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WO2025193869A1 - Système de pose de stent - Google Patents

Système de pose de stent

Info

Publication number
WO2025193869A1
WO2025193869A1 PCT/US2025/019630 US2025019630W WO2025193869A1 WO 2025193869 A1 WO2025193869 A1 WO 2025193869A1 US 2025019630 W US2025019630 W US 2025019630W WO 2025193869 A1 WO2025193869 A1 WO 2025193869A1
Authority
WO
WIPO (PCT)
Prior art keywords
stent
catheter
pads
pusher
wire
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Pending
Application number
PCT/US2025/019630
Other languages
English (en)
Inventor
Eric LARGEN
Ujwal Jalgaonkar
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Balt Usa LLC
Original Assignee
Balt Usa LLC
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 Balt Usa LLC filed Critical Balt Usa LLC
Publication of WO2025193869A1 publication Critical patent/WO2025193869A1/fr
Pending legal-status Critical Current
Anticipated expiration legal-status Critical

Links

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
    • A61F2/95—Instruments specially adapted for placement or removal of stents or stent-grafts
    • A61F2/962—Instruments specially adapted for placement or removal of stents or stent-grafts having an outer sleeve
    • A61F2/966—Instruments specially adapted for placement or removal of stents or stent-grafts having an outer sleeve with relative longitudinal movement between outer sleeve and prosthesis, e.g. using a push rod
    • 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
    • A61F2/95—Instruments specially adapted for placement or removal of stents or stent-grafts
    • A61F2/9517—Instruments specially adapted for placement or removal of stents or stent-grafts handle assemblies therefor
    • 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
    • A61F2/95—Instruments specially adapted for placement or removal of stents or stent-grafts
    • A61F2/962—Instruments specially adapted for placement or removal of stents or stent-grafts having an outer sleeve
    • A61F2/966—Instruments specially adapted for placement or removal of stents or stent-grafts having an outer sleeve with relative longitudinal movement between outer sleeve and prosthesis, e.g. using a push rod
    • A61F2002/9665—Instruments specially adapted for placement or removal of stents or stent-grafts having an outer sleeve with relative longitudinal movement between outer sleeve and prosthesis, e.g. using a push rod with additional retaining means

