Insertion tool for catheter devices

Abstract

To provide an insertion tool for catheter devices.SOLUTION: The disclosed technology includes an insertion tool including a first body comprising a hemostatic valve configured to receive a flexible shaft and prevent fluid from flowing past the hemostatic valve. The insertion tool can include a second body coupled to the first body. The second body includes a chamber, a guide tube smaller than the chamber, and a valve. The guide tube can 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 can be disposed at least partially in the guide tube. The valve can be biased to a closed position and upon insertion of the flexible shaft through the valve to prevent fluid from flowing past the valve.SELECTED DRAWING: Figure 2A

Description

Technical Field

[0001] The present invention generally relates to medical devices, and more particularly to medical probes having a perfusion hub, and still more particularly, but not exclusively, to medical probes configured to preserve a sealing component during insertion of the medical probe into an anatomical region and having a perfusion hub.

Background Art

[0002] Cardiac arrhythmias, such as atrial fibrillation (AF), occur when areas of cardiac tissue abnormally transmit electrical signals to adjacent tissue. This disrupts the normal cardiac cycle and causes asynchronous rhythms. Certain procedures that exist to treat arrhythmias include surgically destroying the source of the signals causing the arrhythmia and destroying the conduction pathways of such signals. It is sometimes possible to stop or alter the propagation of unwanted electrical signals from one part of the heart to another by applying energy via a catheter to selectively ablate cardiac tissue.

Summary of the Invention

Problems to be Solved by the Invention

[0003] Some catheters include a basket design having a plurality of spines. An introducer can be utilized to fold the basket for insertion into a sheath and ultimately into a patient's anatomical region, thereby preventing the introduction of air entry. Conventionally, such an introducer comprises a hemostatic valve at a first end and an open-ended guide tube for folding the spines of the basket when the basket is inserted into the sheath. Unfortunately, the interaction between the hemostatic valve and the spines of the basket catheter can damage the hemostatic valve. Further, it is desirable to provide a valve for isolating or otherwise sealing the guide tube of the introducer to prevent fluid outflow when the catheter is withdrawn from the sheath. Accordingly, there is a need in the art for an introducer that limits the interaction between the end effector and the hemostatic valve and provides an additional valve within the guide tube without interfering with the end effector during insertion into the sheath.

Means for Solving the Problems

[0004] According to an example of the present invention, there is provided an introducer comprising a first body having a flexible shaft and a hemostatic valve configured to prevent fluid from flowing past the hemostatic valve. The introducer can further include a second body coupled to the first body, the second body comprising a chamber and a guide tube smaller than the chamber. The guide tube can be connected distally of the chamber along the longitudinal axis of the second body for guiding the flexible shaft into the sheath. The second body can further include a valve at least partially disposed within the guide tube, the valve being biased in 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 can comprise at least two seals biased towards each other, and the at least two seals can interface with each other to seal the guide tube and prevent backflow into the chamber. The at least two seals can include silicone. The outer surfaces of the at least two seals can have a hardness of about 20 Shore A to 40 Shore A. Each of the two seals can be biased by a compression spring. The second body can further include an infusion coupling for coupling with an infusion line to receive infusion fluid into the chamber. The second body can further include a vent tube that forms a fluid passage from the distal portion of the guide tube into the chamber. The release of the valve can block the vent tube. The distal end of the flexible shaft can include a basket catheter, and the distal end of the chamber can include a catheter guide configured to fold the basket catheter when the basket catheter is moved from the chamber into the guide tube. The first body can be screwed onto the second body.

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

[0007] The valve stop portion may be substantially annular, and the outer diameter of the valve stop portion may be smaller than the inner diameter of the guide tube. The valve stop portion can also include a plurality of protrusions extending from the outer surface of the flexible shaft. The distal end of the flexible shaft can comprise a basket catheter, and the valve stop portion can be configured to prevent interaction between the basket catheter and the hemostatic valve. The distal end of the chamber can comprise a catheter guide configured to fold the basket catheter when the basket catheter is moved from the chamber into the guide tube. The first body can be screwed onto the second body. The valve can comprise at least two seals biased towards each other, and the seals can interface with each other to seal the guide tube and prevent backflow into the chamber.

[0008] The disclosed technique can include a method that includes coupling a first body to a second body. The first body can comprise a hemostatic valve that receives a flexible shaft and is configured to prevent fluid from flowing past the hemostatic valve. The flexible shaft can extend through the hemostatic valve and can comprise a basket catheter disposed distally of the hemostatic valve. The flexible shaft can include a valve stop portion configured to prevent removal of the flexible shaft through the hemostatic valve. The second body can comprise a valve biased in a closed position. The method can further include inserting the basket catheter through the valve along the longitudinal axis, thereby opening the valve. The method can further include moving the basket catheter towards a target position through a sheath.

