Guiding sheath with distal tip locator

Abstract

A guide sheath having a hemostasis valve and a central lumen into which a diagnostic or therapeutic catheter can be introduced and guided into a patient. The hemostasis valve further includes a conductive or proximity sensing element on its proximal end that interacts with a second conductive or proximity sensing element on the proximal end of the diagnostic or therapeutic catheter that can pass through the central lumen of the guide sheath and into the heart of the patient. Interaction between the two conductive or proximity sensing elements enables positioning of the distal end of the diagnostic or therapeutic catheter in the heart of the patient without the need to irradiate the patient.

Description

Technical Field

[0001] This invention relates to a guide sheath particularly suitable for guiding electrophysiological catheters, especially a guide sheath with a distal end positioner. Background Technology

[0002] In medical protocols involving a patient's heart, there are numerous diagnostic and therapeutic procedures, including transseptal left atrial catheterization, which involves inserting a catheter through the left atrium. The transseptal approach provides access for both interventional cardiologists performing antegrade mitral balloon valvuloplasty and cardiac electrophysiologists performing left accessory pathway ablation or transcatheter atrial fibrillation treatment strategies. These strategies are often used in conjunction with a guiding sheath.

[0003] As is well known, guiding sheaths are used to facilitate access for diagnostic or therapeutic catheters. Catheterization in the human heart typically requires the catheter to be inserted into the ventricle via the femoral vein. To provide flexibility in movement, guiding sheaths (much like the catheter passing through them) can be manipulated or deflected using one or more traction lines to improve operability within the patient's vascular system.

[0004] Therefore, a guide sleeve with improved deflection characteristics and smoother operation in the deflection mechanism of the control handle is desired.

[0005] Additionally, many physicians use fluoroscopy during these procedures to perform transseptal punctures. Fluoroscopy is used because physicians need to know the location of the distal end of a diagnostic or therapeutic catheter (such as a dilator) within the heart. The end of the dilator is the part of the system that is first inserted (e.g., with a needle) into the left atrium. Fluoroscopy is not ideal due to radiation exposure. Therefore, a radiation-free method is needed to locate the distal end of the diagnostic or therapeutic catheter (e.g., a dilator) at the transseptal puncture site. Summary of the Invention

[0006] This invention provides a method for locating the distal end of a diagnostic or therapeutic catheter without the use of radiation. To perform this method, a guide sheath may be configured to interact with the diagnostic or therapeutic catheter to provide confirmation of full engagement between the catheter and the guide sheath. For example, but not limited to, this confirmation can be provided by adding a conductive element or other proximity sensing element to each of the guide sheath and the diagnostic or therapeutic catheter, which completes the circuitry and provides visual or audible confirmation of contact when they come into contact with each other. These conductive elements or proximity sensing elements are located at the proximal end of the guide sheath and the diagnostic or therapeutic catheter (i.e., closer to the operator).

[0007] Another example could be a hemostatic valve on the proximal end of a control handle having a first proximity sensing element configured to interact with a second proximity sensing element on the proximal end of a diagnostic or therapeutic catheter. The proximity sensing elements can detect their proximity to each other using electrical, optical, physical, and magnetic sensing methods.

[0008] An exemplary guide sleeve assembly may include an elongated shaft and a control handle located proximal to the shaft, the control handle having a longitudinal axis. The control handle may include a rotatable shaft, a pinion, and a first shuttle and a second shuttle. The shaft may be configured to rotate about the longitudinal axis. The first shuttle may be configured to translate in one direction along the longitudinal axis in response to rotation of the rotatable shaft, and the first shuttle may have a first plurality of teeth. The pinion may engage with the first plurality of teeth and is configured to rotate about an axis substantially perpendicular to the longitudinal axis in response to translation of the first shuttle. The second shuttle may have a second plurality of teeth engaging with the pinion and may be configured to translate along the longitudinal axis in an opposite direction to the first direction in response to rotation of the pinion. The guide sleeve assembly may also have a first pull line and a second pull line, the first pull line extending along one side of the shaft and having a proximal portion at least responsive to translation of the first shuttle in the proximal direction, and the second pull line extending along the other side of the shaft and having a proximal portion at least responsive to translation of the second shuttle in the proximal direction.

[0009] The control handle may also include a hemostatic valve and a central lumen, configured to interact with a diagnostic or therapeutic catheter. The control handle and the diagnostic or therapeutic catheter may include conductive elements or proximity sensing elements configured to indicate engagement of the diagnostic or therapeutic catheter with the control handle. In one example, the conductive element or proximity sensing element may be located on the surface of both the hemostatic valve and the diagnostic or therapeutic catheter. In another example, the conductive element or proximity sensing element may be located on the surface of both the control handle distal to the hemostatic valve and the diagnostic or therapeutic catheter.

[0010] The control handle may include a control knob, and the rotatable shaft may be configured to rotate in response to rotation of the control knob.

[0011] The rotatable shaft may have an internal channel configured to receive a first distal portion of the first shuttle and a second distal portion of the second shuttle.

[0012] The first and second distal portions can be configured to form a cylindrical shape when the first and second shuttles are laterally aligned with each other along the longitudinal axis.

[0013] The inner surface of the internal channel may be threaded, and the outer surface of the first distal portion may be threaded and engage with the inner surface.

[0014] The rotating shaft is rotatably and translationally connected to the control knob.

[0015] The rotating shaft can be rotatably connected to the control knob via a longitudinal ridge formed on the outer surface of the shaft.

[0016] The rotating shaft can be rotatably connected to the control knob by a pin extending through a portion of the control knob and a slot formed in the rotating shaft.

[0017] The rotating shaft is rotatably and translationally connected to the control knob at its distal end.

[0018] The control handle may include a neutral indicator.

[0019] The neutral indicator may include a first component on a first shuttle and a second component on a second shuttle, wherein the first and second components are configured for releasable engagement.

[0020] The neutral indicator can be configured to provide resistance to disengagement and re-engagement.

[0021] The first neutral indicator may include a tapered protrusion, and the second neutral indicator includes a tapered recess.

[0022] The following discussion of examples of conductive elements on hemostatic valves, including control handles that interact with conductive elements on diagnostic or therapeutic catheters, is for illustrative purposes only and does not limit the location of conductive elements to hemostatic valves, nor does it exclude the use of proximity sensing elements.

[0023] In one example, an outward-facing first conductive element on a control handle (e.g., on the surface of a hemostatic valve or on the surface of a control handle distal to the hemostatic valve) may interact with an inward-facing second conductive element on the surface of a diagnostic or therapeutic catheter. In another example, an inward-facing first conductive element on a control handle (e.g., on the surface of a hemostatic valve or on the surface of a control handle distal to the hemostatic valve) may interact with an outwardly projecting element on the surface of a diagnostic or therapeutic catheter.

[0024] In one example, the hemostatic valve may include a first conductive element on the proximal end of a control handle, which completes the circuitry with a second conductive element on the proximal end of a diagnostic or therapeutic catheter.

