Operable medical devices

Abstract

To provide a method and apparatus for a steerable catheter control handle for deflecting a catheter.SOLUTION: A control handle 200 comprises an actuator and means for deflecting a catheter 90 upon actuation of the actuator, the means for deflecting being coupled to the actuator. The control handle further comprises an inefficiency generator configured to interact with the means for deflecting the catheter, where the inefficiency generator provides increasing resistance to actuation, requiring increasing force required to actuate the actuator upon increasing deflection of the catheter.SELECTED DRAWING: Figure 1A

Description

[Technical field]

[0001] The present disclosure relates to a handle for a steerable medical instrument, more particularly, to a handle for a steerable medical instrument that provides an inefficiency generator configured to interact with a means for converting actuation of an actuator into deflection of the steerable instrument.

[0002] In order that the invention may be readily understood, embodiments thereof are illustrated in the accompanying drawings. [Brief description of the drawings]

[0003] [Figure 1A] FIG. 1A is an illustration of a steerable catheter control handle, according to one embodiment of the present invention. [Figure 1B] FIG. 1B is an illustration of a steerable catheter control handle, according to one embodiment of the present invention. [Figure 2A] FIG. 2A is an illustration of a steerable catheter control handle, according to one embodiment of the present invention. [Figure 2B] FIG. 2B is an illustration of a steerable catheter control handle, according to one embodiment of the present invention. [Diagram 3] FIG. 3 is a diagram of a steerable catheter control handle, according to one embodiment of the present invention. [Figure 4A] FIG. 4A is a diagram of a steerable catheter control handle, according to one embodiment of the present invention. [Figure 4B] FIG. 4B is a diagram of a steerable catheter control handle, according to one embodiment of the present invention. [Figure 4C] FIG. 4C is a diagram of a steerable catheter control handle, according to one embodiment of the present invention. [Figure 5A] FIG. 5A is a diagram of a steerable catheter control handle, according to one embodiment of the present invention. [Figure 5B] FIG. 5B is a diagram of a steerable catheter control handle, according to one embodiment of the present invention. [Figure 5C] FIG. 5C is a diagram of a steerable catheter control handle, according to one embodiment of the present invention. [Figure 6A] FIG. 6A is an illustration of a steerable catheter assembly, according to one embodiment of the present invention. [Figure 6B] FIG. 6B is an illustration of a steerable catheter assembly, according to one embodiment of the present invention. [Figure 6C] FIG. 6C is an illustration of a steerable catheter assembly according to one embodiment of the present invention. [Figure 7A] FIG. 7A is an illustration of a steerable catheter control handle, according to one embodiment of the present invention. [Figure 7B] FIG. 7B is an illustration of a steerable catheter control handle, according to one embodiment of the present invention. [Figure 7C] FIG. 7C is an illustration of a steerable catheter control handle, according to one embodiment of the present invention. [Figure 7D] FIG. 7D is an illustration of a steerable catheter control handle, according to one embodiment of the present invention. [Figure 8A] FIG. 8A is a diagram of a steerable catheter control handle according to an alternative embodiment of the present invention. [Figure 8B] FIG. 8B is a diagram of a steerable catheter control handle according to an alternative embodiment of the invention. [Figure 8C] FIG. 8C is a diagram of a steerable catheter control handle according to an alternative embodiment of the invention. [Figure 8D] FIG. 8D is a diagram of a steerable catheter control handle according to an alternative embodiment of the invention. [Figure 9A] FIG. 9A is an illustration of a steerable catheter control handle according to an alternative embodiment of the present invention. [Figure 9B] FIG. 9B is an illustration of a steerable catheter control handle according to an alternative embodiment of the present invention. [Figure 9C] FIG. 9C is an illustration of a steerable catheter control handle according to an alternative embodiment of the present invention. [Figure 10A] FIG. 10A is an illustration of a steerable catheter control handle according to an alternative embodiment of the present invention. [Figure 10B] FIG. 10B is an illustration of a steerable catheter control handle according to an alternative embodiment of the present invention. [Figure 11A] FIG. 11A is a diagram of an inefficiency generator for a steerable catheter control handle, according to an alternative embodiment of the present invention. [Figure 11B] FIG. 11B is a diagram of an inefficiency generator for a steerable catheter control handle, according to an alternative embodiment of the present invention. [Figure 11C] FIG. 11C is a diagram of an inefficiency generator for a steerable catheter control handle, according to an alternative embodiment of the present invention. [Figure 11D] FIG. 11D is a diagram of an inefficiency generator for a steerable catheter control handle, according to an alternative embodiment of the present invention. [Figure 12A] FIG. 12A is a diagram of an inefficiency generator for a steerable catheter control handle, according to an alternative embodiment of the present invention. [Figure 12B] FIG. 12B is a diagram of an inefficiency generator for a steerable catheter control handle, according to an alternative embodiment of the present invention. [Figure 12C] FIG. 12C is a diagram of an inefficiency generator for a steerable catheter control handle, according to an alternative embodiment of the present invention. [Figure 12D] FIG. 12D is a diagram of an inefficiency generator for a steerable catheter control handle, according to an alternative embodiment of the present invention. [Figure 12E] FIG. 12E is a diagram of an inefficiency generator for a steerable catheter control handle, according to an alternative embodiment of the present invention. [Figure 12F] FIG. 12F is a diagram of an inefficiency generator for a steerable catheter control handle, according to an alternative embodiment of the present invention. [Figure 13A]FIG. 13A is an illustration of an inefficiency generator for a steerable catheter control handle, according to an alternative embodiment of the present invention. [Figure 13B] FIG. 13B is an illustration of an inefficiency generator for a steerable catheter control handle, according to an alternative embodiment of the present invention. [Figure 13C] FIG. 13C is an illustration of an inefficiency generator for a steerable catheter control handle, according to an alternative embodiment of the present invention. [Figure 13D] FIG. 13D is an illustration of an inefficiency generator for a steerable catheter control handle, according to an alternative embodiment of the present invention. [Figure 14A] FIG. 14A is a diagram of an inefficiency generator for a steerable catheter control handle, according to an alternative embodiment of the present invention. [Figure 14B] FIG. 14B is a diagram of an inefficiency generator for a steerable catheter control handle, according to an alternative embodiment of the present invention. [Figure 14C] FIG. 14C is a diagram of an inefficiency generator for a steerable catheter control handle, according to an alternative embodiment of the present invention. [Figure 14D] FIG. 14D is a diagram of an inefficiency generator for a steerable catheter control handle, according to an alternative embodiment of the present invention. [Figure 14E] FIG. 14E is a diagram of an inefficiency generator for a steerable catheter control handle, according to an alternative embodiment of the present invention. [Figure 14F] FIG. 14F is a diagram of an inefficiency generator for a steerable catheter control handle, according to an alternative embodiment of the present invention. [Figure 15A] 15A-15D are diagrams of an inefficiency generator for a steerable catheter control handle, according to an alternative embodiment of the present invention. [Figure 15B] FIG. 15B is a diagram of an inefficiency generator for a steerable catheter control handle, according to an alternative embodiment of the present invention. [Figure 15C]FIG. 15C is a diagram of an inefficiency generator for a steerable catheter control handle, according to an alternative embodiment of the present invention. [Figure 15D] FIG. 15D is a diagram of an inefficiency generator for a steerable catheter control handle, according to an alternative embodiment of the present invention. [Figure 16A] FIG. 16A is an illustration of an inefficiency generator for a steerable catheter control handle, according to an alternative embodiment of the present invention. [Figure 16B] FIG. 16B is an illustration of an inefficiency generator for a steerable catheter control handle, according to an alternative embodiment of the present invention. [Figure 16C] FIG. 16C is an illustration of an inefficiency generator for a steerable catheter control handle, according to an alternative embodiment of the present invention. [Figure 16D] FIG. 16D is an illustration of an inefficiency generator for a steerable catheter control handle, according to an alternative embodiment of the present invention. [Figure 17A] FIG. 17AC is a diagram of an inefficiency generator for a steerable catheter control handle, according to an alternative embodiment of the present invention. [Figure 17B] FIG. 17BC is a diagram of an inefficiency generator for a steerable catheter control handle, according to an alternative embodiment of the present invention. [Figure 17C] FIG. 17C is a diagram of an inefficiency generator for a steerable catheter control handle, according to an alternative embodiment of the present invention. [Figure 18A] FIG. 18A is a diagram of an inefficiency generator for a steerable catheter control handle, according to an alternative embodiment of the present invention. [Figure 18B] FIG. 18B is a diagram of an inefficiency generator for a steerable catheter control handle, according to an alternative embodiment of the present invention. [Figure 18C] FIG. 18C is a diagram of an inefficiency generator for a steerable catheter control handle, according to an alternative embodiment of the present invention. [Figure 19A]FIG. 19A is an illustration of an inefficiency generator for a steerable catheter control handle, according to an alternative embodiment of the present invention. [Figure 19B] FIG. 19B is an illustration of an inefficiency generator for a steerable catheter control handle, according to an alternative embodiment of the present invention. [Figure 19C] FIG. 19C is an illustration of an inefficiency generator for a steerable catheter control handle, according to an alternative embodiment of the present invention. [Figure 20A] 20A-20C are diagrams of an inefficiency generator for a steerable catheter control handle, according to an alternative embodiment of the present invention. [Figure 20B] FIG. 20B is a diagram of an inefficiency generator for a steerable catheter control handle, according to an alternative embodiment of the present invention. [Figure 20C] FIG. 20C is a diagram of an inefficiency generator for a steerable catheter control handle, according to an alternative embodiment of the present invention. [Figure 21A] FIG. 21A is an illustration of an inefficiency generator for a steerable catheter control handle, according to an alternative embodiment of the present invention. [Figure 21B] FIG. 21B is an illustration of an inefficiency generator for a steerable catheter control handle, according to an alternative embodiment of the present invention. [Figure 21C] FIG. 21C is an illustration of an inefficiency generator for a steerable catheter control handle, according to an alternative embodiment of the present invention. [Figure 22A] FIG. 22A is an illustration of a steerable catheter control handle according to an alternative embodiment of the present invention. [Figure 22B] FIG. 22B is an illustration of a steerable catheter control handle according to an alternative embodiment of the present invention. [Figure 23A] FIG. 23A is an illustration of a threaded slider mechanism according to an alternative embodiment of the present invention. [Figure 23B] FIG. 23B is an illustration of a threaded slider mechanism according to an alternative embodiment of the present invention. [Figure 23C]FIG. 23C is an illustration of a threaded slider mechanism according to an alternative embodiment of the present invention. [Figure 24A] FIG. 24A is an illustration of an alternative embodiment of a threaded slider mechanism with increased pitch and a corresponding threaded inner knob, according to one embodiment of the present invention. [Figure 24B] FIG. 24B is an illustration of an alternative embodiment of a threaded slider mechanism with increased pitch and a corresponding threaded inner knob, according to one embodiment of the present invention. [Figure 24C] FIG. 24C is an illustration of an alternative embodiment of a threaded slider mechanism with increased pitch and a corresponding threaded inner knob, according to one embodiment of the present invention. [Figure 24D] FIG. 24D is an illustration of an alternative embodiment of a threaded slider mechanism with increased pitch and a corresponding threaded inner knob, according to one embodiment of the present invention. [Figure 24E] FIG. 24E is an illustration of an alternative embodiment of a threaded slider mechanism with increased pitch and a corresponding threaded inner knob, according to one embodiment of the present invention. [Figure 24F] FIG. 24F is an illustration of an alternative embodiment of a threaded slider mechanism with increased pitch and a corresponding threaded inner knob, according to one embodiment of the present invention. [Figure 25A] FIG. 25A is an illustration of an alternative embodiment of a threaded slider mechanism with increased pitch and a corresponding threaded inner knob, according to one embodiment of the present invention. [Figure 25B] FIG. 25B is an illustration of an alternative embodiment of a threaded slider mechanism with increased pitch and a corresponding threaded inner knob, according to one embodiment of the present invention. [Figure 25C] FIG. 25C is an illustration of an alternative embodiment of a threaded slider mechanism with increased pitch and a corresponding threaded inner knob, according to one embodiment of the present invention. [Figure 25D] FIG. 25D is an illustration of an alternative embodiment of a threaded slider mechanism with increased pitch and a corresponding threaded inner knob, according to one embodiment of the present invention. [Figure 25E]FIG. 25E is an illustration of an alternative embodiment of a threaded slider mechanism with increased pitch and a corresponding threaded inner knob, according to one embodiment of the present invention. [Figure 25F] FIG. 25F is an illustration of an alternative embodiment of a threaded slider mechanism with increased pitch and a corresponding threaded inner knob, according to one embodiment of the present invention. [Figure 26A] FIG. 26A is a diagram of an alternative embodiment of a threaded slider mechanism having reverse threads and a corresponding threaded inner knob, in accordance with one embodiment of the present invention. [Figure 26B] FIG. 26B is an illustration of an alternative embodiment of a threaded slider mechanism having reverse threads and a corresponding threaded inner knob, in accordance with one embodiment of the present invention. [Figure 26C] FIG. 26C is a diagram of an alternative embodiment of a threaded slider mechanism having reverse threads and a corresponding threaded inner knob, in accordance with one embodiment of the present invention. [Figure 26D] FIG. 26D is a diagram of an alternative embodiment of a threaded slider mechanism having reverse threads and a corresponding threaded inner knob, in accordance with one embodiment of the present invention. [Figure 26E] FIG. 26E is a diagram of an alternative embodiment of a threaded slider mechanism having reverse threads and a corresponding threaded inner knob, in accordance with one embodiment of the present invention. [Figure 26F] FIG. 26F is an illustration of an alternative embodiment of a threaded slider mechanism having reverse threads and a corresponding threaded inner knob, in accordance with one embodiment of the present invention. [Figure 27A] FIG. 27A is a side view of a slide assembly for use in a manipulable control handle showing a first indicator portion that functions to provide neutral zone feedback according to one embodiment of the present invention. [Figure 27B] FIG. 27B is a bottom view of a slide assembly for use in a manipulable control handle showing a first indicator portion operable to provide feedback, according to one embodiment of the present invention. [Figure 27C]FIG. 27C is a close-up view of a slide assembly for use in a manipulable control handle showing a first indicator portion for providing feedback, according to one embodiment of the present invention. [Figure 27D] FIG. 27D is a side view of the inner housing of the manipulable control handle showing a second indicator portion according to one embodiment of the present invention. [Figure 27E] FIG. 27E is a top view of an inner housing of a manipulable control handle, the inner housing configured to provide feedback, in accordance with an embodiment of the present invention. [Figure 28A] FIG. 28A is an illustration of a feedback mechanism for a manipulable control handle, according to an alternative embodiment of the present invention. [Figure 28B] FIG. 28B is an illustration of a feedback mechanism for a manipulable control handle, according to an alternative embodiment of the present invention. [Figure 28C] 28C-28E are illustrations of feedback mechanisms for manipulable control handles according to alternative embodiments of the present invention. [Figure 28D] FIG. 28D is an illustration of a feedback mechanism for a manipulable control handle, according to an alternative embodiment of the present invention. [Figure 28E] FIG. 28E is an illustration of a feedback mechanism for a manipulable control handle, according to an alternative embodiment of the present invention. [Figure 29A] FIG. 29A is an illustration of a feedback mechanism for a manipulable control handle, according to an alternative embodiment of the present invention. [Figure 29B] FIG. 29B is an illustration of a feedback mechanism for a manipulable control handle, according to an alternative embodiment of the present invention. [Figure 29C] FIG. 29C is an illustration of a feedback mechanism for a manipulable control handle, according to an alternative embodiment of the present invention. [Figure 29D] FIG. 29D is an illustration of a feedback mechanism for a manipulable control handle, according to an alternative embodiment of the present invention. [Figure 29E] FIG. 29E is an illustration of a feedback mechanism for a manipulable control handle, according to an alternative embodiment of the present invention. [Figure 30A] FIG. 30A is an illustration of a feedback mechanism for a manipulable control handle, according to an alternative embodiment of the present invention. [Figure 30B] FIG. 30B is an illustration of a feedback mechanism for a manipulable control handle, according to an alternative embodiment of the present invention. [Figure 31A] FIG. 31A is an illustration of a feedback mechanism for a manipulable control handle, according to an alternative embodiment of the present invention. [Figure 31B] FIG. 31B is an illustration of a feedback mechanism for a manipulable control handle, according to an alternative embodiment of the present invention. [Figure 31C] FIG. 31C is an illustration of a feedback mechanism for a manipulable control handle, according to an alternative embodiment of the present invention. [Figure 32A] FIG. 32A is an illustration of a feedback mechanism for a manipulable control handle, according to an alternative embodiment of the present invention. [Figure 32B] FIG. 32B is an illustration of a feedback mechanism for a manipulable control handle, according to an alternative embodiment of the present invention. [Figure 32C] FIG. 32C is an illustration of a feedback mechanism for a manipulable control handle, according to an alternative embodiment of the present invention. [Figure 33A] FIG. 33A is an illustration of a feedback mechanism for a manipulable control handle, according to an alternative embodiment of the present invention. [Figure 33B] FIG. 33B is an illustration of a feedback mechanism for a manipulable control handle, according to an alternative embodiment of the present invention. [Figure 33C] FIG. 33C is an illustration of a feedback mechanism for a manipulable control handle according to an alternative embodiment of the present invention. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0004] Some medical procedures may use steerable catheters to reach a desired location within a patient's body. The steerable catheter may be deflectable upon actuation of a steerable catheter control handle. Some such steerable catheter control handles include actuation mechanisms that do not provide adequate feedback to allow a user to ascertain the degree of deflection of the steerable sheath. Furthermore, some actuation mechanisms are unable to retain the curvature or position of the sheath once the desired degree of deflection or curvature is achieved. Furthermore, some prior art actuation mechanisms that do not provide adequate feedback may result in breakage or failure of the pull wire because the user may not be able to ascertain that excessive force is being applied to the pull wire.

[0005] For example, a maneuverable catheter control handle may include a mechanical actuation mechanism, e.g., a rotatable knob, whose rotation is translated into linear movement of one or more components within the handle assembly using a threadable fitting. The movement of the one or more components actuates one or more pull wires, resulting in deflection of the distal tip of the catheter. Typically, such systems utilize a square thread to provide a high level of mechanical efficiency in translating rotational motion into linear translation with little loss of energy.

[0006] However, in some such systems with a high level of mechanical efficiency, the reverse conversion of motion from linear to rotational can also be very efficient, such that when the system is under tension, tension in the pull wire and catheter can result in a reverse linear conversion of one or more components resulting in reverse rotation of the control knob when the catheter is deflected. In other words, due to the high efficiency of the system, when the components of the handle assembly are loaded by the pull wire tension, the components can be effectively back-driven to unwind the knob, which can cause the handle to fail to maintain the curvature of the sheath. This results in a loss of positioning when the user releases their grip on the knob. Thus, systems that utilize components that are efficient in rotational to linear movement typically do not self-lock upon actuation, and the desired position of the catheter is not maintained after the desired deflection.

[0007] Furthermore, another problem encountered with efficient components used in control handles is that the level of feedback provided by the handle may not be sufficient to provide the user with feedback on what is happening at the distal tip of the catheter. In such systems, the user can rotate the knob relatively easily, even when the pull wire tension is high, due to the efficiencies within the system. As a result, there is little tactile feedback available to the user, and the user may not be able to easily determine how much the catheter has been deflected. In some such embodiments, the force / deflection graph of the rotational force it takes to cause a deflection of the catheter has a gradual slope, and the difference between the tactile feedback obtained at minimum and maximum deflection of the catheter is insufficient for the user to easily distinguish, so the user does not receive the desired level of tactile feedback. Furthermore, the system may not provide sufficient feedback to allow the user to ascertain how much the catheter is being deflected, and thus the user may not be able to ascertain whether excessive force is being applied to the pull wire.

[0008] In other words, some prior art steerable sheath handle mechanisms cannot reliably maintain maximum sheath curvature when dilators and needles are inserted. Some prior art systems do not provide tactile feedback. Some such prior art systems based on rotational actuation may have very high mechanical efficiency in translating the knob into linear motion of one or more components, which tensions the sheath pull wire and curves the sheath. When the efficiency of this motion translation is high, the user can easily rotate the knob to move one or more components, even when the pull wire tension is high, resulting in no or minimal tactile feedback. High efficiency also means that when one or more components are under load from the pull wire tension, the knob can be effectively driven back to rewind the knob, which prevents the handle from maintaining the sheath curvature.

