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WO2024126130A1 - Modèle optimisé de membrane à enroulement sous forme de cathéter à extension de guidage - Google Patents

Modèle optimisé de membrane à enroulement sous forme de cathéter à extension de guidage Download PDF

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Publication number
WO2024126130A1
WO2024126130A1 PCT/EP2023/084114 EP2023084114W WO2024126130A1 WO 2024126130 A1 WO2024126130 A1 WO 2024126130A1 EP 2023084114 W EP2023084114 W EP 2023084114W WO 2024126130 A1 WO2024126130 A1 WO 2024126130A1
Authority
WO
WIPO (PCT)
Prior art keywords
rolling membrane
catheter
guide extension
outer shaft
connection element
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Ceased
Application number
PCT/EP2023/084114
Other languages
English (en)
Inventor
Matthias Wesselmann
Nadine TROES
Azadeh MEHRABI
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Biotronik AG
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
Priority to EP23813420.9A priority Critical patent/EP4633711A1/fr
Priority to CN202380080773.2A priority patent/CN120187482A/zh
Publication of WO2024126130A1 publication Critical patent/WO2024126130A1/fr
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

Links

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
    • A61M25/01—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
    • 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
    • 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 types of guide extension catheters and a method for using 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 the prevalent anomaly in the blood vessel of a patient (e.g., a stenosis).
  • Such catheters may be adapted to deliver a medical device (e.g., a balloon, a stent, etc.) and/or a drug to an affected region of a blood vessel of a patient to diagnose and/or cure the respective disease.
  • a medical device e.g., a balloon, a stent, etc.
  • drug e.g., a drug to an affected region of a blood vessel of a patient to diagnose and/or cure the respective disease.
  • 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.
  • the buddy wire and/or anchoring balloon technique can be helpful to successfully complete a coronary intervention.
  • the mother-in-child technique is another powerful method for delivering a medical device to a certain target lesion.
  • inserting a 4-French (Fr) catheter (child catheter) into a 6-Fr guiding catheter (mother catheter) may greatly improve the success rate for crossing lesions in which standard methods may fail. Therefore, also the “4-in-6” system is becoming a viable alternative for highly calcified, angular, or tortuous lesions.
  • the rapid-exchange guide extension catheter (GEC) or guide catheter extension has been evolving.
  • Previous studies have proposed a mechanism of its efficiency as increasing back-up support by deep intubation, as a conduit to decrease friction between the vessel wall and the catheter, or for improving co-axial alignment between the catheter and the lesion. It also facilitates stent and balloon delivery in complex coronary lesion, in complex anatomy and or in the left internal thoracic artery graft.
  • a guiding catheter is usually inserted into the access sheath together with the guidewire, once the guiding catheter is in place, the guide wire is pushed out of the guiding catheter and inside the coronaries and through the stenosis and then the guide extension catheter is introduced into the guiding catheter and find its way into the vessel by following the guide wire.
  • PTCA percutaneous transluminal coronary angioplasty
  • a guide extension catheter may be a monorail system.
  • the guide extension portion in average has a length of 25 cm and it may be passed in a rapid exchange fashion and may extend beyond the distal end of the guide catheter.
  • the guide extension catheter may be thinner than the guiding catheter by, e.g., 1 Fr and it may be designed to minimize trauma to the coronary artery.
  • the proximal end of the guide extension catheter may be attached to a thin stainless-steel pushrod, which may be used to push and pull the guide extension catheter independent of the guiding catheter.
  • a (rolling membrane) guide extension catheter comprises a rolling membrane and an outer shaft (e.g. a guiding catheter).
  • the guide extension catheter comprises or consists of a rolling membrane; an outer shaft; an inner shaft, which is at least partially arranged or arrangeable within the outer shaft; and wherein the rolling membrane is connected to the inner shaft, and optionally a connection element for (at least temporarily) connecting the rolling membrane to the outer shaft.
  • a first portion of the rolling membrane is connected to the inner shaft and the catheter further comprises a connection element for temporarily (e.g. releasably) connecting a second portion of the rolling membrane to the outer shaft.
  • the rolling membrane may be adapted to be rolled out along a distal direction.
  • the rolling membrane may be adapted to be rolled in along a proximal direction.
  • the rolling membrane may be configured such that the rolling membrane extends to a larger extent in the longitudinal direction than it extends along a radial direction (i.e. a direction perpendicular to a longitudinal direction along which the rolling membrane is rolled out).
  • the first portion of the rolling membrane may be a distal end of the rolling membrane as seen if the rolling membrane is fully rolled out.
  • the rolling membrane may be configured to exit the outer shaft in the distal direction.
  • the second portion of the rolling membrane may be a proximal end portion of the rolling membrane as seen if the rolling membrane is fully rolled in.
  • the outer shaft may be a guiding catheter.
  • connection element is connected to a proximal portion of the rolling membrane and/or the connection element is adapted such that the connection element is connectable to the outer shaft.