[0025] The proximal end of the control handle may include at least one first conductive element that protrudes outward (e.g., away from the central lumen of the control handle, such as toward the outer surface of the hemostatic valve) or inward (e.g., toward the central lumen of the control handle) and completes circuitry with at least one second conductive element on the proximal end of the diagnostic or therapeutic catheter. The at least one second conductive element may be configured to interact with either the outwardly protruding first conductive element (e.g., the second conductive element may protrude outward or inward from the surface of the diagnostic or therapeutic catheter to complete circuitry with the outwardly protruding first conductive element located on the outer surface of the hemostatic valve) or the inwardly protruding first conductive element (e.g., the second conductive element is located on or proximal to the surface of the diagnostic or therapeutic catheter) to complete circuitry with the inwardly protruding first conductive element protruding into the central lumen of the control handle.

[0026] In one example, an outward-facing first conductive element on the distal end of the control handle and hemostatic valve can interact with an inward-facing second conductive element on the surface of the diagnostic or therapeutic catheter. In another example, the inward-facing first conductive element on the control handle can interact with an outward-projecting element on the surface of the diagnostic or therapeutic catheter.

[0027] In one example, the control handle may include a first conductive element at the distal end of the hemostatic valve of the control handle, the first conductive element completing the circuit with a second conductive element at the proximal end of the diagnostic or therapeutic catheter.

[0028] The proximal end of the control handle may include at least one first conductive element, which is distal to the hemostatic valve and protrudes outward (e.g., away from the central lumen of the control handle) or inward (e.g., toward the central lumen of the control handle), and completes circuitry with at least one second conductive element on the proximal end of the diagnostic or therapeutic catheter. The at least one second conductive element may be configured to interact with either the outwardly protruding first conductive element (e.g., the second conductive element may protrude outward or inward from the surface of the diagnostic or therapeutic catheter to complete circuitry with the outwardly protruding first conductive element located distal to the hemostatic valve) or the inwardly protruding first conductive element (e.g., the second conductive element is located on or proximal to the surface of the diagnostic or therapeutic catheter) to complete circuitry with the inwardly protruding first conductive element protruding into the central lumen of the control handle.

[0029] In one example, a plurality of first conductive elements protrude radially from a control handle, either outwardly on the outer surface of the hemostatic valve or inwardly toward the central lumen of the control handle, and are configured to form a circuit with a plurality of second conductive elements that protrude radially outwardly from the surface of the diagnostic or therapeutic catheter to interact with the first conductive elements on the outer surface of the hemostatic valve or with the first conductive elements protruding inwardly toward the central lumen of the control handle. In one example, the first conductive elements are present on the outer surface of the hemostatic valve, and the second conductive elements are present on a portion of the diagnostic or therapeutic catheter configured to cover the outer surface of the hemostatic valve.

[0030] At least one first conductive element and at least one second conductive element may comprise a set of contacts or may be a single contact. The control handle may include two or more first conductive elements, which may be equally spaced (e.g., symmetrically spaced) or asymmetrically spaced. For example, two first conductive elements may be spaced 180 degrees apart or located on opposite sides of the control handle, or they may be spaced 90 degrees apart. Where it is not desired to be bound by theory, increased spacing between the contacts may reduce the risk of short circuits in the conductive elements, for example, due to splashes from saline, blood, or other fluids. Additionally, asymmetrically positioning the contacts may help avoid incorrect mating between the control handle and the diagnostic or therapeutic catheter (i.e., only one possible mating orientation), optionally including combinations with other proximity sensing elements or interaction elements.

[0031] At least one first conductive element and the second conductive element may include portions of the element that have been cleaned or wiped of liquid from their contact surfaces before they interact.

[0032] The at least one first conductive element may be in the form of a pin or a socket. The at least one second conductive element may be in the form of a socket or a pin, selected to interact with the at least one first conductive element (e.g., if the first conductive element is a pin, then the second conductive element is a socket). The pin and / or socket may be coated with a polymer to allow the connected pin and socket to be sealed (i.e., liquid-tight) once the pin and socket are fully interacting. The socket may include an outlet or orifice to allow fluid to be expelled from the socket when the pin is introduced into it. Each pin and / or socket may include multiple conductive elements such that a single pin and socket pair can provide multiple electrical connections. A protective element may at least partially surround the pin to prevent it from bending.

[0033] Either the first conductive element or the second conductive element discussed herein may be combined with any of the proximity sensing elements, neutral indicators, visual indicators, and / or auditory indicators discussed herein.

[0034] The circuit can be configured to provide a visual or auditory indicator upon completion of the circuit. The visual or auditory indicator can be provided to a system configured to interact with the guide sleeve assembly.

[0035] Diagnostic or therapeutic catheters may include dilators, transseptal needles, mapping catheters, and / or ablation catheters.

[0036] Another exemplary guide sleeve assembly may include an elongated shaft and a control handle located proximal to the shaft. The control handle may have a longitudinal axis and may include a control knob configured to rotate about the longitudinal axis and a hollow rotatable shaft configured to rotate about the longitudinal axis in response to rotation of the control knob. The control handle may also include a first shuttle configured to translate along the longitudinal axis in one direction in response to rotation of the rotatable shaft, and the first shuttle may have a first plurality of teeth and a pinion engaging with the first plurality of teeth. The pinion may be configured to rotate about an axis substantially perpendicular to the longitudinal axis in response to translation of the first shuttle. The control handle may include a second shuttle having a second plurality of teeth engaging with the pinion, and the second shuttle being configured to translate along the longitudinal axis in an opposite direction in response to rotation of the pinion. The guide sheath assembly may further include a first traction wire and a second traction wire, the first traction wire extending along one side of the axis and having a proximal portion responsive to translation of a first shuttle member in a proximal direction, and the second traction wire extending along the other side of the axis and having a proximal portion responsive to translation of a second shuttle member in a proximal direction. The control handle may also include a hemostatic valve and a central lumen configured to interact with a diagnostic or therapeutic catheter. The control handle and the diagnostic or therapeutic catheter may include a conductive element configured to indicate engagement of the diagnostic or therapeutic catheter with the control handle.

[0037] In some embodiments, a control handle for controlling the deflection of a medical guide sheath shaft includes: a control knob configured to rotate about a longitudinal axis of the control handle; and a hollow rotatable shaft configured to rotate about the longitudinal axis in response to rotation of the control knob. The control handle also includes a first shuttle configured to translate along the longitudinal axis in one direction in response to rotation of the rotatable shaft, wherein the first shuttle may have a first plurality of teeth. The control handle may further include a pinion engaging the first plurality of teeth, wherein the pinion may be configured to rotate about an axis substantially perpendicular to the longitudinal axis in response to translation of the first shuttle. The control handle may further include a second shuttle having a second plurality of teeth engaging the pinion, and the second shuttle may be configured to translate along the longitudinal axis in the opposite direction to the first direction in response to rotation of the pinion, wherein the first and second shuttles may be configured to act on a first and a second traction line extending along the guide sheath shaft, respectively. The control handle may also include a hemostatic valve and a central lumen, configured to interact with a diagnostic or therapeutic catheter. The control handle and the diagnostic or therapeutic catheter may include conductive elements configured to indicate engagement of the diagnostic or therapeutic catheter with the control handle when these elements contact each other and complete a circuit.

[0038] In some implementations, the distal ends of the first and second shuttles may extend into the proximal portion of the rotatable shaft.

[0039] In some implementations, the inner surface of the rotatable shaft may be threaded, and the outer surface of the first shuttle may be threaded, for rotatably connecting the rotatable shaft and the first shuttle.

