Electrophysiology device with deflection detection

Abstract

A guide sheath assembly has an elongated shaft and a control handle having a control knob and a shuttle configured for translation in response to manipulation of the control knob. The assembly includes a pull wire extending along the shaft and deflecting the shaft in response to translation of the shuttle. The pull wire has a stop at its proximal end, with a deflection sensor secured to the stop under compression to generate a signal in response to deformation between the first shuttle and the first stop. A catheter having a control handle and a control knob for manipulating a deflection pull wire having a proximal end secured to a stop anchored in a control handle housing, the catheter including a strain gauge secured to the stop configured to detect deformation caused by actuation of the pull wire to deflect the catheter shaft.

Description

Technical Field

[0001] This invention relates to a guiding sheath, which is particularly suitable for guiding electrophysiological catheters, especially a deflectable guiding sheath. Background Technology

[0002] Guiding sheaths and electrophysiological (EP) catheters are well-known for diagnosing and / or treating a variety of cardiovascular conditions, including atrial fibrillation and other abnormal heart rates known as arrhythmias. Catheter insertion into the human heart typically requires the insertion of a thin EP probe into the ventricle via the femoral vein and aorta. To provide variability in movement within such devices, guiding sheaths, catheters, etc., one or more pull cords can be manipulated or deflected for operability within the patient's vascular system. Although control handles are directly operated by the operator to deflect these EP tools within the patient's vascular system and heart, the occurrence and extent of deflection can be difficult to assess over time.

[0003] Using an ablation catheter, flushing the ablation site offers numerous benefits, including cooling the ablated tissue and creating deeper, larger lesions. Fluid, such as saline, is delivered to the ablation site via a lumen, which typically carries fluid from a remote IV bag and infusion chamber to a Luer connector that connects to the flushing tubing, which extends through the control handle and the EP device. Therefore, fluid from the IV bag typically drips into the infusion chamber, and there is a risk that air from the infusion chamber may be introduced into the lumen, the flushing tubing of the EP device, and further into the patient's vascular system when the IV bag is depleted and the infusion chamber's memory is exhausted. Accidental introduction of air can be fatal.

[0004] Therefore, it is desirable to have a guide sheath or catheter that can provide indication of the occurrence and direction of deflection, as well as whether the deflection curve is tight or loose, and also requires an infusion chamber that automatically closes the outlet of the infusion chamber when the IV bag is depleted. Summary of the Invention

[0005] In some embodiments, the guide sleeve assembly includes an elongated shaft and a control handle. The control handle has a longitudinal axis and a control knob, and includes a first shuttle and a second shuttle. The first shuttle is configured to translate along the longitudinal axis in one direction in response to an actuation of the control knob, and the second shuttle is configured to translate along the longitudinal axis in the opposite direction in response to another actuation of the control knob. A first pull line extends on one side of the shaft and deflects the shaft to one side in response to translation of the first shuttle, the first pull line having a first stop at its proximal end. A second pull line extends on the other side of the shaft and deflects the shaft to the other side in response to translation of the second shuttle, the second pull line having a second stop at its proximal end. The assembly also includes a first deflection sensor configured to generate a first signal in response to compression between the first shuttle and the first stop.

[0006] In some embodiments, the guide sheath assembly also includes a second deflection sensor located between the second shuttle and the second stop, and configured to generate a second signal in response to compression between the second shuttle and the second stop.

[0007] In some implementations, the first deflection sensor includes a piezoelectric force sensor.

[0008] In some implementations, the first signal includes a voltage signal.

[0009] In some embodiments, the guide sleeve assembly has an elongated shaft and a control handle. The control handle has a longitudinal axis and includes: a rotatable shaft configured to rotate about the longitudinal axis of the control handle; a first shuttle configured to translate in one direction along the longitudinal axis in response to rotation of the rotatable shaft, the first shuttle having a plurality of first teeth; a pinion engaging the plurality of first teeth, the pinion configured to rotate about an axis substantially perpendicular to the longitudinal axis in response to translation of the first shuttle; and a second shuttle having a plurality of second teeth engaging the pinion, the second shuttle configured to translate along the longitudinal axis in another direction opposite to the first direction in response to rotation of the pinion. The assembly also includes: a first pull line extending on one side of the shaft and having a proximal portion in response to translation of the first shuttle member in a proximal direction, the first pull line having a first stop at its proximal end; a second pull line extending on the other side of the shaft and having a proximal portion in response to translation of the second shuttle member in a proximal direction, the second pull line having a second stop at its proximal end; and a first deflection sensor located between the first shuttle member and the first stop and configured to generate a first signal in response to compression when the first shuttle member is actuated to deflect the elongated shaft in one direction.

[0010] In some embodiments, the guide sheath assembly also includes a second deflection sensor located between the second shuttle and the second stop, and is configured to generate a second signal in response to compression of the second stop when the second shuttle is actuated, causing the elongated shaft to deflect in another direction.

[0011] In some implementations, the first deflection sensor includes a piezoelectric force sensor.

[0012] In some implementations, the first signal includes a voltage signal.

[0013] In some embodiments, the electrophysiological system includes a guide sheath assembly and a controller. The assembly includes an elongated shaft; a control handle located proximal to the shaft, the control handle having a longitudinal axis and a deflection control knob, and including a shuttle configured to translate along the longitudinal axis in response to manipulation of the control knob; a traction wire extending along the shaft and deflecting the elongated shaft in response to translation of the shuttle, the traction wire having a stop at its proximal end; and a deflection sensor configured to generate a signal in response to compression between the shuttle and the stop during deflection of the elongated shaft. The controller includes a processor configured to receive the signal and perform an action of measuring the voltage from the signal, and to determine the occurrence of deflection based on the measured voltage.

