Image guidance of a steerable introducer for minimally invasive procedures

A steerable introduction system for deploying an interventional tool (e.g., a replacement valve) within an anatomical object (e.g. a heart). The steerable introduction system employs a steerable introducer (20) including an end-effector for positioning the interventional tool within the anatomical object (e.g., the end-effector passively guides or actively steers the interventional tool within the anatomical object). The steerable introduction system further employs an image guidance workstation (120) controlling an actuation of a translation, a pivoting and/or a rotation of the end-effector within the anatomical object responsive to surgical image data illustrative of a position of the end-effector within the anatomical object (e.g., ultrasound or X-ray image data illustrative of a surgical position of the end-effector within a heart). The motion actuation by the image guidance workstation (120) of the end-effector facilitates a coaxial alignment and/or a coplanar alignment of the interventional tool and a structure of the anatomical object (e.g., a diseased aortic valve of a heart).

FIELD OF THE INVENTION

The present disclosure generally relates to a steerable introducer for deploying an interventional tool during a minimally invasive procedure of any type (e.g., a minimally invasive surgical valve replacement). The present disclosure specifically relates to novel and inventive steerable introducers for deploying interventional tools.

BACKGROUND OF THE INVENTION

An aortic valve replacement is a medical procedure in which a diseased aortic valve is replaced with an artificial valve. More particularly, a minimally invasive aortic valve replacement generally involves, under image X-ray or ultrasound guidance, a deployment of the artificial valve in a beating heart via a small incision in the patient's body.

There are numerous approaches for executing a minimally invasive aortic valve replacement.

A first example is a transapical approach generally involving a small incision in a lower part of a chest of a patient, and a small puncture in a left ventricle of a beating heart of the patient. An introducer sheath is guided through the small incision and small puncture into the left ventricle via a guidewire, and a balloon catheter supporting the artificial valve is introduced via the introducer sheath into the left ventricle for deploying the artificial valve at the diseased aortic valve site.

A second example is a transaortic approach generally involving a small incision in an upper part of a chest of a patient, and a small puncture in an aorta of a beating heart of the patient. An introducer sheath is guided through the small incision and small puncture into the aorta via a guidewire, and a balloon catheter supporting the artificial valve is introduced via the introducer sheath into the aorta for deploying the artificial valve at the diseased aortic valve site.

For a successful aortic valve replacement, the introduction of the balloon catheter in the left ventricle or the aorta requires both a coaxial alignment and a coplanar alignment of the artificial valve and the diseased aortic valve. However, both a coaxial alignment and a coplanar alignment of the artificial valve and the diseased aortic valve has proven to be challenging for various reasons due to the complex motion of the heart (e.g., heart beating and a flapping of the diseased aortic valve).

One primary reason is that the patient incision point, the heart puncture point and the aorta valve annulus are rarely co-linear, and therefore a straight line introduction of the balloon catheter into the left ventricle or the aorta is not suitable.

To address this straight line limitation of a straight-line introducer sheaths, introducer sheaths as known in the art have been equipped with deflection tendons to actuate a pitch motion and/or a yaw motion of a distal end of the introducer sheath with an aim to achieve the coaxial alignment and the coplanar alignment of the artificial valve and the diseased aortic valve.

However, a transmission length of the deflection tendons extends from the distal end to the proximal end of the introducer sheath and typically fails to provide a precise actuation of a desired pitch motion and/or yaw motion of the distal end of the introducer sheath for the coaxial alignment and the coplanar alignment of the artificial valve and the diseased aortic valve, particularly in view of anatomical structures of the patient (e.g., ribs, hear muscles, trabeculations inside the heart) limiting such actuation of the introducer sheath.

Furthermore, the deflection tendons do not provide a translational motion of the introducer sheath that may be necessary for both the coaxial alignment and the coplanar alignment of the artificial valve and the diseased aortic valve.

SUMMARY OF THE INVENTION

The inventions of the present disclosure improve upon steerable introducers by providing an image guidance of the steerable introducer(s) within an anatomical object to thereby achieve a precise coaxial alignment and/or a precise coplanar alignment of ah interventional tool with a structure of the anatomical object (i.e., any anatomical organ and any blood vessel).

For purposes of the inventions of the present disclosure, the terms “minimally invasive procedure” and “interventional tool” are to be broadly interpreted as understood in the art of the present disclosure and as exemplary described herein.

Examples of a minimally invasive procedure include, but are not limited to, heart valve procedures (aortic, pulmonary, mitral) repair and replacement, atrial septal defect or patent foramen ovale closures, retrieval of foreign bodies or clots from the heart, vascular procedures, video-assisted thoracic surgery and abdominal surgery (liver, kidney, prostate).

Examples of an interventional tool include, but are not limited to, artificial heart devices, closure devices, suction devices, punches, catheters, balloon catheters, ablation catheters, stents and grafts.

For purposes of the inventions of the present disclosure, the term “steerable introducer” broadly encompasses all structural configurations of introducer sheaths, surgical introducers and the like as known in the art that incorporate a steerable actuation of an end-effector for passively guiding or actively steering a positioning of an interventional tool within an anatomical object as understood in the art of the present disclosure and as exemplary described herein, and the term “steerable introduction device” broadly encompasses a combination of two (2) or more steerable introducers in a stacked arrangement as understood in the art of the present disclosure and as exemplary described herein.

One form of the inventions of the present disclosure is a steerable introduction system for deploying an interventional tool (e.g., a replacement valve) within an anatomical object (e.g. a heart) with the steerable introduction system employing a steerable introducer including an end-effector for positioning the interventional tool within the anatomical object (e.g., the end-effector passively guides or actively steers the interventional tool within the anatomical object).

The steerable introduction system further employs an image guidance workstation controlling an actuation of a translation, a pivoting and/or a rotation of the end-effector within the anatomical object responsive to surgical image data illustrative of a position of the end-effector within the anatomical object (e.g., ultrasound or X-ray image data illustrative of a surgical position of the end-effector within a heart).

The motion actuation by the image guidance workstation of the end-effector facilitates a coaxial alignment and/or a coplanar alignment of the interventional tool and a structure of the anatomical object (e.g., a diseased aortic valve of a heart).

For the first form of the steerable introduction system, the steerable introducer may employ a motion coupler coupling a shaft and the end-effector.

The shaft is structurally configured to introduce the interventional tool into the anatomical object (e.g., the interventional tool passes through or over the shaft into the anatomical object). The end-effector is structurally configured to interact with the interventional tool within the anatomical object (e.g., the end-effector is movable to position the interventional tool within the anatomical object).

