Although shown as including a pair of push members 306 in the embodiment illustrated in FIGS. 12 and 13 that extend proximally from the stiffening member 508, embodiments in which the stiffening assembly 500 rnay include a single push member 306 are also envisioned herein.

Although generally described as push members 306, it should be appreciated that the stiffening assembly 500 may also be as a pull member or configured for pulling as well. Any push or pull member may alternatively be configured to both push and/or pull, as desired by the operator. Additionally, it is envisioned that one or more wires and/or other such elongated control members may be incorporated as well.

As discussed above in connection with the stiffening assembly 300 (FIG. 1), the stiffening assembly 500 may be configured for manual manipulation, or that the stiffening assembly 500 (e.g., the push member(s) 306) may be secured (connected) to the controller 400 (FIG. 8) such that axial advancement and retraction of the stiffening assembly 500 is regulated (governed) by the controller 400.

In the illustrated embodiment, the stiffening ring 512 includes a hollow construction substantially cylindrical in configuration and is configured as a hypotube 514 that defines an internal lumen. Embodiments in which the configuration of the stiffening ring/hypotube 512 may be varied are also envisioned. For example, embodiments in which the stiffening ring 512 may include a solid construction (e.g., embodiments in which the stiffening ring 512 is devoid of the internal lumen) are also envisioned herein, as are embodiments in which the stiffening ring 512 may include (one or more) at least one weakened section (e.g., etching, laser cuts, etc.) to increase the flexibility thereof. In such embodiments, the stiffening ring 512 may include a stiffness that is greater than that of the steerable segment 116, but less than that of the proximal segment 108. It may also facilitate alternate shapes of bending. Additionally, or alternatively, it is envisioned that the catheter 100 (e.g., the outer wall 104) may include (one or more) at least one weakened section (e.g., etching, laser cuts, etc.) in certain embodiments in order to facilitate deflection of the catheter 100 so as to achieve a curvature (e.g., bends) with a particular configuration and/or dimensions.

The hypotube can optionally slide over or under a laser cut hypotube, when the laser cut hypotube is incorporated to help influence the bend segment and shape. That is, in some embodiments, the steerable segment can include at least one fixed hypotube embedded in the catheter wall with a first laser cut pattern to facilitate bending in a first predetermined shape, wherein upon activation of a steering force, the steerable segment assumes at least one predetermined configuration. The hypotube in some embodiments can further have a second cut pattern to facilitate bending in a second predetermined shape so the steerable segment assumes a different predetermined configuration. The first and second patterns can be on opposite sides in some embodiments.

While the stiffening member 508 is shown as being located internally within the catheter 100 (e.g., as extending within or substantially within the outer wall 104), embodiments are also envisioned in which the stiffening member 508 may be located fully externally or partially externally of the catheter 100. For example, embodiments in which the stiffening member 508 may (partially or entirely) circumscribe the outer wall 104 of the catheter 100 are also envisioned herein, as are embodiments in which the stiffening member 508 may be positioned entirely within the outer wall 104, and embodiments in which the stiffening member 508 may be positioned partially within the outer wall 104 and partially exposed from the outer wall 104.

The stiffening ring 512 can be of different lengths than that shown. Additionally, it is envisioned that the stiffening ring 512 may be configured as an elongated hypotube or rod of a different length than shown in Figure 13. Additionally, ring 512 may have one or more push/pull members (although 2 are shown in Figure 13.

With reference now to FIG. 14, an alternate embodiment of the endovascular system 10 will be discussed, which is identified by the reference numeral 20, and includes a catheter 600 and the articulation assembly 200. The endovascular system 20 and the catheter 600 are substantially similar in both structure and function to the endovascular system 10 and the catheter 100 discussed above (FIG. 1) and, accordingly, will only be discussed with respect to differences therefrom in the interest of brevity. As such, identical reference numerals will be utilized to refer to elements, structures, features, etc., common to the endovascular systems 10, 20 and the catheters 100, 600.

