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WO2019238964A1 - Dispositifs et procédés de mise en place par voie transvasculaire de dispositifs médicaux - Google Patents

Dispositifs et procédés de mise en place par voie transvasculaire de dispositifs médicaux Download PDF

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Publication number
WO2019238964A1
WO2019238964A1 PCT/EP2019/065778 EP2019065778W WO2019238964A1 WO 2019238964 A1 WO2019238964 A1 WO 2019238964A1 EP 2019065778 W EP2019065778 W EP 2019065778W WO 2019238964 A1 WO2019238964 A1 WO 2019238964A1
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WO
WIPO (PCT)
Prior art keywords
catheter
sheath
delivery
distal end
bent
Prior art date
Application number
PCT/EP2019/065778
Other languages
English (en)
Inventor
Anders JÖNSSON
Brian Packard
Original Assignee
Itso Medical Ab
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 Itso Medical Ab filed Critical Itso Medical Ab
Publication of WO2019238964A1 publication Critical patent/WO2019238964A1/fr

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/95—Instruments specially adapted for placement or removal of stents or stent-grafts
    • A61F2/962—Instruments specially adapted for placement or removal of stents or stent-grafts having an outer sleeve
    • A61F2/966—Instruments specially adapted for placement or removal of stents or stent-grafts having an outer sleeve with relative longitudinal movement between outer sleeve and prosthesis, e.g. using a push rod
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/24—Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body
    • A61F2/2427—Devices for manipulating or deploying heart valves during implantation
    • A61F2/2436—Deployment by retracting a sheath
    • 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
    • A61F2/24—Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body
    • A61F2/2427—Devices for manipulating or deploying heart valves during implantation
    • 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
    • A61M25/00—Catheters; Hollow probes
    • A61M25/0043—Catheters; Hollow probes characterised by structural features
    • A61M25/0045—Catheters; Hollow probes characterised by structural features multi-layered, e.g. coated
    • A61M2025/0046—Coatings for improving slidability
    • A61M2025/0047—Coatings for improving slidability the inner layer having a higher lubricity
    • 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
    • A61M25/00—Catheters; Hollow probes
    • A61M25/10—Balloon catheters
    • A61M2025/1043—Balloon catheters with special features or adapted for special applications
    • A61M2025/1097—Balloon catheters with special features or adapted for special applications with perfusion means for enabling blood circulation only while the balloon is in an inflated state, e.g. temporary by-pass within balloon
    • 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
    • A61M25/00—Catheters; Hollow probes
    • A61M25/0021—Catheters; Hollow probes characterised by the form of the tubing
    • A61M25/0041—Catheters; Hollow probes characterised by the form of the tubing pre-formed, e.g. specially adapted to fit with the anatomy of body channels
    • 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
    • A61M25/00—Catheters; Hollow probes
    • A61M25/0043—Catheters; Hollow probes characterised by structural features
    • A61M25/005—Catheters; Hollow probes characterised by structural features with embedded materials for reinforcement, e.g. wires, coils, braids
    • 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
    • A61M25/00—Catheters; Hollow probes
    • A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
    • A61M25/0102—Insertion or introduction using an inner stiffening member, e.g. stylet or push-rod
    • 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
    • A61M25/00—Catheters; Hollow probes
    • A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
    • A61M25/06—Body-piercing guide needles or the like
    • A61M25/0662—Guide tubes

Definitions

  • This invention pertains in general to the field of medical devices and medical procedures applying such medical devices. More particularly, the invention relates to a catheter 1 device for inserting medical devices into a lumen of a patient, such as the aortic arch, as well as related medical procedures and methods. In particular the invention relates to the positioning of catheters 1 for the delivery of medical devices and the procedures, and more specifically in an example to the transvascular and transcatheter delivery of a medical device to a cardiac valve.
  • the human heart is a hollow muscular organ, responsible for pumping a large volume of blood around the human body every day.
  • the ability to pump the blood is facilitated by several heart valves which open and close appropriately to allow blood passage through the heart.
  • Heart valve dysfunction through natural defects or through the increasing incidence of heart disease, often requires the dysfunctional valve to be treated, with the main treatment modalities being mechanical adjustment of the valve or replacing the valve altogether.
  • Current medical techniques are aimed at moving away from the major open heart surgery procedure, which is very traumatic for the patient, to more minimally invasive catheter based procedures, which are less traumatic, although more complicated procedures.
  • Catheter based procedures require precise positioning of the catheter, used to deliver for example the replacement valve, in an optimal position in relation to the cardiac valve to be treated. This is especially important as misalignment has the potential to damage adjacent cardiac structures leading to severe coronary complications. Placement of the catheter adjacent to a heart valve is hampered by the fact that the heart continues to pump throughout the procedure, giving rise to significant levels of turbulence which the catheter must overcome to maintain its position.
  • WO 2013/056898A1 a catheter system is disclosed for introducing an expandable heart valve stent into the body of a patient.
  • a bend guidewire is mentioned on page 18 of WO 2013/056898A1 to facilitate introduction of the catheter.
  • the guidewire needs to be introduced itself into the aortic arch, which might be difficult and cause embolic material to be scraped off the ostia of the aortic side vessels.
  • a bent guidewire is withdrawn after positioning of a catheter in the aortic arch and suffers from the misalignment drawbacks mentioned in the previous paragraph.
  • improved or alternative medical devices and procedures e.g. for stabilizing the introducer sheath during cardiac valve replacement would be advantageous, in particular allowing for increased cost- effectiveness, and/or patient safety.
  • Improved precision of catheter based delivery of medical devices is desired.
  • Improved stability of catheter based delivery of medical devices is desired.
  • embodiments of the present disclosure preferably seek to mitigate, alleviate or eliminate one or more deficiencies, disadvantages or issues in the art, such as the above-identified, singly or in any combination by providing a medical device and a method according to the appended patent claims.
  • the present disclosure is an introducer sheath that overcomes the positional problems that current catheters or medical methods involving such catheters face. In addition to maintaining and/or stabilizing the position, the disclosure is so devised so that interference with the blood flow is preferably minimal.
  • the devices can advantageously be used in many applications and medical procedures.
  • a catheter device for transvascular delivery of a medical device to a target region of a patient is disclosed.
  • a method of transvascularly delivering a medical device to a target region of a patient comprises providing and minimally invasively introducing a catheter including an elongate sheath with a lumen to said target site.