Definitions

  • Stents play an essential role in vascular surgical and interventional procedures to keep weakened or narrowed vessels open for the flow of oxygen rich blood and other fluids throughout the body and its organs.
  • delivery and deployment of stents into the lumen of blood vessels may be difficult to control, position, and release, as the stents may become lodged or displaced within a catheter used for delivery, deployment and redeployment.
  • the wires forming a stent may become entangled within the catheter when deploying or redeploying/repositioning the stent.
  • This disclosure relates generally to stent delivery and deployment and redeployment/repositioning, including via a catheter and pusher wire to traverse and engage with the stent via pads on the pusher wire that wires at proximal and distal ends of a stent may collapse down and partially or fully imbed into, addressing a need for secure attachment and control of a stent during delivery and deployment within vasculature.
  • a pusher may advance the pusher wire and the stent to which it is coupled during deployment, for example out of an end of a catheter. Described herein is a self-expanding stent that may be used for intracranial vessels and reconstruction of wide-necked post-carotid siphon aneurysms.
  • This disclosure also includes frictional fit mechanisms for holding stents in place within a catheter and improved detachment mechanisms that increase the reliability of stent detachment for deployment.
  • the frictional fit mechanisms and detachment mechanisms utilize pads having heat pre-treatment to grip wires of the stent.
  • stent delivery systems comprising: a selfexpanding stent comprising a plurality of wire lengths; a flexible catheter configured to receive the stent, having a distal end; and a pusher wire comprising a plurality of discrete pads arranged along a distal end region of the pusher, in which the pusher wire extends through the catheter and through the stent to extend distally out of the catheter, and in which the stent is collapsed down onto the multiple pads on the pusher wire wherein the plurality of wire lengths of the stent are heat treated to be at least partially embedded into each of the plurality of discrete pads, further in which one of the plurality of discrete pads is engaged with a distal end of the stent and two or more of the plurality of discrete pads are engaged with a proximal end region of the stent, in which the pusher
  • the plurality of discrete pads are formed of a low-durometer material.
  • the pads may be affixed to the pusher.
  • the pads may be configured to extend complexly or partially around the pusher.
  • the pads may be configured as sleeves, e.g., annular sleeves, that extend around the circumference of the pusher.
  • the stent comprises between 16 and 60 wire lengths.
  • the heat treatment allows the wires of the stent to disengage from the multiple pads to deploy the stent.
  • the plurality of discrete pads comprises between 3 and 12 (e.g., between 3 and 10, between 3 and 9, between 3 and 8, etc.).
  • the plurality of discrete pads are configured so that friction between the plurality of discrete pads and an inner lumen of the flexible catheter is less than friction between the plurality of discrete pads and the plurality of wire lengths of the stent.
  • the stent is held in a collapsed form in a distal end of the catheter prior to deployment of the stent.
  • the friction between the plurality of discrete pads and the plurality of wire lengths of the stent is greater than a friction between the plurality of discrete pads and the inner surface of the catheter.
  • the stent is configured to self-expand during release from the plurality of discrete pads as the stent is pushed out of the distal end of the catheter by the pusher wire.
  • the stent is configured to be pulled back into the catheter before it is fully deployed out of the catheter, wherein the stent is further configured to collapse back onto the plurality of discrete pads for repositioning of the stent.
  • 90% of the stent may be deployed outside of the catheter before the stent cannot be pulled back into the catheter.
  • one or more of the plurality of discrete pads remain engaged with the distal end of the catheter after the catheter is deployed, wherein the one or more of the plurality of discrete pads prevent the catheter from deforming.
  • a plurality of discrete pads are spaced apart from each other by between about 0.5 and 5 mm.
  • the plurality of discrete pads each have a constant diameter.
  • FIG. 3 is another view of a stent.
  • FIG. 4B is a view of a stent deformed at proximal and distal ends due to improper heat treatment.
  • FIG. 5A is an exemplary schematic view of pads on a pusher wire.
  • FIGS. 5B and 5C illustrate additional exemplary views of stent assemblies.
  • FIGS. 5D-5F illustrate additional exemplary views of stent assemblies.
  • FIG. 6A shows an example of a pad on a pusher wire.
  • FIG. 6B shows multiple pads on a pusher wire.
  • FIG. 7 depicts stent wire imprints on a pad.
  • FIGS. 8A-8B illustrates one example of a stent that may be used with any of the apparatuses descried herein.
  • Described herein are methods and apparatuses (e.g., systems and devices) that may address the need for reliable and effective stent delivery, including stent release, from a catheter via a pusher wire extending through the catheter and stent.
