Insertion tool for a catheter device

Abstract

The disclosed technology includes an insertion tool including a first body including a hemostasis valve configured to receive a flexible shaft and prevent fluid flow through the hemostasis valve. The insertion tool may include a second body coupled to the first body, the second body including a chamber, a guide tube smaller than the chamber, and a valve. The guide tube may be connected distal to the chamber and along a longitudinal axis of the second body to guide a flexible shaft into a sheath, and the valve may be at least partially disposed in the guide tube. The valve may be biased to a closed position and prevent fluid flow through the valve when a flexible shaft is inserted therethrough.

Description

Technical Field

[0001] The present invention generally relates to medical devices, and more particularly to medical probes having a flush hub, and further but not exclusively to medical probes constructed with a flush hub configured to hold a seal member during insertion of the medical probe into an anatomical region. Background Art

[0002] When regions of heart tissue abnormally conduct electrical signals to adjacent tissue, arrhythmias such as atrial fibrillation (AF) can occur. This disrupts the normal cardiac cycle and results in an irregular heartbeat. Certain procedures are used to treat arrhythmias, including surgically disturbing the source of the arrhythmia-causing signals and disturbing the conduction pathways for such signals. Selectively ablating heart tissue by applying energy via a catheter can sometimes stop or alter the propagation of unwanted electrical signals from one part of the heart to another.

[0003] Some catheters include a basket design with multiple ridges. Insertion tools can be used to prevent air from being introduced, which is achieved by collapsing the basket to insert it into a sheath and ultimately into the patient's anatomical region. Conventionally, such insertion tools include a hemostatic valve at a first end and an end-open guide tube to collapse the ridges of the basket as it is inserted into the sheath. Unfortunately, the interaction between the hemostatic valve and the ridges of the basket catheter can damage the hemostatic valve. Additionally, it is desirable to provide a valve to isolate or otherwise seal the guide tube of the insertion tool when the catheter is retracted from the sheath to prevent fluid from flowing out. Accordingly, there is a need in the art for an insertion tool that limits the interaction between the end effector and the hemostatic valve and provides an additional valve in the guide tube without obstructing the end effector during insertion into the sheath. Summary of the Invention

[0004] According to one example of the present invention, there is provided an insertion tool including a first body including a hemostatic valve configured to receive a flexible shaft and prevent fluid from flowing through the hemostatic valve. The insertion tool may further include a second body coupled to the first body, the second body including: a chamber and a guide tube smaller than the chamber. The guide tube may be connected distally of the chamber and along the longitudinal axis of the second body to guide the flexible shaft into a sheath. The second body may further include a valve disposed at least partially within the guide tube, the valve being biased to a closed position and configured to prevent fluid from flowing through the valve when the flexible shaft is inserted through the valve.

[0005] The valve may include at least two seals biased towards each other, and the at least two seals may interface with each other to seal the guide tube and prevent backflow into the chamber. The at least two seals may comprise silicone. The outer surfaces of the at least two seals may have a hardness of about 20 Shore A to 40 Shore A. Each of the two seals may be biased by a compression spring. The second body may further include a flush coupling for coupling to a flush line to receive flush fluid into the chamber. The second body may further include a vent tube that forms a fluid passage from a distal portion of the guide tube to the chamber. Opening of the valve may block the vent tube. The distal end of the flexible shaft may include a basket catheter, and the distal end of the chamber may include a catheter guide configured to collapse the basket catheter as the basket catheter moves from the chamber into the guide tube. The first body may be threadably coupled to the second body.

[0006] The disclosed technique may include an insertion tool that includes a first body that includes a hemostatic valve configured to receive a flexible shaft and prevent fluid flow through the hemostatic valve. The insertion tool may further include a valve stop located on an outer surface of the flexible shaft and configured to prevent the distal end of the flexible shaft from passing through the hemostatic valve. The insertion tool may further include a second body configured to removably couple to the first body, the second body defining a chamber and including a guide tube disposed distally of the chamber and along a longitudinal axis of the second body. The guide tube may be configured to guide the flexible shaft into a sheath. The second body may further include a valve that is at least partially disposed within the guide tube. The valve may be biased in a closed position and configured to open to receive the flexible shaft and prevent fluid flow through the valve.

[0007] The valve stop may be generally annular, and an outer diameter of the valve stop may be less than an inner diameter of the guide tube. The valve stop may further include a plurality of protrusions extending from the outer surface of the flexible shaft. The distal end of the flexible shaft may include a basket catheter, and the valve stop may be configured to prevent interaction between the basket catheter and the hemostatic valve. The distal end of the chamber may include a catheter guide configured to collapse the basket catheter as the basket catheter moves from the chamber into the guide tube. The first body may be threadably coupled to the second body. The valve may include at least two seals biased towards each other, and the seals may interface with each other to seal the guide tube and prevent backflow into the chamber.