[0040] In some implementations, the first shuttle can respond directly to the rotation of the rotatable shaft, and the second shuttle can respond directly to the rotation of the pinion. Attached Figure Description

[0041] These and other features and advantages of the invention will be better understood when considered in conjunction with the accompanying drawings and by referring to the following detailed description. It should be understood that some of the selected structures and features are not shown in some of the drawings in order to provide a better view of the remaining structures and features.

[0042] Figure 1 This is a top plan view of a guide sleeve including a control handle according to one embodiment of the present disclosure.

[0043] Figure 2 yes Figure 1 A longitudinal cross-sectional view of the control handle.

[0044] Figure 3 yes Figure 1 An exploded view of the control handle with the housing removed.

[0045] Figure 4 yes Figure 1 A longitudinal cross-sectional view of the distal portion of the control handle, including the control knob.

[0046] Figure 5 yes Figure 1 A perspective view of the control handle with the housing removed.

[0047] Figure 6A This is a top plan view of a neutral indicator having a first and a second component joined according to one embodiment of the present disclosure.

[0048] Figure 6B yes Figure 6A A top view of the neutral indicator in which the first and second components are detached.

[0049] Figure 7A Components of a system including a control handle according to various aspects of the present invention are shown.

[0050] Figure 7B It shows Figure 7A A close-up view of region 7B in the figure shows an alternative proximity sensing system according to various aspects of the invention.

[0051] Figure 8 This is an example of a system including a control handle as described herein, which is used to perform a method for performing trans-septal perforation according to various aspects of the invention.

[0052] Figure 9 A magnified example of the hemostatic valve and the transseptal needle before full insertion is shown.

[0053] Figure 10 A magnified example of the hemostatic valve and the transseptal needle with full insertion is shown.

[0054] Figure 11 A cross-section of another embodiment of the guide sleeve including a control handle according to one embodiment of the invention is shown.

[0055] Figure 12 A top view of another embodiment of the control handle is shown, the control handle having an outward-facing first conductive element located on the outer surface of the hemostatic valve, and a diagnostic or therapeutic catheter including a protrusion that interacts with the hemostatic valve and a second conductive element positioned on the protrusion to complete a circuit with the first conductive element.

[0056] Figures 13A to 13B An embodiment of a first conductive element and a second conductive element in the form of a pin and a socket is shown. Figure 13A The left panel shows a possible interaction between a first conductive element and a second conductive element, wherein the first conductive element is in the form of a socket on the outer surface of a hemostatic valve, and the second conductive element is in the form of a pin protruding outward from a diagnostic or therapeutic catheter. Figure 13A The right panel shows a schematic diagram of this interaction. Figure 13B A schematic diagram of a pin and socket interaction is shown, wherein each pin and socket has multiple conductive parts that interact to form a circuit when the pin and socket are fully engaged. The socket includes an outlet or orifice for the drainage of liquid or fluid caused by the introduction of the pin.

[0057] Figures 14A to 14B An embodiment of the first conductive element located on the control handle distal to the hemostatic valve is shown. Figure 14A The possible interaction between a first conductive element located on the control handle distal to the hemostatic valve and a second conductive element located on the protrusion of a diagnostic or therapeutic catheter is shown. Figure 14B The possible interaction between a first conductive element on a control handle located distal to a hemostatic valve and a second conductive element located on a diagnostic or therapeutic catheter is shown. Detailed Implementation

[0058] As used herein, the term “about” or “approximately” for any numerical value or range indicates a suitable dimensional tolerance that allows a collection of parts or components to achieve the intended purpose as described herein. More specifically, “about” or “approximately” can refer to a range of values ​​±20% of the listed values; for example, “about 90%” can refer to a range of values ​​from 71% to 99%.

[0059] As used herein, the terms “component,” “module,” “system,” “server,” “processor,” “memory,” etc., are intended to include one or more computer-related units, such as, but not limited to, hardware, firmware, a combination of hardware and software, software, or software in execution. For example, a component can be, but is not limited to, a processor, an object, an executable file, an execution thread, a program, and / or a process running on a computer. By way of example, both an application running on a computing device and the computing device itself can be components. One or more components may reside within a process and / or an execution thread, and components may be located on a single computer and / or distributed across two or more computers. Furthermore, these components may be executed by various computer-readable media on which various data structures are stored. Components may communicate via local and / or remote processes, such as data from a component interacting with a local system, another component in a distributed system, and / or other systems via a network such as the Internet, according to signals having one or more data packets. The computer-readable medium may be non-transitory. Non-transitory computer-readable media include, but are not limited to, random access memory (RAM), read-only memory (ROM), electrically erasable programmable ROM (EEPROM), flash memory or other memory technologies, optical disc ROM (CD-ROM), digital versatile optical disc (DVD) or other optical storage devices, magnetic tape cassettes, magnetic tapes, disk storage devices or other magnetic storage devices, or any other tangible physical medium that can be used to store computer-readable instructions and / or data.

[0060] As used herein, the term "computing system" is intended to include a standalone machine or device and / or a combination of machines, components, modules, systems, servers, processors, memory, detectors, user interfaces, computing device interfaces, network interfaces, hardware elements, software elements, firmware elements, and other computer-related units. By way of example, and not limitation, a computing system may include one or more of a general-purpose computer, a special-purpose computer, a processor, a portable electronic device, a portable electronic medical device, a fixed or semi-fixed electronic medical device, or other electronic data processing equipment.

[0061] As used herein, the term “non-transitory computer-readable medium” includes, but is not limited to, random access memory (RAM), read-only memory (ROM), electrically erasable programmable ROM (EEPROM), flash memory or other memory technologies, optical disc ROM (CD-ROM), digital versatile optical disc (DVD) or other optical storage devices, magnetic tape cassettes, magnetic tape, disk storage devices or other magnetic storage devices, or any other tangible physical medium that can be used to store computer-readable information.

[0062] refer to Figure 1In some embodiments of the invention, the guide sheath assembly 10 includes an elongated and flexible sheath 12 and a control handle 16 located proximal to the sheath 12. The sheath 12 includes a proximal segment 13 and a distal deflection segment 14. The control handle 16 can be connected to an electrical connection 17 for transmitting electrical signals, such as those sensed by one or more annular electrodes 19 carried on the sheath 12, including, for example, the deflection segment 14. A hemostatic valve 18 is also attached to the control handle 16, such as... Figure 1 As shown, this hemostatic valve is suitable for receiving diagnostic or therapeutic catheters (in... Figure 7A , Figure 7B and Figure 8 (Shown as 750), the diagnostic or therapeutic catheter can advance through the hemostatic valve 18 and the guide sheath assembly 10 ( Figure 1 and Figure 2 ) and control handle 16 ( Figure 1 and Figure 2 The hemostatic valve 18 also has a side port 21 terminating at a Luer connector, such as a bidirectional stop valve 22 for connection to one or more fluid sources (not shown) for supplying fluid into and through the valve cover 20 of the guide sheath assembly 10. The proximal end 23 of the hemostatic valve 18 also has a conductive element 24a configured to interact with another conductive element 24b located on the proximal end of the diagnostic or therapeutic catheter 750 to indicate engagement of the diagnostic or therapeutic catheter 750 with the hemostatic valve 18. This engagement completes the circuitry between the proximal end 23 of the hemostatic valve 18 and the proximal end of the diagnostic or therapeutic catheter 750. This engagement can be provided by... Figure 8 The computer system shown uses visual or auditory signals to indicate this.

