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EP-4736788-A1 - CATHETER DEVICE AND SYSTEM FOR REMOVING A THROMBUS FROM A VESSEL

EP4736788A1EP 4736788 A1EP4736788 A1EP 4736788A1EP-4736788-A1

Abstract

The invention relates to a catheter device (1) for use in removing or assisting in removing a thrombus (T) from a vessel (V). The catheter device (1) comprises a first shaft (2), a distal anchor (3), and an activator (4). The distal anchor (3) is attached to a distal end portion (5) of the first shaft (2), and the activator (4) is configured to expand the distal anchor(3). The distal portion (5) of the first shaft (2) is adapted to penetrate the thrombus (T) and/or pass next to the thrombus (T) such as to exert a force on the thrombus (T) from a distal side, via the distal anchor (3), when the first shaft (2) is pulled.

Inventors

  • The designation of the inventor has not yet been filed

Assignees

  • Artedrone

Dates

Publication Date
20260506
Application Date
20241105

Claims (15)

  1. A catheter device (1) for use in moving or removing, or assisting in moving or removing, a thrombus (T) within a vessel (V), comprising a first shaft (2), a distal anchor (3), and an activator (4), wherein the distal anchor (3) is attached to a distal end portion (5) of the first shaft (2), and wherein the activator (4) is configured to expand the distal anchor(3), characterized in that the distal portion (5) of the first shaft (2) is adapted engage the thrombus on a distal side, preferably to penetrate the thrombus (T) and/or pass next to the thrombus (T), and further preferably extend from a first side of the thrombus (T) to a second side of the thrombus (T), such as to exert a force on the thrombus (T) from a distal side, via the distal anchor (3), when the first shaft (2) is pulled.
  2. The catheter device according to claim 1, wherein the expandable distal anchor is selected from a balloon (7), one or more hinged arms (6), an umbrella (21), a wire structure (8), a retractive structure (8), and a net (9).
  3. The catheter device according to any one of claims 1 or 2, further comprising a second shaft (10) arranged concentrically around the first shaft (2), wherein the second shaft (10) is configured to hold the distal anchor (3) in a compressed configuration, and wherein a translational movement of the first shaft (2) relative to the second shaft (10) causes expansion of the distal anchor (3).
  4. The catheter device according to any one of the preceding claims, wherein the distal anchor (3) further comprises an attachment element, preferably a suction mechanism (11), to secure the thrombus (t) to the distal anchor (3).
  5. The catheter device according to any one of the preceding claims, comprising a radioopaque element (12), preferably wherein the radioopaque element is arranged on the first shaft (2) and/or on the distal anchor (3).
  6. The catheter device according to any one of the preceding claims, wherein the distal anchor (3) comprises a first magnetic element (13).
  7. A system for removing a thrombus from a vessel, comprising a second medical device (100) and a catheter device (1) according to any one of the preceding claims, the second medical device (100) comprising a third shaft (101) and a suction cup (102) attached to the third shaft (101) at a distal end thereof, wherein the third shaft (101) comprises an inner channel (103) which is in fluid communication with the suction cup (102), the suction cup (102) being adapted to engage the thrombus and/or attach to the thrombus (T), from a proximal side, wherein the catheter device (1) is at least partially deliverable through the second medical device (100), preferably the third shaft (101).
  8. The system according to claim 7, wherein the catheter device (1) is deliverable via an opening of the suction cup (102), or via an opening (111) in the third shaft (101).
  9. The system according to any one of claims 7 or 8, wherein the second medical device comprises a second magnetic element (104), preferably as part of the suction cup (102) and/or arranged on the distal end of the third shaft (101), wherein the second magnetic element (104) is adapted to interact with an external magnet (106, 303) for guiding the second medical device (100).
  10. The system according to any one of claims 7 to 9, wherein the third shaft (101) is at least partially formed as a flexible line (105).
  11. A system for removing a thrombus (T) from a vessel (V), comprising a second medical device (100) and a catheter device (1) according to any one of the preceding claims, wherein the second medical device (100) is an aspiration catheter (400).
  12. A method of removing a thrombus (T) from a patient's vessel, preferably using a system according any one of claims 7 to 10, comprising the steps of - delivering a medical device (100) having a suction cup (102), preferably a medical device (100) which is part of a system according to any one of claims 7 to 10, to thrombus (T), - attaching the suction cup (102) to the thrombus (T), via suction, on a proximal side of the thrombus (T), - delivering a catheter device (1), preferably a catheter device (1) according to any one of claims 1 to 6, preferably through the medical device (100), - penetrating the thrombus (T) and/or passing by the side of the thrombus (T), from the proximal side to a distal side, with the catheter device (1), and attaching a distal anchor (3) of the catheter device (1) to the distal side of the thrombus (T), - retrieving the thrombus (T) by pulling on the medical device (100) and/or the catheter device (1).
  13. The method according to claim 12, wherein the medical device (100) is pulled after attachment of the suction cup (102) to the thrombus (T) but before attaching the distal anchor the thrombus.
  14. The method according to any one of claims 12 or 13, wherein the distal anchor (3) is activated, preferably expanded, before attaching to the thrombus (T).
  15. The method according to any one of claims 12 to 14, wherein the thrombus (T) is pulled, by pulling on the medical device (100) and/or the catheter device (1), into a retrieval chamber (401), preferably a retrieval chamber of an aspiration catheter (400).

