ELONGATED FUNCTIONAL SYSTEM CONFIGURED TO BE ADVANCED IN THE LUMEN OF A PIPE, A DUCT OR A TUBE

Abstract

An elongated functional system configured to be advanced in the lumen of a pipe, a duct or a tube, the system having a body part having a main proximal part and a distal part, the distal part being a continuous extension of the proximal part, the distal part including one functional end terminating with a tip, and at least one active area located upstream the functional end on the distal part; and at least one actuator configured to transform an amount of energy to the distal part sufficient to cause a reversible curvature of the active area, thereby preventing undesired spring back of the whole system; the actuator being connectable to a source of energy.

Claims

1-15. (canceled)

16. An elongated functional system, said system being configured to be advanced in the lumen of a pipe, a duct or a tube, said system comprising: a body part having a main elongated proximal part and a distal part, said distal part being a continuous extension of the proximal part, said distal part comprising one functional end terminating with a tip, and at least one active area located upstream the functional end on the distal part; and at least one first actuator configured to convey or transform an amount of energy to the distal part sufficient to cause a reversible curvature of the active area, greater or equal to the curvature of the center of the tube, this tube curvature being supposed to be non zero, at the location of the active area, thereby preventing snapping effect of the whole system; the actuator being connectable to a source of energy, further comprising at least one second actuator configured to activate the functional end.

17. The elongated functional system according to claim 16, wherein the actuator and, thereby, the active area, are distant from the tip, the distance between the distal end of the tip and the distal end of being of 0.1 to 5, preferably 0.25 to 3, more preferably 0.5 to 2 times the length of the actuator the actuator.

18. The elongated functional system according to claim 16, wherein the main elongated proximal part and/or the distal part are straight and flexible.

19. The elongated functional system according to claim 16, wherein the functional end is straight or curved by design, and flexible.

20. The elongated functional system according to claim 16, wherein actuator, or each independently actuator and actuator are made of, or comprise, at least one shape memory alloy or at least one polymer or at least one metal or at least one piezo-electric material.

21. The elongated functional system according to claim 16, wherein actuator, or each independently actuator and actuator and the body part are each independently made of shape memory alloy, preferably of nickel-titane alloy, also referred to as nitinol.

22. The elongated functional system according to claim 16, wherein the first actuator and/or the second actuator, each independently, contracts or curvates when stimulated by a source of energy, thereby respectively: causing the flexion or curvature of the active area to which they are fixed, and/or activating the functional end.

23. The elongated functional system according to claim 16, wherein the functional end is a steerable end.

24. The elongated functional system according to claim 16, wherein the distal part comprises at least one third actuator.

25. The elongated functional system according to claim 16, wherein the actuation of the at least one actuator generates a simple or a double or a multiple curvature of active area and/or functional end.

26. The elongated functional system according to claim 25, wherein the simple or a double or a multiple curvature is selected in the group consisting of an S-shape, a C-shape, a U-shape, an L-shape, a J-shape and a G-shape of whole or part of distal part.

27. The elongated functional system according to claim 16, further comprising an external control unit located at the proximal end of part, said unit comprising at least one controller device configured to actuate independently each actuator.

28. The elongated functional system according to claim 16, further comprising a source of energy and means for providing energy to the actuator connected to said source of energy.

29. The elongated functional system according to claim 16, which is a catheter guide.

30. A method for stabilizing an elongated functional system advanced in the lumen of a of a pipe, a duct or a tube having at least one curve, wherein the elongated functional system has: a body part having a main proximal part and a distal part, said distal part being a continuous extension of the proximal part, said distal part comprising one functional end terminating with a tip, and at least one active area located upstream the functional end on the distal part; and at least one actuator configured to convey or transform an amount of energy to the distal part sufficient to cause a reversible curvature of the active area greater or equal to the curvature of the center of the tube, at the location of the active area, thereby preventing undesired rotation of the whole system; the actuator being connectable to a source of energy, optionally, the elongated functional system also comprises at least one second actuator configured to activate the functional end, the method comprising the steps of: advancing the system in a curve of the tube; stabilizing the system by actuating the active area so that it reaches curvature equal or greater than that of the curve of the tube; if a double curve has to be operated, actuating the active area through a second actuator.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

[0069] FIG. 1 is a drawing showing the distal part of an elongated functional system wherein the first actuator and the second actuator are actuated.

