WO2024126375A1 - Conception optimisée d'une membrane à enroulement et d'un cathéter pour un cathéter à membrane à enroulement - Google Patents

Conception optimisée d'une membrane à enroulement et d'un cathéter pour un cathéter à membrane à enroulement Download PDF

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Publication number
WO2024126375A1
WO2024126375A1 PCT/EP2023/085131 EP2023085131W WO2024126375A1 WO 2024126375 A1 WO2024126375 A1 WO 2024126375A1 EP 2023085131 W EP2023085131 W EP 2023085131W WO 2024126375 A1 WO2024126375 A1 WO 2024126375A1
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WO
WIPO (PCT)
Prior art keywords
rolling membrane
distal
inner shaft
catheter
rolling
Prior art date
Application number
PCT/EP2023/085131
Other languages
English (en)
Inventor
Matthias Wesselmann
Nadine TROES
Claus Harder
Bodo Quint
Jeremy Wernli
Original Assignee
Biotronik Ag
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 Biotronik Ag filed Critical Biotronik Ag
Publication of WO2024126375A1 publication Critical patent/WO2024126375A1/fr

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Classifications

    • 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
    • A61M25/0009—Making of catheters or other medical or surgical tubes
    • 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
    • A61M25/0105—Steering means as part of the catheter or advancing means; Markers for positioning
    • A61M25/0119—Eversible catheters
    • 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
    • A61M2025/0004—Catheters; Hollow probes having two or more concentrically arranged tubes for forming a concentric catheter system
    • 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
    • A61M25/0067—Catheters; Hollow probes characterised by the distal end, e.g. tips
    • A61M25/0074—Dynamic characteristics of the catheter tip, e.g. openable, closable, expandable or deformable
    • A61M2025/0079—Separate user-activated means, e.g. guidewires, guide tubes, balloon catheters or sheaths, for sealing off an orifice, e.g. a lumen or side holes, of a catheter
    • 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
    • A61M2025/0175—Introducing, guiding, advancing, emplacing or holding catheters having telescopic features, interengaging nestable members movable in relations to one another

Definitions

  • the present invention relates to different catheters comprising a rolling membrane and methods for making the same.
  • a preferred minimally invasive method of supporting an early diagnosis and/or a curing of such diseases is based on the usage of catheters.
  • a catheter may in most cases be implemented as a tubular-shaped, hose-like device which may be inserted into a body of a patient and may be moved along an artery and/or a vein up to an anomaly in the blood vessel of a patient (e.g. a stenosis).
  • Such catheters may be adapted to deliver a medical device (e.g.
  • the forward movement (e.g. in a distal direction) of a catheter and/or the backward movement (e.g. in a proximal direction) of a catheter may be rendered difficult especially in cases in which a blood vessel is occluded (e.g. calcified) and/or tortuous.
  • rolling membrane catheters may contribute to an improved handling of a catheter under the aforementioned conditions.
  • existing rolling membrane catheters still show disadvantages when used for diagnostic and/or curative applications.
  • the rolling membrane when a rolling membrane is at least partially rolled-in, the rolling membrane may sometimes exhibit undesired folding which may, in some exemplary cases, counteract a further rolling-in and/or movement of the rolling membrane in a proximal direction.
  • rolling membrane catheters are oftentimes rolled out along a blood vessel of a patient.
  • the insertion of a guide wire into a rolling membrane may not always be easy and may lead to a damaging of the rolling membrane.
  • the movement of a rolling membrane catheter in a distal direction along a blood vessel of a patient may in some cases be associated with an elevated risk for causing a lesion at an inner wall of the blood vessel of a patient, in particular, if the rolling membrane is in a rolled-in state.
  • the flexural modulus of the distal end of the rolling membrane catheter should not be higher than the flexural modulus of the guidewire, otherwise the distal end will not be able to follow the path laid out by the guide wire.
  • the catheter may comprise a rolling membrane and an atraumatic tip forming a distal tip of the catheter when the rolling membrane is in a rolled-in state.
  • the atraumatic tip may advantageously contribute to a simplified movement of the rolling membrane catheter along the blood vessel of the patient by preventing damage s/lesions caused to an inner wall of the blood vessel, even when the membrane is in a rolled-in state.
  • catheters may be adapted with a rolling membrane to be rolled out in a distal direction along a blood vessel of a patient to allow a friction reduced movement of a catheter along a blood vessel of a patient.
  • the catheter is moved to a desired position in the patient first, and only at that point the rolling membrane may be rolled-out. If the rolling membrane is in a rolled-in state, typically an outer shaft within which the rolling membrane is arranged for being rolled-out forms a distal end of the catheter. This exhibits a potential risk for the inner wall of the blood vessel to be damaged. By an atraumatic tip which forms a distal tip of the catheter when the membrane is in a rolled-in state, this risk is reduced.
  • the rolling membrane may be adapted to be rolled out in a distal direction and along a blood vessel of a patient.
  • the atraumatic tip may preferably comprise a cone-shape for supporting a simplified movement of the catheter along the distal direction along the blood vessel of the patient.
  • the distal-most tip of the atraumatic tip may be provided in a curved shape for further supporting a propagation of the atraumatic tip and the catheter connected thereto along the blood vessel of the patient.
  • the atraumatic tip may preferably be provided with a maximum diameter which is smaller than a diameter of the blood vessel of the patient into which the catheter is to be inserted.
  • the atraumatic tip may be configured to receive a guide wire at a center region of the atraumatic tip.
  • the guide wire may extend from a proximal end of the catheter to a distal end of the catheter (and optionally further in the distal direction along the blood vessel of the patient).
  • the rolling membrane may be adapted to move to a position distal to a position of the atraumatic tip when the rolling membrane is rolled out.
  • the atraumatic tip may be adapted to allow the rolling membrane to at least partially leave the catheter via an opening of the atraumatic tip when the rolling membrane is rolled out in the distal direction. If the rolling membrane is in a rolled-in state, the rolling membrane may be fully located at a position that is proximal to the atraumatic tip.
  • the atraumatic tip may be adapted to form a transitional zone when the membrane is rolled-out.
  • the flexibility of the rolled-out (distal) membrane may be high, the flexibility of the atraumatic tip may be somewhat lower, but still higher than the flexibility of e.g. an outer shaft of the catheter in which the rolling membrane may be located in the rolled-in state.
  • At least a distal portion of the atraumatic tip may be adapted to be widened along a direction perpendicular to an axial direction of the catheter, preferably as a result of the rolling membrane being rolled out.
  • the atraumatic tip may at least partially be connected to an outer shaft of the catheter at least partially enclosing the rolling membrane.
  • the atraumatic tip may be configured to be in a first (closed) state when the rolling membrane is in a rolled-in state.
  • the atraumatic tip may be configured to be in a widened to a second (open) state when the rolling membrane is at least partially rolled out.
  • the pressure within the rolling membrane may apply a radial force to the atraumatic tip, such that its inner diameter may widen.
