Systems and methods for flexible sheath locking with integrated shape sensing

Abstract

Systems and methods for locking an external sheath in place. The system comprises a steerable stylet. The system further comprises an external sheath configured to removably house at least a portion of the steerable stylet. The system also comprises at least one steerable stylet controller configured to control the movement of the steerable stylet and the external sheath in at least one dimension.

Description

SYSTEMS AND METHODS FOR FLEXIBLE SHEATH LOCKING WITHINTEGRATED SHAPE SENSINGCROSS-REFERENCE TO RELATED APPLICATIONS

[0001] This application claims the priority benefit of U.S. Provisional Patent Application Serial No. 63 / 525,454, filed July 7, 2023, which is hereby incorporated by reference in its entirety.STATEMENT REGARDING FEDERALLY SPONSORED RESEARCH OR DEVELOPMENT

[0002] Not ApplicableTHE NAMES OF THE PARTIES TO A JOINT RESEARCH AGREEMENT

[0003] Not ApplicableSEQUENCE LISTING

[0004] Not ApplicableSTATEMENT REGARDING PRIOR DISCLOSURES BY THE INVENTOR OR A JOINT INVENTOR

[0005] Not ApplicableBACKGROUND OF THE DISCLOSURE1. FIELD OF THE INVENTION

[0006] The present invention relates generally to systems and methods, and more particularly to locking a flexible external sheath with shape sensing along the length of the flexible external sheath.2. DESCRIPTION OF RELATED ART

[0007] External sheaths can be used in a variety of tasks such as for interventional procedures. For external sheaths used in interventional procedures, it is difficult to control the locking of the shape of the external sheath along the length of the structure, and as a result, the non-steerable devices(e.g., non-steerable diagnostic devices, non-steerable therapeutic devices) cannot be positioned in one or more desired locations for these interventional procedures.

[0008] External sheaths have been researched in robotics due to their dexterity to work in confined spaces, and to safely interact with their surroundings. They can be divided into several categories such as tendon-driven robots, precurved concentric tube robots, pneumatically actuated robots, rod-based robots, steerable needles, robotic catheters, and modular robots. The external sheaths have been adopted for various surgical, treatment, and diagnostic applications including neurosurgery, ear, nose, and throat surgery, cardiovascular surgery, gastrointestinal surgery, and high-dose-rate (HDR) brachytherapy (BT).

[0009] While having a high flexibility is useful for various surgical procedures, the external sheath may lack the steerability, the ability to become rigid (e.g., lock in place, lock its configuration / shape, etc.), and / or to place non-steerable devices and other structures in a desired configuration to perform an intervention, surgery, and other treatment procedures. These conventional external sheaths lack an active locking system / method, including actively locking the external sheath along the length of the external sheath or at several discrete sections of an external sheath. Thus, a need yet exists for innovative technologies that enable selective and continuous locking of an external sheath along its length.

[0010] Thus, technological innovation is needed to provide systems and methods of locking external sheaths that overcome the limitations of the conventional systems and methods. Thus, one focus of the present invention is to provide an external sheath that can be locked in a specific configuration (e.g., shape and / or location).SUMMARY OF THE INVENTION

[0011] Briefly described, according to exemplary embodiments of the present invention, systems and methods of an innovative system for providing locking control of a flexible external sheath. In some exemplary embodiments, the present invention is manually actuated, and in others, it automatically / robotically actuated.

[0012] In an exemplary embodiment of the present invention, a system for locking an external sheath comprises a steerable stylet. The system may further comprise an external sheath configured to removably house at least a portion of the steerable stylet. The system may also comprise at least one steerable stylet controller configured to control the movement of the steerable stylet and the external sheath in at least one dimension.

[0013] In various embodiments, the steerable stylet may comprise a structure length and a stiffness profile across the structure length. In various embodiments, the external sheath may be configured to be flexible. In various embodiments, the external sheath may be configured to define a wall. The wall may define a first inner lumen configured to removably house at least a portion of the steerable stylet. In various embodiments, the external sheath may further define a second inner lumen. The second inner lumen may be disposed between the outermost surface of the wall and the innermost surface of the wall of the external sheath. In one or more embodiments, the wall of the external sheath may further define one or more additional inner lumens. The one or more additional inner lumens may be disposed between the outermost surface of the wall and the innermost surface of the wall of the external sheath. In various embodiments, the second inner lumen and / or the one or more additional inner lumens may be disposed evenly around the circumference of the external sheath. In other embodiments, the second inner lumen and / or the one or more additional inner lumens may be disposed unevenly around the circumference of the external sheath.

[0014] In various embodiments, the at least one steerable stylet controller may be configured to define a proximal end and a distal end. In various embodiments, the system further may further comprise at least one stiffening rod anchor. The at least one stiffening rod anchor may be disposed at the distal end or the proximal end of the at least one steerable stylet controller. In various embodiments, the system further may further comprise at least one stiffening rod. The at least one stiffening rod may be configured to secure to the at least one stiffening rod anchor. In various embodiments, the at least one stiffening rod anchor may be configured to actuate the at least one stiffening rod manually and / or automatically. The at least one stiffening rod may comprise a single stiffness profile along a length of the at least one stiffening rod.

[0015] In various embodiments, the at least one stiffening rod may be configured to be actuated. The at least one stiffening rod may be configured to apply a modified stiffness profile to the external sheath and / or the steerable stylet. In various embodiments, the modified stiffness profile may be applied by the at least one stiffening rod and may be configured to be different along the length of the at least one stiffening rod. In various embodiments, the modified stiffness profile of the at least one stiffening rod may be configured to at least partially lock the external sheath and / or the steerable stylet in place. In various embodiments, the steerable stylet may be configured to be at least partially removed from the first inner lumen of the external sheath when the modified stiffness profile is applied. The external sheath may be configured to at least partially maintain a locked shape.

[0016] In various embodiments, the system further may comprise one or more additional therapeutic device configured to be inserted into the first inner lumen of the external sheath. In one or more embodiments, the one or more additional therapeutic device may be configured to at least partially conform to the shape of the external sheath once in a predetermined location. In various embodiments, the system further may further comprise one or more additional diagnostic device configured to be inserted into the first inner lumen of the external sheath. In one or more embodiments, the one or more additional diagnostic device may be configured to at least partially conform to the shape of the external sheath once in a predetermined location.

[0017] In various embodiments, the second inner lumen and / or the one or more additional inner lumens may be configured to at least partially house the steerable stylet and / or at least one stiffening rod. In various embodiments, the system may be configured to have at least three stiffening rods. The at least three stiffening rods may be configured to apply a modified stiffness profile to the external sheath and / or steerable stylet in at least one dimension. In various embodiments, one or more of the at least three stiffening rods may be configured to be actuated to apply a modified stiffness profile to the external sheath and / or the steerable stylet. The modified stiffness profile may be applied by the one or more of the at least three stiffening rods is configured to be at least one of: the same modified stiffness along the entire length of the one or more of the at least three stiffening rods or the modified stiffness profile is different at one or more portions along the length of one or more actuated stiffening rods.

[0018] In various embodiments, the modified stiffness profile may be configured to at least partially lock the external sheath and / or the steerable stylet in place in at least one direction. In various embodiments, the steerable stylet may be configured to be at least partially removed from the first inner lumen of the external sheath when the modified stiffness profile is applied. The external sheath may be configured to at least partially maintain a locked shape. In one or more embodiments, one or more additional therapeutic device and / or one or more additional diagnostic device may be configured to be inserted into the first inner lumen of the external sheath. In one or more embodiments, the one or more additional therapeutic device and / or one or more additional diagnostic device may be configured to at least partially conform to the shape of the external sheath once in a predetermined location.

[0019] In various embodiments, a first stiffening rod and at least two additional stiffening rods may comprise a constant stiffness profile. The first stiffness rod may comprise a stiffness profile that is different than at least one additional stiffness rod. In various embodiments, the at least three stiffening rods may be disposed evenly around the circumference of the external sheath. The atleast three stiffening rods may be configured to provide a modified stiffness in at least one dimension. In various embodiments, the at least three stiffening rods may be disposed unevenly around the circumference of the external sheath. The at least three stiffening rods may be configured to provide a modified stiffness in at least one dimension.

[0020] In various embodiments, the at least one steerable stylet controller may be configured to actuate the at least one stiffening rod simultaneously. The actuation of the at least one stiffening rod may modify a stiffness of the external sheath and / or steerable stylet. In various embodiments, the at least one steerable stylet controller may be configured to actuate the at least one stiffening rod individually. The actuation of the at least one stiffening rod may modify a stiffness of the external sheath and / or steerable stylet. In various embodiments, a wall of the external sheath may define a first inner lumen. The first inner lumen may be configured to define one or more additional inner lumens. In various embodiments, the one or more additional inner lumens may be defined by the wall of the external sheath. In various embodiments, the one or more additional inner lumens may be defined by the first inner lumen are configured to removably house at least a portion of the steerable stylet.

[0021] In various embodiments, the system may further comprise at least one additional therapeutic device. The at least one additional therapeutic device may be housed at least partially within the one or more additional inner lumens defined by the first inner lumen of the external sheath. In various embodiments, the system may further comprise at least one additional diagnostic device. The at least one additional diagnostic device may be housed at least partially within the one or more additional inner lumens defined by the first inner lumen of the external sheath.

[0022] In various embodiments, the system may further comprise at least one additional therapeutic device and / or at least one additional diagnostic device. The at least one additional therapeutic device and / or at least one additional diagnostic device may be housed at least partially within the one or more additional inner lumens defined by the first inner lumen of the external sheath. In various embodiments, the steerable stylet comprises a wall defining an inner lumen. In various embodiments, the system may further comprise at least one tendon configured to assist with the movement of the steerable stylet and / or the external sheath.

[0023] In various embodiments, the at least one tendon may be configured to be at least partially disposed within the inner lumen of the steerable stylet. In various embodiments, the at least one tendon may be configured to be spaced evenly around a circumference of the inner lumen of the steerable stylet. In various embodiments, the at least one tendon may be configured to be spaced unevenly around a circumference of the inner lumen of the steerable stylet. In variousembodiments, the system may further comprise at least three tendons configured to assist with the movement of the steerable stylet and / or external sheath in three dimensions. The at least three tendons may be at least partially disposed within the inner lumen of the steerable stylet. In various embodiments, the at least three tendons may be configured to be spaced evenly around a circumference of the inner lumen of the steerable stylet.

[0024] In various embodiments, the at least three tendons may be configured to be spaced unevenly around a circumference of the inner lumen of the steerable stylet. In one or more embodiments, the system may further comprise one or more control unit operably connected to the at least one steerable stylet controller. In various embodiments, the one or more control unit may be configured to control a relative axial alignment of the steerable stylet and / or the external sheath. In various embodiments, the one or more control unit may be configured to control a relative lateral alignment of the steerable stylet and / or the external sheath. In various embodiments, the one or more control unit may be configured to control a relative rotational alignment of the steerable stylet and / or the external sheath. In various embodiments, the one or more control unit may be configured to control an actuation of the at least one stiffening rods.

[0025] In various embodiments, the one or more control unit may be configured to control a movement of the at least one tendon. In various embodiments, the one or more control unit and / or the at least one steerable stylet controller may be configured to manually and / or robotically actuate at least one stiffening rod. In various embodiments, the at least one steerable stylet controller may be configured to control a relative axial alignment of the steerable stylet and / or the external sheath via at least one actuation mechanism. In various embodiments, the at least one steerable stylet controller may be configured to control a relative lateral alignment of the steerable stylet and / or the external sheath via at least one actuation mechanism. In various embodiments, the at least one steerable stylet controller may be configured to control a relative rotational alignment of the steerable stylet and / or the external sheath via at least one actuation mechanism.

[0026] In various embodiments, the system may further comprise one or more shape sensing elements. In various embodiments, the one or more shape sensing elements may be secured within at least a portion of the external sheath. In one or more embodiments, the one or more shape sensing elements may be configured to gather information related to the shape of the external sheath and / or steerable stylet. In various embodiments, the information may be related to the shape of the external sheath and / or steerable stylet is configured to be control the motion of the external sheath and / or steerable stylet. In various embodiments, the one or more shape sensing elements may be configured to reduce the use of ionizing radiation.

[0027] In various embodiments, the one or more shape sensing elements may be configured to guide an imaging plane when operating the system under ultrasound imaging modality and / or another imaging modality. In various embodiments, the one or more shape sensing element may be configured to be selected from at least one of the following: single core Bragg grating (FBG) fiber and / or multicore FBG fibers. In various embodiments, the external sheath may comprise a structure length and stiffness profile along the structure length. In various embodiments, the stiffness profile along the structure length may be configured to be uniform along the entire length. In one or more embodiments, the external sheath may comprise a first stiffness profile at one or more first portions along the length of the external sheath and one or more additional stiffness profiles at one or more additional portions along the length of the external sheath.

[0028] In various embodiments, the external sheath may further comprise at least one articulating join disposed at a distal end of the external sheath. In various embodiments, the at least one articulating joint may be configured to be actuated via at least one actuation mechanism. In various embodiments, upon actuation, the at least one articulating join may be configured to actively manipulate a tip of the external sheath. In various embodiments, the at least one articulating joint may define a wall. The wall may define a first inner lumen. In various embodiments, the at least one articulating joint may be configured to actively steer the external sheath. In various embodiments, an actuation of at least one stiffening rod may be configured to cause one or more of radial expansion, radial compression, longitudinal expansion, longitudinal compression, or a combination thereof. In various embodiments, an actuation of at least one stiffening rod may be one or more of a mechanical actuation, an electrical actuation, a magnet actuation, a thermal actuation, a fluid actuation, or a combination thereof.

[0029] In another exemplary embodiments of the present invention, a method is provided for locking an external sheath. The method may comprise providing a system for locking an external sheath. The system may comprise a steerable stylet. The system may further comprise an external sheath configured to removably house at least a portion of the steerable stylet. The system may also comprise at least one steerable stylet controller configured to control the movement of the steerable stylet and the external sheath in at least one dimension. The system may also comprise a control unit operably connected to the at least one steerable stylet controller. The method may also comprise causing at least one stiffening rod to be selectively actuated. The actuation may be configured to cause a modified stiffness profile to be applied at one or more locations along the length of the external sheath and / or steerable stylet.

