Deflectable device with elongate actuator

Abstract

A deflectable device (100) comprising an elongate body (110) and a folded elongate member (120) is configured to change an orientation of the distal portion (114) of the elongate body (110) with respect to the proximal portion (112) of the elongate body (110) upon an electrical current flowing through the folded elongate member (120) causing a change of a length of the folded elongate member (120).

Claims

1. A deflectable device comprising: a flexible elongate body; at least one electrically conductive U-shaped folded elongate member of a shape memory alloy material eccentrically positioned within the flexible elongate body to a longitudinal axis of the flexible elongate body; wherein a first portion comprising two free ends of the at least one folded elongate member is fixedly secured to a proximal portion of the flexible elongate body and a second portion comprising a fold of the at least one folded elongate member is fixedly secured to a distal portion of the flexible elongate body; and wherein the deflectable device is configured to change an orientation of the distal portion of the elongate body with respect to the proximal portion of the elongate body upon an electrical current flowing through the folded elongate member causing a change of a length of the folded elongate member.

2. The deflectable device of claim 1, wherein the first portion is a proximal end of the folded elongate member, and the second portion is a distal end of the of the folded elongate member.

3. The deflectable device of claim 2, further comprising: multiple folded elongate members.

4. The deflectable device of claim 3, further comprising: an electrical connection of the distal ends of the multiple folded elongate members.

5. The deflectable device of claim 1, wherein at least a leg of the folded elongate member is embedded in electrically insulating material.

6. The deflectable device of claim 5, wherein both legs of the folded elongate member are embedded in polytetrafluoroethylene.

7. The deflectable device of claim 1, wherein the folded elongate member is a flat wire or a strip.

8. A system for deflecting a deflectable device, comprising: a power control unit for providing electrical current; the deflectable device according to claim 1, wherein two legs of the at least one folded elongate member are adapted to be electrically connectable to the power control unit.

9. The system of claim 8, wherein: The deflectable device comprises multiple folded elongate members electrically connected at a distal portion; each leg of the multiple folded elongate members being adapted to be electrically connectable to the power control unit; the power control unit being configured to provide electrical current selectively to the legs of the multiple elongate members.

10. A method of deflecting a deflectable device, comprising: providing a deflectable device comprising: a flexible elongate body; at least one electrically conductive U-shaped folded elongate member of a shape memory alloy material eccentrically positioned within the flexible elongate body to a longitudinal axis of the flexible elongate body; wherein a first portion comprising two free ends of the at least one folded elongate member is fixedly secured to a proximal portion of the at least one flexible elongate body and a second portion comprising a fold of the at least one folded elongate member is fixedly secured to a distal portion of the flexible elongate body; and wherein the device is configured to change an orientation of the distal portion of the elongate body with respect to the proximal portion of the elongate body upon an electrical current flowing through the at least one folded elongate member causing a change of a length of the at least one folded elongate member; controlling the electrical current provided to the at least one folded elongate member within the deflectable device to change the orientation of the distal portion of the elongate body with respect to the proximal portion of the elongate body upon an electrical current flowing through the at least one folded elongate member causing a change of a length of the at least one folded elongate member.

11. A non-transitory computer-readable medium having stored a computer-executable program for deflecting a deflectable device, the computer program comprising program code means for causing a power control unit to selectively apply electrical power to the deflectable device to carry out the method of deflecting a device as claimed in claim 10, when the computer program is run on the power control unit for controlling the deflectable device.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

(1) In the drawings:

(2) FIG. 1 shows schematically a system for deflection of a device, wherein a longitudinal cross section of the device according to the invention is illustrated.

(3) FIG. 2 schematically shows a transversal cross section of the same deflectable device as in FIG. 1.

(4) FIG. 3 schematically shows a folded elongate member with one leg insulated, in accordance with embodiments of the present invention.

(5) FIG. 4 schematically shows a folded elongate member having two insulated legs, in accordance with embodiments of the present invention.

(6) FIG. 5 schematically shows a prior art SMA actuator.

(7) FIG. 6 schematically shows the folds of two elongate actuators of a device comprising two elongate actuators, in accordance with embodiments of the present invention.

(8) FIG. 7 schematically shows a 3D-view of a device comprising two actuators with two electrically connected first sides and with two floating first sides in accordance with embodiments of the present invention.

(9) FIG. 8 schematically shows a 3D-view of the same device as in FIG. 7, but with three first sides connected to the negative pole of a power supply and with one first side connected to the positive pole of a power supply, in accordance with embodiments of the present invention.