[0070] FIG. 2 is a drawing showing an elongated functional system comprising a handle, a first actuator and a second actuator.

[0071] FIG. 3 is a drawing showing an elongated functional system comprising connective wires.

[0072] FIG. 4 is a drawing showing an elongated functional system (1) introduced in the aortic arch in order to reach the supra aortic trunk ostium targeted.

REFERENCES

[0073] 1—Elongated functional system [0074] 2—Proximal part [0075] 3—Distal part [0076] 3p—Active area [0077] 3d—Functional end [0078] 3t—Tip [0079] 30—Actuator of distal part [0080] 30p—Actuator of active area [0081] 30d—Actuator of functional end [0082] 4—Conductive mean [0083] 4p—First conductive means [0084] 4d—Second conductive means [0085] 5p—First controller [0086] 5d—Second controller [0087] 6—body part [0088] 7—Sheath

DETAILED DESCRIPTION

[0089] This invention relates to an elongated system 1.

[0090] One goal of this invention is to be able to counter the snapping phenomenon and master the stability, the position and/or the orientation of the system, especially the distal part of the system, in order to drive it gently in the desired direction, without any undesired spring back effect. As a matter of fact, upstream the body part 6, a curvature is set up on an active area 3p, such curvature angle is higher than the tube where the system is oriented in. It aims at preventing undesired torsion of the whole elongated system so as to stabilize it during its use, for instance by a surgeon.

[0091] In one embodiment illustrated on FIG. 1, the system includes a body part 6, which is flexible, and presents a proximal part 2 and a distal part 3; the distal part 3 prolongs the proximal part 2; the distal part 3 is contiguous to proximal part 2, and comprises areas called active area 3p and a distal part 3d terminated by a tip 3t. According to one embodiment, said body part 6 is elongated, which means that it extends longitudinally. In one embodiment, the body part 6 is a tube. In one embodiment, the body part 6 is a catheter guide. According to one embodiment, the body part 6 is made of elastic or flexible material. In one embodiment, the body part 6 is made of polymer flexible material suitable for invasive use. In one embodiment, the body part 6 is made of a shape memory alloy. Any shape memory alloy authorized for invasive use may be used in this invention. In one embodiment, the shape memory alloy is nitinol.

[0092] In one embodiment, the system further includes at least one actuator. In one embodiment, at least one actuator 30 is fixed at at least one location of the distal part of the body part 6, so that the activation of the actuator which can be a shortening of the length of the actuator, and/or a curvature of the actuator, or a translation of the actuator towards the proximal end of the system, triggers a curvature of the distal part from the point of fixation backwards or between two points of fixation. Thus, limiting undesired torsion of the elongated system so as to stabilize it during its use, for instance by a surgeon. In one embodiment, the system includes only one actuator and this actuator is fixed to the active area 3p. In one embodiment, the system is deprived from any actuator on the functional end 3d or the tip 3t. In one embodiment, the length of the tip 3t ranges from 0 to 10 mm.

[0093] In the embodiment shown in FIG. 1 and in FIG. 2, the system further includes at least two actuators (30p, 30d); first actuator 30p and/or second actuator 30d are each independently at least partially fixed to the body part 6, preferably to the distal part 3, more preferably to the active area 3p and/or to the functional end 3d. In one embodiment, at least two actuators (30p, 30d) are not in contact one with another. The two actuators (30p, 30d) are aligned one after the other longitudinally along axis X. In FIG. 1, the two flexions/curvatures take place in the same plane XY, but it is an embodiment of the invention, of course, where the curvatures can take place in different planes. This would be the case if the actuators of FIG. 3 were actuated. This allows a better displacement within any duct or pipe or lumen.

