WO2023034873A1 - Occlusion contrôlable avec dispositif de perfusion destiné à être utilisé pendant des procédures d'intervention vasculaire à accès radial - Google Patents

Occlusion contrôlable avec dispositif de perfusion destiné à être utilisé pendant des procédures d'intervention vasculaire à accès radial Download PDF

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Publication number
WO2023034873A1
WO2023034873A1 PCT/US2022/075777 US2022075777W WO2023034873A1 WO 2023034873 A1 WO2023034873 A1 WO 2023034873A1 US 2022075777 W US2022075777 W US 2022075777W WO 2023034873 A1 WO2023034873 A1 WO 2023034873A1
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WIPO (PCT)
Prior art keywords
scaffold
catheter
vascular
introducer
lumen
Prior art date
Application number
PCT/US2022/075777
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English (en)
Inventor
Nicholas C. Debeer
Daniel Leong
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Renalpro Medical, 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 Renalpro Medical, Inc. filed Critical Renalpro Medical, Inc.
Publication of WO2023034873A1 publication Critical patent/WO2023034873A1/fr

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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, e.g. tourniquets
    • A61B17/12—Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
    • A61B17/12022—Occluding by internal devices, e.g. balloons or releasable wires
    • A61B17/12027—Type of occlusion
    • A61B17/1204—Type of occlusion temporary occlusion
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/12—Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
    • A61B17/12022—Occluding by internal devices, e.g. balloons or releasable wires
    • A61B17/12099—Occluding by internal devices, e.g. balloons or releasable wires characterised by the location of the occluder
    • A61B17/12109—Occluding by internal devices, e.g. balloons or releasable wires characterised by the location of the occluder in a blood vessel
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/12—Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
    • A61B17/12022—Occluding by internal devices, e.g. balloons or releasable wires
    • A61B17/12131—Occluding by internal devices, e.g. balloons or releasable wires characterised by the type of occluding device
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B90/00—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
    • A61B90/36—Image-producing devices or illumination devices not otherwise provided for
    • A61B90/37—Surgical systems with images on a monitor during operation
    • A61B2090/373—Surgical systems with images on a monitor during operation using light, e.g. by using optical scanners
    • A61B2090/3735—Optical coherence tomography [OCT]
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B90/00—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
    • A61B90/36—Image-producing devices or illumination devices not otherwise provided for
    • A61B90/37—Surgical systems with images on a monitor during operation
    • A61B2090/378—Surgical systems with images on a monitor during operation using ultrasound
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B90/00—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
    • A61B90/39—Markers, e.g. radio-opaque or breast lesions markers
    • A61B2090/3966—Radiopaque markers visible in an X-ray image
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/04—Hollow or tubular parts of organs, e.g. bladders, tracheae, bronchi or bile ducts
    • A61F2/06—Blood vessels
    • A61F2/07—Stent-grafts
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M39/00—Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
    • A61M39/10—Tube connectors; Tube couplings

Definitions

  • FIELD FIELD
  • This application relates to various methods and devices for at least partially occluding peripheral blood flow from a blood vessel while maintaining perfusion to blood vessels and structures distal to the occlusion site.
  • the occlusion devices may also enable a single vascular access point for simultaneous use of a therapeutic device in conjunction with use of the occlusion device.
  • embodiments of the present invention relate generally to medical interventions conducted through vessels of the vasculature such as the major arteries, veins and more particularly to access and deployment configurations for conducting vascular interventions using the right or left renal artery.
  • a single introducer sheath is used to provide access to a scaffold based occlusion with perfusion device modified to allow simultaneous access to a vascular intervention device.
  • Contrast Induced Acute kidney injury also called acute renal failure (ARF)
  • ALF acute renal failure
  • CI- AKI is diagnosed on the basis of characteristic laboratory findings, such as elevated blood creatinine, or inability of the kidneys to produce sufficient amounts of urine.
  • Contrast Induced Acute Kidney Injury is diagnosed on the basis of clinical history and laboratory data.
  • a diagnosis is made when there is rapid reduction in kidney function, as measured by serum creatinine, or based on a rapid reduction in urine output, termed oliguria.
  • the use of intravascular iodinated contrast agents may cause acute kidney injury.
  • CI-AKI contrast-induced AKI
  • Clinical procedures involving intravascular iodine-containing contrast media injection include for example, percutaneous coronary intervention (PCI), peripheral vascular angiography and intervention, neurological angiography and intervention.
  • vascular pathways may be quite tortuous and geometrically small, and thus one of the challenges with percutaneous procedures lies in gaining access, conducting the desired interventional and/or diagnostic procedures, and removing the pertinent instrumentation, without damaging the vasculature or associated anatomy.
  • introducer and dilator sets have been utilized to provide a usable access conduit through an arteriotomy or other surgical access to the vasculature.
  • arteriotomy or other surgical access to the vasculature.
  • cardiovascular diagnostic and/or interventional procedures are conducted on diseased cardiovascular systems and in tortuous anatomy.
  • the un-expanded delivery size of a commercially available aortic valve prosthesis may be up to 18 French or more such as other valves having an un-expanded delivery size of a between 18 and 24 French, depending upon which size is utilized) and to be re-collapsed before or during withdrawal so that the associated anatomy is not undesirably loaded or damaged during such withdrawal.
  • a vascular occlusion device includes a scaffold catheter having a scaffold structure coupled to a scaffold catheter shaft, a scaffold sheathing catheter having a scaffold sheathing catheter shaft with a proximal end and a distal end with a full round distal end section at the distal end, the full round distal end section having a distal end, a lumen and a proximal end and a shaft sleeve having a proximal end and a distal end and a lumen, wherein the scaffold catheter shaft is nested within the scaffold sheathing shaft within the shaft sleeve lumen.
  • the vascular occlusion device can further include one or more layer scaffold covering over at least a portion of the scaffold structure, the one or more layer scaffold covering can have a distal scaffold attachment zone where a portion of the scaffold covering is attached to a distal portion of the scaffold, a proximal scaffold attachment zone where a portion of the scaffold covering is attached to a proximal portion of the scaffold and an unattached zone between the distal attachment zone and the proximal attachment zone wherein the scaffold covering is unattached to an adjacent portion of the scaffold.
  • the vascular device can further include a handle having a first part and a second part wherein the first part is coupled to a proximal portion of the scaffold sheathing catheter shaft and the second part is coupled to a proximal portion of the scaffold catheter shaft and wherein a proximal portion of the shaft sleeve is coupled to the handle so as to allow access to the shaft sleeve lumen by the scaffold sheathing catheter shaft and the scaffold catheter shaft. Movement of the handle first part relative to the handle second part can move the scaffold relative to the full round distal end section.
  • Movement of the handle first part relative to the handle second part can transition the scaffold from a stowed configuration within the full round distal end section lumen and a deployed configuration where the scaffold is outside of the full round section distal end section lumen.
  • the cross section shape of the scaffold catheter shaft and the sheathing catheter shaft can have an outer surface with a curvature conforming to a curvature of an interior wall of an introducer.
  • the cross section shapes of the scaffold catheter shaft and the sheathing catheter shaft can have a complementary shape so that in use the shafts are nested.
  • the cross section shapes of the scaffold catheter shaft, the sheathing catheter shaft and the shaft sleeve can be complementary shapes so that in use the shafts are nested within the shaft sleeve lumen.