The motion coupler includes one or more linear actuators controllable to actuate a translation, a pivoting and/or a rotation of the end-effector relative to the shaft. An actuation of the linear actuator(s) provides a translational motion, a pitch motion and/or a yaw motion of the end-effector to achieve a coaxial alignment and/or a coplanar alignment of the interventional tool with a structure of the anatomical object (e.g., a coaxial alignment and/or coplanar alignment of the artificial valve to a diseased aortic valve of a heart).

The motion coupler may further include one or more linear sliders translatable between the shaft and the end-effector, and/or one or more post extending between the shaft and the end-effector. If included, the linear slider(s) and/or the post(s) support the translation, pivoting and/or a rotation of the end-effector within the anatomical object responsive to an actuation of the linear actuator(s).

The motion coupler may further includes a rotary actuator controllable to actuate a rotation of the end-effector about a rotational axis of the end-effector and/or the steerable introducer further employs a rotary actuator controllable to actuate a rotation of the end-effector about a rotational axis of the shaft. An actuation of the rotary actuator(s) provides a roll motion of the end-effector and/or a revolution motion of the end-effector about the shaft to further achieve the coaxial alignment and/or the coplanar alignment of the interventional tool with the structure of the anatomical object.

For purposes of the inventions of the present disclosure, the structural terms “shaft” and “end-effector” are to be broadly interpreted as understood in the art of the present disclosure and as exemplary described herein.

For purposes of the inventions of the present disclosure, the structural term “motion coupler” broadly encompasses all structural configurations of a coupler actuatable to apply one or more moving force(s) (e.g., linear and/or angular) to a body connected to the coupler (e.g., an end-effector).

For purposes of the inventions of the present disclosure, the structural terms “linear actuator”, “linear slider”, “post” and “rotational actuator” are to be broadly interpreted as understood in the art of the present disclosure and as exemplary described herein.

A non-limiting example of a linear actuator is motorized prismatic joint incorporating a piezoelectric motor or a pneumatic motor.

A non-limiting example of a linear slider is a non-motorized prismatic joint incorporating a pneumatic slider.

A non-liming example of a post is a fulcrum about which an end-effector pivots and/or rotates.

A non-limiting example of a rotational actuator is a motorized rotary joint incorporating a piezoelectric motor.

For purposes of the inventions of the present disclosure, the descriptive terms “introduce”, “interact”, “actuate”, “translate”, “pivot”, “rotate”, “pitch”, “yaw”, “roll”, “revolve”, “coaxial”, “coplanar”, “alignment” and “axis”, and any tenses thereof are to be broadly interpreted as understood in the art of the present disclosure and as exemplary described herein.

More particularly, the term “interact” as related to the end-effector and the interventional device broadly encompasses end-effector affecting a physical disposition of the interventional device within the anatomical object. One non-limiting example is the end-effector guiding a positioning of the interventional device within the anatomical object in terms of location and/or orientation. Another non-limiting example is the end-effector steering a positioning of the interventional device within the anatomical object in terms of location and/or orientation.

A second form of the inventions of the present disclosure is a steerable introduction system for deploying an interventional tool (e.g., a replacement valve) within an anatomical object (e.g. a heart) with the steerable introduction system employing a steerable introduction device including an orienting end-effector and a translating end-effector for positioning the interventional tool within the anatomical object.

The steerable introduction system further employs an image guidance workstation controlling an actuation of a pivoting and/or a rotation of the orienting end-effector within the anatomical object responsive to surgical image data illustrative of a surgical orientation of the translating end-effector within the anatomical object, and further controlling an actuation of a translation of the translating end-effector within the anatomical object responsive to surgical image data illustrative of a surgical location of the translating end-effector within the anatomical object.

The motion actuation by the image guidance workstation of the orienting end-effector and the translating end-effector facilitates a coaxial alignment and/or a coplanar alignment of the interventional tool and a structure of the anatomical object (e.g., a diseased aortic valve of a heart).

For the second form of the steerable introduction system, the steerable introducer may employ an orienting steerable introducer and a translating steerable introducer with a shaft of the translating steerable introducer being adjoined to an end-effector of the orienting steerable introducer. A motion coupler of the orienting steerable introducer includes one or more linear actuators controllable to actuate a pivoting and/or a rotation of the end-effectors of the steerable introducers relative to a shaft of the orienting steerable introducer. A motion coupler of the translating steerable introducer includes one or more linear actuators controllable to actuate a translation of the end-effector of the translating steerable introducer relative to a shaft of the translating steerable introducer.

For purposes of inventions of the present disclosure, the term “adjoined” and any tense thereof broadly encompasses a secure or a separable coupling, connection, affixation, clamping, mounting, etc. of components.

For purposes of the present disclosure, the labels “orienting” and “translating” used herein for the term “steerable introducer” and components thereof distinguishes for identification purposes a particular steerable introducer and components thereof from other steerable introducers as described and claimed herein without specifying or implying any additional limitation to the term “steerable introducers”.

For both forms of the steerable introduction systems, the image guidance workstation may employ a control network including an image controller, an introducer controller and application modules as exemplary described herein.

For purposes of the inventions of the present disclosure, the term “workstation” is to be broadly interpreted as understood in the art of the present disclosure and as exemplary described herein. Examples of a “workstation” include, but are not limited to, an assembly of one or more computing devices, a display/monitor, and one or more input devices (e.g., a keyboard, joysticks and mouse) in the form of a standalone computing system, a client computer, a desktop or a tablet.

For purposes of the present disclosure, the term “controller” broadly encompasses all structural configurations of an application specific main board or an application specific integrated circuit housed within or linked to a workstation for controlling an application of various inventive principles of the present disclosure as subsequently described herein. The structural configuration of the controller may include, but is not limited to, processor(s), computer-usable/computer readable storage medium(s), an operating system, application module(s), peripheral device controller(s), slot(s) and port(s).

For purposes of the present disclosure, the labels “introducer”, “motor”, “image”, “X-ray” and “ultrasound” used herein for the term “controller” distinguishes for identification purposes a particular controller from other controllers as described and claimed herein without specifying or implying any additional limitation to the term “controller”.

For purposes of the present disclosure, the term “application module” broadly encompasses a module incorporated within or accessible by a controller consisting of an electronic circuit and/or an executable program (e.g., executable software stored on non-transitory computer readable medium(s) and/firmware) for executing a specific application.

A third form of the inventions of the present disclosure is an interventional method incorporating a steerable introducer including an end-effector for positioning an interventional tool within an anatomical object. The interventional method involves a placement of the end-effector into the anatomical object.