  • methods and apparatuses that may include a pusher wire having a plurality of discrete pads arranged along a distal end region of the pusher that are configured to reversibly embed a plurality of wire lengths.
  • One or more (e.g., two or more, three or more, etc.) of the plurality of pads may engage a proximal end of the stent and one or more (e.g., two or more, three or more, etc.) of the plurality of pads may engage at a distal end region of the stent.
  • the pads may be configured to be sufficiently resilient to allow for deforming and/or embedding of the stent wire into the pad while the pad is within the lumen of the catheter (e.g., delivery catheter, deployment catheter, etc.), but may release the sent wires to allow them to radially expand when deploying the stent outside of the catheter.
  • the pad may be comprised of a material having a durometer that is appropriate for embedding the wires of the stent, and for controlling the friction between the stent, the pusher and the walls of the catheter.
  • the pusher wire (“pusher”) may deploy the stent out of the distal end of the catheter through distal motion and in some cases may be configured to reposition the stent, e.g., recapturing the stent into the catheter.
  • any of the apparatuses described herein may include pads that extend partially or fully around the pusher.
  • any of these apparatuses may have pads configured as annular sleeves on the pusher that extend completely radially around the perimeter of the pusher.
  • the pads may extend only partially around the pusher, e.g., at certain radial positions, such as at two or more (e.g., 3 or more, 4 or more, 5 or more, 6 or more, etc.) spaced-apart positions radially around the perimeter of the pusher; these positions may be equally spaced.
  • the pad may include one or more pad contact surfaces that are deformable by the stent (e.g., formed of a low-durometer material) that are arranged radially around the pusher.
  • a stent delivery system may include a stent, a catheter configure to receive and deliver the stent and a pusher wire within the stent to deploy (and in some cases, reposition, e.g., recapture and re-deploy) the stent.
  • a stent delivery system may include a stent, a catheter configure to receive and deliver the stent and a pusher wire within the stent to deploy (and in some cases, reposition, e.g., recapture and re-deploy) the stent.
  • Any appropriate stent may be used.
  • the stent may be a self-expanding stent comprising a plurality of wire lengths (e.g., between 15 wires and 48 wires, e.g., between 16 wires and 36 wires, between 16 wires and 30 wires, etc.).
  • the stent may be any appropriate material, including in particular, an alloy of nickel titanium (e.g., Nitinol).
  • the stent may be any appropriate length, e.g., between 30 mm and 80mm (e.g., between 40 mm and 60 mm, between 40 mm and 50 mm, etc.).
  • the catheter may be a flexible catheter that is configured to receive the stent.
  • the catheter receive and/or deploy the stent from the distal end of the catheter.
  • the pusher may be configured as a pusher wire that includes a plurality of discrete pads arranged along a distal end region of the pusher in a configuration that releasably engages with the wires of the stent, e.g., to embed the wires within the low-durometer material of the pads.
  • the pads may be partially or completely annular; in some cases, the pads may be annular pads along the pusher.
  • the pusher wire may extend through the catheter and through the stent to extend distally out of the catheter.
  • the stent may be collapsed down onto the multiple pads on the pusher wire, and as mentioned, may elastically embed into the material of the pad.
  • the pads may be formed of a material having a durometer of less than about 40 Shore A (e.g., 35 or less ShoreA, 30 or less ShoreA, 25 or less Shore A, 20 or less Shore A, 10 or less Shore A, 50 or less ShoreOO, 40 or less ShoreOO, 20 or less ShoreOO, 10 or less Shore 00, between about 5 and 60 Shore 00, between about 5 and 55 Shore 00, between about 5 and 50 Shore 00, between about 5 and 40 Shore 00, between about 5 and 35 Shore 00, between about 5 and 30 Shore 00, etc.).
  • the plurality of wire lengths of the stent may be treated (e.g., heat treated) to be at least partially embedded into each of the plurality of discrete pads.
  • the pad material may be any appropriate material.
  • the pad material comprises a silicone material.
  • the pads may be arranged on the pusher wire so that they engage with both the proximal and distal ends of the stent when the stent is within the catheter.
  • the distal end of the stent may be engaged with one or more of the plurality of discrete pads and the proximal end region of the stent may be engaged with two or more of the plurality of discrete pads.
  • the pusher wire may be configured to be driven distally to deploy the stent out of the distal end of the catheter. Any appropriate number of pads may be arranged on the pusher wire to engage with and control the deployment and/or recapture of the stent.
  • a greater number of pads may be positioned to engage with the proximal end of the stent than the distal end of the stent.
