Intraluminal devices

Abstract

To enable a physician to use a handle from any rotation angle while providing grip stability and maintaining tactile resolution as much as possible. [Solution] The device includes a flexible, elongate shaft having a distal portion and a proximal portion and being inserted into the patient's body, a distal tip including an imaging element and operably associated with the distal portion of the flexible, elongate shaft, and a control handle coupled to the proximal portion of the flexible, elongate shaft, the control handle including a first actuator for positioning the imaging element within the patient's body, and a first friction member coupled to the first actuator and in contact with the first actuator for controlling the positioning of the imaging element.

Description

CROSS-REFERENCE TO RELATED APPLICATIONS

[0001] This application claims the benefit of and priority to U.S. Provisional Patent Application No. 62 / 402,483, filed September 30, 2016, and U.S. Provisional Patent Application No. 62 / 434,093, filed December 14, 2016, which are incorporated herein by reference in their entireties. [Technical field]

[0002]

[0001] The present disclosure relates generally to ultrasound catheters, and more particularly to a steerable intracardiac echocardiography (ICE) catheter having an ergonomic control handle with a variable braking system to provide intuitive, fine catheter steering control. [Background technology]

[0003]

[0002] Diagnostic and therapeutic ultrasound catheters are designed for use in many areas of the human body. In the cardiovascular system, two common diagnostic ultrasound techniques are intravascular ultrasound (IVUS) and intracardiac echocardiography (ICE). Typically, a single rotating transducer or an array of transducer elements is used to transmit ultrasound waves at the tip of the catheter. The same transducer (or a separate transducer) is used to receive echoes from the tissue. Signals generated from such echoes are transmitted to a console, which allows for processing, storage, display or manipulation of the ultrasound-related data.

[0004]

[0003] IVUS catheters are typically used in the large and small vessels (arteries or veins) of the body and are almost always delivered over a guidewire with a flexible tip. ICE catheters are commonly used to image the heart's cavities and surrounding structures to guide and facilitate medical procedures such as transseptal puncture, left atrial appendage closure, atrial fibrillation ablation, and valve repair. Commercially available ICE catheters are not designed to be delivered over a guidewire, but instead have a distal end that can be articulated by a steering mechanism located in a handle at the proximal end of the catheter. For example, an ICE catheter can be inserted via the femoral or carotid arteries when accessing the anatomical structures and is steered within the heart to obtain the images necessary for the safety of the medical procedure.

[0005]

[0004] One type of ICE catheter (EP Medsystems ViewFlex™ Intracardiac Ultrasound Deflectable Catheter) has a single-plane (bidirectional) distal articulation that is operated by a single wheel that rotates about the long axis of the handle. The wheel is rotated to a specific position to obtain the desired catheter shape and remains in place due to the inherent friction against the wheel mechanism. The catheter is torqueable and can be rotated by the handle to facilitate steering in a second plane. The motion required to simultaneously torque and rotate the catheter often requires two-handed operation.

[0006] Another type of ICE catheter (Siemens / ACUSON AcuNav Ultrasound Catheter) has additional steering planes, each accessed by turning one of two corresponding wheels on the handle. These wheels rotate about the longitudinal axis of the handle. A third wheel, also rotating about the longitudinal axis of the handle, is a locking mechanism to freeze the two steering wheels in each orientation. No torque needs to be applied to the entire catheter. The two steering planes allow a large combination of selectable catheter configurations. However, simultaneous steering of both planes to achieve the desired articulation view can be difficult to visualize and coordinate. Summary of the Invention

[0007]

[0006] Although existing ICE catheter devices have proven useful, there remains a need for improved systems and techniques to provide fine and intuitive steering control of the catheter device. An embodiment of the present disclosure provides a catheter including a steering system and a braking system that controls how the distal end of the catheter is deflected. The distal end of the catheter, including the imaging element, can be selectively deflected by a user, such as a physician, to obtain a better view of the anatomical structure to be imaged. A steering mechanism including one or more rotatable wheels deflects the catheter in one or more directions. When the user wishes to maintain the catheter in the deflected position, a braking mechanism delays the catheter from returning to a straight, undeflected state or locks the catheter in the deflected position. The braking mechanism can be adjusted to allow the user to vary the rate at which the catheter returns to a straight, undeflected state.

[0008] In one embodiment, an intraluminal imaging device is provided that includes a flexible elongate shaft having a distal portion and a proximal portion for insertion into a patient's body, a distal tip including an imaging element and operatively associated with the distal portion of the flexible elongate shaft, and a control handle coupled to the proximal portion of the flexible elongate shaft, the control handle including a first actuator for positioning the imaging element within the patient's body, and a first friction member coupled to the first actuator and in contact with the first actuator for controlling positioning of the imaging element.

[0009] In some embodiments, the first actuator includes a first pulley member coupled to a first pair of pullwire segments, the first pair of pullwire segments coupled to the distal portion of the flexible elongate shaft, and a first actuation control member coupled to the first pulley member, the first actuation control member applying tension to the first pair of pullwire segments such that the imaging device and the distal portion of the flexible elongate shaft are deflected along a first plane, the first friction control member being disposed on an opposite side of the first actuation control member from the first pulley member. In some embodiments, an outer periphery of the first friction member includes one or more interference posts oriented into a cavity of the first actuation control member, the one or more interference posts contacting the first actuation control member upon application of a compressive force to the first actuation control member, the contact between the interference posts and the first actuation control member changing a rotational resistance of the first actuation control member. In some embodiments, the control handle further includes a clutch spring coupled to the first pulley member, a clutch cam coupled to the clutch spring, and a clutch control member coupled to the clutch cam, where adjustment of the clutch control member causes the clutch cam to compress the clutch spring toward the first pulley member, thereby exerting a compressive force on the first actuation control member. In some embodiments, the control handle further includes a housing having an elongated shape, where the first friction member, the first actuator, the clutch spring, the clutch cam, and the clutch control member are disposed in a distal portion of the housing, and where the housing includes a plurality of finger-shaped grooves disposed on an outer surface of a proximal portion of the housing. In some embodiments, the control handle further includes an axle passing through the clutch spring, the first pulley member, the first actuation control member, and the first friction member, and where the housing includes a plurality of alignment members disposed to receive the axle.In some embodiments, the first friction member further includes a locking post disposed on an opposite side of the first friction member from the one or more interference posts, and when the locking post is locked with one of the plurality of alignment members, the first actuation control member is maintained in a current position.

[0010] In some embodiments, the first actuation control member includes a first slot and a second slot, the first pulley member includes a first post received in the first slot and a second post received in the second slot, the first post and the second post having different diameters. In some embodiments, the first pulley member includes a plurality of radially spaced holes on an opposite side of the first pulley member from the first post and the second post, and an anchor member disposed at an end of the first pulley member, the pair of first pullwire segments being threaded through the plurality of holes and secured to the anchor member. In some embodiments, the control handle further includes a second actuator, the second actuator including a second pulley member coupled to a second pair of pullwire segments, the second pair of pullwire segments coupled to the distal portion of the flexible elongate shaft, a second actuation control member coupled to the second pulley member, the second actuation control member applying tension to the second pair of pullwire segments such that the imaging element and the distal portion of the flexible elongate shaft are deflected along a second plane different from the first plane, and a second friction control member coupled to the second actuator, the second friction control member contacting the second actuator to control a positioning of the imaging element. In some embodiments, the intraluminal imaging device further includes a housing having an elongate shape, the first actuation control member and the second actuation control member being disposed longitudinally along the housing. In some embodiments, the housing includes a routing member that directs a coaxial cable coupled to the imaging element such that the coaxial cable is spaced away from the first pair of pull wire segments and the second pair of pull wire segments within the housing.In some embodiments, the first actuator is aligned with a central longitudinal axis of the flexible elongate shaft and the second actuator is offset from the central longitudinal axis such that actuation of the first pair of pullwire segments and actuation of the second pair of pullwire segments are independent of one another, In some embodiments, the first plane is a left-right articulation plane and the second plane is a front-to-back articulation plane, and the first actuation control member has a larger size than the second actuation control member.

[0011] In one embodiment, an ultrasound catheter assembly is provided that includes a flexible elongate shaft having a distal portion and a proximal portion for insertion into a patient's body, an imaging sensor attached to the distal portion of the flexible elongate shaft and in communication with a coaxial cable, and a control handle coupled to the proximal portion of the flexible elongate shaft, the control handle including a housing having an elongate shape, an actuator contained within the housing and coupled to a plurality of pull wire segments for positioning the imaging sensor within the patient's body, and a routing member contained within the housing for directing the coaxial cable within the housing and away from the plurality of pull wire segments.

