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WO2025014808A1 - Systèmes et procédés de verrouillage de gaine flexible avec détection de forme intégrée - Google Patents

Systèmes et procédés de verrouillage de gaine flexible avec détection de forme intégrée Download PDF

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Publication number
WO2025014808A1
WO2025014808A1 PCT/US2024/036904 US2024036904W WO2025014808A1 WO 2025014808 A1 WO2025014808 A1 WO 2025014808A1 US 2024036904 W US2024036904 W US 2024036904W WO 2025014808 A1 WO2025014808 A1 WO 2025014808A1
Authority
WO
WIPO (PCT)
Prior art keywords
external sheath
steerable stylet
additional
steerable
inner lumen
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Pending
Application number
PCT/US2024/036904
Other languages
English (en)
Inventor
Jaydev P. Desai
Nancy J. DEATON
Pretesh R. PATEL
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Emory University
Georgia Tech Research Institute
Georgia Tech Research Corp
Original Assignee
Emory University
Georgia Tech Research Institute
Georgia Tech Research Corp
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Emory University, Georgia Tech Research Institute, Georgia Tech Research Corp filed Critical Emory University
Publication of WO2025014808A1 publication Critical patent/WO2025014808A1/fr
Anticipated expiration legal-status Critical
Pending legal-status Critical Current

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
    • A61M25/0102—Insertion or introduction using an inner stiffening member, e.g. stylet or push-rod
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/0043—Catheters; Hollow probes characterised by structural features
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
    • A61M25/0105—Steering means as part of the catheter or advancing means; Markers for positioning
    • A61M25/0133—Tip steering devices
    • A61M25/0144—Tip steering devices having flexible regions as a result of inner reinforcement means, e.g. struts or rods
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
    • A61M25/06—Body-piercing guide needles or the like
    • A61M25/0662—Guide tubes
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B34/00—Computer-aided surgery; Manipulators or robots specially adapted for use in surgery
    • A61B34/20—Surgical navigation systems; Devices for tracking or guiding surgical instruments, e.g. for frameless stereotaxis
    • A61B2034/2046—Tracking techniques
    • A61B2034/2061—Tracking techniques using shape-sensors, e.g. fiber shape sensors with Bragg gratings
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/0043—Catheters; Hollow probes characterised by structural features
    • A61M2025/0063—Catheters; Hollow probes characterised by structural features having means, e.g. stylets, mandrils, rods or wires to reinforce or adjust temporarily the stiffness, column strength or pushability of catheters which are already inserted into the human body
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
    • A61M25/0105—Steering means as part of the catheter or advancing means; Markers for positioning
    • A61M25/0133—Tip steering devices
    • A61M25/0147—Tip steering devices with movable mechanical means, e.g. pull wires

