ROTATIONALLY TORQUABLE ENDOVASCULAR DEVICE WITH ACTUATABLE WORKING END

Abstract

n endovascular device including a hollow shaft having a proximal end and a distal end, and sized for insertion into a blood vessel, may be provided. The endovascular device may also include a control line configured to extend through the hollow shaft and an actuatable working element situated distally from the distal end of the hollow shaft and configured to receive an actuation force transmitted via the control line. The endovascular device may further include an actuator configured to exert the actuation force on the control line to cause relative movement between the control line and the hollow shaft and to actuate the working element. The endovascular device may also include a rotation restriction element configured to substantially impede the control line from rotating relative to the working element, while permitting relative axial movement between the control line and the hollow shaft.

Claims

1. An endovascular device, comprising: a hollow shaft having a proximal end and a distal end, the hollow shaft being sized for insertion into a blood vessel; a control line having a proximal end and a distal end, the control line configured to extend through the hollow shaft; an actuatable working element situated distally from the distal end of the hollow shaft, the working element configured to receive an actuation force transmitted via the distal end of the control line; an actuator configured to exert the actuation force on the proximal end of the control line to thereby cause relative movement between the control line and the hollow shaft and to actuate the working element; at least one control line rotation restrictor integral with the control line and configured to be located at least partially within the hollow shaft; and at least one rotation restriction element associated with at least one of the hollow shaft and the working element, wherein the at least one rotation restriction element is configured to engage with the at least one control line rotation restrictor to substantially impede the control line from rotating relative to the working element, while permitting relative axial movement between the control line and the hollow shaft.

2. The endovascular device of claim 1, wherein the at least one control line rotation restrictor includes at least one deformation of the control line.

3. The endovascular device of claim 2, wherein the at least one deformation includes at least one flattened portion of the control line.

4. The endovascular device of claim 3, wherein the control line includes a region of round cross-section adjacent to the at least one deformation.

5. The endovascular device of claim 1, wherein the hollow shaft is formed of at least one wound wire.

6. The endovascular device of claim 1, wherein the hollow shaft includes a cable formed of a plurality of wires.

7. The endovascular device of claim 1, wherein the working element includes a bendable tip formed of a coiled wire section situated distally from the distal end of the hollow shaft.

8. The endovascular device of claim 7, wherein the coiled wire section is configured for greater flexibility than the hollow shaft.

9. The endovascular device of claim 1, wherein the actuator includes a control handle configured to transmit, at a ratio of approximately 1:1, rotational force exerted on the control handle to rotational force on the working element.

10. The endovascular device of claim 1, wherein the at least one rotation restriction element includes at least one deposit of material within at least one of the hollow shaft and the working element, and wherein the deposit of material narrows a portion of a channel in at least one of the hollow shaft and the working element.

11. (canceled)

12. The endovascular device of claim 1, wherein the at least one rotation restriction element includes: a first rotation restriction element situated at least partially within the hollow shaft; and a second rotation restriction element situated at least partially within a channel of the working element.

13. (canceled)

14. The endovascular device of claim 7, wherein the actuator is configured to enable pulling of the control line to cause the coiled wire section to bend and to transmit rotational torque to the bent coiled wire section when at least a portion of the actuator is rotated.

15. The endovascular device of claim 1, wherein the at least one control line rotation restrictor and the at least one rotation restriction element each have an axial length, such that when axially moved relative to each other, the at least one control line rotation restrictor and the at least one rotation restriction element are configured to remain engaged.

16. The endovascular device of claim 1, wherein when a relative rotational force is applied between a distal tip of the working element and the control line, the at least one control line rotation restrictor and the at least one rotation restriction element are configured to transmit the applied force to the working element without substantial slippage between the at least one control line rotation restrictor and the at least one rotation restriction element.

17. The endovascular device of claim 1, wherein the hollow shaft includes a hollow tube formed of at least one of a metallic material or a polymer; and wherein the working element includes a coiled wire situated distally from the hollow tube.

18. (canceled)

19. The endovascular device of claim 1, wherein the control line is formed of a single wire, and wherein the at least one control line rotation restrictor includes at least one deformation in a cross-sectional area of the single wire of the control line.

20. The endovascular device of claim 19, wherein the at least one control line rotation restrictor includes: at least a first deformation formed in an elongated region of the control line that extends within the hollow shaft; and at least a second deformation formed in a portion of the control line that extends in an elongated region of the working element.

21. An endovascular device, comprising: a hollow shaft having a proximal end and a distal end, the hollow shaft being sized for insertion into a blood vessel and being formed of at least one wound wire arranged in a first winding configuration; an actuatable working element situated distally from the distal end of the hollow shaft, the working element being constructed of at least one wound wire arranged in a second winding configuration that is different from the first winding configuration; and a control line having a proximal end and a distal end, the control line being configured to extend through the hollow shaft, wherein the distal end of the control line is connected to the working element; wherein the working element is configured for greater flexibility than the hollow shaft, and wherein the working element and the hollow shaft are configured such that when a force is applied to the control line, the at least one wire of the working element is configured to bend while the at least one wire of the hollow shaft is configured to resist bending.