The interventional method further involves the image guidance workstation steering the end-effector to a position within the anatomical object including the image guidance workstation controlling an actuation by of at least one of a translation, a pivoting and a rotation of the end-effector within the anatomical object responsive to surgical image data illustrative of a position of the end-effector within the anatomical object.

The foregoing forms and other forms of the inventions of the present disclosure as well as various structures and advantages of the inventions of the present disclosure will become further apparent from the following detailed description of various embodiments of the inventions of the present disclosure read in conjunction with the accompanying drawings. The detailed description and drawings are merely illustrative of the inventions of the present disclosure rather than limiting, the scope of the inventions of the present disclosure being defined by the appended claims and equivalents thereof.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

As an improvement upon prior deflectable introducer sheaths, the inventions of the present disclosure propose a steerable introducer employing one or more linear actuators for localizing necessary degree(s) of freedom of an end-effector to thereby achieve a precise coaxial alignment and/or a precise coplanar alignment of the interventional tool with a structure of an anatomical object (i.e., any anatomical organ and any blood vessel).

For example, an aorta A, a left atrium LA and a left ventricle LV of a beating heart H as shown inFIG. 1Aare involved in a minimally invasive aortic valve replacement requiring a precise coaxial alignment of a replacement artificial valve with a valve annulus axis VAA of a diseased aortic valve AV and a precise coplanar alignment of the replacement artificial valve with a valve annulus plane VAP of the diseased aortic valve AV (or any other plane perpendicular to disease aortic valve as decided by a surgeon). A transapical approach of the minimally invasive surgical aortic valve replacement generally involves a small incision in a lower part of a chest (not shown), and a small puncture in left ventricle LV of the beating heart H. More particularly for this transapical approach, a straight line introduction of the replacement artificial valve into the left ventricle LV to the aortic valve AV does not exist, and space within the left ventricle LV adjacent the aortic valve AV is limited.

An execution of the transapical approach in accordance with the present disclosure may involve a steerable introducer20of the present disclosure guided through the small incision in the chest and small puncture into the left ventricle LV with or without a guidewire. A position of an end-effector of steerable introducer20is therefore misaligned with both the valve annulus axis VAA and the valve annulus plane VAP of the diseased aortic valve AV as shown inFIG. 1B.

As will be further described herein, steerable introducer20of the present disclosure is actuatable to translate, pivot and/or rotate the end-effector of steerable introducer20as needed to position the end-effector in a precise coaxial alignment with the valve annulus axis VAA and in a precise coplanar alignment with the valve annulus plane VAP of the diseased aortic valve AV as shown inFIG. 1C. As such, a balloon catheter BC supporting a replacement artificial valve RV may be introduced via steerable introducer20of the present disclosure into the left ventricle LV as shown inFIG. 1Dwith a precise coaxially alignment of the replacement artificial valve RV with the valve annulus axis VAA of the diseased aortic valve AV and a precise coplanar alignment of the replacement artificial valve RV with the valve annulus plane VAP of the diseased aortic valve AV. The result is a proper deployment of the replacement artificial valve RV as illustrated inFIG. 1E.

To facilitate an understanding of the various inventions of the present disclosure, the following description ofFIG. 2teaches basic inventive principles associated with interventional systems of the present disclosure. From this description, those having ordinary skill in the art will appreciate how to apply the inventive principles of the present disclosure for making and using additional embodiments of interventional systems of the present disclosure. Please note the components of the present disclosure as shown inFIG. 2are not drawn to scale, but drawn to conceptually visualize the inventive principles of the present disclosure.

Referring toFIG. 2, an interventional system of the present disclosure employs steerable introducer20or a steerable introduction device21, a motor controller22, a fluoroscopic imager100(e.g., a mobile c-arm as shown) and/or an ultrasound probe110, an image guidance workstation120and a control network130for deploying an interventional tool within an anatomical object of a patient P lying prone on an operating table OT during a minimally invasive procedure of any type.

As known in the art, fluoroscopic imager100generally includes an X-ray generator101, an image intensifier102and a collar103for rotating fluoroscopic imager100. In operation as known in the art, an X-ray controller104controls a generation by fluoroscopic imager100of imaging data105illustrative of a fluoroscopic image of the anatomical object of patient P (e.g., a heart of patient P during a minimally invasive aortic valve replacement).

In practice, X-ray controller104may be installed within an X-ray imaging workstation (not shown), or alternatively installed within image guidance workstation120.

Ultrasound probe110is any type of probe suitable for a particular minimally invasive procedure (e.g., a Transesophageal echocardiography (TEE) probe for a minimally invasive aortic valve replacement as shown). In operation as known in the art, an ultrasound controller111controls a generation by ultrasound probe110of imaging data112illustrative of an ultrasound image of the anatomical object of patient P (e.g., a heart of patient P during a minimally invasive aortic valve replacement).

In practice, ultrasound controller111may be installed within an ultrasound imaging workstation (not shown), or alternatively installed within image guidance workstation120.

Workstation120is assembled in a known arrangement of a standalone computing system employing a monitor121, a keyboard122and a computer123.

Control network130is installed on computer123, and employs application modules131including an image planning module132and an image steering module133. Control network130further includes an image controller134and an introducer controller135.

Image controller134generally processes image data as known in the art for an illustration of the image on display121. For example, image controller134may process X-ray image data105for an illustration of an X-ray image on display121, and/or process ultrasound image data112for an illustration of an ultrasound image on display121.

In support of the minimally invasive procedure, image controller134executes or accesses image planning module132to facilitate a user delineation of a coaxial alignment and/or a coplanar alignment of an interventional tool to a structure of anatomical object of patient P (e.g., an aortic valve AV of heart of patient P). To this end, image controller134controls an illustration of an X-ray image and/or an ultrasound image of the structure of the anatomical object on display121, or concurrently or alternatively controls an illustration of a registered pre-operative image of the structure of the object on display121(e.g., a computed-tomography image or a magnetic resonance image). An operator of workstation120delineates, within the image(s), a target position of an end-effector of steerable introducer20or of steerable introduction device21for achieving a coaxial alignment and/or a coplanar alignment of the interventional tool to the structure of anatomical object of patient P within the displayed image(s).

For example, the operator of workstation120may delineate, within the image(s), a target position of an end-effector of steerable introducer20or of steerable introduction device21based on an intersection of valve annulus axis VAA and valve annulus plane VAP of a diseased aortic valve AV as shown inFIG. 1A.

