Steerable catheter

Abstract

The present invention relates to a steerable catheter comprising first and second steering sections, each configured to steer in opposite directions within the same plane. The present invention also relates to a system comprising a steerable catheter according to the present invention and a patch deployment device deployable through the catheter.

Description

[Technical Field]

[0001] The present invention relates to a steerable catheter comprising first and second steering sections, each configured to steer in both directions, to create free space adjacent to an anatomical defect requiring surgical intervention. The steerable catheter of the present invention is particularly adapted for use in medical procedures requiring intervention in the interior wall of an anatomical lumen, such as deployment of a cardiovascular repair patch in a cardiovascular wall. The present invention also relates to a system for deploying a patch in an anatomical lumen, the system comprising a steerable catheter according to the present invention and a patch deployment device deployable via the catheter. The present invention also relates to a method of applying a patch to a defect site in an anatomical lumen using the system of the present invention. [Background technology]

[0002] Catheters are used in a variety of medical procedures that require access to anatomical lumens (e.g., blood vessels), for example, for the deployment of medical devices. To address this need, a wide variety of catheters have been developed, ranging from basic delivery tubes to more complex devices with an array of functions.

[0003] A challenge commonly encountered in such medical procedures is the need to navigate a catheter through a tortuous path to access a treatment site. Examples include navigating through the atrial septum to the left side of the heart or through the tricuspid valve to the right ventricle of the heart. A series of catheters have been developed that employ non-linear configurations that allow the catheter to navigate through tortuous blood vessels, navigate tight bends, and access hard-to-reach areas.

[0004] A first category of catheters includes flexible sections that can passively deflect, for example, when the catheter contacts a blood vessel wall. A second category of catheters includes shape-setting sections that adopt a curved shape in the absence of an external force, for example. The present invention relates to a third category of catheters: steerable catheters. As referred to herein, steerable catheters allow active control of one or more sections of the catheter to modify the shape of those sections, for example, to assist in navigating a tortuous path through an anatomical lumen.

[0005] The use of cardiovascular repair patches to repair damaged vascular tissue has been proposed. For example, Patent Document 1 (WO 2019 / 175288) discloses a vascular repair patch that can be used to repair damage to the wall of a blood vessel, particularly aortic dissection. Aortic dissection is a life-threatening condition caused by a tear in the intimal layer of the aorta or bleeding within the aortic wall, causing the layers of the aortic wall to separate (dissect). Blood flow forces several layers of the aortic wall apart, resulting in the formation of a passageway between the layers known as a false lumen. If the blood-filled passageway ruptures through the outside of the aortic wall, this condition can be fatal.

[0006] Intraluminal techniques are minimally invasive methods for accessing and repairing defects in anatomical lumens. International Publication No. WO 2021 / 058602 discloses an intravascular method for deploying a vascular repair patch using a catheter in combination with a deployment device deployable via the catheter. The deployment device adopts an unexpanded configuration when constrained within the catheter lumen, but expands to an expanded configuration when advanced from a distal opening in the catheter lumen with the assistance of a push wire. When a patch is attached to the deployment device and the deployment device adopts the expanded configuration, the patch deploys in preparation for application to the vascular defect. Once the patch is secured at the treatment site, the deployment device can be retracted within the catheter, returning to the unexpanded configuration, and the catheter can then be removed from the patient.

[0007] One challenge that must be addressed when deploying a cardiovascular repair patch in this manner is that the treatment site (the sidewall of the blood vessel) is generally not aligned with the axial direction of the catheter. Unlike other intravascular methods using a catheter, simply being able to guide the patch through the blood vessel is not sufficient. Instead, the tip of the catheter must be actively steered to ensure that the patch is effectively deployed against the cardiovascular wall. Thus, Patent Document 2 (WO 2021 / 058602) proposes the use of a guide catheter with a steerable tip so that the distal end of the catheter can be steered relative to the rest of the catheter to orient the distal end of the catheter toward the treatment site.

[0008] It has now been observed that the method disclosed in International Publication No. 2021 / 058602 suffers from the drawback that the steerable catheter may cause unacceptable distortion, potentially resulting in further damage at a site already in need of repair. The longitudinal axis of the catheter inserted into the blood vessel is substantially aligned with the axial direction of the vessel's interior lumen. Therefore, steering the steerable tip causes the distal end of the catheter to bend away from the longitudinal axis and toward the vessel wall. This risks creating challenges as the catheter tip may contact and distort against the vessel wall at a site already weakened by the cardiovascular defect. Attempting to advance a deployment device through the distal opening of the catheter in this configuration not only further damages the vessel wall but also prevents proper expansion of the deployment device, potentially resulting in misplacement of the patch.

[0009] Conventional steerable catheters, in which the steerable portion is intended to guide the catheter tip through complex anatomical passageways, are unsuitable for applications in which the catheter deploys a therapeutic device against the sidewall of an anatomical structure. In connection with such applications, simply orienting the catheter tip in a desired direction is not sufficient. Instead, the catheter tip must be oriented in a desired direction while also creating sufficient free space between the catheter tip and the adjacent anatomical defect to allow for deployment of the therapeutic device without unwanted contact between the catheter tip and the defect.

[0010] Thus, there is a need for improved catheters that facilitate deployment of medical devices within anatomical lumens, particularly when the treatment site is the wall of the anatomical lumen. Such catheters must be capable of properly orienting the catheter tip for deployment of the medical device within a constrained space and without damaging surrounding physiological structures. In particular, there is a need for improved patch deployment systems that can deploy cardiovascular repair patches without contacting and / or distorting the site of a cardiovascular defect. [Prior art documents] [Patent documents]

[0011] [Patent Document 1] International Publication No. 2019 / 175288 [Patent Document 2] International Publication No. 2021 / 058602 Summary of the Invention

[0012] According to a first aspect of the present invention, In a steerable catheter, the steerable catheter comprises a longitudinal tube having a proximal end, a distal end with a distal opening, and an internal lumen extending to the distal opening; A steering zone is provided adjacent the distal end, the steering zone comprising: (i) a first control section; (ii) a second steering portion disposed proximal to the first steering portion along the longitudinal axis of the catheter; the first steering portion is independently operable to steer in a first direction within a first plane, the first plane being parallel to and intersecting a longitudinal axis of the catheter; the second steering section is independently operable to steer in a second direction opposite the first direction; A steerable catheter is provided in which the steering zone is configured such that when the second steering section is actuated to its maximum steering angle, the distal end of the catheter cannot intersect a second plane, the second plane being parallel to the longitudinal axis of the catheter, intersecting the longitudinal axis of the catheter, and perpendicular to the first plane.

[0013] According to a second aspect of the present invention, In a steerable catheter, the steerable catheter comprises a longitudinal tube having a proximal end, a distal end with a distal opening, and an internal lumen extending to the distal opening; A steering zone is provided adjacent the distal end, the steering zone comprising: (i) a first control section; (ii) a second steering portion disposed proximal to the first steering portion along the longitudinal axis of the catheter; the first steering portion is independently operable to steer in a first direction within a first plane, the first plane being parallel to and intersecting a longitudinal axis of the catheter; the second steering section is independently operable to steer in a second direction opposite the first direction; A steerable catheter is provided in which the first steering section has a maximum steering angle of at least 60°.

[0014] According to a third aspect of the present invention, In a steerable catheter, the steerable catheter comprises a longitudinal tube having a proximal end, a distal end with a distal opening, and an internal lumen extending to the distal opening; A steering zone is provided adjacent the distal end, the steering zone comprising: (i) a first steering element, the first steering element being independently operable to steer in a first direction within a first plane, the first plane being parallel to and intersecting a longitudinal axis of the catheter; (ii) a shape-setting bending steering section disposed proximal to the first steering section along a longitudinal axis of the steerable catheter, the shape-setting bending steering section being independently operable to bend in a second direction and steer in the first direction, the second direction being opposite to the first direction; A steerable catheter is provided, wherein the steering zone is configured such that when the shape-setting curved steering section is not actuated, the distal end of the catheter cannot intersect with a second plane, the second plane being parallel to the longitudinal axis of the catheter and perpendicular to the first plane.

[0015] According to a fourth aspect of the present invention, In a steerable catheter, the steerable catheter comprises a longitudinal tube having a proximal end, a distal end with a distal opening, and an internal lumen extending to the distal opening; A steering zone is provided adjacent the distal end, the steering zone comprising: (i) a first steering element, the first steering element being independently operable to steer in a first direction within a first plane, the first plane being parallel to and intersecting a longitudinal axis of the catheter; (ii) a shape-setting bending steering section disposed proximal to the first steering section along the longitudinal axis of the catheter, the shape-setting bending steering section bending in a second direction within the first plane and independently operable to steer in a first direction within the first plane, the second direction being opposite to the first direction; A steerable catheter is provided in which the first steering section has a maximum steering angle of at least 60°.

[0016] According to a fifth aspect of the present invention, 1. A system for deploying a patch in an anatomical lumen, the system comprising: (a) a steerable catheter according to the first or second aspect of the present invention; (b) a deployment device, the deployment device comprising: (i) a self-expanding deployment structure configured to be in an unexpanded state when disposed within and constrained within the interior lumen of the steerable catheter, and configured to self-expand to an expanded state when displaced through the distal opening and beyond the distal end of the catheter; (ii) a deployment device comprising a pusher wire axially movable within the internal lumen of the catheter to move a self-expanding deployment structure between an unexpanded state within the catheter and an expanded state beyond the distal end of the catheter.

[0017] According to a sixth aspect of the present invention, In a system for deploying a patch into an anatomical lumen, the system comprises: (a) a steerable catheter according to the third or fourth aspect of the present invention; (b) a deployment device, the deployment device comprising: (i) a self-expanding deployment structure configured to be in an unexpanded state when disposed within and constrained within the interior lumen of the steerable catheter, and configured to self-expand to an expanded state when displaced through the distal opening and beyond the distal end of the catheter; (ii) a deployment device comprising a pusher wire axially movable within the internal lumen of the catheter to move a self-expanding deployment structure between an unexpanded state within the catheter and an expanded state beyond the distal end of the catheter.

[0018] According to a seventh aspect of the present invention, 1. A method for patching a defect site in an anatomical lumen, the method comprising: (a) providing a system according to a fifth aspect of the invention comprising a catheter according to the first or second aspect of the invention, wherein the self-expanding deployment structure is disposed in an unexpanded state and is constrained within an internal lumen of the steerable catheter, and further comprising a patch releasably attached to the self-expanding patch deployment structure; (b) inserting the catheter into the anatomical lumen so as to position a distal opening of the catheter adjacent the defect site; (c) actuating the first steering element and the second steering element to orient the distal end of the steerable catheter to the defect site by steering the first steering element in a first direction within a first plane and steering the second steering element in a second direction within the first plane; (d) advancing the pusher wire to move the self-expanding deployment structure beyond the distal opening of the catheter to an expanded state; (e) applying the patch to the defect; (f) releasing the patch from the self-expanding deployment structure; (g) withdrawing the pusher wire to retract the self-expanding patch deployment structure to an unexpanded state within the interior lumen of the catheter; (h) removing the catheter from the anatomical lumen.

[0019] According to an eighth aspect of the present invention, 1. A method of patching a defect site in an anatomical lumen, comprising: The method comprises: (a) providing a system according to the sixth aspect of the invention comprising a catheter according to the third or fourth aspect of the invention, wherein the self-expanding deployment structure is disposed in an unexpanded state and is constrained within an internal lumen of the steerable catheter, and further comprising a patch releasably attached to the self-expanding patch deployment structure; (b) inserting the catheter into the anatomical lumen while actuating the shape-setting curved steering section to position the distal opening of the catheter adjacent the defect site; (c) actuating the first steering element to steer the first steering element in a first direction in a first plane and deactivating the shape-setting curve steering element such that the distal end of the steerable catheter is oriented toward the defect site; (d) advancing the pusher wire to move the self-expanding deployment structure beyond the distal opening of the catheter to an expanded state; (e) applying the patch to the defect; (f) releasing the patch from the self-expanding deployment structure; (g) withdrawing the pusher wire to retract the self-expanding patch deployment structure to an unexpanded state within the interior lumen of the catheter; (h) removing the catheter from the anatomical lumen.

[0020] According to a ninth aspect of the present invention, A method of deploying a medical device using a catheter according to the first or second aspect of the present invention, comprising: The method comprises: (i) inserting a catheter into an anatomical lumen adjacent to a treatment site; (ii) actuating the first steering element and the second steering element to orient the distal end of the catheter to the defect site by steering the first steering element in a first direction within a first plane and steering the second steering element in a second direction within the first plane; (iii) deploying a medical device through the distal opening.