  • the pads at the proximal end of the stent may be separated from each other by a distance of between about 0.5 mm and 2 mm or longer (e.g., a minimum distance of between about 0.3 mm and 3.0 mm, between about 0.5 mm and 2.5 mm, between about 0.7 mm and 1.5 mm, about 1 mm, etc.).
  • the pads may generally be arranged on a distal end region of the pusher, referred to herein as the stent engagement region.
  • the stent engagement region may be approximately the same length as the stent (e.g., 44 mm) or slightly longer (e.g., 5% longer, 10% longer, 20% longer, 15% longer, 25% longer, 30% longer, 35% longer, 40% longer, 50% longer, etc.).
  • the stent engagement region may be proximal to the distal end of the pusher wire.
  • the distal end of the pusher wire may be configured to be very soft and flexible.
  • the number of pads on the pusher wire may depend on the number of wires forming the stent. For example, stents having fewer wires (e.g., 16 or less) may have more pads than stents formed of more wires (e.g., 36 or more, etc.).
  • the pusher may include at least three pads.
  • the plurality of pads may be present on the proximal end of the deployment region of the pusher.
  • FIG. 1 shows an exemplary overview of a stent assembly system 100.
  • Components of system 100 may include a catheter 102, stent 104, pusher 106, pads 108, and pusher wire 110.
  • stent 104 which may be a self-expanding stent made of a plurality of wire lengths, may be placed within catheter 102, which may be a flexible catheter configured to receive stent 104.
  • Pusher wire 110 may have a plurality of pads 108, which in some examples may be annular and/or take other shapes such as rectangular (e.g., having a square cross-section) or cylindrical (e.g., having a round or oval cross-section). In some examples the pads may have a start-shaped cross-section.
  • pads 108 may be formed of a low-durometer material, making them soft and flexible for better engagement with wire lengths of stent 104.
  • the low-durometer material may be any appropriate durometer.
  • the pads may be formed of a material having a durometer of less than about 40 Shore A (e.g., 35 or less ShoreA, 30 or less ShoreA, 25 or less Shore A, 20 or less Shore A, 10 or less Shore A, 50 or less ShoreOO, 40 or less ShoreOO, 20 or less ShoreOO, 10 or less Shore 00, between about 5 and 60 Shore 00, between about 5 and 55 Shore 00, between about 5 and 50 Shore 00, between about 5 and 40 Shore 00, between about 5 and 35 Shore 00, between about 5 and 30 Shore 00, etc.).
  • pads 108 may be arranged along a distal end of pusher wire 110 which may traverse through all or part of catheter 102.
  • pusher wire 110 may extend through catheter 102 and through stent 104 to extend distally out of catheter 102.
  • pads 108 may be arranged differently along pusher wire 110, for example, being spread out across pusher wire 110 or may be clustered or concentrated at distal and proximal ends of pusher wire 110, or even at a midpoint of pusher wire 110.
  • pads 108 may be spaced apart from each other by between about 0.5 and 5 mm.
  • the plurality of wire lengths of stent 104 may be heat treated to collapse down onto the pads 108 of pusher wire 110 and partially or fully embed into each of pads 108.
  • heat treatment of the plurality of wire lengths of stent 104 may help disengage stent 104 from pads 108 for deployment, for example at a target site, with stent 104 self-expanding during release from pads 108 as stent 104 is pushed out of the distal end of catheter 102 by pusher wire 110 and/or pusher 106.
  • one or more of pads 108 engages with a distal end of stent 104 and two or more of pads 108 engage with a proximal end region of stent 104. In some examples, two or more of pads 108 engages with a distal end of stent 104 and one or more of pads 108 engage with a proximal end region of stent 104.
  • Pusher 106 may be distal to stent 104 and advance stent 104 and pusher wire 110 through and out the catheter 102 for deployment at a target site.
  • stent 104 may be configured to be pulled back into catheter 102 before it is fully deployed out of catheter 102 and may collapse back onto pads 108 for repositioning of stent 104.
  • stent 104 may be deployed outside of catheter 102 before stent 104 cannot be pulled back into catheter 102.
  • pads 108 remain engaged with the proximal end of catheter 102 after catheter 102 is deployed, with pads 108 preventing catheter 102 from deforming.
  • stent 104 may have between 16 and 60 wire lengths.
  • Pads 108 may be 3 to 10 in number in one example.
  • Pads 108 may be configured so that friction between pads 108 and an inner lumen of catheter 102 is less than the friction between pads 108 and the wire lengths of stent 104.
  • the friction between pads 108 and the wire lengths of stent 104 may be greater than a friction between pads 108 and the inner surface of catheter 102.
  • the stent 104 may be held in a collapsed form in a distal end of catheter 102 prior to deployment.
  • the catheter including the stent and pusher wire may be configured to be navigated though a tortious anatomy and still allow deployment of the stent from the distal end of the catheter.
  • FIG. 2 shows a view of a stent and pusher wires in a catheter in a model of a tortious vessel 200.
  • stent 204 is placed within catheter 202 and pusher wire 210 traverses through the vessel 200 until a target delivery site is reached, at which point the stent may be deployed by advancing the pusher wire to allow the self-expanding stent to deploy 204.