[0009] As will now be described, the inventors have discovered and invented unique system embodiments for converting or translating actuator actuation into catheter deflection. For example, the inventors have invented unique system embodiments for converting or translating actuator actuation into pull wire movement, such as a means for deflecting one or more pull wires coupled to an actuator. In some such instances, the inventive system may be a single step rotation to linear system. In other instances, the inventive system may be a two step rotation to linear system.

[0010] In some aspects of the present invention, the inventors have discovered and invented aspects of a unique system for a rotation to straight system that allows for confirmation of the degree of deflection of the steerable sheath and / or maintaining the curvature or position of the sheath after the desired degree of deflection or curvature has been achieved. For example, some embodiments enhance the tactile sensation difference between the minimum deflection of the catheter and the maximum deflection of the catheter. Some embodiments further provide an optimized handle design that facilitates handling and ease of use for the physician. Some embodiments may provide sufficient feedback to the user that the physician may be more cautious as the catheter is deflected more, which may help minimize failure of the control wire or pull wire (and may help minimize failure due to the pull wire or control wire being disconnected from the pull ring).

[0011] In accordance with certain specific embodiments of the present invention, a unique steerable catheter handle assembly is described that provides a means for reducing efficiency, or in other words, introducing inefficiency, as a component of the rotatable to linear conversion mechanism.

[0012] Some embodiments of the present invention provide a steerable catheter control handle, and in some embodiments, a means of introducing inefficiencies in rotation to the linear translation system may be provided that may provide feedback regarding catheter deflection at the distal tip. In some such examples, the mechanism may be incorporated into the steerable handle. Some embodiments of the present invention may provide a weighted operation that may inform the user of the relative degree of sheath curvature as well as the neutral zone position (which may be ascertained by when the knob is easiest to turn). In some such embodiments, the means of reducing efficiency or introducing inefficiencies into the mechanical translation system may provide tactile feedback taken directly from the path of rotation to the linear system itself to get a true view of what is happening at the distal tip of the catheter. In some such examples, the mechanism interacts directly with the path of rotation to the linear system coupled to the pull wire [coupled to the catheter] to provide the user with actual feedback to provide an indication of distal tip deflection.

[0013] Some embodiments of the invention may provide a system with a means for reducing efficiency or introducing inefficiencies built into the translation mechanism to allow the catheter to substantially maintain its position after it is deflected. In some such instances, the system for introducing inefficiencies may, for example, introduce sufficient friction into the system to maintain the position of the sheath or catheter after it is deflected. Some embodiments of the invention may provide a system that allows the catheter to self-lock after it is deflected.

[0014] In some such embodiments of the invention, a means of reducing efficiency or introducing inefficiency may be provided that may allow the position of the catheter to be maintained after deflection and may provide feedback using the same system. Thus, in some embodiments, a system or mechanism for introducing inefficiency may be provided that may be incorporated into the rotational-to-linear conversion system to reduce the mechanical efficiency of the conversion. In some such aspects, the system for reducing efficiency or introducing inefficiency may allow the opportunity for feedback and may enable curve holding using the same mechanism.

[0015] In some embodiments of a system that introduces inefficiencies, such as an inefficiency generator, there is increased resistance to actuation, resulting in increased force or increased force actuating the actuator as the catheter deflection increases, which can provide one or more benefits of providing feedback of curve deflection and / or curve retention.

[0016] In some such embodiments, the steerable catheter control handle utilizes a threadable engagement to translate the rotational motion of the knob into a linear motion of the slide assembly that actuates one or more pull wires to deflect a portion of the catheter. In certain instances, the threaded engagement between the knob and slide assembly is provided by an angled thread that serves as a means to reduce the efficiency of the system, or an inefficient introduction system that provides sufficient tactile feedback from the catheter deflection and yet allows the catheter deflection to be maintained. As the sheath is actuated, actuation becomes more and more difficult, giving the user a sense of what is happening at the distal tip. In other words, an inefficient introduction system increases the resistance to actuation, and increasing catheter deflection increases the force to actuate the actuator. In some such instances, a threadable engagement including an angled thread can provide actual feedback regarding the catheter deflection, e.g., the deflection of the distal tip of the catheter. In some such instances, the threadable configuration provides an inefficiency in the system that prevents reverse movement of the slide assembly. In some such instances, the system for reducing mechanical efficiency may provide a self-locking mechanism so that once the catheter is deflected to a desired level of deflection, it is difficult to move the position of the catheter in the absence of force from the user or rotation of the knob by the user.

[0017] Thus, the inventors have discovered that by providing an inefficiency generator in the rotation of the linear translation system itself, the system is easier to manufacture, is more robust, uses fewer components and is therefore less prone to breakage, and can provide the user with true feedback of the catheter's deflection from the system itself. However, by changing the angle of the threads, it increases the slope of the force / deflection graph, increasing the force sensation between the minimum and maximum deflection of the catheter. In this way, the user gets better tactile feedback and can better ascertain the level of deflection at the distal end.

[0018] Other embodiments of the invention may provide means to introduce inefficiencies or reduce efficiencies that may interact with rotation to a linear system. In some such embodiments, an inefficiency generator may be provided that provides a feedback mechanism that provides simulated feedback to provide the user with a picture of what is happening at the distal tip of the catheter. In some such examples, the feedback mechanism may be incorporated into the maneuverable handle. In some such examples, the feedback mechanism may indirectly interact with the path of rotation to a linear system to provide simulated feedback to the user to provide an indication of distal tip deflection.

[0019] In some embodiments of the invention, the introduction of an inefficiency generator allows the physician to curve the steerable sheath or catheter with a dilator and needle inserted, and the inefficiency generator allows the steerable sheath handle to maintain the sheath curve under higher pull wire tension.

[0020] Additionally, some embodiments of the present invention employing an inefficiency generator provide sufficient tactile feedback to allow the physician to rely on tactile feedback from knob rotation to know the relative sheath curvature and the sheath neutral zone. In particular, this tactile feedback means that as the sheath curvature increases, the knob becomes more difficult to turn. This "weighted operation" informs the user not only of the relative sheath curvature, but also the location of the neutral zone (i.e., when the knob is easiest to turn).

[0021] In one broad aspect, an embodiment of the invention comprises a manipulable catheter control handle for deflecting a catheter. The control handle comprises an actuator, one or more pull wires, and a means for converting actuation of the actuator into movement of the pull wires to deflect the pull wires. A distal end of each of the one or more pull wires is coupled to the catheter and a proximal end of each of the pull wires is coupled to the means for deflecting the pull wires. The control handle further includes an inefficiency generator for interacting with the means for deflecting the pull wires, the inefficiency generator substantially increasing the force required to actuate the actuator to deflect the catheter.

[0022] In another broad aspect, an embodiment of the invention includes a manipulable catheter control handle for deflecting a catheter, the control handle including an actuator and a means for deflecting the catheter upon actuation of the actuator, the means for deflecting the catheter being coupled to the actuator, the manipulable catheter control handle further including an inefficiency generator configured to interact with the means for deflecting the catheter, the inefficiency generator increasing resistance to actuation and increasing the force required to actuate the actuator upon increasing deflection of the catheter.

[0023] As a feature of this broad aspect, the force required to actuate varies substantially based on the amount of catheter deflection.

[0024] As another feature of this broad aspect, the force required for actuation varies substantially based on the amount of actuation of the actuator.

[0025] As yet another feature of this broad aspect, the inefficiency generator allows for weighting manipulation by providing feedback to the user regarding the relative degree of catheter deflection.

[0026] As an example of this feature, the inefficiency generator enables curvature retention, allowing the catheter deflection to be maintained at substantially a desired curvature after the catheter is deflected, and enables self-locking, allowing the catheter deflection to be maintained in the absence of actuator actuation, such that the force required to actuate is greater than the force exerted on the actuator by one or more pull wires from the catheter deflection.

[0027] As yet another feature of this broad aspect, the inefficiency generator enables curve retention, which allows the catheter deflection to be maintained substantially at a desired curvature after the catheter is deflected. As one example of this feature, the inefficiency generator enables self-locking such that the force required to actuate is greater than the force exerted by the catheter on the actuator from the catheter deflection, allowing the catheter deflection to be maintained in the absence of actuator actuation (in some such examples, where the catheter includes a pull wire and the actuator is operable to deflect the pull wire, the inefficiency generator enables self-locking such that the force required to actuate is greater than the force exerted by the pull wire on the actuator from the catheter deflection).

[0028] As another feature of this aspect, the means for deflecting the catheter includes a rotation to linear translation system. In some such examples, where the catheter includes a pull wire and the actuator is operable to deflect the pull wire, the means for deflecting the catheter includes a rotation to linear translation system.

[0029] As one example of this feature, the actuator comprises a rotatable knob and the means for deflecting the catheter comprises a rotational-linear conversion system comprising a slide assembly coupled to the rotatable knob via a threadable fitting (in some such examples, the catheter comprises a pull wire operable by the actuator to deflect the pull wire and the means for deflecting the pull wire comprises a rotational-linear conversion system comprising a slide assembly coupled to the rotatable knob via a threadable fitting).

[0030] In one such embodiment, the inefficiency generator includes one or more angled threads that define a threadable engagement. In this particular embodiment, the threadable engagement is defined by an external angled thread on the shaft of the slide assembly and a corresponding internal angled thread on the knob that is matable therewith.

[0031] In one example of this embodiment, the angled thread has an angle greater than about 0 degrees and less than about 180 degrees.

[0032] In one such example, the angled thread has an angle greater than about 160 degrees and less than about 180 degrees. In this particular example, the angled thread has an angle of between about 160° and 163°.

[0033] In some embodiments, the inefficiency generator provides actual feedback of the catheter deflection, hi other embodiments, the inefficiency generator provides simulated feedback of the catheter deflection.

[0034] In some embodiments of the invention, the slide assembly is movable within an inner housing of the steerable catheter control handle.

[0035] In one example of this, the inefficiency generator includes a gradient friction device positioned within the handle housing that interacts with the slide assembly as it moves, increasing friction as the linear movement of the slide assembly increases within the inner housing upon deflection of the catheter.

[0036] In this particular example, the gradient friction device includes opposing triangular friction pads positioned along the inner surface of the handle housing. In this one example, the triangular friction pads are disposed along one or more walls of the inner housing.

[0037] In this alternative example, the inefficiency generator is defined by an inner housing having opposing walls that taper from one another from a center of the inner housing toward the proximal and distal ends of the inner housing, and a sliding assembly that increases friction between the sliding assembly and the opposing walls of the inner housing upon increasing linear movement of the sliding assembly within the inner housing upon deflection of the catheter.

[0038] In this embodiment, the slide assembly is matable with the wall of the inner housing via a biasing mechanism, which in this particular example includes a spring biasing mechanism.

[0039] In one embodiment, the rotation to the linear translation system comprises a single step rotation to the linear translation system, hi another embodiment, the rotation to the linear translation system comprises a two step rotation to the linear translation system.

[0040] As a feature of this broad aspect, the maneuverable catheter control handle includes a bidirectional control handle, the means for deflecting the catheter is coupled to the catheter via one or more pull wires and includes means for deflecting the one or more pull wires, the one or more pull wires comprising two pull wires, actuation of the actuator in first and second directions causes deflection of the pull wires, deflecting the catheter via actuation of the respective pull wires to impart a desired curvature to the catheter in each of the first and second deflection directions, and an inefficiency generator increases the force required to curve the catheter in each of the first and second deflection directions with increasing catheter deflection.

[0041] As another feature of this broad aspect, the maneuverable catheter control handle includes a unidirectional control handle, the means for deflecting the catheter is coupled to the catheter via one or more pull wires and includes means for deflecting the one or more pull wires, the one or more pull wires including a single pull wire, actuation of the actuator causes deflection of the one or more pull wires, deflecting the catheter via actuation of the pull wire to impart a desired curvature to the catheter in the single deflection direction, and an inefficiency generator increases the force required to curve the catheter in the single deflection direction with increasing catheter deflection.

[0042] As another feature of the broad aspect, the means for deflecting the catheter is coupled to the catheter via at least one of one or more pull wires, at least one of the one or more pull wires being coupled to a distal end of the catheter to enable deflection of the distal end of the catheter.

[0043] In a further broad aspect, an embodiment of the invention provides a control handle for a steerable catheter comprising a rotational-linear conversion system for deflecting a catheter, the rotational knob being coupled to the slide assembly via a threaded engagement or arrangement, at least one control wire and a distal end of the control wire being operable to be coupled to the catheter, and a proximal end or portion of at least one control wire or pull wire being coupled or operable to be coupled to the slide assembly. The control handle further comprises a means for introducing an inefficiency into the rotational-linear conversion system, the means for introducing an inefficiency being inherent or integral to a component of the rotational-linear conversion system, rotation of the knob causes linear motion of the slide assembly to enable deflection of the catheter via actuation of the at least one control wire to impart a desired curvature to the catheter, the means for introducing an inefficiency increasing the force required to actuate the at least one control wire to bend the sheath or catheter as the deflection of the catheter increases (e.g., while providing an optimized handle design that provides ease of handling and ease of use for the physician).

[0044] As a feature of this broad aspect, the means for introducing inefficiency substantially increases the amount of force required to rotate the knob and translate the slide assembly, which force varies substantially based on the amount of rotation and / or translation, and provides enhanced tactile feedback (to the user) regarding catheter deflection as the catheter deflection increases.

[0045] As an example of this feature, the means for introducing inefficiency allows for curve retention, which allows the deflection of the catheter to be maintained at substantially a desired curvature after the catheter has been deflected.

[0046] As a further example of this, the means for introducing inefficiency allows for self-locking such that the force required to rotate the knob to move the slide assembly is greater than the force exerted by the catheter on the slide assembly after the catheter is deflected, preventing the curvature of the catheter from changing in the absence of input from the user without actuation of the knob.

[0047] As another example of this feature, the means for introducing inefficiencies includes one or more angled threads that define a threadable engagement or arrangement. As a further example of this feature, the threadable arrangement or engagement is defined by an external angled thread on the shaft of the slide assembly and a corresponding internal angled thread on a knob that is matable therewith.

[0048] In one such embodiment, the angled thread has an angle greater than about 0 degrees and less than about 180 degrees. In one such example, the angled thread has an angle greater than about 160 degrees and less than about 180 degrees. In a particular example, the angled thread has an angle between about 160° and 163°.

[0049] In one such embodiment of a steerable catheter control handle, the threadable engagement is defined by male threads on the shaft of the slide assembly and corresponding female threads on the matable knob. In a particular example, the threads have an angle of about 0°.

[0050] In some embodiments, the means for introducing inefficiencies (which in some instances include an inefficiency generator) provides actual feedback of the catheter deflection. In other embodiments, the means for introducing inefficiencies (which in some instances include an inefficiency generator) provides simulated feedback of the catheter deflection.

[0051] In one embodiment, the slide assembly is movable within a housing of the handle (such as an inner housing of the handle).

[0052] In one such example, the means for introducing inefficiency includes a gradient friction device positioned within the handle housing that interacts with the slide assembly as it moves, the gradient friction device increasing friction upon increasing linear movement of the slide assembly within the housing (such as the inner housing) upon deflection of the catheter. In this specific example, the gradient friction device includes another triangular friction pad (e.g., opposing triangular friction pads) disposed along an inner surface of the handle housing. In a particular example of this example, one or more triangular friction pads (e.g., opposing triangular friction pads) are disposed along one or more walls of the inner housing.

[0053] In another such example, the means for generating inefficiencies (including in some examples an inefficiency generator) is defined by a housing (such as an inner housing) with opposing walls that taper toward one another from a center of the housing toward the proximal and distal ends of the housing, and a slide assembly configured such that friction between the slide assembly and the opposing walls of the housing increases as linear movement of the slide assembly increases within the housing upon deflection of the catheter. In one specific example, the slide assembly is mateable with a wall of the housing via a biasing mechanism. In some examples, the biasing mechanism forms part of the slide assembly. In a particular example of this example, the biasing mechanism includes a spring biasing mechanism.

[0054] As a feature of this broad aspect, the means for deflecting the catheter includes a rotation to linear translation system, and the rotation to linear translation system includes a single step rotation to linear translation system.

[0055] As another feature of this broad embodiment, the means for deflecting the catheter includes a rotation to linear translation system, the rotation to linear translation system including a two-stage rotation to linear translation system.

[0056] As another feature of this broad aspect, the manipulable catheter control handle includes a bidirectional control handle, the means for deflecting the catheter is coupled to the catheter via at least one control wire and includes means for deflecting the at least one control wire, the at least one control wire including two control wires, where rotation of an actuator (e.g., a knob) in first and second rotational directions (e.g., causing linear motion of the slide assembly in respective first and second linear directions) enables deflection of the catheter via actuation of each of the two control wires to impart a desired curvature to the catheter in each of the first and second deflection directions, and the means for introducing inefficiency increases the force required to curve the catheter in each of the first and second deflection directions of the catheter upon increasing deflection of the catheter.

[0057] As another feature of this broad aspect, the maneuverable catheter control handle includes a unidirectional control handle, the means for deflecting the catheter is coupled to the catheter via at least one control wire, the means for deflecting the at least one control wire includes an actuator, rotation of which causes linear motion of a slide assembly via rotation of the actuator (e.g., a knob), and deflects the catheter via actuation of the control wire, allowing a desired curvature to be imparted in a single deflection direction, and the means for introducing inefficiencies increases the force required to bend the sheath or catheter in a single deflection direction with increasing catheter deflection.

[0058] As another feature of this broad aspect, the means for deflecting the catheter is coupled to the catheter via at least one control wire and includes means for deflecting the at least one control wire, the at least one control wire being coupled to a distal end of the catheter to enable deflection of the distal end of the catheter.

[0059] In a further broad aspect, an embodiment of the invention includes an operable catheter control handle for a catheter including a rotatable knob and a slide assembly, the rotatable knob coupled to the slide assembly via a threadable fitting, the threadable fitting including an angled thread, the catheter including at least one control wire and a proximal end or portion of the at least one control wire coupled to or connectable to the slide assembly, where rotation of the knob causes linear movement of the slide assembly (via rotation of the knob) and allows deflection of the catheter via actuation of the at least one control wire to impart a desired curvature to the catheter, the angled thread providing enhanced tactile feedback to the user regarding the deflection of the catheter (e.g., at its distal end) upon increasing deflection of the catheter and / or allowing the deflection of the catheter to be maintained at the desired curvature.

[0060] As a feature of this broad aspect, the angled thread provides accentuated tactile feedback to the user such that there is a substantial difference in the level of tactile feedback provided at minimum deflection of the catheter and maximum deflection of the catheter.

[0061] In another broad aspect (as discussed above), an embodiment of the invention includes a manipulable catheter control handle for deflecting a catheter. The control handle includes an actuator and a means for deflecting the catheter upon actuation of the actuator, the deflecting means being coupled to the actuator. The manipulable catheter control handle further includes an inefficiency generator configured to interact with the means for deflecting the catheter, the inefficiency generator increasing resistance to actuation and increasing the force required to actuate the actuator when increasing deflection of the catheter.

[0062] As a feature of this broad aspect, the one or more pull wires each have a distal end coupled to the catheter, the means for deflecting the catheter includes means for deflecting the one or more pull wires, and a proximal portion of each of the one or more pull wires is coupled to the means for deflecting the one or more pull wires. As an example of this feature, the means for deflecting the one or more pull wires includes a rotation to linear translation system.

[0063] As another feature of this broad aspect, the means for deflecting the catheter includes a translation mechanism that translates actuation of the actuator into deflection of the catheter.

[0064] As another feature of this broad aspect, the inefficiency generator interacts indirectly with the means for deflecting the catheter.

[0065] As a further feature of this broad aspect, the inefficiency generator interacts directly with the means for deflecting the catheter.

[0066] In yet another feature of this broad aspect, the inefficiency generator is defined by a means for deflecting the catheter. In one example of this feature, the inefficiency generator comprises a tactile feedback mechanism that provides tactile feedback regarding the degree of deflection of the catheter upon actuation of the actuator. In one example of this feature, the tactile feedback mechanism includes a neutral zone indicator.