  • the catheter By providing the catheter with a connection element for temporarily connecting a proximal portion of the rolling membrane to an outer shaft, a situational and non-permanent extension of the catheter may be facilitated. This may advantageously increase the field of possible applications, the catheter may be used for. For example, if a catheter may not be able to cross lesions in a blood vessel of a patient, the catheter may additionally be supplied with a suitable extension (e.g., by means of the outer shaft and the connection element to connect a rolling membrane) such that the lesion may be crossed without injuring an inner wall of a respective blood vessel of a patient.
  • a suitable extension e.g., by means of the outer shaft and the connection element to connect a rolling membrane
  • a situationally applicable guide extension catheter may be facilitated with a connected rolling membrane that may be released if not needed.
  • a connected rolling membrane that may be released if not needed.
  • connection element may be adapted for being inserted into the outer shaft and for establishing a connection between the rolling membrane and the outer shaft.
  • the connection element may be connected to the rolling membrane by clamping. In some examples, also welding, gluing, etc. may be used.
  • the connection between the rolling membrane and the outer shaft may be liquid and/or fluid tight.
  • connection element and the rolling membrane may be made from a same material (combination). Alternatively, the connection element and the rolling membrane may differ in at least one constituent material.
  • connection between the connection element and the rolling membrane may be temporary. However, in some examples, the connection between the connection element and the rolling membrane may be permanent.
  • connection element may comprise a first diameter at a proximal portion of the connection element which may be equal or smaller than an inner diameter of the outer shaft and a second diameter at a distal portion of the connection element which may be smaller than the first diameter at the proximal portion of the connection element. This may enable a force fit of the connection element with the outer shaft.
  • first diameter of the proximal portion of the connection element is adapted to be smaller than an inner diameter of the outer shaft, convenient insertion and sliding properties of the connection element into and in the outer shaft may be facilitated. This may contribute to a simplified and overall convenient usability of the catheter.
  • the first diameter may be adapted to be larger than an inner diameter of the outer shaft.
  • At least the proximal end portion of the connection element may be adapted to be flexible such that the proximal end portion of the connection element may be slightly squeezed prior to inserting the connection element into an inner lumen of the outer shaft. Since at least the proximal end portion of the connection element may try to relax back to its original diameter, a pushing force may be applied to an inner wall of the outer shaft which may be accompanied by friction/shear forces such that the connection element may be locked in the outer shaft, preferably by clamping.
  • connection element may be connectable to a distal portion of the rolling membrane.
  • connection element preferably a proximal (end) portion of the connection element, may be connected to a distal (end) portion of the rolling membrane.
  • the proximal (end) portion of rolling membrane may be connected to an inner shaft. Additionally or alternatively, a distal end portion of the connection element may be connectable to the rolling membrane.
  • the connection element may generally be provided with an inner lumen.
  • connection element By adapting the connection element such that it is connectable to the distal portion of the rolling membrane, preferably at a proximal end portion of the connection element, at least a partial accommodation of the rolling membrane in the inner lumen of the connection element may be facilitated. This may contribute to a protection of the rolling membrane if the catheter needs to be applied with a certain pushing force along the distal direction to pass (minor) occlusions without damaging the rolling membrane.
  • connection element may comprise an annular element for exerting a radially acting force onto a distal portion of the rolling membrane and an outer side of the outer shaft or an inner side of the outer shaft.
  • the annular element may be provided as a ring.
  • the annular element may comprise a slid.
  • the annular element may comprise a diameter that it is larger than the inner diameter of the outer shaft. By squeezing the annular element in a radial direction, the diameter of the annular element may be reduceable.
  • the ring By inserting the annular element in the inner lumen of the outer shaft and placing a portion of the rolling membrane between the ring and the inner side of the outer shaft, the ring may exhibit the radially acting force onto the rolling membrane and the inner side of the outer shaft such locking the rolling membrane in the outer shaft.
  • connection element may be adapted for being put over the outer shaft and for establishing a clamping connection between the rolling membrane and the outer shaft.
  • the annular element may comprise a diameter that is smaller than an outer diameter of the outer shaft.
  • the annular element may tend to decrease its diameter when put over the outer shaft and may thus exhibit the radial force onto the outer side of the outer shaft which may advantageously be used for clamping the rolling membrane to the outer side of the outer shaft.
  • connection element By adapting the connection element such that it may be put over the outer shaft, the rolling membrane may be clamped onto the outer side of the outer shaft.
  • an insertion of medical equipment (as it will further be described below) from the inner lumen of the outer shaft into the rolling membrane may be supported.
