Search

EP-4739246-A1 - CARDIOVASCULAR NAVIGATION AND ACTUATION SYSTEM, CARDIOVASCULAR SYSTEM COMPRISING A CARDIOVASCULAR NAVIGATION AND ACTUATION SYSTEM, MECHANICAL INTERFACE, KIT OF PARTS

EP4739246A1EP 4739246 A1EP4739246 A1EP 4739246A1EP-4739246-A1

Abstract

A cardiovascular navigation and actuation system (1) is disclosed. It comprises at least one of and preferably both of a distal unit (2) for translating and/or rotating a cardiovascular delivery system (3), in particular a TAVI or a TAVR delivery system, along its longitudinal axis; and a proximal unit (4) comprising an actuation module (6) for actuating a function of a handle (7) of the delivery system (3), in particular to deploy an artificial cardiovascular valve (40), wherein the mechanical interface (5) provides a connection between the handle (7) and the actuation module (6). In addition, a cardiovascular system is disclosed which comprises a cardiovascular navigation and actuation system (1), a positioning unit and a control unit for controlling the cardiovascular navigation and actuation system (1) and the positioning unit. A mechanical interface, a kit of parts, and a method of using a cardiovascular navigation and actuation system (1) are also disclosed.

Inventors

  • SCHEGG, Pierre
  • SMITS, Jonas Victor Harmen
  • CERRUTI, Giulio
  • BERTHET-RAYNE, Pierre

Assignees

  • Caranx Medical SAS

Dates

Publication Date
20260513
Application Date
20240705

Claims (16)

  1. 1. A cardiovascular navigation and actuation system (1) comprising at least one of and preferably both of - a distal unit (2) for translating and/or rotating a cardiovascular delivery system (3) , in particular a TAVI or a TAVR delivery system, along its longitudinal axis ; - a proximal unit (4) comprising an actuation module (6) for actuating a function of a handle (7) of the delivery system (3) , in particular to deploy an artificial cardiovascular valve (40) .
  2. 2. The system (1) as claimed in claim 1, wherein the proximal unit (4) further comprises a mechanical interface (5) which provides a connection between the handle (7) and the actuation module (6) .
  3. 3. The system (1) as claimed in either of the preceding claims , wherein the proximal unit (4) is mounted on a proximal positioning unit, in particular a proximal robot (8) .
  4. 4. The system (1) as claimed in any of the preceding claims, wherein the distal unit (2) is mounted on a distal positioning unit, in particular a distal robot (8' ) .
  5. 5. The system (1) as claimed in any of the preceding claims, wherein the proximal unit (4) and the distal unit (2) are arranged to move independently from one another.
  6. 6. The system (1) as claimed in any of the preceding claims, wherein the system (1) further comprises a common frame (9) in which the distal unit (2) and the proximal unit (4) are mounted .
  7. 7. The system (1) as claimed in claim 6, wherein the distal unit (2) is fixed at a distal end (10) of the common frame (9) .
  8. 8. The system (1) as claimed in one of claims 6 and 7, wherein the system (1) further comprises a positioning unit, in particular a robot (8) , for positioning the common frame ( 9 ) .
  9. 9. The system (1) as claimed in any of the preceding claims, wherein the proximal unit (4) is movable with respect to the distal unit (2) and/or vice versa.
  10. 10. The system (1) as claimed in any of the preceding claims, wherein the proximal unit (4) is configured to be movable towards the distal unit (2) and to enable actuation of the delivery system (3) .
  11. 11. The system (1) as claimed in any of the preceding claims, wherein the system comprises a centering means for centering a catheter with respect to a secondary known axis, in particular that of a guidewire (12) .
  12. 12. Cardiovascular system comprising a cardiovascular navigation and actuation system (1) as claimed in any of the preceding claims, a positioning unit, in particular a robot (8) , and a control unit for controlling the cardiovascular navigation and actuation system (1) and the positioning unit.
  13. 13. Cardiovascular system according to claim 12, wherein the actuation module (6) and the control unit are configured for positioning and/or deploying an artificial valve (40) in a target location with or without applying rapid pacing to the heart.
  14. 14. A mechanical interface (5) for providing a connection between a handle (7) of a cardiovascular delivery system (3) and an actuation module interface (19) for actuating the handle (7) , wherein the mechanical interface (5) is formed as one or more stand-alone adaptors, each adaptor comprising - a handle interface (18) for connection with the handle (7) and - an actuation module interface (19) for connection with the actuation module (6) .
  15. 15. A kit of parts comprising - a first adaptor with a first handle interface (18) for connection with a first type of handle (7) of a cardiovascular delivery system (3) and - a second adaptor with a second handle interface (18) for connection with a second type of handle (7) of a cardiovascular delivery system (3) , wherein - the first type of handle (7) is different from the second type of handle (7) and - both the first adaptor and the second adaptor have a respective actuation module interface (19) for creating an operative connection with one and the same type of actuation module (6) .
  16. 16. Method of using a cardiovascular navigation and actuation system (1) , in particular a cardiovascular navigation and actuation system (1) as described above, wherein the method comprises at least one of the following steps under the control of at least one automated actuator, in particular in the following order: a. optionally, loading a proximal end of a guidewire (12) into the tip of a delivery system (3) ; b. optionally, advancing a delivery system (3) coaxially on a guidewire (12) to an access site (13) , in particular advancing the delivery system (3) of step a. coaxially on the guidewire (12) of step a. to an access site ( 13 ) ; c. optionally, aligning a delivery system (3) with an introducer sheath (11) that is positioned at an access site (13) , in particular aligning the delivery system (3) of any of the previous steps with an introducer sheath (11) that is positioned at the access site (13) of step b.; d. optionally, pushing a tip of a delivery system (3) through an introducer sheath (11) , in particular pushing the tip of a delivery system (3) of any of the previous steps through the introducer sheath (11) of step c . ; e. advancing a delivery system (3) , in particular the delivery system (3) of any of the previous steps, to a cardiovascular site with a distal unit (2) ; f. optionally, moving a positioning unit, in particular a robot (8) , to a proximal part of the delivery system (3) while maintaining an insertion position; g. optionally, connecting a proximal unit (4) having an actuation module (6) to a handle (7) of the delivery system (3) via a mechanical interface (5) ; h. positioning an artificial valve (40) under the control of an actuation module (6) , in particular the actuation module (6) of step g. with or without applying rapid pacing to the heart; i. deploying an artificial valve (40) , in particular the artificial valve (40) of step h) , under the control of an actuation module (6) , in particular the actuation module (6) of step g. with or without applying rapid pacing to the heart; j . optionally, validating proper positioning of the artificial valve (40) ; k. optionally, moving a positioning unit, in particular the positioning unit of any of steps f. to j . , to an access site (13) , in particular the access site (13) of any of steps b. to i.; l. removing the delivery system (3) .