Description

The present invention relates to a catheter device, systems and methods according to the preamble of the independent claims. Devices for removing blot clots are known in the art. For example, US 2019/374128 A1 discloses a device which can detect and retrieve a blood clot by advancing a catheter with a clot sensing element through a patient vascular. WO 2017/161204 A1 discloses devices, systems and methods for removal of a thrombus or embolus from a vascular channel of the body. The device comprises an expandable scaffold which is inserted into the vascular channel and positioned at the thrombus or embolus in a collapsed configuration. Devices in known in the art present several disadvantages. For example, these devices may exert a force which might break a blood clot. As a result, clot fragments may be washed away and carried downstream, leading to further vessel blockages. Thus, the object of the present invention is to overcome the drawbacks of the prior art, in particular to provide a medical device for improved blood clot removal. This and other objects are achieved by the catheter device, systems, and the methods according to the characterizing portion of the independent claims of the invention. The invention is directed to a catheter device for use in moving or removing, or assisting in moving or removing, a thrombus within (or from) a vessel. The catheter device comprises a first shaft,a distal anchor, and an activator. The distal anchor is attached to a distal end portion of the first shaft. The activator is configured to expand the distal anchor. The distal portion of the first shaft is adapted to engage a thrombus on a distal side of the thrombus, for example by penetrating the thrombus and/or to passing next to the thrombus. Preferably, the distal portion of the first shaft may extend from a first side of the thrombus to a second side of the thrombus, such as to exert a force on the thrombus from a distal side, via the distal anchor, when the first shaft is pulled. The catheter device may obviate the need for guidewires or other assisting devices when navigating and placing the catheter device at a target site. The catheter device may also ensure that that other device which attach to the thrombus from a proximal side (such as aspiration catheters, suctions cups, and/or others) remain in contact with the thrombus, thereby making the treatment safer. The distal anchor may be controlled to pull the thrombus back if a contact to the other device at a proximal side is insufficient. Monitoring of the contact may be performed by any means known in the art, e.g., imaging, sensors, measuring of a variation of a distance between the devices (e.g. catheter device and aspiration catheter/suction cup/etc.) and such. Furthermore, the catheter device may avoid fragmentation of the blood clot. The device according to the invention is also adapted to retrieve a thrombus without relying on fragmentation by other means (e.g. lytic agents). The distal portion of the first shaft may have a stiffness sufficient to push and pierce through a thrombus, even if some bending may occur. Stiffness may be adapted by material choice, dimensioning, and/or geometry of the distal portion. Distal may be understood, in the context of the present disclosure, a general direction away from a user. A distal portion may thus be further away from another portion (e.g. a proximal portion, or a medical device such as a suction or aspiration device) in a distal direction, but it does not need to be the distal-most portion of the device. Similarly, a distal anchor is not necessarily the distal-most portion of the catheter device or medical device. The distal anchor may comprise or consist of hooks and/or barbs. For example, hooks and/or barbs may be arranged on a central shaft to engage the thrombus. Additionally or alternatively, hooks or barbs may be arranged on an expandable element, e.g. an arm. When the distal portion is configured to pass next to the thrombus, the distal portion may be adapted to take the path with less resistance, and thereby may bend to pass between the blood clot and the wall. The rigidity of the distal portion may, in particular, be adapted to achieve this result. Additionally, a magnetic element may be arranged distally such that a magnetic field may be utilized to ensure the progression of the distal portion between the blood clot and the vessel wall. The catheter device may be delivered over the artery wall. The catheter device may have an opening in a side wall of the main channel through which the distal portion may exit, thus ensuring that the catheter device is not delivered in the center of the clot. A hook may be arranged on an external surface of the catheter device, e.g. on a suction cup. The hook may help to guide the catheter device between the clot and the artery wall. The hook may have an inner diameter between 0.2 mm and 0.7 mm. Magnetic attraction may be used guide and orient a magnetic distal par