(10) Any reference signs in the claims shall not be construed as limiting the scope.

(11) In the different drawings, the same reference signs refer to the same or analogous elements.

DETAILED DESCRIPTION OF EMBODIMENTS

(12) The present invention will be described with respect to particular embodiments and with reference to certain drawings but the invention is not limited thereto but only by the claims. The drawings described are only schematic and are non-limiting. In the drawings, the size of some of the elements may be exaggerated and not drawn on scale for illustrative purposes. The dimensions and the relative dimensions do not correspond to actual reductions to practice of the invention.

(13) The terms first, second and the like in the description and in the claims, are used for distinguishing between similar elements and not necessarily for describing a sequence, either temporally, spatially, in ranking or in any other manner. It is to be understood that the terms so used are interchangeable under appropriate circumstances and that the embodiments of the invention described herein are capable of operation in other sequences than described or illustrated herein.

(14) It is to be noticed that the term comprising, used in the claims, should not be interpreted as being restricted to the means listed thereafter; it does not exclude other elements or steps. It is thus to be interpreted as specifying the presence of the stated features, integers, steps or components as referred to, but does not preclude the presence or addition of one or more other features, integers, steps or components, or groups thereof. Thus, the scope of the expression a device comprising means A and B should not be limited to devices consisting only of components A and B. It means that with respect to the present invention, the only relevant components of the device are A and B.

(15) Reference throughout this specification to one embodiment or an embodiment means that a particular feature, structure or characteristic described in connection with the embodiment is included in at least one embodiment of the present invention. Thus, appearances of the phrases in one embodiment or in an embodiment in various places throughout this specification are not necessarily all referring to the same embodiment, but may. Furthermore, the particular features, structures or characteristics may be combined in any suitable manner, as would be apparent to one of ordinary skill in the art from this disclosure, in one or more embodiments.

(16) Similarly it should be appreciated that in the description of exemplary embodiments of the invention, various features of the invention are sometimes grouped together in a single embodiment, figure, or description thereof for the purpose of streamlining the disclosure and aiding in the understanding of one or more of the various inventive aspects. This method of disclosure, however, is not to be interpreted as reflecting an intention that the claimed invention requires more features than are expressly recited in each claim. Rather, as the following claims reflect, inventive aspects lie in less than all features of a single foregoing disclosed embodiment. Thus, the claims following the detailed description are hereby expressly incorporated into this detailed description, with each claim standing on its own as a separate embodiment of this invention.

(17) Furthermore, while some embodiments described herein include some but not other features included in other embodiments, combinations of features of different embodiments are meant to be within the scope of the invention, and form different embodiments, as would be understood by those in the art. For example, in the following claims, any of the claimed embodiments can be used in any combination.

(18) In the description provided herein, numerous specific details are set forth. However, it is understood that embodiments of the invention may be practiced without these specific details. In other instances, well-known methods, structures and techniques have not been shown in detail in order not to obscure an understanding of this description.

(19) An example of a system 1 for deflection of a device 100 is illustrated in FIG. 1. The deflectable device 100 has a flexible elongate body 110 comprising a proximal portion 112 and a distal portion 114. Alternatively, the flexible elongate body 110 comprises a more flexible segment between the proximal portion 112 and the distal portion 114 of stiffer segments. FIG. 1 also shows an elongate actuator 120, in a form of a folded elongate member, comprising a first elongate part 122 and a second elongate part 124, with two electrical contacts at a first side 125, 127 and with, in the example illustrated, a fold 123 at the opposite second side 126, 128 of the elongate actuator 120. The first elongate part 122 is embedded in an insulator 140. The elongate actuator 120 is positioned off-axis with regard to the longitudinal axis 130 of the deflectable medical device 100. Therefore, in operation, the deflectable device 100 (e.g. catheter) bends as result of shrinkage or expansion of one or more elongate parts 122, 124 of the elongate actuator 120. In the exemplary embodiment, the elongate parts 122, 124 of the elongate actuator 120 are positioned in one lumen 200, i.e. hollow space, of a catheter. Such a catheter may have additional lumens not comprising an elongate actuator. The first and second elongate parts 122,124 of one actuator 120, the two legs of the folded elongate member, are positioned within one lumen. Alternatively, they may be positioned in different lumens. By carefully positioning the elongate parts of the elongate actuators, different bending directions and different bending sections of the flexible elongate body 110 (e.g. catheter) can be achieved. In the exemplary embodiment the elongate actuator 120 is fixed in a re-molten (reflow) polymer of the flexible elongate body 110 at its proximal and distal ends. The folded elongate member 120 is electrically connected to a power control unit 10 at its proximal end, specifically at the proximal ends of the legs 122,124 of the folded elongate member 120.

