WO2024009055A1 - Tube extensible destiné à être déployé à l'intérieur d'un vaisseau sanguin - Google Patents

Tube extensible destiné à être déployé à l'intérieur d'un vaisseau sanguin Download PDF

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Publication number
WO2024009055A1
WO2024009055A1 PCT/GB2023/051647 GB2023051647W WO2024009055A1 WO 2024009055 A1 WO2024009055 A1 WO 2024009055A1 GB 2023051647 W GB2023051647 W GB 2023051647W WO 2024009055 A1 WO2024009055 A1 WO 2024009055A1
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WIPO (PCT)
Prior art keywords
frame
expandable tube
longitudinally
closed cell
radially
Prior art date
Application number
PCT/GB2023/051647
Other languages
English (en)
Inventor
Andrew MOOR
George Hsieh
Jodi COLLINS
Original Assignee
Oxford Endovascular Ltd.
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Oxford Endovascular Ltd. filed Critical Oxford Endovascular Ltd.
Publication of WO2024009055A1 publication Critical patent/WO2024009055A1/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
    • A61F2/852—Two or more distinct overlapping stents
    • 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
    • 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
    • A61F2/88—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure the wire-like elements formed as helical or spiral coils
    • 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

Definitions

  • the present invention relates to an expandable tube for deployment within a blood vessel, particularly for use in redirecting blood flow away from an aneurismal sac.
  • An intracranial aneurysm is a weak region in the wall of an artery in the brain, where dilation or ballooning of the arterial wall may occur. Histologically, decreases in the tunica media, the middle muscular layer of the artery, and the internal elastic lamina cause structural defects. These defects, combined with hemodynamic factors, lead to aneurismal out-pouchings. Intracranial aneurysms are quite common diseases with a prevalence ranging from one to five percent among adult population according to autopsy studies. In the US alone, ten to twelve million people may have intracranial aneurysms.
  • Endovascular coiling is a less invasive method involving placement of one or more coils, delivered through a catheter, into the aneurysm until the sac of the aneurysm is completely packed with coils. It helps to trigger a thrombus inside the aneurysm. Although endovascular coiling is deemed to be safer than surgical clipping, it has its own limitations.
  • an expandable tube sometimes referred to as a stent
  • an expandable tube with an area of relatively low porosity is placed across the aneurysm neck in such a way as to redirect blood flow away from the sac and trigger formation of a thrombus within the aneurysm.
  • the aneurysm solidifies naturally on itself, there is less danger of its rupture.
  • the aneurysm will gradually shrink as the thrombus is absorbed. Consequently, the pressure applied on the surrounding tissue can be removed.
  • the expandable tube has to be flexible enough to pass through and adapt to the shape of the very tortuous blood vessels in the brain while at the same time providing sufficiently low porosity to redirect blood flow away from the aneurysm to an adequate extent.
  • a known type of expandable tube is formed from braided filaments, for example of wire.
  • the filaments are braided together to form a mesh tube.
  • Expandable tubes of this type can be radially contracted and longitudinally expanded inside a catheter for placement into blood vessels. When in the correct position over the neck of the aneurysm, the expandable tube is deployed from inside the catheter, whereupon it expands radially and contracts longitudinally so that it becomes lodged in the blood vessel and occludes the blood flow in and out of the aneurysm.
  • a problem with braided filament expandable tubes is that the large number of contact points between filaments in the braided structure create friction. Additionally, each filament is free to move relative to other intersecting filaments resulting in poor radial outward force. This can cause braided filament expandable tubes to radially expand slowly and inconsistently on deployment from the catheter, thereby making correct placement of the expandable tube relative to the neck of the aneurysm more difficult and less reliable.
  • Another existing type of expandable tube is formed of a network of interconnecting and non-overlapping elements. This may be formed, for example, by laser cutting from a narrow tube of a material such as a shape-memory alloy. These laser-cut tubes have the advantage that there are no points of contact between braided filaments to cause friction, and their deployment can be more consistent. However, it can be difficult to design tubes of this type that have sufficiently low porosity to adequately occlude an aneurysm.
  • Both of these types of expandable tube additionally have the limitation that they are often not able to accommodate tight bends in tortuous anatomy, and can twist or not properly expand. Such tortuous anatomy is particularly common in the brain, where many small blood vessels are tightly packed together.
  • an expandable tube for deployment within a blood vessel, the expandable tube being reversibly switchable from a radially contracted and longitudinally expanded state to a radially expanded and longitudinally contracted state, the expandable tube comprising: a first frame; and a second frame connected to the first frame and overlapping with the first frame in the radial direction, the second frame comprising a network of non-overlapping elements, the nonoverlapping elements being non-overlapping with respect to each other in the radial direction, wherein: the network of non-overlapping elements has an interconnected structure comprising a plurality of sub-units that repeat in the longitudinal direction; each sub-unit of the second frame defines a closed cell; and in the radially expanded and longitudinally contracted state, the closed cell has a bulbous region in which the closed cell widens towards a circumferential end of the closed cell and away from a circumferentially central region of the closed cell.
  • a frame defining closed cells having a bulbous region provides a longer path length of the non-overlapping elements around the cells. This improves bending flexibility to allow the expandable tube to bend around tighter curves without kinking.
  • the closed cell comprises two bulbous regions at opposite circumferential ends of the closed cell.
  • Two bulbous regions provide greater symmetry and further improve flexibility.
  • the closed cell is an area around the circumference of the second frame enclosed by the non-overlapping elements.
  • the closed cell defines an area on a circumferential surface of the expandable tube.
  • the network of non-overlapping elements comprises a plurality of longitudinally-extending members defining the interconnected structure, and circumferentially-adjacent longitudinally-extending members are connected at connection points.
  • Using longitudinally-extending members provides greater longitudinal flexibility that contributes to the improved bending flexibility by allowing the closed cells to expand or contract longitudinally around bends.
  • a path along each longitudinally-extending member reverses longitudinal direction between consecutive connection points. Having the longitudinally-extending members double back on themselves creates the bulbous regions and increases the path length along the members.
  • a circumferential line preferably located at the midpoint between consecutive connection points of the longitudinally-extending member, exists for each sub-unit that intersects the longitudinally-extending member three or more times. This ensures that the longitudinally-extending members double back on themselves to create the bulbous regions and increase the path length along the members.
  • the longitudinally-extending members are longitudinally deformable. Having the longitudinally-extending members extend by deformation is a straightforward mechanism for longitudinal extension that reduces manufacturing complexity.
  • each sub-unit defines a plurality of closed cells around a circumference of the second frame, circumferentially-adjacent closed cells being connected at connection points; and in the radially expanded and longitudinally contracted state, a radius of curvature of the longitudinally-extending member decreases away from the connection points.
  • Connecting together the longitudinally-extending members improves torsional rigidity and resist twisting of the expandable tube.
  • the decreasing radius of curvature away from the connection points allows for the bulbous regions to be formed as the longitudinally-extending members double back on themselves.
  • the larger radius adjacent to the connection points encourages low mechanical strain in the radially contracted and longitudinally expanded state.
  • the closed cell has mirror symmetry in a plane parallel to the longitudinal axis of the expandable tube and/or a plane perpendicular to the longitudinal axis of the expandable tube.
  • longitudinally-adjacent sub-units have mirror symmetry in a plane perpendicular to the longitudinal axis of the expandable tube.
  • Mirror symmetry between different levels of the structure improves the uniformity of behaviour of the expandable tube.
  • each sub-unit defines a plurality of closed cells around a circumference of the second frame, circumferentially-adjacent closed cells being connected at connection points. Connecting together the longitudinally-extending members improves torsional rigidity and resist twisting of the expandable tube.
  • circumferentially-adjacent closed cells have mirror symmetry in a plane parallel to the longitudinal axis of the expandable tube. Mirror symmetry between different levels of the structure improves the uniformity of behaviour of the expandable tube.
  • circumferentially-adjacent closed cells are connected at the connection points connected via bridges, optionally wherein the bridges are rigid bridges.
  • the bridges extend circumferentially. Using bridges allows the adjacent cells to remain independent and reduces the effect of the connection on the ability of the non-overlapping elements to deform around the connection points.
  • the bridges have a longitudinal length of at most 0.1mm, preferably at most 0.08 mm.
  • the bridges have a circumferential length of at most 0.2mm, preferably at most 0.1 mm. These dimensions have been found to be effective in joining the adjacent cells while providing good torsional rigidity.
  • the non-overlapping elements comprise straight portions at the connection points.