[0063] like Figure 12As shown, the proximal end of the control handle may include at least one first conductive element 24a, which protrudes outward (e.g., away from the central lumen of the control handle, such as toward the outer surface of the hemostatic valve) or inward (e.g., toward the central lumen of the control handle) and completes circuitry with at least one second conductive element 24b on the proximal end of the diagnostic or therapeutic catheter. The at least one second conductive element 24b may be configured to interact with either the outwardly protruding first conductive element 24a (e.g., the second conductive element 24b may protrude outward or inward from the surface of the diagnostic or therapeutic catheter to complete circuitry with the outwardly protruding first conductive element 24a located on the outer surface of the hemostatic valve) or the inwardly protruding first conductive element 24a (e.g., the second conductive element 24b is located on or proximal to the surface of the diagnostic or therapeutic catheter) to complete circuitry with the inwardly protruding first conductive element 24a protruding into the central lumen of the control handle. In one example, a plurality of first conductive elements 24a protrude radially from a control handle, either outwardly on the outer surface of the hemostatic valve or inwardly toward the central lumen of the control handle, and are configured to form a circuit with a plurality of second conductive elements 24b, which protrude radially outward from the surface of the diagnostic or therapeutic catheter to interact with the first conductive elements 24a on the outer surface of the hemostatic valve or with the first conductive elements 24a protruding inward toward the central lumen of the control handle. In one example, the first conductive elements 24a are present on the outer surface of the hemostatic valve, and the second conductive elements 24b are present on a portion 24c of the diagnostic or therapeutic catheter configured to cover or interact with the outer surface of the hemostatic valve, such as... Figure 12 As shown in the image.

[0064] At least one first conductive element 24a and at least one second conductive element 24b may comprise a set of contacts or may be a single contact. The control handle may include two or more first conductive elements 24a, which may be equally spaced (e.g., symmetrically spaced) or asymmetrically spaced. For example, two first conductive elements 24a may be spaced 180 degrees apart or located on opposite sides of the control handle, or they may be spaced 90 degrees apart.

[0065] One or both of at least one first conductive element 24a and at least one second conductive element 24b may include portions of the contact surfaces of the elements that have been cleaned or wiped of liquid before they interact.

[0066] At least one first conductive element 24a may be in the form of a pin or a socket. For example... Figure 13AAs shown, at least one second conductive element 24b may be in the form of a socket or pin, selected to interact with at least one first conductive element 24a (e.g., if the first conductive element 24a is a pin, then the second conductive element 24b is a socket). The pin and / or socket may be coated with a polymer to allow the connected pin and socket to be sealed (i.e., liquid-tight) once they are fully interacting. Figure 13B As shown, the socket may include an outlet or hole 1301 to allow fluid 1303 to be expelled from the socket when a pin is introduced into the socket. Each pin and / or socket may include multiple conductive portions 1302 such that a single pin and socket pair can provide multiple electrical connections. A protective element may at least partially surround the pin to prevent it from bending.

[0067] like Figures 14A to 14B As shown, the first conductive element may be located at the distal end of the hemostatic valve. The surface 800 of the control handle on the distal side of the hemostatic valve may include at least one first conductive element 24a, which is as follows: Figure 14A The outward protrusion shown (e.g., away from the central lumen of the control handle, such as towards the outer surface of the hemostatic valve) or as Figure 14B The inwardly projecting element (e.g., toward the central lumen of the control handle) and at least one second conductive element 24b on the proximal end of the diagnostic or therapeutic catheter completes circuitry. The at least one second conductive element 24b may be configured to interact with either an outwardly projecting first conductive element 24a (e.g., the second conductive element 24b may project outwardly or inwardly from the surface of the diagnostic or therapeutic catheter to complete circuitry with an outwardly projecting first conductive element 24a on the surface 800 of the control handle located distal to the hemostatic valve) or an inwardly projecting first conductive element 24a (e.g., the second conductive element 24b is located on or near the surface of the diagnostic or therapeutic catheter) to complete circuitry with the inwardly projecting first conductive element 24a protruding into the central lumen of the control handle. In one example, a plurality of first conductive elements 24a protrude radially from the distal surface 800 of the control handle, either outwardly on the outer surface of the hemostatic valve or inwardly toward the central lumen of the control handle, and are configured to form a circuit with a plurality of second conductive elements 24b, which protrude radially outwardly from the surface of the diagnostic or therapeutic catheter to interact with the first conductive elements 24a on the surface 800 of the control handle distal to the hemostatic valve, or with the first conductive elements 24a protruding inwardly toward the central lumen of the control handle on the surface 800 of the control handle distal to the hemostatic valve. In one example, the first conductive elements 24a are present on the surface 800 of the control handle distal to the hemostatic valve, and the second conductive elements 24b are present on the portion 24c of the diagnostic or therapeutic catheter configured to cover or interact with the surface 800 of the control handle distal to the hemostatic valve, such as... Figure 14A As shown in the image.

[0068] Either the first conductive element 24a or the second conductive element 24b discussed herein may be combined with any of the proximity sensing elements, neutral indicators, visual indicators, and / or auditory indicators discussed herein.

[0069] The diagnostic or therapeutic catheter 750 described herein may include (e.g., but not limited to) dilators, transseptal needles, mapping catheters, and / or ablation catheters.

[0070] like Figure 2 and Figure 3 As shown, the control handle 16 includes an elongated, generally cylindrical body 24 with a narrower distal portion or rod 25, and a distal rotary control knob 26 mounted on the distal portion of the rod 25. The body 24 has a semi-shell member formed to define an internal volume V and whose edges 51 meet along a longitudinal seam. The distal rod 25 of the body has a smaller outer diameter D1 than the outer diameter D2 of the proximal portion of the body 24. The control knob 26 is configured to be rotated by the user's thumb and forefinger when the user grips the body 24 of the control handle 16. In order to enable the deflection segment 14 of the guide sheath 12 to be deflected via a first pull line 30A and a second pull line 30B, the control handle 16 includes a rotatable shaft 31, a first shuttle member 32A and a second shuttle member 32B, and a pinion 34 in its internal volume V. The rotatable shaft 31 responds to a control knob 26 that drives the first shuttle 32A to move linearly along the longitudinal axis 55 in a first direction, and a pinion 34 connects the second shuttle 32B to the first shuttle 32A, such that the second shuttle 32B moves linearly along the longitudinal axis in a second direction opposite to the first direction. The proximal ends of the first pull line 30A and the second pull line 30B are respectively anchored to or at least connected to the first shuttle 32A and the second shuttle 32B. The connection and opposite translational movement of the first shuttle and the second shuttle actuate the first pull line and the second pull line to guide the bidirectional deflection of the deflection segment 14 of the sheath 12.

[0071] The rotatable shaft 31 has: a main proximal segment 36 with an outer diameter D3, a shorter distal segment 37 with an outer diameter D4, and a stepped joint J between segments 36 and 37. In the illustrated embodiment, diameter D3 is larger than diameter D4; however, it should be understood that the two diameters may generally be equal or diameter D4 may be larger than diameter D3. Figure 2As can be better seen, the rotatable shaft 31 is positioned relative to the body 24 of the control handle 16 such that its proximal segment 36 extends through both the body 24 and the distal rod 25 of the control handle 16, and passes through the distal end of the distal rod 25, wherein the connector J and the distal segment 37 are located distal to the distal rod 25 of the body 24, such that the distal segment 37 is not surrounded by the distal rod 25. The rotatable shaft 31 is connected to and secured to the body 24 at its proximal end by a proximal outer circumferential lip 38, which engages with an inner circumferential slot defined between circumferential flanges 40 formed in the internal volume V of the body 24.

