Stabilized Coronary Sinus Catheter Handle

Abstract

A stabilized coronary sinus catheter system having proximal and distal sections with a memory shape portion and a distal tip of the memory shape portion. The handle has a body, a tip deflection actuator, a memory shape portion deployment actuator, and a shaft. The tip is aligned with the shaft and the tip deflection actuator is in a first position. When the tip deflection actuator is in a second position, the tip deflects out of alignment with the shaft. The third position is a delivery configuration in which the memory shape portion and the tip are aligned with the shaft. The memory shape portion deployment actuator is in the first location. The deployed configuration allows the memory shape portion to form a predetermined shape that matches the shape of the coronary sinus when the memory shape portion deployment actuator is in the second location.

Description

[Technical field]

[0001] The present disclosure relates generally to control handles for CS catheter systems, and more particularly, the present disclosure relates to an improved handle for a steerable catheter that can be operated with one hand. [Background technology]

[0002] During electrophysiological (EP) heart procedures, a coronary sinus (CS) catheter can be inserted into the heart to provide a reference for the procedure. The CS catheter has electrodes on its surface, and signals acquired by the electrodes are used as a reference for other signals acquired in the procedure, such as EP mapping of the heart chambers. To act as a good reference, the CS catheter should not move within its holding chamber (CS), or any movement should be tolerated.

[0003] Although methods to allow mobility are known in the art, it is preferred that the CS indwelling catheter be fixed in place. Additionally, it is known to deploy a CS catheter with shape memory properties to stabilize the catheter in the CS, but prior art techniques may place undue stress on both the catheter and the inferior vena cava leading to the right atrium. Furthermore, guiding the catheter into the coronary sinus can also be cumbersome.

[0004] Existing catheters, even those with steerability and deflection control, often have limited steering capabilities. This is especially true for procedures where fine movement control is required. Furthermore, existing designs may require two hands or be difficult to control. A physician having to repeatedly look away from the diagnostic tool to see where their hands are located and what part of the handle needs to be actuated can add significant time to a surgical procedure.

[0005] Additionally, electrode catheters are used to stimulate and map electrical activity within the heart and to ablate sites of abnormal electrical activity. In use, the electrode catheter is inserted into a major vein or artery, such as the femoral artery, and then guided into the heart chamber of interest. Within the heart, the ability to control the exact location and orientation of the catheter tip is important. Thus, instability of the electrode catheter can affect the outcome of an associated procedure (e.g., unreliable results of cardiac mapping) and is therefore critical to the success of a particular procedure. Summary of the Invention [Problem to be solved by the invention]

[0006] Thus, there is a need for improved devices, systems, and methods for a control handle that allows for precise steering control of the catheter while also being able to actuate additional functions, such as expanding the sensor fixation coil. It is also highly desirable for the ergonomics of the handle to allow for articulation of these functions to be performed with one hand, so as to avoid operator fatigue. [Means for solving the problem]

[0007] To that end, the present disclosure is a stabilized coronary sinus catheter system having proximal and distal portions with a memory shape portion and a distal tip distal to the memory shape portion. A handle can be disposed proximal to the proximal portion, having a body, a distal tip deflection actuator, a memory shape portion deployment actuator, and a central axis. The distal tip deflection actuator has a first position in which the distal tip is generally aligned with the central axis. It also has a deflected state when the distal tip deflection actuator is in a second position and the distal tip is deflected out of alignment with the central axis. A third position of the distal tip deflection actuator can bring the memory shape portion and the distal tip generally aligned with the central axis and the memory shape portion deployment actuator in the first location. Furthermore, the memory shape portion can be deployed to form a predetermined shape that generally matches the shape of the coronary sinus when the memory shape portion deployment actuator is in the second location.

[0008] The stabilized coronary sinus catheter system can further include a pull wire having a first end fixed to the distal tip and a second end fixed to the body. A distal tip deflection actuator can be attached to the pull wire, the second position displacing the pull wire. The distal tip has a deflection angle of approximately 0° to approximately 180°.

[0009] The coronary sinus catheter further includes an intermediate section distal to the proximal section and having an intermediate stiffness, the proximal section including a proximal stiffness, and the distal tip has a flexibility greater than the proximal stiffness, the intermediate stiffness, and the stiffness of the shape memory section. The single-axis position sensor can be located approximately at the distal tip.

[0010] Additionally, the system includes a flexure actuator lock having an unlocked position that allows the distal tip flexure actuator to move between the first and second positions and a locked position that prevents the distal tip flexure actuator from moving between the first and second positions.

[0011] The shape memory alloy can be disposed along the shape memory portion and have one end fixed within the body. A cover tube can be disposed over a portion of the shape memory alloy and have a memory shape portion deployment end fixed to a memory shape portion deployment actuator. In the delivery configuration, the cover tube constrains the shape memory alloy and in the deployed configuration, the shape memory alloy is not constrained by the cover tube.

[0012] When the shape memory section deployment actuator is in a first location, it maintains the cover tube on the shape memory alloy and prevents the shape memory alloy from returning to the predetermined shape, and when the shape memory section deployment actuator is in a second location, it withdraws the cover tube from the shape memory alloy and allows the shape memory alloy to return to the predetermined shape.

[0013] In one example, the predetermined shape of the shape memory portion of the stabilized coronary sinus catheter system is approximately a helical shape. Proximal bend radius of approximately 8.5 mm to approximately 9.5 mm; Distal bend radius of approximately 7.0 mm to approximately 8.0 mm; A proximal helix angle of approximately 110° to approximately 120°; Distal helix angle of approximately 150° to approximately 160°; The length of the shape memory part is approximately 42.5mm to approximately 44.5mm. a major diameter of the first helical coil of approximately 14.0 mm and approximately 16.0 mm; and / or and a taper angle of approximately 3.5° to approximately 5.5°.