  • the straight portions minimise deformation of the non-overlapping elements around the connection points, which could lead to excessive mechanical strain, accelerated fatigue or damage to the connections.
  • a radius of curvature of the non-overlapping elements adjacent to the straight portion is at least 0.3 mm, preferably at least 0.5 mm, most preferably at least 0.7 mm. This ensures the increase in curvature away from the straight portion occurs at an appropriate rate.
  • a length of the straight portions is at least 0.05 mm, preferably at least 0.1 mm. This length has been found to be effective in reducing strain at the connection points.
  • the closed cell widens by at least 20% in the bulbous region, preferably at least 40%, more preferably at least 60%. This level of widening provides sufficient additional path length to achieve the improved bending flexibility of the expandable tube.
  • the second frame is configured to drive the expandable tube from the radially contracted and longitudinally expanded state to the radially expanded and longitudinally contracted state.
  • Using the second frame to drive the expansion of the first frame helps the tube to deployment more consistently and reliably, thereby reducing the likelihood of a failed deployment.
  • the second frame is configured to drive the expandable tube from the radially contracted and longitudinally expanded state to the radially expanded and longitudinally contracted state by exerting a force on the first frame in a radial direction. Exerting a force in the radial direction means that the first frame will rapidly expand to its full diameter when released from a deployment catheter, so that it can more easily be placed correctly.
  • the network of non-overlapping elements is integrally formed. This reduces the complexity of the manufacturing process by removing the need to join elements of the network. It will also reduce defects or irregularities in the surface of the second frame due to joins between elements.
  • the second frame is connected to the first frame at least at one end of the second frame. Connecting the two frames together ensures that they do not move relative to one another, and the expandable tube behaves consistently and predictably.
  • the second frame is further connected to the first frame at one or more points along the length of the second frame. This means that the interaction of the first frame and second frame is uniform along the length of the expandable tube, and not only constrained at the ends of the expandable tube.
  • the second frame is connected to the first frame by at least one of welding, crimping, an adhesive, or encapsulation. These are particularly convenient joining methods where the first frame is formed of braided filament.
  • the second frame comprises a plurality of filament-receiving apertures, one or more connecting filaments are woven into the first frame, and each connecting filament passes through one or more of the filament-receiving apertures.
  • connecting filaments reduces the profile of the joining between the first and second frames compared to other methods such as crimping or welding, making the surface of the expandable tube more uniform.
  • the connecting filaments comprise filaments of the first frame. This means no additional filaments are added, keeping the dimensions of the expandable tube the same as if no connecting filaments were present.
  • one or more radiopaque markers are attached to one or more of the connecting filaments.
  • the connecting filaments are a convenient attachment point for radiopaque markers that improve the visibility of the expandable tube during deployment.
  • the plurality of filament-receiving apertures comprises filamentreceiving apertures in a longitudinal end region of the second frame. This secures the overall length of the two frames together.
  • the plurality of filament-receiving apertures comprises filamentreceiving apertures spaced along the length of the second frame. Including further apertures spaced along the second frame improves the attachment of the first and second frames to one another, reducing the chance of the two frames separating.
  • the length of the second frame is at least 50% of the length of the first frame.
  • the second frame overlaps with the first frame over at least 50% of the length of the expandable tube.
  • the second frame is positioned within the first frame. Having the braided filament on the outside of the expandable tube means that a uniform sheath is provided along the length of the expandable tube. This provides a greater radial expansion force on the first frame than if the second frame were provided outside of the first frame, thereby further promoting proper deployment of the expandable tube.
  • a radius of the second frame in an unconstrained state in which the second frame is not connected to the first frame and the second frame is radially expanded and longitudinally contracted is greater than a radius of the first frame in an unconstrained state in which the first frame is not connected to the second frame and the first frame is radially expanded and longitudinally contracted.
  • a first elongation ratio of the first frame is within 25% of a second elongation ratio of the second frame, the first elongation ratio being a ratio between the length of the first frame in an unconstrained state in which the first frame is not connected to the second frame and the first frame is radially expanded and longitudinally contracted and the length of the first frame in the radially contracted and longitudinally expanded state, and the second elongation ratio being a ratio between the length of the second frame in an unconstrained state in which the second frame is not connected to the first frame and the second frame is radially expanded and longitudinally contracted and the length of the second frame in the radially contracted and longitudinally expanded state.
  • the network of non-overlapping elements comprises a plurality of longitudinally deformable elements for providing longitudinal expansion and contraction of the second frame, each smallest repeating unit of the network of non-overlapping elements has a first length in the longitudinal direction in the unconstrained state in which the second frame is not connected to the first frame and the second frame is radially expanded and longitudinally contracted state, and a ratio between the first length and a path length along each longitudinally deformable element is within 25% of the first elongation ratio. Choosing the path length along the longitudinally deformable elements correctly will determine the longitudinal expansion of the second frame such that it matches to the first elongation ratio of the first frame.
  • the first frame comprises a shape memory alloy material, preferably nitinol.
  • Shape memory alloys are a convenient choice of material, as they can be designed to revert to a desired shape when released from constraint, thereby removing the need to exert external forces on the tube to cause them to radially expand.
  • the first frame has a porosity such as to redirect blood flow away from the aneurismal sac and thereby promote thrombus formation in the aneurismal sac. This ensures the expandable tube is operative in causing thrombus formation in the aneurysm.
  • the first frame has a porosity of at most 90% in the radially expanded and longitudinally contracted state of the expandable tube. Limiting the porosity of the first frame reduces the porosity of the expandable tube such that it can cause thrombus formation in an aneurysm.
  • the first frame comprises braided filament.
  • Braided filament frames are well-known and their manufacture is well-established. They are also able to provide good porosity values suitable for aneurysm occlusion.
  • the first frame comprises at least 48 filaments. Higher filament count helps to increase pore density, which improves the ability of the expandable tube to occlude aneurysms.
  • the filaments of the first frame have a diameter of at most 30pm. Smaller diameter filaments allow the filament count to be increased while maintaining compatibility with a suitably sized microcatheter.
  • the first frame has a braid angle of at least 50°. This is advantageous in allowing the expandable tube 2 to conform to the tortuous anatomy of blood vessels without exhibiting kinking.
  • a higher braid angle results in improved bending flexibility, smaller pores (permitting higher pore density), and greater longitudinal flexibility.
  • the first frame has a pore density of at least 20 pores/mm 2 .
  • Higher pore density improves the ability of the expandable tube to occlude aneurysms, and promotes endothelialisation of the tube.
  • the second frame comprises a shape memory alloy material, preferably nitinol.
  • Shape memory alloys are a convenient choice of material, as they can be designed to revert to a desired shape when released from constraint, thereby removing the need to exert external forces on the tube to cause them to radially expand.
  • the second frame has a porosity of at least 70%.
  • the first frame is the main determiner of the porosity of the expandable tube, simplifying design of the overall properties of the expandable tube.
  • the expandable tube in the radially contracted and longitudinally expanded state, has a maximum dimension in the radial direction that is at least 30% smaller than the maximum dimension in the radial direction of the expandable tube in the radially expanded and longitudinally contracted state. This will allow for sufficient compression of the expandable tube such that it can be inserted into a catheter for deployment.
  • an elongation of the expandable tube in the longitudinal direction caused by the switching from the radially expanded and longitudinally contracted state to the radially contracted and longitudinally expanded state is at least 10%.
  • Providing for longitudinal expansion and contraction increases the extent to which the expandable tube is able to expand and contract radially.
  • a maximum dimension in the radial direction of the expandable tube is such that the expandable tube can be inserted into a catheter having an inner diameter of at most 1.0 mm.
  • This size of catheter is widely available and routinely used for treatment of brain aneurysms, and so compatibility with this catheter size is desirable.
  • an expandable tube for deployment within a blood vessel, the expandable tube being reversibly switchable from a radially contracted and longitudinally expanded state to a radially expanded and longitudinally contracted state, the expandable tube comprising a frame comprising a network of non-overlapping elements, the non-overlapping elements being nonoverlapping with respect to each other in the radial direction, wherein: the network of nonoverlapping elements has an interconnected structure comprising a plurality of sub-units that repeat in the longitudinal direction; each sub-unit defines a closed cell; in the radially expanded and longitudinally contracted state, the closed cell has a bulbous region in which the closed cell widens towards a circumferential end of the closed cell away from a circumferentially central region of the closed cell; and the closed cell has mirror symmetry in at least one of a plane parallel to the longitudinal axis of the expandable tube and a plane perpendicular to the longitudinal axis of the expandable tube.
