WO2018001812A1

WO2018001812A1 - Steerable introducer for minimially invasive procedures

Info

Publication number: WO2018001812A1
Application number: PCT/EP2017/065193
Authority: WO
Inventors: David Paul NOONAN; Aleksandra Popovic
Original assignee: Koninklijke Philips N.V.
Priority date: 2016-06-28
Filing date: 2017-06-21
Publication date: 2018-01-04

Abstract

A steerable introducer (20) for deploying an interventional tool (e.g., a replacement valve) within an anatomical object (e.g. a heart). The steerable introducer (20) employs a motion coupler (40) coupling a shaft (30) and an end-effector (50). The shaft (30) is structurally configured to introduce the interventional tool into the anatomical object (e.g., the interventional tool passes through or over the shaft (30) into the anatomical object), and the end-effector (50) is structurally configured to interact with the interventional tool within the anatomical object (e.g., the end-effector (50) is movable to position the interventional tool within the anatomical object). The motion coupler (40) includes one or more linear actuators controllable to actuate a translation, a pivoting and/or a rotation of the end-effector (50) relative to the shaft (30). An actuation of the linear actuator(s) facilitates a coaxial alignment and/or a coplanar alignment of the end-effector (50) and a structure of the anatomical object (e.g., a diseased aortic valve of a heart).

Description

STEERABLE INTRODUCER

FOR MINIMIALLY INVASIVE PROCEDURES

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 prior deflectable introducer sheaths for deploying interventional tools during a minimally invasive procedure by providing steerable introducers 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 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.

One form of the inventions of the present disclosure is a steerable introducer for deploying an interventional tool (e.g., a replacement valve) within an anatomical object (e.g., a heart). The steerable introducer employs a motion coupler coupling a shaft and an 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 device employing a combination of two (2) or more of 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.

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.

More particularly for the second form of the inventions of the present disclosure, a steerable introduction device 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 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". A third form of the inventions of the present disclosure is an interventional method utilizing the steerable introducer or the steerable introduction device. The interventional method involves a surgical placement of the end-effector into the anatomical object, and a steering of the end-effector to a position within the anatomical object. The steering of the end-effector includes a translation, a pivoting and/or a rotation of the end-effector within the anatomical object responsive to an actuation of the motion coupler, which provides translational motion, pitch motion and/or 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 a coplanar alignment of the artificial valve to a diseased aortic valve of a heart).

The steering of the end-effector may further include a rotational actuator actuation a rotation of the end-effector about a rotational axis of the shaft and/or a rotational axis of the end-effector to thereby provide any roll motion of the end-effector within the anatomical object necessary to achieve the coaxial alignment and/or coplanar alignment of the interventional tool with the structure of the anatomical object.

A fourth form of the inventions of the present disclosure is an interventional system employing the steerable introducer, and an introducer controller for controlling an actuation by the linear actuator(s) of the translation, the pivoting and/or the rotation of the end-effector within the anatomical object. The introducer controller is installed within or linked to a user input device (e.g., a joystick, a keyboard and/or a graphical user interface of directional icons and/or a replica of the interventional device), or installed within or linked to a workstation incorporating the user input device.

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 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 "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.

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.

BRIEF DESCRIPTION OF THE DRAWINGS FIGS. 1A-1E illustrate an exemplary deployment of a replacement valve by a steerable introducer in accordance with the inventive principles of the present disclosure.

FIG. 2 illustrates an exemplary embodiment of an interventional system in accordance with the inventive principles of the present disclosure.

FIG. 3 illustrates an exemplary general embodiment steerable introducer in accordance with the inventive principles of the present disclosure. FIG. 4 illustrates an exemplary unassembled embodiment of the steerable introducer shown in FIG. 3 in accordance with the inventive principles of the present disclosure.

FIG. 5 illustrates an exemplary assembled embodiment of the steerable introducer shown in FIG. 3 in accordance with the inventive principles of the present disclosure.

FIGS. 6A-6E illustrate exemplary motions of the steerable introducer shown in FIG. 5 in accordance with the inventive principles of the present disclosure.

