Guide sheath with distal tip locator

Abstract

The guide sheath has a hemostatic valve and a central lumen through which a diagnostic or therapeutic catheter can be introduced and guided into a patient. The hemostatic valve also 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 a diagnostic or therapeutic catheter that can be passed through the central lumen of the guide sheath and into the patient's heart. The interaction between the two conductive or proximity sensing elements allows for the location of the distal end of the diagnostic or therapeutic catheter within the patient's heart to be determined without the need to irradiate the patient.

Description

[Technical Field]

[0001] The present invention relates to a guide sheath that is particularly suitable for guiding electrophysiology catheters, particularly guide sheaths having a distal tip locator. [Background technology]

[0002] In medical procedures involving a patient's heart, there are many diagnostic and therapeutic procedures that involve transseptal left heart catheterization, i.e., catheterization through the left atrium. The transseptal approach provides access for both interventional cardiologists performing antegrade mitral balloon valvuloplasty and cardiac electrophysiologists ablating the left-sided accessory pathway or performing transcatheter atrial fibrillation therapeutic strategies. These strategies are often used in combination with a guide sheath.

[0003] Guide sheaths are well known for their use in facilitating the routing of diagnostic or therapeutic catheters. Human cardiac catheterization often requires that the catheter be routed through the femoral vein to the heart chambers. To provide for variable mobility, the guide sheath (which generally resembles the catheter that is threaded through it) may be steerable or deflectable through the use of one or more pull wires to enhance maneuverability within the patient's vasculature. Summary of the Invention [Problem to be solved by the invention]

[0004] Therefore, there is a need for a guide sheath that provides improved deflection characteristics and smoother operation of the deflection mechanism of the control handle.

[0005] Additionally, during these procedures, many physicians use fluoroscopy to perform the transseptal puncture. Fluoroscopy is used because physicians need to know where the distal-most end of a diagnostic or therapeutic catheter, such as a dilator, is located within the heart. The end of the dilator is the part of the system that punctures (e.g., with a needle) and then traverses first into the left atrium. Due to radiation exposure, utilizing fluoroscopy is not ideal. Therefore, a non-radiation-based method is needed to position the distal end of a diagnostic or therapeutic catheter (e.g., a dilator) at the transseptal puncture point. [Means for solving the problem]

[0006] The present invention provides a method for positioning the distal end of a diagnostic or therapeutic catheter without the use of radiation. To perform this method, a guide sheath can be configured to interact with the diagnostic or therapeutic catheter to provide confirmation that the diagnostic or therapeutic catheter is fully engaged with the guide sheath. For example, without limitation, this confirmation can be provided by adding conductive elements or other proximity sensing elements to each of the guide sheath and the diagnostic or therapeutic catheter that complete a circuit upon contact and provide visual or audible confirmation of contact. These conductive elements or proximity sensing elements are located at the proximal (i.e., closer to the operator) ends of the guide sheath and the diagnostic or therapeutic catheter.

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

[0008] An exemplary guide sheath assembly can include an elongate shaft and a control handle proximal to the shaft, the control handle having a longitudinal axis. The control handle can include a rotatable shaft, a pinion, and a first and a second shuttle. The shaft can be configured to rotate about the longitudinal axis. The first shuttle can be configured to translate in one direction along the longitudinal axis in response to rotation of the rotatable shaft, and the first shuttle can have a first plurality of teeth. The pinion can be configured to engage with the first plurality of teeth and rotate about an axis substantially perpendicular to the longitudinal axis in response to translation of the first shuttle. The second shuttle can have a second plurality of teeth engaged with the pinion and can be configured to translate in another direction opposite the one direction along the longitudinal axis in response to rotation of the pinion. The guide sheath assembly can also have a first pull wire extending along one side of the shaft and having a proximal end portion responsive to proximal translational movement of at least the first shuttle, and a second pull wire extending along another side of the shaft and having a proximal end portion responsive to proximal translational movement of at least the second shuttle.

[0009] The control handle can also include a hemostatic valve and a central lumen configured to interface with a diagnostic or therapeutic catheter. The control handle and the diagnostic or therapeutic catheter can include conductive or proximity sensing elements configured to indicate engagement of the diagnostic or therapeutic catheter with the control handle. In one example, conductive or proximity sensing elements can be located on a surface of the hemostatic valve and on a surface of the diagnostic or therapeutic catheter. In another example, conductive or proximity sensing elements can be located on a surface of the control handle distal to the hemostatic valve and on a surface of 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 can have an internal passage configured to receive a first distal portion of the first shuttle and a second distal portion of the second shuttle.

[0012] The first distal portion and the second distal portion can be configured to form a cylindrical configuration when the first shuttle and the second shuttle are aligned laterally relative to one another along the longitudinal axis.

[0013] The inner surface of the inner passage may be threaded and the outer surface of the first distal portion may be threaded to engage the inner surface.

[0014] The rotation shaft may be rotatably and translatably coupled to the control knob.

[0015] The rotatable shaft may be rotatably coupled to the control knob by a longitudinal ridge formed on the outer surface of the shaft.

[0016] The rotatable shaft may be rotatably coupled to the control knob by a pin extending through a portion of the control knob and a slot formed in the rotatable shaft.

[0017] The rotation shaft may be rotatably and translatably coupled at its distal end to a control knob.

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

[0019] The neutral indicator includes a first member on the first shuttle and a second member on the second shuttle, the first member and the second member configured to releasably engage.

[0020] The neutral indicator may 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 an example involving conductive elements on a hemostasis valve of a control handle interacting with conductive elements on a diagnostic or therapeutic catheter is for illustrative purposes only and does not limit the location of the conductive elements to the hemostasis valve, nor does it preclude the use of proximity sensing elements.

[0023] In one example, an outwardly facing first conductive element on the control handle (e.g., on the surface of the hemostatic valve or on the surface of the control handle distal to the hemostatic valve) can interact with an inwardly facing second conductive element on the surface of the diagnostic or therapeutic catheter. In one example, an inwardly facing first conductive element on the control handle (e.g., on the surface of the hemostatic valve or on the surface of the control handle distal to the hemostatic valve) can interact with an outwardly protruding element on the surface of the diagnostic or therapeutic catheter.

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

[0025] The proximal end of the control handle can include at least one first conductive element that projects 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) to complete a circuit with at least one second conductive element on the proximal end of the diagnostic or therapeutic catheter. The at least one second conductive element can be configured to interact with the outwardly projecting first conductive element (e.g., the second conductive element can project outwardly or inwardly from the surface of the diagnostic or therapeutic catheter to complete a circuit with an outwardly projecting first conductive element located on the outer surface of the hemostatic valve) or with an inwardly projecting 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 a circuit with an inwardly projecting first conductive element that projects into the central lumen of the control handle.

[0026] In one example, a first outwardly facing conductive element on the control handle distal to the hemostasis valve can interact with a second inwardly facing conductive element on the surface of the diagnostic or therapeutic catheter. In one example, a first inwardly facing conductive element on the control handle can interact with an outwardly protruding element on the surface of the diagnostic or therapeutic catheter.

[0027] In one example, the control handle can include a first conductive element distal to the hemostasis valve of the control handle, which completes a circuit with a second conductive element on the proximal end of the diagnostic or therapeutic catheter.