  • bulbous regions and symmetrical closed cells allows the expandable tube to have improved flexibility for navigating tortuous anatomy and improved longitudinal stiffness for easier deployment.
  • Fig. l is a schematic of an expandable tube in the radially expanded and longitudinally contracted state
  • Fig. 2 is a schematic of an expandable tube in the radially contracted and longitudinally expanded state
  • Fig. 3 is a schematic of an expandable tube comprising a first frame and a second frame in the radially expanded and longitudinally contracted state;
  • Fig. 4 is a schematic of an expandable tube comprising a first frame and a second frame in the radially contracted and longitudinally expanded state;
  • Fig. 5 shows an expandable tube comprising a first frame and a second frame comprising closed cells with bulbous regions;
  • Fig. 6 shows the repeating sub-units defining closed cells with bulbous regions
  • Fig. 7 shows an expandable tube at varying levels of radial contraction and longitudinal expansion
  • Fig. 8 illustrates how the second frame accommodates tight bends
  • Fig. 9 illustrates apertures at an end of the second frame that can be used for connecting the first and second frames
  • Fig. 10 shows detail of the use of apertures and a connecting filament to connect the first and second frames
  • Fig. 11 shows detail of an alternative design to that of Fig. 10 in which the filaments of the first frame are used as the connecting filaments connecting the first and second frames;
  • Fig. 12 shows the addition of a radiopaque marker to a joining filament
  • Fig. 13 illustrates the change in shape of spaces between the braided filaments in the first frame between the radially expanded and longitudinally contracted, and radially contracted and longitudinally expanded states
  • Fig. 14 illustrates the dimensions of the expandable tube in the radially expanded and longitudinally contracted state, and the radially contracted and longitudinally expanded state
  • Fig. 15 shows a smallest repeating section of the second frame
  • Fig. 16 is a schematic of deployment of an expandable tube from a catheter; and Figs. 17(a)-l 7(c) shows the expandable tube being deployed inside a model blood vessel.
  • the present disclosure provides expandable tubes suitable for deployment within a blood vessel.
  • the expandable tubes which may also be known as stents, are suitable for use in methods for the treatment of aneurysms.
  • the designs herein are suitable use in methods for the treatments of cerebral aneurysms, where the blood vessels in which the expandable tubes must be deployed are narrow and tortuous.
  • Fig. 1 depicts the outer geometry of an expandable tube 2 in a radially expanded and longitudinally contracted state.
  • Fig. 2 depicts the outer geometry of the expandable tube 2 in a radially contracted and longitudinally expanded state.
  • the expandable tube 2 is reversibly switchable from the radially contracted and longitudinally expanded state shown in Fig. 2 to the radially expanded and longitudinally contracted state shown in Fig. 1.
  • the expandable tube 2 comprises a first frame 10, optionally comprising braided filament, and a second frame 12 comprising a network of nonoverlapping elements.
  • the expandable tube 2 is elongate relative to an axis of elongation 4.
  • the expandable tube 2 may be cylindrical for example.
  • the maximum lateral dimension is the same at all positions and angles (i.e. it is equal to the diameter).
  • the maximum lateral dimension may be different at different positions and/or angles.
  • the maximum lateral dimension defines the minimum interior diameter of a cylindrical tube (e.g. a delivery catheter) that the frame could be inserted into.
  • the expandable tube 2 In the radially contracted state the expandable tube 2 is substantially narrower than in the radially expanded state.
  • the expandable tube 2 Preferably in the radially contracted and longitudinally expanded state, the expandable tube 2 has a maximum dimension in the radial direction that is at least 30% smaller than the maximum dimension in the radial direction of the expandable tube 2 in the radially expanded and longitudinally contracted state, more preferably at least 50% smaller.
  • Radially contracting the expandable tube 2 allows the expandable tube 2 to be inserted into a narrower delivery catheter for deployment at the site of interest. It is generally desirable for the delivery catheter to be as narrow as possible. This is particularly the case where access to a deployment site requires navigation of tortuous regions of vasculature. This may often be the case, for example, when treating a cerebral aneurysm.
  • porosity refers to the ratio of the surface area of open regions to the total external surface area occupied by the expandable tube 2, a portion of the expandable tube 2 that is being described, or a frame of the expandable tube 2 (which will be discussed further below).
  • the total external surface area is the sum of the surface area of the open regions and the surface area of the regions occupied by the material of the expandable tube 2 or frame.
  • the total external surface area is simply 2nRL, where R is the radius of the cylinder and L is the length of the cylinder.
  • the second frame 12 of the expandable tube 2 which comprises elements that are not allowed to overlap with each other in the radial direction.
  • the second frame 12 has a porosity p in the fully radially expanded state. If the radius and length of the second frame 12 in the fully radially expanded state are R o and L o , respectively, the minimum radius R m t n that the second frame 12 can achieve in the radially contracted state, defined by the state in which the porosity becomes zero, is governed by where L is the length of the second frame 12 in the radially contracted state.
  • the radius can only reduce by a factor of p.
  • p needs to be quite low (e.g. less than 90 %, preferably less than 80%, at least in a low porosity region, such as a region intended for positioning in use over the opening to an aneurismal sac)
  • this represents a significant limitation to the extent to which the second frame 12 can be narrowed for insertion into a delivery catheter.
  • Permitting an increase in length is also important for a frame comprising braided filaments.
  • a braided frame is unable to reduce in radius if its length cannot change due to its braided structure, and the greater the increase in length that is possible, the greater the possible reduction in radius.
  • Fig. 3 shows further detail of the expandable tube 2 in the radially expanded and longitudinally contracted state.
  • the expandable tube 2 comprises a first frame 10, preferably comprising braided filament, and a second frame 12.
  • Fig. 4 depicts the expandable tube 2 of Fig. 3 in the radially contracted and longitudinally expanded state. In Fig. 4 , both the first frame 10 and the second frame 12 have contracted radially and expanded longitudinally relative to their states in Fig. 3.
  • FIG. 5 shows the expandable tube in the radially expanded and longitudinally contracted state, i.e. the state shown schematically in Fig. 3.
  • the first frame 10 comprising braided filaments and the structure of the second frame 12 can be clearly seen.
  • the first frame 10 preferably comprises braided filament.
  • the first frame 10 may comprise a large number of filaments braided together.
  • the first frame 10 comprises a plurality of helically-arranged filaments.
  • the first frame 10 comprises filaments arranged in both right-handed helices and left-handed helices, preferably of equal diameter. In this way, the filaments of helices of opposing handedness overlap one another in the radial direction in order to form the braided structure of the first frame 10.
  • the filaments of the first frame 10 may have substantially the same diameter.
  • the filaments may comprise a mixture of filaments having different diameters and/or materials.
  • a mixture of filaments of different diameters may provide advantageous mechanical properties.
  • having some filaments, optionally larger-diameter filaments, made of radiopaque material would provide radiopacity to allow the expandable tube to be more easily located during implantation procedures, for example using fluoroscopic visualisation.
  • An individual filament in a helix of a first handedness may alternately pass under and over the filaments of helices of the second handedness (different from the first) in order to form the braided structure (under and over being interpreted as respectively closer to and further from the axis of the expandable tube 2 in the radial direction).
  • filaments in helices of the first handedness may pass alternately under and over pairs of filaments in helices of opposing handedness, or larger sets of filaments, such as three, four, or more filaments. Passing under and over multiple filaments of helices of opposing handedness may be advantageous in reducing the deformation of individual filaments, and reducing strain and friction between the filaments. However, passing under and over too many filaments at a time may reduce the integrity of the first frame 10.
  • the first frame 10, specifically the filaments of the first frame 10, may comprise a shape memory alloy material, preferably nitinol. Shape memory alloy material is advantageous in driving radial expansion of the first frame 10, as it can be configured to urge itself (self-expand) towards the radially expanded state.
  • the first frame 10 may comprise polymer, or other biocompatible material.
  • the first frame 10 may be independently self-expanding. That is, the first frame 10 is configured to self- expand from a radially contracted and longitudinally expanded state to a radially expanded and longitudinally contracted state, even in a state in which the first frame 10 is not connected to the second frame 12.
  • the filaments of the first frame 10 may comprise a radiopaque material, for example platinum.
  • the filaments of the first frame 10 comprise a core of radiopaque material inside a covering of another material.
  • the covering may be a shape memory alloy, preferably nitinol.
  • the filaments of the first frame 10 may comprise drawn-filled tube nitinol wire with a platinum core.