  • the cross section shapes of the scaffold catheter shaft, the sheathing catheter shaft and the shaft sleeve can be complementary shapes to the interior lumen of an introducer so as to provide an interior lumen of an introducer comprising the interior wall of the introducer and an exterior wall of the shaft sleeve or the scaffold catheter.
  • the vascular device can further include an introducer having an interior lumen and a proximal end and a distal end wherein in use with the shaft sleeve present within the introducer lumen and extending beyond the distal end there remains within the introducer lumen sufficient space to pass an intravascular device along the introducer lumen.
  • the intravascular device can have a size of about 5Fr.
  • the intravascular device can have a size of from about 3 Fr to 6Fr.
  • the introducer lumen can be utilized to allow simultaneously access for the shaft sleeve containing the scaffold catheter shaft and the scaffold sheathing catheter shaft alongside a guide catheter adapted for passing an intravascular device that is one of a diagnostic instrument, or an instrument selected from the group consisting of: an angiography catheter, an intravascular ultrasound testing instrument, or an intravascular optical coherence tomography instrument, and the therapeutic instrument is preferably a balloon catheter, a drug-eluting balloon catheter, a bare metal stent, a drug-eluting stent, a drug-eluting biodegradable stent, a rotablator, a thrombus suction catheter, a drug administration catheter, a guiding catheter, a support catheter, or a device or a prosthesis delivered as part of a intravascular procedure or system.
  • a diagnostic instrument or an instrument selected from the group consisting of: an angiography catheter, an intravascular ultrasound testing instrument, or an intravascular optical coherence tomography instrument
  • the therapeutic instrument
  • the scaffold covering can extend completely circumferentially about the scaffold structure from the distal attachment zone to the proximal attachment zone.
  • the scaffold structure can have a distal end, a scaffold transition zone and a proximal end having one or a plurality of legs.
  • the one leg or each leg of the plurality legs can be coupled to a distal portion of the inner shaft.
  • the scaffold structure can move from a stowed configuration when the outer shaft is extended over the scaffold structure and a deployed configuration when the outer shaft is retracted from covering the scaffold structure.
  • a vascular device in one embodiment, includes an introducer having an interior lumen with an interior wall, a shaft sleeve having an inner wall and an outer wall and a lumen having a cross section shape defined by the outer wall and the inner wall, wherein in the outer wall has a shape that is conformal to a curvature of a portion of the interior wall, wherein when the shaft sleeve is within the introducer, the modified introducer interior lumen is defined by the interior wall and the portion of the shaft sleeve outer wall in communication with the interior lumen, a scaffold catheter shaft and a sheathing catheter shaft within the shaft sleeve lumen, and a guide catheter adapted for passing an intravascular device that is one of a diagnostic instrument, or an instrument selected from the group consisting of: an angiography catheter, an intravascular ultrasound testing instrument, or an intravascular optical coherence tomography instrument, and the therapeutic instrument is preferably a balloon catheter, a drug- eluting balloon catheter, a
  • the device can further include a scaffold having a scaffold covering that extends partially circumferentially about the scaffold structure from the distal attachment zone to the proximal attachment zone with an uncovered scaffold structure.
  • the scaffold covering can extend partially circumferentially about 270 degrees of the scaffold structure from the distal attachment zone to the proximal attachment zone.
  • a first scaffold covering can extend partially circumferentially about 45 degrees of the scaffold structure from the distal attachment zone to the proximal attachment zone and a second scaffold covering extends partially circumferentially about 45 degrees of the scaffold structure from the distal attachment zone to the proximal attachment zone, wherein the first scaffold covering and the second scaffold covering are on opposite sides of the longitudinal axis of the scaffold structure.
  • the scaffold covering can be formed from a single or multiple layers.
  • the layers of the multiple layer scaffold covering can be selected from ePFTE, PTFE, FEP, polyurethane or silicone.
  • the scaffold covering or the more than one layers of a multiple layer scaffold covering can be applied to a scaffold structure external surface, to a scaffold structure internal surface, to encapsulate the distal scaffold attachment zone and the proximal scaffold attachment zone, as a series of spray coats, dip coats or electron spin coatings to the scaffold structure.
  • the multiple layer scaffold covering can have a thickness of 5 – 100 microns or wherein the multiple layer scaffold covering has a thickness of about 0.001 inches in an unattached zone and a thickness of about 0.002 inches in an attached zone.
  • a method of providing selective occlusion with distal perfusion using a vascular occlusion device includes: (1) positioning an introducer to access an aortic arch of a patient; (2) advancing the scaffold vascular occlusion device in a stowed condition within a scaffold sheathing catheter along a blood vessel to a position adjacent to one or more peripheral blood vessels in the portion of the vasculature of the patient selected for occlusion while the vascular occlusion device is tethered to a handle outside of the patient; (3) transitioning the vascular occlusion device from the stowed condition to a deployed condition using the handle to withdraw a full round distal end section of the sheathing catheter wherein the deployed vascular occlusion device at least partially occludes blood flow into the one or more peripheral blood vessels selected for occlusion; (4) deflecting a portion of an unattached zone of the covered scaffold in response to the blood flow through the lumen of the covered scaffold into
  • the position of the vascular occlusion device can engage with a superior aspect of the vasculature to direct blood flow into and along a lumen defined by a scaffold structure of the vascular occlusion device.
  • the one or more peripheral blood vessels in the portion of the vasculature of the patient selected for occlusion can be selected from the group consisting of a hepatic artery, a gastric artery, a celiac trunk, a splenic artery, an adrenal artery, a renal artery, a superior mesenteric artery, an ileocolic artery, a gonadal artery and an inferior mesenteric artery.
  • the covered scaffold unattached zone can further include a position of a portion of the unattached zone to deflect into a portion of at least one of a hepatic artery, a gastric artery, a celiac trunk, a splenic artery, an adrenal artery, a renal artery, a superior mesenteric artery, an ileocolic artery, a gonadal artery and an inferior mesenteric artery when the vascular occlusion device is positioned within a portion of the aorta.
  • a method of temporarily occluding a blood vessel includes: (1) advancing a vascular occlusion device in a stowed condition along a blood vessel to a position adjacent to one or more peripheral blood vessels selected for temporary occlusion; (2) transitioning the vascular occlusion device from the stowed condition to a deployed condition by advancing the vascular occlusion device from within a full round distal section of a scaffold sheathing catheter wherein thereafter the vascular occlusion at least partially occludes blood flow into the one or more peripheral blood vessels selected for temporary occlusion while directing the blood flow through and along a lumen of a covered scaffold of the vascular occlusion device; (3) performing a vascular intervention with in the patient vasculature while the vascular occlusion device is present within the blood vessel, wherein using a imaging contrast agent during the vascular intervention initiates a period of temporary occlusion; and (4) transitioning the vascular occlusion
  • Directing the blood flow through and along the lumen of the vascular occlusion device can maintain blood flow to components and vessels distal to the vascular occlusion device while at least partially occluding the blood flow to the one or more peripheral blood vessels.
  • the one or more peripheral blood vessels can be the vasculature of a liver, a kidney, a stomach, a spleen, an intestine, a stomach, an esophagus, or a gonad.