(20) FIG. 2 shows schematically the cross section of the same deflectable device as the device 100 illustrated in FIG. 1. The cross section is taken at position AA illustrated in FIG. 1. The cross section shows the flexible elongate body 110, the first elongate part 122 and the second elongate part 124 of the elongate actuator 120, positioned off axis in the elongate body 110. The first elongate part 122 is embedded in an insulator 140. Both, the first elongate part 122 and the second elongate part 124 are provided in a lumen 200 in the flexible elongate body 110.

(21) In embodiments of the present invention the elongate actuator 120 is a U-shaped SMA element positioned off-axis in a deflectable device 100 implemented as a catheter, such that the two free ends (the first sides 125,127) of the SMA element are electrically connectable at the proximal portion of the deflectable medical device 100 (e.g. catheter) to a conductive connection wire 325, 327, e.g. a metallic connection wire such as for instance a Cu wire. In embodiments of the present invention, the elongate actuator 120 is fixed with the first sides 125, 127 to the proximal portion 112 of the flexible elongate body 110. The opposite sides 126, 128 with the fold 123 of the elongate actuator 120 are fixed to the distal portion 114 of the flexible elongate body 110. Since no conductive, e.g. metallic, connection wire runs along the elongate body 110, exposure of such a conductive, e.g. metallic, wire to repetitive tensile and compressive stresses is avoided.

(22) FIG. 3 schematically illustrates an elongate actuator 120 in accordance with embodiments of the present invention. The elongate actuator 120 comprises a first elongate part 122 and a second elongate part 124. Both elongate parts have a first side 125, 127 and an opposite second side 126, 128. The elongate actuator 120 is folded over a bend or fold 123. The elongate actuator 120 can be integrated in the flexible elongate body 110 with the fold closest to the distal end of the elongate body 110. The fold (bend) 123 at the distal end will be much better fixed after reflow of the catheter polymer or after fixation by gluing, compared to a single SMA wire which is connected with a copper wire as in the prior art implementation illustrated in FIG. 5. Therefore, the risk of failure during operation is smaller for medical devices according to embodiments of the present invention. In embodiments of the present invention the deflectable device may be an intravascular catheter. Such a catheter may be made of a polyether block amide (a block copolymer). By changing the composition, different grades with different hardness can be made. The elongate actuator may for example comprise a long unactuated shaft which is made of stiff material and an actuated tip which is made of more flexible material. In embodiments of the present invention the lumens may have a thin PTFE layer on the outside diameter (OD) of the lumen. The layer is called a PTFE liner.

(23) In this example illustrated in FIG. 3, the first elongate part 122 is insulated, by embedding or covering the first elongate part 122 by an insulator 140. The first and second elongate parts 122, 124 are made of a shape memory alloy. In this example electrical wires 325,327 are electrically connected to the first sides 125, 127.

(24) The elongate parts 122, 124 can be made in different shapes. They can for example be wire shaped, coil shaped, they can be flat wires or they can be elongate strips. Depending on the application one shape may be more appropriate than the other. A wire has a small diameter, a coil can generate more strain but less force. As explained before, flat wires and strips can be applied if a higher force is needed without adding too much to the diameter of the catheter.

(25) A power supply (not illustrated) can be connected to the first sides 125, 127, e.g. by means of the electrical wires 325, 327. In operation, once electrical power is applied, e.g. a voltage is applied, an electrical current will flow through the elongate actuator 120 and it will cause resistive heating of the legs 122,124 of the folded elongate member 120. As a result thereof, the length of the shape memory alloy, of which the elongate actuator 120 is made, will change. The shape memory alloy may for example change from the detwinned martensite phase to the austenite phase resulting in a shrink of the SMA between 3 and 7%. In embodiments of the present invention the shape memory alloy may for example be nitinol (nickel titanium alloy). Alloys with small adaptations in the composition may be used to improve for instance the control of the elongate actuator (e.g. by having an SMA material with less hysteresis). Because the elongate actuator 120 is attached at particular locations to the flexible elongate body 110, a shrinking of the elongate actuator 120, placed off-axis in the elongate body 110, will cause a deformation in this flexible body 110, and thus a bending thereof, or at least of the distal portion 114 thereof.