  • the covering material may also be chosen to have improved biocompatibility relative to the radiopaque core.
  • the covering material may also be chosen to have other advantageous properties, such as the self-expanding properties of shape-memory alloy.
  • stents used to treat aneurysms are their pore density, i.e. the number of pores in the wall of the tube per unit area. Increased pore density is associated with greater flow reduction within the aneurysm sac and more rapid re- endothelialisation of the stent by the blood vessel, both of which lead to better and more reliable patient outcomes. It has therefore been an aim of designers of stents for some time to increase pore density in stents.
  • pore density can be increased by using narrower filaments and increasing the filament count (the total number of filaments around the diameter of the frame).
  • narrower filaments are less stiff, and frames made from narrow filaments have poor expansion properties. Therefore, attempts to improve pore density in braided frames by using narrower filaments typically compound the already non-ideal expansion properties of braided frames.
  • the second frame 12 can expand more easily and consistently than the first frame 10. Consequently, the second frame 12 may be configured to drive the expandable tube 2 from the radially contracted and longitudinally expanded state to the radially expanded and longitudinally contracted state, i.e. such that the expansion properties of the expandable tube 2 are mainly determined by the second frame 12.
  • the advantageous expansion properties of the second frame 12 allow the first frame 10 to be made using filaments having a narrower diameter, because the first frame 10 is not relied on to cause the expansion of the expandable tube 2. Using filaments of narrower diameter allows the filament count of the first frame 10 to be increased relative to conventional braided stents without requiring an increase in the diameter of the expandable tube 2 in the radially contracted and longitudinally expanded state.
  • a maximum dimension in the radial direction of the expandable tube 2 may be such that the expandable tube 2 can be inserted into a catheter having an inner diameter of at most 1.0mm.
  • a maximum dimension in the radial direction of the expandable tube 2 is such that the expandable tube 2 can be inserted into a catheter having an inner diameter of 0.69mm (0.027 inches) or 0.53mm (0.021 inches), or less.
  • the first frame 10 comprises at least 48 filaments, preferably at least 64 filaments, more preferably at least 72 filaments, most preferably at least 96 filaments.
  • the filaments of the first frame 10 have a diameter of at most 30pm, preferably at most 25 m, more preferably at most 20pm.
  • the first frame 10 has a pore density of at least 20 pores/mm 2 , preferably at least 40 pores/mm 2 , more preferably at least 50 pores/mm 2 , most preferably at least 60 pores/mm 2 .
  • the braid angle i.e. the angle between the longitudinal direction of the first frame 10 and an individual filament of the first frame 10.
  • the bending flexibility of the braided filaments of the first frame 10 increases as the braid pitch decreases (i.e. as the braid angle increases). This is advantageous in allowing the expandable tube 2 to conform to the tortuous anatomy of blood vessels without exhibiting kinking.
  • a higher braid angle results in improved bending flexibility, smaller pores (permitting higher pore density), and improved longitudinal flexibility.
  • the braid angle is at least 50°, preferably in the range 50-80°.
  • Dual layer stents have previously been considered. However, existing designs have both layers made from conventional braided filament layers. Some advantages are provided by such a design. However, two braided layers do not have the same improvements in reliability and consistency of expansion that are provided by having one braided frame and one frame of non-overlapping elements.
  • each filament overlaps with the other filaments at crossing points.
  • This results in a cross-section profile i.e. an effective thickness of the wall of the frame in the radial direction
  • the cross-section profile is further increased to 2*filament diameter of inner frame + 2*filament diameter of outer frame.
  • This increased cross- sectional profile is associated with higher thrombogenicity and is undesirable.
  • the present invention can have a reduced cross-sectional profile due to its ability to use thinner filaments and inclusion of the second frame 12 comprising non-overlapping elements.
  • the first frame 10 may have a porosity such as to redirect blood flow away from the aneurismal sac and thereby promote thrombus formation in the aneurismal sac.
  • the first frame 10 may have a porosity of at most 90%, preferably at most 80%, more preferably at most 70%, more preferably at most 60%, most preferably at most 50%, in the radially expanded and longitudinally contracted state of the expandable tube.
  • Porosity may also be expressed in terms of surface coverage, which is inverse to porosity (i.e. a surface coverage of 90% indicates porosity of 10%).
  • the expandable tube 2 further comprises a second frame 12.
  • the second frame 12 comprises a network of non-overlapping elements, wherein the non-overlapping elements are non-overlapping with respect to each other in the radial direction. This is not the case for the braided filaments of the first frame 10, which overlap with one another in a radial direction.
  • An exemplary design of the network of non-overlapping elements is shown in Figs. 6 and 8.
  • the network of non-overlapping elements may be integrally formed, i.e. the nonoverlapping elements are connected together to form the network such that there are no material interfaces between any of the elements. This may be achieved by forming the second frame 12 for example by laser cutting a hollow tube, or by other techniques known in the art for manufacturing such structures. Forming the network of non-overlapping elements integrally is preferred because there are no joins between elements that could increase friction, create likely points of failure or similar. However, it is not essential, and the network of non-overlapping elements may be formed by, for example, welding together a plurality of individual elements or similar.
  • the second frame 12, and specifically the non-overlapping elements may comprise a shape memory alloy material, preferably nitinol.
  • the second frame 12 may have a porosity of at least 70%, preferably at least 80%, preferably at least 85%, more preferably at least 90%, most preferably at least 95%. This allows the second frame 12 to have a less dense network of non-overlapping elements, thereby reducing the likelihood of elements interfering with one another during expansion and contraction of the frame, and simplifying the design of the network. It also means that the porosity of the expandable tube 2 as a whole is determined more completely by the first frame 10 alone, thereby allowing the determination of the overall properties of the expandable tube 2 to be simplified.
  • the second frame 12 may be independently self-expanding. That is, the second frame 12 is configured to self-expand from a radially contracted and longitudinally expanded state to a radially expanded and longitudinally contracted state, even in a state in which the second frame 12 is not connected to the first frame 10.
  • the network of non-overlapping elements of the second frame 12 has an interconnected structure comprising a plurality of sub-units that repeat in the longitudinal direction.
  • This feature has the advantage that the length of the expandable tube 2 can be easily changed to suit any particular application by adding more sub-units. Longitudinally- adjacent sub-units may have mirror symmetry in a plane perpendicular to the longitudinal axis of the expandable tube 2.
  • Each sub-unit of the second frame 12 defines a closed cell 32.
  • Fig. 6 shows two adjacent closed cells 32 of the second frame 12.
  • the closed cell 32 is an area around the circumference of the second frame 12 enclosed by the non-overlapping elements. In other words, the closed cell 32 is a part of the external surface area of the second frame 12, delimited by the network of non-overlapping elements.
  • the closed cell 32 In the radially expanded and longitudinally contracted state, the closed cell 32 has a bulbous region 34 in which the closed cell 32 widens towards a circumferential end of the closed cell 32 and away from a circumferentially central region of the closed cell 32.
  • the closed cell 32 may widen by at least 20% in the bulbous region 34, preferably at least 40%, more preferably at least 60%.
  • the circumferential end refers to an end of the closed cell 32 in a circumferential direction around the second frame 12, i.e. around the external surface of the second frame 12.
  • the circumferentially central region is a region between (for example approximately equidistant between) the circumferential ends of the closed cell 32 in a circumferential direction.
  • the closed cell 32 may comprise two bulbous regions 34 at opposite circumferential ends of the closed cell 32.
  • the network of nonoverlapping elements comprises a series of s-shaped sections.
  • the closed-cell design of the second frame 12 provide greater torsional stiffness and resistance to twisting.
  • the closed cell 32 may have mirror symmetry in one or both of a plane parallel to the longitudinal axis of the expandable tube 2 and a plane perpendicular to the longitudinal axis of the expandable tube 2.
  • the closed cells 32 have mirror symmetry in a plane defined by the longitudinal axis of the expandable tube and a line drawn through every other connection point 30 along the longitudinally-extending members.
  • the closed cells 32 of Fig. 6 also have mirror symmetry in a plane perpendicular to the longitudinal axis of the expandable tube 2 drawn through the connection points 30 at opposite circumferential ends of the closed cell 32.
  • the network of non-overlapping elements may comprise a plurality of longitudinally-extending members 8 defining the interconnected structure.
  • the longitudinally-extending members 8 are longitudinally deformable. In the example of Fig. 6, this means that each closed cell 32 is defined by two circumferentially-adjacent longitudinally-extending members 8.