  • the blood vessel can be an aorta and the peripheral blood vessels are one or more or a combination of: a hepatic artery, a gastric artery, a celiac trunk, a splenic artery, an adrenal artery, a renal artery, a superior mesenteric artery, an ileocolic artery, a gonadal artery and an inferior mesenteric artery.
  • FIG.1 illustrates an exploded view of an exemplary embodiment of an occlusion with perfusion device or scaffold with a scaffold sheathing catheter and shaft sleeve.
  • Diagram of an exemplary invention device comprises an occlusion catheter having a covered scaffold positioned at the infra-renal aorta position near orifices of bilateral renal arteries for treating acute kidney injury.
  • FIG.2 illustrates the components of the scaffold based occlusion with perfusion device of FIG.1 arranged with the scaffold catheter shaft alongside the sheathing catheter shaft with the scaffold structure proximal to the full round distal end of the scaffold sheathing catheter.
  • FIG.3 illustrates the components of FIGs.1 and 2 with the scaffold based occlusion with perfusion device of FIG.1 arranged with the scaffold catheter shaft alongside the sheathing catheter shaft within the shaft sleeve lumen and the scaffold structure within the lumen of the full round distal end of the scaffold sheathing catheter.
  • a guidewire is shown alongside the shaft sleeve and within the scaffold lumen and exiting the full round distal end lumen.
  • FIGs.3A-3D represent the cross section views indicated on FIG.3.
  • FIG.3E is a cross section view of an alternative shaft sleeve having an inner wall that corresponds to the curvature of the scaffold catheter shaft. This illustration is an example of nesting the cross section profiles of the shaft sleeve, the scaffold catheter and the scaffold sheathing catheter.
  • FIG.3D1 is a cross section view of a shaft sleeve as in FIG.3D within an introducer lumen representing the remaining portion of the introducer lumen with the shaft sleeve present.
  • FIG.3E1 is a cross section view of a shaft sleeve as in FIG.3E within an introducer lumen representing the remaining portion of the introducer lumen with the shaft sleeve present
  • FIG.4 is a profile view of the components of the scaffold occlusion with perfusion device of FIG.1 in relationship to an introducer.
  • FIG.5 is an isometric view of the components of the scaffold occlusion with perfusion device of FIG.4 in relationship to the distal end of the introducer as well as exit of the shafts from the distal most end of the shaft sleeve.
  • FIG.6 shows the arrangement of the components in FIG.5 with a guidewire positioned beyond the distal end of the introducer and separated from the shaft sleeve.
  • FIG.7A shows the arrangement of the components in FIG.6 with an intravascular device advanced along the guidewire.
  • FIG.7B is a cross section view along section A-A of FIG.7A showing how the interior of the introducer is apportioned between the interventional device and the shaft sleeve and included shafts. The relative sizes of the components are exaggerated in this view.
  • the intervascular device utilizes a greater portion of the introducer lumen interior than those occupied by the shaft sleeve.
  • the shaft sleeve remains against the interior wall of the introducer lumen such that the lumen accessed by the interventional device is formed by the introducer interior wall not covered by the shaft sleeve and the inner wall of the shaft sleeve (e.g., the wall of the shaft sleeve adjacent to or contacting the interventional device.
  • the shaft sleeve outer wall in conformal to or complementary in shape to the outer wall of the intravascular device.
  • FIG.8 shows at representative arteries access via a radial artery access procedure.
  • FIG.9 shows a guidewire accessing the patient vasculature via the radial artery.
  • FIG.10A is an initial insertion of an introducer and dilator into the radial artery over the guide wire in FIG.9.
  • FIG.10B is an enlarged view of the introducer and dilator into the radial artery over the guide wire in FIG.10A.
  • FIG.11A is an overall view of the introducer and dilator of FIG.10B accessing the aortic arch of the patient.
  • FIG.11B is an enlarged view of the introducer and dilator positioned as in FIG.11A.
  • FIG.12 is the withdrawal of the dilator leaving the introducer distal end accessing the aortic arch.
  • FIG.13 is the withdrawal of the dilator from the access site.
  • FIG.14 is the advancement of the scaffold occlusion with perfusion device of FIG.1 along the guidewire towards the access site.
  • FIG.15A is the advancement of the scaffold occlusion with perfusion device of FIG. 14 beyond the distal end of the introducer and accessing the aortic arch.
  • FIG.15B is an enlarged cross section view of FIG.15A showing the components within the aortic arch.
  • FIG.16 is the continuing advancement of the components in FIG.15B along the guidewire and the aorta.
  • FIG.17A is the continuing advancement of the components in FIG.16 along the guidewire and the aorta into position adjacent to the renal artery ostia. In this position the full round section of the scaffold sheathing catheter containing the stowed scaffold is alongside the ostia.
  • FIG.17B is an enlarged view of the arrangement of the components in FIG.17.
  • FIG.18A is an overall view of the arrangement of the components in FIG.17B as the full round distal section of the scaffold sheathing catheter is withdrawn proximally.
  • FIG.18B is an enlarged view of the arrangement of the components in FIG.18A as the full round distal section of the scaffold sheathing catheter continues to be withdrawn proximally. An additional portion of the distal most portion of the scaffold is transitioning into the deployed configuration to at least partially occlude the renal ostia.
  • FIG.18C is an overall view of the arrangement of the components in FIG.18B as the full round distal section of the scaffold sheathing catheter continues to be withdrawn proximally. An additional portion of the distal most portion of the scaffold is transitioning into the deployed configuration to at least partially occlude the renal ostia.
  • FIG.18D is an enlarged view of the arrangement of the components in FIG.18C as the full round distal section of the scaffold sheathing catheter has been withdrawn proximally beyond the coupling. In this view the scaffold is fully transitioned into the deployed configuration to at least partially occlude the renal ostia.
  • FIG.18E is an enlarged view of the arrangement of the scaffold and the scaffold sheathing catheter while the scaffold is provided occlusion with distal perfusion. In this view the scaffold or scaffold covering is distended into the renal ostia.
  • FIG.18F is an enlarged view of the arrangement of the scaffold and the scaffold sheathing catheter while the scaffold is provided occlusion with distal perfusion.
  • FIG.18G is an overall view of the arrangement of the scaffold and the scaffold sheathing catheter while the scaffold is provided occlusion with distal perfusion as in FIG.18E showing the withdrawal of the guidewire to prepare for the introduction of an interventional device in conjunction with the use of the scaffold occlusion device.
  • FIG.18H represents the continued withdrawal of the guidewire.
  • FIG.18I is the repositioning of the guidewire while adjacent to the shaft sheath and within the same introducer.
  • FIG.18J is the repositioned guidewire for guiding an intervascular device to be used in a procedure accessed using the same introducer and simultaneously with the scaffold occlusion device.
  • FIG.19A is placement of the intervascular device onto the guidewire positioned in FIG.18J. The intervascular device will be used in a procedure accessed using the same introducer and simultaneously with the scaffold occlusion device.
  • FIG.19B is a partial cross section and exploded view of the arrangement of the scaffold components above alongside the intervascular device as it is advanced along the guidewire positioned as in FIG.18J.
  • FIG.19C is an overall view of the components in FIG.19A accessing the aortic arch.
