Introducer sheath systems with position sensing and related methods

Abstract

The invention relates to an introducer sheath system with position sensing and related methods. A system includes a sheath including a handle and a catheter; an endoluminal device having a shaft having a predetermined geometry and configured to pass through the handle and the catheter; and a sensor assembly disposed proximate the handle and configured to determine an insertion length of the endoluminal device within the sheath, thereby determining a position of the distal end of the shaft. Further, a method for visualizing a distal end of an endoluminal device, the method comprising: determining a position of a distal portion of a sheath within a body of a patient; determining an insertion length of a shaft configured with a predetermined geometry within the sheath; determining a position of a distal end of the shaft within the body of the patient based at least in part on the insertion length of the shaft within the sheath, the predetermined geometry of the shaft, and the position of the distal portion of the sheath; and providing a graphical representation of the position of the distal end of the shaft within the body of the patient.

Description

[0001] Cross-references to related patent applications

[0002] This application claims priority to and the benefit of U.S. Provisional Application No. 63 / 525,494, filed on July 7, 2023, the entire contents of which are incorporated herein by reference. Technical Field

[0003] The present invention relates to introducer sheaths and intraluminal devices used with introducer sheaths, such as dilators, therapeutic and diagnostic catheters, and transseptal needles. Background Art

[0004] Arrhythmias are irregular heart beats caused by abnormal electrical signals. Arrhythmias can reduce quality of life and increase the risk of stroke and heart failure. Arrhythmias can be located and identified via diagnostic catheters. These catheters can be used to create electroanatomical maps to help electrophysiologists understand the pathology and plan and deliver treatment, which may include ablation via therapeutic catheters.

[0005] Electrophysiology (EP) catheters, whether diagnostic or therapeutic, are guided by an introducer sheath that is well known for facilitating access within a patient's vasculature, typically through the femoral artery and aorta to ultimately gain access to the four chambers of the heart. For example, the CARTO. The dual-guide sheath allows for imaging via an electromagnetic system (such as Biosense Webster, Inc. Irvine, California). The 3-D Electroanatomical System (EAP-3) visualizes sheaths in a real-time three-dimensional map. The system enables electrophysiologists to construct an accurate 3-D electroanatomical map of the heart and is designed to help electrophysiologists navigate EP vascular devices (such as sheaths, catheters, dilators, and other probe devices) inside the heart by targeting the precise location (positioning and orientation) of the distal ends of these EP vascular devices during diagnostic and therapeutic procedures.

[0006] In order to have 3-system EP vascular device visualization that carries an electromagnetic position sensor having three coils in or near its distal end, each coil responsive to a respective magnetic field generator positioned under the patient bed. Each coil generates a signal that is transmitted by a respective lead extending from the distal end of the instrument along its entire length to and through the instrument's control handle and into an electrical connector that interfaces with a system for processing and generating a depiction of the instrument on a monitor that displays a 3-D anatomical map of the heart. Fluoroscopy is typically used instead of or in addition to electromagnetic position sensing. Ionizing radiation poses a risk to the patient and the electrophysiologist, who must wear heavy, lead-filled clothing. In addition, the view provided is limited to 2D.

[0007] The shaft and distal tip of EP vascular devices must be small, so their construction and assembly require highly skilled workers. Moreover, as the field of cardiac electrophysiology advances, more and more components are housed or carried on the distal tip of the device, where space is already at a premium. Furthermore, because the distal tip is advanced into the heart, medical safety requirements are stringent in order to minimize the risk of inadvertent separation of components from the distal tip or other avoidable traumatic damage to cardiac tissue. And, in cases where electrical components in the distal tip are connected to leads, breakage of the leads results in device failure.

[0008] Visualization is often not available for intraluminal devices, such as dilators and transseptal needles that are advanced into the patient's vasculature. Therefore, the location of dilators and transseptal needles is based primarily on guesswork and best estimates by the operator operating these devices. Although identification of these devices can be accomplished by fluoroscopy with confirmation by ultrasound, reducing the overall fluoroscopy time is in the interest of the patient's health.

[0009] Accordingly, Applicants recognize the need to provide EP vascular devices, particularly those used with introducer sheaths, that allow for position sensing and visualization with less demand on construction, assembly effort, and use of distal end space, while also minimizing the need for leads extending along the length of the device, and recognizing that improper proximity of intracavitary devices in the heart can result in tissue damage and disease, such as cardiac perforation and cardiac tamponade. Summary of the invention

[0010] In some embodiments, a catheter shaft for use in a catheter sheath includes a generally tubular member and a transmitter. The generally tubular member extends from a proximal end to a distal end along a longitudinal axis. The proximal end includes a proximal portion, the transmitter is fixed to the proximal portion, and the distal end includes an end effector.

[0011] In some embodiments, the end effector comprises a septum needle.

[0012] In some embodiments, the end effector includes an electrode assembly configured to map an organ.

[0013] In some embodiments, the end effector includes an ablation electrode assembly.

[0014] In some embodiments, the transmitter includes a magnetic member.

[0015] In some embodiments, the emitter comprises an optically readable pattern.

[0016] In some embodiments, a control handle for use with a catheter sheath includes a passage along a longitudinal axis of the control handle. The passage is configured to receive a proximal portion of a generally tubular member having a transmitter. The control handle includes at least one sensor fixed along the passage, and the sensor is responsive to the transmitter.

[0017] In some embodiments, the control handle includes a light source fixed along the path. The sensor includes a light sensor and the emitter includes an optically readable pattern. The light source is configured to illuminate the optically readable pattern, and the light sensor is configured to detect the optically readable pattern when illuminated by the light source.

[0018] In some embodiments, the light sensor comprises a photodiode and the light source comprises an LED.

[0019] In some embodiments, the transmitter includes a magnetic member and the sensor includes a magnetic sensor.

[0020] In some embodiments, the intracavitary device position sensing system includes a catheter sheath having a shaft and a control handle. The shaft includes an inner cavity, and the control handle includes a passage along the longitudinal axis, and the passage and the inner cavity are connected to each other. The system also includes a first intracavitary device, a first transmitter, and a sensor. The first intracavitary device is configured to have a predetermined geometry and includes a proximal portion and a distal portion, the distal portion is configured to extend through the inner cavity of the sheath, and the proximal portion is configured to extend through the passage of the control handle. The first transmitter is located on the proximal portion of the first intracavitary device, and the sensor is located in the passage of the control handle, and is configured to generate a signal in response to the first transmitter on the proximal portion of the first intracavitary device. The signal represents the position of the distal portion of the first intracavitary device.

[0021] In some embodiments, the first transmitter includes a magnetic member and the sensor includes a magnetic sensor.

[0022] In some embodiments, the first emitter comprises an optically readable pattern such that an optical signal is emitted when illuminated, and the sensor comprises an optical unit having at least an optical detector.

[0023] In some embodiments, the optical unit includes a light source.

[0024] In some embodiments, the first intraluminal device comprises a dilator.

[0025] In some embodiments, the first intraluminal device includes a lumen configured to receive the second intraluminal device.

[0026] In some embodiments, the second transmitter is located on a proximal portion of the second intracavitary device, the proximal portion of the second intracavitary device being configured to be substantially coextensive with the proximal portion of the first intracavitary device.

[0027] In some embodiments, the second intraluminal device comprises a transseptal needle.

[0028] In some embodiments, the predetermined geometry includes an insertion length (LIN1) of the first intraluminal device measured proximally from the distal end of the intraluminal device, the insertion length (LIN1) being configured to pass through a passage of a control handle of the introducer sheath and an inner cavity of the shaft and being a predetermined distance (DD1) greater than a combined length (LT) of the inner cavity and the passage.

[0029] In some embodiments, the sensor is located along the passage of the control handle at a predetermined distance (LS1) measured from the distal end of the lumen of the introducer sheath. The first transmitter is located on the first intraluminal device at a predetermined distance LM1 measured proximally from the distal end of the first intraluminal device, wherein LM1=LS1+DD1, and the signal generated by the sensor in response to the first transmitter represents the distance DD1 of the distal end of the intraluminal device away from the distal end of the lumen of the shaft.

[0030] In some embodiments, the approach distance AD ​​is defined as a predetermined distance measured proximally from the distal end of the lumen of the introducer sheath. Distal to the first transmitter, a second transmitter is located on the first intracavitary device at a predetermined distance LM2 measured proximally from the distal end of the first intracavitary device, wherein LM2=LM1-AD-DD1=LS1-AD, and the signal generated by the sensor in response to the second transmitter represents the distance AD ​​of the distal end of the intracavitary device proximal to the distal end of the lumen of the shaft.

[0031] In some embodiments, the system includes a third transmitter located on the first intracavitary device, between the first transmitter and the second transmitter, at a predetermined distance LM3 measured proximally from the distal end of the first intracavitary device, wherein LM2 = LS1. The signal generated by the sensor in response to the third transmitter represents that the distal end of the intracavitary device is flush with the distal end of the lumen of the shaft.

[0032] In some embodiments, the first transmitter includes a magnetic member, the sensor includes a first magnetic sensor, and the system also includes a second magnetic sensor, which is located at the same axial position in the passage as the first magnetic sensor, but at a different angular position with respect to the longitudinal axis of the first intracavitary device.

[0033] In some embodiments, the transmitter includes a magnetic member and the sensor includes a magnetic sensor, and the magnetic member is positioned off-axis relative to a longitudinal axis of the first intracavitary device.

[0034] In some embodiments, the first transmitter has a first magnetic strength and the second transmitter has a second magnetic strength different from the first magnetic strength.

[0035] In some embodiments, the system includes a second transmitter, wherein the first transmitter generates a first magnetic field and the second transmitter generates a second magnetic field orthogonal to the first magnetic field.

[0036] In some embodiments, the system includes a second transmitter, wherein the first transmitter generates a first magnetic field and the second transmitter generates a second magnetic field at an angle to the first magnetic field.

[0037] In some embodiments, the system includes a plurality of first transmitters and a plurality of sensors, wherein the plurality of first transmitters are located on a proximal portion of a first intracavitary device to form a first linear array of the first transmitters, each of the first transmitters being located at a different axial position along the proximal portion of the first intracavitary device, and the plurality of sensors are located in a passage of a control handle to form a linear array of sensors, each of the sensors being located at a different axial position along the passage.

[0038] In some embodiments, the first intraluminal device is configured such that the distal portion is deflectable.

[0039] In some embodiments, the signal generated by the sensor in response to the second transmitter represents the position of the distal portion of the second intraluminal device when deployed past the distal end of the first intraluminal device.

[0040] In some embodiments, an intracavitary device position sensing system includes a guide sheath having a shaft and a control handle, the shaft including an inner cavity, and the control handle defining a passage along a longitudinal axis therein, the passage and the inner cavity being connected to each other. The system also includes a first intracavitary device having a predetermined geometry, the first intracavitary device including a proximal portion and a distal portion, the distal portion being configured to extend through the inner cavity of the sheath, and the proximal portion being configured to extend through the passage of the control handle. The system also includes a first optically readable pattern located on the proximal portion of the first intracavitary device, and a light source and an optical sensor, the optical sensor being located in the passage of the control handle, the light source being configured to illuminate the first optically readable pattern, the optical sensor being configured to generate a signal in response to the illumination of the first optically readable pattern by the light source, the signal representing the position of the distal portion of the first intracavitary device.