[0067] As a further feature of this broad aspect, the inefficiency generator is integral with the means for deflecting the catheter.

[0068] As another feature of this broad aspect, the inefficiency generator provides discrete feedback regarding the degree of catheter deflection upon actuation of the actuator.

[0069] As another feature of this broad aspect, the inefficiency generator provides a series of feedback regarding the degree of catheter deflection upon actuation of the actuator, increasing catheter deflection.

[0070] In one broad aspect, an embodiment of the invention includes a manipulable catheter control handle for deflecting a catheter, the control handle including an actuator, one or more pull wires each having a distal end coupled to the catheter, a means for converting actuation of the actuator into movement of the pull wires and thereby deflecting the catheter, an actuation converting means coupled to the actuator, a proximal portion of each of the one or more pull wires coupled to the actuation converting means (which in one example includes a conversion mechanism or actuation mechanism), and an inefficiency generator configured to interact with the actuator actuation converting means, wherein the inefficiency generator (substantially) increases the force required to actuate or deflect the one or more pull wires to deflect the catheter.

[0071] In another broad aspect, an embodiment of the invention includes a manipulable catheter control handle for deflecting a catheter, the control handle including an actuator, one or more pull wires each coupled to the catheter or having a distal end coupled to the catheter, a translation mechanism (in other words, an actuation mechanism) that converts actuation of the actuator into deflection of the catheter by deflecting the one or more pull wires, the translation mechanism including a proximal portion of each of the one or more pull wires coupled to the actuator and to the translation mechanism for deflecting the one or more pull wires, and an inefficiency generator configured to interact with the means for deflecting the one or more pull wires, the inefficiency generator substantially increasing the force required to actuate the actuator to deflect the catheter in increasing catheter deflection.

[0072] With particular reference now to the drawings in detail, it is emphasized that the details shown are by way of example and for the purpose of describing certain embodiments of the invention only. Before describing at least one embodiment of the invention in detail, it is to be understood that the invention is not limited in its application to the details of construction and the arrangement of components set forth in the following description or illustrated in the drawings. The invention is capable of other embodiments or of being practiced or carried out in various ways. It is also to be understood that the phraseology and terminology used herein is for the purpose of description and should not be regarded as limiting.

[0073] In some embodiments of the invention, a catheter control handle operable for deflecting the catheter is provided, the control handle including an actuator and a means for deflecting the catheter. In some embodiments, the control handle is operable to deflect the catheter by actuation or deflection of one or more pull wires or control wires coupled at one end to the means for deflecting the catheter and at the other end to a sheath or catheter deflection means. In some such examples, the control handle is provided with a means for converting the actuation of the actuator into movement of the pull wire, thereby deflecting the other pull wire. In other words, the control handle provides a means for converting the actuation of the actuator into movement of the pull wire. In some such examples, a distal end of each of the one or more pull wires is coupled to the sheath or catheter, and a proximal end of each of the pull wires is coupled to a means for deflecting the pull wire [means for converting the actuation of the actuator into movement of the pull wire].

[0074] In one embodiment of the present invention, as shown in Figures 1A and 1B and 4, a steerable catheter control handle 200 is disclosed for deflecting a medical device such as a sheath or catheter 90. The control handle 200 is coupled to the sheath or catheter 90 via a proximal hub portion 80 of the steerable sheath or catheter 90. The control handle 200 comprises a rotation-to-linear conversion system 300 comprising a rotatable knob 10 whose rotational motion is translated into linear motion of a slide assembly 30 via a threadable fitting 302, as further shown in Figures 2A, 2B and 3. In other words, the knob 10 is coupled to the slide assembly via a threadable arrangement or fitting 302 such that upon rotation of the knob 10, the slide assembly 30 is linearly movable within a portion of the housing 20, particularly the inner housing 20a, and the linear motion of the slide assembly 30 is translated into deflection of the catheter or sheath 90 via one or more control or pull wires 40, 42. 2A and 2B, the threadable engagement 302 is defined by external threads 302b formed on the shaft or bolt 32 of the slide assembly 30 and corresponding internal threads 302a on the knob 10 that are matable therewith. In one embodiment, the knob 10 includes an outer knob 10b (FIG. 1) coupled to an inner knob 10a, with the internal threads 302a defined by the inner knob 10a.

[0075] In some such examples, an inefficiency generator is further provided to interact with the means for deflecting the catheter (e.g., the catheter may be deflected by actuating a pull wire). The inefficiency generator functions to introduce inefficiencies in translating actuation into catheter deflection. In some examples, the inefficiency generator effectively increases the force required to actuate the actuator as the catheter deflection increases. In other words, the inefficiency generator increases the sense of force or resistance to actuation to deflect the catheter with increasing catheter deflection.

[0076] In some embodiments, the inefficiency generator is integral with or inherent to the means for converting actuation into catheter deflection, such as in the means for deflecting the pull wires. In some such instances, the inefficiency generator interacts directly with the means for converting actuation into catheter deflection. In other words, the inefficiency generator interacts directly with the means for deflecting the catheter. In other embodiments, the inefficiency generator interacts indirectly with the means for converting actuation into catheter deflection. In other words, the inefficiency generator interacts indirectly with the means for deflecting the catheter. The inefficiency generator functions to introduce or generate energy losses in a system provided for converting actuation of an actuator of a maneuverable control handle into deflection of the catheter, such as by actuation of one or more pull wires.

[0077] In some embodiments of the invention in which an inefficiency generator 400 is provided, the inefficiency generator 400 substantially increases the force required to actuate the actuator to deflect the sheath or catheter 90 with increasing catheter deflection. In other words, the inefficiency generator interacts with the means for deflecting the catheter to increase resistance to actuator actuation as the catheter deflects. In some cases, the inefficiency generator may result in an increased force required to bend the sheath while providing an optimized handle design that provides ease of handling and ease of use for the physician. In some embodiments of the invention, the force required to actuate varies substantially based on the amount of deflection of the sheath or catheter 90, and / or in other embodiments, the force required to actuate varies substantially based on the amount of actuator actuation.

[0078] In some embodiments, the inefficiency generator functions to provide relative feedback regarding catheter deflection, for example, at the distal tip of the catheter, and / or to maintain curvature. The inefficiency generator may provide one or more advantages, such as enhancing the tactile feedback received by the user via the actuator regarding distal tip deflection, for example, by enhancing energy losses in the system, reducing the mechanical efficiency of actuation to deflection of the catheter 90, making actuation and / or deflection more difficult, and / or further allowing the curvature or deflection of the sheath or catheter 90 to be maintained substantially at a desired curvature or deflection after the catheter 90 has been deflected to a desired curvature. The inefficiency generator may, for example, introduce friction into the system, reducing the mechanical efficiency of translating actuator actuation to deflection of the sheath or catheter 90. The inefficiency generator may provide an advantage of providing enhanced tactile feedback to the user, as the physician can more easily see how much the catheter is deflected, and thus the physician can pay more careful attention under increasing catheter deflection. Some embodiments of the present invention may help further minimize failure of the control wire or pull wire (eg, resulting from the pull wire or control wire becoming dislodged from the pull ring).

[0079] In some such examples, the inefficiency generator 400 enables self-locking such that the force required for actuation is greater than the force exerted on the actuator from deflection of the catheter (e.g., by the pull wire after the catheter is deflected), and the inefficiency generator enables the deflection of the catheter to be maintained in the absence of actuation of the actuator.

[0080] In some embodiments of the steerable catheter control handle 200, the means for deflecting the pull wires (or the means for translating actuation into catheter deflection) includes a rotational-to-linear translation system.

[0081] In some embodiments of the present invention, the inefficiency generator of the present invention may further provide a neutral zone indication. The inefficiency generator may provide enhanced tactile feedback to the user, and thus provide a significant difference in sensation or tactile feedback when the sheath or catheter is in the neutral zone. More specifically, the inefficiency generator allows the user to rotate the knob more easily when the sheath or catheter is in the neutral position, as compared to when the sheath or catheter is in the deflected position. Thus, a handle actuator, such as a knob, may feel relatively looser when the sheath or catheter is in its neutral position than when the sheath or catheter is substantially deflected.

[0082] In some such embodiments, the inefficiency generator enhances feedback, such as tactile feedback, in both embodiments where the sheath or catheter can be used alone and where the sheath or catheter can be used in combination with other devices (e.g., one or more devices that can be inserted through the sheath or catheter (internal components), or, e.g., one or more devices that can be inserted through the sheath or catheter itself (external components)).

[0083] In some such embodiments where the sheath or catheter is usable with internal or external components, the tactile feedback provided is correlated based on how stiff or rigid the internal or external components are. For example, the torque sensation may be different if there is internal or external resistance (e.g., resistance to deflection when one or more internal or external components are used with the sheath or catheter). For example, the inefficiency generator may provide a significant difference in the amount of tactile feedback the user receives depending on how hard it is to rotate the actuator. In some such examples, the inefficiency generator may provide sufficient tactile feedback in each of the following scenarios: (i) when, for example, an empty sheath or catheter is deflected, (ii) when, for example, the sheath or catheter is used with an ablation catheter, (iii) when, for example, the sheath or catheter is used with a dilator and a transseptal needle disposed therein (such as an RF transseptal needle or a mechanical transseptal needle). In some such embodiments, the force to actuate the actuator (or the force to rotate a rotary knob into a linear system) may be greater in scenario (iii) than in scenario (i).

[0084] Thus, in some embodiments of the present invention, an inefficiency generator is provided that may provide a difference in feedback that may depend on the device or devices placed within the sheath or catheter and the device or devices into which the sheath or catheter may be placed.

[0085] In some such embodiments of the invention, providing an inefficiency generator in an actuation mechanism that deflects a pull wire, such as in a rotational-linear system, can result in the amount of actuator actuation required to deflect a sheath or catheter (such as the degree of rotation required to deflect a sheath or catheter in a rotational system) being the same as a system without an inefficiency generator, but with a different feel. An actuation mechanism with an inefficiency generator can provide greater feedback than an actuation mechanism without an inefficiency generator. In some such embodiments, the feedback can help minimize failure at the contact point between the wire and the sheath (e.g., by the wire breaking from the pull ring through which the pull wire is attached to the sheath). Thus, in some embodiments of the invention, an inefficiency generator can provide the added benefit of increased feedback to reduce the risk of breakage of the pull wire and / or failure at the contact or connection point with the sheath or catheter.

[0086] The novel control handle 200 of the present invention provides a means for introducing an inefficiency or inefficiency generator 400 into the rotation of the linear transformation system 300, where the inefficiency or inefficiency generator 400 interacts with the rotation of the linear transformation system 300. In some embodiments, the inefficiency generator is integral or inherent to the rotation of the linear system. In other words, the inefficiency generator interacts directly with the rotation of the linear system. In other embodiments, the inefficiency generator interacts indirectly with the rotation of the linear system.

[0087] The inefficiency generator functions to reduce the mechanical efficiency of the rotation to linear translation system in translating the rotation of the actuator into linear motion of the pull wires or control wires. The reduced mechanical efficiency makes it more difficult to deflect or curve the sheath, which requires more force compared to a more efficient system to curve the sheath or catheter 90. In some embodiments, this may provide one or more advantages of providing feedback to the user regarding the relative degree of catheter deflection, may enable weighted manipulation, and / or may enable curve hold, allowing the catheter deflection to be maintained at substantially the desired curvature after it has been deflected.

[0088] 1A-6C, in some aspects of the present invention, a control handle 200 for a steerable catheter 90 is provided that includes a rotational-linear conversion system including a rotatable knob 10 that is actuable about a longitudinal axis of the control handle 200. In some such embodiments, the actuator includes the rotatable knob 10, and the means for deflecting the pull wires (or in other words, the means for translating actuation into deflection of the pull wires) includes a rotational-linear conversion system including a slide assembly 30 that is coupled to the rotatable knob 10 via a threadable fitting. More specifically, the rotatable knob 10 is coupled to the slide assembly 30 via a threadable fitting, and a distal end of at least one control or pull wire 40, 42 is coupled to the catheter and a proximal end of at least one control or pull wire 40, 42 is coupled to the slide assembly 30. Rotation of knob 10 causes linear motion of slide assembly 30 via rotation of knob 10, allowing deflection of sheath or catheter 90 via actuation of at least one of one or more control or pull wires 40, 42, e.g., along its distal end, to impart a desired curvature to the sheath or catheter.

[0089] The control handle 200 includes a means for introducing an inefficiency or inefficiency generator 400 into the rotational-linear conversion system, where the means for introducing the inefficiency or inefficiency generator 400 is integral to or inherent in the rotational-linear conversion system. In accordance with one or more embodiments of the present invention, the means for introducing the inefficiency or inefficiency generator 400 results in a reduction in mechanical efficiency in converting rotational motion of the rotatable knob 10 into linear motion of the slide assembly 30.

[0090] In some such embodiments, the inefficiency generator 400 increases the force required to bend the sheath or catheter 90 while providing an optimized handle design that facilitates physician handling and ease of use. In some such instances, the inefficiency generator 400 requires a greater force or an increased amount of force to bend the sheath or catheter 90 compared to a more efficient system, which makes it more difficult to rotate the knob 10 to deflect the sheath or catheter 90. In other words, the inefficiency generator 400 substantially increases the amount of force required to deflect the sheath or catheter. In some cases, the inefficiency generator can substantially change the force required to deflect based on the amount of deflection of the sheath or catheter 90. And / or the amount of knob rotation can provide one or more advantages, such as providing relative feedback regarding the degree of deflection of the distal tip of the catheter and / or substantially retaining the curvature of the distal tip.

[0091] In some such embodiments, the means for introducing inefficiencies, such as an inefficiency generator, substantially increases or adds or enhances the force required to rotate an actuator, such as knob 10, and / or the amount of translation of slide assembly 30, which force can vary substantially based on the amount of rotation of the actuator and / or the amount of translation of slide assembly 30, and can provide enhanced tactile feedback to the user regarding the behavioral deflection of the catheter.

[0092] In some embodiments of the present invention, the inefficiency generator is embedded within the rotation / linear mechanism 300 of the control handle 200, which provides a control handle 200 that requires an increased amount of force to bend the sheath while providing an optimized sleek handle design that provides ease of handling and ease of use for the physician.

[0093] Thus, some embodiments of the control handle 200 of the present invention provide a handle having limited overall dimensions optimized for ease of use and handling. In some such embodiments, a means of introducing an inefficiency or inefficiency generator 400 is provided in the rotation of the control handle 200 into the linear mechanism 300.

[0094] In some embodiments of the present invention, the steerable catheter control handle 200 comprises a means for introducing an inefficiency or inefficiency generator 400 comprising one or more angled threads 304 forming or defining a threadable fitting 302. The angled threads 304 provide an optimized handle design that increases the force required to bend the sheath or catheter 90 while facilitating physician handling and ease of use. The use of the angled threads 304 to reduce the mechanical efficiency of the rotation to linear system allows the efficiency reduction to be built into the actuation mechanism of the control handle 200 itself. This provides an optimized handle that can reduce the number of components within the handle, thus providing a more robust design and reducing manufacturing complexity and cost.

[0095] In the particular example shown in Figures 1 and 2A-2B, the steerable catheter control handle 200 includes a means for deflecting a pull wire that includes a rotatable-to-linear conversion system that includes a rotatable actuator, such as a control knob 10, that is coupled to a slide assembly 30 via a threadable arrangement 302, or in other words, a threadable fitting 302. In this particular example, as shown in Figures 3, 4B, and 4C (as well as Figures 5A and 5B, 5C), the threadable fitting 302 is defined by an angled thread 304 (an angled external thread 304a formed on the shaft or bolt 32 of the slide assembly 30, and a corresponding angled internal thread 304b on the knob 10 that is matable therewith). In one embodiment, an angled internal thread 304b is defined by the inner knob 10a.

[0096] In some embodiments, as shown in FIGS. 1A-6C, the angled thread 304 has an angle Z greater than about 0 degrees and less than about 180 degrees. In some such embodiments, the angled thread 304 has an angle Z greater than about 160 degrees and less than about 180 degrees. In this example, the angled thread 304 has an angle Z between about 160° and 163°. In a particular embodiment shown in FIGS. 1A-6C, the angled thread 304 has an angle Z of about 163°. In one such example, as shown in FIG. 6C, a thread 304a is shown on the bolt or shaft 32 with an angle Z of about 163°.

[0097] 2A , in certain instances where the angled threads 304 define an inefficiency generator 400, the inefficiency generator 400 increases or substantially increases the force required to rotate the knob 10 to bend or deflect the sheath or catheter 90. In some such embodiments of the invention, a means for introducing inefficiencies is provided or the inefficiency generator 400 is provided or incorporated into the rotational-linear conversion system, and the means for introducing the inefficiencies or the inefficiency generator 400 is integral to or inherent in the rotational-linear conversion system.

[0098] In the illustrated embodiment, a rotation to linear system is provided as shown in Figures 1A-6C. With particular reference to Figure 2A, rotation of the knob 10 causes linear motion of the slide assembly 30 via rotation of the knob 10, allowing deflection of the catheter 90 via actuation of at least one control wire to impart a desired curvature to the catheter 90. For example, as shown in Figures 5A, 5B and 5C, the angled or tapered threads 304 introduce inefficiencies into the system such that the mechanical efficiency in translating the rotation of the knob into linear actuation of the slide assembly 30 is reduced. As a result, the inverse mechanical efficiency of the system is also reduced. Thus, the angled or tapered threads 304 reduce the efficiency of the system in translating linear movement or actuation of the slide assembly 30 under tension from a pull or control wire into rotation of the knob 10.

[0099] Inefficiencies are introduced through the tapered or angled threads 304 that result in increased resistance or greater force or increased force to deflect the catheter 90 upon forward actuation of the control knob 10 to cause linear movement of the slide assembly 30. In some such examples, the force required for deflection varies substantially based on the amount of catheter deflection. As shown in FIGS. 6A-6C, the deflection range of the catheter 90 is illustrated in the example of the maneuverable catheter control handle 200. In some such embodiments, the inefficiency generator is operable to provide relative feedback to the user regarding the deflection of the catheter 90 at the distal tip. The angled or tapered threads 304 provide enhanced tactile feedback to the user such that there is a substantial difference in the level of tactile feedback provided at the minimum deflection of the catheter [e.g., indicated by 90a] and the maximum deflection of the catheter [e.g., indicated by 90b].

[0100] In some such embodiments, the angled threads can provide a substantial difference between the amount of force required to deflect the catheter 90 to minimize deflection 90a of the sheath or catheter 90 and maximize deflection 90b of the sheath or catheter 90. In some such examples, the tapered or angled threads 304 inform the user of the relative deflection or curvature of the sheath or catheter 90, as well as the neutral zone position. The user can identify the neutral zone position as the position where the knob 10 is most easily rotated, and the slide assembly 30 may be positioned within the handle in its substantially unactuated position, not yet substantially moved by rotation of the knob 10, at which deflection of the catheter 90 is the minimum deflection 90a of the catheter 90. The neutral zone position 30N of the slide assembly 30 is shown in FIGS. 2A-2B and 4A, 4B, and 4C. In one example, the position of slide assembly 30 at maximum actuation, and therefore maximum deflection of catheter 90 [indicated by 90B], is shown in Figures 2C and 2D.

[0101] In some such instances, the inefficiency generator or inefficiency introducer 400 may be formed by an angled or tapered thread 304, which reduces the mechanical efficiency in converting the rotation of the knob 10 into the linear motion of the slide assembly 30. As such, the tapered or angled thread 304 may additionally substantially reduce the efficiency of the conversion system, shown in FIGS. 7B and 7C, making it less efficient at converting the rotational motion of the knob 10 into the linear motion of the slide assembly 30, thus increasing the amount of force required to rotate the knob 10, as compared to a system that is more mechanically efficient at converting the rotational motion into the linear motion of the slide assembly 30. For example, as shown in FIG. 7A, a rotation-to-linear conversion system comprising a knob 10 threadedly coupled to the slide assembly 30 via a square thread 306x having an angle of about 0° is more efficient at converting the rotational motion of the knob 10 into the linear motion of the slide assembly 30. The square threads 306x include square threads 306a on the shaft or bolt 32 of the slide assembly 30 and corresponding inner threads 306b on the inner knob 10a.