In contrast to the endovascular system 10, in which stiffness in the steerable segment 116 is varied mechanically via manipulation of the stiffening assembly 300, the endovascular system 20 is devoid of the stiffening assembly 300, and instead utilizes (one or more) at least one shape memory material 628 that is responsive to an external stimulus in order to vary the stiffness of the steerable segment 116. More specifically, the shape memory material(s) are incorporated into the steerable segment 116 such that, upon exposure to the external stimulus, the stiffness of the steerable segment 116 is altered, i.e., increased or decreased. The catheter 600 thus includes a first material of construction in the proximal segment 108, and a second, different material of construction (e.g., the shape memory material(s)) in the steerable segment 116. As discussed above in connection with the catheter 100 (FIG. 1), the material of construction in the distal segment 112 may be the same or different than that in the proximal segment 108. Alternatively, the stiffness of the section may be altered by having pockets within it to accept additions and subtractions of additional substances that may alter the stiffness of a part of the steer zone.

In certain embodiments, it is envisioned that the shape memory material(s) may be incorporated into the catheter 100 such that, upon exposure to the external stimulus, the steerable segment 116 assumed a (predetermined) configuration. For example, it is envisioned that the external stimulus may cause the steerable segment 116 to assume a bend with a certain length and/or radius of curvature.

In the illustrated embodiment, the catheter 600 is configured such that the shape memory material(s) are responsive to an electrical stimulus (e.g., electrical current), which is communicated to the steerable segment 116 from a power source 700 via (one or more) at least one transmission member 702 (e.g., a wire 704). Embodiments in which the shape memory material(s) may be responsive to a heat stimulus (e.g., intracorporeal heat from the patient) are also envisioned herein, however, which would allow for omission of the power source 700 and the transmission member(s) 702. Embodiments in which the catheter 600 may include and/or may be configured for use with robotic and/or automated components are envisioned as well.

Depending upon the particular procedure in which the endovascular system 20 is employed, and the particular memory material(s) used in construction of the catheter 600, the catheter 600 may be configured such that the stiffness of the steerable segment 116 is increased upon exposure to the external stimulus to thereby decrease the curvature of the catheter 600 in the deflected configuration (FIGS. 9A-11). Alternatively, the catheter 600 may be configured such that the stiffness of the steerable segment 116 is decreased upon exposure to the external stimulus to thereby increase the curvature of the catheter 600 in the deflected configuration. The catheter 600 thus allows an operating clinician to selectively stiffen and/or soften various regions of the catheter 600 as desired. Transmission members can be provided to communicate with different regions of steerable segment 116 to selectively stiffen select regions of the steerable segment to create various regions of bend resistance. The multiple transmission members can be selectively powered by a single power source 700 or by individual power sources for one or more transmission members.

With continued reference to FIG 14, a method of performing an endovascular procedure will be discussed using the endovascular system 20. Following insertion of the catheter 600 into the patient’s blood vessel (e.g., with the catheter 600 in the normal configuration (FIG. 14)), the catheter 600 is advanced to the target site, during or after which, the articulation assembly 200 can be actuated in order to reconfigure the catheter 600 via bending of the steerable segment 116. If necessary or desired, during the course of the endovascular procedure, the configuration of the catheter 600 can be altered by varying the stiffness of the steerable segment 116 via exposure to the external stimulus. More specifically, the catheter 600 can be exposed to the external stimulus to thereby increase the stiffness of the steerable segment 116 and, thus, reduce bending of the catheter 600 (e.g., the radius of curvature).

With reference now to FIGS. 15 and 16, an alternate embodiment of the endovascular system 10 will be discussed, which is identified by the reference numeral 30, and includes a catheter 800 and the articulation assembly 200. The endovascular system 30 and the catheter 800 are substantially similar in both structure and function to the endovascular system 10 and the catheter 100 discussed above (FIG. 1) and, accordingly, will only be discussed with respect to differences therefrom in the interest of brevity. As such, identical reference numerals will be utilized to refer to elements, structures, features, etc., common to the endovascular systems 10, 30 and the catheters 100, 800.