[0014] In some implementations, the processor is further configured to perform actions that determine the degree of deflection based on the measured voltage.

[0015] In some implementations, the console includes a memory configured to store indexes associated with a predetermined voltage and a predetermined deflection degree, and the processor is further configured to access the indexes to determine the degree of deflection based on the measured voltage.

[0016] In some implementations, the deflection sensor includes a piezoelectric force sensor.

[0017] In some implementations, the system includes an indicator that is responsive to a controller and configured to provide a user with a prompt indicating that a deflection based on a measured voltage has occurred.

[0018] In some implementations, the indicator is configured to provide visual cues.

[0019] In some implementations, the indicator is configured to provide audio prompts.

[0020] In some embodiments, the electrophysiological catheter has an elongated shaft; and a control handle located proximal to the shaft, the control handle having a longitudinal axis and a control knob. The catheter also includes: a traction wire extending through the shaft and having a proximal end; a rocker arm responsive to the control knob to deflect the elongated shaft, the rocker arm having a pulley member around which the traction wire extends; a stop fixed to the proximal end and anchored to the control handle; and a strain gauge fixed to the stop and configured to generate a signal in response to strain on the stop.

[0021] In some embodiments, the control handle further includes a second pull line extending through the other side of the shaft and having a second proximal end, wherein the rocker arm has a second pulley member around which the second pull line extends. The control handle also has a second stop and a second strain gauge, the second stop being fixed to the second proximal end and anchored to the control handle, the second strain gauge being fixed to the second stop and configured to generate a second signal in response to strain in the second stop.

[0022] In some implementations, the signal includes a voltage signal.

[0023] In some embodiments, the electrophysiological catheter includes an elongated shaft and a control handle. The control handle has a longitudinal axis and a control knob, and further includes: a rocker arm that deflects the elongated shaft in response to the control knob, the rocker arm having a pulley member; a tension member having a distal portion extending through the shaft and a proximal portion extending around the pulley member; a connector extending between the distal and proximal portions of the tension member; and a strain gauge configured to generate a signal in response to strain in the connector.

[0024] In some embodiments, the drip chamber includes a hollow shell defining the chamber in communication with an inlet and an outlet, a bag tip at the inlet, an outlet nozzle located distal to the outlet, and a spherical plug configured to float when liquid is present in the chamber and to drip into the outlet nozzle by gravity when the chamber is empty, and to provide a fluid-impermeable seal in the outlet nozzle.

[0025] In some embodiments, the drip chamber includes a hollow shell defining a chamber communicating with an inlet and a conical outlet, a bag tip at the inlet, an outlet nozzle located distal to the conical outlet, and a plug having a wider upper portion, a middle conical portion, and a lower conical portion, the plug being configured to float when liquid is present in the chamber and to drip into the chamber by gravity when the chamber is empty, wherein the middle conical portion is located in the conical outlet and the lower conical portion is located in the outlet nozzle, providing a fluid-impermeable seal for the outlet nozzle.

[0026] In some implementations, the intermediate conical portion has a larger cone shape and the conical outlet has a smaller cone shape, resulting in a spatial gap between the intermediate conical portion and the conical outlet. Attached Figure Description

[0027] These and other features and advantages of the invention will be better understood when considered in conjunction with the accompanying drawings and by referring to the following detailed description. It should be understood that some selected structures and features are not shown in certain drawings to provide a better view of the remaining structures and features.

[0028] Figure 1 This is a top view of a guide sleeve including a control handle, according to one implementation scheme.

[0029] Figure 2 yes Figure 1 A longitudinal cross-sectional view of the control handle.

[0030] Figure 3 yes Figure 1 An exploded view of the control handle with the housing removed.

[0031] Figure 4 yes Figure 1 A longitudinal cross-sectional view of the distal portion of the control handle, including the control knob.

[0032] Figure 5 yes Figure 1 A perspective view of the control handle with the housing removed.

[0033] Figure 6A It is a top plan view of a neutral indicator having a first and a second component joined according to one embodiment.

[0034] Figure 6B yes Figure 6A A top view of the neutral indicator in which the first and second components are detached.

[0035] Figure 7A and Figure 7B This is a top plan view of the interior of a bidirectional guide sleeve control handle having a first shuttle component, a second shuttle component, and a deflection sensor, according to one embodiment.

[0036] Figure 8A and Figure 8B yes Figure 7A and Figure 7B A detailed side view of the deflection sensor, located between the shuttle component and the stop.

[0037] Figure 9It is a depiction of an EP system, including an EP device (e.g., a guide sheath or catheter) and a console, according to one embodiment, which is operated by an operator in the patient.

[0038] Figure 10 This is a top plan view of the interior of the bidirectional control handle of an EP conduit according to one implementation scheme.

[0039] Figure 11A , Figure 11B and Figure 11C It is in a neutral configuration Figure 10 A simplified depiction of the control handle, which deflects in one direction and in another.

[0040] Figure 12 This is a detailed top plan view of a strain gauge on a tension member connector according to one embodiment.

[0041] Figure 13 This is a side cross-sectional view of a thumb control handle according to one implementation scheme.

[0042] Figure 14A and Figure 14B This is a side cross-sectional view of the drip chamber according to one implementation scheme.

[0043] Figure 15A This is a detailed side view of the infusion chamber according to another implementation scheme.

[0044] Figure 15B yes Figure 15A Side view of the plug.