[0012] In some embodiments, the actuator includes a pulley member coupled to the pull wire segments, the pull wire segments coupled to the distal portion of the flexible elongate shaft, and an actuation control member coupled to the pulley member for tensioning the pull wire segments such that the imaging sensor and the distal portion of the flexible elongate shaft are deflected, and the control handle further includes a friction control member coupled to the actuator, the friction control member contacting the actuator to control the positioning of the imaging sensor. In some embodiments, the control handle further includes a clutch spring coupled to the pulley member, a clutch cam coupled to the clutch spring, and a clutch control member coupled to the clutch cam, and adjustment of the clutch control member causes the clutch cam to compress the clutch spring toward the pulley member, thereby applying a compressive force to the actuation control member and varying the rotational resistance of the actuation control member. In some embodiments, the exterior surface of the housing includes a plurality of finger-shaped grooves. In some embodiments, the control handle further includes an axle passing through the clutch spring, the pulley member, the actuation control member, and the friction member, and the housing includes a plurality of alignment members arranged to receive the axle. In some embodiments, the friction member further includes a locking post, and when the locking post locks with one of the plurality of alignment members, the actuation control member is maintained in a current position.

[0013]

[0012] Further aspects, features, and advantages of the present disclosure will become apparent from the following detailed description. [Brief description of the drawings]

[0014]

[0013] Illustrative embodiments of the present disclosure will now be described in conjunction with the accompanying drawings, in which:

[0015] [Figure 1]FIG. 1 shows a schematic diagram of an ICE imaging system according to an embodiment of the present disclosure. [Diagram 2] FIG. 2 shows a schematic diagram of a portion of an ICE apparatus according to an embodiment of the present disclosure. [Diagram 3]

[0016] FIG. 3 illustrates a schematic diagram of a portion of an ICE apparatus in a deflected state according to an embodiment of the present disclosure. [Figure 4]

[0017] FIG. 4 shows a schematic diagram illustrating the deflection plane of an ICE apparatus according to an embodiment of the present disclosure. [Diagram 5]

[0018] FIG. 5 is a schematic diagram illustrating an interconnection in an ICE apparatus between a tip assembly and a flexible elongate member according to an embodiment of the present disclosure. [Figure 6]

[0019] FIG. 6 is a side cross-sectional view of an imaging core according to an embodiment of the present disclosure. [Figure 7]

[0020] FIG. 7 is a cross-sectional view of a lined variable braided differential durometer multi-lumen catheter shaft according to an embodiment of the present disclosure. [Figure 8]

[0021] FIG. 8 shows a schematic exploded view of a handle according to an embodiment of the present disclosure. [Figure 9]

[0022] FIG. 9 is a schematic exploded perspective view of a steering and / or clutch mechanism configured to be disposed within a handle in accordance with an embodiment of the present disclosure. [Figure 10A]

[0023] FIG. 10A illustrates a schematic perspective view of a pulley of a steering mechanism according to an embodiment of the present disclosure. [Figure 10B]

[0024] FIG. 10B is a schematic end view of the pulley of FIG. 10A. [Figure 11]

[0025] FIG. 11 is a perspective view of a handle including multiple pull wire segments coupled to a pulley in accordance with an embodiment of the present disclosure. [Figure 12]

[0026] FIG. 12 is a perspective view of a handle including multiple pull wire segments coupled to a pulley in accordance with an embodiment of the present disclosure. [Figure 13]

[0027] FIG. 13 is a schematic diagram illustrating the relationship between a pull wire segment and an actuation control member according to an embodiment of the present disclosure. [Figure 14]

[0028] FIG. 14 is a schematic side view of a clutch control member, a clutch cam, and a clutch spring according to an embodiment of the present disclosure. [Figure 15]

[0029] FIG. 15 shows a schematic perspective view of an actuation control member and corresponding friction member according to an embodiment of the present disclosure. [Figure 16]

[0030] FIG. 16 illustrates a schematic side view of an actuation control member and corresponding friction member according to an embodiment of the present disclosure. [Figure 17]

[0031] FIG. 17 illustrates a perspective view of an assembled handle according to an embodiment of the present disclosure. [Figure 18]

[0032] FIG. 18 illustrates a perspective view of a partially assembled handle according to an embodiment of the present disclosure. [Figure 19]

[0033] FIG. 19 illustrates a perspective view of a partially assembled handle according to an embodiment of the present disclosure. [Figure 20]

[0034] FIG. 20 illustrates a perspective view of an assembled handle according to an embodiment of the present disclosure. [Figure 21]

[0035] FIG. 21 illustrates a flow diagram of a method for assembling an endoluminal imaging device according to an embodiment of the present disclosure. [Figure 22]

[0036] FIG. 22 illustrates a flow diagram of a method for acquiring imaging data using an intraluminal imaging device according to an embodiment of the present disclosure. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0016]

[0037] To facilitate understanding of the principles of the present disclosure, reference will be made to illustrated embodiments and specific terms will be used to describe them. However, it will be understood that no limitation of the scope of the present disclosure is intended. Any changes and modifications to the described apparatus, system, method, and further applications of the principles of the present disclosure are fully considered and included in the present disclosure, as would normally occur to one skilled in the art to which the present disclosure pertains. For example, although the ICE system is described in relation to cardiovascular imaging, it will be understood that it is not intended to be limited to this application. The system is equally suitable for any application requiring imaging in a closed cavity. In particular, it is fully considered that features, components, and / or steps described with respect to one embodiment may be combined with features, components, and / or steps described with respect to other embodiments of the present disclosure. However, for the sake of brevity, such multiple combinations of repetitions will not be described separately.

[0017]

[0038] FIG. 1 shows a schematic diagram of an ICE imaging system 100 according to an embodiment of the present disclosure. The system 100 may include an ICE device 110, a connector 124, a control and processing system 130, such as a console and / or computer, and a monitor 132. The ICE device 110 includes a tip assembly 102, a flexible elongate member 108, and a handle 120. The flexible elongate member 108 includes a distal section 104 and a proximal section 106. The distal end of the distal section 104 is attached to the tip assembly 102. The proximal end of the proximal section 106 is attached to the handle 120, for example, by an elastic strain relief 112, for operation of the ICE device 110 and manual control of the ICE device 110. The tip assembly 102 may include an imaging core or imaging sensor having ultrasound transducer elements and associated circuitry. The handle 120 may include the actuator 116, clutch 114, and other steering control components for steering the ICE device 110, e.g., for deflecting the tip assembly 102 and distal portion 104, as described in more detail herein.

[0018]

[0039] The handle 120 is connected to a connector 124 via another strain relief 118 and an electrical cable 122. The connector 124 may be interconnected in any suitable configuration with a processing system 130 and a monitor 132 to process, store, analyze, manipulate, and display data obtained from signals generated by the imaging core in the tip assembly 102. The processing system 130 may include one or more processors, memory, and one or more input devices, such as a keyboard or any suitable command control interface device. The processing system 130 may be operable to facilitate the features of the ICE imaging system 100 described herein. For example, the processor may execute computer-readable instructions stored on a non-transitory tangible computer-readable medium. The monitor 132 may be any suitable display device, such as a liquid crystal display (LCD) panel.

[0019]

[0040] In operation, a physician or clinician advances the flexible elongate member 108 into a blood vessel within the cardiac anatomy. In general, the flexible elongate member 108 may be positioned within any lumen within the patient's body. In some embodiments, the ICE device 110 may be referred to as an intraluminal imaging device. The physician or clinician may steer the flexible elongate member 108 to a position near the region of interest to be imaged by controlling the actuators 116 and clutches 114 on the handle 120. For example, one actuator 116 may deflect the tip assembly 102 and distal section 104 in the left-right plane, while the other actuator 116 may deflect the tip assembly 102 and distal section 104 in the anterior-posterior plane, as described in more detail below. The clutches 114 provide a locking mechanism for locking the position of the actuators 116, and thus the deflection of the flexible elongate member, during imaging of the region of interest.

[0020]

[0041] The imaging process may include activating ultrasonic transducer elements on the tip assembly 102 to generate ultrasonic energy. A portion of the ultrasonic energy is reflected by the region of interest and surrounding anatomical structures, and ultrasonic echo signals are received by the ultrasonic transducer elements. The connector 124 transfers the received echo signals to the processing system 130, where an ultrasound image is reconstructed and displayed on the monitor 132. In some embodiments, the processing system 130 may control the activation of the ultrasonic transducer elements and the replenishment of the echo signals. In some embodiments, the processing system 130 and the monitor 132 may be part of the same system.