FIGS. 7 A and 7B illustrate additional exemplary embodiments of linear actuator platforms in accordance with the inventive principles of the present disclosure.

FIGS. 8A and 8B illustrates exemplary interactions between a balloon catheter and an end-effector in accordance with the inventive principles of the present disclosure.

FIGS. 9 A and 9B illustrate additional exemplary assembled embodiments of the steerable introducer shown in FIG. 3 in accordance with the inventive principles of the present disclosure.

FIG. 10 illustrates an exemplary general embodiment of steerable introduction device in accordance with the inventive principles of the present disclosure.

FIG. 11 illustrates an exemplary assembled embodiment of the steerable introducer shown in FIG. 10 in accordance with the inventive principles of the present disclosure.

FIG. 12 illustrates a flowchart representative of an exemplary embodiment of an interventional method in accordance with the inventive principles of the present disclosure.

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 in FIG. 1 A are 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 introducer 20 of 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 introducer 20 is therefore misaligned with both the valve annulus axis VAA and the valve annulus plane VAP of the diseased aortic valve AV as shown in FIG. IB.

As will be further described herein, steerable introducer 20 of the present disclosure is actuatable to translate, pivot and/or rotate the end-effector of steerable introducer 20 as 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 in FIG. 1C. As such, a balloon catheter BC supporting a replacement artificial valve RV may be introduced via steerable introducer 20 of the present disclosure into the left ventricle LV as shown in FIG. ID with 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 in FIG. IE.

To facilitate an understanding of the various inventions of the present disclosure, the following description of FIG. 2 teaches 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 in FIG. 2 are not drawn to scale, but drawn to conceptually visualize the inventive principles of the present disclosure.

Referring to FIG. 2, an interventional system of the present disclosure employs steerable introducer 20 or a steerable introduction device 21, a motor controller 22, a fluoroscopic imager 100 (e.g., a mobile c-arm as shown) and/or an ultrasound probe 110, an image guidance workstation 120 and a control network 130 for 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 imager 100 generally includes an X-ray generator 101, an image intensifier 102 and a collar 103 for rotating fluoroscopic imager 100. In operation as known in the art, an X-ray controller 104 controls a generation by fluoroscopic imager 100 of imaging data 105 illustrative 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 controller 104 may be installed within an X-ray imaging workstation (not shown), or alternatively installed within image guidance workstation 120.

Ultrasound probe 110 is 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 controller 111 controls a generation by ultrasound probe 110 of imaging data 112 illustrative 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 controller 111 may be installed within an ultrasound imaging workstation (not shown), or alternatively installed within image guidance workstation 120.

Workstation 120 is assembled in a known arrangement of a standalone computing system employing a monitor 121, a keyboard 122 and a computer 123. Control network 130 is installed on computer 123, and employs application modules 131 including a planning module 132 and a user steering module 133. Control network 130 further includes an image controller 134 and an introducer controller 135.

Image controller 134 generally processes image data as known in the art for an illustration of the image on display 121. For example, image controller 134 may process X-ray image data 105 for an illustration of an X-ray image on display 121, and/or process ultrasound image data 112 for an illustration of an ultrasound image on display 121.

In support of the minimally invasive procedure, image controller 134 executes or accesses planning module 132 to facilitate a user visualization or 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 controller 134 controls an illustration of an X-ray image and/or an ultrasound image of the structure of the anatomical object on display 121, or concurrently or alternatively controls an illustration of a registered pre-operative image of the structure of the object on display 121 (e.g., a computed-tomography image or a magnetic resonance image). An operator of workstation 120 visualizes or delineates, within the image(s), a target position of an end-effector of steerable introducer 20 or of steerable introduction device 21 for 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 workstation 120 may visualize or delineate, within the image(s), a target position of an end-effector of steerable introducer 20 or of steerable introduction device 21 for achieving based on an intersection of valve annulus axis VAA and valve annulus plane VAP of a diseased aortic valve AV as shown in FIG. 1A.