  • connection element may comprise a hydrophilic coating and/or a swellable coating such as to swell if exposed to a liquid. If the connection element is inserted into the inner lumen of the outer shaft, the coating may be located in between the connection element and the inner side of the outer shaft.
  • the hydrophilic coating may be a hydrogel (e.g., polyvinylpyrrolidone).
  • the coating may exhibit sealing capabilities at least when exposed to the liquid such that, if the coating is in contact with at least one other contact surface, a passage of, e.g., a liquid is prevented.
  • connection element By providing the connection element with a hydrophilic coating, the connection element may be moved/slide to a desired target location without being affected by friction, also, if the swellable liquid has been exposed to a liquid. Therefore, a single coating may provide two advantageous effects: sealing capabilities while still supporting movability of the connection element.
  • the rolling membrane may further comprise at its proximal portion a sealing element, preferably a hemostatic valve.
  • the rolling membrane By providing the rolling membrane with the hemostatic valve at its proximal portion, a secure and sterile insertion of medical instruments into an inner lumen of the rolling membrane may be facilitated. Additionally, a fluid supply to the rolling membrane may be facilitated allowing an inflation of the rolling membrane.
  • the catheter may further comprise a manipulation element for manipulating the sealing element.
  • the manipulation element may be insertable into the inner lumen of the rolling membrane from a proximal direction.
  • the manipulation element may be adapted for pushing the sealing element in the distal direction (from a proximal direction). Additionally or alternatively, the manipulation element may be adapted to pull the sealing element in the proximal direction (from the proximal direction). Additionally or alternatively, the manipulation element may be adapted to be rotatable about its longitudinal axis, e.g. such as to rotate the sealing element. The manipulation element may allow to manipulate the sealing element from a remote location (e.g., from outside the body of the patient) which may contribute to a simplified manipulation of the catheter, in particular, when inserted into the body of the patient.
  • a remote location e.g., from outside the body of the patient
  • the sealing element may be adaptable in diameter by means of the manipulation element.
  • the sealing element may be provided with a variable diameter.
  • the variable diameter of the sealing element may mechanically be manipulated.
  • the sealing element may be remotely manipulated, from outside the body of a patient.
  • the sealing element may easily be adapted to the situational needs.
  • the sealing element may be set to a small diameter when the sealing element is to be inserted into, e.g., the outer shaft such that the sealing element does not unintentionally counteract an insertion.
  • the diameter of the sealing element may be increased such that desired sealing properties are exhibited.
  • the rolling membrane may be adapted for forming an inner lumen, at least when the rolling membrane is in a rolled-out state.
  • the inner lumen of the rolling membrane may effectively be occupied by the rolling membrane folded therein.
  • the inner shaft may not enter the inner lumen of the rolling membrane when the rolling membrane is in a rolled-out state.
  • a formation of an inner lumen in the rolling membrane may allow a delivery of a medical device (e.g., another catheter and/or a stent, etc.) and/or of a medical drug to a target location which may preferably be located distal to a distal -most tip of the rolling membrane.
  • the delivery may preferably be based on inserting the device and/or the drug to be delivered into the inner lumen of the rolling membrane from a proximal direction of the rolling membrane and a pushing of the device and/or the drug in a distal direction, as seen when the rolling membrane is fully rolled out.
  • connection element may be adapted for pressure tightly sealing an inflatable volume of the rolling membrane.
  • a pressure tight sealing may be understood as a sealing which may not allow any penetration of fluid particles from, e.g., a volume located proximal to the connection element to a volume that lies distal to the connection element up to a certain threshold pressure.
  • the rolling membrane may be inflatable, e.g., from a proximal direction of the connection element, e.g., by supplying a pressurized liquid and/or a gas.
  • the rolling membrane may in particular be inflatable if the rolling membrane is combined with an outer shaft.
  • a second aspect of the present invention relates to a method for using a guide extension catheter, preferably the catheter as described above.
  • the method may comprise providing an outer shaft and providing a rolling membrane connected to an inner shaft at a first portion of the rolling membrane.
  • the method may further comprise releasably/temporarily connecting a second portion of the rolling membrane to the outer shaft, preferably via a connection element, such that the rolling membrane can be rolled out along a longitudinal axis of the outer shaft.
  • the catheter may more simply be adapted to situational needs, even when partially be inserted into a blood vessel of a patient.
  • the method may further comprise inserting a distal end of the outer shaft into a blood vessel and at least partially rolling out a distal end of the rolling membrane along the blood vessel such that an inner lumen may be formed in the rolling membrane for facilitating a delivery of a medical device and/or a medical drug from a proximal end of the rolling membrane to a distal end of the rolling membrane.
  • the synergetic effects of an extended catheter and a rolling membrane may advantageously be used. This may improve the user experience for a member of a medical staff and may reduce the risk for the patient, e.g., arising from a movement of the catheter towards a distal direction.