  • Figs. 1 a and b are schematic illustrations of an elongate sheath 10 connected to a proximal hemostatic valve
  • Fig. 2 is a schematic illustration of an elongate sheath 10 in cross section with independently inflatable and thus varying expandable balloons
  • Fig 3 is a schematic illustration of a catheter 1 wall in cross section with multiple inflation channels
  • Figs. 4a, 4b and 4c are schematic illustrations of a rigid long introducer (including a catheter 1 1 or elongate sheath 10) with a slidable inserted rod (or stiffener wire) for straightening (Fig. 4b) a pre-bent curvature (Fig. 4a) of the introducer (here: at the distal region) during introduction into a body lumen like along the thoracic aorta to the descending aortic arch region, and a cross section (Fig. 4c) through the sheath 10 showing the stiffener element (thicker, stiffer) and the guidewire (thinner , more
  • Figs. 5a and 5b are schematic illustrations of the elongate sheath 10 delivered transfemorally to a cardiac valve (here aortic valve) with introduced dilator over the wire (pigtail distal end in Fig. 5a), and the dilator is removed and expansion elements expanded (here balloons) in Fig. 5b;
  • Fig. 6a is a schematic illustration of an elongate sheath 10 with two sets of anchor units (1 and 2 in the figure) in the ascending 301 and the descending part 302 of the aortic arch 300;
  • Fig. 6b is a schematic illustration of an elongate sheath 10 with a plurality of sets of anchor units (1 , 2 and 3 in the figure) in the ascending, the aortic arch and the descending part of the aortic arch;
  • Fig. 7a is a schematic illustration similar to that of Fig. 6b showing sets of balloons, two sets in the aorta descendens, e.g. for stabilizing and/or locking of the long introducer in position;
  • Fig. 7b is a schematic illustration of a catheter 1 with expandable anchoring units for stabilization of delivery of a TEVAR (thoracic endovascular aortic repair) endoprosthesis or graft stent;
  • TEVAR thoracic endovascular aortic repair
  • Fig. 7c is a schematic illustration of a catheter 1 with expandable anchoring units for stabilization of delivery of a branched aorta arcus endoprosthesis or graft stent;
  • Fig. 8 is a schematic illustration of a catheter 1 with expandable anchoring units for stabilization and positioning (e.g. centering) of delivery of a stent in the renal artery e.g. for treatment of renal artery stenosis and/or hypertension (the stent partly cutting through the arterial wall and nerve tissue);
  • Fig. 9 is a schematic illustration of a catheter 1 with expandable anchoring units for stabilization and positioning (e.g. centering) of devices for mitral valve interventions;
  • Fig. 10 is a schematic illustration of a catheter 1 with expandable anchoring units for stabilization and positioning (e.g. centering) of a PCI catheter 1 or angiographic procedure in coronary vessels via a femoral approach;
  • Fig. 1 1 is a schematic illustration of a catheter 1 with expandable anchoring units for stabilization and positioning (e.g. centering) of a PCI catheter 1 or angiographic procedure in coronary vessels via an approach through the radial artery;
  • Fig. 12 is a schematic illustration of a catheter 1 with expandable anchoring units for stabilization and positioning for neurovascular interventions;
  • Fig. 13a is a schematic illustration of a long aortic arch with a normal annulus angulation and a catheter 1 having exemplary two sets of expandable members, here balloons, for positioning and stabilizing of the catheter 1 in this specific anatomic situation;
  • Fig. 13b is a schematic illustration of a long aortic arch with a horizontal annulus angulation and a catheter 1 having exemplary two sets of expandable members, here balloons, for positioning and stabilizing of the catheter 1 in this specific anatomic situation
  • Fig. 13c is a schematic illustration of a sharp aortic arch with a normal annulus angulation and a catheter 1 having exemplary two sets of expandable members, here balloons, for positioning and stabilizing of the catheter 1 in this specific anatomic situation;
  • Fig. 13d is a schematic illustration of a sharp aortic arch with a horizontal annulus and a catheter 1 having exemplary two sets of expandable members, here balloons, for positioning and stabilizing of the catheter 1 in this specific anatomic situation;
  • Figs. 14 to 19 and 23 are various schematic illustrations, each of a particular anatomical situation where catheters 1 with pre-bent sections and expandable members are shown during certain minimally invasive medical interventions at various target sites and through various vascular access paths;
  • Fig. 14 is a schematic illustration of an exemplary catheter 1 use for Endovascular Aortic Aneurysm Repair (EVAR) e.g. for treatment procedures of abdominal aortic aneurysms (AAA), and vascular interventions in the abdomen including via or in the celiac trunk, superior Mesenteric trunk, the renal arteries, or the inferior Mesenteric trunk, e.g. for treatment procedures of Mesenteric Artery Ischemia (MAI);
  • EVAR Endovascular Aortic Aneurysm Repair
  • AAA abdominal aortic aneurysms
  • MAI Mesenteric Artery Ischemia
  • Fig. 15 is a schematic illustration of an exemplary catheter 1 use for interventions on the tricuspid valve (from right atrium to right ventricle valve) from the Vena Cava Superior (VCS) or Vena Cava Inferior (VCI);
  • VCS Vena Cava Superior
  • VCI Vena Cava Inferior
  • Fig. 16a is a schematic illustration of an exemplary catheter 1 use for interventions on the pulmonic valve from the VCS;
  • Fig. 16b is a schematic illustration of an exemplary catheter 1 use for interventions on the pulmonic valve from the VCI;
  • Fig. 17 is a schematic illustration of an exemplary catheter 1 use for interventions on the mitral valve (left atrium to left ventricle valve transseptally from the VCI;
  • Fig. 18a is a schematic illustration of an exemplary catheter 1 use for Thoracic Endovascular Aortic Repair (TEVAR) interventions, which are minimally invasive procedure to repair the aorta with e.g. stent grafts or other medical treatment procedures, of the aortic arch and the ascendens aorta;
  • TEVAR Thoracic Endovascular Aortic Repair
  • Fig. 18b is a schematic illustration of an exemplary catheter 1 use for neurovascular
  • Fig. 18c is a schematic illustration of an exemplary catheter 1 use for Percutaneous Coronary Intervention (PCI);
  • Fig. 18d is a schematic illustration of an exemplary catheter 1 use for TAVI procedures via the carotic (left) artery access;
  • Fig. 18e is a schematic illustration of an exemplary catheter 1 use for TAVI procedures via the carotic (right) artery access;
  • Fig. 18f is a schematic illustration of an exemplary catheter 1 use for TAVI procedures via a Direct Aortic access
  • Fig. 19a is a schematic illustration of an exemplary catheter 1 use for TAVI interventions via the right subclavian artery;
  • Fig. 19b is a schematic illustration of an exemplary catheter 1 use for TAVI interventions via the left subclavian artery
  • Figs. 20a to 20e are illustrations of an exemplary pre-bent catheter 1 with a single expandable member (here balloon).
  • the straight section is illustrated with a braided reinforcement.
  • the curved section has a coiled reinforcement
  • Figs. 21 and 22 are two illustrations of (one or more) expandable balloons attached to inflation channels in a recess of the outer sheath 10 wall (and outside of an inner reinforcement structure); and Fig. 23 is a schematic illustration of an exemplary catheter 1 use for delivery of a Ventricular Assist Devices (VAD).
  • VAD Ventricular Assist Devices
  • the expandable members are expanded, e.g. when provided as balloons they are Inflated, when in position at the target site.
  • Several sets of balloons along length of catheter 1 / sheath 10 may be provided advantageously. This provides for better locking to the vessel and in a desired position.
  • a Catheter 1 is provided having pre-bent curvature at least at one portion L1 of the catheter 1 , such as pre-bent introducer (pre-bent: not straight).
  • a dilator is provided having pre-bent shape.
  • a pre-bent has curvature has a first outer curvature radius R larger than a second curvature radius.
  • the curvature radius is adapted to a corresponding lumen curvature to be delivered into. It may be a C-shaped curvature, a U-shape curvature, an S-shaped curvature, a J shaped curvature, or similar curvatures, see some examples given in the Figures.
  • the curvature may be a 3D curvature, i.e. it is not straight in a longitudinal cross section but curved in 3D space in more than one dimension, preferably 2 or 3 dimensions.
  • the aortic arch is a complex curvature not only being arched but also the arch being offset, i.e. the ascending aorta is for many patients at a different frontal/back location of a patient than the descending aorta.
  • a single expandable unit may be arranged at said first outer curvature having a larger radius.
  • a single expandable unit, preferably balloon, at the outside of the bend i.e. larger radius
  • One or more sets of balloons blocking the catheter 1 against longitudinal and/or rotational movement in a lumen/vessel may be provided further proximal on the catheter 1 outside.
  • anchoring of the catheter 1 is provided by the set(s) (e.g. the proximal sets as shown in Fig.
  • the stabilisation provides reduced tension in the delivery system.
  • Reduced tension provides in turn that a delivery system including an artificial cardiac valve (such as a stent TAVI valve) can rotate and thus be positioned in relation to left and right coronary arteries orifices.
  • an artificial cardiac valve such as a stent TAVI valve
  • This stability provided by the present devices is of utmost advantage compared to known delivery devices and catheters 1 .
  • Pre-shaped dilators and/or catheter 1 sheath 10s like long introducers are provided in various sizes and shapes dependent on specific patients and morphologies.
  • This provides for instance to more easily pass such delivery device through the aortic arch and to position at an optimal angle towards the aortic valve.
  • the stiffener element (rod/wire) described above may be provided in elements with such coiled reinforcement at the pre-bent section of the catheter 1 sheath 10. This is advantageous as the stiffener, thanks to the reinforcement of the coil, will less likely penetrate the catheter 1 wall when moved distally along the bend and provide reliable straightening/stiffening operation, while allowing for the bend to be advantageous when the stiffener is withdrawn.
  • a channel for the stiffener element in the catheter 1 may be used for delivery of substances, devices etc. at a distal region of the catheter 1 .
  • the catheter 1 might a channel for the stiffener that is open at its end (needs flushing).