During the minimally invasive procedure, image controller 134 executes or accesses steering module 133 to identify an end-effector of steerable introducer 20 or steerable introduction device 21 within the displayed image(s) whereby the operator of workstation 120 may ascertain any necessary translational, pitch and/or rotation of the end-effector of steerable introducer 20 or steerable introduction device 21 necessary to reach the target position to thereby achieve the coaxial alignment and/or the coplanar alignment of an interventional tool to the structure of the anatomical object of patient P.

For example, the operator of workstation 120 may identify, within the image(s), the end-effector of steerable introducer 20 or steerable introduction device 21 relative to the visualized or delineated valve annulus axis VAA and valve annulus plane VAP of a diseased aortic valve AV as shown in FIG. IB whereby the operator of workstation 120 ascertains any necessary translational, pitch and/or rotation of the end-effector of steerable introducer 20 or steerable introduction device 21 necessary to reach the target positon for achieving the coaxial alignment with valve annulus axis VAA and the coplanar alignment of valve annulus plane VAP as shown in FIG. 1C.

The operator of workstation 120 manipulates a user input device of workstation 120 in the form of a joystick, keyboard directional arrows and/or a graphical user interface to actuate the ascertained necessary motions.

In practice, the user input device may be built with the same kinematics as steerable introducer 20 or steerable introduction device 21 and scaled with any scale (preferably larger). In one embodiment, linear actuator(s) of the user input device may include encoders whereby introducer controller 21 interprets signals of the encoders using a known kinematic model of the user input device into linear motion parameter(s) for steerable introducer 20 or steerable introduction device 21.

More particularly, by implementing a kinematic model as known in the art of steerable introducer 21 or steerable introduction device 22, introducer controller 135 interprets encoded motion parameters of the manipulated user input device of workstation 120 (e.g., translation, pitch and yaw motion parameters) into linear motion parameter(s) for linear actuator(s) of steerable introducer 21 or for linear actuator(s) of steerable introduction device 22 as will be further explained herein. Introducer controller 135 generates actuation data 126 informative of a desired linear motion parameter(s) for the linear actuator(s) and communicates actuation data 126 to motor controller 22 for actuating a translation, pivot and/or rotation by the linear actuator(s) of the end-effector of steerable introducer 20 or the end-effector of steerable introduction device 21 to 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 workstation 120 may manipulate the user input device of workstation 120 to actuate a translation pivot and/or rotation by the linear actuator(s) of the end-effector of steerable introducer 20 or steerable introduction device 21 necessary 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 in FIG. 1C.

In practice, motor controller 22 may be a standalone controller or installed within image guidance workstation 120.

To facilitate an understanding of the various inventions of the present disclosure, the following description of FIG. 3 teaches 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 in FIG. 3 are not drawn to scale, but drawn to conceptually visualize the inventive principles of the present disclosure.

Referring to FIG. 3, a steerable introducer 20 of the present disclosure employs a shaft 30, a motion coupler 40, an end-effector 50 and an optional rotary actuator 60.

A structural configuration of shaft 30 is 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 shaft 30 is dependent upon particular minimally invasive procedure(s) utilizing steerable introducer 20.

In a first embodiment, as will be further described herein, shaft 30 is specified as a rigid or a semi-rigid shaft having a hollow central core for passing an

interventional tool through shaft 30 to end-effector 50, and further having one or more lumens for passing electrical wiring through shaft 30 to motion coupler 40.

In a second embodiment, shaft 30 is specified as a rigid or a semi-rigid shaft having a solid central core for passing an interventional tool over shaft 30 to end- effector 50, and further having one or more lumens for passing electrical wiring through shaft 30 to motion coupler 40. A structural configuration of end-effector 50 is specified in terms of shape and dimension for an interaction of end-effector 50 with the interventional tool as the interventional tool is being introduced by shaft 30 into 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-effector 50 is dependent upon particular minimally invasive procedure(s) utilizing steerable introducer 20.

In one embodiment, as would be appreciated by those skilled in the art, end- effector 50 is 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 shaft 30 and end-effector 50 subsequent to a desired positioning of end-effector 50 within the anatomical object, or alternatively the interventional tool is passed through shaft 30 and adjoined to end- effector 50 prior to a placement of steerable introducer 20 into the anatomical object.