During the minimally invasive procedure, image controller134executes or accesses image steering module133to identify an end-effector of steerable introducer20or steerable introduction device21within the displayed image(s) whereby introducer controller135may ascertain any necessary translational, pivot and/or rotation of the end-effector of steerable introducer20or steerable introduction device21necessary to reach the target position for achieving a coaxial alignment and/or a coplanar alignment of an interventional tool to the structure of the anatomical object of patient P.

For example, image controller134may identify, within the image(s), the end-effector of steerable introducer20or steerable introduction device21relative to the delineated valve annulus axis VAA and valve annulus plane VAP of a diseased aortic valve AV as shown inFIG. 1Bwhereby introducer controller135ascertains any necessary translational, pivot and/or rotation of the end-effector of steerable introducer20or steerable introduction device21necessary to reach the target position for achieving the coaxial alignment with valve annulus axis VAA and the coplanar alignment of valve annulus plane VAP as shown inFIG. 1C.

In practice, image steering module133is built to implement the kinematics of steerable introducer20or of steerable introduction device21. By implementing the kinematic model as known in the art of steerable introducer20or steerable introduction device21, an execution of image steering module133by introducer controller135enables introducer controller135to ascertain linear motion parameter(s) for linear actuator(s) of steerable introducer20or for linear actuator(s) of steerable introduction device21to reach the target position as will be further explained herein. Introducer controller135generates actuation data126informative of desired linear motion parameter(s) for the linear actuator(s) and communicates actuation data126to motor controller22for actuating a translation, pivot and/or rotation by the linear actuator(s) of the end-effector of steerable introducer20or the end-effector of steerable introduction device21to reach the target position for achieving a coaxial alignment and/or a coplanar alignment of the interventional tool to the structure of the anatomical object of patient P.

For example, the operator of workstation120may manipulate the user input device of workstation120to actuate a translational, pivot and/or rotation by the linear actuator(s) of the end-effector of steerable introducer20or steerable introduction device21necessary to reach the target position for achieving the coaxial alignment with valve annulus axis VAA and the coplanar alignment of valve annulus plane VAP as shown inFIG. 1C.

In practice, motor controller22may be a standalone controller or installed within image guidance workstation120.

To facilitate an understanding of the various inventions of the present disclosure, the following description ofFIG. 3teaches basic inventive principles of the present disclosure associated with a manufacture of a steerable introducer of the present disclosure. From this description, those having ordinary skill in the art will appreciate how to apply the inventive principles of the present disclosure for making numerous and various embodiments of steerable introducers of the present disclosure. Please note the components of the present disclosure as shown inFIG. 3are not drawn to scale, but drawn to conceptually visualize the inventive principles of the present disclosure.

Referring toFIG. 3, a steerable introducer20of the present disclosure employs a shaft30, a motion coupler40, an end-effector50and an optional rotary actuator60.

A structural configuration of shaft30is specified in terms of shape and dimensions to introduce an interventional tool into an anatomical object. In practice, as would be appreciated by those skilled in the art, a particular structural design and a particular material composition of shaft30is dependent upon particular minimally invasive procedure(s) utilizing steerable introducer20.

In a first embodiment, as will be further described herein, shaft30is specified as a rigid or a semi-rigid shaft having a hollow central core for passing an interventional tool through shaft30to end-effector50, and further having one or more lumens for passing electrical wiring through shaft30to motion coupler40.

In a second embodiment, shaft30is specified as a rigid or a semi-rigid shaft having a solid central core for passing an interventional tool over shaft30to end-effector50, and further having one or more lumens for passing electrical wiring through shaft30to motion coupler40.

A structural configuration of end-effector50is specified in terms of shape and dimension for an interaction of end-effector50with the interventional tool as the interventional tool is being introduced by shaft30into the anatomical object. In practice, as would be appreciated by those skilled in the art, a particular structural design and a particular material composition of end-effector50is dependent upon particular minimally invasive procedure(s) utilizing steerable introducer20.

In one embodiment, as would be appreciated by those skilled in the art, end-effector50is shaped and dimensioned as a cylinder for passively guiding or actively steering a positioning of the interventional tool within the anatomical object. For this embodiment, the interventional tool is passed through shaft30and end-effector50subsequent to a desired positioning of end-effector50within the anatomical object, or alternatively the interventional tool is passed through shaft30and adjoined to end-effector50prior to a placement of steerable introducer20into the anatomical object.

In another embodiment, as would be appreciated by those skilled in the art, end-effector50is shaped and dimensions as a plate for actively steering a positioning of the interventional tool within the anatomical object. For this embodiment, the interventional tool is passed through or over shaft30and adjoined to end-effector50prior to an placement of steerable introducer20into the anatomical object.

A structural configuration of motion coupler40is specified in terms of one or more linear actuator(s) (not shown) serving as motorized prismatic joint(s) coupling shaft30and end-effector50in a manner that facilitates a controllable actuation of the linear actuator(s) to translate, pivot and/or rotate end-effector50relative to shaft30as symbolized by the arrows extending from end-effector50.

In one embodiment, as will be further described herein, a linear actuator includes a piezoelectric motor (not shown) coupled to shaft30for translating a rod (not shown) coupled to end-effector50in a forward direction or a reverse direction.

The structural configuration of motion coupler40may be further specified in terms of one or more linear slider(s) (not shown) serving as a non-motorized prismatic joint translatable between shaft30and end-effector50to facilitate a pivoting and/or rotation of end-effector50relative to shaft30.

In one embodiment, as will be further described herein, a linear slider is a pneumatic slider including a non-translatable member (not shown) coupled to shaft30and a translatable member coupled to end-effector50whereby the translatable member is translatable in a forward direction or a reverse direction.

The structural configuration of motion coupler40may be further specified in terms of one or more posts (not shown) serving as a rigid joint coupled to shaft30and end-effector50.

In one embodiment, as will be further described herein, a post is a fulcrum for enhancing a pivoting and/or rotation of end-effector50relative to shaft30.

If employed, rotary actuator60is coupled to shaft30as shown in a manner that facilitates a controllable actuation of rotary actuator60to rotate shaft30about a rotational axis of shaft30(e.g., a longitudinal axis of shaft30), or alternatively incorporated within motion controller40in a manner that facilitates a controllable actuation of rotary actuator60to rotate end-effector50about a rotational axis of end-effector50(e.g., a central axis of end-effector50).

In operation as previously described herein, introducer controller135is responsive to a user input device (e.g., a joystick, a keyboard or a graphical user interface) for interpreting encoded emotion parameters of the user input device (e.g., translation, pitch and yaw motion parameters) into linear motion parameter(s) for the linear actuator(s), and if applicable, into a rotational motion parameter for rotary actuator60. Introducer controller135generates actuation data136informative of a desired linear motion parameter(s) for the linear actuator(s) and if applicable of a desired rotational motion parameter for rotary actuator60.