The catheter 800 includes (one or more) at least one (internal) chamber 830 (e.g., a cavity, a pocket, etc.) that is defined by the outer wall 104. The chamber(s) 830 are located within the steerable segment 116 and are configured to receive a fluid (e.g., air, water, saline, or other such suitable substance) from a source 900 (e.g., a fluid pump 902), which allows the stiffness of the steerable segment 116 to be varied. More specifically, communication of the fluid (substance) into the chambers(s) 830 (e.g., from the source 900) causes the stiffness of the steerable segment 116 to be increased, whereas communication of the fluid (substance) out from the chamber(s) 830 (e.g., to the source 900) causes the stiffness of the steerable segment 116 to be decreased. The extent of filling the chamber can be utilized to adjust the catheter bend by selecting the desired stiffer segment based on where the stiffening fluid (substance) ends in the catheter.

In various embodiments, it is envisioned that a single chamber 830 may be utilized to increase the stiffness of the catheter 800 when filled with a certain substance or decrease the stiffness of the catheter 800 if the substance is removed. It is also envisioned that a single chamber 830 may be utilized to decrease the stiffness of the catheter 800 when filled with a certain substance or increase the stiffness of the catheter 800 if the substance is removed.

Embodiments in which the stiffness of the catheter 800 may be varied by adding and/or removing different substances are also envisioned herein.

Although shown as including a pair of (first and second) chambers 83 Oi, 830ii that are positioned in generally diametrical opposition, it should be appreciated that the particular number of chambers 830 may be increased or decreased in alternate embodiments without departing from the scope of the present disclosure. For example, embodiments are envisioned in which the catheter 800 may include a single chamber 830, as are embodiments in which the catheter 800 may include three or more chambers 830. Chambers of various shapes, number and position are envisioned, including cylindrical chambers in the circumference of the wall of the device. By filling different chambers, the catheter stiffness can be varied, i.e., the clinician can decide which segment of the catheter to stiffen to adjust its bend, and/or the stiffness of different regions of the catheter 800 may be altered. The multiple chambers can be placed circumferentially aligned and/or axially spaced and can simultaneously or selectively receive fluid.

The chamber(s) 830 are in communication with the fluid (liquid or gas) source 900 via (one or more) at least one conduit 904 (e.g., a tube 906) that is configured for connection to the catheter 800. For example, it is envisioned that the conduit(s) 904 may extend within or substantially within the outer wall 104 of the catheter 800 from a site near a proximal end thereof. The fluid (substance) may be communicated from the source 900 and into the chamber(s) 830 in any suitable manner such as, for example, through (one or more) at least one port, opening, seal, or the like in the body 102 of the catheter 800. A fluid pump(s), injection device, or other devices/mechanisms can be utilized to advance the fluid into the chamber(s) and a suction device(s) or other device/mechanism to remove the fluid can be utilized to withdraw the liquid from the chamber(s).

With continued reference to FIGS. 15 and 16, a method of performing an endovascular procedure will be discussed using the endovascular system 30. Following insertion of the catheter 800 into the patient’s blood vessel (e.g., with the catheter 800 in the normal configuration (FIG. 15)), the catheter 800 is advanced to the target site, during or after which, the articulation assembly 200 can be actuated in order to reconfigure the catheter 800 via bending of the steerable segment 116. If necessary or desired, during the course of the endovascular procedure, prior or subsequent to insertion of the catheter into the body, the configuration of the catheter 800 can be altered by varying the stiffness of the steerable segment 116 via communication of the fluid (substance) into the chamber(s) 830 (e.g., from the 900) and out of the chambers) 830 (e.g., to the source 900). More specifically, communication of the fluid (substance) into the chamber(s) 830 increases the stiffness of the steerable segment 116, thereby reducing bending of the catheter 800 (e.g., the and/or the length of the steerable segment 116 that will bend), and communication of the fluid (substance) from the chamber(s) 830 (e.g., to the source 900) decreases the stiffness of the steerable segment 116, thereby facilitating bending of the catheter 800 (e.g., an increase in the radius of curvature). As such, by varying the volume of the fluid (substance) within the chamber(s) 830, the stiffness of the steerable segment 116 and, thus, the length of curve and/or the curvature of the catheter 800 in the deflected configuration, can be controlled (regulated) with increased precision.