22. The endovascular device of claim 21, wherein the hollow shaft is formed of a plurality of wires arranged in a cable, and wherein the working element is formed of a single wire arranged in a coil.

23. The endovascular device of claim 22, wherein the single wire coil of the working element is connected to and extends distally from the multi-wire cable of the hollow shaft.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

[0027] The accompanying drawings, which are incorporated in and constitute a part of this specification, illustrate disclosed embodiments and, together with the description, serve to explain the disclosed embodiments.

[0028] FIG. 1 is an illustration of a control wire for an exemplary endovascular device, consistent with at least one of the disclosed embodiments;

[0029] FIG. 2 is an illustration of an exemplary endovascular device with the control wire of FIG. 1, consistent with at least one of the disclosed embodiments;

[0030] FIG. 3 is an illustration of an inner cross section of a section of the exemplary endovascular device of FIG. 2, consistent with at least one of the disclosed embodiments;

[0031] FIG. 4 is an illustration of an inner cross section of a section of the exemplary endovascular device of FIG. 2, consistent with at least one of the disclosed embodiments;

[0032] FIG. 5 is an illustration of an inner cross section of a section of the exemplary endovascular device of FIG. 2, consistent with at least one of the disclosed embodiments;

[0033] FIG. 6 is an illustration of a control wire for another exemplary endovascular device, consistent with at least one of the disclosed embodiments;

[0034] FIG. 7 is an illustration of an exemplary endovascular device with the control wire of FIG. 6, consistent with at least one of the disclosed embodiments;

[0035] FIG. 8 is an illustration of an inner cross section of a section of the exemplary endovascular device of FIG. 7, consistent with at least one of the disclosed embodiments;

[0036] FIG. 9 is an illustration of an inner cross section of a section of the exemplary endovascular device of FIG. 7, consistent with at least one of the disclosed embodiments; and

[0037] FIG. 10 is an illustration of an inner cross section of a section of the exemplary endovascular device of FIG. 7, consistent with at least one of the disclosed embodiments.

[0038] Annotations appearing in the figures are exemplary only, and are not restrictive of the invention as claimed.

DETAILED DESCRIPTION

[0039] Reference will now be made in detail to the present embodiments (exemplary embodiments) of the disclosure, examples of which are illustrated in the accompanying drawings.

[0040] FIG. 1 illustrates a control wire 101 of an exemplary endovascular device in accordance with the disclosure, which may be deformed or flattened in two zones 101-3, and may be round in other areas along its axis 101-2. FIG. 2 illustrates an exemplary endovascular device 201 using control wire 101 in accordance with the disclosure. (Solely to illustrate the position of zones 101-2 and 101-3 in endovascular device 201, with the understanding that control wire 101 is part of endovascular device 201, FIG. 2 also separately depicts control wire 101 of FIG. 1, with zones 101-3 and 101-2 generally aligned to endovascular device 201.) As shown in FIG. 2, endovascular device 201 may also include an elongated shaft 204 which may include a tube 205, a cable of wires 206, and a single wire coil 207. A distal tip 210 of the elongated shaft 204 may be attached to control wire 101, for example. At a proximal end of the elongated shaft 204, the control wire 101 may be connected to a slider 211 of a handle 209, with the elongated shaft 204 connected to the handle 209 to facilitate the relative movement. (In FIG. 2, handle 209 is not depicted to the same scale as that of elongated shaft 204.) In accordance with at least some embodiments, two polymers 208 may be inserted between the elongated shaft 204 and the control wire 101 to prevent the radial movement between the control wire 101 and the elongated shaft 204.

[0041] Consistent with the embodiment shown in FIGS. 9 and 10, in at least some embodiments of an exemplary endovascular device of the disclosure, the cable of wires 206 and the single wire coil 207 of the elongated shaft 204 may be elliptical. This elliptical shape resists relative rotation of the elongated shaft 204 and the control wire 101, enabling torqueing of the device. Alternatively, other non-symmetrical shapes (e.g., cross-sections) may be employed, consistent with the invention to resist rotation and to permit torqueing.

[0042] At least some embodiments of an exemplary endovascular device of the disclosure may encompass a fixture enabling transmission of a radial force of the elongated shaft 204 to the control wire 101 with 1:1 ratio. This may be achieved, for example, by preventing axial rotation between the control wire 101 and the elongated shaft 204 without preventing the axial movement between the control wire 101 and the elongated shaft 204. And such axial rotation prevention (without axial movement prevention) may be achieved, for example, by deforming at least a portion of the control wire 101 and making at least a portion of the inner cross section of the round elongated shaft 204 non-round respectively. For example, there may be an overlap between the two rectangular (or flattened) portions 101-3 even during axial movement of the control wire 101 compared to the elongated shaft 204.

[0043] A control wire 101 with at least some flat or rectangular section or sections may be achieved by, for example, selectively pressing the control wire 101, by adhesion of additional materials to form a non-round shape, or by other means.