[0030] In various embodiments, the steerable stylet may comprise a structure length and a stiffness profile across the structure length. In various embodiments, the external sheath may be configured to be flexible. In various embodiments, the external sheath may be configured to define a wall. The wall may define a first inner lumen configured to removably house at least a portion of the steerable stylet. In various embodiments, the external sheath may further define a second inner lumen. The second inner lumen may be disposed between the outermost surface of the wall and the innermost surface of the wall of the external sheath. In one or more embodiments, the wall of the external sheath may further define one or more additional inner lumens. The one or more additional inner lumens may be disposed between the outermost surface of the wall and the innermost surface of the wall of the external sheath. In various embodiments, the second inner lumen and / or the one or more additional inner lumens may be disposed evenly around the circumference of the external sheath. In other embodiments, the second inner lumen and / or the one or more additional inner lumens may be disposed unevenly around the circumference of the external sheath.

[0031] In various embodiments, the at least one steerable stylet controller may be configured to define a proximal end and a distal end. In various embodiments, the system further may further comprise at least one stiffening rod anchor. The at least one stiffening rod anchor may be disposed at the distal end or the proximal end of the at least one steerable stylet controller. In various embodiments, the system further may further comprise at least one stiffening rod. The at least one stiffening rod may be configured to secure to the at least one stiffening rod anchor. In various embodiments, the at least one stiffening rod anchor may be configured to actuate the at least one stiffening rod manually and / or automatically. The at least one stiffening rod may comprise a single stiffness profile along a length of the at least one stiffening rod.

[0032] In various embodiments, the at least one stiffening rod may be configured to be actuated. The at least one stiffening rod may be configured to apply a modified stiffness profile to the external sheath and / or the steerable stylet. In various embodiments, the modified stiffness profile may be applied by the at least one stiffening rod and may be configured to be different along the length of the at least one stiffening rod. In various embodiments, the modified stiffness profile of the at least one stiffening rod may be configured to at least partially lock the external sheath and / or the steerable stylet in place. In various embodiments, the steerable stylet may be configured to be at least partially removed from the first inner lumen of the external sheath when the modified stiffness profile is applied. The external sheath may be configured to at least partially maintain a locked shape.

[0033] In various embodiments, the system further may comprise one or more additional therapeutic device configured to be inserted into the first inner lumen of the external sheath. In one or more embodiments, the one or more additional therapeutic device may be configured to at least partially conform to the shape of the external sheath once in a predetermined location. In various embodiments, the system further may further comprise one or more additional diagnostic device configured to be inserted into the first inner lumen of the external sheath. In one or more embodiments, the one or more additional diagnostic device may be configured to at least partially conform to the shape of the external sheath once in a predetermined location.

[0034] In various embodiments, the second inner lumen and / or the one or more additional inner lumens may be configured to at least partially house the steerable stylet and / or at least one stiffening rod. In various embodiments, the system may be configured to have at least three stiffening rods. The at least three stiffening rods may be configured to apply a modified stiffness profile to the external sheath and / or steerable stylet in at least one dimension. In various embodiments, one or more of the at least three stiffening rods may be configured to be actuated to apply a modified stiffness profile to the external sheath and / or the steerable stylet. The modified stiffness profile may be applied by the one or more of the at least three stiffening rods is configured to be at least one of: the same modified stiffness along the entire length of the one or more of the at least three stiffening rods or the modified stiffness profile is different at one or more portions along the length of one or more actuated stiffening rods.

[0035] In various embodiments, the modified stiffness profile may be configured to at least partially lock the external sheath and / or the steerable stylet in place in at least one direction. In various embodiments, the steerable stylet may be configured to be at least partially removed from the first inner lumen of the external sheath when the modified stiffness profile is applied. The external sheath may be configured to at least partially maintain a locked shape. In one or more embodiments, one or more additional therapeutic device and / or one or more additional diagnostic device may be configured to be inserted into the first inner lumen of the external sheath. In one or more embodiments, the one or more additional therapeutic device and / or one or more additional diagnostic device may be configured to at least partially conform to the shape of the external sheath once in a predetermined location.

[0036] In various embodiments, a first stiffening rod and at least two additional stiffening rods may comprise a constant stiffness profile. The first stiffness rod may comprise a stiffness profile that is different than at least one additional stiffness rod. In various embodiments, the at least three stiffening rods may be disposed evenly around the circumference of the external sheath. The atleast three stiffening rods may be configured to provide a modified stiffness in at least one dimension. In various embodiments, the at least three stiffening rods may be disposed unevenly around the circumference of the external sheath. The at least three stiffening rods may be configured to provide a modified stiffness in at least one dimension.

[0037] In various embodiments, the at least one steerable stylet controller may be configured to actuate the at least one stiffening rod simultaneously. The actuation of the at least one stiffening rod may modify a stiffness of the external sheath and / or steerable stylet. In various embodiments, the at least one steerable stylet controller may be configured to actuate the at least one stiffening rod individually. The actuation of the at least one stiffening rod may modify a stiffness of the external sheath and / or steerable stylet. In various embodiments, a wall of the external sheath may define a first inner lumen. The first inner lumen may be configured to define one or more additional inner lumens. In various embodiments, the one or more additional inner lumens may be defined by the wall of the external sheath. In various embodiments, the one or more additional inner lumens may be defined by the first inner lumen are configured to removably house at least a portion of the steerable stylet.

[0038] In various embodiments, the system may further comprise at least one additional therapeutic device. The at least one additional therapeutic device may be housed at least partially within the one or more additional inner lumens defined by the first inner lumen of the external sheath. In various embodiments, the system may further comprise at least one additional diagnostic device. The at least one additional diagnostic device may be housed at least partially within the one or more additional inner lumens defined by the first inner lumen of the external sheath.

[0039] In various embodiments, the system may further comprise at least one additional therapeutic device and / or at least one additional diagnostic device. The at least one additional therapeutic device and / or at least one additional diagnostic device may be housed at least partially within the one or more additional inner lumens defined by the first inner lumen of the external sheath. In various embodiments, the steerable stylet comprises a wall defining an inner lumen. In various embodiments, the system may further comprise at least one tendon configured to assist with the movement of the steerable stylet and / or the external sheath.

[0040] In various embodiments, the at least one tendon may be configured to be at least partially disposed within the inner lumen of the steerable stylet. In various embodiments, the at least one tendon may be configured to be spaced evenly around a circumference of the inner lumen of the steerable stylet. In various embodiments, the at least one tendon may be configured to be spaced unevenly around a circumference of the inner lumen of the steerable stylet. In variousembodiments, the system may further comprise at least three tendons configured to assist with the movement of the steerable stylet and / or external sheath in three dimensions. The at least three tendons may be at least partially disposed within the inner lumen of the steerable stylet. In various embodiments, the at least three tendons may be configured to be spaced evenly around a circumference of the inner lumen of the steerable stylet.

[0041] In various embodiments, the at least three tendons may be configured to be spaced unevenly around a circumference of the inner lumen of the steerable stylet. In one or more embodiments, the system may further comprise one or more control unit operably connected to the at least one steerable stylet controller. In various embodiments, the one or more control unit may be configured to control a relative axial alignment of the steerable stylet and / or the external sheath. In various embodiments, the one or more control unit may be configured to control a relative lateral alignment of the steerable stylet and / or the external sheath. In various embodiments, the one or more control unit may be configured to control a relative rotational alignment of the steerable stylet and / or the external sheath. In various embodiments, the one or more control unit may be configured to control an actuation of the at least one stiffening rods.

[0042] In various embodiments, the one or more control unit may be configured to control a movement of the at least one tendon. In various embodiments, the one or more control unit and / or the at least one steerable stylet controller may be configured to manually and / or robotically actuate at least one stiffening rod. In various embodiments, the at least one steerable stylet controller may be configured to control a relative axial alignment of the steerable stylet and / or the external sheath via at least one actuation mechanism. In various embodiments, the at least one steerable stylet controller may be configured to control a relative lateral alignment of the steerable stylet and / or the external sheath via at least one actuation mechanism. In various embodiments, the at least one steerable stylet controller may be configured to control a relative rotational alignment of the steerable stylet and / or the external sheath via at least one actuation mechanism.

[0043] In various embodiments, the system may further comprise one or more shape sensing elements. In various embodiments, the one or more shape sensing elements may be secured within at least a portion of the external sheath. In one or more embodiments, the one or more shape sensing elements may be configured to gather information related to the shape of the external sheath and / or steerable stylet. In various embodiments, the information may be related to the shape of the external sheath and / or steerable stylet is configured to be control the motion of the external sheath and / or steerable stylet. In various embodiments, the one or more shape sensing elements may be configured to reduce the use of ionizing radiation.

[0044] In various embodiments, the one or more shape sensing elements may be configured to guide an imaging plane when operating the system under ultrasound imaging modality and / or another imaging modality. In various embodiments, the one or more shape sensing element may be configured to be selected from at least one of the following: single core Bragg grating (FBG) fiber and / or multicore FBG fibers. In various embodiments, the external sheath may comprise a structure length and stiffness profile along the structure length. In various embodiments, the stiffness profile along the structure length may be configured to be uniform along the entire length. In one or more embodiments, the external sheath may comprise a first stiffness profile at one or more first portions along the length of the external sheath and one or more additional stiffness profiles at one or more additional portions along the length of the external sheath.

[0045] In various embodiments, the external sheath may further comprise at least one articulating join disposed at a distal end of the external sheath. In various embodiments, the at least one articulating joint may be configured to be actuated via at least one actuation mechanism. In various embodiments, upon actuation, the at least one articulating join may be configured to actively manipulate a tip of the external sheath. In various embodiments, the at least one articulating joint may define a wall. The wall may define a first inner lumen. In various embodiments, the at least one articulating joint may be configured to actively steer the external sheath. In various embodiments, an actuation of at least one stiffening rod may be configured to cause one or more of radial expansion, radial compression, longitudinal expansion, longitudinal compression, or a combination thereof. In various embodiments, an actuation of at least one stiffening rod may be one or more of a mechanical actuation, an electrical actuation, a magnet actuation, a thermal actuation, a fluid actuation, or a combination thereof.

[0046] In yet another exemplary embodiment, a method is provided for positioning an external sheath. The method may comprise inserting an external sheath comprising a steerable stylet into a portion of a subject. The method may also comprise guiding at least a portion of the external sheath with the steerable stylet. The method may also comprise positioning the external sheath to a desired location.

[0047] In various embodiments, the steerable stylet may comprise a structure length and a stiffness profile across the structure length. In various embodiments, the external sheath may be configured to be flexible. In various embodiments, the external sheath may be configured to define a wall. The may wall may be configured to define a first inner lumen and / or one or more additional inner lumens. The first inner lumen and / or the one or more additional inner lumens may be configured to removably house at least a portion of the steerable stylet. In various embodiments, the methodmay further comprise inserting one or more additional therapeutic device into the inner lumen of the external sheath. The one or more additional therapeutic device may be configured to at least partially conform to the locked external sheath shape.

[0048] In various embodiments, the method may further comprise removing the external sheath from the body. The one or more additional therapeutic device may be configured to remain at least partially stationary. In various embodiments, the method may further comprise inserting one or more additional diagnostic device into the inner lumen of the external sheath. The one or more additional diagnostic device may be configured to at least partially conform to the locked external sheath shape. In various embodiments, the method may further comprise removing the external sheath from the body. The one or more additional diagnostic device may remain at least partially stationary.

[0049] In various embodiments, the system may further comprise one or more control unit operably connected to the at least one steerable stylet controller. In various embodiments, the one or more control unit may be configured to control a relative axial alignment of the steerable stylet and / or the external sheath. In various embodiments, the one or more control unit may be configured to control a relative lateral alignment of the steerable stylet and / or the external sheath. In various embodiments, the one or more control unit maybe configured to control a relative rotational alignment of the steerable stylet and / or the external sheath. In various embodiments, the one or more control unit may be configured to control an actuation of the at least one stiffening rods. In various embodiments, the one or more control unit may be configured to control a movement of the at least one tendon.

[0050] In various embodiments, the one or more control unit and / or the at least one steerable stylet controller may be configured to manually and / or robotically actuate at least one stiffening rod. In various embodiments, the at least one steerable stylet controller may be configured to control a relative axial alignment of the steerable stylet and / or the external sheath via at least one actuation mechanism. In various embodiments, the at least on steerable stylet controller may be configured to control a relative lateral alignment of the steerable stylet and / or the external sheath via at least one actuation mechanism. In various embodiments, the at least one steerable stylet controller may be configured to control a relative rotational alignment of the steerable stylet and / or the external sheath via at least one actuation mechanism. In various embodiments, an actuation of at least one stiffening rod may be configured to cause one or more of radial expansion, radial compression, longitudinal expansion, longitudinal compression, or a combination thereof. In various embodiments, an actuation of at least stiffening rod may be one or more of a mechanical actuation,an electrical actuation, a magnet actuation, a thermal actuation, a fluid actuation, or a combination thereof.

[0051] These and other aspects, features, and benefits of the claimed invention(s) will become apparent from the following detailed written description of the preferred embodiments and aspects taken in conjunction with the following drawings, although variations and modifications thereto may be affected without departing from the spirit and scope of the novel concepts of the disclosure.BRIEF DESCRIPTION OF THE DRAWINGS

[0052] Implementations, features, and aspects of the disclosed technology are described in detail herein and are considered a part of the claimed disclosed technology. Other implementations, features, and aspects can be understood with reference to the following detailed description, accompanying drawings, and claims. Wherever possible, the same reference numbers are used throughout the drawings to refer to the same or like members of an embodiment. Reference will now be made to the accompanying figures and flow diagrams, which are not necessarily drawn to scale.

[0053] FIG. 1A illustrates an exemplary system for steering an external sheath comprising a steerable stylet in accordance with various embodiments of the present disclosure.

[0054] FIG. IB illustrates an exemplary steerable stylet controller with a stiffening rod anchor in accordance with various embodiments of the present disclosure.

[0055] FIG. 1C illustrates an exemplary steerable stylet controller with a steerable portion in accordance with various embodiments of the present disclosure.

[0056] FIG. 2A illustrates an exemplary external sheath in accordance with various embodiments of the present disclosure.

[0057] FIG. 2B illustrates an exemplary cross-sectional view of an external sheath and a steerable stylet in accordance with various embodiments of the present disclosure.

[0058] FIG. 2C illustrates an exemplary external sheath housing at least a portion of a steerable stylet in accordance with various embodiments of the present disclosure.

[0059] FIG. 2D illustrates an exemplary external sheath in accordance with various embodiments of the present disclosure.