In those embodiments of the catheter 800 including a plurality of chambers 830, chambers 830 may be in communication with each other so as to permit communication of the fluid (substance) into the chambers 830 from the source 900 via a single conduit 904, which results in uniform stiffness in the steerable segment 116. Alternatively, the chambers 830 may be devoid of communication, (i.e., independent of each other) which allows the chambers 830 to be filled independently from the source 900 (or multiple sources 900) via corresponding conduits 904, and results in non-uniform stiffness in the steerable segment 116 and/or selective segment stiffening. For example, in such embodiments, and the chamber 83 Oi may receive a (first) volume of the fluid (substance), and the chamber 830ii may receive a (second) volume of the fluid (substance), which may be less than, equal to, or greater than the first volume of the fluid (substance), thereby facilitating additional control over the configuration of the catheter 800. Axially aligned chambers can enable selection via filling of the axial location of the stiffening to select the desired bend radius or curve zone.

In preferred embodiments, the stiffening assemblies disclosed herein will minimally affect the amount of degrees of curvature, although it can sometimes do so to a somewhat unpredictable degree. The stiffening assembly primary purpose is to reduce the length of the catheter that will bend. By reducing the length of catheter bending, many configurations will result in a reduced radius of the curve that the steer will create.

The steerable system is described above for steering a catheter in endovascular procedures. However, it should be appreciated that the steerable systems of the present invention to adjust stiffness can be used in catheters for other procedures as well as used to steer endoscopes for various applications, e.g., gastrointestinal, genito-urinary, pulmonary, enterology, etc. In some of these applications/embodiments, an incorporated imaging system, e.g., camera, and/or lighting system, may be included in the catheter (or endoscope) as well.

The catheter in preferred embodiments has one central working lumen, but in some embodiments can have multiple “working” lumens in addition to the lumens in the wall. One of the lumens can be used for an imaging system.

The steerability system is described above as manually activated, however, it should be appreciated that it could alternatively be robotically activated, computer driven, hydraulically driven, motor driven, etc. Automated artificial intelligence driven steering is envisioned as well.

Steerability systems such as described in U.S. application serial no. 18/668,492, filed May 20, 2024, the entire contents of which are incorporated herein by reference, can also be utilized.

Although the apparatus and methods of the subject disclosure have been described with respect to preferred embodiments, those skilled in the art will readily appreciate that changes and modifications may be made thereto without departing from the spirit and scope of the present disclosure as defined by the appended claims.

Persons skilled in the art will understand that the various embodiments of the disclosure described herein and shown in the accompanying figures constitute non-limiting examples. Additionally, persons skilled in the art will understand that the elements and features shown or described in connection with one embodiment may be combined with those of another embodiment without departing from the scope of the present disclosure and will appreciate further features and advantages of the presently disclosed subject matter based on the description provided.