Actuation data135is communicated to a motor controller22that translates the desired linear motion parameter(s) into linear drive signal(s)23transmitted to one or more of the linear actuator(s) whereby each actuated linear actuator will apply a linear force to end-effector50in a forward direction or a reverse direction. As will be further described herein, the application of the linear force(s) actuates a translation, a pivoting or a rotation of end-effector50relative to shaft30.

If applicable, motor controller22translates the desired rotational motion parameter into a rotational drive signal24transmitted to rotary actuator60whereby rotary actuator60will apply a rotational force to shaft30or end-effector50in a clockwise direction or a counterclockwise direction.

In practice, motor controller22may be external to steerable introducer20as shown, or alternatively as further described herein, each linear actuator40and rotary actuator60if applicable may employ an individual motor controller22.

To facilitate an understanding of the various inventions of the present disclosure, the following description ofFIGS. 4-9Bteaches various embodiments of a steerable introducer of the present disclosure. From this description, those having ordinary skill in the art will appreciate how to apply the inventive principles of the present disclosure for using numerous and various embodiments of steerable introducers of the present disclosure. Please note the components of the present disclosure as shown inFIGS. 4-9Bare not drawn to scale, but drawn to conceptually visualize the inventive principles of the present disclosure.

FIG. 4shows an unassembled view of an embodiment of steerable introducer20(FIG. 3) employing a shaft31, a pair of linear actuators41aand41b, an end-effector51and optional rotary actuator61.

Referring toFIG. 3, shaft31is structurally designed as a rigid or a semi-rigid shaft having a hollow central core32for passing an interventional tool through shaft31to end-effector51, and further having one or more lumens33aand33bfor passing electrical wiring through shaft31to linear actuators41to be housed within slots34aand34b.

End-effector51is shaped and dimensioned as a cylinder for passively guiding or actively steering a positioning of the interventional tool within the anatomical object. In practice, end-effector51may be composed of echogenic material as known in the art for ultrasound imaging purposes and/or an imaging agent as known in the art for X-ray imaging purposes.

Alternatively to end-effector51, an end-effector52is shaped and dimensioned as a plate for actively steering a positioning of the interventional tool within the anatomical object. In practice, end-effector52may also be composed of echogenic material as known in the art for ultrasound imaging purposes and/or an imaging agent as known in the art for X-ray imaging purposes.

Each linear actuator41includes a motor42for translating a rod43in a forward direction F or a reverse direction R. Each linear actuator41afurther includes a motor controller44for controlling motor42. In practice, motor42may be electric (DC, brushless DC, AC), piezoelectric or pneumatic.

Additionally, a linear slider45or a post48may be substituted for one of the linear actuators41.

Linear slider45may include a telescoping elements46and47, or a pneumatic or spring base47for translating a rod46in a forward direction F or a reverse direction R in dependence upon a degree of downward pressure applied to rod46.

Post48serves as a fulcrum about which an end-effector51pivots and/or rotates relative to shaft31.

If employed, rotary actuator61includes a motor62for rotating a rod63in a clockwise direction C or a counter clockwise direction CW. A platform65is geared to rod63to thereby rotate in sync with rod63. Rotary actuator61further includes a motor controller64for respectively controlling motor42. In practice, motor62may be electric (DC, brushless DC, AC), piezoelectric or pneumatic.

FIG. 5shows an assembled view of steerable introducer20(FIG. 3) employing shaft31, linear actuators41aand41b, and an end-effector51.

As shown inFIG. 6A, a translation of rods43aand43bin a forward direction or a reverse direction translates end-effector51relative to shaft31.

As shown inFIG. 6B, an exclusive translation of rod43ain a forward direction or a reverse direction pivots end-effector51relative to shaft31. Similarly, an exclusive translation of rod43bin a forward direction or a reverse direction counter pivots end-effector51relative to shaft31.

As shown inFIG. 6C, a translation of rod43ain a reverse direction and a translation of rod43bin a forward direction rotates end-effector51relative to shaft31. Conversely, a translation of rod43ain the forward direction and a translation of rod43bin the reverse direction counter rotates end-effector51relative to shaft31.

As shown inFIG. 6D, with linear slider45substituted for linear actuator41b, a translation of rod43ain a forward direction or a reverse direction rotates end-effector51relative to shaft31.

As shown inFIG. 6E, with post48substituted for linear actuator41b, a translation of rod43ain a forward direction or a reverse direction pivots end-effector51relative to shaft31.

In practice, those having ordinary skill in the art will appreciate the controllable translation, pivoting and rotating of end-effector51as shown inFIGS. 6A-6Eprovides for a translation motion and a pitch motion of end-effector51.

Also in practice, additional linear actuators41employed motion coupler40provides for a yam motion of end-effector51.

For example,FIG. 7Aillustrates a linear actuator platform49aof three (3) linear actuators43. The three (3) linear actuators43provide for a translation motion, a pitch motion and a yaw motion of end-effector51in three (3) degrees of freedom as shown.

Also by example,FIG. 7Billustrates a Stewart platform49bof six (6) linear actuators43. The six (6) linear actuators43provide for a translation motion, a pitch motion and a yaw motion of end-effector51in six (6) degrees for freedom as shown.

In practice, as previously described herein, end-effector51may passively guide or actively steer a positioning of the interventional tool within the anatomical object.

For example,FIG. 8Aillustrates a passage of a balloon catheter BC supporting a replacement aortic valve RV through shaft31. Balloon catheter BC may be passively guided through end-effector51to a position within the anatomical object subsequent to a targeted positioning of end-effector51within the anatomical object, or alternatively may be separably adjoined to end-effector51whereby a targeted positioning of end-effector51within the anatomical object actively steers balloon catheter BC within the anatomical object to a coaxial alignment and a coplanar alignment with an aortic valve.

By further example,FIG. 8Billustrates a passage of balloon catheter BC supporting replacement aortic valve RV over shaft31for a miniaturized steerable introducer20m. Balloon catheter BC is separably adjoined to end-effector51whereby a targeted positioning of end-effector51within the anatomical object actively steers balloon catheter BC within the anatomical object to a coaxial alignment and a coplanar alignment with an aortic valve.

In practice, as previously described herein, a rotary actuator may be employed with steerable introducer20.

For example,FIG. 9Aillustrates an adjoining of a proximal end of shaft31of steerable introducer20to a cylindrical platform66of rotary actuator61. Rotary rod63is controllable to actuate a rotation of end-effector51about a longitudinal axis of shaft31.