[0008] The disclosed technology may include a method that includes coupling a first body to a second body. The first body includes a hemostatic valve configured to receive a flexible shaft and prevent fluid from flowing through the hemostatic valve. The flexible shaft may extend through the hemostatic valve and may include a basket catheter disposed distal to the hemostatic valve. The flexible shaft may include a valve stop configured to prevent removal of the flexible shaft through the hemostatic valve. The second body may include a valve biased to a closed position. The method may further include inserting and passing the basket catheter through the valve along a longitudinal axis to open the valve. The method may further include passing the basket catheter through a sheath and moving it toward a target location.

[0009] The second body may further include a flush coupling for coupling to a flush line, and the method may further include supplying flush fluid to the second body after coupling the first body to the second body and before inserting the basket catheter through the valve.

[0010] Additional features, functions, and applications of the disclosed technology are discussed in more detail herein. BRIEF DESCRIPTION OF THE DRAWINGS

[0011] Figure 1A is a schematic illustration of a medical system including a medical probe in accordance with the disclosed technology;

[0012] Figure 1B is a schematic illustration of an insertion tool for a medical probe in accordance with the disclosed technology;

[0013] Figure 2A is a schematic illustration showing a perspective view of an insertion tool for a medical probe in accordance with the disclosed technology;

[0014] Figure 2B is a schematic illustration showing a perspective view of components of an insertion tool for a medical probe in accordance with the disclosed technology;

[0015] Figure 2C is a schematic illustration showing a perspective view of components of an insertion tool for a medical probe in accordance with the disclosed technology;

[0016] Figure 3A is a schematic illustration showing a side view of an insertion tool for a medical probe in accordance with the disclosed technology;

[0017] Figure 3B is a schematic illustration showing a side view of an insertion tool for a medical probe in accordance with the disclosed technology;

[0018] Figure 3C is a schematic illustration showing a side view of an insertion tool for a medical probe in accordance with the disclosed technology;

[0019] Figure 3Dis a schematic illustration showing a side view of an insertion tool for a medical probe according to the disclosed technology;

[0020] Figure 3E is a schematic illustration showing a side view of an insertion tool for a medical probe according to the disclosed technology;

[0021] Figure 4A is a schematic illustration showing a sectional side view of an insertion tool for a medical probe according to the disclosed technology;

[0022] Figure 4B is a schematic illustration showing a sectional side view of an insertion tool for a medical probe according to the disclosed technology;

[0023] Figure 4C is a schematic illustration showing a sectional side view of an insertion tool for a medical probe according to the disclosed technology; and

[0024] Figure 5 is a flowchart depicting a method of inserting a medical probe into a sheath of a catheter and reaching a target position using the insertion tool according to the disclosed technology. DETAILED DESCRIPTION

[0025] The following detailed description should be read in conjunction with the accompanying drawings, in which like numerals in different drawings represent the same elements. The drawings (not necessarily to scale) depict selected examples and are not intended to limit the scope of the invention. In accordance with some examples, portions of the drawings are depicted in dashed lines to represent the transparent nature of some of the components. The detailed description illustrates the principles of the invention in an illustrative, but not restrictive, manner. This description will clearly enable one skilled in the art to make and use the invention and describes several embodiments, adaptations, variations, alternatives, and uses of the invention, including what is presently believed to be the best mode of implementing the invention.

[0026] As used herein, the term “about” or “approximately” with respect to any numerical value or range indicates a suitable dimensional tolerance that allows for a collection of parts or components to achieve its intended purpose as described herein. More specifically, “about” or “approximately” can refer to a range of values of ±20% of the recited value, e.g., “about 90%” can refer to a range of values from 71% to 110%. In addition, as used herein, the terms “patient,” “recipient,” “user,” and “subject” refer to any human or animal subject, and are not intended to limit the system or method to human use, although use of the subject invention in human patients represents a preferred embodiment. Similarly, the term “proximal” refers to a position closer to the operator or physician, while “distal” refers to a position farther from the operator or physician.

[0027] As discussed herein, the vasculature of a "patient", "recipient", "user", and "subject" can be that of a human or any animal. It should be understood that the animal can be of any suitable type, including but not limited to mammals, veterinary animals, domestic animals, or pet animals, etc. For example, the animal can be an experimental animal (e.g., rats, dogs, pigs, monkeys, etc.) specifically selected to have certain characteristics similar to humans. It should be understood that the subject can be, for example, any suitable human patient.

[0028] As discussed herein, a "physician" can include a doctor, surgeon, technician, scientist, operator, or any other individual or delivery instrument associated with delivering a multi-electrode catheter for treating drug-refractory atrial fibrillation to a subject.