  • the longitudinally-extending members may be configured such that the angle labelled “A” in Fig. 6 is greater than 180 degrees. This means that, in the radially expanded and longitudinally contracted state, a path along each longitudinally-extending member 8 reverses longitudinal direction between consecutive connection points 30. In the radially-expanded and longitudinally-contracted state, a circumferential line exists for each sub-unit that intersects the longitudinally-extending member 8 three or more times. The circumferential line is preferably located at the midpoint between consecutive connection points 30 of the longitudinally-extending member 8, but will generally exist for a range of longitudinal positions around the midpoint as well depending on how much the longitudinal member curves back on itself between connection points.
  • Angle “A” being greater than 180 degrees enables a longer path length of the longitudinally-extending members 8 to be achieved.
  • Each sub-unit of the second frame 12 may define a plurality of closed cells 32 around a circumference of the second frame 12, so that the closed cells 32 repeat in the circumferential direction.
  • Circumferentially-adjacent closed cells 32 may be connected at connection points 30 (i.e. the non-overlapping elements delimiting the circumferentially- adjacent closed cells 32 are connected at connection points).
  • the second frame 12 comprises a plurality of longitudinally-extending members 8
  • the circumferentially- adjacent longitudinally-extending members 8 are connected at the connection points 30.
  • the structure of the network of non-overlapping elements may repeat itself in both the longitudinal and circumferential directions. Circumferential repetition of the cells allows the radius of the expandable tube 2 to be easily adjusted depending on the requirements of a particular application.
  • the non-overlapping elements may comprise straight portions 36 at the connection points 30.
  • the straight portion 36 has a length “L”.
  • the straight portion 36 minimizes deformation of the non-overlapping elements at the connection point 30. This can greatly reduce fatigue-related failure of the expandable tube 2, because the additional material and/or joints at the connection point 30 may not flex well.
  • a length of the straight portions 36 may be at least 0.05 mm, preferably at least 0.1 mm.
  • the straight portions 36 are preferably centred around the connection point 30.
  • the straight portion 36 need not be exactly straight, but the radius of curvature of the non-overlapping element in the straight portion 36 should be substantially larger than the radius of curvature of the non-overlapping element outside the straight portion 36, for example 25% larger, preferably 50% larger, more preferably 100% larger.
  • the non-overlapping elements do not curve too tightly immediately away from the straight portions 36, in order to further reduce the strain at the connection points 30.
  • a radius of curvature of the nonoverlapping elements adjacent to the straight portion 36 may be at least 0.3 mm, preferably at least 0.5 mm, most preferably at least 0.7 mm.
  • Circumferentially-adjacent closed cells 32 in each sub-unit may have mirror symmetry in a plane parallel to the longitudinal axis of the expandable tube 2.
  • the closed cells have mirror symmetry in such a plane defined by the longitudinal axis of the expandable tube and a line drawn through every other connection point along the longitudinally-extending members 8.
  • the second frame 12 may be configured such that, in the radially expanded and longitudinally contracted state, a radius of curvature of the longitudinally-extending member 8 decreases away from the connection points 30.
  • the decrease in the radius of curvature may be substantially continuous, or may be provided by two or more sections of the longitudinally-extending member 8 having different radii of curvature.
  • Circumferentially-adjacent closed cells 32 may be connected at the connection points 30 via bridges.
  • the bridges are preferably rigid bridges. Using a closed cell design with bridges connecting the longitudinally-extending members 8 provides greater longitudinal stiffness to the second frame 12. This allows the expandable tube 2 to be more easily pushed out from a delivery catheter by a delivery guide wire and can allow the expandable tube 2 to be delivered more easily and consistently from a wider range of designs of delivery systems.
  • the bridges preferably extend circumferentially.
  • the bridges may have a longitudinal length of at most 0.2mm, preferably 0.1 mm, more preferably at most 0.08mm, most preferably at most 0.05mm.
  • the bridges may have a circumferential length of at most 0.1 mm.
  • Fig. 7 demonstrates the process by which the expandable tube 2 switches to the radially contracted and longitudinally expanded state shown schematically in Fig. 4 from the radially expanded and longitudinally contracted state shown in Fig. 5.
  • the expandable tube 2 has been placed inside a tapered glass funnel so that its behaviour at varying levels of radial contraction and longitudinal expansion can be seen.
  • the expandable tube 2 has its maximum diameter, such that it can engage the walls of a blood vessel in which it is deployed. This corresponds to the state of the state in the radially-expanded region 40 of Fig. 7.
  • the porosity of the expandable tube 2 is maximal, because the spaces between filaments in the first frame 10 have their largest area.
  • the closed cells 32 of the second frame 12 have been elongated longitudinally and contracted circumferentially so that they no longer display the bulbous region 34 present in the radially expanded and longitudinally contracted state.
  • the expandable tube 2 has its minimum diameter such that it can be inserted into a catheter for deployment into a blood vessel.
  • the spaces between the filaments of the first frame 10 shift from diamonds with their long axes oriented circumferentially to diamonds with their long axes oriented longitudinally.
  • the closed cells 32 of the second frame 12 have further contracted circumferentially, and expanded longitudinally. As can be seen, most of the deformation of the longitudinally-extending members 8 occurs away from the connection points 30, thereby reducing the mechanical strain around the connection points 30.
  • Fig. 8 demonstrates some of the advantageous effects of the second frame 12 with closed cells 32 having bulbous regions 34.
  • the closed-cell structure provides greater torsional rigidity to resist twisting in tortuous anatomy.
  • Open cell designs can result in protrusion of the elements of the frame (struts) into the vessel lumen around bends. This can cause partial obstruction of the vessel lumen and may lead to thromboembolic complications.
  • the closed cell design also provides for improved apposition of the expandable tube 2 in tortuous anatomy, which is particularly useful in neurovascular applications.
  • the longer path length of the non-overlapping elements provided by the bulbous regions 34 in the in the closed cell design also improves bending flexibility on outer curves without requiring any substantial change in the diameter of the expandable tube 2.
  • the closed cells 32 can open on the outer curve and close on the inner curve without significant protrusion of the elements into the surrounding space.
  • Fig. 8 also shows that the second frame 12 may have flared ends (i.e. the diameter of the second frame 12 is increased in one or both end regions of the second frame 12).
  • the flared ends improve the engagement of the second frame 12 with the vessel walls, maintaining wall apposition around curve and preventing “fish mouthing” of the first frame 10. This is where the ends of the first frame 10 is not completely expanded in the radial direction as a consequence of poor radial force and poor conformability of the structure (especially where the first frame 10 comprises braided filament).
  • the second frame 12 is described herein as part of the expandable tube 2 comprising both the second frame 12 and the first frame 10.
  • the second frame 12 may also be provided independently of the first frame 10 as an expandable tube for deployment within a blood vessel. This may be preferred in some situations, for example where having low porosity of the expandable tube is less important.
  • the second frame 12 may have any of the applicable structural features described herein.
  • the second frame 12 When provided together with the first frame as part of the expandable tube 2, the second frame 12 overlaps with the first frame 10 in the radial direction. That is, for at least some points along the axis of elongation 4, a line perpendicular to the axis of elongation 4 will pass through both the first frame 10 and the second frame 12.
  • the second frame 12 may overlap with the first frame 10 over at least 50%, preferably at least 60%, more preferably at least 70%, most preferably at least 80%, of the length of the expandable tube
  • first frame 10 and second frame 12 overlap over substantially their entire length. Having substantial overlap between the first frame 10 and second frame 12 ensures that the properties of the expandable tube 2 are the same along the expandable tube 2, such that the behaviour of the expandable tube 2 is predictable.
  • first frame 10 and second frame 12 overlap over substantially their entire length. Having substantial overlap between the first frame 10 and second frame 12 ensures that the properties of the expandable tube 2 are the same along the expandable tube 2, such that the behaviour of the expandable tube 2 is predictable.
  • the second frame 12 is positioned within the first frame 10. However, this is not essential, and in other embodiments, the first frame 10 may be within the second frame 12. If the first frame 10 is within the second frame 12, this may further require that the second frame 12 is connected to the first frame 10 at one or more points along the length of the second frame 12.
  • the length of the second frame 12 may be at least 50%, preferably at least 60%, more preferably at least 70%, most preferably at least 80%, of the length of the first frame 10.
  • the first frame 10 and second frame 12 have substantially the same length. This can also contribute to ensuring the properties of the expandable tube 2 are consistent along the length of the expandable tube 2.
