GUIDING SHEATH SYSTEM WITH POSITION SENSING AND RELATED METHODS

A system includes a sheath comprising a handle and a catheter tube, an intralumenal device with a shaft of a predetermined geometry and configured to traverse through the handle and the catheter tube, and a sensor assembly disposed approximate 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. Also, a method for visualizing a distal end of an intralumenal device, comprising determining a position of a distal portion of the sheath within a body of a patient, determining a length of insertion of a shaft configured with a predetermine geometry within a 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.

FIELD OF INVENTION

This invention relates to guiding sheath and intralumenal devices used with guiding sheaths, such as dilators, therapeutic and diagnostic catheters and transseptal needles.

BACKGROUND

Cardiac arrhythmia is irregular beating of the heart caused by aberrant electrical signals. Arrhythmias can reduce quality of life and carry increased risk of stroke and heart failure. Arrythmias can be located and identified via diagnostic catheters. These catheters can be used to create electroanatomical maps to help electrophysiologists understand the pathology and plan and deliver therapy which can include ablation via therapeutic catheters.

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

For visualization of an EP vascular instrument with The CARTO® 3 System, the instrument carries in or near its distal end an electromagnetic position sensor with three coils, each responsive to a respective magnetic field generators positioned under the patient's bed. Each coil generates a signal that is transmitted by a respective lead wire extending from the distal end of the instrument along its entire length to and through a control handle of the instrument and into an electrical connector which connects with the System for processing and generation of a depiction of the instrument on a monitor displaying a 3-D anatomical map of the heart. Fluoroscopy is often use in lieu of or in addition to electromagnetic position sensing. The ionizing radiation poses a risk to patients and to electrophysiologists who must wear heavy lead-filled garments. Moreover, the view provided is limited to 2D.

The shaft and distal tip of EP vascular instruments are small by necessity and thus their construction and assembly require highly skilled workers. Moreover, as the field of cardiac electrophysiology advances, more and more components are housed or carried on the instruments' distal ends where space is already at a premium. Furthermore, because the distal ends are advanced into the heart, medical safety requirements are stringent so as to minimize the risk of inadvertent detachment of components from the distal tip or other avoidable traumatic injury to the heart tissue. And, where electrical components in the distal end are connected to lead wires, breakage in the lead wires results in instrument failure.

For intralumental devices, such as dilators and transseptal needles that are advanced into patient vasculature, visualization is often not available. Thus, the position of the dilator and the transseptal needle is based primarily on guesswork and best estimates of the operators handling these devices. While identification of these devices is possible with fluoroscopy with confirmation by ultrasound, reduction of overall fluoroscopy time is in the interest of the patient's health.

Accordingly, applicants recognized that there is a need to provide EP vascular instruments, especially those used with guiding sheaths, that allow position sensing and visualization with less demands on construction, assembly efforts and use of space in the distal end while also minimizing the need for lead wires that extend along the length of the instruments, with the understanding that improper approach of intralumenal devices in the heart can result in tissue damage and ailments, such as cardiac perforation and cardiac tamponade.

SUMMARY OF THE DISCLOSURE

In some embodiments, a catheter shaft for use in a catheter sheath, comprises a generally tubular member and an emitter. The generally tubular member extends along a longitudinal axis from a proximal end to a distal end. The proximal end includes a proximal portion, with the emitter fixed on the proximal portion, and the distal end includes an end effector.

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

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

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

In some embodiments, the emitter includes a magnetic member.

In some embodiments, the emitter includes an optically-readable pattern.

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 is configured to receive a proximal portion of a generally tubular member with an emitter. The control handle includes at least one sensor fixed along the pathway and the sensor is responsive to the emitter.

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

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

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

In some embodiments, an intralumenal device position sensing system comprises a catheter sheath with a shaft and a control handle. The shaft includes a lumen and the control handle includes a pathway along a longitudinal axis and the pathway and the lumen are in communication with each other. Also included in the system are a first intralumenal device, a first emitter and a sensor. The first intralumenal device is configured with a predetermined geometry and includes a proximal portion and a distal portion, the distal portion being configured to extend through the lumen of the sheath and the proximal portion being configured to extend through the pathway of the control handle. The first emitter is situated on the proximal portion of the first intralumenal device, and the sensor is situated in the pathway of the control handle, configured to generate signals in response to the first emitter on the proximal portion of the first intralumenal device. The signals are representative of a position of the distal portion of the first intralumenal device.

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

In some embodiments, the first emitter includes an optically-readable pattern such that an optical signal is emitted when irradiated and the sensor includes an optical unit with at least an optical detector.

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

In some embodiments, the first intralumenal device includes a dilator.

In some embodiments, the first intralumenal device includes a lumen configured to receive a second intralumenal device.

In some embodiments, a second emitter is situated on a proximal portion of the second intralumenal device that is configured to be generally coextensive with the proximal portion of the first intralumenal device.

In some embodiments, the second intralumenal device includes a transseptal needle.

In some embodiments, the predetermined geometry includes an insertion length (LIN1) of the first intralumenal device measured proximally from a distal end of the intralumenal device, the insertion length (LIN1) configured to pass through the pathway of the control handle of the guiding sheath and the lumen of the shaft and being greater than a combined length (LT) of the lumen and the pathway by a predetermined distance (DD1).

In some embodiments, the sensor is situated along the pathway of the control handle at a predetermined distance (LS1) measured from a distal end of the lumen of the guiding sheath. The first emitter is situated on the first intralumenal device at a predetermined distance LM1measured proximally from a distal end of the first intralumenal device, where LM1=LS1+DD1, and the signals generated by the sensor in response to the first emitter are representative of the distal end of the intralumenal device being distal of the distal end of the lumen of the shaft by the distance DD1.

In some embodiments, an approach distance AD is defined as a predetermined distance measured proximally from the distal end of the lumen of the guiding sheath. Distal of the first emitter, a second emitter is situated on the first intralumenal device at a predetermined distance LM2measured proximally from a distal end of the first intralumenal device, where LM2=LM1−AD−DD1=LS1−AD, and the signals generated by the sensor responsive to the second emitter are representative of the distal end of the intralumenal device being proximal of the distal end of the lumen of the shaft by the distance AD.

In some embodiments, the system includes a third emitter that is situated on the first intralumenal device, between the first and second emitters, at a predetermined distance LM3measured proximally from a distal end of the first intralumenal device, where LM2=LS1. The signals generated by the sensor responsive to the third emitter are representative of the distal end of the intralumenal device being even with the distal end of the lumen of the shaft.

In some embodiments, the first emitter includes a magnetic member, the sensor includes a first magnetic sensor, and the system further comprises a second magnetic sensor situated at a same axial location in the pathway as the first magnetic sensor but at a different angular location about the longitudinal axis of the first intralumenal device.

In some embodiments, the emitter includes a magnetic member and the sensor includes a magnetic sensor, and the magnetic member is situated off-axis relative to a longitudinal axis of the first intralumenal device.

In some embodiments, the first emitter includes a first magnetic strength and the second emitter includes a second magnetic strength different from the first magnetic strength.

In some embodiments, the system includes a second emitter, wherein the first emitter generates a first magnetic field and the second emitter generates a second magnetic field that is orthogonal to the first magnetic field.

In some embodiments, the system includes a second emitter, wherein 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.

In some embodiments, the system includes multiple first emitters and multiple sensors, the multiple first emitters situated on the proximal portion of the first intralumenal device that form a first linear array of first emitters, each of the first emitters situated at a different axial location along the proximal portion of the first intralumenal device, the multiple sensors situated in the pathway of the control handle that form a linear array of sensors, each of the sensors situated at a different axial location along the pathway.

In some embodiments, the first intralumenal device is configured such that the distal portion is deflectable.

In some embodiments, the signals generated by the sensor in response to the second emitter are representative of a position of the distal portion of the second intralumenal device when deployed past a distal end of the first intralumenal device.

In some embodiments, an intralumenal device position sensing system includes a guiding sheath with a shaft and a control handle, the shaft including a lumen, and 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 intralumenal device with a predetermined geometry, the first intralumenal 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 situated on the proximal portion of the first intralumenal device, and an optical source and an optical sensor situated in the pathway of the control handle, the optical source configured to illuminate the first optically-readable pattern, the optical sensor configured to generate signals in response to illumination of the first optically-readable pattern by the optical source, the signals being representative of a position of the distal portion of the first intralumenal device.

