Articulation device and method for tracking a curved surface of an organ

Abstract

An articulation system for a catheter has a top region, a bottom region, a distal region, a proximal region, a series of vertebrae, and a push-pull wire control system. The series of vertebrae has a distal vertebra and a subset series of vertebrae proximal of the distal vertebra, the series of vertebrae nested together and defining an articulable longitudinal axis through the series of vertebrae. The series of vertebrae is shaped and configured to passively pitch and roll, whereby the series of vertebrae maintains contact with a curved surface when the bottom region is pressed against the curved surface. The push-pull wire control system actively yaws the distal vertebra independently from the subset series of vertebrae and actively yaws the subset series of vertebrae independently from the distal vertebra.

Description

Atty Docket No. 2316.101.01WOARTICULATION DEVICE AND METHOD FOR TRACKINGA CURVED SURFACE OF AN ORGANTECHNICAL FIELD

[0001] Embodiments herein are related to medical devices and specifically to devices for accessing an organ.BACKGROUND

[0002] Catheters with articulating tips or sections are commonplace for navigating through vessels and within body cavities such as the abdomen, bladder, kidney calyx, chambers of the heart, bowels, and other body cavities. Each of these, however, is adapted and configured to function in a cavity, where they can articulate freely.

[0003] A special case exists, however, in the need to navigate the surface of the beating heart, the epicardium or epicardial surface. In this case, the catheter is not in a "cavity" with full degrees of freedom, such as a heart chamber or the bladder, because the catheter is being pushed and held against the organ.

[0004] In the case of ventricular tachycardia (VT), endocardial ablation using an articulating catheter inside the chambers of the heart is commonplace. In around 30% of VT cases, however, the foci for the arrhythmia is located on the outside surface of the heart, the epicardium. Many heart rhythm centers perform epicardial ablation using catheters and techniques designed for endocardial therapy. However, such catheters and techniques do not track the curvature of the heart, which can be of relatively short radii in some areas especially around the apex, thus limiting their ability to navigate to specific locations.

[0005] In another application, researchers are currently performing animal trials on new injectable compounds to be injected into the heart wall, such as the myocardium of the left ventricle among other locations. Such new injectates require precise location on the surface of the epicardium, and further require a matrix of injections, such as in a 4 x 5 matrix pattern. This requires accuracy and precision in the articulating catheter, hugging the surface and following the curvature and contours of the heart to position the tip ofAtty Docket No. 2316.101.01WO the catheter for such injections to be performed through the catheter's working channel.

[0006] However, there remains a need for a device to navigate under the pericardium to precise locations on the epicardial surface to implement a therapy or carry out a diagnostic and / or other new and useful methods or devices.SUMMARY

[0007] An exemplary articulation system for a catheter has a top region, a bottom region, a distal region, a proximal region, a series of vertebrae, and a push-pull wire control system. The series of vertebrae has a distal vertebra and a subset series of vertebrae proximal of the distal vertebra, the series of vertebrae nested together and defining an articulable longitudinal axis through the series of vertebrae. The series of vertebrae are shaped and configured to passively pitch and roll, whereby the series of vertebrae is configured to maintain contact with a curved surface when the bottom region is pressed against the curved surface, a normal of the curved surface defining a yaw axis of the articulation system. The push-pull wire control system is configured to (a) actively yaw the distal vertebra independently from the subset series of vertebrae, and (b)actively yaw the subset series of vertebrae independently from the distal vertebra.

[0008] An exemplary medical device for navigating a surface of an organ has the articulation system described above, a proximal handle, and a shaft. The proximal handle is configured for manipulating the push-pull wire control system, the handle having a housing and a tool access port. The shaft is coupled to a distal portion of the handle, the shaft having a longitudinal axis co-linear with a proximal end of the articulable longitudinal axis of the articulation system.

[0009] An exemplary method includes providing a medical device as described above, positioning the distal region between the curved surface of the organ and a compressive anatomical feature, and moving the distal region along the curved surface of the organ, whereby the articulation system passively pitches and rolls to conform to the curved surface. The method includes manipulating the second wire control system to activelyAtty Docket No. 2316.101.01WO yaw the subset series of vertebrae, and manipulating the first wire control system to actively yaw the distal vertebra.