[0021]

[0042] The system 100 can be utilized for a variety of applications, such as transseptal lumen puncture, left atrial appendage closure, atrial fibrillation ablation, and valve repair, and can be used to image vessels and structures in vivo. Although the system 100 is described in the context of an ICE catheter insertion procedure, the system 100 is suitable for use with any catheter procedure. Additionally, the tip assembly 102 can include any suitable physiological sensors, components, and / or functional elements for diagnosis, treatment, and / or therapy. Thus, the handle 120 can be used to guide the articulation of any functional elements at the distal end of the device 110.

[0022]

[0043] FIG. 2 shows a schematic diagram of a portion of an ICE device 110 according to an embodiment of the present disclosure. The tip assembly 102 and the flexible elongate member 108 are shaped and dimensioned for insertion into a blood vessel of a patient's body. The flexible elongate member 108 may be constructed of any suitable material, such as Pebax® polyether block amide. The distal section 104 and the proximal section 106 have a tubular shape and may include a main lumen and one or more pull wire lumens extending longitudinally along the flexible elongate member 108. The main lumen is sized and shaped to accommodate an electrical cable interconnecting the tip assembly 102 and the connector 124 for transporting echo signals obtained from the transducer elements. In some embodiments, the main lumen may be shaped and sized to accommodate other components for diagnostic and / or therapeutic procedures. The pull wire lumen is sized and shaped to accommodate a pull wire extending, for example, from the distal section 104 to the handle 120. The pull wires may be coupled to the actuator 116 and clutch 114 such that the flexible elongate member 108 and tip assembly 102 may be deflected based on actuation of the actuator 116 and clutch 114. In one embodiment, the main lumen has a shape to facilitate alignment of the pull wire lumen. The tubular body of the flexible elongate member 108 may also include a lined variable braided reinforcement layer configured to provide flexibility and kink resistance. The arrangement and configuration of the pull wires, main lumen, pull wire lumen, tip assembly 102, and lined variable braided reinforcement layer are described in more detail herein. The dimensions of the flexible elongate member 108 may vary from embodiment to embodiment. In some embodiments, the flexible elongate member 108 can be a catheter having an outer diameter of about 8 to about 12 French (Fr) and has an overall length 206 of about 80 centimeters (cm) to about 120 cm, the proximal portion 106 can have a length 204 of about 70 cm to about 118 cm, and the distal portion 104 can have a length 202 of about 2 cm to about 10 cm.

[0023]

[0044] 3 shows a schematic diagram of a portion of an ICE device 110 in a deflected state, according to an embodiment of the present disclosure. For example, the flexible elongate member 108 shown in FIG. 2 is in what is referred to as a neutral position. In FIG. 3, the tip assembly 102 and distal portion 104 of the flexible elongate member 108 are deflected from the neutral position.

[0024]

[0045] 4 shows a schematic diagram illustrating deflection planes of an ICE device 110 according to an embodiment of the present disclosure. As shown, the tip assembly 102 and distal section 104 can be deflected along a first plane, as indicated by the solid arrows, and along a second plane, as indicated by the dotted arrows. In FIG. 3, the first plane is represented by the xy plane, and the second plane is represented by the xz plane. For example, for imaging cardiac anatomy, the xy plane can correspond to the left-right plane, and the xz plane can correspond to the anterior-posterior plane.

[0025]

[0046] FIG. 5 is a schematic diagram illustrating an interconnection within an ICE device 110 between a tip assembly 102 and a flexible elongate member 108, according to an embodiment of the present disclosure. As shown, the interconnection between the tip assembly 102 and the distal portion 104 of the flexible elongate member 108 includes a crown element 520 and a sleeve element 540. The crown element 520 is coupled to a distal end of the distal portion 104. The sleeve element 540 is coupled to the crown element 520 and a proximal end of the tip assembly 102. The tip assembly 102 includes an imaging core 562 housed within a tip member 560. The tip assembly 102 may include an alignment portion (not shown) shaped to facilitate alignment during manufacturing, as described in more detail herein. The imaging core 562 is connected to an electrical cable 566 via an electrical interconnect 564. The electrical cable 566 extends longitudinally along the flexible elongate member 108. The crown element 520 and the sleeve element 540 are attached to surround the electrical cable 566 .

[0026]

[0047] Crown element 520 serves as an anchor for pull wire 507, thereby allowing tip assembly 102 and distal section 104 to deflect in response to proximal actuation of pull wire 507, as shown in Figures 3 and 4 and described in more detail herein. Sleeve element 540 serves as an alignment agent to align crown element 520 and pull wire 507 such that deflection provides a predictable or predetermined view of articulation.

[0027]

[0048] In one embodiment, the flexible elongate member 108 may include a lined, variable braided reinforcement layer to provide flexibility and kink resistance, as described in more detail herein. In such an embodiment, the interconnect further includes a braided containment section 502 disposed between the anchor segment 503 and the distal end of the flexible elongate member 108. The braided containment section 502 may be constructed from a material such as polyethylene terephthalate (PET) or any suitable material. The anchor segment 503 may be constructed from a similar material to the flexible elongate member 108. The braided containment section 502 serves as a termination for the braided reinforcement layer. The braided containment section 502 contains the termination of the material (e.g., stainless steel wire) of the braided reinforcement layer, thereby preventing the material from being exposed to the exterior of the ICE device 110. The structure of the flexible elongate member 108 and the braided reinforcement layer are described in more detail herein. Anchor segments 503 couple blade receiving portion 502 to crown element 520 and sleeve element 540 to allow for thermal reflow when joining the components at the interconnect.

[0028]

[0049] The interconnect may further include support members 508 and 509, which are thin sleeves to provide protection over the connections of the different components. The support members 508 and 509 may be constructed from any suitable polymeric material. As shown, the support member 508 is positioned to cover the connections between the sleeve element 540, the tip assembly 102, the crown element 520, and the anchor segment 503. The support member 509 is positioned to cover the connections between the braided housing 502, the anchor segment 503, and the distal portion 104 of the flexible elongate member 108.

[0029]

[0050] 6 is a side cross-sectional view of an imaging core 562 taken along line 591 of FIG. 5 according to an embodiment of the present disclosure. The imaging core 562 may include a transducer circuit layer 620 embedded between an acoustic stack 610 and a backing material layer 630. The transducer circuit layer 620 includes an array of ultrasound transducer elements 622 coupled to one or more multiplexer chips 624, for example, via conductive traces and / or associated circuitry. In some embodiments, the number of ultrasound transducer elements 622 may be 8, 16, 32, 64, or any suitable number. The ultrasound transducer elements 622 are constructed from piezoelectric material. An exemplary transducer for ICE has a typical thickness of about 0.28 mm in piezoelectric material and generates an 8 megahertz (MHz) ultrasound signal, allowing blood to pass through it at a velocity of 1500 meters per second (m / s). The thickness of the transducer can have various thicknesses ranging from about 0.56 mm to 0.19 mm to generate sufficient penetration depth in tissue imaging. In general, the thickness of the transducer can be adjusted with respect to the frequency of sound in the transmission medium for the desired penetration depth in any tissue imaging. The image intensity can be adjusted by the driving voltage of the transducer.

[0030]

[0051] The multiplexer chip 624 multiplexes control signals generated, for example, by the processing system 130, and transmits the control signals to corresponding ultrasonic transducer elements 622. The control signals can control the emission of ultrasonic pulses and / or the reception of echo signals. In the reverse direction, the multiplexer chip 624 multiplexes echo signals reflected by the target tissue and received by the ultrasonic transducer elements 622, and transmits the received echo signals to the processing system 130, for example, for processing and / or display.

[0031]

[0052] The acoustic stack 610 is comprised of a material that is acoustically matched to the ultrasonic transducer elements 622, the transmission medium (e.g., the tip member 560 and the patient's body), and the tissue to be imaged. The backing material layer 630 is comprised of an acoustically absorbing material such that the backing material layer 630 may absorb or reduce ultrasonic waves coming from behind the ultrasonic transducer elements 622. In some embodiments, one or more components of the imaging core 562 (e.g., the transducer elements 622, the tip 624, electrical cables, etc.) may be coupled to the flexible elongated member 108. In some embodiments, one or more components of the imaging core 62 may be disposed within the flexible elongated member 108.