[0060] FIG. 2E illustrates an exemplary articulating joint in accordance with various embodiments of the present disclosure.

[0061] FIG. 2F illustrates an exemplary articulating joint in accordance with various embodiments of the present disclosure.

[0062] FIG. 2G illustrates an exemplary diagnostic device and / or therapeutic device inserted into an external sheath in accordance with various embodiments of the present disclosure.

[0063] FIG. 3A illustrates an exemplary flow diagram of a method for locking an external sheath in accordance with various embodiments of the present disclosure.

[0064] FIG. 3B illustrates an exemplary flow diagram of a method for locking an external sheath in accordance with various embodiments of the present disclosure.

[0065] FIG. 4 illustrates a block diagram of an illustrative computer system architecture in accordance with various embodiments of the present disclosure.DETAILED DESCRIPTION OF THE INVENTION

[0066] Although preferred exemplary embodiments of the disclosure are explained in detail, it is to be understood that other exemplary embodiments are contemplated. Accordingly, it is not intended that the disclosure is limited in its scope to the details of construction and arrangement of components set forth in the following description or illustrated in the drawings. The disclosure is capable of other exemplary embodiments and of being practiced or carried out in various ways. Also, in describing the preferred exemplary embodiments, specific terminology will be resorted to for the sake of clarity.

[0067] To facilitate an understanding of the principles and features of the present disclosure, various illustrative embodiments are explained below. The components, steps, and materials described hereinafter as making up various elements of the embodiments disclosed herein are intended to be illustrative and not restrictive. Many suitable components, steps, and materials that would perform the same or similar functions as the components, steps, and materials described herein are intended to be embraced within the scope of the disclosure. Such other components, steps, and materials not described herein can include, but are not limited to, similar components or steps that are developed after development of the embodiments disclosed herein.

[0068] As used in the specification and the appended claims, the singular forms “a,” “an” and “the” include plural referents unless the context clearly dictates otherwise.

[0069] Also, in describing the preferred exemplary embodiments, terminology will be resorted to for the sake of clarity. It is intended that each term contemplates its broadest meaning asunderstood by those skilled in the art and includes all technical equivalents which operate in a similar manner to accomplish a similar purpose.

[0070] Ranges can be expressed herein as from “about” or “approximately” one particular value and / or to “about” or “approximately” another particular value. When such a range is expressed, another exemplary embodiment includes from the one particular value and / or to the other particular value.

[0071] By “comprising” or “containing” or “including” is meant that at least the named compound, member, particle, or method step is present in the composition or article or method, but does not exclude the presence of other compounds, materials, particles, method steps, even if the other such compounds, material, particles, method steps have the same function as what is named.

[0072] Mention of one or more method steps does not preclude the presence of additional method steps or intervening method steps between those steps expressly identified. Similarly, it is also to be understood that the mention of one or more components in a device or system does not preclude the presence of additional components or intervening components between those components expressly identified.

[0073] The materials described as making up the various members of the invention are intended to be illustrative and not restrictive. Many suitable materials that would perform the same or a similar function as the materials described herein are intended to be embraced within the scope of the invention. Such other materials not described herein can include, but are not limited to, for example, materials that are developed after the time of the development of the invention.

[0074] While the external sheath (e.g., flexible external sheath) can encompass a wide variety of systems, reference to a surgical operation is disclosed without loss of generality to the innovative features applicative to other systems. Thus, as used herein, the technological innovations are related to providing systems and methods of surgical operation control that overcome the limitations of the conventional systems and methods. Thus, one focus of the present invention is to provide an external sheath (e.g., flexible external sheath) with shape sensing elements capable of locking in a desired configuration.

[0075] It will also be understood by those of skill in the art that the terms “stiffness” and / or having the quality of being stiff / rigid can also be described using other relative terms, like “compliant” and / or having the quality of being compliant / flexible. These relative terms can describe a component of the present invention from different directions, for example, a component or portion of a component having an increase in stiffness along a length, or a decrease in compliance. Or be more compliant, meaning having less stiffness.

[0076] As used herein, “flexible sheath,” “external sheath,” and “flexible external sheath” may be used interchangeably.

[0077] FIGS. 1A-1C illustrates a system and portions thereof for locking an external sheath (e.g., flexible external sheath) in accordance with various embodiments of the present disclosure. In various embodiments, the system 10 may comprise at least one or more control units 20, at least one steerable stylet controller 100, and / or at least one steerable portion 200. The one or more control units 20 may operably connect to the at least one steerable stylet controller 100 and / or to the at least one steerable portion 200. In one or more embodiments, the one or more control units 20 may comprise at least a portion of a computing system (e.g., depicted in FIG. 4). In various embodiments, the one or more control units 20 may comprise a steering mechanism configured to assist with the movement of the steerable portion in at least one direction. As depicted, steering mechanism may utilize at least one pulley 12 to assist with movement of the steerable portion 200 of the system. In one or more embodiments, the steering mechanism may utilize one or more of hydraulic mechanism, motors, magnets, electric motors, pneumatic mechanism, or a combination thereof to assist with the movement of the steerable portion 200. In various embodiments, the steering mechanism may comprise two or more pulleys 12, such that the two or more pulleys 12 at least partially assists with the movement of the steerable portion 200 in one or more directions. As depicted in FIG. 1A, in various embodiments, the steering mechanism of the one or more control units 20 may assist with the movement of the steerable portion 200 in the X-axis, the Y - axis, and / or the Z-axis. The steering mechanism may assist with positioning the steerable portion 200 in one or more desired locations and / or one or more desired configurations based on the application of the steerable portion 200.

[0078] In one or more embodiments, the steering mechanism of the one or more control units 20 may assist with micro scale motions of the steerable portion 200 in the X-axis, the Y-axis, and / or the Z-axis. In various embodiments, the steering mechanism of the one or more control units 20 may assist with macro scale motions of the steerable portion 200 in the X-axis, the Y-axis, and / or the Z-axis. In one or more embodiments, the steering mechanism of the one or more control units 20 may move and / or orient the at least one steerable stylet controller 100, such that the at least one steerable stylet controller 100 positions the steerable portion 200 in one or more positions relative to a portion of a subject. In an example embodiment, the steering mechanism of the one or more control units 20 may be further configured to perform an insertion motion, such that the steering mechanism may cause the at least one steerable stylet controller 100 to move forward. Simultaneously and / or alternatively, the at least one steerable stylet controller 100 may actuate thesteerable stylet of the steerable portion and to cause the steerable portion 200 to achieve a steering configuration.

[0079] With further reference to FIG. 1 A, in various embodiments, the at least one steerable stylet controller 100 may utilize the steering mechanism of the one or more control units to assist with movement of the steerable portion 200 in one or more directions. In various embodiments, the at least one steerable stylet controller 100 may utilize two or more pulleys 12, such that the two or more pulleys 12 at least partially assist with the movement of the steerable portion 200 in two or more directions. With even further reference to FIG. 1 A, the one or more control units 20 and the at least one steerable stylet controller 100 may utilize the steering mechanism to assist with movement of the steerable portion 200 in one or more directions.

[0080] As depicted in FIG. IB, in various embodiments, the at least one steerable stylet controller 100 may define a proximal end 112 and a distal end 114. The proximal end 112 of the at least one steerable stylet controller 100 may be configured to attach to at least a portion of the one or more control units (depicted in FIG. 1A). In various embodiments, the attachment of the at least one steerable stylet controller 100 with the one or more control units may be in a manner, such that, the at least one steerable stylet controller 100 is operably connected to the one or more control units. In various embodiments, at least one stiffening rod anchor 102 may be disposed on a portion of the distal end 114 of the at least one steerable stylet controller 100. In various embodiments, the at least one stiffening rod anchor 102 may be disposed on a portion of the proximal end 112 of the at least one steerable stylet controller 100 (not depicted). In various embodiments, the at least one stiffening rod anchor may be operably connected to the at least one steerable stylet controller 100 and / or the one or more control units 20.

[0081] As depicted in FIG. 1C, in various embodiments, the steerable portion 200 may be configured to secure to at least a portion of the at least one stiffening rod anchor 102. In one or more embodiments, the steerable portion 200 may be configured to secure to at least a portion of the distal end 114 of the at least one steerable stylet controller 100. In one or more embodiments, the steerable portion 200 may be configured to secure to at least a portion of the proximal end 112 of the at least one steerable stylet controller 100. In various embodiments, the steerable portion 200 may be configured to secure to at least a portion of the at least one stiffening rod anchor disposed along the proximal end 112 of the at least one steerable stylet controller 100 (not depicted).

[0082] In one or more embodiments, the steerable portion may be operably connected to the one or more control units, such that the one or more control units may control the movement of at leasta portion of the steerable portion 200. In various embodiments, the steerable portion 200 may be operably connected to the at least one steerable stylet controller 100, such that the at least one steerable stylet controller 100 may control the movement of at least a portion of the steerable portion 200. In various embodiments, the steerable portion 200 may be operably connected to the one or more control units and / or the at least one steerable stylet controller 100, such that the one or more control units and / or the at least one steerable stylet controller 100 may control the movement of at least a portion of the steerable portion 200. In various embodiments, the steerable portion 200 may be operably connected to the one or more control units, the at least one steerable stylet controller 100, and / or the at least one stiffening rod anchor, such that the one or more control units, the at least one steerable stylet controller 100, and / or the at least one stiffening rod anchor may control the movement of at least a portion of the steerable portion 200.

[0083] FIGS. 2A-2G illustrate exemplary views of a steerable portion and components thereof in accordance with various embodiments of the present disclosure. In various embodiments, the steerable portion 200 may comprise at least an external sheath (e.g., flexible external sheath) 202. The external sheath may comprise a structure length and a stiffness profile along the structure length. In various embodiments, the structure length of the external sheath 202 may be a predetermined length for performing one or more desired function (e.g., cardiovascular procedures, brain procedures, other medical operations, etc.). In various embodiments, the external sheath may comprise a cylindrical shape. In other embodiments, the external sheath may comprise any geometric shape (e.g., oval, elliptical, triangular, square, rectangular, etc.) needed to achieve a desired function. In various embodiments, the external sheath may comprise at least one material with at least one predetermined modulus of elasticity configured to achieve a desired function. In various embodiments, the external sheath may comprise two or more materials, such that the two or more materials have a different stiffness profile. In various embodiments, the first material may comprise a first stiffness profile at one or more portion along the length of the external sheath and the one or more additional material may comprise one or more additional stiffness profiles at one or more additional portions along the length of the external sheath.

[0084] In an example embodiment, the external sheath (e.g., external flexible sheath) may comprise a single stiffness profile along the entire structure length, such that the stiffness profile allows the external sheath to be at least partially bendable. In other embodiments, the external sheath 202 may comprise two or more stiffness profiles along the structure length of the external sheath, wherein the external sheath may comprise a first stiffness profile at one or more portion of the length and one or more additional stiffness profiles at one or more additional portions of thelength. In various embodiments, the one or more additional stiffness profile may be different (e.g., greater than, less than) the first stiffness profile and / or equal to at least one additional stiffness profile along the length of the external sheath 202. In various embodiments, the external sheath 202 may be configured to selectively attach and / or detach to at least a portion of the at least one stiffening rod anchor 102. In various embodiments, the external sheath 202 may selectively attach and / or detach to at least a portion of the at least one stiffening rod anchor via a snap-on mechanism, a threaded mechanism, a clamping mechanism, and / or any other attachment mechanism necessary to achieve the desired function.

[0085] In various embodiments, the external sheath 202 (e.g., external flexible sheath) may be an external enveloping sheath. The external sheath may be configured to at least partially house a steerable stylet. In one or more embodiments, the external sheath may be further configured to at least partially house one or more stiffening rods, one or more therapeutic devices, one or more diagnostic devices, and / or the like. In various embodiments, the external sheath 202 may comprise a polymer material, metal braided tubing, and / or the like. In other embodiments, the external sheath may comprise any material necessary to achieve a desired function. In various embodiments, the external sheath 202 may comprise a uniform stiffness profile along the entire length of the structure. In various embodiments, the external flexible sheath may comprise a single material along the length of the external flexible sheath, such that the external flexible sheath may comprise a single stiffness profile along the entire length. In one or more embodiments, the external flexible sheath may comprise a first material at one or more first portions along the length and one or more additional materials at one or more additional portions along the length, such that the first material may comprise a first stiffness profile at the one or more portions and the one or more additional materials may comprise one or more additional stiffness profiles. The one or more additional stiffness profiles at the one or more different portions may be different (e.g., less than, greater than, or a combination thereof) than the first stiffness profile at the one or more first portions. In other embodiments, the external sheath 202 may comprise one or more stiffness profiles along one or more portions along the length of the external sheath 202. In one or more embodiments, the steerable stylet, one or more stiffening rods, one or more additional therapeutic devices, and / or one or more additional diagnostic devices may move freely within the external sheath 202. In other embodiments, the steerable stylet, one or more stiffening rods, one or more additional therapeutic devices, and / or one or more additional diagnostic devices may be selectively moved within the external sheath. In some embodiments, the external sheath 202 may beanisotropic configured to offer variable resistance to axial motion, radial motion, transvers motion, or a combination thereof.

[0086] FIG. 2B illustrates an exemplary cross-sectional view of an external sheath (e.g., external flexible sheath) and portions thereof in accordance with various embodiments of the present disclosure. In various embodiments, the external sheath 202 may define a wall 202A, such that the wall 202A comprises a predetermined thickness in order to achieve a desired function. The wall 202A may be configured to define a first inner lumen 220 (e.g., channel, hole, etc.), such that, the first inner lumen 220 extends along at least a portion of the length of the external sheath defining an inner wall along said portion. In various embodiments, the wall 202A may be configured to define a first inner lumen 220 (e.g., channel, hole, etc.), such that, the first inner lumen 220 extends along the entire length of the external sheath 202 defining an inner wall along the entire length of the external sheath. In various embodiments, the first inner lumen 220 may be configured to house and / or receive at least a portion of a steerable stylet 204. The first inner lumen may comprise a diameter slightly larger than the diameter of the steerable stylet.