[0010] This Summary is provided to introduce a selection of concepts in a simplified form that are further described below in the Detailed Description. This Summary is not intended to identify key features or essential features of the claimed subject matter, nor is it intended to be used as an aid in determining the scope of the claimed subject matter. The claimed subject matter is not limited to implementations that solve any or all disadvantages noted in the Background.BRIEF DESCRIPTION OF THE DRAWINGS

[0011] FIG. 1 is a perspective view of a portion of an exemplary medical device positioned the pericardial cavity and navigating a surface of the heart;

[0012] FIG. 2 is a perspective view of the medical device in Fig. 1;

[0013] FIG. 3 is a schematic top view illustrating an articulation system suitable for use in the medical device;

[0014] FIG. 4 is a perspective view of a series of vertebrae suitable for use in the articulation system;

[0015] FIG. 5 illustrates side and end views of a vertebra suitable for use in the articulation system;

[0016] FIG. 6 is a perspective view of some components suitable for use in the articulation system;

[0017] FIG. 7 is a schematic side view of some components suitable for use in the articulation system;

[0018] FIG. 8 is a schematic side view of some components suitable for use in the articulation system;

[0019] FIG. 9 is a side section view of some components suitable for use in the articulation system;

[0020] FIG. 10 is a top view of some components suitable for use in the articulation system; and

[0021] FIG. 11 is a flowchart of an exemplary method.Atty Docket No. 2316.101.01WODETAILED DESCRIPTION

[0022] Before providing a detailed description of embodiments disclosed herein, it is expedient to describe certain surgical procedures or needs, as well as to provide an overview. First, as an example, in some procedures, a surgeon must access the epicardium, which is the outermost layer of the heart wall and may be referenced herein as the heart surface, and / or the pericardial cavity, a thin, lubricious space that allows the heart to move smoothly within the pericardium. The pericardium or pericardial sac is a fibroserous membrane that surrounds the heart, providing protection, anchorage, and lubrication to reduce friction during heartbeats.

[0023] Commonly used means to access the epicardium are needles or similar probe devices which enter the chest of the patient though a small incision under the ribcage (subxiphoid) and create a puncture in the pericardial sac, entering under the pericardial sac. Two-dimensional fluoroscopy is commonly employed to help guide this process. Once the needle or probe is underneath the pericardial sac, a guidewire can be inserted into the pericardial space against the epicardium, and the needle or probe removed. This results in a guidewire from the pericardial cavity or epicardium to outside the body through the subxiphoid incision.

[0024] Because the pericardium performs important functions, it is desirable to avoid disturbing (e.g. heating during an ablation procedure or cutting) the pericardium as much as possible. It is also desirable for patient outcomes to avoid disturbing structures adjacent or near the heart as much as possible. This, however, presents other challenges for surgeons. Currently-available devices may be difficult to navigate within the pericardial cavity, particularly when precise locating procedures are required, and / or require the surgeon to disturb the pericardium or other structures more than they would like to do.

[0025] Embodiments of the invention described herein may therefore improve access and maneuverability within the pericardial cavity and / or within a space between two organs pressing against the device.Atty Docket No. 2316.101.01WO

[0026] Generally, embodiments herein include an articulating catheter that may be positioned in the pericardial cavity and pressed against the epicardial surface by the pericardium. That is, the pericardium may exert pressure downward on the catheter as it advances around the heart structure. For the catheter to remain in contact with the epicardial surface, it may be configured to adapt to the curvature of the heart, whether near the crown when radii are larger, or near the apex where radii are smaller. Further, the catheter only actively articulates in an X-Y (i.e., left and right) plane or relative to a yaw axis relative to the epicardial surface.

[0027] For the purposes of this document, unless otherwise stated, the term "proximal" shall be associated with an area near a user (not the patient) or user interface of a medical device or articulation system, and the term "distal" shall be associated with the area opposing the user, usually the area associated with the patient or working end of a medical device.

[0028] For the purpose of this document, the term "vertebra" shall mean a segment for use in a series of segments that allows bending (pitch), twisting (roll), or articulation (yaw). A "series of vertebrae" shall be understood to mean a plurality of vertebrae configured to mimic a substantially spinal motion.

[0029] Fig. 1 illustrates an example of how a medical device 100 for navigating a surface of the heart may function. As illustrated, a distal portion of the device 100 may be positioned in the pericardial cavity, and an articulation system 200 may provide a surgeon with the ability to access nearly any location on the surface of the beating heart.

[0030] Turning now to Fig. 2, a medical device 100 for navigating a surface of an organ according to some embodiments is first generally described. The medical device 100 has an articulation system 200, a proximal handle 300, and a shaft 400.