[0029] As discussed herein, when referring to the devices and corresponding systems of the present disclosure, the term "ablation" refers to components and structural features configured to reduce or prevent the generation of unstable cardiac signals in cells by using non-thermal energy (such as reversible or irreversible electroporation (IRE), interchangeably referred to as pulsed electric field (PEF) and pulsed field ablation (PFA) in the present disclosure) or thermal energy (such as radiofrequency (RF) ablation or cryoablation). "Ablation" as used throughout the present disclosure, when referring to the devices and corresponding systems of the present disclosure, refers to thermal or non-thermal ablation of cardiac tissue for certain conditions, including but not limited to arrhythmia, atrial flutter ablation, pulmonary vein isolation, supraventricular tachycardia ablation, and ventricular tachycardia ablation. The term "ablation" also includes known methods, devices, and systems for achieving various forms of ablation of body tissue understood by those skilled in the relevant art.

[0030] As discussed herein, the terms "tubular" and "tube" should be understood broadly and are not limited to structures that are a perfect cylinder or have a completely circular cross-section or a uniform cross-section along their entire length. For example, a tubular structure is typically illustrated as a structure that is substantially a perfect cylinder. However, without departing from the scope of the present disclosure, the tubular structure can have a tapered or curved outer surface.

[0031] Figure 1AAn exemplary catheter-based electrophysiological mapping and ablation system 10 is shown. The system 10 includes a plurality of catheters that are inserted by a physician 24 through the vasculature of a patient 23 via the skin into the chambers or vascular structures of the heart 12. Generally, a delivery sheath catheter is inserted into the left atrium or right atrium near a desired location in the heart 12. Then, a plurality of catheters can be inserted into the delivery sheath catheter to reach that desired location. The plurality of catheters can include a catheter dedicated to sensing intracardiac electrogram (IEGM) signals, a catheter dedicated to ablation, and / or a catheter dedicated to both sensing and ablation. In an example of sensing IEGM signals, the physician 24 contacts the distal end of the catheter 14 (i.e., the basket catheter 184 in this case) with the heart wall for sensing or ablating a target site in the heart 12.

[0032] The catheter 14 is an exemplary catheter that includes a basket catheter 184 disposed at the distal end of a flexible shaft 180. The flexible shaft may further include an end effector valve stop 125 for preventing interaction between the basket catheter 184 and the hemostatic valve of the insertion tool (e.g., the hemostatic valve 120 as depicted in Figures 2A to 4C as further described herein. The basket catheter can be configured to detect electrophysiological signals and / or deliver ablation energy to tissue. The catheter 14 may additionally include a magnetic-based position sensor embedded in or near the basket catheter 184 for tracking the position and orientation of the basket catheter 184. The basket catheter 184 may further include one or more impedance-based electrodes for tracking position and orientation.

[0033] The magnetic-based position sensor can operate in conjunction with a positioning pad 25 that includes a plurality of magnetic coils 32 configured to generate a magnetic field in a predetermined workspace. The real-time position of the end effector of the catheter 14 can be tracked based on the magnetic field generated by the positioning pad 25 and sensed by the magnetic-based position sensor. The magnetic-based position sensor can be a uniaxial sensor, a biaxial sensor, or a triaxial sensor, depending on the particular configuration. Details of magnetic-based position sensing techniques are described in U.S. Patent Nos. 5,391,199, 5,443,489, 5,558,091, 6,172,499, 6,239,724, 6,332,089, 6,484,118, 6,618,612, 6,690,963, 6,788,967, and 6,892,091, each of which is incorporated herein by reference as if fully set forth herein.

[0034] System 10 includes one or more electrode patches 38 that are positioned to contact the skin of patient 23 to establish a position reference for the positioning pad 25 and impedance-based tracking of the electrodes. For impedance-based tracking, current is directed toward the electrodes and sensed at the electrode-skin patches 38 such that the position of each electrode can be triangulated via the electrode patches 38. Details of impedance-based position tracking techniques are described in U.S. Patent Nos. 7,536,218, 7,756,576, 7,848,787, 7,869,865, and 8,456,182, each of which is incorporated herein by reference.

[0035] Recorder 11 displays an electrogram 21 captured using the body surface ECG electrodes 18 and an intracardiac electrogram (IEGM) captured using the electrodes disposed on the catheter 14. Recorder 11 may include pacing capabilities for pacing the heart rhythm and / or may be electrically connected to an independent pacemaker.

[0036] System 10 may include an ablation energy generator 50 that is adapted to conduct ablation energy to one or more electrodes at the distal end of a catheter configured for ablation. The energy generated by ablation energy generator 50 may include, but is not limited to, radiofrequency (RF) energy or pulsed field ablation (PFA) energy (including monopolar or bipolar high voltage DC pulses that can be used to effect irreversible electroporation (IRE)), or a combination thereof.

[0037] The patient interface unit (PIU) 30 is an interface configured to establish electrical connectivity between the catheter, electrophysiology equipment, power supply, and a workstation 55 for controlling the operation of System 10. The electrophysiology equipment of System 10 may include, for example, multiple catheters, positioning pad 25, body surface ECG electrodes 18, electrode patches 38, ablation energy generator 50, and recorder 11. Optionally and preferably, PIU 30 additionally includes processing capabilities for performing real-time calculations of the position of the catheter and for performing ECG calculations.