In another embodiment, as would be appreciated by those skilled in the art, end- effector 50 is 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 shaft 30 and adjoined to end-effector 50 prior to an placement of steerable introducer 20 into the anatomical object.

A structural configuration of motion coupler 40 is specified in terms of one or more linear actuator(s) (not shown) serving as motorized prismatic joint(s) coupling shaft 30 and end-effector 50 in a manner that facilitates a controllable actuation of the linear actuator(s) to translate, pivot and/or rotate end-effector 50 relative to shaft 30 as symbolized by the arrows extending from end-effector 50.

In one embodiment, as will be further described herein, a linear actuator includes a piezoelectric motor (not shown) coupled to shaft 30 for translating a rod (not shown) coupled to end-effector 50 in a forward direction or a reverse direction.

The structural configuration of motion coupler 40 may be further specified in terms of one or more linear slider(s) (not shown) serving as a non-motorized prismatic joint translatable between shaft 30 and end-effector 50 to facilitate a pivoting and/or rotation of end-effector 50 relative to shaft 30.

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 shaft 30 and a translatable member coupled to end-effector 50 whereby the translatable member is translatable in a forward direction or a reverse direction.

The structural configuration of motion coupler 40 may be further specified in terms of one or more posts (not shown) serving as a rigid joint coupled to shaft 30 and end-effector 50.

In one embodiment, as will be further described herein, a post is a fulcrum for enhancing a pivoting and/or rotation of end-effector 50 relative to shaft 30.

If employed, rotary actuator 60 is coupled to shaft 30 as shown in a manner that facilitates a controllable actuation of rotary actuator 60 to rotate shaft 30 about a rotational axis of shaft 30 (e.g., a longitudinal axis of shaft 30), or alternatively incorporated within motion controller 40 in a manner that facilitates a controllable actuation of rotary actuator 60 to rotate end-effector 50 about a rotational axis of end- effector 50 (e.g., a central axis of end-effector 50).

In operation as previously described herein, introducer controller 135 is 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 actuator 60. Introducer controller 135 generates actuation data 136 informative of a desired linear motion parameter(s) for the linear actuator(s) and if applicable of a desired rotational motion parameter for rotary actuator 60.

Actuation data 135 is communicated to a motor controller 22 that translates the desired linear motion parameter(s) into linear drive signal(s) 23 transmitted to one or more of the linear actuator(s) whereby each actuated linear actuator will apply a linear force to end-effector 50 in 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-effector 50 relative to shaft 30.

If applicable, motor controller 22 translates the desired rotational motion parameter into a rotational drive signal 24 transmitted to rotary actuator 60 whereby rotary actuator 60 will apply a rotational force to shaft 30 or end-effector 50 in a clockwise direction or a counterclockwise direction. In practice, motor controller 22 may be external to steerable introducer 20 as shown, or alternatively as further described herein, each linear actuator 40 and rotary actuator 60 if applicable may employ an individual motor controller 22.

To facilitate an understanding of the various inventions of the present disclosure, the following description of FIGS. 4-9B teaches 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 in FIGS. 4-9B are not drawn to scale, but drawn to conceptually visualize the inventive principles of the present disclosure.

FIG. 4 shows an unassembled view of an embodiment of steerable introducer 20 (FIG. 3) employing a shaft 31, a pair of linear actuators 41a and 41b, an end-effector 51 and optional rotary actuator 61.

Referring to FIG. 3, shaft 31 is structurally designed as a rigid or a semi-rigid shaft having a hollow central core 32 for passing an interventional tool through shaft 31 to end-effector 51, and further having one or more lumens 33a and 33b for passing electrical wiring through shaft 31 to linear actuators 41 to be housed within slots 34a and 34b.

End-effector 51 is 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-effector 51 may 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-effector 51 , an end-effector 52 is shaped and dimensioned as a plate for actively steering a positioning of the interventional tool within the anatomical object. In practice, end-effector 52 may 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 actuator 41 includes a motor 42 for translating a rod 43 in a forward direction F or a reverse direction R. Each linear actuator 41a further includes a motor controller 44 for controlling motor 42. In practice, motor 42 may be electric (DC, brushless DC, AC), piezoelectric or pneumatic.

