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WO2025125953A1 - Dispositifs, systèmes et méthodes de fermeture de ponctions tissulaires - Google Patents

Dispositifs, systèmes et méthodes de fermeture de ponctions tissulaires Download PDF

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Publication number
WO2025125953A1
WO2025125953A1 PCT/IB2024/061727 IB2024061727W WO2025125953A1 WO 2025125953 A1 WO2025125953 A1 WO 2025125953A1 IB 2024061727 W IB2024061727 W IB 2024061727W WO 2025125953 A1 WO2025125953 A1 WO 2025125953A1
Authority
WO
WIPO (PCT)
Prior art keywords
shaft
mesh
adhesive
end portion
delivery channel
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Pending
Application number
PCT/IB2024/061727
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English (en)
Inventor
Derek W. Prusener
Jonathan E. Baxter
Mikayle A. HOLM
Kevin R. Seifert
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.)
Medtronic Inc
Original Assignee
Medtronic Inc
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 Medtronic Inc filed Critical Medtronic Inc
Publication of WO2025125953A1 publication Critical patent/WO2025125953A1/fr
Pending legal-status Critical Current
Anticipated expiration legal-status Critical

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/00491—Surgical glue applicators
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/0057—Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/0057—Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect
    • A61B2017/00646—Type of implements
    • A61B2017/0065—Type of implements the implement being an adhesive

Definitions

  • the present technology relates generally to tissue puncture closure devices, and more particularly, to devices and methods for delivery of bioadhesive materials to a tissue puncture.
  • transcatheter procedures have been developed that inflict significantly less trauma on the patient’s body. Transcatheter procedures involve percutaneously accessing a blood vessel through a patient’s skin and inserting a catheter into the lumen of the blood vessel. The catheter can be navigated through the patient’s vasculature to deliver a medical device to a treatment site within the cardiovascular system.
  • a distal end of the catheter can be navigated into the patient’s heart and a leadless pacemaker can be delivered through the catheter into the patient’s heart.
  • a leadless pacemaker can be delivered through the catheter into the patient’s heart.
  • the catheter itself can perform the medical intervention.
  • transcatheter procedures are less invasive, safer, and more efficient than open surgical procedures.
  • the subject technology is illustrated, for example, according to various aspects described below, including with reference to FIGS. 1-4D. Various examples of aspects of the subject technology are described as examples and do not limit the subject technology.
  • a device for delivering a medical adhesive to a subcutaneous region proximate an opening in a wall of a blood vessel comprising: a tubular shaft comprising a proximal end portion and a distal end portion opposite the proximal end portion along a longitudinal dimension of the shaft, the shaft having: an inner surface defining an instrument lumen extending longitudinally through the shaft, the instrument lumen being open at the proximal and distal end portions of the shaft, wherein the instrument lumen is configured to receive an elongate member therethrough, and an outer surface; a delivery channel extending between an inlet at the proximal end portion of the shaft and an outlet, wherein the delivery channel is positioned radially outward of the instrument lumen, and wherein the delivery channel is configured to receive a medical adhesive therethrough; and a mesh extending circumferentially around the outer surface of the shaft and longitudinally between a proximal end portion and a distal end portion, wherein the mesh comprises
  • a method for delivering a medical adhesive to a subcutaneous region proximate an opening in a wall of a blood vessel comprising: positioning an adhesive delivery device over an elongate medical device, wherein the adhesive delivery device comprises a tubular shaft and a mesh extending circumferentially around an outer surface of the shaft, the mesh defining a plurality of pores; while a distal portion of the elongate medical device is positioned through a tissue puncture tract and within a blood vessel lumen, sliding the adhesive delivery device distally over the elongate medical device until the mesh is positioned within the tissue puncture tract, surrounded by subcutaneous tissue; and injecting a medical adhesive into a space between the outer surface of the shaft and the mesh, then continuing to inject the adhesive to force the adhesive through the pores of the mesh and onto the surrounding subcutaneous tissue.
  • a system for delivering a medical adhesive to a subcutaneous region proximate an opening in a wall of a blood vessel comprising: an elongate medical device comprising a tubular shaft having a distal portion configured to be positioned through a tissue puncture tract, though an opening in a blood vessel wall, and into the blood vessel lumen; and an adhesive delivery device comprising a tubular shaft defining a lumen therethrough, wherein the elongate medical device is configured to be positioned through the lumen of the adhesive delivery device, and wherein the adhesive delivery device comprises: a mesh extending circumferentially around an outer surface of the shaft and longitudinally between a proximal end portion and a distal end portion, wherein the mesh comprises a material defining a plurality of pores, and a delivery channel extending between an inlet at a proximal end portion of the adhesive delivery device and an outlet at or distal to the proximal end portion of the mesh, wherein the delivery channel is
  • FIG. 1 illustrates a treatment system in accordance with several embodiments of the present technology.