[0028] The proximal end of the control handle can include at least one first conductive element distal to the hemostatic valve that 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) to complete a circuit with at least one second conductive element on the proximal end of the diagnostic or therapeutic catheter. The at least one second conductive element can be configured to interact with the outwardly protruding first conductive element (e.g., the second conductive element protrudes outward or inward from the surface of the diagnostic or therapeutic catheter to complete a circuit with an outwardly protruding first conductive element located distal to the hemostatic valve, or with an 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 a circuit with an inwardly protruding first conductive element that protrudes into the central lumen of the control handle.

[0029] In one example, a plurality of first conductive elements protrude radially from the control handle, either outward on the outer surface of the hemostatic valve or inward toward the central lumen of the control handle, and are configured to form a circuit with a plurality of second conductive elements protruding radially outward 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 the first conductive elements protruding inward 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] The at least one first conductive element and the at least one second conductive element can include a group of contacts or can be a single contact. The control handle can include two or more first conductive elements, which can be equally spaced (e.g., symmetrically spaced) or asymmetrically spaced. For example, the two first conductive elements can be spaced 180° apart, i.e., on opposite sides of the control handle, or 90° apart. Without wishing to be bound by theory, increasing the spacing between the contacts can reduce the risk of shorting the conductive elements, for example, due to splashback from saline, blood, or other fluids. Asymmetrically positioning the contacts can also help avoid imprecise mating between the control handle and the diagnostic or therapeutic catheter (i.e., there is only one possible mating orientation), optionally including in combination with other proximity sensing or interaction elements.

[0031] At least one of the first conductive element and the second conductive element may include a portion for cleaning or wiping liquid from the contact surfaces of the elements before they interact.

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

[0033] Any of the first conductive elements and second conductive elements discussed herein can be combined with any of the proximity sensing elements, neutral indicators, visual indicators, and / or audible indicators discussed herein.

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

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

[0036] Another example guide sheath assembly can include an elongate shaft and a control handle proximal to the shaft. The control handle can have a longitudinal axis and can 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 can also include a first shuttle configured for translational movement in one direction along the longitudinal axis in response to rotation of the rotatable shaft, the first shuttle can have a first plurality of teeth and a pinion engaging the first plurality of teeth. The pinion can be configured to rotate about an axis substantially perpendicular to the longitudinal axis in response to translational movement of the first shuttle. The control handle can include a second shuttle that can have a second plurality of teeth engaging the pinion, the second shuttle configured for translational movement in another direction opposite the one direction along the longitudinal axis in response to rotation of the pinion. The guide sheath assembly can further include a first pull wire extending along one side of the shaft and having a proximal end portion responsive to proximal translation of at least the first shuttle, and a second pull wire extending along another side of the shaft and having a proximal end portion responsive to proximal translation of at least the second shuttle. The control handle can also include a hemostatic valve and a central lumen configured to interface with a diagnostic or therapeutic catheter. The control handle and the diagnostic or therapeutic catheter can 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 use in controlling deflection of a medical guide sheath shaft includes a control knob that can be configured to rotate about a longitudinal axis of the control handle and a hollow rotatable shaft that can be configured to rotate about the longitudinal axis in response to rotation of the control knob. The control handle also includes a first shuttle that can be configured for unidirectional translation along the longitudinal axis in response to rotation of the rotatable shaft, the first shuttle can have a first plurality of teeth. The control handle can further include a pinion that engages the first plurality of teeth, the pinion can be configured to rotate about an axis substantially perpendicular to the longitudinal axis in response to translation of the first shuttle. The control handle can also include a second shuttle having a second plurality of teeth that engage with the pinion, the second shuttle being configured to translate in an opposite direction along the longitudinal axis in response to rotation of the pinion, and the first and second shuttles being configured to act on first and second pull wires, respectively, extending along the guide sheath shaft. The control handle can also include a hemostatic valve and a central lumen configured to interact with the diagnostic or therapeutic catheter. The control handle and the diagnostic or therapeutic catheter can include conductive elements configured to indicate engagement of the diagnostic or therapeutic catheter with the control handle when the conductive elements contact each other to complete a circuit.

[0038] In some embodiments, the distal ends of the first shuttle and the second shuttle can extend within the proximal portion of the rotatable shaft.

[0039] In some embodiments, the inner surface of the rotatable shaft can be threaded and the outer surface of the first shuttle can be threaded to rotatably couple the rotatable shaft and the first shuttle.

[0040] In some embodiments, the first shuttle may be directly responsive to rotation of the rotatable shaft and the second shuttle may be directly responsive to rotation of the pinion. [Brief explanation of the drawings]

[0041] These and other features and advantages of the present invention will be more fully understood by considering the following detailed description in conjunction with the accompanying drawings, in which it is understood that in certain drawings, selected structures and features are not shown to facilitate viewing of remaining structures and features. [Figure 1] FIG. 1 is a plan view of a guide sheath including a control handle, according to one embodiment of the present invention. [Figure 2] FIG. 2 is a longitudinal cross-sectional view of the control handle of FIG. 1. [Figure 3] FIG. 2 is an exploded view of the control handle of FIG. 1 with the housing removed. [Figure 4] FIG. 2 is a longitudinal cross-sectional view of a distal portion of the control handle of FIG. 1, including a control knob. [Figure 5] FIG. 2 is a perspective view of the control handle of FIG. 1 with the housing removed. [Figure 6A] FIG. 2 is a top view of a neutral indicator with the first and second members engaged, according to one embodiment of the present invention. [Figure 6B] 6B is a plan view of the neutral indicator of FIG. 6A with the first and second members disengaged; FIG. [Figure 7A] FIG. 1 illustrates components of a system with a control handle, according to an aspect of the present invention. [Figure 7B] 7B is an enlarged view of region 7B of FIG. 7A showing an alternative proximity sensing system according to an embodiment of the present invention. [Figure 8] FIG. 1 is a diagram of a system including a control handle as described herein being used to perform a method for performing a transseptal puncture, according to an aspect of the present invention. [Figure 9]FIG. 13 shows an example of a close-up of the hemostatic valve and transseptal needle before full insertion. [Figure 10] FIG. 13 shows an example of a close-up of the hemostatic valve and transseptal needle at full insertion. [Figure 11] 12A is a cross-sectional view of another embodiment of a guide sheath including a control handle, according to an embodiment of the present invention. [Figure 12] FIG. 10 is a top view of another embodiment of a control handle having a diagnostic or therapeutic catheter including an externally facing first conductive element on the outer surface of a hemostasis valve, a protrusion that interacts with the hemostasis valve, and a second conductive element positioned on the protrusion to form a circuit with the first conductive element. [Figure 13A] FIG. 2 illustrates an embodiment of a first conductive element and a second conductive element in the form of a pin and socket. [Figure 13B] 13A and 13B illustrate one embodiment of a first conductive element and a second conductive element in the form of a pin and a socket. The left panel of Fig. 13A illustrates a possible interaction between the first conductive element and the second conductive element, where the first conductive element is in the form of a socket on the outer surface of the hemostasis valve and the second conductive element is in the form of a pin protruding outward from the diagnostic or therapeutic catheter. The right panel of Fig. 13A illustrates a schematic of this interaction. Fig. 13B illustrates a schematic of a pin and socket interaction, where the pin and socket each have multiple conductive portions that interact to form a circuit when the pin and socket are fully engaged. The socket includes a vent or hole to allow liquids or fluids to escape from the socket upon the introduction of the pin. [Figure 14A] 10A-10C show an embodiment of a first conductive element located on a control handle distal to a hemostasis valve. [Figure 14B]14A and 14B illustrate an embodiment of a first conductive element located on a control handle distal to a hemostatic valve. Figure 14A illustrates a possible interaction between a first conductive element located on a control handle distal to a hemostatic valve and a second conductive element located on a prong of a diagnostic or therapeutic catheter. Figure 14B illustrates a possible interaction between a first conductive element located on a control handle distal to a hemostatic valve and a second conductive element located on a diagnostic or therapeutic catheter. DETAILED DESCRIPTION OF THE INVENTION