[0014] A method of using a coronary sinus catheter for mapping electrical activity of the heart, the coronary sinus catheter having a distal portion with a memory shape portion and a distal tip distal to the memory shape portion. Also included is a body, a distal tip deflection actuator, a memory shape portion deployment actuator, a cover tube disposed over a portion of the memory shape portion, and a handle having a central axis and disposed proximal to the proximal portion. The method includes delivering the coronary sinus catheter in a delivery configuration to the coronary sinus such that the distal portion of the coronary sinus catheter is generally aligned with the central axis. Then, by actuating the distal tip deflection actuator, deflecting the distal tip out of alignment with the central axis to steer the coronary sinus catheter. And thereafter, deploying the memory shape portion of the distal portion of the coronary sinus catheter into the coronary sinus, withdrawing the cover tube from the memory shape portion, and returning the memory shape portion to a preformed shape. There is a step of applying a lateral force to the coronary sinus with the memory shape portion deployed.

[0015] Different examples of stabilized coronary sinus catheters can include a primary sensor probe having multiple primary sensors disposed along a first length of the primary sensor probe, and multiple secondary sensor probes each having a second length shorter than the first length and a secondary sensor disposed at a distal location. There can be a sheath catheter having a lumen configured to allow the primary sensor probe and the multiple secondary sensor probes to pass through. In the sheathed position, the multiple secondary sensor probes are enclosed within the lumen and at least a portion of the primary sensor probe is outside the lumen. In the unsheathed position, both the primary sensor probe and the multiple secondary sensor probes are outside the lumen and the multiple secondary sensor probes are angled away from the primary sensor probe to apply a lateral force to the coronary sinus.

[0016] The second length has a plurality of sub-lengths, each of a portion of the plurality of secondary sensor probes having a different sub-length. Further included is a midline axis, the primary sensor probe being disposed generally along the midline axis. The plurality of secondary sensor probes are generally parallel to the midline axis in the covered position and form an angle away from the midline axis in the uncovered position.

[0017] The secondary sensor probe angle may be formed between the secondary sensor probe and the midline axis at an angle of approximately 0° to approximately 90°, and more preferably, the secondary sensor probe angle may be between approximately 0° to approximately 10°. [Brief description of the drawings]

[0018] [Figure 1] FIG. 2 is a side view of an example stabilized coronary sinus catheter of the present disclosure. [Figure 2A] FIG. 2 is a side view of an example of a distal portion of a stabilized coronary sinus catheter of the present disclosure. [Figure 2B] FIG. 2 is a side view of an example of a distal portion of a stabilized coronary sinus catheter of the present disclosure. [Diagram 3] FIG. 2 is a front view of an example of a distal portion of a stabilized coronary sinus catheter of the present disclosure. [Figure 4]FIG. 4 is a cross-sectional view of the distal end of the stabilized coronary sinus catheter of FIG. [Diagram 5] 1 is an image of the heart identifying the coronary sinus. [Figure 6] 1 is an image of an example stabilized coronary sinus catheter of the present disclosure fully deployed in the coronary sinus. [Figure 7A] 1 shows the continuous deployment of the handle and helical portion with a deflectable tip. [Figure 7B] 1 shows the continuous deployment of the handle and helical portion with a deflectable tip. [Figure 7C] 1 shows the continuous deployment of the handle and helical portion with a deflectable tip. [Figure 8] FIG. 13 is a cross-sectional view of an example handle of the present disclosure showing the elements involved in tip deflection. [Figure 9A] 13 shows the piston movement of the handle to deflect the tip of the catheter. [Figure 9B] 13 shows the piston movement of the handle to deflect the tip of the catheter. [Figure 10] FIG. 13 is a cross-sectional view of an example handle of the present disclosure, illustrating the elements involved in deploying the helical portion to a non-deployed position. [Figure 11] 10A is an enlarged cross-section AA of FIG. 10 showing the shape memory partially deployed actuator in a non-deployed position. [Figure 12] FIG. 13 is a cross-sectional view of an example handle of the present disclosure, showing the elements involved in deploying the helical portion to a deployed position. [Figure 13] 12A is an enlarged cross-section BB of FIG. 12 showing the shape memory partial deployment actuator in a deployed position. [Figure 14] FIG. 1 is a cross-sectional view of a stabilized coronary sinus catheter having an additional lumen. [Figure 15] FIG. 1 is a side view of another example of a stabilized coronary sinus catheter of the present disclosure. [Figure 16A] 1A-1C show side views of further examples of stabilized coronary sinus catheters of the present disclosure, each deployed within the coronary sinus. [Figure 16B]1A-1C show side views of further examples of stabilized coronary sinus catheters of the present disclosure, each deployed within the coronary sinus. [Figure 17] 1 is a flow chart illustrating a method for deploying a stabilized coronary sinus catheter with an advanced handle. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0019] As used herein, the term "about" or "approximately" in relation to any numerical value or range is intended to indicate a suitable tolerance that allows a portion or collection of components to function for the intended purpose described herein. More specifically, "about" or "approximately" may refer to a range of values ​​of ±10% of the recited value, e.g., "about 90%" may refer to a range of values ​​of 81% to 99%.

[0020] As used herein, a "subject" or "patient," including blood vessels from a subject or patient, refers to any relevant human patient, as well as any mammal, veterinary animal, livestock animal, or pet animal, etc. In one example, the animal may be a laboratory animal (e.g., rats, dogs, pigs, rabbits, monkeys, etc.) that has been specifically selected to have certain characteristics similar to humans.

[0021] As used herein, "operator" may include a doctor, surgeon, or any other individual or instrument associated with a medical procedure used in conjunction with the device(s) of the present disclosure.

[0022] Additionally, the terms "patient," "host," "user," and "subject" refer to any human or animal subject, and are not intended to limit the above-described systems or methods to use in humans, although use of the present disclosure in subjects of human patients represents a preferred embodiment.

[0023] As used herein, the term "computing system" is intended to include a stand-alone machine or apparatus and / or combinations of machines, components, modules, systems, servers, processors, memories, detectors, user interfaces, computing device interfaces, network interfaces, hardware elements, software elements, firmware elements, and other computer-related units. By way of example and not limitation, a computing system may include one or more of a general purpose computer, a special purpose computer, a processor, a portable electronic device, a portable electronic medical device, a stationary or semi-stationary electronic medical device, or other electronic data processing device.