  • FIG. 2A is a top view of an adhesive delivery device in accordance with several embodiments of the present technology.
  • FIG. 2B is a front view of the adhesive delivery device shown in FIG. 2A.
  • FIG. 2C illustrates the adhesive delivery device of FIG. 2B with the mesh removed, showing grooves in the housing in accordance with several embodiments of the present technology.
  • FIG. 2D is an axial cross-sectional view taken along line 2D-2D in FIG. 2C.
  • FIG. 3A is a perspective view of an adhesive delivery device configured in accordance with embodiments of the present technology.
  • FIG. 3B is an axial cross-sectional view of the adhesive delivery device of FIG. 3 A taken along line 3B-3B.
  • FIGS. 4A-4D show an example method of closing a puncture tract using the adhesive delivery devices of the present technology.
  • the present technology relates to devices, systems, and methods for closing openings in blood vessels and the surrounding tissue.
  • Some embodiments of the present technology are directed to devices, systems, and methods for delivering an adhesive to an extravascular space proximate an opening in a wall of a blood vessel.
  • the adhesive can be used to adhere together portions of the subcutaneous tissue circumferentially surrounding and defining the puncture tract leading to the vessel opening to effectively seal the vessel opening and prevent or limit blood flow therethrough.
  • an adhesive delivery device of the present technology comprises a tubular shaft configured to be slidably positioned over a vascular access device (e.g., an introducer sheath, a dilator, a catheter, etc.) or any interventional device configured to extend from an extracorporeal location through a puncture tract to a location within the vessel lumen.
  • the delivery device can include a mesh region extending around the circumference of the tubular shaft and configured to be positioned within the puncture tract, in apposition with the surrounding tissue.
  • Adhesive can be delivered through the device to a space between the mesh and an outer surface of the shaft before being expelled through apertures in the mesh to coat the surrounding tissue.
  • the mesh of the present technology facilitates consistent and even application of adhesive within the puncture tract.
  • the portion of the surface of the shaft underlying the mesh may include one or more circumferential and/or longitudinal grooves that also help distribute the adhesive along the mesh region.
  • the delivery devices of the present technology are configured to be delivered over such proceduresupporting devices, thereby enabling adhesive delivery while the procedure-supporting device(s) remain within the vessel opening, preventing the outflow of blood. This beneficially reduces the time and steps for the physician while reducing the risk of hematoma formation.
  • the delivery devices herein can be configured for delivery over a wide range of diameters, including over procedure-supporting devices having a diameter of at least 23 French.
  • FIG. 1 shows a treatment system 100 (or “system 100”) configured in accordance with several embodiments of the present technology.
  • the treatment system 100 can include an adhesive delivery device 200 (or “device 200”), an interventional device 300 comprising an elongate shaft 302, and an adhesive 402 (such as a bioadhesive) carried by an adhesive source 400 (e.g., a syringe).
  • the interventional device 300 can comprise a catheter, a dilator, an introducer, and/or any other medical device configured to extend from an extracorporeal location through a puncture tract to a location within the vessel lumen.
  • the delivery device 200 can comprise a tubular shaft 202 configured to be slidably received over the elongate shaft 302 of the interventional device 300, and a mesh 204 disposed at an outer surface of the device 200.
  • the mesh 204 can extend circumferentially around the outer surface of the shaft 202 and is configured to be positioned within subcutaneous tissue during adhesive delivery.
  • the adhesive 402 can be delivered through a filling lumen of the device 200 to a space between the outer surface of the shaft 202 and the mesh 204 before being expelled through the openings in the mesh 204 to the surrounding tissue.
  • the system 100 comprises only the device 200, only the device 200 and the interventional device 300, or only the device 200 and the adhesive source 400.
  • FIGS. 2A-2D show various views of the adhesive delivery device 200 shown in FIG. 1.
  • FIG. 2A is a top view of the device 200
  • FIG. 2B is a front view of the device 200
  • FIG. 2C is a front view of the device 200 with the mesh 204 removed
  • FIG. 2D is an axial cross-sectional view of the device 200 taken along line 2D-2D in FIG. 2B.
  • the device 200 includes a proximal end portion 200a, a distal end portion 200b opposite the proximal end portion 200a along a longitudinal dimension of the device 200, and an intermediate portion 200c between the proximal and distal end portions 200a, 200b.