  • FIG.19D is the enlarged view of the components in FIG.19C accessing the aortic arch with the intervascular device exiting the same introducer used for the scaffold occlusion device while the scaffold device is present and adjacent to the renal arteries.
  • FIGs.20A and 20B are perspective views of an alternative scaffold structure using deflectable rings on the scaffold catheter.
  • FIG.20A illustrates the rings in a deployed configuration.
  • FIG.20B represents the rings in a stowed condition as would be within the full round distal section (See FIG.3)
  • FIGs.20C and 20D illustrate the rings of FIG.20A and 20B with a scaffold covering in place that extends between the rings.
  • FIGs.21A-21C represent the delivery of an embodiment of the rings in FIG.20C within the aorta to occlude the renal ostia.
  • FIG.22A is an embodiment of the rings in FIG.20C where the scaffold covering only extends about 270 degrees around the rings. This embodiment is deployed in the aorta in the view of FIG.22C and in the cross section view of FIG.22E.
  • FIG.22B is an embodiment of the rings in FIG.20C where the scaffold covering only extends about two partial segments around the rings. This embodiment is deployed in the aorta in the view of FIG.22D and in the cross section view of FIG.22F.
  • FIGs.23A and 23B are perspective views of an alternative scaffold structure using deflectable rings on the scaffold catheter of different sizes.
  • FIG.23A illustrates the rings in a deployed configuration with a larger diameter proximal ring than the distal ring.
  • FIG.23B represents the rings in a stowed condition as would be within the full round distal section (See FIG.3)
  • FIGs.23C and 23D illustrate the rings of FIG.23A and 23B with a scaffold covering in place that extends between the rings.
  • FIG.23E represents the delivery of an embodiment of the rings in FIG.23C within the aorta to occlude the renal ostia.
  • FIG.24A is a scaffold structure that extends along the scaffold catheter responsive to the movement of the full round distal end.
  • FIG.24B is the scaffold structure of FIG.24A when deployed.
  • FIG.24C is the scaffold device of FIG.24A adjacent to the renal ostia.
  • FIG.24D is the scaffold structure of FIG.24B in position to occlude the renal ostia once the full round section has been withdrawn.
  • FIG.25A is a scaffold structure that extends along the scaffold catheter responsive to the movement of the full round distal end. A coil structure withing the covering is extended while stowed.
  • FIG.25B is the scaffold structure of FIG.25A when deployed by allowing the coil structure to move when unconstrained by the full round section.
  • FIG.25C is the coil scaffold structure of FIG.25B in position to occlude the renal ostia constrained by the full round section.
  • FIG.25D is the scaffold structure of FIG.25C in position to occlude the renal ostia in a deployed configuration since the full round section has been withdrawn.
  • FIG.26 is a flow chart of an exemplary method of providing occlusion with perfusion using an embodiment of a vascular occlusion device herein according to the method 2600.
  • FIG.27 is a flow chart of an exemplary method of providing occlusion with perfusion using an embodiment of a vascular occlusion device according to the method 2700.
  • DETAILED DESCRIPTION [0075] Current treatments/managements for acute kidney injury (AKI), especially contrast- induced acute kidney injury are mainly supportive.
  • PCI percutaneous coronary intervention
  • HP-osmolar contrast media by using low-osmolar or iso-osmolar contrast media
  • reducing the amount of contrast media during PCI and (4) applying intravenously isotonic sodium chloride solution or sodium bicarbonate solution hours before and after PCI, (5) avoiding use of nephrotoxic drugs (such as nonsteroidal anti-inflammatory drugs, aminoglycosides antibiotics, etc.) See Stevens 1999, Schweiger 2007, Solomon 2010. However, none of them were proven with consistent effect in preventing CI-AKI.
  • nephrotoxic drugs such as nonsteroidal anti-inflammatory drugs, aminoglycosides antibiotics, etc.
  • CI-AKI renal outer medulla ischemia and/or prolonged transit of contrast media inside the kidneys.
  • the embodiments described herein may be used simultaneously with other vascular interventional devices prior to the use of imaging contrast or to remain in a deployed condition throughout the vascular intervention procedure.
  • a device for treating acute kidney injury comprising a scaffold based occlusion with perfusion structure adapted and configured to occlude partially or completely the ostia on both sides of the aorta for the renal arteries while allowing blood flow going through the lumen of the scaffold structure and into the distal portions of the aorta beyond the device and on to distal vascular structures.
  • a position indication means is provided on the scaffold structure or associated sheathing structure which may be a radio-opaque marker, or the like.
  • Radio opaque markers are vital prerequisites on an increasing number of endovascular medical devices and are appropriately provided on the various embodiments to allow positioning of the temporary occlusion device. The value of radio opaque markers is clearly seen in visibility improvement during deployment of the device. Markers allow for improved tracking and positioning of an implantable device during a procedure using fluoroscopy or radiography. [0079] While some embodiments have been described for use in mitigating CI-AKI, alternative non-balloon based occlusion or partial occlusion devices are also provided. Moreover, such alternative partial or complete peripheral occlusion devices simultaneously provide for distal perfusion blood flow into vessels and structures beyond the occlusion device.
  • various occlusion device embodiments may be provided that are adapted and configured to provide temporary occlusion of the peripheral vasculature of the suprarenal and infrarenal abdominal aortic area while maintaining distal perfusion.
  • Exemplary clinical applications include but are not limited to: [0082] Total or nearly total vascular occlusion of blood flow during the surgical treatment of renal tumors through Retroperitoneoscopic Radical Nephrectomy (RRN), Open Radical Nephrectomy (ORN), Open Nephron-sparing Surgery (ONR), or other surgical interventions where it is beneficial to provide temporary vascular occlusion to peripheral organs.
  • RRN Retroperitoneoscopic Radical Nephrectomy
  • ORN Open Radical Nephrectomy
  • ONR Open Nephron-sparing Surgery
  • FIG.1 illustrates an exploded view of an exemplary embodiment of an occlusion with perfusion device 100.
  • the occlusion with perfusion device 100 includes a scaffold sheathing catheter 110 and a scaffold catheter 130.
  • the scaffold catheter 130 includes a scaffold catheter shaft 132 with a coupling 134 on the distal most portion.
  • the coupling 134 is modified and adapted for use with the geometry, type, shape and functional characteristics of the scaffold 140.
  • the scaffold 140 includes a scaffold structure 144 and suitable covering 146. In some embodiments, the scaffold structure 144 may be uncovered in which case the covering 146 is omitted.
  • the scaffold covering 146 may covered scaffold with attached and unattached zones as described further herein.
  • the scaffold sheathing catheter 110 includes a shaft 115 and a full round distal end section 120 having a distal end 122 and a proximal end 124.
  • the full round distal end section 120 defines a lumen 128 sized to stow or maintain the scaffold 140 in a stowed configuration. Additionally, in use, the full round distal section distal end 122 engages with the scaffold in the deployed configuration and moves it into a stowed configuration within the lumen 128.
  • FIG.2 shows the components arranged for use with the shaft sleeve 150 withdrawn from the shafts 115, 132 in order to show their nested relation.
  • FIG.3 shows the components of FIG.2 with the scaffold 140 within the lumen 128 which is the configuration for advancing along the introducer and then the vasculature into the position for use within the aorta.
  • FIG.3A is a section view A-A through a portion of the full round
  • the device is an "assist device" which does not interfere with the standard catheterization procedure and comply with the standard activities in the catheterization lab.