Additionally, a linear slider 45 or a post 48 may be substituted for one of the linear actuators 41.

Linear slider 45 may include a telescoping elements 46 and 47, or a pneumatic or spring base 47 for translating a rod 46 in a forward direction F or a reverse direction R in dependence upon a degree of downward pressure applied to rod 46.

Post 48 serves as a fulcrum about which an end-effector 51 pivots and/or rotates relative to shaft 31.

If employed, rotary actuator 61 includes a motor 62 for rotating a rod 63 in a clockwise direction C or a counter clockwise direction CW. A platform 65 is geared to rod 63 to thereby rotate in sync with rod 63. Rotary actuator 61 further includes a motor controller 64 for respectively controlling motor 42. In practice, motor 62 may be electric (DC, brushless DC, AC), piezoelectric or pneumatic.

FIG. 5 shows an assembled view of steerable introducer 20 (FIG. 3) employing shaft 31, linear actuators 41a and 41b, and an end-effector 51.

Referring to FIG. 5, motor 42a and motor controller 44a of linear actuator 41a are housed within shaft 31 and motor 42a is rigidly coupled to shaft 31 via a rotary joint 81a. Rod 43 a extends from shaft 31 and is rotatably coupled to end-effector 51 via a rotary joint 80a.

Similarly, motor 42b and motor controller 44b of linear actuator 41b are housed within shaft 31 and motor 42b is rigidly coupled to shaft 31 via a rotary joint 81b. Rod 43b extends from shaft 31 and is rotatably coupled to end-effector 51 via a rotary joint 80b.

As shown in FIG. 6A, a translation of rods 43a and 43b in a forward direction or a reverse direction translates end-effector 51 relative to shaft 31.

As shown in FIG. 6B, an exclusive translation of rod 43a in a forward direction or a reverse direction pivots end-effector 51 relative to shaft 31. Similarly, an exclusive translation of rod 43b in a forward direction or a reverse direction counter pivots end- effector 51 relative to shaft 31.

As shown in FIG. 6C, a translation of rod 43a in a reverse direction and a translation of rod 43b in a forward direction rotates end-effector 51 relative to shaft 31. Conversely, a translation of rod 43 a in the forward direction and a translation of rod 43b in the reverse direction counter rotates end-effector 51 relative to shaft 31.

As shown in FIG. 6D, with linear slider 45 substituted for linear actuator 41b, a translation of rod 43 a in a forward direction or a reverse direction rotates end-effector 51 relative to shaft 31.

As shown in FIG. 6E, with post 48 substituted for linear actuator 41b, a translation of rod 43 a in a forward direction or a reverse direction pivots end-effector 51 relative to shaft 31.

In practice, those having ordinary skill in the art will appreciate the controllable translation, pivoting and rotating of end-effector 51 as shown in FIGS. 6A-6E provides for a translation motion and a pitch motion of end-effector 51.

Also in practice, additional linear actuators 41 employed motion coupler 40 provides for a yam motion of end-effector 51.

For example, FIG. 7A illustrates a linear actuator platform 49a of three (3) linear actuators 43. The three (3) linear actuators 43 provide for a translation motion, a pitch motion and a yaw motion of end-effector 51 in three (3) degrees of freedom as shown.

Also by example, FIG. 7B illustrates a Stewart platform 49b of six (6) linear actuators 43. The six (6) linear actuators 43 provide for a translation motion, a pitch motion and a yaw motion of end-effector 51 in six (6) degrees for freedom as shown.

In practice, as previously described herein, end-effector 51 may passively guide or actively steer a positioning of the interventional tool within the anatomical object.