In some embodiments, the optical source includes an LED.

In some embodiments, the optical sensor includes a photodiode.

In some embodiments, the system includes a second optically-readable pattern situated on the proximal portion of the first intralumenal device at a second location different from a first location of the first optically-readable pattern.

In some embodiments, the system includes a second optically-readable pattern situated on the proximal portion of the first intralumenal device at a second location diametrically opposite from a first location of the first optically-readable pattern.

In some embodiments, the system includes multiple optical emitters and multiple optical sensors that form respective pairs of an optical emitter and an optical sensor, each pair situated at a different axial location along the pathway.

In some embodiments, an intralumenal device position sensing system includes a guiding sheath with a shaft and a control handle, the shaft including a lumen, and the control handle that defines a pathway therein along a longitudinal axis, the pathway and the lumen in communication with each other. The system also includes a first intralumenal device with a predetermined geometry, the first intralumenal 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 position of the distal portion of the first intralumenal based on position of the proximal portion of the first intralumenal device in the pathway of the control handle.

In some embodiments, the position of the distal position includes a position of the distal portion deployed past a distal end of the shaft of the guiding sheath.

In some embodiments, the means for determining position includes electromagnetic emitter and electromagnetic sensor.

In some embodiments, the means for determining position includes optical source and optical sensor.

In some embodiments, a method for determining position of an intralumenal device, includes determining a first length of a guiding sheath that includes a shaft and a control handle, the first length defined between a distal end of the sheath and a sensor site in the control handle, and determining a position of the distal end of the sheath within a patient's body. The method also includes determining a second length of an intralumenal device configured to pass through the shaft and control handle of the guiding sheath, the second length defined between a distal end of the intralumenal device and an emitter site on a proximal portion of the intralumenal device that coincides in the control handle. The method further includes determining a position of the emitter site of the intralumenal device relative to the control handle, and determining a position of a distal end of the intralumenal device in the patient's body based on the determined location of the emitter site of the intralumenal device.

In some embodiments, the determining a position of the emitter site of the intralumenal device relative to the control handle includes electromagnetic sensing.

In some embodiments, the determining a position of the emitter site of the intralumenal device relative to the control handle include optical sensing.

In some embodiments, the determining a position of the distal end of the sheath within a patient's body includes electromagnetic position sensing.

In some embodiments, the method includes displaying a graphical representation of the position of the distal end of the intralumenal device.

In some embodiments, the position of the distal end of the intralumenal device includes linear position.

In some embodiments, the position of the distal end of the intralumenal device includes rotational position.

In some embodiments, a system includes a sheath comprising a handle and a catheter tube extending distally from the handle, and an intralumenal device comprising a shaft configured with a predetermined geometry and being configured to traverse through the handle and the catheter tube. The system also includes a sensor assembly disposed approximate 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.

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

In some embodiments, the sheath includes a navigation sensor approximate a distal end of the catheter tube.

In some embodiments, a distal portion of the catheter tube includes a curvature, and a distal portion of the shaft includes a pre-shaped curvature.

In some embodiments, a distal portion of the catheter tube is deflectable.

In some embodiments, a distal portion of the shaft lacks a navigation sensor.

In some embodiments, the system includes a transseptal puncture kit comprising the sheath and the intralumenal device.

In some embodiments, the intralumenal device includes a transseptal needle.

In some embodiments, the intralumenal device includes a dilator.

In some embodiments, the shaft of the intralumenal device is non-deflectable.

In some embodiments, the intralumenal 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.

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

In some embodiments, the sensor assembly includes a sensor array within the handle of the sheath and a sensor marker disposed on a proximal portion of the shaft of the intralumenal device, the sensor array being configured to determine a position of the sensor marker within the handle to thereby determine the position of a distal end of the shaft.

In some embodiments, the sensor array includes a length approximately equal to a length of a distal portion of the shaft that is distal of a distal end of the catheter tube of the sheath when the intralumenal device is fully distally inserted into the sheath.

In some embodiments, the sensor marker includes a ferromagnetic material, and the sensor array comprising a plurality of magnetic sensors.

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

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

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

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

In some embodiments, the computer readable medium includes instructions, that when executed by the processor, cause the system to determine a position of the distal end of the intralumenal device in relation to the fossa ovalis within the heart of the patient.

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 determine a position of the distal end of the intralumenal device in relation to the navigation sensor.

In some embodiments, the computer readable medium includes instructions, that when executed by the processor, cause the system to determine the predetermined geometry of the shaft based at least in part on an identification marker on the intralumenal device.

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

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 determine a position of the distal end of the intralumenal device in relation to the navigation sensor.

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 the body of a patient, and determine a position of the distal end of the shaft within the body of the patient based at least in part on the position of the distal portion of the catheter tube, the length of insertion of the intralumenal device, and the predetermined geometry of the shaft.

In some embodiments, the computer readable medium incudes instructions, that when executed by the processor, cause the system to provide a display output comprising a graphical representation of the position of the distal end of the shaft in the body.

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

In some embodiments, the computer readable medium includes instructions, that when executed by the processor, cause the system to determine a position of the distal end of the intralumenal device in relation to the fossa ovalis within the heart of the patient.

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

In some embodiments, a method for visualizing a distal end of an intralumenal device includes determining a position of a distal portion of the sheath within a body of a patient, and determining a length of insertion of a shaft configured with a predetermine geometry within a sheath. The method also includes 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.

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

In some embodiments the third conductive member includes a ring electrode disposed on the proximal portion of the intralumenal device.

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

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

In some embodiments, the system further comprises an impedance sensor to measure impedance of a respective completed electrical circuit.

In some embodiments, the proximal portion of the intralumenal device includes visual indicia disposed between adjacent third conductive members, on an outer surface of the intralumenal device.

In some embodiments the visual indicia include alphanumeric symbols.

In some embodiments, the visual indicia include colors.

In some embodiments, a system for visualization of intralumenal device, includes a lumened device with a first predetermined geometry and including a first proximal portion and a first distal portion and an intralumenal device with a second predetermined geometry, the intralumenal 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 the lumen of the lumened device. The system also includes a processor, a display; and a non-transitory computer readable medium with instructions thereon, that when executed by the processor, causes the display to provide visualization representative of the first distal portion with a graphic element representative of an exposed section of the second distal portion extending distally of a distal end of the first distal portion.

In some embodiments, the graphic element comprises a circle with a diameter based on a length of the exposed distal portion.

In some embodiments, the diameter varies in real-time based on a length of the exposed distal portion as the exposed distal portion translate along the pathway.

In some embodiments, the lumened device includes a dilator and the intralumenal device includes a guidewire.

In some embodiments, the system further includes a guiding sheath and a position sensing assembly. The guiding sheath includes a control handle and a sheath, the sheath including a third proximal portion and a third distal portion, the sheath configured with a lumen through which the lumened device extends. The position sensing assembly is configured to determine a position of the first distal portion of lumened device relative to the third distal portion of the guiding sheath based on a position of the first proximal portion of the lumened device relative to the third proximal portion of the guiding sheath.

In some embodiments, the system further includes a guiding sheath and a position sensing assembly. The guiding sheath includes a control handle and a sheath, the sheath including a third proximal portion and a third distal portion, the sheath configured with a lumen through which the lumened device extends. The position sensing assembly is configured to determine a position of the second distal portion of the intralumenal device relative to the third distal portion of the guiding sheath based on a position of the second proximal portion of the intralumenal device relative to the third proximal portion of the guiding sheath.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

Referring toFIG.1A,FIG.2A, andFIG.3, in some embodiments of the present invention, a guiding sheath10includes an elongated flexible catheter tube or sheath12, and a control handle16proximal of sheath12. The sheath12is configured with a lumen14through which various intralumenal devices can traverse and be guided through a patient's vascular to ultimately reach chambers in the patient's heart. The control handle16at its proximal end has an electrical connector17for connection to a remote control and processing system in transmitting electrical signals for energizing components of the devices and the guiding sheath and/or receiving signals generated or detected by components of the intralumenal devices and the guiding sheath.