  • the delivery of medical devices/instruments and/or medical drugs may be supported (e.g. by widening the atraumatic tip) without disadvantageous ⁇ affecting the atraumatic properties of the atraumatic tip when the catheter is moved (e.g. when the atraumatic tip is in the closed state) in a distal direction along the blood vessel of the patient.
  • the atraumatic tip may comprise an elastomer.
  • the elastomer may, e.g. be a thermoplastic elastomer. In some cases, the elastomer may be a thermosetting polymer.
  • the elastomer may comprise a polyamide-based elastomer, a polyester-based elastomer, a polyolefin-based elastomer and/or any other suitable type of elastomer or plastic/polymer material.
  • the atraumatic tip may be made from a combination of one or more of the aforementioned materials.
  • the atraumatic tip may possess increased failure strain and may be deformed under strain and tension without rupturing. Moreover, a simplified and cost-effective manufacturing procedure, e.g. by means of thermoforming, of the atraumatic tip may be supported as a simplified shaping of the atraumatic tip comprising the elastomer may be facilitated. Moreover, elastomers may provide increased biocompatibility thus avoiding allergic reactions of the patient.
  • the atraumatic tip may be formed by a portion of the rolling membrane. In some exemplary implementations, at least a distal portion, as seen in a rolled-in state of the rolling membrane, may be adapted to not being fully folded inwards into itself (e.g.
  • the rolling membrane may be adapted such that, in the fully retracted state, the distal portion of the rolling membrane is still rolled out.
  • the distal portion of the membrane may comprise an increased stiffness as compared to the remaining portion, e.g. as provided by thermoforming such as to form an atraumatic tip with a suitable resilience.
  • a pressure in a predetermined range may be applied to the distal portion of the membrane such as to provide suitable resilience.
  • the atraumatic tip may be permanently connected to the rolling membrane and/or an outer shaft of the catheter (to which, e.g. the rolling membrane may be connected).
  • the atraumatic tip may comprise a compressible material, preferably a plastic foam.
  • the atraumatic tip may be adapted to be retractable via the inner lumen of the rolling membrane.
  • the atraumatic tip may be provided with an atraumatic tip shaft extending from the atraumatic tip to a proximal end of the catheter.
  • the atraumatic tip shaft may be provided with a narrow inner lumen which may, e.g. encompass the guide wire. The atraumatic tip may then for example be retracted prior to rolling out the rolling membrane. Therefore, an obstacle free rolling -out of the rolling membrane may be ensured.
  • a second aspect relates to a catheter which may comprise a rolling membrane and a protection element, wherein the protection element may be arrangeable within an inner lumen of the rolling membrane for protecting the rolling membrane when inserting a guide wire into the rolling membrane from a distal end of the catheter.
  • the rolling membrane may comprise a polyamide-based elastomer (e.g. PA12 or Pebax), polyester (e.g. PET), a polyester-based elastomer (e.g. Hytrel), polyurethane, a polyolefin-based elastomer (e.g. EPDM/EPDM-PP) and/or any other suitable material.
  • a polyamide-based elastomer e.g. PA12 or Pebax
  • polyester e.g. PET
  • a polyester-based elastomer e.g. Hytrel
  • polyurethane e.g. EPDM/EPDM-PP
  • EPDM/EPDM-PP polyolefin-based elastomer
  • the protection element may be arranged within the inner lumen of the rolling membrane when the rolling membrane is in a rolled-in state.
  • Providing the rolling membrane with a protection element an insertion of a guide wire into the inner shaft of the rolling membrane may be facilitated (in particular if the rolling membrane is in a rolled-in state) without damaging the rolling membrane. Damages may, e.g. arise from a sharp tip of the guide wire and/or undesired friction arising from contacting an inner wall of the rolling membrane by the guide wire, e.g. when the guide wire is distally inserted into the rolling membrane.
  • a distal end of the protection element may comprise a larger diameter as compared to a proximal end of the protection element for facilitating a simplified insertion of the guide wire.
  • the protection element may comprise a funnel-like shape.
  • the distal end of the protection element may be provided with a diameter which may be at least 1.5 times as large as the diameter of the proximal end of the protection element.
  • the distal end may be provided with a diameter which may be at least 2 times, 3 times, 4 times, 5 times, 6 times, or even up to 10 times as large as the diameter of the proximal end.
  • the diameter of the distal end may differ from the diameter of the proximal end by at least 0.5 French, 1 French, 1.5 French, 2.0 French, 2.5 French, 3 French, 3.5 French, 4.0 French or more. 1 French is defined as 1/3 mm.
  • the funnel-like shape of the protection element may advantageously support a simplified insertion of the guide wire into the inner lumen of the rolling membrane as a larger opening cross section of the distal end to the inner lumen of the rolling membrane may artificially be provided.
  • the protection element may comprise one or more predetermined breaking points extending along an axial direction of the catheter.
  • the one or more predetermined breaking points may be provided as respective one or more perforations and/or indentations in the protection element.
  • one or more point-like perforations and/or indentations may be provided.
  • the one or more breaking points may be provided as respective one or more slits or grooves (each preferably extending along an axial direction of the catheter).
  • the protection element may further be provided with a color and/or material different from the rolling membrane and/or remaining parts of the catheter (e.g. an outer shaft).
  • the protection element may be provided with a signal color (e.g. a bright color such as yellow, green, etc.) and/or a haptic feeling different from the remaining catheter.
  • a signal color e.g. a bright color such as yellow, green, etc.
  • a haptic feeling different from the remaining catheter.
  • the protection element may be adapted to be removable from the catheter by pulling the at least one distal end portion, and thus tearing apart the protection element along an axial direction of the catheter, preferably along the one or more breaking points.
  • the protection element may be provided with at least two breaking points, arranged opposite to each other, as seen relative to the axial direction of the catheter, such that the protection element may be divided into two semi -cylinder-like shaped parts when tearing apart the protection element along two opposing directions relative to the axial direction of the catheter. Tearing apart the protection element may allow a simple removal of the protection element prior to inserting the catheter into a blood vessel of the patient.
  • a third aspect of the invention relates to another catheter.
  • the catheter may comprise a rolling membrane, wherein the rolling membrane may be provided with at least one reinforcement means adapted to support a rolling -in of the rolling membrane.
  • Providing the rolling membrane with at least one reinforcement means may, e.g. counteract (and preferably prevent) a bulging of the rolling membrane when the rolling membrane is rolled in.
  • the bulging may be understood as an at least local overlap of at least two layers of the rolling membrane.
  • the bulging may be understood as an accordion-like deformation of the rolling membrane along at least a cylindrical-shaped section of the rolling membrane, as seen when the rolling membrane is fully rolled out.
  • the at least one reinforcement means may also counteract (and preferably prevent) a rolling-in of the membrane at undesired positions, e.g. at positions of connection to an outer shaft of the catheter.