[0072] refer to Figure 4 The rotatable shaft 31 is hollow and has an internal channel 42. The channel 42 communicates with a distal inlet 44, the diameter of which is only slightly larger than the diameter of the guide sleeve 12. The channel 42 is threaded and has diameters that accommodate both the guide sleeve 12 and the shuttles 32A and 32B circumferentially surrounding the guide sleeve 12, as discussed in further detail below.

[0073] The control knob 26, mounted on the distal rod 25 of the body 24 of the control handle 16, and the rotatable shaft 31 have a main proximal portion 46 and a short distal portion 47. The control knob 26 is generally cylindrical, with a longitudinally hollow interior extending through its entire length. The hollow interior has a main proximal segment 49, an intermediate segment 49', and a distal segment 49'". The main proximal segment 49' of the hollow interior is defined by a larger first radius R1 and a larger first length L1 to accommodate and circumferentially surround the guide sheath 12 and the shuttles 32A and 32B. The distal segment 49' of the hollow interior is defined by a smaller second radius R2 and a shorter second length L2, where R1>R2 and L1>L2, to accommodate and circumferentially surround the distal segment 37 of the guide sheath 12 and the rotatable shaft 31. The hollow interior intermediate segment 49' is defined by a third radius R3 and a third length L3, where R1>R3>R2 and L1>L3, to accommodate and circumferentially surround the connector J of the guide sleeve 12 and the rotatable shaft 31. A friction-sensing cover 60 can be mounted on the outer surface of the control knob 26 to allow for easy and comfortable manipulation and rotation of the control knob relative to the body 24 of the control handle 16.

[0074] In order to rotatably connect the rotatable shaft 31 to the control knob 26, the outer surface of the distal segment of the shaft has a longitudinal ridge 70. Figure 3 The longitudinal ridge is received in and engages with the corresponding longitudinal recess 71. Figure 4The longitudinal recess forms an inner surface defining the hollow interior 49” of the control knob 26. To translationally secure the control knob 26 to the rotatable shaft 31 and thus to the body 24, the outer surface of the shaft 31 also has one or more linear slots 74 oriented perpendicular to the longitudinal axis of the rotatable shaft 31. Each slot 74 is aligned with a corresponding hole 76. Figure 5 The hole is formed on one side of the distal portion 47 of the control knob 26, so that a corresponding pin 77 can be inserted into the hole 76 and the slot 74 to connect the control knob 26 and the rotatable shaft 31.

[0075] It should be understood that other embodiments of the guide sheath assembly may provide a rotatable shaft 31 with an exposed portion for direct manipulation by the user without the need for control knob 26.

[0076] like Figure 3 and Figure 5 As shown, shuttles 32A and 32B have a similar configuration to each other, where each is generally understood to be a mirror image of the other, but the first shuttle 32A is driven by a rotatable shaft 31, and the second shuttle 32B is driven by the first shuttle 32A via a pinion 34 located between them. Each shuttle 32A and 32B has a corresponding elongated body having: distal portions 80A and 80B with C-shaped end cross sections, and corresponding proximal rack portions 90A and 90B with longitudinally arranged corresponding plurality of teeth 92A and 92B. The first and second shuttles are arranged to face each other and engage the pinion 34, such that the distal portions 80A and 80BC together can form a cylindrical shape having an outer circumferential surface mating within a threaded channel 42 and an inner circumferential surface defining a channel 93 through which the guide sheath 12 passes. Figure 5 As shown, the rack portions 90A and 90B of each shuttle face each other between the pinions 34, such that the teeth 92A and 92B of each rack portion can engage with the teeth of the pinions 34, which are mounted to rotate about an axis perpendicular to the longitudinal axis 55 of the control handle 16.

[0077] refer to Figure 2 and Figure 3 The outer surface of the distal portion 80A of the first shuttle member 32A is provided with an external thread surface or a male thread surface 85. The inner circumferential surface of the rotatable shaft 31 is provided with an internal thread surface or a female thread surface 86. Figure 4The internal or female thread surface 86 receives the male thread surface 85 of the first shuttle 32A, which connects the first shuttle 32A and the rotatable shaft 31 to convert the rotational movement of the rotatable shaft 31 into the translational movement of the first shuttle 32A. In contrast, the outer surface of the distal portion 80B of the second shuttle 32B is smooth and does not feature any engagement with the rotatable female thread surface, allowing it to move independently of the male thread surface 85. Therefore, when the user rotates the control knob 26 in the first direction, the rotatable shaft 31, which is rotatably connected to the control knob 26 via the longitudinal ridge 70, also rotates. The rotatable shaft 31 is rotatably and translationally locked to the control knob 26 via the longitudinal ridge 70 and one or more pins 77, and the rotation of the shaft 31 drives the first shuttle 32A to translate along the longitudinal axis in the first direction (e.g., proximal). When the first shuttle 32A translates, its teeth 92A drive the pinion 34 to rotate in a first direction (e.g., clockwise), which in turn drives the second shuttle 32B to translate along the longitudinal axis 55 in a second direction opposite to the first direction (e.g., distally). This arrangement allows the male thread surface 85 and the female thread surface 86 to convert the rotational movement of the control knob 26 into linear movement of the shuttles 32A and 32B. The proximal ends of the first pull line 30A and the second pull line 30B are respectively anchored, connected, or otherwise responsive to the first shuttle 32A and the second shuttle 32B, whose linear and opposite movements actuate the pull lines to guide bidirectional deflection of the deflection segment 14 of the sheath 12. In the illustrated embodiment, the proximal ends of the pull lines 30A and 30B are respectively connected to the rack portions 90A and 90B of the shuttles 32A and 32B. Therefore, when one pull line is pulled proximally under tension through its corresponding shuttle, the other pull line moves distally through its corresponding shuttle while being released from tension.

[0078] like Figure 2 As shown, the proximal segments of each pull wire 30A and 30B extend outside the sheath 12 in the corresponding longitudinal channels 88A and 88B formed in the proximal rack portions 90A and 90B of each shuttle 32A and 32B. Figure 5As shown, stops 89A and 89B (e.g., hypotubes) are fixed to the proximal ends of each pull line 30A and 30B, and the stops are positioned at the proximal ends 87A and 87B of the corresponding rack portions 90A and 90B, such that the rack portions can be pushed or otherwise acted on the stops 89A and 89B respectively to pull the pull lines 30A and 30B proximally as the shuttles 32A and 32B move proximally. When the shuttles 32A and 32B move distally, the proximal ends of the rack portions 90A and 90B disengage from the stops 89A and 89B, thereby releasing the tension in the pull lines 30A and 30B. It should be understood that stops 89A and 89B can also be embedded or otherwise anchored to any part of the rack portion or the shuttle to achieve deflection of the sheath.

[0079] Because the first shuttle 32A and the second shuttle 32B move in opposite directions along the longitudinal axis 55, the initial positioning of the shuttles relative to each other and the channel 42 is prepared during the assembly of the control handle. For example, as Figure 2 As shown, each shuttle is positioned in a channel 42 of the rotatable shaft 31 such that they are adjacent to each other along the longitudinal axis 55 and each has a distal end typically positioned at the midpoint along the channel 42, such that each shuttle has sufficient space to move accordingly proximally or distally within the rotatable shaft 31. Stops 89A and 89B can be positioned relative to the shuttles such that minimal or constant tension is applied to each pull line 30A and 30B for a generally neutral guide sheath with little deflection (if any). This arrangement allows the shuttles to be in a “neutral” or initial configuration from which the user can uniformly deflect the guide sheath bidirectionally.