Definitions

  • 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.
  • External sheaths can be used in a variety of tasks such as for interventional procedures.
  • the non-steerable devices e.g., non-steerable diagnostic devices, non-steerable therapeutic devices
  • 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).
  • HDR high-dose-rate
  • 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.
  • 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).
  • the present invention systems and methods of an innovative system for providing locking control of a flexible external sheath.
  • the present invention is manually actuated, and in others, it automatically/robotically actuated.
  • 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.
  • the steerable stylet may comprise a structure length and a stiffness profile across the structure length.
  • the external sheath may be configured to be flexible.
  • 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.
  • 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.
  • 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.
  • 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.
  • the at least one steerable stylet controller may be configured to define a proximal end and a distal end.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • the system further may comprise one or more additional therapeutic device configured to be inserted into the first inner lumen of the external sheath.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • the at least three stiffening rods may be disposed evenly 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • the steerable stylet comprises a wall defining an inner lumen.
  • the system may further comprise at least one tendon configured to assist with the movement of the steerable stylet and/or the external sheath.
  • 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 various embodiments, 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.
  • the at least three tendons may be configured to be spaced unevenly around a circumference of the inner lumen of the steerable stylet.
  • the system may further comprise one or more control unit operably connected to the at least one steerable stylet controller.
  • the one or more control unit may be configured to control a relative axial alignment of the steerable stylet and/or the external sheath.
  • the one or more control unit may be configured to control a relative lateral alignment of the steerable stylet and/or the external sheath.
  • the one or more control unit may be configured to control a relative rotational alignment of the steerable stylet and/or the external sheath.
  • the one or more control unit may be configured to control an actuation of the at least one stiffening rods.
  • the one or more control unit may be configured to control a movement of the at least one tendon.
  • 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.
  • 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.
  • 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.
  • 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.
  • the system may further comprise one or more shape sensing elements.
  • the one or more shape sensing elements may be secured within at least a portion of the external sheath.
  • 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.
  • 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.
  • the one or more shape sensing elements may be configured to reduce the use of ionizing radiation.
  • 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.
  • 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.
  • the external sheath may comprise a structure length and stiffness profile along the structure length.
  • the stiffness profile along the structure length may be configured to be uniform along the entire length.
  • 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.
  • the external sheath may further comprise at least one articulating join disposed at a distal end of the external sheath.
  • the at least one articulating joint may be configured to be actuated via at least one actuation mechanism.
  • the at least one articulating join upon actuation, may be configured to actively manipulate a tip of the external sheath.
  • the at least one articulating joint may define a wall. The wall may define a first inner lumen.
  • the at least one articulating joint may be configured to actively steer the external sheath.
  • 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.
  • 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.
  • a method 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.
  • the steerable stylet may comprise a structure length and a stiffness profile across the structure length.
  • the external sheath may be configured to be flexible.
  • 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.
  • 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.
  • 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.
  • 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.
  • the at least one steerable stylet controller may be configured to define a proximal end and a distal end.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • the system further may comprise one or more additional therapeutic device configured to be inserted into the first inner lumen of the external sheath.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • the at least three stiffening rods may be disposed evenly 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • the steerable stylet comprises a wall defining an inner lumen.
  • the system may further comprise at least one tendon configured to assist with the movement of the steerable stylet and/or the external sheath.
  • 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 various embodiments, 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.
  • the at least three tendons may be configured to be spaced unevenly around a circumference of the inner lumen of the steerable stylet.
  • the system may further comprise one or more control unit operably connected to the at least one steerable stylet controller.
  • the one or more control unit may be configured to control a relative axial alignment of the steerable stylet and/or the external sheath.
  • the one or more control unit may be configured to control a relative lateral alignment of the steerable stylet and/or the external sheath.
  • the one or more control unit may be configured to control a relative rotational alignment of the steerable stylet and/or the external sheath.
  • the one or more control unit may be configured to control an actuation of the at least one stiffening rods.
  • the one or more control unit may be configured to control a movement of the at least one tendon.
  • 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.
  • 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.
  • 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.
  • 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.
  • the system may further comprise one or more shape sensing elements.
  • the one or more shape sensing elements may be secured within at least a portion of the external sheath.
  • 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.
  • 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.
  • the one or more shape sensing elements may be configured to reduce the use of ionizing radiation.
  • 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.
  • 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.
  • the external sheath may comprise a structure length and stiffness profile along the structure length.
  • the stiffness profile along the structure length may be configured to be uniform along the entire length.
  • 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.
  • the external sheath may further comprise at least one articulating join disposed at a distal end of the external sheath.
  • the at least one articulating joint may be configured to be actuated via at least one actuation mechanism.
  • the at least one articulating join may be configured to actively manipulate a tip of the external sheath.
  • the at least one articulating joint may define a wall. The wall may define a first inner lumen.
  • the at least one articulating joint may be configured to actively steer the external sheath.
  • 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.
  • 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.
  • a method 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.
  • the steerable stylet may comprise a structure length and a stiffness profile across the structure length.
  • the external sheath may be configured to be flexible.
  • 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.
  • the method may 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.
  • 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.
  • 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.
  • 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.
  • the system may further comprise one or more control unit operably connected to the at least one steerable stylet controller.
  • the one or more control unit may be configured to control a relative axial alignment of the steerable stylet and/or the external sheath.
  • the one or more control unit may be configured to control a relative lateral alignment of the steerable stylet and/or the external sheath.
  • the one or more control unit maybe configured to control a relative rotational alignment of the steerable stylet and/or the external sheath.
  • the one or more control unit may be configured to control an actuation of the at least one stiffening rods.