  • the third aspect may advantageously contribute to a simplified handling of the catheter, inter alia, by reducing the risk for complications arising from a rolling -in of the rolling membrane. This may increase the safety of the usage of the catheter, may avoid undue time consumption for medical staff arising from an undesired rolling-in behaviour of the rolling membrane.
  • the catheter may for example comprise an inner shaft, wherein a first end of the rolling membrane is attached to the inner shaft.
  • the first end of the rolling membrane may be adapted to form an angle of less than 180° and more than 30°, preferably of less than 120° and more than 60°, with the inner shaft for supporting the rolling-in of the rolling membrane.
  • the rolling-in of the rolling membrane at the first end may be promoted.
  • the relatively large angle may be seen as a reinforcement means as it counteracts an uncontrolled folding and/or bulging of the membrane at undesirable positions but promotes rolling-in at the first position.
  • the first end of the rolling membrane may be located at a distal end of the rolling membrane when the rolling membrane is in a rolled-out state. At least a distal portion of the rolling membrane, e.g. arranged at the first position, may preferably be made from a flexible material for supporting a flexible folding of the rolling membrane inwards, thus supporting a rolling -in of the rolling membrane.
  • the catheter may further comprise an outer shaft, wherein a second end of the rolling membrane may be attached to the outer shaft, wherein the second end of the rolling membrane may be adapted to form an angle of more than 0° and up to 30°, more preferably of 1-20°, most preferably of 5-7°, with the outer shaft for supporting the rolling -in of the rolling membrane.
  • the second end of the rolling membrane may be located at a proximal end of the rolling membrane when the rolling membrane is in a rolled-out state.
  • the second end of the rolling membrane may preferably be made from a material which is less flexible than the material which may be used for forming the distal portion of the rolling membrane, e.g. the first end, e.g. by thermoforming.
  • the second end may be made from a non-flexible (e.g. a non-bendable) material.
  • the at least one reinforcement means may comprise at least one thread-like element extending at least partially along an axial direction of the catheter and/or helically around an axial direction of the catheter and/or in a zigzag pattern around an axial direction of the catheter.
  • the at least one reinforcement means may be provided as at least one reinforcement thread.
  • the at least one reinforcement thread may be made from nitinol and/or any other shape-memory alloy and/or any other suitable material which may provide reinforcement capabilities.
  • the at least one reinforcement means may be attached to an outer surface of the rolling membrane (e.g. intended for vessel contact in a rolled-out state), e.g. by welding and/or gluing and/or any other suitable procedure.
  • the at least one reinforcement means may be incorporated into the rolling membrane such that the at least one reinforcement means may be located in the volume of the material of the rolling membrane (e.g. the at least one reinforcement means may not be visible at the surface of the rolling membrane).
  • the at least one reinforcement means may additionally or alternatively be provided by a cone-shape of the rolling membrane such that, when the rolling membrane is rolled in, a smaller diameter portion of the rolling membrane is inserted into a larger diameter portion of the rolling membrane.
  • the rolling membrane may be configured such that, when in a rolled-out state, it comprises a smaller diameter at a distal portion of the rolling membrane as compared to a proximal portion of the rolling membrane.
  • the diameter of the rolling membrane may increase, e.g. linearly (e.g. at least linearly over a certain portion).
  • the diameter of the rolling membrane may reach a maximum between the distal portion and the proximal portion of the rolling membrane such that the diameter of the rolling membrane at a distal end of the rolling membrane and the diameter at the proximal end of the rolling membrane may both be smaller than the maximum diameter.
  • location (relative to an axial direction of the catheter) of the maximum diameter of the rolling membrane may be closer to the proximal end of the rolling membrane than to the distal end of the rolling membrane (as seen in the rolled-out state).
  • the inner shaft having an inner shaft wall surrounding an inner shaft lumen, a distal inner shaft end, a proximal inner shaft end, the inner shaft having an outer diameter
  • the outer shaft having an outer shaft wall surrounding an outer shaft lumen, a distal outer shaft end, a proximal outer shaft end, the outer shaft having an outer diameter being larger than the outer diameter of the inner shaft,
  • a rolling membrane having a shallow angle between the rolling membrane and the outer shaft can be plastic/polymer welding, wherein with the aid of heat at least on (thermoplastic) polymer is molten and thus a bonding between two components (e.g. inner/outer shaft, balloon) is achieved.
  • a bonding material is a material which enables due to heat melting a connection of two or more components (e.g. inner/outer shaft and balloon).
  • the bonding material may comprise or consist of at least one (thermoplastic) polymer.
  • the second/proximal end of the rolling membrane may be welded to an inner side of the outer shaft wall or to an outer side of the outer shaft wall and the first/distal end of the rolling membrane may be welded to an inner side of the inner shaft wall or to an outer side of the inner shaft wall, preferably to the outer side of the inner shaft wall.
  • Inverting the rolling membrane may be done by pulling the proximal end of the rolling membrane over the inner shaft in a proximal direction. Inverting the rolling membrane my be done with or without applying a (elevated) pressure through the inner shaft.
  • the rolling membrane within this method may be provided with at least one reinforcement means (adapted to support a rolling -in and/or a rolling -out of the rolling membrane).
  • the at least one reinforcement means may comprise at least one thread-like element extending at least partially along an axial direction of the rolling membrane and/or helically around an axial direction of the rolling membrane and/or in a zigzag pattern around an axial direction of the rolling membrane.
  • the method may further comprise a step wherein a distal end region of the rolling membrane is thermoformed such that it forms an angle of less than 180° and more than 30°, preferably of less than 120° and more than 60°, with the inner shaft and/ or a step wherein a proximal end region of the rolling membrane is thermoformed such that it forms an angle of more than 0° and up to 30°, preferably of 1° to 20°, with the outer shaft.
  • the bonding material may be a suitable (thermoplastic) polymer.
  • the inner shaft is made of a first material (e.g. a (thermoplastic) polymer) and the balloon is made of another material (e.g. second (thermoplastic) being different from the first material of the inner shaft, the bonding material may be made of the same material as the balloon (or from a different material).
  • a rolling membrane catheter is a catheter comprising a rolling membrane.
  • a method for making a rolling membrane catheter comprises or consists of the steps of
  • An adhesive material is a material which can (without heat) connect two components (e.g. inner/outer shaft and balloon).
  • the adhesive material may be a glue.
  • Connecting the distal inner shaft end to the first/distal end of the rolling membrane may be done by (plastic) welding the distal inner shaft end to the first/distal end of the rolling membrane by using a welding wire which was inserted into an inner shaft lumen.
  • the bonding material may be a suitable (thermoplastic) polymer.
  • the inner shaft is made of a first material (e.g. a (thermoplastic) polymer) and the balloon is made of another material (e.g. second (thermoplastic) being different from the first material of the inner shaft, the bonding material may be made of the same material as the balloon (or from a different material).
  • Inverting the rolling membrane may be done by pulling the second/proximal end of the rolling membrane over the inner shaft in a proximal direction.