  • a third aspect of the present invention relates to a guide extension catheter which comprises or consists of a rolling membrane, a proximal shaft and an outer shaft, preferably a guiding catheter.
  • the proximal shaft can be considered as an inner shaft which is partially arranged within the outer shaft, preferably the guiding catheter.
  • the proximal shaft may comprise an inner lumen.
  • the rolling membrane comprises a first portion and a second portion.
  • the first portion may be arranged at a distal end of the rolling membrane whereas the second portion may be arranged at a proximal end of the rolling membrane.
  • the rolling membrane may be configured to form an inner rolling membrane lumen in a rolled-in state and/or in a rolled-out state of the rolling membrane.
  • This inner rolling membrane lumen has a larger diameter than conventional inner shafts.
  • the diameter of the inner rolling membrane lumen enables for guiding (medical and/or sensoring) devices through the inner rolling membrane lumen (e.g. whenever the rolling membrane function is not required).
  • the proximal shaft may be connected to the second portion of the rolling membrane.
  • the proximal shaft may be connected to the rolling membrane such that the proximal shaft at least partially accommodates the second end of the rolling membrane in the inner lumen of the proximal shaft.
  • the rolling membrane may be connected to an inner side of the proximal shaft.
  • the proximal shaft may not limit the inner diameter of an inner rolling membrane lumen.
  • the proximal shaft may have a push-pull function, namely to push the rolling membrane in a distal direction (towards a patient) and pull the rolling membrane in a proximal direction (towards the operator/doctor).
  • the outer shaft preferably the guiding catheter, may be adapted to at least partially enter a body of a patient with a portion I of the outer shaft.
  • the outer shaft, preferably the guiding catheter, may further be adapted to at least partially remain outside the body of the patient with a portion of the outer shaft.
  • a diameter of the outer shaft, preferably the guiding catheter, may increase at its proximal part (at the portion O which stays outside the body) compared to its distal part.
  • the diameter of the guiding catheter may increase at its proximal part, such that the proximal shaft cannot enter a distal part of the guiding catheter. Because the outer shaft, preferably the guiding catheter, has a smaller diameter at its distal portion than at its proximal portion, it hinders the proximal shaft to be inserted into the distal portion of the outer shaft.
  • the length of the rolling membrane to exit the outer shaft, preferably the guiding catheter, in the rolled out state can be defined by the length of the distal portion of the outer shaft, preferably the guiding catheter, having a smaller diameter than the proximal portion of the outer shaft.
  • the proximal shaft may be adapted to remain outside of a body of a patient during use of the catheter with the patient. In other words, the proximal shaft may be adapted to not enter the body of a patient.
  • the rolling membrane may be adapted to be rolled out along a distal direction.
  • the rolling membrane may be adapted to be rolled in along a proximal direction.
  • the rolling membrane may be configured such that the rolling membrane extends to a larger extent in the longitudinal direction than it extends along a radial direction.
  • the first portion of the rolling membrane may be a distal end of the rolling membrane as seen if the rolling membrane is fully rolled out.
  • the rolling membrane is configured to exit the outer shaft, preferably the guiding catheter, in the distal direction.
  • the outer shaft accommodates at least a portion of the rolling membrane. At least a distal portion of the outer shaft, preferably the guiding catheter, may be connected to the first portion of the rolling membrane.
  • the proximal shaft may be adapted to push the rolling membrane into the distal direction D and/or to pull the rolling membrane in a proximal direction P.
  • the inner lumen of the proximal shaft may be connected to the inner lumen of the rolling membrane such that, e.g., medical devices and/or medical drugs may be fed from a proximal portion of the catheter to a distal portion of the catheter.
  • the rolling membrane may have a smaller wall thickness than the inner shaft. Therefore, it compromises the inner rolling membrane lumen less than a conventional inner shaft.
  • the proximal end of the rolling membrane may be connected to an inner side of the proximal shaft and wherein a distal end of the rolling membrane may be connected to outer shaft, preferably the guiding catheter.
  • the outer shaft may accommodate at least a portion of the rolling membrane.
  • the outer shaft may be terminated with a sealing element.
  • the sealing element may preferably be a hemostatic valve.
  • the proximal shaft may at least partially extend through the sealing element.
  • a fourth aspect of the present invention relates to a guide extension catheter which comprises or consists of a rolling membrane, an outer shaft (e.g. a guiding catheter) through which the rolling membrane partially extends through, and wherein a proximal portion of the rolling membrane is slidably connected to a sealing valve and a distal portion of the rolling membrane is connected to a connection element.
  • a guide extension catheter which comprises or consists of a rolling membrane, an outer shaft (e.g. a guiding catheter) through which the rolling membrane partially extends through, and wherein a proximal portion of the rolling membrane is slidably connected to a sealing valve and a distal portion of the rolling membrane is connected to a connection element.
  • the sealing valve and/or the connection element may comprise a hydrophilic coating and/or a swellable coating such as to swell if exposed to a liquid.
  • the sealing valve may comprise at least one hemostatic valve, for example the sealing valve may be a Tuohy Borst valve.