  • the distal end of the channel for the stiffener might include a section that is penetrable by the stiffener when pushed over its normal operational stiffening length into the channel.
  • the penetrable section might be provided as an intentional weakening in the catheter 1 wall and/or reinforcement (coil).
  • the channel for the stiffener may be used for multiple purposes. For instance when the catheter 1 is positioned at its target location (e.g. aortic arch as shown in Fig. 4a), delivery of a substance and/or a medical device like an embolic protection filter/deflector may be done through this channel.
  • the catheter 1 sheath 10 of the present disclosure may be expandable, such as disclosed in WO 2013/037505, which is herein incorporated in its entirety for all purposes, but in particular for the expandable catheter sheath such as shown in Figures 2 to 6 and the corresponding description. In this manner, a smaller and less invasive access to a target site in a patient is providable.
  • Figs. 20a-20e is an illustration of an exemplary pre-bent catheter 1 with a single expandable member 200 (here balloon) as an example only. The measures in the Figure are not to be construed as limiting for the disclosure.
  • the straight section L2 is here illustrated - with a braided reinforcement 1 10.
  • the braid is preferably arranged sandwiched between a (Teflon) inner liner 130 and an outer extruded sheath 10.
  • the curved section has in the example a coiled reinforcement 120.
  • the coiled reinforcement is arranged at the interior of the lumen.
  • An inner lubricious liner e.g. Teflon or PTFE may be arranged at the very inner.
  • the coiled reinforcement is provided as a flat coil, which allows better integration with the sheath 10 material, broad coverage (surface percent) and protection of the outer sheath 10 when e.g. stiff devices are delivered through the lumen, while facilitating manufacture and maintaining the pre-bend reinforced section.
  • a coil at the inside provides also for another advantage, namely when one or more inflation channels 140 (or other channels to be accessed distally e.g. for fluid delivery) running in the catheter 1 sheath 10 are present.
  • Such a channel may be protruded when extruding the outer catheter 1 sheath 10 of a suitable plastic material.
  • Nylon Urethane may be particularly suitable. It may be occluded or closed at the distal end. Access to the channel can easily be done through the exterior wall of the sheath 10, by e.g. drilling, cutting burning etc. access hole(s) and the attaching a balloon (lobe) of the expandable unit at the outside over the access hole to the channel. No drilling through a metal reinforcement coil or braiding is needed. The drilling/cutting 145 depth can be limited suitably to not reach as deep as the inner reinforcement. The balloon can be easily attached by gluing to the outer wall of the sheath 10 at that location. See also Figs. 21 and 22 for this detail.
  • the inflation channel 140 preferably has an inner lumen wall with a lubricious surface, such as a coating of a lubricious material for instance PTFE or Teflon, and/or an inner lining of a lubricious material for instance PTFE or Teflon.
  • a lubricious surface such as a coating of a lubricious material for instance PTFE or Teflon, and/or an inner lining of a lubricious material for instance PTFE or Teflon.
  • An exemplary catheter 1 device for transvascular delivery of a medical device to a target region, such as a heart valve region, of a patient.
  • the catheter 1 comprises an elongate catheter 1 sheath 10 with a lumen, a proximal end, a distal end.
  • a distal end portion of the catheter 1 includes the distal end and is configured to be positioning at, or in the vicinity to, or adjacent to the target region, such as in a particular example being the heart valve region.
  • the catheter 1 sheath 10 has a distal end configured to transvascularly navigate through the vascular system and including at least one radially expandable unit proximate the distal end of the catheter 1 sheath 10 and at an exterior of the catheter 1 sheath 10 and arranged to allow for blood flow outside the sheath 10 and past the radially expandable unit wherein a distal portion of the catheter 1 sheath 10 is curved and pre-bent and a proximal portion adjacent the distal portion of the catheter 1 sheath 10 is substantially straight.
  • Examples of the device for transvascular delivery of a medical device to a target heart valve region of a patient may have the distal end configured to be positioned at, or in the vicinity to, or adjacent to the heart valve region.
  • the catheter 1 sheath 10 has a distal end configured to transvascularly navigate through the vascular system upstream the aorta to a position at and/or downstream the aortic cardiac valve.
  • At least one of the radially expandable units is configured to be in apposition with the interior vessel wall in the ascending aorta downstream the aortic valve and upstream all side branch vessels of the aortic arch.
  • the radially expandable units are arranged for expanding to temporarily position the distal end in relation to the cardiac valve.
  • the expandable units are arranged to allow for blood flow outside the sheath 10 and past lobes of the radially expandable units when in a position for delivering the artificial aortic valve. See also Figs. 21 -23.
  • the exterior of the catheter 1 sheath 10 may be provided with a hydrophilic property.
  • a suitable material o the sheath 10 may be chosen.
  • a hydrophilic coating may be applied.
  • a hydrophilic film maybe provided on the outside of the sheath 10. It may be heat shrunk to the latter. Delivery of the catheter 1 may thus be facilitated by better slideability along vessel walls for deployment of the catheter 1 distal end to a target site.
  • the inside lumen is preferably made slippery by a lubricious material described herein. This is synergetic in combination with the inner reinforcement (in particular flat coil preferably of metal) and a prebend. Test have shown surprising easy access through an aortic arch with otherwise difficult to deliver stent valves.
  • the catheter 1 may have multiple sets of the anchoring units at a longitudinal distance from each other at the sheath 10. For instance, a first set is being arranged in the ascendens aorta and a second set is arranged in the descendens aorta. A distal portion of the catheter 1 sheath 10 is curved and pre-bent to navigate through the aortic arch.
  • Multiple sets of the anchoring units may be arranged at a longitudinal distance from each other at the catheter 1 sheath 10, such as a first set configured to be arranged in the ascendens aorta and a second set configured to be arranged in the descendens aorta.
  • the catheter 1 sheath 10 is in examples curved and pre-bent with for instance about 180° in a specific example.
  • the device examples have the distal portion of the catheter 1 sheath 10 pre-bent with a curvature and radius corresponding to the aortic arch.
  • the device of some examples includes a dilator configured to be inserted into the catheter 1 sheath 10.
  • a distal portion of such dilator is preferably curved and pre-bent.
  • a proximal portion adjacent the distal portion of the dilator is preferably substantially straight. In this manner, anatomical target sites may be reached easier.
  • a pre-shaped dilator facilitates passage through anatomic sites such as the aortic arch and positioning in relation to anatomical target sites such as the cardiac / aortic valve.
  • the device of some examples has at least one (stiffener element) rod 400 insertable towards a distal end and into the dilator and/or catheter 1 .
  • the rod 400 is substantially straight and has a larger stiffness than the dilator and/or catheter 1 at the pre-bent section such that the curvature of the dilator and/or catheter 1 is straightened out when the (stiffer) rod 400 is inserted into the dilator and/or catheter 1 and at least partly along the pre-bent section.
  • anatomical target sites may be reached easier.
  • the straightening during deployment to the target site can be substantially facilitated.
  • a substantially straight i.e.
  • catheter 1 travels smoother along substantially straight lumen like the abdominal aorta.
  • catheter 1 Once approaching more torturous passages or target sites, like the aortic arch or branch vessels to be entered with the distal catheter 1 and/or dilator portion/end/tip, withdrawal of the stiffener element/rod 400 allows for advantageous entering into these target site as the pre-bend kicks in. See also Figs. 4a-4c.
  • the device of any of examples may include that the catheter 1 sheath 10 has a lubricious inside, such as of PTFE, Teflon or Teflon coating.
  • the catheter 1 sheath 10 can have an inner lining with improved sliding characteristics, like a lining of PTFE or Teflon.
  • At least one of the optional expandable units is an inflatable balloon and the catheter 1 sheath 10 has at least one inflation channel for the balloon, wherein said inflation channel preferably has an inner lumen wall with a lubricious surface, such as a coating of a lubricious material for instance PTFE or Teflon, and/or an inner lining of a lubricious material for instance PTFE or Teflon.
  • the inflation channel may be used at least partly for the stiffener rod during deployment.
  • the catheter 1 sheath 10 has a reinforcement braiding along a substantially straight portion of the sheath 10 to avoid kinking of the substantially straight portion.