  • the requirements of overlapping and on the relative length of the first frame 10 and second frame 12 will also enable connecting the first frame 10 and second frame 12 together at the ends of the expandable tube 2, which may be preferred in some embodiments.
  • the second frame 12 is connected to the first frame 10.
  • the connection may be achieved in any suitable way.
  • the second frame 12 may be connected to the first frame 10 by at least one of welding, crimping, an adhesive, weaving or braiding, or encapsulation.
  • Connecting the first frame 10 and the second frame 12 at a point by encapsulation may be achieved by locally coating the first frame 10 and the second frame 12 together in a contiguous portion of a suitable material, such as a biocompatible polymer (for example PTFE).
  • a suitable material such as a biocompatible polymer (for example PTFE).
  • the second frame 12 is connected to the first frame 10 using connecting filaments 16.
  • Figs. 9 to 12 show various aspects of connecting the frames together using connecting filaments 16.
  • the design of the network of nonoverlapping elements of the second frame 12 differs in Figs. 10 to 12 from that discussed in relation to Figs. 6 to 8.
  • the methods of connecting the two frames are equally applicable to any design of the second frame 12.
  • the second frame 12 comprises a plurality of filament-receiving apertures 18.
  • One or more connecting filaments 16 are woven into the first frame 10, and each connecting filament 16 passes through one or more of the filament-receiving apertures 18.
  • connecting filaments 16 are to reduce the profile of the joining between the first and second frames 10, 12 compared to other methods such as crimping or welding, making the surface of the expandable tube 2 more uniform.
  • the filaments also enable joining of a laser-cut structure to a continuous braid (i.e. a braid with a continuous pitch). Further, the filaments 16 are able to deform during expansion and contraction of the expandable tube 2.
  • the use of connecting filaments 16 thereby enables a smooth transition between the radially-contracted and longitudinally-expanded state and the radially-expanded and longitudinally-contracted state, while fixing the first and second frames 10, 12 together at the locations of the filament-receiving apertures 18.
  • Fig. 9 shows an example of a longitudinal end region of the second frame 12 in an embodiment in which the plurality of filament-receiving apertures 18 comprises filamentreceiving apertures 18 in a longitudinal end region of the second frame 12.
  • the longitudinal end region may comprise a region within a distance of an end of the expandable tube 2 that is at most 10%, preferably at most 5% of the length of the expandable tube 2.
  • the second frame 12 may comprise filament-receiving apertures 18 in one or both end regions of the expandable tube 2.
  • the filament-receiving apertures 18 in the embodiment of Fig. 9 are located on the longitudinally most distal elements of the network of interconnected elements of the second frame 12.
  • filament-receiving apertures 18 in the embodiment of Fig. 9 are also located on the longitudinally most proximal elements of the network of interconnected elements of the second frame 12.
  • one or more connecting filaments 16 are woven into the first frame 10, and each connecting filament 16 passes through one or more of the filament-receiving apertures 18.
  • the second frame 12 comprises two filament-receiving apertures 18 on the same element of the second frame 12.
  • the angle between a line between the filament-receiving apertures 18 on the same element and the longitudinal axis 4 of the expandable tube 2 is preferably the same as the braid angle of the braided filaments of the first frame 10.
  • the connecting filaments 16 are woven into the first frame 10. In this way, the connecting filaments 16 alternately pass over and under the filaments of the first frame 10 (under and over being interpreted as respectively closer to and further from the axis of the expandable tube 2 in the radial direction). Other arrangements are also possible. For example, the connecting filaments 16 may pass alternately under and over pairs of filaments of the first frame 10, or larger sets of filaments, such as three, four, or more filaments. Passing under and over multiple filaments of the first frame 10 may be advantageous in reducing assembly time. Alternatively, passing under and over fewer filaments of the first frame 10 may be advantageous to increase the bond strength of the first frame 10 to the second frame 12.
  • the arrangement of the connecting filaments 16 may match the arrangement of the filaments of the first frame 10, or may be different. For example, if the connecting filaments 16 have a larger diameter than the filaments of the first frame 10, it may be desirable for the connecting filaments 16 to pass over and under larger sets of filaments of the first frame 10 than do the filaments of the first frame 10 themselves.
  • the connecting filaments 16 may be woven into the first frame 10 around a circumference of the first frame 10.
  • An example of such an embodiment is shown in Fig. 10.
  • the connecting filaments 16 bend at regular intervals to alternately follow the filaments of the right-handed helices and left-handed helices of the first frame 10.
  • the connecting filaments 16 may be bent to the desired shape before being woven into the first frame 10. This helps to retain the bends at the correct position and angle after the connecting filament 16 has been woven into the first frame 10.
  • the wire may be shape set to achieve the bending at the desired positions to facilitate the transition between radially contracted and radially expanded configurations.
  • the connecting filaments 16 are woven into the first frame 10 around a circumference of the first frame 10 may also improve the expansion properties of the expandable frame 2, as the connecting filaments 16 at the ends of the expandable tube 2 can contribute to encouraging radial expansion when the expandable tube 2 is deployed from a catheter.
  • the connecting filaments 16 may comprise the same material and/or have the same diameter as the filaments of the first frame 10.
  • the connecting filaments 16 comprise filaments of the first frame 10.
  • joining the first and second frames 10, 12 together may comprise unbraiding one or more filaments of the first frame 10 to use as the connecting filaments 16.
  • the connecting filaments 16 are then passed through the apertures 18 in the second frame 12 and woven back into the other braided filaments of the first frame 10.
  • the connecting filaments 16 may have a different diameter or be made of a different material to the filaments of the first frame 10.
  • the connecting filaments 16 may comprise nitinol wire.
  • the connecting filaments 16 may comprise materials typically used for medical sutures. In this embodiment, two ends of the suture can be tied to secure the two frames together.
  • the plurality of filament-receiving apertures 18 comprises filamentreceiving apertures 18 spaced along the length of the second frame 12.
  • the filamentreceiving apertures 18 may be spaced at intervals along the length of the second frame 12, preferably equal intervals.
  • the spacing between filament-receiving apertures 18 may be at most 50% of the length of the expandable tube 2, preferably at most 25%, more preferably at most 10%.
  • each longitudinally-expandable element 8 of the second frame 12 comprises a filament-receiving aperture.
  • Including filament-receiving apertures 18 spaced along the second frame 12 improves the attachment of the first and second frames 10, 12 to one another, reducing the chance of the two frames separating.
  • This also means that the connecting filaments 16 do not need to be bent in the manner shown in Fig. 10, but can instead follow the helical path of the braided filaments of the first frame 10 along the entire length of the first frame 10. This is advantageous because the connecting filaments 16 are under less tension than when bent.
  • Multiple connecting filaments 16 may be provided, following both the right-handed and left-handed helices of the braided filaments of the first frame 10.
  • the apertures 18 are arranged such that each connecting filament 16 follows the braid angle of the braided filaments of the first frame 10 as the connecting filament 16 passes through the apertures 18.
  • the angle between a line between the filament-receiving apertures 18 on the same element and the longitudinal axis 4 of the expandable tube 2 is preferably the same as the braid angle of the braided filaments of the first frame 10. This also reduces unnecessary bending of the connecting filaments 16 and reduces tension in the connecting filaments 16.
  • the connecting filaments 16 may contribute to improving the visibility of the expandable tube 2 during deployment.
  • the connecting filaments 16 may comprise a radiopaque material.
  • one or more radiopaque markers 19 may be attached to one or more of the connecting filaments 16.
  • the connection should be achieved in a way which is biocompatible, so that it does not affect the ability of the expandable tube 2 to be inserted into the body of a human or animal.
  • the expandable tube 2 may be left in the body for an extended time after deployment, typically indefinitely. It is therefore also important that any materials used for connection are biocompatible.
  • the second frame 12 may be connected to the first frame 10 at least at one end of the second frame 12. Connection at the end of the second frame 12 may be convenient because the ends of elements of the second frame 12 can be joined to the first frame 10, for example to ends of the filaments of the first frame 10.
  • the second frame 12 may be further connected to the first frame 10 at one or more points along the length of the second frame 12. Joining the first frame 10 and second frame 12 at further points along the length of the second frame 12 will contribute to preventing the first frame 10 and second frame 12 from separating at any point along the length of the expandable tube 2, or buckling or creasing. This is particularly relevant when the expandable tube 2 is expanding or contracting. Separation of the first frame 10 and second frame 12 could cause incorrect deployment of or damage to the expandable tube 2. However, joining at multiple points along the length of the expandable tube 2 would increase the complexity of manufacture of the expandable tube 2, and so may not be preferred in all embodiments.