The lumen14of the sheath12is in communication with a longitudinal pathway18provided in the control handle16. The pathway18has a length L18and is configured to receive an intralumenal device that can traverse from the pathway18of the control handle16into the lumen14of the sheath12. In some embodiments, a proximal end of the pathway18is defined by a hemostatic valve22extending proximally from a proximal end of the control handle16, where access into the proximal end of the pathway18is through a fluid-tight seal of the valve22that permits entry and passage of the intralumenal device without fluid leaking out or air entering the valve22. If lumened, a first (or outer) intralumenal device24that is advanced through the pathway18of the control handle16and further through the lumen14of the sheath12allows a second (or inner) intralumenal device26to be passed through a lumen25of the first intralumenal device24. It is understood that either of the intralumenal devices may include an end effector, for example, a septum needle, an electrode assembly configured to map an organ, and/or an ablation electrode assembly.

In some embodiments, the first intralumenal device24is a lumened catheter or dilator that is advanced through the guiding sheath10into a patient's heart and followed by a transseptal needle or wire as the second intralumenal device26that is advanced through a lumen25of the catheter or dilator24into the patient's heart.

The guiding sheath10including the sheath12and the control handle16has a total length LT from a proximal end16P of the control handle to a distal end of the sheath12D. In some embodiments, for example, where the first intralumenal device24is a dilator, the device has a handle27, a valve23and a shaft28. Whereas the shaft28is configured for insertion into the guiding sheath10, the handle27and the valve23are configured to remain proximal of the control handle16of the guiding sheath10. The shaft28of the device24has a predetermined length LIN1between a proximal end28P and a distal end28D, where the length LIN1is greater than the length LT of the guiding sheath10by at least a length of DD1, such that the distal end28D of the first intralumenal device24has an exposed length of at DD1past the distal end12D of the guiding sheath10when the first intralumenal device24is sufficiently advanced within the guiding sheath for deployment at its distal end28D (for example, with its handle27abutting the proximal end16P of the control handle16). The first intralumenal device24has a total length L24between the valve23and the distal end28D.

The second intralumenal device26has an elongated body31of length LIN2between a proximal end26P and a distal end26D, where the length LIN2is greater than the total length L24of the first intralumenal device24such that the body31has at least a distal exposed length DD2distal of the distal end28D of the first intralumenal device24(if not also a proximal excess length LEX proximal of the valve23of the first intralumenal device24) when the second intralumenal device26is extending through the first intralumenal device24with its distal end26deployed at the treatment site within the patient's heart, for example, the septum. As a safety precaution, the distal exposed length DD2of the second intralumenal device26may be limited by a stop26S positioned to set a calibrated maximum advance position of the second intralumenal device26relative to the first intralumenal device24and/or the guiding sheath10, in minimizing the risks of inadvertent tissue punctures by the distal end26D.

In typical use of these devices, with reference toFIG.1A,FIG.1BandFIG.1C, an electrophysiologist inserts the sheath12of the guiding sheath10into the patient's femoral artery. The shaft28of the first intralumenal device24is inserted through the hemostatis valve22into the pathway18of the control handle16and then further advanced distally into the lumen14of the guiding sheath10. The first intralumenal device24is advanced distally relative to the guiding sheath10until the distal end28D passes the distal end12D of the guiding sheath10. With distal end28D exposed, the first intralumenal device24is deployed and ready for diagnostic use, therapeutic use and/or receiving the second intralumenal device26. In the latter instance, the second instrument26is advanced distally through the lumen25of the first intralumenal device24until the distal end26D passes the distal end28D of the first intralumenal device24. With the distal end exposed26D, the second intralumenal device26is deployed and ready for diagnostic and/or therapeutic use.

During these approach and deployment stages, the user's interest in knowing the position of the first intralumenal device24generally heightens when the distal end28D is approaching the distal end12D of the guiding sheath10(FIG.1E) and advancing past it (FIG.1F). The heightened interest may continue at least as long as the distal end28D is exposed outside of the sheath12. Calibrated maximum distal advancement of the first intralumenal device24relative to the sheath12may be limited by the device handle27abutting the hemostatis valve22or the proximal end16P of the control handle16of the guiding sheath10(FIG.1B). Likewise, where the second intralumenal device26has been inserted into the first intralumenal device24, the user's interest in knowing the position of the second intralumenal device26generally heightens when the distal end26D is approaching the distal end28D of the shaft28of the first intralumenal device24(in solid lines inFIG.1F) and advancing past it (in broken lines inFIG.1F). The heightened interest may continue at least as long as the distal end26D is exposed outside of the distal end28D of the first intralumenal device24. Depending on the configuration of the proximal end of the second intralumenal device26, there may be a calibrated maximum distal advancement of the second intralumenal device relative to the first intralumenal device24and/or the guiding sheath10. For example, where the first intralumenal device24is a dilator that is advanced through the guiding sheath10and followed by a transseptal needle as the second intralumenal device26that is advanced through the dilator, both the distal ends of the dilator and the transseptal needle are narrower and/or more steeply tapered relative to the guiding sheath which can be traumatic and injurious to heart tissue if they are advanced too far distally past the distal end12D of the sheath12. Therefore, it is in the user's interest to track or monitor linear advancement and placement of the distal ends28D and26D relative to distal end12D of guiding sheath10so as to minimize the risk of injury to the patient, including the risk of any inadvertent puncturing of heart tissue.

For one or more of the intralumenal devices, in particular as to their distal ends, to be visualized on a display monitor for the user, a guiding sheath system in some embodiments, includes components of an advanced electrophysiology (“EP”) imaging system S that support components of a position sensing assembly40advantageously provided on respective proximal portions of the guiding sheath10and of each of the intralumenal devices24,26. The position sensing assembly40provides signals that are generated by the proximal portions of the intralumenal devices24,26and transmitted to the system S via the electrical connector17for processing by the system in determining positions (including location and orientation) of the distal ends of the intralumenal devices24,26relative to the guiding sheath10.

In some embodiments, with reference toFIG.4AandFIG.4B, the EP imaging system S includes a console122which may include an ablation power generator125, a patient interface unit (PIU)126, and one or more displays127and128to display 3-D maps and electrograms. The operations, functions and acts of the EP imaging system S are managed by the system controller100that includes a processing unit132communicating with a memory134wherein is stored software for operation of the system. In some embodiments, the system controller100is an industry-standard personal computer including a general-purpose computer processing unit. However, in some embodiment, at least some of the operations, functions or acts of the system controller are performed using custom-designed hardware and software, such as an application specific integrated circuit (ASIC) or a field programmable gate array (FPGA). In some embodiments, the system controller is managed by an operator using a pointing device and a graphical user interface (GUI), which enable the operator to set parameters of the system. The GUI typically also displays results of the procedure to the operator on a display. The software in memory may be downloaded to the controller in electronic form, over a network, for example. Alternatively or additionally, the software may be provided on non-transitory tangible media, such as optical, magnetic or electronic storage media.

In some embodiments, the memory134includes multiple modules used by the processing unit132, such as, for example, a force sensing module151, temperature sensing module152, a 3-D mapping module153, an ablation module154, and an irrigation module155, the functions of which are known in the art, for example, for respectively, measuring tissue temperature, determining position of components within the patient's body with the use of electromagnetic navigation/position sensors responsive to external magnetic field generators positioned outside of the patient's body (for example, below the patient's bed), energizing electrodes to ablate tissue, and controlling flow of irrigation fluid to the treatment site. Further included in the memory134is a position sensing module160supporting the position sensing assembly and position sensing methods used by the processing unit132.

In some embodiments, with reference toFIG.1A,FIG.2AandFIG.2B, components of the position sensing assembly40include at least emitter42A advantageously situated on a proximal portion of the first intralumenal device24and at least one sensor44fixed or otherwise situated along the pathway18in the control handle16of the guiding sheath10, such that the emitter42A and the sensor44can interact with each other as the first intralumenal device moves through the pathway18. For example, as the emitter42A carried on the first intralumenal device24moves into sensing proximity of the sensor44, signals are generated by the sensor in response to the presence and/or movement of the emitter42A relative thereto wherein such generated signals are indicative of at least the position (linear and/or rotational) of the proximal portion of the first intralumenal device24relative to the control handle16, if not also representative of the position (linear and/or rotational) of the distal end28D of the first intralumenal device24due to its predetermined configurations and geometries.

In some embodiments, with reference toFIG.1AandFIG.2AandFIG.2B, components of the position sensing assembly40also include at least one emitter42B advantageously situated on a proximal portion of the second intralumenal device26, such that the emitter42B and the sensor44can interact with each other as the second intralumenal device moves through the lumen25of the first intralumenal device24. For example, as the emitter42B carried on the second intralumenal device26moves into sensing proximity of the sensor44, signals are generated by the sensor in response to the presence and/or movement of the emitter42B relative thereto wherein such generated signals are indicative of at least the position (linear and/or rotational) of the proximal portion of the second intralumenal device26relative to the control handle, if not also representative of the position (linear and/or rotational) of the distal end26D of the second intralumenal device26due to predetermined configurations and geometries of the intralumenal device26and the guiding sheath10.