[0041] In some embodiments, the light source comprises an LED.

[0042] In some embodiments, the optical sensor includes a photodiode.

[0043] In some embodiments, the system includes a second optically readable pattern located at a second location on the proximal portion of the first intraluminal device that is different from the first location of the first optically readable pattern.

[0044] In some embodiments, the system includes a second optically readable pattern located at a second location on the proximal portion of the first intraluminal device diametrically opposite the first location of the first optically readable pattern.

[0045] In some embodiments, the system includes a plurality of optical emitters and a plurality of optical sensors, the plurality of optical emitters and the plurality of optical sensors forming corresponding pairs of optical emitters and optical sensors, each pair of optical emitters and optical sensors being located at a different axial position along the pathway.

[0046] In some embodiments, an intracavitary device position sensing system includes a guide sheath having a shaft and a control handle, the shaft including an inner cavity, and the control handle defines a passage along a longitudinal axis therein, the passage and the inner cavity being in communication with each other. The system also includes a first intracavitary device having a predetermined geometry, the first intracavitary device including a proximal portion and a distal portion, the distal portion being configured to extend through the inner cavity of the sheath, and the proximal portion being configured to extend through the passage of the control handle. The system also includes a device for determining the position of the distal portion of the first intracavitary device based on the position of the proximal portion of the first intracavitary device in the passage of the control handle.

[0047] In some embodiments, the location of the distal position includes a location where the distal portion is deployed past the distal end of the shaft of the introducer sheath.

[0048] In some embodiments, the means for determining position includes an electromagnetic transmitter and an electromagnetic sensor.

[0049] In some embodiments, the means for determining position includes a light source and an optical sensor.

[0050] In some embodiments, a method for determining a position of an intracavitary device includes: determining a first length of an introducer sheath including a shaft and a control handle, the first length defined between a distal end of the sheath and a sensor site in the control handle; and determining a position of the distal end of the sheath within a patient. The method also includes determining a second length of the intracavitary device, the second length configured to pass through the shaft of the introducer sheath and the control handle, the second length defined between a distal end of the intracavitary device and a transmitter site on a proximal portion of the intracavitary device, the transmitter site coinciding with the control handle. The method also includes determining a position of the transmitter site of the intracavitary device relative to the control handle, and determining a position of the distal end of the intracavitary device within the patient based on the determined positioning of the transmitter site of the intracavitary device.

[0051] In some embodiments, determining the position of the transmitter site of the intracavitary device relative to the control handle includes electromagnetic sensing.

[0052] In some embodiments, determining the position of the transmitter site of the intracavitary device relative to the control handle includes optical sensing.

[0053] In some embodiments, determining the position of the distal end of the sheath within the patient comprises electromagnetic position sensing.

[0054] In some embodiments, the method includes displaying a graphical representation of the position of the distal end of the endoluminal device.

[0055] In some embodiments, the position of the distal end of the intraluminal device comprises a linear position.

[0056] In some embodiments, the position of the distal end of the intraluminal device includes a rotational position.

[0057] In some embodiments, the system includes: a sheath including a handle and a catheter extending distally from the handle; and an intracavitary device including a shaft configured to have a predetermined geometry and configured to pass through the handle and the catheter. The system also includes a sensor assembly disposed near the handle and configured to determine the insertion length of the intracavitary device in the sheath, thereby determining the position of the distal end of the shaft.

[0058] In some embodiments, the system also includes a processor; and a non-transitory computer-readable medium having instructions thereon that, when executed by the processor, cause the system to determine an insertion length of the intracavitary device within the sheath, and determine a position of the distal end of the shaft based at least in part on the insertion length of the intracavitary device within the sheath and a predetermined geometry of the shaft.

[0059] In some embodiments, the sheath includes a navigation sensor proximate the distal end of the catheter.

[0060] In some embodiments, the distal portion of the catheter includes a bend and the distal portion of the shaft includes a pre-formed bend.

[0061] In some embodiments, the distal portion of the catheter is deflectable.

[0062] In some embodiments, the distal portion of the shaft is devoid of navigation sensors.

[0063] In some embodiments, a system includes a transseptal puncture kit comprising a sheath and an intraluminal device.

[0064] In some embodiments, the intraluminal device comprises a transseptal needle.

[0065] In some embodiments, the intraluminal device comprises a dilator.

[0066] In some embodiments, the shaft of the intraluminal device is non-deflectable.

[0067] In some embodiments, the intraluminal device includes an identification mark, and the handle includes an identification circuit configured to determine the predetermined geometry of the shaft based at least in part on the identification mark.

[0068] In some embodiments, the identification tag includes a radio frequency identification (RFID) circuit.

[0069] In some embodiments, the sensor assembly includes a sensor array located within a handle of the sheath and sensor markers disposed on a proximal portion of a shaft of the intracavitary device, the sensor array being configured to determine a position of the sensor markers within the handle, thereby determining a position of a distal end of the shaft.

[0070] In some embodiments, the sensor array comprises a length approximately equal to the length of a distal portion of the shaft that is distal to a distal end of the catheter of the sheath when the intraluminal device is fully inserted distally into the sheath.

[0071] In some embodiments, the sensor label comprises a ferromagnetic material and the sensor array comprises a plurality of magnetic sensors.

[0072] In some embodiments, the sensor array includes a plurality of sensors arranged linearly along the longitudinal axis and adjacent to a lumen within the handle configured to receive a shaft of an intraluminal device.

[0073] In some embodiments, the system also includes a processor; and a non-transitory computer-readable medium having instructions thereon that, when executed by the processor, cause the system to determine a position of a sensor marker within the handle based at least in part on electrical signals from the sensor array, and to determine a position of a distal end of an axis of the intracavitary device based at least in part on the electrical signals from the sensor array and a predetermined geometry of the axis.

[0074] In some embodiments, the computer readable medium includes instructions that, when executed by a processor, cause the system to determine a position of a distal end of the endoluminal device within the body of a patient.

[0075] In some embodiments, the computer readable medium includes instructions that, when executed by a processor, cause the system to determine a position of a distal end of the endoluminal device within a patient's heart.

[0076] In some embodiments, the computer readable medium includes instructions that, when executed by the processor, cause the system to determine a position of a distal end of the endoluminal device relative to a fossa ovalis within the patient's heart.

[0077] In some embodiments, the computer readable medium includes instructions that, when executed by the processor, cause the system to determine a position of a navigation sensor disposed on a distal portion of the catheter and a position of a distal end of the intraluminal device relative to the navigation sensor.

[0078] In some embodiments, the computer-readable medium includes instructions that, when executed by the processor, cause the system to determine a predetermined geometry of the shaft based at least in part on identification markings on the intraluminal device.

[0079] In some embodiments, a system includes a processor; and a non-transitory computer-readable medium having instructions thereon that, when executed by the processor, cause the system to determine an insertion length of an axis of an intracavitary device within a sheath, the axis comprising a predetermined geometry, the sheath comprising a handle and a catheter extending distally from the handle, and determine a position of a distal end of the axis based at least in part on the insertion length of the intracavitary device within the sheath and the predetermined geometry of the axis.

[0080] In some embodiments, the computer readable medium includes instructions that, when executed by a processor, cause the system to determine a position of a navigation sensor disposed on a distal portion of the catheter; and determine a position of a distal end of the intracavitary device relative to the navigation sensor.

[0081] In some embodiments, the computer-readable medium includes instructions that, when executed by a processor, cause the system to determine a position of a distal portion of the catheter within the patient's body and a position of a distal end of the shaft within the patient's body based at least in part on the position of the distal portion of the catheter, an insertion length of the intracavitary device, and a predetermined geometry of the shaft.

[0082] In some embodiments, the computer-readable medium includes instructions that, when executed by the processor, cause the system to provide a display output that includes a graphical representation of the position of the distal end of the shaft within the body.

[0083] In some embodiments, the computer readable medium includes instructions that, when executed by a processor, cause the system to determine a position of a distal end of the endoluminal device within a patient's heart.

[0084] In some embodiments, the computer readable medium includes instructions that, when executed by the processor, cause the system to determine a position of a distal end of the endoluminal device relative to a fossa ovalis within the patient's heart.

[0085] In some embodiments, the computer readable medium includes instructions that, when executed by the processor, cause the system to determine an insertion length of the intraluminal device within the sheath based at least in part on electrical signals from a sensor array within the handle.

[0086] In some embodiments, a method for visualizing a distal end of an intraluminal device includes determining a position of a distal portion of a sheath within a patient's body, and determining an insertion length of a shaft configured with a predetermined geometry within the sheath. The method also includes determining a position of the distal end of the shaft within the patient's body based at least in part on the insertion length of the shaft within the sheath, the predetermined geometry of the shaft, and the position of the distal portion of the sheath, and providing a graphical representation of the position of the distal end of the shaft within the patient's body.

[0087] In some embodiments, the device for determining position includes a first conductive member and a second conductive member disposed along a pathway, a third conductive member disposed on a proximal portion of the intracavitary device and configured to contact the first conductive member and the second conductive member to form a completed circuit when the proximal portion moves along the pathway, and a circuit detector configured to detect the completed circuit.

[0088] In some embodiments, the third conductive member comprises a ring electrode disposed on a proximal portion of the intraluminal device.

[0089] In some embodiments, the system further includes an impedance sensor configured to measure the impedance of the completed circuit.

[0090] In some embodiments, the device for determining position includes a first array of first conductive members and a second array of second conductive members disposed along a pathway, a third array of third conductive members disposed on a proximal portion of the intracavitary device (each third conductive member being configured to contact a corresponding pair of first conductors and second conductors to form a corresponding completed circuit when the proximal portion moves along the pathway), and a circuit detector configured to detect the corresponding completed circuit.

[0091] In some embodiments, the system further includes an impedance sensor to measure the impedance of the corresponding completed circuit.

[0092] In some embodiments, the proximal portion of the endoluminal device includes a visual indicia disposed between adjacent third conductive members on an outer surface of the endoluminal device.

[0093] In some embodiments, the visual indicia includes alphanumeric symbols.

[0094] In some embodiments, the visual cue includes color.

[0095] In some embodiments, a system for visualizing an intraluminal device includes a lumen-bearing device having a first predetermined geometry and including a first proximal portion and a first distal portion, and an intraluminal device having a second predetermined geometry, the intraluminal device including a second proximal portion and a second distal portion, the second proximal portion and the second distal portion being configured to extend distally through the lumen of the lumen-bearing device. The system also includes a processor, a display; and a non-transitory computer-readable medium having instructions thereon that, when executed by the processor, cause the display to provide visualization representing the first distal portion using a graphical element representing an exposed portion of the second distal portion extending distally from the distal end of the first distal portion.

[0096] In some embodiments, the graphical element comprises a circle having a diameter based on the length of the exposed distal portion.

[0097] In some embodiments, as the exposed distal portion translates along the pathway, the diameter changes in real time based on the length of the exposed distal portion.

[0098] In some embodiments, the intraluminal device comprises a dilator and the intraluminal device comprises a guidewire.