[0045] Figure 15C yes Figure 15A A detailed view of the space between the plug and the sidewall of the drip chamber. Detailed Implementation

[0046] refer to Figure 1 In some embodiments of the invention, the guide sheath assembly 10 includes an elongated and flexible sheath 12 and a control handle 16 located proximal to the sheath 12. The sheath 12 includes a proximal segment 13 and a distal deflection segment 14. The control handle 16 can be connected to an electrical connection 17 for transmitting electrical signals, such as those sensed by one or more annular electrodes 19 carried on the sheath 12, including, for example, the deflection segment 14. Also attached to the control handle 16, such as Figure 1 As shown, a hemostatic valve 18 is adapted to receive a catheter (not shown) that can be advanced through the central lumen 22 of the guide sheath assembly 10. Figure 1The hemostatic valve 18 also has a side port 21 terminating at a Luer connector, such as a bidirectional stop valve 23 for connecting to one or more fluid sources (not shown) for supplying fluid into and through the inner cavity 22 of the guide sheath assembly 10.

[0047] like Figure 2 and Figure 3 As shown, the control handle 16 includes an elongated, generally cylindrical body 24 with a narrower distal portion or rod 25, and a distal rotary control knob 26 mounted on the distal portion of the rod 25. The body 24 has a semi-shell member formed to define an internal volume V and whose edges 51 meet along a longitudinal seam. The distal rod 25 of the body has a smaller outer diameter D1 than the outer diameter D2 of the proximal portion of the body 24. The control knob 26 is configured to be rotated by the user's thumb and forefinger when the user grips the body 24 of the control handle 16. In order to enable the deflection segment 14 of the guide sheath 12 to be deflected via a first pull line 30A and a second pull line 30B, the control handle 16 includes a rotatable shaft 31, a first shuttle member 32A and a second shuttle member 32B, and a pinion 34 in its internal volume V. The rotatable shaft 31 responds to a control knob 26 that drives the first shuttle 32A to move linearly along the longitudinal axis 55 in a first direction, and a pinion 34 connects the second shuttle 32B to the first shuttle 32A, such that the second shuttle 32B moves linearly along the longitudinal axis in a second direction opposite to the first direction. The proximal ends of the first pull line 30A and the second pull line 30B are respectively anchored to or at least connected to the first shuttle 32A and the second shuttle 32B. The connection and opposite translational movement of the first shuttle and the second shuttle actuate the first pull line and the second pull line to guide the bidirectional deflection of the deflection segment 14 of the sheath 12.

[0048] The rotatable shaft 31 has: a main proximal segment 36 with an outer diameter D3, a shorter distal segment 37 with an outer diameter D4, and a stepped joint J between segments 36 and 37. In the illustrated embodiment, diameter D3 is larger than diameter D4; however, it should be understood that the two diameters may generally be equal or diameter D4 may be larger than diameter D3. Figure 2 As can be better seen, the rotatable shaft 31 is positioned relative to the body 24 of the control handle 16 such that its proximal segment 36 extends through both the body 24 and the distal rod 25 of the control handle 16, and passes over the distal end of the distal rod 25, wherein the connector J and the distal segment 37 are located distal to the distal rod 25 of the body 24, such that the distal segment 37 is not surrounded by the distal rod 25. The rotatable shaft 31 is connected by a proximal outer circumferential lip 38 and fixed to the body 24 at its proximal end, which engages with an inner circumferential slot defined between circumferential flanges 40 formed in the internal volume V of the body 24.

[0049] refer to Figure 4 The rotatable shaft 31 is hollow and has an internal channel 42. The channel 42 communicates with a distal inlet 44, the diameter of which is only slightly larger than the diameter of the guide sleeve 12. The channel 42 is threaded and has diameters that accommodate both the guide sleeve 12 and the shuttles 32A and 32B circumferentially surrounding the guide sleeve 12, as discussed in further detail below.

[0050] The control knob 26, mounted on the distal rod 25 of the body 24 of the control handle 16, and the rotatable shaft 31 have a main proximal portion 46 and a short distal portion 47. The control knob 26 is generally cylindrical, with a longitudinally hollow interior extending through its entire length. The hollow interior has a main proximal segment 49, an intermediate segment 49', and a distal segment 49'". The main proximal segment 49' of the hollow interior is defined by a larger first radius R1 and a larger first length L1 to accommodate and circumferentially surround the guide sheath 12 and the shuttles 32A and 32B. The distal segment 49' of the hollow interior is defined by a smaller second radius R2, where R1>R2, and a shorter second length L2, where L1>L2, to accommodate and circumferentially surround the distal segment 37 of the guide sheath 12 and the rotatable shaft 31. The hollow interior intermediate segment 49' is defined by a third radius R3 and a third length L3, where R1>R3>R2 and L1>L3, to accommodate and circumferentially surround the connector J of the guide sleeve 12 and the rotatable shaft 31. A friction-sensing cover 60 can be mounted on the outer surface of the control knob 26 for easy and comfortable operation and rotation by the user relative to the body 24 of the control handle 16.

[0051] In order to rotatably connect the rotatable shaft 31 to the control knob 26, the outer surface of the distal segment of the shaft has a longitudinal ridge 70. Figure 3 The longitudinal ridge is received in and engages with the corresponding longitudinal recess 71. Figure 4 The longitudinal recess forms an inner surface defining the hollow interior 49” of the control knob 26. To translationally secure the control knob 26 to the rotatable shaft 31 and thus to the body 24, the outer surface of the shaft 31 also has one or more linear slots 74 oriented perpendicular to the longitudinal axis of the rotatable shaft 31. Each slot 74 is aligned with a corresponding hole 76. Figure 5 The hole is formed on one side of the distal portion 47 of the control knob 26, so that a corresponding pin 77 can be inserted into the hole 76 and the slot 74 to connect the control knob 26 and the rotatable shaft 31.

[0052] It should be understood that other embodiments of the guide sheath assembly may provide a rotatable shaft 31 with an exposed portion for direct manipulation by the user without the need for control knob 26.