[0087] In one or more embodiments, the first inner lumen 220 may be configured to house and / or receive at least a portion of one or more additional therapeutic devices and / or one or more additional diagnostic devices. The first inner lumen may comprise a diameter slightly larger than the diameter of the one or more additional therapeutic devices and / or the one or more additional diagnostic devices. In some embodiments, the one or more additional therapeutic devices and / or the one or more additional diagnostic devices may comprise the same diameter as the steerable stylet. In other embodiments, the one or more additional therapeutic devices and / or the one or more additional diagnostic devices may comprise a diameter less than or greater than the diameter of the steerable stylet. In various embodiments, the steerable stylet, the one or more additional therapeutic devices, and / or the one or more additional diagnostic devices may comprise the same structural shape as the external sheath. In various embodiments, the steerable stylet, the one or more additional therapeutic devices, and / or the one or more additional diagnostic devices may comprise at least one different structural shape than the external sheath.

[0088] In various embodiments, the steerable stylet 204 may further define one or more apertures 206 (e.g., notches, slits, slots, holes, joint, brace, etc., depicted in FIG. 2C). In various embodiments, the one or more apertures may be disposed on the wall of the steerable stylet 204, such that the one or more apertures may assist with the flexibility of the steerable stylet 204. In various embodiments, the one or more apertures 206 may be spaced evenly along one or more portions of the length of the steerable stylet. In various embodiments, the one or more apertures206 may be spaced evenly along the entire length of the steerable stylet. In other embodiments, the one or more apertures 206 may be spaced evenly at one or more first portions along the length of the steerable stylet and spaced unevenly at one or more additional portions along the length of the steerable stylet. In various embodiments, the one or more apertures 206 may be spaced unevenly along one or more portions of the length of the steerable stylet.

[0089] In various embodiments, the one or more apertures may extend through the entire thickness of the wall of the steerable stylet. In other embodiments, the one or more apertures may extent through a portion of the thickness of the wall of the steerable stylet. In various embodiments, the one or more apertures 206 may assist with restricting one or more tendons disposed within the steerable stylet. In various embodiments, the one or more apertures may be configured to be internal apertures. In various embodiments, the one or more apertures may assist with the flexibility of the steerable stylet at one or more locations along the length of the steerable stylet. In one or more embodiments, the one or more apertures 206 may assist with the flexibility of the steerable stylet in one or more desired directions. In various embodiments, upon actuation of at least one actuation mechanism (e.g., tendons, mechanical actuation, an electrical actuation, a magnet actuation, a thermal actuation, a fluid actuation, or a combination thereof), the one or more apertures 206 may assist with at least a portion of the steerable stylet to bend and / or deflect in the one or more desired configurations and / or one or more desired directions.

[0090] With further reference to FIG. 2B, in various embodiments, the first inner lumen 220 may be configured to house at least a portion of a steerable stylet 204. In various embodiments, the steerable stylet may be made of Nitinol (NiTi). The steerable stylet 204 may comprise an outer diameter slightly less than the inner diameter of the external sheath (e.g., the inner diameter of the first inner lumen). The steerable stylet 204 may further comprise a structure length and a stiffness profile along the structure length. In various embodiments, the steerable stylet 204 may comprise a structure length that is a predetermined length for performing one or more desired function (e.g., cardiovascular procedures, brain procedures, other medical procedures, etc.). In one or more embodiments, the steerable stylet 204 may comprise a length that is equal to the length of the external sheath 202 (e.g., external flexible sheath). In various embodiments, the steerable stylet 204 may comprise a structure length less than or equal to the structure length of the external sheath. In other embodiments, the steerable stylet 204 may comprises a structure length that is greater than or equal to the structure length of the external sheath. In various embodiments, the steerable stylet 204 may comprise a single stiffness profile along the entire structure length, such that the steerable stylet is at least partially steerable. In another embodiment, the steerable stylet 204 may comprisetwo or more stiffness profiles along the structure length of the steerable stylet 204, such that the steerable stylet may comprise a first stiffness profile at one or more portions of the length and one or more additional stiffness profiles at one or more additional portions of the length.

[0091] In various embodiments, the one or more additional stiffness profile may be different (e.g., greater than, less than) than the first stiffness profile and / or equal to at least one additional stiffness profile along the length of the steerable stylet. In various embodiments, the steerable stylet may comprise one or more stiffness profiles at one or more portions of the length of the steerable stylet that may be different to the one or more stiffness profiles at one or more portions of the length of the external sheath. In other embodiments, the one or more stiffness profiles at one or more portions of the length of the steerable stylet may be greater than, less than, and / or equal to the one or more stiffness profiles at one or more portions length of the external sheath. In various embodiments, the steerable stylet and the external sheath may comprise the same stiffness profile along the entire length, respectively.

[0092] In various embodiments, the steerable stylet 204 may define an inner stylet lumen 222 (e.g., channel, hole, etc.), such that, the inner stylet lumen 222 extends along at least a portion of the length of the steerable stylet 204 defining an inner wall along at least a portion of the length of the steerable stylet 204. In various embodiments, the inner stylet lumen 222 may extend along the entire length of the steerable stylet, such that the inner stylet lumen 222 defines an inner wall along the entire length of the steerable stylet. The inner stylet lumen 222 may be configured to house one or more tendons 208N. In some embodiments, the one or more tendons 208N may attach to a portion of the wall of the inner stylet lumen 222. In various embodiments, the one or more tendons 208N may be configured to assist with the movement of the steerable stylet 204 and / or the external sheath in one or more directions (e.g., X-axis, Y-axis, Z-axis, rotationally, etc.).

[0093] As depicted in FIG. 2B, in various embodiments, the steerable stylet 204 may comprise at least three tendons 208N disposed within the inner stylet lumen 222. The three tendons 208N may be evenly spaced around the circumference of the inner stylet lumen 222. In other embodiments, the three tendons 208N may be unevenly spaced around the circumference of the inner stylet lumen 222. In various embodiments, the three tendons 208N may be configured to assist with the movement of the steerable stylet 204 and / or the external sheath 202 in at least three directions. In various embodiments, at least a portion of the three tendons may attach to a portion of the one or more control units, at least one steerable stylet controller, and / or at least one stiffening rod anchor, such that the three tendons may be operable and assist with the movement of the steerable stylet and / or external sheath.

[0094] In various embodiments, at least a portion of the steerable stylet 204 may be disposed externally relative to the first inner lumen 220 of the external sheath (e.g., external flexible sheath), such that a portion of the steerable stylet 204 operable connects with one or more control units and / or at least one steerable stylet controller. In various embodiments, at least a portion of the steerable stylet may be operably connected to the one or more control units and / or the at least one steerable stylet controller, such that the steerable stylet 204 may be steered manually and / or robotically. In various embodiments, at least a portion of the one or more tendons 208N and / or the steerable stylet 204 may connect to the one or more control units and / or the at least one steerable stylet controller, such that the one or more control units and / or the at least one steerable stylet controller may assist with the movement of the steerable stylet and / or the external sheath. In one or more embodiments, the steerable stylet may further define a connection point disposed at a proximal end of the steerable stylet. The steerable stylet may be selectively attached and / or detached to the steerable stylet controller via an attachment mechanism (e.g., threads, magnets, snaps, hooks, latches, clamps, etc.).

[0095] In various embodiments, the steerable stylet may further define a tip 204A disposed at a distal end of the steerable stylet (e.g., opposite to the one or more control units). In various embodiments, at least a portion of the steerable stylet may be disposed externally relative to the distalmost edge of the external sheath, such that at least a portion of the steerable stylet may be used to guide the external sheath within a subject. The tip 204A of the steerable stylet may be conical and / or sharp, such that the tip 204A may be used to puncture tissue of a subjection. In various embodiments, the tip 204A of the steerable stylet may be round and / or blunt. In various embodiments, the tip 204A may be made of Nitinol (NiTi). In one or more embodiments, the tip 204A may be the steerable stylet of the system.

[0096] With even further reference to FIGS. 2B-2C, in various embodiments, the wall 202A of the external sheath 202 (e.g., external flexible sheath) may be configured to define a second inner lumen. In some embodiments, the wall 202A of the external sheath 202 may further define one or more additional inner lumens. In various embodiments, the second inner lumen and / or the one or more additional inner lumens may be disposed between the outermost surface of the external sheath and the inner most surface of the wall of the first inner lumen. In various embodiments, the second inner lumen and / or the one or more additional inner lumens may be disposed evenly around the circumference of the wall 202A of the external sheath. In other embodiments, the second inner lumen and / or the one or more additional inner lumens may be disposed unevenly around the circumference of the wall 202A of the external sheath. In various embodiments, at least onestiffening rod may be disposed within at least a portion of the second inner lumen and / or one or more additional inner lumens. In various embodiments, the at least one stiffening rod may be a tendon, pull rod, spring, gas, fluid, magnet, shape memory alloy, and / or the like configured to be actuated by a stimulus to at least partially apply one or more modified stiffness profiles to one or more portions of the length of the external sheath, such that the one or more modified stiffness profiles may at least partially lock the external sheath and / or steerable stylet in place. In various embodiments, the at least one stiffening rod, at least one shape sensing element, one or more additional diagnostic device, one or more additional therapeutic device, and / or the steerable stylet may be disposed individually in the one or more additional inner lumens of the wall of the external sheath.

[0097] In various embodiments, the external sheath 202 may be configured to removably house at least a portion of the steerable stylet in the first inner lumen. Simultaneously and / or individually, the external sheath may be configured to at least partially house one or more additional therapeutic devices and / or one or more additional diagnostic devices in one or more additional inner lumens. In one or more embodiments, the first inner lumen 220 may define one or more additional inner lumens (not depicted). The one or more additional inner lumens may be defined by the same wall that defines the first inner lumen. In various embodiments, the first inner lumen 220 may be divided into subsections configured to define one or more additional inner lumens. The one or more inner lumens may simultaneously and / or individually receive and / or house one or more of: at least one stiffening rod, at least one actuation mechanism (for example tendon), at least one additional therapeutic device, at least one additional diagnostic device, and / or the steerable stylet. In various embodiments, the one or more additional inner lumens defined by the first inner lumen may be configured to removably house at least a portion of the steerable stylet. In various embodiments, at least one additional therapeutic device may be housed at least partially within the one or more additional inner lumens defined by the first inner lumen of the external sheath. In other embodiments, at least one additional diagnostic device may be housed at least partially within the one or more additional inner lumens defined by the first inner lumen of the external sheath. In various embodiments, at least one additional therapeutic device, at least one additional diagnostic device, and / or steerable stylet may be housed at least partially within the one or more additional inner lumens defined by the first inner lumen of the external sheath.

[0098] In various embodiments, the at least one stiffening rod 21 ON may be operably connected to the at least one stiffening rod anchor, at least one steerable stylet controller, and / or the one or more control units. The at least one stiffening rod may be selectively actuated and de-actuated,such that the at least one stiffening rod may apply at least one modified stiffness profile to one or more portions of the length of the external sheath. In various embodiments, the one or more modified stiffness profiles may be different (e.g., less than, greater than) than the first stiffness profile at one or more portions of the length of the external sheath. In various embodiments, the one or more modified stiffness profiles may be configured to lock at least a portion of the external sheath in one or more desired configurations and / or one or more desired locations.

[0099] In various embodiments, the at least one stiffening rod may comprise a single stiffness profile along the entire length of the at least one stiffening rod. In one or more embodiments, the at least one stiffening rod anchor, at least one steerable stylet controller, and / or the one or more control units may actuate the at least one stiffening rod to apply a single stiffness profile along the entire length of the at least one stiffening rod. In other embodiments, the at least one stiffening rod may comprise a single stiffness profile along the entire length of the at least one stiffening rod. In one or more embodiments, the at least one stiffening rod anchor, at least one steerable stylet controller, and / or the one or more control units may actuate the at least one stiffening rod to apply a single stiffness profile at one or more portions along the length of the at least one stiffening rod. In various embodiments, a first stiffening rod and at least one additional stiffening rod may comprise a constant stiffness profile. In various embodiments, the first stiffness rod may comprise a stiffness profile that is different (e.g., less than or greater than) the stiffness profile of at least one additional stiffness rod.

[0100] In various embodiments, the at least one stiffening rod may comprise two or more stiffness profiles along the length of the at least one stiffening rod. In various embodiments, one or more first portions along the length of the at least one stiffening rod may comprise a first stiffness profile and one or more additional portions along the length of the at least one stiffening rod may comprise one or more additional stiffness profiles. The one or more additional stiffness profiles may be different (e.g., less than, greater than) than the first stiffness profile at one or more portions of the length of the at least one stiffening rod. In various embodiments, when actuated, the at least one stiffening rod may apply a first modified stiffness profile at the one or more first portions and one or more additional modified stiffness profiles at the one or more additional portions along the length of the at least one stiffening rod. The one or more additional modified stiffness profiles may be different (e.g., less than, greater than) than the first modified stiffness profile. In one or more embodiments, the first modified stiffness profile and / or the one or more additional modified stiffness profile may be configured to lock one or more first portions and / or one or more additional portions along the length of the flexible sheath. In various embodiments, one or more stiffeningrods may comprise fundamentally different stiffnesses than one or more additional stiffening rods. In addition, the at least one stiffening rods may comprise stiffness variation along the length of the stiffening rod.

[0101] In various embodiments, the at least one stiffening rod may be actuated continuously for a predetermined amount of time. In various embodiments, the at least one stiffening rod may be actuated continuously for a predetermined amount of time. In various embodiments, the at least one stiffening rod 2 ION may be actuated simultaneously, individually, or a combination thereof. In other embodiments, the at least one stiffening rod may be actuated at one or more portions of the length of the external sheath. In various embodiments, the at least one stiffening rod may be actuated along the entire length of the external sheath. In various embodiments, the at least one stiffening rod may be actuated manually, robotically, or a combination thereof.

[0102] As depicted in FIG. 2B, in various embodiments, the external sheath (e.g., external flexible sheath) comprises at least three stiffening rods 2 ION. The at least three stiffening rods may be operably connected to the at least one stiffening rod anchor, at least one steerable stylet controller, and / or the one or more control units. The at least three stiffening rods 2 ION may be selectively actuated and de-actuated, such that the at least three stiffening rods apply one or more modified stiffness profiles to one or more portions of the length of the external sheath. In various embodiments, the one or more modified stiffness profiles may be different (e.g., less than, greater than) than the first stiffness profile at one or more portions of the length of the external sheath. In various embodiments, the one or more modified stiffness profiles may be configured to lock at least a portion of the external sheath in one or more desired configurations and / or one or more desired locations. In various embodiments, the at least one stiffening rod may be actuated continuously for a predetermined amount of time.

