central longitudinal axis Lc of the device 3000.
  • the second apices 3018 of the second bend regions 3014 are radially spaced apart from the central longitudinal axis Lc by the same distance.
  • the second apices 3018 can be radially spaced apart from the central longitudinal axis Lc by different distances. As shown in FIG.
  • a circle C2 circumscribing the device 3000 and extending through each of the second apices 3018 can have a diameter d2 that is less than, substantially equivalent to, or slightly greater than (e.g., no more than 10% greater than) the maximum cross-sectional dimension of the native vessel lumen. Accordingly, when the device 3000 is positioned within the vessel in the expanded diastolic state, the device 3000 may not substantially stretch the vessel wall. If the vessel is tapered over its length, the device 3000 may similarly be tapered to optimize its fit with the vessel.
  • the second diameter d2 can vary along a length of the device 3000.
  • the second diameter d2 can be substantially constant along a length of the device 3000.
  • a maximum cross-sectional dimension of the intermediate portion 3000c of the device 3000 can be less than, substantially equivalent to, or slightly greater than (e.g., no more than 10% larger than) the maximum cross-sectional dimension of the native vessel lumen such that the device 3000 does not substantially stretch the vessel wall.
  • the maximum cross-sectional dimension is substantially equivalent to the diameter d2 of the circle C2 circumscribed by the second bend regions 3014. In some variations, the maximum cross-sectional dimension of the intermediate portion 3000c is less than the diameter d2.
  • a device having an odd number of second bend regions 3014 that are equally spaced apart about the perimeter of the device may have a maximum cross- sectional dimension less than the diameter d2 of the circle C2 (e.g., because the second apices 3018 are not directly radially opposite one another)
  • a device having an even number of second bend regions 3014 that are equally spaced apart about the perimeter of the device may have a maximum cross-sectional dimension that is the same as the diameter d2 (e.g., because pairs of second apices of such a device may be positioned directly radially opposite one another).
  • the device embodiments with odd numbers of second bend regions 3014 equally spaced apart about the circumference of the device 3000 may impart less stress on the vessel wall when positioned in the vessel in the expanded diastolic state than corresponding embodiments with even numbers of second bend regions 3014 equally spaced apart about the circumference of the device 3000.
  • a radial distance between the central longitudinal axis Lc of the device 3000 and one of the second apices 3018 can be based on the number of second bend regions 3014 of the intermediate portion 3000c. For example, as the number of second bend regions 3014 increases, the radial distances between the central longitudinal axis Lc and the second apices 3018 can decrease. As but one example, the radial distance between the central longitudinal axis Lc and one of the second apices 3018 of a device 3000 comprising three second bend regions 3014 may be greater than the radial distance between the central longitudinal axis Lc and one of the second apices 3018 of a device 3000 comprising four second bend regions 3014.
  • the first bend regions 3012 can be configured to preferentially flex, bend, and/or otherwise deform such that the device 3000 transitions to the expanded systolic state in response to changes in pressure when the device 3000 is implanted within a vessel. Accordingly, the first bend regions 3012 can be flexible. In some embodiments, the first bend regions 3012 are more flexible than the second bend regions 3014. As previously noted, the device 3000 can comprise a mesh structure, and one or more properties or dimensions of the mesh structure can be selected based on an intended flexibility of the device 3000. In some embodiments, the mesh comprises a plurality of interconnected struts 3008 defining a plurality of openings 3010 therebetween.
  • the flexibility of some or all of the struts 3008 of the first bend regions 3012 can be enhanced by reducing a thickness and/or axial cross-sectional dimension of the struts 3008 relative to the struts 3008 in the second bend regions 3014.
  • the thickness of a strut 3008 can be measured along the thickness of the device 3000, e.g., a dimension that is orthogonal to the central longitudinal axis Lc of the device 3000 when the device 3000 is in a substantially tubular configuration and/or a dimension that is orthogonal to a plane of the device 3000 when the device 3000 is represented in a laid-flat configuration.
  • angles between the struts 3008 and/or the lengths of the struts 3008 of the first bend regions 3012 can be varied to enhance the flexibility of the first bend regions 3012 (e.g., relative to the second bend regions 3014).
  • the length of a strut 3008 is measured between opposite longitudinal ends of the strut 3008.
  • a strut 3008 can be longer and/or can extend along a serpentine, zig-zag, or other non-linear path from one end to the other to increase a flexibility of the strut 3008.
  • the struts 3008 can be heat-treated to be more flexible.
  • the first and second bend regions 3012, 3014 may undergo different heat treatments that selectively impart greater flexibility to the first bend regions 3012.
  • the first bend regions 3012 can be designed to facilitate cyclical flexing with reduced risk of fatigue failure.
  • the struts 3008 of the first bend regions 3012 can have shapes, dimensions, and/or other properties that ensure that strain experienced by the struts 3008 during normal use of the device 3000 does not exceed a predetermined strain threshold.
  • the struts 3008 of the first bend regions 3012 can be longer than the struts 3008 of the second bend regions 3014 so that strain that develops in the struts 3008 of the first bend regions 3012 does not exceed a predetermined threshold during normal use of the device.
  • the first bend regions 3012 may also be designed to reduce or minimize stress and strain on the vessel wall surrounding the device 3000. Vessel stress and/or strain may be reduced or minimized by spreading an area of significant flexing over the majority of the first bend regions 3012.
  • the effectiveness of the device 3000 in increasing vessel compliance may be enhanced if the device 3000 is configured to transition more completely from the non-circular and non-ovular cross-sectional shape in the expanded diastolic state to a more completely round cross- sectional shape in response to a certain predetermined pressure within the vessel lumen, rather than gradually changing shape in response to gradually increasing pressure.
  • the first bend regions 3012 can be configured to transition from convex towards the lumen 3006 to a corresponding shape in which the first bend regions 3012 are concave towards the lumen 3006 at a certain predetermined pressure within the vessel lumen, causing the device 3000 to assume a relatively round overall cross-sectional shape.
  • certain regions of the device 3000 can have more bending flexibility than others.
  • transition regions between the first bend regions 3102 and the second bend regions 3014 can have a greater bending flexibility to facilitate the transition of the first bend regions 3012 from convex to concave towards the lumen 3006.
  • the first bend region 3012 can have a sufficiently high circumferential and longitudinal stiffness, so that the first bend regions 3012 preferentially assume a convex or a concave shape, rather than an intermediate flat shape.
  • the first bend regions 3012 may tend to quickly change from convex to concave, rather than flattening, in response to changes in pressure in order to maintain their lengths.