[0031] The proximal handle 300 is provided to allow a user, such as a physician, to manipulate a wire control system to control or articulate the articulation system 200 (which will be described below). The handle 300 may have a housing 302, a tool access port 304, a guidewire port 306, and / or a hood control interface 308. Those skilled in theAtty Docket No. 2316.101.01WO art will understand how the tool access port 304, guidewire port 306, hood control interface 308, and the associated tool(s) guidewire, and hood function and are used. For the purpose of this document, unless otherwise stated, a tool shall be understood to be a camera, fluid delivery system, therapeutic delivery system, tube, and / or any other item that is delivered to or through the distal end or end effector 514 of the medical device 100.

[0032] The shaft 400 may be coupled to a distal portion of the handle 300 such that a longitudinal axis A-A of the shaft 400 co-linear with a proximal end of an articulable longitudinal axis B-B of the articulation system 200. The shaft 400 may be coupled to the handle 300 and articulation system 200.

[0033] Simultaneously referencing Figs. 3 and 4, more details of the articulation system 200 are now described. Fig. 3 is a top view schematic (not to scale) illustrating general concepts of the articulation system 200, and Fig. 4 illustrates concepts of a series of vertebrae 500 that may be used in the articulation system 200. As shown in Fig. 3, the vertebrae 500 may be configured to "snake" along a curved surface of an organ, when pressed against the organ surface by another feature, such as a pericardium in the case of a heart, or another organ adjacent the primary organ surface. That is, the series of vertebrae 500 may be configured to passively pitch and roll, to maintain contact with the organ surface, and to actively yaw, to provide access to a desired location.

[0034] For the purpose of this document, the terms "passive" or "passively", when referencing pitch and roll movement of the vertebrae 500 is intended to mean that no controls in the system 200 or device 100 cause the pitch or roll movement; instead, it is external pressure, such as pressure from the pericardium or external organ, that causes the pitch and roll conformance to the surface of the organ. That is, "passive" and "passively" mean the articulation system 200 or device 100 does not have a mechanism to cause pitch and roll conformance to the surface of the organ.

[0035] Conversely, the term "active" or "actively", when referencing yaw movement of the vertebrae 500 is intended to mean that the articulation system 200 or device 100 has a mechanism to cause the movement, e.g. a push-pull wire control system 600.Atty Docket No. 2316.101.01WO

[0036] The articulation system 200 may be designed for use with a catheter for accessing an internal organ. The articulation system 200 may have a top region 202, a bottom region 204, a distal region 206, a proximal region 208, and a series of vertebrae 500.

[0037] The series of vertebrae 500 may have a distal vertebra 502 and a subset series of vertebrae 504 proximal of the distal vertebra 502. The series of vertebrae 500 may be nested together and define an articulable longitudinal axis B-B through the series of vertebrae 500.

[0038] Turning now briefly to Fig. 5, which illustrates end and side views of an exemplary vertebra 503 in the series of vertebrae 500 positioned on a surface, each of the series of vertebrae 500 may have a central passage 510 shaped and configured to accommodate a tool, such as a hood lift wire 702 (see Fig. 6) or other feature or equipment. In addition, although Fig. 6 illustrates the first wire set 602, 604 passing through a first set of specialized holes 630, 632 and the second wire set 606, 608 passing through a second set of specialized holes 634, 636, this is not required. For example, in some embodiments, the first set of wires 602, 604 may pass through the central passage 510 of the subset series of vertebrae 504, then couple to the distal vertebra 502. In some embodiments, the first set of wires 602, 604 passes through the central passage 510 of the subset series of vertebrae 504 and a central passage in another vertebra 503, before coupling to sides of the distal vertebra 502. That is, the first wire set 602, 604 may control a series of distal vertebrae, not just one vertebra 502, distal of the subset series of vertebrae 504. Those skilled in the art will recognize that control of the series of distal vertebrae can be achieved using the teachings presented herein.

[0039] In some embodiments, the first wire set 602, 604 may pass through a passage in all vertebrae except a distal vertebra 502 of the plurality of vertebra 500. Distal ends 640, 642 of the first wire set 602, 604 may couple to the distal vertebra 502.

[0040] In some embodiments, the second wire set 606, 608 may pass through a passage in all except a distalmost one 508 of the subset series of vertebrae 504. Distal ends 644,Atty Docket No. 2316.101.01WO646 of the second wire set 606, 608 may couple to the distalmost one 508 of the subset series of vertebrae 504.

[0041] Those skilled in the art will also recognize that the push-pull wire control system 600 may have other features not illustrated, such as wire guides or housings, to protect or control movement or locations of the wires.