  • Braided reinforcement elements/layers have the advantage of maintaining straight portions of catheters 1 in contrast to coiled reinforcement elements/layers.
  • the catheter 1 has a coiled reinforcement along at least a portion of the bent distal portion to avoid kinking and allow bendability of that portion.
  • the coil is preferably arranged at an inner layer of said catheter 1 sheath 10, such as sandwiched between an inner lubricous liner and an outer sheath 10 with at least one inflation channel. This allows access to the inflation channel and easier manufacturing of catheters 1 with stabilizing balloons because no reinforcement layer has to be penetrated.
  • the coil is preferably a coil wound and made of a flat material such as a band, preferably of metallic material.
  • This arrangement provides for particular strength of the coiled reinforcement layer, which is for instance very advantageous when delivering stiff, almost harpoon like, medical devices through the catheter 1 , as for instance some artificial heart valves (e.g. some stent based TAVI valves).
  • some artificial heart valves e.g. some stent based TAVI valves.
  • the catheter 1 is a device for transvascular delivery of a medical device to a target region, such as a heart valve region, of a patient.
  • the device includes an elongate sheath 10 with a lumen, a proximal end, a distal end, and a distal end portion including the distal end is configured to be positioning at, or in the vicinity to, or adjacent to the target region, such as the heart valve region.
  • the elongate sheath 10 has an increasing flexibility towards the distal end in addition or alternatively to the pre-bend and/or expandable elements described herein.
  • An exemplary system includes a catheter 1 with a pre-bent catheter 1 section, and/or a dilator with a pre-bent section, wherein the catheter 1 and/or dilator including at least one channel for insertion of a rod for changing a shape of the pre-bent section of the catheter 1 and/or dilator.
  • the channel may be used as an inflation channel or delivery channel post deployment of the catheter 1 to its target site.
  • An example of a method of intraluminal navigation with a catheter 1 includes introducing a catheter 1 with a dilator and/or retracting a catheter 1 from a target location in a patient.
  • the method may comprise a step of facilitating intraluminal navigation with the catheter 1 by introducing at least one rod upon/before/during insertion or retraction into the catheter 1 and/or dilator.
  • an example of a method of transvascularly delivering a medical device to a cardiac valve of a patient comprises introducing a catheter 1 comprising an elongate sheath 10 with a lumen in a relaxed state into the vascular system; navigating a distal end of the elongate sheath 10 through the vascular system to the cardiac valve; radially expanding at least one expandable member of the catheter 1 towards an inner vessel wall downstream the cardiac valve for stabilizing a distal end of the catheter 1 in relation to the cardiac valve; and delivering a medical device through the lumen of the locked elongate sheath 10 to the cardiac valve.
  • the method may include the step of radially expanding expandable units of the catheter 1 or an elongate member positioned beyond a distal end of the sheath 10, to temporarily position in relation to the valve the elongate sheath 10; and optionally delivering a medical device through the lumen of the locked elongate sheath 10 to the heart valve.
  • the method may in examples include expanding multiple sets of the anchoring units at a longitudinal distance from each other at the sheath 10, such as a first set arranged in the ascendens aorta and a second set arranged in the descendens aorta.
  • the method may in examples include positioning a distal end region of the catheter 1 being prebent in the aortic arch and expanding at least one expandable unit.
  • the method may in examples include, wherein the catheter 1 has a pre-bent distal portion, inserting a substantially straight rod into the pre-bent distal portion thus straightening out the pre-bent portion 100 prior to introducing the catheter 1 into the vascular system.
  • the method may in examples include withdrawing the rod from the pre-bent portion 100 upon entering the aortic arch with the pre-bent portion 100 for facilitating entry and delivery of the distal portion, e.g. through the aortic arch for installing the pre-bend section in and along the target location like the aortic arch.
  • the method may in examples include, wherein the catheter 1 has a pre-bent distal portion and inserting a substantially straight rod into the pre-bent distal portion thus straightening out the pre-bent portion 100 when retracting the catheter 1 from the aortic arch to facilitate removal of the catheter 1 out of the vascular system.
  • the method may in examples include introducing the rod into the pre-bent portion 100 upon withdrawal from the aortic arch with the pre-bent portion 100 for facilitating removal and withdrawal of the distal portion from the aortic arch, such as by partly drawing the catheter 1 over the rod.
  • the stiffener / rod is removable for straighten out / reshapes the prebend. For instance, it can be withdrawn when entering the aortic arch. It may be re-inserted when withdrawing the dilator or catheter 1 with a pre-bend from the aortic arch.
  • Advantageous access to otherwise difficult to reach target sites, as well as omission of steerable catheters 1 is thus provided.
  • At least one of the radially expandable units is configured to be in apposition with the interior vessel wall in the ascending aorta downstream the aortic valve and upstream all side branch vessels of the aortic arch.
  • the method may in examples include the catheter 1 sheath 10 has an increasing flexibility towards the distal end.
  • the method may in examples include, a catheter 1 device combined with an introducer device configured to provide vascular, such as femoral access to the patient’s vascular system, the introducer has a shorter length than the delivery catheter 1 , and a lower flexibility than the delivery catheter 1 .
  • Many commercially replacement valves, like TAVI stent valves have a high stiffness and low bendability, almost harpoon like behaviors when travelling along a catheter 1 .
  • the present examples avoid penetration of the catheter 1 wall in advantageous manner, e.g. by the coiled reinforcement at the pre-bend region thereof.
  • Some examples other of the disclosure include
  • a catheter 1 device for transvascular delivery of a medical device to a target region, such as a heart valve region, of a patient includes an elongate sheath 10 with a lumen, a proximal end, a distal end, and a distal end portion including the distal end is configured to be positioning at, or in the vicinity to, or adjacent to the target region, such as the heart valve region, wherein the elongate sheath 10 has an increasing flexibility towards the distal end.
  • the catheter 1 device of such example includes at least one, preferably a plurality of expandable units being arranged for temporarily positioning the elongate sheath 10 in relation to the cardiac valve when in an expanded state.
  • the catheter 1 device may include an elongate member with a distal end portion includes the plurality of radially expandable units, wherein the elongate member is retractably insertable into the lumen.
  • the catheter 1 device of any examples, wherein the plurality of radially expandable units comprises expandable balloons, preferably three balloons positioned radially equidistant around a longitudinal axis of the elongate sheath 10.
  • the catheter 1 device of such example may include the plurality of radially expandable units comprise expandable mechanical levers, or swellable units, such as sponges, retractable into the sheath 10
  • the catheter 1 device of any examples may include the medical device being an artificial replacement valve or a valve repair device, wherein the cardiac valve preferably is an aortic valve of the patient.
  • kits of a catheter 1 device of any of these examples includes a medical device for a cardiac valve, such as an artificial replacement valve, with advantageous deployment, delivery of the device, less time to deliver, less puncture size to access the delivery vessel, less side effects for such treatment etc.
  • An exemplary system for transvascularly delivering a medical device to an aortic cardiac valve region of a patient includes a catheter 1 which in turn includes an elongate catheter 1 sheath 10 with a lumen for minimally invasively introducing into the vascular system.
  • the exemplary catheter 1 being configured to transvascularly deliver an artificial heart valve to the aortic cardiac valve region.
  • the catheter 1 sheath 10 preferably has a distal end configured to transvascularly navigate through the vascular system upstream the aorta to a position at and/or downstream the aortic cardiac valve.
  • a plurality of radially expandable units at least temporarily may in examples be providable proximate the distal end of the catheter 1 sheath 10 and at an exterior of the catheter 1 sheath 10; wherein at least one of the radially expandable units is configured to be in apposition with the interior vessel wall in the ascending aorta downstream the aortic valve and upstream all side branch vessels of the aortic arch.
  • the radially expandable units are in examples arranged for expanding to temporarily position the distal end in relation to the cardiac valve (or other target sites).
  • the expandable units are arranged to allow for blood flow outside the sheath 10 and past lobes of the radially expandable units, such as when in a target position e.g. for delivering the artificial aortic valve.
  • the at least one of the radially expandable units is preferably configured to be in apposition with the interior vessel wall in the ascending aorta downstream the aortic valve and upstream all side branch vessels of the aortic arch.
  • the sheath 10 has preferably a lubricious inside, such as of Teflon or Teflon coating.
