Guiding sheath system with position sensing and related methods

Abstract

To provide a guiding sheath system.SOLUTION: A system includes: a sheath comprising a handle and a catheter tube; an intralumenal device having a shaft of a predetermined geometry and configured to pass through the handle and the catheter tube; and a sensor assembly disposed near the handle and configured to determine a length of insertion of the intralumenal device within the sheath to thereby determine a position of a distal end of the shaft. A method for visualizing a distal end of an intralumenal device comprises: determining a position of a distal portion of a sheath within a body of a patient; determining a length of insertion of a shaft configured with a predetermine 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 length of insertion 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.SELECTED DRAWING: Figure 1A

Description

[Technical field]

[0001] (CROSS REFERENCE TO RELATED APPLICATIONS) This application claims priority to and the benefit of U.S. Provisional Patent Application No. 63 / 525,494, filed July 7, 2023, the entire contents of which are incorporated herein by reference.

[0002] FIELD OF THEINVENTION The present invention relates to guide sheaths and intraluminal devices for use with the guide sheaths, such as dilators, therapeutic and diagnostic catheters, and transseptal needles. [Background technology]

[0003] Cardiac arrhythmias are irregular beatings of the heart caused by abnormal electrical signals. Arrhythmias can reduce quality of life and be associated with an increased risk of stroke and heart failure. Arrhythmias can be localized and identified via diagnostic catheters. These catheters can be used to create electroanatomical maps to help electrophysiologists understand pathology and plan and deliver treatments, which may include ablation via therapeutic catheters.

[0004] Electrophysiology (EP) catheters, whether diagnostic or therapeutic, are guided by guiding sheaths that are well known for use in facilitating a path through a patient's vasculature, typically through the femoral artery and aorta, to ultimately access the four chambers of the heart. For example, the CARTO.VIZIGO® Bi-Directional Guiding Sheath by Biosense Webster, Inc., Irvine, California, allows the sheath to be visualized in a real-time three-dimensional map via an imaging electromagnetic system, such as the CARTO® 3 System by Biosense Webster, Inc., Irvine, California. The system allows electrophysiologists to build an accurate 3D electroanatomical map of the heart and is designed to assist electrophysiologists in navigating EP vascular instruments, such as sheaths, catheters, dilators, and other probe devices, within the heart by pinpointing the exact position (location and orientation) of the distal ends of these EP vascular instruments during diagnostic and therapeutic procedures.

[0005] For visualization of EP vascular instruments with the CARTO® 3 System, the instrument carries an electromagnetic position sensor at or near its distal end, with three coils, each responsive to a respective magnetic field generator positioned under the patient's bed. Each coil generates a signal, which is transmitted by a respective lead wire that extends from the distal end of the instrument along its entire length to the instrument's control handle, through the control handle, and into an electrical connector that connects to a system for processing and generating a representation of the instrument on a monitor that displays a 3D anatomical map of the heart. Fluoroscopy is often used instead of, or in addition to, electromagnetic position sensing. Ionizing radiation poses a hazard to the patient and the electrophysiologist, who must wear heavy leaded clothing. Moreover, the view provided is limited to 2D.

[0006] The shafts and distal tips of EP vascular instruments are necessarily small, and therefore their construction and assembly require highly skilled personnel. Moreover, as the field of cardiac electrophysiology advances, more and more components are housed or carried on the distal end of the instrument, where space is already limited. Furthermore, as the distal end is advanced into the heart, medical safety requirements are stringent to minimize the risk of accidental detachment of components from the distal tip or other avoidable traumatic damage to cardiac tissue. And if the electrical components at the distal end are connected to a lead wire, breakage of the lead wire will result in failure of the instrument.

[0007] For endoluminal devices such as dilators and transseptal needles that are advanced into the patient's vasculature, visualization is often not available. Thus, the location of the dilators and transseptal needles is based primarily on guesswork and best estimates of the operator handling these devices. Although identification of these devices is possible through fluoroscopy with ultrasound confirmation, reducing overall fluoroscopy time is beneficial to the patient's health. Summary of the Invention [Problem to be solved by the invention]

[0008] Thus, with the understanding that improper access of an endoluminal device within the heart can result in tissue damage and disease, such as cardiac perforation and cardiac tamponade, Applicants have recognized a need to provide an EP vascular device, particularly an EP vascular device for use with a guide sheath, that requires less construction, assembly labor, and space usage at the distal end while also minimizing the need for lead wires extending along the length of the device to enable position sensing and visualization. [Means for solving the problem]

[0009] In some embodiments, a catheter shaft for use in a catheter sheath comprises a generally tubular member extending along a longitudinal axis from a proximal end to a distal end, the proximal end including a proximal portion, the emitter being fixed on the proximal portion, and the distal end including an end effector.

[0010] In some embodiments, the end effector includes a septum needle.

[0011] In some embodiments, the end effector includes an electrode assembly configured to map the organ.

[0012] In some embodiments, the end effector includes an ablation electrode assembly.

[0013] In some embodiments, the emitter includes a magnetic member.

[0014] In some embodiments, the emitter includes an optically readable pattern.

[0015] In some embodiments, a control handle for use with a catheter sheath includes a pathway along a longitudinal axis of the control handle, the pathway configured to receive a proximal portion of the generally tubular member with an emitter, and the control handle includes at least one sensor secured along the pathway, the sensor responsive to the emitter.

[0016] 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 configured to illuminate the optically readable pattern, and the light sensor configured to detect the optically readable pattern when illuminated by the light source.

[0017] In some embodiments, the light sensor includes a photodiode and the light source includes an LED.

[0018] In some embodiments, the emitter includes a magnetic member and the sensor includes a magnetic sensor.

[0019] In some embodiments, an intraluminal device position sensing system includes a catheter sheath having a shaft and a control handle. The shaft includes a lumen, and the control handle includes a pathway along a longitudinal axis, the pathway and the lumen being in communication with each other. The system also includes a first intraluminal device, a first emitter, and a sensor. The first intraluminal device is configured with a predetermined geometry and includes a proximal portion and a distal portion, the distal portion configured to extend through the lumen of the sheath, and the proximal portion configured to extend through the pathway of the control handle. The first emitter is located on the proximal portion of the first intraluminal device, and the sensor is located in the pathway of the control handle and configured to generate a signal in response to the first emitter on the proximal portion of the first intraluminal device. The signal is indicative of a position of the distal portion of the first intraluminal device.

[0020] In some embodiments, the first emitter includes a magnetic member and the sensor includes a magnetic sensor.

[0021] In some embodiments, the first emitter includes an optically readable pattern such that an optical signal is emitted when illuminated, and the sensor includes an optical unit having at least an optical detector.

[0022] In some embodiments, the optical unit includes a light source.

[0023] In some embodiments, the first intraluminal device includes a dilator.

[0024] In some embodiments, the first intraluminal device includes a lumen configured to receive the second intraluminal device.

[0025] In some embodiments, the second emitter is located on a proximal portion of a second intraluminal device that is configured to be generally coextensive with the proximal portion of the first intraluminal device.

[0026] In some embodiments, the second intraluminal device includes a transseptal needle.

[0027] In some embodiments, the predetermined geometric shape includes an insertion length (LIN1) of the first endoluminal device measured proximally from a distal end of the first endoluminal device, the insertion length (LIN1) being configured to pass through the control handle pathway and shaft lumen of the guide sheath and being a predetermined distance (DD1) longer than the combined length (LT) of the lumens and pathway.

[0028] In some embodiments, the sensor is located a predetermined distance (LS1) along the path of the control handle measured from the distal end of the guide sheath's lumen, the first emitter is located on the first endoluminal device a predetermined distance LM1 measured proximally from the distal end of the first endoluminal device, where LM1=LS1+DD1, and a signal generated by the sensor in response to the first emitter represents that the distal end of the endoluminal device is the distance DD1 distal from the distal end of the shaft's lumen.

[0029] In some embodiments, the approach distance AD ​​is defined as a predetermined distance measured proximally from the distal end of the guide sheath lumen. Distal to the first emitter, the second emitter is located on the first endoluminal device at a predetermined distance LM2 measured proximally from the distal end of the first endoluminal device, where LM2=LM1-AD-DD1=LS1-AD, and a signal generated by the sensor in response to the second emitter represents that the distal end of the endoluminal device is proximal to the distal end of the shaft lumen by the distance AD.

[0030] In some embodiments, the system includes a third emitter located on the first intraluminal device between the first and second emitters at a predetermined distance LM3 measured proximally from the distal end of the first intraluminal device, where LM2 = LS1. A signal generated by the sensor in response to the third emitter represents the distal end of the intraluminal device being flush with the distal end of the shaft lumen.

[0031] In some embodiments, the first emitter includes a magnetic member, the sensor includes a first magnetic sensor, and the system further includes a second magnetic sensor located at the same axial location in the pathway as the first magnetic sensor but at a different angular location around the longitudinal axis of the first intraluminal device.

[0032] In some embodiments, the emitter includes a magnetic member, the sensor includes a magnetic sensor, and the magnetic member is located off-axis relative to a longitudinal axis of the first intraluminal device.

[0033] In some embodiments, the first emitter includes a first magnetic strength and the second emitter includes a second magnetic strength that is different from the first magnetic strength.

[0034] In some embodiments, the system includes a second emitter, where the first emitter generates a first magnetic field and the second emitter generates a second magnetic field orthogonal to the first magnetic field.

[0035] In some embodiments, the system includes a second emitter, where the first emitter generates a first magnetic field and the second emitter generates a second magnetic field that is off-angle to the first magnetic field.

[0036] In some embodiments, the system includes a plurality of first emitters and a plurality of sensors, the plurality of first emitters located on a proximal portion of the first intraluminal device forming a first linear array of first emitters, each of the first emitters located at a different axial location along the proximal portion of the first intraluminal device, and the plurality of sensors located within a pathway of the control handle forming a linear array of sensors, each of the sensors located at a different axial location along the pathway.

[0037] In some embodiments, the first intraluminal device is configured such that the distal portion is deflectable.

[0038] In some embodiments, the signal generated by the sensor in response to the second emitter represents the position of a distal portion of the second intraluminal device when deployed beyond the distal end of the first intraluminal device.

[0039] In some embodiments, the endoluminal device position sensing system includes a guide sheath having a shaft and a control handle, the shaft including a lumen, the control handle defining a pathway therein along a longitudinal axis, the pathway and the lumen in communication with one another. The system also includes a first endoluminal device having a predetermined geometry, the first endoluminal device including a proximal portion and a distal portion, the distal portion configured to extend through the lumen of the sheath, and the proximal portion configured to extend through the pathway of the control handle. The system further includes a first optically readable pattern located on the proximal portion of the first endoluminal device, and an optical source and an optical sensor located in the pathway of the control handle, the optical source configured to illuminate the first optically readable pattern, and the optical sensor configured to generate a signal in response to illumination of the first optically readable pattern by the optical source, the signal representing a position of the distal portion of the first endoluminal device.