[0024] As used herein, terms such as "component," "module," "system," "server," "processor," "memory," and the like are intended to include one or more computer-related units, such as, but not limited to, hardware, firmware, a combination of hardware and software, software, or software in execution. For example, a component may be, but is not limited to, a process running on a processor, an object, an executable, a thread of execution, a program, and / or a computer. By way of example, both an application running on a computing device and the computing device may be a component. One or more components may reside within a process and / or thread of execution, and a component may be localized on one computer and / or distributed between two or more computers. Additionally, these components may execute from various computer readable media having various data structures stored thereon.

[0025] Components may communicate by local and / or remote processes, such as according to signals having one or more data packets, such as data from one component interacting with another component in a local system, a distributed system, and / or data over a network such as the Internet with other systems by signals. Computer-readable media may be non-transitory. The term "non-transitory computer-readable media" includes, but is not limited to, random access memory (RAM), read-only memory (ROM), electronically erasable programmable ROM (EEPROM), flash memory or other memory technology, compact disc ROM (CD-ROM), digital versatile disk (DVD) or other optical storage, magnetic cassette, magnetic tape, magnetic disk storage or other magnetic storage, or any other tangible physical medium that can be used to store computer-readable instructions and / or data.

[0026] As used herein, the term "trace" includes conductive paths in an electrical circuit such as paths integrated into a printed circuit, individual wires, conductors in a ribbon cable, or other such structures that will be recognized and understood by those of ordinary skill in the art following the teachings of the present disclosure.

[0027] As used herein, the terms "tubular" and "tube" are not limited to right circular cylinders or structures whose cross section is strictly circular or uniform throughout their length. For example, a tubular structure or system is generally illustrated as a substantially right circular cylindrical structure. However, a tubular system may have a tapered outer surface, a curved outer surface, and / or a partially flat outer surface without departing from the scope of the present disclosure.

[0028] 1, a stabilized coronary sinus catheter system is shown including a coronary sinus catheter 100 configured to enter the coronary sinus 20 of a heart 10 (see FIGS. 5 and 6). During an electrophysiological (EP) cardiac procedure, a coronary sinus (CS) catheter 100 may be inserted into the heart 10 to provide a reference for the procedure. The CS catheter 100 has a proximal section 102, an intermediate section 104, and a distal section 106. A handle 300 may be disposed proximal to the proximal section 102 to allow a user to control the movement and deployment of features of the CS catheter 100. The intermediate section 104 may be distal to the proximal section 102 and may have an intermediate stiffness. The proximal section 102 may have a proximal stiffness and the distal tip 202 may have a flexibility greater than the proximal stiffness, the intermediate stiffness, and the stiffness of the shape memory section 200.

[0029] While stiffness is a general term, there are many ways to form the catheter sections 102, 104, 106 with different stiffness or conversely flexibility. Each section can be formed from one or more polymers and / or materials with different hardness or durometer. Additionally, braids or other stiffening materials can be used around the inside, outside, or directly molded into the catheter sections 102, 104, 106. Alternatively or additionally, strain relief features (such as physical scoring) can be added to enhance flexibility.

[0030] 2A and 2B show features of the distal portion 106. The distal portion 106 may have electrodes or sensors 208 along its surface. The signals acquired by the sensors 208 are used as a reference for other signals acquired in a procedure such as EP mapping of the heart 10. To act as a good reference, the CS catheter 100 should not move within its holding chamber (CS 20), or any movement must be tolerated. To that end, the distal portion 106 also includes a memory shape portion 200 and a distal tip 202 distal to the memory shape portion 200. FIGS. 2A and 2B show the memory shape portion 200 in a deployed configuration, where the memory shape portion 200 forms a predetermined shape that approximately matches the shape of the coronary sinus 20. The shape may include a spiral or a basket. When the memory shape portion 200 assumes the deployed shape (and in this example, the spiral shape), the electrodes 208 are pushed into contact with the CS 20 wall. The pressure of the shape memory portion 200 into the wall locks the catheter 100 in place. The distal tip 202 can also include a single axis position sensor 224 to help guide the sensor 208 into the CS 20 before it is deployed.

[0031] To facilitate the locking aspect, the shape memory portion 200 has a proximal end 206 and a distal portion axis 204 extending from the proximal end 206 to the distal tip 202. In the example shown in Figures 2A, 2B, and 3, the predetermined shape of the shape memory portion 200 has some exemplary measurements for a tapered helical shape. The proximal portion bend radius 210 can measure from approximately 8.5 mm to approximately 9.5 mm, and the distal portion bend radius 212 can measure from approximately 7.0 mm to approximately 8.0 mm. The proximal portion helix angle 214 can be from approximately 110° to approximately 120°. The distal portion helix angle 216 can be from approximately 150° to approximately 160°. The shape memory portion can have a length 218 when deployed of approximately 42.5 mm to approximately 44.5 mm. The major diameter 220 of the first helical coil may be approximately 14.0 mm to approximately 16.0 mm, and may have a taper angle 222 of approximately 3.5° to approximately 5.5°.

[0032] FIG. 4 shows an example of a cross section of the catheter 100. In this example, there may be a guidewire lumen 108 that allows the catheter 100 to ride on a guidewire 40 to guide the catheter 100 from the insertion point (typically a groin puncture) to the heart 10. Once near or in the CS 20, the guidewire 40 may be removed to allow further functions of the handle 300, which will be described in more detail below. The sensor wire lumen 110 may include a sensor wire 50 (see FIG. 14) that connects the sensor 208 to the system to read data from the sensor and display it to the user. In one example, there may be at least 40 sensors 208 deployed along the distal portion 106. The sensor wire 50 may also transmit a signal from a single-axis position sensor 224. The movement of the catheter 100 is tracked with at least the single-axis position sensor 224 to enable proper placement within the CS 20. Once the catheter 100 is properly placed and the shape memory portion 200 is deployed, the catheter 100 is tracked and the CS chamber is fully demonstrated in the user's mapping system. Tracking of the catheter 100 can use any known tracking technology, such as CARTO®.