  • Connecting the distal outer shaft end to the second/proximal end of the rolling membrane may be done by welding the distal outer shaft end to the second/proximal end of the rolling membrane by using a welding tube which was inserted into the outer shaft lumen and between the outer shaft wall and the inner shaft wall or by using a welding wire which was inserted into a rolling membrane lumen.
  • the bonding material may be a suitable (thermoplastic) polymer.
  • the inner shaft is made of a first material (e.g. a (thermoplastic) polymer) and the balloon is made of another material (e.g. second (thermoplastic) being different from the first material of the inner shaft, the bonding material may be made of the same material as the balloon (or from a different material).
  • the method may further comprise a step of removing the welding wire from the inner shaft lumen.
  • the method according may comprise a step of removing the welding wire from the inner shaft lumen and removing the welding tube.
  • the method may further comprise a step of connecting the inner shaft and/or the outer shaft to a proximal shaft, preferably the proximal shaft is made of a metal or metal alloy.
  • the method may further comprise a step of connecting the inner shaft to a pushing rod, preferably the pushing rod is made of a stiffer material than the material of the inner shaft.
  • Another method for making a rolling membrane catheter comprises or consists of the steps of
  • Connecting the distal inner shaft end to the first/distal end of the rolling membrane may be done by welding the distal inner shaft end to the first/distal end of the rolling membrane by using a welding wire or welding tube which was inserted into an inner shaft lumen. Welding the distal inner shaft end to the first/distal end of the rolling membrane by using a welding wire which was inserted into the inner shaft lumen, can be done via a bonding material which was placed between the first/distal end of the rolling membrane and the distal inner shaft end.
  • the bonding material may be a suitable (thermoplastic) polymer.
  • the inner shaft is made of a first material (e.g. a (thermoplastic) polymer) and the balloon is made of another material (e.g. second (thermoplastic) being different from the first material of the inner shaft
  • the bonding material may be made of the same material as the balloon or from a different material.
  • Connecting the distal outer shaft end to the second/proximal end of the rolling membrane may be done by welding the distal outer shaft end to the second/proximal end of the rolling membrane by using a welding tube which was inserted into the outer shaft lumen and between the outer shaft wall and the inner shaft wall or by using a welding wire which was inserted into a rolling membrane lumen.
  • Welding the distal outer shaft end to the second/proximal end of the rolling membrane by using a welding tube which was inserted into the outer shaft lumen and between the outer shaft wall and the inner shaft wall or by using a welding tube which was inserted into the rolling membrane lumen can be done with or without a bonding material.
  • the bonding material may be placed between the second/proximal end of the rolling membrane and the distal outer shaft end.
  • the bonding material may be a suitable (thermoplastic) polymer.
  • the inner shaft is made of a first material (e.g. a (thermoplastic) polymer) and the balloon is made of another material (e.g. second (thermoplastic) being different from the first material of the inner shaft, the bonding material may be made of the same material as the balloon or from a different material.
  • the method may further comprise a step removing the welding wire and/or welding tube from the inner shaft lumen and the outer shaft lumen.
  • the method may further comprise a step of connecting the inner shaft and/or the outer shaft to a proximal shaft, preferably the proximal shaft is made of a metal or metal alloy.
  • the method may further comprise a step of connecting the inner shaft to a pushing rod, preferably the pushing rod is made of a stiffer material than the material of the inner shaft.
  • the pushing rod may be made of a metal or metal alloy.
  • the rolling membrane throughout the described methods may be provided with at least one reinforcement means.
  • the at least one reinforcement means may comprise at least one thread-like element extending at least partially along an axial direction of the catheter and/or helically around an axial direction of the catheter and/or in a zigzag pattern around an axial direction of the catheter.
  • FIG. 1 Illustration of an exemplary rolling membrane catheter
  • Fig. 2 Illustration of an exemplary usage of a guiding element to support the insertion of a guide wire into an inner shaft of a rolling membrane catheter with an at least partially rolled-in rolling membrane;
  • FIG. 3A-3C Illustration of exemplary embodiments for providing a rolling membrane catheter with an atraumatic tip
  • FIG. 4A-4C Illustration of exemplary problems arising during a rolling-in of a rolling membrane
  • FIG. 5A-5C Illustration of exemplary embodiments to at least partially counter undesired folding of a rolling membrane during rolling-in;
  • FIGS. 6A-6C Illustration of exemplary embodiments for providing a rolling membrane with at least one reinforcement means at a first end of the rolling membrane;
  • Figs. 7A-7C Illustration of exemplary embodiments for providing a rolling membrane with at least one reinforcement means at a first end of the rolling membrane and at the second end of the rolling membrane;
  • Figs. 8A-8B Illustration of exemplary embodiments for providing a rolling membrane with at least one reinforcement means at a first end of the rolling membrane and at the second end of the rolling membrane;
  • FIGs. 9A-9C Illustration of exemplary embodiments for providing a rolling membrane with at least one reinforcement means at a first end of the rolling membrane;
  • FIG. 10A-10C Illustration of exemplary embodiments for providing a rolling membrane with at least one reinforcement means at a first end of the rolling membrane;
  • FIGs. 11A-11C Illustration of exemplary embodiments for providing a rolling membrane with at least one reinforcement means extending from a distal portion of the rolling membrane to a proximal portion of the rolling membrane;
  • Figs. 12A-12B Illustration of exemplary embodiments for providing a rolling membrane with at least one reinforcement means extending from a distal portion of the rolling membrane to a proximal portion of the rolling membrane;
  • FIG. 13A-13B Illustration of exemplary embodiments for providing a rolling membrane with improved rolling-in capabilities
  • FIGs. 14A-14B Illustration of an exemplary rolling membrane catheter with an atraumatic tip in a nonpressurized and pressurized state.
  • Fig. 1 shows an example of basic elements of a rolling membrane catheter 1.
  • Fig. 1 exemplary shows the rolling membrane catheter 1 with a rolling membrane 2 fully rolled-out.
  • Rolling membrane catheter 1 may comprise an outer shaft 6 and an inner shaft 7.
  • the rolling membrane 2 forms an inner lumen 3 and comprises a proximal end 4 and a distal end 5.
  • the proximal end 4 of the rolling membrane 2 is connected to the outer shaft 6 whereas the distal end 5 of the rolling membrane 2 is connected to the inner shaft 7.
  • the inner shaft 7 may at least partially be accommodated by the inner lumen 3 of the rolling membrane 2.
  • a guide wire G may be located in an inner lumen 3 of the rolling membrane 2 and/or the inner shaft 7.
  • Fig. 2 shows an exemplary embodiment of a rolling membrane catheter according to a second aspect of the present invention which relates to an improved and simplified insertion of a guide wire G into an inner lumen of the rolling membrane 2 when the rolling membrane 2 is in a rolled-in state.
  • a proximal end 4 of the rolling membrane 2 is connected to an outer shaft 6 whereas a distal end 5 of the rolling membrane 2 is connected to an inner shaft 7.