[0021] According to a tenth aspect of the present invention, A method of deploying a medical device using a catheter according to the third or fourth aspect of the present invention, the method comprising: (i) inserting the catheter into an anatomical lumen while actuating a shape-setting curved steering section to position a distal opening of the catheter adjacent to a treatment site; (ii) actuating the first steering element to steer the first steering element in a first direction within a first plane and deactivating the shape-setting curve steering element such that a distal opening of the steerable catheter is oriented toward the defect site; (iii) deploying a medical device through the distal opening. [Brief explanation of the drawings]

[0022] [Figure 1A] FIG. 1A is a schematic diagram of a prior art steerable catheter having a single steering section. [Figure 1B] FIG. 1B is a schematic diagram of the steerable catheter of FIG. 1A during deployment of a self-expanding deployment structure through the distal end of the catheter. [Figure 2A] FIG. 2A is a schematic diagram of a steerable catheter according to a first embodiment of the present invention in an unactuated (straight) configuration. [Figure 2B] FIG. 2B is a schematic diagram of the steerable catheter of FIG. 2A in an actuated configuration. [Figure 3A] FIG. 3A is a schematic diagram of the steerable catheter of FIG. 2A showing the arc traced by the distal end of the catheter upon actuation of the first steering portion. [Figure 3B] FIG. 3B shows an enlarged view of area A of FIG. 3A. [Figure 4] FIG. 4 shows an example of a self-expanding deployment structure 50 in an expanded state beyond the distal end of a steerable catheter. [Figure 5] Figure 5 shows a portion of the descending aorta with a tear in its wall. [Figure 6A] FIG. 6A shows a steerable catheter positioned adjacent to the cleft. [Figure 6B] FIG. 6B shows the application of a patch to the cleft. [Figure 7] FIG. 7 is a schematic diagram of the system of the present invention being used to repair a tear in the wall of the ascending aorta. [Figure 8] FIG. 8 is a further schematic diagram of a patch deployment system of the present invention including a handle structure. [Figure 9] Figures 9(a)-9(f) show the steerable catheter of the present invention in various operational configurations. [Figure 10a] FIG. 10a is a schematic cross-sectional view of the proximal shaft of a catheter according to the present invention. [Figure 10b] FIG. 10b is a schematic cross-sectional view of the second (proximal) steering section of a catheter according to the present invention. [Figure 10c] FIG. 10c is a schematic cross-sectional view of a connector portion of a catheter according to the present invention. [Figure 10d] FIG. 10d is a schematic cross-sectional view of the first (distal) steering section of a catheter according to the present invention. DETAILED DESCRIPTION OF THE INVENTION

[0023] In the following description, the catheters of the present invention will be described in detail, with particular reference to the catheters of the first and second aspects of the invention, and to the extent that any feature described herein is common to one or more aspects of the invention, it will be understood that the present disclosure is applicable to all aspects of the invention.

[0024] The steerable catheters of the first and second aspects of the present invention are generally defined by a distal end and a proximal end. The distal end includes a distal opening, and an internal lumen extends through the catheter to the distal opening. A steering zone is provided adjacent the distal end, the steering zone including a first steering section and a second steering section disposed proximal to the first steering section along the longitudinal axis of the catheter. The catheter generally further includes a substantially straight shaft extending from the proximal end to the second steering section, and optionally a tip extending from the first steering section to the distal end.

[0025] The first steering section and the second steering section are independently actuatable to steer in opposite directions. It has been found that a steerable catheter according to the present invention overcomes the drawbacks of steerable catheters having only a single steering section, as discussed above.

[0026] Actuation of the first steering element has the effect of orienting the distal end of the catheter toward the sidewall of the blood vessel at the site requiring treatment. This achieves the correct orientation of the distal opening for proper medical device deployment while also displacing the distal end from the longitudinal axis of the catheter toward the treatment site (referred to herein as the "forward direction"). As discussed above, this displacement can result in the distal end of the catheter contacting and distorting against the wall of the anatomical lumen at the treatment site and / or leaving insufficient space between the distal opening of the catheter and the treatment site for proper medical device deployment.

[0027] The provision of a second steering element addresses this challenge by allowing the distal end of the catheter to be displaced away from the treatment site (referred to herein as the "rearward direction"), thereby compensating for the forward displacement of the distal end caused by actuation of the first steering element. This allows the distal opening of the catheter to be oriented toward the treatment site while creating free space between the distal opening and the treatment site to allow for proper treatment device deployment.

[0028] The longitudinal axis of the catheter is defined as the central axis of the internal lumen, determined just proximal to the steering zone. Thus, the distal end of the catheter is aligned with the longitudinal axis when both steering sections are positioned at a steering angle of 0°. The steering angle of the second steering section is always determined relative to the longitudinal axis of the catheter.

[0029] The motion of the catheter can be described with reference to two perpendicular planes, each parallel to and intersecting the longitudinal axis of the catheter. The first plane is defined as the steering plane of the first steering section. The second plane is parallel to, intersecting the longitudinal axis of the catheter and perpendicular to the first plane.

[0030] The first and second planes may be defined by referencing Cartesian coordinates, with the longitudinal axis of the catheter defined as the y-axis. The steering plane of the first steering element is defined as the xy plane. Steering the first steering element in a first direction in the first plane results in a displacement of the distal end of the catheter in a forward direction (defined herein as the x+ direction in the xy plane). Steering the second steering element in a second direction causes a compensating displacement of the distal end of the catheter in a backward direction (i.e., the x- direction in the xy plane). When both the first steering element and the second steering element are actuated, the steering zone has a generally S-shaped configuration.

[0031] Using the same Cartesian coordinate system, the second plane is the yz-plane. According to a first aspect of the invention, the catheter is configured such that the distal end of the catheter cannot intersect the second plane when the second steering section is positioned at its maximum steering angle.

[0032] Thus, the first steering section and the second steering section cooperate such that any movement of the distal end of the catheter in the x+ direction upon actuation of the first steering section is fully compensated when the second steering section is actuated to its maximum steering angle, and there is no net forward movement of the distal end of the catheter out of the second plane towards the treatment site.

[0033] In other words, the catheter is configured such that when the second steering element is actuated to the maximum steering angle, the arc traversed by the distal end of the catheter upon actuation of the first steering element does not intersect with the second plane, thereby creating a free space between the distal end of the catheter and the treatment site located in the forward direction, allowing the medical device to be deployed from the distal opening of the catheter without causing distortion at the treatment site.

[0034] Whereas catheters of the type described in Patent Document 2 (WO 2021 / 058602) having only a single steering element inevitably cause displacement of the catheter tip from the longitudinal axis towards the treatment site, the catheter of the present invention provides a steering zone in which displacement of the distal end from the longitudinal axis towards the treatment site is compensated for by a second steering element.

[0035] The maximum steering angle of the first steering section defines the ability (maximum volume) of the catheter to orient the distal opening towards the treatment site. According to a second aspect of the invention, the first steering section has a maximum steering angle of at least 60°.

[0036] As used herein, the maximum steering angle of each control defines the maximum steering range of the control. For example, a control with a maximum steering angle of 60° can typically be steered through angles ranging from 0° to a maximum of 60° in each steering direction. The range of angles each control can assume is referred to herein as the "steering range."

[0037] The required steering angle depends on the shape of the anatomical lumen at the treatment site. For example, if the treatment site is essentially parallel to the longitudinal axis of the catheter, a steering angle greater than 90° is typically appropriate for the first steering section to allow for orientation of the distal opening toward the treatment site while accounting for the opposing curvature of the second steering section. For example, a steering angle of 110° for the first steering section will orient the catheter tip perpendicular to the longitudinal axis of the catheter when the second steering section employs a steering angle of 20°. In curved regions of the blood vessel, a lower steering angle may be sufficient to position the catheter tip perpendicular to the anatomical wall.

[0038] A preferred steerable catheter incorporates features of the catheters of both the first and second aspects of the present invention. Accordingly, a preferred steerable catheter according to the present invention comprises a longitudinal tube having a proximal end, a distal end with a distal opening, and an internal lumen extending to the distal opening; A steering zone is provided adjacent the distal end, the steering zone comprising: (i) a first control section; (ii) a second steering portion disposed proximal to the first steering portion along the longitudinal axis of the catheter; the first steering portion is independently operable to steer in a first direction within a first plane, the first plane being parallel to and intersecting a longitudinal axis of the catheter; the second steering section is independently operable to steer in a second direction opposite the first direction within the first plane; the steering zone is configured such that, when the second steering section is actuated to a maximum steering angle, the distal end cannot intersect with a second plane, the second plane being parallel to and intersecting the longitudinal axis of the catheter and perpendicular to the first plane; The first control section has a maximum control angle of at least 60°.

[0039] The steerable catheters according to the first and second aspects of the invention are preferably configured such that when the second steering element is actuated to its maximum steering angle, the distal end of the catheter is spaced from the second plane by a minimum distance throughout the steering range of the first steering element, optionally the minimum distance is at least 0.1 mm, or at least 0.5 mm, or at least 1 mm, or at least 2 mm, or at least 5 mm, or at least 10 mm, or at least 15 mm, or at least 20 mm, or at least 25 mm, or at least 30 mm.

[0040] In other words, the steerable catheter of the present invention is preferably configured such that when the second steering section is actuated to its maximum steering angle, the minimum distance between the arc traced by the distal end of the catheter up to the first steering angle and the second plane is at least 0.1 mm, at least 0.5 mm, at least 1 mm, at least 2 mm, at least 5 mm, at least 10 mm, at least 15 mm, at least 20 mm, at least 25 mm, or at least 30 mm.

[0041] Generally, the further the distal end of the catheter is positioned from the second plane, the more free space is available for deployment of a medical device through the distal opening of the catheter.

[0042] Preferably, the first control section has a maximum steering angle (in the first direction) of at least 60°, or at least 70°, or at least 80°, or at least 90°. More preferably, the first control section has a maximum steering angle greater than 90°, for example at least 100°, at least 110°, or at least 120°, or at least 130°, or at least 140°, or at least 150°, or at least 160°. Optionally, the maximum steering angle of the first control is 270° or less, or 240° or less, or 210° or less, or 180° or less, or 170° or less.

[0043] The first steering element preferably has a steering range (in the first direction) of 0° to at least 60°, or 0° to at least 70°, or 0° to at least 80°, or 0° to at least 90°. More preferably, the first steering element has a steering range greater than 0° to 90°, for example 0° to at least 100°, or 0° to at least 110°, or 0° to at least 120°, or 0° to at least 130°, or 0° to at least 140°, or 0° to at least 150°, or 0° to at least 160°.

[0044] Optionally, the first steering section has a steering range (in the first direction) of 0° to 270° or less, or 0° to 240° or less, or 0° to 210° or less, or 0° to 180° or less, or 0° to 170° or less.

[0045] The first control element preferably has a steering radius at its maximum steering angle in the range of 5 mm to 200 mm, or 5 mm to 100 mm, or 8 mm to 50 mm, or 10 mm to 40 mm, or 12 mm to 30 mm, or 15 mm to 25 mm, where the steering radius of the first control element as defined herein is measured relative to the centerline of the first control element.

[0046] The second control element preferably has a maximum steering angle (in the second direction) of at least 10°, or at least 20°, or at least 30°, or at least 40°, or at least 50°, or at least 60°, or at least 70°, or at least 80°, or at least 90°. Optionally, the maximum steering angle of the second control element is 210° or less, 180° or less, or 150° or less, or 120° or less, or 110° or less, or 100° or less.

[0047] The second steering section preferably has a steering range of 0° to at least 10°, or 0° to at least 20°, or 0° to at least 30°, or 0° to at least 40°, or 0° to at least 50°, or 0° to at least 60°, or 0° to at least 70°, or 0° to at least 80°, or 0° to at least 90°.

[0048] Optionally, the second steering section has a steering range (in the second direction) of 0° to 210° or less, 0° to 180° or less, 0° to 150° or less, 0° to 120° or less, 0° to 110° or less, 0° to 100° or less, 0° to 90° or less, 0° to 80° or less, 0° to 70° or less, 0° to 60° or less, or 0° to 50° or less.

[0049] The second control element preferably has a steering radius at its maximum steering angle in the range of 10 mm to 700 mm, or 10 mm to 500 mm, or 15 mm to 200 mm, or 25 mm to 150 mm, or 30 mm to 120 mm, or 35 mm to 100 mm, or 40 mm to 80 mm, or 40 mm to 60 mm, or 40 mm to 50 mm. The steering radius of the second control element as defined herein is measured relative to the centerline of the first control element.