[0099] In some embodiments, the system further comprises an introducer sheath and a position sensing assembly. The introducer sheath comprises a control handle and a sheath, the sheath comprising a third proximal portion and a third distal portion, the sheath being configured with an inner cavity through which the device with the inner cavity extends. The position sensing assembly is configured to determine the position of the first distal portion of the device with the inner cavity relative to the third distal portion of the introducer sheath based on the position of the first proximal portion of the device with the inner cavity relative to the third proximal portion of the introducer sheath.

[0100] In some embodiments, the system further comprises an introducer sheath and a position sensing assembly. The introducer sheath comprises a control handle and a sheath, the sheath comprising a third proximal portion and a third distal portion, the sheath being configured with an inner cavity through which the device with the inner cavity extends. The position sensing assembly is configured to determine the position of the second distal portion of the intraluminal device relative to the third distal portion of the introducer sheath based on the position of the second proximal portion of the intraluminal device relative to the third proximal portion of the introducer sheath. BRIEF DESCRIPTION OF THE DRAWINGS

[0101] These and other features and advantages of the present invention will be better understood by referring to the following detailed description when considered in conjunction with the accompanying drawings. It should be understood that selected structures and features are not shown in certain drawings in order to provide a better view of the remaining structures and features.

[0102] Figure 1A is a top view of an introducer sheath system having position sensing and at least one intraluminal device extending therethrough, according to an embodiment.

[0103] Figure 1B is a first intraluminal device having a distally advanced Figure 1A A top view of an introducer sheath system of the present invention, wherein the first intraluminal device has an exposed distal end.

[0104] Figure 1C The invention is a method of providing a first intracavitary device and a second intracavitary device which are advanced distally. Figure 1B A top view of an introducer sheath system, wherein the first intraluminal device and the second intraluminal device both have exposed distal ends.

[0105] Figure 1D yes Figure 1C A side cross-sectional view of the distal end of when deflected.

[0106] Figure 1E is a cross-sectional view of a distal end of a first intraluminal device at an approximation distance AD1 (in solid lines) and a deployment distance DD1 (in dashed lines) relative to an introducer sheath, according to an embodiment.

[0107] Figure 1Fis a cross-sectional view of a distal end of a second intraluminal device at an approximation distance AD2 (in solid lines) and a deployment distance DD2 (in dashed lines) relative to a first intraluminal device, according to an embodiment.

[0108] Figure 1G is a side cross-sectional view of a proximal portion of a second intraluminal device coextensive with a proximal portion of a first intraluminal device extending through an introducer sheath, according to an embodiment.

[0109] Figure 2A is a perspective view of an introducer sheath control handle partially cut away to show a passageway aligned with a sensor, the passageway being configured to receive a first intracavitary device carrying a transmitter and a second intracavitary device, according to an embodiment.

[0110] Figure 2B are co-extensive Figure 2A A perspective view of a first intracavitary device and a second intracavitary device.

[0111] Figure 3 is a schematic diagram of the relative configuration and geometry of an introducer sheath and first and second intraluminal devices according to an embodiment.

[0112] Figure 4A is an illustration of an introducer sheath system with advanced EP imaging, according to one embodiment.

[0113] Figure 4B is an example according to one embodiment Figure 4A A schematic block diagram of the operation of the system.

[0114] Figure 4C is an example according to another embodiment Figure 4A A schematic block diagram of the operation of the system.

[0115] Figure 5A , Figure 5B and Figure 5C is an end cross-sectional view of a first intracavitary device and a second intracavitary device having corresponding transmitters extending together through an introducer sheath having a sensor according to an embodiment; and corresponding voltages generated by the sensor in response to different rotation angles of the transmitters around the longitudinal axis of the intracavitary device.

[0116] Fig. 6A and Figure 6B is a side cross-sectional view of an intracavitary device having a magnetic transmitter in an opposing configuration with an introducer sheath having a sensor according to an embodiment; and corresponding voltages generated by the sensor in response to different longitudinal positions and orientations of the transmitter.

[0117] Fig. 7A and Figure 7Bis an end cross-sectional view of an intraluminal device having a ring transmitter extending through an introducer sheath having a sensor, the ring transmitter being at different rotational angles relative to the sensor.

[0118] Fig. 8A is a perspective view of an introducer sheath control handle partially cut away to show a passageway aligned with an optical sensor, the passageway being configured to receive an intracavitary device carrying an optical emitter, according to an embodiment.

[0119] Figure 8B yes Fig. 8A Perspective view of the intracavitary device.

[0120] Fig. 9 is a graph of photodiode voltage versus optically readable pattern element.

[0121] Fig.10 is a flow chart illustrating steps for position sensing an endoluminal device at a proximal portion of the endoluminal device to determine a position of a distal end thereof relative to an introducer sheath through which the endoluminal device extends, according to an embodiment.

[0122] Fig.11 is a flow chart illustrating steps for position sensing an endoluminal device at a proximal portion of the endoluminal device to determine a position of a distal end thereof relative to an introducer sheath through which the endoluminal device extends, according to another embodiment.

[0123] Fig.12 is a flow chart illustrating the steps of performing position sensing of one or more intraluminal devices at respective proximal portions of the intraluminal devices to determine the positions of their respective distal ends relative to an introducer sheath through which the one or more intraluminal devices extend, according to yet another embodiment.

[0124] Fig.13 is an illustration of an EP image displayed on a display monitor depicting a first intracavitary device and a second intracavitary device having their distal ends deployed through a distal end of an introducer sheath within a chamber of a patient's heart.

[0125] Fig.14A , Fig. 14B and Fig. 14C is a side cross-sectional view of an introducer sheath control handle and an intraluminal device distally advanced therethrough, the introducer sheath control handle and the intraluminal device each having conductive members configured to contact to complete an electrical circuit.

[0126] Fig.15A is formed by the first conductive member, the second conductive member and the third conductive member in contact Fig. 14C A schematic diagram of the completed circuit.

[0127] Fig. 15B Figure 14 Fig. 14B and Fig. 14C A graph of the linear displacement versus conductivity of a circuit.

[0128] Fig.16A , Fig. 16B and Fig. 16C is a side cross-sectional view of an introducer sheath control handle and an intraluminal device distally advanced therethrough, each having an array of conductive members configured to contact to form a respective completed electrical circuit.

[0129] Fig.17 yes Fig.16A A schematic diagram of an array of corresponding circuits, each circuit having a circuit sensor.

[0130] Fig.18 is a graph of linear displacement versus impedance.

[0131] Fig.19 is a schematic diagram of a circuit for measuring the impedance of a completed circuit formed by first, second, and third conductive members in contact.

[0132] Fig. 20A , Fig. 20C , Fig.20E , Figure 20G and Fig.20I is a side cross-sectional view of an endoluminal device as it is advanced distally through the lumen of the device penetrating the septum.

[0133] Fig. 20B , Fig.20D , Fig.20F , Fig. 20H and Fig. 20J yes Fig. 20A , Fig. 20C , Fig.20E , Figure 20G and Fig.20I A visualization of an endoluminal device and a device with an intraluminal lumen, wherein the graphical element represents an exposed distal portion of the endoluminal device distal to the distal end of the device with the intraluminal lumen. DETAILED DESCRIPTION

[0134] refer to Figure 1A , Figure 2A and Figure 3In some embodiments of the present invention, the guide sheath 10 includes an elongated flexible catheter or sheath 12, and a control handle 16 located proximal to the sheath 12. The sheath 12 is configured with an inner lumen 14 through which various intracavitary devices can be passed and guided through the patient's blood vessels to ultimately reach the chambers of the patient's heart. The control handle 16 has an electrical connector 17 at its proximal end for connecting to a remote control and processing system to transmit electrical signals for energizing components of the device and the guide sheath and / or receiving signals generated or detected by components of the intracavitary device and the guide sheath.

[0135] The lumen 14 of the sheath 12 is in communication with a longitudinal passage 18 disposed in the control handle 16. The passage 18 has a length L18 and is configured to receive an intraluminal device that can be passed from the passage 18 of the control handle 16 into the lumen 14 of the sheath 12. In some embodiments, the proximal end of the passage 18 is defined by a hemostatic valve 22 extending proximally from the proximal end of the control handle 16, wherein the passage into the proximal end of the passage 18 is a fluid-tight seal through the valve 22 that allows entry and passage of an intraluminal device without fluid leakage and air entering the valve 22. If there is an intraluminal lumen, a first (or external) intraluminal device 24 that is advanced through the passage 18 of the control handle 16 and further through the lumen 14 of the sheath 12 allows a second (or internal) intraluminal device 26 to pass through the lumen 25 of the first intraluminal device 24. It should be understood that any intraluminal device may include an end effector, such as a septal needle, an electrode assembly configured to map an organ, and / or an ablation electrode assembly.

[0136] In some embodiments, the first intracavitary device 24 is a catheter or dilator with an inner lumen, which is advanced into the patient's heart through the guide sheath 10; followed by a transseptal needle or guide wire as the second intracavitary device 26, which is advanced into the patient's heart through the inner lumen 25 of the catheter or dilator 24.

[0137] The guide sheath 10 including the sheath 12 and the control handle 16 has an overall length LT from the proximal end 16P of the control handle to the distal end of the sheath 12D. In some embodiments, for example, where the first intraluminal device 24 is a dilator, the device has a handle 27, a valve 23, and a shaft 28. The shaft 28 is configured for insertion into the guide sheath 10, while the handle 27 and the valve 23 are configured to be retained proximal to the control handle 16 of the guide sheath 10. The shaft 28 of the device 24 has a predetermined length LIN1 between the proximal end 28P and the distal end 28D, wherein the length LIN1 is greater than the length LT of the guide sheath 10 by at least a length DD1, so that when the first intraluminal device 24 is fully advanced within the guide sheath to be deployed at its distal end 28D (e.g., its handle 27 abuts the proximal end 16P of the control handle 16), the distal end 28D of the first intraluminal device 24 has an exposed length at DD1 that exceeds the distal end 12D of the guide sheath 10. The first intraluminal device 24 has an overall length L24 between the valve 23 and the distal end 28D.

[0138] The second intraluminal device 26 has an elongated body 31 of length LIN2 between the proximal end 26P and the distal end 26D, wherein the length LIN2 is greater than the overall length L24 of the first intraluminal device 24, such that when the second intraluminal device 26 is extended through the first intraluminal device 24 and its distal end 26D is deployed at a treatment site (e.g., septum) within the patient's heart, the body 31 has at least a distal exposed length DD2 distal to the distal end 28D of the first intraluminal device 24 (if not a proximal excess length LEX proximal to the valve 23 of the first intraluminal device 24). As a safety precaution, the distal exposed length DD2 of the second intraluminal device 26 may be limited by a stop 26S positioned to set a calibrated maximum advancement position of the second intraluminal device 26 relative to the first intraluminal device 24 and / or the introducer sheath 10, thereby minimizing the risk of inadvertent tissue puncture by the distal end 26D.