[0053] like Figure 3 and Figure 5 As shown, shuttles 32A and 32B have a similar configuration to each other, where each is generally understood to be a mirror image of the other, but the first shuttle 32A is driven by a rotatable shaft 31, and the second shuttle 32B is driven by the first shuttle 32A via a pinion 34 located between them. Each shuttle 32A and 32B has a corresponding elongated body having: distal portions 80A and 80B with C-shaped end cross sections, and corresponding proximal rack portions 90A and 90B with longitudinally arranged corresponding plurality of teeth 92A and 92B. The first and second shuttles are arranged to face each other and engage the pinion 34, such that the distal portions 80A and 80BC together can form a cylindrical shape having an outer circumferential surface mating within a threaded channel 42 and an inner circumferential surface defining a channel 93 through which the guide sheath 12 passes. Figure 5 As shown, the rack portions 90A and 90B of each shuttle face each other between the pinions 34, such that the teeth 92A and 92B of each rack portion can engage with the teeth of the pinions 34, which are mounted to rotate about an axis perpendicular to the longitudinal axis 55 of the control handle 16.

[0054] refer to Figure 2 and Figure 3 The outer surface of the distal portion 80A of the first shuttle member 32A is provided with an external thread surface or a male thread surface 85. The inner circumferential surface of the rotatable shaft 31 is provided with an internal thread surface or a female thread surface 86. Figure 4The internal or female thread surface 86 receives the male thread surface 85 of the first shuttle 32A, which connects the first shuttle 32A and the rotatable shaft 31 to convert the rotational movement of the rotatable shaft 31 into the translational movement of the first shuttle 32A. In contrast, the outer surface of the distal portion 80B of the second shuttle 32B is smooth and does not feature any engagement with the rotatable female thread surface, allowing it to move independently of the male thread surface 85. Therefore, when the user rotates the control knob 26 in the first direction, the rotatable shaft 31, which is rotatably connected to the control knob 26 via the longitudinal ridge 70, also rotates. The rotatable shaft 31 is rotatably and translationally locked to the control knob 26 via the longitudinal ridge 70 and one or more pins 77, and the rotation of the shaft 31 drives the first shuttle 32A to translate along the longitudinal axis in the first direction (e.g., proximal). When the first shuttle 32A translates, its teeth 92A drive the pinion 34 to rotate in a first direction (e.g., clockwise), which in turn drives the second shuttle 32B to translate along the longitudinal axis 55 in a second direction opposite to the first direction (e.g., distally). This arrangement allows the male thread surface 85 and the female thread surface 86 to convert the rotational movement of the control knob 26 into linear movement of the shuttles 32A and 32B. The proximal ends of the first pull line 30A and the second pull line 30B are respectively anchored, connected, or otherwise responsive to the first shuttle 32A and the second shuttle 32B, whose linear and opposing movements actuate the pull lines to guide bidirectional deflection of the deflection segment 14 of the sheath 12. In the illustrated embodiment, the proximal ends of the pull lines 30A and 30B are respectively connected to the rack portions 90A and 90B of the shuttles 32A and 32B. Therefore, when one pull line is pulled proximally under tension through its corresponding shuttle, the other pull line moves distally through its corresponding shuttle while being released from tension.

[0055] like Figure 2 As shown, the proximal segments of each pull wire 30A and 30B extend outside the sheath 12 in the corresponding longitudinal channels 88A and 88B formed in the proximal rack portions 90A and 90B of each shuttle 32A and 32B. Figure 5 As shown, stops 89A and 89B (e.g., hypotubes) are fixed to the proximal ends of each pull line 30A and 30B, and the stops are positioned at the proximal ends 87A and 87B of the corresponding rack portions 90A and 90B, such that the rack portions can be pushed or otherwise acted on stops 89A and 89B respectively to pull pull lines 30A and 30B proximally as shuttles 32A and 32B move proximally. When the shuttles move distally, the proximal ends of the rack portions contact the corresponding stops, thereby releasing the pull lines from tension. It should be understood that stops 89A and 89B can also be embedded or otherwise anchored to the corresponding rack portions or any part of the shuttles to achieve sheath deflection.

[0056] Because the first shuttle 32A and the second shuttle 32B move in opposite directions along the longitudinal axis 55, the initial positioning of the shuttles relative to each other and the channel 42 is prepared during the assembly of the control handle. For example, as Figure 2 As shown, each shuttle is positioned in a channel 42 of the rotatable shaft 31 such that they are adjacent to each other along the longitudinal axis 55 and each has a distal end typically positioned at the midpoint along the channel 42, such that each shuttle has sufficient space to move accordingly proximally or distally within the rotatable shaft 31. Stops 89A and 89B can be positioned relative to the shuttles such that minimal or constant tension is applied to each pull line 30A and 30B for a generally neutral guide sheath with little deflection (if any). This arrangement allows the shuttles to be in a “neutral” or initial configuration from which the user can uniformly deflect the guide sheath bidirectionally.

[0057] like Figure 5 As shown, pinion 34 is positioned between and relative to shuttles 32A and 32B such that their teeth 92A and 92B remain engaged while translating in response to user operation of control knob 26. In this respect, rack portions 90A and 90B are long enough to ensure such continuous engagement.

[0058] It should be understood that by changing one or more factors, including, for example, the length of channel 42, the length of each distal portion 80A and 80B, the length of rack portions 90A and 90B, the position of pinion 34 and the number of pinions 34, different shuttle movement and deflection characteristics and limitations can be achieved as needed or desired.