  • FIG. 3 is another view of a stent 300.
  • stent 300 has a proximal end 304 A and a distal end 304B.
  • FIG. 4 A shows an enlarged view of the deployed stent of FIG. 2, showing the stent 400 deployed within a model vessel.
  • FIG. 4B shows a view of two example stents that were deployed as described herein. In both cases, deployment may slightly deform the stent at proximal and distal ends due to improper heat treatment 404.
  • proximal end 404A and distal and 404B of stent 404 may be deformed (i.e. curled or bent) when stent 404 is treated at incorrect temperatures and/or for an incorrect duration. Such deformation may disrupt or make stent delivery and deployment unfeasible by causing stent 404 to become at least partially lodged or trapped in a catheter due to the deformed shape of stent 404.
  • a 2 mm x 35 mm stent may be used with a pusher having three proximal pads and three distant pads and was reliably and repeatably able to release (and in some cases recapture and reposition). Similar results were seen using a 2 mm x 15 mm stent and a pusher having two proximal and one distal pad.
  • the apparatuses shown and described herein the pads held well on the pusher and the stents deployed from off of the pads reliably. In some cases, the stents were deformed proximally after detachment.
  • the methods and apparatuses described herein may be used with any stent (with or without loops at the ends) to assist in deploying/retraction of the stent.
  • the number of pads used may be inversely correlated with the number of wires, e.g., the greater the number of wires in the stent, the fewer pads may be necessary and conversely, the lower number of wires may use a greater number of pads.
  • the spacing between pads were separated by about 1 mm.
  • pads were placed centrally on the stent. Heat pretreatment of the pads did not appreciably deform the ends of the stent.
  • the pads held well on the pusher and the stents disengaged from the pads. Deformation of the stents was minimal. Thus, the pads generally did not deform the stents. In any of these examples the stent wires were well imprinted on the pad. [0055] Pads having a smaller outer diameter also did not appreciably deform the proximal end of the stent.
  • FIG. 5A is a schematic view of one example of pads on a pusher wire 500.
  • the pusher 506 includes pads 507 on elongate body of the pusher wire 510.
  • spacing 509 between pads 407 and/or between pads 507 and pusher 506 may be variable.
  • spacing between pads 507 may be, e.g., between about 0.5 mm and about 5 mm.
  • FIGS. 5B and 5C illustrate views of additional exemplary stent assemblies.
  • the dimensions shown are merely exemplary, and other dimensions may be used.
  • FIG. 5B shows one example of a stent assembly including a stent 104, and a pusher with a pusher ring 116, introducer or catheter 102, and pusher body 106, as well as a plurality of pads (under the stent).
  • FIG. 5C shows a detailed view of the distal end of a pusher.
  • the pusher may include a distal spring or coil 128, which may have a diameter of, e.g., between 0.1-0.3 mm (e.g., about 0.20 mm, about 0.22mm, etc.) and a stretched length or between about 8-11 mm (e.g., about 9 +/-0.5mm, etc.).
  • the distal coil is glued distally and proximally on about 7 to 9 turns.
  • pads 108 which in some examples may be configured as annular sleeves having a diameter of, e.g., about 0.13 x 0.32mm
  • pusher ring 116 which in certain examples may have a diameter of about 0.18 x 0.45 x 0.40 mm, crimped at 0.38mm
  • inner sheath 126 which may have a length between about 20 mm and 30 mm
  • outer sheath 130 Also shown are sandblasting area 132 and ring position 134.
  • a range of pusher dimensions, ring positions, and sheath (pad) lengths are possible (e.g., +/- about 5% of those in the examples above, +/- about 10% of those in the examples above, +/- about 15% of those in the examples above, etc.).
  • a manufacturing range of stent assembly 100 is possible.
  • the apparatus may include pushers having a pusher ring of dimensions 14 x 0.45 x 0.55 0 0.40 mm +, and 0.14 x 0.45 x 0.55 0 0.40 mm.
  • FIGS. 5D and 5E-5F illustrate views of additional exemplary stent assemblies.
  • the dimensions shown are merely exemplary, and other dimensions may be used.
  • FIG. 5D shows one example of a stent assembly including a stent 104, and a pusher with a pusher ring 116, introducer or catheter 102, and pusher body 106, as well as a plurality of pads (under the stent).
  • FIGS. 5E and 5F show detailed views of the distal end of two examples of pushers similar to that shown in FIG. 5C.
  • the pusher may also include a distal spring or coil 128, which may have a diameter of, e.g., between 0.1-0.3 mm (e.g., about 0.20 mm, about 0.22mm, etc.) and a stretched length or between about 8-11 mm (e.g., about 9 +/- 0.5mm, etc.).
  • a distal spring or coil 128 may have a diameter of, e.g., between 0.1-0.3 mm (e.g., about 0.20 mm, about 0.22mm, etc.) and a stretched length or between about 8-11 mm (e.g., about 9 +/- 0.5mm, etc.).
  • the distal coil is glued distally and proximally on about 7 to 9 turns.