  • Fig. 2 depicts an exemplary embodiment of the rolling membrane catheter 1 which has additionally been provided with a protection element 15.
  • protection element 15 may be provided to catheters having atraumatic tips as outlined with reference to Figs. 3A-C. More specifically, Fig.
  • the protection element 15 may be placed in the inner lumen 3 of the rolling membrane 2 by medical staff prior to inserting the guide wire G. Alternatively, the rolling membrane catheter 2 may be shipped already having the protection element 15 inserted by a manufacturer.
  • the protection element 15 may be configured to protect the entire inner lumen of the (rolled-in) rolling membrane, e.g. from a distal tip of outer shaft 6 to a distal tip of inner shaft 7.
  • the protection element 15 may simply be removed, e.g. by pulling or sliding the protection element 15 in the distal direction.
  • An enlarged opening 16 of the protection element 15 at a distal end, e.g. in form of a funnel, may support the operator in pulling the protection element 15 out of the rolling membrane catheter 1.
  • the protection element 15 may be adapted with one or more breaking points (not shown). The one or more breaking points may, e.g.
  • the protection element 15 may be provided with at least two lines of one or more breaking points extending from a distal end of the protection element 15 in the proximal direction. Such an arrangement of the at least two lines may allow a tearing apart of the protection element 15 along a predefined axis (e.g. along the axial direction of the catheter 1) into at least two pieces. In other words, the protection element 15 may be provided such that it may effectively be peeled-off the rolling membrane catheter 1.
  • Figs. 3A-C show exemplary embodiments of a rolling membrane catheter according to a first aspect of the present invention, directed to providing a rolling membrane catheter with an atraumatic tip (as distal tip 9), preferably made of an elastomer or a polymeric foam.
  • the rolling membrane catheter comprises a rolling membrane 2 having an inner lumen 3. A proximal end of the rolling membrane 2 is connected to an outer shaft 6 whereas a distal end 5 of the rolling membrane 2 is connected to an inner shaft 7.
  • Like numerals generally designate like elements outlined with reference to Fig. 1.
  • the atraumatic tip 8 may preferably comprise a maximum radius which is smaller than a minimum radius of a blood vessel of a patient to be investigated by the rolling membrane catheter 1.
  • Fig. 3A shows a first exemplary embodiment for proving the rolling membrane catheter 1 with an atraumatic tip 8 forming a distal tip 9 of the catheter 1.
  • the atraumatic tip is formed by a distal -most portion of the rolling membrane 2.
  • the rolling membrane may generally be adapted to being folded inwards into the inner lumen 3 when the rolling membrane 2 is rolled-in.
  • the distal- most portion may be adapted to not fold inwards, but instead to form a conus-like shape forming the atraumatic tip 8.
  • the atraumatic tip 8 may be formed by the rolling membrane 2, by one or more of e.g.
  • the rolling membrane catheter 1 may be moved in a distal direction D along a blood vessel of a patient guided by the guide wire G. By the atraumatic tip 8, the catheter 1 may be safely moved distally even when the rolling membrane 2 is in a retracted state.
  • Fig. 3B shows a second exemplary embodiment for providing the rolling membrane catheter 1 with an atraumatic tip 10 as distal tip 9.
  • the atraumatic tip 10 may comprise a cone-like cross-section and may be formed monolithically (e.g. as a cap) and or by two half-shells 11, 12 (or a larger number of components) which may be configured to form a conus shape at the distal end of outer shaft 6.
  • the atraumatic tip 10 may be arranged around an outer side of outer shaft 6 and optionally around an outer side of rolling membrane 2 which may be attached to the distal end of the outer shaft 6.
  • the atraumatic tip 10 may comprise a distal, e.g. central, opening for accommodating the guide wire G therein.
  • half-shells 11 and 12 may be concentrically arranged about the guide wire G.
  • the atraumatic tip 10 may be made of an elastomeric material like an elastomer.
  • the atraumatic tip 10 may be adapted to be widened (e.g. as a result of the rolling membrane 2 being at least partially rolled out in the distal direction D). The widening may lead to an increase of a separation between the half-shells 11 and 12 (or e.g. four quarter shells).
  • Fig. 3C shows a third exemplary embodiment for providing the rolling membrane catheter 1 with an atraumatic tip 13, preferably made of a polymeric foam.
  • the atraumatic tip 13 may be retracted in a proximal direction P of the rolling membrane catheter 1.
  • the atraumatic tip 13 may be compressible and may be compressed as a result of retracting the atraumatic 13 in the proximal direction P.
  • the atraumatic tip 13 may be connected to an atraumatic tip shaft 14, e.g. a dilator, for retracting the atraumatic tip 13 in the proximal direction P.
  • the atraumatic tip 13 and/or the atraumatic tip shaft 14 may be coated.
  • the atraumatic tip 13 and/or the atraumatic tip shaft 14 may preferably be coated with a hydrophilic coating for improved retractability of the atraumatic tip shaft 14 (and the atraumatic tip 13 connected thereto) in the proximal direction P.
  • the atraumatic tip shaft 14 may at least partially be arranged in the inner shaft 7.
  • Figs. 4A-4C show exemplary issues of a rolling membrane catheter 1 which are addressed by the third aspect which relates to supporting a desired rolling -in behavior of the rolling membrane 2. Also the third aspect may be combined with the first and/or second aspect.
  • the distal portion of the rolling membrane 2 needs to be folded inwards into itself (e.g. into the inner lumen 3 of the rolling membrane 2) to allow a desired rolling-in (e.g. as indicated in Fig. 13B).
  • a desired rolling-in e.g. as indicated in Fig. 13B
  • the desired folding of the rolling membrane 2 may not occur and the rolling membrane 2 may be folded and/or rolled-in in an undesired manner.
  • a proximal end 4 of the rolling membrane 2 is connected to an outer shaft 6 whereas a distal end 5 of the rolling membrane 2 is connected to an inner shaft 7.
  • Fig. 4A exemplarily depicts an undesired folding of the rolling membrane 2 at the proximal end 4 (e.g. in the presence of an inner pressure in the rolling membrane 2) of the rolling membrane 4.
  • This undesired folding of the rolling membrane 2 may lead to a further folding of the rolling membrane 2 at the proximal end 4 from the proximal direction P towards the distal direction D, instead of a folding of the rolling membrane 2 at the distal end 5 from the distal direction D along the proximal direction P.
  • the undesired folding of the rolling membrane 2 from the proximal direction P may counteract the desired folding of the rolling membrane 2 originating from the distal direction D.
  • Fig. 4B exemplarily depicts a further undesired folding of the rolling membrane 2 which may comprise an undesired overlapping 19 of the at least one layer of the rolling membrane 2.
  • This undesired overlap may, e.g. arise from a kinking of a certain portion of the rolling membrane 2 (e.g. a cylinder-shaped portion of the rolling membrane 2 as seen when the rolling membrane 2 is rolled out).