[0050] It is not excluded that the second control element can be steered in a different plane relative to the first control element (i.e., so that the displacement includes a z-direction component using the above-mentioned Cartesian coordinate system). However, the angle of the second control element is defined here in the second direction (x-direction) and therefore excludes any z-direction component. In other words, the angle of the second control element is defined in a planar view as determined by looking along the z-direction. Preferably, the first control element and the second control element steer in substantially the same plane (e.g., the steering planes differ by no more than ±30°, preferably no more than ±20°, more preferably no more than ±10°, more preferably no more than ±5°, when viewed along the y-axis). Most preferably, the first control element and the second control element steer in the same plane. For the avoidance of doubt, the first plane (xy plane) is defined here when the steering angle of the second control element is 0°.

[0051] Preferably, the first steering element and the second steering element are independently operable to orient the distal end of the steerable catheter perpendicular to the longitudinal axis of the catheter. It will be understood that the distal end of the steerable catheter is oriented perpendicular to the longitudinal axis when the difference between the steering angle of the first steering element in a first direction and the steering angle of the second steering element in a second direction is 90°. Thus, it is preferred that the first steering element have a maximum steering angle of at least (90+n)° and the second steering element have a maximum steering angle of at least n°, where n is at least 10, or at least 20, or at least 30, or at least 40, or at least 50.

[0052] Preferably, the maximum steering angle of the first control section is at least 100°, or at least 110°, or at least 120°, or at least 130°, or at least 140°, or at least 150°, or at least 160°, and the maximum steering angle of the second control section is at least 10°.

[0053] More preferably, the maximum steering angle of the first control section is at least 100°, or at least 110°, or at least 120°, or at least 130°, or at least 140°, or at least 150°, or at least 160°, and the maximum steering angle of the second control section is at least 30°.

[0054] More preferably, the maximum steering angle of the first control section is at least 100°, or at least 110°, or at least 120°, or at least 130°, or at least 140°, or at least 150°, or at least 160°, and the maximum steering angle of the second control section is at least 50°.

[0055] More preferably, the maximum steering angle of the first control section is at least 100°, or at least 110°, or at least 120°, or at least 130°, or at least 140°, or at least 150°, or at least 160°, and the maximum steering angle of the second control section is at least 70°.

[0056] More preferably, the first steering element and the second steering element are independently operable to orient the distal end of the steerable catheter such that when the distal end is oriented in the vertical direction and when the second steering element is simultaneously actuated to a maximum steering angle, the distal end is perpendicular to the longitudinal axis of the steerable catheter and the minimum distance between the distal end of the steerable catheter and the second plane is at least 0.1 mm, at least 0.5 mm, or at least 1 mm, at least 2 mm, at least 5 mm, at least 10 mm, at least 15 mm, at least 20 mm, at least 25 mm, or at least 30 mm.

[0057] In particular, the steerable catheter of the present invention is preferably configured such that the first steering section and the second steering section are independently operable to orient the distal end of the steerable catheter perpendicular to the longitudinal axis of the steerable catheter when the second steering section is actuated to its maximum steering angle. Preferably, the minimum distance between the distal end of the catheter and the second plane in said configuration is at least 0.1 mm, or at least 0.5 mm, or at least 1 mm, or at least 2 mm, or at least 5 mm, or at least 10 mm, or at least 15 mm, or at least 20 mm, or at least 25 mm, or at least 30 mm.

[0058] The dimensions of the steering zone are selected so that the steerable catheter is operable within the anatomical lumen requiring treatment. Generally, for cardiovascular uses, the first steering section preferably has a length ranging from 5 mm to 180 mm, or from 10 mm to 180 mm, or from 20 mm to 150 mm, or from 30 mm to 120 mm, or from 40 mm to 100 mm, or from 45 mm to 90 mm, or from 50 mm to 80 mm. The length of the first steering section is defined as the circumference of the first steering section at its maximum steering angle.

[0059] The second control section preferably has a length in the range of 5 mm to 180 mm, or 10 mm to 180 mm, or 20 mm to 150 mm, or 30 mm to 120 mm, or 40 mm to 100 mm, or 45 mm to 90 mm, or 50 mm to 80 mm. The length of the second control section is defined as the circumference of the second control section at its maximum control angle.

[0060] More preferably, both the first control element and the second control element have a length in the range of 5 mm to 180 mm, or 10 mm to 180 mm, or 20 mm to 150 mm, or 30 mm to 120 mm, or 40 mm to 100 mm, or 45 mm to 90 mm, or 50 mm to 80 mm, each length defined as the circumference of each control element at its maximum steering angle.

[0061] Optionally, the first steering portion has a length L1 and the second steering portion has a length L2, where L1>L2.

[0062] Preferably, the sum of L1+L2 is in the range of 10 to 200 mm, or 20 to 200 mm, or 25 to 150 mm, or 30 mm to 120 mm.

[0063] The steering zone optionally further comprises a substantially linear connector disposed between the first steering section and the second steering section. The effect of the linear connector is to increase the displacement of the distal end of the catheter in the rearward direction substantially in proportion to its length. The connector can have a length L3, where L3 is in the range of 5 mm to 100 mm, or 10 mm to 90 mm, or 15 mm to 80 mm, or 20 mm to 70 mm, or 25 mm to 60 mm, or 30 mm to 50 mm.

[0064] Preferably, the steering zone has a total length (L1+L2+L3) in the range of 20mm to 300mm, or 50mm to 300mm, or 55mm to 250mm, or 60mm to 200mm, or 65mm to 180mm, or 70mm to 160mm, or 75mm to 150mm.

[0065] Each steering section may be independently steerable in one or two directions. If each steering section is steerable in one direction, as described above, the respective steering directions must be opposite (bidirectional) in the first plane. However, this does not preclude one or both steering sections from being steerable in both directions. It will be understood that only configurations in which the first and second steering sections are steered in opposite directions are suitable for deployment of a medical device, utilizing the catheter's ability to create free space. However, the ability to steer both steering sections in the same direction may be useful during guidance of the steerable catheter to the treatment site.

[0066] In one configuration, the first control section and the second control section are each steerable in opposite directions.

[0067] In another configuration, the first control section is steerable in both directions and the second control section is steerable in a single direction.

[0068] In another configuration, the first control section is steerable in a single direction and the second control section is steerable in both directions.

[0069] In another configuration, the first control section and the second control section are each steerable in both directions.

[0070] Unless otherwise specified, references herein to the steering angles of the first and second control units refer to the steering angle of the first control unit in a first steering direction and the steering angle of the second control unit in a second steering direction (i.e., the opposite direction).

[0071] If the first control unit is bidirectional, the maximum steering angle in the second steering direction may be the same as or different from the maximum steering angle in the first steering direction. Similarly, if the second control unit is bidirectional, the maximum steering angle in the first steering direction may be the same as or different from the maximum steering angle in the second steering direction.

[0072] As noted above, catheters of the present invention generally include a proximal shaft extending from the proximal end to the steering zone. The purpose of the proximal shaft is primarily to span the distance between an insertion site, such as an incision, through which the catheter is inserted into an anatomical lumen, and the treatment site. This shaft is generally substantially straight, although it is not excluded that the shaft may have one or more pre-defined curves. This shaft may be resiliently flexible so that it can conform to the local shape of the anatomical lumen between the insertion site and the treatment site.

[0073] The steerable catheter may optionally further comprise a tip extending distally from the first steering section to the distal end. The tip is essentially the non-steerable terminal portion of the catheter tube. Because the tip extends beyond the first steering section, it increases the proximity of the distal end to the second plane and / or the treatment site. In other words, the tip reduces the free space between the distal opening and the treatment site. Therefore, the length of the tip, defined herein as L4, is preferably 50 mm or less, 40 mm or less, 30 mm or less, 20 mm or less, 10 mm or less, 8 mm or less, 6 mm or less, 5 mm or less, 4 mm or less, or 2 mm or less. Nevertheless, a straight tip of a significant length may facilitate deployment of the medical device from the distal opening because the medical device does not flex within the curvature of the first steering section immediately prior to deployment.

[0074] The steering zone preferably has an outer diameter of about 13.3 mm (40 Fr), about 6.7 mm (20 Fr), about 6 mm (18 Fr), about 4.7 mm (14 Fr), about 3.3 mm (10 Fr), about 2.7 mm (8 Fr), about 2 mm (6 Fr), or about 1.7 mm (5 Fr). The catheter, including the steering zone, is substantially uniform from the proximal end to the distal end and is about 13.3 mm (40 Fr), about 8.3 mm (25 Fr), about 6 mm (18 Fr), about 4.7 mm (14 Fr), about 3.3 mm (10 Fr), or about 2.7 mm (8 Fr), or about 7 mm (7 Fr), or about 2 mm (6 Fr), or about 1.7 mm (5 Fr). One French gauge unit is equivalent to 1 / 3 mm, so 18 Fr is equivalent to 6 mm.

[0075] The interior lumen of the steerable catheter preferably has a circular cross section.

[0076] As used herein, the term "independently actuatable" means that the first steering portion and the second steering portion are actively steerable independently of one another during application of the actuation mechanism. Some known catheters include passively deflectable elastic zones, but passive deflection relies on contact between the catheter and the sidewall of the anatomical lumen and therefore cannot create free space.

[0077] Preferably, actuation of the steering elements is by first and second pull wires configured to actuate the first and second steering elements, respectively, and each pull wire is preferably disposed within one or more guide lumens extending from the proximal end of the catheter to the steering zone.

[0078] The catheter optionally includes a handle portion at a proximal end including a first actuator and a second actuator configured to manually actuate the first steering portion and the second steering portion, respectively. Each actuator may be configured as a circular band rotatable around the handle. Each actuator may be lockable so that the steering angle is fixed even when the actuator is released.

[0079] Alternatively, the proximal end of the catheter may include an electronic actuator and, optionally, an interface for a computer to facilitate computer actuation of the first and second controls. The proximal end of the catheter may further include means for connecting the catheter to a robotic arm.

[0080] If one or both of the first and second control sections are steerable in two directions, an additional pull wire may be provided to actuate steering in both directions.

[0081] The catheters of the present invention can be manufactured from a variety of materials and combinations of materials, such as stainless steel, nitinol, and polymers (e.g., PTFE extrusions) of different durometers and lengths. The catheter structure can include multiple layers, such as coiled pipe, metal or polymer wire, braided structures, and polymer extrusions forming separate lumens. The layers within the catheter body can be continuous or discontinuous along the entire axis, tailored to achieve the desired flexibility for each section. The steerable catheter optionally further includes an outer coating, such as a polymer coating, that provides a smooth catheter surface, which can reduce friction and trauma during insertion. The catheter optionally further includes an inner liner, such as a polymer liner, more preferably a fluoropolymer liner, which forms the wall of the inner lumen and can provide a smooth inner surface with a low coefficient of friction.

[0082] The first and second steering sections can each have directional anisotropy, such that the resistance of each steering section to bending within the steering plane is lower than the resistance to bending in directions outside the steering plane. In other words, there can be limited directional freedom in the flexibility of each steering section, such that each steering section is relatively flexible in the intended steering direction and relatively inflexible in other directions. As a result, the deflection of each steering section is substantially constrained to the intended steering direction.

[0083] In conventional steerable catheters, where the purpose of steerability is primarily to facilitate guidance of the catheter tip through complex anatomical structures, it is advantageous for the steering zone to have multiple steering degrees of freedom so that the catheter tip can be steered as needed to achieve the desired guidance. However, the catheter of the present invention addresses a different function: the need to create free space between the catheter tip and the sidewall of the anatomy. Creating free space requires actuation of two steering sections, controlling both the relative direction of steering of each steering section and the steering angle of each steering section.

[0084] When the control elements have multiple degrees of freedom, simultaneously maneuvering both control elements in a manner that creates the required free space in the required direction is complex to achieve, requiring simultaneous control of each control angle and each control direction. Furthermore, the possibility of passive deflection of the control zone due to anatomical structures presents another potential difficulty in achieving the relative positioning of both control elements required to achieve free space.

[0085] By limiting the directional degrees of freedom of each steering section, the present invention provides a steerable catheter that is optimized for the purpose of creating free space and is easier to both steer and manufacture.

[0086] Thus, the first steering element preferably has less resistance to bending in the first plane (xy plane) than in the second plane (yz plane). Preferably, the resistance to bending in the first plane is 50% or less, or 20% or less, or 10% or less, or 5% or less of the resistance to bending in the second plane. More preferably, the first steering element is inflexible in the second plane (yz plane in both z- and z+ directions).