  • the cross-sectional shape of the device 3000 at the first and second end portions 3000a, 3000b can be different than the cross-sectional shape of the intermediate portion 3000c.
  • the cross-sectional shape of the device 3000 at the first and second end portions 3000a, 3000b can be substantially circular in both the expanded diastolic and expanded systolic states.
  • the circular cross-sectional shape of the first and second end portions 3000a, 3000b can enable the first and second end portions 3000a, 3000b to engage the vessel wall in a manner that prevents or limits motion of the device 3000 relative to the vessel.
  • the first end portion 3000a and/or the second end portion 3000b of the device 3000 has a diameter d3 less than, substantially equivalent to, or slightly larger than (e.g., no more than 10% larger than) a maximum cross-sectional dimension of the native vessel lumen that the device 3000 is configured to be positioned within.
  • a diameter d3 less than, substantially equivalent to, or slightly larger than (e.g., no more than 10% larger than) a maximum cross-sectional dimension of the native vessel lumen that the device 3000 is configured to be positioned within.
  • the cross-sectional shape and diameter of the first and second end portions 3000a, 3000b can be configured to prevent or limit motion of the device 3000 relative to the vessel at the first and second end portions 3000a, 3000b, and thereby limit the stress imparted on the vessel by the device 3000. Additionally or alternatively, the cross-sectional shape and diameter of the first and second end portions 3000a, 3000b can be configured to prevent or limit blood from flowing between the sidewall of the device 3000 and the vessel wall. In some embodiments, the cross-sectional shape of the device 3000 is the same along its entire length (e g., the first and second end portions 3000a, 3000b have the same cross-sectional shape as the intermediate portion 3000c).
  • the mesh structure can comprise a plurality of struts 3008 and openings 3010 between the struts 3008.
  • the mesh structure can be formed, for example, by laser cutting a tube or sheet of material, etching a tube or sheet of material, interconnecting components (e g., by laser welding), depositing material in a specific pattern (e g., photolithography, vapor deposition, etc.), and/or other suitable techniques.
  • the mesh structure can then be pre-formed into a desired expanded shape as described in more detail below.
  • the device 3000 may be formed by cutting a pattern of struts 3008 from a tube or by cutting a pattern of struts 3008 from a flat sheet and then rolling the flat sheet into a generally tubular shape.
  • the mesh structure can have other suitable configurations.
  • the mesh structure comprises a plurality of braided and/or interwoven filaments, or a single filament braided or woven with itself.
  • the mesh structure comprises a series of circumferential z-stents.
  • the mesh structure can comprise one or more elongated members wound about the central longitudinal axis Lc of the device 3000 to form a series of circumferential rings.
  • the circumferential rings can be connected end to end and/or the circumferential rings can be connected to one another via one or more longitudinally extending members.
  • the mesh structure comprises a series of circumferential rings that are not connected to one another.
  • the device 3000 can include one or more adhering portions carried by and/or formed on the mesh structure that are configured to induce and/or expedite adherence of the device 3000 to the vessel wall, thereby causing the vessel wall to conform to the device 3000.
  • the adhering portion is configured to mechanically engage the vessel wall and/or promote ingrowth of tissue of the vessel wall into the device 3000.
  • the adhering portion can be disposed at the outer surface 3002 of the mesh structure, the inner surface 3004 of the mesh structure, and/or between the outer surface 3002 and the inner surface 3004 (e.g., along a thickness dimension of a strut 3008).
  • the adhering portion can be disposed continuously around the perimeter of the mesh structure, or may be disposed along only select regions (e.g., only the first bend regions 3012, only the second bend regions 3014, etc.). Likewise, the adhering portions can be disposed continuously along a length of the mesh structure, or may be disposed intermittently along select regions.
  • the adhering portion comprises a covering member (not shown) secured to the mesh structure via suturing, bonding, welding, adhesive, and/or another suitable securing technique.
  • the covering member can comprise any suitable biocompatible material, such as a graft material, for example.
  • the covering member comprises a fabric and/or a polymer.
  • the covering member can comprise a polyester, polytetrafluoroethylene (PTFE), expandable PTFE (ePTFE), urethane, thermoplastic elastomer, and/or other suitable materials.
  • the covering member can be woven and/or braided.
  • the covering member comprises a biological material, such as an autograft, an allograft, and/or a xenograft.
  • the covering member can be configured to facilitate and/or promote tissue ingrow th into the covering member and/or the mesh structure, to facilitate adhesion of the vessel wall to the mesh structure.
  • the covering member can be substantially impermeable to blood to advantageously prevent or limit blood from passing from the vessel lumen through the sidewall of the device 3000 into a space between the sidewall and the vessel wall. Blood that becomes trapped between the sidewall of the device 3000 and the vessel wall can prevent or limit the bend regions from flexing as intended, which could reduce the efficacy of the device 3000.
  • the adhering portion comprises a biocompatible adhesive carried by the mesh structure.
  • a biocompatible adhesive carried by the mesh structure.
  • Such an adhesive can be pre-loaded onto the device 3000 prior to delivery and/or can be applied to the device 3000 after the device 3000 has been deployed at the treatment site within the blood vessel.
  • the biocompatible adhesive can comprise any suitable biologic material (e.g., fibrin adhesive, etc.) and/or chemical material (e.g., methacrylates, etc.).
  • the adhering portion can include one or more surface features (not shown) of the mesh structure that are configured to facilitate adhesion of the vessel wall to the device 3000.
  • the outer surface 3002 of the mesh structure can be roughened to increase a surface area of the device 3000 and promote adhesion of the vessel wall to the outer surface 3002.
  • the adhering portion includes one or more securing members along the length of the mesh structure and/or about the perimeter of the mesh structure.
  • the securing members can be configured to engage the vessel wall to prevent the vessel wall from separating from the device 3000.
  • Such securing members can comprise tines, hooks, barbs, struts, and/or other suitable structures.
  • the securing members can be integral with the sidewall (e.g., with the struts 3008, etc.) of the device 3000 or may be secured to the device 3000 via welding, crimping, gluing, adhering, screwing, melting, etc.
  • FIGS. 31A and 3 IB illustrate axial cross-sectional views of the intermediate portion 3000c of the device 3000 positioned within a lumen of a vessel in the expanded diastolic state and the expanded systolic state, respectively.
  • the maximum cross- sectional dimension of the intermediate portion 3000c of the device 3000 and/or the diameter d2 of the circle C2 circumscribing the intermediate portion 3000c can be less than, substantially equivalent to, or slightly larger than the maximum cross-sectional dimension of the native vessel lumen in the expanded diastolic state such that the device 3000 does not substantially stretch the vessel wall VW in this state.