[0038] Workstation 55 includes a memory, a processor unit with a memory or storage device loaded with appropriate operating software, and user interface capabilities. Workstation 55 may provide a plurality of functions, optionally including: (1) performing three-dimensional (3D) modeling of the endocardial anatomy and rendering a model or anatomical map 20 for display on a display device 27; (2) displaying, on the display device 27, an activation sequence (or other data) compiled from the recorded electrogram 21 as representative visual markers or images superimposed on the rendered anatomical map 20; (3) displaying the real-time position and orientation of multiple catheters within the heart chambers; and (5) displaying on the display device 27 sites of interest, such as where ablation energy has been applied. A commercial product embodying the elements of System 10 may be CARTOTM The 3 system was purchased from Biosense Webster, Inc., 31 Technology Drive, Suite 200, Irvine, CA 92618 USA.

[0039] As Figure 1B shown, the catheter 14 may include a handle 45 for operating the catheter 14. The handle 45 may extend along a longitudinal axis 70. The flexible shaft 180 of the catheter 14 may be received and extend from a proximal end 52 of the handle 45. The sheath 190 may extend from a distal end 54 of the handle 45 toward a target site within a patient's anatomical region. As further described herein, the insertion tool 100 may be disposed within the handle 45 of the catheter 14. The insertion tool 100 may be coupled to the flush tube 40 such that flush fluid may be provided to the insertion tool 100.

[0040] Figures 2A to 5 An exemplary insertion tool is depicted. The insertion tool 100 may include a first body 110 that is configured to removably couple to a second body 150. In some examples, the first body 110 includes threads 116 that are configured to mate with threads 156 of the second body 150 such that the first body 110 may be threadably coupled to the second body 150. In some examples, the first body 110 is coupled to the second body 150 by an adhesive, a latch, a press fit, or other coupling method. The first body 110 may be referred to as the insertion hub component of the insertion tool 100. The second body 150 may be referred to as the chamber hub component of the insertion tool 100.

[0041] See Figure 2A , the first body 110 of the insertion tool may include a proximal hole 112 leading to a shaft tube 114. A distal end of the shaft tube 114 may include a hemostatic valve 120. In some examples, the hemostatic valve 120 is configured to form a seal around the outer periphery of the flexible shaft to prevent air from entering the insertion tool and to prevent flush fluid from leaking from the insertion tool. The hemostatic valve 120 may be constructed of a flexible material (e.g., silicone, polydimethylsiloxane, or other suitable elastomeric material) and may include a star cut valve having lobes.

[0042] The hemostatic valve 120 can form a seal around the circumference of the flexible shaft 180 while allowing the flexible shaft 180 to move relative to the hemostatic valve 120. Due to the softer and / or more flexible nature of the material that can form the hemostatic valve 120, if the basket catheter 184 disposed at the distal end 182 of the flexible shaft passes through the hemostatic valve 120 or otherwise interacts with the hemostatic valve, the hemostatic valve 120 may be damaged by the basket catheter 184. Alternatively or additionally, the basket catheter 184 may be damaged by the hemostatic valve 120. Therefore, a valve stop 125 can be disposed near the distal end 182 of the flexible shaft 180, proximal to the basket catheter 184, to prevent interaction between the basket catheter 184 and the hemostatic valve 120.

[0043] The valve stop 125 can be generally annular and extend outward from the flexible shaft 180. The outer circumference of the valve stop 125 can be greater than the outer circumference of the flexible shaft 180 and can include a plurality of outwardly extending protrusions. Spaces or gaps can be provided between the protrusions of the valve stop 125 to allow fluid to flow therethrough.

[0044] See Figure 2B , the second body 150 of the insertion tool can include a chamber 156. When the ridges of the basket catheter 184 are in the deployed position, the chamber 156 can include an inner diameter that is greater than or approximately equal to the outer diameter of the basket catheter 184. In some examples, the distal end of the chamber 184 is tapered to form a catheter guide 154. The catheter guide 154 can lead to a guide tube 158. In some examples, the proximal portion 157 of the guide tube 158 is disposed adjacent to the catheter guide 154. The distal portion 159 of the guide tube 158 extends out of the second body 150 of the insertion tool and into the sheath 190 of the catheter. In some examples, the distal portion 159 of the guide tube 158 extends outward from the second body 150 and into the sheath 190. The distal end of the distal portion 159 of the guide tube 158 can be tapered outwardly. The outward taper provided at the distal end of the guide tube 158 can facilitate retraction of the basket catheter 184 from the sheath 190 into the guide tube 158 and / or can enhance the fixation of the sheath 190 to the distal end of the guide tube 158.