By further example,FIG. 9Billustrates a housing of rotary actuator61within shaft31with motors42and motor controllers44of linear actuators41being adjoined to cylindrical platform66of rotary actuator61. Rod63is controllable to actuate a rotation of end-effector51about a longitudinal axis of end-effector51.

To facilitate an understanding of the various inventions of the present disclosure, the following description ofFIG. 10teaches basic inventive principles of the present disclosure associated with a manufacture of a steerable introduction device of the present disclosure. From this description, those having ordinary skill in the art will appreciate how to apply the inventive principles of the present disclosure for making numerous and various embodiments of steerable introduction devices of the present disclosure. Please note the components of the present disclosure as shown inFIG. 10are not drawn to scale, but drawn to conceptually visualize the inventive principles of the present disclosure.

Generally, a steerable introduction device of the present disclosure employs two (2) or more steerable introducers in a stacked arrangement. For a pair of adjacent steerable introducers, a shaft of one of the steerable introducers is adjoined to an end-effector of the other steerable introducer.

Referring toFIG. 10, a steerable introduction device120employs an orienting steerable introducer20(O) and a translating steerable introducer20(T) in a stacked arrangement involving an adjoining of shaft30(T) of steerable introducer20(T) to end-effector50(O) of steerable introducer20(O). For this embodiment, introducer controller137generates distinct respective actuation data136oand136tfor sequentially or concurrently actuating motion coupler40(O) and motion coupler40(T).

In operation, the linear actuator(s) of motion coupler40(O) is(are) controllable by an introducer controller135to actuate a translation, a pivoting and/or a rotation of end-effector50(O) and end-effector50(T) relative to shaft30(O), and linear actuators40(T) is(are) controllable by introducer controller135to actuate a translation, a pivoting and/or a rotation of end-effector50(T) relative to shaft30(T). In this context, the linear actuator(s) of motion coupler40(O) may be exclusively utilized for orienting end-effector50(T) and the linear actuator(s) of motion coupler40(T) may be exclusively utilized for translating end-effector50(T).

In practice, the adjoining of shaft30(T) of steerable introducer20to end-effector50(O) of steerable introducer20may be secured, or separable whereby the steerable introducers20may disjoined and used individually.

Further in practice, motor controller22may be external to steerable introducers20(O) and20(T) as shown, or alternatively as further described herein, each linear actuator of motion couplers40(O) and40(T), and rotary actuator60if applicable may employ an individual motor controller22.

FIG. 11illustrates an embodiment of steerable introduction device21(FIG. 10) employing employs an orienting steerable introducer20(O) and a translating steerable introducer20(T) in a stacked arrangement involving an adjoining of shaft31(T) of steerable introducer20(T) to end-effector51(O) of steerable introducer20(O). In operation, rods43a(O) and43b(O) are controllable to actuate a translation, a pivoting and/or a rotation of end-effector51(O) and end-effector51(T) relative to shaft31(O), and rods43a(T) and43b(T) are controllable to actuate a translation, a pivoting and/or a rotation of end-effector51(T) relative to shaft31(T). In this context, the linear actuator(s) of orienting steerable introducer20(O) may be exclusively utilized for orienting end-effector51(T), and the linear actuator(s) of translating steerable introducer20(T) may be exclusively utilized for translating end-effector50(T).

To facilitate a further understanding of the various inventions of the present disclosure, the following description ofFIG. 12teaches basic inventive principles associated with interventional methods of the present disclosure in the context of a minimally invasive aortic valve replacement. From this description, those having ordinary skill in the art will appreciate how to apply the inventive principles of the present disclosure for making and using additional embodiments of interventional methods of the present disclosure for any type of minimally invasive procedure suitable for a steerable introducer/introduction device of the present disclosure. Please note the components of the present disclosure as shown inFIG. 12are not drawn to scale, but drawn to conceptually visualize the inventive principles of the present disclosure.

Referring toFIG. 12, a stage S142of a flowchart140encompasses a user placement of steerable introducer20(FIG. 2) or steerable introduction device21(FIG. 2) into a heart of a patient as illustrated in a surgical image via fluoroscopic imager100(FIG. 2) encircling the thoracic cavity of the patient or via TEE probe110(FIG. 2) placed in the esophagus of the patient.

A transapical approach of stage S142involves a small incision in a lower part of a chest, and a small puncture in left ventricle of the beating heart. The placement of steerable introducer20or of steerable introduction device21into the heart may position an end-effector of steerable introducer20or of steerable introduction device21anywhere within the left ventricle as illustrated in the surgical image via fluoroscopic imager100or TEE probe110.

For example, a scenario150ais an exemplary coaxial alignment and coplanar misalignment of an end-effector of steerable introducer20with an aortic valve AV of the heart.

By further example, a scenario151ais an exemplary coaxial misalignment and coplanar misalignment of an end-effector of steerable introducer20with an aortic valve AV of the heart.

By further example, a scenario152ais an exemplary coaxial misalignment and coplanar misalignment of an end-effector of steerable introduction device21with an aortic valve AV of the heart.

A transaortic approach of stage S142involves a small incision in an upper part of a chest of the patient, and a small puncture in the aorta of the beating heart of the patient. The placement of steerable introducer20or of steerable introduction device21into the heart may position (i.e., location and orientation) an end-effector of steerable introducer20or of steerable introduction device21anywhere within the aorta as illustrated in the surgical image via TEE probe110or alternatively fluoroscopic imager100.

Those having skill in the art will appreciate exemplary transapical scenarios of the transaortic approach analogous to the scenarios150a-152a.

A stage S144of flowchart140encompasses image controller134(FIG. 2) facilitating a registration of steerable introducer20or of steerable introduction device21to the applicable imaging modality, fluoroscopic imager100or TEE probe110.

In practice, the registration may be executed by any known technique in the art for generating a transformation matrix between an actuation coordinate system of steerable introducer20or of steerable introduction device21to an image coordinate system of the applicable imaging modality.

The actuation coordinate system of steerable introducer20or of steerable introduction device21defines a reference point for tracking a position of the end-effector of steerable introducer20or of steerable introduction device21within the actuation coordinate system, particularly in terms of a location of specified point of the end-effector (e.g., a central point) and the orientation of the end-effector about the location of the specified point of the end-effector.

The image coordinate system of the applicable imaging modality defines a reference point for identifying positions of anatomical structures and of steerable introducer20or of steerable introduction device21within the live images of the anatomical object.