[0059] refer to Figure 6A and Figure 6B Each shuttle 32A and 32B has a neutral indicator on the outer surface of each rack portion 90A and 90B opposite to the teeth 92A and 92B. The neutral indicator includes a first member 62A and a second member 62B, which are configured to releasably engage with each other to indicate a neutral position between the first shuttle 32A and the second shuttle 32B, i.e., where the pull lines 30A and 30B are in a neutral relative position and the guide sheath 12 is generally straight without deflection. In the illustrated embodiment, a first or male member 62A formed on a first shuttle 32A has a tapered protrusion 63 facing a second or female member 62B formed on a second shuttle 32B. The protrusion 63 includes a pair of flexible guides 64, on either side of which a fixed end 65 is fixed to the second shuttle 32B and a free end 66 is configured to together form a tapered recess 67. When the shuttles 32A and 32B are in a neutral configuration, the tapered protrusion 63 is nested in the tapered recess 67.

[0060] Therefore, the user typically initially presents an undeflected guide sleeve 12, wherein the first and second shuttle elements 32A and 32B are identical to each other, wherein the tapered protrusion 63 is nested in the tapered recess 67, as... Figure 6A As shown. When the user rotates the control knob 26 in one direction that drives the first and second shuttles 32A and 32B to translate in opposite directions, as... Figure 6B As shown, the tapered protrusion 63 disengages from and moves out of the tapered recess 67, but only when the user rotates the control knob with sufficient force to bend the guide rail 64 and overcome the resistance presented by its angled ends 68. As the tapered protrusion 63 rides on one of the angled ends 68 and moves past that angled end, the guide rail 64 tilts, causing the resistance to movement of the tapered protrusion 63 to decrease as the tapered protrusion 63 moves further away from the tapered recess 67. Therefore, when rotating the control knob 26 to deflect the guide sleeve 12, the user experiences greater or maximum resistance when the shuttles 32A and 32B initially move out of the neutral configuration, then the ease of movement increases as the shuttles 32A and 32B translate in opposite directions. The control handle 16 may carry visual and / or tactile markings to provide a constant orientation of the deflection direction. For example, clockwise rotation of control knob 26 always deflects shaft 12 toward the side or direction of side port 21, and counterclockwise rotation of control knob 26 always deflects shaft 12 toward the opposite side or direction.

[0061] Conversely, when the deflection of the guide sleeve 12 is released, the user rotates the control knob 26 in the opposite direction. As the shuttles 32A and 32B translate and approach each other and begin to realign again, the tapered protrusion 63 and the tapered recess 67 approach each other, and the user applies increased force to rotate the control knob 26 so that it returns above the inclined end 68 of the guide rail 64 before the tapered protrusion 63 can nest in the tapered recess 67. Thus, the increased resistance provided by either of the inclined rails 64 and the greater or maximum resistance provided by the angled end 68 provide the user with a tactile feel or indication as the tapered protrusion 63 comes into close proximity to the tapered recess 67. The engagement of the tapered protrusion 63 and the tapered recess 67 can provide the user with an audible “click” or signal when the flexible guide rail 64 snaps into its natural configuration when the tapered protrusion 63 no longer applies any load to it.

[0062] In some implementation schemes, such as Figure 7A and Figure 7BAs shown, for example, the control handle 100 for a deflectable guide sheath includes stops 189A and 189B respectively fixed to the proximal ends of pull lines 130A and 130B, wherein stops 189A and 189B are located proximal to the proximal ends 187A and 187B of shuttles 132A and 132B, such that selective movement of the shuttles by the user operating the control knob 126 acts on stops 189A and 189B to deflect the flexible guide shaft (see example...). Figure 1 (12) The flexible guide shaft is located distal to the control handle 100 and the pull line extends through the flexible guide shaft. In this respect, each shuttle 132A, 132B has a corresponding deflection sensor 102A, 102B (shown in dashed lines) configured to detect at least the occurrence of deflection, if not the amount, degree, or extent of deflection of the guide shaft.

[0063] exist Figure 7A In this configuration, the control knob 126 has been actuated by the user (e.g., rotated about the longitudinal axis 55) to translate shuttle 132A proximally (arrow A) and shuttle 132B distally (arrow B). Specifically, proximal end 187A pushes against stop 189A, moving the stop proximally, while proximal end 187B moves distally to release stop 189B. Therefore, pull line 130A is taut in the proximal direction to deflect the guide sheath toward one side of the control handle 126, while pull line 130B moves freely distally to allow such deflection.

[0064] exist Figure 7B In this configuration, the control knob 126 has been actuated by the user (e.g., rotated about the longitudinal axis 55) to translate the shuttle 132A distally (arrow A) and simultaneously translate the shuttle 132B proximally (arrow B). Specifically, the proximal end 187B pushes against the stop 189B to move the stop proximally, while the proximal end 187A moves distally to release the stop 189A. Thus, the pull line 130B is tightened proximally to deflect the guide sheath toward one side of the control handle 126, while the pull line 130A can move freely distally to allow this deflection.

[0065] In some embodiments, each deflection sensor 102 includes a corresponding piezoelectric pressure sensor, which, as understood by those skilled in the art, generates a voltage proportional to the applied pressure. Figure 8A and Figure 8B In the illustrated embodiment, the piezoelectric pressure sensor includes a piezoelectric element 106 and a corresponding voltmeter circuit 107. The piezoelectric element, which may be, for example, a crystal, is positioned between the stop 189 and the proximal end 187 of the shuttle, such that actuation of the shuttle causes compression of the piezoelectric element 106. When the compressive force F( Figure 8AAn electric charge is applied to the piezoelectric element 106, and as those skilled in the art will understand, a charge is generated across the surface of the piezoelectric element 106. This charge can be measured as a voltage V in circuit 107 proportional to the compressive force. Advantageously, no external voltage or current source is required. Each piezoelectric element 106 generates an output signal directly from the applied compressive pressure, which is measured by a voltmeter circuit comprising two leads 109, 110 for each piezoelectric element.