[0087] Optionally, the first control is bidirectionally flexible in a first plane (x+ and x- directions), so that the first control is steerable throughout the first plane, but is relatively inflexible or even inflexible in a second plane (yz plane in both z- and z+ directions), in which case the first control has two directional degrees of freedom (i.e., forward (x+) and backward (x-)).

[0088] Alternatively, the first steering element may have a lower resistance to bending in the forward direction (x+ direction) compared to both the rearward direction (x- direction) and the z- direction, such that the first steering element is flexible in the forward direction (x+ direction) in a first plane, but is relatively inflexible or even inflexible in both the rearward direction (x- direction) and a second plane (yz plane in the z- direction and z+ direction). In this case, the first steering element has one directional degree of freedom (i.e., the forward direction (x+)).

[0089] Similarly, the second steering section preferably has less resistance to bending in the steering plane than it does to bending perpendicular to the steering plane.

[0090] As mentioned above, the steering plane of the second control unit is preferably the same as the steering plane of the first control unit (i.e., the xy plane), although it is not excluded that the steering planes of the first and second control units can be offset such that the steering plane of the second control unit includes a z-direction component. In the following discussion, steering of the second control unit is described with reference to forward and rearward directions, which generally correspond to the x+ and x- directions, respectively, but optionally have a z-direction component.

[0091] Preferably, the bending resistance of the second control section in the control plane is 50% or less, or 20% or less, or 10% or less, or 5% or less of the bending resistance in a direction perpendicular to the control plane. More preferably, the second control section is inflexible in a direction perpendicular to the control plane.

[0092] Optionally, the second control unit is flexible in both directions (forward and rearward) in the control plane so as to be steerable throughout the control plane, but is relatively inflexible or even inflexible in a direction perpendicular to the control plane, in which case the second control unit has two directional degrees of freedom (forward and rearward in the control plane).

[0093] Alternatively, the second control section has less resistance to bending in the aft direction than in both the forward direction and the direction perpendicular to the control plane, while the first control section is flexible in the aft direction in the control plane, while being relatively inflexible or even inflexible in both the forward direction and the direction perpendicular to the control plane, in which case the second control section has one degree of freedom (aft in the control plane).

[0094] If the first and second control elements have directional anisotropy, the control planes of the first and second control elements preferably have fixed relative orientations, in other words, the first and second control elements are preferably connected (optionally via a connection) such that the control planes cannot rotate relative to each other.

[0095] Preferably, the first steering section and the second steering section have a fixed relative orientation, with both steering planes being the first plane (x-y plane). Preferably, the first steering section and the second steering section each comprise an articulating hypotube section. As used herein, an articulating hypotube section refers to a catheter hypotube section having a plurality of flexibility-enhancing features that impart increased flexibility to the hypotube section in the intended steering plane relative to flexibility out of the steering plane. Preferably, the flexibility-enhancing features comprise a plurality of cuts in the hypotube wall, the geometry or pattern of the cuts being selected together to increase the flexibility of the catheter in the intended steering direction and define the steering range (maximum steering angle) of the steering section.

[0096] More preferably, the steering zone (comprising the first and second steering sections and, optionally, a connector disposed between the first and second steering sections) is integrally formed from a single hypotube with first and second articulation zones corresponding to the first and second steering sections, respectively. Optionally, a non-articulation zone corresponding to the connector is provided between the first and second articulation zones. Preferably, each of the first and second articulation zones comprises a plurality of cuts in the hypotube wall, the cut pattern in each of the first and second articulation zones being selected to enhance flexibility of each steering section in its respective steering direction.

[0097] The hypotube can be used in combination with other components that provide additional functionality to the steering zone. For example, the hypotube can be surrounded by an outer jacket comprising one or more layers, such as a coiled pipe, a metal or polymer wire, or a braided structure. The outer jacket can optionally further comprise a polymer coating extending the entire length of the catheter. The hypotube can also comprise an inner liner, such as a polymer liner, more preferably a fluoropolymer liner, that forms the wall of the catheter lumen in the steering zone. The inner liner optionally extends the entire length of the catheter's internal lumen. An inner liner can be useful to reduce the coefficient of friction of the catheter's inner wall.

[0098] An additional advantage of using an articulated steering zone in the catheters of the present invention is that the flexibility of the steering zone is substantially increased relative to the flexibility of the proximal shaft. In conventional steerable catheters, the force applied to the pull wire to actuate the steering zone acts not only on the steering zone but can also act on the proximal portion of the catheter shaft, resulting in unwanted deformation of the catheter shaft in addition to the desired steering action at the distal portion of the catheter. Deformation of the catheter shaft is undesirable because it reduces control over catheter tip placement and can introduce forces into the anatomical structures between the catheter insertion point and the treatment site. Thus, it has been discovered that the catheters of the present invention allow actuation of both portions of the steering zone without substantial deformation of the proximal shaft of the catheter, thereby avoiding the need for additional measures (e.g., stiffening members) to reduce deformation of the proximal shaft.

[0099] Where it is not necessary to provide additional measures, such as stiffening members, to reduce deformation of the proximal shaft, the catheters of the present invention can have a high ratio of internal lumen diameter to outer diameter in the proximal shaft. Preferably, the ratio of internal lumen diameter to outer diameter of the catheter in the proximal shaft is at least 0.60, or at least 0.65, or at least 0.70, or at least 0.75, or at least 0.80, or at least 0.85, or at least 0.90.

[0100] More preferably, the ratio of the inner lumen diameter to the outer diameter of the catheter is at least 0.60, or at least 0.65, or at least 0.70, or at least 0.75, or at least 0.80, or at least 0.85, or at least 0.90 throughout the proximal shaft and steering zone.

[0101] The catheters of the present invention may optionally further comprise a carrier catheter extending through the inner lumen of the steerable catheter, the carrier catheter being axially movable relative to the steerable catheter. The carrier catheter preferably has an inner lumen and is passively flexible in response to actuation of the steerable catheter.

[0102] The third and fourth aspects of the present invention correspond in all respects to the first and second aspects of the present invention, except that the second steering section is replaced by a shape-set curve steering section. As used herein, a shape-set curve steering section refers to a steering section of a catheter that adopts a preset curve in the absence of any actuation force and can be steered in a direction opposite to the direction of the preset curve. Thus, the second steering section and the shape-set curve steering section perform the same function, except that the effect of actuation is opposite. The first steering section requires actuation to increase the angle of the curve in the second direction, whereas the shape-set curve steering section requires actuation to decrease the angle of the curve in the second direction.

[0103] Thus, these two catheter designs are complementary to each other, allowing for either active or passive curvature of the proximal steering section in the deployed configuration.

[0104] Thus, all features disclosed with respect to the catheters of the first and second aspects of the present invention are applicable to equivalent catheters in which the second steering section is replaced by a shape-setting bending steering section that bends in a second direction and is independently operable to steer in a first direction. This applies in particular, but not exclusively, to features of the first steering section (including its dimensions and maximum steering angle), the substantially straight connecting section, the tip section, the shaft section, the tip section, and the proximal section (including the handle, actuator, and / or electronic interface).

[0105] A preferred catheter incorporates features of both the third and fourth catheters. Therefore, a preferred steerable catheter is a longitudinal tube having a proximal end, a distal end with a distal opening, and an internal lumen extending to the distal opening; A steering zone is provided adjacent the distal end, the steering zone comprising: (i) a first steering element, the first steering element being independently operable to steer in a first direction within a first plane, the first plane being parallel to and intersecting a longitudinal axis of the catheter; (ii) a shape-setting bending steering section disposed proximal to the first steering section along a longitudinal axis of the steerable catheter, the shape-setting bending steering section being independently operable to bend in a second direction and steer in the first direction, the second direction being opposite to the first direction; the steering zone is configured such that when the shape-setting curve steering section is not actuated, the distal end of the catheter cannot intersect a second plane, the second plane being parallel to and intersecting the longitudinal axis of the catheter and perpendicular to the first plane; The first control section has a maximum control angle of at least 60°.

[0106] The catheter according to the third aspect of the invention is preferably configured such that the distal end of the catheter is spaced from the second plane by a minimum distance throughout the steering range of the first steering portion, optionally the minimum distance being at least 0.1 mm, or at least 0.5 mm, or at least 1 mm, or at least 2 mm, or at least 5 mm, or at least 10 mm, or at least 15 mm, or at least 20 mm, or at least 25 mm, or at least 30 mm.

[0107] In other words, the catheter of the first aspect of the present invention is configured so that the minimum distance between the arc traced by the distal end of the catheter when the first steering section is actuated to its maximum steering angle and the second plane is at least 0.1 mm, at least 0.5 mm, at least 1 mm, at least 2 mm, at least 5 mm, at least 10 mm, at least 15 mm, at least 20 mm, at least 25 mm, or at least 30 mm.

[0108] Preferably, the first steering element is independently actuatable to orient the distal end of the steerable catheter substantially perpendicular to the longitudinal axis of the catheter. Thus, the first steering element preferably has a maximum steering angle of at least (90+m)°, where m defines the angle of the shape-setting curve, e.g., m is at least 10, or at least 20, or at least 30, or at least 40, or at least 50.

[0109] Preferably, the angle of the shape-setting curve control section in the absence of actuation is in the range of 10° to 210°, or 10° to 180°, or 10° to 150°, or 10° to 120°, or 10° to 90°, or 15° to 60°, or 20° to 45°. As mentioned above, the angle of the shape-setting curve control section is defined herein without any component in the z-direction (i.e., in a plan view looking along the z-direction).

[0110] The shape-set curve steering section preferably has a steering radius at its maximum bend angle in the range of 10 mm to 700 mm, or 10 mm to 500 mm, or 15 mm to 200 mm, or 25 mm to 150 mm, or 30 mm to 120 mm, or 35 mm to 100 mm. The steering radius of the shape-set curve steering section as defined herein is measured relative to the centerline of the shape-set curve steering section.

[0111] The shape-set curve steering section preferably has a length in the range of 5 mm to 180 mm, or 10 mm to 180 mm, or 20 mm to 150 mm, or 30 mm to 120 mm, or 40 mm to 100 mm, or 45 mm to 90 mm, or 50 mm to 80 mm. The length of the shape-set curve steering section is defined as the circumference of the shape-set curve steering section at its shape-set angle.

[0112] Optionally, both the first steering section and the shape-set curve steering section have lengths in the range of 5 to 180 mm, or 10 mm to 180 mm, or 20 mm to 150 mm, or 30 mm to 120 mm, or 40 mm to 100 mm, or 45 mm to 90 mm, or 50 mm to 80 mm, each length being defined as a respective circumference as defined above.

[0113] Optionally, the first steering section has a length L1 and the shape-set curve steering section has a length L5, where L1>L5.

[0114] Preferably, the steering zone has a total length (L1+L3+L5) in the range of 20mm to 300mm, or 50mm to 300mm, or 55mm to 250mm, or 60mm to 200mm, or 65mm to 180mm, or 70mm to 160mm, or 75mm to 150mm.

[0115] Preferably, actuation of the first steering portion is by a first pull wire, suitably disposed within a guide lumen extending from the proximal end of the catheter to the steering zone.

[0116] According to the third and fourth aspects, the first steering section can be steerable in one direction or two directions. If the first steering section is steerable in one direction, the steering direction must be opposite to the curvature of the shape-setting curve, as described above. As described above, a configuration in which the first steering section is steered in the opposite direction to the shape-setting curve is suitable for deploying a medical device while utilizing the ability of the catheter of the present invention to create free space. However, the ability to steer the first steering section in the same direction as the shape-setting curve may be useful during guidance of the steerable catheter to the treatment site.

[0117] According to the third and fourth aspects, the first steering portion can have directional anisotropy, such that the resistance of the first steering portion to bending in the steering plane is lower than the resistance to bending in directions outside the steering plane.

[0118] Thus, the first steering element preferably has less resistance to bending in the first plane (xy plane) than in the second plane (yz plane). Preferably, the bending resistance in the first plane is 50% or less, or 20% or less, or 10% or less, or 5% or less of the bending resistance in the second plane. More preferably, the first steering element is inflexible in the second plane (yz plane in both z- and z+ directions).

[0119] Optionally, the first control is bidirectionally flexible in a first plane (x+ and x- directions), so that the first control is steerable throughout the first plane, but is relatively inflexible or even inflexible in a second plane (yz plane in both z- and z+ directions), in which case the first control has two directional degrees of freedom (i.e., forward (x+) and backward (x-)).