[0040] In some embodiments, the optical source includes an LED.

[0041] In some embodiments, the optical sensor includes a photodiode.

[0042] In some embodiments, the system includes a second optically readable pattern located on a proximal portion of the first intraluminal device at a second location different from the first location of the first optically readable pattern.

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

[0044] In some embodiments, the system includes a plurality of optical emitters and a plurality of optical sensors forming respective pairs of optical emitters and optical sensors, each pair being located at a different axial location along the path.

[0045] In some embodiments, the endoluminal device position sensing system includes a guide sheath having a shaft and a control handle, the shaft including a lumen, the control handle defining a pathway therein along a longitudinal axis, the pathway and the lumen in communication with each other. The system also includes a first endoluminal device having a predetermined geometry, the first endoluminal device including a proximal portion and a distal portion, the distal portion configured to extend through the lumen of the sheath, and the proximal portion configured to extend through the pathway of the control handle. The system further includes means for determining a position of the distal portion within the first lumen based on a position of the proximal portion of the first endoluminal device within the pathway of the control handle.

[0046] In some embodiments, the location of the distal position includes a location of a distal portion deployed beyond a distal end of a shaft of the guide sheath.

[0047] In some embodiments, the means for determining a position includes an electromagnetic emitter and an electromagnetic sensor.

[0048] In some embodiments, the means for determining a position includes an optical source and an optical sensor.

[0049] In some embodiments, a method for determining a position of an endoluminal device includes determining a first length of a guide sheath including a shaft and a control handle, the first length being defined between a distal end of the sheath and a sensor site in the control handle, and determining a location of the distal end of the sheath within the patient. The method also includes determining a second length of an endoluminal device configured to pass through the shaft of the guide sheath and the control handle, the second length being defined between the distal end of the endoluminal device and an emitter site on a matching proximal portion of the endoluminal device in the control handle. The method further includes determining a location of the emitter site of the endoluminal device relative to the control handle, and determining a location of the distal end of the endoluminal device within the patient based on the determined location of the emitter site of the endoluminal device.

[0050] In some embodiments, determining the position of the emitter site of the endoluminal device relative to the control handle includes electromagnetic sensing.

[0051] In some embodiments, determining the position of the emitter site of the endoluminal device relative to the control handle includes optical sensing.

[0052] In some embodiments, determining the position of the distal end of the sheath within the patient includes electromagnetic position sensing.

[0053] In some embodiments, the method includes displaying a graphical representation of the position of the distal end of the endoluminal device.

[0054] In some embodiments, the position of the distal end of the endoluminal device comprises a linear position.

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

[0056] In some embodiments, the system includes a sheath comprising a handle and a catheter tube extending distally from the handle, and an endoluminal device comprising a shaft configured with a predetermined geometry and configured to pass through the handle and the catheter tube. The system also includes a sensor assembly disposed proximate the handle and configured to determine a length of insertion of the endoluminal device within the sheath, thereby determining a position of a distal end of the shaft.

[0057] In some embodiments, the system further includes a processor and a non-transitory computer readable medium having instructions that, when executed by the processor, cause the system to determine a length of insertion of the endoluminal device within the sheath and determine a position of a distal end of the shaft based at least in part on the length of insertion of the endoluminal device within the sheath and a predetermined geometric shape of the shaft.

[0058] In some embodiments, the sheath includes a navigation sensor proximate the distal end of the catheter tube.

[0059] In some embodiments, the distal portion of the catheter tube includes a curve and the distal portion of the shaft includes a pre-formed curve.

[0060] In some embodiments, the distal portion of the catheter tube is deflectable.

[0061] In some embodiments, the distal portion of the shaft is devoid of navigational sensors.

[0062] In some embodiments, the system includes a transseptal puncture kit comprising a sheath and an endoluminal device.

[0063] In some embodiments, the intraluminal device includes a transseptal needle.

[0064] In some embodiments, the intraluminal device includes a dilator.

[0065] In some embodiments, the shaft of the intraluminal device is non-deflectable.

[0066] In some embodiments, the intraluminal device includes an identification marker and the handle includes an identification circuit configured to determine the predetermined geometry of the shaft based at least in part on the identification marker.

[0067] In some embodiments, the identification marker includes a radio frequency identification (RFID) circuit.

[0068] In some embodiments, the sensor assembly includes a sensor array in a handle of the sheath and a sensor marker disposed on a proximal portion of the shaft of the endoluminal device, the sensor array configured to determine a position of the sensor marker in the handle, thereby determining the position of the distal end of the shaft.

[0069] In some embodiments, the sensor array comprises a length approximately equal to the length of the distal portion of the shaft distal to the distal end of the catheter tube of the sheath when the endoluminal device is fully inserted distally into the sheath.

[0070] In some embodiments, the sensor marker comprises a ferromagnetic material and the sensor array comprises a plurality of magnetic sensors.

[0071] In some embodiments, the sensor array includes a plurality of sensors arranged linearly along the longitudinal axis and adjacent to a lumen in the handle, the lumen configured to receive a shaft of an intraluminal device.

[0072] In some embodiments, the system also includes a processor and a non-transitory computer-readable medium having instructions that, when executed by the processor, cause the system to determine a position of a sensor marker in the handle based at least in part on the electrical signals from the sensor array, and to determine a position of a distal end of a shaft of the endoluminal device based at least in part on the electrical signals from the sensor array and a predetermined geometric shape of the shaft.

[0073] In some embodiments, a computer readable medium includes instructions that, when executed by a processor, cause a system to determine a position of a distal end of an endoluminal device within a patient's body.

[0074] 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 an intraluminal device within a patient's heart.

[0075] In some embodiments, a computer readable medium includes instructions that, when executed by a processor, cause the system to determine a position of a distal end of an endoluminal device relative to the fossa ovalis in 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 navigation sensor disposed on a distal portion of the catheter tube and to determine a position of a distal end of the endoluminal device relative to the navigation sensor.

[0077] 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 an identification marker on the endoluminal device.

[0078] In some embodiments, a system includes a processor and a non-transitory computer readable medium having instructions that, when executed by the processor, cause the system to determine an insertion length of a shaft of an endoluminal device within a sheath, the shaft comprising a predetermined geometric shape, the sheath comprising a handle and a catheter tube extending distally from the handle, and to determine a position of a distal end of the shaft based at least in part on the insertion length of the endoluminal device within the sheath and the predetermined geometric shape of the shaft.

[0079] 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 tube and to determine a position of a distal end of the endoluminal device relative to the navigation sensor.

[0080] 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 portion of the catheter tube within a patient's body and determine 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 tube, the length of insertion of the endoluminal device, and a predetermined geometric shape of the shaft.

[0081] In some embodiments, the computer-readable medium includes instructions that, when executed by the processor, cause the system to provide a display output including a graphical representation of the position of the distal end of the shaft within the body.

[0082] 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 an intraluminal device within a patient's heart.

[0083] In some embodiments, a computer readable medium includes instructions that, when executed by a processor, cause the system to determine a position of a distal end of an endoluminal device relative to the fossa ovalis in 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 length of insertion of the endoluminal device within the sheath based at least in part on an electrical signal from a sensor array in the handle.

[0085] In some embodiments, a method for visualizing a distal end of an endoluminal device includes determining a position of a distal portion of a sheath within a patient and determining a length of insertion 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 based at least in part on the length of insertion 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.

[0086] In some embodiments, the means for determining position includes a first conductive member and a second conductive member disposed along the pathway, a third conductive member disposed on a proximal portion of the endoluminal device and configured to contact the first conductive member and the second conductive member in forming a completed electrical circuit as the proximal portion moves along the pathway, and a circuit detector configured to detect the completed electrical circuit.

[0087] In some embodiments, the third conductive member includes a ring electrode disposed on a proximal portion of the intraluminal device.

[0088] In some embodiments, the system further includes an impedance sensor configured to measure the impedance of the completed electrical circuit.

[0089] In some embodiments, the means for determining position includes a first array of first conductive members and a second array of second conductive members disposed along the path, a third array of third conductive members disposed on a proximal portion of the endoluminal device, each third conductive member configured to contact a respective pair of the first conductors and the second conductors in forming a respective completed electrical circuit as the proximal portion moves along the path, and a circuit detector configured to detect each completed electrical circuit.

[0090] In some embodiments, the system further comprises an impedance sensor for measuring the impedance of each completed electrical circuit.

[0091] In some embodiments, the proximal portion of the intraluminal device includes visual indicia disposed between adjacent third conductive members on the outer surface of the intraluminal device.

[0092] In some embodiments, the visual indicia includes alphanumeric symbols.

[0093] In some embodiments, the visual indicia includes a color.

[0094] In some embodiments, a system for visualization of an endoluminal device includes a luminal device having a first predetermined geometry and including a first proximal portion and a first distal portion, and an endoluminal device having a second predetermined geometry, the endoluminal device including a second proximal portion and a second distal portion, the second proximal portion and the second distal portion configured to extend distally through a lumen of the luminal device. The system also includes a processor, a display, and a non-transitory computer-readable medium having instructions that, when executed by the processor, cause the display to provide a visualization representing the first distal portion with graphical elements representing an exposed portion of the second distal portion extending distally of a distal end of the first distal portion.

[0095] In some embodiments, the graphical element includes a circle having a diameter based on the length of the exposed distal portion.

[0096] In some embodiments, the diameter changes in real time based on the length of the exposed distal portion as it translates along the path.

[0097] In some embodiments, the luminal device comprises a dilator and the intraluminal device comprises a guidewire.

[0098] In some embodiments, the system further includes a guide sheath including a control handle and a sheath including a third proximal portion and a third distal portion, the sheath configured to have a lumen through which the lumen device extends, and the position sensing assembly configured to determine a position of the first distal portion of the lumen device relative to the third distal portion of the guide sheath based on a position of the first proximal portion of the lumen device relative to the third proximal portion of the guide sheath.