[0102] Unlike a system using a square thread as shown in FIG. 7A, the use of an angled or tapered thread 304 as shown in FIGS. 7B-7C and 7D may provide one or more additional advantages. In some such examples, the angled thread 304 allows the force required to rotate the knob 10 to be substantially varied based on the amount of rotation of the knob 10, and thus the amount of translation of the slide assembly 30, providing enhanced tactile feedback to the user, for example at the distal tip of the catheter, regarding the behavior or deflection of the catheter. The further the knob 10 is rotated, the more difficult it becomes to actuate or rotate the knob 10. This allows feedback to be provided to the user. Additionally, as discussed above, introducing inefficiencies into the system reduces the inverse mechanical efficiency of the system as well. Thus, the angled or tapered threads 304 (including tapered threads 304a and tapered or internal threads 304b on the slide assembly 30, particularly on the bolt or shaft 32 of the slide assembly 30) reduce the efficiency of the system in translating linear motion or actuation of the slide assembly 30 under tension from the pull or control wires into rotation of the knob 10.

[0103] This facilitates curve retention, as shown in Figures 6A, 6B, and 6C, and allows the deflection or curvature of the sheath or catheter 90 to be substantially maintained at any desired curvature after deflection, for example, between the minimum deflection of catheter 90a and the maximum deflection of catheter 90b. In one such example, a means of introducing inefficiency, such as an inefficiency generator 400 defined by an angled or tapered thread 304, allows for self-locking such that the force required to rotate the knob 10 to move the slide assembly 30 is greater than the force on the slide assembly 30 from the deflection of the catheter 90, preventing the deflection or curvature of the catheter 90 from being altered in the absence of input from the user. Thus, the curve or position of the sheath or catheter 90 upon deflection of the sheath or catheter 90 is maintained with or without rotational actuation of the knob 10. In the particular example shown, the inefficiency generator 400 defined by the angled thread 304 provides actual feedback of the deflection of the sheath or catheter 90.

[0104] Accordingly, in some such embodiments of the present invention, a manipulable catheter control handle 200 for a catheter is provided that includes a rotatable knob 10 and a slide assembly 30, where the rotatable knob 10 is coupled to the slide assembly 30 via a threadable fitting 302, where the threadable fitting 302 includes an angled thread 304. The catheter includes at least one control or pull wire 40, 42, where a distal end of the at least one control or pull wire 40, 42 is coupled to a sheath or catheter 90 and a proximal end of the at least one control or pull wire 40, 42 is coupled to the slide assembly 30. Rotation of the knob 10 causes linear motion of the slide assembly 30 via rotation of the knob, and allows deflection of the sheath or catheter 90 via actuation of the at least one control wire 40, 42 to impart a desired curvature to the catheter. In some such embodiments, the angled threads 304 provide enhanced tactile feedback to the user regarding the behavior or deflection of the sheath or catheter 90 at the distal end and enable curve holding, which allows the deflection or curvature of the sheath or catheter 90 to be maintained at a desired curvature. In some such examples, the angled threads 304 provide enhanced tactile feedback to the user such that there is a substantial difference in the level of tactile feedback provided at minimum deflection of the catheter and maximum deflection of the sheath or catheter 90.

[0105] In some such embodiments of the invention, a neutral zone feedback is provided, where the knob 10 is easier to actuate or rotate, and therefore may feel looser at the start, before rotation begins. In some such embodiments of the invention, the angled threads 304 provide true feedback of what is going on at the distal tip of the sheath or catheter 90, or the behavior of the sheath or catheter 90 under deflection. The angled threads 304 provide tactile feedback that provides a true view of what is happening at the distal tip. In such instances, the user may not get a constant sensation. As the knob 10 is actuated and the sheath is pulled, it becomes increasingly difficult to actuate or rotate the knob 10 as a result of the angled threads 304, and that is the feedback the user is getting. In other words, the system provides a weighting operation that provides feedback of what is happening at the distal tip (i.e., the behavior of the sheath or catheter 90 upon deflection), and such an indication is an indication of the degree or amount of deflection of the sheath or catheter 90 based on the actuation of the knob 10.

[0106] In one such example where the inefficiency generator 400 comprises an angled thread 304 with the interaction of the knob 10 (such as the inner knob) and the threads of the slide assembly 30, there is no or minimal feedback when the sheath or catheter 90 is not present, or in other words when not coupled to the steerable catheter control handle 200. In some such examples, it is the interaction of the entire assembly or system (including the steerable catheter control handle 200 coupled to the sheath or catheter 90) and the sheath or catheter 90 (including in some examples the pull wire or control wire that is tensioned as the knob 10 is turned) that provides feedback to the user, giving the user a sense of what is happening with respect to the deflection or behavior of the sheath or catheter 90. In some such examples, something inside or directly coupled to the translation mechanism (including the actuator and sheath and the translation system for translating sheath actuation into sheath deflection) may provide feedback when tapped at any point along or within the system. As such, feedback may be obtained from any part of the system formed by the actuator, the translation system, and the sheath or catheter coupled thereto (e.g., through an inefficiency generator 400 that is part of the system or directly coupled to the system), the translation mechanism being for translating actuation of the actuator into deflection of the sheath or catheter 90. In some such examples, the inefficiency generator 400 provides true feedback of deflection of the sheath or catheter.

[0107] In some embodiments of the invention, a system including the inefficiency generator 400 provides feedback to a user regarding the amount of deflection of the sheath or catheter 90 due to actuation or rotation of the knob 10. In some such examples, a system including the inefficiency generator 400 as defined by the angled thread 304 also provides feedback regarding what is happening at the distal tip based on an internal input resulting from actuation of the knob 10. Thus, the feedback obtained can be from the level or deflection of the sheath or catheter 90. In some such examples, a maneuverable handle system including a maneuverable control handle 200 coupled to the sheath or catheter 90 also provides feedback regarding what is happening at the distal tip based on an external input, for example, due to a force (e.g., a contact force) on the distal tip resulting from actuation of the knob 10. Thus, the feedback obtained can be a result of the behavior of the distal tip (e.g., in a particular anatomy), for example, the distal tip of the sheath or catheter 90 against some hard object or an occlusion that is carried back to the user. Thus, the feedback obtained may come from the force applied by the sheath or catheter 90 at the distal tip, or from an external force applied by something to the distal tip (e.g., if the catheter or sheath 90 is not able to deflect). In some such embodiments, the feedback obtained is true feedback that reflects the actual behavior of the sheath or catheter.

[0108] In some such embodiments as described above, the angled thread 304 also allows for self-locking. In some such instances, the efficiency of the linear rotation mechanism (i.e., movement of the knob 10 by movement of the slide assembly 30 by tension in the pull wires) is such that the forces in the system (even at maximum actuation) cannot rotate the knob 10. In other words, a system in which the inefficiency generator 400 is defined by the angled thread 304 reduces the risk of reverse movement of the slide assembly 30 tensioned to rotate the knob 10 (and consequently shifting the position of the sheath or catheter 90), allowing the position of the sheath or catheter 90 to be maintained.

[0109] Additionally, the inefficiency generator defined by the angled thread 304 can enable repeatability and allow the position of the sheath or catheter 90 to be maintained under repeated actuations for the same operation, for example. In some such instances, a more reliable and / or more predictable operable catheter control system is provided.

[0110] In some embodiments of the present invention, the inefficiencies for the reverse movements, i.e., rotational versus linear movements (rotation of knob 10 relative to movement of slide assembly 30), as well as the linear versus rotational movements of knob 10, may not be equal.

[0111] In one example where the inefficiency generator 400 defines the angled thread 304, the inefficiencies of the "rotation to linear" and "linear to rotation" movements are not equal. In such an example, if the efficiencies are not equal, the reverse movement, i.e., the "linear to rotation" movement, may be substantially or completely inefficient, which may allow for self-locking because the forces in the system from the deflected sheath cannot overcome the energy barrier built into the system from the inefficiency generator 400. Thus, the inefficiency generator 400 adds inefficiency to the "linear to rotation" movement. The inefficiency generator also adds inefficiency to the "rotation to linear" movement. As the load increases (e.g., with deflection of the sheath or catheter 90), the force increases and the resistance to actuating the knob 10 is felt more by the user, which provides the feedback. In some such examples, the inefficiencies in the system provide an inefficiency in the "rotation to linear" movement to provide sufficient feedback while still allowing the user to actuate the knob and therefore the sheath without difficulty, while providing an inefficiency in the "linear to rotation" or reverse movement to allow self-locking. In some such examples, the inefficiencies are modified in the same manner, for example, where the inefficiency generator 400 including the angled thread 304 introduces inefficiencies in both the "rotation to linear" and "linear to rotation" movements. However, in such examples, the magnitude of the two inefficiencies (or inefficiencies in the two directions) may vary. In some such examples, the feedback in the "rotation to linear" movement upon actuation of the knob may be based on the difference in the effort required to actuate the knob based on the level of deflection of the sheath or catheter 90.

[0112] In some such embodiments of the present invention in which an inefficiency generator is provided in an assembly or system comprising a steerable catheter control handle for a steerable sheath, the system (which in one example may be a single step rotation to linear translation system) still allows the user to manipulate the knob 10, but the reverse translation of linear to rotational motion under tension adds enough inefficiency that it cannot allow for self-locking upon actuation, while at the same time allowing the system (including the handle 200 and sheath 90) to provide a reliable level of feedback, allowing the user to get a true view of what is happening at the distal tip.

[0113] In this particular example, the inefficiency generator 400 defined by the angled thread 304, as described above, provides a self-locking mechanism built into the system 200; in other words, it is essentially built into the rotary-to-linear conversion system by providing the angled thread 304. Additionally, in some such examples, inputs from any part of the system can be used to get a view of what is happening at the distal tip. As the sheath 90 is actuated, it becomes more and more difficult to actuate, which gives the user a feel for what is happening at the distal tip, and further, the system provides feedback to the user if the sheath 90 is against something. In some such examples, by providing a system that provides an inefficiency built into the conversion mechanism to allow for self-locking, the opportunity to get feedback is also enabled.

[0114] As such, some such embodiments of the present invention provide tactile feedback by increasing the force required to rotate the knob as the curvature of the sheath increases. In some such embodiments, the inefficiency generator may be defined by the angle and / or material of the threads on the inner knob and part of the slide assembly. In some such embodiments, the components of the system are the slider, the inner knob, the sheath and the sheath pull wire. In some such examples, the inefficiency generator is defined by the internal and external thread geometries of the inner knob and slide assembly, respectively. The threads allow the conversion of the knob rotation (controlled by the user) into a linear displacement of the slide assembly, which increases the pull wire tension and deflects the sheath or catheter within the tam. In other words, the pull wire tension is lowest when the sheath or catheter is in the neutral zone and increases as the curvature of the sheath increases. The inefficiency generator, defined by the thread geometry and material, increases how much feedback the user feels when rotating the knob with increasing tension in the pull wire. The inefficiency generator allows the user to feel the change in pullwire tension as a cue to the sheath neutral zone and / or the amount of sheath or catheter deflection.

[0115] In some such examples, a steerable catheter control handle is provided as the assembly is manipulable to deflect the sheath. In some such examples, the steerable catheter assembly may be provided for different curve sizes. In some embodiments, the steerable catheter assembly may be provided in three separate curve sizes, where in all three curve sizes the following parameters are identical for the screw provided in the threadable arrangement defined by the knob and slide assembly:

[0116] [Table 1]

[0117] In some such embodiments, in steerable catheters, for example, control handles for small and medium curves, have an additional surface coating on the bolt or shaft components of the sliding assembly to modify the coefficient of friction or friction coefficient.

[0118] [Table 2]

[0119] In alternative embodiments of the present invention, the inefficiency generator is defined by a threaded inner knob and a threaded slide assembly. In some such examples, the inefficiency generator is defined by a thread form and / or a material. In some such examples, the inefficiency generator may provide one or more benefits of curve retention and / or tactile feedback. In some such examples, the inefficiency generator provides curve retention through a thread form.

[0120] In some such instances, the inefficiency generator is defined by a thread angle, such as an angled thread as described in this disclosure, hi certain instances, the thread angle is increased to be greater than about 0 degrees and less than about 180 degrees.

[0121] In other instances, the inefficiency generator is defined by the thread pitch and / or the thread pitch diameter. In some such instances, the thread pitch diameter increases and / or the thread pitch decreases.

[0122] In still other instances, the inefficiency generator is further defined by the material of the thread, in some such instances a high friction material is used.

[0123] The above inefficiency generators may provide one or more advantages of the inefficiency generators as provided in this disclosure, including preventing curve relaxation.

[0124] In some embodiments of the present invention, an inefficiency generator is provided that increases curve retention capability and / or provides tactile feedback, and in some embodiments, the inefficiency generator is defined by the material and thread angle of the slide assembly and inner knob. In some embodiments of the present invention, the inefficiency generator is defined by an increase in the thread angle and an increase in the coefficient of friction of the material. In some such examples, the material for the screw or bolt of the slide assembly (defining the thread) includes Delrin. In other examples, the material of the screw or bolt of the slide assembly includes a PTFE layer on top of the Delrin. In some such examples, the screw is defined by a combination of Delrin and PTFE, with an additional PTFE lubricant on top. In other words, the Delrin includes PTFE on the surface to provide a desired coefficient of friction and enable curve retention and / or tactile feedback. In some such examples, the lubricant is provided in the cavity of an O-ring, such as Nyogel 774. In some such embodiments, depending on the thread angle, e.g., the thread angle and the coefficient of friction, the inefficiency generator provides one or more advantages as outlined in this disclosure. In some embodiments of the present invention, an inefficiency generator, whether provided by an angled thread or provided within the actuation mechanism (such as a rotation to linear translation system), may allow for the introduction of inefficiencies from a rotation to linear system while maintaining the external dimensions of the handle. This may allow for a rotation to linear translation system, allowing for a smooth external profile to be maintained while introducing inefficiencies into the system to provide one or more advantages provided in the present disclosure, including curved surface retention, tactile feedback, and / or minimizing pull wire breakage / failure, by providing an ergonomic handle design that allows for ease of use and handling. In alternative embodiments of the present invention, an inefficiency generator 400 may be provided that provides feedback [such as simulated feedback] of the deflection of the catheter 90. In one such example, the slide assembly 30 is movable within the inner housing 20a of the steerable catheter control handle 200.

[0125] In one such example, a maneuverable catheter control handle 210 is provided, which is similar to the embodiment described herein above with respect to FIGS. 1A-7D with respect to actuation of the maneuverable control handle 210, and the inefficiency generator 400 includes a gradient friction device 314 positioned within the handle housing 20 (such as the inner housing 20a), with particular reference to FIGS. 8A-8D. The gradient friction device 314 interacts with the slide assembly 30 upon movement of the slide assembly 30 to provide increasing friction upon increasing linear movement of the slide assembly 30 within the inner housing 20a upon deflection of the catheter 90. In some such examples, the slide assembly 30 may include a bolt or shaft 32 having a square thread 306x with an angle of about 0°, as shown in FIGS. 7A, 7B, 7C, and 7D. Alternatively, the thread may be a tapered or angled thread 304, as shown in any of the embodiments disclosed herein.

[0126] In a specific example, as shown in Figures 8A, 8B, 8C, and 8D, the gradient friction device 314 comprises opposing triangular friction pads 314a, 314b disposed along an inner surface of the handle housing, for example, along inner wall 20w, as shown in Figures 8A and 8B. In some such embodiments, the opposing triangular friction pads 314a, 314b can be disposed along one or more walls (e.g., opposing walls) 20w1, 20w2 of the inner housing 20a, as shown in Figures 8C and 8D. In one such example, the opposing triangular friction pads 314a, 314b are disposed along both walls 20w1 and 20w2 of the inner housing 20a, as shown.

[0127] In operation, when the slide assembly 30 is in a neutral position 30N as shown in FIG. 8A, the slide assembly 30 has minimal contact with the friction device 314 as shown, which is when the sheath or catheter 90 is in its substantially undeflected position 90a as shown in FIGS. 6A-6C. When the knob 10 is actuated to cause linear movement of the slide assembly 30, the slide assembly 30 moves from its neutral position 30N to one of its translated positions 30T, where, for example, the slide assembly 30 traverses the length of the handle housing 20 (such as the inner housing 20a), as shown in FIG. 8B. The slide assembly 30 has maximal contact with the friction device 314 as shown, which is when the sheath or catheter 90 is in one of its deflected positions 90b, where, for example, the sheath or catheter 90 can bend to its maximum curvature, as shown in FIGS. 6A-6C. Thus, the gradient friction device 314 provides the greatest amount of friction when the sheath or catheter 90 is in its most deflected position 90b compared to when the sheath or expander is in its substantially undeflected position 90a.

[0128] Thus, the inefficiency generator 400 defined by the friction device 314 reduces the efficiency of rotational versus linear translation of the control handle assembly 210 to provide the user with simulated feedback regarding the deflection of the sheath or catheter at the distal tip. The inefficiency generator 400 defined by the gradient friction device 314 itself indirectly interacts with the rotation to linear translation system, providing increased friction with increasing rotation of the knob 10, providing the user with a sense of the amount of deflection or relative deflection of the sheath or catheter 90 (in other words, tactile feedback regarding the deflection of the sheath or catheter 90). The inefficiency generator 400 with the gradient friction device 314 further enables curve retention by providing sufficient friction to allow the steerable catheter control handle 210 to maintain the position of the sheath or catheter 90 after it has been deflected. In the particular embodiment shown, rotating the knob 10 translates the slide assembly 30 and increases the amount of friction so that the amount of friction in the rotational / linear system changes with the amount of deflection to maintain the position of the sheath or catheter 90.

[0129] In some embodiments of the present invention, the inefficiency generator 400 provides simulated feedback. In one such example, the inefficiency generator 400 with the friction device 314 provides simulated feedback. In one such example, the handle 200 may still function to provide feedback when the handle 200 is not coupled to the sheath 90. Thus, it provides feedback to the user regarding the behavior of the sheath 90 when it is coupled, where the feedback reflects the behavior of the sheath at the tip, but may not be representative of the actual behavior of the sheath 90, i.e., true feedback.

[0130] In some such embodiments of the invention, the interacting components are the slide assembly and the inner housing of the housing in which the slide assembly is movable. For example, an inefficiency generator with a gradient friction device increases the interference between the slider and the inner handle based on the position of the slide assembly. When the interference increases, there is more friction between the slide assembly and the inner housing, which requires the user to rotate the knob with more force and provides more tactile feedback. When the slider is in the neutral position (when the slide assembly is in its nominal or neutral position when the knob is not rotating and the sheath is not deflected), there is less interference than when it is in other positions. In other words, the user needs to rotate the knob with less force in the neutral zone. This change in knob rotation force (or the force required to turn the knob) can be used as a tactile cue of the neutral zone.

[0131] In an alternative embodiment of the present invention, an inefficiency generator 400 may be provided that provides feedback of the deflection of the catheter 90. In one such example, the slide assembly 30 is movable within the inner housing 20a of the steerable catheter control handle 200.

[0132] In one embodiment of the present invention, a maneuverable catheter control handle 220 is provided, shown in Figures 9A, 9B and 9C, which includes an inefficiency generator 400 defined by an inner housing 20a. In one such example, the inner housing 20a is defined by a tapered inner housing 20aT, where opposing walls 20w1, 20w2 of the inner housing 20a taper toward each other toward the ends of the housing [from the center [M] of the inner housing 20a toward the proximal and distal ends [P, D] of the inner housing 20a]. The sliding assembly 30 is configured such that as the linear movement of the sliding assembly 30 increases within the inner housing upon deflection of the sheath or catheter 90, friction between the sliding assembly 30 and the opposing walls [20wT] of the inner housing 20a increases.

[0133] In some such examples, the maneuverable catheter control handle 220, slide assembly 30 can mate with the inner housing wall 20wT via a biasing mechanism 30B. As a specific example, as shown in Figures 9B and 9C, the biasing mechanism 30B comprises a spring biasing mechanism.