[0080] like Figure 5 As shown, pinion 34 is positioned between and relative to shuttle members 32A and 32B such that their teeth 92A and 92B remain engaged while translating in response to user operation of control knob 26. In this respect, rack portions 90A and 90B are long enough to ensure such continuous engagement.

[0081] It should be understood that by changing one or more factors, including, for example, the length of channel 42, the length of each distal portion 80A and 80B, the length of rack portions 90A and 90B, the position of pinion 34 and the number of pinions 34, different shuttle movement and deflection characteristics and limitations can be achieved as needed or desired.

[0082] refer to Figure 6A and Figure 6BEach shuttle 32A and 32B has a neutral indicator on the outer surface of each rack portion 90A and 90B opposite to the teeth 92A and 92B. The neutral indicator includes a first member 62A and a second member 62B, which are configured to releasably engage with each other to indicate a neutral position between the first shuttle 32A and the second shuttle 32B, i.e., where the pull lines 30A and 30B are in a neutral relative position and the guide sheath 12 is generally straight without deflection. In the illustrated embodiment, a first or male member 62A formed on a first shuttle 32A has a tapered protrusion 63 facing a second or female member 62B formed on a second shuttle 32B. The protrusion 63 includes a pair of flexible guides 64, on either side of which a fixed end 65 is fixed to the second shuttle 32B and a free end 66 is configured to together form a tapered recess 67. When the shuttles 32A and 32B are in a neutral configuration, the tapered protrusion 63 is nested in the tapered recess 67.

[0083] Therefore, the user typically initially presents an undeflected guide sleeve 12, wherein the first and second shuttle elements 32A and 32B are identical to each other, wherein the tapered protrusion 63 is nested in the tapered recess 67, as... Figure 6A As shown. When the user rotates the control knob 26 in one direction that drives the first and second shuttles 32A and 32B to translate in opposite directions, as... Figure 6B As shown, the tapered protrusion 63 disengages from and moves out of the tapered recess 67, but only when the user rotates the control knob with sufficient force to bend the guide rail 64 and overcome the resistance presented by its angled ends 68. As the tapered protrusion 63 rides on one of the angled ends 68 and moves past that angled end, the guide rail 64 tilts, causing the resistance to movement of the tapered protrusion 63 to decrease as the tapered protrusion 63 moves further away from the tapered recess 67. Therefore, when rotating the control knob 26 to deflect the guide sleeve 12, the user experiences greater or maximum resistance when the shuttles 32A and 32B initially move out of the neutral configuration, then the ease of movement increases as the shuttles 32A and 32B translate in opposite directions. The control handle 16 may carry visual and / or tactile markings to provide a constant orientation of the deflection direction. For example, clockwise rotation of control knob 26 always deflects shaft 12 toward the side or direction of side port 21, and counterclockwise rotation of control knob 26 always deflects shaft 12 toward the opposite side or direction.

[0084] Conversely, when the deflection of the guide sleeve 12 is released, the user rotates the control knob 26 in the opposite direction. As the shuttles 32A and 32B translate and approach each other and begin to realign again, the tapered protrusion 63 and the tapered recess 67 approach each other, and the user applies increased force to rotate the control knob 26 so that it returns above the inclined end 68 of the guide rail 64 before the tapered protrusion 63 can nest in the tapered recess 67. Thus, the increased resistance provided by either of the inclined rails 64 and the greater or maximum resistance provided by the angled end 68 provide the user with a tactile feel or indication as the tapered protrusion 63 comes into close proximity to the tapered recess 67. The engagement of the tapered protrusion 63 and the tapered recess 67 can provide the user with an audible “click” or signal when the flexible guide rail 64 snaps into its natural configuration when the tapered protrusion 63 no longer applies any load to it.

[0085] Figure 7A and Figure 7B An exemplary system 700 is illustrated, configured to utilize procedures such as the guide sheath assembly and control handle described herein. This exemplary system includes a diagnostic or therapeutic catheter 750 and a dilator 705, as well as a transseptal needle 710 configured to enter a patient's heart, specifically into the right atrium. A guidewire can be used to deliver the diagnostic or therapeutic catheter 750, dilator 705, and transseptal needle 710 into the patient's heart, as is known in the art.

[0086] During transseptal perforation using the exemplary system 700, the transseptal needle 710 punctures tissue in the septum between the right and left atria, such as at the foramen ovale or fossa ovale, and exits into the left atrium.

[0087] System 700 may also include an ablation device and a pump 770. A transseptal needle 710 and / or dilator 705 may be connected to the pump 770 to provide flushing at the treatment site as part of the ablation treatment. The size and shape of the dilator 705 may be set and otherwise configured to deliver the transseptal needle 710 to the fossa ovalis and to dilate the transseptal perforation once it has been created by the transseptal needle 710.

[0088] System 700 may also include a navigation system 760, and the transseptal needle 710 may further include one or more sensors (e.g., magnetic field sensors) that can provide the navigation system 760 with information about the location of the transseptal needle 710. The navigation system 760 may be configured to interpret data from the sensors (e.g., magnetic field data) to determine the location of the transseptal needle 710. In one example, these sensors are located near the distal end of the transseptal needle 710 during the procedure, and then typically within the patient's heart. While useful for positioning purposes, the system can be enhanced by the present invention.

[0089] Figure 7B A first proximity sensing element 240a and a second proximity sensing element 240b are shown. When these elements 240a and 240b are engaged or in a very close proximity state, they send signals to the navigation system 760. The signals generated from elements 240a and 240b provide the navigation system 760 with another data point beyond the distal end of the sheath, and thus extrapolate its position within the patient's heart. For example, but not limited to, the first proximity sensing element 240a and the second proximity sensing element 240b may include an optical sensing system or a photosensitive system, wherein one of the proximity sensing elements generates an optical signal and the other proximity sensing element receives the optical signal when the elements are engaged or in a very close proximity state, and subsequently sends another signal indicating engagement or proximity to the navigation system 760.

[0090] In another example, the first proximity sensing element 240a and the second proximity sensing element 240b may include a magnetic sensing system, wherein one of the proximity sensing elements generates a magnetic field, and the other proximity sensing element senses the magnetic field when the elements are engaged or in a very close proximity state, and subsequently sends a signal indicating engagement or proximity to the navigation system 760. In another example, the first proximity sensing element 240a and the second proximity sensing element 240b may include a physical interaction system, wherein one of the proximity sensing elements has a protrusion (e.g., a tongue, tooth, shaft, or tapered protrusion), and the other proximity sensing element is configured to receive the protrusion (e.g., a groove, pinion, notch) when the elements are engaged or in a very close proximity state, and subsequently sends a signal indicating engagement or proximity to the navigation system 760.

[0091] Figure 8 This is an example of a system 920 for performing a method for performing transseptal perforation using a guide sheath assembly and / or control handle as described herein. The system 920 can be used during a medical procedure for the heart 922 of a patient 924 to perform transseptal perforation. This procedure can be performed by one or more operators 926, including a medical professional. The system 920 can be configured to present images of cavities (such as the internal chambers of the heart 922), thereby allowing operator 926 to visualize the characteristics of the cavities. The system 920 can be further configured to present images of dilator 750 and / or transseptal needle 710. The system 920 may also include or be configured to control... Figure 7A The components of system 700 shown.