[0139] In typical use of these devices, reference Figure 1A , Figure 1B and Figure 1C, the electrophysiologist inserts the sheath 12 of the introducer sheath 10 into the femoral artery of the patient. The shaft 28 of the first intraluminal device 24 is inserted into the passage 18 of the control handle 16 through the hemostatic valve 22 and then further advanced distally into the lumen 14 of the introducer sheath 10. The first intraluminal device 24 is advanced distally relative to the introducer sheath 10 until the distal end 28D passes through the distal end 12D of the introducer sheath 10. When the distal end 28D is exposed, the first intraluminal device 24 is deployed and prepared for diagnostic use, therapeutic use and / or receiving the second intraluminal device 26. In the latter case, the second device 26 is advanced distally through the lumen 25 of the first intraluminal device 24 until the distal end 26D passes through the distal end 28D of the first intraluminal device 24. With the distal end 26D exposed, the second intraluminal device 26 is deployed and prepared for diagnostic use and / or therapeutic use.

[0140] During these approximation and deployment phases, as distal end 28D approaches distal end 12D ( Figure 1E ) and advance through it ( Figure 1F ), the user's interest in knowing the location of the first intraluminal device 24 is generally heightened. This heightened interest can continue at least as long as the distal end 28D is exposed to the exterior of the sheath 12. The calibrated maximum distal advancement of the first intraluminal device 24 relative to the sheath 12 can be limited by the device handle 27, which abuts against the hemostatic valve 22 or the proximal end 16P of the control handle 16 of the introducer sheath 10. Figure 1B Similarly, when the second intracavitary device 26 has been inserted into the first intracavitary device 24, when the distal end 26D approaches the distal end 28D of the shaft 28 of the first intracavitary device 24 (at Figure 1F solid line in the middle) and advance through it (in Figure 1F When the user's interest in knowing the location of the second intracavitary device 26 is generally increased when the distal end 26D is exposed outside the distal end 28D of the first intracavitary device 24. This provided interest can continue at least as long as the distal end 26D is exposed outside the distal end 28D of the first intracavitary device 24. Depending on the configuration of the proximal end of the second intracavitary device 26, the second intracavitary device can have a calibrated maximum distal end advancement relative to the first intracavitary device 24 and / or the guide sheath 10. For example, in the case where the first intracavitary device 24 is a dilator that is advanced through the guide sheath 10 and is subsequently advanced through the dilator as the second intracavitary device 26, the distal ends of the dilator and the transseptal needle are both narrower and / or more steeply tapered relative to the guide sheath, which may cause trauma and damage to the heart tissue if they are advanced too far distally and pass through the distal end 12D of the sheath 12. Therefore, the user is interested in tracking or monitoring the linear advancement and placement of distal ends 28D and 26D relative to distal end 12D of introducer sheath 10 in order to minimize the risk of injury to the patient, including the risk of any inadvertent puncture of cardiac tissue.

[0141] For one or more intraluminal devices to be visualized for a user on a display monitor, particularly with respect to their distal ends, in some embodiments, the introducer sheath system includes components of an advanced electrophysiology ("EP") imaging system S that supports components of a position sensing assembly 40 that is advantageously disposed on the respective proximal portions of each of the introducer sheath 10 and the intraluminal devices 24, 26. The position sensing assembly 40 provides signals generated by the proximal portions of the intraluminal devices 24, 26 and transmitted to the system S via the electrical connector 17 for processing by the system in determining the position (including location and orientation) of the distal ends of the intraluminal devices 24, 26 relative to the introducer sheath 10.

[0142] In some embodiments, reference Figure 4A and Figure 4B , the EP imaging system S includes a console 122, which may include an ablation power generator 125, a patient interface unit (PIU) 126, and one or more displays 127 and 128 for displaying 3-D maps and electrograms. The operation, functions, and actions of the EP imaging system S are managed by a system controller 100, which includes a processing unit 132, which is connected to a memory 134 in which software for the operation of the system is stored. In some embodiments, the system controller 100 is an industrial standard personal computer including a general-purpose computer processing unit. However, in some embodiments, at least some of the operations, functions, or actions of the controller are performed using custom-designed hardware and software (such as an application-specific integrated circuit (ASIC) or a field-programmable gate array (FPGA)). In some embodiments, the system controller is managed by an operator using a pointing device and a graphical user interface (GUI), which enables the operator to set parameters of the system. The GUI also typically displays the results of the procedure to the operator on a display. The software in the memory can be downloaded to the controller in electronic form, such as over a network. Alternatively or additionally, the software may be provided on non-transitory tangible media, such as optical, magnetic or electronic storage media.

[0143] In some embodiments, the memory 134 includes a plurality of modules used by the processing unit 132, such as a force sensing module 151, a temperature sensing module 152, a 3-D mapping module 153, an ablation module 154, and an irrigation module 155, the functions of which are known in the art, such as respectively used to measure tissue temperature, determine the position of components within the patient using an electromagnetic navigation / position sensor responsive to an external magnetic field generator positioned outside the patient's body (e.g., under the patient's bed), stimulate electrodes to ablate tissue, and control the flow of irrigation fluid to the treatment site. Also included in the memory 134 is a position sensing module 160 that supports position sensing components and position sensing methods used by the processing unit 132.

[0144] In some embodiments, reference Figure 1A , Figure 2A and Figure 2B , the components of the position sensing assembly 40 include at least a transmitter 42A advantageously located on a proximal portion of the first intracavitary device 24 and at least one sensor 44 affixed along the passageway 18 or otherwise located in the control handle 16 of the introducer sheath 10, such that the transmitter 42A and the sensor 44 may interact with each other as the first intracavitary device moves through the passageway 18. For example, when the transmitter 42A carried on the first intracavitary device 24 moves into sensing proximity with the sensor 44, the sensor generates a signal in response to the presence and / or movement of the transmitter 42A relative thereto, wherein such generated signal is indicative of at least the position (linear and / or rotational) of the proximal portion of the first intracavitary device 24 relative to the control handle 16, if not representative of the position (linear and / or rotational) of the distal end 28D of the first intracavitary device 24 due to its predetermined configuration and geometry.

[0145] In some embodiments, reference Figure 1A and Figure 2A and Figure 2B , the components of the position sensing assembly 40 also include at least one transmitter 42B advantageously located on the proximal portion of the second intraluminal device 26, such that the transmitter 42B and the sensor 44 can interact with each other as the second intraluminal device moves through the lumen 25 of the first intraluminal device 24. For example, when the transmitter 42B carried on the second intraluminal device 26 moves into sensing proximity with the sensor 44, the sensor generates a signal in response to the presence and / or movement of the transmitter 42B relative thereto, wherein such generated signal is indicative of at least the position (linear and / or rotational) of the proximal portion of the second intraluminal device 26 relative to the control handle, if not representative of the position (linear and / or rotational) of the distal end 26D of the second intraluminal device 26 due to the predetermined configuration and geometry of the intraluminal device 26 and the introducer sheath 10.

[0146] It should be appreciated that each of the first and second intraluminal devices 24 and 26 have respective predetermined configurations and geometries such that the spatial relationship between their respective distal ends and proximal portions is known and generally remains predictable, regardless of whether the devices are configured for unidirectional or bidirectional deflection (see Figure 1D The configuration and geometry of the first and second intraluminal devices and the introducer sheath for use with the system are stored in the configuration and geometry subroutine 156 of the memory 134 ( Figure 4B ). Thus, the system can utilize the signals generated by the sensor in response to the transmitter in the proximal portion of each of the first and second intracavitary devices to reliably determine the position (position and orientation) of the respective distal ends of these devices relative to the introducer sheath.

[0147] In some embodiments, reference Figure 1A and Figure 2A , wherein a plurality of sensors 44 are located in the passage 18 of the control handle 16 of the guide sheath, the sensors 44 are linearly arranged and evenly spaced to form an N by 1 sensor array 46, the N by 1 sensor array having a length L46 extending along the passage 18 parallel to the longitudinal axis 48 of the control handle 16. The length L46 can be substantially equal to the length L18 of the passage, so L18 and L46 can be used interchangeably herein. N can range between 1 and 10, and is preferably 6 in some embodiments.

[0148] like Figure 3 As shown, one or more transmitters 42A of the first intracavitary device 24 are supported on a proximal portion of the shaft 28, which proximal portion is coextensive with the passageway 18 at a position adjacent to the sensor 44 of the array 46 when the first intracavitary device 24 has been sufficiently advanced into the introducer sheath 10 to be deployed past the distal end 12D of the introducer sheath 10. One or more transmitters 42B of the second intracavitary device 26 are supported on a proximal portion of the elongated body 31 of the device 26, which extends through the lumen 25 of the shaft 28 and is coextensive with the passageway 18 when the second intracavitary device 26 has been sufficiently advanced into the first intracavitary device 24 to be deployed past the distal end 28D of the first intracavitary device 24.

[0149] The approach distance AD ​​of the endoluminal device is defined herein as a predetermined distance within which the user's interest increases as the distal tip of the endoluminal device approaches the distal end of the guide sheath (or first or external endoluminal device) distally. The exposed (or deployed) length DD of the endoluminal device is defined herein as a predetermined maximum distance that the user allows the distal end of the endoluminal device to extend beyond the distal end of the guide sheath (or first or external endoluminal device).

[0150] In an embodiment where the length L46 of the sensor array 46 is less than (i) the exposed length DD1 of the first intracavitary device 24 or (ii) the exposed length DD2 of the second intracavitary device 26, the respective intracavitary devices 24, 26 may be configured to carry a plurality of transmitters dispersed along the respective proximal portions a distance equal to or greater than the length L45 to compensate for the insufficient length of the sensor array L46 relative to the larger exposed lengths DD1 and / or DD2, the separation distance between each transmitter being at least partially dependent on the length L46 of the sensor array.

[0151] In some embodiments, the length L46 of the sensor array 46 in the control handle 16 of the introducer sheath 10 is greater than each of: (i) the proximity distance AD1 of the first intracavitary device 24 and the proximity distance AD2 of the second intracavitary device 26, such as Figure 3 and (ii) the deployment distance DD1 of the first intracavitary device 24 and the deployment distance DD2 of the second intracavitary device 26, as shown in FIG. Figure 3 As shown in , each intracavity device may carry a single transmitter, since scaling is not required. However, it should be understood that the intracavity devices are not limited to carrying a single transmitter, and each intracavity device may carry multiple transmitters, if appropriate or necessary.

[0152] In order for the system to perform finer detection and higher position sensing resolution, it should be understood that the N sensors 44 in the array 46 and / or the separation distance between adjacent sensors 44 can be changed as needed or appropriate. In some embodiments, the separation distance between adjacent sensor members 44 in the array 46 is equal to or less than the smaller of the approach distances AD1, AD2. In some embodiments, the separation distance is equal to or less than the smaller of the deployment distances DD1, DD2. In some embodiments, the separation distance is equal to or less than the smaller of the approach distances AD1, AD2 and the deployment distances DD1, DD2.

[0153] In some embodiments, the separation distance between adjacent sensors 44 is less than the distance or field of detection of sensors 44, such that the detection fields of two adjacent sensors include an overlap, and thus an emitter is detected by at least one sensor at any given time the emitter is within the detection of sensor array 46.

[0154] As described herein, as the endoluminal devices move along the pathway of the control handle, the linear movement and position of the external endoluminal device and the internal endoluminal device relative to the control handle of the introducer sheath can be detected and determined through the interaction between the transmitters 42A, 42B and the sensor array 46. In some embodiments, the transmitters can include magnetic field generating members, such as permanent or temporary magnets, and the sensors include magnetic field sensors, such as Hall sensors or coil-based sensors.