[0099] In some embodiments, the system further includes a guide sheath including a control handle and a sheath including a third proximal portion and a third distal portion, the sheath configured to have a lumen through which the lumen device extends, and the position sensing assembly configured to determine a position of the second distal portion of the endoluminal device relative to the third distal portion of the guide sheath based on a position of the second proximal portion of the endoluminal device relative to the third proximal portion of the guide sheath. [Brief description of the drawings]

[0100] These and other features and advantages of the present invention will be more fully understood from the following detailed description considered in conjunction with the accompanying drawings, in which it is understood that in certain drawings, selected structures and features are not shown in order to better illustrate remaining structures and features. [Figure 1A]1 illustrates a top view of a guide sheath system having a position sensing and at least one endoluminal device extending therethrough, according to one embodiment. [Figure 1B] FIG. 1B is a top view of the guide sheath system of FIG. 1A with the first endoluminal device advanced distally to expose its distal end. [Figure 1C] FIG. 1C is a top view of the guide sheath system of FIG. 1B with a first endoluminal device and a second endoluminal device advanced distally, both with exposed distal ends. [Figure 1D] FIG. 1D is a side cross-sectional view of the distal end of FIG. 1C in a deflected state. [Figure 1E] 1 is a cross-sectional view of a distal end of a first intraluminal device at an approach distance AD1 (solid lines) and a deployed distance DD1 (dashed lines) relative to a guide sheath, according to one embodiment. [Figure 1F] 1 is a cross-sectional view of a distal end of a second intraluminal device at an approach distance AD2 (solid lines) and a deployed distance DD2 (dashed lines) relative to a first intraluminal device, according to one embodiment. [Figure 1G] 1 is a side cross-sectional view of a proximal portion of a second endoluminal device coextensive with a proximal portion of a first endoluminal device extending through a guide sheath, according to one embodiment. [Figure 2A] FIG. 1 is a perspective view of a guide sheath control handle partially cut away to show a pathway aligned with a sensor, the pathway configured to receive a first intraluminal device carrying an emitter and a second intraluminal device, according to one embodiment. [Figure 2B] 2B is a coextensive perspective view of the first and second intraluminal devices of FIG. 2A. [Diagram 3] 1 is a schematic diagram of the relative configuration and geometry of a guide sheath and first and second endoluminal devices, according to one embodiment. [Figure 4A] FIG. 1 is a diagram of a guide sheath system with advanced EP imaging, according to one embodiment. [Figure 4B] FIG. 4B is a schematic block diagram illustrating the operation of the system of FIG. 4A, according to one embodiment. [Figure 4C]FIG. 4B is a schematic block diagram illustrating the operation of the system of FIG. 4A according to another embodiment. [Figure 5A] 1 is a cross-sectional end view of a first endoluminal device and a second endoluminal device having respective emitters coextensive with a sensor through a guide sheath, and corresponding voltages generated by the sensor in response to the emitters at different rotational angles about the longitudinal axis of the endoluminal device, according to one embodiment. [Figure 5B] 1 is a cross-sectional end view of a first endoluminal device and a second endoluminal device having respective emitters coextensive with a sensor through a guide sheath, and corresponding voltages generated by the sensor in response to the emitters at different rotational angles about the longitudinal axis of the endoluminal device, according to one embodiment. [Figure 5C] 1 is a cross-sectional end view of a first endoluminal device and a second endoluminal device having respective emitters coextensive with a sensor through a guide sheath, and corresponding voltages generated by the sensor in response to the emitters at different rotational angles about the longitudinal axis of the endoluminal device, according to one embodiment. [Figure 6A] 1 is a side cross-sectional view of an intraluminal device having a magnetic emitter in a relative configuration with a guide sheath having a sensor, according to one embodiment, and corresponding voltages generated by the sensor in response to different longitudinal positions and orientations of the emitter. [Figure 6B] 1 is a side cross-sectional view of an intraluminal device having a magnetic emitter in a relative configuration with a guide sheath having a sensor, according to one embodiment, and corresponding voltages generated by the sensor in response to different longitudinal positions and orientations of the emitter. [Figure 7A] 1A-1C are cross-sectional end views of an endoluminal device having a ring emitter extending through a guide sheath having a sensor, the ring emitter at different rotational angles relative to the sensor. [Figure 7B] 1A-1C are cross-sectional end views of an endoluminal device having a ring emitter extending through a guide sheath having a sensor, the ring emitter at different rotational angles relative to the sensor. [Figure 8A]1 is a perspective view of a guide sheath control handle, partially cut away to show a path aligned with an optical sensor configured to receive an intraluminal device carrying an optical emitter, according to one embodiment. [Figure 8B] 8B is a perspective view of the intraluminal device of FIG. 8A. [Figure 9] 1 is a graph of photodiode voltage versus optically readable pattern units. [Figure 10] 11 is a flow chart illustrating steps for position sensing an endoluminal device at its proximal portion to determine the position of a distal end of the endoluminal device relative to a guide sheath through which the endoluminal device extends, according to one embodiment. [Figure 11] 11 is a flow chart illustrating steps for position sensing an endoluminal device at its proximal portion to determine the position of a distal end of the endoluminal device relative to a guide sheath through which the endoluminal device extends, according to another embodiment. [Figure 12] 10 is a flow chart showing steps for position sensing one or more endoluminal devices at respective proximal portions thereof to determine the position of their respective distal ends relative to a guide sheath through which the one or more endoluminal devices extend, according to yet another embodiment. [Figure 13] FIG. 2 is an EP image displayed on a display monitor showing a first endoluminal device and a second endoluminal device with their distal ends deployed beyond the distal end of a guide sheath within a chamber of a patient's heart. [Figure 14A] FIG. 1 is a side cross-sectional view of a guide sheath control handle and an endoluminal device advanced distally therethrough, each having conductive members configured to contact and form a completed electrical circuit. [Figure 14B] FIG. 1 is a side cross-sectional view of a guide sheath control handle and an endoluminal device advanced distally therethrough, each having conductive members configured to contact and form a completed electrical circuit. [Figure 14C]FIG. 1 is a side cross-sectional view of a guide sheath control handle and an endoluminal device advanced distally therethrough, each having conductive members configured to contact and form a completed electrical circuit. [Figure 15A] FIG. 14D is a schematic diagram of the completed electrical circuit of FIG. 14C formed by the contacting first conductive member, second conductive member, and third conductive member. [Figure 15B] 14B, 14C and 14C. FIG. 14C is a graph of linear displacement versus conductivity for the electrical circuit of FIG. [Figure 16A] FIG. 1 is a side cross-sectional view of a guide sheath control handle and a lumen advanced distally therethrough, having an array of conductive members configured to contact each other to form a respective completed electrical circuit. [Figure 16B] FIG. 1 is a side cross-sectional view of a guide sheath control handle and a lumen advanced distally therethrough, having an array of conductive members configured to contact each other to form a respective completed electrical circuit. [Figure 16C] FIG. 1 is a side cross-sectional view of a guide sheath control handle and a lumen advanced distally therethrough, having an array of conductive members configured to contact each other to form a respective completed electrical circuit. [Figure 17] FIG. 16B is a schematic diagram of the electrical circuits of each of the arrays of FIG. 16A, each having a circuit sensor. [Figure 18] 1 is a graph of linear displacement versus impedance. [Figure 19] 1 is a schematic diagram of a circuit for measuring impedance of a completed electrical circuit formed by contacting first, second, and third conductive members. [Figure 20A] 13 is a side cross-sectional view of an endoluminal device being advanced distally through the luminal device as it penetrates the septum. FIG. [Figure 20B] 20A, 20C, 20E, 20G, and 20I, where the graphical element represents an exposed distal portion of the endoluminal device distal to the distal end of the endoluminal device. [Figure 20C] 13 is a side cross-sectional view of an endoluminal device being advanced distally through the luminal device as it penetrates the septum. FIG. [Figure 20D] 20A, 20C, 20E, 20G, and 20I, where the graphical element represents an exposed distal portion of the endoluminal device distal to the distal end of the endoluminal device. [Figure 20E] 13 is a side cross-sectional view of an endoluminal device being advanced distally through the luminal device as it penetrates the septum. FIG. [Figure 20F] 20A, 20C, 20E, 20G, and 20I, where the graphical element represents an exposed distal portion of the endoluminal device distal to the distal end of the endoluminal device. [Figure 20G] 13 is a side cross-sectional view of an endoluminal device being advanced distally through the luminal device as it penetrates the septum. FIG. [Figure 20H] 20A, 20C, 20E, 20G, and 20I, where the graphical element represents an exposed distal portion of the endoluminal device distal to the distal end of the endoluminal device. [Figure 20I] 13 is a side cross-sectional view of an endoluminal device being advanced distally through the luminal device as it penetrates the septum. FIG. [Figure 20J] 20A, 20C, 20E, 20G, and 20I, where the graphical element represents an exposed distal portion of the endoluminal device distal to the distal end of the endoluminal device. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0101] 1A, 2A, and 3, in some embodiments of the present invention, a guide sheath 10 includes an elongated flexible catheter tube or sheath 12 and a control handle 16 proximal to the sheath 12. The sheath 12 is configured with a lumen 14 through which various endoluminal devices may 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 that transmits electrical signals to energize the devices and components of the guide sheath and / or receives signals generated or detected by the endoluminal devices and components of the guide sheath.

[0102] The lumen 14 of the sheath 12 communicates with a longitudinal passageway 18 provided in the control handle 16. The passageway 18 has a length L18 and is configured to receive an intraluminal device that can pass from the passageway 18 of the control handle 16 into the lumen 14 of the sheath 12. In some embodiments, the proximal end of the passageway 18 is defined by a hemostatic valve 22 extending proximally from the proximal end of the control handle 16, and access to the proximal end of the passageway 18 is through a fluid-tight seal of the valve 22, allowing for the entry and passage of an intraluminal device without fluid leaking out of the valve 22 or air entering the valve 22. If a lumen is present, a first (or outer) intraluminal device 24 advancing through the passageway 18 of the control handle 16 and further through the lumen 14 of the sheath 12 allows a second (or inner) intraluminal device 26 to pass through the lumen 25 of the first intraluminal device 24. It will be appreciated that any of the intraluminal devices may include an end effector, such as a septum needle, an electrode assembly configured to map an organ, and / or an ablation electrode assembly.

[0103] In some embodiments, the first intraluminal device 24 is an intraluminal catheter or dilator that is advanced through the guide sheath 10 into the patient's heart, followed by a transseptal needle or wire as a second intraluminal device 26 that is advanced through the lumen 25 of the catheter or dilator 24 into the patient's heart.

[0104] 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 12D of the sheath. In some embodiments, for example, when 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 to be inserted into the guide sheath 10, while the handle 27 and the valve 23 are configured to remain proximal to the control handle 16 of the guide sheath 10. The shaft 28 of the device 24 has a length LIN1 between the proximal and distal ends 28P, 28D that is at least a length DD1 longer than the length LT of the guide sheath 10, such that when the first intraluminal device 24 is advanced sufficiently within the guide sheath to deploy at its distal end 28D (e.g., with its handle 27 abutting the proximal end 16P of the control handle 16), the distal end 28D of the first intraluminal device 24 has an exposed length of DD1 beyond 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.