[0042] As used herein, the terms "about" or "approximately" in connection with any numerical value or range of values ​​indicates a dimensional tolerance appropriate for allowing a portion of a component or a collection of components to function for its intended purpose as described herein. More specifically, "about" or "approximately" may refer to a range of values ​​of ±20% of the recited value; for example, "about 90%" may refer to a range of values ​​of 71% to 99%.

[0043] As used herein, terms such as “component,” “module,” “system,” “server,” “processor,” and “memory” 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 may be, but is not limited to, a processor, an object, an executable, a thread of execution, 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 may be a component. One or more components may reside within a process and / or thread of execution, and a component may be localized on one computer and / or distributed between two or more computers. Additionally, these components may execute from various computer-readable media having various data structures stored thereon. Components may communicate via local and / or remote processes, such as pursuant to a signal having one or more data packets, such as data from one component interacting with another component in a local system, a distributed system, and / or via a network, such as the Internet, with other systems via signals. The computer-readable medium may be non-transitory. The term "non-transitory computer-readable medium" includes, but is not limited to, random access memory (RAM), read-only memory (ROM), electronically erasable programmable ROM (EEPROM), flash memory or other memory technology, compact disc ROM (CD-ROM), digital versatile disk (DVD) or other optical storage device, magnetic cassette, magnetic tape, magnetic disk storage or other magnetic storage device, or any other tangible physical medium that can be used to store computer-readable instructions and / or data.

[0044] As used herein, the term "computing system" is intended to include a standalone machine or apparatus and / or combinations of machines, components, modules, systems, servers, processors, memories, 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 stationary or semi-stationary electronic medical device, or other electronic data processing device.

[0045] As used herein, the term "non-transitory computer-readable medium" includes, but is not limited to, random access memory (RAM), read-only memory (ROM), electronically erasable programmable ROM (EEPROM), flash memory or other memory technology, compact disc ROM (CD-ROM), digital versatile disc (DVD) or other optical storage device, magnetic cassette, magnetic tape, magnetic disk storage or other magnetic storage device, or any other tangible physical medium that can be used to store computer-readable information.

[0046] 1 , in some embodiments of the present invention, a guide sheath assembly 10 includes an elongated, flexible sheath 12 and a control handle 16 proximal to the sheath 12. The sheath 12 includes a proximal portion 13 and a distal deflection portion 14. The control handle 16 may be connected to an electrical connector 17 for transmitting electrical signals sensed by one or more ring electrodes 19 carried on the sheath 12, including, for example, the deflection portion 14. Also shown in FIG. 1 , attached to the control handle 16 is a hemostatic valve 18 adapted to receive a diagnostic or therapeutic catheter (shown as 750 in FIGS. 7A, 7B, and 8 ) that can be advanced through a lumen 28 defined by the hemostatic valve 18 and the guide sheath assembly 10 ( FIGS. 1 and 2 ) and the control handle 16 ( FIGS. 1 and 2 ). The hemostatic valve 18 also has a side port 21 terminating in a Luer hub, such as a two-way stopcock 22, for connection to one or more fluid sources (not shown) for providing fluid into and through the valve cap 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 a circuit between the proximal end 23 of the hemostatic valve 18 and the proximal end of the diagnostic or therapeutic catheter 750. This engagement may be indicated by a visual or audio signal provided to a computer system, as shown in FIG. 8 .

[0047] As shown in FIG. 12, the proximal end of the control handle can include at least one first conductive element 24a that projects 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 a circuit with at least one second conductive element 24b on the proximal end of the diagnostic or therapeutic catheter. At least one second conductive element 24b can be configured to interact with an outwardly protruding first conductive element 24a (e.g., the second conductive element 24b can protrude outward or inward from the surface of the diagnostic or therapeutic catheter to complete a circuit with an outwardly protruding first conductive element 24a located on the outer surface of the hemostasis valve) or an inwardly protruding first conductive element 24a (e.g., the second conductive element 24b can be located on or proximal to the surface of the diagnostic or therapeutic catheter) to complete a circuit with an inwardly protruding first conductive element 24a that protrudes into the central lumen of the control handle. In one example, a plurality of first conductive elements 24a project radially from the control handle, either outward on the outer surface of the hemostatic valve or inward toward the central lumen of the control handle, and are configured to form a circuit with a plurality of second conductive elements 24b projecting 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 the first conductive elements 24a projecting inward toward the central lumen of the control handle. In one example, as shown in FIG. 12, 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 that is configured to cover or interact with the outer surface of the hemostatic valve.

[0048] The at least one first conductive element 24a and the at least one second conductive element 24b can include a group of contacts or can be a single contact. The control handle can include two or more first conductive elements 24a, which can be equally spaced (e.g., symmetrically spaced) or asymmetrically spaced. For example, the two first conductive elements 24a can be spaced 180° apart, i.e., on opposite sides of the control handle, or can be spaced 90° apart.

[0049] One or both of the at least one first conductive element 24a and the at least second conductive element 24b may include a portion for cleaning or wiping liquid from the contact surfaces of the elements before they interact.

[0050] At least one first conductive element 24a can be in the form of a pin or a socket. At least one second conductive element 24b can be in the form of a socket or pin selected to interact with at least one first conductive element 24a, as shown in FIG. 13A (e.g., if the first conductive element 24a is a pin, the second conductive element 24b is a socket). The pin and / or socket can be coated with a polymer to allow the connected pin and socket to be sealed (i.e., liquid-tight) when they fully interact. The socket can include a vent or hole 1301 to allow fluid 1303 to be forced out of the socket when the pin is introduced into the socket, as shown in FIG. 13B. Each of the pins and / or sockets can include multiple conductive portions 1302 to allow a single pin and socket pair to provide multiple electrical connections. A protective element can at least partially surround the pin to prevent the pin from bending.