For example, FIG. 8A illustrates a passage of a balloon catheter BC supporting a replacement aortic valve RV through shaft 31. Balloon catheter BC may be passively guided through end-effector 51 to a position within the anatomical object subsequent to a targeted positioning of end-effector 51 within the anatomical object, or alternatively may be separably adjoined to end-effector 51 whereby a targeted positioning of end- effector 51 within 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. 8B illustrates a passage of balloon catheter BC supporting replacement aortic valve RV over shaft 31 for a miniaturized steerable introducer 20m. Balloon catheter BC is separably adjoined to end-effector 51 whereby a targeted positioning of end-effector 51 within 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 introducer 20.

For example, FIG. 9A illustrates an adjoining of a proximal end of shaft 31 of steerable introducer 21 to a cylindrical platform 66 of rotary actuator 61. Rotary rod 63 is controllable to actuate a rotation of end-effector 51 about a longitudinal axis of shaft 31.

By further example, FIG. 9B illustrates a housing of rotary actuator 61 within shaft 31 with motors 42 and motor controllers 44 of linear actuators 41 being adjoined to cylindrical platform 66 of rotary actuator 61. Rod 63 is controllable to actuate a rotation of end-effector 51 about a longitudinal axis of end-effector 51.

To facilitate an understanding of the various inventions of the present disclosure, the following description of FIG. 10 teaches 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 in FIG. 10 are 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 to FIG. 10, a steerable introduction device 120 employs an orienting steerable introducer 20(O) and a translating steerable introducer 20(T) in a stacked arrangement involving an adjoining of shaft 30(T) of steerable introducer 20(T) to end- effector 50(O) of steerable introducer 20(O). For this embodiment, introducer controller 137 generates distinct respective actuation data 136o and 136t for sequentially or concurrently actuating motion coupler 40(O) and motion coupler 40(T). In operation, the linear actuator(s) of motion coupler 40(O) is(are) controllable by an introducer controller 135 to actuate a translation, a pivoting and/or a rotation of end-effector 50(O) and end-effector 50(T) relative to shaft 30(O), and linear actuators 40(T) is(are) controllable by introducer controller 135 to actuate a translation, a pivoting and/or a rotation of end-effector 50(T) relative to shaft 30(T). In this context, the linear actuator(s) of motion coupler 40(O) may be exclusively utilized for orienting end-effector 50(T) and the linear actuator(s) of motion coupler 40(T) may be exclusively utilized for translating end-effector 50(T).

In practice, the adjoining of shaft 30(T) of steerable introducer 20 to end- effector 50(O) of steerable introducer 20 may be secured, or separable whereby the steerable introducers 20 may disjoined and used individually.

Further in practice, motor controller 22 may be external to steerable introducers 20(O) and 20(T) as shown, or alternatively as further described herein, each linear actuator of motion couplers 40(O) and 40(T), and rotary actuator 60 if applicable may employ an individual motor controller 22.

FIG. 11 illustrates an embodiment of steerable introduction device 21 (FIG. 10) employing employs an orienting steerable introducer 20(O) and a translating steerable introducer 20(T) in a stacked arrangement involving an adjoining of shaft 31(T) of steerable introducer 20(T) to end-effector 51(0) of steerable introducer 20(O). In operation, rods 43a(0) and 43b(0) are controllable to actuate a translation, a pivoting and/or a rotation of end-effector 51(0) and end-effector 51(T) relative to shaft 31(0), and rods 43a(T) and 43b(T) are controllable to actuate a translation, a pivoting and/or a rotation of end-effector 51(T) relative to shaft 31(T). In this context, the linear actuator(s) of orienting steerable introducer 20(O) may be exclusively utilized for orienting end-effector 51(T), and the linear actuator(s) of translating steerable introducer 20(T)may be exclusively utilized for translating end-effector 50(T).

To facilitate a further understanding of the various inventions of the present disclosure, the following description of FIG. 12 teaches 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 in FIG. 12 are not drawn to scale, but drawn to conceptually visualize the inventive principles of the present disclosure.

Referring to FIG. 12, a stage S 142 of a flowchart 140 encompasses a user placement of steerable introducer 20 (FIG. 2) or steerable introduction device 21 (FIG. 2) into a heart of a patient as illustrated in a surgical image via fluoroscopic imager 100 ( FIG. 2) encircling the thoracic cavity of the patient or via TEE probe 1 10 (FIG. 2) placed in the esophagus of the patient.