It is understood that each of the first and second intralumenal devices24and26has respective predetermined configurations and geometries such that the spatial relationship between its respective distal end and proximal portion is known and remains generally predictable, whether or not the devices are configured for deflection unidirectionally or bidirectionally (seeFIG.1D). The configurations and geometries of the first and second intralumenal devices and the guiding sheath for use with the system are stored in configurations and geometries subroutine156of memory134(FIG.4B). Accordingly, the system can utilize the signals generated by the sensor in response to the emitter in the proximal portion of each of the first and second intralumenal devices to reliably determine the position (location and orientation) of the respective distal ends of these devices relative to the guiding sheath.

In some embodiments, with reference toFIG.1AandFIG.2A, where a plurality of sensors44are situated in the pathway18of the control handle16of the guiding sheath, the sensors44are arranged linearly and spaced apart evenly to form an N-by-1 sensor array46that has a length L46that extends along the pathway18, parallel with a longitudinal axis48of the control handle16. The length L46may be generally equal to the length L18of the pathway and thus L18and L46may be used interchangeably herein. N may range between 1 and 10, and preferably be 6 in some embodiments.

As shown inFIG.3, the one or more emitters42A of the first intralumenal device24are supported on a proximal portion of the shaft28that is coextensive with the pathway18in the immediate proximity of the sensors44of the array46when the first intralumenal device24has been sufficiently advanced into the guiding sheath10for deployment past the distal end12D of the guiding sheath10. The one or more emitters42B of the second intralumenal device26are supported on a proximal portion of an elongated body31of the device26that extends through the lumen25of the shaft28and is coextensive with the pathway18when the second intralumenal device26has been sufficiently advanced into the first intralumenal device24for deployment past the distal end28D of the first intralumenal device24.

An approach distance AD of an intralumenal device is defined herein as a predetermined distance within which a user's interest is heightened when a distal tip of the intralumenal device is distally approaching the distal end of the guiding sheath (or of a first or outer intralumenal device). An exposed (or deployed) length DD of an intralumenal device is defined herein as a predetermined maximum distance that a user permits a distal end of the intralumenal device to extend past the distal end of the guiding sheath (or of a first or outer intralumenal device),

In embodiments where the length L46of the sensor array46is less than either of (i) exposed DD1of the first intralumenal device24or (ii) exposed length DD2of the second intralumenal device26, the respective intralumenal device24,26may be configured to carry multiple emitters spread along the respective proximal portion for a distance equal to or greater than the length L45to compensate for the shortage in length of the sensor array L46relative to the greater exposed length DD1and/or DD2, with the separation distance between each emitter being dependent at least in part on the length L46of the sensor array.

In some embodiments, where the length L46of the sensor array46in the control handle16of the guiding sheath10is greater than each of (i) approach distances AD1of the first intralumenal device24and AD2of the second intralumenal device26, as shown inFIG.3, and (ii) deployed distances DD1of the first intralumenal device24and DD2of the second intralumenal device26, as shown inFIG.3, each intralumenal device may carry a single emitter, as scaling is not needed. However, it is understood that an intralumenal device is not limited to carrying a single emitter and that each intralumenal device may carry multiple emitters, as appropriate or desired.

For finer detection and greater resolution in position sensing by the system, it is understood that the N plurality of sensors44in the array46and/or the separation distance between adjacent sensors44can be varied as desired or appropriate. In some embodiments, the separation distance between adjacent sensor members44in the array46is equal or less than the lesser of approach distances AD1, AD2. In some embodiments, the separation distance is equal or less than the lesser of deployed distances DD1, DD2. In some embodiments, the separation distance is equal or less than the lesser of the approach distances AD1, AD2and the deployed distances DD1, DD2.

In some embodiments, the separation distance between adjacent sensors44is less than the distance or field of detection of a sensor44so that the detection fields of two adjacent sensors include an overlap and thus an emitter is detected by at least one sensor at any given time while the emitter is within the detection of the sensor array46.

As described herein, detection and determination of linear movement and position of an outer intralumenal device and an inner intralumenal device relative to the control handle of the guiding sheath are enabled by interaction between the emitters42A,42B and the sensor array46as the intralumenal devices move along the pathway of the control handle. In some embodiments, the emitters may include magnetic field generating members, for example, permanent or temporary magnets, and the sensors include magnetic field sensors, for example, Hall sensors or coil-based sensors.

In embodiments where the emitters42A,42B are magnetic rings that are carried circumferentially on outer surfaces of the intralumenal devices and are magnetically radially symmetrical about the longitudinal axis of the intralumenal devices, the rings may not adequately provide information on the rotational position (movement or displacement, used interchangeably herein) of the intralumenal devices to the sensor array along the pathway. Thus, in some embodiments, as shown inFIG.5A,FIG.5BandFIG.5C, for detection and determination of rotational movement and position of the intralumenal devices24,26about their longitudinal axis Z, additional magnetic field generating members42A and44B are situated off the Z axis on the intralumenal devices24,26, respectively, configured in the form of off-axis tabs for interaction with orthogonal (or off-angle at greater or less than 90 degrees) sensors44xand44yfor detecting and determining “roll” movement and position. The sensors44xand44yare located in the same axial position (same x/y plane) along the longitudinal axis Z of the control handle16but at different angular positions about the longitudinal axis Z. As each of the intralumenal devices24and26rotates or otherwise assumes different radial angles about the Z axis relative to the sensor44x(along the x axis) and sensor44y(along the y axis), different and distinguishable signals are generated in response to the different angular positions of each member42A,42B relative to each of the orthogonal sensors. Thus, the orthogonal (or off angle) sensors44x,44ycan provide signals representative of rotational movement and displacement in the x/y plane of each intralumenal device. In embodiments where pairs or sets of sensors44xand44yare located at different axial locations along the z axis, multiple sensors44xextending in the Z axis direction can form a sensor array46xand multiple sensors44yextending in the Z axis direction can form a sensor array46y, where these arrays can generate signals representative of both linear and rotational movement and position of each intralumenal devices as they advance through the guiding sheath10.

In some embodiments, with reference toFIG.6AandFIG.6B, a pathway18of a control handle16has a single linear array46with a proximal sensor44P and a distal sensor44D. Extending therethrough is an intralumenal device24with a proximal magnetic field emitter42P and a distal magnetic field emitter42D configured so that their respective magnetic dipoles or fields are orthogonal to each other. For example, as depicted, the proximal emitter42P generates magnetic field lines that are perpendicular to the longitudinal axis Z of the intralumenal device24, whereas the distal emitter42D generates magnetic field lines that are parallel to the longitudinal axis Z. The emitters42P,42D may be embedded in the shaft of the intralumenal device. In some embodiments, the distal emitter42P is configured with its magnetic field lines parallel to the longitudinal axis Z which produce a changing voltage in a 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. As such, the signals generated by the distal sensor44D can be representative of linear position or movement of the intralumenal device20, and direction of movement. In some embodiments, the proximal emitter42D is configured with its magnetic field lines orthogonal to the longitudinal axis Z which produce a changing voltage from 0.0V to 3.0V when the intralumenal device24is rotated 180 degrees about its longitudinal axis relative to a sensor. As such, the signals generated by the proximal sensor44P can be representative of rotational position or movement of the intralumenal device20. Total voltage readings between 0.0 V and 6.0 V are representative of the degree of linear and rotational position and movement.

In some embodiments, with reference toFIG.7AandFIG.7B, a pathway18of a control handle16has two orthogonal (or off angle) arrays of sensors46xand46yand an intralumenal device20extending therethrough has a diametrically magnetized member (or ring magnet)42with its magnetic field lines being diametrical to the intralumenal device20or perpendicular to the longitudinal axis of the intralumenal device20. The emitter member42is configured to produce a voltage change in the sensors of both arrays, where a purely linear movement without rotational movement of the intralumenal device20produces generally identical responsive signals between each sensor46xof the orthogonal arrays and generally identical responsive signals between each sensor46yof the orthogonal arrays, and a purely rotational movement of the intralumenal device20without linear movement produces responsive signals in only the orthogonal pair of46xand46yin the same axial position. A combination of linear and rotational movement in the intralumenal device20produces responsive signals in the sensors of both arrays that are representative of the combination movement.