  • the maximum cross-sectional dimension of the intermediate portion 3000c and/or the diameter d2 can be substantially the same in the expanded diastolic and expanded systolic states.
  • the vessel wall VW substantially conforms to the device 3000 such that the vessel wall VW assumes a cross-sectional shape corresponding to a cross-sectional shape of the device 3000.
  • the device 3000 assumes the expanded diastolic state in which the first bend regions 3012 are convex towards the lumen 3006 of the device 3000 and the intermediate portion 3000c of the device 3000 has anon-ovular, non-circular cross-sectional shape.
  • the length of vessel wall VW conformed to the intermediate portion 3000c also assumes the non-ovular, non-circular cross-sectional shape corresponding to the cross- sectional shape of the device 3000.
  • the non-ovular, non-circular cross-sectional shape has a smaller area than the cross-sectional shape of the native vessel lumen.
  • the device 3000 can transition from the expanded diastolic state shown in FIG. 31 A to the expanded systolic state shown in FIG. 3 IB. Specifically, as pressure increases, blood within the vessel lumen can exert a radially outward force on the inner surface 3004 of the device 3000, causing the first bend regions 3012 to flex radially outwardly. As the first bend regions 3012 flex radially outwardly, the first apices 3016 can move radially away from the central longitudinal axis Lc of the device 3000, thereby increasing a cross-sectional area of the intermediate portion 3000c of the device 3000.
  • the first bend regions 3012 are configured to invert and become concave towards the lumen 3006 as pressure increases in the vessel lumen. Additionally or alternatively, a radius of curvature of one or more of the first bend regions 3012 and/or the second bend regions 3104 can change as the device 3000 deforms between the expanded diastolic and systolic states. For example, the radii of curvature of the second bend regions 3014 in the expanded systolic state can be greater than the radii of curvature of the second bend regions 3014 in the expanded diastolic state.
  • a cross- sectional area of the vessel increases, thereby providing compliance to the vessel.
  • the device 3000 is configured to be deformed from a non-circular, non-ovular cross- sectional shape to a circular cross-sectional shape when blood acts against the inner surface 3004 of the device 3000.
  • some of the ovular devices previously disclosed herein rely on the vessel wall VW acting upon the device to deform the device from the ovular cross-sectional shape to the circular cross-sectional shape.
  • the portions of the vessel wall VW facing the minor diameter of the ovular device can move outwards and the portions of the vessel wall VW facing the major diameter of the ovular device can move inwards due to the substantially fixed circumference of the vessel wall VW.
  • the stretched vessel wall VW moves towards a more circular shape, thereby compressing the ovular device along its major diameter and forcing the ovular device into a more circular cross-sectional shape.
  • the vessel wall VW must undergo significant stress to effect the desired change in cross-sectional shape of the device and thereby the vessel.
  • the device 3000 of FIGS. 30A-31B does not substantially stretch the vessel wall VW and does not rely upon deformation of the vessel wall VW to cause the change in cross-sectional shape of the device 3000.
  • the device 3000 can improve compliance of the vessel with significantly less stress on the vessel.
  • the device 3000 can be configured to transition from the expanded diastolic state to the expanded systolic state continuously as pressure increases within the vessel lumen.
  • the first bend regions 3012 can be configured to flex radially outwardly continuously with and/or proportionally to the changing vessel pressure such that the transition of the device 3000 from the expanded diastolic state to the expanded systolic state occurs over a longer duration of time.
  • the first bend regions 3012 are configured to undergo little to no deformation until the vessel pressure rises above or drops below a predetermined threshold. In these examples, the first bend regions 3012 can be configured to flex radially outwardly over a shorter duration of time or a smaller change in internal pressure.
  • the first bend regions 3012 can “pop” or “oilcan” from convex towards the lumen 3006 to concave towards the lumen 3006.
  • Quick flexing of the first bend regions 3012 can result in a greater change in volume of the device 3000 over the cardiac cycle. This greater volume change means the blood pressure can be lowered even further in systole, and blood pressure can be increased further in diastole.
  • the device 3000 is configured to selfexpand from a low-profile configuration to an expanded configuration in which the device 3000 has a predetermined shape.
  • Various embodiments of the present technology are therefore directed to methods of setting the predetermined shape of the device 3000.
  • FIG. 32 illustrates an axial cross-sectional view of a forming assembly 3200 (or “assembly 3200”) for setting a shape of the device 3000 with the device 3000 secured to the assembly 3200.
  • the assembly 3200 can include a first forming member 3202 and a second forming member 3204 (collectively “forming members 3202, 3204”).
  • the forming members 3202, 3204 may be configured to be positioned adjacent one another with the device 3000 positioned between the forming members 3202, 3204 such that the device 3000 substantially conforms to a surface of each of the forming members 3202, 3204.
  • a shape of each of the forming members 3202, 3204 may be based on a desired predetermined shape of the device 3000 and/or the geometry of the artery to be treated. As shown in FIG. 32, the desired predetermined shape of the device 3000 can comprise the shape of the device 3000 in the expanded diastolic state [0150] As shown in FIG.
  • the first forming member 3202 is configured to be positioned within the lumen 3006 of the device 3000 and/or the second forming member 3204 is configured to be positioned proximate the outer surface 3002 of the device 3000 such that the device 3000 conforms to an outer surface of the first forming member 3202 and an inner surface of the second forming member 3204.
  • the second forming member 3204 can be configured to force the device 3000 to conform to the outer surface of the first forming member 3202.
  • the second forming member 3204 comprises two or more separate portions that can be moved relative to one another to facilitate positioning of the device 3000 between the second forming member 3204 and the first forming member 3202.
  • the second forming member 3204 can comprise a first portion 3204a and a second portion 3204b.
  • the first forming member 3202 can be positioned within the lumen 3006 of the device 3000 and then one of the first portion 3204a or the second portion 3204b of the second forming member 3204 can be positioned about the device 3000 and the first forming member 3202 such that the portion of the device 3000 between the first or second portion 3204a, 3204b and the first forming member 3202 conforms to the assembly 3200. Then the other of the first portion 3204a or the second portion 3204b of the second forming member 3204 can be positioned about the device 3000 and the first forming member 3202 such that the remainder of the device 3000 conforms to the assembly 3200.
  • first and second portions 3204a, 3204b can be configured to releasably secure to one another.
  • FIG. 32 illustrates the second forming member 3204 comprising two portions 3204a, 3204b
  • the second forming member 3204 can comprise any suitable number of portions, such as one portion, two portions, three portions, four portions, five portions, etc.