A transapical approach of stage S I 42 involves a small incision in a lower part of a chest, and a small puncture in left ventricle of the beating heart. The placement of the steerable introducer 20 or steerable introduction device 21 into the heart may position an end-effector of steerable introducer 20 or of steerable introduction device 21 anywhere within the left ventricle as illustrated in the surgical image via fluoroscopic imager 100 or TEE probe 1 10.

For example, a scenario 150a is an exemplary coaxial alignment and coplanar misalignment of an end-effector of steerable introducer 20 with an aortic valve AV of the heart.

By further example, a scenario 151a is an exemplary coaxial misalignment and coplanar misalignment of an end-effector of steerable introducer 20 with an aortic valve AV of the heart.

By further example, a scenario 152a is an exemplary coaxial misalignment and coplanar misalignment of an end-effector of steerable introduction device 21 with an aortic valve AV of the heart.

A transaortic approach of stage S I 42 involves 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 the steerable introducer 20 or steerable introduction device 21 into the heart may position (i.e., location and orientation) an end-effector of steerable introducer 20 or of steerable introduction device 21 anywhere within the aorta as illustrated in the surgical image via TEE probe 1 10 or alternatively fluoroscopic imager 100.

Those having skill in the art will appreciate exemplary scenarios of the transaortic approach analogous to the transapical scenarios 150a- 152a. A stage SI 44 of flowchart 140 encompasses an operator actuation of steerable introducer 20 or steerable introduction device 21 for steering the end-effector thereof to the target positon for achieving a coaxial alignment and/or a coplanar alignment of the end-effector of steerable introducer 20 or of steerable introduction device 21 with an aortic valve AV of the heart as shown in live images of the heart (e.g., X-ray or ultrasound).

For example, a scenario 150b is 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 introducer 20 with an aortic valve AV of the heart.

By further example, a scenario 15 lb is 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 introducer 20 with an aortic valve AV of the heart.

By further example, a scenario 152b is 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 device 21 with an aortic valve AV of the heart.

Those having skill in the art will appreciate exemplary scenarios of the transaortic approach analogous to the transapical scenarios 150b- 152b.

A stage SI 46 of flowchart 140 encompasses a deployment of an artificial valve by passing a balloon catheter supporting the artificial valve through steerable introducer 20 or steerable introduction device 21 and 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 introducer 20 or of steerable introduction device 21 during stages SI 42 and SI 44 whereby the operator via the surgical image identifies and accounts for the balloon catheter during the placement of the steerable introducer of stage SI 42 and the positioning of the end-effector during stage SI 44.

Flowchart chart 140 is terminated upon deployment of the artificial valve.

Referring to FIGS. 1-12, those having ordinary skill in the art will appreciate numerous benefits of the inventions of the present disclosure including, but not limited to, 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 steerable introducers and systems and methods incorporating such 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.

Claims

1. A steerable introducer (20) for deploying an interventional tool within an anatomical object, the steerable introducer (20) comprising:

a shaft (30) structurally configured to introduce the interventional tool into the anatomical object;

an end-effector (50) structurally configured to interact with the interventional tool within the anatomical object; and

a motion coupler (40) coupling the shaft (30) and the end-effector (50),

wherein the motion coupler (40) includes at least one linear actuator controllable to actuate at least one of a translation, a pivoting and a rotation of the end- effector (50) relative to the shaft (30).

2. The steerable introducer (20) of claim 1, wherein at least one of:

the at least one linear actuator is rotatably coupled to the end-effector (50); and the at least one linear actuator is rigidly coupled to the shaft (30).

3. The steerable introducer (20) of claim 1, wherein the motion coupler (40) further includes:

at least one linear slider translatable between the shaft (30) and the end-effector (50) responsive to an actuation of the at least one linear actuator.

4. The steerable introducer (20) of claim 3, wherein at least one of:

the at least one linear slider is rotatably coupled to the end-effector (50); and the at least one linear slide is rigidly coupled to the shaft (30).

5. The steerable introducer (20) of claim 1, wherein the motion coupler (40) further includes:

at least one post extending between the shaft (30) and the end-effector (50).