[0105] The second intraluminal device 26 has an elongated body 31 of length LIN2 between its proximal end 26P and distal end 26D, which length LIN2 is longer than the overall length L24 of the first intraluminal device 24, such that when the second intraluminal device 26 extends through the first intraluminal device 24 and its distal end 26 is deployed at a treatment site within the patient's heart, e.g., at the septum, the body 31 has at least a distally 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 measure, the distally 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 guide sheath 10 while minimizing the risk of inadvertent tissue puncture by the distal end 26D.

[0106] In a typical use of these devices, referring to Figures 1A, 1B, and 1C, an electrophysiologist inserts the sheath 12 of the guide sheath 10 into the femoral artery of a patient. The shaft 28 of a first intraluminal device 24 is inserted into the passageway 18 of the control handle 16 through the hemostasis valve 22 and then advanced distally further into the lumen 14 of the guide sheath 10. The first intraluminal device 24 is advanced distally relative to the guide sheath 10 until the distal end 28D passes through the distal end 12D of the guide sheath 10. With the distal end 28D exposed, the first intraluminal device 24 is deployed and ready for diagnostic use, therapeutic use, and / or receipt of a second intraluminal device 26. In the latter case, the second instrument 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 ready for diagnostic and / or therapeutic use.

[0107] During these approach and deployment phases, the user's interest in knowing the location of the first endoluminal device 24 is typically heightened as the distal end 28D approaches the distal end 12D of the guide sheath 10 (FIG. 1E) and as it advances past the distal end 12D (FIG. 1F). The heightened interest may continue for at least as long as the distal end 28D is exposed outside the sheath 12. The calibrated maximum distal advancement of the first endoluminal device 24 relative to the sheath 12 may be limited by the hemostasis valve 22 or the device handle 27 abutting the proximal end 16P of the control handle 16 of the guide sheath 10 (FIG. 1B). Similarly, when a second intraluminal device 26 is inserted into a first intraluminal device 24, the user's interest in knowing the location of the second intraluminal device 26 typically increases when the distal end 26D is approaching (solid line in FIG. 1F) and advancing beyond (dashed line in FIG. 1F) the distal end 28D of the shaft 28 of the first intraluminal device 24. The increased interest may continue as long as at least the distal end 26D is exposed outside the distal end 28D of the first intraluminal device 24. Depending on the configuration of the proximal end of the second intraluminal device 26, there may be a calibrated maximum distal advancement of the second intraluminal device relative to the first intraluminal device 24 and / or the guide sheath 10. For example, if the first intraluminal device 24 is a dilator advanced through the guide sheath 10, followed by a transseptal needle as the second intraluminal device 26 advanced through the dilator, the distal ends of both the dilator and the transseptal needle are narrower and / or more steeply tapered relative to the guide sheath that may cause trauma and damage to cardiac tissue if advanced too distally beyond the distal end 12D of the sheath 12. It is therefore in the user's interest to track or monitor the linear advancement and placement of the distal ends 28D and 26D relative to the distal end 12D of the guide sheath 10 so as to minimize risk of injury to the patient, including the risk of inadvertent puncture of cardiac tissue.

[0108] In order for one or more of the endoluminal devices, particularly their distal ends, to be visualized on a display monitor for a user, the guide sheath system in some embodiments includes components of an advanced electrophysiology ("electrophysiology") imaging system S that supports components of a position sensing assembly 40 that are advantageously provided on the respective proximal portions of the guide sheath 10 and each of the endoluminal devices 24, 26. The position sensing assembly 40 provides signals that are generated by the proximal portions of the endoluminal devices 24, 26 and transmitted via electrical connector 17 to the system S for processing by the system in determining the position (including location and orientation) of the distal ends of the endoluminal devices 24, 26 relative to the guide sheath 10.

[0109] 4A and 4B, in some embodiments, the EP imaging system S includes a console 122 that may include an ablation power generator 125, a patient interface unit (PIU) 126, and one or more displays 127 and 128 for displaying 3D maps and electrograms. The operations, functions, and behavior of the EP imaging system S are managed by a system controller 100, which includes a processing unit 132 in communication with a memory 134 in which software for the operation of the system is stored. In some embodiments, the system controller 100 is an industry-standard personal computer that includes a general-purpose computer processing unit. However, in some embodiments, at least some of the operations, functions, or behavior of the system controller are implemented 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) that allows 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, for example, over a network. Alternatively or additionally, the software can be provided on a non-transitory tangible medium, such as an optical, magnetic or electronic storage medium.

[0110] In some embodiments, memory 134 includes multiple modules used by processing unit 132, such as, for example, a force sensing module 151, a temperature sensing module 152, a 3D mapping module 153, an ablation module 154, and an irrigation module 155, whose functions (e.g., measuring tissue temperature, determining the location of components within the patient's body using electromagnetic navigation / position sensors responsive to external magnetic field generators positioned outside the patient's body (e.g., under the patient's bed), energizing electrodes to ablate tissue, and controlling the flow of irrigation fluid to the treatment site, respectively) are known in the art. Memory 134 further includes a position sensing module 160 that supports position sensing assemblies and methods used by processing unit 132.

[0111] 1A, 2A, and 2B, the components of the position sensing assembly 40 include at least an emitter 42A advantageously located on a proximal portion of the first intraluminal device 24 and at least one sensor 44 fixed or otherwise located along the pathway 18 within the control handle 16 of the guide sheath 10, such that the emitter 42A and the sensor 44 can interact with one another as the first intraluminal device moves through the pathway 18. For example, as the emitter 42A carried on the first intraluminal device 24 moves into sensing proximity of the sensor 44, a signal is generated by the sensor in response to the presence and / or movement of the emitter 42A relative to the sensor 44, such generated signal being indicative of at least the position (linear and / or rotational) of the proximal portion of the first intraluminal device 24 relative to the control handle 16 and, due to its predetermined configuration and geometry, also the position (linear and / or rotational) of the distal end 28D of the first intraluminal device 24.

[0112] 1A and 2A-2B, in some embodiments, the components of the position sensing assembly 40 also include at least one emitter 42B advantageously located on a proximal portion of the second intraluminal device 26, such that the emitter 42B and the sensor 44 can interact with one another as the second intraluminal device moves through the lumen 25 of the first intraluminal device 24. For example, as the emitter 42B carried on the second intraluminal device 26 moves into sensing proximity of the sensor 44, a signal is generated by the sensor in response to the presence and / or movement of the emitter 42B relative to the sensor 44, such generated signal being 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, and also the position (linear and / or rotational) of the distal end 26D of the second intraluminal device 26 according to a predetermined configuration and geometry of the intraluminal device 26 and the guide sheath 10.

[0113] It will be appreciated that each of the first and second intraluminal devices 24 and 26 has a respective predetermined configuration and geometry such that the spatial relationship between their respective distal ends and proximal portions remains known and generally predictable, regardless of whether the devices are configured to deflect unidirectionally or bidirectionally (see FIG. 1D). The configurations and geometries of the first and second intraluminal devices and the guide sheath for use with the system are stored in the configuration and geometry subroutine 156 of the memory 134 (FIG. 4B). Thus, the system can utilize signals generated by sensors in response to emitters in the proximal portions of each of the first and second intraluminal devices to reliably determine the position (location and orientation) of the distal ends of each of these devices relative to the guide sheath.

[0114] 1A and 2A, in some embodiments, when multiple sensors 44 are located in the passageway 18 of the guide sheath's control handle 16, the sensors 44 are linearly arranged and evenly spaced to form an N×1 sensor array 46 having a length L46 extending along the passageway 18 parallel to the longitudinal axis 48 of the control handle 16. The length L46 may be generally equal to the passageway length L18, and thus L18 and L46 may be used interchangeably herein. N may range from 1 to 10, and in some embodiments is preferably 6.

[0115] 3, the one or more emitters 42A of the first intraluminal device 24 are supported on a proximal portion of the shaft 28 immediately adjacent the sensors 44 of the array 46 and coextensive with the pathway 18 when the first intraluminal device 24 is advanced sufficiently into the guide sheath 10 for deployment beyond the distal end 12D of the guide sheath 10. The one or more emitters 42B of the second intraluminal device 26 extend through the lumen 25 of the shaft 28 and are supported on a proximal portion of the elongate body 31 of the device 26 that is coextensive with the pathway 18 when the second intraluminal device 26 is advanced sufficiently into the first intraluminal device 24 for deployment beyond the distal end 28D of the first intraluminal device 24.

[0116] The approach distance AD ​​of the endoluminal device is defined herein as the predetermined distance at which a user becomes concerned when the distal tip of the endoluminal device is distally approaching the distal end of the guide sheath (or the first or outer endoluminal device). The exposed (or deployed) length DD of the endoluminal device is defined herein as the predetermined maximum distance that a user will allow the distal end of the endoluminal device to extend beyond the distal end of the guide sheath (or the first or outer endoluminal device).

[0117] In embodiments in which the length L46 of the sensor array 46 is shorter than either (i) the exposed length DD1 of the first endoluminal device 24 or (ii) the exposed length DD2 of the second endoluminal device 26, each endoluminal device 24, 26 may be configured to carry multiple emitters extending along their respective proximal portions over a distance of length L45 or more to compensate for the deficiency of the sensor array length L46 relative to the longer exposed lengths DD1 and / or DD2, with the separation distance between each emitter depending at least in part on the sensor array length L46.

[0118] In some embodiments, if the length L46 of the sensor array 46 within the control handle 16 of the guide sheath 10 is greater than each of (i) the approach distance AD1 of the first intraluminal device 24 and the approach distance AD2 of the second intraluminal device 26, as shown in Figure 3, and (ii) the deployed distance DD1 of the first intraluminal device 24 and the deployed distance DD2 of the second intraluminal device 26, as shown in Figure 3, each intraluminal device may carry a single emitter since no scaling is required. However, it is understood that the intraluminal devices are not limited to carrying a single emitter and each intraluminal device may carry multiple emitters as needed or desired.

[0119] It is understood that for finer detection and higher resolution in position sensing by the system, the separation distance between the N plurality of sensors 44 and / or adjacent sensors 44 in the array 46 may be varied as desired 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 deployed 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 deployed distances DD1, DD2.

[0120] In some embodiments, the separation distance between adjacent sensors 44 is less than the distance or field of detection of the sensors 44 such that the detection fields of two adjacent sensors include overlap, and thus while an emitter is within detection of the sensor array 46, it is detected by at least one sensor at any given time.