[0103] In various embodiments, the at least three stiffening rods 210N may be actuated simultaneously, individually, or a combination thereof. In other embodiments, the at least three stiffening rods may be actuated at one or more portions of the length of the external sheath. In various embodiments, the at least three stiffening rods may be actuated along the entire length of the external sheath. In various embodiments, the at least three stiffening rods may be actuated manually, robotically, or a combination thereof. In various embodiments, a single stiffening rod of the at least three stiffening rods may be actuated, such that the single stiffening rod at least partially locks the external sheath and / or steerable stylet in place in one dimension. In various embodiments, two stiffening rods of the at least three stiffening rods may be actuated, such that the two stiffening rod at least partially locks the external sheath and / or steerable stylet in place inone or more dimensions. In various embodiments, the at least three stiffening rods may be actuated, such that the at least three stiffening rods at least partially locks the external sheath and / or steerable stylet in place in one or more dimensions. In various embodiments, the at least three stiffening rods may be actuated, such that the at least three stiffening rods at least partially locks the external sheath and / or steerable stylet in place in three dimensions.

[0104] In various embodiments, the at least one stiffening rod 21 ON may further comprise one or more shape sensing elements. In various embodiments, the at least one stiffening rod 2 ION comprising one or more shape sensing elements may be selectively actuated to at least partially lock the external sheath 202 (e.g., external flexible sheath) in one or more desired locations and / or one or more desired configurations. In various embodiments, the at least one stiffening rod 21 ON comprising one or more shape sensing elements may be configured to actuate at one or more portions of the length of the external sheath, such that the at least one stiffening rod 21 ON assists with locking the external sheath 202 at the respective location. In various embodiments, the at least one stiffening rod 21 ON comprising one or more shape sensing elements may be configured to actuate along the entire length of the external sheath 202, such that the at least one stiffening rod 210N assists with locking the entire external sheath 202. In various embodiments, the one or more shape sensing element may be separate from the at least one stiffening rod, such that the one or more shape sensing element 212 may be at least partially disposed in the first inner lumen, second inner lumen, and / or one or more additional inner lumens of the wall of the external sheath.

[0105] In various embodiments, the one or more shape sensing element 212 may be multicore fiber Bragg grating (FBG) fibers, single core FBG fibers, and / or the like configured for intrinsic three-dimensional shape sensing. In various embodiments, the one or more shape sensing elements 212 may be integrated into the wall 202A of the external sheath 202 at one or more portions of the length of the external sheath 202. In various embodiments, the one or more shape sensing elements may be integrated into the wall 202A of the external sheath 202 along the entire length of the external sheath. The one or more shape sensing elements may determine the shape and / or the configuration of the external sheath 202 while simultaneously minimizing the use of ionizing radiation, such as X-ray. In various embodiments, the one or more shape sensing elements 212 may be used, in combination with a steerable stylet, to position the steerable portion of the system in one or more desired locations and / or one or more desired configurations. In various embodiments, while performing one or more medical operations under an MRI environment, the one or more shape sensing elements 212 may be used to guide at least one imaging plane of an MRI system and / or control the motion of a steerable stylet within a subject (e.g., within a humanbody, within an animal body etc.). In various embodiments, the one or more shape sensing elements 212 may be used to guide the imaging plane when the system is used under ultrasound imaging modality or one or more additional alternate imaging modalities.

[0106] With even further reference to FIGS. 2B-2C, in various embodiments, the one or more additional inner lumens may be configured to at least partially receive and / or house one or more stiffening rods 2 ION. In various embodiments, the one or more stiffening rods 2 ION may be disposed evenly around the circumference of the external sheath 202. In various embodiments, the one or more stiffening rods 2 ION may be disposed unevenly around the circumference of the external sheath 202. In one or more embodiments, the one or more additional inner lumens of the wall 202A may be space, for example, -120° apart. In other embodiments, the one or more additional inner lumens of the wall 202A may be spaced arbitrarily in order to complete one or more task requirements.

[0107] In various embodiments, at least a portion of the at least one stiffening rod 21 ON may be disposed externally to the one or more additional inner lumen, such that the at least one stiffening rod 210N may secure to the one or more control units and / or at least one stiffening rod anchor externally. In various embodiments, the at least one stiffening rod 210N may be disposed completely within the one or more additional inner lumen, such that at least one stiffening rod secures to the one or more control units and / or at least one stiffening rod anchor internally. In various embodiments, the at least one stiffening rod 210N may be selectively actuated to apply one or more modified stiffness profiles to one or more portions of the length of the external sheath 202 and / or the steerable stylet 204, such that at least a portion of the external sheath and / or the steerable stylet is at least partially locked in place. In various embodiments, the actuation of at least one stiffening rod may be configured to cause the at least one stiffening rod to radially expand, radially compress, longitudinally expand, longitudinally compress, or a combination thereof, such that a stiffness profile of at least a portion of the external sheath is modified. In various embodiments, the actuation of the at least one stiffening rod 210N may be one or more of a mechanical actuation, an electrical actuation, a magnet actuation, a thermal actuation, a fluid actuation, or a combination thereof.

[0108] FIGS. 2D-2F illustrate exemplary views of a steerable portion and components thereof in accordance with various embodiments of the present disclosure. In various embodiments, the steerable portion 200 may further comprise at least one articulating joint (depicted in FIGS. 2E- 2F). As illustrates in FIGS. 2E-2F, in various embodiments, the flexible sheath may comprise at least one articulating joint 214. The at least one articulating joint 214 may be disposed at a distalend of the steerable portion 200. In various embodiments, the at least one articulating joint 214 may be selectively actuated by the one or more control units, the at least one steerable stylet controller, and / or the at least one stiffening rod anchor, such that the at least one articulating joint may be actuated via at least one actuation mechanism (e.g., tendon 208, mechanical actuation, an electrical actuation, a magnet actuation, a thermal actuation, a fluid actuation, or a combination thereof). In one or more embodiments, the at least one articulating joint may define a wall, such that the wall can define a first inner lumen. In various embodiments, the at least one actuating joint 214 may allow the at least one actuation mechanism (for example, tendon 208) be routed through an inner lumen of the at least one articulating joint 214. In various embodiments, the at least one articulating joint 214 may be at least partially hallow. In various embodiments, the hollow interior of the at least one articulating joint may at least partially house one or more additional diagnostic device, one or more additional therapeutic device, at least one tendon, at least one stiffening rod, and / or at least a portion of the steerable stylet.

[0109] In various embodiments, the at least one articulating joint 214 may comprise the same material as the external sheath. In other embodiments, the at least one articulating joint 214 may comprise a different material than the external sheath. In one or more embodiments, the at least one articulating joint 214 may comprise two or more materials. In various embodiments, the at least one articulating joint may comprise a stiffness profile along the length of the at least one articulating joint. In various embodiments, the stiffness profile may be the same as the external sheath. In other embodiments, the at least one articulating joint may comprise a stiffness profile different than the external sheath. In various embodiments, the at least one articulating joint may comprise two or more stiffness profiles at one or more locations along the length of the at least one articulating joint. In one or more embodiments, the at least one articulating joint may be disposed at one or more additional locations along the length of the external sheath. In other embodiments, the at least one articulating joint may be disposed at a proximal end of the external sheath.

[0110] In one or more embodiments, the inner lumen of the at least one articulating joint may comprise the same circumference as the first inner lumen of the external sheath, such that the inner lumen of the at least on articulating joint and the first inner limen of the external sheath act as a single inner lumen. In other embodiments, the inner lumen of the at least one articulating joint may comprise a different circumference as the first inner lumen of the external sheath. In one or more embodiments, the at least one articulating joint 214 may further define at least one or more additional inner lumens. The one or more additional inner lumens may be at least partially houseat least one tendon 208, at least one stiffening rod, one or more additional therapeutic devices, and / or one or more additional diagnostic devices.

[0111] With further reference to FIGS. 2E-2F, in various embodiments, the at least one articulating joint may further comprise one or more apertures 216 (e.g., notches, slits, slots, holes, joint, brace, etc.). In various embodiments, the one or more apertures may be disposed on the wall of the at least one articulating joint 214, such that the one or more apertures may assist with the flexibility of the at least one articulating joint 214. In various embodiments, the one or more apertures 216 may be spaced evenly along one or more portions of the length of the at least one articulating joint 214. In various embodiments, the one or more apertures 216 may be spaced evenly along the entire length of the at least one articulating joint 214. In other embodiments, the one or more apertures 216 may be spaced evenly at one or more first portions along the length of the at least one articulating joint 214 and spaced unevenly at one or more additional portions along the length of the at least one articulating joint 214. In various embodiments, the one or more apertures 216 may be spaced unevenly along one or more portions of the length of the at least one articulating joint 214.

[0112] In various embodiments, the one or more apertures 216 may extend through the entire thickness of the wall of the at least one articulating joint 214. In various embodiments, the one or more apertures 216 may comprise one or more geometric shape needed to achieve the desired function. In other embodiments, the one or more apertures 216 may extent through a portion of the thickness of the wall of the at least one articulating joint 214. In various embodiments, the one or more apertures 216 may assist with restricting one or more tendons disposed within the at least one articulating joint 214. In various embodiments, the one or more apertures 216 may be configured to be internal apertures. In various embodiments, the one or more apertures 216 may assist with the flexibility of the at least one articulating joint 214 at one or more locations along the length of the at least one articulating joint 214. In one or more embodiments, the one or more apertures 216 may assist with the flexibility of the at least one articulating joint 214 in one or more desired directions. In various embodiments, upon actuation of at least one actuation mechanism (e.g., tendons, mechanical actuation, an electrical actuation, a magnet actuation, a thermal actuation, a fluid actuation, or a combination thereof), the one or more apertures 216 may cause at least a portion of the at least one articulating joint 214 to bend and / or deflect in the one or more desired configuration. In various embodiments, the actuation of at least one actuation mechanism may be configured to actively manipulate the tip of the external sheath simultaneously and / orindividually to the at least one stiffening rod locking at least a portion of the external sheath in place.

[0113] FIG. 2G illustrates an exemplary steerable portion in a locked configuration in accordance with various embodiments of the present disclosure. In various embodiments, while at least one stiffening rod may be actuated (e.g., locked configuration), the steerable stylet may be detached from the at least one steerable stylet controller, such that the steerable stylet can be removed from the first inner lumen of the external sheath. In one or more embodiments, while at least one stiffening rod may be actuated, the steerable stylet, while connected to the at least one steerable stylet controller, may be removed from the first inner lumen of the external sheath. The steerable stylet may be fully removed while the external sheath may maintain the lock configuration. In various embodiments, one or more additional therapeutic devices 230 and / or one or more additional diagnostic devices 230 may be at least partially inserted into the first inner lumen of the external sheath. In various embodiments, the one or more additional therapeutic devices 230 and / or one or more additional diagnostic devices 230 may at least partially conform to the shape of the external sheath in the locked configuration while being inserted. In various embodiments, one or more additional therapeutic device and / or one or more additional diagnostic devices may be at least partially inserted into the first inner lumen, the second inner lumen, and / or the one or more additional inner lumens of the external sheath.

[0114] In various embodiments, one or more additional therapeutic devices 230 and / or one or more additional diagnostic devices 230 may be fully inserted into the first inner lumen of the external sheath, such that a distal end 234 of the one or more additional therapeutic devices 230 and / or one or more additional diagnostic devices 230 may be aligned with the distalmost edge of the external sheath. In other embodiments, the distal end 234 of the one or more additional therapeutic devices 230 and / or one or more additional diagnostic devices 230 may extend at least partially past the distalmost edge of the external sheath. In various embodiments, the one or more additional therapeutic devices 230 and / or one or more additional diagnostic devices 230 may not be inherently steerable, such that without the external sheath the one or more additional therapeutic devices 230 and / or one or more additional diagnostic devices 230 could not reach a desired location and / or could not achieve a desired configuration. In various embodiments, the distal end 234 of the one or more additional therapeutic devices 230 and / or one or more additional diagnostic devices 230 may be blunt, such that the distal end 234 does not at least partially puncture the wall of the external sheath. In various embodiments, the one or more additional therapeutic devices 230 and / or one or more additional diagnostic devices 230 may further comprise at least one fluid barrier232. The at least one fluid barrier 232 may prevent any contamination of the radiation source when the external sheath is removed.

[0115] FIGS. 3A-3B illustrates a flow diagram of an exemplary method 300 for selectively locking an external sheath (e.g., external flexible sheath) in accordance with various embodiments of the present disclosure. The steps of method 300 may be performed by one or more components of the system as describe in more detail with respect to FIGS. 1A-2D. The one or more control units operably connected to the at least one steerable stylet controller, at least one stiffening rod anchor, and / or the steerable stylet may begin the method 300.

[0116] Method 300 may begin with inserting at least a portion an external sheath housing at least a portion of a steerable stylet into a portion of a subject, block 302. In various embodiments, the external sheath and / or the steerable stylet may be operably connected to the one or more control units, at least one steerable stylet controller, and / or at least one stiffening rod anchor, such that one or more tendons within the steerable stylet may be used to steer the steerable stylet and / or the external sheath. In various embodiments, the at least one stiffening rod disposed within the external sheath may be selectively actuated by the one or more control units, at least one steerable stylet controller, and / or at least one stiffening rod anchor. In various embodiments, a subject may be a human and / or an animal. In one or more embodiments, the external sheath comprising the steerable stylet may be inserted into an incision made into a portion of the subject. In various embodiments, the tip of the steerable stylet may be configured to puncture one or more holes in the tissue of the subject, such that the external sheath may reach one or more desired locations and / or one or more desired configurations. In other embodiments, the external sheath comprising the steerable stylet may be inserted into one or more orifice of the subject.

[0117] In block 304, the steerable stylet may assist in positioning the external sheath in one or more desired locations and / or one or more desired configurations. In various embodiments, the steerable stylet may be operably connected to the steerable stylet controller and / or one or more control units, such that the steerable stylet may be manually and / or robotically controlled. In various embodiments, the steerable stylet controller may assist with moving the steerable stylet and / or external sheath in the X-axis, Y-axis, Z-axis, and / or rotationally.

[0118] In block 306, the at least one steerable stylet controller and / or the one or more control units may position the external sheath comprising the steerable stylet in one or more desired configurations and / or one or more desired locations. In various embodiments, the external sheath may be passively steered by the steerable stylet, such that at least one stiffening rod disposed within the wall of the external sheath may not need to be actuated. The at least one stiffening rod,while not actuated, may allow the external sheath to at least partially conform to the configuration of the steerable stylet.