  • the connection between the first frame 10 and the second frame 12 may also be designed to reduce the likelihood of damaging a blood vessel into which the expandable tube 2 is deployed.
  • the ends of the braided filaments of the first frame 10 and the elements of the second frame 12 may be contained in a terminating element.
  • the terminating element is configured to reduce the likelihood of damage to the interior of a blood vessel, for example by preventing any sharp points at the ends of filaments or other sharp surfaces from coming into contact with the interior walls of a blood vessel.
  • the terminating element itself may have smooth and/or curved surfaces to prevent any damage to the blood vessel.
  • the second frame 12 is configured to drive the expandable tube 2 from the radially contracted and longitudinally expanded state to the radially expanded and longitudinally contracted state.
  • a problem with prior art expandable tubes composed only of braided filaments is that they do not always expand uniformly or reliably due to friction between the filaments.
  • the second frame 12 which is configured to drive the expandable tube 2 to expand radially and contract longitudinally, the behaviour of the expandable tube 2 can be made more reliable and consistent.
  • the second frame 12 is configured to drive the expandable tube 2 from the radially contracted and longitudinally expanded state to the radially expanded and longitudinally contracted state by exerting a force on the first frame 10 in a radial direction.
  • Consistent radial expansion is important such that the expandable tube 2 expands to its final size and engages with the interior walls of the blood vessel in which it is deployed.
  • the second frame 12 may drive the expandable tube 2 from the radially contracted and longitudinally expanded state to the radially expanded and longitudinally contracted state by exerting a force on the first frame 10 in a longitudinal direction.
  • this is not generally preferred, because the drive to expand the expandable tube 2 radially is then only indirect, and may not have as great an improvement in the consistency of radial expansion on deployment.
  • a radius of the second frame 12 in an unconstrained state in which the second frame 12 is not connected to the first frame 10 and the second frame 12 is radially expanded and longitudinally contracted is greater than a radius of the first frame 10 in an unconstrained state in which the first frame 10 is not connected to the second frame 12 and the first frame 10 is radially expanded and longitudinally contracted.
  • Both the first frame 10 and second frame 12 are configured to urge themselves towards a radially expanded and longitudinally contracted state, and will have a maximum radius that they attain when unconstrained.
  • their respective maximum radii in the radially expanded and longitudinally contracted state of the expandable tube 2 will be constrained to be the same, i.e.
  • the second frame 12 By designing the second frame 12 such that its radius in an unconstrained state is larger than that of the first frame 10 in an unconstrained state, the second frame 12 will drive the first frame 10 to expand to its maximum radius and minimise the risk of radial separation between the two frames, particularly when deployed in tortuous anatomy. This will improve the consistency of the radial expansion of the first frame 10, which comprises braided filaments. This feature also means that fewer fixation points are required to join the two frames together securely.
  • At least one of the first frame 10 and the second frame 12 may be provided with a hydrophilic coating and/or an anti -thrombotic coating.
  • This multi-layered expandable tube 2 design comprising a first frame 10 and a second frame 12 relies on the first frame 10 and second frame 12 longitudinally expanding and contracting, and radially expanding and contracting, together with each other.
  • the extent of longitudinal and radial expansion and contraction of the expandable tube 2 is determined primarily by the braided structure of the first frame 10, and the second frame 12, for example containing longitudinally and circumferentially independent elements, adapts to the longitudinal and radial movement of the braided structure.
  • a first elongation ratio of the first frame 10 is within 25%, preferably within 15%, more preferably within 10%, most preferably within 5%, of a second elongation ratio of the second frame 12.
  • the first elongation ratio of the first frame 10 is a ratio between an unconstrained length of the first frame 10 and the length of the first frame 10 in the radially contracted and longitudinally expanded state.
  • the unconstrained length of the first frame is the length of the first frame 10 in an unconstrained state in which the first frame 10 is not connected to the second frame 12 and the first frame 10 is radially expanded and longitudinally contracted.
  • the second elongation ratio is a ratio between an unconstrained length of the second frame 12 and the length of the second frame 12 in the radially contracted and longitudinally expanded state.
  • the unconstrained length of the second frame 12 is the length of the second frame 12 in an unconstrained state in which the second frame 12 is not connected to the first frame 10 and the second frame 12 is radially expanded and longitudinally contracted.
  • the radially contracted and longitudinally expanded state referred to is that of the first frame 10 or second frame 12 when it is part of the expandable tube 2 (i.e. connected to the second frame 12) and the expandable tube 2 is in its radially contracted and longitudinally expanded state. This may be, for example, when the expandable tube 2 is inside a catheter ready to be deployed.
  • the first method outlines a detailed approach by determining length and height change of a single pore of the first frame 10 between the radially expanded and longitudinally contracted state and the radially contracted and longitudinally expanded state.
  • a pore is a single space defined by neighbouring filaments in the first frame 10, as illustrated schematically in Fig. 13.
  • the radially contracted and longitudinally expanded state may also be referred to as the loaded state, since this is the state of the expandable tube 2 when it is loaded into a catheter prior to deployment into a blood vessel.
  • the second method offers a more simplistic approach to estimate the total length change of the first frame 10 between the radially expanded and longitudinally contracted state and the radially contracted and longitudinally expanded state.
  • the first method starts with the diameter 0 expanded °f the expandable tube 2 in the radially expanded and longitudinally contracted state, as seen in Fig. 14(a), and the braid angle, Obraid-
  • the braid angle Obraid is the angle between the longitudinal direction of the first frame 10 and an individual filament of the first frame 10. This angle will change depending on whether the expandable tube 2 is in the radially expanded and longitudinally contracted state, or the radially contracted and longitudinally expanded state.
  • the circumference of the expandable tube 2 C can then be calculated using Eq. 1.
  • the circumferential distance, D c , between the filaments in the first frame 10 can be calculated using Eq. 2.
  • N wire is the number of filaments in the first frame 10.
  • the pores of the first frame 10 have a rhombus shape with the length of each side of the pore remaining constant as the diameter of the first frame 10 reduces, resulting in a decrease in pore height and an increase in pore length, as shown in Fig. 13(b).
  • the longitudinal length of a pore, L pore is calculated using Eq. 3.
  • the circumferential height of a pore, H pore can be calculated using Eq. 4.
  • N c The total number of pores around the circumference, N c , can be calculated using Eq. 5.
  • the total number of pores in a single row along the length of the first frame 10, N h can be calculated using Eq. 6.
  • L expanded is the length of the first frame 10 in the radially expanded and longitudinally contracted state, as seen in Fig. 14(a).
  • N c the circumferential height of each pore in the loaded state, Hi oaded , can be calculated using Eq. 7.
  • D catheter is the internal diameter that the expandable tube 2 must be reduced to for deployment, e.g. the internal diameter of the delivery catheter.
  • the braid angle in the loaded state Graded can be calculated using Eq. 8.
  • the length of the first frame 10 in the loaded state, Li oaded , as seen in Fig. 14(b), can then be calculated using Eq. 10.
  • the first elongation ratio, e can be determined using Eq. 11.
  • the second method is a more simplistic approach applied to estimate the elongation ratio of the first frame 10 assuming the length of an individual filament in the first frame 10 is equal to the length of the first frame 10 in the loaded state.
  • the first step is to calculate the pitch P of a helix with a known braid angle, G braid , and circumference C using Eq. 12.
  • the number of turns N turns per filament in the first frame 10 can be determined for a defined length in the radially expanded and longitudinally contracted state, L expanded , using Eq. 13.
  • Eq. 11 can be used to determine the first elongation ratio. Additionally, the number of sub-units, N ce n s , can be determined by applying Eq. 15.
  • the number of sub-units in the second frame 12 should be a whole number, and this must be taken into account when choosing the parameters of the first frame 10 to ensure that the lengths remain the same for the first frame 10 and second frame 12 in both the radially expanded and longitudinally contracted state and the radially contracted and longitudinally expanded state.
  • the second frame 12 is designed to match the diameter and length change characteristics of the first frame 10 to ensure uniform performance of the expandable tube 2. This is done for embodiments where the sub-units of the network of non-overlapping elements of the second frame 12 that repeat in the longitudinal direction themselves comprise a plurality of cells that repeat in the circumferential direction (as described above).