  • FIG. 32 illustrates the second forming member 3204 as comprising two separate circumferential portions
  • the second forming member 3204 can additionally or alternatively comprise two or more separate longitudinal portions.
  • the assembly 3200 comprises multiple forming members for the multiple longitudinal portions of the device 3000.
  • the first and second forming members 3202, 3204 can be used to set a shape of the intermediate portion 3000c of the device 3000 while a third forming member (not shown) can be used to set a shape of the first end portion 3000a of the device 3000 and/or a fourth forming member (not shown) can be used to set a shape of the second end portion 3000b of the device 3000.
  • the third forming member and/or the fourth forming member may comprise a shaft having a substantially round outer surface that is configured to be positioned within the lumen 3006 of the device 3000.
  • the third and fourth forming members are integral with or secured to the ends of the first forming member 3202.
  • Setting a shape of the device 3000 can comprise subjecting the device 3000 and assembly 3200 to a heat treatment procedure while the device 3000 is conformed to the forming members 3202, 3204.
  • a heat treatment procedure can include heating the assembly 3200 and the device 3000 to a selected temperature for a selected period of time.
  • the assembly 3200 and device 3000 can be rapidly cooled after heating.
  • the rapid cooling can be achieved by any suitable cooling procedure such as, but not limited to water quench or air-cooling.
  • the heat treatment procedure may be carried out in an air or vacuum furnace, salt bath, fluidized sand bed or other suitable system.
  • the heat treatment procedure may comprise a single procedure or multiple procedures.
  • the device 3000 After completing the heat treatment, the device 3000 has a desired predetermined shape.
  • Other suitable heat-treating procedures may be employed including, but not limited to resistive heating or heating by running a current though the device 3000.
  • setting a shape of the device 3000 comprises a heat-free procedure such as mechanical deformation.
  • FIGS. 33-36 illustrate representative examples of devices 3300-3600 having different cross-sectional shapes.
  • the features of the devices 3300-3600 can be generally similar to the features of the device 3000 of FIGS. 30A-32. Accordingly, like numbers (e.g., first bend regions 3012 versus first bend regions 3312) are used to identify similar or identical components in FIGS. 30A-36, and the discussion of the devices 3300-3600 of FIGS. 33-36 will be largely limited to those features that differ from the device 3000 of FIGS. 30A-32. Additionally, any of the features of the devices 3300-3600 of FIGS. 33-36 can be combined with each other and/or with the features of the device 3000 of FIGS. 30A-32.
  • FIGS. 30A-32 illustrate the device 3000 comprising three first bend regions 3012 and three second bend regions 3014.
  • a device having three first bend regions 3012 and three second bend regions 3014 can have a sufficiently small cross-sectional area in the expanded diastolic state for substantially improving compliance without disrupting blood flow or causing thrombosis.
  • FIG. 33 illustrates an axial cross-sectional view of an intermediate portion 3300c of a device 3300 in an expanded diastolic state comprising one first bend region 3312 and one second bend region 3314. Similar to the device 3000 of FIGS.
  • the first bend region 3312 is convex to a lumen 3306 of the device 3300 while the second bend region 3314 is concave to the lumen 3306 in the expanded diastolic state.
  • the first bend region 3312 extends inwardly towards the lumen 3306 and has a first apex 3316 that is closer to a central longitudinal axis Lc of the device 3300 than the rest of the perimeter of the intermediate portion 3300c.
  • a cross-sectional shape of the intermediate portion 3300c of the device 3300 is non-circular and non-ovular in the expanded diastolic state and has a smaller cross-sectional area than that of a corresponding circular cross-sectional shape (e g., the cross-sectional shape of the intermediate portion 3300c in the expanded systolic state).
  • a circle C2 circumscribing the intermediate portion 3300c and fit to the outer surface 3302 of the device 3300 in the expanded diastolic state can have a diameter d2. Similar to the device 3000 of FIGS.
  • the diameter d2 can be less than, substantially equivalent to, or slightly larger than (e.g., no more than 10% larger than) a maximum cross-sectional dimension of the native vessel lumen configured to receive the device 3300 therein. When the device 3300 is positioned within the vessel lumen, the device 3300 does not substantially stretch the vessel wall.
  • the device 3300 can be configured to transition from the expanded diastolic state to the expanded systolic state by the first bend region 3312 flexing radially outwardly such that the first apex 3316 moves away from the central longitudinal axis Lc of the device 3300 and/or the first bend region 3312 becomes concave towards the lumen 3306.
  • the intermediate portion 3300c can be configured to transition towards a more circular cross-sectional shape in the expanded systolic state, and the circular cross-sectional shape can have a larger cross-sectional area.
  • the intermediate portion 3300c may undergo a smaller change in cross-sectional area from the expanded diastolic state to the expanded systolic state than the intermediate portion 3000c of FIGS. 30A-32 if both intermediate portions 3000c, 3300c assume the same circular cross-sectional shape having the same diameter in the expanded systolic state, because the cross-sectional area of the intermediate portion 3300c in the expanded diastolic state is larger than the cross-sectional area of the intermediate portion 3000c in the expanded diastolic state.
  • the device 3300 may provide a smaller improvement in compliance than the device 3000.
  • the first bend region 3312 can extend more deeply into the lumen 3306, for example across the central longitudinal axis Lc of the device 3300.
  • a minimum luminal distance T between two points on the inner surface 3304 of the device 3300 can be defined between the first apex 3316 and an opposing radial portion of the inner surface 3304 facing the first apex 3316.
  • the minimum luminal distance T of the device 3300 may be larger than the minimum luminal distance T of the device 3000 of FIGS. 30A-32 and thus, the device 3300 may facilitate blood flow through its lumen 3306 to a greater degree than the device 3000.
  • FIG. 34 illustrates an axial cross-sectional view of an intermediate portion 3400c of a device 3400 in an expanded diastolic state comprising four first bend regions 3412 and four second bend regions 3414.
  • the intermediate portion 3400c shown in FIG. 34 may have a larger cross-sectional area in the expanded diastolic state than the intermediate portion 3000c of FIGS. 30A-32.
  • the intermediate portion 3400c has a similar cross-sectional area in the expanded systolic state to that of the intermediate portion 3000c, the intermediate portion 3400c would undergo a smaller change in cross-sectional area from the expanded diastolic state to the expanded sy stolic state, imparting a smaller improvement in compliance to the vessel.
  • the geometry of the intermediate portion 3400c shown in FIG. 34 could be modified so that the intermediate portion 3400c has a cross-sectional area in the expanded diastolic state equivalent to or less than the cross-sectional area of the intermediate portion 3000c in the expanded diastolic state.