  • sheath 10 have a reinforcement braiding to avoid kinking, preferably of straight portions of the sheath 10.
  • the device includes in some examples multiple sets of the anchoring units at a longitudinal distance from each other at and along the sheath 10.
  • the sets can for instance be arranged a) in the ascendens aorta and b) in the descendens aorta. This may provide for improved hemodynamic stability during positioning in the aortic arch.
  • Each set of anchoring units allows for blood flow in-between the anchoring units along the sheath 10 exterior. Hemodynamic pressure waves may be smoothed out and improve hemodynamic stability has several sets of anchoring units arranged in that manner, see Figures.
  • An exemplary method of transvascularly delivering a medical device to a cardiac valve of a patient includes introducing a catheter 1 includes an elongate sheath 10 with a lumen in a relaxed state into the vascular system; navigating a distal end of the elongate sheath 10 through the vascular system to a target site like the cardiac valve.
  • the method may further include expanding an embolic protection unit from a second channel in the sheath 10 to cover ostia of the side branch vessels in the aortic arch and to stabilize a distal end of the sheath 10 at the cardiac valve, and preferably delivering a medical device through the lumen of the locked elongate sheath 10 to the target site, in the example a heart valve area while the embolic protection unit covers the ostia.
  • the method according to examples may include radially expanding expandable units of the catheter 1 or an elongate member positioned beyond a distal end of the sheath 10, to temporarily position in relation to the valve the elongate sheath 10; and optionally delivering a medical device through the lumen of the locked elongate sheath 10 to the heart valve.
  • the exemplary method may include inserting an elongate member with a distal end portion includes a plurality of the radially expandable units, into the lumen of the elongate sheath 10; and advancing the elongate member through the elongate sheath 10 to the distal end of the elongate sheath 10. Retracting the expandable units and withdrawing the elongate member from the lumen of the elongate sheath 10 at a desired time, e.g. after concluding a medical procedure at least partly done through the sheath 10.
  • the devices and methods can be used or applied in many applications with tubular devices in body lumen, the tubular devices being elongate and including anchoring unit(s) for stabilizing and/or position with precision the tubular device at a desired target site in the body/lumen.
  • Various bent shapes may be provided for different applications and/or patient specific shapes for different patients.
  • Various number and shapes as well as sizes of expandable members may be provided for different applications and/or patient specific adaptations for different patients, see the examples below
  • Fig. 7a is a schematic illustration similar to that of Fig. 6b showing sets of balloons, two sets in the aorta descendens 302, e.g. for stabilizing and/or locking of the long introducer in position.
  • Fig. 7b is a schematic illustration of a catheter 1 with expandable anchoring units for stabilization of delivery of a TEVAR (thoracic endovascular aortic repair) endoprosthesis or graft stent.
  • the distal end of the catheter 1 is locked in place for a secure delivery of the TEVAR device in place.
  • the distal part of the TEVAR device 500 may thus be delivered out of the catheter, then the balloons 200 may be deflated and the catheter withdrawn a distance while pushing the TEVAR device further out of the catheter.
  • This initial anchoring of the distal TEVAR part only allows to re-position the device if desired by withdrawing it into the catheter again, moving the catheter (deflate balloons, move catheter, re-inflate balloons at new better position, re-deploy distal end of TEVAR).
  • Once a TEVAR is deployed and released it is only possible to remove surgically otherwise, if in the wrong position. This is in particular critical when branched stents as in Fig. 7c are delivered and the branch is malpositioned (kinking of the branch, bad blood flow through the branch at misaligned main prosthesis/branch part).
  • the potential re-positioning is applicable to all examples described herein, which is advantageous in a clinical aspect (reliable and precise positioning).
  • Fig. 7c is a schematic illustration of a catheter 1 with expandable anchoring units for stabilization of delivery of a branched aorta arcus endoprosthesis or graft stent 510. See also above description for Fig. 7b.
  • Fig. 8 is a schematic illustration of a catheter 1 with expandable anchoring units for stabilization and positioning (e.g. centering) of delivery of a stent 520 in the renal artery 31 Oe.g. for treatment of renal artery stenosis and/or hypertension (the stent partly cutting through the arterial wall and nerve tissue).
  • Wedging the catheter 1 at a suitable position with the expandable elements 200, 201 provides for precision delivery, in particular with a suitable pre-bend end portion bent towards the renal artery 310 orifice in the abdominal aorta.
  • Fig. 9 is a schematic illustration of a catheter 1 with expandable anchoring units for stabilization and positioning (e.g. centering) of devices for mitral valve 320 interventions, like delivery of artificial valves, annuloplasty devices, mitral clip devices, chordae downsizing devices, leaflet repair devices, paravalvular leakage repair devices, etc.
  • the approach is made from the Vena cava inferior 325 through a puncture in the septal wall 330 between the left and right cardiac atrium.
  • the expandable device can be wedged into position in the Vena cava inferior 325 (see balloons 200, 201 ).
  • the set of expandable devices 200, 201 at the septal wall 330 in the left atrium provides a retaining force at that position.
  • a suitable prebend at the distal end directs the distal catheter end towards the mitral valve region.
  • a pre-bend from the vena cava inferior to the septal wall provides an advantages approach.
  • Left atrial appendage (LAA) closure devices may be delivered when the distal catheter end is provided with a suitable pre-bend.
  • the LAA is opposite the septal wall 300 to the right in Fig. 9.
  • Fig. 10 is a schematic illustration of a catheter 1 with expandable anchoring units for stabilization and positioning (e.g. centering) of a PCI catheter 530 or angiographic procedure in coronary vessels 345 via a femoral artery 340 approach. Stent delivery may be made in this approach.
  • a second catheter 510 can be delivered through the main catheter 1 .
  • the second catheter may have the same features like the main catheter, i.e. pre-bend section(s), stiffening wire(s), expandable units for anchoring and/or precise positioning. In this manner, smaller, otherwise not accessible target regions, are accessible in an advantageous manner.
  • Fig. 1 1 is a schematic illustration of a catheter 1 with expandable anchoring units for stabilization and positioning (e.g. centering) of a PCI catheter 510 or angiographic procedure in coronary vessels via an approach through the radial artery 530.
  • Fig. 12 is a schematic illustration of a catheter 1 with expandable anchoring units for stabilization and positioning for neurovascular interventions. Delivery of micro or nano catheters is thus facilitated in an advantageous manner.
  • Fig. 13a is a schematic illustration of a long aortic arch with a normal annulus angulation 360 and a catheter 1 having exemplary two sets of expandable members, here balloons, for positioning and stabilizing of the catheter 1 in this specific anatomic situation.
  • Fig. 13b is a schematic illustration of a long aortic arch with a horizontal annulus angulation 361 and a catheter 1 having exemplary two sets of expandable members, here balloons, for positioning and stabilizing of the catheter 1 in this specific anatomic situation.
  • Fig. 13c is a schematic illustration of a sharp aortic arch with a normal annulus angulation 362 and a catheter 1 having exemplary two sets of expandable members, here balloons, for positioning and stabilizing of the catheter 1 in this specific anatomic situation.
  • Fig. 13d is a schematic illustration of a sharp aortic arch with a horizontal annulus 363 and a catheter 1 having exemplary two sets of expandable members, here balloons, for positioning and stabilizing of the catheter 1 in this specific anatomic situation.
  • Figs. 14 to 19 and 23 are various schematic illustrations, each of a particular anatomical situation where catheters 1 with pre-bent sections and expandable members are shown during certain minimally invasive medical interventions at various target sites and through various vascular access paths.
  • Fig. 14 is a schematic illustration of an exemplary catheter 1 use for Endovascular Aortic Aneurysm Repair (EVAR) e.g. for treatment procedures of abdominal aortic aneurysms (AAA) 373, and vascular interventions in the abdomen including via or in the celiac trunk 370, superior Mesenteric trunk 371 , the renal arteries 310, or the inferior Mesenteric trunk 372, e.g. for treatment procedures of Mesenteric Artery Ischemia (MAI).
  • EVAR Endovascular Aortic Aneurysm Repair
  • AAA abdominal aortic aneurysms
  • MAI Mesenteric Artery Ischemia
  • Fig. 15 is a schematic illustration of an exemplary catheter 1 use for interventions on the tricuspid valve 322 (from right atrium to right ventricle valve) from the Vena Cava Superior (VCS) 325 or Vena Cava Inferior (VCI) 326.