[0033] In the example of shape memory section 200 shown in Figures 5 and 6, the helical structure also functions as a fixation mechanism that locks catheter 100 in place within CS 20. It also provides continuous contact of sensor 208 within the CS 20 chamber wall to provide stable readings free of artifacts such as heartbeat and respiration. These are improvements over prior art CS catheters. Electrocardiogram (ECG) artifacts are generated from motions associated with movement between the electrodes and CS walls during heart contraction and respiration-related motion.

[0034] When the shape memory portion 200 secures the catheter 100, the distal tip 202, which is followed by the intermediate portion 104, is used as a strain relief. Being radially soft, the retraction of the guidewire can minimize the force applied to the shape memory portion 200, leaving this portion to operate within the right atrium. The proximal portion 102 can be made more rigid by pushing it somewhat forward after the guidewire is fully retracted, building a strain relief portion. This prevents the heart movement due to breathing and heartbeat from exerting force on the shape memory portion 200. This can further prevent the risk of movement of the shape memory portion 200 in the CS 20. With the catheter 100 firmly stabilized in the CS 20, any movement of the catheter 100 is monitored and used to alert the mapping system and the user.

[0035] Having many sensors 208 (e.g., 2-3 mm apart) surrounding the CS20 chamber allows for the selection of sensors 208 with atrial or ventricular activity, allowing selective detection of atrial or ventricular activity. Additionally, in the case of left and right atrial dissociation, each atrial activity can be tracked independently. The sensors 208 can be oriented to be sensitive both along and laterally to the distal segment axis 204, providing an accurate view of activity in any direction. This can be achieved by taking a wide bipolar signal to subtract, not just the nearest electrodes. Having a full view of the CS20 provides better tracking of activation morphology representing both the far field (activity further from the CS20) and the near field (activity associated with ECG generated near the CS20). This capability provides a more robust tracking tool that allows for detection of similar ECG activity and supports suturing of different locations of the mapping catheter (as used by CARTO® during LAT mapping). Some tachycardias involve activation in the CS20. Mapping the CS 20 is difficult with current tools because activity can be proximal or contralateral to the thermal wall. The helical shape of the shape memory portion 200 allows for a complete activity map in the CS.

[0036] Other elements of the catheter 100 are the lead wire lumen 112 and the shape memory lumen 114. The shape memory lumen 114 contains a shape memory alloy 116 (see FIG. 14). The shape memory alloy 116 can be made of a material that can automatically recover its shape when released from a significantly distorted delivery configuration. Superelastic shape memory materials such as Nitinol or alloys with similar properties are particularly suitable. These materials have sufficient elastic strain capacity so that the shape memory portion 200 does not exceed its elastic limit when constrained in the delivery configuration. This elastic strain capacity allows the shape memory portion 200 to self-expand upon deployment. The shape memory lumen 114 can extend the length of the catheter 100, or in one example, only the length of the shape memory portion 200 or the distal portion 106.

[0037] The catheter 100 may also include a pullwire lumen 118 that houses a pullwire 120. The pullwire 120 may be used to deflect the distal tip 202. The pullwire 120 may be secured at its proximal end to a handle (described in more detail below). The pullwire 120 may be made of any suitable metal, such as stainless steel or nitinol, and is preferably coated with Teflon 7 or any other coating that provides lubricity to the pullwire 120.

[0038] 7A-13 show different examples of the handle 300. The handle 300 can include a body 301, a distal tip bending actuator 302, a shape memory portion deployment actuator 304, and a central axis 306. The handle 300 is designed for ease of use. FIG. 7A shows the handle control 302, 304 in a neutral position and a delivery configuration. In the neutral position, the distal tip 202 can be approximately aligned with the central axis 306. In the neutral position, the distal tip bending actuator 302 is in a first position. The first position is the most proximal position of the distal tip bending actuator 302. FIG. 7A also shows the delivery configuration where the shape memory portion 200 and the distal tip 202 are approximately aligned with the central axis 306. Here, the shape memory portion deployment actuator 304 can be in its most distal position. The distal tip bending actuator 302 is in a first position and the shape memory portion deployment actuator 304 is in its first location. The neutral position and delivery configuration allows the catheter 100 to ride over the guidewire 40 and deliver the distal portion 106 to the CS 20.

[0039] FIG. 7B shows the handle 300 and catheter 100 in a deflected position, where the guidewire 40 has been removed completely or within the intermediate section 104 and the distal tip 202 has been deflected out of alignment with the central axis 306. Deflection can be caused by the distal tip deflection actuator 302 being moved to a second position distal to the first position. FIGS. 8, 9A, 9B, and 13 show the deflection mechanism. The pullwire 120 has a first end fixed to the distal tip 202 and a second end attached to a fixed point 303 (tension screw shown) within the body 301. The distal tip deflection actuator 302 can be attached to the pullwire 120 such that any movement along the central axis 306 displaces the pullwire 120. By extending the distal tip deflection actuator 302, the distal tip 302 can be deflected over a deflection angle of approximately 0° to approximately 180°. Deflection of the distal tip 202 allows the distal portion 106 to be directed to an appropriate location within the CS 20 such that the distal tip 202 is directed into the inferior vena cava (FIG. 6).

[0040] 9A and 9B show the locked and unlocked positions of the flexure actuator lock 310. In this example, a simple twist can lock and unlock the ability to flex the distal tip 202. Thus, the flexure actuator lock 310 has an unlocked position that allows the distal tip flexure actuator 302 to move between a first position (most proximal) and a second position (most distal). And, the locked position prevents the distal tip flexure actuator 310 from moving between the first and second positions. Additionally, the handle flexure brake 308 is evident on the handle 300 that stops at different flexure angles, allowing the user to look at the handle 300 and determine how much the distal tip 202 is flexed. The distal tip 202 can flex when the shape memory portion 200 is undeployed and / or in a delivery configuration.

[0041] 7C and 10-13 show the deployed configuration of the shape memory portion 200. The shape memory alloy 116, as described above, can be disposed along at least the shape memory portion 200 and has one end secured within the body 301. The shape memory alloy 116 is preset to an expanded shape configured to secure the distal portion 106 of the coronary sinus catheter 100 in the coronary sinus 20. As shown, the preset shape is a helix offset from a central axis 306, although any shape that is atraumatic and can conform to the wall of the CS 20 can be contemplated.