[0051] As shown in Figures 14A-14B, a first conductive element can be positioned distal to the hemostatic valve. A surface 800 of the control handle distal to the hemostatic valve can include at least one first conductive element 24a that projects outward (e.g., away from the central lumen of the control handle, such as toward the outer surface of the hemostatic valve), as shown in Figure 14A, or inward (e.g., toward the central lumen of the control handle), as shown in Figure 14B, and completes a circuit with at least one second conductive element 24b on the proximal end of the diagnostic or therapeutic catheter. At least one second conductive element 24b can be configured to interact with an outwardly protruding first conductive element 24a (e.g., the second conductive element 24b can protrude outward or inward from the surface of the diagnostic or therapeutic catheter to complete a circuit with an outwardly protruding first conductive element 24a located on the surface 800 of the control handle distal to the hemostasis valve), or with an 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 a circuit with an inwardly protruding first conductive element 24a that protrudes into the central lumen of the control handle. In one example, a plurality of first conductive elements 24a protrude radially from a distal surface 800 of the control handle, either outward on the outer surface of the hemostasis valve or inward toward the central lumen of the control handle, and are configured to form a circuit with a plurality of second conductive elements 24b protruding radially outward from the surface of the diagnostic or therapeutic catheter to interact with first conductive elements 24a on the surface 800 of the control handle distal to the hemostasis valve, or with first conductive elements 24a on the surface 800 of the control handle distal to the hemostasis valve that protrude inward toward the central lumen of the control handle. In one example, as shown in FIG. 14A , the first conductive elements 24a are present on the surface 800 of the control handle distal to the hemostasis 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 surface 800 of the control handle distal to the hemostasis valve.

[0052] Any of the first conductive elements 24a and second conductive elements 24b discussed herein can be combined with any of the proximity sensing elements, neutral indicators, visual indicators, and / or audible indicators discussed herein.

[0053] The diagnostic or therapeutic catheters 750 described herein may include, for example, but are not limited to, dilators, transseptal needles, mapping catheters, and / or ablation catheters.

[0054] As shown in FIGS. 2 and 3 , the control handle 16 includes an elongated, generally cylindrical body 24 having a narrower distal portion or shaft 25 to which a distal rotation control knob 26 is attached. The body 24 has outer shell halves formed to define an interior volume V, with edges 51 thereof meeting along a longitudinal seam. The body distal shaft 25 has a smaller outer diameter D1 compared to the outer diameter D2 of the proximal portion of the body 24. The control knob 26 is configured to be rotated by a user's thumb and index finger when the user grasps the body 24 of the control handle 16. To enable deflection of the deflection portion 14 of the guide sheath 12 by the first and second pull wires 30A and 30B, the control handle 16 includes a rotatable shaft 31, first and second shuttles 32A and 32B, and a pinion 34 within the interior volume V of the control handle 16. Rotatable shaft 31, in response to control knob 26, drives first shuttle 32A to move linearly in a first direction along longitudinal axis 55, and pinion 34 couples second shuttle 32B to first shuttle 32A such that second shuttle 32B moves linearly along longitudinal axis 55 in a second direction opposite the first direction. Because the proximal ends of first pull wire 30A and second pull wire 30B are fixed to, or at least coupled to, first shuttle 32A and second shuttle 32B, respectively, this coordinated translational movement of the first and second shuttles in opposite directions actuates the first and second pull wires to cause bidirectional deflection of deflectable portion 14 of guide sheath 12.

[0055] The rotatable shaft 31 has a main proximal portion 36 having an outer diameter D3, a shorter distal portion 37 having an outer diameter D4, and a stepped junction J between portions 36, 37. In the illustrated embodiment, diameter D3 is greater than diameter D4, although it will be understood that the two diameters may be approximately equal or that diameter D4 may be greater than diameter D3. As better shown in FIG. 2 , the rotatable shaft 31 is positioned relative to the body 24 of the control handle 16 such that its proximal portion 36 passes through both the body 24 and the distal shaft 25 of the control handle 16 and extends beyond the distal end of the distal shaft 25; because junction J and the distal portion 37 are distal to the distal shaft 25 of the body 24, the distal portion 37 is not enclosed by the distal shaft 25. At its proximal end, the rotatable shaft 31 is connected and fixed to the body 24 by a proximal outer circumferential lip 38 that engages with an inner circumferential slot defined between circumferential flanges 40 formed within the interior volume V of the body 24.

[0056] 4, rotatable shaft 31 is hollow with an internal passageway 42. Passageway 42 communicates with a distal inlet 44 having a diameter just slightly larger than the diameter of guide sheath 12. Passageway 42 is threaded and has a diameter to accommodate both guide sheath 12 and shuttles 32A and 32B that circumferentially surround guide sheath 12, as described in more detail below.

[0057] The control knob 26 is attached to the distal shaft 25 of the body 24 of the control handle 16 and the rotatable shaft 31 and has a main proximal portion 46 and a short distal portion 47. The control knob 26 is generally cylindrical with a longitudinal hollow interior extending through its entire length. The hollow interior has a main proximal portion 49, an intermediate portion 49', and a distal portion 49''. The main proximal portion 49 of the hollow interior is defined by a larger first radius R1 and a larger first length L1 that accommodates and surrounds the guide sheath 12 and the distal portion 37 of the rotatable shaft 31. The distal portion 49'' of the hollow interior is defined by a smaller second radius R2 (R1 > R2) and a shorter second length L2 (L1 > L2) that accommodates and surrounds the guide sheath 12 and the distal portion 37 of the rotatable shaft 31. The hollow interior intermediate portion 49' accommodates the connection J of the guide sheath 12 and the rotatable shaft 31 and is defined by a third radius R3 (R1 > R3 > R2) surrounding the periphery thereof and a third length L3 (L1 > L3). A friction-generating cover 60 may be attached to the outer surface of the control knob 26 to allow a user to easily and comfortably manipulate and rotate the control knob relative to the body 24 of the control handle 16.

[0058] To rotatably couple the rotatable shaft 31 to the control knob 26, the outer surface of the distal portion of the shaft has a longitudinal ridge 70 ( FIG. 3 ) that is received in and engages with a corresponding longitudinal recess 71 ( FIG. 4 ) formed in the 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 further has one or more linear slots 74 oriented perpendicular to the longitudinal axis of the rotatable shaft 31. Each slot 74 aligns with a corresponding hole 76 ( FIG. 5 ) formed through the side of the distal end portion 47 of the control knob 26, such that a corresponding pin 77 may be inserted into the hole 76 and slot 74 to couple the control knob 26 to the rotatable shaft 31.

[0059] It will be appreciated 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 use of control knob 26 .

[0060] 3 and 5, shuttles 32A and 32B have similar structures and can be understood to be substantially mirror images of each other. However, first shuttle 32A is driven by rotatable shaft 31, and second shuttle 32B is driven by first shuttle 32A via pinion 34 disposed between the shuttles. Each shuttle 32A and 32B has an elongated body having a distal portion 80A, 80B with a C-shaped end cross-section, and a proximal rack portion 90A, 90B having a plurality of teeth 92A, 92B arranged longitudinally. The first and second shuttles are positioned opposite each other and engage with pinion 34, allowing distal portions 80A, 80BC to form a cylindrical shape having an outer circumferential surface that fits within threaded passage 42 and an inner circumferential surface that defines passage 93 through which guide sheath 12 is passed. As shown in FIG. 5, the rack portions 90A and 90B of each shuttle face each other with the pinion 34 therebetween so that the teeth 92A and 92B of each rack portion can mesh with the teeth of the pinion 34, which is mounted for rotation about an axis perpendicular to the longitudinal axis 55 of the control handle 16.