[0032]

[0053] 7 is a cross-sectional view of the flexible elongate member 108 taken along line 592 of FIG. 5 according to an embodiment of the present disclosure. The flexible elongate member 108 has a tubular body including a tubular wall 702, a central lumen 708, and a number of secondary lumens 706 extending between the distal and proximal ends of the flexible elongate member 108. The central lumen 708 has a cross-sectional shape of a rounded cross. Each arm 710 of the cross-section forms a recess that can fix the angular position of each secondary lumen 706. For example, the secondary lumens 706 are disposed between adjacent arms 710 during manufacture. The secondary lumens 706 are shaped and sized to accommodate a pull wire, such as the pull wire 507. Thus, the secondary lumens 706 are also referred to as pull wire lumens. The secondary lumens 706 are spaced apart from each other by an angle 780 of approximately 90 degrees and disposed radially within the tubular wall 702. For example, the pull wire 507 can be threaded through the secondary lumen 706 and coupled to the actuator 116 at the handle 120. The actuator 116 can thus be configured to control or apply tension in the pull wire 507 to bend the tip assembly 102 and distal section 104 as shown in FIGS.

[0033]

[0054] In one embodiment, the central lumen 708 and the secondary lumens 706 may be lined with a lubricious lining material (not shown), such as a polytetrafluoroethylene (PTFE) material. The lining material provides a frictionless surface for the passage, delivery, and actuation of a pull wire or any other suitable diagnostic sensor assembly. Additionally, the lining material may act as a support structure to prevent the central lumen 708 and the secondary lumens 706 from collapsing. Additionally, the lining material may act as a barrier to protect against abrasion caused by frequent movement or actuation of the pull wire and / or the passage of other diagnostic sensor assemblies.

[0034]

[0055] In one embodiment, the flexible elongate member 108 may include a layer of braided elements 704 disposed within the tubular wall 702. The braided elements 704 may be constructed of any suitable material and geometry. For example, the braided elements 704 may include stainless steel flat wire, which may provide optimal use of radial space and additional strength. The braided elements 704 are braided with a pitch that varies along the longitudinal length of the flexible elongate member 108. The braid may include any suitable braid pattern. The braid pattern may be selected to improve torque transmission, pushability, and / or kink resistance. In some embodiments, the braided element 704 may include a braid having a higher per inch count at the distal portion 104 than at the proximal portion 106, such that the distal portion 104 has a higher flexibility than the proximal portion 106. Additionally, the braided element 704 can include a braid having a varying PIC around the junction where the distal portion 104 meets the proximal portion 106 .

[0035]

[0056] In one embodiment, the tubular wall 702 of the flexible elongate member 108 may be constructed from materials having different durometers at the distal and proximal portions 104, 106 to further improve maneuverability and kink resistance. For example, the tubular wall 702 may be constructed from a low durometer material at the distal portion 104 and a high durometer material at the proximal portion 106 without a transition region. Thus, the flexible elongate member 108 may be relatively stiff at the proximal portion 106 while being significantly softer or flexible at the distal portion 104.

[0036]

[0057] Figure 8 illustrates a perspective view of several components of a handle 120 in accordance with an embodiment of the present disclosure. The embodiment of Figure 8 includes similar features as those shown and described with respect to Figure 1. It should be understood that the handle 120 may include additional components, such as those described with respect to Figures 9-16. Features of the handle 120 shown in Figure 8 can also be seen in Figures 11, 12, and 18-20, for example.

[0037]

[0058] 8, the handle 120 includes a top shell 810 and a bottom shell 820. The top shell 810 and the bottom shell 820 may have a matching clamp design. During assembly, the shells 810, 820 may be placed against one another and secured together via mechanical snaps, screws, adhesives, and / or other suitable mechanisms. The top shell 810 and the bottom shell 820 may be constructed from any suitable material, such as, for example, plastic, plastic composites, polymers, etc. In one embodiment, the top shell 810 and the bottom shell 820 may be constructed using acrylonitrile butadiene styrene (ABS). Any suitable manufacturing method may be used, such as, for example, injection molding. The top shell 810 and the bottom shell 820 together form an elongated housing 811 including a distal portion 892 and a proximal portion 894. The elongated housing 811 extends in a direction parallel to the longitudinal axis of the device 110.

[0038]

[0059] The spaced cavities in the top shell 810 and the bottom shell 820 are configured to accommodate steering control components. For example, the actuator 116, the clutch 114, and other steering related components may be located in the distal portion 892. As shown, the bottom shell 820 includes a plurality of alignment members 822 in the distal portion 892. The alignment members 822 include notches or cutouts 826 for aligning the steering control components, such as the axles 952, 954 (FIG. 9). Referring again to FIG. 8, the alignment members 822 may be triangular or any suitable shape. The slots 824 in the distal portion 892 of the bottom shell 820 are shaped to allow for the attachment of the clutch 114 (FIG. 1). The top shell 810 may include an alignment member similar to the alignment member 822 and a slot similar to the slot 824 that is aligned with the alignment member 822 and the slot 824 in the bottom shell 820. Additionally, the top shell 810 includes an open slot 812 shaped to expose a portion of the top control surface of the actuator 116 when each actuator 116 is longitudinally mounted within the housing 811 as shown in FIG. 1. In some embodiments, the bottom shell 820 may also include an open slot 812. Thus, the top and bottom control surfaces of each actuator 116 may be exposed when each actuator 116 is longitudinally mounted within the housing 811. Thus, a physician or clinician may manipulate or rotate the actuator 116 or clutch 114, for example, using a thumb or finger, while holding the handle 120 for steering. Steering control components and mechanisms are described in more detail herein.

[0039]

[0060] The exterior surfaces of the top shell 810 and bottom shell 820 have an ergonomically designed shape to allow for one-handed operation of the handle 120. As shown, the exterior surfaces include a plurality of finger grooves 830 at the proximal portion 894. The finger grooves 830 may provide grip stability while a user uses other fingers (e.g., thumb and index finger) to operate the actuator 116 and / or clutch 114.

[0040]

[0061] The interior cavities of the top shell 810 and the bottom shell 820 may further include support members 832 to facilitate attachment of the shells 810, 820 to one another. For example, the support members 832 may include recesses including threads to receive screws for joining the shells 810, 820 to one another.

[0041]

[0062] The top shell 810 further includes a tubular connecting member 814 at a distal end and a slot 816 at a proximal end. The bottom shell 820 further includes a slot 827 at a distal end and a slot 828 at a proximal end. When the top shell 810 and the bottom shell 820 are assembled, the tubular connecting member 814 fits into the slot 827, and the slots 816 and 828 form a proximal opening. The tubular connecting member 814 can be coupled to the strain relief 112. For example, the outer diameter of the tubular connecting member 814 is sized to fit into the inner diameter of the strain relief 112. The proximal opening can be sized and shaped to accommodate the strain relief 118. For example, when assembled into the device 110, the strain reliefs 112 and 118 couple the handle 120 to the flexible elongate member 108 and the electrical cable 122, respectively. The handle 120 receives a pull wire segment 507 that extends through the secondary lumen 706. The pull wire segment 507 is coupled to a steering control component disposed within the handle 120. The handle 120 routes an electrical cable 566 through the housing 811 and into the strain relief 118. The cable 122 may include the electrical cable 566 between the strain relief 118 and the connector 124. The strain reliefs 112, 118 may be made from a flexible material, such as a thermoplastic elastomer, that is compatible with standard sterilization methods. In some embodiments, the strain reliefs 112, 118 are overmolded onto the proximal shaft 106 for a stronger bond and a smoother transition between the handle 120 and the proximal shaft 106. The strain reliefs 112, 118 may be made of an overmoldable material.

[0042]

[0063] FIG. 9 illustrates an exploded perspective view of a steering control arrangement 900 according to an embodiment of the present disclosure. The handle 120 can employ the arrangement 900 to provide steering control of the device 110. The arrangement 900 includes a clutch control member 910, a clutch cam 920, a clutch spring 930, pulleys 942 and 944, axles 952 and 954, actuation control members 962 and 964, and friction members 972 and 974. In some embodiments, the components in the arrangement 900 can be directly or indirectly coupled to one another when the handle 120 is assembled. In some embodiments, the components of the arrangement 900 can be positioned adjacent to one another and / or in contact with one another when the handle 120 is assembled. For example, the components of the arrangement 900 can be positioned within the handle 120 to mechanically engage one another. The axle 952 extends through respective holes in the clutch spring 930, the pulley 942, the actuation control member 962, and the friction member 972. The axle 954 extends through respective holes in the clutch spring 930, the pulley 944, the actuation control member 964, and the friction member 974. The axles 952, 954 may be formed from any suitable material, including a metal or metal alloy. The pulleys 942, 944 and the actuation control members 962, 964 rotate about the axle 952, 954. The axle 952, 954 also aids in centering the clutch spring 930.