  • This folding may prevent a regular rolling -in of the rolling membrane.
  • Fig. 4C exemplarily shows a further undesired folding of the rolling membrane 2 based at least in part on a bulging of the rolling membrane 2 such that a certain portion 20 of the rolling membrane is compressed along a longitudinal extension of the rolling membrane catheter 1 (e.g. a cylinder-shaped portion of the rolling membrane 2 as seen when the rolling membrane 2 is rolled out) similar to an accordion. Also such bulging may prevent a regular rolling -in of the rolling membrane.
  • Figs. 5A-5C exemplary show different embodiments for providing the rolling membrane 2 with at least one reinforcement means 21 for counteracting the undesired folding (e.g. as described with reference to Figs. 4A-4C, above).
  • the rolling membrane 2 is connected to an outer side of the outer shaft 6 at a second end 40 of the rolling membrane 2 and to an outer side of the inner shaft 7 at a first end 50 of the rolling membrane 2.
  • Fig. 5A shows a first embodiment of providing the rolling membrane 2 with at least one reinforcement means 21 at a first end 50 of the rolling membrane 2, e.g. at a distal end of the rolling membrane 2.
  • a steeper cone angle of 30° a ⁇ 180° and/or a more bendable conus at a first end 50 of rolling membrane 2 end than at the second end 40 of the rolling membrane 2 may facilitate the inversion of the distal rolling membrane cone when the inner shaft 7 is moved in the proximal direction P (causing a distal rolling movement of the rolling membrane 2). Therefore, an undesired folding of the rolling membrane 2 may be counteracted.
  • Fig. 5B shows a second embodiment of providing the rolling membrane 2 with at least one reinforcement means 21 at a second end 40 of the rolling membrane 2, e.g. at a proximal end of the rolling membrane 2.
  • the rolling membrane 2 may form a shallow angle of 30° > > > 0° with the outer shaft 6 as depicted in Fig. 5B.
  • a shallower angle and /or a more bending resistant conus at the second end 40 of the rolling membrane 2 than at the first end 50 of the rolling membrane 2 may counteract an undesired folding of the rolling membrane 2 at its proximal end and may thus contribute to an undisturbed folding of the rolling membrane 2 from a distal end of the rolling membrane 2.
  • Fig. 5C shows a third embodiment of providing the rolling membrane 2 with at least one reinforcement means 21 extending along an axial direction of the rolling membrane catheter 1 such that the rolling membrane 2 may be provided with axial kinking resistance counteracting a bulging of the rolling membrane 2 when being rolled-in.
  • Figs. 6A-6C show exemplary manufacturing steps of the rolling membrane 2 which may be provided with at least one reinforcement means 21 at a distal end 5 of the rolling membrane 2.
  • a proximal end 4 of the rolling membrane 2 is connected to an outer shaft 6 whereas the distal end 5 of the rolling membrane 2 is connected to an inner shaft 7.
  • Fig. 6A exemplarily depicts a dedicated preform which may be adapted to form the rolling membrane, e.g. by thermoforming, such that a steep angle of about 90° is formed at the distal end 5 of the rolling membrane.
  • the shape of the preform of the rolling membrane may be provided such that the rolling membrane may intrinsically exhibit a shallow angle of about 30° or less at the proximal end 4 of the rolling membrane.
  • elements may be provided that promote a desired rolling-in and counteract undesired rolling-in, bulging, etc.
  • Fig. 6B exemplarily depicts a connecting process for connecting the rolling membrane to an inner shaft.
  • Two overlapping sections of the rolling membrane may be connected to the inner shaft, e.g. by thermoforming, welding, heat-bonding, adhesive etc. This may facilitate automatically ensuring an angle between 180° and 30° when initiating the rolling-in of the membrane.
  • Fig. 6C exemplarily depicts another method for providing the rolling membrane 2 with a steep angle at its distal 5 end relative to the inner shaft 7 which may be achieved by placing a fixation element 22 (e.g. a ring) around the rolling membrane 2 which may (rigidly) fix the rolling membrane 2 to the inner shaft 7. Due to the associated shortening of the material of the rolling membrane 2 in the fixation element 22, a steep angle between the rolling membrane 2 and the inner shaft 7 may be generated.
  • a fixation element 22 e.g. a ring
  • Figs. 7A-7C illustrate an exemplary method of providing a rolling membrane catheter 1 wherein the rolling membrane 2 is connected to an inner shaft 7 with its distal rolling membrane end 5 and the rolling membrane 2 is connected to an outer shaft 6 with its proximal rolling membrane end 4.
  • the inner shaft has an inner shaft wall surrounding an inner shaft lumen, a distal inner shaft end, a proximal inner shaft end and the inner shaft has an outer diameter.
  • the outer shaft has an outer shaft wall surrounding an outer shaft lumen, a distal outer shaft end, a proximal outer shaft end.
  • the outer shaft 6 has an outer diameter being larger than the outer diameter of the inner shaft 7.
  • Fig. 7A shows a first exemplary embodiment for providing the rolling membrane 2 with a first end of the rolling membrane which in the final rolling membrane catheter 1 is the distal end 5 of the rolling membrane 2 (when the rolling membrane 2 is in a rolled-out state).
  • the (first) distal rolling membrane end 5 is connected (e.g. by welding) to the inner shaft 7.
  • a welding wire 22 may be inserted into the inner shaft lumen of the inner shaft 7 to avoid an unintentional collapse of the rolling membrane 2 during welding. It is understood that also further techniques for connecting rolling membrane 2 and inner shaft 7 may be used.
  • Fig. 7B exemplarily illustrates an inverting of the rolling membrane 2.
  • the inverting of the rolling membrane may be done, such that a second end of the rolling membrane 2, which in the final rolling membrane catheter 1 is the proximal end 4 of the rolling membrane 2 (when the rolling membrane 2 is in a rolled-out state), is pulled over the inner shaft 7 in a proximal direction, as shown in Fig. 7C. Then the inverted rolling membrane and the inner shaft 7 are inserted into the outer shaft (this process step not shown).
  • Fig. 7C shows an exemplary step of connecting the rolling membrane 2 to the outer shaft 6 at the (second) proximal end 4 of the rolling membrane.
  • Fig. 7C further depicts an exemplary welding process of the rolling membrane 2 to the outer shaft 6 such that a shallow angle between the rolling membrane 2 and the outer shaft 6 may be formed.
  • a welding tube 23 may be inserted into an inner lumen of the outer shaft 6 (also called outer shaft lumen) for further supporting the welding process and to avoid an unintentional collapse of the rolling membrane 2 and/or the outer shaft 6 at the region of welding and due to the welding as such.
  • the welding tube was inserted between the outer shaft wall and the inner shaft wall. After welding the welding wire is removed from the inner shaft lumen and optionally the welding tube is removed. Additionally a bonding material could be used.
  • Figs. 8A and 8B show an alternative method of providing the rolling membrane 3 with at least one reinforcement means 21.