[0009] The second body can further comprise an irrigation coupling for coupling to an irrigation line, and the method can further include supplying irrigation 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 uses of the disclosed technique are discussed in more detail herein.

Brief Description of the Drawings

[0011]

Figure 1A

Figure 1B

Figure 2A

Figure 2B

Figure 2C

Figure 3A

Figure 3B

Figure 3C

Figure 3D

Figure 3E

Figure 4A

Figure 4B

Figure 4C

Figure 5

Modes for Carrying Out the Invention

[0012] The following detailed description should be read with reference to the drawings, and like elements in different drawings are numbered the same. The drawings are not necessarily to scale and show selected embodiments and are not intended to limit the scope of the invention. In some instances, portions of the drawings are shown in dashed lines to represent the transparent nature of some of the components. The detailed description is illustrative and not restrictive, and by way of example, illustrates the principles of the invention. This description enables one skilled in the art to make and use the invention and describes some embodiments, adaptations, variations, alternatives, and uses of the invention, including what is presently considered to be the best mode of carrying out the invention.

[0013] As used herein, the terms "about" or "substantially" with respect to any numerical value or range indicate a suitable dimensional tolerance that allows a portion or collection of components to function for the intended purpose described herein. More specifically, "about" or "substantially" can refer to a range of values within ±20% of the recited value. For example, "about 90%" can refer to a range of values from 71% to 110%. Additionally, as used herein, the terms "patient," "host," "user," and "subject" refer to any human or animal subject, and the use of the invention in human patients represents a preferred embodiment, but is not intended to limit the system or method to human use. Similarly, the term "proximal" indicates the position closer to the operator or physician, while "distal" indicates a position farther from the operator or physician.

[0014] As contemplated herein, the vasculature of a "patient", "host", "user", and "subject" can be that of a human or any animal. It should be understood that the animal can be of any of a variety of applicable types, including, but not limited to, mammals, veterinary animals, livestock animals, or pet animals. By way of example, the animal can be a laboratory animal (e.g., rat, dog, pig, monkey, etc.) specifically selected to have certain properties similar to humans. It should be understood that the subject can be, for example, any applicable human patient.

[0015] As contemplated herein, a "physician" can include an internist, surgeon, technician, scientist, operator, or any other individual or delivery instrument related to the delivery of a multi - electrode catheter for the treatment of drug - refractory atrial fibrillation to a subject.

[0016] As discussed herein, the term "ablating" or "ablation," when referring to the devices and corresponding systems of the present disclosure, refers throughout the present disclosure to components and structural features configured to reduce or prevent the generation of irregular cardiac signals within cells by utilizing non-thermal energy such as reversible electroporation or irreversible electroporation (IRE), which are interchangeably referred to as pulsed electric field (PEF) and pulsed field ablation (PFA) throughout the present disclosure, or thermal energy such as radiofrequency (RF) ablation or cryoablation. When referring to the devices and corresponding systems of the present disclosure, ablating or ablation is used throughout the present disclosure with reference to thermal or non-thermal ablation of cardiac tissue in certain conditions, including but not limited to arrhythmias, atrial fibrillation ablation, pulmonary vein isolation, supraventricular tachycardia ablation, and ventricular tachycardia ablation. The terms "ablating" or "ablation" also include known methods, devices, and systems for achieving various forms of body tissue ablation, as would be understood by one of ordinary skill in the art.

[0017] As discussed herein, the terms "tubular" and "tube" are to be construed broadly and are not limited to a straight cylindrical structure, or a structure having a cross-section that is strictly circular, or a structure having a uniform cross-section throughout its length. For example, a tubular structure is generally illustrated as a substantially straight cylindrical structure. However, a tubular structure may have a tapered or curved outer surface without departing from the scope of the present disclosure.

[0018] Figure 1A shows an exemplary catheter-based electrophysiology mapping and ablation system 10. The system 10 includes a plurality of catheters that are percutaneously inserted by a physician 24 into a chamber or vascular structure of the heart 12 through the vasculature of a patient 23. Typically, a delivery sheath catheter is inserted into the left atrium or right atrium near a desired location of the heart 12. Thereafter, a plurality of catheters can be inserted into the delivery sheath catheter to reach the desired location. The plurality of catheters may include catheters dedicated to sensing intracardiac electrogram (IEGM) signals, ablation-only catheters, and / or catheters dedicated to both sensing and ablation. In an example of sensing IEGM signals, the physician 24 contacts the distal tip of catheter 14 (i.e., in this case, basket catheter 184) with the heart wall to sense or ablate a target site within the heart 12.