[0155] In embodiments where the transmitters 42A, 42B are magnetic rings carried circumferentially on the outer surface of the endoluminal device and are magnetically radially symmetric about the longitudinal axis of the endoluminal device, the rings may not be sufficient to provide information about the rotational position (movement or displacement, used interchangeably herein) of the endoluminal device to the sensor array along the pathway. Figure 5A , Figure 5B and Figure 5C As shown, in order to detect and determine the rotational movement and position of the intracavitary devices 24, 26 about their longitudinal axis Z, additional magnetic field generating members 42A and 44B are located on the intracavitary devices 24, 26 at locations offset from the Z axis, respectively, and are configured in the form of off-axis tabs for interacting with orthogonal (or offset angles greater than or less than 90 degrees) sensors 44x and 44y for detecting and determining "rolling" movement and position. Sensors 44x and 44y are located at the same axial position (same x / y plane) along the longitudinal axis Z of the control handle 16, but at different angular positions with respect to the longitudinal axis Z. When each of the intracavitary devices 24 and 26 rotates about the Z axis relative to sensor 44x (along the x-axis) and sensor 44y (along the y-axis) or otherwise assumes different radial angles, different and distinguishable signals are generated in response to the different angular positions of each member 42A, 42B relative to each orthogonal sensor. Thus, the orthogonal (or offset angle) sensors 44x, 44y can provide signals representing the rotational movement and displacement of each intracavitary device in the x / y plane. In embodiments where pairs or groups of sensors 44x and 44y are located at different axial locations along the z-axis, multiple sensors 44x extending in the z-axis direction can form a sensor array 46x, and multiple sensors 44y extending in the z-axis direction can form a sensor array 46y, wherein these arrays can generate signals representing the linear and rotational movement and position of each intracavitary device as they are advanced through the introducer sheath 10.

[0156] In some embodiments, reference Fig. 6A and Figure 6B, the passage 18 of the control handle 16 has a single linear array 46 having a proximal sensor 44P and a distal sensor 44D. An intracavitary device 24 having a proximal magnetic field transmitter 42P and a distal magnetic field transmitter 42D extends therethrough, the proximal magnetic field transmitter and the distal magnetic field transmitter being configured so that their respective magnetic dipoles or magnetic fields are orthogonal to each other. For example, as depicted, the proximal transmitter 42P generates magnetic field lines perpendicular to the longitudinal axis Z of the intracavitary device 24, while the distal transmitter 42D generates magnetic field lines parallel to the longitudinal axis Z. The transmitters 42P, 42D may be embedded in the shaft of the intracavitary device. In some embodiments, the distal transmitter 42P is configured so that its magnetic field lines are parallel to the longitudinal axis Z, and when moving distally past the sensor, the magnetic field lines produce a varying voltage of 0.0V to 3.0V in the sensor, and when moving proximally past the sensor, a varying voltage of 3.0V to 0.0V is produced. Thus, the signal generated by the distal sensor 44D can represent the linear position or movement and the direction of movement of the intracavitary device 20. In some embodiments, the proximal transmitter 42D is configured such that its magnetic field lines are orthogonal to the longitudinal axis Z, and the magnetic field lines produce a changing voltage of 0.0V to 3.0V when the intracavitary device 24 is rotated 180 degrees about its longitudinal axis relative to the sensor. Thus, the signal generated by the proximal sensor 44P can represent the rotational position or movement of the intracavitary device 20. The total voltage reading between 0.0V and 6.0V represents the degree of linear and rotational position and movement.

[0157] In some embodiments, reference Fig. 7A and Figure 7B , the passage 18 of the control handle 16 has two orthogonal (or offset angle) arrays of sensors 46x and 46y, and the endocavity device 20 extending through the passage has a radially magnetized member (or annular magnet) 42, whose magnetic field lines are radially opposite to the endocavity device 20 or perpendicular to the longitudinal axis of the endocavity device 20. The transmitter member 42 is configured to produce voltage changes in the sensors of the two arrays, wherein pure linear movement of the endocavity device 20 without rotational movement produces substantially the same response signal between each sensor 46x of the orthogonal array, and produces substantially the same response signal between each sensor 46y of the orthogonal array, and pure rotational movement of the endocavity device 20 without linear movement produces a response signal only in the orthogonal pair 46x and 46y in the same axial position. The combination of linear and rotational movement in the endocavity device 20 produces a response signal in the sensors of the two arrays that represents the combined movement.

[0158] In some embodiments, reference Fig. 8A and Figure 8B, components of the position sensing assembly 240 include an optical sensor 252 and an optical emitter (or sensor marker), including, for example, an optically detectable pattern 254, whose optical emission is detected by the optical sensor 252 when illuminated by the light source 250. The light source 250 and the optical sensor 252 may form an optical unit in the control handle 16. The optically detectable pattern 254 is disposed on the proximal portion 220P of the endoluminal device 220, and the light source 250 and the optical sensor 252 are positioned along the passage 218 of the control handle 216 of the introducer sheath 210 that receives the endoluminal device 220. The optical sensor 252 generates a signal in response to the presence, movement, and location of the illuminated optically detectable pattern 254, wherein such generated signal represents the displacement and position (linear and / or rotational) of the proximal portion 220P of the endoluminal device 220 relative to the control handle 16, if not also the displacement and position of the distal portion of the endoluminal device relative to the control handle 16.

[0159] In some embodiments, a plurality of optical units are provided to form a linear optical array extending longitudinally along the passage 18. In some embodiments, two optical arrays 246a and 246b are provided, diametrically opposed to each other along the passage 18, to minimize interference between optical illumination and sensing between the two arrays.

[0160] like Figure 8B As shown, the optically detectable pattern may include at least two different patterns 254a and 254b disposed at different or relative locations on the surface of the intracavitary device 220, such that the signal generated by the optical sensor 252 in response to the two different patterns may indicate an angular rotation of the intracavitary device 220 about its longitudinal axis. The optically detectable pattern may also be unique to a single intracavitary device, such that each intracavitary device may be identified and limited to a single-use device.

[0161] In some embodiments, one or more of the intraluminal devices 24, 26 include identification markings 170, and the control handle 16 of the introducer sheath 10 includes identification circuitry 172, such as Figure 2A As shown. The identification circuit 172 is configured to determine or identify the predetermined configuration and geometry of the intracavitary device based at least in part on the identification tag 170, which may include a radio frequency identification (RFID) circuit. The identification tag 170 can be fixed to the proximal portion of each intracavitary device so that it is read by the identification circuit 172 positioned along the passage 18 of the control handle 16 when it is inserted into the control handle or shortly thereafter. In some embodiments, the identification tag 170 can be read by a scanning unit 176, which is separate from or in addition to the identification circuit 172 in the control handle 16 and is in communication with the ID subroutine 159 of the position sensing module 160 ( Figure 4B ).

[0162] In some embodiments, light source 250 comprises an LED, optical sensor 252 comprises a photodiode, and optically detectable pattern 254 as an optical emitter comprises a bar code or binary alternating symbol at multiple axis locations on a circumference on the surface of intracavitary device 220. It should be understood that the optically detectable pattern as an optical emitter, which typically comprises discrete indicia of dark and light tones, reflects light energy in a corresponding pattern that is detected by an optical detector whose output voltage increases with higher reflected light energy and decreases with lower reflected light energy, as shown in FIG. Fig. 9 The position sensing assembly 240 may include a plurality of light sources 250 and a plurality of optical detectors 252 arranged in pairs, with each pair of optical emitters and optical sensors located at a different position along the passage 18. It should be understood that the parameters of the configuration of the position sensing assembly 240 depend on a variety of factors, including the size of the illumination field of each emitter, the length of the optically detectable pattern, the acceptable degree of uncertainty in the precise positioning of the intracavitary device relative to the introducer sheath, etc.

[0163] It is important to emphasize that all components of the position sensing assembly are within the confines of the control handle of the guide sheath, and for improved patient safety, outside the patient's heart, if not outside the patient's body. In addition, the electrical connections to and from the electromagnetic sensor do not extend distally beyond the control handle. That is, the electrical connector (such as a lead) used to transmit the signal representing the position of the distal end of either the first intracavitary device or the second intracavitary device no longer needs to pass through the entire length of the shaft of these instruments, which significantly saves the manual labor required for the construction and assembly of these instruments, not to mention the space saved in the distal end, which would otherwise be occupied by a conventional electromagnetic position sensor using an x / y / z coil.

[0164] It should be understood that the means for determining position, including means for determining the position of a distal portion of an intracavitary device, are shown and described in one of many examples associated with magnetic field transmitters and magnetic field sensors, including, for example, Figure 2A and Figure 2B The magnet and Hall effect sensor shown in FIG. 1 and the optical sensor and optical emitter illuminated by a light source are shown and described in one of many examples, including for example Fig. 8A and Figure 8B The photodiode, optically readable pattern and LED shown in FIG. It should also be understood that determining position can include determining length, and thus the means for determining position can be used interchangeably with the means for determining length as needed or appropriate. It should also be understood that the means for determining position includes a conductive member configured to complete an electrical circuit and a sensor for detecting the completed electrical circuit and a sensor for measuring impedance, as discussed further below.

[0165] It should also be understood that the position sensing assembly is not limited to only electromagnetic components or optical components, and both types of components may be combined and used together as needed or desired.

[0166] refer to Fig.13 , the operator has already passed such as 3 system's advanced electrophysiology (EP) imaging system S acquires a 3D map of the patient's body including the patient's heart. The displayed image generated by system S includes not only the 3D map of the patient's heart, but also a depiction of a first (or external) intracavitary device 24 (e.g., a dilator) and a second (or internal) intracavitary device 26 (e.g., a transseptal needle), particularly their respective distal ends.

[0167] In obtaining this image of the first and second intraluminal devices according to some embodiments, the user takes the following actions, including the user inputting various user-selectable parameters of the procedure into the system S using a pointing device and a graphical user interface, including the selection of an introducer sheath and the first and second intraluminal devices to be used in the procedure. The geometries and configurations of the introducer sheath 10 and intraluminal devices (including the selected first and second intraluminal devices 24, 26) suitable for use with the system S have been stored in the configuration and geometry subroutine 156 of the memory 134 ( Figure 4B The configuration and geometry provide for predictable and reliable determination of the positioning, location and / or orientation of the distal portion of the endoluminal device based on the positioning, position and / or orientation of the proximal portion of the endoluminal device relative to the control handle of the introducer sheath through which the endoluminal device extends. Figure 3 , the parameters stored in the configuration and geometry subroutine 156 may include, for example, the following:

[0168] Table 1

[0169]

[0170]

[0171] In the event that an introducer sheath and first and second intraluminal devices are used in a procedure identified by the user, the system may retrieve relevant parameters from the configuration and geometry subroutine 156 for the position sensing module 160 to use and apply, including the parameters listed above.