  • the peripheral portions of the scaffold catheter and the scaffold sheathing catheter may provide a guiding function to therapy devices advancing along the introducer.
  • the shafts may provide a base structure for the manipulation of the vascular intervention device by providing an additional structure to push against or use as a base for manipulation of interventional devices.
  • the shaft sleeve is only one option for maintaining the nested adjacency of the shafts of the scaffold catheter and the scaffold sheathing catheter.
  • the edges of the catheter shafts may be keyed to maintain adjacency but allow for longitudinal translation.
  • the lower surface of the scaffold catheter and the upper surface of the scaffold sheathing catheter may also be keyed or provided with tab/slot arrangements that will maintain the adjacency while permitting longitudinal movement. Guiding or keying structures may be placed along all or a portion or on particular portions of the shaft length.
  • FIG.3 illustrates the components of FIGs.1 and 2 with the scaffold based occlusion with perfusion device of FIG.1 arranged with the scaffold catheter shaft alongside the sheathing catheter shaft within the shaft sleeve lumen and the scaffold structure within the lumen of the full round distal end of the scaffold sheathing catheter.
  • a guidewire 30 is shown alongside the shaft sleeve 150 and within the scaffold lumen and exiting the full round distal end lumen 128.
  • the sheathing catheter 110 has a proximal partial circumference shaft (outer larger circumference within the shaft sleeve) with a full circumference sheath on the distal end.
  • the sheath is sized (a) to be advanced along the introducer interior diameter and (b) hold the scaffold 140 in the stowed configuration.
  • the full round section of the scaffold sheathing catheter 120 is longer than the scaffold 140.
  • the scaffold sheathing catheter 110 has a length ranging from about 110 cm to 145 cm.
  • the introducer sheath has a length ranging from about 45 cm to about 80 cm.
  • the diameter of the introducer sheath is 7fr which is sized for use in the aorta.
  • the full round section of the scaffold sheathing catheter has an outer diameter ranging from 2.3mm to 1.67mm with an inner diameter ranging from 2mm to 1mm. [0095]
  • FIGs.3A-3D represent the cross-section views indicated on FIG.3.
  • FIG.3E is a cross section view of an alternative shaft sleeve 150 having an inner wall that corresponds to the curvature of the scaffold catheter shaft 132. This illustration is an example of nesting the cross-section profiles of the shaft sleeve 150, the scaffold catheter 130 and the scaffold sheathing catheter 110.
  • FIG.3D1 is a cross section view of a shaft sleeve 150 as in FIG.3D within an introducer lumen 24 representing the shaft sleeve lumen 152 and the remaining portion of the introducer lumen available for use by, for example, a vascular therapeutic device while the shaft sleeve 150 is present. The components within the shaft sleeve 150 are removed for clarity purposes.
  • FIG.3E1 is a cross section view of a shaft sleeve 150 as in FIG.3E within an introducer lumen 24 representing the shaft sleeve lumen 152 and the remaining portion of the introducer lumen 24 available for use by, for example, a vascular therapeutic device while the shaft sleeve 150 is present. The components within the shaft sleeve are removed for clarity purposes. [0099] While the shaft sleeve 150 is shown at a six o’clock position in Figures 3D-3E1, it will be appreciated that the shaft sleeve may be rotated within the introducer into any other rotational position as needed in support of, for example, the simultaneous use for performing a vascular intervention procedure.
  • FIG.4 is a profile view of the components of the scaffold occlusion with perfusion device 100 of FIG.1 in relationship to an introducer 20.
  • the scaffold 140 is positioned within the scaffold sheathing catheter 110.
  • a coupler 134 is shown on a distal portion of the scaffold catheter 130.
  • a shaft sleeve 150 is shown proximal to the scaffold sheathing catheter 110.
  • FIG.5 is an isometric view of the components of the scaffold occlusion with perfusion device 100 of FIG.4 in relationship to the distal end 22 of the introducer 20 as well as exit of the shafts 132, 115 from the distal most end of the shaft sleeve 150.
  • FIG.6 shows the arrangement of the components in FIG.5 with a guidewire 30 positioned beyond the distal end 22 of the introducer 20 and separated from the shaft sleeve 150.
  • FIG.7A shows the arrangement of the components in FIG.6 with an intravascular device 50 advanced along the guidewire 30.
  • FIG.7B is a cross section view along section A-A of FIG.7A showing how the interior of the introducer 20 is apportioned between the interventional device 50 and the shaft sleeve 150 and included shafts 110, 130. The relative sizes of the components are exaggerated in this view.
  • the intervascular device 50 utilizes a greater portion of the introducer lumen interior than those occupied by the shaft sleeve 150.
  • the shaft sleeve remains against the interior wall of the introducer lumen such that the lumen accessed by the interventional device 50 is formed by the introducer interior wall not covered by the shaft sleeve 150 and the inner wall of the shaft sleeve (e.g., the wall of the shaft sleeve adjacent to or contacting the interventional device.
  • the shaft sleeve outer wall in conformal to or complementary in shape to the outer wall of the intravascular device.
  • FIG.8 includes the radial artery 214, the brachial artery 206, the subclavian arch 204, the aortic arch 202, the descending aorta 210, the renal arteries 208, 212, the renal artery ostia 218, and the kidneys 216.
  • FIG.9 shows a guidewire 30 accessing the patient vasculature via the radial artery 214.
  • FIG.10A is an initial insertion of an introducer 20 and dilator 23 into the radial artery 214 over the guide wire in FIG.9.
  • FIG.10B is an enlarged view of the introducer 20 and dilator into the radial artery over the guide wire in FIG.10A.
  • FIG.11A is an overall view of the introducer and dilator of FIG.10B accessing the aortic arch 202 of the patient.
  • FIG.11B is an enlarged view of the introducer 20 and dilator positioned as in FIG.11A.
  • FIG.12 is an enlarged view of the withdrawal of the dilator 23 leaving the introducer 20 distal end 22 accessing the aortic arch 202.
  • FIG.13 is an overall view of the withdrawal of the dilator from the access site.
  • FIG.14 is an overall view of the advancement of the scaffold occlusion with perfusion device 100 of FIG.1 along the guidewire 30 towards the access site.
  • FIG.15A is an overall view of the advancement of the scaffold occlusion with perfusion device 100 of FIG.14 beyond the distal end 22 of the introducer 20 and accessing the aortic arch 202.
  • FIG.15B is an enlarged cross section view of FIG.15A showing the components within the aortic arch 202. Shown in 15B are the guide wire 30, the scaffold sheathing catheter 110 and scaffold catheter 130. The scaffold sheathing catheter 110 and scaffold 140 are shown extending out of the distal end 22 of the introducer 20. The shaft sleeve 150 is shown over the sheathing catheter 110 and scaffold catheter 130 within the introducer 20.
  • FIG.16 shows the continuing advancement of the components in FIG.15B along the guidewire and the aorta.
  • FIG.17A shows the continuing advancement of the components in FIG.16 along the guidewire and the aorta into position adjacent to the renal artery ostia 218. In this position the full round section 120 of the scaffold sheathing catheter containing the stowed scaffold is alongside the ostia.
  • FIG.17B is an enlarged view of the arrangement of the components in FIG.17A.