[0121] As described herein, detection and determination of the linear motion and position of the outer and inner endoluminal devices relative to the control handle of the guide sheath is made possible by interaction between the emitters 42A, 42B and the sensor array 46 as the endoluminal devices move along the path of the control handle. In some embodiments, the emitters may 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.

[0122] In embodiments where the emitters 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 adequately provide information regarding the rotational position (movement or displacement used interchangeably herein) of the endoluminal device to the sensor array along the path. Thus, in some embodiments, as shown in Figures 5A, 5B, and 5C, for detection and determination of rotational movement and position of the endoluminal devices 24, 26 about their longitudinal axis Z, additional magnetic field generating members 42A and 44B are arranged offset from the Z axis on the endoluminal devices 24, 26, respectively, and configured in the form of off-axis tabs for interaction with orthogonal (or off-angle greater than or less than 90 degrees) sensors 44x and 44y for detection and determination of "rotational" movement and position. The 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 about the longitudinal axis Z. As each of the endoluminal devices 24 and 26 rotates about the Z axis or otherwise assumes a different radial angle relative to the sensor 44x (along the x-axis) and the sensor 44y (along the y-axis), different identifiable signals are generated in response to the different angular positions of each member 42A, 42B relative to each of the orthogonal sensors. Thus, the orthogonal (or off-angle) sensors 44x, 44y can provide signals representative of rotational movement and displacement in the x / y plane of each endoluminal device. In embodiments in which pairs or sets of sensors 44x and 44y are located at different axial locations along the z-axis, multiple sensors 44x extending in the Z-axis direction may form a sensor array 46x, and multiple sensors 44y extending in the Z-axis direction may form a sensor array 46y, which may generate signals representative of both the linear and rotational movement and position of each endoluminal device as it advances through the guide sheath 10.

[0123] 6A and 6B, in some embodiments, the pathway 18 of the control handle 16 has a single linear array 46 with a proximal sensor 44P and a distal sensor 44D. The intraluminal device 24 has a proximal magnetic field emitter 42P and a distal magnetic field emitter 42D extending through the intraluminal device 24, configured with their respective magnetic dipoles or fields orthogonal to one another. For example, as shown, the proximal emitter 42P generates magnetic field lines perpendicular to the longitudinal axis Z of the intraluminal device 24, while the distal emitter 42D generates magnetic field lines parallel to the longitudinal axis Z. The emitters 42P, 42D may be embedded in the shaft of the intraluminal device. In some embodiments, the distal emitter 42P is configured such that its magnetic field lines are parallel to the longitudinal axis Z, which produces a changing voltage in the sensor from 0.0V to 3.0V when moved distally past the sensor, and a changing voltage from 3.0V to 0.0V when moved proximally past the sensor. Thus, the signal generated by the distal sensor 44D can represent the linear position or movement of the intraluminal device 20, and the direction of movement. In some embodiments, the proximal emitter 42D is configured such that its magnetic field lines are orthogonal to the longitudinal axis Z, which produces a changing voltage from 0.0V to 3.0V when the intraluminal device 24 is rotated 180° 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 intraluminal device 20. A total voltage reading of 0.0V to 6.0V represents the linear and rotational position and extent of movement.

[0124] 7A and 7B, in some embodiments, the pathway 18 of the control handle 16 has two orthogonal (or off-angle) arrays of sensors 46x and 46y through which the endoluminal device 20 extends has an oppositely magnetized member (or ring magnet) 42 whose magnetic field lines are either diametrically opposed to the endoluminal device 20 or perpendicular to the longitudinal axis of the endoluminal device 20. The emitter member 42 is configured to produce voltage changes in the sensors of both arrays such that pure linear motion of the endoluminal device 20 without rotational motion produces nearly identical response signals between each sensor 46x of the orthogonal array, produces nearly identical response signals between each sensor 46y of the orthogonal array, and pure rotational motion of the endoluminal device 20 without linear motion produces response signals only for the orthogonal pairs of 46x and 46y at the same axial location. A combination of linear and rotational motion in the endoluminal device 20 produces response signals in the sensors of both arrays that are representative of the combined motion.

[0125] 8A and 8B, components of the position sensing assembly 240 include an optical sensor 252 and an optical emitter (or sensor marker) that includes, for example, an optically detectable pattern 254 whose optical radiation is detected by the optical sensor 252 when illuminated by the optical source 250. The optical source 250 and the optical sensor 252 may form an optical unit within the control handle 16. The optically detectable pattern 254 is provided on a proximal portion 220P of the intraluminal device 220, and the optical source 250 and the optical sensor 252 are located along a path 218 of the control handle 216 of the guide sheath 210 that receives the intraluminal device 220. The optical sensor 252 generates a signal in response to the presence, movement, and location of the illuminated optically detectable pattern 254, and 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, and may also represent the displacement and position of the distal portion of the endoluminal device relative to the control handle 16.

[0126] In some embodiments, multiple optical units are provided to form a linear optical array extending longitudinally along path 18. In some embodiments, two optical arrays 246a and 246b are provided that are diametrically opposed to each other along path 18 to minimize interference between optical illumination and sensing between the two arrays.

[0127] 8B, the optically detectable pattern may include at least two different patterns 254a and 254b disposed at different or opposing locations on the surface of the endoluminal device 220 such that a signal generated by the optical sensor 252 in response to the two different patterns may indicate the angular rotation of the endoluminal device 220 about its longitudinal axis. The optically detectable pattern may also be unique to each individual endoluminal device such that each endoluminal device may be identified and limited as a single use device.

[0128] In some embodiments, as shown in FIG. 2A, one or more of the endoluminal devices 24, 26 include an identification marker 170, and the control handle 16 of the guide sheath 10 includes an identification circuit 172. The identification circuit 172 is configured to determine or identify a predetermined configuration and geometry of the endoluminal device based at least in part on the identification marker 170, which may include a radio frequency identification (RFID) circuit. The identification marker 170 may be affixed to a proximal portion of each endoluminal device so that it is read by the identification circuit 172 located along the path 18 of the control handle 16 upon or shortly thereafter insertion into the control handle. In some embodiments, the identification marker 170 may be read by a scanning unit 176 separate from or in addition to the identification circuit 172 in the control handle 16, which communicates with the ID subroutine 159 of the position sensing module 160 (FIG. 4B).

[0129] In some embodiments, the optical source 250 includes an LED, the optical sensor 252 includes a photodiode, and the optically detectable pattern 254 of optical emitters includes a bar code or binary alternating symbol at circumferential and multi-axial locations on the surface of the intraluminal device 220. It is understood that the optically detectable pattern of optical emitters typically consists of distinct indicia of dark and light shades that reflect light energy in a corresponding pattern 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. 9. The position sensing assembly 240 may include multiple optical sources 250 and multiple optical detectors 252 arranged in pairs, with each pair located at a different location along the path 18. It is understood that the parameters of the configuration of the position sensing assembly 240 depend on various 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 exact location of the intraluminal device relative to the guide sheath, etc.

[0130] It is emphasized that all of the components of the position sensing assembly are within the control handle of the guide sheath, which is well outside the patient's heart, if not outside the patient's body, to improve safety for the patient. Moreover, the electrical connections to and from the electromagnetic sensor do not extend distally beyond the control handle. That is, electrical connectors such as lead wires for transmitting signals representative of the position of the distal tip of either the first or second endoluminal device no longer need to pass the entire length of the shaft of these instruments, which greatly reduces the manual labor required to build and assemble these instruments, not to mention the space saved at the distal tip occupied by conventional electromagnetic position sensors that use x / y / z coils.

[0131] It is understood that the means for determining position, including the means for determining the position of the distal portion of the endoluminal device, are shown and described in one of many examples with reference to magnetic field emitters and magnetic field sensors, including, for example, magnets and Hall effect sensors shown in Figures 2A and 2B, and with reference to optical sensors and optical emitters illuminated by optical sources, including, for example, photodiodes, optically readable patterns, and LEDs shown in Figures 8A and 8B. It is further understood that determining position may include determining length, and thus the means for determining position may be used interchangeably with the means for determining length, as needed or appropriate. It is further understood that the means for determining position includes a conductive member configured to complete an electrical circuit, a sensor for detecting the completed electrical circuit, and a sensor for measuring impedance, as described further below.

[0132] It will also be understood that the position sensing assembly is not limited to only electromagnetic or optical components, and further, that both of these types of components may be incorporated and used together as needed or desired.

[0133] 13, an operator uses an advanced electrophysiology (EP) imaging system S, such as the CARTO® 3 System, to obtain a 3D map of a patient's body, including the patient's heart. The image generated by the system S that is displayed not only includes the 3D map of the patient's heart, but also includes a depiction of a first (or outer) endoluminal device 24, e.g., a dilator, and a second (or inner) endoluminal device 26, e.g., a transseptal needle, particularly their respective distal ends.

[0134] In arriving at this image of the first and second endoluminal devices according to some embodiments, the user performed 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, and including the selection of the guide sheath and the first and second endoluminal devices to be used in the procedure. The geometries and configurations of the guide sheath 10 and endoluminal devices suitable for use with the system S, including the selected first and second endoluminal devices 24 and 26, are stored in the configuration and geometry subroutine 156 of the memory 134 ( FIG. 4B ). These configurations and geometries provide a predictable and reliable determination of the location, position, and / or orientation of the distal portion of the endoluminal device based on the location, position, and / or orientation of the proximal portion of the endoluminal device relative to the control handle of the guide sheath through which the endoluminal device extends. With reference to FIG. 3 , the parameters stored in the configuration and geometry subroutine 156 may include, for example:

[0135] [Table 1]

[0136] Once the guide sheath and the first and second endoluminal devices are to be used in a procedure identified by the user, the system can retrieve relevant parameters from the configuration and geometry subroutine 156, including the above parameters, to be used and applied by the position sensing module 160.

[0137] In some embodiments of the systems, devices, and associated methods, reference is made to the flow chart of Figure 10. At block 502, a determination is made of a location of a distal portion of a guide sheath within a patient, for example, by the mapping module 153. At block 504, a determination is made of a length of insertion of a shaft of an endoluminal device having a predetermined geometry within the sheath. At block 506, a determination is made of a location of a distal end of the shaft within the patient based at least in part on the length of insertion of the shaft of the sheath. At block 508, a graphical representation of the location of the distal end of the shaft within the patient is provided.