[0092] System 920 can be controlled by a system processor 930 capable of being implemented as a general-purpose computer. Processor 930 may be installed in console 940. Console 940 may include operating controls 942 (such as a keypad) and pointing devices (such as a mouse or trackball) for operator 926 to interact with processor 930. The results of operations performed by processor 930 can be provided to the operator on a display 944 connected to processor 930. Display 944 may further present a graphical user interface to the operator, enabling the operator to control system 920, including indications of engagement between conductive element 24a located proximal to hemostatic valve 18 and conductive element 24b on proximal to diagnostic or therapeutic catheter 750. Operator 926 may be configured to use controls 942 to input parameter values ​​used by processor 930 in the operation of system 920.

[0093] Processor 930 uses computer software to operate system 920. For example, the software may be downloaded to processor 930 electronically via a network, or alternatively or otherwise, the software may be provided and / or stored on a non-transitory tangible computer-readable medium such as magnetic, optical, or electronic memory.

[0094] In operating system 920, operator 926 inserts diagnostic or therapeutic catheter 960 into patient 24, such that the distal end of the catheter enters the left atrium 916 of the patient's heart via inferior vena cava 922. Operator 926 delivers diagnostic or therapeutic catheter 750 (such as dilator 705 and / or transseptal needle 710) through diagnostic or therapeutic catheter 750 into left atrium 716. Processor 730 may be configured to track the distal end of transseptal needle 710, typically both its position and orientation within heart 910. Transseptal needle 710 may include a tracking coil at its distal end. Processor 730 may utilize a magnetic tracking system, such as that manufactured by Biosense Webster of Irvine, Calif. The system 920 may include a magnetic field transmitter 966 located near the patient 924, such that a magnetic field from the transmitter interacts with one or more tracking coils at the distal end of the transseptal needle 710. The coils interacting with the magnetic field generate a signal that is transmitted to a processor 930, and the processor analyzes the signal to determine the position and orientation of the transseptal needle 710. In one embodiment, the tracking coils and magnetic tracking system may be used to position the dilator 705 and the transseptal needle 710, and thus to position them as needed by the operator 926.

[0095] In another embodiment, operator 926 may insert diagnostic or therapeutic catheter 750 into hemostatic valve 18 of guide sheath assembly 10. The contact and formation of the circuit between conductive element 24a on the proximal end of diagnostic or therapeutic catheter 750 and conductive element 24b on the proximal end of hemostatic valve 18 facilitates visualization of the position and orientation of dilator 705 and transseptal needle 710 using system 920. Therefore, irradiation of patient 924 is not required for operator 926 to determine the location of dilator 705 and transseptal needle 710.

[0096] Figure 9 and Figure 10 The above concepts are further illustrated. Figure 9 An example of a diagnostic or therapeutic catheter 750 and its sheath assembly 10 partially inserted into the hemostatic valve 18 is shown. Here, the circuit between the conductive elements 24a and 24b is not closed, therefore there is no indication of the proximal end of the diagnostic or therapeutic catheter 750. Figure 10 In the process, the circuit between the conductive elements 24a and 24b at the proximal ends 780 and 790 of the hemostatic valve and the diagnostic or therapeutic catheter is closed, thereby sending a signal to the mapping / navigation system to notify the system to locate another data point at the farthest end.

[0097] The exemplary catheter 750 can be visualized in the mapping / navigation software system 760, but many physicians still require fluoroscopy. The reason for using fluoroscopy is that physicians need to know the location of the distal end of the catheter 750 within the patient's heart and its position relative to important structures (e.g., the diaphragm). The tip of the exemplary therapeutic catheter 750 (e.g., a dilator) is the part of the system that is punctured and first passed into the left atrium. The system described above allows the operator to know precisely where the tip of the diagnostic or therapeutic catheter 750 is located based on extrapolation from the distal end of the guide sheath assembly 10. What the system 760 currently does not know is when the diagnostic or therapeutic catheter is fully engaged in the guide sheath assembly 10 for this extrapolation to be performed. By incorporating a first proximity sensing element 240a and a second proximity sensing element 240b (e.g., conductive elements 24a, 24b) into the hemostatic valve 18 of the guide sheath assembly 10 and the Luer connector of the diagnostic or therapeutic catheter 750 connected to the guide sheath assembly 10, the navigation system 760 is now able to identify when the diagnostic or therapeutic catheter 750 is fully engaged with the guide sheath assembly 10. This is identified by the mapping system 760 because the diagnostic or therapeutic catheter 750 has a similar conductive surface at the Luer face of the hemostatic valve 18 where the diagnostic or therapeutic catheter 750 and the guide sheath assembly 10 are connected. The conductive element on the sheath 24b may have an electrical interruption that closes only when the diagnostic or therapeutic catheter 750 is fully engaged and the conductive portion on the end 24b of the diagnostic or therapeutic catheter 750 completes the circuit. Further examples exist to allow the navigation system 760 to be informed of the full engagement between the guide sheath assembly 10 and the diagnostic or therapeutic catheter 750. Other examples include incorporating sensors or distal loops into the diagnostic or therapeutic catheter 750, replacing the aforementioned conductive surfaces with photoelectric sensors or other optical sensors, magnetic field sensors, or similar proximity detectors.

[0098] Figure 11A cross-sectional view of another embodiment of the guide sheath assembly 1010 is shown. The guide sheath assembly 1010 includes a sensor 1090 for detecting the time it takes for the guide sheath assembly 1010 to be inserted to a specific depth. The sensor 1090 may be a conductive sensor, a photoelectric sensor, or other optical sensor, or a magnetic field sensor. The guide sheath assembly 1010 has a hub 1014 and a tubular sheath 1012 attached to the distal end of the hub 1014. The guide sheath assembly includes a hemostatic valve 1016 to provide a seal around the sheath 1012 around a catheter tubular body 1022 extending along a longitudinal axis 1021 of the sheath introducer through a central lumen 1015 extending through the hub 1014 and the sheath 1012. A branch tube 1020 and a locking sleeve 1121 exiting the hub 1014 are provided to allow connection to saline solutions or medications and access to other medical procedures. It should be understood that the guidewire or diagnostic or therapeutic catheter 750 may also extend through the guiding sheath assembly, as it is frequently used in conjunction with a catheter. Sheath introducers or assemblies are described in U.S. Patent Nos. 5,807,350 and 10,194,937, the entire contents of which are incorporated herein by reference.

[0099] A releasable rotary locking assembly 1030, including an end cap 1032 and a user interface 1034, is mounted near the hub. Figure 11 In the illustrated embodiment, the user interface includes a knob 1036. An end cap 1032 is disposed proximally on the hub 1014 to cover and secure the hemostatic valve 1016. The end cap 1032 has a distal portion 1038 that snaps into the proximal circumferential portion 1040 of the hub 1014. The end cap 1032 has a neck portion 1042 disposed proximally, defining an axial opening 1044 leading to a central lumen 1015 of the guide sheath assembly 1010. The knob 1036, mounted on the neck portion 1042, is shaped as a disc with a circumferential edge 1050, the outer diameter of which is approximately equal to the outer diameter of the end cap 1032. The knob 1036 has a central bore 1052 that receives the neck portion 1042 of the end cap 1032 and allows the knob 1036 to rotate and adjust bidirectionally about the longitudinal axis 1021 of the guide sheath assembly 1010.