In some embodiments, with reference toFIG.8AandFIG.8B, the components of a position sensing assembly240include an optical sensor252and an optical emitter (or sensor marker), including, for example, an optically-detectable pattern254whose optical emission when illuminated by an optical source250is detected by the optical sensor252. The optical source250and the optical sensor252may form an optical unit in the control handle16. The optically-detectable pattern254is provided on a proximal portion220P of an intralumenal device220, and the optical source250and the optical sensor252are situated along a pathway218of a control handle216of a guiding sheath210that receives the intralumenal device220. The optical sensor252generates signals in response to the presence, movement and location of the illuminated optically-detectable pattern254, wherein such generated signals are representative of the displacement and position (linear and/or rotational) of the proximal portion220P of the intralumenal device220relative to the control handle16, if not also of the distal portion of the intralumenal device relative to the control handle16.

In some embodiments, a plurality of optical units are provided to form a linear optical array that extends longitudinally along the pathway18. In some embodiments, two optical arrays246aand246bare provided, diametrically opposing each other along the pathway18, so as to minimize interference between optical illumination and sensing between the two arrays.

As shown inFIG.8B, the optically-detectable pattern may include at least two different patterns254aand254bprovided on different or opposing locations on the surface of the intralumenal device220so that the signals generated by the optical sensor252in response to the two different patterns can indicate angular rotation of the intralumenal device220about its longitudinal axis. The optically-detectable patterns can also be unique to an individual intralumenal device so that each intralumenal device can be identified and limited as a single-use device.

In some embodiments, one or more of the intralumenal devices24,26includes an identification marker170and the control handle16of the guiding sheath10includes an identification circuit172, as shown inFIG.2A. The identification circuit172is configured to determine or identify the predetermined configuration and geometry of the intralumenal device based at least in part on the identification marker170, which may include a radio frequency identification (RFID) circuit. The identification marker170may be affixed to a proximal portion of each intralumenal device so that it is read upon insertion into the control handle or shortly after by the identification circuit172situated along the pathway18of the control handle16. In some embodiments, the identification marker170may be read by a scan unit176separate from or in addition to the identification circuit172in the control handle16, and in communication with an ID subroutine159of the position sensing module160(FIG.4B).

In some embodiments, the optical source250includes an LED, the optical sensor252includes a photodiode, and the optically-detectable pattern254as the optical emitter includes a bar code or binary-alternating symbols on multi-axial locations circumferentially on the surface of the intralumenal device220. It is understood that the optically-detectable pattern, as an optical emitter, typically comprising of discrete indicia of dark and light shades reflects light energy in a corresponding pattern that is detected by the optical detector whose output voltage increases with higher reflected light energy and decreases with lower reflected light energy, as shown inFIG.9. The position sensing assembly240may include multiple optical sources250and multiple optical detectors252arranged in pairs, each pair located at a different location along the pathway18. It is understood that parameters of the configuration of position sensing assembly240depend on a variety of factors, including the size of the field of illumination of each emitter, the length of the optically-detectable pattern, the acceptable degree of uncertainty in the exact location of the intralumenal device relative to the guiding sheath, etc.

It bears emphasis that all of the components of the position sensing assembly are within the confines of the control handle of the guiding sheath, which is well outside of the patient's heart, if not outside the patient's body for improved safety to the patient. Moreover, electrical connections to and from the electromagnetic sensors do not extend distally past 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 intralumenal device no longer need to pass through the entire length of the shafts of these instruments, which saves significantly on the manual labor that would otherwise be necessary for construction and assembly of these instruments, not to mention the space saved in the distal tips that would otherwise be occupied by conventional electromagnetic position sensors using x/y/z coils.

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

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

With reference toFIG.13, an operator has acquired a 3D map of a patient body, including the patient's heart by means of the advanced electrophysiology (EP) imaging system S, such as the CARTO® 3 System. The image generated by the system S that is displayed not only includes the 3D map of the patient's heart, but it also includes depictions of a first (or outer) intralumenal device24, for example, a dilator, and a second (or inner) intralumenal device26, for example, a transseptal needle, especially their respective distal ends.

In arriving at this image of the first and second intralumenal devices according to some embodiments, the user has taken the following actions, including the user using the pointing device and the graphical user interface to enter various user-selectable parameters of the procedure into the system S, including the selection of the guiding sheath and the first and second intralumenal devices to be used in the procedure. Geometries and configurations of guiding sheath10and of intralumenal devices suitable for use with the system S, including the selected first and second intralumenal devices24and26, have been stored in the configurations and geometries subroutine156of the memory134(FIG.4B). The configurations and geometries provide predictable and reliable determination of the location, position and/or orientation of the distal portion of an intralumenal device based on the location, position and/or orientation of the proximal portion of the intralumenal device in relation to the control handle of a guiding sheath through which intralumenal device extends. With reference toFIG.3, parameters stored in the configurations and geometries subroutine156may include, for example, the following:

TABLE 1ParametersDefinitionLTtotal length of guiding sheath 10 (including sheath 12, controlhandle 16 and hemostatis valve 22)LS1distance between sensor 44 and distal end 12D of guidingsheath 10LIN1insertion length of first intralumenal device 24 (=length of shaft28 of first intralumenal device 24)LM1 (=LS1 − AD1)distance between proximal emitter 42A1 of first intralumenaldevice 24 and distal end 12DLM2 (=LS1)distance between middle emitter 42A2 of first intralumenaldevice 24 and distal end 12DLM3 (=LS1 + DD1)distance between distal emitter 42A3 of first intralumenal device24 and distal end 12DAD1approach distance of intralumenal device 24 to distal end 12Dof guiding sheath 10DD1length of exposed (deployed) distal portion of first intralumenaldevice 24 distal of distal end 12D when device 24 is deployedLIN2insertion length of second intralumenal device 26 (=length ofelongated body 31 of second intralumenal device 26)LE1 (=LS1 + DD1 −distance between proximal emitter 42B1 of second intralumenalAD2)device 26 and distal end 28DLE2(=LS1 + DD1)distance between middle emitter 42B2 of second intralumenaldevice 26 and distal end 28DLE3 (=LS1 + DD1 +distance between distal emitter 42B3 of second intralumenalDD2)device 26 and distal end 28DAD2approach distance of intralumenal device 26 to distal end 28Dof first intralumenal device 24DD2Length of exposed (deployed) distal portion of secondintralumenal device 26 distal of distal end 28D when device 26is deployed

With the guiding sheath and the first and second intralumenal devices to be used in a procedure identified by the user, the system can retrieve from the configuration and geometries subroutine156the relevant parameters, including the above-listed parameters, to be used and applied by the position sensing module160.

In some embodiments of the system, devices and related methods, reference is made to the flow chart ofFIG.10. In Block502, a determination is made of the position of a distal portion of the guiding sheath within a body of a patient, for example, by the mapping module153. In Block504, a determination is made of a length of insertion of a shaft of an intralumenal device having a predetermined geometry within the sheath. In Block506, a determination is made of a position of the 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. In Block508, a graphical representation is provided of the position of the distal end of the shaft within the body of the patient.

In some embodiments of methods related to the system and devices, reference is made to the flow chart ofFIG.11. The flow chart begins at Block300. In Block302, parameters of the configuration and geometries of a guiding sheath and an intralumenal device are determined and stored in the configurations/geometries subroutine of the memory of the EP imaging system S. In Block304, the guiding sheath is inserted into the patient. In Block304, the intralumenal device is inserted into the guiding sheath. In Block306, the intralumenal device is advanced relative to the guiding sheath with an emitter on the intralumenal device moving toward a sensor situated in a control handle of the guiding sheath. In Block308, the sensor senses the emitter and generates signals in response to the emitter. In Block310, the position sensing module accesses the parameters and determines the position of the distal end of the intralumenal device based on the signals. In Block312, the EP imaging system S displays the position of the distal end of the intralumenal device. It is understood that position may include location and orientation.