[0138] In some embodiments of the method related to the system and device, reference is made to the flow chart of FIG. 11. The flow chart begins at block 300. In block 302, configuration and geometry parameters of the guide sheath and the endoluminal device are determined and stored in a configuration / geometry subroutine in the memory of the EP imaging system S. In block 304, the guide sheath is inserted into the patient. In block 304, the endoluminal device is inserted into the guide sheath. In block 306, the endoluminal device is advanced relative to the guide sheath with an emitter on the endoluminal device moving toward a sensor located in the control handle of the guide sheath. In block 308, the sensor senses the emitter and generates a signal in response to the emitter. In block 310, a position sensing module accesses the parameters and determines the position of the distal end of the endoluminal device based on the signal. In block 312, the EP imaging system S displays the position of the distal end of the endoluminal device. It is understood that the position may include location and orientation.

[0139] In some embodiments of the method related to the system and device, reference is made to the flow chart of FIG. 12. The flow chart begins at block 400. In block 402, the parameters of Table 1 are determined and stored in the configuration / geometry subroutine in memory 134. In block 404, the user inserts the guide sheath 10 into the vasculature of the patient, e.g., the femoral artery, and fixes the position of the guide sheath 10 in a fixed relationship to the patient. In block 406, the EP imaging system S determines the position of the distal end 12D of the guide sheath, e.g., by electromagnetic navigation sensors, as known in the art. In block 408, the user inserts a first intraluminal device 24 into the lumen 14 of the guide sheath 10 through the hemostasis valve 22. In block 410, the user advances the device 24 distally toward the distal end 12D of the guide sheath 10. In block 412, when the distal emitter 42A1 on the shaft 28 of the first intraluminal device 24 approaches the sensor 44 in the control handle 16 of the guide sheath, the sensor 44 senses the distal emitter 42A1 and generates a signal in response to the emitter 42A1. In block 414, the position sensing module 160 monitors the signal for an event, e.g., a peak (calibrated maximum value) or a particular characteristic indicative of the distal emitter 42A1 aligned alongside and closest to the sensor 44 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. The first intraluminal device 24 has a predetermined geometry including, for example, that the position LM1 of the distal emitter 42A1 on the shaft 28 relative to the distal end 28D is equal to the length LS1 (i.e., the distance between the sensor 44 and the distal end 12D of the guide sheath) minus the approach distance AD1, so that the signal generated by the sensor 44 when the sensor 44 and the distal emitter 42A1 are aligned side by side and in closest proximity advantageously indicates the relative position between the device 24 and the guide sheath 10, including that the distal end 28D of the first intraluminal device 24 has reached the approach distance AD1 of the distal end 12D of the guide sheath.At decision block 418, a query is made as to whether an event indicates or is related to the distal end 28D reaching the approach distance AD1. If the sensor 44 is generating a signal (or a peak signal) in response to the distal emitter 42A1, the answer to the query is yes and the flow chart proceeds to block 420, which activates an indicator, e.g., visual alarm 160 and / or audio alarm 162, to notify the user that the distal end 28D has reached the approach distance AD1 and that the distal end 28D may soon protrude from the distal end 12D of the sheath 12, before proceeding to block 422. The indicator may automatically terminate after a predetermined duration or may remain active until deactivated by the user. If the sensor 44 is not generating a signal (or a peak signal) in response to the distal emitter 42A1, the answer to the inquiry at block 418 is no and the flowchart proceeds 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 a display of the distal end 12D of the guide sheath within the patient's heart on the display monitor and according to the configuration and geometric parameters of the first intraluminal device 24. In this manner, the determined position and display of the distal end 28D of the intraluminal device 24 is advantageously based on the signal generated by the proximal end of the first intraluminal device 24.

[0140] At decision block 424, an inquiry is made as to whether the first intraluminal device 24 continues to advance distally relative to the guide sheath 10. This determination can be made, for example, by evaluating a change in the signal sensed by the sensor 44 with reference to a parameter of the first intraluminal device 24. If yes, the flowchart returns to block 412. As the intermediate emitter 42A2 of the first intraluminal device 24 approaches the sensor 44, the sensor 44 senses the intermediate emitter 42A2 and generates a signal in response to the intermediate emitter 42A2. At block 414, the positioning module 160 monitors the signal for an event, e.g., a peak (calibrated maximum value) or a particular characteristic, indicative of the intermediate emitter 42A2 being aligned alongside and closest to the sensor 44 along the longitudinal axis of the control handle 16. At block 416, the position sensing module 160 accesses parameters stored in the configuration and geometry subroutine 156 of the first intraluminal device 24 and the intermediate emitter 42A2 based on the signal event. Because the first intraluminal device 24 has a predetermined geometry including, for example, a position of the intermediate emitter 42A2 on the shaft 28 relative to the distal end 28D equal to the length LS1, a signal generated by the sensor 44 when the sensor 44 and the intermediate emitter 42A2 are aligned side-by-side and in closest proximity advantageously indicates a relative position between the device 24 and the guide sheath 10 including that the distal end 28D is at the distal end 12D. At block 418, since the distal end 28D is not at the approach distance AD1 (but has actually moved past the approach distance AD1), the flowchart continues at block 422 where the processing unit 132 continues to display in real time on the display monitor the location of the distal end 28D relative to the distal end 12D of the guide sheath within the patient's heart on the display monitor. Again, the determined location and display of the distal end 28D of the endoluminal device 24 is advantageously based on signals generated by the proximal end of the first endoluminal device. At decision block 424, a query is made as to whether the first endoluminal device 24 continues to advance 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 intraluminal device 24, or by an input by the user that the first intraluminal device 24 is still being advanced. If yes, the flowchart returns to block 412. Additionally or alternatively, the inquiry of decision block 424 may include a determination as to whether the distal end 28D is at the maximum deployed distance DD1 by accessing a parameter stored in the configuration and geometry subroutine 146. If no, the flowchart returns to block 412.

[0141] The loop including blocks 412, 414, 416, 418, 420, 422, and 424 may be repeated for the proximal emitter 42A3 on the first intraluminal device 24. In block 416, the position sensing module 160 accesses parameters stored in the configuration and geometry subroutine 156 of the first intraluminal device 24 and the proximal emitter 42A3. Because the first intraluminal device 24 has a predetermined geometry including, for example, a position of the proximal emitter 42A3 on the shaft 28 relative to the distal end 28D equal to the length LS1 plus a calibrated maximum exposed distance DD1 of the distal end 28D of the first intraluminal device 24 distal to the distal end 12D of the control handle, the signal generated when the sensor 44 and the proximal emitter 42A3 are aligned side-by-side and in closest proximity advantageously indicates a relative position between the device 24 and the guide sheath 10 including the distal end 28D being at the calibrated maximum exposed length DD1 distal to the distal end 12D. Again, the flowchart continues to block 422 as the distal end 28D has been advanced past the approach distance AD1. In block 422, the processing unit 132 continues to display on the display monitor in real time the location of the distal end 28D relative to the distal end 12D of the guide sheath within the patient's heart, the determined position and display of the distal end 28D being advantageously based on signals generated by the proximal end of the first intraluminal device 24.

[0142] When the first intraluminal device is no longer advanced relative to the guide sheath, as determined by the position sensing module evaluating a change in the signal sensed by the sensor 44 with reference to a parameter of the first intraluminal device 24, or by input by the user that the first intraluminal device 24 has not yet been advanced, decision block 424 continues to decision block 426 with an inquiry as to whether another intraluminal device should be inserted. This determination may be based on user input. If yes, the flow chart returns to block 410, where the second intraluminal device 26 is inserted into the first intraluminal device 24, via the valve 23, and advanced distally toward the distal end 28D of the first intraluminal device 24. In block 412, as the distal emitter 42B1 on the elongate body 31 of the second intraluminal device 26 approaches the sensor 44 in the control handle of the guide sheath, the sensor 44 senses the emitter 42B1 and generates a signal in response to the emitter 42B1. At block 414, the position sensing module 160 monitors the signal for an event, e.g., a peak (calibrated maximum value) or a particular characteristic, as indicative of the sensor 44 and the distal emitter 42B1 being most closely aligned side-by-side along the longitudinal axis of the control handle 16. At block 416, the position sensing module 160 accesses parameters stored in the configuration and geometry subroutine 156 based on the signal event. The signal is generated when the second intraluminal device 26 has a predetermined geometry including, for example, a position LE1 of the distal emitter 42B1 on the elongate body 31 relative to the distal end 26D being equal to the length LS1 plus the calibrated maximum exposure distance DD1 of the first intraluminal device 24 minus the approach distance AD2, advantageously indicating a relative position between the device 24 and the guide sheath 10 including the distal end 26D of the second intraluminal device 26 being at the approach distance AD2 of the distal end 28D of the first intraluminal device 24. In this manner, the determined location and indication 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.

[0143] At decision block 418, the processing unit 132, in response to the signal indicating that the distal end 26D is at the approach distance AD2 of the distal end 28D, activates an indicator (e.g., an audio alarm 162 or a visual alarm 164) to notify the user that the distal end 26D has reached the approach distance AD2 and that the distal end 26D may soon protrude from the distal end 28D of the first intraluminal device 24. At block 422, the processing unit 132 begins displaying in real time on the display monitor 127 the location of the distal end 26D according to the configuration and geometric parameters of the second intraluminal device 26 relative to the representation of the distal end 28D and the distal end 12D within the patient's heart on the display monitor.

[0144] If, at decision block 424, the user continues to advance the second intraluminal device 26 distally relative to the guide 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 emitter 42B2 and the proximal emitter 42B3. For the intermediate emitter 42B2, at block 414, the position sensing module 160 monitors the signal for an event, such as a peak (calibrated maximum value) or a particular characteristic, that would indicate that the sensor 44 and the intermediate emitter 42B2 are in closest proximity and aligned side-by-side along the longitudinal axis of the control handle 16. At 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 including a position of the intermediate emitter 42B2 on the elongate body 31 relative to the distal end 26D equal to the length LS1 plus the calibrated maximum exposed length DD1 of the first intraluminal device 24, the signal generated when the sensor 44 and the intermediate emitter 42B2 are aligned side-by-side and in closest proximity advantageously indicates a relative position between the device 24 and the guide 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 location of the distal end 26D of the second intraluminal device 26 relative to the distal end 28D of the first intraluminal device 24 within the patient's heart and the distal end 12D of the guide sheath 10.

[0145] For the proximal emitter 42B3, in block 414, the position sensing module 160 monitors the signal for an event, such as a peak (calibrated maximum value) or a particular characteristic, that would indicate that the sensor 44 and the proximal emitter 42B3 are in closest proximity and aligned side-by-side 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 for the second intraluminal device 26 including, for example, a position of the proximal emitter 42B3 on the elongate 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, a signal generated when the sensor 44 and the proximal emitter 42B3 are aligned side-by-side and in closest proximity advantageously indicates a relative position between the device 24 and the guide sheath 10 including that the distal end 26D is at a calibrated maximum exposure length distal to the distal end 28D. In block 422, the processing unit 132 continues to display in real time on the display monitor the location of the distal end 26D and the distal end 28D relative to the distal end 12D of the guide sheath within the patient's heart on the display monitor.