  • the shaft 202 is defined by a tubular sidewall 206 that circumferentially surrounds a lumen 208 running longitudinally through the shaft 202 from a proximal opening 208a to a distal opening 208b (best visualized in FIG. 1).
  • the lumen 208 is sized to receive the shaft 302 of the interventional device 300 therethrough.
  • the lumen 208 can be, for example, about 8 Fr to about 36 Fr, about 12 Fr to about 28 Fr, no less than 22 Fr, no less than 23 Fr, or no less than 24 Fr.
  • the outer diameter of the shaft 202 is substantially constant along the intermediate portion 200c of the shaft and tapers at the distal end portion 200b to facilitate introduction of the device 200 into the opening in the tissue.
  • the shaft 202 has a substantially constant outer diameter along its entire length, or may taper continuously in a distal direction along its length.
  • the proximal end portion 200a of the device 200 may optionally include lateral projections 210 that extend radially away from the proximal end portion of the shaft 202 and are configured to facilitate grasping and/or manipulating the device 200.
  • the projections 210 having a combined width that is wider than the outer diameter of the shaft 202.
  • the projections 120 can be monolithic with the shaft 202 or can comprise a distinct component formed separately from and later coupled to the shaft 202 (e.g., via mechanical fastening, welding, adhesive, etc.).
  • the device 200 includes a single projection (example shown in FIG. 3 A), such as a single continuous projection that extends around the full circumference of the shaft 202. In some examples, the device 200 does not include any projections at the proximal end portion 200a.
  • the device 200 further includes a delivery tube 214 extending longitudinally along the device 200.
  • the delivery tube 214 is configured to receive an adhesive from an extracorporeal location and deliver the adhesive to a space between the shaft 202 and the mesh 204.
  • the delivery tube 214 defines a delivery channel 215 (FIG. 2A) extending therethrough, and has a proximal end portion 214a at or proximal of the proximal end portion 200a of the device 200, and a distal end portion 214b disposed at or distal to a proximal end portion 204a of the mesh 204.
  • the delivery tube 214 is a structure separate from the shaft 202 that extends longitudinally along an outer surface of the shaft 202 and through one of the projections 210. In other embodiments, the delivery tube 214 is positioned adjacent the projection 210 (rather than extending through the projection).
  • the mesh 204 extends circumferentially around an outer surface of the shaft 202 and longitudinally between a proximal end portion 204a (FIG. 2B) along the intermediate portion 200c of the device 200 and a distal end portion 204b (FIG. 2B) at or near the distal end portion 200b of the device 200.
  • the mesh 204 is sealed against and secured to the shaft 202 at its proximal and distal end portions 204a, 204b to prevent loss of the adhesive through the proximal and distal end portions 204a, 204b during adhesive delivery.
  • the mesh is secured to the shaft 202 and/or sealed against the shaft 202 via a band of material 220 that extends around the circumference of the proximal and/or distal end portions 204a, 204b of the mesh 204, thus overlapping both the mesh 204 and the shaft 202.
  • the band 220 may comprise, for example, a shrink wrap material, a polymer, or other suitable materials.
  • an adhesive including but not limited to a UV-curable adhesive
  • the mesh 204 is positioned directly adjacent the outer surface of the shaft 202 to ensure the device 200 does not catch on the tissue and/or a supporting medical device when being inserted into or removed from the puncture tract. Still, the mesh 204 remains sufficiently flexible to allow the adhesive to flow between the outer surface of the shaft 202 and an inner surface of the mesh 204. In some examples, the mesh 204 is positioned on or slightly separated from the shaft 202. As best visualized in FIGS. 2C and 2D, the outer surface of the shaft 202 coincident with the mesh 204 can optionally define one or more grooves 216 configured to promote distribution of the adhesive along the mesh 204.
  • the grooves can have any suitable shape, including but not limited to one or more grooves extending partially or completely around the circumference of the shaft 202, one or more longitudinal grooves extending the entire length or only a portion of the length of the shaft 202 coincident with the mesh 204, one or more grooves extending helically around the shaft 202 (along all or a portion of the length of the shaft 202), and/or any combination of the foregoing.
  • the grooves 216 may be spaced apart from one another, or may be intersecting.
  • the grooves 216 can include one or more circumferential grooves 216a extending around all or a portion of the circumference of the shaft 202, and one or more longitudinal grooves extending along all or a portion of a length of the shaft 202 coincident with the mesh 204.
  • the shaft 202 includes a circumferential groove 216a positioned at or near the proximal end portion 204a of the mesh 204 and a plurality of longitudinal grooves 216b continuous with and extending distally from the circumferential groove 216a along the outer surface of the shaft 202.