[0172] In some embodiments of the systems, devices, and related methods, reference Fig.10In box 502, the position of the distal portion of the guide sheath within the patient's body is determined, for example, by the mapping module 153. In box 504, the insertion length of the shaft of the intracavitary device having a predetermined geometry within the sheath is determined. In box 506, the position of the distal end of the shaft within the patient's body is determined based at least in part on the insertion length of the shaft within the sheath. In box 508, a graphical representation of the position of the distal end of the shaft within the patient's body is provided.

[0173] In some embodiments of methods related to systems and devices, reference is made to Fig.11 . The flowchart begins at box 300. In box 302, parameters of the configuration and geometry of the guide sheath and the intracavitary device are determined and stored in a configuration / geometry subroutine in the memory of the EP imaging system S. In box 304, the guide sheath is inserted into the patient. In box 304, the intracavitary device is inserted into the guide sheath. In box 306, the intracavitary device is advanced relative to the guide sheath while a transmitter on the intracavitary device moves toward a sensor located in a control handle of the guide sheath. In box 308, the sensor senses the transmitter and generates a signal in response to the transmitter. In box 310, the position sensing module accesses the parameters and determines the position of the distal end of the intracavitary device based on the signal. In box 312, the EP imaging system S displays the position of the distal end of the intracavitary device. It should be understood that the position may include positioning and orientation.

[0174] In some embodiments of methods related to systems and devices, reference is made to Fig.12. The flowchart begins at box 400. In box 402, the parameters of Table 1 are determined and stored in the configuration / geometry subroutine of the memory 134. In box 404, the user inserts the guide sheath 10 into the patient's vascular system (e.g., the femoral artery) and fixes the position of the guide sheath 10 to be in a fixed relationship with the patient. In box 406, the EP imaging system S determines the position of the distal end 12D of the guide sheath by, for example, an electromagnetic navigation sensor known in the art. In box 408, the user inserts the first intracavitary device 24 into the lumen 14 of the guide sheath 10 via the hemostatic valve 22. In box 410, the user advances the device 24 distally toward the distal end 12D of the guide sheath 10. In box 412, when the distal transmitter 42A1 on the shaft 28 of the first intracavitary device 24 approaches the sensor 44 in the control handle 16 of the guide sheath, the sensor 44 senses the distal transmitter 42A1 and generates a signal in response to the transmitter 42A1. In block 414, the position sensing module 160 monitors the signal for an event, such as a peak value (calibrated maximum value) or a specific characteristic, as representative of the distal transmitter 42A1 being closest to the sensor 44 in side-by-side alignment along the longitudinal axis of the control handle 16. In block 416, the position sensing module 160 accesses parameters stored in the configuration and geometry subroutine 156 based on the signal event. Because the first intracavitary device 24 has a predetermined geometry, for example, including the position LM1 of the distal transmitter 42A1 on the shaft 28 relative to the distal end 28D being equal to the length LS1 (i.e., the distance between the sensor 44 and the distal end 12D of the introducer sheath) minus the approach distance AD1, when the sensor 44 and the distal transmitter 42A1 are closest in side-by-side alignment, the signal generated by the sensor 44 advantageously indicates the relative position between the device 24 and the introducer sheath 10, including that the distal end 28D of the first intracavitary device 24 has reached the approach distance AD1 of the distal end 12D of the introducer sheath. At decision box 418, an inquiry is made as to whether the event indicates or is related to the distal end 28D reaching the proximity distance AD1. If the sensor 44 generates a signal (or peak signal) in response to the distal transmitter 42A1, the answer to the inquiry is yes, and the flowchart continues to box 420, which activates an indicator, such as a visual alarm 160 and / or an audio alarm 162, to notify the user that the distal end 28D has reached the proximity distance AD1 and that the distal end 28D may soon protrude from the distal end 12D of the sheath 12 before continuing to box 422. The indicator may automatically terminate after a predetermined duration or remain active until deactivated by the user.If the sensor 44 does not generate a signal (or peak signal) in response to the distal transmitter 42A1, the answer to the query of block 418 is no, and the flowchart continues to block 422, where the processing unit 132 displays (or continues to display) the distal end 28D on the display monitor in real time relative to the distal end 12D of the introducer sheath displayed on the display monitor within the patient's heart based on the parameters of the configuration and geometry of the first intracavitary device 24. In this way, the determined position and display of the distal end 28D of the intracavitary device 24 is advantageously based on the signal generated by the proximal end of the first intracavitary device 24.

[0175] At decision box 424, an inquiry is made as to whether the first intracavitary device 24 continues to be advanced distally relative to the guide sheath 10. This determination can be made by, for example, evaluating the change in the signal sensed by the sensor 44 with reference to the parameters of the first intracavitary device 24. If yes, the flowchart returns to box 412. When the intermediate transmitter 42A2 of the first intracavitary device 24 approaches the sensor 44, the sensor 44 senses the intermediate transmitter 42A2 and generates a signal in response to the intermediate transmitter 42A2. In box 414, the positioning module 160 monitors the signal of the event, such as a peak value (calibrated maximum value) or a specific characteristic, as a representative of the intermediate transmitter 42A2 being aligned side by side with the sensor 44 along the longitudinal axis of the control handle 16 closest to the sensor. In box 416, the position sensing module 160 accesses the parameters stored in the configuration and geometry subroutine 156 of the first intracavitary device 24 and the intermediate transmitter 42A2 based on the signal event. Because the first intracavitary device 24 has a predetermined geometry, such as including the position of the intermediate transmitter 42A2 on the shaft 28 relative to the distal end 28D equal to the length LS1, when the sensor 44 and the intermediate transmitter 42A2 are closest to each other in a side-by-side alignment, the signal generated by the sensor advantageously indicates the relative position between the device 24 and the guide sheath 10, including the distal end 28D at the distal end 12D. Since the distal end 28D is not at the approach distance AD1 in frame 418 (but has actually moved past the approach distance AD1), the flowchart continues to frame 422, where the processing unit 132 continues to display the positioning of the distal end 28D relative to the distal end 12D of the guide sheath in the patient's heart on the display monitor in real time on the display monitor. In the same way, the determined position and display of the distal end 28D of the intracavitary device 24 are advantageously based on the signal generated by the proximal end of the first intracavitary device. At decision frame 424, an inquiry is made as to whether the first intracavitary device 24 continues to be advanced distally relative to the guide sheath 10. This determination may be made, for example, by evaluating a change in the signal sensed by the sensor 44 with reference to a parameter of the first intracavitary device 24 or by a user input that he is still advancing the first intracavitary device 24. If yes, the flowchart returns to block 412. Additionally or alternatively, the query of decision block 424 may include determining whether the distal end 28D is at the maximum deployed distance DD1 by accessing parameters stored in the configuration and geometry subroutine 146. If no, the flowchart returns to block 412.

[0176] The loop including blocks 412, 414, 416, 418, 420, 422, and 424 may be repeated for the proximal transmitter 42A3 on the first intracavitary device 24. In block 416, the position sensing module 160 accesses parameters stored in the configuration and geometry subroutine 156 of the first intracavitary device 24 and the proximal transmitter 42A3. Because the first intracavitary device 24 has a predetermined geometry, including, for example, a position of the proximal transmitter 42A3 on the shaft 28 relative to the distal end 28D equal to the length LS1 plus the calibrated maximum exposure distance DD1 of the distal end 28D of the first intracavitary device 24 distal to the distal end 12D of the control handle, the signal generated when the sensor 44 and the proximal transmitter 42A3 are in closest proximity in side-by-side alignment advantageously indicates the relative position between the device 24 and the introducer sheath 10, including the distal end 28D being at the calibrated maximum exposure length DD1 distal to the distal end 12D. Again, because the distal end 28D has been advanced past the approximation distance AD1, the flowchart continues to box 422. In box 422, the processing unit 132 continues to display in real time on the display monitor the positioning of the distal end 28D relative to the distal end 12D of the introducer sheath within the patient's heart on the display monitor, wherein the determined position and display of the distal end 28D is advantageously based on the signal generated by the proximal end of the first intracavitary device 24.

[0177] When the first intracavitary device is no longer advanced relative to the guide sheath, as determined by the change in the signal sensed by the sensor 44 with reference to the parameters of the first intracavitary device 24 evaluated by the position sensing module or by the user input that he is still no longer advancing the first intracavitary device 24, the decision box 424 continues to the decision box 426, asking whether to insert another intracavitary device. This determination can be based on the user input. If yes, the flowchart returns to the box 410, wherein the second intracavitary device 26 is inserted into the first intracavitary device 24 via the valve 23 and is advanced distally toward the distal end 28D of the first intracavitary device 24. In box 412, when the distal transmitter 42B1 on the elongated body 31 of the second intracavitary device 26 approaches the sensor 44 in the control handle of the guide sheath, the sensor 44 sensing the transmitter 42B1 generates a signal in response to the transmitter 42B1. In box 414, the position sensing module 160 monitors the signal for an event, such as a peak value (calibrated maximum value) or a specific characteristic, as representative of the closest sensor 44 and distal transmitter 42B1 aligned side by side along the longitudinal axis of the control handle 16. In box 416, the position sensing module 160 accesses parameters stored in the configuration and geometry subroutine 156 based on the signal event. Because the second intracavitary device 26 has a predetermined geometry, such as including a position LE1 of the distal transmitter 42B1 on the elongated body 31 relative to the distal end 26D equal to the length LS1 plus the calibrated maximum exposure distance DD1 of the first intracavitary device 24 minus the proximity distance AD2, the generated signal advantageously indicates the relative position between the device 24 and the introducer sheath 10, including the distal end 26D of the second intracavitary device 26 being at the proximity distance AD2 of the distal end 28D of the first intracavitary device 24. In this manner, the determined position and display of the distal end 26D of the second intraluminal device 26 is advantageously based on the signal generated by the proximal end of the second intraluminal device 26 .

[0178] In decision block 418, processing unit 132 activates an indicator (e.g., audio alarm 162 or visual alarm 164) in response to a signal representing that distal end 26D is at proximity distance AD2 of distal end 28D to notify the user that distal end 26D has reached proximity distance AD2 and that distal end 26D may soon protrude from distal end 28D of first intracavitary device 24. In block 422, processing unit 132 begins to display the position of distal end 26D in real time on display monitor 127 based on the parameters of the configuration and geometry of second intracavitary device 26 relative to distal end 28D and distal end 12D displayed on the display monitor within the patient's heart.

[0179] In decision block 424, if the user continues to advance the second intraluminal device 26 distally relative to the introducer sheath 10, the flowchart returns to block 412. The loop including blocks 412, 414, 416, 418, 422, and 424 may be repeated for the intermediate transmitter 42B2 and the proximal transmitter 42B3. For the intermediate transmitter 42B2, in block 414, the position sensing module 160 monitors the signal for an event, such as a peak value (calibrated maximum value) or a specific characteristic, as representative of the closest proximity of the sensor 44 and the intermediate transmitter 42B2 in side-by-side alignment along the longitudinal axis of the control handle 16. In block 416, the position sensing module 160 accesses parameters stored in the configuration and geometry subroutine 156 based on the signal event. Because the second intracavitary device 26 has a predetermined geometry, including the position of the intermediate emitter 42B2 on the elongated body 31 relative to the distal end 26D equal to the length LS1 plus the calibrated maximum exposed length DD1 of the first intracavitary device 24, the signal generated when the sensor 44 and the intermediate emitter 42B2 are aligned in closest proximity side by side advantageously indicates the relative position between the device 24 and the introducer sheath 10, including that the distal end 26D has reached the distal end 28D. In block 422, the processing unit 132 continues to display in real time on the display monitor the positioning of the distal end 26D of the second intracavitary device 26 relative to the distal end 28D of the first intracavitary device 24 and the distal end 12D of the introducer sheath 10 within the patient's heart on the display monitor.