  • the scaffold 140 is positioned within the full round section 120 of the scaffold sheathing catheter.
  • the scaffold sheathing catheter 110 and scaffold catheter 130 are shown extending through the shaft sleeve 150.
  • FIG.18A is an overall view of the continuing advancement of the components in FIG.17B as the full round distal section 120 of the scaffold sheathing catheter 110 is withdrawn proximally.
  • the distal most portion of the scaffold is shown beginning the transition to the deployed configuration to at least partially occlude the renal ostia 218.
  • FIG.18B is an enlarged view of the arrangement of the components in FIG.18A as the full round distal section 120 of the scaffold sheathing catheter 110 continues to be withdrawn proximally.
  • the distal most portion of the scaffold 140 is shown beginning the transition to the deployed configuration to at least partially occlude the renal ostia.
  • FIG.18C is an overall view of the arrangement of the continuing advancement of the components in FIG.18B as the full round distal section 120 of the scaffold sheathing catheter 110 continues to be withdrawn proximally. An additional portion of the distal most portion of the scaffold 140 is transitioning into the deployed configuration to at least partially occlude the renal ostia.
  • FIG.18D is an enlarged view of the arrangement of the components in FIG.18C as the full round distal section 120 of the scaffold sheathing catheter 110 has been withdrawn proximally beyond the coupling 134. In this view the scaffold 140 is fully transitioned into the deployed configuration to at least partially occlude the renal ostia 218.
  • FIG.18E is an enlarged view of the arrangement of the scaffold 140 and the scaffold sheathing catheter 110 while the scaffold 140 is providing occlusion with distal perfusion. In this view the scaffold 140 or scaffold covering 146 is distended into the renal ostia 218.
  • FIG.18F is an enlarged view of the arrangement of the scaffold 140 and the scaffold sheathing catheter 110 while the scaffold sheathing catheter is being withdrawn. In this view the scaffold 140 or scaffold covering 146 is providing occlusion with distal perfusion but is not distended into the renal ostia 218.
  • FIG.18G is an overall view of the arrangement of the scaffold 140 and the scaffold sheathing catheter 110 while the scaffold 140 is providing occlusion with distal perfusion as in FIG.18E showing the withdrawal of the guidewire 30 to prepare for the introduction of an interventional device in conjunction with the use of the scaffold occlusion device.
  • FIG.18H represents the continued withdrawal of the guidewire 30.
  • FIG.18I is an enlarged view of the repositioning of the guidewire 30 while adjacent to the shaft sleeve 150 and within the same introducer 20.
  • FIG.18J is an overall view of the repositioned guidewire 30 for guiding an intervascular device to be used in a procedure accessed using the same introducer 20 and simultaneously with the scaffold occlusion device.
  • FIG.19A shows placement of the intervascular device onto the guidewire 30 positioned in FIG.18J. The intervascular device will be used in a procedure accessed using the same introducer and simultaneously with the scaffold occlusion device.
  • FIG.19B is a partial cross section and exploded view of the arrangement of the scaffold components above alongside the intervascular device 50 as it is advanced along the guidewire 30 positioned as in FIG.18J.
  • FIG.19C is an overall view of the components in FIG.19A accessing the aortic arch 202.
  • FIG.19D is the enlarged view of the components in FIG.19C accessing the aortic arch 202 with the intervascular device exiting the same introducer used for the scaffold occlusion device while the scaffold device is present and adjacent to the renal arteries.
  • FIGs.20A and 20B are perspective views of an alternative scaffold structure 140 using deflectable rings 2202 on the scaffold catheter 130.
  • FIG.20A illustrates the rings 2202 in a deployed configuration.
  • FIG.20B represents the rings 2202 in a stowed condition as would be within the full round distal section (See FIG.3)
  • FIGs.20C and 20D illustrate the rings 2202 of FIG.20A and 20B with a scaffold covering 146 in place that extends between the rings 2202.
  • FIGs.21A-21C represent the delivery of an embodiment of the rings 2202 in FIG. 20C within the aorta to occlude the renal ostia 218.
  • FIG.22A is an embodiment of the rings 2202 in FIG.20C where the scaffold covering 146 only extends about 270 degrees around the rings 2202. This embodiment is deployed in the aorta in the view of FIG.22C and in the cross section view of FIG.22E.
  • FIG.22B is an embodiment of the rings 2202 in FIG.20C where the scaffold covering 146 only extends about two partial segments around the rings 2202. This embodiment is deployed in the aorta in the view of FIG.22D and in the cross section view of FIG.22F.
  • FIGs.23A and 23B are perspective views of an alternative scaffold structure 140 using deflectable rings 2202 on the scaffold catheter 130 of different sizes.
  • FIG.23A illustrates the rings 2202 in a deployed configuration with a larger diameter proximal ring than the distal ring.
  • FIG.23B represents the rings 2202 in a stowed condition as would be within the full round distal section (See FIG.3)
  • FIGs.23C and 23D illustrate the rings 2202 of FIG.23A and 23B with a scaffold covering 146 in place that extends between the rings 2202.
  • FIG.23E represents the delivery of an embodiment of the rings 2202 in FIG.23C within the aorta to occlude the renal ostia 218.
  • FIG.24A is a scaffold structure 140 that extends along the scaffold catheter 130 responsive to the movement of the full round distal end.
  • FIG.24B is the scaffold structure of FIG.24A when deployed.
  • the scaffold structure 140 of FIG 24A can comprise a fixed coupler 2404 and a floating coupler 2402.
  • the catheter 130 may have an atraumatic catheter distal tip 2406 (e.g., knob, protrusion, etc.) or other radially extending element at its distal end.
  • the distal tip 2406 can be configured to limit the distal movement of the scaffold 140 along the scaffold catheter.
  • the scaffold sheathing catheter round distal end constrains the scaffold structure when the scaffold structure is positioned within the scaffold sheathing catheter.
  • the scaffold structure can comprise a stent like structure.
  • the stent like structure can comprise a plurality of intersecting struts.
  • the scaffold structure is non- woven. In other embodiments, the scaffold structure may be woven.
  • FIG.24C is the scaffold device 140 of FIG.24A adjacent to the renal ostia 218.
  • FIG.24D is the scaffold structure of FIG.24B in position to occlude the renal ostia 218 once the full round section has been withdrawn.
  • FIG.25A is a scaffold structure 140 that extends along the scaffold catheter 130 responsive to the movement of the full round distal end.
  • a coil structure 2502 within the covering 146 is extended while stowed.
  • the coil structure 2502 extends between ends 2504.
  • FIG.25B is the scaffold structure 140 of FIG.25A when deployed by allowing the coil structure 2504 to move when unconstrained by the full round section. When unconstrained, the coil structure 2504 can decrease in length and increase in diameter.
  • FIG.25C is the coil scaffold structure 140 of FIG.25B in position to occlude the renal ostia 218 constrained by the full round section 120.
  • FIG.25D is the scaffold structure of FIG.25C in position to occlude the renal ostia in a deployed configuration since the full round section has been withdrawn.
  • FIG.26 is a flow chart of an exemplary method of providing occlusion with perfusion using an embodiment of a vascular occlusion device herein according to the method 2600.
  • the introducer is used to access the right radial artery.