  • the sealing valve may be limited in its distal movement by the outer catheter.
  • a distal end of the sealing valve and a proximal end of the outer catheter may form a positive connection (form fit connection).
  • the valve may comprise a shaft shaped portion, directed in the distal direction, and comprising and outer diameter slightly smaller in diameter than an inner diameter of the outer shaft.
  • the shaft shaped portion may be provided with an inner diameter of at least 4 Fr.
  • the outer shaft may be movably arranged on the rolling membrane.
  • the outer shaft may be moved in a proximal direction, wherein, as a result of the translation of the outer shaft, the connection element may (further) enter the outer shaft in a distal direction.
  • Said sliding movement of the connection element may advantageously be supported by a preferred hydrophilic coating of the connection element which may reduce friction during the sliding translation.
  • the rolling membrane may extend through the sealing valve (e.g. Tuohy Borst valve).
  • the rolling membrane may be connected to a proximal shaft in a proximal end portion of the rolling membrane.
  • connection element may be adapted to seal a distal end portion of the catheter.
  • the guide extension catheter according to the present invention may synergistically combine the advantageous of a guide extension catheter (as described above) and a rolling membrane for improving catheter-based inventions as described above.
  • the catheter may further comprise an external shaft at least partially enclosing the rolling membrane, wherein at least a proximal portion of the external shaft remains outside of the body of the patient during use of the catheter with the patient.
  • Figs 1A-1B Illustration of an exemplary rolling membrane catheter without inner shaft
  • Figs. 2A-2C Illustration of an exemplary rolling membrane catheter with an inner shaft and an additional connection element
  • Figs. 3A-3B Illustration of an exemplary rolling membrane catheter with an inner shaft and an additional connection element
  • Fig. 4 Illustration of exemplary components of a rolling membrane guide extension catheter
  • Fig. 5 Illustration of an exemplary combination of an outer shaft with a rolling membrane catheter
  • Figs. 6A-6B Illustration of an assembled rolling membrane guide extension catheter.
  • Figs. 1A and IB depict a first exemplary embodiment of a rolling membrane catheter according to an aspect of the present invention.
  • Fig. 1A shows an exemplary embodiment of a catheter 100 which comprises a rolling membrane 101 (depicted in a rolled-in state).
  • the rolling membrane 101 comprises a first portion 102 and a second portion 103.
  • the first portion 102 may be arranged in a distal portion of the rolling membrane 101 whereas the second portion 103 may be arranged in a proximal portion of the rolling membrane 101.
  • the rolling membrane 101 may be configured to form an inner lumen 104 in a rolled-in state of the rolling membrane 101 and/or in a rolled-out state of the rolling membrane 101.
  • the catheter 100 may further comprise an outer shaft 105, which may accommodate at least a portion of the rolling membrane 101.
  • the outer shaft 105 may be a guiding catheter.
  • the outer shaft 105 may be adapted to at least partially enter a body of a patient with a portion I of the outer shaft 105.
  • the outer shaft 105 may further be adapted to at least partially remain outside the body of the patient with a portion O of the outer shaft 105.
  • a diameter of the outer shaft 105 may increase at its proximal part (at the portion O which stays outside the body) compared to its distal part.
  • At least a distal portion of the outer shaft 105 may be connected to the first portion 102 of the rolling membrane 101.
  • the outer shaft 105 may be terminated with a sealing element 106.
  • the sealing element 106 may preferably be a hemostatic valve.
  • the catheter 100 may further comprise a proximal shaft 107.
  • the proximal shaft 107 may at least partially extend through the sealing element 106.
  • the proximal shaft 107 may comprise an inner lumen.
  • the proximal shaft 107 may be connected to the second portion 103 of the rolling membrane 101.
  • the proximal shaft 107 may be connected to the rolling membrane 101 such that the proximal shaft 107 at least partially accommodates the second end 103 of the rolling membrane 101 in the inner lumen of the proximal shaft 107.
  • the rolling membrane 101 may be connected to an inner side of the proximal shaft 107.
  • the proximal shaft 107 may not limit an inner diameter of the inner lumen 104 of the rolling membrane 101 and therefore of the outer shaft (guiding catheter) 105 itself.
  • the proximal shaft 107 may be adapted to always remain outside the body of the patient, preferably in a portion O.
  • the proximal shaft 107 may be adapted to push the rolling membrane 101 into the distal direction D and/or to pull the rolling membrane 2 in a proximal direction P.
  • the inner lumen of the proximal shaft 107 may be connected to the inner lumen 104 of the rolling membrane 101 such that, e.g., medical devices and/or medical drugs may be fed from a proximal portion of the catheter 100 to a distal portion of the catheter 100.
  • Fig. IB shows the exemplary implementation of a catheter 100 of Fig. 1A, wherein the rolling membrane 101 has fully been rolled out along the distal direction D.
  • the proximal shaft 107 may remain within the outer shaft 105 and particular that portion of outer shaft 105 that is outside the patient and may have an increased diameter.
  • Figs. 2A-B shows a further embodiment of a catheter 200 according to an aspect of the present invention.
  • Fig. 2A illustrates the combination of an outer shaft 205 with a rolling membrane 201 for forming a rolling membrane guide extension catheter (RMGCE).
  • the rolling membrane 201 may be provided with a length between 1 cm and 30 cm (as seen in a fully rolled-out state of the rolling membrane 201).