[0100] The rotary locking assembly 1030 also includes a plurality of locking members or pins 1060 mounted on the proximal side of the end cap 1032. These locking members or pins are adapted to contact and clamp the tubular body 1022 of the conduit extending through the guide sheath assembly 1010 when the knob 1036 is rotated in one direction, and to release the tubular body 1022 when the knob 1036 is rotated in another direction. When arranged in a radial pattern that is substantially equidistant and equiangular from each other, the pins 1060 are each fixedly but rotatably or pivotally (interchangeably used herein) mounted on a corresponding pin 1064 formed to project from the proximal end of the neck portion 1042. The pins 1064 extend parallel to the longitudinal axis 1021 of the guide sheath assembly 1010. The proximal end of each pin has a head 1065 that retains the pin 1060 on the pin 1064 and, consequently, the knob 1036 on the neck portion 1042 of the hub 1014.

[0101] The orifice 1078 causes a corresponding cam actuator or pin 1080 formed as a protrusion extending from the proximal end face of the knob 1036 to engage with the cam portion of the pin 1060, thereby connecting the rotational movement of the knob 1036 with the rotational movement of each pin in the pin 1060.

[0102] The guide sheath assembly 1010 may also include a conductive element 24a (not shown) on the hemostatic valve 1016, which is configured to interact with another conductive element 24b located proximal to the diagnostic or therapeutic catheter 750 to indicate engagement of the diagnostic or therapeutic catheter 750 with the hemostatic valve 1016. This engagement completes the circuitry between the hemostatic valve 1016 and the proximal end of the diagnostic or therapeutic catheter 750. This engagement can be provided by... Figure 8 The computer system shown uses visual or auditory signals to indicate this.

[0103] The foregoing description has been presented with reference to the presently preferred embodiments of the invention. Those skilled in the art will recognize that changes and modifications can be made to the structures without intentionally departing from the principles, spirit, and scope of the invention. Any feature or structure disclosed in one embodiment may be incorporated, as needed or appropriate, to replace or supplement other features of any other embodiment. As will be understood by those skilled in the art, the drawings are not necessarily drawn to scale. Therefore, the specific embodiments described above should not be construed as suitable only for the precise structures shown and illustrated in the drawings, but should be construed as conforming to and supporting the following claims, which have a full and fair scope of the invention.

Claims

1. A guide sleeve assembly, comprising: An elongated shaft defining a lumen extending along a longitudinal axis; A control handle, located near the shaft, the control handle comprising: A hemostatic valve, the hemostatic valve being located on the proximal end of the control handle; and At least one first conductive element is disposed on at least one of the control handle and the hemostatic valve, the at least one first conductive element being configured to interact with at least one second conductive element on a diagnostic or therapeutic catheter to complete a circuit, the diagnostic or therapeutic catheter including a dilator and a transseptal needle, the circuit enabling tracking of the position and orientation of the dilator and the transseptal needle. The at least one first conductive element includes one of a pin or a socket, and the at least one second conductive element includes the other of a pin or a socket, the socket including a flush outlet to allow fluid to flow out of the socket when the pin is received by the socket. The hemostatic valve is connected to the lumen for introducing the diagnostic or therapeutic catheter into the lumen.

2. The guide sleeve assembly according to claim 1, wherein, The at least one first conductive element is located on the proximal end of the hemostatic valve, and the at least one second conductive element is located on the proximal end of the diagnostic or therapeutic catheter.

3. The guide sleeve assembly according to claim 1, wherein, The circuit can be configured to provide a visual or auditory indicator when the circuit is completed.

4. The guide sleeve assembly according to claim 3, wherein, The visual or auditory indicator can be provided to a system configured to interact with the guide sheath assembly.

5. The guide sleeve assembly according to claim 1, wherein, The hemostatic valve also includes: A valve body extending along the longitudinal axis from a proximal portion to a distal portion; and A sensor, disposed near the proximal portion of the valve body, provides an indication of a predetermined insertion distance of the instrument through the lumen when the instrument is inserted into the hemostatic valve.

6. A system comprising: Diagnostic or therapeutic catheters, including dilators and transseptal needles, The guide sheath assembly according to any one of claims 1 to 5 comprises: An elongated shaft defining a lumen extending along a longitudinal axis; A control handle, located proximal to the shaft, includes: A control knob configured to rotate about the longitudinal axis; A hollow rotatable shaft, the hollow rotatable shaft being configured to rotate about the longitudinal axis in response to rotation of the control knob; A hemostatic valve, located on the proximal end of the control handle and connected to the lumen; and A plurality of first proximity sensing elements are asymmetrically arranged around at least one of the control handle and the hemostatic valve, the plurality of first proximity sensing elements being configured to interact with a plurality of second proximity sensing elements asymmetrically arranged around the diagnostic or therapeutic catheter, such that when the first proximity sensing elements interact with the second proximity sensing elements, signals are generated and the position and orientation of the dilator and the transseptal needle are determined.

7. The system according to claim 6, wherein, The plurality of first proximity sensing elements are located on the proximal end of the hemostatic valve, and the plurality of second proximity sensing elements are located on the proximal end of the dilator of the diagnostic or therapeutic catheter, the dilator being configured to be inserted into the lumen.

8. The system according to claim 6, wherein, The plurality of first proximity sensing elements and the plurality of second proximity sensing elements are optical sensors or magnetic field sensors.

9. The system according to claim 8, wherein, The plurality of first proximity sensing elements include a protrusion, and the plurality of second proximity sensing elements are configured to receive the protrusion, and the engagement or close proximity of the plurality of first proximity sensing elements and the plurality of second proximity sensing elements provides a visual and / or auditory indicator.

10. The system according to claim 6, wherein, The hemostatic valve also includes: Valve body; and A sensor, disposed on the valve body, provides an indication of a predetermined insertion distance of the diagnostic or therapeutic catheter through the lumen when the catheter is inserted into the hemostatic valve.

11. The system according to claim 6, wherein, The plurality of first proximity sensing elements and the plurality of second proximity sensing elements include an optical sensing system or a photosensitive system, wherein one of the plurality of first proximity sensing elements and the plurality of second proximity sensing elements is configured to generate an optical signal, and the other of the plurality of first proximity sensing elements and the plurality of second proximity sensing elements is configured to receive the optical signal when the elements are engaged or in a very close proximity state, and subsequently send a signal indicating engagement or proximity to the navigation system.

12. The system according to claim 6, wherein, The plurality of first proximity sensing elements and the plurality of second proximity sensing elements include a magnetic sensing system, wherein one of the plurality of first proximity sensing elements and the plurality of second proximity sensing elements is configured to generate a magnetic field, and the other of the plurality of first proximity sensing elements and the plurality of second proximity sensing elements is configured to sense the magnetic field when the elements are engaged or in a very close proximity state, and subsequently send a signal indicating engagement or proximity to the navigation system.

13. The system according to claim 6, wherein, The hemostatic valve further includes at least one first conductive element, and the diagnostic or therapeutic catheter further includes at least one second conductive element, wherein the at least one first conductive element is configured to interact with the at least one second conductive element to complete a circuit.

Images