  • a pusher wire 110 pads 108 (which in some examples may be configured as annular sleeves having a diameter of, e.g., about 0.13 x 0.32mm), pusher ring 116 (which in certain examples may have a diameter of about 0.18 x 0.45 x 0.40 mm, crimped at 0.38mm), inner sheath 126 (which may have a length between about 20 mm and 30 mm), and outer sheath 130.
  • FIG. 5F shows another variation of a pusher including one pad at the distal end region and two pads at the proximal end region (configured to engage with a distal and proximal ends of a stent, respectively).
  • a range of pusher dimensions, ring positions, and sheath (pad) lengths are possible (e.g., +/- about 5% of those in the examples above, +/- about 10% of those in the examples above, +/- about 15% of those in the examples above, etc.).
  • a manufacturing range of stent assembly 100 is possible.
  • the apparatus may include pushers having a pusher ring of dimensions 14 x 0.45 x 0.55 0 0.40 mm +, and 0.14 x 0.45 x 0.55 0 0.40 mm.
  • the pads may be secured to the pusher by an adhesive.
  • the pad may be secured to the pusher by inserting through an opening or passage in body of the pusher.
  • the pad may be secured to the pusher by crimping or clamping to the pusher.
  • the pads e.g., in variations in which the pad it annular, such as a pad configured as a sleeve
  • the pad may be secured to the pusher by heat shrinking the pad to the pusher.
  • the pusher ring may be secured to the pusher in any appropriate manner.
  • the pusher ring may be secured by an adhesive, by crimping, etc.
  • the material applied to the pusher including any adhesive or bonding agent, crimp, etc., may be biocompatible and/or sterilizable.
  • FIG. 6A shows an example of a pad on a pusher (e.g., pusher wire) 600.
  • a pusher wire 610 there is a pusher wire 610 and pad 607.
  • crimping 607A on pad 607 resulting from heat pre-treatment.
  • Crimping 607A may be a hallmark indication of pretreatment, and may vary in pattern and depth depending on the temperature and duration of heat pre-treatment. Crimping may be limited to prevent stent wires from becoming trapped within pad 607.
  • length of pad 607B may be approximately 20 mm long (e.g., between about 3 mm and 30 mm, between about 5 mm and 25 mm, between about 10 mm and 25 mm, between about 18 mm and 23 mm, etc.).
  • FIG. 6B shows multiple pads on a pusher wire 650.
  • spacing 609 between pads 607 on pusher wire 610 may be approximately 30 mm long as shown. In some cases, the spacing may be between about 1 mm and 50 mm or longer (e.g., between about 2 mm and 40 mm, between about 5 mm and 35 mm, etc.).
  • FIG. 7 depicts stent wire imprints on a pad 700. As shown here, there are imprints 704C on pad 707. According to certain examples, heat pre-treatment and/or low durometric material that pads 707 may be made from may allow for at least partial embedding of wires of a stent such as stent 104 from FIG. 1 into pads 707, resulting in imprints 704C that may be visualized after stent 104 is released or disengaged from pads 707.
  • a catheter e.g., including a self-expanding stent and a pusher wire within a vessel lumen of the catheter, may be inserted into the body and advanced to a target site.
  • the pusher e.g., pusher wire
  • the pusher wire may include a plurality of discrete pads formed of a low- durometer material in which a plurality of wire lengths of the stent may be embedded.
  • the pads may be any of the pads described herein, and may be arranged on the pusher (e.g., pusher wire) in any appropriate configuration, particularly with the discrete pads arranged so that the end regions of the stent, distal and proximal, are embedded.
  • the pusher wire may extend through the catheter and through the stent to extend distally out of the catheter.
  • the pusher wire may be driven distally relative to the catheter to deploy the stent out of a distal end of the catheter so that the stent self-expands releasing the plurality of wire lengths from the plurality of discrete pads as the stent is pushed distally out of the distal end of the catheter, while sliding the plurality of discrete pads within the catheter lumen.
  • the wires of the stent may uncouple from the pad (in which they are initially embedded) once the pad and the corresponding region of the stent pass out of the distal end of the catheter.
  • the more-distal region of the stent may be released from the pads before the more proximal regions.
  • any of these methods may include preloading the stent onto the pusher and within he catheter, e.g., by inserting the self-expanding stent into a flexible catheter configured to receive the stent via a pusher wire within the catheter having multiple pads to receive the stent, in which the pusher wire extends through the catheter and through the stent to extend distally out of the catheter, and collapsing the stent down onto the multiple pads on the pusher wire, in which the wires of the stent connect the stent to the pusher wire via a heat pre- treatment configured to indent (“crimp”) the wires of the stent into the multiple pads, wherein the multiple pads on the pusher wire engage with a proximal end of the stent and at least one of the multiple pads distally engages with a distal end of the stent.
  • crimp indent
  • the stent may be recaptured (reloaded) and/or repositioned using the pusher and catheter, particularly before the stent is released from the most proximal pad.