[0019] 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 to prevent interaction between the basket catheter 184 and a hemostasis valve of an inserter (e.g., hemostasis valve 120 as shown in FIGS. 2A-4C), as further described herein. The basket catheter may be configured to detect electrophysiological signals and / or deliver ablation energy to tissue. Catheter 14 may further include a position sensor embedded within or near the basket catheter 184 to track the position and orientation of the basket catheter 184. The basket catheter 184 can further include one or more impedance-based electrodes for tracking position and orientation.

[0020] The magnetic-based position sensor can operate with a position pad 25 that includes a plurality of magnetic coils 32 configured to generate a magnetic field within a predetermined working volume. The real-time position of the end effector of the catheter 14 can be tracked based on the magnetic field generated by the position 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 the magnetic-based position sensing technology 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.

[0021] System 10 includes one or more electrode patches 38 placed on the patient 23 for skin contact to establish position referencing of the position pad 25 and impedance-based tracking of the electrodes. For impedance-based tracking, current is directed to the electrodes and sensed at the electrode-skin patches 38, whereby the position of each electrode can be triangulated via the electrode patches 38. Details of the impedance-based position tracking technology 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.

[0022] Recorder 11 displays the electrogram 21 captured by the body surface ECG electrodes 18 and the intracardiac electrograms (IEGMs) captured by the electrodes provided on the catheter 14. Recorder 11 may include pacing capabilities for pacing the rhythm of the heart and / or may be electrically connected to an independent pacer.

[0023] System 10 may include an ablation energy generator 50 adapted to transmit ablation energy to one or more of the electrodes at the distal tip of a catheter configured to ablate. The energy generated by ablation energy generator 50 may include radiofrequency (RF) energy or Pulsed-Field Ablation (PFA) energy, or a combination thereof, including unipolar or bipolar high voltage DC pulses such that they can be used to effect irreversible electroporation (IRE), but is not limited thereto.

[0024] The patient interface unit (PIU) 30 is an interface configured to establish electrical communication between the catheter, the electrophysiology equipment, the power supply, and a workstation 55 that controls the operation of system 10. The electrophysiology equipment of system 10 may include, for example, a plurality of catheters, position pads 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 implementing real-time calculation of the catheter's position and performing ECG calculations.

[0025] The workstation 55 includes a memory, a processor unit having a memory or a storage device into which appropriate operating software is loaded, and a user interface function. The workstation 55 may optionally (1) model the endocardial anatomical structure in three dimensions (3D) and render it for display on the display device 27 as a model or anatomical map 20, (2) display on the display device 27 the activation sequence (or other data) compiled from the recorded electrogram 21 in a representative visual display or image superimposed on the rendered anatomical map 20, (3) display the real-time positions and orientations of a plurality of catheters within the heart chamber, and (5) display on the display device 27 regions of interest such as locations where ablation energy is being applied, and may provide a plurality of functions including these. One commercially available product embodying the elements of the system 10 is available as the CARTO (trademark) 3 system, commercially available from Biosense Webster, Inc., 31 Technology Drive, Suite 200, Irvine, CA, 92618, USA.

[0026] As shown in FIG. 1B, the catheter 14 can include a handle 45 for manipulating the catheter 14. The handle 45 may extend along the longitudinal axis 70, and the flexible shaft 180 of the catheter 14 may be received and extend from the proximal end 52 of the handle 45. The sheath 190 may extend from the distal end 54 of the handle 45 toward a target site within the patient's anatomical region. As further described herein, the inserter 100 may be provided within the handle 45 of the catheter 14. The inserter 100 may be coupled to the perfusion tube 40 such that perfusion fluid can be provided to the inserter 100.

[0027] Figures 2A to 5D show exemplary inserters. The inserter 100 can include a first body 110 configured to removably couple to a second body 150. In some examples, the first body 110 includes a thread 116 configured to engage with a thread 156 of the second body 150, whereby the first body 110 can be screwed onto the second body 150. In some examples, the first body 110 is coupled to the second body 150 by an adhesive, a latch, press-fitting, or other coupling method. The first body 110 can be referred to as the insertion hub component of the inserter 100. The second body 150 can be referred to as the chamber hub component of the inserter 100.