  • step 2610 there is a process of advancing an occlusion with perfusion scaffold device through the introducer to a position adjacent to a renal artery ostium. At this point, the occlusion with perfusion device is in position but in a stowed condition. Additionally or optionally, the occlusion with perfusion device may be transitioned into the deployed position before or during the steps of the intervention (step 2620) or wait until the use of imaging contrast (step 2625).
  • step 2615 there is a process of advancing a vascular intervention device through the introducer to a vascular intervention site.
  • step 2620 there is a process of performing a vascular intervention at the vascular intervention site using the vascular intervention device.
  • step 2625 there is a process of transitioning the occlusion with perfusion scaffold device into an occlusion configuration to occlude the renal ostia before delivery of an imaging contrast agent in support of the vascular intervention.
  • step 2630 there is a method of transitioning the occlusion with perfusion scaffold device into a stowed condition after delivery of the imaging contrast agent.
  • FIG.27 is a flow chart of an exemplary method of providing occlusion with perfusion using an embodiment of a vascular occlusion device according to the method 2700.
  • step 2705 there is a process of accessing an aortic arch with an introducer via a radial artery.
  • step 2710 there is a process of advancing an occlusion with perfusion scaffold device through the introducer to a position adjacent to a renal artery ostium. Additionally or optionally, the occlusion with perfusion device may be transitioned into the deployed position before or during the steps of the intervention (step 2720) or wait until the use of imaging contrast (step 2725).
  • step 2715 there is a process of advancing a vascular intervention device through the introducer to a vascular intervention site.
  • step 2720 there is a process of performing a vascular intervention at the vascular intervention site using the vascular intervention device.
  • step 2725 there is a process of withdrawing a scaffold sheathing catheter to transition the occlusion with perfusion scaffold device into an occlusion configuration to occlude the renal ostia before delivery of an imaging contrast agent in support of the vascular intervention.
  • step 2730 there is a process of transitioning the occlusion with perfusion scaffold device into a stowed condition after delivery of the imaging contrast agent by advancing the scaffold sheathing catheter over the occlusion with perfusion scaffold device.
  • step 2735 there is a process of repeating steps 2625 and 2630 for any additional uses of imaging contrast agent during the vascular intervention.
  • step 2740 there is a process of withdrawing the vascular intervention device via the introducer after completion of the vascular intervention.
  • step 2745 there is a process of withdrawing the occlusion with perfusion scaffold device.
  • embodiments of the various handle structures described in International Application Number PCT/US2021/020550 entitled “INTRODUCER HAVING CONTROLLABLE OCCLUSION WITH PERFUSION CAPABILITIES” having an international filing date of March 2, 2021 may be modified for use to provide advancement and withdrawal of the occlusion with perfusion device along the introducer lumen and the vasculature as well as to provide for relative movement between the scaffold and the full round portion of the distal end of the scaffold sheathing catheter.
  • the handle 1550 described in that application is configured to provide the controlled and repeated transition of the scaffold or occlusion with perfusion device between a stowed condition within a suitable structure at the distal end of the of the scaffold sheathing catheter and a deployed condition where the scaffold structure is capable of providing occlusion of peripheral vascular structures while allowing perfusion of distal vascular structures.
  • the covered scaffold structures of FIGs.1, 2, 18A- 18H, 20C, 20D, 21A-22F, 23C-E, and 24A-25C described herein may be adapted to billow or deform in response to blood flow pressure through the device as shown and described in FIGs. 44A-44C of International Application Number PCT/US2021/020550 entitled “INTRODUCER HAVING CONTROLLABLE OCCLUSION WITH PERFUSION CAPABILITIES” having an international filing date of March 2, 2021.
  • a covered scaffold structure or a vascular occlusion with perfusion device embodiment so configured when positioned for occlusion of the renal arteries and perfusion of the arterial tree in the lower extremities would permit distention or bulging of any unattached portions of the scaffold covering in response to the blood flow pressure generated within the scaffold.
  • the scaffold catheter, scaffold device (i.e., an embodiment of an occlusion with perfusion device) and the scaffold sheathing catheter may be modified or adapted for use as described in International Application Number PCT/US2021/020550 entitled “INTRODUCER HAVING CONTROLLABLE OCCLUSION WITH PERFUSION CAPABILITIES” having an international filing date of March 2, 2021.
  • such modification includes a procedure for diagnosis or treatment of a coronary artery 320 by use of a diagnostic instrument or a therapeutic instrument through the introducer sheath and occlusion with perfusion device according to a suitable embodiment described with reference to FIG.6 of that application.
  • one or more of these steps may be modified by one or more of the steps described in method 800 in FIG.8 of that application.
  • FIG.55 of that application there is a schematic illustration of a condition in which the introducer sheath and occlusion with perfusion device is inserted in a predetermined blood vessel of a patient 300.
  • the steps of this method may be modified to advantageously employ the embodiments of the scaffold, scaffold catheter and scaffold sheathing catheter as described herein.
  • a covering may be attached to a scaffold embodiment as described in International Application Number PCT/US2020/052899 entitled “DEVICES AND METHODS FOR AT LEAST PARTIALLY OCCLUDING A BLOOD VESSEL WHILE MAINTAINING DISTAL PERFUSION” having an international filing date of September 25, 2020, in particular with regard to the use of single or multiple layer coverings as well as scaffold encapsulation methods and attachment by folding over the ends of the covering onto scaffold structures.
  • there may also be attached and unattached zones between a covering and a scaffold structure.
  • the covering may be attached to the circumference of the proximal and distal rings using the folded over attachment method described above.
  • the folded over attachment method with varying amounts of overlap may be incorporated in scaffold-covering embodiments to provide a variety of overlap and single covering combinations.
  • Exemplary Simultaneous Combination Vascular Access and Occlusion with Perfusion Devices [0174] The various alternative configurations and capabilities of the perfusion with occlusion device and combination occlusion with access device may be sized for a variety of applications and different vascular procedures.
  • intravascular devices 50 sized in a range from 5 Fr to 8Fr (0.065 to 0.105 inches) or may range from 4Fr to 7Fr (0.053 to 0.092 inches) depending on the particular procedure may simultaneously access the vasculature using the same introducer as used for the occlusion scaffold device.
  • the intravascular device 50 may advantageously utilize the shafts of the scaffold catheter and/or the sheathing catheter as a base of support during the interventional or therapeutic procedure being performed while the occlusion with perfusion device is present in the vasculature.
  • the relationship between the intravascular device 50 and the shafts 115, 132 or the shaft sleeve 150 is represented in the views of FIGs.17A and 19D. Both the occlusion device proximal portion and the intravascular device are present together at the distal end of the introducer.
  • One advantage of the reduced shaft profile of embodiments of the occlusion with perfusion device is the shared introducer lumen design. This design concept provides for a sharing between the shaft of the deployed occlusion with perfusion device and the catheter or access for the interventional device.
  • FIGs.7A, 7B The relative position of the intravascular device with respect to the occlusion with perfusion device is seen, by way of example and not limitation, in FIGs.7A, 7B, as well as with reference to the general positions within the introducer lumen as shown in FIGs.3D1 and 3E1.
  • this design attribute may be used with advantage by adjusting the position of the shafts 115, 132 or the shaft sleeve 150 relative to the introducer lumen. Since the shafts 115, 132 and the shaft sleeve 150 are free to move within the introducer lumen they may be placed along any aspect of the lumen interior into any of a number of positions as if the interior of the introducer lumen were a clock face.