In some embodiments of the methods related to the system and device, reference is made to the flow chart ofFIG.12. The flow chart begins with Block400. In Block402, the parameters of Table 1, are determined and stored in Configurations/Geometries Subroutine of Memory134. In Block404, the user inserts the guiding sheath10into the patient's vasculature, e.g., a femoral artery, and secures the position of the guiding sheath10in fixed relationship with the patient. In Block406, the EP imaging system S determines the position of the distal end12D of the guiding sheath by, for example, an electromagnetic navigation sensor, as known in the art. In Block408, the user inserts the first intralumenal device24into the lumen14of the guiding sheath10via the hemostatis valve22. In Block410, the user advances the device24distally toward the distal end12D of the guiding sheath10. In Block412, as distal emitter42A1on the shaft28of the first intralumenal device24approaches the sensor44in the control handle16of the guiding sheath, the sensor44senses the distal emitter42A1and generates signals in response to the emitter42A1. In Block414, the position sensing module160monitors the signals for an event, for example, a peak (a calibrated maximum) or a particular characteristic, as representative of the distal emitter42A1being in closest proximity to the sensor44, in side-by-side alignment therewith, along the longitudinal axis of the control handle16. In Block416, the position sensing module160accesses the parameters stored in the configurations and geometries subroutine156based on the signal event. Because the first intralumenal device24has a predetermined geometry, for example, including that the position LM1of the distal emitter42A1on the shaft28relative to the distal end28D is equal to the length LS1(namely, the distance between the sensor44and the distal end12D of the guiding sheath) less the approach distance AD1, the signals generated by the sensor44when the sensor44and the distal emitter42A1are in their closest proximity, in side-by-side alignment, advantageously indicate a relative position between the device24and the guiding sheath10, including that the distal end28D of the first intralumenal device24has reached the approach distance AD1of the distal end12D of the guiding sheath. At Decision Block418, a query is made as to whether the event indicates or is related to the distal end28D reaching the approach distance AD1. If the sensor44is generating signals (or a peak signal) in response to the distal emitter42A1, then the answer to the query is yes and the flow chart continues to Block420which activates an indicator, e.g., a visual alarm160and/or an audio alarm162to notify the user that the distal end28D has reached the approach distance AD1and that the distal end28D may soon protrude from the distal end12D of the sheath12, before continuing to Block422. The indicator may automatically terminate after a predetermined duration or remain active until deactivated by the user. If the sensor44is not generating signals (or a peak signal) in response to the distal emitter42A1, then the answer to the query of Block418is no and the flow chart continues to Block422where the processing unit132displays (or continues to display) the distal end28D on the display monitor in real time according to the parameters of the configurations and geometries of the first intralumenal device24relative to the display of the distal end12D of guiding sheath within the patient's heart on the display monitor. In this manner, the determined position and display of the distal end28D of the intralumenal device24are advantageously based on signals generated by the proximal end of the first intralumenal device24.

At Decision Block424, a query is made as to whether the first intralumenal device24is continuing in its advancement distally relative to the guiding sheath10. This determination can be made by, for example, assessing changes in the signals sensed by the sensor44with reference to the parameters of the first intralumenal device24. If yes, the flow chart returns to Block412. As the mid-emitter42A2of the first intralumenal device24approaches the sensor44, the sensor44senses the mid-emitter42A2and generates signals in response to the mid-emitter42A2. In Block414, the positioning module160monitors the signals for an event, for example, a peak (a calibrated maximum) or a particular characteristic, as representative of the mid-emmitter42A2being in closest proximity to the sensor44, in side-by-side alignment therewith, along the longitudinal axis of the control handle16. In Block416, the position sensing module160accesses the parameters stored in the configurations and geometries subroutine156for the first intralumenal device24and the mid-emitter42A2based on the signal event. Because the first intralumenal device24has a predetermined geometry, for example, including that the position of the mid-emitter42A2on the shaft28relative to the distal end28D is equal to the length LS1, the signals generated by the sensor44when it and the mid-emitter42A2are in their closest proximity, in side-by-side alignment, advantageously indicate a relative position between the device24and the guiding sheath10, including that the distal end28D is at the distal end12D. As the distal end28D is not at the Approach Distance AD1in Block418(but has in fact moved past it), the flow chart continues to Block422where the processing unit132continues to display on the display monitor in real time the location of the distal end28D relative to the distal end12D of guiding sheath within the patient's heart on the display monitor. Again in this manner, the determined position and display of the distal end28D of the intralumenal device24are advantageously based on signals generated by the proximal end of the first intralumenal device. At Decision Block424, a query is made as to whether the first intralumenal device24is continuing in its advancement distally relative to the guiding sheath10. This determination can be made by, for example, assessing changes in the signals sensed by the sensor44with reference to the parameters of the first intralumenal device24or by input by the user that he is still advancing the first intralumenal device24. If yes, the flow chart returns to Block412. Additionally or in lieu, the query of Decision Block424may include a determination as to whether the distal end28D is at maximum deployment distance DD1by accessing the parameters stored in the configurations and geometries subroutine146. If no, the flow chart returns to Block412.

The loop including Blocks412,414,416,418,420,422and424can be repeated for the proximal emitter42A3on the first intralumenal device24. In Block416, the position sensing module160accesses the parameters stored in the configuration and geometries subroutine156for the first intralumenal device24and the proximal emitter42A3. Because the first intralumenal device24has a predetermined geometry, for example, including that the position of the proximal emitter42A3on the shaft28relative to the distal end28D is equal to the length LS1plus the calibrated maximum exposed distance DD1of the distal end28D of the first intralumenal device24distal of the distal end12D of the control handle, the signals generated when the sensor44and the proximal emitter42A3are in their closest proximity to, in side-by-side alignment, advantageously indicate a relative position between the device24and the guiding sheath10, including that the distal end28D is at the calibrated maximum exposed length DD1distal of distal end12D. Again, because the distal end28D has advanced past the approach distance AD1, the flow chart continues to Block422. In Block422, the processing unit132continues to display on the display monitor in real time the location of the distal end28D relative to the distal end12D of guiding sheath within the patient's heart on the display monitor, where the determined position and display of the distal end28D are advantageously based on signals generated by the proximal end of the first intralumenal device24.

When the first intralumenal device is no longer being advanced relative to the guiding sheath as determined by the position sensing module assessing changes in the signals sensed by the sensor44with reference to the parameters of the first intralumenal device24or by input by the user that he is still no longer advancing the first intralumenal device24, the Decision Block424continues to Decision Block426with a query as to whether another intralumenal device is to be inserted. This determination may be based on user input. If yes, the flow chart returns to Block410where the second intralumenal device26is inserted into the first intralumenal device24via the valve23, and advanced distally toward the distal end28D of the first intralumenal device24. In Block412, as distal emitter42B1on the elongated body31of the second intralumenal device26approaches the sensor44in the control handle of the guiding sheath, the sensor44sensing the emitter42B1generates signals in response to the emitter42B1. In Block414, the position sensing module160monitors the signals for an event, for example, a peak (a calibrated maximum) or a particular characteristic, as representative of the sensor44and the distal emitter42B1in closest proximity, in side-by-side in alignment, along the longitudinal axis of the control handle16. In Block416, the position sensing module160accesses the parameters stored in the configurations and geometries subroutine156based on the signal event. Because the second intralumenal device26has a predetermined geometry, for example, including that the position LE1of the distal emitter42B1on the elongated body31relative to the distal end26D is equal to the length LS1plus the calibrated maximum exposed distance DD1of the first intralumenal device24less the approach distance AD2, the signals generated when the advantageously indicate a relative position between the device24and the guiding sheath10, including that the distal end26D of the second intralumenal device26is at the approach distance AD2of the distal end28D of the first intralumenal device24. In this manner, the determined position and display of the distal end26D of the second intralumenal device26are advantageously based on signals generated by the proximal end of the second intralumenal device26.

In Decision Block418, the processing unit132in response to the signals representative of the distal end26D being at the approach distance AD2of the distal end28D activates the indicator (e.g., the audio alarm162or the visual alarm164) to notify the user that the distal end26D has reached the approach distance AD2and that the distal end26D may soon protrude from the distal end28D of the first intralumenal device24. In Block422, the processing unit132begins to display the location of the distal end26D on the display monitor127in real time according to the parameters of the configuration and geometry of the second intralumenal device26, relative to the display of the distal end28D and the distal end12D within the patient's heart on the display monitor.