[0134] Thus, the inefficiency generator 400 with the tapered inner housing 20aT reduces the efficiency of rotational to linear translation of the control handle assembly 220 to provide feedback to the user regarding the deflection of the sheath or catheter 90 at the distal tip. The inefficiency generator 400 with the tapered inner housing 20aT indirectly interacts with the rotation to linear translation system itself, increasing friction with increasing rotation of the knob 10 and providing the user with a sense of the amount or relative deflection of the sheath or catheter 90 (in other words, tactile feedback regarding the deflection of the sheath or catheter 90). The inefficiency generator 400 with the tapered inner housing 20aT further enables curve retention by providing sufficient friction to allow the steerable catheter control handle 220 to maintain the position of the sheath or catheter 90 after it is deflected. In the particular embodiment shown, the amount of frictional fit between the slide assembly 30 and the walls 20wT of the tapered inner housing 20aT increases as the knob 10 is rotated, and as the slide assembly 30 translates, the amount of friction in the rotary-linear system changes with the amount of deflection to maintain the position of the sheath or catheter 90. In some such embodiments, the tapered inner housing 20aT provides actual feedback to the user regarding the deflection of the catheter at the distal tip.

[0135] In an alternative embodiment of the invention, a maneuverable catheter control handle 230 is provided that may include one or more means for creating inefficiencies in the actuation system for deflecting the sheath or catheter 90. In one example as shown in FIGS. 10A, 10B, the coupling means for coupling the rotatable knob 10 to the inner housing 20a may include an inefficiency generator or means for creating or introducing inefficiencies 400 that includes a tapered pin and groove joint 320 that includes a pin 322 that can be threaded into a tapered groove 324 formed in a wall or surface 11 of the knob 10 to maintain the coupling between the knob 10 and a portion of the handle housing 20 (such as the inner housing 20a). In the particular example shown, the tapered groove 324 includes tapered or angled walls 324a, 324b that may increase the normal force that exists between the pin 322 and the angled groove 326, increasing the amount of friction between the knob and a portion of the handle housing. This may help maintain the position or curvature of the catheter after it has been deflected. This mechanism may increase friction by indirectly interacting with the rotational-linear conversion system and mechanism, and may indirectly affect the operation of the rotational-linear conversion system by making it more inefficient to deflect the sheath or catheter 90. As such, an embodiment such as that shown in FIGS. 10A-10B may introduce inefficiencies into the rotational to linear conversion system for deflecting the catheter, and may provide one or more advantages of the means for introducing inefficiencies as provided in other embodiments described herein in this disclosure. The tapered pin and groove joint 320 may help provide feedback to the user regarding the deflection of the catheter, and may provide some tactile feedback to the user. Additionally, the inefficiency generator 400 provided by the tapered pin and groove joint 320 may further introduce friction between the knob 10 and the inner housing 20a to help the sheath or catheter 90 maintain its position after it has been deflected.

[0136] In some such embodiments of the invention, the inefficiency generator is defined by a modified inner knob-pin contact angle. In some such examples, the inner knob-pin contact angle is modified such that the inner knob groove (which receives the pin) has angled walls as shown. In some such examples, the steerable catheter handle includes an inner knob, pin, and slide assembly, and an inner handle housing. In one such example, there are two through holes in the inner handle (or inner housing). The through holes are positioned such that when the pin is inserted, it seats in the inner knob groove, locking the inner knob in place, as shown in the figure. As shown, in one example, a tapered groove is provided that increases the contact angle (i.e., a "V" shaped groove may provide an increased contact angle over a square groove). As the contact angle increases, the normal force on the pin also increases, which increases friction at the pin joint.

[0137] In some additional aspects of the invention, as shown in FIGS. 22A and 22B, the inefficiency generator is defined by an O-ring 900 that can be used with one or more inefficiency generators of the invention. In some such embodiments, a maneuverable catheter control handle 910 is provided that includes components including an O-ring 900, an inner knob 10a, an inner handle (or inner housing) 20a, and a slide assembly 30. In some such examples, the O-ring 900 is provided at the interface between the inner knob 10a and the inner handle (or inner housing) 20a. Squeezing of the O-ring 900 between the inner knob 10a and the inner handle (or inner housing) 20a creates friction, which can enable curve retention. In one such example, the O-ring 900 is placed on the inner knob 10a. The inner knob 10a is then inserted into the inner handle (inner housing) 20a. As a result, the O-ring 900 is clamped and compressed between the inner knob 10a and the inner housing 20a. The compression of the O-ring 900 creates a constant normal force against the inner surface of the inner handle (or inner housing) 20a, which creates a constant frictional force against the rotation of the knob 10. The magnitude of the frictional force is defined by the size (diameter and thickness) of the O-ring 900, the material of the O-ring 900, and the material of the inner handle (or inner housing) 20a.

[0138] An embodiment of a maneuverable catheter control handle of the present invention can include one or more means for creating inefficiencies in a system for translating actuator actuation into deflection of the sheath or catheter 90, as described herein, and can provide one or more advantages of the means for creating inefficiencies, as described herein.

[0139] In some embodiments, the steerable catheter control handle [200, 210, 220] and its operation are described with particular reference to FIG. 2A , in which a steerable sheath or catheter 90 includes at least one control or pull wire 40, 42, a distal end of the control wire 40, 42 coupled to the sheath or catheter 90, and a proximal end of the at least one control or pull wire 40, 42 coupled to the slide assembly 30. In one particular example, the control handle 200 includes a bidirectional control handle 200A, in which the at least one control wire 40, 42 includes at least two control wires 40, 42, a distal end of each of the at least two control wires coupled to the sheath or catheter 90, and a proximal end of each of the at least two control wires coupled to the slide assembly 30. In this particular example, one of the control wires, such as control wire 40, also referred to as non-pulley control wire 40, is routed proximally from a sheath or catheter 90, e.g., the distal end of the sheath or catheter 90 to which the non-pulley control wire 40 is coupled at its distal end. The proximal end of the non-pulley control wire 40 is then routed through a handle (such as handle housing 20) and slide assembly 30, and then directly coupled to slide assembly 30. For example, the proximal end of the non-pulley control wire is crimped against a proximal surface of a portion of the slide assembly 30, such as a portion of the carriage 34, such as a wall of the carriage 34.

[0140] 1A-6C, other control wires, such as control wire 42, also referred to as pulley control wire 42, are also routed proximally from sheath or catheter 90, such as, for example, the distal end of sheath or catheter 90 to which pulley control wire 42 is coupled at its distal end. The proximal end of pulley control wire 42 is then also routed through handle housing 20 and slide assembly 30, and then indirectly coupled to slide assembly 30. For example, the proximal end of pulley control wire 42 extends through slide assembly 30, then passes around redirecting element 50, such as pulley 52, through a portion of slide assembly 30 (such as a portion of carriage 34, such as a wall of carriage 34), and is crimped at its distal surface.

[0141] In operation, rotation of the knob 10 in a first rotational direction causes linear movement of the slide assembly 30 in a first linear direction, allowing deflection of the sheath or catheter 90 via actuation of one of the at least two control wires 40, 42 (e.g., the non-pulley wire 40) to impart a desired curvature to the sheath or catheter 90 in the first direction (e.g., 90A as shown in FIGS. 6A-6C). Rotation of the knob 10 in a second rotational direction causes linear movement of the slide assembly 30 in a second linear direction, allowing deflection of the sheath or catheter 90 via actuation of the other of the at least two control wires 40, 42 (e.g., the pulley control wire 42) to impart a desired curvature to the sheath or catheter 90 in the second direction (e.g., 90B as shown in FIGS. 6A-6C).

[0142] In some such embodiments, the inefficiency generator 400 provides feedback to the user regarding the behavior or deflection of the sheath or catheter 90 at the distal end, for example, and enables curve holding, which allows the deflection or curvature of the catheter to be maintained at a desired curvature in both of its deflection directions. In some such embodiments of the invention, the inefficiency generator 400 increases the force required to curve the sheath or catheter 90 in each of the first and second deflection directions.

[0143] In the particular example of a bidirectionally steerable catheter control handle 200 as shown in FIG. 2A , in which the inefficiency generator 400 is provided as an angled thread 304, the angled thread 304 provides true feedback regarding the behavior or deflection of the sheath or catheter 90 in each of its deflection directions, e.g., at its distal end, and provides enhanced tactile feedback to the user enabling the deflection or curvature of the catheter to be maintained at a desired curvature in each of the deflection directions of the sheath or catheter 90.

[0144] Thus, in some embodiments of the invention, a maneuverable catheter control handle 200 includes a bidirectional control handle 200, 210, 220, wherein one or more control wires or pull wires [40, 42] include two control wires or pull wires 40, 42, and actuation of an actuator in first and second directions 90A and 90B rotates a means for deflecting the control wires or pull wires 40, 42 (e.g., defined by knob 10 and slide assembly 30) into a linear system to enable deflection of the sheath or catheter 90 via respective actuation of the respective pull wires, imparting a desired curvature to the sheath or catheter 90 in the respective first and second deflection directions [90A, 90B], and an inefficiency generator 400 increases the force required to curve the sheath or catheter 90 in each of the first and second deflection directions [90A, 90B].

[0145] In some embodiments, a steerable catheter control handle [200, 210, 220] is provided, the operation of which is described with reference to FIG. 2A. In some such examples, the steerable catheter control handle [200, 210, 220] comprises a one-way control handle, a steerable sheath or catheter 90 comprises one of the control or pull wires 40, 42, a distal end of the control wire 40 or 42 is coupled to the sheath or catheter 90, and a proximal end of the control or pull wire 40 or 42 is coupled to the slide assembly 30. In one particular example, the control handle 200 comprises a one-way control handle, a distal end of the control wire 40, 42 is coupled to the sheath or catheter 90, and a proximal end of the control wire 40 or 42 is coupled to the slide assembly 30.

[0146] 1A-6C, only one control wire is provided, e.g., the distal end of the sheath or catheter 90 to which the non-pulley control wire 40 is coupled at its distal end. The proximal end of the non-pulley control wire 40 is then routed through the handle housing 20 (such as the inner housing 20a) and the slide assembly 30, and then directly coupled to the slide assembly 30. For example, the proximal end of the non-pulley control wire is crimped against a proximal surface of a portion of the slide assembly 30, such as a portion of the carriage 34, such as a wall of the carriage 34.

[0147] 1A-6C, only one control wire is provided, the control wire including a control wire 42, also referred to as a pulley control wire 42, that is routed proximally from a sheath or catheter 90, such as, for example, the distal end of the sheath or catheter 90 to which the pulley control wire 42 is coupled at its distal end. The proximal end of the pulley control wire 42 is then also routed through the handle 20 and the slide assembly 30, and then indirectly coupled to the slide assembly 30. For example, the proximal end of the pulley control wire 42 extends through the slide assembly 30, then passes around a redirecting element 50, such as a pulley 52, through a portion of the slide assembly 30 (such as a portion of the carriage 34, such as a wall of the carriage 34) and is crimped at its distal surface.

[0148] In operation, rotation of knob 10 in a single rotational direction causes linear movement of slide assembly 30 in a single linear direction (90A or 90B, as shown in Figures 6A-6C), allowing deflection of sheath or catheter 90 through actuation of a single control or pull wire [either non-pulley control wire 40 or pulley control wire 42] to impart a desired curvature to sheath or catheter 90 in the single deflection direction.

[0149] In some such embodiments, the inefficiency generator 400 provides feedback to the user regarding the behavior or deflection of the sheath or catheter 90 at the distal end, for example, and enables curve holding, which allows the deflection or curvature of the sheath or catheter 90 to be maintained at a desired curvature in a single deflection direction [90A or 90B]. In the particular example of a unidirectional steerable catheter control handle 200 with one of the control wires 40, 42 shown in FIG. 2A, the inefficiency generator 400 is provided as an angled thread 304, which provides enhanced tactile feedback to the user, for example, providing true feedback regarding the behavior or deflection of the sheath or catheter 90 in a single deflection direction at the distal end, which allows the deflection or curvature of the catheter to be maintained at a desired curvature in a single deflection direction of the sheath or catheter 90. In some such embodiments, the means of introducing the inefficiency or [the inefficiency generator 400] increases the force required to curve the sheath in a single deflection direction. In some such embodiments of the present invention, the inefficiency generator 400 provides continuous feedback along the entire range of deflection or curvature of the sheath or catheter.

[0150] In some such embodiments, the maneuverable catheter control handle 200 includes a unidirectional control handle, where the one or more pull wires include a single control or pull wire [40, 42], actuation of an actuator (such as knob 10) results in a means for deflecting the pull wire (such as rotation into a linear system defined by knob 10 and slide assembly 30), actuation of the pull wire enables deflection of the sheath or catheter 90 to impart a desired curvature to the catheter in a single deflection direction [90A or 90B], and an inefficiency generator 400 [such as an angled thread] increases the force required to curve the sheath or catheter 90 in the single deflection direction [90A or 90B].

[0151] 1A-9C, a rotation to linear translation system includes a single step rotation to linear translation system. In some such embodiments, a rotatable knob 10 is provided that converts rotational actuation of the knob 10 into linear motion of the slide assembly 30. In some such embodiments, a single slide assembly 30 is provided as shown, where rotation of the knob 10 is converted into linear motion of the single slide assembly 30.

[0152] In other embodiments of the present invention, the rotation to linear translation system includes a two-step rotation to linear translation system. In some such embodiments, a rotatable knob 10 is provided that converts the rotational actuation of the knob 10 into linear motion of two or more slide assemblies, such as slide assemblies, via a threadable arrangement. In some such embodiments, two slides are provided, including a first slide with a left-hand thread and a second slide with a right-hand thread, and rotation of the knob 10 is converted into linear motion of both the first and second slides in opposite linear directions. In some such embodiments, a means for introducing an inefficiency or inefficiency generator 400 is provided, the means being of the type provided in any of the above-mentioned embodiments. In one particular example, one or more of the first slide and the second slide include left and right threads that are angled left and right threads that provide inefficiencies in the rotation to linear motion in the manner previously described herein for the single-step rotation to linear translation system, providing one or more advantages thereof.

[0153] For example, with reference to Figures 2A and 6A, in some embodiments of steerable catheter control handles such as [200, 210, 220] of the present invention, one or more control wires [non-pulley control wire 40 and / or pulley control wire 42] are coupled to the distal end [90d] of the sheath or catheter 90 to enable deflection of the distal end 90d of the catheter.

[0154] 11A-19D, in an alternative embodiment of the present invention, an inefficiency generator 400 is provided that includes a threadable fitting 302 that includes an angled thread 304 with an external angled thread 304a on the shaft or bolt 32 of the slide assembly 30 that is matable with a corresponding internal angled thread 304b along the inner surface of the knob 10. These embodiments of the inefficiency generator 400 provide one or more of the advantages of the inefficiency generating means 400 described in this disclosure.

[0155] In one example, the inner knob 10a and slide assembly 30 each have tapered angled threads 304 (including external angled threads 304a and internal angled threads 304b) having an angle of approximately 140°, as shown in FIGS. 11A, 11B, 11C, and 11D.

[0156] In one example, the inner knob 10a and slide assembly 30 each have tapered angled threads 304 (including outer angled threads 304a and inner angled threads 304b) having an angle of approximately 148°, as shown in Figures 12A, 12B, 12C and 12D. In one such example, the inner knob 10a is shown mated with the bolt 32 of the slide assembly 30 to define a threadable mating 302 and an inefficiency generator 400, as shown in Figures 12E and 12F.

[0157] In one example, the inner knob 10a and slide assembly 30 each have tapered angled threads 304 (including outer angled threads 304a and inner angled threads 304b) having an angle of approximately 156°, as shown in FIGS. 13A, 13B, 13C, and 13D.

[0158] In one example, the inner knob 10a and slide assembly 30 each have tapered angled threads 304 (including outer angled threads 304a and inner angled threads 304b) having an angle of approximately 160°, as shown in Figures 14A, 14B, 14C, 14D. In one such example, the inner knob 10a is shown mated with the bolt 32 of the slide assembly 30 to define a threadable mating 302 and an inefficiency generator 400, as shown in Figures 14E and 14F.

[0159] In one example, the inner knob 10a and slide assembly 30 each have tapered angled threads 304 (including external angled threads 304a and internal angled threads 304b) having an angle of approximately 162°, as shown in FIGS. 15A, 15B, 15C and 15D.

[0160] In one example, the inner knob 10a and slide assembly 30 each have tapered angled threads 304 (including external angled threads 304a and internal angled threads 304b) having an angle of approximately 166°, as shown in FIGS. 16A, 16B, 16C, and 16D.

[0161] In one example, the inner knob 10a and slide assembly 30 each have tapered angled threads 304 (including outer angled threads 304a and inner angled threads 304b) having an angle of approximately 30°, as shown in FIGS. 17A, 17B, and 17C.

[0162] In one example, the inner knob 10a and slide assembly 30 each have tapered angled threads 304 (including external angled threads 304a and internal angled threads 304b) having an angle of approximately 60°, as shown in FIGS. 18A, 18B, and 18C.

[0163] In one example, the inner knob 10a and slide assembly 30 each have tapered angled threads 304 (including external angled threads 304a and internal angled threads 304b) having an angle of approximately 70°, as shown in FIGS. 19A, 19B, and 19C.

[0164] In one example, the inner knob 10a and slide assembly 30 each have tapered angled threads 304 (including outer angled threads 304a and inner angled threads 304b) having an angle of approximately 0°, as shown in FIGS. 20A, 20B, and 20C.

[0165] In one example, the inner knob 10a and slide assembly 30 each have tapered angled threads 304 (including outer angled threads 304a and inner angled threads 304b) having an angle of approximately 120°, as shown in FIGS. 21A, 21B, and 21C.

[0166] In some embodiments of the invention, a 0° thread angle is provided for the threaded arrangement defined by the inner knob and slide assembly, and some other means of introducing inefficiencies are provided in the rotational-to-linear conversion system of the steerable catheter control handle in accordance with embodiments described herein.

[0167] In some embodiments of the invention, a rotation to linear translation system is provided, such as a single step rotation to linear system utilizing a square thread (having an angle of approximately 0 degrees), and a compensation mechanism to retain the curvature of the catheter, such as an inefficiency generator, can be provided in the form of a larger handle, and by providing a larger diameter rotatable knob, the ability of the manipulable control mechanism to maintain the position of the catheter after it has been deflected can be increased. This can further increase the amount of tactile feedback provided.

[0168] In some embodiments, rotation to linear systems are provided in a threadable arrangement in which the threads have an angle greater than or equal to 0 degrees and less than about 180 degrees. In some such instances, an angled thread is defined as a thread having an angle greater than about 0 degrees and less than about 180 degrees.

[0169] In an alternative embodiment of the present invention, a steerable catheter control handle having a smooth profile is desired to enhance maneuverability and ease of handling by the user. As such, a steerable catheter control handle is provided having an optimized design for minimized profile, and an alternative compensation mechanism such as an inefficiency generator is provided without increasing the outer diameter of the handle. In one such example, the inefficiency generator is incorporated into a rotary-linear system, e.g., the inefficiency generator is defined by an angled screw.

[0170] In some embodiments of the present invention, a maneuverable catheter control handle is provided that includes a compensation system that defines an inefficiency generator that may provide curve retention and / or tactile feedback. In some such examples, the tactile feedback provides a difference in feel between the maximum deflection of the catheter and the minimum deflection of the catheter. In some examples, the inefficiency generator may enhance the friction / force of deflection at both the maximum and minimum deflection of the catheter by a differential amount. Thus, some embodiments of the system of the present invention may provide an improved mechanism that makes it easier for a user to ascertain how much the catheter has been deflected, thus enhancing the difference in tactile feel between the minimum deflection of the catheter and the maximum deflection of the catheter.

[0171] Some embodiments of the invention can provide a two-step rotation-linear system that includes an inefficiency generator, where a rotating knob simultaneously moves two slides in opposite linear directions. This can essentially introduce inefficiencies into the two-step rotation to linear translation system. When the knob is rotated to move one slide to pull one wire, the other slide moves in the opposite direction to push the other wire, resulting in the catheter deflecting in a first direction and moving the second slide that pushes the other wire. Some such systems of the invention can include an inefficiency generator of the type described above. In some such examples, the inefficiency generator is defined by an angled screw. Additionally, the inefficiency generator can provide sufficient energy loss to hold the deflection and can also provide sufficient tactile feedback, for example through the use of an angled screw.

[0172] 23A and 23B, in some embodiments of the present invention, an inefficiency generator is incorporated into one or more medical devices that are used to steer, guide, or otherwise manipulate other devices. In particular, an inefficiency generator is provided that is included in a steerable device, such as a steerable sheath or catheter, as described above.