  • the radius of curvature of one or more of the first bend regions 3412 and/or the second bend regions 3414 could be modified to reduce the cross-sectional area of the intermediate portion 3400c.
  • modifications to the geometry of the intermediate portion 3400c that reduce its cross-sectional area may reduce the minimum luminal distance T between two points facing one another on the inner surface 3404 and/or the diameter dl of a circle Cl inscribed by the intermediate portion 3400c, which may impede blood flow through the device lumen 3406.
  • reducing the cross-sectional area of the intermediate portion 3400c may increase a stiffness of the first bend regions 3412, reducing their ability to flex radially outwardly from the expanded diastolic state to the expanded systolic state.
  • a radius of curvature and/or a length of a first bend region and/or a second bend region of devices of the present technology can be varied based on intended properties of the device.
  • the devices 3000 and 3400 of FIGS. 30A-32 and 34, respectively have second bend regions 3014, 3414 with small radii of curvature. Accordingly, when the devices 3000 and 3400 are initially positioned within a blood vessel, a small length of the second bend regions 3014, 3414 may contact the vessel wall before the vessel wall is adhered and conformed to the device.
  • the radii of curvature of the second bend regions 3014, 3414 should be sufficiently large so that the second bend regions 3014, 3414 are not sharp and do not damage the vessel wall.
  • FIGS. 35 and 36 illustrate intermediate portions 3500c, 3600c of example devices 3500, 3600 having three and four second bend regions 3514, 3614, respectively, with the second bend regions 3514, 3516 having larger radii of curvature and longer lengths than the corresponding second bend regions 3014, 3414 of FIGS. 30A-32 and 34, respectively.
  • increasing the radii of curvature and/or the lengths of the second bend regions 3514, 3614 can increase the diameter dl of the circle Cl inscribed by the intermediate portions 3500c, 3600c. Accordingly, the devices 3500, 3600 may obstruct blood flow to a lesser degree than other devices disclosed herein with a smaller diameter dl.
  • the intermediate portions 3500c, 3600c also each have a larger cross-sectional area in the expanded diastolic state than a corresponding intermediate portion with a smaller diameter dl and may therefore provide less compliance to a vessel.
  • the lengths of the first bend regions 3512, 3612 can be increased and/or the radii of curvature of the first bend regions 3512, 3612 can be decreased.
  • a device of the present technology can have a sidewall that is substantially impermeable to blood to prevent or limit blood from becoming trapped between the sidewall and the vessel wall, as such trapped blood can prevent or limit flexing of the device between the expanded diastolic and expanded systolic states.
  • various embodiments of the present technology are directed to devices, systems, and methods for removing blood from between the sidew all of the device and the vessel wall during placement of the device within the vessel lumen and/or after placement of the device within the vessel lumen.
  • one or more suction tubes 3701 can be placed on the outer surface of the device 3700 to remove blood from between the sidewall of the device 3700 and the vessel wall VW, for example as shown in Figures 37A-37C.
  • the device 3700 can be configured to be delivered in a low- profile configuration through a catheter 3703 to the vessel lumen.
  • the device 3700 and/or catheter 3703 can be slidably advanced over an elongate member 3705 (e.g., a guidewire, a coil, etc.). While the device 3700 is positioned within a lumen of the catheter 3703, the device 3700 can remain in the low-profile configuration.
  • the suction tubes 3701 can be positioned within the lumen of the catheter 3703. In some embodiments, the suction tubes 3701 are positioned radially between the sidewall of the device 3700 and an inner surface of the catheter 3703 while the device 3700 is constrained within the catheter 3703.
  • the catheter 3703 can be proximally retracted relative to the device 3700 and/or the device 3700 can be distally advanced relative to the catheter 3703 such that the device 3700 is expelled from the lumen of the catheter 3703.
  • the device 3700 can then radially expand (e.g., via self-expansion, plastic deformation, etc.) at least partially into contact with the vessel wall VW.
  • the device 3700 can continue to radially expand and can move the suction tubes 3701 towards the vessel wall VW as the sidewall of the device 3700 moves towards the vessel wall VW.
  • the suction tubes 3701 can thus be positioned between the sidewall of the device 3700 and the vessel wall VW, for example as shown in FIG. 37C.
  • the distal end portions of the suction tubes 3701 can be located at the intermediate portion of the device, at the first end portion of the device, or at the second end portion of the device.
  • the proximal end portions of the suction tubes 3701 can be fluidically coupled to a vacuum source, which can be activated to generate a negative pressure within the lumens of the suction tubes 3701 and cause blood trapped between the device 3700 sidewall and the vessel wall VW to be drawn into and proximally through the suction tubes 3701.
  • the vacuum source and the proximal end portions of the suction tubes 3701 can be located extracorporeally.
  • a suction tube 3701 can be provided at each first bend region of the device 3700.
  • three suction tubes 3701 can be provided about the circumference of a device 3700 comprising three first bend regions. Still other numbers and configurations of suction tubes 3701 are possible.
  • the suction tubes 3701 can be used to remove blood during deployment of the device 3700 and can be removed from the vessel after their initial use and/or after any blood has been removed from between the device 3700 and the vessel wall VW. Once the suction tubes 3701 are withdrawn from the vessel, the device 3700 can radially expand further such that the portions of the device 3700 previously underlying the suction tubes 3701 contact the vessel wall VW.
  • blood can be removed from a space between the vessel wall and the device sidewall by radially expanding an expandable member (e.g., a balloon, an expandable mesh, a stent, etc.) within the lumen of the device to cause the first bend regions of the device to flex radially outwardly such that the device assumes a circular cross-sectional shape approximating that of the native vessel during diastole as well as systole.
  • an expandable member e.g., a balloon, an expandable mesh, a stent, etc.
  • such an expandable member can be used to maintain the device in a circular cross-sectional shape for an initial duration to allow the vessel wall to adhere and conform to the device.
  • the vessel can be conformed to the device such that blood is not able to become trapped between the vessel wall and the device sidewall.
  • a device in accordance with various embodiments of the present technology can include a passive pump configured to transport blood from outside an outer surface of the device to within the lumen of the device.
  • the pump can advantageously remove blood that is trapped between the sidewall of the device and the wall of the vessel that could hinder flexing during normal operation of the device.
  • FIGS. 38A and 38B illustrate axial cross-sectional views of one example device 3800 including a pump 3820 for transporting blood across the sidewall of the device. Still, other active and/or passive pumping mechanisms can be incorporated into devices of the present technology.