[0120] Alternatively, the first steering portion may have a lower resistance to bending in the forward direction (x+ direction) compared to both the backward direction (x-direction) and the z-direction, such that the first steering portion is flexible in the forward direction (x+ direction) within a first plane, but is relatively inflexible or even inflexible in both the backward direction (x-direction) and a second plane (yz plane in both the z-direction and z+ direction).

[0121] In this case, the first control element has one directional degree of freedom (i.e., forward (x+)). If the first control element has directional anisotropy, the control plane of the first control element preferably has a fixed relative orientation to the control plane of the shape-set curve control element.

[0122] Preferably, the control planes of the first control section and the shape-set curve control section are both in the first plane (xy plane). Also, preferably, the shape-set curve control section has a lower resistance to bending in the control plane than in a direction perpendicular to the control plane. Preferably, the bending resistance of the shape-set curve control section in the control plane is 50% or less, or 20% or less, or 10% or less, or 5% or less of the bending resistance in a direction perpendicular to the control plane. More preferably, the shape-set curve control section is inflexible in a direction perpendicular to the control plane.

[0123] The fifth and sixth aspects of the present invention provide a system for deploying a patch in an anatomical lumen, comprising a catheter according to any one of the first to fourth aspects of the present invention and a self-expanding deployment structure as described above.

[0124] The self-expanding deployment structure is configured to deploy the patch into a defect in an anatomical lumen. The self-expanding deployment structure is configured to hold the patch in a folded configuration while in an unexpanded state and to unfold to deploy the patch after self-expanding to an expanded state. Preferably, the self-expanding deployment structure in the expanded state supports the deployed patch in a plane substantially perpendicular to the end of the catheter. In this way, the self-expanding deployment structure forms a support substantially perpendicular to the longitudinal axis of the pusher wire, which can then be used to press the patch against the patch application site.

[0125] An example of a suitable self-expanding deployment structure for use in the system of the present invention is disclosed in Patent Document 2 (WO 2021 / 058602). The deployment device described in Patent Document 2 (WO 2021 / 058602) includes a pusher wire having a proximal end and a distal end, and a plurality of deployment wires, each having a first end and a second end, the first end and the second end connected to the distal end of the pusher wire. Each deployment wire is configured to be in an unexpanded state when disposed within and constrained by a catheter, and to self-expand to an expanded state when disposed beyond the distal end of the catheter. In the expanded state, at least a portion of each deployment wire lies substantially in a plane substantially perpendicular to the longitudinal axis of the pusher wire and has an asymmetric configuration when viewed along a direction parallel to the longitudinal axis of the pusher wire. In the expanded state, the plurality of deployment wires are configured to be utilized to apply a patch to an application site.

[0126] Optionally, the system of the present invention comprises a steerable catheter according to the present invention and an inner carrier catheter as described above, wherein the self-expanding deployment structure is configured to be disposed within and constrained within an inner lumen of the carrier catheter, which is itself configured to be disposed within the inner lumen of the steerable catheter. Preferably, the distal end of the carrier catheter is generally aligned or movable into alignment with the distal end of the steerable catheter.

[0127] Seventh and eighth aspects of the present invention provide methods of patching a defect site in an anatomical lumen using the systems of the fifth and sixth aspects, respectively.

[0128] According to the seventh and eighth aspects of the present invention, the anatomical lumen may be a blood vessel and the defect site may be a cardiovascular defect, such as a tear or other injury in the cardiovascular wall. Optionally, the cardiovascular defect may be a defect in the wall of the aorta. The defect may be located in the ascending or descending aorta. Optionally, the cardiovascular defect is an aortic dissection.

[0129] The patch is releasably attached to the self-expanding deployment structure prior to application to the defect site. Releasably attaching the patch to multiple self-expanding deployment structures means that the patch can be released from the deployment wire once positioned and secured to the defect site. The patch can be releasably attached to the self-expanding deployment structure by dissolvable sutures that dissolve upon contact with anatomical fluids (such as blood), thereby releasing the patch from the deployment structure immediately after deployment.

[0130] The ninth and tenth aspects of the invention provide general methods of using the catheters of the invention to deploy medical devices.

[0131] Various features of the present invention will be described with reference to the accompanying drawings, which are intended to be non-limiting.

[0132] FIG. 1A is a schematic diagram of a prior art catheter 10. The catheter 10 has a proximal end 11 (not shown) and a distal end 12 with a distal opening. A longitudinal shaft 13 extends to a single steering section 14 that terminates in a distal tip 15. The longitudinal axis of the catheter is indicated by a dotted line 16, and arrows 17 and 18 indicate forward and rearward directions, respectively, relative to the orientation of the distal end of the catheter. The steering section 14 is shown to be at an angle of approximately 90° after actuation. Actuation results in the catheter's distal end 12 being displaced from the longitudinal axis 16 in the forward direction 17 so as to contact the wall of an anatomical lumen 19 at a treatment site 20.

[0133] 1B shows a schematic diagram of the catheter of FIG. 1A during the advancement of a self-expanding deployment structure 21 beyond the distal end of the catheter. The self-expanding deployment structure contacts and strains against the wall of the anatomical lumen 19, causing deformation of the wall of the treatment site 20.

[0134] 2A shows a schematic diagram of a catheter 30 according to a first embodiment of the present invention in an unactuated (straight) configuration. Catheter 30 has a proximal end 31 (not shown) and a distal end 32 with a distal opening. A longitudinal shaft 33 extends to a steering zone 34 with a first steering section 35, a second steering section 36, and a junction 37 between the first and second steering sections. A distal tip 38 is located distal to the steering zone. The longitudinal axis of the catheter is indicated by a dotted line 39, and arrows 40 and 41 indicate the forward (x+) and rearward (x-) directions, respectively.

[0135] Figure 2B shows a schematic diagram of the catheter 30 of Figure 2A in an actuated configuration. The first steering element is actuated to steer in a first direction, and the second steering element is actuated to steer in a second direction in a first plane that is parallel to and intersects the longitudinal axis 39 of the catheter. The steering angle 44 of the second steering element is defined by the longitudinal axis of the catheter 39 and dotted line 42. The steering angle 45 of the first steering element is defined by dotted lines 42, 43. The distal end 38 of the catheter does not intersect the second plane that is parallel to and intersects the longitudinal axis 39 of the catheter, but is perpendicular to the first plane. Instead, the distal end 38 of the catheter is spaced from the longitudinal axis by a distance 48, which represents the free space achieved by the catheter in the illustrated configuration.

[0136] 3A shows a schematic diagram of the catheter of FIG. 2A, where dotted line 46 indicates the arc traversed by the distal end 38 of the catheter as the first steering section is actuated from 0° to its maximum steering angle 47. Arc 46 does not intersect a second plane that is parallel to the longitudinal axis 39 of the catheter and perpendicular to the first plane.

[0137] Figure 3B shows an enlarged view of region A of Figure 3A. Distance 48 represents the minimum distance between the distal end 38 of the catheter and a second plane that is parallel to and intersects the longitudinal axis 39 of the catheter and perpendicular to the first plane.

[0138] 4 shows an example of a self-expanding deployment structure 50 in an expanded state beyond the distal end 38 of the catheter 30. The self-expanding deployment structure includes a plurality of deployment wires 51 and a pusher wire 52 connected to the deployment wires 51 at their distal ends.

[0139] The procedure for utilizing the patch deployment system will now be described with reference to Figures 5, 6A and 6B.

[0140] FIG. 5 depicts a portion of the descending aorta 55, the wall of which has a breach 56. This results in blood flow into an area known as a false lumen 57. FIG. 6A shows the steerable catheter 30 positioned adjacent to the breach 56 in the aortic wall 55. The first steering section 35 and the second steering section 36 are actuated to steer in opposite directions to create free space between the distal end 38 of the catheter and the breach 56 in the aortic wall. This free space allows the self-expanding deployment structure 50 to be advanced from the distal end 38 of the catheter through the distal opening without causing any strain on the damaged aortic wall. FIG. 6B depicts a patch 58 applied to the breach 56 by being compressed onto the breach by the self-expanding deployment structure 50, thereby blocking blood flow into the false lumen 57. The self-expanding deployment structure 50 can be retracted through the distal opening of the steerable catheter 30, where it is again in its unexpanded configuration. The steerable catheter 30 can then be removed from the aorta.

[0141] Another procedure for utilizing the patch deployment system of the present invention will now be described with reference to FIG.

[0142] FIG. 7 shows a portion of the ascending aorta 60, the wall of which has a cleft 61. A steerable catheter 30 according to the present invention is positioned adjacent to the cleft 61 by actuating the first steering element 35 and the second steering element 36 in opposite directions. The free space thus created allows the self-expanding deployment structure 50 to be advanced from the distal end 38 of the catheter through the distal opening without causing any strain on the damaged aortic wall. FIG. 7 demonstrates how the catheters and systems of the present invention can be used to create free space even in complex regions of the vasculature, as the steerable catheter can simultaneously function to help guide the distal end of the catheter to the treatment site and to create free space at the treatment site.

[0143] 8 shows a patch deployment system of the present invention having a handle structure 70 at the proximal end of the catheter. The handle includes a first actuator 71 for actuating the first steering element and a second actuator 72 for actuating the second steering element. The first actuator 71 is located distal to the second actuator 72, corresponding to the positions of the first and second steering elements. The steerable catheter 30 functions as an actively steerable guide catheter to obtain the correct orientation for deployment of the self-expanding deployment structure 50. An inner carrier catheter (not shown) is disposed within the interior lumen of the steerable catheter, and the self-expanding deployment structure 50 is disposed within the carrier catheter prior to deployment.

[0144] 9(a)-9(f) show catheters according to the present invention in various operational configurations, demonstrating the versatility of the catheters of the present invention.

[0145] 10a-10d show cross-sectional views of a catheter according to the present invention at various positions between the proximal and distal ends.

[0146] 10a shows a cross-sectional view of proximal shaft 80 as viewed from the proximal end. The proximal shaft comprises a catheter body 81 of any suitable construction, such as a coiled pipe construction, a braided construction, or a polymer extrusion, optionally with an outer polymer jacket and / or an inner liner. Catheter body 81 encloses an internal lumen 82. Extending through proximal shaft 80 are a first pullwire 83 in a first pullwire lumen 84 and a second pullwire 85 in a second pullwire lumen 86.

[0147] FIG. 10b shows a cross-sectional view of the second (proximal) steering section 88 as viewed from the proximal end. The second steering section is located at the distal end of the proximal shaft 80 and, in the illustrated embodiment, comprises an articulating hypotube section 89. Lateral sections 89a, 89b of the articulating hypotube comprise flexibility-enhancing features that increase the catheter's flexibility in the steering plane (from side to side as shown), while upper and lower sections 89c, 89d of the articulating hypotube are relatively inflexible, preventing bending of the second steering section in a direction perpendicular to the steering plane. The first and second pull wires and their respective lumens are shown in FIG. 10a. The distal end of the second pull wire is fixed such that tension in the second pull wire actuates the second steering section to steer it leftward as shown. The second steering section further comprises an outer jacket 90 and an inner liner 91.

[0148] FIG. 10c shows a cross-sectional view of connecting portion 92 from the proximal end. Connecting portion 92 is disposed between the first steering portion and the second steering portion. As shown, connecting portion comprises hypotube section 93 that is substantially rigid and inflexible along its entire length. Optionally, hypotube section 93 may be integrally formed with articulating hypotube section 89 of the second steering portion and / or articulating hypotube section 95 of the first steering portion (see below). First pullwire 83 and first pullwire lumen 84 extend through the connecting portion to the first steering portion. The connecting portion further comprises an outer jacket 90 and an inner liner 91.

[0149] FIG. 10d shows a cross-sectional view of the first (distal) steering section 94 from the proximal end. The first steering section is located at the distal end of the connecting section 92 and, in the illustrated embodiment, comprises an articulating hypotube section 95. Lateral sections 95a, 95b of the articulating hypotube comprise flexibility-enhancing features that increase the catheter's flexibility in the steering plane (from side to side as shown), while upper and lower sections 95c, 95d of the articulating hypotube are relatively inflexible, preventing bending of the first steering section in a direction perpendicular to the steering plane. A first pullwire 83 and a first pullwire lumen 84 extend through the first steering section. The distal end of the first pullwire is anchored so that tension in the first pullwire actuates the first steering section to steer it to the right as shown. The first steering section further comprises an outer jacket 90 and an inner liner 91.

[0150] Optionally, the articulating hypotubes 89, 95 of the first and second steering sections and the connecting section hypotube 93 can be integrally formed from a single hypotube having distinct articulation zones corresponding to the first and second steering sections and non-articulation zones corresponding to the connecting section. Similarly, the liner 91 and / or jacket 90 can each be integrally formed along the entire steering zone.