[0042] The series of vertebrae 500 may be shaped and configured to passively pitch and roll to maintain contact with a curved surface when the bottom region 204 of the series of vertebrae 500 is pressed against the curved surface. The curved surface, such as a curved surface of a heart, may define pitch, roll, and yaw axes of the articulation system 200. For example, in some embodiments, the yaw axis is normal to the curved surface, while the roll axis may be parallel to the curved surface and co-linear with a longitudinal axis A-A, B-B defined by the vertebrae 500, and the pitch axis may be parallel to the curved surface and perpendicular to the longitudinal axis A-A, B-B. Those skilled in the art will recognize that the yaw axis adjusts based on the location of the device 100 relative to the surface it is pressed against.

[0043] The articulation system 200 may have a push-pull wire control system 600 configured to actively yaw the distal vertebra 502 independently from the subset series of vertebrae 504, and / or to actively yaw the subset series of vertebrae 504 independently from the distal vertebra 502. In some embodiments, the push-pull wire control system 600 is configured to actively yaw the distal vertebra 502 and a second distal vertebra 506 independently of the subset series of vertebrae 504.

[0044] With simultaneous reference now to Fig. 3 and Fig. 5, in some embodiments, the push-pull wire control system 600 may have a first wire set (see wires 602, 604) and a second wire set (see wires 606, 608).

[0045] The first wire set 602, 604 may be a first push-pull wire set having distal ends 640, 642 coupled to the distal vertebra 502 and manipulable by a first control wheel 210 (see also Fig. 2). The first wire set 602, 604 may pass through a passage or passages as illustrated in the subset series of vertebrae 504 and couple to the distal vertebra 502 using any means known to those skilled in the art.Atty Docket No. 2316.101.01WO

[0046] The second wire set 606, 608 may be a second push-pull wire set having distal ends 644, 646 coupled to a distal one 508 of the subset series of vertebrae 504 and manipulable by a second control wheel 212.

[0047] Manipulation of the first control wheel 210 may be configured to cause articulation of the distal vertebra 502.

[0048] Manipulation of the second control wheel 212 may be configured to cause articulation of the subset series of vertebrae 504.

[0049] In some embodiments, the first wire set 602, 604 has a first wire 602 passing through each of the subset series of vertebrae 504 and a second wire 604 passing through each of the subset series of vertebrae 504. The first wire 602 may be coupled to a first side of the distal vertebra 502, such as a right side (see Fig. 3). The second wire 604 may be coupled to a second side of the distal vertebra 502 (see Fig. 3).

[0050] In some embodiments, the second wire set 606, 608 has a third wire 606 passing through at least one of the subset series of vertebrae 504 and a fourth wire 608 passing through at least one of the subset series of vertebrae 504, the third wire 606 coupled to a first side of a distal one 508 of the subset series of vertebrae 504, the fourth wire 608 coupled to a second side of the distal one 508 of the subset series of vertebrae 504.

[0051] Figs. 7 and 8 are schematics of how the control wheels 210, 212 manipulate the wires 602, 604, 606, 608.

[0052] As illustrated in Fig. 7, a first control wheel 210 may be configured to control the first set of push-pull wires 602, 604. For example, proximal ends 614, 616 of the first wire set 602, 604 may be coupled to the first control wheel 210. The proximal ends 614, 616 may be coupled to the first control wheel 210 at a first radius r from a pivot center of the first control wheel 210. Those skilled in the art will recognize that this will result in a relatively small motion of the first wire set 602, 604 relative to a user's thumb motion on the wheel 210. For example, although the degree of rotation is the same for the wire ends and the wheel, the distance of movement of the first wire set 602, 604 may be relatively small. As a result, the first wire set 602, 604 may be configured to give a physician a fine control of the distal vertebra 502.Atty Docket No. 2316.101.01WO

[0053] As illustrated in Fig. 8, a second control wheel 212 may be configured to control the second set of push-pull wires 606, 608. For example, proximal ends 618, 620 of the second wire set 606, 608 may be coupled to the second control wheel 212. The proximal ends 618, 620 may be coupled to the second control wheel 212 a second radius R from a pivot center of the second control wheel 212. The second radius R may be greater than the first radius r. Those skilled in the art will recognize that this will result in a greater motion of the second wire set 606, 608 relative to the motion of the first wire set 602, 604. For example, although the degree of rotation is the same for the wire ends and the wheel 212, the distance of movement of the second wire set 606, 608 may be relatively large. As a result, the second wire set 606, 608 may be configured to give a physician course control of the subset series of vertebrae 504.