[0119] In block 308, once the external sheath is in a desired configuration and / or a desired location, at least one stiffening rod may be selectively actuated by the at least one stiffening rod anchor and / or one or more control units. In one or more embodiments, the actuation of the at least one stiffening rod may be a mechanical actuation, an electrical actuation, a magnet actuation, a thermal actuation, a fluid actuation, or a combination thereof. The actuation of the at least one stiffening rod may cause radial expansion, radial compression, longitudinal expansion, longitudinal compression, or a combination thereof, such that the actuation causes one or more modified stiffness profiles may be applied to one or more portions of the length of the external sheath. In various embodiments, the one or more modified stiffness profile may lock the external sheath in the configuration and / or location. After the completion of block 308, the method may include an optional “B” as shown in FIG. 3B.

[0120] In block 310 of FIG. 3B, the method may optionally include removing the steerable stylet from the first inner lumen of the external sheath while the external sheath remains in the locked configuration. The external sheath may be configured to at least partially maintain the same configuration and / or positioning while the steerable stylet is removed. In various embodiments, the steerable stylet may be disconnected from the at least one steerable stylet controller before the steerable stylet is removed from the first inner lumen of the external sheath.

[0121] In block 312, one or more additional therapeutic devices and / or one or more additional diagnostic devices may be at least partially inserted into the first inner lumen of the external sheath. In various embodiments, the one or more additional therapeutic devices and / or one or more additional diagnostic devices may be inserted manually and / or robotically. In various embodiments, the one or more additional therapeutic devices and / or one or more additional diagnostic devices may at least partially conform to the configuration of the external sheath in the locked configuration (e.g., at least one stiffening rod actuated). In one or more embodiments, the one or more additional therapeutic devices and / or one or more additional diagnostic devices may be completely inserted into the first inner lumen of the external sheath, such that at least a portion of the one or more additional therapeutic devices and / or one or more additional diagnostic devices extends beyond the distalmost edge of the external sheath. In various embodiments, the one or more additional therapeutic devices and / or one or more additional diagnostic devices may be operably connected to the one or more control units, computing system, and / or the like to perform the desired function (e.g., imaging, drug delivery, incisions, injecting, and / or the like).

[0122] In block 314, the external sheath may be at least partially removed from the subject. In various embodiments, the at least partial removal of the external sheath may expose additional surface area of the one or more additional therapeutic devices and / or one or more additional diagnostic devices within the subject. In one or more embodiments, the one or more additional therapeutic devices and / or one or more additional diagnostic devices may at least partially maintain the configuration before the external sheath was at least partially removed. In some embodiments, the external sheath may be completely removed from the subject.

[0123] Aspects of the disclosed invention may be implemented using at least some of the components illustrated in the computing device architecture 400 (e.g., one or more control units), as depicted in FIG. 4. As shown, the computing device architecture includes a central processing unit (CPU) 402, where computer instructions are processed; a display interface 404 that acts as a communication interface and provides functions for rendering video, graphics, images, patient vitals information, and texts on the display. In certain example implementations of the disclosed technology, the display interface 404 may be directly connected to a local display, such as a touchscreen display associated with a mobile computing device. In another example implementation, the display interface 404 may be configured for providing data, images, and other information for an extemal / remote display that is not necessarily physically connected to the mobile computing device. For example, a desktop monitor may be utilized for mirroring graphics and other information that is presented on a mobile computing device. In certain example implementations, the display interface 404 may wirelessly communicate, for example, via a Wi-Fi channel or other available network connection interface 412 to the extemal / remote display.

[0124] In various embodiments, the network connection interface 412 may be configured as a communication interface and may provide functions for rendering video, graphics, images, text, other information, or any combination thereof on the display. In one example, a communication interface may include a serial port, a parallel port, a general-purpose input and output (GPIO) port, a game port, a universal serial bus (USB), a micro-USB port, a high-definition multimedia (HDMI) port, a video port, an audio port, a Bluetooth port, a near-field communication (NFC) port, another like communication interface, or any combination thereof. In one example, the display interface 404 may be operatively coupled to a local display, such as a touch-screen display associated with a mobile device. In another example, the display interface 404 may be configured to provide video, live video, live video feed, graphics, images, live images, text, other information, or any combination thereof for an extemal / remote display that is not necessarily connected to the mobile computing device. In one example, a desktop monitor may be utilized for mirroring or extendinggraphical information that may be presented on a mobile device. In another example, the display interface 404 may wirelessly communicate, for example, via the network connection interface 412 such as a Wi-Fi transceiver to the external / remote display.

[0125] In various embodiments, the computing device architecture 400 may include a keyboard interface 406 that provides a communication interface to a keyboard. According to certain example implementations of the disclosed technology, the system may communicate with various devices such as one or more control units, an external sheath, a steerable stylet, at least one actuator, at least one actuator anchor, at least one steerable stylet controller, one or more therapeutic devices, one or more diagnostic devices, a touch screen, a camera, a sensor, etc. In various embodiments, the keyboard may be configured to control the movement of the external sheath and / or steerable stylet.

[0126] The computing device architecture 400 may be configured to use an input device via one or more of input / output interfaces (for example, the keyboard interface 401, the display interface 404, network connection interface 412, camera interface 414, etc.) to allow a user to capture information into the computing device architecture 400. The input device may include a mouse, a trackball, a directional pad, a track pad, a touch-verified track pad, a presence-sensitive track pad, a controller, a touch screen, a presence-sensitive display, a scroll wheel, a digital camera, a digital video camera, a web camera, a microphone, a sensor, a smartcard, and the like. In various embodiments, the input device may be configured to control the movement of the external sheath and / or steerable stylet. Additionally, the input device may be integrated with the computing device architecture 400 or may be a separate device. For example, the input device may be an accelerometer, a magnetometer, a digital camera, a microphone, and an optical sensor.

[0127] Example implementations of the computing device architecture 400 may include an antenna interface 410 that provides a communication interface to an antenna; a network connection interface 412 that provides a communication interface to a network. As mentioned above, the display interface 404 may be in communication with the network connection interface 412, for example, to provide information for display on a remote display that is not directly connected or attached to the system. According to example implementations, a random-access memory (RAM) 418 is provided, where computer instructions and data may be stored in a volatile memory device for processing by the CPU 402. In various embodiments, the RAM 418 comprises instructions to actuate at least one actuator to apply a modified stiffness profile at one or more locations along the length of the continuum structure.

[0128] According to an example implementation, the computing device architecture 400 includes a read-only memory (ROM) 420 where invariant low-level system code or data for basic system functions such as basic input and output (I / O), startup, or reception of keystrokes from a keyboard are stored in a non-volatile memory device. According to an example implementation, the computing device architecture 400 includes a storage medium 422 or other suitable type of memory (e.g., such as RAM, ROM, programmable read-only memory (PROM), erasable programmable read-only memory (EPROM), electrically erasable programmable read-only memory (EEPROM), magnetic disks, optical disks, floppy disks, hard disks, removable cartridges, flash drives), where the files include an operating system 424, application programs 426 (including, for example, a web browser application, a widget or gadget engine, and or other applications, as necessary) and data files 428 are stored. According to an example implementation, the computing device architecture 400 includes a power source 430 that provides an appropriate alternating current (AC) or direct current (DC) to power components.

[0129] According to an example implementation, the CPU 402 has appropriate structure to be a computer processor. In one arrangement, the CPU 402 may include more than one processing unit. The RAM 418 interfaces with the computer bus 434 to provide quick RAM storage to the CPU 402 during the execution of software programs such as the operating system application programs, and device drivers. More specifically, the CPU 402 loads computer-executable process steps from the storage medium 422 or other media into a field of the RAM 418 in order to execute software programs. Data may be stored in the RAM 418, where the data may be accessed by the computer CPU 402 during execution. In one example configuration, the device architecture 400 includes at least 98 MB of RAM, and 256 MB of flash memory.

[0130] The storage medium 422 itself may include a number of physical drive units, such as a redundant array of independent disks (RAID), a flash memory, a USB flash drive, an external hard disk drive, thumb drive, pen drive, key drive, a High-Density Digital Versatile Disc (HD-DVD) optical disc drive, an internal hard disk drive, a Blu-Ray optical disc drive, or a Holographic Digital Data Storage (HDDS) optical disc drive, an external mini-dual in-line memory module (DI MM) synchronous dynamic random-access memory (SDRAM), or an external micro-DI MM SDRAM. Such computer readable storage media allow a computing device to access computer-executable process steps, application programs and the like, stored on removable and non-removable memory media, to off-load data from the device or to upload data onto the device. A computer program product, such as one utilizing a communication system may be tangibly embodied in storage medium 422, which may comprise a machine-readable storage medium.

[0131] According to one example implementation, the term computing device, as used herein, may be a CPU, or conceptualized as a CPU (for example, the CPU 402 of FIG. 4). In this example implementation, the CPU may be coupled, connected, and / or in communication with one or more peripheral devices, such as display. In another example implementation, the term computing device, as used herein, may refer to a mobile computing device such as a smartphone, tablet computer, or smart watch. In this example embodiment, the computing device may output content to its local display and / or speaker(s). In another example implementation, the computing device may output content to an external display device (e.g., over Wi-Fi) such as a TV or an external computing system.Example 1. High-Dose-Rate Brachytherapy

[0132] In an example embodiment, the system for locking an external sheath may comprise at least a steerable stylet, an external flexible sheath, and / or at least one steerable stylet controller. The system may further comprise one or more control units and / or at least one stiffening rod anchor. The one or more control units may be operably connected to the at least one steerable stylet controller, at least one stiffening rod anchor, at least one stiffening rod, and / or at least a portion of the steerable stylet. In the example embodiment, the system may be a magnetic resonance imaging (MRI)- guided robotic steerable stylet positioning system with an MRI steerable stylet configured to guide the external sheath to at least one appropriate location for facilitating in-situ placement of radiation therapy needles (e.g., one or more additional therapeutic devices) for high-dose-rate (HDR) brachytherapy (BT).

[0133] The MRI-compatible system may be mounted on a surgical table to allow the clinician to position the steerable stylet for tissue puncture into the perineum (e.g., subject). The MRI- compatible platform may be driven by at least one steering mechanism comprising at least one piezomotor configured to move the XYZ stages of the platform. The steering mechanism (e.g., at least one piezomotor and / or at least one tendon) will allow the clinician to finely control the stylet insertion point (e.g., stylet tip). Additionally, the system will allow the clinician to manually push the stylet through the perineum if the clinician chooses to manually insert the stylet. In some embodiments, the stylet insertion through the perineum may be done robotically. Once the perineum is punctured, the robotic system will lock the XYZ stages, such that the steerable stylet controller can only be translated in the direction of insertion or retraction. Additionally, the steerable stylet controller will enable the clinician to guide the steerable stylet and thus the surrounding external sheath.

[0134] The external sheath (e.g., external flexible sheath) will have at least one inner lumen that will enable the steerable stylet to be inserted into it. The steerable stylet along with the external sheath surrounding it will be guided to the target location manually, robotically, or a combination thereof. In this embodiment, the system could comprise two or more degrees of freedom (DoFs) to enable motion of the stylet in three-dimensions. Additionally, the stylet will be hollow to facilitate routing of, for example, three tendons inside it. The tip of the steerable stylet could be conical and sharp to enable puncturing the tissue. For use of the overall system in MRI, the steerable stylet could be made of Nitinol (NiTi) with outer diameter slightly less than the inner diameter of the external sheath. To enable distal dexterity of the steerable stylet within the MRI guided robotic steerable stylet positioning system, the system could use at least one piezomotor as one or more actuators. In an example embodiment, the at least one piezomotor may be packaged inside the steerable stylet.

[0135] The annular wall of the external sheath will have at least one additional inner lumen to house the at least one stiffening rod as well as one or more shape sensing element(s). The at least one stiffening rod(s) could be secured, for example, within a respective additional inner lumen and / or outside a respective additional inner lumen to enable locking the external sheath into a desired shape. The integrated shape sensing element(s) could be secured, for example, within a respective additional inner lumen and / or outside a respective additional inner lumen to determine the shape of the external sheath. In one particular embodiment, the at least one additional inner lumen could be spaced, for example, -120° apart. In other embodiments, the at least one additional inner lumen could be spaced arbitrarily, based on the task requirements.

[0136] In some embodiments, the external sheath may comprise at least one additional inner lumen to house at least on multicore fiber Bragg grating (FBG) fiber, for example, for intrinsic 3D shape sensing. The intrinsic shape sensing may be able to determine the shape of the external sheath and / or the steerable stylet and use that information to control the motion of the steerable stylet. The intrinsic shape sensing may minimize the use of ionizing radiation, such as X-ray, to image the stylet if this steerable stylet system is operated under X-ray imaging modality. Similarly, while operating under the MRI environment, the intrinsic shape sensing may be used to guide the imaging plane of the MRI and control the motion of the steerable stylet within the tissue of the subject. Likewise, intrinsic shape sensing could also be used to guide the imaging plane when operating the system under ultrasound imaging modality. By using intrinsic shape sensing, the system and / or the operator may be able to determine the overall configuration of the steerable stylet and / or the external sheath to the control of the system. In various embodiments, the one ormore additional inner lumens of the external sheath may comprise two or more shape sensing elements. The shape sensing element(s) may be incorporated into the annular wall of the external sheath. The shape sensing element(s) may be a single core FBG fibers, multicore FBG fibers, etc.

[0137] The steerable stylet, with the surrounding external sheath (e.g., external flexible sheath) comprising inner diameter (ID) will be slightly more than the outer diameter of the steerable stylet, will be inserted through the template used for BT. For example, a clamping system that will enable, for example, mechanical locking of the at least one stiffening rods at the proximal end and the distal end of the at least one stiffening rod could be secured within the one or more additional inner lumens by keeping the one or more additional inner lumens closed on the distal end of the external sheath. It is important to note that while the external sheath is being passively steered by the steerable stylet within its conduit, the at least one stiffening rods within the one or more additional inner lumens of the external sheath may not need to be locked (e.g., actuated). The at least one stiffening rod will allow the external sheath to deform as desired. Once the external sheath is in the desired configuration, the external sheath may be locked in place by locking (e.g., actuating) the at least one stiffening rod, appropriately. After the actuation, the steerable stylet will be withdrawn, and the steerable stylet controller will be detached via a quick-connect mechanism. The external sheath will be left locked in place.