[0173] As outlined above, medical devices used for guidance (e.g., steerable sheaths) can be used to aid in guiding and positioning the device within the patient's body. In some such devices, a user may manipulate a control component, such as a handle on the steerable sheath, to articulate a portion of the device. In some cases, the user may manipulate the control component so that an articulating portion of the device achieves a particular curve or orientation. In some such instances, the user may want the curve or direction to be maintained by the device. Additionally, the user may want feedback to determine actuation of the articulating portion of the device.

[0174] As outlined above, the inability of a medical device under certain circumstances to maintain its curvature or orientation of an articulating portion can lead to undesired movement of the articulating portion. Disclosed herein are several further embodiments, conceived by and reduced to practice, of features or components for use in such medical devices to help maintain a desired position of an articulating component or portion (such as a sheath or catheter 90) by maintaining the position or state of a control component (such as an actuator, such as the control knob 10 of an actuation mechanism for deflecting the sheath or catheter 90). Some such embodiments can further provide feedback to the user regarding the curvature or degree of articulation of the articulating portion or component (such as the sheath or catheter 90).

[0175] In some such instances, the features or components include means for reducing inefficiencies or introducing inefficiencies built into a system that includes a sheath or catheter and a translation mechanism for deflecting it.

[0176] The features or components for introducing inefficiencies may allow the catheter to substantially maintain its position after it is deflected. In some such instances, the system for introducing inefficiencies may, for example, introduce sufficient friction into the system to maintain the position of the sheath or catheter after it is deflected. As with the previous embodiment, some embodiments of the present invention may provide a system that allows the catheter to self-lock after it is deflected. The features or components for introducing inefficiencies may further provide feedback of the behavior of the sheath or catheter, such as, for example, the degree of curvature or deflection of the sheath or catheter at the distal tip of the sheath or catheter.

[0177] 23A and 23B, some such embodiments of the present invention include an inefficiency generator 400 defined by a threadable fitting 302 between the slide assembly 30 and the knob 10 that forms a rotation to linear translation system 300. In some such examples, the means for introducing inefficiency is incorporated into a system that includes the sheath or catheter 90 and a translation mechanism (defined by the rotation to linear translation mechanism 300) for deflecting the same. In some examples, the threadable fitting 302 functions to increase static friction between the rotatable, longitudinally translatable components of the steerable sheath handle 200.

[0178] 23A and 23B show a threaded slider mechanism or slide assembly 30 for use in an embodiment of the present invention including an operable catheter control handle (such as control handle 200) for the sheath or catheter 90 shown above, including a rotation to linear translation system 300. As with the embodiment described above, the rotation to linear translation system 300 includes a rotatable knob 10 and a threaded slider mechanism or slide assembly 30, where rotational motion of the knob 10 is translated into linear motion of the slide assembly 30 via a threadable fitting 302. As with the embodiment discussed above, the threadable fitting 302 is defined by male threads 302b formed on the shaft or bolt 32 of the slide assembly 30 and corresponding female threads 302a on the knob 10 that are matable therewith.

[0179] As with the previous examples, the control handle 200 includes a means for introducing an inefficiency or inefficiency generator 400 into the rotation of the linear transformation system 300, where the inefficiency or the means for introducing the inefficiency generator 400 is integral or inherent to the rotation of the linear transformation system 300.

[0180] 23A and 23B, the rotatable knob 10 is coupled to the slide assembly 30 via a threadable fitting 302 that includes a threaded slider mechanism or slide assembly 30 having a modified thread 306 that can mate with the knob 10 having a corresponding thread, defining an inefficiency generator 400. In some such examples, the modified thread 306 includes a right-handed thread as previously described, as shown in FIG. 23A. In other examples, as described above, the modified thread 306 includes a reverse thread or portion 308 on the slide assembly 30, as shown in FIG. 23C. More specifically, in the illustrated embodiment, the reverse-thread portion 308 includes a left-handed thread 310.

[0181] In one such example, embodiments of the present invention provide an inefficiency generator 400 comprising a threadable fitting 302 comprising a threaded slider mechanism or slide assembly 30, such as, for example, a reverse-threaded slider mechanism or slide assembly 30 comprising a reverse-threaded thread 308, to increase static friction between rotatable, longitudinally translatable components of the steerable sheath 90. In some such examples, the reverse-threaded slider mechanism or slide assembly 30 includes a left-handed thread 310.

[0182] In some such examples, referring to FIG. 23A, an inefficiency generator 400 is defined by a slider mechanism or slide assembly 30 having a reverse threaded portion or bolt 32 that includes a left-handed thread 310. The defined inefficiency generator 400 may be provided on a manipulable device, such as a manipulable handle control system 200, that has a greater range of motion for counterclockwise rotation of the knob 10 of the manipulable device than for clockwise rotation of the knob 10. In some such devices, the threaded slider mechanism or slide assembly 30 (coupled to the knob 10) is positioned within the handle 100 in a fully extended or translated position at a substantially unactuated position of the knob 10 or at a substantially minimal rotation of the knob 10, defining a neutral position of the slide assembly 30, with the catheter or sheath 90 in a substantially undeflected position. Positioning the slide assembly 30 in this manner results in a minimum threaded fit between the threaded slider mechanism and the internal threads of the knob 10 at a minimum deflected or minimally deflected position of the sheath or catheter 90. Then, when the knob 10 of the maneuverable catheter control handle is actuated upon counterclockwise rotation of the knob 10, the use of left-handed threads in the current configuration of the maneuverable catheter control handle 200 helps the threaded slider mechanism or slide assembly 30 to positively translate toward the knob 10, thereby creating maximum threaded engagement between the threaded slider mechanism or slide assembly 30 and the internal threads of the knob 10. In other words, counterclockwise actuation of the knob 10 causes deflection of the sheath or catheter 90 as the threadable engagement 302 tightens, thereby creating maximum engagement between the threaded slider mechanism or slide assembly 30 and the knob 10 (in other words, the male threads 302b on the bolt or shaft 32 of the slide assembly 30 and the internal or female threads 302a of the knob 10) upon maximum deflection of the sheath or catheter 90, as described below with respect to FIGS.

[0183] 23B, in an alternative example, an inefficiency generator 400 with a right-hand thread 309 can be provided within the maneuverable handle control system 200 that has a greater range of motion for clockwise rotation of the knob 10 of a maneuverable device or maneuverable handle 200 than for counterclockwise rotation of the knob 10. In other words, in some examples, the slide assembly 30 can be positioned within the handle 200 in a fully extended or translated position at a substantially unactuated position of the knob 10 or upon substantially minimal rotation of the knob 10, defining a neutral position of the slide assembly 30 in which the catheter or sheath 90 is in a substantially undeflected position. Then, when the knob 10 of the maneuverable catheter control handle is actuated upon clockwise rotation of the knob 10, this causes a deflection of the sheath or catheter 90, for example, as the threadable fitting 302 is tightened, thereby creating maximum threaded engagement between the threaded slider mechanism (or, in other words, the slide assembly 30, specifically the male threads 302b on the bolt or shaft 32 of the slide assembly 30) and the inner or female threads 302a of the knob 10. In other words, rotating the knob 10 clockwise with maximum deflection of the sheath or catheter 90 creates maximum engagement between the slide assembly 30 and the knob 10.

[0184] 23A and 23B, in some such embodiments of the invention, the inefficiency generator 400 allows for increased engagement between the actuator and the means for actuating the sheath or catheter 90 upon increased actuation, and thereby increased deflection of the sheath or catheter 90. Thus, the inefficiency generator 400 may help reduce slippage. As noted above, in some such examples, the threadable engagement 302 includes a reverse thread slider mechanism or slide assembly 30 including, for example, a left-handed thread 310. In other examples, the threadable engagement 302 includes a right-handed thread 309.

[0185] In some such examples, also shown in FIGS. 26A-26F , where the inefficiency generator 400 is defined by a threadable fitting or configuration 302, a neutral zone of the slide assembly 30 is provided such that the maximum range of motion of the sheath or catheter 90 is defined in a direction that, upon rotation of the knob, results in maximum threaded fit between the threaded slider mechanism (i.e., in other words, the slide assembly 30, specifically the male threads 302b on the bolt or shaft 32 of the slide assembly 30) and the female threads 302a of the knob 10 when the inefficiency generator 400 is, for example, tightened. In such an example, furthermore, a minimum range of motion of the sheath or catheter 90 is defined in the opposite direction, such that when the knob is rotated in the opposite direction, the inefficiency generator 400 provides a minimum threaded fit between the threaded slider mechanism (or, in other words, the slide assembly 30, and in particular the male threads 302b on the bolt or shaft 32 of the slide assembly 30), for example, when the threadable fit 302 is loosened.

[0186] Alternatively, some embodiments of the present invention include a threaded slider mechanism or slide assembly 30 having a reduced thread pitch to increase static friction between a rotatable component (such as knob 10) of the maneuverable sheath control handle 200 and a vertically translatable component (such as the threaded slider mechanism or slide assembly 30).

[0187] 23C and 24A, 24B, 24C, 24D and 24E, 24F. The threaded slider mechanism 30 (or in other words the slide assembly 30) has a threaded portion with modified threads 306 where the spacing between the threads is reduced and the pitch 312 is increased. In such an embodiment, the inefficiency generator 400 is defined by or is integrated with a rotary-to-linear conversion system 300 comprising the slide assembly 30 and the knob 10, and a threadable engagement 302 is provided between the slide assembly 30 (such as the bolt or shaft 32 of the slide assembly 30 having a reduced pitch) and a corresponding internal or external thread 302a of the knob 10 having a reduced pitch 312. Decreasing the spacing between the threads and increasing the pitch of the threads 302 (such as from 1 / 4 inch to 1 / 2 inch) serves to further increase the static friction (or, in other words, frictional fit) between the slider mechanism 30, or slide assembly 30 (particularly the male threads 302b on the bolt or shaft 32 of the slide assembly 30 and the inner or internal threads 302a of the rotatable component (e.g., knob 10)), thereby enabling the articulating portion of the steerable sheath or catheter 90 to maintain a desired position, curve, or orientation.

[0188] Both of the foregoing embodiments (comprising left-handed or left-handed threads 310, right-handed or right-handed threads 309, and / or modified threads 306 with reverse threads 308, such as increased thread pitch 312) may be utilized, alone or in combination, to provide an inefficiency generator 400 that, in some examples, functions to increase friction between the rotatable (i.e., knob 10) and transformable (e.g., slider mechanism or slide assembly 30) components of the maneuverable sheath handle 200. In such examples, the rotatable component of the maneuverable sheath assembly (e.g., knob 10) includes threads 302b that are operable with threads 302a of the threaded slider mechanism or slide assembly 30, such that rotation of the knob 10 effects linear translation of the threaded slider mechanism or slide assembly 30.

[0189] In some such instances, the number of threads on the threaded slider mechanism or slide assembly 30 may vary based on the particular application, for example, based on the desired degree of deflection of the articulating portion of the steerable sheath or catheter 90.

[0190] In alternative embodiments, the inefficiency generator 400 may be provided by modifying other components (e.g., components integral or inherent to the rotation of the linear translation system 300 or integral or inherent to the system including the sheath or catheter and the means for deflecting the sheath or catheter 90) of the control component of the medical device such as the steerable sheath or catheter 90. In some such examples, the inefficiency generator 400 may function to improve the device's ability to maintain a particular position, curve, or orientation of the articulating portion of the device. For example, the overall stroke (extension or translation distance) of the slider mechanism or slide assembly 30 may be reduced, thereby limiting the range of motion of the device to ensure sufficient threadable engagement between the rotatable and translatable components. Alternatively or in addition, O-rings or similar components may be included or increased in size to increase friction. Additionally, lubricants and / or damping greases may be employed or modified to optimize friction. Additionally, in embodiments of the sheath assembly that are manipulable with a control handle, such as control handle 200, a direction reversing element, such as a pulley, may be utilized to guide one of the pull wires of the device, reversing the routing or configuration of the pull wires or control wires on the two sides of the sheath such that a greater range of motion is damped by using a pulley. In further alternative embodiments, the sheath tube may be modified to reduce the force for deflection.

[0191] Further details regarding exemplary medical devices in which embodiments of the present invention may be utilized are provided in U.S. Provisional Patent Application No. 61 / 661,664, filed June 19, 2012, and PCT Application No. PCT / IB2013 / 055013, filed in English on June 18, 2013, designating the United States, both of which are incorporated herein by reference in their entireties.

[0192] 24A-24F, an alternative embodiment of a threaded slider mechanism or slide assembly 30 usable within a maneuverable handle 200 as previously described herein is provided. The slide assembly 30 is provided with an external thread 302a having an increased pitch 312, and a corresponding screw knob 10 (such an internal knob) is provided with an internal thread 302b having an increased pitch, this combination defining an inefficiency generator 400 in accordance with one embodiment of the present invention. The increased pitch 312 provides a reduced spacing between the threads 302, allowing the inefficiency generator 400 to improve the ability of a device (in other words, the ability of the maneuverable handle 200) to maintain a particular position, curve, or orientation of an articulating portion of the device, such as a sheath or catheter 90. In the illustrated embodiment, shown in FIGS. 24A-24F, the inefficiency generator 400 comprises a right-hand thread 309 having an increased pitch 312 equivalent to approximately ¼ inch pitch.

[0193] 25A, 25B, 25C, 25D, 25E ​​and 25F, an alternative embodiment of an inefficiency generator 400 is shown comprising a threaded slider mechanism or slide assembly 30 with increased pitch and reduced spacing between threads 302 (external threads 302a) and a corresponding threaded knob 10 (such as an inner knob) having internal threads 302b, according to one embodiment of the present invention. The increased pitch 312 provides reduced spacing between the threads 302 and improves the ability of the device to maintain a particular position, curve or orientation of the articulating portion of the device. In the illustrated embodiment, the inefficiency generator 400 comprises a right hand thread 309 with an increased pitch 312 equivalent to approximately 3 / 8 inch pitch.

[0194] 26A, 26B, 26C, 26D, 26E and 26F, an alternative embodiment of a threaded slider mechanism or slide assembly 30 is provided with a reverse or inverted thread 308, and a corresponding threaded knob 10 (such as a threaded inner knob) with a reverse thread 308, the combination defining an inefficiency generator 400, in accordance with one embodiment of the present invention. The inefficiency generator 400 with a reverse thread 308 can be used within the maneuverable handle 200, as previously described herein. The reverse thread 308 allows the slide assembly 30 to be positioned within the maneuverable handle 200 in a manner that allows the inefficiency generator 400 with a thread 302 with a reverse thread 308 to improve the ability of a device (in other words, the ability of the maneuverable handle 200) to maintain a particular position, curvature, or orientation of an articulating portion of the device, such as a sheath or catheter 90. The reverse threads 308 ensure that there is maximum engagement between the slide assembly 30 and the knob 10 (such as the inner knob) when the sheath is fully deflected, as the knob 10 is rotated counterclockwise and the slide assembly 30 is in its minimum extended or outward position away from the knob 10. This is when the sheath is fully deflected. In the illustrated embodiment, as shown in FIGS. 26A-26F, the inefficiency generator 400 includes a left-handed thread 310 having a pitch equal to approximately ½ inch pitch.

[0195] Accordingly, some embodiments of the present invention relate to some embodiments of an inefficiency generator 400 (e.g., including one or more components of the steerable handle 200), as outlined in this disclosure, that can be used in a medical instrument to assist in maintaining a desired position of an articulating component, such as a sheath or catheter 90, in some instances by retaining the position or state of a control component. For example, some embodiments of the inefficiency generator 400 disclosed herein are operable to increase friction between a rotatable (i.e., knob 10) component and a translatable (e.g., slider mechanism or slide assembly 30) component of the steerable handle 200 of a steerable sheath assembly.

[0196] As previously mentioned, some embodiments of the present invention provide an inefficiency generator 400 that functions to add inefficiency to a movement mechanism or system of the steerable catheter control system 200 that allows deflection of the sheath or catheter 90 via movement of the slide assembly 30 upon actuation of the knob 10 (e.g., rotation to linear translation system 300, etc.). The inefficiency generator 400 functions to increase the amount of force required to actuate (in other words, resist actuation of) an actuator (such as knob 10) in increasing deflection of the sheath or catheter 90. The inefficiency generator 400 provides one or more advantages as outlined herein above, including curve retention and / or providing feedback regarding the amount of actuation and / or degree of deflection of the sheath or catheter 90.

[0197] Some embodiments of the invention provide an inefficiency generator 400 within a steerable catheter control handle 200 to allow a user, such as a physician, when manipulating such a steerable control mechanism, to ascertain how far the sheath is deflected upon actuation, including when the sheath is in the neutral zone or how far away from the sheath, the neutral zone being the area where none of the deflection wires are under tension. Thus, in some embodiments of the invention as outlined herein, as provided within a steerable control system 200 for a steerable sheath or catheter 90, the inefficiency generator 400 provides feedback regarding the deflection of the steerable sheath (e.g., how much the sheath or catheter 90 has deflected upon actuation, or in other words, the relative degree of deflection of the sheath or catheter 90), and may further provide a feedback mechanism that provides an indication when the catheter control mechanism or assembly 200 is in its neutral position, such as providing neutral zone feedback.

[0198] More specifically, in accordance with one embodiment of the present invention, the inefficiency generator 400 provides (or in other words includes) a mechanism for providing tactile feedback to identify the deflection or position of the sheath or catheter 90, and in some embodiments, to identify the neutral zone.

[0199] 27A, 27B, 27C, and 27D and 27E, in accordance with one embodiment of the present invention, a maneuverable catheter control handle 200 as previously described includes an actuation mechanism for deflecting a sheath or catheter 90 (or, in other words, a means for deflecting a sheath or catheter or a deflection mechanism). In some such examples, the actuation mechanism or deflection mechanism includes a control knob 10 that is operable to deflect a distal end of the sheath or catheter 90 by causing linear motion of a slide assembly 30 within a housing 20, such as the inner housing 20a, as shown in FIGS. 27D and 27E. In the particular embodiment shown, the handle 200 includes an inefficiency generator that includes a feedback mechanism 402 (in other words, includes or incorporates a feedback mechanism 402). In some examples, the feedback mechanism 402 may introduce inefficiencies into the actuation mechanism of the handle 200 that enable deflection of the sheath or catheter 90 upon actuation of the knob 10. The feedback mechanism 402 interacts with the actuation mechanism to provide feedback. The actuation mechanism in this example is a rotary-linear mechanism 300 with a knob 10 that actuates a slide assembly 30, which translates within a track in the inner housing 20a of the handle 200 to actuate one of two pull wires on the sheath or catheter 90, deflecting the distal end of the sheath or catheter 90.

[0200] Similar to the embodiments outlined above, the pull wires may be coupled at their proximal ends to the slide assembly 30 (e.g., to the carriage 34, or to the wire crimped region of the slide 35, particularly via a crimp), with one of the wires passing through a direction reversing element before being coupled to the slide 35. The pull wires may also be coupled at their respective distal ends to the distal ends of the sheaths. Actuation of the knob 10 results in movement of the slide assembly 30, which includes a bolt or threaded fastener or shaft 32 coupled to the slide 35, which is operable to mate with the control knob 10 to permit movement of the slide assembly 30.

[0201] In this example, the inefficiency generator 400 includes a feedback mechanism 402 that indirectly interacts with (in other words, includes or incorporates) the rotation to linear system 300. In particular, the feedback mechanism 402 includes a tactile feedback mechanism 404 that provides a tactile indicator or feedback. In the particular example shown, the feedback mechanism 402 provides tactile feedback when the slide assembly 30 reaches a particular point along the track of the inner housing, indicating a deflection of the sheath or catheter 90, which in some examples indicates a neutral region, and in some examples indicates a level or degree of deflection or curvature of the catheter sheath on the actuator of the actuator.

[0202] For example, the inefficiency generator 400 comprises a feedback or indicator mechanism 402 (i.e., the inefficiency generator 400 includes or incorporates the feedback mechanism 402). The feedback mechanism 402 is defined by a tactile indicator, or in other words a tactile feedback mechanism 404, which in one embodiment is provided by the addition of material at designated locations on the handle track (formed within the inner housing 20a) and the slide assembly 30 when the handle knob 10 activates the slide assembly 30 to move through a designated location along the track. In one such example, the feedback mechanism 402 is positioned to indicate deflection of the sheath or catheter 90. The steerable catheter control handle 200 may be assembled such that the tactile indicator coincides with the position of the slide assembly when the sheath is bent (the tactile indicator provides feedback to the physician indicative of how much the distal end of the catheter control handle and sheath are deflected. In one such example, the feedback mechanism 402 is positioned toward the opposite side of the track 21a (e.g., toward the end of the track 21a).