In the preceding description, reference may be made to the spatial relationship between the various structures illustrated in the accompanying drawings, and to the spatial orientation of the structures. However, as will be recognized by those skilled in the art after a complete reading of this disclosure, the structures described herein may be positioned and oriented in any manner suitable for their intended purpose. Thus, the use of terms such as “above,” “below,” “upper,” “lower,” “inner,” “outer,” “left,” “right,” “upward,” “downward,” “inward,” “outward,” etc., should be understood to describe a relative relationship between the structures and/or a spatial orientation of the structures. Those skilled in the art will also recognize that the use of such terms may be provided in the context of the illustrations provided by the corresponding figure(s). Additionally, terms such as “approximately,” “generally,” “substantially,” and the like should be understood to allow for variations in any numerical range or concept with which they are associated and encompass variations on the order of 25% or to allow for manufacturing tolerances and/or deviations in design. Although terms such as “first,” “second,” “third,” etc., may be used herein to describe various operations, elements, components, regions, and/or sections, these operations, elements, components, regions, and/or sections should not be limited by the use of these terms in that these terms are used to distinguish one operation, element, component, region, or section from another. Thus, unless expressly stated otherwise, a first operation, element, component, region, or section could be termed a second operation, element, component, region, or section without departing from the scope of the present disclosure.

Each and every claim is incorporated as further disclosure into the specification and represents embodiments of the present disclosure. Also, the phrases “at least one of A, B, and C” and “A and/or B and/or C” should each be interpreted to include only A, only B, only C, or any combination of A, B, and C.

Claims

WHAT IS CLAIMED IS:

1. A system configured for use during an endovascular procedure, the system comprising: a, catheter configured for insertion into a patient’s blood vessel, the catheter including: a proximal segment; and at least one steerable segment located distal to the proximal segment; a steering assembly operatively connected to the catheter and configured to facilitate reconfiguration thereof, wherein the proximal segment has a first stiffness, and the steerable segment has a second stiffness less than the first stiffness to facilitate bending of the steerable segment during reconfiguration of the catheter; and a stiffening assembly configured for movement with respect to the steerable segment to increase the second stiffness and restrict bending thereof.

2. The system of claim 1, wherein the steering assembly includes: at least one steering member extending within the catheter and secured thereto; and a tensioning mechanism connected to the at least one steering member such that upon actuation of the tensioning mechanism, a force is applied to the catheter via the at least one steering member to facilitate reconfiguration thereof.

3. The system of claim 2, wherein the at least one steering member extends substantially within an outer wall of the catheter.

4. The system of claim 2, wherein the at least one steering member extends within a channel defined by the outer wall of the catheter.

5. The system of claim 2, wherein the at least one steering member includes: a first steering member secured to the catheter such that upon actuation of the tensioning mechanism, the first steering member causes deflection of the catheter in a first direction; and a second steering member secured to the catheter such that, upon actuation of the tensioning mechanism, the second steering member causes deflection of the catheter in a second direction.

6. The system of claim 1, wherein the catheter includes a distal segment distal of the steering segment.

7. The system of claim 6, wherein the distal segment has a third stiffness greater than the second stiffness.

8. The system of claim 1, wherein the proximal segment includes a first material having a first durometer, and the steerable segment includes a second material having a second durometer.

9. The system of claim 8, wherein the second durometer is less than the first durometer.

10. The system of claim 1, wherein the stiffening assembly includes: a push member; and a stiffening member secured to the push member such that movement of the push member causes corresponding movement of the stiffening member.

11 The system of claim 1, wherein the steering assembly includes a steering member, and further comprising a controller connected to the steering member and configured to cause axial movement of the steering member to cause axial movement of the stiffening assembly within the steerable segment.

12. The system of claim 1, wherein the stiffening assembly includes at least one hypotube substantially within a wall of the catheter and movable within the wall.

13. The system of claim 1, wherein the stiffening assembly includes at least one substantially cylindrical member substantially within a wall of the catheter and movable within the wall?

14. The system of claim 1, wherein moving the stiffening assembly alters the length of the steering segment.

15. The system of claim 14, wherein when the steering segment is shortened by positioning of the stiffening assembly, the turning radius is decreased.

16. The system of claim 13, wherein the stiffening assembly further includes at least one steering member attached to the substantially cylindrical member to cause movement of the substantially cylindrical member.