[0042] To facilitate the delivery and deployment configuration, a cover tube 312 can be placed over the shape memory portion 200 or even a portion of the shape memory alloy 116. In one example, the cover tube 312 can have a memory shape portion deployment end 314 secured to the memory shape portion deployment actuator 304. In the delivery configuration, the cover tube 312 restrains the shape memory portion 200 / shape memory alloy 116, and in the deployed configuration, the shape memory portion 200 / shape memory alloy 116 are not restrained by the cover tube 312.

[0043] 10 and 11 show the memory shape portion deployment actuator 304 in a distal-most position (its first location) that maintains the cover tube 312 over the shape memory portion 200 / shape memory alloy 116 preventing the shape memory alloy 116 from returning to its predetermined shape. Moving the memory shape portion deployment actuator 304 to a proximal position (its second location) withdraws the cover tube 312 from the shape memory portion 200 / shape memory alloy 116, allowing the shape memory alloy 116 to return to its predetermined shape. This position is shown in FIGS. 12 and 13.

[0044] In other words, in one example, the cover tube 312 covers almost the entire catheter 100 from the handle 300 to just before the distal tip 202. The cover tube 312 can be flexible made of Nitinol, stainless steel, or a semi-rigid polymer, and the tube can also be laser cut to allow for additional flexibility. The cover tube 312 needs to be rigid enough to inhibit the shape memory portion 200 / shape memory alloy 116 from returning to its preformed shape, but flexible enough to allow the catheter 100 to traverse the vessel in which it is deployed within the CS 20. The shape memory alloy 116 is fixed at one end inside the body 301, over which the cover tube 312 is deployed. The cover tube 312 can be external to the entire catheter 100, or can be coaxial inside the shape memory lumen 114. The cover tube 312 has a shorter length than the shape memory alloy 116, and when the memory shape portion deployment actuator 304 is distal at a first location, the cover tube 312 covers and restrains the shape memory portion 200. When the cover tube 312 is retracted by moving the memory shape portion deployment actuator 304 to a second location, due to the difference in length, the shape memory alloy 116 is now unrestrained and is able to return to its preset shape.

[0045] Additionally, during or after a procedure, the shape memory portion deployment actuator 304 can be moved distally (i.e., back to the first location) to reconstrain the shape memory alloy 116 and return the catheter 100 to its delivery configuration and remove it from the blood vessel. The shape memory alloy 116 can also be reconstrained if the shape memory portion 200 needs to be repositioned during a procedure for any reason.

[0046] 15 and 16 show other examples of coronary sinus catheters. FIG. 15 shows an example in which the pull wire 120 can be used to deflect the distal tip 202 and then pulled with additional force to deflect the shape memory portion 200 to its deployed configuration. In this example, the shape memory alloy 116 can be preset to be straight, and tension pulls the alloy to "deform," for example, into a helical shape. In the example shown, the pull wire 120 is within the pull wire lumen 118 only up to the middle portion 104. The pull wire 120 is then outside the lumen up to the distal tip 202. This allows the distal portion 106 to deform under tension.

[0047] 16A and 16B show yet another stabilized coronary sinus catheter 400 having a primary sensor probe 402. The primary sensor probe 402 may function similarly to the distal tip 202 described above with at least a single axis position sensor 424 to guide the catheter 400 and may include multiple primary sensors 406 disposed along the length of the primary sensor probe 402. However, instead of the shape memory portion 200, this example has multiple secondary sensor probes 404. The multiple secondary sensor probes 404 have a second length that is shorter than the first length and at least one secondary sensor 406 disposed at a distal location / tip. The second (shorter) length may be multiple different sub-lengths, and one or more of the secondary sensor probes 404 may have different sub-lengths.

[0048] The sheath catheter 450 can have a lumen configured to allow the primary sensor probe 402 and the multiple secondary sensor probes 404 to pass through. During delivery, the sheathed position can have the multiple secondary sensor probes 404 enclosed within the lumen and at least a portion of the primary sensor probe 402 outside the lumen. This allows a compact delivery profile to move the catheter 400 through the blood vessel to the CS 20. Once in the CS 20, the catheter 400 can be withdrawn and the unsheathed position can have both the primary sensor probe 402 and the multiple secondary sensor probes 404 outside the lumen. Additionally, the multiple secondary sensor probes 404 can be angled at an angle α away from the primary sensor probe 402 and can exert a lateral force against the coronary sinus 20. This lateral force acts as an anchoring force to stabilize the catheter 400 within the CS 20 for all the reasons discussed above.

[0049] Stated another way, the catheter 400 can have a midline axis 408, and the primary sensor probe 402 is disposed approximately along the midline axis 408. The multiple secondary sensor probes 404 can then form an angle α that is approximately parallel to the midline axis 408 in the coated position and away from the midline axis in the uncoated position. Specifically, the secondary sensor probe angle α is formed between at least one of the secondary sensor probes 404 and the midline axis 408. The secondary sensor probe angle α can be approximately 0° to approximately 90°, more specifically approximately 0° to approximately 10°. The secondary sensor probes 404 can be tilted away from the midline axis 408 because they have a shape memory alloy or some other form of bias to tilt them away. The bias can also be formed from a thin profile of spring steel or other metal.

[0050] 17 illustrates a method of using a coronary sinus catheter (i.e., 100, 400) to map electrical activity of the heart 10. The coronary sinus catheter 100, 400 can include a distal portion 106 having a memory shape portion 200 and a distal tip 202 distal to the memory shape portion 200. A handle 300 is disposed proximal to the proximal portion 102 of the catheter and includes a body 301, a distal tip deflection actuator 302, a memory shape portion deployment actuator 304, a cover tube 312 disposed over a portion of the memory shape portion 200, and a central shaft 306. An example step can include delivering the coronary sinus catheter in a delivery configuration to the coronary sinus such that a distal portion of the coronary sinus catheter is approximately aligned with the central shaft (1700). The distal tip 402 can be deflected (1702) out of alignment with the central axis 306 to steer the coronary sinus catheter 100 by actuating the distal tip deflection actuator 302. The memory shape portion 200 of the distal section 106 can be deployed (1704) into the coronary sinus 20. Deploying the memory shape portion 200 can have the additional steps of withdrawing (1706) the cover tube from the memory shape portion and returning (1708) the memory shape portion to a preformed shape. Additionally, the method can include applying a lateral force against the coronary sinus 20 with the deployed memory shape portion 200 (1710).