[0203] In another example, the feedback mechanism 402 is positioned to identify the neutral zone. The steerable catheter control handle 200 may be constructed such that a tactile indicator coincides with the neutral position of the distal sheath curvature to indicate when the sheath or catheter 90 is in its nominal or neutral position. In one such example, the feedback mechanism 402 is positioned toward the center of the track 21a.

[0204] In some such embodiments, the inefficiency generator 400 comprises a feedback mechanism 402 comprising additional material (in other words, includes or incorporates the feedback mechanism 402) provided both on the underside of the slide 35 of the slide assembly 30 and within the track 21a of the inner handle (particularly, the inner housing 20a of the handle, such as the handle 100, 200, to provide tactile feedback). More specifically, the tactile indicator is provided within an operable catheter control handle comprising a first indicator portion 37a (as shown in Figs. 27A-27C) extending downward from the bottom surface of the slide 35 along a position on the slide 35, and one or more second indicator portions 37b, 37c (as shown in Figs. 27D-27E) formed at one or more positions within the track 21a of the inner housing 20a and extending upwardly into the handle interior. The position of the first indicator portion 37a on the slide 35 may be referred to as an actuation point on the slide assembly 30. To deflect the sheath or catheter 90 in a first or second direction upon actuation of the knob 10, the slide assembly 30 may first traverse the neutral zone.

[0205] In some such embodiments, the physician can choose to deflect the sheath or catheter 90 in a first direction by actuating the knob 10 clockwise, and the physician can also choose to deflect the sheath or catheter 90 in a second direction by rotating the knob counterclockwise, allowing the slide assembly 30 to move distally along the track 20t in a second direction opposite the first direction of movement. To deflect the sheath in the second direction, the slide assembly 30 must first cross the neutral zone. In one example, inefficiency generator 400 with feedback mechanism 402 (or in other words, including or incorporating feedback mechanism 402), when slide assembly 30 reaches the neutral zone (e.g., when switching between clockwise and counterclockwise actuation of knob 10), first indicator portion 37a of slide assembly 30 interacts with second indicator portion 37b to provide a tactile indication to inform the physician that the steerable sheath is now in its neutral position. In one such example, the first and second indicator portions 37a, 37b provide a mechanical indication as well as an audible indication upon mutual interaction. The first and second indicators 37a, 37b are tactile indicators and interact with each other such that sufficient resistance is generated to provide a tactile indication, but the movement of the slide assembly 30 is not stopped. In this example, the feedback mechanism 402 provides simulated feedback of the catheter deflection. The inefficiency generator 400 with the feedback mechanism 402 further provides individual feedback of the deflection state of the sheath or catheter 90 (particularly when the sheath or catheter is not substantially deflected and the slide assembly 30 is in the neutral zone, thus indicating that the sheath or catheter 90 is in a neutral position).

[0206] In another example of an inefficiency generator 400 with (in other words, including or incorporating) a feedback mechanism 402, when the sheath or catheter 90 is deflected in a first or second direction, upon actuation, the slide assembly 30 moves toward the opposite end of the inner housing 20a, and the first indicator portion 37a of the slide assembly 30 interacts with the second indicator portion 37c to provide a tactile indication to inform the physician that the steerable sheath is now in its neutral position. The first and second indicator portions 37a, 37c that define the tactile indicator interact with one another such that sufficient resistance is generated to provide a tactile indication, but the movement of the slide assembly 30 is not stopped. Similar to the neutral zone feedback, in this example, the inefficiency generator 400 provides simulated feedback of the catheter deflection. The inefficiency generator 400 with the feedback mechanism 402 further provides a discrete feedback of the deflection state of the sheath or catheter 90 (particularly indicating that the sheath or catheter is in a substantially deflected position and the slide assembly 30 has passed the neutral zone toward the maximum travel position of the slide assembly 30, and thus the sheath or catheter 90 is in a deflected position). In some such examples, the discrete indication provided by the inefficiency generator 400 with the feedback mechanism 402 may provide an indication of the bending of the sheath or catheter 90 upon deflection. In one example, the feedback mechanism 402 may provide an indication for a 90 degree deflection or bending of the sheath or catheter 90. In another example, the feedback mechanism may provide an indication for a 180 degree deflection or bending of the sheath of the catheter 90. In one such example, the first and second indicator portions 37a, 37c provide a tactile indication that provides a mechanical indication and an audible indication upon interaction with one another.

[0207] One particular example of the inefficiency generator 400 includes a feedback mechanism 402 (in other words, the inefficiency generator 400 includes or incorporates the feedback mechanism 402). The feedback mechanism 402 includes first and second indicator portions 37a and 37b, 37c, respectively, which may have a height of about 1 mm. In such cases, sufficient clearance may be provided within the handle to allow the slide assembly 30 to butt up onto the second indicator portion 37b, 37c. In some embodiments, the additional material of the first and second indicator portions 37a and 37b, 37c may have square leading and trailing edges. In some embodiments, the trailing and leading edges of the first and second indicator portions 37a and 37b, 37c may be angled at the second indicator portion 37b, 37c, which may make the movement of the slide assembly 30 along the track 20t smoother and minimize the risk of binding. This allows the physician to continue to rotate the knob 10 either clockwise or counterclockwise to deflect the sheath or catheter 90 in a first or second direction as desired. Thus, according to one embodiment of the present invention, the feedback mechanism 402 provides a neutral zone indicator that identifies a neutral zone for the bidirectionally maneuverable control handle. The tactile indicator allows a single neutral zone to be identified regardless of the direction in which the slide assembly 30 moves. According to one embodiment of the present invention, instead of or in conjunction with a neutral zone indicator, the feedback mechanism 402 provides an indication that identifies the degree of deflection for the bidirectionally maneuverable control handle. In some examples, the indicator may provide a relative degree of deflection of the sheath 90. In other examples, the indicator may provide an indication of a substantially absolute deflection of the sheath 90 (eg, the angle of curvature of the sheath 90).

[0208] In some such embodiments, the material forming the first and second indicator portions 37a and 37b, 37c is sufficiently hard to provide a tactile indication, but thin or narrow enough to provide feedback without impeding or stopping the movement of the slide assembly 30 within the handle. As such, the tactile indicator provides feedback to the user without impeding the function of the system control system. In this specific example, each of the first and second indicator portions 37a and 37b, 37c has a relatively narrow length along the longitudinal axis of the handle, relative to the longitudinal length of the slide 35 and inner housing 20a. In some such embodiments, the closer the additive material forming the indicator portions 37a and 37b, 37c is to a line / dot [i.e., the shorter the length of additive material], the more accurate the tactile indicator will be, since the tactile trigger can be triggered during movement of the slide assembly 30 in both the proximal and distal directions along the track 20t. In one such example, the first and second portions 37a and 37b, 37c of the tactile indicator are positioned to promote reproducibility during manufacturing and to ensure that the remaining components of the handle assembly can be assembled and positioned relative thereto.

[0209] In some embodiments of the present invention, the first and second indicator portions 37a and 37b, 37c may be permanently fixed to the slide assembly 30 and the inner housing 20a, respectively. In one such example, the first and second indicator portions 37a and 37b, 37c may be formed by injection molding, or alternatively, the first and second indicator portions 37a and 37b, 37c may be machined features. Alternatively, these components may be machined. In one particular example, the slide assembly 30 and the first indicator portion 37a may be molded together and may include Delrin®, while acrylonitrile butadiene styrene (ABS) may be used for the inner housing 20a, as well as the second indicator portions 37b, 37c. Alternatively, in some embodiments, polycarbonate may be used to form one or more of the components.

[0210] Alternatively, in some embodiments of the present invention, the slide assembly 30 may be modified such that the position of the first indicator portion 37a (or in other words the actuation point on the slide assembly 30) may be altered or changed. In some such embodiments, the first indicator portion 37a may be located at a different position on the slide 35 and may have various geometric shapes or dimensions. Similarly, the inner housing 20a may be modified such that the position of the second indicator portion 37b, 37c (or in other words the actuation point on the inner housing 20a) may be altered. In some such embodiments, the second indicator portion 37b, 37c may be located at a different position within the track 21a of the inner housing 20a and may have various geometric shapes or dimensions. Thus, in some examples, the inefficiency generator 400 provides a feedback mechanism 402 to indicate when the slide assembly 30 itself, the operable control system, and the distal end of the sheath are within the neutral zone. In other words, the handle 200 includes a mechanism for providing feedback when the slide assembly 30 reaches a point along the track 21a where none of the pull wires are under tension and the distal end of the sheath is in its neutral position. The inefficiency generator 400 providing feedback, such as feedback of deflection of the sheath or catheter 90 in a substantially undeflected state, provides neutral zone feedback, and as such may facilitate use of the manipulable control handle by the physician during the procedure, further reducing the complexity and / or time of the procedure. In one such embodiment, feedback may be provided in the form of a tactile indicator when the slide assembly 30 reaches a particular point along the track 21a of the inner housing 20a that indicates the neutral zone.

[0211] Thus, the inefficiency generator 400 may facilitate the physician's use of the manipulable control handle 200 during a procedure, further reducing the complexity and / or time of the procedure. Additionally, the inefficiency generator 400 of the present invention may provide tactile feedback and thus not cause the user to look at their hands or the product during a procedure, thus facilitating the physician's use of the steerable sheath.

[0212] Thus, in accordance with an embodiment of the present invention, a method and apparatus is disclosed for a steerable catheter control handle 200 that provides an inefficiency generator 400 that functions to provide feedback in the form of indicators to assist a physician in identifying the degree of deflection of the sheath or catheter 90, which may include, for example, an indication of a neutral zone.

[0213] In one embodiment of the invention, a manipulable control system comprising a handle with inefficiency generator 400 includes a feedback mechanism 402 that may include feedback of sheath deflection and / or neutral feedback indicators as discussed hereinabove, which in some instances may be used to steer an introducer sheath for use in an electrophysiology environment. In a further alternative, the thread pitch on the threaded portion may be increased such that the handle knob rotates less than about 360 degrees in each direction, and visual or tactile indicators may be integrated directly into the handle to provide an indication of the deflection of the sheath or catheter 90, including, for example, the neutral region.

[0214] In an alternative embodiment, the handle may be attached to and used with other steerable catheter products that may be used in other applications and may be provided with an inefficiency generator 400 that may function to provide an indication of the neutral zone when deflecting the steerable product. Alternatively, the inefficiency generator 400 may provide a neutral feedback mechanism that may be used within the handle to indicate, for example, another distal curve position when deflecting the steerable product.

[0215] Further details regarding exemplary medical devices in which embodiments of the present invention may be utilized are provided in U.S. Provisional Patent Application No. 61 / 661,664, filed June 19, 2012, and PCT Application No. PCT / IB2013 / 055013, filed in English on June 18, 2013, designating the United States, both of which are incorporated herein by reference in their entireties.

[0216] As discussed above, the inventors have discovered an apparatus and method for a steerable catheter control handle that provides an inefficiency generator 400 that provides an indicator for identifying deflection of the sheath or catheter 90 and provides a feedback mechanism 402 that can aid in identifying the neutral zone of the steerable control handle. More specifically, in accordance with an embodiment of the present invention, a mechanism is provided for identifying deflection of the sheath or catheter 90 by tactile feedback. Further examples are provided herein below regarding an inefficiency generator 400 with a feedback mechanism 402 for indicating deflection of the sheath or catheter 90, such as a neutral zone feedback mechanism for a steerable control handle.

[0217] 28A-28B, in accordance with further embodiments of the present invention, an inefficiency generator 400 is provided that includes a feedback mechanism 402 that includes a tactile indicator. In one such example, the feedback mechanism includes a handle position indicator. In some embodiments, a steerable catheter control handle 200 is provided, such as a bidirectional steerable handle 200.

[0218] As previously mentioned, the actuator is provided on the control handle 200, including the knob 10 on the manipulable control handle 200, and can be actuated, for example by rotating or twisting, to pull one of two pull wires to deflect the sheath or catheter 90, such as the distal tip of the sheath or catheter 90. In the embodiments described herein, an inefficiency generator 400 is provided that provides a feedback mechanism 402 that provides enhanced feedback when deflecting the distal tip from one direction to the next, which can be advantageous to indicate to a user the degree and / or direction of deflection of the sheath or catheter 90.

[0219] The feedback mechanism 402 can further indicate a change or switch in the direction of deflection of the sheath or catheter 90. Additionally, as previously discussed, in some embodiments, the steerable catheter control handle 200 provides a "dead zone" where neither of the two pull wires are under tension (e.g., over several millimeters) as the knob 10 is turned, and the inefficiency generator 400 with the currently provided feedback mechanism 402 can provide tactile feedback indicative of this "dead zone," or in other words, tactile feedback can be provided from this "dead zone." Thus, the present disclosure provides an inefficiency generator 400 that provides a feedback mechanism 402 that provides enhanced feedback of sheath or catheter deflection, such as, for example, the degree of sheath curvature and / or the direction of sheath curvature and / or neutral zone feedback for the steerable control handle.

[0220] In one embodiment, an inefficiency generator 400 is provided that includes a feedback mechanism 402 that provides a tactile indication. The feedback mechanism 402 includes a first indicator portion 37a that is incorporated into a rear portion of the slider or slide 35 of the slide assembly 30, for example as shown in Figures 28A and 28B, and in one embodiment includes one or more fins, such as fins. The feedback mechanism 402 further includes a second indicator portion 37b that in one embodiment includes one or more ridges (which may resemble washboards) that are added to a handle housing 20, such as the inner housing 20a of the steerable catheter control handle 200 (or an inner portion of its inner handle). When the knob 10 of the maneuverable catheter control handle 200 is actuated, for example, by turning it or twisting it, the slide assembly 30 moves via a threadable engagement 302 between the bolt or shaft 32 of the slide assembly 30 and the knob 10, moving the slide 35 within the inner housing 20a and generating an interaction between the first indicator portion 37a and the second indicator portion 37b (in other words, the two features (fin and ridge) meet). At this point, the inefficiency generator 400 includes a feedback mechanism 402 that provides a mechanical indication that allows a user, such as a physician, to receive tactile or acoustic feedback indicating that the first indicator portion 37a, such as a fin, is moving relative to the second indicator portion 37b, either one or more ridges that indicate, for example, an amount of deflection or a state of the sheath or catheter as to how much it is curved. In one such example as shown, the feedback mechanism 402 as shown indicates that the sheath or catheter 90 (such as its distal tip) is in a neutral state (in other words, the sheath or catheter 90 is not substantially deflected), as in another example, similar to the embodiment shown in Figures 27A-27D.The second indicator 37b (such as a ridge) may be located elsewhere within the inner housing 20a of the steerable catheter control handle 200 such that the feedback mechanism 402 indicates the deflection of the sheath or catheter 90 (such as its distal tip) to indicate whether it is in its deflected position. In some such examples, the feedback mechanism 402 may indicate that the sheath or catheter 90 is substantially deflected. In some such examples, the feedback mechanism 402 provides discrete feedback. In other examples, the feedback mechanism 402 provides relative feedback of the deflection. In some such examples, the feedback mechanism 402 may provide variable feedback for the range of deflection of the sheath or catheter 90.

[0221] In further embodiments of the present invention as described herein, the positions of the first and second indicator portions 37a, 37b of the inefficiency generator 400 (such as one or more fins and ridges) and the geometric dimensions of the first indicator portion 37a and second indicator portion 37b (such as one or more fins and ridges) may be varied.

[0222] In another such embodiment of the invention, as shown in Figures 31A, 31B, and 31C, an inefficiency generator 400 includes (or in other words includes or incorporates) a feedback mechanism 402 to provide or add tactile feedback to indicate sheath deflection. As previously described, the feedback mechanism 402 includes a first indicator portion 37a on a bottom of the slide portion 35 of the slide assembly 30, such as a fin (as shown in Figure 31B) operable to interact with a second indicator portion 37b, such as one or more ridges or bumps, on the inner housing 20a (e.g., along the track 21a of the inner housing 20a, as shown in Figure 31A). The first indicator portion 37a is operable to interact with the second indicator portion 37b as the slide assembly 30 moves relative thereto, as shown in FIG. 31C, which indicates how much the sheath or catheter is bent, or the amount of deflection of the sheath or catheter, or the position of the neutral zone where the sheath 90 is in a substantially undeflected state, as shown in FIGS. 31A-31C.

[0223] In another such embodiment of the invention, as shown in Figures 32A, 32B and 32C, an inefficiency generator 400 is provided that includes a feedback mechanism 402 (in other words, includes or incorporates a feedback mechanism 402) for providing or adding tactile feedback to indicate sheath deflection. As previously described, the feedback mechanism 402 includes a first indicator portion 37a, such as a side bump (shown in Figure 32B), on a side of the slide or slide portion 35 of the slide assembly 30 that is operable to interact with a second indicator portion 37b, such as one or more side bumps, on the inner housing 20a (e.g., along an inner wall of the inner housing 20a, as shown in Figure 32A). The first indicator portion 37a is operable to interact with the second indicator portion 37b as the slide assembly 30 moves relative thereto, as shown in FIG. 32C, which indicates how much the sheath or catheter is bent, or the amount of deflection of the sheath or catheter, or the position of the neutral zone where the sheath 90 is in a substantially undeflected state, as shown in FIGS. 32A-32C.

[0224] In another such embodiment of the invention, as shown in Figures 33A, 33B, and 33C, an inefficiency generator 400 is provided that includes (i.e., includes or incorporates) a feedback mechanism 402 for providing or adding tactile feedback indicative of sheath deflection. As previously described, the feedback mechanism 402 comprises a first indicator portion 37a on a side of the slide portion 35 of the slide assembly 30, such as a lateral ridge along a cantilever portion 39 of the slide assembly (as shown in Figure 33B), operable to interact with a second indicator portion 37b, such as one or more grooves on the inner housing 20a (e.g., along an inner wall of the inner housing 20a, as shown in Figure 33A). The first indicator portion 37a is operable to interact with the second indicator portion 37b, for example, by being received within one or more grooves in the second indicator portion 37b, when the slide assembly 30 moves relative to the second indicator portion 37b, as shown in FIG. 33C, which indicates the amount of deflection as to how curved it is, or the state of the sheath or catheter 90, or the position of the neutral zone where the sheath 90 is in a substantially undeflected state, as shown in FIGS. 33A-33C.

[0225] 28C-28E, in accordance with further embodiments of the present invention, an inefficiency generator 400 is provided that includes a feedback mechanism 402 that includes a tactile indicator. In some such examples, the feedback mechanism 402 includes a tactile knob feedback. In some embodiments, a steerable catheter control handle 200 is provided, such as the bi-directional steerable handle 200. In one such example, the tactile indicator can be used in conjunction with other forms of visualizing, for example, the position or deflection of the bi-directional steerable sheath during its use. For example, a visual indication is provided to the physician regarding the distal tip curve response to handle knob rotation through the use of medical imaging (i.e., fluoroscopy).

[0226] In one embodiment of the present invention, tactile feedback is provided via a feedback mechanism 402 that defines an efficiency generator 400, as described below with reference to FIGS. 28C, 28D, and 28E. In some embodiments, the feedback mechanism 402 may provide variable tactile feedback over the range of motion of the knob rotation. In other words, the feedback mechanism 402 may provide variable feedback based on the amount of rotation of the knob 10. In some such examples, as the knob 10 is rotated, the amount of feedback given to the user varies, giving the user different tactile indications or sensations as the knob 10 is rotated. This allows the user to ascertain whether the user is in a neutral position or if the sheath or catheter is deflected, and may further provide the user with an indication of the amount or degree of deflection of the steerable sheath. In some embodiments, the tactile sensation of the knob rotation may have some variability over the range of motion (both curve directions) in the current embodiment. In some embodiments, the tactile feel can also be influenced (e.g., to enhance or reduce the tactile feel) by incorporating additional components and their properties, such as, for example, friction-enhancing components such as O-rings and / or lubricants such as dampening greases.