[0180] For the proximal transmitter 42B3, in block 414, the position sensing module 160 monitors the signal for an event, such as a peak value (calibrated maximum value) or a specific characteristic, as representative of the sensor 44 and the proximal transmitter 42B3 being closest in side-by-side alignment along the longitudinal axis of the control handle 16. In block 416, the position sensing module 160 accesses parameters stored in the configuration and geometry subroutine 156 based on the signal event. Because the second intraluminal device 26 has a predetermined geometry of the second intraluminal device 26, for example, including the position of the proximal transmitter 42B3 on the elongated body 31 relative to the distal end 26D equal to the length LS1 plus the calibrated maximum exposure distance DD1 and the calibrated maximum exposure distance DD2, the signal generated when the sensor 44 and the proximal transmitter 42B3 are closest in side-by-side alignment advantageously indicates the relative position between the device 24 and the introducer sheath 10, including the distal end 26D being distal to the calibrated maximum exposure length of the distal end 28D. In box 422, the processing unit 132 continues to display in real time on the display monitor the positioning of the distal end 26D and the distal end 28D relative to the distal end 12D of the introducer sheath within the patient's heart on the display monitor.

[0181] It should be understood that the detection of any transmitter on the endoluminal device (e.g., 42A1, 42A2, 42A3, 42B1, 42B2, 42B3) by the sensor generates a signal representing the insertion length of the endoluminal device, whose transmitter is detected due to the predetermined configuration and geometry of the endoluminal device, including, for example, parameters LM1, LM2, LM3, LE1, LE2, LE3. And further due to the predetermined configuration and geometry of the endoluminal device, the insertion length can be used to determine the position (or at least the location) of the distal end of the endoluminal device relative to the introducer sheath.

[0182] It should also be understood that the flowchart accommodates any number of launchers, as long as the intracavitary device is advanced relative to the control handle. That is, the loop is repeated for each launcher until the decision block 424 produces a "no" to the inquiry as to whether the intracavitary device is still advanced relative to the control handle. And, if there are no more intracavitary devices to be inserted according to the decision block 426, the flowchart can end at block 428.

[0183] It should be understood that in some embodiments, wherein one or more of transmitters 42A1, 42A2, 42A3, 42B1, 42B2, and 42B3 are off-axis on axis 28 of first intracavitary device 24 and elongated body 31 of second intracavitary device 26, respectively, the signal generated by sensor 44 in response thereto also represents rotation of first intracavitary device 24 and second intracavitary device 26 about their respective longitudinal axes, as shown. Figure 5A , Figure 5B and Figure 5C As shown. The parameters include calibration sensor readings corresponding to the rotation angle of the off-axis transmitter. Therefore, in boxes 312 and box 416, the parameters accessed include signal values ​​or characteristics representing the position (including positioning and rotational orientation) of the distal end 28D and the distal end 26D. In this regard, the predetermined configuration and geometry of the first intracavitary device and the second intracavitary device include a predetermined stiffness of the device over its length and its torsional stiffness, so that the application of a translational and / or rotational force at the proximal end of the device produces a predictable translation and / or rotation at its distal end.

[0184] In some embodiments, the position sensing module 160 includes a calibration table of signal readings corresponding to the longitudinal and rotational positions of each transmitter of the first intracavitary device and the second intracavitary device relative to the sensor 44, which can be referenced by the module to determine and / or confirm the relative positions of the transmitters on the proximal portions of the devices 24 and 26 relative to the sensor 44, which relative positions are referenced by the processing unit to determine (or reliably predict) the positions of the distal ends 28D and 26D of the intracavitary devices 24 and 26 for display on the display monitor.

[0185] refer to Fig.14A , Fig. 14B and Fig. 14CIn some embodiments, the position sensing assembly 600 includes a first conductive member (or electrode) 602 and a second conductive member (or electrode) 604 positioned along a passage 618 of a control handle 616 of an introducer sheath 616, and a third conductive member (or electrode) 606 located on a proximal portion 608P of an intraluminal device 608, the third conductive member (or electrode) being configured to be inserted into the passage 618 and advanced distally through a lumen 614 of a sheath 612 extending distally from a control handle 610. The first circuit member 602 and the second circuit member 604 are separate and distinct from each other and may be disposed, for example, in diametrically opposed positions across the passage 618 from each other, and the first circuit member and the second circuit member may each have the same size or width W along the passage 618, which is aligned with a longitudinal axis L defined by the control handle 616. The third conductive member 606 may be configured as a circumferential band 620 disposed on an outer surface 609 of the intraluminal device 608. The band has a width WB along the longitudinal axis that is equal to or greater than the first and second widths W.

[0186] In use, the distal end 608D of the endoluminal device 608 is inserted into the hemostatic valve 622 at the proximal end 616P of the control handle 616 to enter the passage 618. The distal end 608D then enters the lumen 614 of the sheath 612 of the introducer sheath 610. As the endoluminal device 608 continues to be advanced distally, the proximal portion 608P enters the passage 618 and the third conductive member 606 approaches the first conductive member 602 and the second conductive member 604 ( Fig.14A ). With further distal advancement, the third conductive member 606 contacts both the first conductive member 602 and the second conductive member 604 ( Fig. 14B 15 , each of the first conductive element 602 and the second conductive element 604 is connected to a respective lead 625, 627 that extends through an electrical connector that can be connected to a power / current source 629 (see Figure 1A Thus, by establishing contact with the first conductive member 602 and the second conductive member 604, the third conductive element 606 completes a circuit 624 including the first conductive member, the third conductive member and the second conductive member, thereby detecting conductivity ( Fig. 15B); that is, once the third conductive member 606 contacts the first conductive member 602 and the second conductive member 604, the circuit 624 is completed, thereby determining the presence of the intracavitary device 608. Because the device 608 has a predetermined geometry, for example, a predetermined position of the third conductive member 606 from the distal end or the proximal end of the device 608, the signal generated when the circuit 624 is completed by the conductive contact between the first conductive member 602, the second conductive member 604, and the third conductive member 606 advantageously indicates the relative position between the device 608 and the guide sheath 610, for example, including the distal end 608D approaching the distal end 612D of the sheath 612 or protruding from the distal end 612D of the sheath 612. Fig. 15B As shown, during linear translation of device 608 relative to control handle 616, electrical conductivity is maintained for a long period of time as long as contact exists between member 602 and member 606, and between member 606 and member 604.

[0187] In this regard, Figure 4C The illustrated system S includes a circuit sensing subroutine 165 in the position sensing module 160. By measuring and monitoring the completion of the circuit 624, the system S is configured to determine the position of the proximal portion of the device 608 relative to the control handle 616, and thus the position of the distal end 608D relative to the distal end of the sheath 612, based on the configuration and geometry subroutine 156 of the memory 134 for the device 608. The stored configuration and geometry of the device 608 provides a predictable and reliable determination of the position, location, and / or orientation of the distal end 608D of the device 608 based on the position, location, and / or orientation of the proximal portion 608P of the device 608 relative to the control handle 616 of the introducer sheath 610 through which the device 608 extends.

[0188] refer to Fig.16A , Fig. 16B and Fig. 16C In some embodiments, the control handle 616 includes a first array A of a plurality of first conductive members 602 and a second array B of a plurality of second conductive members 604, wherein each second conductive member is radially opposed to a corresponding first conductive member along the passage 618 to form a corresponding pair of separate and distinct conductive members. A third array C of a plurality of third conductive members 606 is located on a proximal portion 608P of the intracavitary device 608, wherein each third conductive member 606 can contact a pair of conductive members 602, 604 to complete a corresponding electrical circuit 624 with the connected pair 602, 604 as the device 608 moves relative to the control handle 616.

[0189] like Fig.17As shown, when the intracavitary device 608 is advanced distally along the passage 618 in the control handle 616 and the third array C of the third conductive member 608 approaches the first array A and the second array B, the number of circuits completed by the third conductive member 606 between the corresponding pair of first conductive members 602 and the second conductive member 604 indicates the relative position and movement between the proximal portion 608P of the device 608 and the control handle 616, and therefore indicates the relative position and movement between the distal end 608D of the device 608 and the distal end 610D of the guide sheath 610 based on the configuration and geometry of the device 608.

[0190] Using N first and second conductive members 602, 604 and N current sensors A1 to AN, the completion of each circuit between a corresponding pair of first and second conductive members 602, 604 by connecting the third conductive member 606 is detected by the current sensors A1 to AN. By detecting the progress of the completion of the circuit along the arrays A, B by the current sensors A1 to AN, the system S determines the relative position and movement of the proximal portion 608P of the device 608 and the control handle 616. The detection of the completion of the circuit A1 indicates that the proximal portion 608P is in position P1 relative to the control handle. For example, as Fig.17 As shown, detection of completion of the circuits A1, A2, A3 by the third conductive members 606A, 606B, 606C indicates that the proximal portion 608P is in a corresponding position relative to the control handle 616. Similarly, it should be understood that detection of completion of the circuits A1, A2, A3, A4 by the third conductive members 606A, 606B, 606C, 606D indicates that the proximal portion 608P is in a corresponding position more distally relative to the control handle 616. Based on the known configuration and geometry of the device 608 and the guide sheath 610, the corresponding position of the distal end 608D of the device 608 relative to the distal end of the guide sheath 610 is determined relative to each corresponding position of the control handle. It should be understood that the width and spacing between the conductive members of the arrays A1, A2, A3 can vary depending on the desired accuracy or resolution of the relative position and movement of the device 608. In some embodiments, the third conductive member 606 can be configured as a ring electrode or a mounted flexible electrode.

[0191] In some embodiments, such as Fig.17, the proximal portion 608P of the device 608 includes a visual marker 630 configured for viewing by a user to visually inform the user of the relative position between the device 608 and the control handle 616 and, therefore, the relative position between the distal end 608D of the device 608 and the distal end of the sheath 612 of the introducer sheath 610. In some embodiments, the visual marker 630 may include, for example, an alphanumeric symbol 630N at a selected location indicating the distance from the corresponding location to the proximal end of the device 608, where the location is between adjacent third conductive members 606. In some embodiments, the visual marker 630 may include color-coded markings or bands 630B, for example, a green marking at a distal position D, a yellow marking at an intermediate position M, and a red marking at a proximal position P, wherein the green marking indicates that the distal end 608D of the device 608 is proximal to the distal end 612D of the sheath 612, the yellow marking indicates that the distal end 608D is close to the distal end 612, and the red marking indicates that the distal end 608D will soon pass through the distal end 612 and protrude from the distal end 612 as distal advancement continues.