  • VCS Vena Cava Superior
  • VCI Vena Cava Inferior
  • Fig. 16a is a schematic illustration of an exemplary catheter 1 use for interventions on the pulmonic valve 324 from the VCS 325.
  • Fig. 16b is a schematic illustration of an exemplary catheter 1 use for interventions on the pulmonic valve 324 from the VCI 326.
  • the catheter 1 has a double pre-bend in an S-shape manner for such approach.
  • Fig. 17 is a schematic illustration of an exemplary catheter 1 use for interventions on the mitral valve 320 (left atrium to left ventricle valve transseptally from the VCI 326.
  • Fig. 18a is a schematic illustration of an exemplary catheter 1 use for Thoracic Endovascular Aortic Repair (TEVAR) interventions, which are minimally invasive procedure to repair the aorta with e.g. stent grafts or other medical treatment procedures, of the aortic arch and the ascendens aorta.
  • TEVAR Thoracic Endovascular Aortic Repair
  • Fig. 18b is a schematic illustration of an exemplary catheter 1 use for neurovascular
  • Fig. 18c is a schematic illustration of an exemplary catheter 1 use for Percutaneous Coronary Intervention (PCI).
  • PCI Percutaneous Coronary Intervention
  • Fig. 18d is a schematic illustration of an exemplary catheter 1 use for TAVI procedures via the carotic (left) artery 352 access.
  • Fig. 18e is a schematic illustration of an exemplary catheter 1 use for TAVI procedures via the carotic (right) artery 354 access.
  • Fig. 18f is a schematic illustration of an exemplary catheter 1 use for TAVI procedures via a Direct Aortic access.
  • Fig. 19a is a schematic illustration of an exemplary catheter 1 use for TAVI interventions via the right subclavian artery 356.
  • Fig. 19b is a schematic illustration of an exemplary catheter 1 use for TAVI interventions via the left subclavian artery 358;
  • Fig. 23 is a schematic illustration of an exemplary catheter 1 use for delivery of a Ventricular Assist Devices (VAD) 540.
  • VAD Ventricular Assist Devices
  • Anchoring units for stabilizing and/or target position a gastroscope when expanded / inflated are Anchoring units for stabilizing and/or target position a gastroscope when expanded / inflated.
  • Pre-bent delivery catheters 1 as described herein may provide for easier access to the target site.
  • expandable units of the delivery catheter 1 as described herein may provide for stabilizing and/or anchoring said delivery catheter 1 in relation to said target site.
  • Minimal invasive delivery enabled by catheter 1 devices of the present disclosure provide for more precise delivery of drugs or execution of an interventional procedures
  • the delivery catheter 1 is configured to facilitate implantation in a medical procedure via an access path for instance: via the oesophagus Stabilization in close proximity to the site of interest.
  • the pre-bent portion 100 provides the following advantage: Less tension on the interventional tolls used for the procedure and allowing access to sites that are otherwise difficult to access
  • Expanding such expandable unit(s) is done as follows: Positioning of delivery catheter 1 over the wire and when in targeted position inflation of stabilising unit(s)
  • the expanded unit(s) provides stabilizing and/or anchoring said catheter 1 in relation to said target site because: it straightens out the access route, allows to access anatomical sites not accessible for straight catheters 1 , and provides stability during the procedure when the catheter 1 is in place at otherwise difficult to reach anatomical sites.
  • Such sites might not be accessible with steerable catheter 1 that have a larger outer diameter than the presently disclosed catheter 1 devices.
  • Anchoring units for stabilizing and/or target position an endoscope when expanded / inflated are Anchoring units for stabilizing and/or target position an endoscope when expanded / inflated.
  • Pre-bent delivery catheters 1 as described herein may provide for easier access to the target site.
  • expandable units of the delivery catheter 1 as described herein may provide for stabilizing and/or anchoring said delivery catheter 1 in relation to said target site.
  • Minimal invasive delivery enabled by catheter 1 devices of the present disclosure provide for more precise delivery of drugs or execution of an interventional procedures
  • the delivery catheter 1 is configured to facilitate implantation in a medical procedure via an access path for instance: the oesophagus/intestines/peritoneal cavity. Stabilization in close proximity to the site of interest,
  • the pre-bent portion 100 provides the following advantage: Less tension on the interventional tolls used for the procedure and allowing access to sites that are otherwise difficult to access
  • Expanding such expandable unit(s) is done as follows: Positioning of delivery catheter 1 over the wire and when in targeted position inflation of stabilising unit(s)
  • the expanded unit(s) provides stabilizing and/or anchoring said catheter 1 in relation to said target site because it straightens out the access route and provides stability during the procedure.
  • Pre-bent delivery catheters 1 as described herein may provide for easier access to the target site.
  • expandable units of the delivery catheter 1 as described herein may provide for stabilizing and/or anchoring said delivery catheter 1 in relation to said target site.
  • Minimal invasive delivery enabled by catheter 1 devices of the present disclosure provide for similar results as mentioned above for gastroscopy.
  • the delivery catheter 1 is configured to facilitate implantation in a medical procedure via an access path for instance: similar as mentioned above for gastroscopy.
  • the delivery catheter 1 has a pre-bent portion 100 as described herein, the pre-bent portion 100 provides the following advantage: similar results as mentioned above for gastroscopy.
  • Expanding such expandable unit(s) e.g. balloon
  • Expanding such expandable unit(s) is done as follows.
  • the expanded unit(s) provides stabilizing and/or anchoring said catheter 1 in relation to said target site because: similar advantages and procedures as mentioned above for gastroscopy.
  • Target/Target site(s)
  • Pre-bent delivery catheters 1 as described herein may provide for easier access to the target site.
  • expandable units of the delivery catheter 1 as described herein may provide for stabilizing and/or anchoring said delivery catheter 1 in relation to said target site.
  • Minimal invasive delivery enabled by catheter 1 devices of the present disclosure provide for similar advantages as mentioned above for gastroscopy.
  • the delivery catheter 1 is configured to facilitate implantation in a medical procedure via an access path for instance via the colon.
  • the pre-bent portion 100 provides the following advantage: similar as mentioned above for gastroscopy.
  • Anchoring units for stabilizing and/or target position an elongate tracheal access device when expanded / inflated
  • Target/Target site(s)
  • Pre-bent delivery catheters 1 as described herein may provide for easier access to the target site.
  • expandable units of the delivery catheter 1 as described herein may provide for stabilizing and/or anchoring said delivery catheter 1 in relation to said target site.
  • Minimal invasive delivery enabled by catheter 1 devices of the present disclosure provide for advantageous target site access as the catheter 1 device and its use allow for straightening out the access route, allows to access anatomical sites not accessible for straight catheters 1 , and provides stability during the procedure when the catheter 1 is in place at otherwise difficult to reach anatomical sites. Such sites might not be accessible with steerable catheter 1 that have a larger outer diameter than the presently disclosed catheter 1 devices.
  • the delivery catheter 1 is configured to facilitate implantation in a medical procedure via an access path for instance: the trachea to bronchial site in the trachea and the lung
  • the pre-bent portion 100 provides the following advantage: Minimal invasive delivery enabled by catheter 1 devices of the present disclosure provide for advantageous target site access as the catheter 1 device and its use allow for straightening out the access route, allows to access anatomical sites not accessible for straight catheters 1 , and provides stability during the procedure when the catheter 1 is in place at otherwise difficult to reach anatomical sites. Such sites might not be accessible with steerable catheter 1 that have a larger outer diameter than the presently disclosed catheter 1 devices.
  • the expanded unit(s) provides stabilizing and/or anchoring said catheter 1 in relation to said target site because: Stabilization in close proximity to the site of interest
  • Target/Target site(s)
  • Pre-bent delivery catheters 1 as described herein may provide for easier access to the target site.
  • expandable units of the delivery catheter 1 as described herein may provide for stabilizing and/or anchoring said delivery catheter 1 in relation to said target site.