[0146] It will be appreciated that detection of any emitter on the endoluminal device (e.g., 42A1, 42A2, 42A3, 42B1, 42B2, 42B3) by the sensor will produce a signal representative of the length of insertion of the endoluminal device at which the emitter is being detected, for a given configuration and geometry of the endoluminal device, including, for example, parameters LM1, LM2, LM3, LE1, LE2, LE3. Furthermore, for a given configuration and geometry of the endoluminal device, the length of insertion can be used to determine the position (or at least the location) of the distal end of the endoluminal device relative to the guide sheath.

[0147] It is further understood that the flowchart accommodates any number of emitters so long as the endoluminal device is advanced relative to the control handle, i.e., the loop is repeated for each emitter until decision block 424 yields a "no" to the inquiry of whether the endoluminal device is still advanced relative to the control handle, and if no other endoluminal devices are to be inserted at decision block 426, the flowchart may end at block 428.

[0148] In some embodiments where one or more of the emitters 42A1, 42A2, 42A3, 42B1, 42B2 and 42B3 are off-axis on the shaft 28 of the first intraluminal device 24 and the elongate body 31 of the second intraluminal device 26, respectively, it will be appreciated that the signals generated by the sensor 44 in response thereto will also represent the rotation of the first intraluminal device 24 and the second intraluminal device 26 about their respective longitudinal axes, as shown in Figures 5A, 5B and 5C. The parameters include calibrated sensor readings corresponding to the rotational angles of the off-axis emitters. Thus, in blocks 312 and 416, the parameters accessed include signal values ​​or characteristics representative of the position of the distal ends 28D and 26D, including location and rotational orientation. In this regard, the predetermined configurations and geometries of the first and second intraluminal devices include a predetermined device stiffness over the length of the device and a torsional stiffness of the device such that application of a translational and / or rotational force to the proximal end of the device produces a predictable translation and / or rotation at the distal end.

[0149] In some embodiments, the position sensing module 160 includes a calibration table of signal readings corresponding to the longitudinal and rotational positions of each emitter of the first and second intraluminal devices relative to the sensor 44, which may be referenced by the module to determine and / or ascertain the relative positions of the emitters on the proximal portions of the devices 24 and 26 relative to the sensor 44, which are referenced by the processing unit to determine (or reliably predict) the positions of the distal ends 28D and 26D of the intraluminal devices 24 and 26 for display on the display monitor.

[0150] 14A, 14B, and 14C, in some embodiments, a position sensing assembly 600 includes first and second conductive members (or electrodes) 602, 604 located along a pathway 618 of a control handle 616 of a guide sheath 610, and a third conductive member (or electrode) 606 located on a proximal portion 608P of an intraluminal device 608 configured for insertion into the pathway 618 and distal advancement through a lumen 614 of a sheath 612 extending distally of the control handle 616. The first and second circuit members 602, 604 are separate and distinct from one another, for example, and may be located diametrically opposite one another across the pathway 618, and each may have the same dimension or width W along the pathway 618 that 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 the outer surface 609 of the intraluminal device 608. The band has a width WB along the longitudinal axis that is greater than or equal to the first and second widths W.

[0151] In use, the distal end 608D of the intraluminal device 608 is inserted into the hemostasis valve 622 at the proximal end 616P of the control handle 616 and enters the passageway 618. The distal end 608D then enters the lumen 614 of the sheath 612 of the guide sheath 610. As advancement of the intraluminal device 608 continues distally, the proximal portion 608P enters the passageway 618 and the third conductive member 606 approaches the first conductive member 602 and the second conductive member 604 (FIG. 14A). Upon further distal advancement, the third conductive member 606 comes into contact with both the first conductive member 602 and the second conductive member 604 (FIG. 14B). As shown in Figure 15, each of the first conductive element 602 and the second conductive element 604 is connected to a respective lead wire 625, 627 that extends through an electrical connector (see electrical connector 17 in Figure 1A) that allows connection to a power / current source 629. Thus, by establishing contact with the first conductive member 602 and the second conductive member 604, the third conductive element 606 completes an electrical circuit 624 that includes the first conductive member, the third conductive member, and the second conductive member, such that electrical conductivity is detected (Figure 15B). That is, when the third conductive member 606 contacts the first conductive member 602 and the second conductive member 604, the circuit 624 is completed, thereby identifying the presence of the intraluminal device 608. Because the device 608 has a predetermined geometry, e.g., a predetermined position of the third conductive member 606 from the distal or proximal end of the device 608, the signal generated when the electrical circuit 624 is completed by conductive contact between the first conductive member 602, the second conductive member 604, and the third conductive member 606 advantageously indicates a relative position between the device 608 and the guide sheath 610, including, e.g., that the distal end 608D is approaching or protruding from the distal end 612D of the sheath 612. As shown in FIG. 15B, electrical conductivity is maintained during linear translation of the device 608 relative to the control handle 616 as long as there is contact between members 602 and 606, and between members 606 and 604.

[0152] In this regard, the system S as shown in FIGURE 4C includes a circuit sensing subroutine 165 within 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 in the memory 134 for the device 608. The stored configuration and geometry of the device 608 provides a predictable and reliable determination of the location, position, and / or orientation of the distal end 608D of the device 608 based on the location, position, and / or orientation of the proximal portion 608P of the device 608 relative to the control handle 616 of the guide sheath 610 through which the device 608 extends.

[0153] 16A, 16B, and 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 common plurality of second conductive members 604, each second conductive member diametrically opposed from a respective first conductive member along a pathway 618 to form a separate and distinct conductive member of a respective pair. A third array C of a plurality of third conductive members 606 is located on a proximal portion 608P of the intraluminal device 608, each of the third conductive members 606 may contact a pair of conductive members 602, 604 upon movement of the device 608 relative to the control handle 616 in completing a respective electrical circuit 624 with the connected pair 602, 604.

[0154] As shown in FIG. 17, as the intraluminal device 608 advances distally within the control handle 616 along the path 618 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 between each pair of the first conductive member 602 and the second conductive member 604 by the third conductive member 606 indicates the relative position and movement between the proximal portion 608P of the device 608 and the control handle 616, and therefore the relative position and movement between the distal end 608D of the device and the distal end 610D of the guide sheath 610 based on the configuration and geometry of the device 608.

[0155] Using a plurality of N first and second conductive members 602 and 604 and a plurality of N current sensors A1-AN, the completion of each circuit between each pair of the first and second conductive members 602 and 604 by connecting the third conductive member 606 is detected by the current sensors A1-AN. ​​Through the progression of the current sensors A1-AN detecting the completion of the circuit along the arrays A, B, the system S determines the relative position and movement of the proximal portion 608P and the control handle 616 of the device 608. Detection of the completion of the circuit A1 indicates that the proximal portion 608P is at a position P1 relative to the control handle. For example, as shown in FIG. 17, detection of the completion of the circuits A1, A2, A3 by the third conductive members 606A, 606B, 606C indicates that the proximal portion 608P is at a respective position relative to the control handle 616. Similarly, it is understood that detection of the completion of the circuits A1, A2, A3, A4 by the third conductive members 606A, 606B, 606C, 606D indicates that the proximal portion 608P is at a more distal respective position relative to the control handle 616. Each respective position relative to the control handle determines the respective position of the distal end 608D of the device 608 relative to the distal end of the guide sheath 610 based on the known configuration and geometry of the device 608 and the guide sheath 610. It is understood that the width and spacing of the conductive members of the arrays A1, A2, A3 can be varied 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.

[0156] 17, the proximal portion 608P of the device 608 includes visual indicia 630 configured to be viewed by a user in visually informing the user of the relative position between the device 608 and the control handle 616, and thus the relative position between the distal end 608D of the device 608 and the distal end of the sheath 612 of the guide sheath 610. In some embodiments, the visual indicia 630 may include, for example, alphanumeric symbols 630N at selected locations indicating the distance from the respective locations to the proximal end of the device 608, the locations being between adjacent third conductive members 606. In some embodiments, the visual indicia 630 may include color-coded markers or bands 630B, for example, a green marker at a distal location D, a yellow marker at an intermediate location M, and a red marker at a proximal location P, where the green marker indicates that the distal end 608D of the device 608 is proximal to the distal end 612D of the sheath 612, the yellow marker indicates that the distal end 608D is approaching the distal end 612, and the red marker indicates that the distal end 608D has just passed and is protruding from the distal end 612 and distal advancement is continuing.

[0157] It will be appreciated that increasing the cross-sectional area of ​​the conductor reduces the electrical impedance, as shown in FIG. 18. As 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, resulting in a decrease in the electrical impedance Z of the completed circuit. Thus, when calibrated to a position value, the impedance reading of the completed circuit indicates the linear position of the device 608 relative to the control handle 616, and thus relative to the distal end 612D of the guide sheath 612 and sheath 610. The position value can be correlated to the distance the distal end 608D of the device 608 protrudes from the distal end 612D of the sheath 612, or the approach distance remaining before the distal tip 608D exits the distal end 612D of the sheath 612.

[0158] In some embodiments, as shown in Figure 19, the 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. Figure 18 is a graph of the impedance (in ohms) measured across the circuit 625 as a function of the distance (displacement) of the third conductive member 606 relative to the first conductive member 602 and the second conductive member 604, representing the amount of contact surface area between the first, second and conductive members 602, 604, 606. When the third conductive member 606 is not in contact with the first conductive member 602 and the second conductive member 604 (Figure 14A), the graph in Figure 18 shows the impedance measured at a maximum. As the intraluminal device 608 advances distally, the third conductive member 606 comes into contact with the second and third members 602 and 604 (FIG. 14B), and the measured impedance Z decreases. As the intraluminal device 608 advances further distally, the third conductive member 606 comes into full contact with the second and third members (FIG. 14C), and the measured impedance decreases further. In this regard, the system S shown in FIG. 4C includes an impedance subroutine 166 in the position sensing module 160. By measuring and monitoring the 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 in the memory 134 for the device 608. The stored configuration and geometry of the device 608 provides a predictable and reliable determination of the location, position, and / or orientation of the distal end 608D of the device 608 based on the location, position, and / or orientation of the proximal portion 608P of the device 608 relative to the control handle 616 of the guide sheath 610 through which the device 608 extends.