[0192] It should be understood that as the cross-sectional area of ​​the conductor increases, the electrical impedance decreases, e.g. Fig.18 As shown. When the device 608 is advanced (or displaced) distally relative to the control handle 616, the contact area between the third conductive element 606 and the first conductive element 602 and the second conductive element 604 increases, which causes the electrical impedance Z of the completed circuit to decrease. Therefore, when calibrated to the position value, the impedance reading of the completed circuit indicates the linear position of the device 608 relative to the control handle 616 and therefore relative to the guide sheath 610 and the distal end 612D of the sheath 612. The position value can be associated with the distance that the distal end 608D of the device 608 protrudes from the distal end 612D of the sheath 612, or the proximity distance remaining before the distal tip 608D leaves the distal end 612D of the sheath 612.

[0193] In some embodiments, such as Fig.19 As shown, a circuit 625 completed by the first conductive member 602, the second conductive member 604, and the third conductive member 606 includes a signal generator 626 and an impedance measuring device 628, such as an oscilloscope, an AC voltmeter, or an impedance meter. Fig.18 606 relative to the first and second conductive members 602 and 604, wherein φ represents the amount of contact surface area between the first conductive member 602, the second conductive member 604, and the conductive member 606. When the third conductive member 606 is not in contact with the first and second conductive members 602 and 604 ( Fig.14A ), Fig.18 The curve graph shows the maximum impedance measured. When the intracavitary device 608 is advanced distally, the third conductive member 606 contacts the second member 602 and the third member 604 ( Fig. 14B ), and the measured impedance Z decreases. When the intracavitary device 608 is further advanced distally, the third conductive member 606 is in full contact with the second member and the third member ( Fig. 14C ), and the measured impedance is further reduced. In this regard, Figure 4C The illustrated system S includes an impedance subroutine 166 in the position sensing module 160. By measuring and monitoring impedance, the system S is configured to determine the position of the proximal portion of the device 608 relative to the control handle 616, and thus the position of the distal end 608D relative to the distal end of the sheath 612, based on the configuration and geometry subroutine 156 of the memory 134 for the device 608. The stored configuration and geometry of the device 608 provides a predictable and reliable determination of the position, location, and / or orientation of the distal end 608D of the device 608 based on the position, location, and / or orientation of the proximal portion 608P of the device 608 relative to the control handle 616 of the introducer sheath 610 through which the device 608 extends.

[0194] In some embodiments, the system S is configured to display images on a display via an imaging electromagnetic system (such as Biosense Webster, Inc. Irvine, California). 3 system) provides users with visual region-of-interest markers in real-time 3-D electroanatomical maps. Fig. 20A , Fig. 20B , Fig. 20C , Fig.20D , Fig.20E , Fig.20F , Figure 20G , Fig. 20H , Fig.20I and Fig. 20J, a generated 3-D electroanatomical visualization of an endoluminal device 702 (e.g., a transseptal guidewire inserted through the lumen 706 of the lumen-bearing device 704 (e.g., a dilator inserted through the introducer sheath 701)) includes a visual marker 700 representing a region of interest ROI occupied by a protruding distal portion 702D. In some embodiments, the distal portion 702D of the endoluminal device 702 has a shape memory such that it straightens from a predetermined 2-D or 3-D configuration to be inserted into and advanced through the lumen 706, and then elastically re-adopts the predetermined configuration when it exits the lumen or is otherwise unconstrained and free from external forces. The predetermined configuration can be a "J" shape or any other 2-D or 3-D shape that is re-adopted by the distal portion 702D after the distal portion has exited the lumen-bearing device 704, penetrated the septum 712, and advanced distally into the left atrium 714.

[0195] In some embodiments, the dynamic visual marker 700 is displayed as a graphical element adjacent to or extending from a depiction or visualization of the distal end 704D of the lumen-bearing device 704 to represent the 2D or 3D area in the left atrium occupied by the distal portion 702D. Fig. 20A In the embodiment, the distal portion 702D has not yet left the lumen 706, so the distal portion is shown on the display as Fig. 20B As shown, it is visualized as a first graphical element 715, such as an ellipse, which can be displayed in a first color. Fig. 20C As shown, the dynamic visual marker 700 in the visualization of the distal portion 702D changes to a second graphical element 716, such as a circle, which may be displayed in a second color. Fig.20D As shown, the circle represents the spherical area that can be occupied by the distal portion 702D. It is worth noting that based on the determination of the linear translation of the intraluminal device 702 by the position sensing assembly, the diameter of the circle is scaled to represent the length of the exposed distal portion 702D that protrudes beyond the distal end 704D of the lumen device 704. With further distal advancement, the distal portion 702D has penetrated the septum 712 and entered the left atrium 714, as shown in FIG. Fig.20E As shown in FIG. 1 , the circle of the second graphical element 716 increases in size as the diameter is scaled to a length representing a greater exposed length of the distal portion 702D protruding beyond the distal end 704D, as shown in FIG. Fig.20F as shown in .

[0196] In some embodiments, wherein the distal portion 704D of the endoluminal device 704 has a predetermined configuration, such as a "J" bend, which is re-adopted by the distal portion 704D after the septum 712 penetrates further into the left atrium 714, such as Figure 20GAs shown, the diameter of the second graphical element 716 and thus the circle is further increased so that the circle completely circumscribes the exposed distal portion 702D, as shown in FIG. Fig. 20H The indicated circular and spherical regions advantageously cover all possible positioning of the "J" bend regardless of its axial rotation along the longitudinal axis of the lumen device 704. In the event that the distal portion 704D extends further into the left atrium 714, for example beyond a predetermined threshold length past the distal end 704D, as shown in FIG. Fig.20I As shown, the visualization of the distal portion 704D becomes a third graphical element 719, such as another circle of another color, whose diameter is scaled to represent the predetermined threshold length, such as Fig. 20J As shown. The third graphic element 719 can be used to warn the user that the distal portion 702D is "out of range". By applying the known configurations and geometries of the intracavitary device 702, the device with an inner cavity 704 and / or the device with an outer cavity, any of the above-mentioned embodiments of the position sensing assembly 40 can determine the relative linear translation of the device 702 at its proximal end to determine the relative linear translation of the device 702 at its distal end. Moreover, the visual marker 700 and the visualization of any, some or all of these devices are dynamically displayed to the user in real time, so that the user has a visual reminder of the area where the distal portion 702D of the intracavitary device 702 can be located at any given time during the procedure. The foregoing description has been presented with reference to the current preferred embodiment of the present invention. Those skilled in the art of the present invention will know that changes and modifications can be made to the structure without intentionally departing from the principles, essence and scope of the present invention. Any feature or structure disclosed in one embodiment can be incorporated as needed or appropriate to replace or supplement other features of any other embodiment. As understood by those of ordinary skill in the art, the drawings are not necessarily drawn to scale. Therefore, the above detailed description should not be read as being adapted only to the precise structures described and shown in the drawings, but should be read as being consistent with and supporting the following claims, which have the full and fair scope of the present invention.

Claims

1. A system, comprising: a sheath comprising a handle and a catheter extending distally from the handle; an intraluminal device comprising a shaft having a predetermined geometry and configured to pass transversely through the handle and the catheter; and A sensor assembly is disposed adjacent the handle and is configured to determine a parameter of the intraluminal device within the sheath, thereby determining the position of the distal end of the shaft, the parameter including a length of insertion or rotation of the intraluminal device.

2. The system according to claim 1, further comprising: processor; and a non-transitory computer-readable medium having instructions thereon that, when executed by the processor, cause the system to: determining an insertion length of the intraluminal device within the sheath; and The position of the distal end of the shaft is determined based at least in part on the insertion length of the intraluminal device within the sheath and the predetermined geometry of the shaft.

3. The system of claim 1, wherein the sheath comprises a navigation sensor proximate a distal end of the catheter.

4. The system of claim 1, the distal portion of the catheter comprising a bend, and the distal portion of the shaft comprising a pre-formed bend.

5. The system according to claim 1, further comprising: A transseptal puncture kit is provided, wherein the transseptal puncture kit comprises the sheath and the intracavitary device.

6. The system of claim 1, wherein the intraluminal device comprises a transseptal needle.

7. The system of claim 1, wherein the intraluminal device comprises a dilator.

8. The system of claim 1, the intracavitary device further comprising an identification mark, and the handle further comprising an identification circuit configured to determine the predetermined geometry of the shaft based at least in part on the identification mark.

9. The system of claim 8, the identification tag comprising a radio frequency identification (RFID) circuit.

10. According to the system of claim 1, the sensor assembly includes a sensor array located within the handle of the sheath and a sensor marker arranged on the proximal portion of the axis of the intracavitary device, and the sensor array is configured to determine the position of the sensor marker within the handle to determine the position of the distal end of the axis.

11. The system of claim 10, the sensor tag comprising a ferromagnetic material and the sensor array comprising a plurality of magnetic sensors.

12. The system of claim 10, the sensor array comprising a plurality of sensors arranged linearly along a longitudinal axis and adjacent a lumen within the handle, the lumen configured to receive the shaft of the intraluminal device.

13. The system according to claim 10, further comprising: processor; and a non-transitory computer-readable medium having instructions thereon that, when executed by the processor, cause the system to: determining the position of the sensor marker within the handle based at least in part on electrical signals from the sensor array; as well as The position of the distal end of the shaft of the intraluminal device is determined based at least in part on the electrical signals from the sensor array and the predetermined geometry of the shaft.

14. An intracavity device position sensing system, the intracavity device position sensing system comprising: a guide catheter sheath having a shaft including a lumen and a control handle having a passageway in the control handle along a longitudinal axis, the passageway and the lumen being in communication with each other; a first intraluminal device having a predetermined geometry, a proximal portion and a distal portion, the distal portion being configured to extend through the lumen of the sheath, and the proximal portion being configured to extend through the passageway of the control handle; a first transmitter located on the proximal portion of the first intracavitary device; and A sensor is positioned in the passageway of the control handle, the sensor being configured to generate a signal in response to the first transmitter on the proximal portion of the first endoluminal device, the signal being representative of a position of the distal portion of the first endoluminal device.

15. The system of claim 14, wherein: The first transmitter includes a magnetic member, and the sensor includes a magnetic sensor.

16. The system of claim 14, wherein: The first emitter comprises an optically readable pattern such that an optical signal is emitted when illuminated, and the sensor comprises an optical unit having at least an optical detector.

17. The system of claim 16, wherein: The optical unit includes a light source.

18. The system of claim 14, wherein: The first intraluminal device comprises a dilator.

19. The system of claim 14, wherein: The first intraluminal device includes a lumen configured to receive a second intraluminal device.

20. An intracavity device position sensing system, the intracavity device position sensing system comprising: an introducer sheath having a shaft and a control handle, the shaft including a lumen, and the control handle defining a passageway therein along a longitudinal axis, the passageway and the lumen being in communication with each other; a first intraluminal device having a predetermined geometry, the first intraluminal device comprising a proximal portion and a distal portion, the distal portion being configured to extend through the lumen of the sheath, and the proximal portion being configured to extend through the passageway of the control handle; a first optically readable pattern located on the proximal portion of the first intraluminal device; and A light source and an optical sensor, wherein the optical sensor is located in the passage of the control handle, the light source is configured to illuminate the first optically readable pattern, and the optical sensor is configured to generate a signal in response to illumination of the first optically readable pattern by the light source, the signal representing the position of the distal portion of the first intracavitary device.

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