[0227] Accordingly, some embodiments of the present invention provide an inefficiency generator 400 that provides (or includes or incorporates) a feedback mechanism 402 to provide or add tactile feedback (related to the expected distal tip curvature response to the physician) that can be directly or indirectly tied to the rotation of the knob, and in some embodiments, tactile feedback indicating a neutral zone that can correlate with a substantially straight sheath tube, or in other words, substantially no distal curvature actuation.

[0228] 28C, 28D and 28E, another embodiment of the present invention incorporates an inefficiency generator 400 that comprises (in other words, includes or incorporates) a feedback mechanism 402 that provides tactile feedback. In one such example, the feedback mechanism 402 includes a first indicator portion 37a that includes a spring biased protrusion or protruding surface 47, or a spring protruding surface 47, and a second indicator portion 37b that includes one or more indentations or grooves 48a, as shown in FIG. 28D and 28E. When the knob 10 is actuated to move the slide assembly 30, a tactile indication is created as the spring biased protruding surface 47 moves over a fixed surface, such as defined by a bottom surface of the inner housing 20a that includes the indentations or grooves 48a, as shown in FIG. In some such examples, the recess or groove 48a may be formed in the bottom surface of the inner housing 20a, where the raised protrusion or ridge 48b is formed or defined by the bottom surface of the inner housing 20a of the handle 200. In another example, as shown in FIG. 28D, the raised protrusion or ridge 48b is formed along the bottom surface of the inner housing 20a, where the recess or groove 48a is formed or defined by the bottom surface of the inner housing 20a, as shown in FIG. 28D. In some such embodiments, with reference to FIGS. 28D and 28E, the length of the recess or groove 48a may be varied to define different zones of actuation and corresponding deflection of the sheath or catheter 90 upon actuation of the knob 10. In one such example, a longer recess or groove 48c is provided along a portion of the inner housing 20a that corresponds to the position of the slide assembly 30 when the sheath or catheter 90 is in a substantially undeflected position. In some such embodiments, when the knob 10 is actuated, a neutral zone can be felt as the slide assembly 30 moves within the inner housing 20a along the fixed surface area or extent of the elongated recess or groove 48c.

[0229] In some such instances, the spring-biased protruding surface 47 provides a spring-biased characteristic that increases resistance to actuation as the knob 10 is actuated, and thus, it may become more difficult to actuate the knob 10 as the spring-biased protruding surface 47 moves across the raised protrusion or ridge 48b until it finds the next recess or groove 48a or 48c. In other words, the inefficiency generator 400 provides a feedback mechanism 402 including a combination of a series of dimples or grooves 48a, 48c spaced apart by raised protrusions or ridges 48b that provides one or more indications based on the degree of resistance, in other words, how hard it is for the physician to rotate to the next groove, the spring constant of the spring biased component, the size and / or frequency of the dimples or grooves 48a, 48c, the size and / or frequency of the raised protrusions or ridges 48b, and surface features on the component that interact with each other to generate the indication (such as the spring biased protruding surface 47 and grooves 48a, 48c, and ridges 48b of the slide assembly 30). In other words, in some such embodiments, rotating the knob 10 moves the protruding surface 47 of the slide assembly 30 to the next dimple or groove 48a, 48c, creating an audible "click." The frequency of the grooves 48a of the feedback mechanism 402 defined by this embodiment can function to affect the lubricity of the handle (which can make turning the knob 10 more difficult), as well as the frequency of feedback received by the physician (based on the number and spacing of the grooves 48a, 48c and ridges 48b).

[0230] An embodiment of a steerable sheath is provided in PCT Application No. PCT / IB2013 / 055013. In some such embodiments, an inefficiency generator 400 is provided that includes a feedback mechanism 402 that includes a spring-biased protruding surface 47 on the bottom of a portion of the slide assembly 30, such as the slide 35, and one or more grooves 48a, 48c applied to the base or bottom of the inner housing 20a of the handle 200 (or in other words, which may be referred to as an inner handle rail).

[0231] 29A, 29B, 29C and 29D and 29E, similar to the embodiments described above, the inventors have discovered an apparatus and method for a steerable catheter control handle 200 that provides an inefficiency generator 400 that provides (in other words, includes or incorporates) an indicator for identifying deflection of the sheath or catheter 90 and further provides a feedback mechanism 402 that can aid in identifying a neutral zone of the steerable control handle 200. More specifically, in accordance with one embodiment of the present invention, a mechanism is provided for identifying deflection of the sheath or catheter 90 by tactile feedback.

[0232] This may be useful when the steerable sheath 200 is inside a patient since it may be difficult to know the direction of the sheath curve. The inefficiency generator 400 with feedback mechanism 402 provides tactile feedback to provide an indication of the sheath curvature and / or neutral zone. In some such embodiments, the feedback mechanism 402 provides a tactile differential or differential sensation or resistance when the sheath or catheter 90 is curved compared to when the sheath or catheter 90 is in the neutral zone. In some embodiments, the handle 200 may provide an optimized actuation mechanism such that the user may not need to turn the handle knob 10 a significant amount to exit the neutral zone, and a corresponding feedback mechanism 402 is provided to give an indication to the user when the slide assembly 30 and sheath 90 exit the neutral zone.

[0233] In this embodiment, shown in FIGS. 29A-29E, the inefficiency generator 400 includes (or in other words includes or incorporates) a feedback mechanism 402 that provides variable friction such that the neutral zone is distinguished from the curved zone by a difference in friction when turning the handle knob 10.

[0234] Referring to FIG. 29A, in this embodiment, the feedback mechanism 402 comprises a feature added to the slider 35 that protrudes outward and forms a friction fit or interaction with the inner handle. In one such example, the feature comprises a protrusion 57 that provides a friction fit between the slide assembly 30 and the inner housing 20a. In some such embodiments, as shown in FIGS. 29A and 29C, a constant frictional feel or frictional fit (such as a high friction interface) is created to indicate the outer region of the neutral zone and also to indicate that the sheath or catheter 90 is within the deflectable or curved region of the sheath or catheter 90. The constant frictional fit creates a constant high friction on both sides of the neutral zone region, reducing the risk of confusion as to which side of the neutral zone region the user is on (in other words, whether the user has entered the neutral zone or the sheath or catheter is in the deflectable region). Thus, the feedback mechanism 402 of this embodiment provides a combination of the projection 57 and the inner housing 20a that provides a wider or longer feedback region (beyond the neutral region) that indicates that the sheath or catheter 90 is deflected upon actuation of the actuator. In some such instances, as shown in Figures 29C and 29E, a neutral zone exists and a cavity 58 is created or provided in the bottom of the inner handle (specifically, the inner housing 20a). Thus, when the slide assembly 30 enters the cavity 58, the friction that existed between the projection 57 and the inner housing 20a is relieved, creating a low friction region that substantially corresponds to the sheath or catheter 90 when in a substantially undeflected position. In some such embodiments, the feedback mechanism 402 provides a low friction region that is long enough to provide a neutral zone region that is long enough for the user to feel a change in friction, while the low friction region is short enough that a comfortable rotation may be sufficient to exit the neutral zone. In another example, the feedback mechanism 402 including the combination of the protrusion 57 and the inner housing 20a can provide a single friction fit point that provides individual feedback similar to the embodiments described above.

[0235] 29B and 29D, the slide assembly 30 defines a slide 35 having a uniform lower surface that interacts with a bottom surface of the inner housing 20a defining a uniform surface along its bottom surface. The inefficiency generator 400, in some such embodiments, may comprise (or in other words include or incorporate) a feedback mechanism 402 as provided in the alternative embodiments as shown and described in this disclosure.

[0236] Accordingly, some embodiments of the present invention provide a bidirectional sheath control handle 200 with an inefficiency generator 400 with a feedback mechanism 402 (or in other words, includes or incorporates a feedback mechanism 402) with a neutral zone identifier that minimizes user confusion without falsely indicating a neutral point in the handle 200. The provided feedback mechanism 402 does not interfere with the functionality of the control handle 200. In some such embodiments of the present invention, even if the slide assembly 30 moves in both directions, the feedback mechanism 402 of this embodiment identifies only one neutral, regardless of the direction in which the slide assembly 30 moves. In some such embodiments, the feedback mechanism can help reduce conflicting information regarding the location of the neutral zone. As such, some such embodiments can help reduce confusion about which side of the neutral zone area the user is on.

[0237] 30A, 30B, similar to the embodiments described above, the inventors have discovered an apparatus and method for a steerable catheter control handle 200 that provides an inefficiency generator 400. The inefficiency generator 400 comprises (or in other words includes or incorporates) a feedback mechanism 402 that provides an indicator for identifying deflection of the sheath or catheter 90, and can further aid in identifying a neutral zone of the steerable control handle 200. More specifically, in accordance with an embodiment of the present invention, a mechanism is provided for identifying deflection of the steerable sheath or catheter 90 via tactile and auditory feedback to the direction of the curve.

[0238] In such an embodiment, the inefficiency generator 400 provides a feedback mechanism 402 that facilitates the physician to determine the direction of curvature of the distal end of the sheath or catheter 90 when inside the patient, based on which the handle knob 10 is actuated (such as by turning it). In some such examples, the feedback mechanism 402 can provide information regarding the curvature of the sheath, for example, when it is difficult to see the shape of the sheath curve from a fluoroscopic image, particularly when the sheath is artificially curved due to anatomy (e.g., even when the pull wire is fully engaged, regardless of the amount of actuator actuation). Additionally, the feedback mechanism 402 can help the physician avoid damaging the sheath or catheter 90, for example, by minimizing the risk that the physician thinks he or she is bending the sheath when he or she is straightening it out. The feedback mechanism 402 as provided can help avoid placing unnecessary stress on the pull wire. Additionally, the feedback mechanism 402 can help provide an indication that allows the physician to verify whether the sheath 90 is being straightened while attempting to retract the sheath 90, which can help avoid the procedural complication of pulling a curved sheath through the vasculature or dislodging other devices.

[0239] 30A and 30B, an embodiment of the present invention provides a steerable sheath handle 200 with an inefficiency generator 400 with a feedback mechanism 402 that provides a tactile response and an audible click when the sheath or catheter 90 is bending and has a smooth response when the sheath or catheter 90 is straightening. This can be useful for providing feedback to the physician without having to see the sheath or rely solely on fluoroscopic images.

[0240] With particular reference to FIG. 30B, in some embodiments, the inefficiency generator 400 comprises (in other words, includes or incorporates) a feedback mechanism 402 that provides a manipulable sheath handle component that serves to tighten a pull wire (such as an actuator like the knob 10). In a particular example, the knob 10 has a wavy inner surface 13. In some such embodiments, the wavy surface 13 is raised, includes a series of ridges 14, and is operable to interact with a complementary inner ring 15. The feedback mechanism 402, defined as the wavy inner surface 13 and the complementary inner ring 15 (which it functions to interact with), provides a feedback mechanism 402 that provides a smooth feel when the knob 10 is actuated or rotated in one direction to actuate the sheath. The feedback mechanism 402 thus defined provides tactile and / or audible feedback, such as a clicking sound, when the inner ring 15 mates with the wavy inner surface 13 of the outer handle component and the knob 10 is actuated or pivoted in the opposite direction.

[0241] In some such instances, a feedback mechanism 402 defined by the interaction between the inner ring 15 and the wavy inner surface 13 of the inner handle component may increase the torque required by the user to bend the sheath.

[0242] In some such instances, the feedback mechanism 402 defined by the interaction between the inner ring 15 and the wavy inner surface 13 of the inner handle component may not significantly increase the torque required by the user to bend the sheath.

[0243] Some embodiments of the feedback mechanism 402 described herein may be usable with one or more of the manipulable handles 200, 210, 220, 230 described herein.

[0244] In one broad aspect, an embodiment of the invention comprises a manipulable catheter control handle for deflecting a catheter. The control handle comprises an actuator, one or more pull wires, and a means for converting actuation of the actuator into movement of the pull wires to deflect the pull wires. A distal end of each of the one or more pull wires is coupled to the catheter and a proximal end of each of the pull wires is coupled to the means for deflecting the pull wires. The control handle further includes an inefficiency generator for interacting with the means for deflecting the pull wires, the inefficiency generator substantially increasing the force required to actuate the actuator to deflect the catheter.

[0245] In a further broad aspect, an embodiment of the invention includes a rotational-linear conversion system, where a control handle for a steerable catheter includes a rotatable knob, a slide assembly coupled to the slide assembly via a threadable fitting, and the catheter includes at least one control wire. A distal end of the control wire is coupled to the catheter, and a proximal end of at least one control or pull wire is coupled to the slide assembly. The control handle further includes a means for introducing inefficiencies into the rotational-linear conversion system, where rotation of the knob causes linear motion of the slide assembly via rotation of the knob, allowing deflection of the catheter via actuation of the at least one control wire, imparting a desired curvature to the catheter, and where the means for introducing inefficiencies increases the force required to bend the sheath while providing an optimized handle design that provides ease of handling and ease of use for the physician.

[0246] In a further broad aspect, an embodiment of the invention includes an operable catheter control handle for a catheter including a rotatable knob and a slide assembly, the rotatable knob coupled to the slide assembly via a threadable fitting, the threadable fitting including an angled thread, the catheter including at least one control wire, a distal end of the at least one control wire coupled to the catheter, a proximal end of the at least one control wire coupled to the slide assembly, rotation of the knob causes linear motion of the slide assembly via rotation of the knob, and enables deflection of the catheter via actuation of the at least one control wire to impart a desired curvature to the catheter, the angled thread providing enhanced tactile feedback to a user regarding catheter deflection at the distal end and enabling the deflection of the catheter to be maintained at the desired curvature.

[0247] The embodiments of the invention described above are intended to be exemplary only, and the scope of the invention is therefore intended to be limited only by the appended claims.

[0248] It will be appreciated that certain features of the invention that are, for clarity, described in the context of separate embodiments, can also be provided in combination in a single embodiment. Conversely, various features of the invention that are, for clarity, described in the context of a single embodiment, can also be provided separately or in any suitable subcombination.

[0249] Although the present invention has been described in conjunction with specific embodiments thereof, it is apparent that many alternatives, modifications, and variations will be apparent to those skilled in the art. Accordingly, it is intended to embrace all such alternatives, modifications, and variations that fall within the broad scope of the appended claims. All publications, patents, and patent applications mentioned in this specification are incorporated by reference in their entirety into the specification to the same extent as if each individual publication, patent, or patent application was specifically and individually indicated to be incorporated herein by reference. Furthermore, citation or identification of any reference in this application should not be construed as an admission that such reference is available as prior art to the present invention. The technical ideas that can be understood from the above-described embodiment will be described below as supplementary notes. [Appendix 1] A steerable catheter control handle having a rotational-linear translation system for deflecting a catheter, A rotatable knob; a slide assembly coupled to the rotatable knob via a threadable engagement; at least one control wire having a steerable distal end coupled to the catheter and a proximal portion coupled to the slide assembly; a means integral to the rotary-to-linear conversion system for introducing inefficiencies into said rotary-to-linear conversion system; Rotation of the knob induces linear motion of a slide assembly, enabling deflection of the catheter via actuation of at least one control wire to impart a desired curvature to the catheter; the means for introducing inefficiency increases the force required to actuate at least one control wire to bend the catheter upon increasing deflection of the catheter; the means for introducing inefficiency substantially increases the amount of force required to rotate the knob and translate the slide assembly, which force varies substantially based on the amount of rotation to provide enhanced tactile feedback regarding the deflection of the catheter as the deflection of the catheter increases; the means for introducing inefficiency allows for curve retention, allowing the catheter to maintain a deflection at substantially a desired curve after the catheter has been deflected; A maneuverable catheter control handle, wherein the means for introducing inefficiencies comprises one or more angled threads defining the threadable engagement. [Appendix 2] 2. The operable catheter control handle of claim 1, wherein the means for introducing inefficiency enables self-locking such that the force required to rotate the knob to move the slide assembly is greater than the force exerted by the catheter on the slide assembly after deflection of the catheter, preventing the curvature of the catheter from being changed in the absence of user input without actuation of the knob. [Appendix 3] 2. The operable catheter control handle of claim 1, wherein the threadable engagement is defined by external angled threads on the shaft of the slide assembly and corresponding internal angled threads on the knob that are mateable therewith. [Appendix 4] 2. The steerable catheter control handle of claim 1, wherein the means for introducing inefficiency provides actual feedback of the catheter deflection. [Appendix 5] 2. The maneuverable catheter control handle of claim 1, wherein the means for introducing inefficiency provides simulated feedback of deflection of the catheter. [Appendix 6] 2. The operable catheter control handle of claim 1, wherein the slide assembly is movable within a housing of the handle. [Appendix 7] 7. The operable catheter control handle of claim 6, wherein the means for introducing inefficiency includes a gradient friction device positioned within the handle housing that interacts with the slide assembly as the slide assembly moves, the gradient friction device increasing friction as linear movement of the slide assembly increases within the housing upon deflection of the catheter. [Appendix 8] 8. The operable catheter control handle of claim 7, wherein the gradient friction device comprises one or more triangular friction pads disposed along an inner surface of the handle housing. [Appendix 9] the means for introducing inefficiencies is defined by the housing; the housing includes opposing walls that taper toward one another from a center of the housing toward proximal and distal ends of the housing; 7. The operable catheter control handle of claim 6, wherein the slide assembly increases friction between the slide assembly and the opposing wall of the housing as linear movement of the slide assembly within the housing increases upon deflection of the catheter. [Appendix 10] 10. The maneuverable catheter control handle of claim 9, wherein the slide assembly is engageable with the wall of the housing via a biasing mechanism forming part of the slide assembly.

Claims

1. 1. A steerable catheter control handle having a rotational-linear translation system for deflecting a catheter, the steerable catheter control handle comprising: A rotatable knob; a slide assembly coupled to the rotatable knob via a threadable engagement; at least one control wire, a distal end of the control wire coupled to the catheter and a proximal portion of the control wire coupled to the slide assembly; rotation of the knob induces linear motion of the slide assembly, enabling deflection of the catheter via actuation of the at least one control wire to impart a desired curvature to the catheter; a means for introducing inefficiencies into the rotational-linear conversion system, the means for introducing inefficiencies comprising one or more angled threads defining the threadable fitting, whereby the amount of inefficiency increases as the amount of deflection of the catheter increases to provide enhanced tactile feedback regarding the deflection of the catheter as the deflection of the catheter increases; Equipped with The means for introducing inefficiency is a manipulable catheter control handle that allows for curve retention, allowing the deflection of the catheter to be maintained at substantially a desired curve after the catheter has been deflected.

2. 2. The steerable catheter control handle of claim 1, wherein the means for introducing inefficiency enables self-locking such that the force required to rotate the knob to move the slide assembly is greater than the force exerted by the catheter on the slide assembly after deflection of the catheter, preventing the curvature of the catheter from being changed in the absence of user input without actuation of the knob.

3. 2. The steerable catheter control handle of claim 1, wherein the threadable engagement is defined by external angled threads on the shaft of the slide assembly and corresponding internal angled threads on the knob that are matable therewith.

4. The steerable catheter control handle of claim 1 , wherein the means for introducing inefficiency provides actual feedback of the catheter deflection.

5. The steerable catheter control handle of claim 1 , wherein the means for introducing inefficiencies provides simulated feedback of the catheter deflection.

6. The steerable catheter control handle of claim 1 , wherein the slide assembly is movable within a housing of the handle.

7. 7. The steerable catheter control handle of claim 6, wherein the means for introducing inefficiencies includes a gradient friction device positioned within the handle housing that interacts with the slide assembly as the slide assembly moves, the gradient friction device increasing friction as linear movement of the slide assembly increases within the housing upon deflection of the catheter.

8. The steerable catheter control handle of claim 7 , wherein the gradient friction device comprises one or more triangular friction pads disposed along an inner surface of the handle housing.

9. the means for introducing inefficiencies is defined by the housing; the housing includes opposing walls that taper toward one another from a center of the housing toward proximal and distal ends of the housing; 7. The steerable catheter control handle of claim 6, wherein the slide assembly increases friction between the slide assembly and the opposing wall of the housing as linear movement of the slide assembly within the housing increases upon deflection of the catheter.

10. The steerable catheter control handle of claim 9 , wherein the slide assembly is mateable with the wall of the housing via a biasing mechanism forming part of the slide assembly.

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