  • Rolling membrane 201 may be connected to an inner shaft 208. Rolling membrane 201 may be connected to the inner shaft 208 in a distal portion of inner shaft 208. Rolling membrane 201 may be connected to the inner shaft 208 at an outer side of the inner shaft 208. Rolling membrane 201 may be connected to the inner shaft 208 by welding, gluing, clamping and/or any other suitable method.
  • connection element 209 may be provided as an annular element, e.g., a ring such as a circlip 210 as exemplarily depicted in Fig. 2C.
  • connection element 209 may be implemented as an elastic stent-like structure.
  • connection element 209 may be provided as a spring seal element.
  • connection element 209 may be placed at some distance to the distal end of the outer shaft 205 to allow the rolling membrane 201 to be self-sealing against the inner side of the outer shaft 205. If the connection element 209 is provided as the spring seal element, the spring seal element must assure a sufficient pressure loss for any liquid passing between spring element and the outer shaft 205 (e.g., a guiding catheter), so that the pressure within an inflatable volume of the rolling membrane 201 is higher than on the outside of the rolling membrane 201.
  • connection element 209 may preferably be adapted to be slidable in the inner lumen of the outer shaft 205 and then fixed therein.
  • the connection element 209 may alternatively also be adapted to be put over the outer side of the outer shaft 205 and clamp the rolling membrane 201 onto the outer shaft 205.
  • connection element 209 when the rolling membrane 201 is fully rolled out, the portion of the rolling membrane 201 in contact with connection element 209 may form the proximal end of the rolling membrane.
  • Inner shaft 208 may bring the portion of the rolling membrane 201 connected to the inner shaft 208 to a distal-most position.
  • Fig. 2B shows the outer shaft 205 and connection element 209 connected, wherein the connection element 209 is adapted to be inserted into the inner lumen of the outer shaft 205.
  • the connection element is connected to a distal part of outer shaft.
  • connection element 209 may be provided as an annular element (as described with reference to Fig. 2A, above) and may be provided with a diameter which may be larger than an inner diameter of the outer shaft 205.
  • the connection element 209 When inserting the connection element 209 into the inner lumen of the outer shaft 205, the connection element 209 may exhibit a force onto the rolling membrane 201 and the inner side of the outer shaft 205 such that the rolling membrane 201 is at least temporarily connected to the outer shaft 205.
  • connection element 309 depicts a further exemplary embodiment of a connection element 309.
  • the connection element 309 is attached to a distal portion of a rolling membrane 301 and a proximal portion of the rolling membrane is attached to an inner shaft 308 preferably at the proximal side.
  • connection element 309 may be provided as funnel-shaped element, which may comprise a first diameter at a proximal portion of the connection element 309 which may be smaller or equal (at a rest state, i.e., a state in which the connection element 309 is not connected to an outer shaft 305) than the inner diameter of the outer shaft 305.
  • Fig. 3B shows an exemplary combination of the outer shaft 305, which may be configured as described, above, and the connection element 309.
  • the connection element 309 may be insertable into the inner lumen of the outer shaft 305.
  • the connection element is connected to a proximal part of outer shaft.
  • the connection element 309 may be connected to the inner side of the outer shaft 305 and may be locked in the inner lumen of the outer shaft 305 by means of the proximal portion of the connection element 309 which may be compressed in diameter and thus radial press against the inner sides of outer shaft 305 at its proximal side. Thereby, a temporary connection of the connection element 309 and the outer shaft 305 may be facilitated.
  • the diameter of the connection element 309 may generally be provided with a diameter which may allow an insertion of the connection element 309 into the outer shaft 305.
  • the rolling membrane 301 is provided as a 4 Fr element and if the outer shaft is a 6 Fr element, the proximal portion of the connection element 309 may be provided with 6 Fr or less to create a sealing between outer shaft 305and connection element 309.
  • the outer shaft 305 may be provided with an inner diameter that is 1 Fr larger than the diameter of the rolling membrane 301 for facilitating an application of a mother-child technique (e.g., a smaller catheter may be inserted into the inner volume of a bigger catheter).
  • the outer shaft 305 may be provided as a 6 Fr part and the connection element may be provided as a 4 Fr part.
  • a rolling membrane guide extension catheter may be formed by a member of a medical staff.
  • the RMGCE may be formed from any guiding catheter acting as the outer shaft 305.
  • Fig. 4 depicts a further exemplary embodiment of a catheter 400, notably of a rolling membrane catheter which may comprise an inner shaft (not shown) with an additional tension lock for forming a rolling membrane guide extension catheter (RMGCE) which needs to be inserted into a guiding catheter of the right inner diameter.
  • the catheter 400 may comprise a rolling membrane 401 extending axially from a distal direction D to a proximal direction P.
  • the rolling membrane 401 may be connected to sealing and/or connecting element 409.
  • Sealing element 409 may comprise a hydrophilic coating and/or a swellable coating. Sealing element 409 may preferably comprise a sealing element.
  • the sealing element may be provided as a spring sealing element.
  • the rolling membrane 401 may be passed through a valve 411, e.g., a Tuohy borst adapter.
  • the valve 411 may preferably be placed outside of a body of a patient.