  • Fig. 8A shows another embodiment of the rolling membrane 2 of the rolling membrane catheter 1, wherein the rolling membrane 2 has been configured to support a rolling -in of the rolling membrane 2.
  • the rolling membrane 2 may be provided with a relatively large connection angle at its distal end 5.
  • an annular element 24 e.g. a circlip
  • Fig. 8B shows an exemplary manufacturing method for providing the rolling membrane 2 with at least one reinforcement means 21 at the proximal end 4 (as seen when the rolling membrane 2 is in the rolled-out state).
  • the rolling membrane 2 has been welded to the inner shaft 7 (e.g. as outlined with reference to Fig. 7A)
  • an outer shaft may be put over the rolling membrane 2 and the inner shaft 7.
  • the proximal end 4 of the rolling membrane 2 may be connected (e.g. by welding) to the inner wall of the outer shaft 6.
  • a welding wire 22 may be inserted into the inner lumen 3 of the rolling membrane 2 for supporting the welding process.
  • the welding wire 22 may be provided with a diameter which is slightly smaller (e.g.
  • the aforementioned welding process may lead to a connection of the rolling membrane 2 and the inner wall of the outer shaft 6 (as compared to the outer wall in Fig. 7C) and may additionally ensure a tight sealing.
  • the annular element 24 may be inserted into the inner lumen 3 of the rolling membrane 2 at a position close (e.g. separated by 0.5 cm, 1 cm, 2 cm, 3 cm, 4 cm, 5 cm or any other suitable distance) to the proximal- most portion 4 of the rolling membrane 2, before or after the optional connection step.
  • the manufacturing steps of sealing the rolling membrane 2 to the outer shaft 6 and supporting a rolling out (and/or rolling-in) of the rolling membrane 2 may be separated.
  • the portion 25 of the rolling membrane 2 is brought into the position shown in Fig. 8A.
  • Figs. 9A-12C depict exemplary production steps for providing the rolling membrane 2 having a wall thickness gradient with respect to the length of the rolling membrane 2. These production steps enable better rollability of the rolling membrane 2 and less risk of collapse when rolling the rolling membrane back due to an advantageous wall thickness profile of the rolling membrane 2.
  • Fig. 9A shows the formation of the rolling membrane 2 out of a preform 26 (e.g. a balloon, or tube) as a result of applying different temperatures Ti, T2 and T3 to the preform 26 in distinct spatial sections and a pressure p to an inner lumen of the preform 26.
  • the temperatures Ti, T2 and T3 may be chosen such that a highest temperature T3 may be applied to the preform 26 at a location of the preform 26 which may later form the distal end 5 of the rolling membrane 2 (as seen when the rolling membrane is fully rolled out).
  • Preform 26 may generally be shaped into a cylindrical shape with a conical section at both ends.
  • a second temperature T2 may be applied to the preform 26 wherein the temperature T2 may be smaller than T3 and wherein the temperature T2 may extends over a larger portion of the preform 26 as compared to the temperature T3. Temperature T2 may essentially be applied in the area in which the distal conical section of preform 26 will be formed. In the remaining part of preform 26, temperature T2 may be applied which is lower than temperature T2.
  • Fig. 9B exemplarily shows the formation of the rolling membrane 2 (starting from a distal- tip) of the preform 26 when the inner lumen 3 of the later formed rolling membrane 2 is pressurized.
  • a wall thickness of the rolling membrane 2 may be obtained which may be thinner in this portion of the rolling membrane 2, when inflating the preform 26 by pressurizing the preform 26, as compared to a situation in which the preform 26 may be exposed to a uniform temperature when inflating the preform 25.
  • the rolling membrane 2 may be more flexible (e.g. foldable) in this region such that the distal end 5 of the rolling membrane 2 may more easily be folded inwards into the inner lumen 3 of the rolling membrane 2 when the rolling membrane 2 is at least partially rolled in.
  • Fig. 9C shows the final rolling membrane 2 after fully inflating the preform 26 in the presence of temperatures Ti, T2 and T3.
  • Figs. 10A-10C show a further exemplary manufacturing method for providing the rolling membrane 2 with at least one reinforcement means 21 at the first end (e.g. the distal -most tip) of the rolling membrane 2.
  • Fig. 10A exemplarily shows the preform 26 which may be similar to that of Figs. 9A-C and which is exposed to a temperature Ti at a distal end 5 and which may be exposed to a second temperature T2 at a proximal end 4 which may lower than Ti. Additionally, the distal end 5 may be exposed to pressure pi (referring to a pressure applied to an inner lumen of the preform 26) and the proximal end 4 may be exposed to a pressure P2 wherein pi may be chosen to be larger than p2, e.g. by a dynamical flow.
  • Fig. 10B exemplarily shows a subsequent manufacturing step in which the preform 26 may be inflated from a distal end 5 by ensuring the aforementioned temperature and pressure distribution.
  • the preform may thus be inflated sequentially from the distal to the proximal end.
  • Fig. IOC exemplarily shows the resulting rolling membrane 2 after inflating the preform 26 while ensuring the temperature and pressure distribution as described above with reference to Figs. 10A and 10B.
  • a wall thickness of the rolling membrane 2 at its distal end 5 may be smaller than a wall thickness of the rolling membrane 2 at its proximal end 4.
  • the thinner wall thickness at the distal end 5 may be obtained by the higher temperature Ti (as compared to T2) while simultaneously applying a higher pressure pi in the portion of the higher temperature Ti. This combination may promote an expansion of the preform 26 in particular in said portion which may lead to a thinner wall thickness and increased flexibility of the rolling membrane 2 in the respective portion.
  • a thinner wall thickness may be obtained at the distal end 5 as compared to the proximal end 4 which may contribute to increased folding capabilities of the rolling membrane 2 when the rolling membrane 2 is rolled-in (as outlined above).
  • a pressure gradient can arise dynamically, even if the pressure is initially constant because of the large cross-section. The pressure will drop during balloon forming when the balloon tube is separated from the pressure source, e.g. by squeezing, and a pressure drop will occur due to an expansion of the enclosed gas volume.
  • Figs. 11A-11C show a further embodiment of providing the rolling membrane 2 with at least one reinforcement means 21, wherein one or more thread-like elements (e.g.
  • Fig. 11A exemplarily shows a plurality of thread-like elements 21 (wherein the exact number of thread like elements may vary) extending along the axial direction A of the rolling membrane 2, in particular, in the cylinder shaped portion of the rolling membrane 2 (as seen when the rolling membrane 2) is fully rolled out.
  • rolling membrane 2 may comprise a distal and proximal conical end portion.
  • Fig. 11B exemplarily shows a cross-section of the rolling membrane 2 (taken along a perpendicular direction relative to the axial direction A) and an embedding of the at least one reinforcement means 21 in the material of the rolling membrane 2.