[0044] Achieving a non-round inner cross section may be achieved, for example, by attaching rectangular shaped materials 208 to an inner wall of the elongated shaft 204. As another example, a polymer 208 may be inserted through the wire cable to create a non-round cross section. The polymer 208 may be heated and inserted through holes in the wall of the elongated shaft 204 and shaped as needed by a rectangular mandrel.

[0045] As shown in FIG. 3, which illustrates an inner cross section A-A of a section of exemplary endovascular device 201, the control wire 101 may be made from 0.14 mm Nitinol wire. A distal tip of the wire 101 may be gradually grinded to an outer diameter of about 70 um. The elongated shaft 204 may be made from a 130 cm Nitinol tube with an inner diameter of 0.18 mm which may be bonded to a PTFE covered cable of ten 70 um Nitinol wires and the distal section may be a single 70 um wire which may be coiled.

[0046] As shown in FIG. 4, which illustrates an inner cross section B-B of a section of exemplary endovascular device 201, the control wire 101 may be pressed to create flat sections 101-3 of about 0.16 mm0.12 mm of 30 mm of length. Using a rectangular mandrel, a polymer 208 may be inserted through the wire cable 206 to create a non-round cross section in areas that overlap the non-round sections of the control wire 101. As a result, relative axial movement between the control wire 101 and the elongated shaft 204 may be maintained while the axial rotation between the control wire 101 and the elongated shaft 204 (which includes cable 206) may be prevented.

[0047] FIG. 5 illustrates an inner cross section C-C of a section of exemplary endovascular device 201, similar to cross section B-B of FIG. 4. Again, as a result, relative axial movement between the control wire 101 and the elongated shaft 204 may be maintained while the axial rotation between the control wire 101 and the elongated shaft 204 (which includes single wire coil 207) may be prevented.

[0048] In a further embodiment, FIG. 6 illustrates a control wire 601 of an exemplary endovascular device in accordance with the disclosure, which may be deformed or flattened in zone 601-3, and may be round in other areas along its axis 601-2. FIG. 7 illustrates an exemplary endovascular device 701 using control wire 601 in accordance with the disclosure. (Solely to illustrate the position of zones 601-2 and 601-3 in endovascular device 701, with the understanding that control wire 601 is part of endovascular device 701, FIG. 7 also separately depicts control wire 601 of FIG. 6, with zones 601-3 and 601-2 generally aligned to endovascular device 701.) As shown in FIG. 7, endovascular device 701 may also include an elongated shaft 704 which may include a tube 705, a cable of wires 706, and a single wire coil 707. A distal tip 710 of the elongated shaft 704 may be attached to control wire 601, for example. At a proximal end of the elongated shaft 704, the control wire 601 may be connected to a slider 211 of a handle 209, with the elongated shaft 704 connected to the handle 209 to facilitate the relative movement. (In FIG. 7, handle 209 is not depicted to the same scale as that of elongated shaft 704.)

[0049] FIG. 8 illustrates an inner cross section D-D of a section of exemplary endovascular device 701. The control wire 601 may be made from 0.14 mm Nitinol wire. A distal tip of the wire 601 may be gradually grinded to an outer diameter of about 70 um. The elongated shaft 704 may be made from a 130 cm Nitinol tube with an inner diameter of 0.18 mm which may be bonded to a PTFE covered cable of ten 70 um Nitinol wires and the distal section may be a single 70 um wire which may be coiled.

[0050] As shown in FIGS. 9 and 10, which illustrates inner cross sections E-E and F-F of a section of exemplary endovascular device 701, the control wire 601 may be pressed to create flat sections 101-3 of about 0.16 mm0.12 mm of 30 mm of length. As mentioned above, in FIGS. 9 and 10, the cable of wires 706 and the single wire coil 707 of the elongated shaft 704 may be elliptical. This elliptical shape resists relative rotation of the elongated shaft 704 and the control wire 601, enabling torqueing of the device. Alternatively, other non-symmetrical shapes (e.g., cross-sections) may be employed, consistent with the invention to resist rotation and to permit torqueing.

[0051] In other embodiments, a single wire coil may be provided, extending from a multi-wire cable with a control wire that runs through the core of both. This enables the control wire to steer the more flexible coiled end of the coil, without causing the multi-wire cable to appreciably bend.

[0052] Moreover, while illustrative embodiments have been described herein, the scope includes any and all embodiments having equivalent elements, modifications, omissions, combinations (e.g., of aspects across various embodiments), adaptations or alterations based on the present disclosure. The elements in the claims are to be interpreted broadly based on the language employed in the claims and not limited to examples described in the present specification or during the prosecution of the application, which examples are to be construed as non-exclusive. Further, the steps of the disclosed methods can be modified in any manner, including by reordering steps or inserting or deleting steps. It is intended, therefore, that the specification and examples be considered as example only, with a true scope and spirit being indicated by the following claims and their full scope of equivalents.