  • the features of the device 3800 can be generally similar to the features of the device 3000 and 3300-3600 of FIGS. 30A-36. Accordingly, like numbers (e.g., first bend regions 3812 versus first bend regions 3012) are used to identify similar or identical components in FIGS. 30A-38, and the discussion of the device 3800 of FIGS. 38A and 38B will be largely limited to those features that differ from the devices 3000 and 3300-3600. Additionally, any of the features of the devices 3000 and 3300-3600 can be combined with each other and/or with the features of the device 3800.
  • the pump 3820 can include an interior wall 3822 extending across a lumen 3806 of the device from one portion of an inner surface 3804 of the device 3800 to another circumferentially offset portion of the inner surface 3804 of the device 3800.
  • the interior wall 3822 can comprise one or more struts, membranes, or other suitable structures. In some embodiments, the interior wall 3822 is elastic and may stretch and/or compress.
  • the inner surface 3804 of the device 3800 and the interior wall 3822 define an enclosed chamber 3824 within the lumen 3806 of the device 3800.
  • the sidewall of the device 3800 surrounding the chamber can be impermeable to blood except at a first opening 3810.
  • the first opening 3810 can be an opening defined between struts and/or an opening in a covering member positioned on the outer surface 3802 and/or the inner surface 3804 of the device 3800.
  • the pump 3820 can include an inlet valve 3826 positioned proximate the first opening 3810.
  • the inlet valve 3826 can be on the inner surface 3804 of the sidewall, the outer surface 3802 of the sidewall, and/or within the first opening 3810.
  • the inlet valve 3826 can be configured to move between an open configuration (see FIG. 38 A) in which the inlet valve 3826 permits blood flow from outside the device 3800 through the first opening 3810 into the chamber 3824 and a closed configuration (see FIG. 38B) in which the inlet valve 3826 prevents blood flow through the first opening 3810.
  • the interior wall 3822 can be impermeable to blood except at a second opening 3828.
  • the pump 3820 can include an outlet valve 3830 positioned proximate the second opening 3828.
  • the outlet valve 3830 can be on an inner surface of the interior wall 3822 and within the chamber 3824, on an outer surface of the interior wall 3822 outside of the chamber 3824, and/or within the second opening 3828.
  • the outlet valve 3830 can be configured to move between an open configuration (see FIG. 38B) in which the outlet valve 3830 permits blood flow from the chamber 3824 through the second opening 3828 into the lumen 3806 of the device and a closed configuration (see FIG. 38A) in which the outlet valve 3830 prevents blood flow through the second opening 3828.
  • the chamber 3824 can be located proximate a second bend region 3814 of the device 3800.
  • FIG. 38A illustrates the device 3800 when the device 3800 is in an expanded diastolic state
  • FIG. 38B illustrates the device 3800 in an expanded systolic state.
  • the second bend region 3814 has a smaller radius of curvature such that the ends of the interior wall 3822 are closer to one another and the chamber 3824 has a first volume.
  • the second bend region 3814 When the device 3800 is in the expanded systolic state, the second bend region 3814 has a larger radius of curvature such that the ends of the interior wall 3822 are located further apart from one another and the chamber 3824 has a second volume less than the first volume.
  • the inlet valve 3826 can assume the open configuration in the expanded diastolic state and/or as the device 3800 transitions from the expanded systolic state to the expanded diastolic state, which can allow blood to flow from outside of the device 3800 through the first opening 3810 into the chamber 3824.
  • the outlet valve 3830 can assume the closed configuration when the inlet valve 3826 assumes the open configuration (e.g., in and/or transitioning to the expanded diastolic state) so that the chamber 3824 fills with blood.
  • the outlet valve 3830 can assume the open configuration when the inlet valve 3826 assumes the open configuration (e.g., in and/or transitioning to the expanded diastolic state) so that blood passes into the chamber 3824 and directly through the chamber 3824 into the lumen 3806 of the device 3800.
  • the outlet valve 3830 can assume the open configuration to allow blood to flow through the second opening 3828 from the interior volume of the chamber 3824 into the lumen 3806 of the device 3800.
  • the inlet valve 3826 closes as the device 3800 transitions from the expanded diastolic state to the expanded systolic state, which can prevent blood from flowing out of the first opening 3810 into the space between the device 3800 and the vessel.
  • the pump 3820 can be configured to create negative pressure within the chamber 3824 to transport blood from outside of the device 3800 into the lumen 3806 of the device 3800.
  • the chamber 3824 can be located proximate a first bend region 3812 of the device 3800.
  • first bend region 3812 of the device 3800.
  • positioning the chamber 3824 proximate the first bend region 3812 can allow for pumping a greater volume of blood, as the first bend regions 3812 may be more flexible and/or may undergo more deformation than the second bend regions 3814 as the device 3800 transitions between the expanded diastolic and expanded systolic states.
  • a device of the present technology can be configured to be positioned within any suitable blood vessel, including, but not limited to, an artery .
  • the device can be configured to be positioned within an aorta of a patient.
  • a device can be configured to treat a blood vessel that is at least partly aneurysmal and/or significantly aneurysmal.
  • a device of the present technology can be configured to treat an abdominal aortic aneurysm, a thoracic aortic aneurysm, and/or other aneurysms at various locations within a patient’s vasculature.
  • An aneurysmal vessel can include a vessel wall having at least one region that has stretched, ballooned, bulged, or otherwise deformed to define an aneurysm. Blood can flow from the vessel lumen into the aneurysm via an opening between the vessel lumen and the aneurysm. Such blood flow can further deform the vessel wall, creating a risk of rupture. Additionally or alternatively, pressure within the vessel and aneurysm can cause the aneurysm to rupture. Devices of the present technology can be configured to provide mechanical reinforcement of the vessel and/or the aneurysm and/or to prevent or limit blood flow into the aneurysm to reduce the risk of rupture. Additionally or alternatively, the device can be configured to increase compliance of the vessel, for example as described in greater detail herein.
  • a device of the present technology can be configured to be positioned within a lumen of an aneurysmal vessel at or proximate to the aneurysm.
  • the device can be positioned within the vessel lumen such that at least a portion of the device extends across the opening of to the aneursym.
  • At least a portion of a sidewall of such a device can be impenneable to fluid and/or blood. This portion of the sidewall can be positioned across the opening to the aneurysm to prevent or limit blood flow from the vessel lumen into the aneurysm cavity via the opening.
  • such a device can comprise a stent with a fluid-impermeable sidewall.
  • the device can include a fluid- impermeable coating, covering member, etc.
  • the device can include first and second end portions opposite one another along a length of the device and an intennediate portion between the first and second end portions.