  • the one or more control unit may be configured to control a movement of the at least one tendon.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • FIG. 1A illustrates an exemplary system for steering an external sheath comprising a steerable stylet in accordance with various embodiments of the present disclosure.
  • FIG. IB illustrates an exemplary steerable stylet controller with a stiffening rod anchor in accordance with various embodiments of the present disclosure.
  • FIG. 1C illustrates an exemplary steerable stylet controller with a steerable portion in accordance with various embodiments of the present disclosure.
  • FIG. 2A illustrates an exemplary external sheath in accordance with various embodiments of the present disclosure.
  • 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.
  • 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.
  • FIG. 2D illustrates an exemplary external sheath in accordance with various embodiments of the present disclosure.
  • FIG. 2E illustrates an exemplary articulating joint in accordance with various embodiments of the present disclosure.
  • FIG. 2F illustrates an exemplary articulating joint in accordance with various embodiments of the present disclosure.
  • 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.
  • FIG. 3A illustrates an exemplary flow diagram of a method for locking an external sheath in accordance with various embodiments of the present disclosure.
  • FIG. 3B illustrates an exemplary flow diagram of a method for locking an external sheath in accordance with various embodiments of the present disclosure.
  • FIG. 4 illustrates a block diagram of an illustrative computer system architecture in accordance with various embodiments of the present disclosure.
  • 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.
  • the external sheath e.g., flexible external sheath
  • reference to a surgical operation is disclosed without loss of generality to the innovative features applicative to other systems.
  • the technological innovations are related to providing systems and methods of surgical operation control that overcome the limitations of the conventional systems and methods.
  • 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.
  • 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.
  • stiffible sheath As used herein, “flexible sheath,” “external sheath,” and “flexible external sheath” may be used interchangeably.
  • 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.
  • 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.
  • the one or more control units 20 may comprise at least a portion of a computing system (e.g., depicted in FIG. 4).
  • 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.
  • steering mechanism may utilize at least one pulley 12 to assist with movement of the steerable portion 200 of the system.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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 the steerable stylet of the steerable portion and to cause the steerable portion 200 to achieve a steering configuration.
  • 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.
  • 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.
  • 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.
  • 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).
  • 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.
  • 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.
  • 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).
  • 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 least a portion of the steerable portion 200.
  • 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.
  • 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.
  • 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.
  • FIGS. 2A-2G illustrate exemplary views of a steerable portion and components thereof in accordance with various embodiments of the present disclosure.
  • 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.
  • 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.).
  • the external sheath may comprise a cylindrical shape.
  • the external sheath may comprise any geometric shape (e.g., oval, elliptical, triangular, square, rectangular, etc.) needed to achieve a desired function.
  • the external sheath may comprise at least one material with at least one predetermined modulus of elasticity configured to achieve a desired function.
  • the external sheath may comprise two or more materials, such that the two or more materials have a different stiffness profile.
  • 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.
  • 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.
  • 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 the length.
  • 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.
  • 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.
  • the external sheath 202 may be an external enveloping sheath.
  • the external sheath may be configured to at least partially house a steerable stylet.
  • 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.
  • the external sheath 202 may comprise a polymer material, metal braided tubing, and/or the like.
  • the external sheath may comprise any material necessary to achieve a desired function.
  • the external sheath 202 may comprise a uniform stiffness profile along the entire length of the structure.
  • 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.
  • 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.
  • the external sheath 202 may comprise one or more stiffness profiles along one or more portions along the length of the external sheath 202.
  • 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.
  • 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.
  • the external sheath 202 may be anisotropic configured to offer variable resistance to axial motion, radial motion, transvers motion, or a combination thereof.
  • 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.
  • 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.
  • a first inner lumen 220 e.g., channel, hole, etc.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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).
  • 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.
  • 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 apertures 206 may be spaced evenly along the entire length of the steerable stylet.
  • 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.
  • 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.
  • 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.
  • actuation mechanism e.g., tendons, mechanical actuation, an electrical actuation, a magnet actuation, a thermal actuation, a fluid actuation, or a combination thereof
  • the first inner lumen 220 may be configured to house at least a portion of a steerable stylet 204.
  • 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.
  • 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.).
  • 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.
  • the steerable stylet 204 may comprise two 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.
  • 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.
  • 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.
  • 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.
  • the steerable stylet and the external sheath may comprise the same stiffness profile along the entire length, respectively.
  • 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.
  • 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.
  • 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.).
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.).
  • 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).
  • 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.
  • the tip 204A of the steerable stylet may be round and/or blunt.
  • 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.
  • the wall 202A of the external sheath 202 may be configured to define a second inner lumen.
  • the wall 202A of the external sheath 202 may further define one or more additional inner lumens.
  • 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.
  • 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.
  • 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.
  • at least one stiffening rod may be disposed within at least a portion of the second inner lumen and/or one or more additional inner lumens.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • the at least one stiffening rod may comprise a single stiffness profile along the entire length of the at least one stiffening rod.
  • 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.
  • the at least one stiffening rod may comprise a single stiffness profile along the entire length of the at least one stiffening rod.
  • 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.
  • a first stiffening rod and at least one additional stiffening rod may comprise a constant stiffness profile.
  • 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.
  • the at least one stiffening rod may comprise two or more stiffness profiles along the length of the at least one stiffening rod.
  • 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.
  • the at least one stiffening rod when actuated, 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.
  • 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.
  • one or more stiffening rods may comprise fundamentally different stiffnesses than one or more additional stiffening rods.
  • the at least one stiffening rods may comprise stiffness variation along the length of the stiffening rod.
  • 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.
  • 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.
  • 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.
  • 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.
  • the at least one stiffening rod may be actuated continuously for a predetermined amount of time.
  • 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.