[0028] Referring to FIG. 2A, the first body 110 of the inserter may include a proximal opening 112 that leads to a shaft tube 114. The distal end of the shaft tube 114 can include a hemostatic valve 120. In some examples, the hemostatic valve 120 is provided to form a seal around the outer circumference of the flexible shaft to prevent air from entering the inserter and to prevent leakage of the perfusion fluid from the inserter. The hemostatic valve 120 can be composed of a flexible material (e.g., silicone, polydimethylsiloxane, or other suitable elastomeric material) and may include a star cut valve with valve tips.

[0029] The hemostatic valve 120 can create 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 from which the hemostatic valve 120 can be constructed, the hemostatic valve 120 can be damaged by a basket catheter 184 provided at the distal end 182 of the flexible shaft when the basket catheter 184 passes over or otherwise interacts with the hemostatic valve 120. Alternatively or additionally, the basket catheter 184 can be damaged by the hemostatic valve 120. Thus, a valve stop 125 can be provided near the distal end 182 of the flexible shaft 180 and proximal to the basket catheter 184 to prevent interaction between the basket catheter 184 and the hemostatic valve 120.

[0030] The valve stop portion 125 is substantially annular and can extend outwardly from the flexible shaft 180. The outer circumference of the valve stop portion 125 can be larger than the outer circumference of the flexible shaft 180 and can include a plurality of protrusions extending outwardly. A space or gap may be provided between the protrusions of the valve stop portion 125 to allow fluid to flow therethrough.

[0031] Referring to FIG. 2B, the second body 150 of the inserter can include a chamber 156. The chamber 156 may have an inner diameter that is larger than or approximately equal to the outer diameter of the basket catheter 184 when the spine of the basket catheter 184 is in the expanded position. In some examples, the distal end of the chamber 184 tapers to form a catheter guide 154. The catheter guide 154 can lead into a guide tube 158. In some examples, the proximal portion 157 of the guide tube 158 is provided adjacent to the catheter guide 154. The distal portion 159 of the guide tube 158 exits the second body 150 of the inserter and enters the sheath 190 of the catheter. In some examples, the distal portion 159 of the guide tube 158 extends outwardly from the second body 150 and into the sheath 190. The distal end of the distal portion 159 of the guide tube 158 may be tapered outwardly. The outer taper provided at the distal end of the guide tube 158 can facilitate the retraction of the basket catheter 184 back into the guide tube 158 from the sheath 190 and / or can enhance the fixation of the sheath 190 to the distal end of the guide tube 158.

[0032] The tapered catheter guide 154 is configured to fold the spine of the basket catheter 184 so 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 smaller than the inner diameter of the sheath 190.

[0033] In some examples, the second body 150 of the introducer comprises a valve 160. The valve 160 can 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 the proximal portion 157 and the distal portion 159 of the guide tube 158. The seals 166 may be composed of a material having a hardness of about 20 Shore A to 40 Shore A, or about 30 Shore A to 40 Shore A. In some examples, the seals 166 include silicone.

[0034] In some examples, the valve 160 is configured to open when the basket catheter 184 is pushed through the guide tube 158. In some examples, the seals 166 are biased toward each other into the guide tube 158 by a compression spring 164 provided in the spring cavity 162 to place the valve 160 in a closed position. The valve seals 166 may include rounded tips that facilitate movement of the seals 166 into the spring cavity 162 when the basket catheter 184 is pushed through the guide tube 158, thereby opening the valve 160. When the basket catheter 184 advances from the guide tube 158 into the sheath 190, the seal 166 may abut against the flexible shaft 180 of the catheter and the valve 160 may remain open.

[0035] In some examples, the second body 150 of the introducer comprises an irrigation coupling 140 for connecting the second body 150 to the irrigation tube 40. The coupling of the introducer to the irrigation tube can enable irrigation fluid to flow into the chamber 152. The irrigation fluid supplied to the chamber 152 can continue through the guide tube 158 into the sheath 190 and then to the target anatomical region.

[0036] The vent tube 168 may be provided 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. Air can move through the vent tube 167 and out of the chamber 152 into the perfusion tube 40 through the perfusion junction 140.