  • first end portion and/or the second end portion has a substantially circular cross-sectional shape.
  • the first end portion and/or the second end portion can be configured to contact a wall of a vessel about a substantial portion of a circumference of the device.
  • the first end portion and/or the second end portion can be configured to contact a wall of a vessel about at least 75% of the circumference of the device, at least 80% of the circumference of the device, at least 85% of the circumference of the device, at least 90% of the circumference of the device, at least 95% of the circumference of the device, or about 100% of the circumference of the device.
  • the first end portion and/or the second end portion of the device can be configured to prevent or limit blood from flowing into a space between the sidewall of the device and the wall of the blood vessel and/or the aneurysm at the end portions of the device.
  • the first end portion and/or the second end portion can be configured to create a blood-tight seal with the vessel wall.
  • the intermediate portion of the device can be substantially impermeable to fluid and/or blood, as described herein.
  • the intermediate portion of the device when the device is positioned within the blood vessel, the intermediate portion of the device does not substantially contact the vessel wall about a circumference of the device.
  • the intermediate portion is configured to contact the vessel wall about no more than 30% of the circumference of the device, about no more than 25% of the circumference of the device, about no more than 20% of the circumference of the device, about no more than 15% of the circumference of the device, about no more than 10% of the circumference of the device, or about no more than 5% of the circumference of the device.
  • the intermediate portion can have a cross- sectional dimension that is smaller than a cross-sectional dimension of the blood vessel lumen. In some embodiments, the intermediate portion does not deform the vessel wall. Still, in some embodiments the intermediate portion can be configured to contact one or more portions of the vessel wall and/or cause one or more portions of the vessel wall to conform to the intermediate portion, as described elsewhere herein.
  • devices of the present technology that are configured to treat an aneurysmal vessel may not be configured to actively remove blood from the space between the sidewall of the device and the vessel wall.
  • such devices may not include the suction tubes or pumps disclosed herein for removing blood from between the device and the vessel wall.
  • such devices are configured to remove blood from between the sidewall of the device and the vessel wall, for example using suction tubes and/or pumps.
  • FIG. 39 illustrates an example calculation of the cross-sectional area of the intermediate portion 3000c of the device 3000 of FIGS. 30A-30C.
  • the device 3000 is configured to be positioned within a vessel lumen having a diameter of 30 mm.
  • the intermediate portion 3000c can have a radius Rs in the expanded systolic state of 15 mm (e.g., having a diameter of about 30 mm corresponding to the diameter of the native vessel lumen).
  • the circumference Cs of the intermediate portion 3000c in the expanded systolic state is based on the radius Rs of the intermediate portion 3000c and can be about 94.25 mm in this example.
  • the circumference of the intermediate portion 3000c in the expanded diastolic state can be approximately equivalent to the circumference Cs of the intermediate portion 3000c in the expanded systolic state.
  • the circumference of the vessel with the intermediate portion 3000c positioned therein can be about the same during systole and diastole.
  • the area Asys of the intermediate portion 3000c in the expanded systolic state is also based on the radius Rs of the intermediate portion 3000c and can be about 706.89 square mm.
  • the area Adiast of the intermediate portion 3000c in the expanded diastolic state can be less than the area Asys of the intermediate portion 3000c in the expanded systolic state, as demonstrated below.
  • the cross-sectional shape of the intermediate portion 3000c of the device 3000 can be approximated by multiple geometric shapes.
  • the second bend regions 3014 can be approximated as half circles.
  • a minimum luminal distance T between interior portions of the device 3000 facing one another can be maintained above a predetermined threshold so that the device 3000 does not substantially impede blood flow.
  • the minimum luminal distance T is about 6 mm.
  • This minimum luminal distance T also corresponds to the diameter of the half circles.
  • the area Aa of each Half Circle A is equal to about 14 14 square mm.
  • the circumference Ca of each Half Circle A is equal to about 9.42 mm.
  • the first bend regions 3012 can comprise arcs positioned between circumferentially adjacent second bend regions 3014.
  • an Arc B can have a length Lb based on the circumference Cs of the intermediate portion 3000c in the expanded systolic state and the circumferences Ca of the Half Circles A. In this example, the length Lb is about 21.99 mm.
  • An angle 0 of the Arc B can be about 60 degrees, as shown in FIG. 39, when the intermediate portion 3000c comprises three second bend regions 3014 approximating half circles.
  • a radius Rb of the Arc B is based on the length Lb of the Arc B and the angle 0 of the Arc B and, in this example, is about 21 mm.
  • a chord Cb extending between the ends of the Arc B can also be about 21 mm.
  • a Trapezoid C can have two sides Sc corresponding to the chords Cb of two of the Arcs B, one base corresponding to the minimum luminal thickness T, and another base Be extending from an endpoint of one of the Half Circles A to an endpoint of another one of the Half Circles A.
  • the area Ac of the Trapezoid C can be about 300.08 square mm, as detailed in FIG. 39.
  • a Trapezoid D can have a first base Bl d corresponding to the base Be of the Trapezoid C, a second base B2d corresponding to the chord Cb of the bottom Arc B, and two sides corresponding to the minimum luminal thickness T. As detailed in FIG.
  • the area Ad of the Trapezoid D can be about 124.7 square mm.
  • Segments E define the free space between the sides Sc of Trapezoid C and the corresponding Arcs B and between the second base B2d of Trapezoid D and the corresponding Arc B.
  • the area Ae of one of the Segments E can be based on the radius Rb and the angle 0 of the corresponding Arc B. In this example, the area Ae of each Segment E can be about 39.95 square mm.
  • the total cross-sectional area Adiast of the intermediate portion 3000c of the device 3000 in the expanded diastolic state can be equal to the sum of the areas Aa of the Half Circles A, the area Ac of the Trapezoid C, and the area Ad of the Trapezoid D with the areas Ae of the Segments E subtracted from this sum.
  • the total cross- sectional area Adiast of the intermediate portion 3000c of the device 3000 in the expanded diastolic state can be about 347.34 square mm (e.g., 3.47 square cm).
  • the cross-sectional area of the intermediate portion 3000c can increase by about 359.55 square mm.
  • the net change in area of the intermediate portion 3000c between the expanded diastolic and systolic states can comprise an increase of about 3.6 square cm.
  • the compliance added to the vessel by the device 3000 is the length of the intermediate portion 3000c multiplied by the net change in area of the intermediate portion 3000c.