[0066] In such Figure 8A In some embodiments shown, the voltage V representing the amount of compressive force acting on the piezoelectric element 106 is measured across the distal end D and proximal end P of each piezoelectric element 106, i.e., longitudinally across the piezoelectric element in a direction generally parallel to the longitudinal axis A of the control handle 100, because the compressive force exerted on the piezoelectric element 106 by the shuttle 132 between the stop 189 and the proximal end 187 of the shuttle is greatest in the direction of the longitudinal axis A. Therefore, lead 109 is connected to the distal end D of the piezoelectric element, and lead 110 is connected to the proximal end P of the piezoelectric element. As will be understood by those skilled in the art, leads 108 and 109 may extend proximally across the control handle from a remote signal processing location in the electrophysiological system 170 including the controller 180 to another location, such as further proximal. Figure 9 As shown, processor 182 is configured to process the output signal from the deflection sensor. Piezoelectric pressure sensors are particularly sensitive to dynamic changes in compressive force and are therefore especially suitable for measuring small variations in compressive force.

[0067] In some embodiments, the degree or curvature of deflection of the guide shaft 112, located distal to the control handle 100 and actuated by shuttles 132A, 132B in response to user manipulation of control knob 126, is calibrated to different voltages generated by piezoelectric elements 106A, 106B in response to the amount of compressive force applied to the piezoelectric element between the respective shuttle and stop when shaft 112 deflects. Therefore, when the catheter is used in a patient's procedure, an index relating the measured voltage to the degree or curvature of deflection can be stored in the memory 184 of the processor 182 of the console 180 and is referred to as providing an output with the degree or curvature of deflection to the user 186 based on an input of the measured voltage derived from the voltmeter circuitry of the deflection sensor. Generally, the higher the measured voltage V, the greater the compressive force, and therefore the greater the degree or curvature of deflection of the guide shaft in the selected direction. In some embodiments, the minimum voltage output by the deflection sensor is 0.0V and the maximum voltage output is approximately 5.0V. In some implementations, the maximum voltage output is approximately 10V. In some implementations, the maximum voltage output is approximately 20V.

[0068] In some embodiments, the electrophysiological system 170 includes a display 188 configured to respond to a processor 182 when displaying a voltage indicator or reading 191 to a user. In some embodiments, the system 170 includes one or more deflection indicators, such as LED 190a and a speaker 190b, configured to be enabled by the processor 58 to provide an audio and / or visual cue to the user when the voltage output of a deflection sensor exceeds a predetermined threshold representing the maximum deflection of shaft 12 to avoid breakage or damage to the shaft. The deflection indicators can also be configured to provide distinguishable audio and / or visual cues between left deflection, right deflection, and / or neutral (no deflection) in the guide shaft based on the consistency of deflection sensors 102A, 102B that produce a voltage output or the absence of a voltage output by the left and right deflection sensors. It should be understood that the processor can also be configured to detect the rate of change of voltage measured in determining other aspects of deflection, for example, regardless of whether the deflection curve is tight or loose.

[0069] It should be understood that deflection sensors can be incorporated into any suitable control handle of an electrophysiological (EP) device with unidirectional or bidirectional deflection, including catheters and probes with elements within the control handle that are movably coupled or engaged with each other, such that the elements are subjected to compressive or tensile forces during axial deflection. Figure 10 As shown, a control handle 200 suitable for use with an EP catheter or probe has a shaft 201 that can be deflected by a user-operated deflection control lever 202, which actuates a rocker arm 203 that pulls on a first tension member 204A and a second tension member 204B. A suitable control handle is disclosed in U.S. Patent 7,377,906 entitled “Steering Mechanism For Bi-Directional Catheter,” the entire disclosure of which is incorporated herein by reference. Each tension member includes: a distal portion D (e.g., a tension wire) extending distally into the shaft 201; and a proximal portion P (e.g., a spindle, for example...). The proximal portion of the rocker arm 203 surrounds the corresponding pulleys 205A and 205B, with the proximal end fixed to the corresponding stops 207A and 207B, which are anchored in the housing of the control handle. The distal portion D and proximal portion P of each tension member are connected by corresponding connectors 208A and 208B, such as collars. As will be understood by those skilled in the art, when the user rotates the deflection control lever 202, the rocker arm 203 rotates with the lever, which pulls one pulley proximally and moves the other pulley distally, as... Figure 11A , Figure 11B and Figure 11C As shown. The pulley pulls the proximal portion P, which applies a force, including strain force, to the collar 208A.

[0070] Strain gauges 210 are mounted on the surface of each collar 208, such as Figure 12 As shown, deformation of the collar is detected to produce a shift in resistance within the strain gauge, which is proportional to the strain applied to the surface. In some embodiments, strain gauge 210 includes a winding pattern of etched metal wires 212 (e.g., a copper-nickel alloy) on a substrate 214 (e.g., a flexible polyimide film). As understood by those skilled in the art, a strain gauge alters its resistance due to geometric changes. In particular, when the metal wire experiences tensile strain, the wire becomes elongated and its cross-sectional area decreases, which contributes to an increase in the wire's resistance. Similarly, when the wire experiences compressive strain, the wire shortens and its cross-sectional area increases, which contributes to a decrease in the wire's resistance. When coupled to the surface of a connector (e.g., collar 208), strain gauge 210 experiences the strain forces experienced by the connector when the pulley is pulled. The strain gauge bends and distorts uniformly with the surface of the connector, resulting in a shift in the strain gauge's resistance that is proportional to the strain applied to the surface. The strain is measured by a voltmeter circuit comprising leads 215 and 216, which performs the voltmeter circuitry. As will be understood by those skilled in the art, leads 215 and 216 may extend proximally through a control handle to another location at a remote signal processing location in the electrophysiological system 170, the remote signal processing location including a console 180 having a processor 182 configured to process output signals from deflection sensors, wherein similar indices of different outputs have different deflection curvatures, as described above.