  • the longitudinal grooves 216b can be spaced apart from one another around the circumference of the shaft 202.
  • the opening at the distal end portion 214b of the delivery tube 214 is positioned at or proximal of the circumferential groove 216a such that adhesive delivered through the delivery tube 214 is initially deposited into the circumferential groove 216a and subsequently travels around the circumferential groove 216a before being distributed distally within the longitudinal grooves 216b.
  • the grooves thus advantageously facilitate even distribution of the adhesive along the puncture tract and help avoid and/or reduces build-up or “bolusing” of the adhesive at a given longitudinal or circumferential location.
  • the circumferential grooves 216a may lie within a plane substantially perpendicular to the longitudinal axis of the device 200 (as shown in FIG. 2C), or may be disposed at an angle between 0 and 90 degrees.
  • the mesh 204 can comprise a material defining a plurality of pores 218 (FIG. 2B) therein.
  • the pore size may be the same or vary along the length of the mesh 204. For example, in some embodiments the pore size may decrease in a distal direction along the mesh 204. Alternatively, the pore size may increase in a distal direction along the mesh. Additionally or alternatively, the pore size may vary around the circumference of the mesh 204.
  • the pores 218 can be large enough to permit movement of the high viscosity adhesive through the pores 218, but small enough to prevent immediate dispensing through the mesh without sufficient distribution of the adhesive down and around the shaft 202.
  • the average pore size (measured as the largest dimension inscribed by the pore) can be about 0.01 inches to about 0.15 inches, about 0.01 inches to about 0.11 inches, about 0.01 inches to about 0.07 inches, about 0.02 inches to about 0.04 inches, no more than 0.02 inches, no more than 0.03 inches, no more than 0.035 inches, no more than 0.040 inches, no more than 0.05 inches, no more than 0.07 inches, no more than 0.11 inches, etc.
  • the pores can have any suitable shape, including a circle, oval, ellipsoid, teardrop, diamond, kite-shaped, triangle, square, or any polygon.
  • one, some, or all of the pores 218 are diamond-shaped, with a long dimension of 0.035 inches and a short dimension of 0.007 inches.
  • a device 200 configured for use with a lower viscosity adhesive may have a mesh 204 with an average pore size that is smaller than that of a device 200 configured for use with a higher viscosity adhesive.
  • the average pore size can be about 0.005 inches to about 0.145 inches, about 0.005 inches to about 0.11 inches, about 0.005 inches to about 0.07 inches, about 0.01 inches to about 0.04 inches, no more than 0.015 inches, no more than 0.02 inches, no more than 0.025 inches, no more than 0.035 inches, no more than 0.04 inches, no more than 0.05 inches, no more than 0.06 inches, no more than 0.11 inches, etc.
  • the mesh 204 can have a thickness, measured between an inner and outer surface of the mesh 204, of about 0.003 inches to about 0.02 inches, about, 0.006 inches to about 0.01 inches, or less than 0.01 inches.
  • the mesh material comprises a lubricious material, for example to reduce and/or prevent adherence of the adhesive to the mesh 204 during delivery (and potentially bond the mesh 204 to the tissue). Such lubricity can also facilitate introduction of the device 200 into the tissue opening by preventing the mesh 204 or other portion of the device from adhering to the tissue.
  • the material can comprise a lubricious polymer, such as polytetrafluoroethylene (PTFE) and others.
  • the adhesive 402 can comprise any suitable composition for facilitating adhesion of subcutaneous tissue to itself.
  • Example adhesives 402 may include cyanoacrylate (e.g., 2-octyl cyanoacrylate), such as an aliphatic 2-cyanoacrylate ester, such as an alkyl, cycloalkyl, alkenyl or alkoxyalkyl2-cyanoacrylate ester.
  • the alkyl group may have from 1 to 16 carbon atoms in some embodiments, and can be a C1-C8 alkyl ester or a C1-C4 alkyl ester.
  • esters include the methyl, ethyl, npropyl, isopropyl, n-butyl, isobutyl, pentyl, hexyl, cyclohexyl, heptyl, octyl, 2-methoxy ethyl and 2-ethoxy ethyl esters of cyanoacrylic acid.
  • the adhesive 402 comprises a n-butyl cyanoacrylate, such as VenaSealTM adhesive, sold by Medtronic, Inc.