Description

Cardiovascular navigation and actuation system, cardiovascular system comprising a cardiovascular navigation and actuation system, mechanical interface, kit of parts, and method of using a cardiovascular navigation and actuation system The present invention pertains to cardiovascular navigation and actuation systems, to cardiovascular systems comprising a cardiovascular navigation and actuation system, to mechanical interfaces, to kits of parts, and to methods of using a cardiovascular navigation and actuation system. Such systems and methods may be used, for example, for navigating a TAVR (Transcatheter Aortic Valve Replacement) or a TAVI (Transcatheter Aortic Valve Implantation) delivery system (i.e., to move its tip where a prosthetic valve is loaded from a percutaneous access site to a native aortic valve across the vascular network) and to actuate the handle of such a system to deploy a valve in a target location and configuration. US 2021/0236773 Al discloses a robotic system comprising a robotic catheter steerable by a motorized drive system. Shaikh et al. (The Amigo Remote Catheter System: From Concept to Bedside. J Innov Card Rhythm Manag. 2017 Aug 15 ; 8 ( 8 ) : 2795-2802 , doi: 10.19102/icrm.2017.080806. PMID: 32494463; PMCID: PMC7252924, https : / /www. innovationsinerm. com/ images/pdf/ crm-08- 08-2795.pdf) discloses a remote catheter system using a catheter and handle designed for the system. Handles of delivery systems are very different depending on the manufacturer. Automated systems disclosed in the prior art have the disadvantage that they can cooperate with only one single kind of handle which has been specifically designed for use with this system, and none of the commercially available hand-held systems . It is one obj ect of the present invention to overcome the disadvantages in the prior art . In particular, a cardiovascular system should be provided which allows to employ di f ferent delivery systems . In one aspect , the invention pertains to a cardiovascular navigation and actuation system comprising at least one of and preferably both of - a distal unit for translating and/or rotating a cardiovascular delivery system along its longitudinal axis ; - a proximal unit comprising an actuating module for actuating a function of a handle of the delivery system, in particular to deploy an arti ficial cardiovascular valve . The actuating module may be designed for at least one of : - actuating a handle of the delivery system for deploying a sel f-expanding arti ficial valve ; - actuating a handle of a delivery system for deploying a balloon-expanding arti ficial valve ; - moving concentric catheters relative to one another, in particular inside a patient ' s body; - flexing a catheter body, in particular a tip of the catheter body; - rotating a balloon catheter ; - engaging and/or disengaging a balloon lock; - moving a concentric guidewire relative to a delivery system or catheter . The actuation module designed for actuating the handle of the delivery system for deploying a balloon-expanding arti ficial valve may comprise a safety stop . The safety stop of the actuation module may be configured to prevent further actuating of the handle of the delivery system i f one of ( i ) a predetermined inflation volume threshold of the balloon is exceeded, ( ii ) a resistance for actuating the handle is exceeded, and/or ( iii ) a pressure threshold within a balloon inflation means of the actuation module is exceeded . Alternatively or additionally, to prevent further actuating the safety stop may be configured to generate a visual and/or auditive inflation warning . In some embodiments , actuation of any of the functions of the handle may be achieved by human gesture recognition . Advantageously, the proximal unit comprises a mechanical interface which provides a connection between the handle and the actuation module . The mechanical interface can trans fer forces between the actuation module and the handle . The cardiovascular navigation and actuation system may further contain the delivery system or a portion of it , e . g . , a delivery catheter . A cardiovascular navigation and actuation system according to the invention has the advantage that only the proximal unit , in particular only the mechanical interface , has to be speci fically adapted to cooperate with a speci fic delivery system handle . The mechanical interface can be an integral part of the actuation module . It can also be formed by one or more adaptors which can be brought in operative connection with the actuation module . Preferably, the proximal unit is also configured to load and/or unload the delivery system . It may therefore serve several purposes . In one embodiment , the distal unit may be adapted to be arranged near a percutaneous access site . It can, for example , be clamped directly on the patient , on the side of a bed, or on an active manipulator, such as a robot , or on a passive manipulator . The passive mani