[0071] It should be understood that when the rocker arm is manipulated to deflect the guide shaft, the strain gauge 210 can also be fixed to the surfaces of the stops 207A and 207B respectively to detect the deformation of the stops when the stops are subjected to deformation.

[0072] The aforementioned deflection sensor can also be incorporated into a one-way control handle. A suitable one-way deflection control handle is described in U.S. Patent 6,602,242 entitled "Irrigated Tip Catheter," the entire contents of which are incorporated herein by reference. Figure 13 As shown, the longitudinal movement of the traction wire 342, which causes deflection of the tip segment (not shown), relative to the catheter body 312 is accomplished by appropriate manipulation of the control handle 316. The distal end of the control handle 316 includes a piston 354 having a thumb control 356 for manipulating the traction wire 342. The proximal end of the catheter body 312 is connected to the piston 354 by means of a contraction cannula 328.

[0073] A pull wire 342 and other components (e.g., lead wire, thermocouple wire, and first infusion tubing segment 388) extend through the piston 354. The pull wire 342 is anchored to an anchoring pin 357 located proximal to the piston 354. Within the control handle 16, the lead wire and thermocouple wire are housed within a protective sleeve 339. Within the piston 354, the first infusion tubing segment 388 extends into another protective sleeve 391, preferably made of polyurethane. Protective sleeves 339 and 391 are preferably anchored to the piston 354 at a glue joint 353 by polyurethane adhesive or the like, thereby allowing longitudinal movement of the first infusion tubing segment 388, lead wire, and thermocouple wire within the control handle 316 such that they do not break when the piston 354 is adjusted to manipulate the pull wire 342. Within the piston 354, the pull wire 342 extends through a transfer tube 327, preferably a polyimide tube, to allow longitudinal movement of the pull wire near the glue joint 353.

[0074] Piston 354 is located within barrel 355 of the control handle. Barrel 355 is typically solid and has a piston chamber for receiving piston 354. Extending proximally from the piston chamber are three longitudinal holes 358, 359, and 360, and a transverse hole for receiving anchor pin 357. Second longitudinal hole 359 communicates with the transverse hole. A first infusion tubing segment 388 within protective sheath 391 extends through the first longitudinal hole 358. Pull wire 342 extends through the second longitudinal hole 359 and is anchored to anchor pin 357 in the transverse hole. Thermocouple wires and leads within protective sheath 399 extend through the third longitudinal hole 360. Between the distal ends of longitudinal holes 358, 359, and 360 and the proximal end of piston 354, chamber 362 provides additional space to prevent undesirable bending of the first infusion tubing segment 388.

[0075] In some implementations, the pull wire 342 includes a distal portion and a proximal portion connected by a connector, for example, Figure 12 The collar 208 is located in the barrel 355, wherein the aforementioned strain gauge 210 is positioned on the connector and undergoes tensile force experienced by the collar 208 when pulled by the piston 354. In some embodiments, the strain gauge is fixed to the anchoring pin 357 to detect the strain and deformation of the anchor to which the proximal end of the pull wire is attached.

[0076] An embodiment of the infusion chamber 400 for IV bags is described in Figure 14A as well as Figure 14BThe drip chamber 400 has a generally cylindrical hollow shell 402 defining a chamber C communicating with an inlet 404 and an outlet 406. The inlet 404 may be configured with a bag tip 408 for insertion into a IV bag, or may be configured to receive a bag tip cap 408C that covers and seals the inlet 404. The outlet 406 may be configured with a tapered outlet nozzle 412 (which may be formed as a cap 412' that covers and seals the outlet 406). Those skilled in the art will understand that the outlet nozzle 412 is configured to connect to the proximal end of a conduit 416, which may have an injection port in its distal portion and a needle or Luer lock and adapter (not shown) at its distal end. It should also be understood that after the bag tip 408 is inserted into the IV bag, fluid F from the IV bag drips under gravity through the bag tip 408 and into chamber C, where the droplet enters a volume before the fluid F leaves chamber C via the outlet 406. Chamber C has an inner diameter DC. The outlet nozzle 412 has a tapered configuration that is defined at the outlet 406 by a larger inner diameter D1 and a smaller inner diameter D2 on the distal side of the outlet.

[0077] In some embodiments, the drip chamber 400 includes a plug 418 that is buoyant or hollow and configured to float in the volume of fluid collected in chamber C. Figure 14A ) and in the gravity drop to exit 406 ( Figure 14B Whenever chamber C is free of collected fluid, the plug is inserted into outlet nozzle 412. In this respect, the shape and diameter of plug 418 are configured to fit snugly within outlet nozzle 412, for example, a spherical configuration with a diameter d as defined below:

[0078] DC>D1>d>D2 (Equation 1)

[0079] in:

[0080] DC = Inner diameter of chamber C

[0081] D1 = Inner diameter at outlet 406

[0082] D2 = Minimum diameter of outlet nozzle 412

[0083] d = diameter of spherical plug 418

[0084] In some implementations, the diameter d of the plug 418 is greater than the diameter D1, such that the plug is typically held above or otherwise outside the outlet nozzle 412, making it easier for the plug to float again when the chamber is refilled.

[0085] Thus, when chamber C is empty, the plug 418 is configured to be positioned within the outlet nozzle 412, so as to seal the outlet nozzle and prevent any air in the chamber from leaving the drip chamber through the outlet nozzle. Whenever fluid F refills chamber C, the buoyant plug 418 floats above the outlet nozzle 412 and unblocks the outlet 406, allowing fluid to exit the drip chamber via the outlet nozzle again. Accordingly, the buoyant plug 418 floats freely at the fluid level in chamber C, so as to self-adjust in response to the amount of fluid in the chamber to allow fluid to pass through the outlet nozzle in the presence of fluid, and to be inserted into the outlet nozzle in the absence of fluid, thereby preventing any air in the chamber from flowing out of the outlet nozzle.