  • Fig. 15 shows the smallest repeating unit of the closed cell design shown in Figs. 5- 9. This repeating unit is repeated longitudinally to create the longitudinally-extending members 8, which are themselves repeated circumferentially to form the complete second frame 12. Note that for this reason, the smallest repeating unit is not the same as the subunits of the second frame 12, because each smallest repeating unit does not alone define a closed cell 32.
  • the cell length L ce u is given by where L path is the path length along the smallest repeating unit, and e is the first elongation ratio of the first frame as above.
  • the half-cell height H ce u as seen in Fig. 15 (i.e. half the circumferential height of a single closed cell 32) is given by where C is the circumference of the expandable tube 2.
  • the longitudinally-extending members 8 are designed to match the elongation of the first frame 10 by ensuring that the path length along each longitudinally- extending member 8, L path , and the first length L ce u (i.e. the longitudinal length of each smallest repeating unit in the radially expanded and longitudinally contracted state) are in proportion to the first elongation ratio of the first frame 10.
  • a ratio between the first length and the path length along each longitudinally deformable element 8 is within 25%, preferably within 15%, more preferably within 10%, most preferably within 5%, of the first elongation ratio.
  • the expandable tube 2 may be configured for use in a delivery system 20 such as that shown in Fig. 16.
  • the delivery system 20 comprises a tubular member 24, also referred to as a catheter, and an elongate body 22, also referred to as a guide wire.
  • the elongate body 22 is positioned within the tubular member 24, and the expandable tube 2 is positioned between the tubular member 24 and the elongate body 22.
  • the expandable tube 2 engages inwardly with the elongate body 22 and outwardly with the tubular member 24.
  • the delivery system 20 is positioned at an appropriate location near an aneurysm in a blood vessel, and the elongate body 22 is extended beyond the end of the tubular member 24.
  • the longitudinal engagement forces between the elongate body 22 and the expandable tube 2 and between the expandable tube 2 and the tubular member 24 are such that the expandable tube is also moved longitudinally and deployed out of the tubular member 24.
  • the expandable tube 2 expands radially and contracts longitudinally, thereby disengaging from the elongate body 22 and deploying into the blood vessel. Once the expandable tube 2 is fully deployed out of the tubular member 24, the delivery system 20 can be withdrawn from the blood vessel, leaving the expandable tube 2 in place.
  • Fig. 17 demonstrates the deployment of the expandable tube 2 using a delivery system such as that of Fig. 16 into a model of a blood vessel.
  • the expandable tube is still fully contained within the tubular member 24.
  • a distal part of the expandable tube 2 has been deployed from the tubular member 24, while a proximal part remains within the tubular member 24.
  • the elongate body 22 has been extended further beyond the end of the tubular member 24 to deploy the expandable tube 2.
  • the expandable tube 2 is fully deployed and released from the delivery system entirely. The tubular member 24 and elongate body 22 can then be withdrawn from the vessel, leaving the expandable tube 2 in place.
  • the expandable tube 2 may also be used with other suitable types of conventional delivery system.
  • the expandable tube 2 may be deployed using a delivery system which does not comprise an elongate body that engages outwardly with the expandable tube 2.
  • the expandable tube 2 may be deployed using a delivery system that pushes the expandable tube 2 from the proximal end.
  • This type of delivery system is often not suitable for expandable tubes comprising a network of non-overlapping elements. This is particularly true when those expandable tubes are designed to have high longitudinal flexibility, e.g. for use in neurovascular applications, and therefore have poor longitudinal stiffness.
  • the hybrid design of the present expandable tube 2 allows deployment using this type of delivery system because of the higher filament density afforded by the first frame 10.
  • An expandable tube for deployment within a blood vessel, the expandable tube being reversibly switchable from a radially contracted and longitudinally expanded state to a radially expanded and longitudinally contracted state, the expandable tube comprising: a first frame; and a second frame connected to the first frame and overlapping with the first frame in the radial direction, the second frame comprising a network of non-overlapping elements, the non-overlapping elements being non-overlapping with respect to each other in the radial direction, wherein: the network of non-overlapping elements has an interconnected structure comprising a plurality of sub-units that repeat in the longitudinal direction; each sub-unit of the second frame defines a closed cell; and in the radially expanded and longitudinally contracted state, the closed cell has a bulbous region in which the closed cell widens towards a circumferential end of the closed cell and away from a circumferentially central region of the closed cell.
  • the second frame comprises a plurality of filament-receiving apertures; one or more connecting filaments are woven into the first frame; and each connecting filament passes through one or more of the filament-receiving apertures.
  • a first elongation ratio of the first frame is within 25% of a second elongation ratio of the second frame, the first elongation ratio being a ratio between the length of the first frame in an unconstrained state in which the first frame is not connected to the second frame and the first frame is radially expanded and longitudinally contracted and the length of the first frame in the radially contracted and longitudinally expanded state, and the second elongation ratio being a ratio between the length of the second frame in an unconstrained state in which the second frame is not connected to the first frame and the second frame is radially expanded and longitudinally contracted and the length of the second frame in the radially contracted and longitudinally expanded state.
  • the network of non-overlapping elements comprises a plurality of longitudinally deformable elements for providing longitudinal expansion and contraction of the second frame; each smallest repeating unit of the network of non-overlapping elements has a first length in the longitudinal direction in the unconstrained state in which the second frame is not connected to the first frame and the second frame is radially expanded and longitudinally contracted state; and a ratio between the first length and a path length along each longitudinally deformable element is within 25% of the first elongation ratio.
  • the first frame comprises a shape memory alloy material, preferably nitinol.
  • the first frame has a porosity such as to redirect blood flow away from the aneurismal sac and thereby promote thrombus formation in the aneurismal sac.
  • the expandable tube of any preceding clause wherein in the radially contracted and longitudinally expanded state, the expandable tube has a maximum dimension in the radial direction that is at least 30% smaller than the maximum dimension in the radial direction of the expandable tube in the radially expanded and longitudinally contracted state.

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  • Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Cardiology (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Transplantation (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Vascular Medicine (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Prostheses (AREA)
  • Materials For Medical Uses (AREA)

Abstract

Tube extensible destiné à être déployé à l'intérieur d'un vaisseau sanguin pouvant être commuté de manière réversible d'un état radialement contracté et déployé longitudinalement à un état radialement déployé et contracté longitudinalement. Le tube extensible comprend un premier cadre, et un second cadre relié au premier cadre et chevauchant le premier cadre dans la direction radiale. Le second cadre comprend un réseau d'éléments non chevauchants, les éléments non chevauchants ne se chevauchant pas les uns par rapport aux autres dans la direction radiale. Le réseau d'éléments non chevauchants a une structure interconnectée comprenant une pluralité de sous-unités qui se répètent dans la direction longitudinale. Chaque sous-unité du second cadre définit une cellule fermée, et dans l'état radialement déployé et contracté longitudinalement, la cellule fermée a une région bulbeuse dans laquelle la cellule fermée s'élargit vers une extrémité circonférentielle de la cellule fermée et à l'opposé d'une région centrale circonférentielle de la cellule fermée.
PCT/GB2023/051647 2022-07-04 2023-06-23 Tube extensible destiné à être déployé à l'intérieur d'un vaisseau sanguin WO2024009055A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
GB2209796.8 2022-07-04
GBGB2209796.8A GB202209796D0 (en) 2022-07-04 2022-07-04 An expandable tube for deployment within a blood vessel

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WO2024009055A1 true WO2024009055A1 (fr) 2024-01-11

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AR (1) AR129698A1 (fr)
GB (1) GB202209796D0 (fr)
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Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20080140172A1 (en) * 2004-12-13 2008-06-12 Robert Hunt Carpenter Multi-Wall Expandable Device Capable Of Drug Delivery Related Applications
US20090248137A1 (en) * 2001-09-11 2009-10-01 Xtent, Inc. Expandable stent
WO2021234340A1 (fr) * 2020-05-20 2021-11-25 Oxford Endovascular Ltd. Tube extensible destiné à être déployé à l'intérieur d'un vaisseau sanguin

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20090248137A1 (en) * 2001-09-11 2009-10-01 Xtent, Inc. Expandable stent
US20080140172A1 (en) * 2004-12-13 2008-06-12 Robert Hunt Carpenter Multi-Wall Expandable Device Capable Of Drug Delivery Related Applications
WO2021234340A1 (fr) * 2020-05-20 2021-11-25 Oxford Endovascular Ltd. Tube extensible destiné à être déployé à l'intérieur d'un vaisseau sanguin

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AR129698A1 (es) 2024-09-18
GB202209796D0 (en) 2022-08-17

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