[0061] 2 and 3, the outer surface of the distal portion 80A of the first shuttle 32A is provided with an external or external threaded surface 85. The inner surface of the rotatable shaft 31 is provided with an internal or internal threaded surface 86 (FIG. 4) that receives the external threaded surface 85 of the first shuttle 32A, thereby coupling the first shuttle 32A to the rotatable shaft 31 and converting rotational motion of the rotatable shaft 31 into translational motion 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 include any mechanism for engaging the internal threaded surface of the rotatable portion, allowing it to move independently of the external threaded surface 85. Thus, when a user rotates the control knob 26 in a first direction, the rotatable shaft 31, which is rotatably coupled to the control knob 26 via the longitudinal ridge 70, also rotates. Because the rotatable shaft 31 is rotatably and translationally locked to the control knob 26 via the longitudinal ridges 70 and one or more pins 77, rotation of the shaft 31 drives the first shuttle 32A to translate in a first direction (e.g., proximally) along the longitudinal axis. As 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 in a second direction opposite the first direction (e.g., distally) along the longitudinal axis 55. With this configuration, the external and internal threaded surfaces 85, 86 convert the rotational motion of the control knob 26 into linear motion of the shuttles 32A and 32B. The proximal ends of first pull wire 30A and second pull wire 30B are fixedly coupled to, or otherwise responsive to, first shuttle 32A and second shuttle 32B, respectively, so that linear and opposing motion of the shuttles actuates the pull wires to cause bidirectional deflection of deflection portion 14 of guide sheath 12. In the illustrated embodiment, the proximal ends of pull wires 30A and 30B are coupled to rack portions 90A and 90B of shuttles 32A and 32B, respectively, so that as one pull wire is pulled proximally under tension by its corresponding shuttle, the other pull wire is simultaneously released from tension by its corresponding shuttle moving distally.

[0062] As shown in Figure 2, the proximal end portion of each pull wire 30A and 30B extends outside of sheath 12 within a corresponding longitudinal groove 88A and 88B formed in a proximal rack portion 90A and 90B of each shuttle 32A and 32B. As shown in Figure 5, a locking element 89A and 89B, such as a hypotube, is secured to the proximal end of each pull wire 30A and 30B and is positioned proximal to the proximal end 87A and 87B of the respective rack portion 90A and 90B such that proximal movement of shuttles 32A and 32B causes the rack portions to push or otherwise act on locking elements 89A and 89B, respectively, to pull pull wires 30A and 30B proximally. As shuttles 32A and 32B are moved distally, the proximal ends of rack portions 90A and 90B move out of contact with locking elements 89A and 89B, releasing pullwires 30A and 30B from tension. It will be appreciated that locking elements 89A and 89B may be embedded or otherwise secured to any portion of the rack portion or shuttle to deflect the sheath.

[0063] Because the first and second shuttles 32A and 32B move in opposite directions along the longitudinal axis 55, their initial positioning relative to each other and the passageway 42 is determined during assembly of the control handle. For example, as shown in FIG. 2 , when the shuttles are positioned within the passageway 42 of the rotatable shaft 31 so that they are aligned with each other along the longitudinal axis 55, the distal end of each shuttle is positioned approximately midway along the passageway 42, providing sufficient space for each shuttle to move proximally or distally within the rotatable shaft 31. In a nearly neutral guide sheath with little deflection, the locking elements 89A and 89B may be positioned relative to each shuttle to minimize or uniformly apply tension to each pullwire 30A and 30B. In such a configuration, the shuttles assume a “neutral” initial configuration from which the user may uniformly deflect the guide sheath in two directions.

[0064] 5, pinion 34 is positioned between and relative to shuttles 32A and 32B so that shuttle teeth 92A and 92B remain engaged during translation of the shuttle in response to user manipulation of control knob 26. In this regard, the length of rack portions 90A and 90B is sufficient to ensure such continuous engagement.

[0065] It will be appreciated that by varying one or more factors, such as, for example, the length of passage 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, different shuttle movement and deflection characteristics and limitations can be achieved as needed or desired.

[0066] 6A and 6B, a neutral indicator is provided on the outer surface of each rack portion 90A and 90B opposite the teeth 92A and 92B of each shuttle 32A and 32B. The neutral indicator includes a first member 62A and a second member 62B configured to releasably engage with one another to indicate a neutral position between the first shuttle 32A and the second shuttle 32B, i.e., a relative position in which the pullwires 30A and 30B are neutral, thereby causing the guide sheath 12 to be substantially straight without deflection. In the illustrated embodiment, a first, or male, member 62A formed on the first shuttle 32A has a tapered protrusion 63 facing a second, or female, member 62B formed on the second shuttle 32B, the second member 62B including a pair of opposing flexible guide rails 64, the fixed ends 65 of which are fixedly attached to the second shuttle 32B, and the free ends 66 of the guide rails 64 are configured together to form a tapered recess 67 into which the tapered protrusion 63 fits when the shuttles 32A and 32B are in their neutral configurations.

[0067] Thus, a user will typically initially present guide sheath 12 in an undeflected state in which first shuttle 32A and second shuttle 32B are aligned with one another, with tapered protrusion 63 nested within tapered recess 67, as shown in FIGURE 6A. When a user rotates control knob 26 in one direction to drive first shuttle 32A and second shuttle 32B in opposite translational motion, as shown in FIGURE 6B, tapered protrusion 63 will disengage and move out of tapered recess 67, but to do so, the user must rotate control knob with enough force to deflect guide rail 64 and overcome the resistance offered by its angled end 68. Once the tapered protrusion 63 clears one of the angled ends 68, the guide rail 64 is angled so that the resistance to the movement of the tapered protrusion 63 decreases as the tapered protrusion 63 moves further from the tapered recess 67. Thus, when rotating the control knob 26 to deflect the guide sheath 12, the user experiences greater or greatest resistance as the shuttles 32A and 32B initially move out of the neutral configuration, followed by increasing ease of movement as the shuttles 32A and 32B translate in opposite directions. The control handle 16 may have visual and / or tactile indicators to provide a consistent orientation of the deflection direction. For example, clockwise rotation of the control knob 26 consistently deflects the shaft 12 toward the side, i.e., toward the side port 21, while counterclockwise rotation of the control knob 26 deflects the shaft 12 toward the opposite side or direction.

[0068] Conversely, to release the deflection of guide sheath 12, the user rotates control knob 26 in the opposite direction. As shuttles 32A and 32B translate toward one another and begin to realign laterally, tapered protrusion 63 and tapered recess 67 approach one another, and the user applies greater force to rotate control knob 26 so that tapered protrusion 63 again overcomes angled ends 68 of guide rails 64 before tapered protrusion 63 can rest within tapered recess 67. Thus, the increasing resistance offered by either of angled rails 64 and the greater or maximum resistance offered by angled ends 68 provide a tactile sensation or indication to the user that tapered protrusion 63 is approaching tapered recess 67. The engagement of the tapered protrusion 63 with the tapered recess 67 can provide the user with an audible "click" sound or signal as the guide rail 64 springs back to its natural shape once the tapered protrusion 63 is no longer applying load against the flexible guide rail 64.