[0086] In some embodiments, as shown in Figure 15A , a drip chamber 430 having features similar to the aforementioned drip chamber 400 has a generally cylindrical hollow housing 431, a tapered outlet 432, and a tapered outlet nozzle 434 (which may be formed as a cap that covers and seals the tapered outlet). Chamber C has an inner diameter DC. The outlet nozzle 434 tapers from a larger inner diameter D1 at its proximal end to a smaller inner diameter D2 at its distal end. The outlet 432 connects chamber C and the outlet nozzle 434, and thus tapers from a proximal inner diameter of diameter DC to a distal inner diameter of diameter D1.

[0087] As shown in Figure 15B , the buoyant or hollow plug 440 has an upper portion 442 defined by a diameter Dj that is substantially uniform along its longitudinal dimension T, a generally frustoconical middle portion 444 that tapers from a proximal diameter of Dj to a distal diameter of Dk, and a generally frustoconical bottom portion 446 that tapers from a proximal diameter of Dk to a distal diameter of Dm. In some embodiments, the total length L of the plug 440 is greater than or at least slightly greater than the chamber diameter DC, such that when floating, the plug generally remains upright inside the chamber. In some embodiments, the sum of the length L1 of the upper portion 442 and the length L2 of the middle portion 444 is less than or equal to the length L3 of the bottom portion 446, which may help maintain the plug in a generally upright position. Notably, the tapered middle portion 444 facilitates self-alignment of the plug 440 with the outlet nozzle 434, and when chamber C is depleted of fluid F and the plug 440 descends into the drip chamber 430, the inclined inner wall 433 of the outlet 432 pushes and guides the lower portion 446 of the plug into the outlet nozzle 434.

[0088] The above dimensional relationships can be expressed as follows:

[0089] DC<LT (Equation 2)

[0090] L3≥L1+L2 (Equation 3)

[0091] DC>Dj>Dk>Dm (Equation 4)

[0092] in:

[0093] DC = Inner diameter of chamber C

[0094] LT = Total length of 430mm

[0095] L1 = Length of the upper part 442

[0096] L2 = Length of the middle part 444

[0097] L3 = Length of the outlet nozzle 446

[0098] Dj = Inner diameter of the upper part 442

[0099] Dk = Lower / Distal Inner Diameter of Middle Section 444

[0100] Dm = Lower part 446 / distal inner diameter

[0101] It is worth noting that, such as Figure 15C As shown, the tapered shape of the middle portion 444 of the plug 440 is larger / sharper than the tapered shape of the inner surface 433 of the outlet 432, such that when the plug 440 is located in the outlet nozzle 446, the annular space gap G separates between the middle portion 444 and the inner surface 433. In this way, the plug 440 (in...) Figure 15A and Figure 15C (shown as a broken line) When located in the outlet nozzle 446, it may have an upper portion 442 and a middle portion 444 surrounded by fluid, and is ensured to float when chamber C is replenished with fluid from the tip of the bag from the receiving drip chamber 430.

[0102] The foregoing description has been presented with reference to the presently preferred embodiments of the invention. Those skilled in the art will recognize that changes and modifications can be made to the structures without intentionally departing from the principles, spirit, and scope of the invention. Any feature or structure disclosed in one embodiment may be incorporated, as needed or appropriate, to replace or supplement other features of any other embodiment. As will be understood by those skilled in the art, the drawings are not necessarily drawn to scale. Therefore, the specific embodiments described above should not be construed as suitable only for the precise structures shown and illustrated in the drawings, but should be construed as conforming to and supporting the following claims, which have a full and fair scope of the invention.

Claims

1. An electrophysiological system, comprising: Guide sleeve assembly, the guide sleeve assembly comprising: Slender shaft; A control handle located near the shaft, the control handle having a longitudinal axis and a deflection control knob, and including a shuttle configured to translate along the longitudinal axis in response to actuation of the control knob; A draw line extending along the axis and deflecting the elongated axis in response to translation of the shuttle, the draw line having a stop at its proximal end; and A deflection sensor, configured to generate a signal in response to compression between the shuttle and the stop when the elongated shaft is deflected; and The controller has a processor configured to receive the signal and perform the following actions: Measure the voltage from the signal; and The occurrence of deflection is determined based on the measured voltage.

2. The system according to claim 1, wherein, The processor is further configured to perform an action to determine the degree of deflection based on the measured voltage.

3. The system according to claim 2, wherein, The controller includes a memory configured to store indexes associated with a predetermined voltage and a predetermined deflection degree, and the processor is further configured to access the indexes to determine the degree of deflection based on the measured voltage.

4. The system according to claim 1, wherein, The deflection sensor includes a piezoelectric force sensor.

5. The system of claim 1 further includes an indicator responsive to the controller and configured to provide a user with a prompt indicating that the deflection has occurred based on the measured voltage.

6. The system according to claim 5, wherein, The indicator is configured to provide visual cues.

7. The system according to claim 5, wherein, The indicator is configured to provide audio prompts.

8. An electrophysiological catheter, comprising: Slender shaft; A control handle, located proximal to the shaft, having a longitudinal axis and a control knob, and comprising: A rocker arm that responds to the control knob to deflect the elongated shaft, the rocker arm having a pulley component; A tension member having a distal portion extending through the shaft and a proximal portion extending around the pulley member; A connector extending between the distal and proximal portions of the tension member; and A strain gauge, which is fixed to the connector and configured to generate a signal in response to strain in the connector.

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