  • Additional example adhesives 402 can include biological glue such as a bovine serum albumin-gluteraldehyde combination (e.g., BIOGLUE, Cryolife, Atlanta, Ga.), PV A, Biogard, collagen, fibrinogen, fibronectin, vitronectin, laminin, thrombin, gelatin, combinations thereof, or other biocompatible adhesives.
  • the adhesive 402 can also include a therapeutic agent such as a thrombogenic agent, an antiinflammatory agent, an anti-infective agent, an anesthetic, a pro-inflammatory agent, a cell proliferative agent, or combinations thereof.
  • the adhesive 402 can be bioabsorbable and/or biodegradable, according to some embodiments.
  • the adhesive 402 can have a viscosity sufficiently high such that the adhesive 402 does not inadvertently prolapse from the tissue opening into the vessel opening.
  • a viscosity of the adhesive 402 can be between about between about 5,000 centipoise (cP) and about 25,000 cP, for example between about 10,000 cP and about 20,000 cP.
  • the adhesive 402 can have a viscosity of at least 5,000 cP, at least 10,000 cP, at least 15,000 cP, at least 20,000 cP, at least 25,000 cP, or at least 30,000 cP.
  • the adhesive 402 can have a lower viscosity to facilitate passage of the adhesive 402 through the pores 218 of the mesh 204.
  • the adhesive 402 can have a viscosity between about 40 cP and about 5,000 cP. .
  • FIGS. 3A and 3B show another example adhesive delivery device 500 (or “device 500”) configured in accordance with the present technology.
  • the device 500 can comprise a tubular shaft 502 configured to be slidably received over the elongate shaft 302 of the interventional device 300, and a mesh 504 positioned around an outer surface of the shaft 502 and configured to be positioned within subcutaneous tissue during a tissue closing procedure.
  • the device 500 further includes a proximal end portion 500a, a distal end portion 500b opposite the proximal end portion 500a along a longitudinal dimension of the device 500, and an intermediate portion 200c between the proximal and distal end portions 500a, 500b.
  • the shaft 502 is defined by a tubular sidewall 506 that circumferentially surrounds a lumen 508 running longitudinally through the shaft 502 from a proximal opening 508a to a distal opening 508b.
  • the sidewall 506 has a thickness t (FIG. 3B) measured in a radial dimension.
  • the outer diameter of the shaft 502 is substantially constant along the intermediate portion 500c of the shaft and tapers at the distal end portion 500b to facilitate introduction of the device 500c into an opening in the tissue.
  • the shaft 502 has a substantially constant outer diameter along its entire length, or may taper continuously in a distal direction along its length.
  • the shaft 502 may define one or more circumferential and/or longitudinal grooves at its outer surface at a location underlying the mesh 504.
  • the delivery channel 515 of the device 500 extends longitudinally within the sidewall 506 of the shaft 502 such that the sidewall 506 defines the delivery channel 515.
  • the delivery channel 515 thus has a proximal opening 530 at the proximal end portion 500b of the shaft 502 and a distal opening (not visible in FIG. 3A) at or distal of the proximal end portion 504a of the mesh 504. Integration of the delivery channel 515 with the shaft 502 has the benefit of providing the device 500 exterior with a more uniform or smoother topography for introduction into the tissue opening, as well as ease of manufacturing.
  • the device 500 is shown with a single, continuous annular projection, it will be appreciated that the device 500 can have any projection configuration disclosure herein, or no projection at all. Likewise, the device 200 comprising the separate delivery tube 214 can have any configuration or projection, or none at all.
  • FIGS. 4A-4D illustrate an example method of closing an opening in tissue proximate a puncture site in a blood vessel using the treatment system 100 of FIG. 1.
  • a needle is inserted through the skin, subcutaneous tissue, and vessel wall to provide access to the vessel lumen.
  • the needle may be inserted at a nonperpendicular angle to the vessel.
  • the vessel can be accessed via a cutdown procedure in which an incision is made through the patient’s skin and subcutaneous tissue.
  • a guidewire (not shown) can be inserted through a lumen of the needle into the vessel lumen to provide and maintain access to the vessel lumen.
  • the needle can be retracted proximally over the guidewire and removed from the subcutaneous tissue and skin, leaving an opening in the subcutaneous tissue and skin surrounding the guidewire.
  • the adhesive delivery device 200 can be positioned over a proximal or intermediate portion of the shaft 302 of the interventional device 300, for example by placing device 200 over the distal end portion of the shaft 302 and sliding the device 200 proximally. As shown in FIG. 4, the interventional device 300 can then be fed over a guidewire (not visible) through the tissue opening and into the lumen of the targeted blood vessel, such as the internal jugular vein, external jugular vein, subclavian vein, etc.