[0045] The tapered catheter guide 154 is configured to collapse the ridges of the basket catheter 184 such that the basket catheter can be received by the sheath 190. In some embodiments, the inner diameter of the guide tube 158 is approximately equal to or less than the inner diameter of the sheath 190.

[0046] In some examples, the second body 150 of the insertion tool includes a valve 160. The valve 160 may include a mechanical valve. In some examples, the valve 160 includes two seals 166. The seals 166 may be biased together to close and seal the guide tube 158 between a proximal portion 157 and a distal portion 159 of the guide tube 158. The seals 166 may be constructed of a material having a hardness of from about 20 Shore A to 40 Shore A or from about 30 Shore A to 40 Shore A. In some examples, the seals 166 comprise silicone.

[0047] In some examples, the valve 160 is configured to open as the basket catheter 184 is pushed through the guide tube 158. In some examples, the seals 166 are biased toward each other by a compression spring 164 disposed in a spring chamber 162 and into the guide tube 158 to provide the valve 160 in a closed position. The seals 166 of the valve may include rounded ends that facilitate movement of the seals 166 into the spring chamber 162 as the basket catheter 184 is pushed through the guide tube 158, thereby opening the valve 160. As the basket catheter 184 advances from the guide tube 158 and into the sheath 190, the seals 166 may abut the flexible shaft 180 of the catheter and the valve 160 may remain open.

[0048] In some examples, the second body 150 of the insertion tool includes a flush connector 140 for connecting the second body 150 to a flush tube 40. Connecting the insertion tool to the flush tube may allow flush fluid to flow into the chamber 152. The flush fluid supplied to the chamber 152 may continue through the guide tube 158, into the sheath 190, and to the target anatomical region.

[0049] A vent tube 168 may be disposed between the catheter guide 154 and the distal portion of the guide tube 159. In some examples, the vent tube allows fluid communication between the chamber 152 and the distal portion 159 of the guide tube when the valve 160 is closed. The vent tube 168 may also facilitate removal of any air from the sheath 190 or the distal portion 159 of the guide tube 158. The air may travel through the vent tube 167 and out of the chamber 152, through the flush connector 140 and into the flush tube 40.

[0050] The valve 160 may separate the vent tube 168 between a proximal portion 167 and a distal portion 169. In some examples, a through hole (e.g., Figure 4AThe aperture 172 depicted is configured to pass through the seal 166 closest to the vent tube 168 to provide fluid communication between the proximal portion 167 of the vent tube and the distal portion 169 of the vent tube when the valve is closed. In some examples, the fluid communication between the proximal portion 167 and the distal portion 169 of the vent tube may be provided by the spring chamber 162 closest to the vent tube 168. In some examples, when the valve 160 is open, the seal 166 closes the vent tube 168, thereby preventing fluid communication between the proximal portion 167 and the distal portion 169 of the vent tube. The vent tube 168 may also be adjacent to the valve 160 such that the valve 160 does not interfere with the vent tube 168 and the vent tube 168 can remain open at all times.

[0051] See Figures 3A to 3E , in accordance with some examples of the present disclosure, an exemplary operation of the catheter 184 using the insertion tool 100 is depicted. See Figure 3A , the first body 110 is initially separated from the second body 150. Since the valve stop 125 is configured to face the distal end of the flexible shaft 180 of the catheter, the first body 110 is configured to be coupled to the flexible shaft 180 such that the hemostatic valve 120 is configured to be proximal to the valve stop 125. The valve stop 125 is sized larger relative to the hemostatic valve 120, which can prevent the flexible shaft 180 from fully retracting from the first body 110 and prevent the basket catheter 184 from interacting with the hemostatic valve 120, thereby preventing potential damage to the hemostatic valve and / or preventing the hemostatic valve 120 from damaging the basket catheter 184.

[0052] See Figure 3B , in accordance with some examples, the first body 110 of the insertion tool 100 may be removably coupled to the second body 150 of the insertion tool 100. The first body 110 may include threads 116 that mate with the threads 156 of the second body 150 to removably secure the first body 110 to the second body 150. The coupling of the first body 110 to the second body 150 may provide a fluid seal between the first body and the second body. In some examples, the first body 110 is coupled to the second body 150 by an adhesive, a latch, a press fit, or other coupling method.

[0053] Once the first body 110 is coupled to the second body 150, the flush fluid may be supplied to the insertion tool 100 via the flush tube 40 coupled to the insertion tool 100 through the flush coupling 140. In some examples, the flush fluid travels from the flush tube 40 and through the flush coupling 140 into the chamber 152. The flush fluid may then pass through the vent tube (e.g., as Figure 2BThe shown vent tube 168) is transmitted to the distal portion 159 of the guide tube and enters the sheath 190, where the flushing fluid can ultimately reach the target anatomical region. In some examples, when the valve 160 is closed, the flushing fluid flows from the proximal portion 167 of the vent tube through the hole provided by the seal 166 of the valve 160 (e.g., Figure 4A the hole 172 depicted in

[0054] See Figure 3C , as the basket catheter 184 advances distally along the longitudinal axis 70, the wall of the catheter guide 154 forces the basket catheter 184 into a collapsed position, thus facilitating the entry of the basket catheter into the proximal portion 157 of the guide tube.