[0054] Those skilled in the art will recognize that although the fine control and distal vertebra 502 are associated with a first control wheel 210 and first wire set 602, 604, and the course control and proximal subset series of vertebrae 504 are associated with a second control wheel 212 and second wire set 606, 608, the physician is likely to manipulate the second control wheel 212 first, to place the distal end of the articulation system 200 or device 100 in a general position, then manipulate the first control wheel 210 to finetune a location of the distal vertebra 502 to carry out an action on the organ. This order of operation, however, is not necessary.

[0055] Those skilled in the art will also recognize that, although the figures illustrate the first wheel 210 to the user's left and the second wheel 212 to the user's right, this also is not necessary. The wheels could be positioned in any orientation or position that is suitable for the particular action to be carried out.

[0056] Continuing primarily with reference to Figs. 7-8, the articulation system 200 may be configured to lock the series of vertebrae 500 from passive yawing movement. In some embodiments, the push-pull wire control system 600 may have control wheels 210, 212 that are biased toward a lock direction. In some embodiments of the articulation system 200, the first control wheel 210 is biased toward a lock direction, whereby the first wire set 602, 604 is configured to lock the distal vertebra 502. In someAtty Docket No. 2316.101.01WO embodiments, the second control wheel 212 is biased toward a lock direction, whereby the second wire set 606, 608 is configured to lock the subset series of vertebrae 504.

[0057] The control wheels 210, 212 may be biased in a lock direction by a bias mechanism 622, 624, such as a spring. For example, the control wheels 210, 212 may be biased upward by springs 622, 624.

[0058] With brief reference to Fig. 9, which illustrates the second control wheel 212 side or right side, along with Fig. 6, one or both of the control wheels 210, 212 may be biased upward by a spring 622, 624 mounted or positioned on the handle housing 302. Teeth 626 on the control wheel(s) 210, 212 may engage corresponding teeth or surfaces (not shown) in the housing 302 to prevent the wheels 210, 212 from inadvertently turning. That is, the wheels 210, 212 may be configured to turn only when the user presses downward, thereby disengaging the wheel(s) 210, 212 from the housing 302 and allowing the user to manipulate the wheels 210, 212 to actively yaw the vertebra(e) 500, 502, 504.

[0059] Having the first control wheel 210 biased in a locked direction, e.g. up, has the effect of automatically locking the distal vertebra 502 in whatever yaw orientation it is in when the surgeon lets go of the first control wheel 210. The distal vertebra 502 can, however, still pitch and roll as the physician moves the device 100 in the pericardial cavity.

[0060] Similarly, having the second control wheel 212 biased in a locked direction, e.g. up, has the effect of automatically locking the subset series of vertebrae 504 in whatever yaw orientation they are in when the physician lets go of the second control wheel 212. The subset series of vertebrae 504 can, however, still pitch and roll as the surgeon moves the device 100 in the pericardial cavity.

[0061] The wheels 210, 212 may be configured to give the physician visual, tactile, or audible feedback to indicate a turn location of the wheels 210, 212 using any means known to those skilled in the art. For example, one or more divots 226 on the wheels 210, 212 may give the surgeon an indication of how many degrees the wheel has been rotated forward or backward.Atty Docket No. 2316.101.01WO

[0062] Returning now, briefly, to Fig. 2 and Fig. 3, in some embodiments, the push-pull wire control system 600 is configured to hold the series of vertebrae 500 in a nested configuration. For example, the system 600 may compress the vertebrae 500 together. The shape of the vertebrae 500 (see Fig. 5) may, however, still allow the vertebrae to passively pitch and / or roll when positioned between two organs, or between the pericardium and the epicardium.

[0063] In some embodiments, the articulation system 200 has a flexible sleeve 216 encircling at least some of the series of vertebrae 500. Although, generally, the push- pull wire control system 600 may be configured to hold the vertebrae in a nested configuration, the sleeve 216 may provide protection and / or structural stability.

[0064] In some embodiments, at least one of the series of vertebrae 500 has a substantially flat bottom surface (not illustrated). It is believed, however, that a concave bottom surface may provide better contact with the curved surface against which the articulation system 200 may be pressed (see, e.g., Fig. 5).

[0065] In some embodiments, at least one of the series of vertebrae 500 has a concave bottom surface 522. The concave bottom surface 522 may be configured to improve contact between a curved surface of an organ and the articulation system 200.