[0151] The present invention is further described with reference to the following non-limiting embodiments. A1) In a steerable catheter, the steerable catheter comprises a longitudinal tube having a proximal end, a distal end with a distal opening, and an internal lumen extending to the distal opening; A steering zone is provided adjacent the distal end, the steering zone comprising: (i) a first control section; (ii) a second steering portion disposed proximal to the first steering portion along the longitudinal axis of the catheter; the first steering portion is independently operable to steer in a first direction within a first plane, the first plane being parallel to and intersecting a longitudinal axis of the catheter; the second steering section is independently operable to steer in a second direction opposite the first direction; A steerable catheter, wherein the steering zone is configured such that when the second steering section is actuated to its maximum steering angle, the distal end cannot intersect a second plane, the second plane being parallel to the longitudinal axis of the catheter, intersecting the longitudinal axis of the steerable catheter, and perpendicular to the first plane.

[0152] A2) In a steerable catheter, the steerable catheter comprises a longitudinal tube having a proximal end, a distal end with a distal opening, and an internal lumen extending to the distal opening; A steering zone is provided adjacent the distal end, the steering zone comprising: (i) a first control section; (ii) a second steering portion disposed proximal to the first steering portion along the longitudinal axis of the catheter; the first steering portion is independently operable to steer in a first direction within a first plane, the first plane being parallel to and intersecting a longitudinal axis of the catheter; the second steering section is independently operable to steer in a second direction opposite the first direction; A steerable catheter, wherein the first steering section has a maximum steering angle of at least 60°.

[0153] A3) A steerable catheter according to embodiment A2, wherein the steering zone is configured such that when the second steering section is actuated to its maximum steering angle, the distal end cannot intersect with a second plane, the second plane being parallel to the longitudinal axis of the steerable catheter, intersecting the longitudinal axis of the steerable catheter, and perpendicular to the first plane.

[0154] A4) A steerable catheter according to embodiment A1 or embodiment A3, wherein the steering zone is configured such that when the second steering element is actuated to its maximum steering angle, the minimum distance between the distal end and the second plane is at least 0.1 mm, or at least 0.5 mm, or at least 1 mm, or at least 2 mm, or at least 5 mm, or at least 10 mm, or at least 15 mm, or at least 20 mm, or at least 25 mm, or at least 30 mm.

[0155] A5) A steerable catheter according to any one of embodiments A1-A4, wherein the first steering section has a maximum steering angle of at least 60°, or at least 70°, or at least 80°, or at least 90°, or at least 100°, or at least 110°, or at least 120°, or at least 130°, or at least 140°, or at least 150°, or at least 160°.

[0156] A6) A steerable catheter according to any one of embodiments A1-A5, wherein the first steering section has a maximum steering angle of 270° or less, or 240° or less, or at least 210° or less, or 180° or less, or 170° or less.

[0157] A7) A steerable catheter according to any one of embodiments A1-A6, wherein the second steering section has a maximum steering angle of at least 10°, or at least 20°, or at least 30°, or at least 40°, or at least 50°, or at least 60°, or at least 70°, or at least 80°, or at least 90°.

[0158] A8) A steerable catheter according to any one of embodiments A1 to A7, wherein the second steering section has a maximum steering angle of 210° or less, or 180° or less, or 150° or less, or 120° or less, or 110° or less, or 100° or less.

[0159] A9) A steerable catheter according to any one of embodiments A1 to A8, wherein the first steering section and the second steering section are independently operable to orient the distal end of the steerable catheter substantially perpendicular to the longitudinal axis of the catheter.

[0160] A10) A steerable catheter according to any one of embodiments A1-A9, wherein the maximum steering angle of the first steering element is at least 100°, or at least 110°, or at least 120°, or at least 130°, or at least 140°, or at least 150°, or at least 160°, and the maximum steering angle of the second steering element is at least 10°.

[0161] A11) A steerable catheter according to any one of embodiments A1-A10, wherein the maximum steering angle of the first steering element is at least 100°, or at least 110°, or at least 120°, or at least 130°, or at least 140°, or at least 150°, or at least 160°, and the maximum steering angle of the second steering element is at least 50°.

[0162] A12) A steerable catheter according to any one of embodiments A1-A11, wherein the maximum steering angle of the first steering element is at least 100°, or at least 110°, or at least 120°, or at least 130°, or at least 140°, or at least 150°, or at least 160°, and the maximum steering angle of the second steering element is at least 90°.

[0163] A13) The steerable catheter according to any one of embodiments A1 to A12, wherein the length of the first steering portion is in the range of 5 mm to 180 mm, or 10 mm to 180 mm, or 20 mm to 150 mm, or 30 mm to 120 mm, or 40 mm to 100 mm, or 45 mm to 90 mm, or 50 mm to 80 mm.

[0164] A14) The steerable catheter according to any one of embodiments A1 to A13, wherein the length of the second steering portion is in the range of 5 mm to 180 mm, or 10 mm to 180 mm, or 20 mm to 150 mm, or 30 mm to 120 mm, or 40 mm to 100 mm, or 45 mm to 90 mm, or 50 mm to 80 mm.

[0165] A15) A steerable catheter according to any one of embodiments A1-A14, wherein the first steering portion has a length L1 and the second steering portion has a length L2, where L1>L2.

[0166] A16) A catheter according to any one of embodiments A1 to A15, wherein the steering zone further comprises a substantially linear connection portion disposed between the first steering portion and the second steering portion.

[0167] A17) The steerable catheter according to embodiment A16, wherein the connecting portion has a length L3, L3 being in the range of 5 mm to 100 mm, or 10 mm to 90 mm, or 15 mm to 80 mm, or 20 mm to 70 mm, or 25 mm to 60 mm, or 30 mm to 50 mm.

[0168] A18) A steerable catheter according to any one of embodiments A1 to A17, wherein the steering zone has a total length (L1+L2+L3) in the range of 20mm to 300mm, or 50mm to 300mm, or 55mm to 250mm, or 60mm to 200mm, or 65mm to 180mm, or 70mm to 160mm, or 75mm to 150mm.

[0169] A19) The steerable catheter of any one of embodiments A1-A18, wherein the steerable catheter further comprises a tip extending distally from the first steering section to a distal end.

[0170] A20) A steerable catheter according to embodiment A19, wherein the tip has a length L4, and L4 is 50 mm or less, or 40 mm or less, or 30 mm or less, or 20 mm or less, or 10 mm or less, or 8 mm or less, or 6 mm or less, or 5 mm or less, or 4 mm or less, or 2 mm or less.

[0171] A21) A steerable catheter according to any one of embodiments A1-A20, wherein the outer diameter of the steering zone is 20 Fr or less, or 18 Fr or less, or 16 Fr or less, or 14 Fr or less, or 12 Fr or less, or 10 Fr or less.

[0172] A22) A steerable catheter according to any one of embodiments A1 to A21, wherein the steerable catheter comprises a first pull wire and a second pull wire configured to actuate the first steering section and the second steering section, respectively.

[0173] A23) A steerable catheter according to any one of embodiments A1 to A22, wherein the steerable catheter comprises a handle portion at a proximal end, the handle portion comprising a first actuator and a second actuator configured to actuate each of the first and second steering portions, respectively.

[0174] A24) The steerable catheter of any one of embodiments A1-A23, wherein the steerable catheter further comprises a carrier catheter extending therethrough, the carrier catheter being axially movable relative to the steerable catheter.

[0175] A25) A steerable catheter according to any one of embodiments A1-A24, wherein the first steering section has a lower resistance to bending in the first plane (xy plane) than in the second plane (yz plane), and the second steering section preferably has a lower resistance to bending in the steering plane than in a direction perpendicular to the steering plane.

[0176] A26) A steerable catheter according to embodiment A25, wherein the first steering section is flexible in both directions within the first plane and relatively inflexible or even inflexible within the second plane (yz plane in both the z- and z+ directions).

[0177] A27) A steerable catheter according to embodiment A25, wherein the first steering section is flexible in the forward direction (x+ direction) in a first plane and relatively inflexible or even inflexible in both the backward direction (x-direction) and in a second plane (yz plane in the z-direction and z+ direction).

[0178] A28) A steerable catheter in any one of embodiments A25-A27, wherein the second steering section is flexible in both directions in the steering plane (forward and backward) and relatively inflexible or even inflexible in a direction perpendicular to the steering plane.

[0179] A29) A steerable catheter according to any one of embodiments A25-A27, wherein the second steering section is flexible in a rearward direction in the steering plane and relatively inflexible or even inflexible in both a forward direction in the steering plane and a direction perpendicular to the steering plane.

[0180] A30) A steerable catheter according to any one of embodiments A25-A29, wherein the steering plane of the second steering portion is the first plane.

[0181] A31) The steerable catheter of any one of embodiments A25-A30, wherein the first steering section and the second steering section each comprise an articulated hypotube section.

[0182] A32) A steerable catheter according to embodiment A31, wherein the steering zone is integrally formed from a single hypotube comprising a first articular zone, a second articular zone, and optionally a non-articular zone between the first articular zone and the second articular zone.

[0183] A33) The steerable catheter of any one of embodiments A1-A32, wherein the steerable catheter further comprises a proximal shaft extending from the proximal end to the steering zone.

[0184] A34) A steerable catheter according to embodiment A33, wherein the ratio of inner lumen diameter to outer diameter of the catheter within the proximal shaft is at least 0.60, or at least 0.65, or at least 0.70, or at least 0.75, or at least 0.80, or at least 0.85, or at least 0.90.

[0185] A35) A steerable catheter according to embodiment A34, in which the ratio of the inner lumen diameter to the outer diameter of the catheter is at least 0.60, or at least 0.65, or at least 0.70, or at least 0.75, or at least 0.80, or at least 0.85, or at least 0.90 throughout the proximal shaft and steering zone.

[0186] A36) A system comprising a steerable catheter according to any one of embodiments A1-A35 and a carrier catheter extending through the steerable catheter, the carrier catheter being axially movable relative to the steerable catheter.

[0187] B1) In a steerable catheter, the steerable catheter comprises a longitudinal tube having a proximal end, a distal end with a distal opening, and an internal lumen extending to the distal opening; A steering zone is provided adjacent the distal end, the steering zone comprising: (i) a first steering element, the first steering element being independently operable to steer in a first direction within a first plane, the first plane being parallel to and intersecting a longitudinal axis of the steerable catheter; (ii) a shape-setting bending steering section disposed proximal to the first steering section along a longitudinal axis of the steerable catheter, the shape-setting bending steering section being independently operable to bend in a second direction and steer in the first direction, the second direction being opposite to the first direction; A steerable catheter, wherein the steering zone is configured such that when the shape-setting curved steering section is not actuated, the distal end of the catheter cannot intersect a second plane, the second plane being parallel to the longitudinal axis of the catheter, intersecting the longitudinal axis of the catheter, and perpendicular to the first plane.

[0188] B2) In a steerable catheter, the steerable catheter comprises a longitudinal tube having a proximal end, a distal end with a distal opening, and an internal lumen extending to the distal opening; A steering zone is provided adjacent the distal end, the steering zone comprising: (i) a first steering element, the first steering element being independently operable to steer in a first direction within a first plane, the first plane being parallel to and intersecting a longitudinal axis of the catheter; (ii) a shape-setting bending steering section disposed proximal to the first steering section along the longitudinal axis of the catheter, the shape-setting bending steering section bending in a second direction within the first plane and independently operable to steer in a first direction within the first plane, the second direction being opposite to the first direction; A steerable catheter, wherein the first steering section has a maximum steering angle of at least 60°.

[0189] B3) A steerable catheter according to embodiment B2, wherein the steering zone is configured so that the distal end cannot intersect with a second plane, the second plane being parallel to the longitudinal axis of the catheter and intersecting the longitudinal axis of the catheter and perpendicular to the first plane.

[0190] B4) A steerable catheter according to embodiment B1 or embodiment B3, wherein the steering zone is configured such that the minimum distance between the distal end and the second plane is at least 0.1 mm, or at least 0.5 mm, or at least 1 mm, or at least 2 mm, or at least 5 mm, or at least 10 mm, or at least 15 mm, or at least 20 mm, or at least 25 mm, or at least 30 mm.

[0191] B5) A steerable catheter according to any one of embodiments B1-B4, wherein the first steering section has a maximum steering angle of at least 60°, or at least 70°, or at least 80°, or at least 90°, or at least 100°, or at least 110°, or at least 120°, or at least 130°, or at least 140°, or at least 150°, or at least 160°.