  • the stent may be re-engaged by pulling the pusher wire proximally to collapse the stent back onto the plurality of discrete pads before the stent is fully deployed out of the catheter.
  • the plurality of discrete pads are formed of a low-durometer material that is configured to indent when with the wires of the stent when receiving the stent, compressing into the low-durometer material (e.g., a material having a durometer of less than about 40 Shore A (e.g., 35 or less ShoreA, 30 or less ShoreA, 25 or less Shore A, 20 or less Shore A, 10 or less Shore A, 50 or less ShoreOO, 40 or less ShoreOO, 20 or less ShoreOO, 10 or less Shore 00, between about 5 and 60 Shore 00, between about 5 and 55 Shore 00, between about 5 and 50 Shore 00, between about 5 and 40 Shore 00, between about 5 and 35 Shore 00, between about 5 and 30 Shore 00, etc.).
  • a material having a durometer of less than about 40 Shore A e.g., 35 or less ShoreA, 30 or less ShoreA, 25 or less Shore A, 20 or less Shore A, 10 or less Shore A, 50 or less ShoreOO, 40 or less ShoreOO,
  • the stent may be prepared for deployment following insertion of the self-expanding stent, formed of a plurality of wire lengths, into a lumen of a catheter so that a plurality of wire lengths are embedded into each of a plurality of discrete pads of a pusher wire.
  • the pusher wire may extend through the catheter and through the stent to extend distally out of the catheter.
  • a distal pad of the plurality of discrete pads is engaged with a distal end region of the stent and two or more discrete pads of the plurality of discrete pads may be engaged with a proximal end region.
  • the plurality of wire lengths of the stent may be heat treated to embed into the discrete pads and to reduce the friction between the stent and the pusher.
  • the heat treatment may be configured to attain a target treatment time and a target treatment temperature, in which the heat treatment is configured to expose wires on the multiple pads, in which the heat-treatment prevents deformation of the stent.
  • the stent may comprise, e.g., between 20 and 40 strands.
  • the heat treatment may be configured to prepare the wires of the stent to disengage from the multiple pads to deploy the stent. For example, resistance to longitudinal compression of the stent inside the catheter may increase as the number of wires comprising the stent increases. [0076] According to some examples, the multiple pads on the pusher wire having the heat treatment may only engage with the proximal end of the stent when a diameter of the stent is below a threshold diameter.
  • the stent may be held in a collapsed form in a distal end of the catheter prior to deployment of the stent.
  • Any of the methods (including user interfaces) described herein may be implemented as software, hardware or firmware, and may be described as a non-transitory computer-readable storage medium storing a set of instructions capable of being executed by a processor (e.g., computer, tablet, smartphone, etc.), that when executed by the processor causes the processor to control perform any of the steps, including but not limited to: displaying, communicating with the user, analyzing, modifying parameters (including timing, frequency, intensity, etc.), determining, alerting, or the like.
  • a processor e.g., computer, tablet, smartphone, etc.
  • spatially relative terms such as “under”, “below”, “lower”, “over”, “upper” and the like, may be used herein for ease of description to describe one element or feature's relationship to another element(s) or feature(s) as illustrated in the figures. It will be understood that the spatially relative terms are intended to encompass different orientations of the device in use or operation in addition to the orientation depicted in the figures. For example, if a device in the figures is inverted, elements described as “under” or “beneath” other elements or features would then be oriented “over” the other elements or features. Thus, the exemplary term “under” can encompass both an orientation of over and under.
  • the device may be otherwise oriented (rotated 90 degrees or at other orientations) and the spatially relative descriptors used herein interpreted accordingly.
  • the terms “upwardly”, “downwardly”, “vertical”, “horizontal” and the like are used herein for the purpose of explanation only unless specifically indicated otherwise.
  • first and second may be used herein to describe various features/elements (including steps), these features/elements should not be limited by these terms, unless the context indicates otherwise. These terms may be used to distinguish one feature/element from another feature/element. Thus, a first feature/element discussed below could be termed a second feature/element, and similarly, a second feature/element discussed below could be termed a first feature/element without departing from the teachings of the present invention.
  • a numeric value may have a value that is +/- 0.1% of the stated value (or range of values), +/- 1% of the stated value (or range of values), +/- 2% of the stated value (or range of values), +/- 5% of the stated value (or range of values), +/- 10% of the stated value (or range of values), etc.
  • Any numerical values given herein should also be understood to include about or approximately that value, unless the context indicates otherwise. For example, if the value “10” is disclosed, then “about 10” is also disclosed.