[0066] Fig. 10 is a schematic of how the series of vertebrae 500 may yaw. In some embodiments, at least one vertebra 502, 503, 504 of the series of vertebrae 500 is configured to articulate at an angle 0 relative to a vertebra proximal of the at least one vertebra. The angle 0 may be relative to a central axis B-B defined by the series of vertebrae 500. The angle 0 may be at least five degrees. The angle 0 may be at least ten degrees. The angle 0 may be at least fifteen degrees. The angle 0 may be about eighteen degrees (as illustrated). The angle 0 may be between 15 and 20 degrees.

[0067] In some embodiments, each vertebra of the series of vertebrae 500 is configured to articulate at an angle 0 relative to an adjacent proximal vertebra. The angle 0 may be relative to a central axis B-B defined by the series of vertebrae 500. The angle 0 may be at least five degrees. The angle 0 may be at least ten degrees. The angle 0 may be atAtty Docket No. 2316.101.01WO least fifteen degrees. The angle 0 may be about eighteen degrees (as illustrated). The angle 0 may be between 15 and 20 degrees. The angle 0 may be up to 27 degrees.

[0068] Those skilled in the art will recognize that the angle 0 and the number of vertebrae in the subset series of vertebrae 504 and / or the number of distal vertebrae 502, 506 (e.g. one, two, or more) affects how far the respective vertebrae articulate. For example, if the angle 0 is 18 degrees for each of the series of vertebrae, and there are ten vertebrae in the subset series of vertebrae 504, then the distalmost one 508 of the subset series of vertebrae 504 can articulate 180 degrees relative to the most proximal one 512 of the subset series of vertebrae 504. This aspect can be most clearly seen in Fig. 6.

[0069] Similarly, if the angle 0 is 18 degrees for all vertebrae 500, and there is only one distal vertebra 502, the distal vertebra 502 may articulate 18 degrees relative to the distalmost one 508 of the subset series of vertebrae 504. This is the same regardless of whether the subset series of vertebrae 504 are articulated or not. This may allow the physician to actively yaw the distal vertebra 502 a great distance using the second control wheel 212, then to fine tune yaw the distal vertebra 502 using the first control wheel 210.

[0070] In some embodiments, the articulation system 200 is configured to actively yaw the distal vertebra 502 up to 180 degrees, or at least 180 degrees relative to a most proximal one 512 of the subset series of vertebrae 504. In some embodiments, the articulation system 200 is configured to actively yaw the distal vertebra 502 up to 198 degrees, or at least 198 degrees relative to a most proximal one 512 of the subset series of vertebrae 504. In some embodiments, the articulation system 200 is configured to actively yaw the distal vertebra 502 an additional + / - 18 degrees relative to the most distal vertebra 508 of the subset series of vertebrae 504. Those skilled in the art will recognize the movement of the vertebrae 500 in this manner creates a turn radius such that actively yawing the distal vertebra 502 180 degrees will cause the distal vertebra 502 to be parallel, but "facing" the opposite direction from the most proximal one 512 of the subset series of vertebrae 504.Atty Docket No. 2316.101.01WO

[0071] In some embodiments, the distal vertebra 502 forms or has an end effector 514 shaped and configured to allow passage of a tool, such as a camera or an RF ablation catheter, toward the organ. In some embodiments, the distal vertebra 502 may be attached to a hood, tip or end effector 516 for selectively allowing the tool to extend through a passage in the distal vertebra 502, or head 514. The hood 516 may be lifted using a hood control wire 518 and / or other methods known to those skilled in the art.

[0072] Those skilled in the art will recognize that, although the articulation system 200 has been described in detail as having two series of vertebrae (e.g. the subset series of vertebrae 504, the distal vertebra 502 (a series of one), and the series of distal vertebrae 502, 506), the articulation system 200 may have three series of vertebrae, or more.

[0073] Turning now to Fig. 11, a method 800 is now described.

[0074] The method 800 may include providing 802 a medical device for navigating a curved surface of an organ, the device comprising a distal region having the articulation system as described herein, a proximal handle for manipulating the push-pull wire control system, and a shaft having a longitudinal axis co-linear with a proximal end of the articulable longitudinal axis of the articulation system. The method 800 may include positioning 804 the distal region between the curved surface of the organ and a compressive anatomical feature. The method 800 may include moving 806 the distal region along the curved surface of the organ, whereby the articulation system passively pitches and rolls to conform to the curved surface. The method 800 may include manipulating 808 the second wire control system to actively yaw the subset series of vertebrae. The method 800 may include manipulating 810 the first wire control system to actively yaw the distal vertebra. The method 800 may be performed using actions described herein in relation to the medical device 100 and / or the articulation system 200.