[0192] B6) A steerable catheter according to any one of embodiments B1-B5, wherein the first steering section has a maximum steering angle of 270° or less, or 240° or less, or 210° or less, or 180° or less, or 170° or less.

[0193] B7) A steerable catheter according to any one of embodiments B1 to B6, wherein the shape-set curve steering section has a shape-set curve angle in the range of 10° to 210°, or 10° to 180°, or 10° to 150°, or 10° to 120°, or 10° to 90°, or 15° to 60°, or 20° to 45°.

[0194] B8) A steerable catheter according to any one of embodiments B1 to B7, wherein the first steering portion is operable to orient the distal end of the steerable catheter so that it is substantially perpendicular to the longitudinal axis of the catheter.

[0195] B9) A steerable catheter according to any one of embodiments B1-B8, wherein the maximum steering angle of the first steering section is at least 100°, or at least 110°, or at least 120°, or at least 130°, or at least 140°, or at least 150°, or at least 160°, and the shape-set bend angle of the shape-set bend steering section is at least 10°.

[0196] B10) A steerable catheter according to any one of embodiments B1-B9, wherein the maximum steering angle of the first steering section is at least 100°, or at least 110°, or at least 120°, or at least 130°, or at least 140°, or at least 150°, or at least 160°, and the shape-set bend angle of the shape-set bend steering section is at least 15°.

[0197] B11) A steerable catheter according to any one of embodiments B1-B10, wherein the maximum steering angle of the first steering section is at least 100°, or at least 110°, or at least 120°, or at least 130°, or at least 140°, or at least 150°, or at least 160°, and the shape-set bend angle of the shape-set bend steering section is at least 30°.

[0198] B12) The steerable catheter according to any one of embodiments B1 to B11, wherein the length of the first steering portion is in the range of 5 mm to 180 mm, or 10 mm to 180 mm, or 20 mm to 150 mm, or 30 mm to 120 mm, or 40 mm to 100 mm, or 45 mm to 90 mm, or 50 mm to 80 mm.

[0199] B13) The steerable catheter according to any one of embodiments B1 to B12, wherein the length of the shape-set curved steering section is in the range of 5 mm to 180 mm, or 10 mm to 180 mm, or 20 mm to 150 mm, or 30 mm to 120 mm, or 40 mm to 100 mm, or 45 mm to 90 mm, or 50 mm to 80 mm.

[0200] B14) The steerable catheter of any one of embodiments B1-B13, wherein the first steering section has a length L1 and the shape-set curved steering section has a length L5, where L1>L5.

[0201] B15) A catheter according to any one of embodiments B1 to B14, wherein the steering zone further comprises a substantially linear connection portion disposed between the first steering portion and the shape-set curved steering portion.

[0202] B16) A steerable catheter according to embodiment B15, wherein the connecting portion has a length L3, and L3 is in the range of 5 mm to 100 mm, or 10 mm to 90 mm, or 15 mm to 80 mm, or 20 mm to 70 mm, or 25 mm to 60 mm, or 30 mm to 50 mm.

[0203] B17) A steerable catheter according to any one of embodiments B1-B16, wherein the steering zone has a total length (L1+L5+L3) in the range of 20mm to 300mm, or 50mm to 300mm, or 55mm to 250mm, or 60mm to 200mm, or 65mm to 180mm, or 70mm to 160mm, or 75mm to 150mm.

[0204] B18) The steerable catheter of any one of embodiments B1-B17, further comprising a tip extending distally from the first steering section to the distal end.

[0205] B19) A steerable catheter according to embodiment B18, wherein the tip has a length L4, where L4 is 50 mm or less, or 40 mm or less, or 30 mm or less, or 20 mm or less, or 10 mm or less, or 8 mm or less, or 6 mm or less, or 5 mm or less, or 4 mm or less, or 2 mm or less.

[0206] B20) The steerable catheter of any one of embodiments B1-B19, wherein the steering zone outer diameter is 20 Fr or less, or 18 Fr or less, or 16 Fr or less, or 14 Fr or less, or 12 Fr or less, or 10 Fr or less.

[0207] B21) A steerable catheter according to any one of embodiments B1-B20, comprising a first pull wire configured to actuate the first steering portion.

[0208] B22) A steerable catheter according to any one of embodiments B1 to B21, wherein the steerable catheter comprises a handle portion at a proximal end, the handle portion comprising a first actuator configured to actuate the first steering portion.

[0209] 23) The steerable catheter of any one of embodiments B1 to B22, wherein the steerable catheter further comprises a carrier catheter extending therethrough, the carrier catheter being axially movable relative to the steerable catheter.

[0210] B24) A steerable catheter according to any one of embodiments B1-B23, wherein the first steering section has a lower resistance to bending in the first plane (xy plane) than to bending in the second plane (yz plane).

[0211] B25) A steerable catheter according to embodiment B24, wherein the first steering section is flexible in both directions within a first plane and relatively inflexible or even inflexible within a second plane (the yz plane in both the z- and z+ directions).

[0212] B26) A steerable catheter according to embodiment B24, wherein the first steering section is flexible in the forward direction (x+ direction) in a first plane and relatively inflexible or even inflexible in the backward direction (x-direction) and in a second plane (yz plane in both the z-direction and z+ direction).

[0213] B27) The steerable catheter of any one of embodiments B24-B26, wherein the shape-set curved steering section has lower resistance to bending in the steering plane than to bending in a direction perpendicular to the steering plane.

[0214] B28) The steerable catheter of any one of embodiments B1-B27, wherein the steerable catheter further comprises a proximal shaft extending from the proximal end to the steering zone.

[0215] B29) The steerable catheter of embodiment B28, wherein the ratio of inner lumen diameter to outer diameter of the catheter within the proximal shaft is at least 0.60, or at least 0.65, or at least 0.70, or at least 0.75, or at least 0.80, or at least 0.85, or at least 0.90.

[0216] B30) The steerable catheter of embodiment B29, wherein the ratio of the inner lumen diameter to the outer diameter of the catheter is at least 0.60, or at least 0.65, or at least 0.70, or at least 0.75, or at least 0.80, or at least 0.85, or at least 0.90 throughout the proximal shaft and steering zone.

[0217] B31) A system comprising a steerable catheter according to any one of embodiments B1-B30 and a carrier catheter extending through the steerable catheter, the carrier catheter being axially movable relative to the steerable catheter.

[0218] C1) A system for deploying a patch into an anatomical lumen, comprising: The system comprises: (a) a steerable catheter as defined in any of embodiments A1-A35; (b) a deployment device, the deployment device comprising: (i) a self-expanding deployment structure configured to be in an unexpanded state when disposed within and constrained within the interior lumen of the steerable catheter, and configured to self-expand to an expanded state when displaced through the distal opening and beyond the distal end of the catheter; (ii) a deployment device comprising a pusher wire axially movable within the internal lumen of the catheter to move a self-expanding deployment structure between an unexpanded state within the catheter and an expanded state beyond the distal end of the catheter.

[0219] C2) The self-expanding deployment structure includes a plurality of deployment wires, each of which: (i) having a first end and a second end, the first end and the second end being connected to a distal end of the pusher wire; (ii) A system according to embodiment C1, which is configured to be in an unexpanded state when placed within the catheter and restrained, and which is configured to self-expand to an expanded state when placed beyond the distal end of the catheter and unrestrained, wherein in the expanded state at least a portion of the wire is disposed substantially in a plane substantially perpendicular to the longitudinal axis of the pusher wire.

[0220] C3) A system according to embodiment C1 or C2, wherein each deployment wire has an asymmetric configuration when viewed along a direction parallel to the longitudinal axis of the pusher wire.

[0221] C4) A system according to any one of embodiments C1 to C3, wherein the system further comprises a patch releasably attached to the self-expanding deployment structure.

[0222] C5) The system according to embodiment C4, wherein the patch is a cardiovascular repair patch.

[0223] C6) A system according to any one of embodiments C1 to C5, wherein the system further comprises a carrier catheter, the carrier catheter being configured to be disposed within the internal lumen of the steerable catheter and to be axially movable, and the self-expanding deployment structure being configured to be disposed within and constrained within the internal lumen of the carrier catheter.

[0224] D1) A system for deploying a patch into an anatomical lumen, comprising: The system comprises: (a) a steerable catheter as defined in any of embodiments B1-B24; (b) a deployment device, the deployment device comprising: (i) a self-expanding deployment structure configured to be in an unexpanded state when disposed within and constrained within the interior lumen of the steerable catheter, and configured to self-expand to an expanded state when displaced through the distal opening and beyond the distal end of the catheter; (ii) a pusher wire axially movable within the internal lumen of the catheter to move the self-expanding deployment structure between an unexpanded state within the catheter and an expanded state beyond the distal end of the catheter.

[0225] D2) The self-expanding deployment structure comprises a plurality of deployment wires, each deployment wire comprising: (i) having a first end and a second end, the first end and the second end being connected to a distal end of the pusher wire; (ii) A system according to embodiment D1, configured to be in an unexpanded state when placed within the catheter and restrained, and configured to self-expand to an expanded state when placed beyond the distal end of the catheter and unrestrained, wherein in the expanded state at least a portion of the wire is positioned substantially in a plane substantially perpendicular to the longitudinal axis of the pusher wire.

[0226] D3) A system according to embodiment D1 or D2, wherein each deployment wire has an asymmetric configuration when viewed along a direction parallel to the longitudinal axis of the pusher wire.

[0227] D4) A system according to any one of embodiments D1 to D3, wherein the system further comprises a patch releasably attached to the self-expanding deployment structure.

[0228] D5) The system according to embodiment D4, wherein the patch is a cardiovascular repair patch.

[0229] D6) A system according to any one of embodiments D1 to D5, wherein the system further comprises a carrier catheter, the carrier catheter being configured to be disposed within an internal lumen of a steerable catheter and to be axially movable, and the self-expanding deployment structure being configured to be disposed within and constrained within the internal lumen of the carrier catheter.

[0230] E1) A method of patching a defect in an anatomical lumen, comprising: The method comprises: (i) providing a system as defined in embodiment C4 or C5, wherein the self-expanding deployment structure is disposed in an unexpanded state within an internal lumen of a catheter and is constrained, and the self-expanding patch deployment structure comprises a patch releasably attached to the self-expanding patch deployment structure; (ii) inserting a catheter into the anatomical lumen such that a distal end of the catheter is positioned adjacent the defect site; (iii) actuating the first steering element and the second steering element to orient the distal end of the steerable catheter to the defect site by steering the first steering element in a first direction within a first plane and steering the second steering element in a second direction within the first plane; (iv) advancing the pusher wire to move the self-expanding patch deployment structure beyond the distal end of the catheter to an expanded state; (v) applying the patch to the defect; (v) releasing the patch from a self-expanding patch deployment structure; (vi) withdrawing the pusher wire to retract the self-expanding patch deployment structure to an unexpanded state within the interior lumen of the catheter; (vii) removing the catheter from the anatomical lumen.

[0231] E2) The method according to embodiment E1, wherein the anatomical lumen is a blood vessel and the defect site is a cardiovascular defect.

[0232] E3) The method according to embodiment E2, wherein the cardiovascular defect is a defect in the wall of the aorta.

[0233] E4) The method of embodiment E3, wherein the cardiovascular defect is an aortic dissection.

[0234] E5) The method according to embodiment E1, wherein the defect site is a cardiovascular defect.

[0235] F1) A method of patching a defect in an anatomical lumen, comprising: The method comprises: (i) providing the system defined in embodiment D4 or D5, wherein the self-expanding deployment structure is disposed and constrained in an unexpanded state within an internal lumen of a catheter, and further comprising a patch releasably attached to the self-expanding patch deployment structure; (ii) inserting the catheter into the anatomical lumen while actuating the shape-setting curved steering section to position the distal end of the catheter adjacent the defect site; (iii) actuating the first steering element to steer the first steering element in a first direction within a first plane and deactivating the shape-setting curve steering element such that the distal end of the steerable catheter is oriented toward the defect site; (iv) advancing the pusher wire to move the self-expanding patch deployment structure beyond the distal end of the catheter to an expanded state; (v) applying said patch to the defect site; (v) releasing the patch from a self-expanding patch deployment structure; (vi) withdrawing the pusher wire to retract the self-expanding patch deployment structure to an unexpanded state within the interior lumen of the catheter.

[0236] F2) The method of embodiment F1, wherein the anatomical lumen is a cardiovascular lumen and the defect site is a cardiovascular defect.

[0237] F3) The method according to embodiment F2, wherein the cardiovascular defect is a defect in the wall of the aorta.