[0043]

[0064] The components of configuration 900 may be made from one or more of any suitable material. For example, axles 952, 954 and clutch spring 930 may be constructed from any suitable material, such as metal, and constructed using machining or stamping techniques. Clutch control member 910, clutch cam 920, pulleys 942 and 944, actuation control members 962 and 964, and friction members 972, 974 may be constructed from any suitable material, such as plastic or polymeric materials. These components may be manufactured using any suitable method, such as, for example, 3D printing and injection molding.

[0044]

[0065] Pulleys 942, 944, axles 952, 954, and actuation control members 962, 964 work together to provide a mechanism for controlling bending of ICE apparatus 110 as shown in Figures 3 and 4. For example, a pair of pull wire segments 507 that control bending in the fore-aft plane may be wrapped around pulley 942, and another pair of pull wire segments 507 that control bending in the left-right plane may be wrapped around pulley 944. When coupled in a defined position, actuation control member 962 rotates about axle 952, which rotates pulley 942 and tensions pull wire 507 that controls bending in the fore-aft plane. Similarly, actuation control member 964 rotates about axle 954, which rotates pulley 944 and tensions pull wire 507 that controls bending in the left-right plane. The coupling of pulleys 942 and 944, actuation control members 962 and 964, and pull wires 507 are described in more detail herein. In some embodiments, one or more of the pulleys 942, 944 and one or more of the actuation control members 962, 964, respectively, are collectively referred to as one or more steering actuators. Although rotation of the actuation control members 962 and 964 is described, it will be appreciated that any suitable type of actuation is contemplated, such as translation, movement along an arc, button depression, etc.

[0045]

[0066] Generally, when the physician releases their fingers from the actuation controls 962, 964, the tip assembly 102 and distal section 104 return to their respective resting, undeflected states. As long as the physician maintains finger pressure on the actuation controls 962, 964, the tip assembly 102 and distal section 104 maintain their respective deflected states.

[0046]

[0067] The clutch control member 910, clutch cam 920, clutch spring 930, and friction members 972, 974 work together to form a variable braking system for providing feedback resistance to a user manipulating the actuation control members 962 and / or 964, and a locking mechanism for locking the position of the actuation control members 962 and 964 when a desired articulation view is achieved. In this regard, the clutch control member 910 may be selectively moved (e.g., rotated) to control the resistance of the actuation control members 962, 964 to movement. When the clutch control member 910 is moved in a first direction (e.g., clockwise), the resistance increases. Thus, when the user releases the actuation control members 962, 964, the tip assembly 102 and distal portion 104 return relatively slowly to their respective resting states. The actuation control members 962, 964 are braked in the sense that they return more slowly to their respective undeflected states. Once coupled in place, adjusting or rotating the clutch control member 910 in a first direction causes the clutch cam 920 to press against the clutch spring 930, which in turn creates a compressive force towards the pulleys 942 and 944, forcing the actuation control members 962 and 964 against the friction members 972, 974. The friction members 972, 974 may be referred to as frictional in that they operate based on contact with the actuation control members 962, 964 resulting in friction between the contacting components. The outer periphery of the friction members 972, 974 is configured to make frictional contact with the actuation control members 962, 964 to provide a feedback resistance or to lock the rotational position of the actuation control members 962, 964, as described in more detail herein.

[0047]

[0068] When the clutch control member 910 is moved in a second direction (e.g., counterclockwise), the resistance decreases. Thus, when the user releases the actuation control members 962, 964, the tip assembly 102 and distal portion 104 return relatively quickly to their respective resting states. When coupled in place, adjusting or rotating the clutch control member 910 in a second direction reduces the contact between the clutch cam 920 and the clutch spring 930, reducing the compressive force on the pulleys 942 and 944. Thus, the actuation control members 962 and 964 are pressed less against the friction members 972, 974. The outer periphery of the friction members 972, 974 is designed to allow the actuation control members 962, 964 to rotate freely when the clutch / brake is off, and to be restricted when the clutch / brake is on.

[0048]

[0069] In some embodiments, by increasing the compressive force on the clutch mechanism, it becomes more difficult to rotate the actuation control members 962, 964. Thus, a user must apply more force to move the actuation control members 962, 964 to deflect the tip assembly 102 and distal portion 104. Similarly, when less or no compressive force is applied to the clutch mechanism, it is relatively easy to rotate the actuation control members 962, 964. Thus, a user may apply less force to move the actuation control members 962, 964 to deflect the tip assembly 102 and distal portion 104.

[0049]

[0070] In some embodiments, one or more of the components in configuration 900 may be larger in size (e.g., diameter) than the corresponding components. For example, friction member 972 may be larger than friction member 974. Actuation control member 962 may be larger than actuation control member 964. Pulley 942 may be larger than pulley 944. In other embodiments, corresponding components are similarly sized to one another. For example, friction members 972, 974 may have equal diameters, actuation control members 962, 964 may have equal diameters, and / or pulleys 942, 944 may have equal diameters.

[0050]

[0071] 10A shows a perspective view of a pulley 942 according to an embodiment of the present disclosure. The pulley 942 includes a base disk 1010 coupled to a top disk 1030 via a tubular connecting member 1020. The base disk 1010 includes an open groove 1012 and an anchor member 1016. The anchor member 1016 can be T-shaped in some embodiments. The open groove 1012 is disposed along at least a portion of the circumference of the base disk 1010. The top disk 1030 includes posts 1032, 1036 and an opening 1034. The opening 1034 extends longitudinally or axially through the body of the pulley 942, for example through the connecting member 1020 and the base disk 1010. The axle 952 extends through the opening 1034. The posts 1032 and 1036 protrude from a surface 1038 of the top disk 1030. The posts 1032 and 1036 are received in respective holes in each actuation control member 962 when the handle 120 is assembled. With the posts 1032, 1036 housed in their respective holes, the actuation control member 962 may be coupled to the pulley 942. That is, movement of the actuation control member 962 causes corresponding movement of the pulley 942, the tip assembly 102, and the distal section 104. In some embodiments, the posts 1032 and 1036 may have different diameters to facilitate alignment with the actuation control member 962. As will be described in more detail with respect to FIGS. 12 and 13, a pair of pull wire segments 507 are wrapped around the open groove 1012 and tied to the anchor member 1016. The pulley 944 has similar characteristics to the pulley 942. In some embodiments, the size of the pulley 942, e.g., the diameter of the base disk 1010, is larger than the pulley 944.

[0051]

[0072] 10B is a rear view of pulley 942 taken in the direction indicated by line 1001 according to an embodiment of the present disclosure. Pulley 942 includes a plurality of apertures or holes 1040 spaced radially around the circumference of base disk 1010. The plurality of apertures 1040 are disposed on an opposite side of pulley 942 from posts 1032, 1036. The apertures 1040 may be in communication with open groove 1012 such that pullwire segment 507 may extend from open groove 1012 through aperture 1040 to anchor member 1016.

[0052]

[0073] 11 and 12 are perspective views of handle 120. FIGS. 11 and 12 include components of handle 120 similar to those described with respect to, for example, FIGS. 8-10B. FIGS. 11 and 12 include pullwire segments 1102, 1104, 1106, and 1108 similar to pullwire segment 507, where pullwire segments 1102, 1104, 1106, and 1108 may be more proximal portions of pullwire segment 507. FIGS. 11 and 12 also illustrate exemplary steps in a method of assembling ICE device 110. The steps illustrated in FIGS. 11 and 12 may be referred to as a pullwire termination process. FIG. 11 illustrates pullwire segments 1102 and 1104 positioned within open groove 1012 of pulley 942. From their respective portions of open channel 1012, pullwire segment 1102 passes through opening 1040a and pullwire segment 1104 passes through opening 1040b. Both pullwire segments 1102, 1104 pass through opening 1040c. Pullwire segments 1102, 1104 may be twisted together after passing through opening 1040c.