  • Valve 411 may be provided with means 414 for providing a fluid (e.g., a liquid and/or a gas) to an inflatable volume of the rolling membrane 401.
  • Catheter 400 may further comprise a manipulation element 412 arranged in an inner lumen 404 of the rolling membrane 401.
  • the manipulation element 412 may be connected to the sealing element 409 and may extend or be operably coupled to a position outside the patient.
  • the manipulation element 412 may be adapted for avoiding that the sealing element 409 (and the rolling membrane 401) unintentionally enters the blood vessel of the patient by a too large distance (in particular, if the rolling membrane 401 is inflated the hydraulic pressure applied to the rolling membrane 401 will pull the sealing element 409 out of the guiding catheter).
  • Manipulation element 412 may allow to place the sealing element 409, e.g. within an outer shaft (not shown)
  • Fig. 5 exemplarily illustrates an insertion of rolling membrane 501 (e.g., the rolling membrane 401 as described with reference to Fig. 4, above) into an outer shaft 505 (e.g., a guide catheter such as to form an RMGCE) in five stages i)-v).
  • rolling membrane 501 e.g., the rolling membrane 401 as described with reference to Fig. 4, above
  • outer shaft 505 e.g., a guide catheter such as to form an RMGCE
  • Stage i) shows the rolling membrane 501 which may be configured as described with reference to Fig. 4, above.
  • Stage ii) shows the rolling membrane 501 to be inserted into the outer shaft 505.
  • the maximum radius of the rolling membrane 501 may be configured to be smaller than an inner diameter of the outer shaft 505.
  • Stage iii) shows a scenario in which the rolling membrane 501 is inserted into the outer shaft 505.
  • Connection and/or sealing element 509 (preferably provided with a hydrophilic and swellable coating) may have been exposed to a liquid such that a sealing of the inner lumen of the outer shaft 505 may be exhibited.
  • the sealing may cause a preferably gas tight separation from a distal volume portion of the inner lumen of the outer shaft 505 from a proximal volume portion of the inner lumen of the outer shaft 505. It may releasably connect the rolling membrane 501 to the outer shaft 505 (e.g. a proximal portion of the rolling membrane).
  • Stage iii) further depicts a blocking element 513 which may comprise a volume element which is configured with dimensions that exceed a diameter of the outer shaft 505 such that the blocking element may not be able to enter the outer shaft 505, e.g., from a proximal direction P.
  • This configuration may ensure that the manipulation element 512 may not accidentally enter a blood vessel of a patient.
  • Stage iii) further depicts the rolling membrane 501 in an at least partially rolled-out state.
  • Stage iv) depicts the rolling membrane 501 of stage iii) wherein a medical device 514 has been inserted into an inner lumen 504 of the rolling membrane 501.
  • the medical device 514 may, e.g., be a catheter which may be inserted from the proximal direction P into the distal direction D through the inner lumen of the rolling membrane 501.
  • Stage v) depicts the rolling membrane 501 of stage iv) wherein the medical device 514 has been delivered to a position which lies distal to a distal-most tip of the rolling membrane 501.
  • the rolling membrane 501 may preferably be everted into a narrow, tortuous blood vessel. Upon everting the rolling membrane 501 into the blood vessel (as shown in stage iii), the rolling membrane 501 may be at least partially deflated (stage iv) and any catheter smaller than 4 Fr may be pushed towards the target location.
  • Figs. 6A and 6B exemplarily show a catheter 600 as it has been described with reference to Figs. 4 and 5, above.
  • Fig. 6A shows a potential combination of a rolling membrane 601 with an outer shaft 605 (e.g., the outer shaft 505 as described with reference to Fig. 5, above) and a valve 611 (e.g., valve 411 as described with reference to Fig. 4, above).
  • the rolling membrane 601 has at least partially been inserted into the outer shaft 605.
  • Outer shaft 605 may be moved in a proximal direction P, wherein, as a result of the translation of the outer shaft 605, the connection element 609 may further enter the outer shaft 605 in a distal direction.
  • Said sliding movement of the connection element 609 may advantageously be supported by a preferred hydrophilic coating of the connection element 609 which may reduce friction during the sliding translation.
  • Fig. 6B shows the catheter of Fig. 6A, wherein the outer shaft 605 has been contacted with the valve 611 by moving the outer shaft 605 of Fig. 6A further in the proximal direction thus forming an RMGCE.
  • Fig. 6B further shows the rolling membrane 601 in an at least partially everted state.
  • the rolling membrane 601 may comprise a diameter that is smaller than a diameter of a blood vessel of a patient. Moreover, the rolling membrane 601 may comprise a diameter that may be larger in diameter than an inner diameter of the outer shaft 605 (at least in a rolled-out state of the rolling membrane 601).
  • the rolling membrane 601 may be connected to a proximal shaft in a proximal end portion of the rolling membrane 601.
  • Connection element 609 may further be adapted to seal the catheter 600 in distal end portion of the catheter 600.
  • the valve 611 may comprise a shaft shaped portion, directed in the distal direction D, and comprising and outer diameter slightly smaller in diameter than an inner diameter of the outer shaft 605.
  • the shaft shaped portion may be provided with an inner diameter of at least 4 Fr.
  • the catheter 600 may be provided with an additional tube inside the inner lumen of the rolling membrane 601 as an additional manipulation element 612 for manipulating the connection element 609.
  • Valve 611 may be configured to be pressure tight and may be adapted to seal a proximal end portion of the catheter 600.
  • Volume element 613 may be similar to volume element 513 outlined with reference to Fig. 5.