Also in practice, the actuation coordinate system of steerable introducer20or of steerable introduction device21is assumed to be static in view of a shaft of steerable introducer20or of steerable introduction device21being anchored in a heart muscle. By comparison, the image coordinate system may be static in view of a fixed positioning of the applicable imaging modality whereby the initial registration is maintained over an execution of flowchart140. Conversely, the image coordinate system may be dynamic in view of a changing positioning of the applicable imaging modality whereby the initial registration is updated as needed over an execution of flowchart140.

Stage S144of flowchart140further encompasses image controller134facilitating a surgeon delineation or an image delineation of a target position of the end-effector of steerable introducer20or of steerable introduction device21within the live image of the anatomical object.

In one embodiment, a surgeon may outline a desired target position of the end-effector of steerable introducer20or of steerable introduction device21within the live image of the anatomical object.

In a second embodiment, image controller134performs an automatic segmentation of the targeted structure within the live image of the anatomical object as known in the art, and determines a desired target position of the end-effector of steerable introducer20or of steerable introduction device21relative to the segmented structure.

In practice, the delineated target position may be described as a plane defined by a center and a unit vector normal to the plane.

A stage S146of flowchart140encompasses an actuation of steerable introducer20or of steerable introduction device21by introducer controller135for steering the end-effector thereof to the delineated target position for achieving a coaxial alignment and/or a coplanar alignment of the end-effector of steerable introducer20or of steerable introduction device21with an aortic valve AV of the heart as shown in live images of the heart (e.g., X-ray or ultrasound).

For example, a scenario150bis an exemplary translation motion of the end-effector to thereby achieve a coaxial alignment and a coplanar alignment of an end-effector of a steerable introducer20with an aortic valve AV of the heart.

By further example, a scenario151bis an exemplary translation motion and pitch motion of the end-effector to thereby achieve a coaxial alignment and a coplanar alignment of an end-effector of steerable introducer20with aortic valve AV of the heart.

By further example, a scenario152bis an exemplary translation motion and pitch motion of the end-effector to thereby achieve a coaxial alignment and a coplanar alignment of an end-effector of steerable introduction device21with aortic valve AV of the heart.

Those having skill in the art will appreciate exemplary scenarios of the transaortic approach analogous to the transapical scenarios150b-152b.

A stage S148of flowchart140encompasses a deployment of an artificial valve by passing a balloon catheter supporting the artificial valve through steerable introducer20or steerable introduction device21and the end-effector thereof guiding a positioning of a balloon catheter supporting an artificial valve. Alternatively, the balloon catheter may be securely or separably adjoined to the end-effector of steerable introducer20or of steerable introduction device21during stages S142and S144whereby introducer controller135via the live image identifies and accounts for the balloon catheter during the placement of steerable introducer20or of steerable introduction device21of stage S142and the positioning of the end-effector during stage S146.

Flowchart chart140is terminated upon deployment of the artificial valve.

To facilitate a further understanding of the various inventions of the present disclosure, the following description ofFIGS. 13 and 14teaches basic inventive principles associated with image registration, target position delineation and image guidance of an interventional method of the present disclosure. From this description, those having ordinary skill in the art will further appreciate how to apply the inventive principles of the present disclosure for making and using additional embodiments of interventional methods of the present disclosure for any type of minimally invasive procedure suitable for a steerable introducer/steerable introduction device of the present disclosure. Please note the components of the present disclosure as shown inFIGS. 13 and 14are not drawn to scale, but drawn to conceptually visualize the inventive principles of the present disclosure.

Referring toFIG. 13A, a transapical approach160involves a placement of steerable introducer20within left ventricle LV of a heart whereby steerable introducer20is anchored in the heart muscle to define an actuation coordinate system CSSI. TEE probe110is positioned within an esophagus (not shown) to image end-effector51of steerable introducer20relative to aortic valve AV of the heart. TEE probe110has an imaging coordinate system CSTEEthat may be static whereby a single registration between the coordinate systems CSSI/CSTEEis required, or dynamic whereby the registration between the coordinate systems CSSI/CSTEEis sporadically or continually updated.

Transapical approach160further involves a delineation of a target position TP described as a plane defined by a center cvdenoting a target location of end-effector51within the registered imaging coordinate system CSTEE, and a unit vector {right arrow over (n)}vnormal to the plane denoting a target orientation of end-effector51within the registered imaging coordinate system CSTEE.

Optionally, one or more safe zones may be delineated within left ventricle LV. For example, adherence to a safe zone SZ1impedes any potential damage to an interventricular septum of the heart and adherence to a safe zone SZ2impedes any potential damage to a mitral valve of the heart.

Referring toFIGS. 13A and 13B, a control loop161for the transapical approach160ofFIG. 13Ais based on a positioning error differential between a delineation of a target position of the end-effector within the anatomical object as illustrated by the surgical image data and an identification of the position of the end-effector within the anatomical object as illustrated by the surgical image data.

Specifically, control loop161includes image controller134processing ultrasound image data112for the delineation of a target position137within the live ultrasound image in accordance with stage S144(FIG. 12) and for subsequently detecting a device position138of end-effector51within the live ultrasound image in accordance with stage S146(FIG. 12).

Control loop161further includes a digital subtractor139for ascertaining a position distance error signal edas a dot differential between the center cvof the target position and the center cdof the end-effector in accordance with the following equation [1]:
ed=∥cv−cd∥  [1]

Digital subtractor139further generates an alignment error signal eaas a dot product of two planes normal indicative of an angular error in accordance with the following equation [2]:
ea={right arrow over (n)}v·{right arrow over (n)}d[2]

An additional digital subtractor (not shown) may be included to generate a safety error signal esas a dot differential between the center cvof the detected end-effector51and a spot location csof the anatomical object closest to end-effector51in accordance with the following equation [3]:
ed=∥cs−cd∥  [3]

Control loop161further includes introducer controller135processing the applicable error signals as inputs to an inverse kinematics computation of image registered steerable introducer20to ascertain required linear motion(s) of linear actuator(s)43of steerable introducer20. Actuation data136informative of such linear motion(s) is communicated from introducer controller135to motor controller22, which in turns applies linear drive signals23to linear actuator(s)43of the steerable introducer20to actuate the necessary motion of end-effector51to target position TP.

Control loop161is cyclical until such time end-effector51reaches target position TP. Those having ordinary skill in the art will appreciate a transaortic approach of control loop161.

Referring toFIG. 14A, a transapical approach162involves a placement of steerable introduction device21within left ventricle LV of a heart whereby steerable introduction device21is anchored in the heart muscle to define an actuation coordinate system CSSID. As previously described, TEE probe110is positioned within an esophagus (not shown) to image end-effector51(T) of steerable introduction device21relative to aortic valve AV of the heart. TEE probe110as an imaging coordinate system CSTEEthat may be static whereby a single registration between the coordinate systems is required, or dynamic whereby the registration between the coordinate systems is sporadically or continually updated.