(26) FIG. 4 shows a similar elongate actuator 120 as FIG. 3. In this elongate actuator 120, not only the first elongate part 122 but also the second elongate part 124 is insulated. Different types of insulating material such as a PTFE (polytetrafluoroethylene) liner can be used for insulating the first and/or second elongate part 122, 124 of the elongate actuator 120. Insulating both elongate parts requires a larger lumen, which can sometimes be critical like for microcatheters which have to be very thin. Insulating both elongate parts can be beneficial as both wire sections have the same thermal insulation around them, and therefore a more equal temperature, which makes them easier to control. In embodiments of the present invention the first and second elongate parts are insulated (e.g. with a PTFE tube) before obtaining the elongate actuator 120 by folding. After folding, the insulation, e.g. the PTFE, at the bend 123 is preferably removed to improve the fixing of the elongate actuator in the distal portion 114 of the elongate body 110.

(27) FIG. 5 schematically illustrates a prior art SMA wire actuator, for comparison and instruction purposes only. This actuator 510 has electrically conductive wires 520, 530 connected at both its distal and its proximal end. During actuation, the SMA wire 510 shrinks. However, the electrical connect wire does not shrink and hinders SMA wire shrinkage. This effect is even stronger in a small diameter lumen than in a catheter or guided wire.

(28) In contrast, embodiments of the present invention (FIG. 3 and FIG. 4) have an elongate actuator 120 comprising a first elongate part 122 and a second elongate part 124 wherein both parts are made of SMA and hence wherein both parts are shrinking when a current is flowing through them. Therefore, the actuation is better controlled and smoother/more continuous than in an actuator as illustrated in FIG. 5. Furthermore, in embodiments implementing a bent elongate actuator, as illustrated in FIG. 3 and FIG. 4, the connection (i.e. the bend) between the first and the second elongate part 122, 124 may be stronger than the connection made between SMA wires as the first and second elongate parts, and a conductive wire, e.g. a metallic wire such as a copper wire at the distal end.

(29) FIG. 6 schematically illustrates the folds 123, 623 of two elongate actuators of a medical device in accordance with embodiments of the present invention. The figure shows a first bend 123 of a first elongate actuator 120, and a second bend 623 of a second elongate actuator at the distal end of the deflectable medical device. The bends of both elongate actuators are electrically interconnected using an electrical connection 610. The electrical connection 610 can for example interconnect the second end of an elongate part of the first elongate actuator 120 and the second end of an elongate part of the second elongate actuator. The electrical connection 610 can be realized by applying the electrical connection (e.g. soldering wires at the folds 123 and 623) before the folded elongate members 120,620 are introduced into the flexible elongate body, after which fixing the proximal sides and the distal sides of the folded elongate members is achieved by re-flow of the flexible elongate body material at the desired portions. Alternatively, an electrically conductive plate (or wire) at the distal end of the lumen 200 hosting the folded elongate members may be used for electrical connection of the folds 123 and 623 of the folded elongate members 120,620. In this case the folded elongate members 120,620 are introduced into the lumen 200 of the elongate body 110 to the distal end of the lumen 200, where the folds 123,623 reach the electrically conductive plate, and then subsequently the proximal sides and the distal sides of the folded elongate members are securely fixed by re-flow of the flexible elongate body material at the desired portions.

(30) In another aspect, embodiments of the present invention relate to a method for deflecting a medical device, more particularly a deflectable device 100 according to embodiments of the first aspect of the present invention. For this method the device comprises multiple electrically conductive folded elongate members. The current through the elongate parts of the elongate actuator is controlled such that the current through at least one leg of the folded elongate members is higher than the current through the other legs.

(31) An example of such a method is elucidated herein below. This method is applied to a deflectable medical device as illustrated in FIG. 6, FIG. 7 and FIG. 8. These devices include an elongate actuator formed by a plurality of folded elongate members that are electrically interconnected at the distal portion. In embodiments of the present invention, illustrated in the drawings, two folded elongate actuators are electrically connected to one another at the level of their folds. The folds 123 of the folded elongate actuators are interconnected using an electrical connection 610. This enables multiple steering directions without having electrical connect wires running from the distal portion of the device to its proximal portion. At the proximal part, different voltages can be applied between the legs of the folded elongate members, or some of the legs of one or more folded elongate members can be left floating.