[0055] See Figure 3D , as the basket catheter 184 further advances distally along the longitudinal axis 70, the distal end of the basket catheter 184 forces the valve 160 to open, and the seal 166 retracts into the spring chamber. As the basket catheter advances past the valve 160, the seal abuts the flexible shaft 180 of the catheter. In some examples, the valve stop 125 includes an outer diameter that is slightly smaller than the inner diameter of the guide tube. In some examples, the valve stop includes one or more protrusions and the spaces between the protrusions. When the valve stop 125 is disposed in the guide tube, the spaces between the protrusions may allow the flushing fluid to continue to enter the sheath 190 from the flushing tube 40. These spaces may also allow air to escape from the sheath 190 or the distal end of the insertion tool 100 and escape through the flushing tube 40.

[0056] See Figure 3E , according to some examples, as the basket catheter 184 further advances distally along the longitudinal axis 70 and enters the sheath 190, the guide tube holds the basket catheter 184 in a collapsed position such that it fits within the inner diameter of the sheath 190. In some examples, the valve stop 125 includes an outer diameter that is slightly smaller than the inner diameter of the sheath. In some examples, the valve stop includes one or more protrusions and the spaces between the protrusions, and when the valve stop 125 is disposed in the sheath 190, the spaces between the protrusions allow the flushing fluid to continue from the flushing tube 40 and through the sheath 190.

[0057] Figures 4A to 4CDepicts a cross-sectional view of a catheter advancing distally through an insertion tool 100 and into a sheath 190. As shown, the flexible shaft 180 includes a shaft lumen 186. The shaft lumen 186 can be used to supply irrigation fluid and / or provide a connection for electrode wiring disposed on the basket catheter 184 to a housing of a controller. The shaft lumen can also accommodate additional components, such as a positioning sensor. A sheath lumen 196 is also shown, and as the basket catheter advances distally toward a target anatomical region, the sheath lumen provides an inner diameter for the basket catheter 184 and the flexible shaft 180. The sheath lumen 196 can also supply irrigation fluid to the target anatomical region.

[0058] See Figure 4A , according to some examples, the first body 110 of the insertion tool 100 can be removably coupled to the second body 150 of the insertion tool 100. As the basket catheter 184 advances distally along the longitudinal axis 70, the wall of the catheter guide 154 can force the basket catheter 184 into a collapsed position. As the basket catheter 184 advances further distally along the longitudinal axis 70, the distal end of the basket catheter 184 forces the valve 160 to open, and the seal 166 retracts into the spring chamber. Once the first body 110 is coupled to the second body 150, irrigation fluid can be supplied to the insertion tool 100 via the irrigation tube 40. In some examples, when the valve 160 is closed, the irrigation fluid flows from the proximal portion 167 of the vent tube through a hole 172 provided by the seal 166 of the valve 160 and into the distal portion 169 of the vent tube.

[0059] See Figure 4B , as the basket catheter advances past the valve 160, the seal 166 of the valve 160 abuts the flexible shaft 180 of the catheter. In some examples, the valve stop 125 includes an outer diameter that is slightly smaller than the inner diameter of the guide tube. As the basket catheter 184 advances further distally along the longitudinal axis 70 and toward the sheath 190, the guide tube can hold the basket catheter 184 in a collapsed position such that it fits within the inner diameter of the sheath 190.

[0060] See Figure 4C , as the basket catheter 184 advances further distally along the longitudinal axis 70 and into the sheath 190, the inner diameter of the sheath 190 of the basket catheter 184 holds the basket catheter 184 in a collapsed position as the basket catheter 184 advances toward the target anatomical region. In some examples, the valve stop 125 includes an outer diameter that is slightly smaller than the inner diameter of the sheath. In some examples, the valve stop includes one or more protrusions and spaces between the protrusions, and when the valve stop 125 is disposed in the sheath 190, the spaces between the protrusions allow irrigation fluid to continue to flow from the irrigation tube 40 and through the sheath 190.

[0061] See Figure 5, an exemplary method 500 of guiding the basket catheter 184 to a target location using the insertion tool 100 is illustrated. According to the exemplary method 500, the first step 502 includes coupling the first body 110 of the insertion tool 100 to the second body 150 of the insertion tool 100. After the first body 110 is coupled to the second body 150, at the second step 504, a flushing fluid is supplied to the chamber 152 of the second body 150. As described herein, the flushing fluid can be supplied through the insertion tool 100. The flushing fluid can further travel through the sheath 190 and reach the target anatomical location. At the third step 506, the basket catheter 184 is advanced distally along the longitudinal axis 70, and the basket catheter 184 is inserted into the catheter guide 154, which facilitates the collapse of the basket catheter 184. As the basket catheter 184 advances distally through the insertion tool 100, the seal 166 of the valve 160 is pushed outward by the distal end of the basket catheter 184 and the valve 160 opens. At the fourth step 508, the basket catheter 184 moves from the distal portion 167 of the guide tube 168 and into the sheath 190 while remaining in the collapsed configuration. The basket catheter 18 can advance through the sheath 190 and toward the target location. In some examples, as the basket catheter 184 exits the sheath 190, the basket freely moves into the deployed configuration.