In Decision Block424, if the user continues to advance the second intralumenal device26distally relative to the guiding sheath10, the flow chart returns to Block412. The loop including Blocks412,414,416,418,422and424can be repeated for the mid emitter42B2and the proximal emitter42B3. For mid emitter42B2, in Block414, the position sensing module160monitors the signals for an event, for example, a peak (a calibrated maximum) or a particular characteristic, as representative of the sensor44and the mid-emitter42B2being in closest proximity, in side-by-side alignment, along the longitudinal axis of the control handle16. In Block416, the position sensing module160accesses the parameters stored in the configurations and geometries subroutine156based on the signal event. Because the second intralumenal device26has a predetermined geometry including that the position of the mid emitter42B2on the elongated body31relative to the distal end26D is equal to the length LS1plus the calibrated maximum exposed length DD1of the first intralumenal device24, the signals generated when the the sensor44and the mid-emitter42B2are in closest proximity, in side-by-side alignment, advantageously indicate a relative position between the device24and the guiding sheath10, including that the distal end26D has reached the distal end28D. In Block422, the processing unit132continues to display on the display monitor in real time the location of the distal end26D of the second intralumenal device26relative to the distal end28D of the first intralumenal device24and the distal end12D of the guiding sheath10within the patient's heart on the display monitor.

For proximal emitter42B3, in Block414, the position sensing module160monitors the signals for an event, for example, a peak (a calibrated maximum) or a particular characteristic, as representative of the sensor44and the proximal emitter42B3in closest proximity, in side-by-side alignment, along the longitudinal axis of the control handle16. In Block416, the position sensing module160accesses the parameters stored in the configurations and geometries subroutine156based on the signal event. Because the second intralumenal device26has a predetermined geometry of the second intralumenal device26, for example, including that the position of the proximal emitter42B3on the elongated body31relative to the distal end26D is equal to the length LS1plus the calibrated maximum exposed distance DD1and the calibrated maximum exposed distance DD2, the signals generated when the sensor44and the proximal emitter42B3are in closest proximity, in side-by-side alignment, advantageously indicate a relative position between the device24and the guiding sheath10, including that the distal end26D is at the calibrated maximum exposed length distal of distal end28D. In Block422, the processing unit132continues to display on the display monitor in real time the location of the distal end26D and the distal end28D relative to the distal end12D of guiding sheath within the patient's heart on the display monitor.

It is understood that the detection of any emitter on the intralumenal devices, for example,42A1,42A2,42A3,42B1,42B2,42B3, by the sensor gives rise to signals that are representative of a length of insertion of the intralumenal device whose emitter is being detected because of the predetermined configurations and geometries of the intralumenal device, including, for example, the parameters LM1, LM2, LM3, LE1, LE2, LE3. And further because of the predetermined configurations and geometries of the intralumenal device, a length of insertion can be used to determine position (or at least the location) of a distal end of the intralumenal device relative to the guiding sheath.

It is further understood that the flow chart accommodates any plurality of emitters so provided the intralumenal device is being advanced relative to the control handle. That is, the loop repeats for each emitter until the Decision Block424produces a “no” to the query of whether the intralumenal device is still being advanced relative to the control handle. And, if no other intralumenal device is to be inserted per Decision Block426, the flow chart may end at Block428.

It is understood that in some embodiments where one or more of the emitters42A1,42A2,42A3,42B1,42B2and42B3are off-axis on the shaft28of the first intralumenal device24and the elongated body31of the second intralumenal device26, respectively, the signals generated by the sensor44in response thereto are also representative of rotation of the first and second intralumenal devices24and26about their respective longitudinal axes, as shown inFIG.5A,FIG.5BandFIG.5C. Parameters include calibrated sensor readings that correspond with rotational angles of the off-axis emitters. Thus, in Block312and Block416, the parameters accessed include signals values or characteristics that are representative of the position of the distal ends28D and26D including location and rotational orientation. In that regard, the predetermined configurations and geometries of the first and second intraluminal devices include predetermined rigidity of the devices over their length and their torsional rigidity such that the application of a translation and/or rotational force at the proximal ends of the devices produces a predictable translation and/or rotation at their distal ends.

In some embodiments, the position sensing module160includes a table of calibrations of signal readings corresponding to the longitudinal and rotational positions of each emitter of the first and second intralumenal devices relative to the sensors44that may be referenced by the module to determine and/or confirm the relative positions of the emitters on the proximal portion of the devices24and26to the sensor44, which are referenced by the processing unit to determine (or reliably predict) the positions of distal ends28D and26D of the intralumenal devices24and26for display on the display monitor.

With reference toFIG.14A,FIG.14BandFIG.14C, in some embodiments, the position sensing assembly600includes first and second electrically-conductive members (or electrodes)602,604situated along a pathway618of a control handle616of a guiding sheath610, and a third electrically-conductive member (or electrode)606situated on a proximal portion608P of an intralumenal device608configured for insertion into the pathway618and distal advancement through a lumen614of a sheath612extending distally of the control handle616. The first and second circuit members602,604are separate and distinct from each other and may be disposed, for example, across the pathway618from each other, in diametrically opposite positions, and each may have a same dimension or width W along the pathway618which is aligned with a longitudinal axis L defined by the control handle616. The third conductive member606may be configured as a circumferential band620disposed on an outer surface609of the intralumenal device608. The band has a width WB along the longitudinal axis that is equal to or greater than the width W of the first and second.

In use, a distal end608D of the intralumenal device608is inserted into a hemostatis valve622at a proximal end616P of the control handle616to enter the pathway618. The distal end608D then enters the lumen614of the sheath612of the guiding sheath610. As the advancement of the intralumenal device608continues distally, the proximal portion608P enters the pathway618and the third conductive member606approaches the first and second conductive members602,604(FIG.14A). With further distal advancement, the third conductive member606comes into contact with both of the first and second conductive members602,604(FIG.14B). As shown inFIG.15, each of the first and second conductive elements602,604is connected to a respective lead wire625,627that extends through an electrical connector (see electrical connector17inFIG.1A) which enables connection to a power/current source629. Thus, by establishing contact with the first and second conductive members602,604, the third conductive element606completes an electrical circuit624that includes the first, third and second conductive members whereupon electrical conductivity is detected (FIG.15B); that is, once the third conductive member606is in contact with the first and second conductive members602,604, the circuit624is completed thereby identifying the presence of the intralumenal device608. Because the device608has a predetermined geometry, e.g., a predetermined position of the third conductive member606from the distal or proximal end of the device608, the signals generated when the electrical circuit624is completed by conductive contact between the first, second and third conductive members602,604,606advantageously indicate a relative position between the device608and the guiding sheath610, for example, including that the distal end608D is approaching or protruding from a distal end612D of the sheath612. As shown inFIG.15B, the electrical conductivity remains long as there is contact between the members602and606and between members606and604during linear translation of the device608relative to the control handle616.

In that regard, a system S as shown inFIG.4C, includes a circuit sensing subroutine165in a position sensing module160. By measuring and monitoring the completion of the circuit624, the system S is configured to determine the position of the proximal portion of the device608relative to the control handle616and thus the position of the distal end608D relative to the distal end of the sheath612based on the configurations and geometries subroutine156of the memory134for the device608. The stored configuration and geometry of the device608provides predictable and reliable determination of the location, position and/or orientation of the distal end608D of the device608based on the location, position and/or orientation of the proximal portion608P of the device608in relation to the control handle616of the guiding sheath610through which the device608extends.

With reference toFIG.16A,FIG.16BandFIG.16C, in some embodiments, the control handle616includes a first array A of a plurality of first conductive members602and a second array B of a common plurality of second conductive members604, with each second conductive member being diametrically opposed from a respective first conductive member along the pathway618to form a respective pair of separate and distinct conductive members. A third array C of a plurality of third conductive members606is situated on the proximal portion608P of the intralumenal device608where each of third conductive member606can contact a pair of conductive members602,604in completing a respective electrical circuit624with the connected pairs602,604with movement of the device608relative to the control handle616,

As shown inFIG.17, as the intralumenal device608is advanced distally in the control handle616along the pathway618and the third array C of third conductive members608approaches the first and second arrays A, B, the number of circuits completed between a respective pair of first and second conductive members602,604by the third conductive members606indicates relative position and movement between the proximal portion608P of the device608and the control handle616, and thus relative position and movement between the distal end608D of the device and a distal end610D of the guiding sheath610based on the configuration and geometry of the device608.