[0069] 7A and 7B illustrate an exemplary system 700 configured for a procedure utilizing the guide sheath assembly and control handle described herein. The exemplary system includes a diagnostic or therapeutic catheter 750, a dilator 705, and a transseptal needle 710 configured to enter a patient's heart, specifically the right atrium. As is known in the art, a guidewire can be utilized to deliver the diagnostic or therapeutic catheter 750, the dilator 705, and the transseptal needle 710 to the patient's heart.

[0070] During transseptal puncture using the exemplary system 700, the transseptal needle 710 punctures tissue in the septum between the right and left atria, for example, the fossa ovalis or foramen ovale, and exits into the left atrium.

[0071] The system 700 can further include an ablation means and a pump 770. The transseptal needle 710 and / or the dilator 705 can be connected to the pump 770 to provide irrigation to the treatment site as part of the ablation treatment. The dilator 705 can be sized, shaped, or otherwise configured to deliver the transseptal needle 710 to the fossa ovalis and to dilate the transseptal puncture once created by the transseptal needle 710.

[0072] The system 700 can further include a navigation system 760, and the transseptal needle 710 can further include one or more sensors (e.g., magnetic field sensors) that can provide information regarding the location of the transseptal needle 710 to the navigation system 760. The navigation system 760 can be configured to interpret data (e.g., magnetic field data) from the sensor(s) to determine the location of the transseptal needle 710. These sensors, in one example, are positioned near the distal end of the transseptal needle 710 during the procedure, and are then typically positioned within the patient's heart. This system, while useful for location purposes, can be enhanced by the present invention.

[0073] 7B shows first and second proximity sensing elements 240a and 240b, which transmit a signal to the navigation system 760 when they are engaged or in close proximity. The signals generated from the elements 240a and 240b provide the navigation system 760 with additional data points for extrapolating the distal-most end of the sheath and, therefore, its location within the patient's heart. For example, without limitation, the first and second proximity sensing elements 240a and 240b can include optical or photosensitive systems, where one of the proximity sensing elements generates an optical signal and the other receives the optical signal when the elements are engaged or in close proximity and then transmits another signal to the navigation system 760 indicating the engagement or proximity.

[0074] In another example, the first proximity sensing element 240a and the second proximity sensing element 240b can include a magnetic sensing system, where one of the proximity sensing elements generates a magnetic field and the other proximity sensing element senses that magnetic field when the elements are engaged or in close proximity, and then transmits a signal indicative of the engagement or proximity to the navigation system 760. In another example, the first proximity sensing element 240a and the second proximity sensing element 240b can include a physically interacting system, where one of the proximity sensing elements has a protrusion (e.g., a tongue, a tooth, a shaft, or a tapered protrusion) and the other proximity sensing element is configured to receive the protrusion (e.g., a groove(s), a pinion, a recess) when the elements are engaged or in close proximity, and then transmits a signal indicative of the engagement or proximity to the navigation system 760.

[0075] FIG. 8 is an illustration of a system 920 for using the guide sheath assembly and / or control handle described herein to implement a method for performing a transseptal puncture. The system 920 can be used during a medical procedure on a heart 922 of a patient 924 to perform a transseptal puncture. The procedure can be performed by one or more operators 926, including medical professionals. The system 920 can be configured to present an image of a cavity, such as the lumen of the heart 922, allowing the operator 926 to visualize features of the cavity. The system 920 can be further configured to present an image of the dilator 750 and / or the transseptal needle 710. The system 920 can further include and / or be configured to control the components of the system 700 shown in FIG. 7A.

[0076] The system 920 can be controlled by a system processor 930, which can be implemented as a general-purpose computer. The processor 930 can be attached to a console 940. The console 940 can include operational controls 942, such as a keypad, and a pointing device, such as a mouse or trackball, that the operator 926 can use to interact with the processor 930. Results of calculations performed by the processor 930 can be provided to the operator on a display 944 connected to the processor 930. The display 944 can further present the operator with a graphic user interface that allows the operator to control the system 920, including an indication of the engagement of the conductive element 24a located at the proximal end 780 of the hemostasis valve 18 with the conductive element 24b on the proximal end 790 of the diagnostic or therapeutic catheter 750. The operator 926 can be configured to use the controls 942 to input values ​​for parameters used by the processor 930 in the operation of the system 920.

[0077] Processor 930 uses computer software to operate system 920. This software may be downloaded to processor 930 in electronic form, for example over a network, or alternatively or additionally, may be provided and / or stored on a non-transitory, tangible, computer-readable medium, such as magnetic, optical, or electronic memory.

[0078] In operation of the system 920, an operator 926 inserts a diagnostic or therapeutic catheter 960 into the patient 24 so that the distal end of the catheter enters the left atrium 916 of the patient's heart via the inferior vena cava 922. The operator 926 delivers a diagnostic or therapeutic catheter 750, such as a dilator 705 and / or a transseptal needle 710, through the diagnostic or therapeutic catheter 750 and into the left atrium 716. The processor 730 can be configured to track the distal end of the transseptal needle 710, typically both the location and orientation of the distal end, while the distal end is within the heart 910. The transseptal needle 710 can include tracking coil(s) at its distal end. The processor 730 can utilize a magnetic tracking system such as that provided by the Carto® system manufactured by Biosense Webster (Irvine, Calif.). The system 920 can include a magnetic field transmitter 966 in proximity to the patient 924 such that the 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 signals that are transmitted to the processor 930, which analyzes the signals to determine the location and orientation of the transseptal needle 710. In one embodiment, the tracking coils and magnetic tracking system can be used to identify the location of the dilator 705 and transseptal needle 710 so that the operator 926 can position them as needed.

[0079] In another embodiment, the operator 926 can insert a diagnostic or therapeutic catheter 750 into the hemostasis valve 18 of the guide sheath assembly 10. Contact and completion of the circuit between the conductive element 24a on the proximal end of the diagnostic or therapeutic catheter 750 and the conductive element 24b on the proximal end of the hemostasis valve 18 serves to allow the location and orientation of the dilator 705 and transseptal needle 710 to be visualized using the system 920. Thus, the operator 926 does not need to irradiate the patient 924 to determine the positioning of the dilator 705 and transseptal needle 710.

[0080] 9 and 10 further illustrate the above concepts. Figure 9 shows an example of a diagnostic or therapeutic catheter 750 and its sheath assembly 10 partially inserted into a hemostasis valve 18. Here, the circuit between conductive elements 24a and 24b is not closed, and therefore there is no identification of the proximal-most end of the diagnostic or therapeutic catheter 750. In Figure 10, the circuit between conductive elements 24a and 24b at the hemostasis valve and proximal ends 780, 790 of the diagnostic or therapeutic catheter is closed, thereby sending a signal to the mapping / navigation system to provide the system with another data point in locating the distal-most end.