[0062] The disclosed techniques described herein can be further understood in accordance with the following clauses:

[0063] Clause 1: An insertion tool, the insertion tool comprising: a first body including a hemostatic valve configured to receive a flexible shaft and prevent fluid from flowing through the hemostatic valve; and a second body coupled to the first body, the second body including: a chamber; a guide tube smaller than the chamber, the guide tube connected distally to the chamber and along the longitudinal axis of the second body to guide the flexible shaft into a sheath; and a valve at least partially disposed in the guide tube, the valve being biased to a closed position and preventing fluid from flowing through the valve when the flexible shaft is inserted through the valve.

[0064] Clause 2: The insertion tool according to clause 1, wherein the valve includes at least two seals biased toward each other, wherein the at least two seals intersect each other to seal the guide tube and prevent backflow into the chamber.

[0065] Clause 3: The insertion tool according to clause 2, wherein the at least two seals comprise silicone.

[0066] Clause 4: The insertion tool according to clause 3, wherein the outer surface of the at least two seals has a hardness of about 20 Shore A to 40 Shore A.

[0067] Clause 5: The insertion tool according to Clause 2 or 3, wherein each of the two seals is biased by a compression spring.

[0068] Clause 6: The insertion tool according to any one of Clauses 1 to 5, wherein the second body further includes a flushing connector for coupling to a flushing line to receive flushing fluid into the chamber.

[0069] Clause 7: The insertion tool according to any one of Clauses 1 to 6, wherein the second body further defines a vent tube that forms a fluid passage from a distal portion of the guide tube to the chamber.

[0070] Clause 8: The insertion tool according to Clause 7, wherein opening of the valve blocks the vent tube.

[0071] Clause 9: The insertion tool according to any one of Clauses 1 to 8, wherein the distal end of the flexible shaft includes a basket catheter, and wherein the distal end of the chamber includes a catheter guide configured to collapse the basket catheter as the basket catheter moves from the chamber into the guide tube.

[0072] Clause 10: The insertion tool according to any one of Clauses 1 to 9, wherein the first body is threadedly coupled to the second body.

[0073] Clause 11: An insertion tool comprising: a first body including a hemostatic valve configured to receive a flexible shaft and prevent fluid flow through the hemostatic valve; a valve stop disposed on an outer surface of the flexible shaft and configured to prevent a distal end of the flexible shaft from passing through the hemostatic valve; and a second body configured to removably couple to the first body, the second body defining a chamber and including: a guide tube disposed distally of the chamber and along a longitudinal axis of the second body, the guide tube configured to guide the flexible shaft into a sheath; and a valve at least partially disposed in the guide tube, the valve being biased in a closed position and configured to open to receive the flexible shaft and prevent fluid flow through the valve.

[0074] Clause 12: The insertion tool according to Clause 11, wherein the valve stop is generally annular.

[0075] Clause 13: The insertion tool according to Clause 12, wherein an outer diameter of the valve stop is less than an inner diameter of the guide tube.

[0076] Clause 14: The insertion tool according to Clause 12 or 13, wherein the valve stop includes a plurality of protrusions extending from the outer surface of the flexible shaft.

[0077] Clause 15: The insertion tool according to any one of Clauses 11 to 14, wherein the distal end of the flexible shaft includes a basket catheter, and the valve stop is configured to prevent interaction between the basket catheter and the hemostatic valve.

[0078] Clause 16: The insertion tool according to any one of Clauses 11 to 15, wherein the distal end of the flexible shaft includes a basket catheter, and wherein the distal end of the chamber includes a catheter guide configured to collapse the basket catheter as the basket catheter moves from the chamber into the guide tube.

[0079] Clause 17: The insertion tool according to any one of Clauses 11 to, wherein the first body is threadedly coupled to the second body.

[0080] Clause 18: The insertion tool according to any one of Clauses 11 to 17, wherein the valve includes at least two seals biased towards each other, wherein the at least two seals intersect each other to seal the guide tube and prevent backflow into the chamber.

[0081] Clause 19: A method comprising: coupling a first body to a second body, the first body including a hemostatic valve configured to receive a flexible shaft and prevent fluid flow through the hemostatic valve, the flexible shaft extending through the hemostatic valve and including a basket catheter disposed distally of the hemostatic valve and a valve stop configured to prevent removal of the flexible shaft through the hemostatic valve, and the second body including a valve biased in a closed position; inserting and passing the basket catheter along a longitudinal axis through the valve, thereby opening the valve; and moving the basket catheter through a sheath and towards a target location.