  • the at least one reinforcement means 21 e.g. provided as thread-like elements
  • Fig. 11C shows a further exemplary embodiment of the implementation of the at least one reinforcement means 21, wherein the at least one reinforcement means 21 is provided in a zigzag pattern extending on the rolling membrane 2 along and/or about the axial direction A.
  • the at least one reinforcement means 21 may be wound helically about the axial direction A of the rolling membrane catheter 1 (not shown in Fig 11C).
  • Such an arrangement of the at least one reinforcement means 21 may avoid a blocking of a rolling in of the rolling membrane 2 as a result of mechanically interfering reinforcement means 21, as the helical arrangement of the at least one reinforcement means may essentially form a cylinder-like element when the rolling membrane 2 is rolled-in.
  • Figs. 12A-12B show a further embodiment of providing the rolling membrane 2 with at least one reinforcement means 21, wherein the at least reinforcement means 21 is provided as at least one predefined folding in the rolling membrane 2.
  • Fig. 12A shows a catheter with a rolling membrane 2 and an inner shaft 7 in a cross-sectional view taken. If the rolling membrane 2 is inflated (e.g. rolled out), the rolling membrane 2 may form a circular-shaped cross section and the predefined-folds may not be visible as they may be pressed radially outwards relative to the inner shaft 7.
  • Fig. 12B shows the rolling membrane 2 of Fig. 12A in a situation in which the pressure in the inflatable volume of the rolling membrane 2 is lower.
  • the predefined folds of the rolling membrane 2 may lead to a predefined folding of the rolling membrane 2 at the locations of the predefined folding(s).
  • the rolling membrane 2 is sufficiently resistant to an uncontrolled collapse.
  • the controlled collapse may be achieved by providing the rolling membrane 2 with respective reinforcement threads as described with reference to Figs. 11A and 1 IB, above.
  • Figs. 13A and 13B show a further embodiment of the rolling membrane 2. More specifically, Fig. 13A depicts a possible embodiment of the rolling membrane 2, wherein the rolling membrane 2 is provided in a conus-shape.
  • the conus-shaped rolling membrane 2 may be adapted such that it has a smaller diameter at a distal portion of the rolling membrane 2 (when rolled-out), as compared to a diameter at a location which lies proximal to the distal portion of the rolling membrane 2.
  • Fig. 13B exemplarily shows the rolling in of the rolling membrane 2 adapted according to Fig. 13A.
  • a smaller-diameter portion of the rolling membrane 2 may be folded into a larger diameter portion of the rolling membrane 2. This may counter an undesired folding of the rolling membrane 2 when the rolling membrane is rolled in.
  • Fig. 14A an 14B show another exemplary embodiment for providing the rolling membrane catheter 1 with an atraumatic tip 10.
  • Fig. 14A shows the rolling membrane in a non-pressurized (rolled-in) state
  • Fig. 14B shows the rolling membrane in a pressurized (rolled-out) state.
  • the rolling membrane catheter 1 comprises a rolling membrane 2 having an inner lumen. A proximal end of the rolling membrane 2 is connected to an outer shaft 6 whereas a distal end of the rolling membrane 2 is connected to an inner shaft 7.
  • the atraumatic tip 10 may be made of an elastomeric material like an elastomer.
  • the atraumatic tip 10 may comprise a cone-like cross-section.
  • the atraumatic tip 10 may be formed monolithically (e.g. as a cap) or by two half-shells (or a larger number of components) which may be configured to form a conus shape at the distal end of outer shaft 6.
  • the atraumatic tip 10 may be arranged around an outer side of the distal end of the outer shaft 6 and at least partially on an inner side of rolling membrane 2.
  • the atraumatic tip 10 may comprise a distal, e.g. central, opening for accommodating the guide wire G therein. In a closed state of the atraumatic tip 10, half-shells and (or e.g. four quarter shells) may be concentrically arranged about the guide wire G.

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Abstract

La présente invention se rapporte aux cathéters à membrane à enroulement et concerne des procédés de fabrication d'un cathéter à membrane à enroulement. L'invention concerne également un procédé de raccordement d'une tige interne et d'une tige externe à une membrane à enroulement. La membrane à enroulement peut comprendre une pointe atraumatique formant une pointe distale du cathéter lorsque la membrane à enroulement est dans un état enroulé.
PCT/EP2023/085131 2022-12-12 2023-12-11 Conception optimisée d'une membrane à enroulement et d'un cathéter pour un cathéter à membrane à enroulement WO2024126375A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
EP22212729.2 2022-12-12
EP22212729 2022-12-12

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WO2024126375A1 true WO2024126375A1 (fr) 2024-06-20

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Citations (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP1461106B1 (fr) * 2001-12-13 2007-08-08 Boston Scientific Limited Catheter pour la recuperation de filtre a pointe retractable commandee hydrauliquement
US20090171278A1 (en) * 2005-10-14 2009-07-02 Endocross Ltd. Balloon catheter system for treating vascular occlusions
US20090254063A1 (en) * 2007-07-13 2009-10-08 Randolf Von Oepen Drug Coated Balloon Catheter
US20110152760A1 (en) * 2009-12-22 2011-06-23 Cook Incorporated Deployment and Dilation With An Expandable Roll Sock Delivery System
US20110270296A1 (en) * 2010-04-28 2011-11-03 Biotronik Ag Combined rolling membrane-balloon catheter
US20120265236A1 (en) * 2011-04-14 2012-10-18 Biotronik Ag Catheter device
WO2019010244A1 (fr) * 2017-07-03 2019-01-10 Crossbay Medical, Inc. Appareil et procédé pour retourner un cathéter avec alignement et pressurisation flexible
US20200206463A1 (en) * 2017-08-31 2020-07-02 Crossbay Medical, Inc. Apparatus and methods for everting catheters with expandable lumens

Patent Citations (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP1461106B1 (fr) * 2001-12-13 2007-08-08 Boston Scientific Limited Catheter pour la recuperation de filtre a pointe retractable commandee hydrauliquement
US20090171278A1 (en) * 2005-10-14 2009-07-02 Endocross Ltd. Balloon catheter system for treating vascular occlusions
US20090254063A1 (en) * 2007-07-13 2009-10-08 Randolf Von Oepen Drug Coated Balloon Catheter
US20110152760A1 (en) * 2009-12-22 2011-06-23 Cook Incorporated Deployment and Dilation With An Expandable Roll Sock Delivery System
US20110270296A1 (en) * 2010-04-28 2011-11-03 Biotronik Ag Combined rolling membrane-balloon catheter
US20120265236A1 (en) * 2011-04-14 2012-10-18 Biotronik Ag Catheter device
WO2019010244A1 (fr) * 2017-07-03 2019-01-10 Crossbay Medical, Inc. Appareil et procédé pour retourner un cathéter avec alignement et pressurisation flexible
US20200206463A1 (en) * 2017-08-31 2020-07-02 Crossbay Medical, Inc. Apparatus and methods for everting catheters with expandable lumens

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