With an N plurality of first conductive members602and second conductive members604, and an N plurality of current sensors A1-AN, the completion of each circuit between a respective pair of first and second conductive members602,604by a connecting third conductive member606is detected by current sensors A1-AN. By the progression of current sensors A1-AN detecting the completion of the circuits along the arrays A, B, the system S determines the relative position and movement of the proximal portion608P of the device608and the control handle616. The detection of the completion of circuits A1, indicates the proximal portion608P is in position P1relative to the control handle. For example, as shown inFIG.17, the detection of the completion of circuits A1, A2, A3by third conductive members606A,606B,606C indicates that the proximal portion608P is in a respective position relative to the control handle616. Likewise, it is understood that the detection of the completion of circuits A1, A2, A3, A4by third conductive members606A,606B,606C,606D indicates that the proximal portion608P is in a more distal respective position relative to the control handle616. Each respective position relative to the control handle is determinative of a respective position of the distal end608D of the device608relative to the distal end of the guiding sheath610based on known configurations and geometries of the device608and the guiding sheath610. It is understood that the width of and spacing between the conductive members of the arrays A1, A2, A3can vary depending upon the desired accuracy or resolution of the relative position and movement of the device608. In some embodiments, the third conductive members606may be configured as ring electrodes or mounted flexible electrodes.

In some embodiments, as shown inFIG.17, the proximal portion608P of the device608includes visual indicia630configured for viewing by the user in visually notifying the user of the relative position between the device608and the control handle616, and thus the relative position between the distal end608D of the device608and the distal end of the sheath612of the guiding sheath610. In some embodiments, the visual indicia630may include, for example, alphanumeric symbols630N at selected locations indicating the distances from the respective locations to a proximal end of the device608, wherein the locations are in between adjacent third conductive members606. In some embodiments, the visual indicia630may include color-coded marker or bands630B, for example, a green marker at a distal location D, a yellow marker at a mid-location M and a red marker at a proximal location P, wherein the green marker indicates that the distal end608D of the device608is proximal of the distal end612D of the sheath612, the yellow marker indicates that the distal end608D is approaching the distal end612, and the red marker indicates that the distal end608D will soon pass and protrude from the distal end612with continued distal advancement.

It is understood that electrical impedance decreases when the area of cross-section of a conductor is increased, as shown inFIG.18. As the device608is advanced (or displaced) distally relative to the control handle616, the contact area between the third conductive element606and the first and second conductive elements602,604increases which results in a decreasing electrical impedance Z of the completed circuit. Accordingly, when calibrated to a positional value, the impedance reading of the completed circuit indicates a linear position of the device608relative to the control handle616and thus relative to the guiding sheath610and the distal end612D of the sheath612. The positional value can be correlated to a distance that the distal end608D of the device608protrudes from the distal end612D of the sheath612, or an approach distance remaining before the distal tip608D exits the distal end612D of the sheath612.

In some embodiments, as shown inFIG.19, a circuit625completed by the first, second and third conductive members602,604,606includes a signal generator626and an impedance measuring device628, e.g., an oscilloscope, an AC volt meter or an impedance meter.FIG.18is a graph of measured impedance (in Ohms) across the circuit625as a function of the distance (displacement) of the third conductive member606relative to the first and second conductive members602,604, with represents the amount of contact surface area between the first, second and conductive members602,604,606. When the third conductive member606has not made contact with the first and second conductive members602,604(FIG.14A), the graph ofFIG.18shows the measured impedance at a maximum. As the intralumenal device608is advanced distally, the third conductive member606makes contact with the second and third members602,604(FIG.14B) and the measured impedance Z decreases. As the intralumenal device608is further advanced distally, the third conductive member606makes full contact with the second and third members (FIG.14C) and the measured impedance decreases further. In that regard, the system S as shown inFIG.4C, includes an impedance subroutine166in a position sensing module160. By measuring and monitoring the impedance, the system S is configured to determine the position of the proximal portion of the device608relative to the control handle616and thus the position of the distal end608D relative to the distal end of the sheath612based on the configurations and geometries subroutine156of the memory134for the device608. The stored configuration and geometry of the device608provides predictable and reliable determination of the location, position and/or orientation of the distal end608D of the device608based on the location, position and/or orientation of the proximal portion608P of the device608in relation to the control handle616of the guiding sheath610through which the device608extends.

In some embodiments, the system S is configured to provide to the user on a display a visual region-of-interest indicium in real-time 3-D electroanatomical maps via an imaging electromagnetic system, such as The CARTO® 3 System by Biosense Webster, Inc. Irvine, California. With reference toFIG.20A,FIG.20B,FIG.20C,FIG.20D,FIG.20E,FIG.20F,FIG.20G,FIG.20H,FIG.20IandFIG.20J, a generated 3-D electroanatomical visualization of an intralumenal device702, for example, a transseptal guidewire, inserted through a lumen706of a lumened device704, for example, a dilator, inserted through a guiding sheath701, includes a visual indicium700that represents a region of interest ROI occupied by a protruding distal portion702D. In some embodiments, the distal portion702D of the intralumenal device702has shape memory such that it is straightened from a predetermined 2-D or 3-D configuration for insertion into and advancement through the lumen706and then elastically readopts the predetermined configuration when it exits the lumen or is otherwise unconfined and free from external forces. The predetermined configuration may be a “J” shape or any other 2-D or 3-D shape which is re-adopted by the distal portion702D after the distal portion has exited the inner lumened device704, penetrated septum712and distally advanced into left atrium714.

In some embodiments, the dynamic visual indicium700is displayed as a graphic element near or extending from a depiction or visualization of a distal end704D of the lumened device704to represent a 2D or 3D region occupied by the distal portion702D in the left atrium. InFIG.20A, the distal portion702D has not yet exited the lumen706so the distal portion is visualized on a display, as shown inFIG.20B, as a first graphic element715, e.g., an oval, which may be displayed in a first color. As the distal portion702D is advanced distally and pierces the septum712, as shown inFIG.20C, the dynamic visual indicium700in the visualization of the distal portion702D becomes a second graphic element716, e.g., a circle, which may be displayed in a second color. The circle, as shown inFIG.20D, represents a spherical region that may be occupied by the distal portion702D. Notably, a diameter of the circle is scaled to represent the length of the exposed distal portion702D that is protruding past the distal end704D of the lumened device704based on a determination of linear translation of the intralumenal device702by a position sensing assembly. With further distal advancement, the distal portion702D has penetrated through the septum712and into the left atrium714, as shown inFIG.20E, the circle of the second graphic element716increases in size as the diameter is scaled to a length representative of the greater exposed length of the distal portion702D protruding past the distal end704D, as shown inFIG.20F.

In some embodiments where the distal portion704D of the intralumenal device704has a predetermined configuration, e.g., a “J” curvature, that is readopted by the distal portion704D after further penetration of the septum712into the left atrium714, as shown inFIG.20G, the diameter and hence the circle of the second graphic element716are further increased such that the circle circumscribes the exposed distal portion702D in its entirety, as shown inFIG.20H. The circle and the spherical region represented advantageously cover all possible location of the “J” curvature regardless of its axial rotation along the longitudinal axis of the lumened device704. In the event the distal portion704D is further extended into the left atrium714, e.g., beyond a predetermined threshold length past the distal end704D, as shown inFIG.20I, the visualization of the distal portion704D becomes a third graphic element719, e.g., another circle of another color, whose diameter is scaled to represent the predetermined threshold length, as shown inFIG.20J. The third graphic element719may serve to warn the user that the distal portion702D is “out of range.” Any of the aforementioned embodiments of the position sensing assembly40by applying the known configurations and geometries of the intralumenal device702, lumened device704and/or an outer lumened device can determine the relative linear translation of the device702at its proximal end to determine the relative linear translation of the device702at its distal end. And, the visual indicium700is dynamically displayed to the user in real-time with the visualization of any, some or all of these devices, so that the user has a visual cue of the region where the distal portion702D of the intralumenal device702may be located at any given time during a procedure. The preceding description has been presented with reference to presently preferred embodiments of the invention. Workers skilled in the art and technology to which this invention pertains will appreciate that alterations and changes in the described structure may be practiced without meaningfully departing from the principal, spirit and scope of this invention. Any feature or structure disclosed in one embodiment may be incorporated in lieu of or in addition to other features of any other embodiments, as needed or appropriate. As understood by one of ordinary skill in the art, the drawings are not necessarily to scale. Accordingly, the foregoing description should not be read as pertaining only to the precise structures described and illustrated in the accompanying drawings, but rather should be read consistent with and as support to the following claims which are to have their fullest and fair scope.