[0051] Specific aspects of the general disclosure may include two configurations, one straight and the other with a helical shape. The helical shape is created with a preformed wire of shape memory alloy (nitinol). The configurations are switched by extending or retracting the tube inside the catheter shaft. There is a deflectable tip for maneuverability. Multiple sensors allow visualization in a mapping system. A locking ring is placed on the plunger / distal tip deflection actuator to prevent unwanted deflection while extending or retracting the tube. For example, a multi-lumen plastic extrusion can be used to keep components such as wires, nitinol and tubes separated. Electrodes across the length of the helix allow for multiple rounds of cardiac information.

[0052] With respect to the attachment points in the handle, the pull-wire may be fixed distally at the distal region of the deflectable tip and proximally to the shaft in the proximal region of the handle body. The proximal fixation point of the pull-wire allows for adjustment of tension in the wire during assembly. The Nitinol wire having a preformed helical shape may be fixed distally to the catheter tip, distal to the helical shape. The Nitinol wire may be further fixed proximally at the proximal end of the plunger component, allowing the entire length of the Nitinol wire to move with the shaft during tip deflection. The distal end of the tube is free floating in the catheter lumen and is fixed to a stud located in the handle.

[0053] The nitinol and tube also have an exemplary behavior of acting as a guide and support surface for the tube over which the nitinol wire passes. The tube has two sections, the distal section is more flexible to facilitate movement over the helical shape and through the anatomy. The proximal section is more rigid, allowing for higher force transmission. A lubricant is used at the interface between the nitinol wire and the tube to reduce friction during tube extension. A lubricant can also be used between the tube and the catheter lumen. The tube assembly can have projections with a smooth contour ("bead") around the circumference spaced along the distal length, including the distal tip, to reduce friction during tube extension. The plunger and handle have clearance for the tube fixation stud to allow movement of the tube relative to these components.

[0054] Examples for tip deflection include handles having stroke limiting features that allow adjustment of allowable pull wire deflection during assembly. Wire coils can be used in the shaft sections just proximal and distal to the helical region rather than in the helical region to add stiffness to the catheter that improves tip deflection. The distal deflectable tip, however, is soft but allows deflection.

[0055] Other features of the stabilized coronary sinus catheter with distal strain relief include a proximal section with a proximal stiffness, a distal section distal to the proximal section with an intermediate stiffness, and an intermediate section, a distal section distal to the intermediate section. The distal section can include a memory shape section, a distal tip distal to the memory shape section, a shape memory lumen disposed along the shape memory section, and a shape memory alloy disposed in the shape memory lumen. There can be a delivery configuration including a memory shape section and a distal tip that generally coincides with the central axis, and a deployed configuration including a memory shape section that forms a shape that generally coincides with the shape of the coronary sinus. The distal tip can include a flexibility that is greater than the proximal stiffness, the intermediate stiffness, and the stiffness of the shape memory alloy.

[0056] The stabilized coronary sinus catheter can have a distal tip configured to hang down into the right atrium when in a deployed configuration. The shape of the shape memory portion can have a generally helical shape and be configured to apply a lateral force to the coronary sinus. Also, the helix can be formed along a distal portion axis that is offset from a central axis. A plurality of sensors can be disposed along the distal portion, and a sensor wire lumen including a sensor cable disposed therein can connect the plurality of sensors.

[0057] The guidewire lumen can be further positioned from the proximal portion to the distal portion such that the delivery configuration further has a distal portion that conforms to the shape of a guidewire disposed in the guidewire lumen. The guidewire is then partially removed from the guidewire lumen to result in the deployed configuration. The pullwire lumen can be additionally positioned from the proximal portion to the distal tip, and a pullwire can be disposed in the pullwire lumen. The neutral position can include a distal tip that is approximately in line with the central axis and a deflected position that displaces the pullwire with the distal tip moving out of alignment with the central axis.

[0058] Another stabilized coronary sinus catheter system can have a coronary sinus catheter having a proximal portion, a distal portion (including a memory shape portion and a distal tip distal to the memory shape portion), a shape memory lumen disposed along the shape memory portion, and a shape memory alloy disposed in the shape memory lumen. A handle can be disposed proximal to the proximal portion and includes a distal tip deflection actuator, a memory shape portion deployment actuator, and a central shaft. The neutral position can include the distal tip and the distal tip deflection actuator approximately aligned with the central axis in a first position, and the deflected position includes the distal tip moving out of alignment with the central axis and the distal tip deflection actuator in a second position. The delivery configuration can then include the memory shape portion and the distal tip approximately aligned with the central axis and the memory shape portion deployment actuator in a third position, and a deployed configuration including the memory shape portion and the memory shape portion deployment actuator forming a shape approximately matching the shape of the coronary sinus in a fourth position.

[0059] The pull wire lumen can be disposed from the proximal portion to the distal tip, and a pull wire can be disposed in the pull wire lumen. The distal tip deflection actuator can be attached to the pull wire, and the second position displaces the pull wire. The guide wire lumen is disposed from the proximal portion to the distal tip.

[0060] An intermediate section distal to the proximal section can include an intermediate stiffness, the proximal section includes a proximal stiffness, and the distal tip includes a flexibility greater than the proximal stiffness, the intermediate stiffness, and the stiffness of the shape memory alloy. A plurality of sensors can be disposed along the distal section, and the sensor wire lumen has a sensor cable disposed therein connecting the multiple sensors.