  • Anchoring units for stabilizing and/or target position a neurosurgical catheter 1 device when expanded / inflated e.g. a micro catheter 1 or nano catheter 1
  • Target/Target site(s)
  • Pre-bent delivery catheters 1 as described herein may provide for easier access to the target site.
  • expandable units of the delivery catheter 1 as described herein may provide for stabilizing and/or anchoring said delivery catheter 1 in relation to said target site.
  • Minimal invasive delivery enabled by catheter 1 devices of the present disclosure provide for Minimal invasive delivery enabled by catheter 1 devices of the present disclosure provide for advantageous target site access as the catheter 1 device and its use allow for straightening out the access route to neurological sites, e.g. in the brain, allows to access anatomical sites not accessible for straight catheters 1 , and provides stability during the procedure when the catheter 1 is in place at otherwise difficult to reach anatomical sites. Such sites might not be accessible with steerable catheter 1 that have a larger outer diameter than the presently disclosed catheter 1 devices.
  • Target/Target site(s)
  • Urinary tract system /Kidneys/Reproductive system Pre-bent delivery catheters 1 as described herein may provide for easier access to the target site.
  • expandable units of the delivery catheter 1 as described herein may provide for stabilizing and/or anchoring said delivery catheter 1 in relation to said target site.
  • Minimal invasive delivery enabled by catheter 1 devices of the present disclosure provide for Minimal invasive delivery enabled by catheter 1 devices of the present disclosure provide for advantageous target site access as the catheter 1 device and its use allow for straightening out the access route to Urinary tract system /Kidneys/Reproductive system, and allows to access such anatomical sites not accessible for straight catheters 1 , and provides stability during the procedure when the catheter 1 is in place at otherwise difficult to reach anatomical sites. Such sites might not be accessible with steerable catheter 1 that have a larger outer diameter than the presently disclosed catheter 1 devices. Stabilization in close proximity to the site of interest.
  • Pre-bent delivery catheters 1 as described herein may provide for easier access to the target site.
  • expandable units of the delivery catheter 1 as described herein may provide for stabilizing and/or anchoring said delivery catheter 1 in relation to said target site.
  • Minimal invasive delivery enabled by catheter 1 devices of the present disclosure provide for Minimal invasive delivery enabled by catheter 1 devices of the present disclosure provide for advantageous target site access as the catheter 1 device and its use allow for straightening out the access route to abdominal vessels and organs, allows to access anatomical sites not accessible for straight catheters 1 , and provides stability during the procedure when the catheter 1 is in place at otherwise difficult to reach anatomical sites. Such sites might not be accessible with steerable catheter 1 that have a larger outer diameter than the presently disclosed catheter 1 devices. Stabilization in close proximity to the site of interest.
  • the delivery catheter 1 is configured to facilitate implantation in a medical procedure via an access path for instance: as shown in Fig. 14.
  • the pre-bent portion 100 provides the following advantage: easy access to branch vessels in the aorta for access to target sites in and at the branch vessels.
  • Pre-bent delivery catheters 1 as described herein may provide for easier access to the target site.
  • expandable units of the delivery catheter 1 as described herein may provide for stabilizing and/or anchoring said delivery catheter 1 in relation to said target site.
  • Minimal invasive delivery enabled by catheter 1 devices of the present disclosure provide for Minimal invasive delivery enabled by catheter 1 devices of the present disclosure provide for advantageous target site access as the catheter 1 device and its use allow for straightening out the access route to cardiac vessels and organs, allows to access anatomical sites not accessible for straight catheters 1 , and provides stability during the procedure when the catheter 1 is in place at otherwise difficult to reach anatomical sites. Such sites might not be accessible with steerable catheter 1 that have a larger outer diameter than the presently disclosed catheter 1 devices. Stabilization in close proximity to the site of interest.
  • the delivery catheter 1 is configured to facilitate implantation in a medical procedure via an access path for instance: see Figures
  • Pre-bent delivery catheters 1 as described herein may provide for easier access to the target site.
  • expandable units of the delivery catheter 1 as described herein may provide for stabilizing and/or anchoring said delivery catheter 1 in relation to said target site.
  • Minimal invasive delivery enabled by catheter 1 devices of the present disclosure provide for Minimal invasive delivery enabled by catheter 1 devices of the present disclosure provide for advantageous target site access as the catheter 1 device and its use allow for straightening out the access route to aortic sites, allows to access anatomical sites not accessible for straight catheters 1 , and provides stability during the procedure when the catheter 1 is in place at otherwise difficult to reach anatomical sites. Such sites might not be accessible with steerable catheter 1 that have a larger outer diameter than the presently disclosed catheter 1 devices. Stabilization in close proximity to the site of interest.
  • the delivery catheter 1 is configured to facilitate implantation in a medical procedure via an access path for instance: see Figures
  • PLD U Paravalvular leakage closure devices
  • Pre-bent delivery catheters 1 as described herein may provide for easier access to the target site.
  • expandable units of the delivery catheter 1 as described herein may provide for stabilizing and/or anchoring said delivery catheter 1 in relation to said target site.
  • Minimal invasive delivery enabled by catheter 1 devices of the present disclosure provide for Minimal invasive delivery enabled by catheter 1 devices of the present disclosure provide for advantageous target site access as the catheter 1 device and its use allow for straightening out the access route to paravalvular sites for instance at the mitral valve, allows to access anatomical sites not accessible for straight catheters 1 , and provides stability during the procedure when the catheter 1 is in place at otherwise difficult to reach anatomical sites. Such sites might not be accessible with steerable catheter 1 that have a larger outer diameter than the presently disclosed catheter 1 devices. Stabilization in close proximity to the site of interest.
  • the delivery catheter 1 is configured to facilitate implantation in a medical procedure via an access path for instance: see for instance Figures.
  • LVADs temporary and permanently implanted LVADs.
  • Such assist devices are commercially available, such as e.g. the Impella CP® or Impella 2.5® temporary heart pump devices.
  • LVADs/RVADs typically provide for cardiac assist and increased cardiac pump function.
  • the Impella devices temporary devices
  • the Impella devices pull blood from the left ventricle through an inlet area near the tip and expels blood from the catheter 1 into the ascending aorta. Insertion of such LVAD devices can be inserted via a standard catheter 1 ization procedure through the femoral artery, into the ascending aorta, across the valve and into the left ventricle.
  • Pre-bent delivery catheters 1 as described herein may provide for easier access to the target site.
  • expandable units of the delivery catheter 1 as described herein may provide for stabilizing and/or anchoring said delivery catheter 1 in relation to said target site, in particular for a ventricular assist device temporarily implanted into the beating heart such as the Impella, but also for permanently implanted ventricular assist devices.
  • Minimal invasive delivery enabled by catheter 1 devices of the present disclosure provide for reduction of stroke rates, reduced bleeding risk, reduced risk for infections, etc., i.e. improved patient safety.
  • the delivery catheter 1 is configured to facilitate implantation in a medical procedure via an access path for instance: see for instance Figure 24.
  • Pre-bent delivery catheters 1 as described herein may provide for easier access to the target site.
  • expandable units of the delivery catheter 1 as described herein may provide for stabilizing and/or anchoring said delivery catheter 1 in relation to said target site.
  • Minimal invasive delivery enabled by catheter 1 devices of the present disclosure provide for Minimal invasive delivery enabled by catheter 1 devices of the present disclosure provide for advantageous target site access as the catheter 1 device and its use allow for straightening out the access route to atrial target sites, allows to access anatomical sites not accessible for straight catheters 1 , and provides stability during the procedure when the catheter 1 is in place at otherwise difficult to reach anatomical sites. Such sites might not be accessible with steerable catheter 1 that have a larger outer diameter than the presently disclosed catheter 1 devices. Stabilization in close proximity to the site of interest.
  • the delivery catheter 1 is configured to facilitate implantation in a medical procedure via an access path for instance: see for instance Figures.
  • Pre-bent delivery catheters 1 as described herein may provide for easier access to the target site.
  • expandable units of the delivery catheter 1 as described herein may provide for stabilizing and/or anchoring said delivery catheter 1 in relation to said target site.