  • 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 in one or more dimensions.
  • 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.
  • 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.
  • the at least one stiffening rod 21 ON may further comprise one or more shape sensing elements.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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 human body, within an animal body etc.).
  • 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.
  • 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.
  • the one or more stiffening rods 2 ION may be disposed evenly around the circumference of the external sheath 202.
  • the one or more stiffening rods 2 ION may be disposed unevenly around the circumference of the external sheath 202.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • FIGS. 2D-2F illustrate exemplary views of a steerable portion and components thereof in accordance with various embodiments of the present disclosure.
  • the steerable portion 200 may further comprise at least one articulating joint (depicted in FIGS. 2E- 2F).
  • the flexible sheath may comprise at least one articulating joint 214.
  • the at least one articulating joint 214 may be disposed at a distal end of the steerable portion 200.
  • 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).
  • the at least one articulating joint may define a wall, such that the wall can define a first inner lumen.
  • 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.
  • the at least one articulating joint 214 may be at least partially hallow.
  • 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.
  • 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.
  • 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.
  • 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.
  • the inner lumen of the at least one articulating joint may comprise a different circumference as the first inner lumen of the external sheath.
  • 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 house at least one tendon 208, at least one stiffening rod, one or more additional therapeutic devices, and/or one or more additional diagnostic devices.
  • the at least one articulating joint may further comprise one or more apertures 216 (e.g., notches, slits, slots, holes, joint, brace, etc.).
  • 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.
  • 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.
  • the one or more apertures 216 may be spaced evenly along the entire length of the at least one articulating joint 214.
  • 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.
  • 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.
  • 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/or individually to the at least one stiffening rod locking at least a portion of the external sheath in place.
  • FIG. 2G illustrates an exemplary steerable portion in a locked configuration in accordance with various embodiments of the present disclosure.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • the one or more additional therapeutic devices 230 and/or one or more additional diagnostic devices 230 may further comprise at least one fluid barrier 232. The at least one fluid barrier 232 may prevent any contamination of the radiation source when the external sheath is removed.
  • 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.
  • 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.
  • 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.
  • 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.
  • a subject may be a human and/or an animal.
  • the external sheath comprising the steerable stylet may be inserted into an incision made into a portion of the subject.
  • 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.
  • the external sheath comprising the steerable stylet may be inserted into one or more orifice of the subject.
  • 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.
  • 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.
  • At least one stiffening rod may be selectively actuated by the at least one stiffening rod anchor and/or one or more control units.
  • 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.
  • the one or more modified stiffness profile may lock the external sheath in the configuration and/or location.
  • 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.
  • 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.
  • 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.
  • the one or more additional therapeutic devices and/or one or more additional diagnostic devices may be inserted manually and/or robotically.
  • 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).
  • 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.
  • 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).
  • the external sheath may be at least partially removed from the subject.
  • 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.
  • 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.
  • the external sheath may be completely removed from the subject.
  • the computing device architecture 400 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.
  • the display interface 404 may be directly connected to a local display, such as a touchscreen display associated with a mobile computing device.
  • 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.
  • a desktop monitor may be utilized for mirroring graphics and other information that is presented on a mobile computing device.
  • 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.
  • 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.
  • 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.
  • the display interface 404 may be operatively coupled to a local display, such as a touch-screen display associated with a mobile device.
  • 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.
  • a desktop monitor may be utilized for mirroring or extending graphical information that may be presented on a mobile device.
  • 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.
  • the computing device architecture 400 may include a keyboard interface 406 that provides a communication interface to a keyboard.
  • 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.
  • the keyboard may be configured to control the movement of the external sheath and/or steerable stylet.
  • 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.
  • 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.
  • the input device may be an accelerometer, a magnetometer, a digital camera, a microphone, and an optical sensor.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • ROM read-only memory
  • 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.
  • the computing device architecture 400 includes a power source 430 that provides an appropriate alternating current (AC) or direct current (DC) to power components.
  • AC alternating current
  • DC direct current
  • 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.
  • RAID redundant array of independent disks
  • HD-DVD High-Density Digital Versatile Disc
  • HD-DVD High-Density Digital Versatile Disc
  • HDDS Holographic Digital Data Storage
  • DI MM mini-dual in-line memory module
  • SDRAM synchronous dynamic random-access memory
  • micro-DI MM SDRAM 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.
  • the term computing device may be a CPU, or conceptualized as a CPU (for example, the CPU 402 of FIG. 4).
  • the CPU may be coupled, connected, and/or in communication with one or more peripheral devices, such as display.
  • the term computing device may refer to a mobile computing device such as a smartphone, tablet computer, or smart watch.
  • the computing device may output content to its local display and/or speaker(s).
  • 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.
  • 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.
  • 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).
  • MRI magnetic resonance imaging
  • HDR high-dose-rate
  • BT brachytherapy
  • 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
  • the steering mechanism will allow the clinician to finely control the stylet insertion point (e.g., stylet tip).
  • the system will allow the clinician to manually push the stylet through the perineum if the clinician chooses to manually insert the stylet.
  • the stylet insertion through the perineum may be done robotically.
  • 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.
  • the steerable stylet could be made of Nitinol (NiTi) with outer diameter slightly less than the inner diameter of the external sheath.
  • the system could use at least one piezomotor as one or more actuators.
  • the at least one piezomotor may be packaged inside the steerable stylet.
  • 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.
  • 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.
  • 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.
  • FBG fiber Bragg grating
  • 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.
  • 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.
  • intrinsic shape sensing could also be used to guide the imaging plane when operating the system under ultrasound imaging modality.
  • 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.
  • the one or more 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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 and the steerable stylet.
  • MRI magnetic resonance imaging
  • ultrasound imaging environment to determine the overall configuration of the external sheath and steerable stylet.
  • 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.
  • 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.
  • 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.