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Biophysics (AREA)
  • Pulmonology (AREA)
  • Engineering & Computer Science (AREA)
  • Anesthesiology (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Hematology (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Media Introduction/Drainage Providing Device (AREA)

Abstract

La présente invention concerne, entre autres, un cathéter à extension de guidage comprenant une membrane à enroulement ; une tige interne, une première partie de la membrane à enroulement étant reliée à la tige interne et le cathéter comprenant en outre un élément de liaison pour relier temporairement une seconde partie de la membrane à enroulement à une tige externe.
PCT/EP2023/084114 2022-12-12 2023-12-04 Modèle optimisé de membrane à enroulement sous forme de cathéter à extension de guidage Ceased WO2024126130A1 (fr)

Priority Applications (2)

Application Number Priority Date Filing Date Title
EP23813420.9A EP4633711A1 (fr) 2022-12-12 2023-12-04 Modèle optimisé de membrane à enroulement sous forme de cathéter à extension de guidage
CN202380080773.2A CN120187482A (zh) 2022-12-12 2023-12-04 滚动膜作为引导延伸导管的优化设计

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
EP22212728 2022-12-12
EP22212728.4 2022-12-12

Publications (1)

Publication Number Publication Date
WO2024126130A1 true WO2024126130A1 (fr) 2024-06-20

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PCT/EP2023/084114 Ceased WO2024126130A1 (fr) 2022-12-12 2023-12-04 Modèle optimisé de membrane à enroulement sous forme de cathéter à extension de guidage

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EP (1) EP4633711A1 (fr)
CN (1) CN120187482A (fr)
WO (1) WO2024126130A1 (fr)

Citations (9)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20090254063A1 (en) * 2007-07-13 2009-10-08 Randolf Von Oepen Drug Coated Balloon Catheter
US20100249815A1 (en) * 2009-03-25 2010-09-30 Cook Incorporated Everted sheath thrombectomy device
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
US20160235478A1 (en) * 2013-04-16 2016-08-18 Calcula Technologies, Inc. Basket and everting balloon with simplified design and control
US20170303942A1 (en) * 2016-04-25 2017-10-26 Stryker Corporation Pre-loaded inverting tractor thrombectomy apparatuses and methods
WO2017199155A1 (fr) * 2016-05-15 2017-11-23 Thermopeutix, Inc. Cathéter à ballonnet de taille variable pour traitement de vaisseaux
US20180070968A1 (en) * 2016-09-12 2018-03-15 Stryker Corporation Self-rolling thrombectomy apparatuses and methods
US20200206463A1 (en) * 2017-08-31 2020-07-02 Crossbay Medical, Inc. Apparatus and methods for everting catheters with expandable lumens

Patent Citations (9)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20090254063A1 (en) * 2007-07-13 2009-10-08 Randolf Von Oepen Drug Coated Balloon Catheter
US20100249815A1 (en) * 2009-03-25 2010-09-30 Cook Incorporated Everted sheath thrombectomy device
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
US20160235478A1 (en) * 2013-04-16 2016-08-18 Calcula Technologies, Inc. Basket and everting balloon with simplified design and control
US20170303942A1 (en) * 2016-04-25 2017-10-26 Stryker Corporation Pre-loaded inverting tractor thrombectomy apparatuses and methods
WO2017199155A1 (fr) * 2016-05-15 2017-11-23 Thermopeutix, Inc. Cathéter à ballonnet de taille variable pour traitement de vaisseaux
US20180070968A1 (en) * 2016-09-12 2018-03-15 Stryker Corporation Self-rolling thrombectomy apparatuses and methods
US20200206463A1 (en) * 2017-08-31 2020-07-02 Crossbay Medical, Inc. Apparatus and methods for everting catheters with expandable lumens

Also Published As

Publication number Publication date
EP4633711A1 (fr) 2025-10-22
CN120187482A (zh) 2025-06-20

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