  • Minimal invasive delivery enabled by catheter 1 devices of the present disclosure provide for Minimal invasive delivery enabled by catheter 1 devices of the present disclosure provide for advantageous target site access as the catheter 1 device and its use allow for straightening out the access route to cardiac sites, allows to access anatomical sites not accessible for straight catheters 1 , and provides stability during the procedure when the catheter 1 is in place at otherwise difficult to reach anatomical sites. Such sites might not be accessible with steerable catheter 1 that have a larger outer diameter than the presently disclosed catheter 1 devices. Stabilization in close proximity to the site of interest.
  • the catheter 1 target delivery is done with high spatial precision. Blood flow in the lumen around the anchored sheath 10 is maintained in-between the anchoring unit(s) or radially distally of some anchoring units when not in lumen wall apposition. Partially expanded anchoring units may contribute to mechanical stability of the sheath 10 in the lumen, a pulsatile movement of the sheath 10 may be dampened by intermittent apposition of the anchoring units to interior wall tissue of the lumen.
  • Several sets of expansion elements like one or more balloons along length of catheter 1 / sheath 10 may be provided advantageously. This provides better locking /securing to the vessel lumen at the position of expansion. This multiple sets of expansion elements prevents kinking of the delivery catheter 1 when expandable members are expanded. They also in addition or alternatively prevent rotation of the delivery catheter 1 in the vessel lumen when expandable members are expanded.
  • the catheter 1 device according to the examples may additionally or alternatively have the medical device being an artificial replacement valve or a valve repair device, wherein the cardiac valve preferably is an aortic valve of the patient.
  • the catheter 1 device according to the examples may be provided in a kit of the catheter 1 device and a medical device for delivery to a cardiac valve region, such as an artificial replacement valve.
  • a system for transvascularly delivering a medical device to an aortic cardiac valve region of a patient.
  • the system includes a catheter 1 comprising an elongate catheter 1 sheath 10 with a lumen for minimally invasively introducing into the vascular system, the catheter 1 being configured to transvascularly deliver an artificial heart valve to the aortic cardiac valve region.
  • the catheter 1 sheath 10 has a distal end configured to transvascularly navigate through the vascular system upstream the aorta to a position at and/or downstream the aortic cardiac valve.
  • the expandable units are arranged to allow for blood flow outside the sheath 10 and past lobes of the radially expandable units when in a position for delivering the artificial aortic valve.
  • the catheter 1 sheath 10 has distal end configured to transvascularly navigate through the vascular system upstream the aorta to a position at and/or downstream the aortic cardiac valve.
  • the catheter 1 sheath 10 includes at least one or a plurality of radially expandable units proximate the distal end of the catheter 1 sheath 10 and at an exterior of the catheter 1 sheath 10. At least one of the radially expandable units is configured to be in apposition with the interior vessel wall in the ascending aorta downstream the aortic valve and upstream all side branch vessels of the aortic arch.
  • the radially expandable units are arranged for expanding to temporarily position the distal end in relation to the cardiac valve.
  • the device of these examples may be combined with an introducer device configured to provide vascular, such as femoral access to the patients vascular system, wherein the introducer has a shorter length than the delivery catheter 1 , and preferably a lower flexibility than the delivery catheter 1 sheath 10. This allows for most advantageous delivery of a medical device over a long distance to a position remote of the puncturing site entering the vascular system (e.g. femoral approach).
  • a method may include radially expanding expandable units of the catheter 1 or an elongate member positioned beyond a distal end of the sheath 10, to temporarily position in relation to the valve the elongate sheath 10; and optionally delivering a medical device through the lumen of the elongate sheath 10 to the heart valve, wherein the elongate sheath 10 is preferably locked in position in the lumen by expandable member(s).
  • the method may additionally include inserting an elongate member with a distal end portion comprising a plurality of the radially expandable units, into the lumen of the elongate sheath 10; advancing the elongate member through the elongate sheath 10 to the distal end of the elongate sheath 10; retracting the expandable units and withdrawing the elongate member from the lumen of the elongate sheath 10.
  • the catheter 1 may be positioned and locked in other cardiac anatomical structures than illustrated. Medical devices delivered through the catheter sheath may be any medical device to be delivered to the cardiac valve tissue. The scope of the invention is only limited by the appended patent claims.
  • AAA abdominal aortic aneurysms
  • TEVAR thoracic endovascular aortic repair
  • graft stent 510 branched aorta arcus endoprosthesis or graft stent
  • VAD Ventricular Assist Devices

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  • Health & Medical Sciences (AREA)
  • Cardiology (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Transplantation (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Vascular Medicine (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Media Introduction/Drainage Providing Device (AREA)

Abstract

L'invention porte sur un dispositif de cathéter pour la pose par voie transvasculaire d'un dispositif médical au niveau d'une région cible, telle qu'une région de valvule cardiaque, d'un patient. Le cathéter comprend une gaine de cathéter (10) allongée ayant une lumière, une extrémité proximale, une extrémité distale et une partie d'extrémité distale comprenant ladite extrémité distale est configurée pour être positionnée au niveau, ou à proximité de ladite région cible, ou adjacente à ladite région cible, telle que ladite région de valvule cardiaque. La gaine de cathéter (10) a une extrémité distale configurée pour naviguer par voie transvasculaire à travers ledit système vasculaire et comprenant au moins une unité radialement expansible à proximité de ladite extrémité distale de ladite gaine de cathéter (10) et à l'extérieur de ladite gaine de cathéter (10) et agencée pour permettre un écoulement de sang à l'extérieur de ladite gaine (10) et au-delà de ladite unité radialement expansible. Une partie distale de la gaine de cathéter (10) est incurvée et pré-pliée et une partie proximale adjacente à ladite partie distale de ladite gaine de cathéter (10) est sensiblement droite.
PCT/EP2019/065778 2018-06-14 2019-06-14 Dispositifs et procédés de mise en place par voie transvasculaire de dispositifs médicaux WO2019238964A1 (fr)

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Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN113855334A (zh) * 2021-10-26 2021-12-31 金仕生物科技（常熟）有限公司 预压弯远端外管及输送系统
WO2024242773A1 (fr) * 2023-05-19 2024-11-28 Evalve, Inc. Système de pose à rigidité variable pour réparation transcathéter de valve bout à bout

Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2013037505A1 (fr) 2011-01-11 2013-03-21 Symetis Sa Procédé et appareil utiles pour l'implantation de la valve sigmoïde par cathétérisme
WO2013056898A1 (fr) 2011-10-21 2013-04-25 Jenavalve Technology Inc. Système de cathéter pour l'introduction d'un stent expansible pour valvule cardiaque dans le corps d'un patient, système d'insertion avec un système de cathéter et dispositif médical pour le traitement d'un défaut d'une valvule cardiaque
US20150202038A1 (en) * 2011-05-08 2015-07-23 Swat Medical Ab Device And Method For Delivery Of Medical Devices To A Cardiac Valve
US20160213470A1 (en) * 2015-01-27 2016-07-28 Medtronic Vascular, Inc. Delivery System Having an Integral Centering Mechanism for Positioning a Valve Prosthesis in Situ

Patent Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2013037505A1 (fr) 2011-01-11 2013-03-21 Symetis Sa Procédé et appareil utiles pour l'implantation de la valve sigmoïde par cathétérisme
US20160193047A1 (en) * 2011-01-11 2016-07-07 Symetis Sa Method and Apparatus Useful for Transcatheter Aortic Valve Implantation
US20150202038A1 (en) * 2011-05-08 2015-07-23 Swat Medical Ab Device And Method For Delivery Of Medical Devices To A Cardiac Valve
WO2013056898A1 (fr) 2011-10-21 2013-04-25 Jenavalve Technology Inc. Système de cathéter pour l'introduction d'un stent expansible pour valvule cardiaque dans le corps d'un patient, système d'insertion avec un système de cathéter et dispositif médical pour le traitement d'un défaut d'une valvule cardiaque
US20160213470A1 (en) * 2015-01-27 2016-07-28 Medtronic Vascular, Inc. Delivery System Having an Integral Centering Mechanism for Positioning a Valve Prosthesis in Situ

Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN113855334A (zh) * 2021-10-26 2021-12-31 金仕生物科技（常熟）有限公司 预压弯远端外管及输送系统
WO2024242773A1 (fr) * 2023-05-19 2024-11-28 Evalve, Inc. Système de pose à rigidité variable pour réparation transcathéter de valve bout à bout

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