[0138] Subsequently, a blunt HDR BT plastic needle(s) (e.g., one or more additional therapeutic devices) will be manually inserted into the external sheath. The blunt tip of the HDR BT needle will prevent the tip of the needle from puncturing through the wall of the external sheath. At the proximal end of the HDR BT needle, the HDR BT needle may comprise a fluid barrier. The fluid barrier may prevent any contamination of the radiation source when the external sheath is removed. This process will be repeated to implant all plastic HDR BT needles. If necessary, the external sheath could be removed and leave the HDR BT needles exposed to the surrounding environment.Example 2. Specific Advantages

[0139] One advantage of the one or more systems, as described herein, is the ability to place nonsteerable devices and other structures in a configuration, which could not be achieved without steerability. Another advantage is the ability to intrinsically sense the shape of the external sheath to control the movement of the external sheath to the target location with reduced X-ray imaging (if the system is operated under X-ray imaging modality). Additionally, integrated shape sensing may be used to guide the imaging plane in, for example, magnetic resonance imaging (MRI) or ultrasound imaging environment to determine the overall configuration of the external sheath and steerable stylet. The configuration information may be used to control of the external sheath andthe steerable stylet. Furthermore, the one or more systems expands the possible configurations that can be achieved by the external sheath and / or expands the possible target locations within a subject that can be reached. In the case of HDR BT, this expansion of the possible dose plans a patient can receive, optimizes the treatment for the patient. By having at least one needle be able to follow a nonlinear path, it can reduce the number of needles needed to achieve adequate tumor radiation coverage. Furthermore, the ability for at least one needle to follow a nonlinear path may enable obstacle avoidance. The obstacle avoidance may allow the at least one needle to steer around anatomical structures, which the user does not wish to damage and thus reduce morbidity. This system can also be employed for other applications, such as search and rescue operations, where it might be necessary to introduce certain tools and components, for example, through the conduit of an external sheath for both delivery and retrieval purposes.

[0140] While certain embodiments of the disclosed technology have been described in connection with what is presently considered to be the most practical embodiments, it is to be understood that the disclosed technology is not to be limited to the disclosed embodiments, but on the contrary, is intended to cover various modifications and equivalent arrangements included within the scope of the appended claims. Although specific terms are employed herein, they are used in a generic and descriptive sense only and not for purposes of limitation.

[0141] This written description uses examples to disclose certain embodiments of the disclosed technology, including the best mode, and also to enable any person skilled in the art to practice certain embodiments of the disclosed technology, including making and using any devices or systems and performing any incorporated methods. The patentable scope of certain embodiments of the disclosed technology is defined in the claims, and may include other examples that occur to those skilled in the art. Such other examples are intended to be within the scope of the claims if they have structural elements that do not differ from the literal language of the claims, or if they include equivalent structural elements with insubstantial differences from the literal language of the claims.

Claims

WHAT IS CLAIMED IS:

1. A system for locking an external sheath, the system comprising: a steerable stylet; an external sheath configured to removably house at least a portion of the steerable stylet; and at least one steerable stylet controller configured to control the movement of the steerable stylet and the external sheath in at least one dimension.

2. The system of claim 1 , wherein the steerable stylet comprises a structure length and a stiffness profile across the structure length.

3. The system of claim 1, wherein the external sheath is configured to be flexible.

4. The system of claim 1 , wherein the external sheath defines a wall, wherein the wall defines a first inner lumen configured to removably house at least a portion of the steerable stylet.

5. The system of claim 1, wherein the external sheath further defines a second inner lumen, wherein the second inner lumen is disposed between the outermost surface of the wall and the innermost surface of the wall of the external sheath.

6. The system of claim 5, wherein the wall of the external sheath further defines one or more additional inner lumens, wherein the one or more additional inner lumens are disposed between the outermost surface of the wall and the innermost surface of the wall of the external sheath.

7. The system of claim 6, wherein the second inner lumen and / or the one or more additional inner lumens are disposed evenly around the circumference of the external sheath.

8. The system of claim 6, wherein the second inner lumen and / or the one or more additional inner lumens are disposed unevenly around the circumference of the external sheath.

9. The system of claim 6, wherein the at least one steerable stylet controller is configured to define a proximal end and a distal end.

10. The system of claim 9, wherein the system further comprises at least one stiffening rod anchor, wherein the at least one stiffening rod anchor is disposed at the distal end or the proximal end of the at least one steerable stylet controller.

11. The system of claim 10, wherein the system further comprises at least one stiffening rod, wherein the at least one stiffening rod is configured to secure to the at least one stiffening rod anchor.

12. The system of claim 11, wherein the at least one stiffening rod anchor is configured to actuate the at least one stiffening rod manually and / or automatically, wherein the at least one stiffening rod comprises a single stiffness profile along a length of the at least one stiffening rod.

13. The system of claim 12, wherein the at least one stiffening rod is configured to be actuated, wherein the at least one stiffening rod is configured to apply a modified stiffness profile to the external sheath and / or the steerable stylet.

14. The system of claim 13, wherein the modified stiffness profile applied by the at least one stiffening rod is configured to be different along the length of the at least one stiffening rod.

15. The system of claim 14, wherein the modified stiffness profile of the at least one stiffening rod is configured to at least partially lock the external sheath and / or the steerable stylet in place.

16. The system of claim 15, wherein the steerable stylet is configured to be at least partially removed from the first inner lumen of the external sheath when the modified stiffness profile is applied, wherein the external sheath is configured to at least partially maintain a locked shape.

17. The system of claim 16, wherein the system further comprises one or more additional therapeutic device configured to be inserted into the first inner lumen of the external sheath.

18. The system of claim 17, wherein the one or more additional therapeutic device is configured to at least partially conform to the shape of the external sheath once in a predetermined location.

19. The system of claim 16, wherein the system further comprises one or more additional diagnostic device configured to be inserted into the first inner lumen of the external sheath.

20. The system of claim 19, wherein the one or more additional diagnostic device is configured to at least partially conform to the shape of the external sheath once in a predetermined location.

21. The system of claim 12, wherein the second inner lumen and / or the one or more additional inner lumens are configured to at least partially house the steerable stylet and / or at least one stiffening rod.

22. The system of claim 12, wherein the system is configured to have at least three stiffening rods, wherein the at least three stiffening rods are configured to apply a modified stiffness profile to the external sheath and / or steerable stylet in at least one dimension.

23. The system of claim 22, wherein one or more of the at least three stiffening rods are configured to be actuated to apply a modified stiffness profile to the external sheath and / or the steerable stylet, wherein the modified stiffness profile applied by the one or more of the at least three stiffening rods is configured to be at least one of: the same modified stiffness along the entire length of the one or more of the at least three stiffening rods or the modified stiffness profile is different at one or more portions along the length of one or more actuated stiffening rods.

24. The system of claim 23, wherein the modified stiffness profile is configured to at least partially lock the external sheath and / or the steerable stylet in place in at least one direction.

25. The system of claim 24, wherein the steerable stylet is configured to be at least partially removed from the first inner lumen of the external sheath when the modified stiffness profile is applied, wherein the external sheath is configured to at least partially maintain a locked shape.

26. The system of claim 25, wherein one or more additional therapeutic device and / or one or more additional diagnostic device is configured to be inserted into the first inner lumen of the external sheath.

27. The system of claim 26, wherein the one or more additional therapeutic device and / or one or more additional diagnostic device is configured to at least partially conform to the shape of the external sheath once in a predetermined location.

28. The system of claim 22, wherein a first stiffening rod and at least two additional stiffening rods comprise a constant stiffness profile, wherein the first stiffness rod comprises a stiffness profile that is different than at least one additional stiffness rod.

29. The system of claim 23, wherein the at least three stiffening rods are disposed evenly around the circumference of the external sheath, wherein the at least three stiffening rods are configured to provide a modified stiffness in at least one dimension.

30. The system of claim 23, wherein the at least three stiffening rods are disposed unevenly around the circumference of the external sheath, wherein the at least three stiffening rods are configured to provide a modified stiffness in at least one dimension.

31. The system of claim 9, wherein the at least one steerable stylet controller is configured to actuate the at least one stiffening rod simultaneously, wherein the actuation of the at least one stiffening rod modifies a stiffness of the external sheath and / or steerable stylet.

32. The system of claim 9, wherein the at least one steerable stylet controller is configured to actuate the at least one stiffening rod individually, wherein the actuation of the at least one stiffening rod modifies a stiffness of the external sheath and / or steerable stylet.

33. The system of claim 1, wherein a wall of the external sheath defines a first inner lumen, wherein the first inner lumen is configured to define one or more additional inner lumens, wherein the one or more additional inner lumens are defined by the wall of the external sheath.

34. The system of claim 33, wherein the one or more additional inner lumens defined by the first inner lumen are configured to removably house at least a portion of the steerable stylet.

35. The system of claim 34, wherein the system further comprises at least one additional therapeutic device, wherein the at least one additional therapeutic device is housed at least partially within the one or more additional inner lumens defined by the first inner lumen of the external sheath.

36. The system of claim 34, wherein the system further comprises at least one additional diagnostic device, wherein the at least one additional diagnostic device is housed at least partially within the one or more additional inner lumens defined by the first inner lumen of the external sheath.

37. The system of claim 34, wherein the system further comprises at least one additional therapeutic device and / or at least one additional diagnostic device, wherein the at least one additional therapeutic device and / or at least one additional diagnostic device is housed at least partially within the one or more additional inner lumens defined by the first inner lumen of the external sheath.

38. The system of claim 1, wherein the steerable stylet comprises a wall defining an inner lumen.

39. The system of claim 38, wherein the system further comprises at least one tendon configured to assist with the movement of the steerable stylet and / or the external sheath.

40. The system of claim 39, wherein the at least one tendon is configured to be at least partially disposed within the inner lumen of the steerable stylet.

41. The system of claim 40, wherein the at least one tendon is configured to be spaced evenly around a circumference of the inner lumen of the steerable stylet.

42. The system of claim 40, wherein the at least one tendon is configured to be spaced unevenly around a circumference of the inner lumen of the steerable stylet.

43. The system of claim 39, wherein the system further comprises at least three tendons configured to assist with the movement of the steerable stylet and / or external sheath in three dimensions, wherein the at least three tendons are at least partially disposed within the inner lumen of the steerable stylet.

44. The system of claim 43, wherein the at least three tendons are configured to be spaced evenly around a circumference of the inner lumen of the steerable stylet.

45. The system of claim 43, wherein the at least three tendons are configured to be spaced unevenly around a circumference of the inner lumen of the steerable stylet.

46. The system of claim 1, wherein the system further comprises one or more control unit operably connected to the at least one steerable stylet controller.

47. The system of claim 46, wherein the one or more control unit is configured to control a relative axial alignment of the steerable stylet and / or the external sheath.

48. The system of claim 46, wherein the one or more control unit is configured to control a relative lateral alignment of the steerable stylet and / or the external sheath.

49. The system of claim 46, wherein the one or more control unit is configured to control a relative rotational alignment of the steerable stylet and / or the external sheath.

50. The system of claim 46, wherein the one or more control unit is configured to control an actuation of the at least one stiffening rods.

51. The system of claim 46, wherein the one or more control unit is configured to control a movement of the at least one tendon.

52. The system of claim 46, wherein the one or more control unit and / or the at least one steerable stylet controller is configured to manually and / or robotically actuate at least one stiffening rod.

53. The system of claim 1, wherein the at least one steerable stylet controller is configured to control a relative axial alignment of the steerable stylet and / or the external sheath via at least one actuation mechanism.

54. The system of claim 1, wherein the at least one steerable stylet controller is configured to control a relative lateral alignment of the steerable stylet and / or the external sheath via at least one actuation mechanism.

55. The system of claim 1, wherein the at least one steerable stylet controller is configured to control a relative rotational alignment of the steerable stylet and / or the external sheath via at least one actuation mechanism.

56. The system of claim 1, wherein the system further comprises one or more shape sensing elements.

57. The system of claim 56, wherein the one or more shape sensing elements is secured within at least a portion of the external sheath.

58. The system of claim 57, wherein the one or more shape sensing elements is configured to gather information related to the shape of the external sheath and / or steerable stylet.

59. The system of claim 58, wherein the information related to the shape of the external sheath and / or steerable stylet is configured to be control the motion of the external sheath and / or steerable stylet.

60. The system of claim 58, wherein the one or more shape sensing elements is configured to reduce the use of ionizing radiation.

61. The system of claim 58, wherein the one or more shape sensing elements is configured to guide an imaging plane when operating the system under ultrasound imaging modality and / or another imaging modality.

62. The system of claim 56, wherein the one or more shape sensing element is configured to be selected from at least one of the following: single core Bragg grating (FBG) fiber and / or multicore FBG fibers.

63. The system of claim 1, wherein the external sheath comprises a structure length and stiffness profile along the structure length.

64. The system of claim 63, wherein the stiffness profile along the structure length is configured to be uniform along the entire length.

65. The system of claim 63, wherein the external sheath comprises a first stiffness profile at one or more first portions along the length of the external sheath and one or more additional stiffness profiles at one or more additional portions along the length of the external sheath.

66. The system of claim 1, wherein the external sheath further comprises at least one articulating join disposed at a distal end of the external sheath.

67. The system of claim 66, wherein the at least one articulating joint is configured to be actuated via at least one actuation mechanism.

68. The system of claim 67, wherein, upon actuation, the at least one articulating join is configured to actively manipulate a tip of the external sheath.

69. The system of claim 66, wherein the at least one articulating joint defines a wall, wherein the wall defines a first inner lumen.

70. The system of claim 66, wherein the at least one articulating joint is configured to actively steer the external sheath.

71. The system of any one of claims 1-70, wherein an actuation of at least one stiffening rod is configured to cause one or more of radial expansion, radial compression, longitudinal expansion, longitudinal compression, or a combination thereof.

72. The system of any one of claims 1-70, wherein an actuation of at least one stiffening rod is one or more of a mechanical actuation, an electrical actuation, a magnet actuation, a thermal actuation, a fluid actuation, or a combination thereof.

73. A method for locking an external sheath, the method comprising: providing a system for locking an external sheath, the system comprising: a steerable stylet; an external sheath configured to removably house at least a portion of the steerable stylet; at least one stiffening rod configured to apply a modified stiffness profile to the external sheath and / or steerable stylet; at least one steerable stylet controller configured to control the movement of the steerable stylet and the external sheath in at least one dimension; a control unit operably connected to the at least one steerable stylet controller, causing at least one stiffening rod to be selectively actuated, wherein an actuation is configured to cause a modified stiffness profile to be applied at one or more locations along the length of the external sheath and / or steerable stylet.