[0159] In some embodiments, the system S is configured to provide a user with visual region of interest indicia on a display within a real-time 3D electroanatomical map via an imaging electromagnetic system such as the CARTO® 3 System by Biosense Webster, Inc., Irvine, California. Referring to Figures 20A, 20B, 20C, 20D, 20E, 20F, 20G, 20H, 20I, and 20J, the generated 3D electroanatomical visualization of an endoluminal device 702, such as, for example, a transseptal guidewire, inserted through a lumen 706 of a luminal device 704, such as, for example, a dilator, inserted through a guide sheath 701 includes visual indicia 700 representing a region of interest ROI occupied by a protruding distal portion 702D. In some embodiments, the distal portion 702D of the intraluminal device 702 has a shape memory such that it is straightened from a predetermined 2D or 3D configuration for insertion into and advancement through the lumen 706, and then elastically reconforms the predetermined configuration upon exiting the lumen or when otherwise unconstrained and released from external forces. The predetermined configuration may be a "J" shape or any other 2D or 3D shape that is reconformed by the distal portion 702D after it exits the internally lumenal device 704, penetrates the septum 712, and advances distally into the left atrium 714.

[0160] In some embodiments, the dynamic visual indicia 700 is displayed as a graphical element near or extending from a depiction or visualization of the distal end 702D of the luminal device 704 to represent a 2D or 3D area occupied by the distal portion 704D within the left atrium. In FIG. 20A, the distal portion 702D has not yet exited the lumen 706, so the distal portion is visualized on the display as a first graphical element 715, e.g., an oval, which may be displayed in a first color, as shown in FIG. 20B. As the distal portion 702D is advanced distally and punctures the septum 712, as shown in FIG. 20C, the dynamic visual indicia 700 in the visualization of the distal portion 702D becomes a second graphical element 716, e.g., a circle, which may be displayed in a second color. The circle represents a spherical area that may be occupied by the distal portion 702D, as shown in FIG. 20D. In particular, 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 lumenal device 704 based on the position sensing assembly's determination of the linear translation of the intraluminal device 702. Upon further distal advancement, the distal portion 702D penetrates the septum 712 and enters the left atrium 714, as shown in Figure 20E, and the circle of the second graphical element 716 increases in size as the diameter is scaled to a length that represents the greater exposed length of the distal portion 702D that protrudes beyond the distal end 704D, as shown in Figure 20F.

[0161] In some embodiments where the distal portion 704D of the endoluminal device 704 has a predefined configuration, e.g., a "J" bend, that is reconformed by the distal portion 704D after further penetration of the septum 712 into the left atrium 714, as shown in FIG. 20G, the diameter of the second graphical element 716, and therefore the circle, is further increased such that the circle circumscribes the entire exposed distal portion 702D, as shown in FIG. 20H. The represented circle and spherical area advantageously covers all possible locations of the "J" bend, regardless of its axial rotation along the longitudinal axis of the luminal device 704. If the distal portion 704D extends further into the left atrium 714, e.g., beyond the distal end 704D beyond a predefined threshold length, as shown in FIG. 20I, the visualization of the distal portion 704D becomes a third graphical element 719, e.g., another circle of a different color, whose diameter is scaled to represent the predefined threshold length, as shown in FIG. The third graphical element 719 may serve to alert the user that the distal portion 702D is "out of range." Any of the above-described embodiments of the position sensing assembly 40 by applying known configurations and geometries of the endoluminal device 702, the luminal device 704, and / or the outer luminal device may 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. Additionally, the visual indicia 700 may be dynamically displayed to the user in real-time along with visualization of any, some, or all of these devices, such that the user has a visual cue of the area in which the distal portion 702D of the endoluminal device 702 may be located at any given time during the procedure. The above description has been presented in connection with a currently preferred embodiment of the invention. Those skilled in the art and technology to which the invention pertains will recognize that modifications and variations may be made in the described structures without significantly departing from the principle, spirit, and scope of the invention. Any feature or configuration disclosed in one embodiment may be incorporated in place of, or in addition to, other features of any other embodiment, as appropriate or desired.As one of ordinary skill in the art will appreciate, the drawings are not necessarily to scale.Accordingly, the above description should not be read in relation solely to the precise configuration as described and illustrated in the accompanying drawings, but rather should be read in accordance with and in support of the following claims, which are to have their fullest and fairest scope.

[0162] [Embodiment] (1) A system comprising: a sheath comprising a handle and a catheter tube extending distally from the handle; an intraluminal device having a shaft with a predetermined geometry and configured to pass through said handle and said catheter tube; a sensor assembly positioned adjacent to the handle and configured to determine a parameter of the endoluminal 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 endoluminal device. (2) a processor; and a non-transitory computer readable medium having instructions that, when executed by the processor, cause the system to: determining the length of insertion of the endoluminal device within the sheath; 2. The system of embodiment 1, wherein the position of the distal end of the shaft is determined based at least in part on the insertion length of the endoluminal device within the sheath and the predetermined geometric shape of the shaft. (3) The system of embodiment 1, wherein the sheath includes a navigation sensor proximate the distal end of the catheter tube. (4) The system of embodiment 1, wherein the distal portion of the catheter tube comprises a curve and the distal portion of the shaft comprises a preformed curve. (5) The system of embodiment 1, further comprising a transseptal puncture kit comprising the sheath and the intraluminal device.

[0163] (6) The system of embodiment 1, wherein the intraluminal device comprises a transseptal needle. (7) The system of embodiment 1, wherein the intraluminal device includes an expander. (8) The system of embodiment 1, wherein the intraluminal device further comprises an identification marker, and the handle further comprises an identification circuit configured to determine the predetermined geometric shape of the shaft based at least in part on the identification marker. (9) The system of embodiment 8, wherein the identification marker comprises a radio frequency identification (RFID) circuit. (10) The system of embodiment 1, wherein the sensor assembly comprises a sensor array in the handle of the sheath and a sensor marker disposed on a proximal portion of the shaft of the endoluminal device, the sensor array configured to determine a position of the sensor marker in the handle, thereby determining the position of the distal end of the shaft.

[0164] (11) The system of embodiment 10, wherein the sensor marker comprises a ferromagnetic material and the sensor array comprises a plurality of magnetic sensors. (12) The system of embodiment 10, wherein the sensor array comprises a plurality of sensors arranged linearly along a longitudinal axis and adjacent to a lumen in the handle, the lumen being configured to receive the shaft of the intraluminal device. (13) a processor; and a non-transitory computer readable medium having instructions that, when executed by the processor, cause the system to: determining the location of the sensor marker within the handle based at least in part on the electrical signal from the sensor array; The system of embodiment 10, further comprising: determining the position of the distal end of the shaft of the intraluminal device based at least in part on the electrical signal from the sensor array and the predetermined geometric shape of the shaft. (14) An intraluminal device position sensing system, comprising: a guide catheter sheath having a shaft and a control handle, the shaft including a lumen, the control handle having a passageway therein along a longitudinal axis, the passageway and the lumen being in communication with each other; a first endoluminal device having a predetermined geometry, a proximal portion, and a distal portion, the distal portion configured to extend through the lumen of the sheath and the proximal portion configured to extend through the passageway of the control handle; a first emitter located on the proximal portion of the first intraluminal device; a sensor located within the path of the control handle and configured to generate a signal in response to the first emitter on the proximal portion of the first intraluminal device, the signal representing a position of the distal portion of the first intraluminal device. (15) The system of embodiment 14, wherein the first emitter includes a magnetic member and the sensor includes a magnetic sensor.

[0165] (16) The system of embodiment 14, wherein the first emitter includes an optically readable pattern such that an optical signal is emitted when illuminated, and the sensor includes an optical unit having at least an optical detector. (17) The system of embodiment 16, wherein the optical unit includes a light source. (18) The system of embodiment 14, wherein the first intraluminal device is a dilator. (19) The system of embodiment 14, wherein the first intraluminal device includes a lumen configured to receive a second intraluminal device. (20) An intraluminal device position sensing system, comprising: a guide sheath having a shaft and a control handle, the shaft including a lumen, 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 geometric shape, the first intraluminal device including a proximal portion and a distal portion, the distal portion configured to extend through the lumen of the sheath and the proximal portion 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; an optical source and an optical sensor located within the pathway of the control handle, the optical source configured to illuminate the first optically readable pattern, and the optical sensor configured to generate a signal in response to illumination of the first optically readable pattern by the optical source, the signal representing a position of the distal portion of the first intraluminal device.

Claims

1. 1. A system comprising: a sheath comprising a handle and a catheter tube extending distally from the handle; an intraluminal device having a shaft with a predetermined geometry and configured to pass through said handle and said catheter tube; a sensor assembly positioned adjacent to the handle and configured to determine a parameter of the endoluminal 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 endoluminal device.

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

4. The system of claim 1 , wherein the distal portion of the catheter tube comprises a curve and the distal portion of the shaft comprises a preformed curve.

5. The system of claim 1 , further comprising a transseptal puncture kit comprising the sheath and the endoluminal 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 , wherein the intraluminal device further comprises an identification marker, and the handle further comprises an identification circuit configured to determine the predetermined geometric shape of the shaft based at least in part on the identification marker.

9. The system of claim 8 , wherein the identification marker comprises a radio frequency identification (RFID) circuit.

10. 2. The system of claim 1, wherein the sensor assembly comprises a sensor array in the handle of the sheath and a sensor marker disposed on a proximal portion of the shaft of the endoluminal device, the sensor array configured to determine a position of the sensor marker in the handle, thereby determining the position of the distal end of the shaft.

11. The system of claim 10 , wherein the sensor marker comprises a ferromagnetic material and the sensor array comprises a plurality of magnetic sensors.

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

13. A processor; and a non-transitory computer readable medium having instructions that, when executed by the processor, cause the system to: determining the location of the sensor marker within the handle based at least in part on the electrical signal from the sensor array; The system of claim 10 , further comprising: a sensor array configured to detect a position of the distal end of the shaft of the endoluminal device based at least in part on the electrical signals from the sensor array and the predetermined geometric shape of the shaft.

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

15. The system of claim 14 , wherein the first emitter comprises a magnetic member and the sensor comprises a magnetic sensor.

16. The system of claim 14 , wherein the first emitter includes an optically readable pattern such that an optical signal is emitted when illuminated, and the sensor includes 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 is a dilator.

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

20. 1. An endoluminal device position sensing system, comprising: a guide sheath having a shaft and a control handle, the shaft including a lumen, 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 including a proximal portion and a distal portion, the distal portion configured to extend through the lumen of the sheath and the proximal portion 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; an optical source and an optical sensor located within the path of the control handle, the optical source configured to illuminate the first optically readable pattern, and the optical sensor configured to generate a signal in response to illumination of the first optically readable pattern by the optical source, the signal representing a position of the distal portion of the first intraluminal device.

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