  • a guidewire not visible
  • multiple interventional devices 300 can be inserted over the guidewire and advanced distally through the tissue and into the vessel lumen, for example to increase a diameter of the tissue opening to accommodate a larger interventional device 300 (which is then subsequently advanced).
  • a medical procedure e.g., placement of a pacemaker, heart valve repair or replacement, etc.
  • the physician can slide the adhesive delivery device 200 distally along the shaft 302 into the tissue opening, as shown in FIG. 4A.
  • the physician can continue advancing the device 200 until the distal end portion 200b of the device 200 contacts the external surface of the vessel wall, which may be sensed by the physician as an increase in resistance during advancement. In some cases, the physician may cease advancement of the device 200 prior to reaching the vessel wall.
  • the physician places the adhesive source 400 in fluid communication with the delivery channel 215 of the delivery tube 214 and begins delivering the adhesive 402 into the delivery channel 215.
  • a needle 406 of the syringe may be inserted into the proximal opening 214a of the delivery tube 214.
  • the adhesive 402 moves distally through the delivery channel 215 until being expelled through the distal opening (at distal end portion 214b) into a space between the mesh 204 and the outer surface of the shaft 202.
  • the adhesive 402 can be delivered into or proximate a circumferential groove 216a, which distributes the adhesive 402 around a circumference of the shaft 202.
  • the adhesive 402 fills the circumferential groove 216a, it begins flowing distally through the longitudinal grooves 216b, thereby distributing the adhesive 402 uniformly about the length and circumference of the mesh 204 as the adhesive 402 is expelled through the pores.
  • the device 200 continues injection of the adhesive 402 through the mesh 204 causes the device 200 to deposit a thin coating 404 (FIG. 6B) of adhesive 402 on the tissue surrounding the puncture tract.
  • the mesh 204 can be positioned in contact with the subcutaneous tissue defining the tissue opening so that, when the adhesive 402 is expelled from the mesh 204, the adhesive immediately contacts the subcutaneous tissue and does not travel distally along the puncture tract and into the vessel opening.
  • the amount of adhesive delivered during a closing procedure can be from about 0.25 mL to about 10 mL, or about 0.1 mL to about 0.5 mL.
  • the physician may rotate the device 200 one or more times (while holding the shaft 302 of the interventional device 300 stationary or while also rotating the shaft 302) to ensure even distribution of the adhesive 402 around the entire circumference of the puncture tract.
  • the physician may then remove all instrumentation (e.g., the interventional device 300, the adhesive delivery device 200, and the guidewire) together from the access site (as shown in FIG. 4C) and hold pressure on the tissue opening to bring the opposing portions of the subcutaneous tissue together. Pressure may be held for 2-3 minutes until the adhesive 402 sets and the opening is closed (as shown in FIG. 4D).
  • the adhesive 402 can be configured to polymerize, cure, dry, harden, and/or otherwise set once delivered to the tissue opening and/or puncture tract.
  • the adhesive 402 can have a setting time of between about 5 seconds to about 120 seconds, about 10 seconds to about 90 seconds, about 30 seconds to about 60 seconds, about 10 seconds, about 30 seconds, about 60 seconds, about 90 seconds, or about 120 seconds.
  • the adhesive 402 can be configured to set in response to exposure to an activator such as light (e.g., ultraviolet, infrared, etc.), air, blood, tissue, other chemicals, mechanical force, etc. The exposure can occur upon expelling the adhesive 402 from the mesh 204 into the tissue opening and/or the exposure can be provided by an operator.
  • the setting time of the adhesive 402 can be sufficiently long to facilitate the opposing portions of the subcutaneous tissue being brought into contact with one another (e.g., via collapse of the tissue opening on its own, traction and/or pressure applied by the operator, etc.) prior to setting of the adhesive 402.
  • Example 1 A device for delivering a medical adhesive to a subcutaneous region proximate an opening in a wall of a blood vessel, the device comprising: a tubular shaft comprising a proximal end portion and a distal end portion opposite the proximal end portion along a longitudinal dimension of the shaft, the shaft having: an inner surface defining an instrument lumen extending longitudinally through the shaft, the instrument lumen being open at the proximal and distal end portions of the shaft, wherein the instrument lumen is configured to receive an elongate member therethrough, and an outer surface; a delivery channel extending between an inlet at the proximal end portion of the shaft and an outlet, wherein the delivery channel is positioned radially outward of the instrument lumen, and wherein the delivery channel is configured to receive a medical adhesive therethrough; and a mesh extending circumferentially around the outer surface of the shaft and longitudinally between a proximal end portion and a distal end portion, wherein the mesh comprises a material defining
  • Example 2 The device of Example 1, wherein a portion of the outer surface of the shaft underlying the mesh defines one or more grooves configured to receive and distribute the adhesive.