[0075] The method 800 may include pressing 812 a second control wheel to unlock the second control wheel 812 from teeth 626 to unlock the subset series of vertebrae, thereby allowing the subset series of vertebrae to yaw. The method 800 may includeAtty Docket No. 2316.101.01WO pressing 814 a first control wheel to unlock the first control wheel from its teeth (not shown) to unlock the distal vertebra, thereby allowing the distal vertebra to yaw.

[0076] In some embodiments, the method 800 includes one or more of the following: (a) while holding the second thumbwheel down, rotating the second thumbwheel in one direction to yaw the subset series of vertebrae toward one side; (b) while holding the second thumbwheel down, rotating the second thumbwheel in another direction to yaw the subset series of vertebrae toward another side; (c) while holding the first thumbwheel down, rotating the first thumbwheel in one direction to yaw the distal vertebra toward one side; or (d) while holding the first thumbwheel down, rotating the first thumbwheel in another direction to yaw the distal vertebra toward another side.

[0077] In some embodiments of the method 800, the organ is a beating heart, and the compressive anatomical feature is a pericardium of the heart.

[0078] In summary, the device 100 described herein may be configured to navigate to essentially any point on the epicardial surface and implement whatever therapy or diagnostic is desired. The controls available may be essentially: push the catheter forward, pull the catheter back, articulate (yaw) along the surface of the heart to the right and articulate (yaw) along the surface of the heart to the left. The articulation sections, e.g. vertebrae 500 of the catheter passively conform to the curvature of the surface including pitch and roll.

[0079] Each of the various elements disclosed herein may be achieved in a variety of manners. This disclosure should be understood to encompass each such variation, be it a variation of an embodiment of any apparatus embodiment, a method or process embodiment, or even merely a variation of any element of these. Particularly, it should be understood that the words for each element may be expressed by equivalent apparatus terms or method terms— even if only the function or result is the same. Such equivalent, broader, or even more generic terms should be considered to be encompassed in the description of each element or action. Such terms can be substituted where desired to make explicit the implicitly broad coverage to which this invention is entitled.Atty Docket No. 2316.101.01WO

[0080] As but one example, it should be understood that all action may be expressed as a means for taking that action or as an element which causes that action. Similarly, each physical element disclosed should be understood to encompass a disclosure of the action which that physical element facilitates. Regarding this last aspect, the disclosure of a "attachment mechanism" should be understood to encompass disclosure of the act of "attaching" —whether explicitly discussed or not— and, conversely, were there only disclosure of the act of "attaching", such a disclosure should be understood to encompass disclosure of a "attaching mechanism". Such changes and alternative terms are to be understood to be explicitly included in the description.

[0081] Moreover, the claims shall be construed such that a claim that recites "at least one of A, B, or C" shall read on a device that requires "A" only. The claim shall also read on a device that requires "B" only. The claim shall also read on a device that requires "C" only. The claim shall also read on a device that requires "A+B". The claim shall also read on a device that requires "A+B+C", and so forth.

[0082] Those skilled in the art can readily recognize that numerous variations and substitutions may be made in the invention, its use and its configuration to achieve substantially the same results as achieved by the embodiments described herein.

[0083] Accordingly, there is no intention to limit the invention to the disclosed exemplary forms. Many variations, modifications and alternative constructions fall within the scope and spirit of the invention as expressed in the claims.

Claims

1. Atty Docket No. 2316.101.01WOCLAIMS1. An articulation system for a catheter, the system comprising: a top region; a bottom region; a distal region; a proximal region; a series of vertebrae having a distal vertebra and a subset series of vertebrae proximal of the distal vertebra, the series of vertebrae nested together and defining an articulable longitudinal axis through the series of vertebrae, the series of vertebrae shaped and configured to passively pitch and roll, whereby the series of vertebrae is configured to maintain contact with a curved surface when the bottom region is pressed against the curved surface, a normal of the curved surface defining a yaw axis of the articulation system; and a push-pull wire control system configured to: actively yaw the distal vertebra independently from the subset series of vertebrae; and actively yaw the subset series of vertebrae independently from the distal vertebra.

2. The articulation system of claim 1, wherein: each of the series of vertebrae comprises a central passage shaped and configured to accommodate a tool.