[0053]

[0074] 12 shows the proximal portions of the pullwire segments 1102, 1104 being threaded through the opening 1040c and then tied around the anchor member 1016. Any suitable knotting method can be used to secure the pullwire segments 1102, 1104 to the anchor member 1016. After knotting and termination, adhesive can be applied to one or more points in the handle 120 (such as the junction hole 1040c, the anchor member 1016, etc.) to further strengthen the attachment of the pullwire segments to the pulley. Because the pullwire segments 1102, 1104 are tied to the pulley 942 at the proximal portion of the device 110 and to the crown member 520 at the distal portion of the device 110, movement of the actuation member 962 creates tension in the pullwire segments 1102, 1104, which causes the tip assembly 102 and distal portion 104 to deflect. Similar steps may be performed to attach the pullwire segments 1106, 1108 to the pulley 944.

[0054]

[0075] 11 and 12 further illustrate the routing member 840 of the handle 120. The routing member 840 directs or redirects the coaxial cable 566 within the handle 120 and away from the pullwire segments 1102, 1104, 1106, 1108. In this regard, the coaxial cable 566 and the pullwire segments 1102, 1104, 1106, 1108 enter the handle via the tubular connecting member 814. The routing member 840 directs the coaxial cable away from the plurality of pullwire segments 1102, 1104, 1106, 1108 such that assembly and / or operation of the components of the configuration 900 does not interfere with the coaxial cable 566. The routing member 840, in cooperation with the support member 832 and the alignment member 822, can position the cable 556 along an inner circumference of the handle 120. In this regard, in some embodiments, the support member 832 and the alignment member 822 may be referred to as a routing member 840 .

[0055]

[0076] 13 is a schematic diagram illustrating how the pullwire segments 1102, 1104, 1106, 1108 interact with the actuation control members 962, 964. In this regard, it should be understood that the pullwire segments 1102, 1104, 1106, 1108 are directly coupled to the pulleys 942, 944. The actuation control members 962, 964 are coupled to the pulleys 942, 944, respectively, such that movement of the actuation control members 962, 964 causes movement of the pulleys 942, 944 and the pullwire segments 1102, 1104, 1106, 1108. Thus, the components designated by reference numerals 962, 964 may represent the actuation control members 962, 964 and / or the pulleys 942, 944. As illustrated, the cable 566 is spaced apart from the pullwire segments 1102, 1104, 1106, 1108. Movement of pullwire segments 1102, 1104, 1106, 1108 need not affect cable 566. Although actuation control member 962 is shown in FIG. 13 to be larger than actuation control member 964, it should be understood that actuation control member 964 may be larger than actuation control member 962, or actuation control members 962 and 964 may have the same size (e.g., have the same diameter).

[0056]

[0077] In an exemplary embodiment, the actuation control member 962 can control the movement of the tip assembly 102 and the distal section 104 along an anterior-posterior plane. For example, the pull wire segment 1102 can be associated with forward movement and the pull wire segment 1104 can be associated with rearward movement. In an exemplary embodiment, the actuation control member 964 can control the movement of the tip assembly 102 and the distal section 104 along a left-right plane. For example, the pull wire segment 1106 can be associated with rightward movement and the pull wire segment 1108 can be associated with leftward movement. The components of the configuration 900, including the actuation control members 962, 964, the pulleys 942, 944, and the pull wire segments 1102, 1104, 1106, 1108, can be positioned within the handle 120 such that the movement of one of the actuation control members 962, 964 does not affect the movement of the other actuation control members 962, 964.

[0057]

[0078] In an exemplary embodiment, ICE device 110 includes two pull wires. Each pull wire may include two segments. That is, each pull wire may be arranged to split into two segments. For example, a first pull wire may include pull wire segments 1102, 1106. In such an embodiment, the first pull wire may include segments 1102, 1106 associated with forward and rightward movement. A second pull wire may include pull wire segments 1104, 1108. That is, the second pull wire may include segments 1104, 1108 associated with backward and leftward movement.

[0058]

[0079] FIG. 14 is an exploded side view of the clutch mechanism including the clutch control member 910, the clutch cam 920, and the clutch spring 930. The clutch mechanism allows the user to control how quickly or slowly the tip assembly 102 and the distal portion 104 return to their undeflected state after the user reduces the force applied to the actuation control members 962, 964. The clutch control member 910 may be moved (e.g., rotated) between a continuous series of positions to control the resistance of the actuation control members 962, 964. That is, the user can select the speed at which the tip assembly 102 and the distal portion 104 return to their respective undeflected states based on the movement of the clutch control member 910. The circumference and / or outer surface of the clutch control member 910 may be textured (e.g., may be provided with a plurality of grooves) to allow for easy movement as desired by the user. Although rotation of the clutch control member 910 is described, it will be appreciated that any suitable type of actuation is contemplated, such as translation, movement along an arc, button depression, etc.

[0059]

[0080] The clutch control member 910 includes a recess 912 sized and shaped to accommodate the clutch cam 920. The clutch cam 920 includes a threaded neck 922 and a shoulder 926. A post 924 extends from the shoulder 926 in a direction opposite the neck 922. The post 924 is received within a hole 934 in the clutch spring 930. Axles 952, 954 pass through respective holes 932 in the clutch spring 930. The recess 912 in the clutch control member 910 is threaded to accommodate the threaded neck 922 of the clutch cam. When the handle 120 is assembled, the clutch cam 920 is received within the recess 912. When the clutch control member 910 is rotated, the threads in the recess 912 engage the threaded neck 922.

[0060]

[0081] Movement / rotation of the clutch control member 910 in a first direction (e.g., clockwise) causes the clutch cam 920 to move in a direction 1402 toward the clutch spring 930. That is, movement / rotation of the clutch control member 910 in a first direction (e.g., clockwise) applies a compressive force to the clutch spring 930 via the clutch cam 920. The shoulder 926 applies a compressive force when it contacts a central portion 936 of the clutch spring 930. As shown in FIG. 14, the clutch spring 930 may be curved in an uncompressed state. The central portion 936 of the clutch spring 930 straightens in response to the compressive force from the clutch cam 920. As the compressive force increases, the resistance to rotation of the actuation control members 962, 964 increases.

[0061]

[0082] Movement / rotation of the clutch control member 910 in the second direction (e.g., counterclockwise) moves the clutch cam 920 away from the clutch spring 930 in the direction 140. That is, movement / rotation of the clutch control member 910 in the second direction (e.g., counterclockwise) reduces or removes the compressive force on the clutch spring 930 via the clutch cam 920. When the compressive force is reduced or removed, the clutch spring 930 returns to its bent configuration as it would in an uncompressed state. The central portion 936 of the clutch spring 930 bends in response to the reduction / removal of the compressive force from the clutch cam 920. As the compressive force increases, the resistance to rotation of the actuation control members 962, 964 increases.

[0062]

[0083] FIG. 15 is a schematic exploded perspective view of the actuation control members 1502, 1504 and the friction members 1532, 1534. FIG. 16 is a schematic exploded side view of the actuation control members 1502 and the friction members 1532. The actuation control members 1502, 1504 may share similar features as the actuator 116 and the actuation control members 962, 964. The outer periphery 1522, 1524 of the actuation control members 962, 964 may be textured (e.g., grooved) to allow for easy movement (e.g., rotation) by the physician's fingers. In some embodiments, linear markers may be placed on the actuation control members 962, 964 to indicate the degree of bending / steering of the device or to indicate that the device is in a neutral linear position where there is no tension acting on the device in any of the four directions. The actuation control members 962, 964 include holes 1508, 1518 through which the axles 952, 954 pass. The actuation control members 962, 964 also include bores or holes 1506, 1516, 1518 through which the posts 1032, 1036 of the pulleys 942, 944 pass. Cavities 1512, 1514 are formed in the actuation control members 1502, 1504 adjacent the friction members 1532, 1534 and opposite the side where the pulleys 942, 944 are disposed within the handle 120.

[0063]

[0084] The friction members 1532, 1534 may share similar features as the friction members 972, 974. The friction members 1532, 1534 include holes 1538 through which the axles 952, 954 pass. The outer periphery of the friction members 1532, 1534 includes one or more interference posts 1536. In some embodiments, the interference posts 1536 extend the entire circumference of the friction members 1532, 1534. The interference posts 1536 face toward the cavities 1512, 1514 of the actuation control members 1502, 1504. In some examples, the interference posts 1536 may form a frusto-conical shape for the friction members 1532, 1534. The cavities 1512, 1514 of the actuation control members 1502, 1504 form a chamber that includes an inner circumferential surface 1552 shaped to mate with the interference post 1536 of the friction members 1532, 1534. For example, as shown in the side view of FIG. 16, the outer surface 1537 of the interference post 1536 and the inner circumferential surface 1552 extend parallel to one another. When a compressive force is applied to the clutch spring 930 by the clutch cam 920, the actuation control members 1502, 1504 are moved in the direction 1402 toward the friction members 1532, 1534. The inner circumferential surface 1552 of the actuation control members 1502, 1504 contacts the outer surface 1537 of the interference post 1536. The frictional contact between the interference post 1536 and the actuation control members 1502, 1504 prevents movement (e.g., rotation) of the actuation control members 1502, 1504. That is, there is greater resistance to rotation of the actuation control members 1502, 1504. Thus, the actuation control members 1502, 1504 return more slowly to their resting states. In such a situation, finer control of the deflection of the tip assembly 102 and distal section 104 is achieved.