[0081] Although the exemplary catheter 750 can be visualized in the mapping / navigation software system 760, many physicians still require the use of fluoroscopy. Fluoroscopy is used because the physician needs to know where the distal-most end of the catheter 750 is located relative to critical structures (e.g., the septum) within the patient's heart. The end of the exemplary therapeutic catheter 750 (e.g., a dilator) is part of a system that first punctures the left atrium and then traverses into the left atrium. The system allows the operator to know exactly where the end of the diagnostic or therapeutic catheter 750 is based on extrapolation from the distal end of the guide sheath assembly 10. What is not currently known by the system 760 to perform this extrapolation is when the diagnostic or therapeutic catheter is fully engaged within the guide sheath assembly 10. By including first and second proximity sensing elements 240a, 240b (e.g., conductive elements 24a, 24b) on the hemostasis valve 18 of the guide sheath assembly 10 and on the luer of the diagnostic or therapeutic catheter 750 that connects to the guide sheath assembly 10, the navigation system 760 can now recognize when the diagnostic or therapeutic catheter 750 is fully engaged with the guide sheath assembly 10. The mapping system 760 recognizes this by the diagnostic or therapeutic catheter 750 having a similar conductive surface on the face of the luer on the hemostasis valve 18 where the diagnostic or therapeutic catheter 750 and the guide sheath assembly 10 connect. The conductive element on the sheath 24b can have an electrical break that can only be completed when the diagnostic or therapeutic catheter 750 is fully engaged and a conductive portion on the end 24b of the diagnostic or therapeutic catheter 750 completes the circuit. There are further examples that allow for the navigation system 760 to be informed of complete engagement between the guide sheath assembly 10 and the diagnostic or therapeutic catheter 750 .Other examples include incorporating sensors or distal rings onto the diagnostic or therapeutic catheter 750 and replacing the conductive surfaces described above with light or other optical sensors, magnetic field sensors, or similar proximity detectors.

[0082] FIG. 11 shows a cross-sectional view of another embodiment of a guide sheath assembly 1010. This guide sheath assembly 1010 includes a sensor 1090 that can be used to detect when the guide sheath assembly 1010 has been inserted to a specific depth. The sensor 1090 can be a conductivity sensor, an optical sensor, or other optical sensor, or a magnetic field sensor. The guide sheath assembly 1010 includes 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 for sealing the sheath 1012 around a catheter tubular body 1022 that extends 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 conduit 1020 and a locking sleeve 1121 from the hub 1014 are provided to, among other things, allow connection of saline or medication and access for other medical procedures. It is understood that a guidewire or diagnostic or therapeutic catheter 750 may also extend through the guide sheath assembly, as is often the case with catheters. 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.

[0083] Attached proximally to the hub is a releasable rotation lock assembly 1030 that includes an end cap 1032 and a user interface 1034. In the embodiment shown in FIG. 11 , the user interface includes a knob 1036. The end cap 1032 is attached to the proximal end of the hub 1014 and covers and secures the hemostasis valve 1016. The end cap 1032 has a distal portion 1038 that snap-fits with a proximal circumferential portion 1040 of the hub 1014. The end cap 1032 has a neck portion 1042 at its proximal end that defines an axial opening 1044 that connects to the central lumen 1015 of the guide sheath assembly 1010. The knob 1036 attached to the neck portion 1042 is shaped as a disk having a periphery 1050 and an outer diameter approximately equal to the outer diameter of the end cap 1032. Knob 1036 has a central bore 1052 that receives neck portion 1042 of end cap 1032 , allowing knob 1036 to be bidirectionally rotatable and adjustable about longitudinal axis 1021 of guide sheath assembly 1010 .

[0084] The rotational lock assembly 1030 further includes a plurality of locking members or prongs 1060 mounted on the proximal surface of the end cap 1032 and adapted to contact and grip the catheter tubular body 1022 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 the other direction. The prongs 1060 are arranged in a radial pattern that is approximately equidistant and equiangular from one another and are each fixedly but rotatably or pivotally (used interchangeably herein) mounted on a respective pin 1064 formed as a protrusion 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 a prong 1060 on the pin 1064 and, in turn, a knob 1036 on the neck portion 1042 of the hub 1014 .

[0085] The openings 1078 allow respective cam actuators or pins 1080 formed as protrusions extending from the proximal face of the knob 1036 to engage with cam portions of the prongs 1060 in coupling the rotational movement of the knob 1036 with the rotational movement of each of the prongs 1060.

[0086] The guide sheath assembly 1010 may also include a conductive element 24a (not shown) on the hemostatic valve 1016 that is 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 1016. This engagement completes a circuit between the hemostatic valve 1016 and the proximal end of the diagnostic or therapeutic catheter 750. This engagement may be indicated by a visual or audio signal provided to a computer system shown in FIG. 8.

[0087] The foregoing description has been presented in connection with the presently preferred embodiments of the present invention. Those skilled in the art and technology to which the present invention pertains will recognize that modifications and variations may be made to the described structures without materially departing from the principles, spirit, and scope of the present invention. Any feature or configuration disclosed in one embodiment may be incorporated in place of, or in addition to, other features of any other embodiment, as necessary or appropriate. Those skilled in the art will appreciate that the drawings are not necessarily to scale. Therefore, the foregoing description should not be read solely in connection with the exact configuration described and illustrated in the accompanying drawings, but rather in accordance with and in support of the following claims, which are to have their fullest and fairest scope.

[0088] [Embodiment] (1) A guide sheath assembly, an elongate shaft defining a lumen extending along a longitudinal axis; a control handle proximal to the shaft, the control handle comprising: a hemostasis valve on the proximal end of the control handle; at least one first conductive element disposed on at least one of the control handle and the hemostasis valve, the at least one first conductive element configured to interact with at least one second conductive element on a diagnostic or therapeutic catheter to complete an electrical circuit; the hemostatic valve; and a control handle connected to the lumen for introducing the diagnostic or therapeutic catheter into the lumen. (2) A guide sheath assembly as described in embodiment 1, wherein the at least one first conductive element is located on the proximal end of the hemostasis valve and the at least one second conductive element is located on the proximal end of the diagnostic or therapeutic catheter. (3) A guide sheath assembly as described in embodiment 1, wherein the circuit can be configured to provide a visual or audible indicator upon completion of the electrical circuit. (4) A guide sheath assembly as described in embodiment 3, wherein the visual indicator or audible indicator can be provided to a system configured to interact with the guide sheath assembly. (5) The guide sheath assembly of embodiment 1, wherein the diagnostic or therapeutic catheter comprises one of a dilator, a transseptal needle, a mapping catheter, and / or an ablation catheter.

[0089] (6) The hemostatic valve is a valve body extending along the longitudinal axis from a proximal portion to a distal portion of the valve body; A guide sheath assembly as described in embodiment 1, further comprising: a sensor positioned adjacent to the proximal portion of the valve body so as to provide an indication of a predetermined insertion distance of the instrument through the lumen when the instrument is inserted into the hemostasis valve. (7) A system comprising: a diagnostic or therapeutic catheter; 1. A guide sheath assembly, comprising: an elongate shaft defining a lumen and extending along a longitudinal axis; a control handle proximal to the shaft, a control knob configured to rotate about the longitudinal axis; a hollow rotatable shaft configured to rotate about the longitudinal axis in response to rotation of the control knob; a hemostatic valve on the proximal end of the control handle and coupled to the lumen; a control handle including at least one first proximity sensing element disposed on at least one of the control handle and the hemostasis valve, the first proximity sensing element configured to interact with a second proximity sensing element disposed on the diagnostic or therapeutic catheter, such that a signal is generated when the first proximity sensing element interacts with the second proximity sensing element; and a guide sheath assembly including: (8) The system of embodiment 7, wherein the first proximity sensing element is located on the proximal end of the hemostatic valve and the second proximity sensing element is located on the proximal end of an expander configured to be inserted into the lumen. (9) The system of embodiment 7, wherein the first proximity sensing element and the second proximity sensing element include a light sensor, an optical sensor, a magnetic field sensor, and a physically interactive element. (10) The system of embodiment 9, wherein the first proximity sensing element includes a protrusion and the second proximity sensing element is configured to receive the protrusion, and engagement or close proximity of the first proximity sensing element and the second proximity sensing element provides a visual indicator and / or an audible indicator.