[0094] In one embodiment, the activation of the first actuator 30p or of the second actuator 30d drives the deformation respectively of said actuators; and, as the actuators are fixed to the body part 6, the deformation of the actuators, which can be a shortening of the length of the actuator, and/or a curvature of the actuator, or a translation of the actuator towards the proximal end, results in the curvature of the body part 6. For either one or both actuators 30p and/or 30d, the actuation is able to curve the body part within an angle comprised between 0 and 180°, the angle zero being excluded. Preferably, the angle is between 5 and 180° and even more preferably between 10 and 180°.

[0095] In one embodiment shown in FIG. 2, the elongated functional system 1 further comprises a sheath 7 surrounding the body part 6.

[0096] In one embodiment illustrated on FIG. 3, the elongated functional system 1 further comprises an energy source (such as for example an electric energy source) and means for providing and/or for transmitting energy from the energy source to the first actuator 30p and/or to the second actuator 30d, said means preferably being at least one conductive wire 9. In one embodiment, a first set of conductive wires 4p is connected to the first actuator 30p. According to one embodiment, a second set of conductive wires 4d is connected to the second actuator 30d. According to one embodiment, said conductive wires (4p and 4d) are arranged to provide or to transmit an electric current or heat along their longitudinal portion to respectively the first actuator 30p and the second actuator 30d in a controlled manner. In one embodiment, the first set of conductive wires 4p is connected to the first controller 5p. According to one embodiment, the second set of conductive wires 4d is connected to the second controller 5d. In one embodiment, the first controller 5p and/or the second controller 5d allow applying an electric current to a portion of respectively the first actuator 30p and/or the second actuator 30d by means of the conductive wires 9, thereby providing the actuation of said actuators 30.

[0097] In one embodiment, the first actuator 30p and/or the second actuator 30d comprise pulling means, such as for example a pull wire or a pull cable. According to one embodiment, the pull wire or cable is fastened in the distal part of the active area 3p or of the functional end 3d and actioned at the proximal end of the proximal part 2. When a tension is applied on said pull wire in the proximal direction, the pull wire leads to bend the body part 6. The withdrawal of said tension allows the body part 6 to return to its original shape. Any pulling means able to engage a modification of the curves of the active area 3p and/or the functional end 3d may be implemented according to the invention. In an alternative embodiment, the actuators of the invention are deprived of pulling means.

[0098] In one embodiment illustrated on FIG. 4, the active area 3p is configured such that it can take the shape of any curvature of the tube where it is advanced. For example, the active area 3p takes the curve of the aortic arch. In one embodiment, the active area 3p is configured to change, when actuated, from a rest shape (for example with no curvature) to a curved shape corresponding to the curvature of the tube. In one embodiment of the invention, the system follows the curvature of the center of the tube, or is more curved than the curvature of the center of the tube, upon activation of the active area, thereby stabilizing the system against the snapping. In one embodiment, the activation of the distal end is carried out at the same time or after the activation of the active area 3p.

[0099] In one embodiment, the plane of curvature and the radius of curvature of the first curve of the active area 3p are predetermined. The deformation of the shape of the active area 3p may be designed and predefined so that it can be reproduced upon activation.

[0100] In another embodiment, shown in FIG. 1, the first actuator 30p and the second actuator 30d may be longitudinal actuators. In one embodiment, said actuators (30p, 30d) extend along the body part 6 and are fixed to body part 6. In one embodiment, the actuators (30p, 30d) are arranged each on one side of the tube. In one embodiment, the first actuator 30p and the second actuator 30d show an angular shift with respect to one another. The angular shift ranges from 0 to 180°, preferably more than 0 to 180°. In one embodiment, the angular shift ranges from 90° to 180° In one embodiment, the angular shift is 180°. In one embodiment, the angular shift of first actuator 30p and the second actuator 30d helps leading to control the orientation of the functional end with respect to the active area, ensuring a deformation of the active area 3p and/or of the functional end 3d in predefined directions with respect to one another.