  • the shafts 115, 132 and the shaft sleeve 150 would be in the 6 o'clock position in the view of FIG.7A. Also in this view and this exemplary scale of the drawings, the shafts 115, 132 or the shaft sleeve 150 occupy roughly from the 4 o'clock position to the 8 o'clock position. As a result, in this illustrative embodiment, the intravascular device has the remainder of the introducer interior – from 4 o'clock to 12 o'clock to 8 o'clock in which to operate.
  • the occlusion with perfusion device may be rotated in a variety of different support positions relative to the intravascular procedure being performed.
  • the shafts 115, 132 or the shaft sleeve 150 are rotated to block access to a portion of the vasculature to be avoided.
  • the open or accessible portion of the lumen may be oriented so that when exiting the introducer lumen the intravascular device is blocked in certain areas.
  • the shafts 115, 132 or the shaft sleeve 150 are rotated with respect to the distal end of the introducer such that the shafts 115, 132 or the shaft sleeve 150 are used act as a guide to direct the placement of the intravascular device.
  • the shafts 115, 132 or the shaft sleeve 150 are rotated with respect to the distal end of the introducer such that the shafts 115, 132 or the shaft sleeve 150 are used act as a guide to direct the placement or block the movement of the intravascular device and then, during the intravascular procedure, the shafts 115, 132 or the shaft sleeve 150 are moved into a different position so as to act as a base of support for tools or devices or movement of the intravascular device during the intravascular procedure.
  • alternative embodiments of the methods 2600 and 2700 may be provided in furtherance of the combined use methods described herein.
  • the combinations of employing the shafts and/or shaft sleeve in a blocking mode, guiding mode or supporting mode may be performed in conjunction with other steps in the methods 2600 and 2700.
  • Exemplary steps in such a modified method may include rotating the shafts 115, 132 or the shaft sleeve 150 within the introducer lumen relative to a portion of the intravascular device so that in use a portion of the shafts 115, 132 or the shaft sleeve 150 (a) selectively blocks movement of the intravascular device in a portion of the introducer lumen; (b) guides the movement of the intravascular device relative to the introducer lumen; and/or (c) support the use of the intravascular device during the intravascular procedure or intervention.
  • one or more of the steps of methods 2600 and 2700 are modified to include performing one or more steps of a vascular intervention by an interplay of blocking, guiding or supporting the intravascular device using one or a combination of the shafts 115, 132 or the shaft sleeve 150.
  • the type of scaffold structure and covering placement may be selected based on the type of combined methods to be practiced.
  • scaffold and covering designs which, in use, generally cover the vessel lumen interior may find greater utilization in the various combined techniques listed above.
  • Non-limiting examples include those covered scaffold embodiments illustrated and described with respect to FIGs.18A-18H, 20C, 21C, 23C, 23E, and 24A-25D.
  • any of the devices described for carrying out the subject diagnostic or interventional procedures may be provided in packaged combination for use in executing such interventions. These supply “kits” may further include instructions for use and be packaged in sterile trays or containers as commonly employed for such purposes.
  • the invention includes methods that may be performed using the subject devices. The methods may comprise the act of providing such a suitable device. Such provision may be performed by the end user. In other words, the "providing" act merely requires the end user obtain, access, approach, position, set-up, activate, power-up or otherwise act to provide the requisite device in the subject method.
  • one or more lubricious coatings may be used in connection with various portions of the devices, such as relatively large interfacial surfaces of movably coupled parts, if desired, for example, to facilitate low friction manipulation or advancement of such objects relative to other portions of the instrumentation or nearby tissue structures.
  • hydrophilic polymers such as polyvinylpyrrolidone-based compositions, fluoropolymers such as tetrafluoroethylene, hydrophilic gel or silicones
  • any optional feature of the inventive variations described may be set forth and claimed independently, or in combination with any one or more of the features described herein.
  • Reference to a singular item includes the possibility that there are plural of the same items present. More specifically, as used herein and in claims associated hereto, the singular forms "a,” “an,” “said,” and “the” include plural referents unless the specifically stated otherwise. In other words, use of the articles allow for "at least one" of the subject item in the description above as well as claims associated with this disclosure. It is further noted that such claims may be drafted to exclude any optional element.
  • 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.
  • any numerical range recited herein is intended to include all sub-ranges subsumed therein. It is also understood that when a value is disclosed that “less than or equal to” the value, “greater than or equal to the value” and possible ranges between values are also disclosed, as appropriately understood by the skilled artisan. For example, if the value “X” is disclosed the “less than or equal to X” as well as “greater than or equal to X” (e.g., where X is a numerical value) is also disclosed. It is also understood that the throughout the application, data is provided in a number of different formats, and that this data, represents endpoints and starting points, and ranges for any combination of the data points.

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Abstract

L'invention concerne des dispositifs d'occlusion vasculaire temporaire et des procédés d'utilisation de ceux-ci qui assurent une occlusion vasculaire temporaire tout en maintenant une perfusion distale avec un accès vasculaire. Le dispositif d'occlusion vasculaire temporaire peut comprendre un revêtement de support multicouche ayant des zones de fixation proximale et distale séparées par une zone de revêtement de support non fixée où le revêtement de support est adjacent mais non fixé directement à la structure de support. Des dispositifs pour une intervention vasculaire peuvent accéder aux vaisseaux à l'aide d'un cathéter de guidage dans la tige du dispositif d'occlusion. Le dispositif d'occlusion peut ensuite être utilisé pour assurer une protection vis-à-vis des milieux de contraste utilisés pendant la procédure vasculaire effectuée à l'aide de l'accès fourni par le dispositif d'occlusion.
PCT/US2022/075777 2021-09-01 2022-08-31 Occlusion contrôlable avec dispositif de perfusion destiné à être utilisé pendant des procédures d'intervention vasculaire à accès radial WO2023034873A1 (fr)

Applications Claiming Priority (4)

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US202163239940P 2021-09-01 2021-09-01
US63/239,940 2021-09-01
US202163241925P 2021-09-08 2021-09-08
US63/241,925 2021-09-08

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WO2023034873A1 true WO2023034873A1 (fr) 2023-03-09

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Citations (3)

* Cited by examiner, † Cited by third party
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US20140142598A1 (en) * 2009-08-13 2014-05-22 Nfinium Vascular Technologies, Llc Temporary Vascular Scaffold and Scoring Device
US20200078570A1 (en) * 2013-12-27 2020-03-12 RenaIPro Medical, Inc. Devices and methods for treating acute kidney injury
US20200100792A1 (en) * 2018-06-21 2020-04-02 Renalpro Medical, Inc. Multi-chambered balloon catheter devices and methods

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20140142598A1 (en) * 2009-08-13 2014-05-22 Nfinium Vascular Technologies, Llc Temporary Vascular Scaffold and Scoring Device
US20200078570A1 (en) * 2013-12-27 2020-03-12 RenaIPro Medical, Inc. Devices and methods for treating acute kidney injury
US20200100792A1 (en) * 2018-06-21 2020-04-02 Renalpro Medical, Inc. Multi-chambered balloon catheter devices and methods

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