  • the device 3000 for implantation in the pulmonary artery has a total length of about 5 cm and a length of the intermediate portion 3000c is about 3 cm
  • the device 3000 can provide a potential compliance of about 11 mL over the cardiac cycle, which would serve to meaningfully reduce systolic pulmonary' artery pressure and increase diastolic pulmonary artery pressure.
  • Pulmonary hypertension is a serious and life-threatening disease, with serious longterm sequalae.
  • pulmonary hypertension There are multiple causes for pulmonary hypertension, including left heart failure, significant flow resistance within the lungs, generalized fluid overload, and other causes.
  • Many drugs and devices have been developed and tested to reduce pulmonary arterial pressure, including the Aria CV Pulmonary Hypertension System (Aria CV PH System).
  • the Aria device comprises a balloon deployed in the pulmonary artery communicating with a compliance chamber outside of the vascular system. In systole the balloon is compressed by the higher pressure, pushing gas out of the balloon into the compliance chamber and increasing the blood volume in the pulmonary artery'. In diastole the gas flows back into the balloon, decreasing the blood volume in the pulmonary artery.
  • This system has been demonstrated clinically to reduce systolic pulmonary artery' pressures. However, it is a complex system and the device limits the ability' to pass other devices through the pulmonary' artery due to the balloon and buffering stent blocking the lumen.
  • the anatomic details of the pulmonary arterial system are as shown in FIG. 29.
  • the main pulmonary artery is relatively short, about 50mm long between the pulmonary' valve and the point where it branches into the left and right pulmonary arteries.
  • the main pulmonary artery' has an average diameter of about 26.2 mm, but in patients with pulmonary hypertension the diameter averages about 34.7 mm.
  • the left pulmonary artery is relatively short and has an average diameter of 22.1 mm, and typically appears as a continuation of the main pulmonary artery.
  • the right pulmonary artery is longer and slightly narrower, with an average diameter of 19.8 mm.
  • the wall thickness of the pulmonary' arteries averages 0.162 mm.
  • any of the devices disclosed herein can be deployed within any portion of the pulmonary arteries to reduce systolic pulmonary artery pressure and treat pulmonary hypertension.
  • multiple devices may be deployed at different locations within the pulmonary arteries (e.g., one device at the right pulmonary artery and one device at the left pulmonary artery, one device is the right pulmonary artery, one device at the left pulmonary artery, and one device at the main pulmonary artery, two devices in the right pulmonary artery, etc.).
  • To effectively moderate pulmonary artery pressure one or more of the devices in the larger sections of the main pulmonary artery', left pulmonary artery, and/or right pulmonary artery.
  • a device of the present technology placed in the main pulmonary artery can deployed at a location that is spaced apart from the pulmonary valve (e.g., spaced apart by 10 mm, 20 mm, about 10 mm to about 20 mm, greater than 20 mm, etc.) so that the deformation of the device and the resulting deformation of the artery does not distort the geometry of the pulmonary valve.
  • pulmonary arterial systolic and diastolic pressures are about 18-25 mmHg and 10 mmHg, respectively, and mean pulmonary arterial pressure is about 12-16 mmHg.
  • Pulmonary venous pressure also measured as pulmonary capillary wedge pressure (PCWP)
  • PCWP pulmonary capillary wedge pressure
  • PH Pulmonary Hypertension
  • a device of the present technology can be delivered to the pulmonary artery using a catheter inserted into a patient's vasculature via a sheath in the jugular vein and/or femoral vein.
  • the device can have a length that is sufficiently small to negotiate the curves in the right atrium and right ventricle to access the pulmonary artery.
  • the device can be configured to assume a compressed configuration within a lumen of a catheter for delivery of the device to the pulmonary artery'.
  • a catheter can be about 15 French to about 24 French in diameter.
  • the device can be deployed within the arterial lumen by retracting a cover sleeve that radially constrains the device in the compressed configuration such that the radial constraint is removed.
  • the device is releasably connected to an inner catheter.
  • a proximal end portion of the device and/or one or more elements thereof can be releasably connected to the inner catheter.
  • the device can be intended for permanent implantation, the device can also be configured to be removed after delivery.
  • the device can be removed after delivery by introducing a removal catheter into the artery, which would grasp a proximal end of one or more portions of the device (e.g., a proximal end of the spring, a coil at a proximal end of the sleeve, etc.) and advancing a sleeve over the spring of the device to collapse it towards a flat configuration.
  • the sleeve can be advanced over the entire device, just the spring, or one or more other discrete elements of the device. In some embodiments, an additional larger-diameter sleeve can be advanced over the device to capture the two buffers of the device during withdrawal.

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Abstract

La présente invention concerne des dispositifs de traitement d'artères. Dans plusieurs modes de réalisation, par exemple, la présente invention comprend une structure expansible conçue pour être positionnée de manière intravasculaire à l'intérieur d'une lumière de l'artère au niveau d'un site de traitement, l'artère ayant une forme de section transversale sensiblement circulaire au niveau du site de traitement avant le déploiement de la structure expansible à l'intérieur de celle-ci. Lorsque la structure expansible est dans un état déployé et positionnée en apposition avec la paroi artérielle au niveau du site de traitement sous pression diastolique, l'artère et la structure expansible peuvent avoir une forme de section transversale non circulaire. Une aire de section transversale de l'artère dans la forme de section transversale non circulaire peut être inférieure à une aire de section transversale de l'artère dans la forme de section transversale sensiblement circulaire.
PCT/US2023/073987 2022-09-12 2023-09-12 Dispositifs de traitement vasculaire ainsi que systèmes associés et méthodes d'utilisation WO2024059572A1 (fr)

Applications Claiming Priority (4)

Application Number Priority Date Filing Date Title
US202263375365P 2022-09-12 2022-09-12
US63/375,365 2022-09-12
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Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2012125184A1 (fr) * 2011-03-16 2012-09-20 Boston Scientific Scimed, Inc. Endoprothèse et système de pose
WO2020198162A1 (fr) * 2019-03-28 2020-10-01 Edwards Lifesciences Corporation Endoprothèse ovale
WO2020206048A1 (fr) * 2019-04-01 2020-10-08 The Foundry, Llc Dispositifs de traitement vasculaire ainsi que systèmes associés et méthodes d'utilisation

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2012125184A1 (fr) * 2011-03-16 2012-09-20 Boston Scientific Scimed, Inc. Endoprothèse et système de pose
WO2020198162A1 (fr) * 2019-03-28 2020-10-01 Edwards Lifesciences Corporation Endoprothèse ovale
WO2020206048A1 (fr) * 2019-04-01 2020-10-08 The Foundry, Llc Dispositifs de traitement vasculaire ainsi que systèmes associés et méthodes d'utilisation

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