  • Example 3 The device of Example 2, wherein the one or more grooves comprises a circumferential groove extending around the circumference of the shaft.
  • Example 4 The device of Example 2 or Example 3, wherein the one or more grooves comprises a longitudinal groove extending longitudinally along the outer surface of the shaft.
  • Example 5 The device of any one of the previous Examples, wherein the proximal and distal end portions of the mesh are adhered to the outer surface of the shaft, thereby forming a fluid-tight seal at the proximal and distal end portions of the mesh.
  • Example 6 The device of any one of the previous Examples, wherein the shaft comprises a tubular sidewall, and wherein the delivery channel is formed within the sidewall.
  • Example 7 The device of any one of Examples 1 to 5, wherein the delivery channel is defined by a tube coupled to and extending alongside the shaft.
  • Example 8 The device of any one of the previous Examples, wherein an outer diameter of the shaft tapers at the distal end portion of the shaft.
  • Example 9 The device of any one of the previous Examples, wherein a diameter of the instrument lumen is at least 23 French.
  • Example 10 A method for delivering a medical adhesive to a subcutaneous region proximate an opening in a wall of a blood vessel, the method comprising: positioning an adhesive delivery device over an elongate medical device, wherein the adhesive delivery device comprises a tubular shaft and a mesh extending circumferentially around an outer surface of the shaft, the mesh defining a plurality of pores; while a distal portion of the elongate medical device is positioned through a tissue puncture tract and within a blood vessel lumen, sliding the adhesive delivery device distally over the elongate medical device until the mesh is positioned within the tissue puncture tract, surrounded by subcutaneous tissue; and injecting a medical adhesive into a space between the outer surface of the shaft and the mesh, then continuing to inject the adhesive to force the adhesive through the pores of the mesh and onto the surrounding subcutaneous tissue.
  • Example 11 The method of Example 10, further comprising rotating the adhesive delivery device within the tissue puncture tract during and/or after depositing the adhesive onto the subcutaneous tissue.
  • Example 12 The method of Example 10 or Example 11, further comprising withdrawing the elongate medical device and the adhesive delivery device together from the tissue puncture tract and blood vessel lumen, with the adhesive delivery device still positioned over the elongate medical device.
  • Example 13 The method of any one of the previous Examples, wherein positioning the adhesive delivery device over the elongate medical device comprises sliding the elongate medical device through a lumen of the adhesive delivery device.
  • Example 14 The method of any one of the previous Examples, further comprising inserting a distal portion of the elongate medical device through the tissue puncture tract and through an opening in the blood vessel wall while the adhesive delivery device is disposed over the elongate medical device.
  • Example 15 The method of any one of the previous Examples, wherein a portion of the outer surface of the shaft underlying the mesh defines one or more grooves configured to receive and distribute the adhesive, and wherein injection of the adhesive to the space between the outer surface of the shaft and the mesh causes the adhesive to flow within the one or more grooves.
  • Example 16 The method of any one of the previous Examples, wherein the elongate medical device has an outer diameter of at least 23 Fr.
  • Example 17 A system for delivering a medical adhesive to a subcutaneous region proximate an opening in a wall of a blood vessel, the system comprising: an elongate medical device comprising a tubular shaft having a distal portion configured to be positioned through a tissue puncture tract, though an opening in a blood vessel wall, and into the blood vessel lumen; and an adhesive delivery device comprising a tubular shaft defining a lumen therethrough, wherein the elongate medical device is configured to be positioned through the lumen of the adhesive delivery device, and wherein the adhesive delivery device comprises: a mesh extending circumferentially around an outer surface of the shaft and longitudinally between a proximal end portion and a distal end portion, wherein the mesh comprises a material defining a plurality of pores, and a delivery channel extending between an inlet at a proximal end portion of the adhesive delivery device and an outlet at or distal to the proximal end portion of the mesh, wherein the delivery channel is configured to receive
  • Example 18 The system of Example 17, wherein the elongate medical device has an outer diameter of at least 23 Fr.
  • Example 19 The system of Example 17 or Example 18, wherein a portion of the outer surface of the shaft underlying the mesh defines one or more grooves configured to receive and distribute the adhesive.
  • Example 20 The system of any one of the previous Examples, wherein the shaft comprises a tubular sidewall, and wherein the delivery channel is formed within the sidewall.