(32) Examples of such a structure are shown in FIG. 7 and in FIG. 8. FIG. 7 shows a schematic 3D-view of a medical device comprising two elongate actuators 120, 620, each having two elongate parts 122, 124 and 622, 624, respectively. The elongate parts 122, 124, 622, 624 are all electrically connected to one another at their second side (distal end), and are all electrically separate at their first side (proximal end). In the example illustrated, two of the elongate parts 122, 124 forming one of the elongate actuators 120 are electrically connected to a power control unit 10 (electrical power supply) at their first sides and the other two elongate parts 622, 624 are left floating at their first sides. The figure shows a first elongate actuator 120 comprising a first elongate part 122 and a second elongate part 124, a second elongate actuator 620 comprising a first elongate part 622 and a second elongate part 624, and shows two open electrical switches 631, 632. The second elongate part 124 of the first elongate actuator is electrically connected with the second elongate part 624 of the second elongate actuator by an electrical connection 610. The elongate parts are positioned such that, when selectively running a current through some of these parts, shrinking of these parts causes a resulting force on the elongate body orthogonal to the longitudinal axis. In this example, the elongate parts 122, 124, 622, 624 are all at the same distance from the longitudinal axis of the deflectable medical device. In this example the angle between neighboring planes formed by the elongate parts and the longitudinal axis is 45. The invention is, however, not limited thereto and any other suitable configuration for bending the medical device at a certain place in a certain direction is possible. In this example, the electrical switches 631, 632 are open and a power supply is connected with the positive pole to the first side of the second elongate part 124, and with the negative pole to the first side of the first elongate part 122 of the first elongate actuator 120. This results in a current through the first elongate actuator which causes shrinking of this actuator, which causes bending of the elongate medical device. The connection with the first sides of the elongate parts may be made in a handle of the deflectable medical device or by electronics of the deflectable medical device.

(33) FIG. 8 shows a schematic 3D-view of the same medical device as in FIG. 7, but with three first sides of the three elongate parts 122, 622, 624 connected to the negative pole of a power supply and with one first side of one elongate part 124 connected to the positive pole of a power supply, in accordance with embodiments of the present invention. In this example, current flows in one direction through a first elongate part of an elongate actuator and flows through the three remaining elongate parts in the other direction. Thereby the current through the first elongate part is high enough to cause heating of the elongate part above the transformation temperature of the SMA (the austenite transformation temperature). The current through the three remaining elongate parts in the other direction is heating these elongate parts but not to the same extent, in particular not above the transformation temperature of the SMA. Thus only the first elongate part 124 is shortening due to the applied voltage. This shortening causes a resulting force to the elongate body orthogonal to the longitudinal axis of the deflectable medical device.

(34) When using full actuation or no actuation of the elongate parts of the actuators in the examples illustrated in FIG. 7 and FIG. 8, such a structure allows deflection of the flexible elongate body 110 in eight different directions. Firstly, two neighboring elongate parts can be activated by connecting them to different voltages. In this way the flexible elongate body 110 can be deflected in 4 directions. Secondly, by actuating a single elongate part the elongate body can be deflected in 4 other directions. These directions differ 45 degrees from the first mentioned directions.

(35) In order to prevent stresses hampering deflection of the distal portion of the elongate body with respect to the proximal portion of the elongate body it is an option to, for instance, fully actuate the first elongate part 122 of the first elongate actuator 120, half actuate the second elongate part 124 of the first elongate actuator 120 and the second elongate part 624 of the second actuator 620, and not actuate the first elongate part 622 of the second elongate actuator 620.

(36) It is an advantage of embodiments of the present invention that many more directions can be realized by using different partial actuation levels of the folded elongate members by applying the appropriate voltage differences to the legs of the multiple folded elongate members, resulting in different current (and heating levels) of the legs enabling a continuous (step free) movement in all directions.

(37) The elongate actuators may for example be applied in steerable catheters, guided wires, (introducer) sheaths.

(38) Medical devices according to embodiments of the present invention may comprise a computer readable medium having stored a computer-executable program for deflecting a medical device. The computer program comprising program code means for causing the deflectable device to carry out a method controlling the current through the elongate parts of the elongate actuator, when the computer program is run on a computer of a control unit controlling the deflectable device. The method may be adapted to send a higher current though one elongate part and a lower current through another elongate part as explained above.

(39) Although a deflectable medical device is used for the exemplary description of the embodiments, it can be understood and effected by those skilled in the art that the invention is applicable to any device comprising a deflectable elongate body.