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Abstract

L'invention concerne des procédés, des systèmes et des appareils qui répondent au besoin d'administration et de libération de stent à partir d'un cathéter par l'intermédiaire d'un fil poussoir s'étendant à travers le cathéter et le stent, le fil poussoir ayant une pluralité de tampons discrets agencés le long d'une région d'extrémité distale du poussoir conçue pour incorporer de manière réversible une pluralité de longueurs de fil, l'un de la pluralité de tampons étant en prise au niveau d'une extrémité distale du stent et au moins deux de la pluralité de tampons étant en prise au niveau d'une région d'extrémité proximale du stent, et le fil poussoir pour déployer le stent hors de l'extrémité distale du cathéter par l'intermédiaire d'un mouvement distal. D'autres exemples sont divulgués.
PCT/US2025/019630 2024-03-12 2025-03-12 Système de pose de stent Pending WO2025193869A1 (fr)

Applications Claiming Priority (2)

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US202463564489P 2024-03-12 2024-03-12
US63/564,489 2024-03-12

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WO2025193869A1 true WO2025193869A1 (fr) 2025-09-18

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Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
FR2939637B1 (fr) * 2008-12-17 2012-01-13 Newco Dispositif pour delivrer un stent et procede pour sa fabrication
US10265203B2 (en) * 2005-01-28 2019-04-23 Boston Scientific Scimed, Inc. Stent retrieval member and devices and methods for retrieving or repositioning a stent
US20210059846A1 (en) * 2018-08-06 2021-03-04 DePuy Synthes Products, Inc. Stent delivery with expansion assisting delivery wire
WO2021135352A1 (fr) * 2019-12-31 2021-07-08 上海鸿脉医疗科技有限公司 Système de pose d'implant et son procédé d'utilisation
US20240058122A1 (en) * 2019-01-28 2024-02-22 Tricares SAS Three part stent second generation

Patent Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US10265203B2 (en) * 2005-01-28 2019-04-23 Boston Scientific Scimed, Inc. Stent retrieval member and devices and methods for retrieving or repositioning a stent
FR2939637B1 (fr) * 2008-12-17 2012-01-13 Newco Dispositif pour delivrer un stent et procede pour sa fabrication
US20210059846A1 (en) * 2018-08-06 2021-03-04 DePuy Synthes Products, Inc. Stent delivery with expansion assisting delivery wire
US20240058122A1 (en) * 2019-01-28 2024-02-22 Tricares SAS Three part stent second generation
WO2021135352A1 (fr) * 2019-12-31 2021-07-08 上海鸿脉医疗科技有限公司 Système de pose d'implant et son procédé d'utilisation

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