[0082] Clause 20: The method according to Clause 19, wherein the second body further includes a flush coupling for coupling to a flush line, and wherein the method further includes supplying flush fluid to the second body after coupling the first body to the second body and before inserting the basket catheter through the valve.

[0083] The above embodiments are cited by way of example, and the present invention is not limited to what is specifically shown and described above. Instead, the scope of the present invention includes combinations and sub - combinations of the various features described above, as well as their variations and modifications, which will occur to those skilled in the art upon reading the above description and which are not disclosed in the prior art.

Claims

1. An insertion tool, comprising: a first body including a hemostatic valve configured to receive a flexible shaft and prevent fluid flow through the hemostatic valve; and A second body, the second body is coupled to the first body, the second body comprising: Chamber; a guide tube smaller than the lumen, the guide tube being connected at a distal side of the lumen and along a longitudinal axis of the second body to guide the flexible shaft into the sheath; and A valve is at least partially disposed in the guide tube, the valve being biased to a closed position and preventing fluid flow through the valve when the flexible shaft is inserted through the valve.

2. The insertion tool according to claim 1, wherein: The valve includes at least two seals biased toward each other, wherein the at least two seals interface with each other to seal the guide tube and prevent backflow into the chamber.

3. The insertion tool according to claim 2, wherein: The at least two seals comprise silicone.

4. The insertion tool according to claim 3, wherein: The outer surfaces of the at least two seals have a hardness of about 20 Shore A to 40 Shore A.

5. The insertion tool according to claim 2, wherein: Each of the at least two seals is biased by a compression spring.

6. The insertion tool according to claim 1, wherein: The second body also includes a flushing coupling for coupling with a flushing line to receive flushing fluid into the chamber.

7. The insertion tool according to claim 1, wherein: The second body also defines a vent tube that forms a fluid passage from a distal portion of the guide tube to the lumen.

8. The insertion tool according to claim 7, wherein: Opening of the valve blocks the vent tube.

9. The insertion tool according to claim 1, wherein: The distal end of the flexible shaft includes a basket catheter, and wherein the distal end of the lumen includes a catheter guide configured to collapse the basket catheter as the basket catheter moves from the lumen into the guide tube.

10. The insertion tool according to claim 1, wherein: The first body is threadedly connected to the second body.

11. An insertion tool, comprising: a first body including a hemostatic valve configured to receive a flexible shaft and prevent fluid flow through the hemostatic valve; a valve stopper disposed on an outer surface of the flexible shaft and configured to prevent a distal end of the flexible shaft from passing through the hemostatic valve; and a second body configured to be removably coupled to the first body, the second body defining a chamber and comprising: a guide tube disposed distally of the lumen and along a longitudinal axis of the second body, the guide tube being configured to guide the flexible shaft into the sheath; and A valve is at least partially disposed in the guide tube, the valve being biased in a closed position and configured to open to receive the flexible shaft and prevent fluid flow through the valve.

12. The insertion tool according to claim 11, wherein The valve stop is generally annular.

13. The insertion tool according to claim 12, wherein: The outer diameter of the valve stopper is smaller than the inner diameter of the guide tube.

14. The insertion tool according to claim 12, wherein: The valve stop includes a plurality of protrusions extending from the outer surface of the flexible shaft.

15. The insertion tool according to claim 11, wherein The distal end of the flexible shaft includes a basket catheter, and the valve stop is configured to prevent interaction between the basket catheter and the hemostatic valve.

16. The insertion tool according to claim 11, wherein: The distal end of the flexible shaft includes a basket catheter, and wherein the distal end of the lumen includes a catheter guide configured to collapse the basket catheter as the basket catheter moves from the lumen into the guide tube.

17. The insertion tool according to claim 11, wherein: The first body is threadedly connected to the second body.

18. The insertion tool according to claim 11, wherein: The valve includes at least two seals biased toward each other, wherein the at least two seals interface with each other to seal the guide tube and prevent backflow into the chamber.

19. A method comprising: coupling a first body to a second body, the first body comprising a hemostatic valve configured to receive a flexible shaft and prevent fluid flow through the hemostatic valve, the flexible shaft extending through the hemostatic valve and comprising a basket catheter disposed distally of the hemostatic valve and a valve stop configured to prevent removal of the flexible shaft through the hemostatic valve, and the second body comprising a valve biased in a closed position; inserting the basket catheter along the longitudinal axis and through the valve, thereby opening the valve; as well as The basket catheter is passed through the sheath and moved toward the target site.

20. The method according to claim 19, wherein: The second body further includes a flush coupling for coupling with a flush line, wherein the method further includes supplying a flush fluid to the second body after coupling the first body to the second body and before inserting the basket catheter through the valve.

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