[0090] (11) The hemostatic valve is A valve body; The system of embodiment 6, further comprising: a sensor disposed on the valve body so as to provide an indication of a predetermined insertion distance of the diagnostic or therapeutic catheter through the lumen when the diagnostic or therapeutic catheter is inserted into the hemostasis valve. (12) A hemostatic valve for a guide sheath assembly, the hemostatic valve comprising: a valve body extending along a longitudinal axis and defining a lumen extending through a portion of the valve body; a branch conduit in communication with the lumen; a seal inserted into the lumen to separate a proximal portion and a distal portion of the valve body, the distal portion communicating with the branch conduit; and a sensor positioned adjacent the proximal portion of the valve body to provide an indication of a predetermined insertion distance of the instrument through the lumen when the instrument is inserted into the hemostasis valve. (13) A hemostatic valve as described in embodiment 12, wherein the sensor is selected from the group consisting of a conductivity sensor, an optical sensor, an optical sensor, a magnetic field sensor, and combinations thereof. (14) A guide sheath assembly, an elongate shaft defining a lumen extending along a longitudinal axis; a control handle proximal to the shaft, the control handle comprising: A hemostasis valve; a control handle including a sensor disposed proximate to the hemostasis valve so as to provide an indication of a predetermined insertion distance of the instrument through the lumen when the instrument is inserted through the hemostasis valve; The hemostasis valve is a valve body extending along a longitudinal axis and defining a lumen extending through a portion of the valve body; a branch conduit in communication with the lumen; a seal inserted into the lumen to separate a proximal portion and a distal portion of the valve body, the distal portion being in communication with the branch conduit. (15) The guide sheath assembly of embodiment 14, wherein the sensor is selected from the group consisting of a conductivity sensor, an optical sensor, an optical sensor, a magnetic field sensor, and combinations thereof.

[0091] (16) The guide sheath assembly of embodiment 14, wherein the device comprises a guidewire or a diagnostic or therapeutic catheter. (17) The guide sheath assembly of embodiment 16, wherein the diagnostic or therapeutic catheter comprises a dilator, a transseptal needle, a mapping catheter, and / or an ablation catheter. (18) The first proximity sensing element and the second proximity sensing element are conductive elements; the first conductive element is located on the proximal end of the hemostasis valve and projects either outward or inward to complete the circuit with at least one second conductive element on the proximal end of the diagnostic or therapeutic catheter; the outward direction is away from a central lumen of the control handle; A guide sheath assembly as described in embodiment 1, wherein the inward direction is toward the central lumen of the control handle. (19) The system described in embodiment 7, wherein the hemostatic valve further comprises at least one first conductive element, and the diagnostic or therapeutic catheter further comprises at least one second conductive element, and the at least one first conductive element is configured to interact with the at least one second conductive element to complete an electrical circuit. (20) A hemostatic valve as described in embodiment 12, wherein the hemostatic valve further comprises a first conductive element and the diagnostic or therapeutic catheter further comprises a second conductive element.

Claims

1. 1. A guide sheath assembly, comprising: an elongate shaft defining a lumen extending along a longitudinal axis; a control handle proximal to the shaft, the control handle comprising: a hemostasis valve on the proximal end of the control handle; at least one first conductive element disposed on at least one of the control handle and the hemostasis valve, the at least one first conductive element configured to interact with at least one second conductive element on a diagnostic or therapeutic catheter to complete an electrical circuit; the hemostatic valve comprises a control handle connected to the lumen for introducing the diagnostic or therapeutic catheter into the lumen; one of the at least one first conductive element and the at least one second conductive element is a pin, and the other of the at least one first conductive element and the at least one second conductive element is a socket capable of receiving the pin, the socket having a hole that allows fluid within the socket to flow out of the socket when the pin is received in the socket.

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

3. The guide sheath assembly of claim 1 , wherein the electrical circuit is configurable to provide a visual or audible indicator upon completion of the electrical circuit.

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

5. The guide sheath assembly of claim 1 , wherein the diagnostic or therapeutic catheter comprises one of a dilator, a transseptal needle, a mapping catheter, and / or an ablation catheter.

6. The hemostasis valve is a valve body extending along the longitudinal axis from a proximal portion to a distal portion of the valve body; 10. The guide sheath assembly of claim 1, further comprising: a sensor disposed proximate the proximal portion of the valve body to provide an indication of a predetermined insertion distance of the instrument through the lumen when the instrument is inserted into the hemostasis valve.

7. 1. A system comprising: a diagnostic or therapeutic catheter; 1. A guide sheath assembly, comprising: an elongate shaft defining a lumen and extending along a longitudinal axis; a control handle proximal to the shaft, a control knob configured to rotate about the longitudinal axis; a hollow rotatable shaft configured to rotate about the longitudinal axis in response to rotation of the control knob; a hemostatic valve on the proximal end of the control handle and coupled to the lumen; a guide sheath assembly including a control handle including at least one first proximity sensing element disposed on at least one of the control handle and the hemostasis valve, the at least one first proximity sensing element configured to interact with a second proximity sensing element disposed on the diagnostic or therapeutic catheter such that a signal is generated when the first proximity sensing element interacts with the second proximity sensing element; a system in which one of the first proximity sensing element and the second proximity sensing element is a pin, and the other of the first proximity sensing element and the second proximity sensing element is a socket capable of receiving the pin, the socket having a hole that allows fluid within the socket to flow out of the socket when the pin is received in the socket.

8. 8. The system of claim 7, wherein the first proximity sensing element is located on a proximal end of the hemostatic valve and the second proximity sensing element is located on a proximal end of a dilator configured to be inserted into the lumen.

9. The system of claim 7 , wherein the first proximity sensing element and the second proximity sensing element include a light sensor, an optical sensor, a magnetic field sensor, and a physically interactive element.

10. The system of claim 9, wherein engagement or close proximity of the first proximity sensing element and the second proximity sensing element provides a visual indicator and / or an audible indicator.

11. The hemostasis valve is A valve body; 8. The system of claim 7, further comprising: a sensor disposed on the valve body to provide an indication of a predetermined insertion distance of the diagnostic or therapeutic catheter through the lumen when the diagnostic or therapeutic catheter is inserted into the hemostasis valve.

12. The at least one first conductive element is located on the proximal end of the hemostatic valve and protrudes either outward or inward to complete the electrical circuit with the at least one second conductive element on the proximal end of the diagnostic or therapeutic catheter; the outward direction is away from a central lumen of the control handle; The guide sheath assembly of claim 1 , wherein the inward direction is toward the central lumen of the control handle.

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