74. The method of claim 73, wherein the steerable stylet comprises a structure length and a stiffness profile across the structure length.

75. The method of claim 73, wherein the external sheath is configured to be flexible.

76. The method of claim 73, wherein the external sheath defines a wall, wherein the wall defines a first inner lumen configured to removably house at least a portion of the steerable stylet.

77. The method of claim 73, wherein the external sheath further defines a second inner lumen, wherein the second inner lumen is disposed between the outermost surface of the wall and the innermost surface of the wall of the external sheath.

78. The method of claim 77, wherein the wall of the external sheath further defines one or more additional inner lumens, wherein the one or more additional inner lumens are disposedbetween the outermost surface of the wall and the innermost surface of the wall of the external sheath.

79. The method of claim 78, wherein the second inner lumen and / or the one or more additional inner lumens are disposed evenly around the circumference of the external sheath.

80. The method of claim 78, wherein the second inner lumen and / or the one or more additional inner lumens are disposed unevenly around the circumference of the external sheath.

81. The method of claim 78, wherein the at least one steerable stylet controller is configured to define a proximal end and a distal end.

82. The method of claim 81, wherein the system further comprises at least one stiffening rod anchor, wherein the at least one stiffening rod anchor is disposed at the distal end or the proximal end of the at least one steerable stylet controller.

83. The method of claim 82, wherein the system further comprises at least one stiffening rod, wherein the at least one stiffening rod is configured to secure to the at least one stiffening rod anchor.

84. The method of claim 83, wherein the at least one stiffening rod anchor is configured to actuate the at least one stiffening rod manually and / or automatically, wherein the at least one stiffening rod is configured to apply a modified stiffness profile along a length of the at least one stiffening rod.

85. The method of claim 84, wherein the at least one stiffening rod is configured to be actuated, wherein the at least one stiffening rod is configured to apply a modified stiffness profile to the external sheath and / or the steerable stylet.

86. The method of claim 85, wherein the modified stiffness profile applied by the at least one stiffening rod is configured to be different along the length of the at least one stiffening rod.

87. The method of claim 86, wherein the modified stiffness profile applied by the at least one stiffening rod is configured to be different along the length of the at least one stiffening rod.

88. The method of claim 87, wherein the modified stiffness profile of the at least one stiffening rod is configured to at least partially lock the external sheath and / or the steerable stylet in place.

89. The method of claim 88, wherein the steerable stylet is configured to be at least partially removed from the first inner lumen of the external sheath when the modified stiffness profile is applied, wherein the external sheath is configured to at least partially maintain a locked shape.

90. The method of claim 89, wherein the system further comprises one or more additional therapeutic device configured to be inserted into the first inner lumen of the external sheath.

91. The method of claim 90, wherein the one or more additional therapeutic device is configured to at least partially conform to the shape of the external sheath once in a predetermined location.

92. The method of claim 89, wherein the system further comprises one or more additional diagnostic device configured to be inserted into the first inner lumen of the external sheath.

93. The method of claim 92, wherein the one or more additional diagnostic device is configured to at least partially conform to the shape of the external sheath once in a predetermined location.

94. The method of claim 84, wherein the second inner lumen and / or the one or more additional inner lumens are configured to at least partially house the steerable stylet and / or at least one stiffening rod.

95. The method of claim 84, wherein the system is configured to have at least three stiffening rods, wherein the at least three stiffening rods are configured to apply a modified stiffness profile to the external sheath and / or steerable stylet in at least one dimension.

96. The method of claim 95, wherein one or more of the at least three stiffening rods are configured to be actuated to apply a modified stiffness profile to the external sheath and / or the steerable stylet, wherein the modified stiffness profile applied by the one or more of the at least three stiffening rods is configured to be at least one of: the same modified stiffness along the entire length of the one or more of the at least three stiffening rods or the modified stiffness profile is different at one or more portions along the length of one or more actuated stiffening rods.

97. The method of claim 95, wherein the modified stiffness profile is configured to at least partially lock the external sheath and / or the steerable stylet in place.

98. The method of claim 97, wherein the steerable stylet is configured to be at least partially removed from the first inner lumen of the external sheath when the modified stiffness profile is applied, wherein the external sheath is configured to at least partially maintain a locked shape.

99. The method of claim 98, wherein one or more additional therapeutic device and / or one or more additional diagnostic device is configured to be inserted into the first inner lumen of the external sheath.

100. The method of claim 99, wherein the one or more additional therapeutic device is configured to at least partially conform to the shape of the external sheath once in a predetermined location.

101. The method of claim 99, wherein the one or more additional diagnostic device is configured to at least partially conform to the shape of the external sheath once in a predetermined location.

102. The method of claim 96, wherein the at least three stiffening rods are disposed evenly around the circumference of the external sheath, wherein the at least three stiffening rods are configured to provide a modified stiffness in at least one dimension.

103. The method of claim 96, wherein the at least three stiffening rods are disposed unevenly around the circumference of the external sheath, wherein the at least three stiffening rods are configured to provide a modified stiffness in at least one dimension.

104. The method of claim 81, wherein the at least one steerable stylet controller is configured to actuate the at least one stiffening rod simultaneously, wherein the actuation of the at least one stiffening rod modifies a stiffness of the external sheath and / or steerable stylet.

105. The method of claim 81, wherein the at least one steerable stylet controller is configured to actuate the at least one stiffening rod individually, wherein the actuation of the at least one stiffening rod modifies a stiffness of the external sheath and / or steerable stylet.

106. The method of claim 73, wherein a wall of the external sheath defines a first inner lumen, wherein the first inner lumen is configured to define one or more additional inner lumens, wherein the one or more additional inner lumens are defined by the wall of the external sheath.

107. The method of claim 106, wherein the one or more additional inner lumens defined by the first inner lumen are configured to removably house at least a portion of the steerable stylet.

108. The method of claim 107, wherein the system further comprises at least one additional therapeutic device, wherein the at least one additional therapeutic device is housed at least partially within the one or more additional inner lumens defined by the first inner lumen of the external sheath.

109. The method of claim 107, wherein the system further comprises at least one additional diagnostic device, wherein the at least one additional diagnostic device is housed at least partially within the one or more additional inner lumens defined by the first inner lumen of the external sheath.

110. The method of claim 107, wherein the system further comprises at least one additional therapeutic device and / or at least one additional diagnostic device, wherein the at least one additional therapeutic device and / or at least one additional diagnostic device is housed at leastpartially within the one or more additional inner lumens defined by the first inner lumen of the external sheath.

111. The method of claim 73, wherein the steerable stylet comprises a wall defining an inner lumen.

112. The method of claim 111, wherein the system further comprises at least one tendon configured to assist with the movement of the steerable stylet and / or the external sheath.

113. The method of claim 112, wherein the at least one tendon is configured to be at least partially disposed within the inner lumen of the steerable stylet.

114. The method of claim 113, wherein the at least one tendon is configured to be spaced evenly around a circumference of the inner lumen of the steerable stylet.

115. The method of claim 113, wherein the at least one tendon is configured to be spaced unevenly around a circumference of the inner lumen of the steerable stylet.

116. The method of claim 112, wherein the system further comprises at least three tendons configured to assist with the movement of the steerable stylet and / or external sheath in three dimensions, wherein the at least three tendons are at least partially disposed within the inner lumen of the steerable stylet.

117. The method of claim 116, wherein the at least three tendons are configured to be spaced evenly around a circumference of the inner lumen of the steerable stylet.

118. The method of claim 116, wherein the at least three tendons are configured to be spaced unevenly around a circumference of the inner lumen of the steerable stylet.

119. The method of claim 73, wherein the system further comprises one or more control unit operably connected to the at least one steerable stylet controller.

120. The method of claim 119, wherein the one or more control unit is configured to control a relative axial alignment of the steerable stylet and / or the external sheath.

121. The method of claim 119, wherein the one or more control unit is configured to control a relative lateral alignment of the steerable stylet and / or the external sheath.

122. The method of claim 119, wherein the one or more control unit is configured to control a relative rotational alignment of the steerable stylet and / or the external sheath.

123. The method of claim 119, wherein the one or more control unit is configured to control an actuation of the at least one stiffening rods.

124. The method of claim 119, wherein the one or more control unit is configured to control a movement of the at least one tendon.

125. The method of claim 119, wherein the one or more control unit and / or the at least one steerable stylet controller is configured to manually and / or robotically actuate at least one stiffening rod.

126. The method of claim 73, wherein the at least one steerable stylet controller is configured to control a relative axial alignment of the steerable stylet and / or the external sheath via at least one actuation mechanism127. The method of claim 73, wherein the at least one steerable stylet controller is configured to control a relative lateral alignment of the steerable stylet and / or the external sheath via at least one actuation mechanism.

128. The method of claim 73, wherein the at least on steerable stylet controller is configured to control a relative rotational alignment of the steerable stylet and / or the external sheath via at least one actuation mechanism.

129. The method of claim 73, wherein the system further comprises one or more shape sensing elements.

130. The method of claim 129, wherein the one or more shape sensing elements may be secured within at least a portion of the external sheath.

131. The method of claim 130, wherein the one or more shape sensing elements is configured to gather information related to the shape of the external sheath and / or steerable stylet.

132. The method of claim 131, wherein the information related to the shape of the external sheath and / or steerable stylet is configured to be control the motion of the external sheath and / or steerable stylet.

133. The method of claim 131, wherein the one or more shape sensing elements is configured to reduce the use of ionizing radiation.

134. The method of claim 131, wherein the one or more shape sensing elements is configured to guide an imaging plane when operating the system under ultrasound imaging modality and / or another imaging modality.

135. The method of claim 129, wherein the one or more shape sensing element is configured to be selected from at least one of the following: single core Bragg grating (FBG) fiber and / or multicore FBG fibers.

136. The method of claim 73, wherein the external sheath comprises a structure length and stiffness profile along the structure length.

137. The method of claim 136, wherein the stiffness profile along the structure length is configured to be uniform along the entire length.

138. The method of claim 137, wherein the external sheath comprises a first stiffness profile at one or more first portions along the length of the external sheath and one or more additional stiffness profiles at one or more additional portions along the length of the external sheath.

139. The method of claim 73, wherein the external sheath further comprises an articulating join disposed at a distal end of the external sheath.

140. The method of claim 139, wherein the articulating joint is configured to be actuated via at least one actuation mechanism.

141. The method of claim 140, wherein upon actuating the articulating join is configured to active manipulation a tip of the external sheath.

142. The method of claim 139, wherein the articulating joint defines a wall, wherein the wall defines a first inner lumen.

143. The method of claim 139, wherein the articulating joint is configured to actively steer the external sheath.

144. The method of any one of claims 73-143, wherein an actuation of at least one stiffening rod is configured to cause one or more of radial expansion, radial compression, longitudinal expansion, longitudinal compression, or a combination thereof.

145. The method of any one of claims 73-143, wherein an actuation of at least one stiffening rod may be one or more of a mechanical actuation, an electrical actuation, a magnet actuation, a thermal actuation, a fluid actuation, or a combination thereof.

146. A method for positioning an external sheath, the method comprising: inserting an external sheath comprising a steerable stylet into a portion of a subject; guiding at least a portion of the external sheath with the steerable stylet; and positioning the external sheath to a desired location.

147. The method of claim 146, wherein the steerable stylet comprises a structure length and a stiffness profile across the structure length.

148. The method of claim 146, wherein the external sheath is configured to be flexible.

149. The method of claim 146, wherein the external sheath defines a wall, wherein the wall defines a first inner lumen and / or one or more additional inner lumens, wherein the first inner lumen and / or the one or more additional inner lumens are configured to removably house at least a portion of the steerable stylet.

150. The method of claim 149, wherein the method further comprising: actuating at least one stiffening rod, wherein the actuation of the at least one stiffening rod applies a modified stiffness profile to the external sheath and / or steerable stylet, wherein the modified stiffness profile locks the external sheath and / or steerable stylet in place.

151. The method of claim 150, wherein the method further comprising: removing the steerable stylet from the inner lumen of the external sheath, wherein the external sheath remains at least partially stationary.

152. The method of claim 151, wherein the method further comprising: inserting one or more additional therapeutic device into the inner lumen of the external sheath, wherein the one or more additional therapeutic device at least partially conforms to the locked external sheath shape.

153. The method of claim 152, wherein the method further comprising: removing the external sheath from the body, wherein the one or more additional therapeutic device remains at least partially stationary.

154. The method of claim 151, wherein the method further comprising: inserting one or more additional diagnostic device into the inner lumen of the external sheath, wherein the one or more additional diagnostic device at least partially conforms to the locked external sheath shape.

155. The method of claim 154, wherein the method further comprising: removing the external sheath from the body, wherein the one or more additional diagnostic device remains at least partially stationary.

156. The method of claim 146, wherein the system further comprises one or more control unit operably connected to the at least one steerable stylet controller.

157. The method of claim 156, wherein the one or more control unit is configured to control a relative axial alignment of the steerable stylet and / or the external sheath.

158. The method of claim 156, wherein the one or more control unit is configured to control a relative lateral alignment of the steerable stylet and / or the external sheath.

159. The method of claim 156, wherein the one or more control unit is configured to control a relative rotational alignment of the steerable stylet and / or the external sheath.

160. The method of claim 156, wherein the one or more control unit is configured to control an actuation of the at least one stiffening rods.

161. The method of claim 156, wherein the one or more control unit is configured to control a movement of the at least one tendon.

162. The method of claim 156, wherein the one or more control unit and / or the at least one steerable stylet controller is configured to manually and / or robotically actuate at least one stiffening rod.

163. The method of claim 146, wherein the at least one steerable stylet controller is configured to control a relative axial alignment of the steerable stylet and / or the external sheath via at least one actuation mechanism.

164. The method of claim 146, wherein the at least on steerable stylet controller is configured to control a relative lateral alignment of the steerable stylet and / or the external sheath via at least one actuation mechanism.

165. The method of claim 146, wherein the at least one steerable stylet controller is configured to control a relative rotational alignment of the steerable stylet and / or the external sheath via at least one actuation mechanism.

166. The method of any one of claims 146-165, wherein an actuation of at least one stiffening rod is configured to cause one or more of radial expansion, radial compression, longitudinal expansion, longitudinal compression, or a combination thereof.

167. The method of any one of claims 146-165, wherein an actuation of at least stiffening rod is one or more of a mechanical actuation, an electrical actuation, a magnet actuation, a thermal actuation, a fluid actuation, or a combination thereof.

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