[0061] A method for mapping cardiac electrical activity using a coronary sinus catheter includes delivering the coronary sinus catheter in a delivery configuration to the coronary sinus such that a distal portion of the coronary sinus catheter is substantially aligned with a central axis, deploying a memory-shape portion of the distal portion of the coronary sinus catheter in the coronary sinus such that a distal tip of the distal portion hangs within the right atrium when the memory-shape portion is deployed, and applying a lateral force to the coronary sinus when the memory-shape portion is deployed.

[0062] The further stabilized coronary sinus catheter includes a primary sensor probe including a plurality of primary sensors and a plurality of secondary sensor probes disposed along a first length of the primary sensor probe. The secondary sensor probes each include a second length shorter than the first length and a secondary sensor disposed at a distal location. The sheath catheter can have a lumen configured to allow the primary sensor probe and the plurality of secondary sensor probes to pass through. The covered position can have the plurality of secondary sensor probes enclosed within the lumen and at least a portion of the primary sensor probe outside the lumen. The uncovered position includes both the primary sensor probe and the plurality of secondary sensor probes outside the lumen and the plurality of secondary sensor probes angled away from the primary sensor probe to apply a lateral force to the coronary sinus.

[0063] The second length of the stabilized coronary sinus catheter has a plurality of sub-lengths, and a portion of the plurality of secondary sensor probes each have a different sub-length. A midline axis is included, and the primary sensor probe is disposed approximately along the midline axis. Additionally, the plurality of secondary sensor probes are approximately parallel to the midline axis in the covered position and form an angle away from the midline axis in the uncovered position. A secondary sensor probe angle may be formed between the secondary sensor probe and the midline axis. Here, the secondary sensor probe angle may be between approximately 0° and approximately 90°. More specifically, the secondary sensor probe angle may be between approximately 0° and approximately 10°.

[0064] The descriptions contained herein are examples of embodiments of the present disclosure and are not intended to limit the scope of the present disclosure in any way. As described herein, the present disclosure contemplates many variations and modifications of ablation and diagnostic tools, including alternative numbers of electrodes, alternative combinations of electrodes, combinations of components shown in separate figures, alternative materials, alternative component geometries, and alternative component arrangements. Modifications and variations that are obvious to those skilled in the art following the teachings of the present disclosure are intended to be within the scope of the following claims.

[0065] [Embodiment] (1) A stabilized coronary sinus catheter system, comprising: 1. A coronary sinus catheter comprising: A proximal portion; a distal portion, A shape memory portion; a distal tip distal to the memory shape portion; and a handle disposed proximally of the proximal portion, a body defining a central axis; a distal tip deflection actuator configured to be in one of a first position, a second position, or a third position along the central axis such that: (a) in the first position of the actuator, the distal tip is substantially aligned with the central axis; (b) in the second position of the actuator for deflection of the distal tip, the distal tip is out of alignment with the central axis; (c) a distal tip deflection actuator, wherein in the third position of the actuator for delivery, the memory shape portion and the distal tip are generally aligned with the central axis; a handle including a shape memory portion deployment actuator configured to be at one of a first location and a second location relative to the central axis such that the shape memory portion deployment actuator is at the first location during delivery or deflection of the tip and at the second location for deployment of the shape memory portion to form a predetermined shape that generally matches a shape of the coronary sinus; 1. A stabilized coronary sinus catheter system comprising: (2) The method further includes a pull wire, the pull wire comprising: a first end secured to the distal tip; a second end secured to the body; the distal tip deflection actuator is attached to the pull wire; 2. The stabilized coronary sinus catheter system of claim 1, wherein the second position displaces the pull wire. (3) The stabilized coronary sinus catheter system of claim 1, further comprising: the distal tip including a deflection angle of approximately 0° to approximately 180°. (4) The coronary sinus catheter comprises: a medial portion distal to the proximal portion, the medial portion including an intermediate stiffness; the proximal portion includes a proximal stiffness; and the distal tip comprises a flexibility greater than the proximal stiffness, the intermediate stiffness, and a stiffness of a shape memory portion. 2. A stabilized coronary sinus catheter system as described in embodiment 1. (5) The stabilized coronary sinus catheter system of claim 1, further comprising a single-axis position sensor disposed approximately at the distal tip.

[0066] (6) The actuator further includes a flexure actuator lock, an unlocked position that allows the distal tip deflection actuator to move between the first position and the second position; a locked position that prevents the distal tip deflection actuator from moving between the first position and the second position. 2. A stabilized coronary sinus catheter system as described in embodiment 1. (7) a shape memory alloy disposed along the shape memory portion and including one end fixed to the body; a cover tube disposed over a portion of the shape memory alloy and including a shape memory portion deployment end secured to the shape memory portion deployment actuator; In a delivery configuration, the cover tube constrains the shape memory alloy; and 2. The stabilized coronary sinus catheter system of claim 1, wherein in the deployed configuration, the shape memory alloy is not constrained by the cover tube. (8) the shape memory portion deployment actuator in the first location maintains the cover tube on the shape memory alloy to prevent the shape memory alloy from returning to the predetermined shape; The stabilized coronary sinus catheter system of embodiment 7, wherein the memory shape portion deployment actuator in the second location pulls the cover tube from the shape memory alloy, allowing the shape memory alloy to return to the predetermined shape. (9) A stabilized coronary sinus catheter system as described in embodiment 1, wherein the predetermined shape of the shape memory portion comprises an approximately helical shape. (10) The predetermined shape of the shape-memory portion is a proximal bend radius of approximately 8.5 mm to approximately 9.5 mm; a distal bend radius of approximately 7.0 mm to approximately 8.0 mm; A proximal helix angle of approximately 110° to approximately 120°; A distal portion helix angle of approximately 150° to approximately 160°; The length of the shape memory part is approximately 42.5mm to approximately 44.5mm, a major diameter of the first helical coil of approximately 14.0 mm and approximately 16.0 mm; A taper angle of approximately 3.5° to approximately 5.5°. 10. The stabilized coronary sinus catheter system of embodiment 9, comprising at least one of:

[0067] (11) A method of using a coronary sinus catheter for mapping electrical activity of the heart, the coronary sinus catheter comprising: a distal portion including a memory shape portion and a distal tip distal to the memory shape portion; and a handle disposed proximal to the proximal portion, the handle including a body, a distal tip deflection actuator, a shape memory portion deployment actuator, a cover tube disposed over a portion of the memory shape portion, and a central shaft; delivering the coronary sinus catheter in a delivery configuration into the coronary sinus such that a distal portion of the coronary sinus catheter is generally aligned with a central axis; deflecting the distal tip out of alignment with the central axis to steer the coronary sinus catheter by actuating the distal tip deflection actuator; deploying the memory shape portion of the distal portion of the coronary sinus catheter into the coronary sinus, withdrawing the cover tube from the shape memory portion; and returning the memory shape portion to a preformed shape. A method comprising: (12) The method of embodiment 11, further comprising applying a lateral force to the coronary sinus with the memory shape portion deployed. (13) A stabilized coronary sinus catheter, comprising: a primary sensor probe including a plurality of primary sensors disposed along a first length of the primary sensor probe; a plurality of secondary sensor probes, a second length less than the first length; a plurality of secondary sensor probes each including a secondary sensor disposed at the distal location; a sheath catheter including a lumen configured to allow the primary sensor probe and the plurality of secondary sensor probes to pass therethrough; A covering position, the plurality of secondary sensor probes are enclosed within the lumen; and at least a portion of the primary sensor probe being outside of the lumen; An uncovered position, both the primary sensor probe and the plurality of secondary sensor probes are outside the lumen; an uncovered position, the plurality of secondary sensor probes tilting away from the primary sensor probe to apply a lateral force to the coronary sinus; 1. A stabilized coronary sinus catheter comprising: (14) The stabilized coronary sinus catheter of embodiment 13, wherein the second length includes a plurality of sub-lengths, and each of the portions of the plurality of secondary sensor probes has a different sub-length. (15) further comprising a midline axis; the primary sensor probe is disposed generally along the midline axis; 14. The stabilized coronary sinus catheter of claim 13, wherein the plurality of secondary sensor probes are approximately parallel to the midline axis in the covered position and form an angle away from the midline axis in the uncovered position.

[0068] (16) The stabilized coronary sinus catheter of embodiment 15, further comprising a secondary sensor probe angle formed between a secondary sensor probe and the midline axis. (17) The stabilized coronary sinus catheter of embodiment 15, wherein the secondary sensor probe angle is between approximately 0° and approximately 90°. (18) The stabilized coronary sinus catheter of embodiment 15, wherein the secondary sensor probe angle is between approximately 0° and approximately 10°.

Claims

1. 1. A stabilized coronary sinus catheter system, comprising:

1. A coronary sinus catheter comprising: a proximal portion including a proximal stiffness; an intermediate portion distal to the proximal portion, the intermediate portion including an intermediate stiffness; a distal portion, A shape memory portion; a distal tip distal to the memory shape portion, the distal tip comprising the proximal stiffness, the intermediate stiffness, and a flexibility greater than the stiffness of the memory shape portion; a handle disposed proximally of the proximal portion, a body defining a central axis; a distal tip deflection actuator configured to be in a first position or a second position along the central axis such that: (a) in the first position of the actuator, the distal tip is substantially aligned with the central axis; (b) a distal tip deflection actuator, wherein in the second position of the actuator for deflection of the distal tip, the distal tip is out of alignment with the central axis; and a shape-memory-section deployment actuator configured to be in one of a first location and a second location relative to the central axis, the shape-memory-section deployment actuator configured to configure the shape-memory-section to a delivery configuration when in the first location and to configure the shape-memory-section to a predetermined shape that generally corresponds to a shape of the coronary sinus when in the second location; Equipped with The method further includes the step of: a first end secured to the distal tip; a second end secured to the body; the distal tip deflection actuator is attached to the pull wire; The second position displaces the pull wire.

2. The stabilized coronary sinus catheter system of claim 1, wherein the flexibility of the distal tip is configured such that when the coronary sinus catheter is delivered to the coronary sinus and in a deployed configuration, the distal tip hangs down into the right atrium.

3. The stabilized coronary sinus catheter system of claim 1 , further comprising: the distal tip including a deflection angle of approximately 0° to approximately 180°.

4. 10. The stabilized coronary sinus catheter system of claim 1, further comprising a single axis position sensor located approximately at the distal tip.

5. and a flexure actuator lock, the flexure actuator lock comprising: an unlocked position that allows the distal tip deflection actuator to move between the first position and the second position; a locked position that prevents the distal tip deflection actuator from moving between the first position and the second position.

10. The stabilized coronary sinus catheter system of claim 1.

6. A shape memory alloy including one end disposed along the shape memory portion and fixed to the body; a cover tube disposed over a portion of the shape memory alloy and including a shape memory portion deployment end secured to the shape memory portion deployment actuator; In a delivery configuration, the cover tube constrains the shape memory alloy; and The stabilized coronary sinus catheter system of claim 1 , wherein in a deployed configuration, the shape memory alloy is unconstrained by the cover tube.

7. the shape memory portion deployment actuator in the first location maintains the cover tube over the shape memory alloy to prevent the shape memory alloy from returning to the predetermined shape; 7. The stabilized coronary sinus catheter system of claim 6, wherein the memory shape portion deployment actuator in the second location withdraws the cover tube from the shape memory alloy, allowing the shape memory alloy to return to the predetermined shape.

8. The stabilized coronary sinus catheter system of claim 1, wherein the predetermined shape of the memory shape portion includes an approximately helical shape.

9. The predetermined shape of the shape memory portion is a proximal bend radius of approximately 8.5 mm to approximately 9.5 mm; a distal portion bend radius of approximately 7.0 mm to approximately 8.0 mm; a proximal portion helix angle of approximately 110° to approximately 120°; a distal portion helix angle of approximately 150° to approximately 160°; a memory shape portion length of approximately 42.5 mm to approximately 44.5 mm; a major diameter of the first helical coil of approximately 14.0 mm and approximately 16.0 mm; A taper angle of approximately 3.5° to approximately 5.5°; 9. The stabilized coronary sinus catheter system of claim 8, comprising at least one of:

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