Transapical approach162further involves a delineation of a target position TP described as a plane defined by a center cvdenoting a target location of end-effector51(T) within the registered imaging coordinate system CSTEE, and a unit vector {right arrow over (n)}vnormal to the plane denoting a target orientation of end-effector51(T) within the registered imaging coordinate system CSTEE.

As previously described, one or more safe zones may be delineated within left ventricle LV. For example, adherence to a safe zone SZ1impedes any potential damage to an interventricular septum of the heart and adherence to a safe zone SZ2impedes any potential damage to a mitral valve of the heart.

Referring toFIGS. 14A and 14B, a control loop163afor the transapical approach162ofFIG. 14Ais based on an orientation error differential between a targeted orientation of the translating end-effector within the anatomical object and the surgical orientation of the translating end-effector within the anatomical object as illustrated by the surgical image data.

Specifically, control loop163aincludes image controller134processing ultrasound image data112for the delineation of a target orientation137owithin the live ultrasound image in accordance with stage S144(FIG. 12) and for subsequently detecting a device orientation138oof end-effector51(T) within the live ultrasound image in accordance with stage S146(FIG. 12).

Control loop163aincludes digital subtractor139generating an alignment error signal eaas a weighted dot product of two planes normal indicative of an angular error in accordance with the following equation [4]:
ea=m·{right arrow over (n)}v·{right arrow over (n)}d[4]

Control loop163afurther includes introducer controller135processing the alignment error signal as input to an inverse kinematics computation of image registered steerable introduction device21to ascertain required linear motion(s) of linear actuator(s)43of end-effector51(O). Actuation data136oinformative of such linear motion(s) is communicated from introducer controller135to motor controller22, which in turns applies linear drive signals23oto linear actuator(s)43of the steerable introduction device21to actuate the necessary motion of end-effector51(T) to target position TP.

Control loop163ais cyclical until such time end-effector51(T) reaches a target orientation of target position TP. Those having ordinary skill in the art will appreciate a transapical approach to control loop163a.

Referring toFIGS. 14A and 14C, a control loop163bfor the transapical approach162ofFIG. 14Ais based a location error differential between a targeted location of the translating end-effector within the anatomical object and the surgical location of the translating end-effector within the anatomical object as illustrated by the surgical image data.

Specifically, control loop163bincludes image controller134processing ultrasound image data112for the delineation of a target location1371within the live ultrasound image in accordance with stage S144(FIG. 12) and for subsequently detecting a device location1381of end-effector51(T) within the live ultrasound image in accordance with stage S146(FIG. 12).

Control loop161further includes digital subtractor139for generating a weighted distance error signal edas a dot differential between the center cvof the target position and the center cdof the end-effector in accordance with the following equation [5]:
ed=n·∥cv−cd∥[5]

Control loop163bfurther includes introducer controller135processing the distance error signal as an input to an inverse kinematics computation of image registered steerable introduction device21to ascertain required linear motion(s) of linear actuator(s)43of end-effector51(T). Actuation data136tinformative of such linear motion(s) is communicated from introducer controller135to motor controller22, which in turns applies linear drive signals23fto linear actuator(s)43of the steerable introduction device21to actuate the necessary motion of end-effector51(T) to a target location of target position TP.

Control loop163bis cyclical until such time end-effector51(T) reaches a target location of target position TP. Those having ordinary skill in the art will appreciate a transapical approach to control loop163b.

Referring toFIGS. 1-14C, those having ordinary skill in the art will appreciate numerous benefits of the inventions of the present disclosure including, but not limited to, image guidance for a precise coaxial alignment and/or a precise coplanar alignment of an interventional tool as needed with a structure of an anatomical object in support of a deployment of the interventional tool during a minimally invasive procedure.

Further, as one having ordinary skill in the art will appreciate in view of the teachings provided herein, structures, elements, components, etc. described in the present disclosure/specification and/or depicted in the Figures may be implemented in various combinations of hardware and software, and provide functions which may be combined in a single element or multiple elements. For example, the functions of the various structures, elements, components, etc. shown/illustrated/depicted in the Figures can be provided through the use of dedicated hardware as well as hardware capable of executing software in association with appropriate software for added functionality. When provided by a processor, the functions can be provided by a single dedicated processor, by a single shared processor, or by a plurality of individual processors, some of which can be shared and/or multiplexed. Moreover, explicit use of the term “processor” or “controller” should not be construed to refer exclusively to hardware capable of executing software, and can implicitly include, without limitation, digital signal processor (“DSP”) hardware, memory (e.g., read only memory (“ROM”) for storing software, random access memory (“RAM”), non-volatile storage, etc.) and virtually any means and/or machine (including hardware, software, firmware, combinations thereof, etc.) which is capable of (and/or configurable) to perform and/or control a process.

Moreover, all statements herein reciting principles, aspects, and embodiments of the invention, as well as specific examples thereof, are intended to encompass both structural and functional equivalents thereof. Additionally, it is intended that such equivalents include both currently known equivalents as well as equivalents developed in the future (e.g., any elements developed that can perform the same or substantially similar function, regardless of structure). Thus, for example, it will be appreciated by one having ordinary skill in the art in view of the teachings provided herein that any block diagrams presented herein can represent conceptual views of illustrative system components and/or circuitry embodying the principles of the invention. Similarly, one having ordinary skill in the art should appreciate in view of the teachings provided herein that any flow charts, flow diagrams and the like can represent various processes which can be substantially represented in computer readable storage media and so executed by a computer, processor or other device with processing capabilities, whether or not such computer or processor is explicitly shown.

Having described preferred and exemplary embodiments of novel and inventive image guidance of steerable introducers, and systems and methods incorporating such image guidance of steerable introducers, (which embodiments are intended to be illustrative and not limiting), it is noted that modifications and variations can be made by persons skilled in the art in light of the teachings provided herein, including the Figures. It is therefore to be understood that changes can be made in/to the preferred and exemplary embodiments of the present disclosure which are within the scope of the embodiments disclosed herein.

Moreover, it is contemplated that corresponding and/or related systems incorporating and/or implementing the device/system or such as may be used/implemented in/with a device in accordance with the present disclosure are also contemplated and considered to be within the scope of the present disclosure. Further, corresponding and/or related method for manufacturing and/or using a device and/or system in accordance with the present disclosure are also contemplated and considered to be within the scope of the present disclosure.