[0064]

[0085] A smaller compressive force causes the actuation control members 1502, 1504 to move in the direction 1404 away from the friction members 1532, 1534. Less or no contact between the interference post 1536 and the actuation control members 1502, 1504 allows the actuation control members 1502, 1504 to return to their respective rest states more quickly.

[0065]

[0086] The friction members 1532, 1534 and / or interference posts 1536 may have any shape suitable for the surfaces of the friction members 1532, 1532 to contact the corresponding surfaces of the control members 1502, 1504. In some embodiments, as shown in the cross-sectional view of FIG. 16, the friction members 1532, 1534 have a frusto-conical shape that fits within the correspondingly shaped cavities 1512, 1514 of the control members 1502, 1504.

[0066]

[0087] The friction members 1532, 1534 include one or more locking posts 1535. The locking posts 1535 are disposed on opposite sides of the friction members 1532, 1534 from the one or more interference posts 1536. The locking posts 1535 are configured to mechanically engage with the alignment members 822 of the shells 810, 820. Engagement between the locking posts 1535 and the alignment members 822 locks the actuation control members 1502, 1504 against rotation and maintains the deflection of the tip assembly 102 and distal section 104. In this regard, a physician may selectively engage and disengage the locking posts 1535 with the alignment members 822 based on movement of the actuation control members 1502, 1504.

[0067]

[0088] FIG. 17 shows a perspective view of the handle 120 in an assembled state. The handle 120 is configured to allow a user to grasp the handle 120 with one or both hands and move the actuation control members 962, 964 and / or the clutch control member 910. The actuation controls 962, 964 are disposed on or parallel to the central longitudinal axis of the handle 120. In some embodiments, the actuation control 962 is aligned closer to the central longitudinal axis while the actuation control 964 is laterally offset from the longitudinal axis. For example, an actuation control associated with a more frequently used actuation direction may be aligned closer to the central longitudinal axis. In one embodiment, the actuation control 962 controls forward and backward deflection. The illustrated embodiment shows the distal strain relief 112 disposed about the tubular connecting member 814. The bottom shell 820 is disposed about the junction of the distal strain relief 112 and the tubular connecting member 814.

[0068]

[0089] 18-20 show an embodiment of a distal strain relief 112 having a locking feature 1806. FIGS. 18-20 are top views of the handle 120 over the course of a method step as the distal strain relief 112 is coupled to the handle 120. In FIG. 18, the proximal shaft is attached to the top shell 810. FIG. 18 further shows the distal strain relief 112 being threaded proximally over the shaft 106 toward the distal end 1802 of the top shell 810. The locking feature 1806 extends from a proximal portion of the strain relief 112. The distal end 1802 of the top shell 810 includes a corresponding space for the locking feature 1806. FIG. 19 shows the handle 120 after the strain relief 112 has been coupled to the bottom shell 810. For example, the strain relief 112 can be pressed flush against the distal end 1802 of the shell 810. Twisting the strain relief 112 moves the locking feature 1806 into space within the distal end 1802, allowing the strain relief 112 to mechanically lock to the shell 810. Figure 20 shows the handle in an assembled state after the bottom shell 820 is placed over the top shell 810. The handle 120 is configured to allow a user to grasp the handle 120 with one or both hands and move the actuation control members 962, 964 and / or the clutch control member 910.

[0069]

[0090] The embodiment of Figures 18-20 creates an outer dome around the proximal shaft slot of both the top shell 810 and the bottom shell 820 in the same surface alignment as the distal portion of the handle 120. The most distal diameter hole of this dome may be slightly smaller than the diameter of the adjacent proximal hole. The adjacent proximal hole may extend to the base of the proximal shaft slot. Also, a custom distal strain relief 112 may be used where there is a transition in the component from a large outer diameter segment to a smallest outer diameter segment to a larger outer diameter segment on the vertical axis. The larger diameter segment of the component opposite the tapered end of the strain relief 112 should be an offset diameter design where half of the segment's profile has a diameter that matches the smallest outer diameter segment of the component and the other half has a larger outer diameter to match the maximum diameter of the dome feature of the shells 810, 820.

[0070]

[0091] 18 and 19 also show the components of the steering control arrangement 900 disposed within the handle 120. The components of the arrangement 900 may be disposed adjacent to and / or in contact with one another. As shown in FIGS. 18 and 19, the components of the arrangement 900 may be directly or indirectly coupled to one another when the handle 120 is assembled. One or more components within the handle 120 may include specially rounded edges to prevent wear and tear damage around the contact points of the pull wire segments.

[0071]

[0092] Figure 21 is a flow diagram of a method 2100 of assembling an endoluminal imaging device as described herein. In other embodiments, the steps of method 2100 may be performed in a different order than shown in Figure 21, additional steps may be provided before, during or after the steps, and / or some of the steps described may be replaced or eliminated. The steps of method 2100 may be performed by a manufacturer of the endoluminal imaging device.

[0072]

[0093] At step 2110, the method 2100 includes obtaining a flexible elongate member. The flexible elongate member may include an imaging core at a distal portion. An electrical cable is connected to the imaging core and extends along the length of the flexible elongate member from the distal portion to the proximal portion. Additionally, one or more pull wires or pull wire segments extend along the length of the flexible elongate member from the distal portion to the proximal portion, the pull wires or pull wire segments configured to selectively deflect the distal portion of the flexible elongate member including the imaging core.

[0073]

[0094] At step 2120, method 2100 includes guiding the electrical cable and pull wire segments into a handle of the endoluminal imaging device. For example, the electrical cable and pull wire segments may enter through a lumen at a distal portion of the handle. In some embodiments, the handle includes a clamshell design made up of two or more components (e.g., a top shell and a bottom shell). Step 2120 may include guiding the electrical cable and pull wire segments into the top shell or the bottom shell.

[0074]

[0095] At step 2130, the method 2100 includes directing the electrical cable away from the pull wire segment using a routing member of the handle. For example, the routing member may divert the electrical cable so that it is away from the pull wire segment.

[0075]

[0096] At step 2140, method 2100 includes coupling the pullwire segments to one or more pulleys. Each pulley may include a groove and one or more holes in communication with the groove. The first pullwire segment may be disposed along a first portion of the groove. The second pullwire segment may be disposed along a second portion of the groove. The first pullwire segment may extend from the groove through a first hole in a sidewall of the pulley. The second pullwire segment may extend from the groove through a second hole in the sidewall of the pulley. In some embodiments, the first and second pullwire segments may both pass through a third hole in the sidewall of the pulley. The first and second pullwire segments may be coupled to an anchor member, for example, by tying a knot.

[0076]

[0097] In step 2150, the method 2100 includes disposing one or more components of a steering mechanism, including the one or more pulleys, and / or a clutch mechanism, within the handle shell. For example, the one or more components of the steering mechanism may include a clutch control member, a clutch, a clutch spring, an axle, an actuation control member, and a friction member. The steering mechanism allows for selective deflection of a distal portion of the flexible elongate member. The clutch mechanism allows for varying the resistance of the actuation control member to control the rate at which the deflected distal portion returns to an undeflected state.

[0077]

[0098] At step 2160, the method 2100 includes forming a complete handle. For example, a second half of a handle shell may be placed over and attached, such as by fasteners and / or adhesives, to the half of the handle shell housing the components of the steering mechanism (step 2150).

[0078]

[0099] At step 2170, the method 2100 includes coupling a proximal strain relief and a distal strain relief to the handle. For example, the distal strain relief may be disposed on a shaft extending from a distal end of the handle. For example, the proximal strain relief may be disposed on a cable extending from a proximal end of the handle.

[0079]

[0100] Figure 22 is a flow diagram of a method 2200 for acquiring imaging data from within a patient's body using an intraluminal imaging device. In other embodiments, the steps of method 2200 may be performed in a different order than shown in Figure 22, additional steps may be provided before, during or after the steps, and / or some of the steps described may be replaced or eliminated. The steps of method 2200 may be performed by a user of the intraluminal imaging device.