  • Example 21 The system of any one of Examples 17 to 19, wherein the delivery channel is defined by a tube coupled to and extending alongside the shaft.
  • the terms “generally,” “substantially,” “about,” and similar terms are used as terms of approximation and not as terms of degree, and are intended to account for the inherent variations in measured or calculated values that would be recognized by those of ordinary skill in the art.
  • the term “at least partially” includes both a partial and complete relationship between the parts being described.
  • the outer wall at least partially circumferentially surrounds the inner wall means the outer wall may surround only a portion of the circumference of the inner wall, or may surround the entirety of the circumference of the inner wall.

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  • Health & Medical Sciences (AREA)
  • Surgery (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Biomedical Technology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Engineering & Computer Science (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Medical Informatics (AREA)
  • Molecular Biology (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Cardiology (AREA)
  • Media Introduction/Drainage Providing Device (AREA)

Abstract

Sont divulgués des dispositifs, des systèmes et des méthodes de traitement d'ouvertures de vaisseau. Selon certains modes de réalisation, un dispositif de traitement d'une ouverture de vaisseau comprend un arbre tubulaire ayant une lumière d'instrument, un canal de distribution s'étendant entre un orifice d'entrée au niveau de la partie extrémité proximale de l'arbre et un orifice de sortie, et configuré pour recevoir un adhésif médical, ainsi qu'un maillage s'étendant circonférentiel autour de la surface externe de l'arbre. L'orifice de sortie du canal de distribution peut être aligné avec la partie extrémité proximale du maillage ou distal de celle-ci, de sorte qu'un adhésif distribué dans le canal de distribution s'écoule par l'orifice de sortie dans un espace situé entre la surface externe de l'arbre et le maillage, puis à travers les pores du maillage jusqu'à un environnement externe.
PCT/IB2024/061727 2023-12-13 2024-11-22 Dispositifs, systèmes et méthodes de fermeture de ponctions tissulaires Pending WO2025125953A1 (fr)

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Publication number Priority date Publication date Assignee Title
US6334865B1 (en) * 1998-08-04 2002-01-01 Fusion Medical Technologies, Inc. Percutaneous tissue track closure assembly and method
US6439789B1 (en) * 2000-09-27 2002-08-27 Closure Medical Corporation Polymerizable 1, 1-disubstituted ethylene monomer formulation applicators, applicator tips, applicator kits and methods
US20100318121A1 (en) * 2008-10-20 2010-12-16 PolyTouch Medical, Inc. Device and method for attaching an implant to biological tissue
US20110034954A1 (en) * 2007-04-13 2011-02-10 Pacesetter, Inc. Sutureless reinforcement for and method of treating a myocardial infarction
US20110282368A1 (en) * 2010-05-12 2011-11-17 Swayze Jeffrey S Fistula Repair Device with Extendable Barbs and Therapeutic Cell Delivery
EP2349013B1 (fr) * 2008-08-13 2020-02-26 Andrea Del Corso Dispositif d'occlusion pour chirurgie vasculaire
US10874384B2 (en) * 2011-01-19 2020-12-29 Accessclosure, Inc. Apparatus and methods for sealing a vascular puncture
US20220313438A1 (en) * 2019-12-20 2022-10-06 Edwards Lifesciences Innovation (Israel) Ltd. Implant-adhering techniques

Patent Citations (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US6334865B1 (en) * 1998-08-04 2002-01-01 Fusion Medical Technologies, Inc. Percutaneous tissue track closure assembly and method
US6439789B1 (en) * 2000-09-27 2002-08-27 Closure Medical Corporation Polymerizable 1, 1-disubstituted ethylene monomer formulation applicators, applicator tips, applicator kits and methods
US20110034954A1 (en) * 2007-04-13 2011-02-10 Pacesetter, Inc. Sutureless reinforcement for and method of treating a myocardial infarction
EP2349013B1 (fr) * 2008-08-13 2020-02-26 Andrea Del Corso Dispositif d'occlusion pour chirurgie vasculaire
US20100318121A1 (en) * 2008-10-20 2010-12-16 PolyTouch Medical, Inc. Device and method for attaching an implant to biological tissue
US20110282368A1 (en) * 2010-05-12 2011-11-17 Swayze Jeffrey S Fistula Repair Device with Extendable Barbs and Therapeutic Cell Delivery
US10874384B2 (en) * 2011-01-19 2020-12-29 Accessclosure, Inc. Apparatus and methods for sealing a vascular puncture
US20220313438A1 (en) * 2019-12-20 2022-10-06 Edwards Lifesciences Innovation (Israel) Ltd. Implant-adhering techniques

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