[0101] In one embodiment, the actuation and the deformation of the first actuator 30p and/or of the second actuator 30d, provides a deformation of the body part 6 and of the elongated functional system 1. In one embodiment, the first actuator 30p and/or the second actuator 30d are radially fixed to the body part 6. The first actuator 30p and the second actuator 30d respectively actuate the deformation of the active area 3p and functional end 3d of body part 6, at same of different times.

[0102] In one embodiment, the first provided curve is included in a first plane, the deformation of the active area 3p being maintained in the first plane. In one embodiment, the second curve is included in a second plane, the deformation of the functional end 3d being maintained in the second plane. When both the active area 3p and the distal functional end 3d are actuated at the same time or sequentially, the orientation of the second plane is fixed with respect to the first plane. In one embodiment, the elongated functional system 1 comprises means freezing the orientation of the second plane with respect to the first plane.

[0103] In one embodiment illustrated on FIG. 4, the functional end 3d comprises an actuator 30d and the active area 3p comprises an actuator 30p. In one embodiment, the actuator 30d extends on the body part 6 from the distal part of the first actuator 30p, optionally with an angular shift, so that the actuators are not in contact one with another. In another embodiment, the actuator 30d is spaced from the actuator 30p. According to one embodiment, said space ranges from 0 to 50 mm According to one embodiment, said space ranges from 0 to 10 mm.

[0104] In one embodiment, the first actuator 30p and/or the second actuator 30d are mechanically linked to the body part 6 with one degree of freedom in translation. According to one embodiment, the first actuator 30p and/or the second actuator 30d are mechanically linked to the body part 6 with one degree of freedom in translation along the longitudinal axis of the body part 6; which means that said mechanical linkage allows the wire to translate or retract along the longitudinal axis of the body part 6, while being retained on at least one point, preferably at least two points on the distal part 3.

[0105] In one embodiment, the maximum radius of curvature and the direction of curvature of the first curve and the second curve are predetermined. In one embodiment, the orientation of the first plane with respect to the second plane is predetermined. In one embodiment, the predetermination is made by preparing the nitinol actuator(s) prior to assembly of the system.

[0106] According to another embodiment, the functional end 3d comprises two second actuators 30d leading to allow two predetermined orientations, radii of curvature and/or directions of curvature of the functional end 3d. According to one embodiment, the elongated functional system 1 comprises two second controllers 5d, one for each second actuator 30d. Consequently, the controllers 5p, 5d advantageously allows actuating independently each second actuators 30d, providing the functional end 3d being curved in two different pre-defined planes and two predefined radii of curvature, depending of which second actuator 30d is actuated.

[0107] In one embodiment, the distal part 3 comprises at least three actuators, each able to provide a different second curve as detailed above. The advantage is, by a modulation of the intensity of the three actuators, to control the orientation of the plane of the second curve about 360°. This embodiment advantageously allows the surgeon to correct the angle between the first plane and the second plane or the radius of curvature of the second curve during the operation if necessary e.g. if the angle between the trunk artery and the duct is different than expected.

[0108] According to one embodiment, the distal part 3 comprises at least two active areas 3p. In said embodiment, a first active area extends distally from the main body proximal part 2 and comprises a first actuator providing a first curve in a first plane when actuated. In said embodiment, a second active area is located between said first active area and the functional end and comprises a third actuator providing a third curve in a third plane when actuated. Said second active area advantageously allows providing three successive curves on the distal part 3 of the elongated functional system 1 to navigate inside complex duct system. In one embodiment, the first and the second actuator are positioned on the body part with an angular shift of more than 0°. In one embodiment, the second and the third actuator are positioned on the body part with an angular shift of more than 0°. In one embodiment, the first and the third actuators are aligned.

[0109] According to one embodiment, the distal part 3 comprises at least three active areas or a plurality of active areas as described above.