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Abstract

L'invention concerne des systèmes et des procédés de verrouillage d'une gaine externe en place. Le système comprend un stylet orientable. Le système comprend en outre une gaine externe conçue pour loger de manière amovible au moins une partie du stylet orientable. Le système comprend également au moins un dispositif de commande de stylet orientable conçu pour commander le mouvement du stylet orientable et de la gaine externe dans au moins une dimension.
PCT/US2024/036904 2023-07-07 2024-07-05 Systèmes et procédés de verrouillage de gaine flexible avec détection de forme intégrée Pending WO2025014808A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US202363525454P 2023-07-07 2023-07-07
US63/525,454 2023-07-07

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WO2013026012A1 (fr) * 2011-08-18 2013-02-21 President And Fellows Of Harvard College Robot hybride en forme de serpent pour intervention minimalement invasive
US20180279994A1 (en) * 2017-03-30 2018-10-04 Alan Schaer Medical tool positioning devices, systems, and methods of use and manufacture
US20210308423A1 (en) * 2018-10-29 2021-10-07 Canon U.S.A., Inc. Support structure for medical apparatus and method of manufacturing same

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US20070287992A1 (en) * 2006-06-13 2007-12-13 Intuitive Surgical, Inc. Control system configured to compensate for non-ideal actuator-to-joint linkage characteristics in a medical robotic system
WO2013026012A1 (fr) * 2011-08-18 2013-02-21 President And Fellows Of Harvard College Robot hybride en forme de serpent pour intervention minimalement invasive
US20180279994A1 (en) * 2017-03-30 2018-10-04 Alan Schaer Medical tool positioning devices, systems, and methods of use and manufacture
US20210308423A1 (en) * 2018-10-29 2021-10-07 Canon U.S.A., Inc. Support structure for medical apparatus and method of manufacturing same

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