17. The system of claim 1 , wherein the steerable segment includes at least one shape memory material such that, upon exposure to an external stimulus, the steerable segment assumes a predetermined configuration.

18. The system of claim 16, wherein the steerable segment includes at least one shape memory material such that, upon exposure to an external stimulus, the steerable segment assumes a predetermined configuration.

19. The system of claim 1 , wherein the steerable segment includes at least one fixed hypotube embedded in the catheter wall with a first cut pattern to facilitate bending in a first predetermined shape, wherein upon activation of a steering force, the steerable segment assumes at least one predetermined configuration.

20. The system of claim 19, wherein the hypotube has a second cut pattern to facilitate bending in a second predetermined shape so the steerable segment assumes a different predetermined configuration.

21. A system configured for use during a procedure, the system comprising: an elongated member including: a first segment; and a second segment located distally of the first segment; and a steering assembly connected to the elongated member and configured to facilitate reconfiguration thereof, wherein a stiffness of the second segment can be increased or decreased to increase or decrease resistance to bending to influence a radius of curve of the second segment.

22. The system of claim 21, wherein the second segment includes at least one shape memory material, wherein the at least one shape memory material is responsive to an external stimulus such that upon exposure to the external stimulus, the stiffness of the second segment is increased.

23. The system of claim 21 , wherein the steerable segment includes at least one fixed hypotube embedded in the catheter wall with a first cut pattern to facilitate bending in a first predetermined shape, wherein upon activation of a steering force, the steerable segment assumes at least one predetermined configuration.

24. The system of claim 23, wherein the hypotube has a second cut pattern to facilitate bending in a second predetermined shape so the steerable segment assumes a different predetermined configuration.

25. The system of claim 21, wherein the elongated member includes an imaging system.

26. The system of claim 25, wherein the catheter has multiple working lumens.

27. The system of claim 21, wherein the elongated member includes at least one chamber located within the second segment and configured to receive a substance from a source such that upon communication of the substance into the at least one chamber, the second segment alters in stiffness.

28. The system of claim 21, wherein the first segment has a first durometer, and the second segment has a second durometer less than the first durometer such that the second segment includes a stiffness less than that of the first segment.

29. The system of claim 21, wherein the first segment and second segment have different materials to create different stiffnesses 30.

30. The system of claim 21 , wherein the first segment and second segment have different layers to create different stiffnesses.

31. The system of claim 21, further comprising a stiffening assembly axially movable with respect to the second segment to increase and decrease the stiffness thereof.

32. The system of claim 21, further comprising a stiffening assembly, wherein the stiffening assembly includes at least one substantially cylindrical member substantially within a wall of the catheter and movable within the wall to alter the length of at least one steering segment.

33. The system of 21, wherein when a steering segment is shortened, its turning radius is decreased.

34. The system of claim 32, wherein the stiffening assembly further includes at least one steering member attached to the substantially cylindrical member to cause movement thereof.

35. A method of performing an endovascular procedure, the method comprising: a) inserting a catheter into a blood vessel in a first configuration, wherein the catheter includes: a first segment; and a second segment located distally of the first segment; b) advancing the catheter towards a target site; c) actuating a steering assembly connected to the catheter to thereby reconfigure the catheter from the first configuration into a second configuration via bending of the second segment; and d) either prior to or subsequent to step (c), altering a stiffness of the second segment to alter bending thereof.

36. The method of claim 35, wherein increasing the stiffness of the second segment includes advancing a stiffening assembly axially within the second segment.

37. The method of claim 35, wherein increasing the stiffness includes moving a substantially cylindrical member positioned substantially in the wall of a catheter into a select region of the second segment via an elongated member attached thereto.

38. The method of claim 35, wherein increasing the stiffness of the second segment includes exposing the second segment to an external stimulus.

39. The method of claim 35, wherein increasing the stiffness of the second segment includes communicating a substance into at least one chamber located within the second segment.