[0238] F4) The method according to embodiment F3, wherein the cardiovascular defect is an aortic dissection.

[0239] F5) The method according to embodiment F1, wherein the defect site is a cardiovascular defect.

[0240] G1) A method of deploying a medical device using a steerable catheter as defined in any of embodiments A1-A35, The method comprises: (i) inserting a catheter into an anatomical lumen adjacent to a treatment site; (ii) actuating the first steering element and the second steering element to orient the distal end of the catheter to the defect site by steering the first steering element in a first direction within a first plane and steering the second steering element in a second direction within the first plane; (iii) deploying a medical device through the distal opening.

[0241] H1) A method of deploying a medical device using a catheter as defined in any of embodiments B1-B24, The method comprises: (i) inserting the catheter into an anatomical lumen while actuating a shape-setting curved steering section to position a distal opening of the catheter adjacent to a treatment site; (ii) actuating the first steering element to steer the first steering element in a first direction within a first plane and deactivating the shape-setting curve steering element such that a distal opening of the steerable catheter is oriented toward the defect site; (iii) deploying a medical device through the distal opening.

Claims

1. In a steerable catheter, the steerable catheter comprises a longitudinal tube having a proximal end, a distal end with a distal opening, and an internal lumen extending to the distal opening; A steering zone is disposed adjacent the distal end, the steering zone comprising: (i) a first control; (ii) a second steering portion disposed proximal to the first steering portion along the longitudinal axis of the steerable catheter; the first steering section is independently operable to steer in a first direction within a first plane, the first plane being parallel to and intersecting a longitudinal axis of the steerable catheter; the second steering section is independently operable to steer in a second direction opposite the first direction; the steering zone is configured such that when the second steering element is actuated to its maximum steering angle, the distal end cannot intersect with a second plane; The second plane is parallel to and intersects the longitudinal axis of the steerable catheter and is perpendicular to the first plane.

2. 2. The steerable catheter of claim 1, wherein the steering zone is configured such that when the second steering portion is actuated to its maximum steering angle, the minimum distance between the distal end and the second plane is at least 0.1 mm, or at least 0.5 mm, or at least 1 mm, or at least 2 mm, or at least 5 mm, or at least 10 mm, or at least 15 mm, or at least 20 mm, or at least 25 mm, or at least 30 mm.

3. 3. The steerable catheter of claim 1 or 2, wherein the first steering section has a maximum steering angle of at least 60°, or at least 70°, or at least 80°, or at least 90°, or at least 100°, or at least 110°, or at least 120°, or at least 130°, or at least 140°, or at least 150°, or at least 160°.

4. The steerable catheter of any one of claims 1 to 3, wherein the first steering section has a maximum steering angle of 270° or less, or 240° or less, or 210° or less, or 180° or less, or 170° or less.

5. 5. The steerable catheter of claim 1, wherein the second steering section has a maximum steering angle of at least 10°, or at least 20°, or at least 30°, or at least 40°, or at least 50°, or at least 60°, or at least 70°, or at least 80°, or at least 90°.

6. The steerable catheter of any one of claims 1 to 5, wherein the second steering section has a maximum steering angle of 210° or less, 180° or less, 150° or less, 120° or less, 110° or less, or 100° or less.

7. The steerable catheter of any one of claims 1 to 6, wherein the first steering section and the second steering section are independently operable to orient the distal end of the steerable catheter substantially perpendicular to the longitudinal axis of the steerable catheter.

8. 8. The steerable catheter of claim 1, wherein the maximum steering angle of the first steering section is at least 100°, or at least 110°, or at least 120°, or at least 130°, or at least 140°, or at least 150°, or at least 160°, and the maximum steering angle of the second steering section is at least 10°.

9. 9. The steerable catheter of claim 1, wherein the maximum steering angle of the first steering section is at least 100°, or at least 110°, or at least 120°, or at least 130°, or at least 140°, or at least 150°, or at least 160°, and the maximum steering angle of the second steering section is at least 50°.

10. 10. The steerable catheter of claim 1, wherein the length of the first steering section ranges from 5 mm to 180 mm, or from 10 mm to 180 mm, or from 20 mm to 150 mm, or from 30 mm to 120 mm, or from 40 mm to 100 mm, or from 45 mm to 90 mm, or from 50 mm to 80 mm.

11. 11. The steerable catheter of any one of claims 1 to 10, wherein the length of the second steering section ranges from 5mm to 180mm, or from 10mm to 180mm, or from 20mm to 150mm, or from 30mm to 120mm, or from 40mm to 100mm, or from 45mm to 90mm, or from 50mm to 80mm.

12. The steerable catheter of any one of claims 1 to 11, wherein the first steering section has a length L1 and the second steering section has a length L2, where L1 > L2.

13. the steering zone further comprises a substantially linear connection disposed between the first steering portion and the second steering portion; Optionally, the connecting portion has a length L3, wherein L3 ranges from 5 mm to 100 mm, or from 10 mm to 90 mm, or from 15 mm to 80 mm, or from 20 mm to 70 mm, or from 25 mm to 60 mm, or from 30 mm to 50 mm.

14. 14. The steerable catheter of any one of claims 1 to 13, wherein the steering zone has a total length (L1 + L2 + L3) in the range of 20 mm to 300 mm, or 50 mm to 300 mm, or 55 mm to 250 mm, or 60 mm to 200 mm, or 65 mm to 180 mm, or 70 mm to 160 mm, or 75 mm to 150 mm.

15. the steerable catheter further comprises a tip extending distally from the first steering section to the distal end; 15. The steerable catheter of any one of claims 1-14, wherein optionally the tip portion has a length L4, wherein L4 is 50 mm or less, 40 mm or less, 30 mm or less, 20 mm or less, 10 mm or less, 8 mm or less, 6 mm or less, 5 mm or less, 4 mm or less, or 2 mm or less.

16. The steerable catheter of any one of claims 1 to 15, wherein the steerable catheter comprises a first pull wire and a second pull wire configured to actuate the first steering section and the second steering section, respectively.

17. 17. A steerable catheter according to any one of claims 1 to 16, wherein the first steering section has a lower resistance to bending in the first plane (xy plane) than in the second plane (yz plane), and / or the second steering section preferably has a lower resistance to bending in the steering plane than in a direction perpendicular to the steering plane.

18. 18. The steerable catheter of claim 17, wherein the first steering section is flexible in both directions in the first plane and relatively inflexible or even inflexible in the second plane (yz plane in both the z- and z+ directions).

19. 18. The steerable catheter of claim 17, wherein the first steering section is flexible in the forward direction (x+ direction) in the first plane and relatively inflexible or even inflexible in the backward direction (x- direction) and in the second plane (yz plane in both z- and z+ directions).

20. 20. The steerable catheter of any one of claims 17 to 19, wherein the second steering section is flexible in both directions in the steering plane (forward and backward) and relatively inflexible or even inflexible in a direction perpendicular to the steering plane.

21. 20. The steerable catheter of any one of claims 17 to 19, wherein the second steering section is flexible in a rearward direction in the steering plane and relatively inflexible or even inflexible in both a forward direction in the steering plane and a direction perpendicular to the steering plane.

22. The steerable catheter of any one of claims 17 to 21, wherein the steering plane of the second steering section is the first plane.

23. The steerable catheter of any one of claims 17 to 22, wherein the first steering section and the second steering section each comprise an articulating hypotube section.

24. 24. The steerable catheter of claim 23, wherein the steering zone is integrally formed from a single hypotube, comprising a first articulation zone, a second articulation zone, and optionally a non-articulation zone between the first articulation zone and the second articulation zone.

25. The steerable catheter of any one of claims 1 to 24, further comprising a proximal shaft extending from the proximal end to the steering zone.

26. 26. The steerable catheter of claim 25, wherein the ratio of inner lumen diameter to outer catheter diameter within the proximal shaft is at least 0.60, or at least 0.65, or at least 0.70, or at least 0.75, or at least 0.80, or at least 0.85, or at least 0.

90.

27. 27. The steerable catheter of claim 26, wherein the ratio of the inner lumen diameter to the outer diameter of the steerable catheter throughout the proximal shaft and the steering zone is at least 0.60, or at least 0.65, or at least 0.70, or at least 0.75, or at least 0.80, or at least 0.85, or at least 0.

90.

28. In a steerable catheter, the steerable catheter comprises a longitudinal tube having a proximal end, a distal end with a distal opening, and an internal lumen extending to the distal opening; A steering zone is disposed adjacent the distal end, the steering zone comprising: (i) a first steering portion, the first steering portion independently operable to steer in a first direction within a first plane, the first plane being parallel to and intersecting a longitudinal axis of the steerable catheter; (ii) a shape-setting bend steering section disposed proximal to the first steering section along a longitudinal axis of the steerable catheter, the shape-setting bend steering section being bent in a second direction and independently operable to steer in the first direction, the second direction being opposite to the first direction; A steerable catheter, wherein the steering zone is configured such that when the shape-setting curved steering section is not actuated, the distal end of the steerable catheter cannot intersect a second plane, the second plane being parallel to the longitudinal axis of the steerable catheter, intersecting the longitudinal axis of the steerable catheter, and perpendicular to the first plane.

29. 30. The steerable catheter of claim 28, further comprising a carrier catheter extending therethrough, the carrier catheter being axially movable relative to the steerable catheter.

30. 1. A system for deploying a patch in an anatomical lumen, comprising: The system comprises: (a) a steerable catheter according to any one of claims 1 to 28; (b) a deployment device, the deployment device comprising: (i) a self-expanding deployment structure configured to be in an unexpanded state when disposed within and constrained within the interior lumen of the steerable catheter, and configured to self-expand to an expanded state when displaced through a distal opening and beyond the distal end of the steerable catheter; (ii) a deployment device comprising a pusher wire axially movable within the interior lumen of the steerable catheter to move the self-expanding deployment structure between an unexpanded state within the steerable catheter and an expanded state beyond the distal end of the steerable catheter.

31. The self-expanding deployment structure comprises a plurality of deployment wires, each deployment wire comprising: (i) having a first end and a second end, the first end and the second end being connected to the distal end of the pusher wire; and (ii) configured to be in an unexpanded state when disposed within and constrained by the steerable catheter, and configured to self-expand to an expanded state when disposed beyond the distal end of the catheter and unconstrained; 31. The system of claim 30, wherein in the expanded state, at least a portion of the pusher wire is disposed substantially in a plane substantially perpendicular to a longitudinal axis of the pusher wire.

32. 32. The system of claim 30 or 31, wherein the system further comprises a patch releasably attached to the self-expanding deployment structure, optionally the patch being a cardiovascular repair patch.

33. The system further includes a carrier catheter, the carrier catheter being configured to be axially movable within the interior lumen of the steerable catheter; The system of any one of claims 30 to 32, wherein the self-expanding deployment structure is configured to be disposed within and constrained within an internal lumen of the carrier catheter.

34. 1. A method of patching a defect site in an anatomical lumen, comprising: The method comprises: (i) providing a system according to any one of claims 31 to 33, wherein the self-expanding deployment structure is disposed and constrained in an unexpanded state within an internal lumen of a catheter, and further comprising a patch releasably attached to the self-expanding patch deployment structure; (ii) inserting the steerable catheter into the anatomical lumen so as to position a distal end of the steerable catheter adjacent a defect site within the anatomical lumen; (iii) actuating the first steering element and the second steering element to orient the distal end of the steerable catheter to the defect site by steering the first steering element in a first direction within a first plane and steering the second steering element in a second direction within the first plane; (iv) advancing a pusher wire to move a self-expanding patch deployment structure beyond the distal end of the steerable catheter to an expanded state; (v) applying the patch to the defect; (v) releasing the patch from the self-expanding patch deployment structure; (vi) withdrawing the pusher wire to retract the self-expanding patch deployment structure to an unexpanded state within the interior lumen of the steerable catheter; (vii) removing the steerable catheter from the anatomical lumen.

35. 35. The method of claim 34, wherein the anatomical lumen is a blood vessel and the defect site is a cardiovascular defect.

36. 36. The method of claim 35, wherein the cardiovascular defect is a defect in the aortic wall.

37. 37. The method of claim 36, wherein the cardiovascular defect is an aortic dissection.

38. A method of deploying a medical device using the catheter of any one of claims 1 to 29, comprising: The method comprises: (i) inserting a catheter into an anatomical lumen adjacent to the treatment site; (ii) actuating the first steering element and the second steering element to orient the distal end of the steerable catheter to the defect site by steering the first steering element in a first direction within a first plane and steering the second steering element in a second direction within the first plane; (iii) deploying the medical device through the distal opening.

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