6. The steerable introducer (20) of claim 6, wherein at least one of:

the at least one post is rotatably coupled to the end-effector (50); and least one post is rigidly coupled to the shaft (30).

7. The steerable introducer (20) of claim 1 , wherein the motion coupler (40) further includes:

a rotary actuator controllable to actuate a rotation of the end-effector (50) about a rotational axis of the end-effector (50).

8. The steerable introducer (20) of claim 1, further comprising:

a rotary actuator coupled to the shaft (30),

wherein the rotary actuator is controllable to actuate a rotation of the shaft (30) about a rotational axis of the shaft (30).

9. The steerable introducer (20) of claim 1, wherein the shaft (30) is shaped and dimensioned to pass the interventional tool through the shaft (30) into the anatomical object.

10. The steerable introducer (20) of claim 1, wherein the shaft (30) is shaped and dimensioned to pass the interventional tool over the shaft (30) into the anatomical object.

11. The steerable introducer (20) of claim 1 , wherein the end-effector (50) is shaped and dimensioned to guide a positioning of the interventional tool within the anatomical object.

12. The steerable introducer (20) of claim 1, wherein the end-effector (50) is shaped and dimensioned to a steer a positioning of the interventional tool within the anatomical object.

13. A steerable introduction device for deploying an interventional tool within anatomical object, the steerable introduction device comprising:

an orienting steerable introducer (20) including an orienting shaft (30) structurally configured to introduce the interventional tool into the anatomical object,

an orienting end-effector (50) structurally configured to interact with the interventional tool within the anatomical object, and

an orienting motion coupler (40) coupling the orienting shaft (30) and the orienting end-effector (50);

a translating steerable introducer (20) including

a translating shaft (30) structurally configured to further introduce the interventional tool into the anatomical object,

a translating end-effector (50) structurally configured to interact with the interventional tool within the anatomical object, and

a translating motion coupler (40) coupling the translating shaft (30) and the translating end-effector (50);

wherein the translating shaft (30) is adjoined to the orienting end-effector (50); wherein the orienting motion coupler (40) includes at least one orienting linear actuator controllable to actuate at least one of a pivoting and a rotation of the orienting end-effector (50) and the translating steerable introducer (20) collectively relative to the orienting shaft (30); and

wherein the translating motion coupler (40) includes at least one translating a linear actuator controllable to actuate a translation of the translating end-effector (50) relative to the translating shaft (30).

14. A steerable introduction device of claim 13, wherein translating shaft (30) is separably adjoined to the orienting end-effector (50).

15. A steerable introduction device of claim 13, wherein translating shaft (30) is securely adjoined to the orienting end-effector (50).

16. An interventional method incorporating a steerable introducer (20) for deploying an interventional tool within an anatomical object, the steerable introducer (20) including a motion coupler (40) coupling a shaft (30) and an end-effector (50), the interventional method comprising: surgically placing the end-effector (50) into the anatomical object; and steering the end-effector (50) to a position within the anatomical object,

wherein the steering of the end-effector (50) includes at least one of a translation, a pivoting and a rotation of the end-effector (50) within the anatomical object responsive to an actuation of the motion coupler (40).

17. The interventional method of claim 16, wherein the position of the end-effector (50) within the anatomical object provides at least one of a coaxial alignment and a coplanar alignment of the interventional tool with a structure of the anatomical object.

18. The interventional method of claim 16,

wherein the anatomical object is a heart;

wherein the interventional tool is an artificial valve; and

wherein the end-effector (50) positions the artificial valve within the heart relative to an aortic valve of the heart.

19. The interventional method of claim 18, wherein the position of the end-effector (50) within the heart provides at least one of a coaxial alignment and a coplanar alignment of the artificial valve with the aortic valve of the heart.

20. The interventional method of claim 16, further comprising:

an user input device generating at least one motion parameter specifying the at least one of the translation, the pivoting and the rotation of the end-effector (50) within the anatomical object; and

actuating the motion coupler (40) responsive to the generation by the user input device of the least one motion parameter.