3. The articulation system of claim 1, wherein: the push-pull wire control system is configured to yaw the distal vertebra and a second distal vertebra independently of the subset series of vertebrae.Atty Docket No. 2316.101.01WO4. The articulation system of claim 1, wherein: the push-pull wire control system comprises a first wire set and a second wire set, the first wire set being a first push-pull wire set having distal ends coupled to the distal vertebra and manipulable by a first control wheel, the second wire set being a second push-pull wire set having distal ends coupled to a distal one of the subset series of vertebrae and manipulable by a second control wheel; manipulation of the first control wheel is configured to cause articulation of the distal vertebra; and manipulation of the second control wheel is configured to cause articulation of the subset series of vertebrae.

5. The articulation system of claim 4, wherein: at least one of: the first control wheel is biased toward a lock direction, whereby the first wire set is configured to lock the distal vertebra; or the second control wheel is biased toward a lock direction, whereby the second wire set is configured to lock the subset series of vertebrae.

6. The articulation system of claim 4, wherein: the first wire set has a first wire passing through each of the subset series of vertebrae and a second wire passing through each of the subset series of vertebrae, the first wire coupled to a first side of the distal vertebra, the second wire coupled to a second side of the distal vertebra; the second wire set has a third wire passing through at least one of the subset series of vertebrae and a fourth wire passing through at least one of the subset series of vertebrae, the third wire coupled to a first side of a distal one of the subset series of vertebrae, the fourth wire coupled to a second side of the distal one of the subset series of vertebrae.Atty Docket No. 2316.101.01WO7. The articulation system of claim 1, wherein: the articulation is configured to lock the series of vertebrae from passive yawing movement.

8. The articulation system of claim 1, further comprising: a flexible sleeve encircling at least some of the series of vertebrae.

9. The articulation system of claim 1, wherein: the push-pull wire control system is configured to hold the series of vertebrae in a nested configuration.

10. The articulation system of claim 1, wherein: at least one of the series of vertebrae has a substantially flat bottom surface.

11. The articulation system of claim 1, wherein: at least one of the series of vertebrae has a concave bottom surface.

12. The articulation system of claim 1, wherein: at least one vertebra of the series of vertebrae is configured to articulate at least 10 degrees relative to a vertebra proximal of the at least one vertebra.

13. The articulation system of claim 1, wherein: the system is configured to articulate the distal vertebra at least 180 degrees relative to a most proximal one of the subset series of vertebrae.

14. The articulation system of claim 13, wherein: the system is configured to articulate the distal vertebra up to 198 degrees relative to a most proximal one of the subset series of vertebrae.Atty Docket No. 2316.101.01WO15. The articulation system of claim 1, wherein: the distal vertebra comprises an end effector configured to selectively allow a tool to extend through a passage in the distal vertebra.Atty Docket No. 2316.101.01WO16. A medical device for navigating a surface of an organ, the device comprising: the articulation system of claim 1; a proximal handle for manipulating the push-pull wire control system, the handle having a housing and a tool access port; and a shaft coupled to a distal portion of the handle, the shaft having a longitudinal axis colinear with a proximal end of the articulable longitudinal axis of the articulation system.

17. The medical device of claim 16, wherein: each of the series of vertebrae comprises a central passage shaped and configured to allow a tool to move longitudinally within the central passage.Atty Docket No. 2316.101.01WO18. A method, comprising: providing a medical device for navigating a curved surface of an organ, the device comprising a distal region having the articulation system of claim 1, a proximal handle for manipulating the push-pull wire control system, and a shaft having a longitudinal axis co-linear with a proximal end of the articulable longitudinal axis of the articulation system; positioning the distal region between the curved surface of the organ and a compressive anatomical feature; moving the distal region along the curved surface of the organ, whereby the articulation system passively pitches and rolls to conform to the curved surface; manipulating the second wire control system to actively yaw the subset series of vertebrae; and manipulating the first wire control system to actively yaw the distal vertebra.

19. The method of claim 18, further comprising: at least one of: pressing a second control wheel to unlock the subset series of vertebrae; or pressing a first control wheel to unlock the distal vertebra.

20. The method of claim 19, further comprising: at least one of: while holding the second thumbwheel down, rotating the second thumbwheel in one direction to yaw the subset series of vertebrae toward one side; while holding the second thumbwheel down, rotating the second thumbwheel in another direction to yaw the subset series of vertebrae toward another side; while holding the first thumbwheel down, rotating the first thumbwheel in one direction to yaw the distal vertebra toward one side; or while holding the first thumbwheel down, rotating the first thumbwheel in another direction to yaw the distal vertebra toward another side.

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