[0080]

[0101] At step 2210, the method 2200 includes obtaining an endoluminal imaging device. The endoluminal imaging device may include a flexible elongate member extending from a handle. A distal portion of the flexible elongate member may include an imaging core. The handle controls one or more pull wire segments extending along the length of the flexible elongate member to facilitate selective deflection of the distal portion including the imaging core. At step 2220, the method 2200 includes inserting the imaging device into the patient's body. For example, the imaging device may be positioned in any suitable lumen within the body.

[0081]

[0102] In step 2230, the method 2200 includes steering the distal portion of the imaging device using a steering mechanism on the handle. In step 2240, the method 2200 includes using a clutch mechanism to control the rate at which the distal portion of the imaging device returns to the undeflected state. One or more components of the steering mechanism may include a pulley coupled to a pull wire segment, an axle, and an actuation control member. The actuation control member may be coupled to the pull wire segment via a pulley such that movement of the actuation control member causes a corresponding deflection of the distal portion of the flexible elongate member. The clutch mechanism includes a clutch control member, a clutch cam, a clutch spring, and a friction member. The clutch control member may be moved to increase or decrease a compressive force on the clutch cam. The clutch cam applies an appropriate compressive force to the clutch spring. The friction member is positioned adjacent to and / or in contact with the actuation control member. The actuation control member is urged into contact with the friction member in response to a control force. Increased contact slows the rate of return to the undeflected state. The less contact there is, the faster it will return to its undeflected state.

[0082]

[0103] At 2250, the method 200 includes acquiring imaging data from within the patient's body using an imaging device. The method 2200 may further include an optional step for reviewing the acquired data.

[0083]

[0104] The embodiments of the present disclosure provide numerous advantages. For example, the actuation direction of the pull wire is in line with the actuation control member and pulley for each direction, which reduces the force required to rotate the actuation control member to actuate the device. The present disclosure provides a device that can be actuated to significantly higher angles than commercially available devices with less force through the actuation control member and with a more direct reaction action (e.g., less rotations, less control dead band, etc.). The use of a lined variable braided differential durometer multi-lumen shaft enhances this efficiency.

[0084]

[0105] Additionally, the wire routing between the proximal shaft and pulley is designed to ensure that each pull wire is adequately isolated from one another so that tensioning a single wire does not unintentionally tension other wires. The present disclosure also limits the amount of angle the pull wire experiences as it travels from the shaft to the pulley in order to more directly and efficiently apply the force exerted by rotating the actuation control member. This allows for high stroke actuation with only small rotations of the actuation control member, allowing the embodiments described herein to accommodate a wide range of sensitivities when optimizing device usability, thus enhancing overall device usability.

[0085]

[0106] The overall ergonomic shape of the embodiments described herein, and the ability to place both fingers on the desired actuation control member when rotating to control actuation, are intended to allow the physician to use the handle from any rotational angle while providing grip stability and maintaining tactile resolution as much as possible. The shape of the actuation control members, the finger grooves on the proximal end, their proximity and offset placement relative to one another, the different sizes and shapes of each actuation control member, and the brake controls relative to one another are intended to allow the physician to use the device one-handed (or either hand) and to intuitively control the handle without the physician having to look directly at it.

[0086]

[0107] The variable braking system allows the user to select the appropriate balance between the feedback resistance on the actuation control member during maneuvering and the desired holding force on the actuation control member to maintain the current actuation state when the actuation control member is released. The friction member used as the base of the actuation control member and functioning as part of the variable braking system also cooperates with the outer housing. The actuation control member itself creates an interference post to limit the actuation range of the device. The actuation range and the wheel rotation may be limited independently of each other. The stroke to wheel rotation ratio can be further optimized for usability by simply changing the size of the interference post and pulley on the above components without having to change the shaft of the device itself.

[0087]

[0108] Those skilled in the art will recognize that the above-described devices, systems, and methods may be modified in various ways. Therefore, those skilled in the art will understand that the embodiments covered by the present disclosure are not limited to the specific embodiment examples described above. Although illustrative embodiments have been shown and described, the above disclosure contemplates various modifications, changes, and substitutions. It is understood that such modifications may be made above without departing from the scope of the present disclosure. Therefore, it is appropriate that the appended claims be broadly construed in accordance with the present disclosure.

Claims

1. a flexible elongate shaft for insertion into a patient's body, the flexible elongate shaft including a distal portion and a proximal portion; a deflectable distal tip operatively associated with the distal portion of the flexible elongate shaft; a control handle coupled to the proximal portion of the flexible elongate shaft, the control handle comprising: a first actuator for positioning the distal tip within the patient; a first friction member coupled to the first actuator for contacting the first actuator to control deflection of the distal tip; The first actuator includes: a first pulley member coupled to a first pair of pullwire segments, the first pair of pullwire segments being coupled to the distal portion of the flexible elongate shaft; a first actuation control member coupled to the first pulley member, the first actuation control member applying tension to the first pair of pullwire segments such that the distal portion of the flexible elongate shaft is deflected along a first plane; The first pulley member includes: a plurality of radially spaced holes in a surface of the first pulley member; the first pair of pull wire segments are threaded through the plurality of holes; the first friction member is disposed on an opposite side of the first operation control member from the first pulley member, an outer periphery of the first friction member includes one or more interference posts directed toward the cavity of the first actuation control member; the one or more interference posts contact the first actuation control member when a compressive force is applied to the first actuation control member; contact between the interference post and the first actuation control member changes the resistance to rotation of the first actuation control member; Intraluminal devices.

2. The control handle further comprises: a clutch spring coupled to the first pulley member; a clutch cam coupled to the clutch spring; a clutch control member coupled to the clutch cam, wherein adjustment of the clutch control member causes the clutch cam to compress the clutch spring toward the first pulley member, thereby applying a compressive force to the first actuation control member. The intraluminal device of claim 1 .

3. 3. The intraluminal device of claim 2, wherein the control handle further includes a housing having an elongated shape, the first friction member, the first actuator, the clutch spring, the clutch cam, and the clutch control member being disposed in a distal portion of the housing, and the housing including a plurality of finger-shaped grooves disposed on an outer surface of a proximal portion of the housing.

4. The control handle includes: the clutch spring further includes an axle extending through the first pulley member, the first operation control member, and the first friction member; the housing includes a plurality of alignment members disposed to receive the axles; The intraluminal device of claim 3.

5. 5. The intraluminal device of claim 4, wherein the first frictional member further includes a locking post protruding in an opposite direction of the first frictional member from the one or more interference posts, and when the locking post locks with one of the plurality of alignment members, the first actuation control member is maintained in a current position.

6. 2. The intraluminal device of claim 1, wherein the first actuation control member includes a first slot and a second slot, the first pulley member includes a first post received in the first slot and a second post received in the second slot, the first post and the second post having different diameters.

7. The first pulley member includes: an anchor member disposed on an end of the first pulley member; the first pair of pull wire segments are secured to the anchor member; The intraluminal device of claim 1 .

8. The control handle further a second pulley member coupled to a second pair of pullwire segments, the second pair of pullwire segments being coupled to the distal portion of the flexible elongate shaft; a second actuation control member coupled to the second pulley member, the second actuation control member applying tension to the second pair of pullwire segments such that the distal tip and the distal portion of the flexible elongate shaft are deflected along a second plane different from the first plane. A second actuator; and a second friction member coupled to the second actuator, the second friction member contacting the second actuator to control deflection of the distal tip. The intraluminal device of claim 1 .

9. a housing having an elongated shape, the first actuation control member and the second actuation control member being disposed longitudinally along the housing; The intraluminal device of claim 8.

10. 10. The intraluminal device of claim 9, wherein the housing includes a routing member that directs a coaxial cable coupled to the distal tip such that the coaxial cable is spaced away from the first pair of pullwire segments and the second pair of pullwire segments within the housing.

11. 9. The intraluminal device of claim 8, wherein the first actuator is aligned with a central longitudinal axis of the flexible elongate shaft and the second actuator is offset from the central longitudinal axis such that actuation of the first pair of pullwire segments and actuation of the second pair of pullwire segments are independent of each other.

12. The intraluminal device of claim 8 , wherein the first plane is a left-right articulation plane, the second plane is an anterior-posterior articulation plane, and the first actuation control member has a larger size than the second actuation control member.

Images