[0037] The valve 160 can divide the vent tube 168 into a proximal portion 167 and a distal portion 169. In some examples, a through-hole (e.g., hole 172 shown in FIG. 4A) is provided through the seal 166 closest to the vent tube 168 to fluidly connect the proximal portion 167 of the vent tube to the distal portion 169 of the vent tube when the valve is closed. In some examples, the fluid communication between the proximal portion 167 of the vent tube and the distal portion 169 of the vent tube can be provided by the spring cavity 162 closest to the vent tube 168. In some examples, when the valve 160 is open, the seal 166 closes the vent tube 168 and prevents fluid communication between the proximal portion 167 of the vent tube and the distal portion 169 of the vent tube. The vent tube 168 can also be positioned 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 always open.

[0038] Referring to FIGS. 3A-3E, an exemplary operation of the catheter 184 using the inserter 100 according to some examples of the disclosed technique is shown. Referring to FIG. 3A, the first body 110 is initially not coupled to the second body 150. Since the valve stop 125 is provided towards the distal end of the flexible shaft 180 of the catheter, the first body 110 is coupled to the flexible shaft 180 such that the hemostatic valve 120 is provided proximal to the valve stop 125. The larger size of the valve stop 125 relative to the hemostatic valve 120 prevents the flexible shaft 180 from being fully retracted from the first body 110, preventing the basket catheter 184 from interacting with and potentially damaging the hemostatic valve 120 and / or preventing the hemostatic valve 120 from damaging the basket catheter 184.

[0039] Referring to FIG. 3B, according to some examples, the first body 110 of the inserter 100 may be removably coupled to the second body 150 of the inserter 100. The first body 110 can 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 can provide a fluid-tight seal between the first and second bodies. In some examples, the first body 110 is coupled to the second body 150 by an adhesive, a latch, press-fitting, or other coupling method.

[0040] When the first body 110 is coupled to the second body 150, irrigation fluid can be supplied to the introducer 100 via an irrigation tube 40 coupled to the introducer 100 by an irrigation coupling 140. In some examples, the irrigation fluid moves from the irrigation tube 40 through the irrigation coupling 140 and into the chamber 152. The irrigation fluid may then pass through a vent tube (e.g., vent tube 168 as depicted in FIG. 2B) to the distal portion 159 of the guide tube and then into the sheath 190 and ultimately reach the target anatomical area. In some examples, the irrigation fluid flows from the proximal portion 167 of the vent tube through a hole (e.g., hole 172 shown in FIG. 4A) provided through the seal 166 of the valve 160 and into the distal portion 169 of the vent tube when the valve 160 is closed. In some examples, the irrigation tube 40 is connected to one or more pumps that enable the irrigation fluid to be pumped through the introducer 100 and the sheath 190.

[0041] Referring to FIG. 3C, as the basket catheter 184 advances distally along the longitudinal axis 70, the wall of the catheter guide 154 pushes the basket catheter 184 into a folded position, facilitating entry of the basket catheter into the proximal portion 157 of the guide tube.

[0042] Referring to FIG. 3D, as the basket catheter 184 further advances distally along the longitudinal axis 70, the distal end of the basket catheter 184 opens the valve 160 and the seal 166 retracts into the spring cavity. As the basket catheter advances through the valve 160, the seal abuts the flexible shaft 180 of the catheter. In some examples, the valve stop 125 has an outer diameter slightly smaller than the inner diameter of the guide tube. In some examples, the valve stop comprises one or more protrusions and spaces between the protrusions. Since the valve stop 125 is provided within the guide tube, the spaces between the protrusions can allow the irrigation fluid to continue to flow from the irrigation tube 40 into the sheath 190. The spaces can also allow air to flow out of the distal end of the sheath 190 or the introducer 100 and out through the irrigation tube 40.

[0043] Referring to FIG. 3E, according to some examples, when the basket catheter 184 is further advanced distally into the sheath 190 along the longitudinal axis 70, the guide tube holds the basket catheter 184 in a folded position such that the basket catheter 184 fits within the inner diameter of the sheath 190. In some examples, the valve stop 125 has 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 the spaces between the protrusions allow the perfusion fluid to continue to flow through the sheath 190 from the perfusion tube 40 when the valve stop 125 is disposed within the sheath 190.

[0044] FIGS. 4A-4C show cross-sectional views of a catheter advancing distally through the introducer 100 into the sheath 190. As shown, the flexible shaft 180 includes a shaft lumen 186. The shaft lumen 186 can be used to supply perfusion fluid and / or provide a housing for wiring electrodes provided on the basket catheter 184 to a controller. The shaft lumen may also accommodate additional components such as a positioning sensor. A sheath lumen 196 is also shown and provides the inner diameter for the basket catheter 184 and the flexible shaft 180 as the basket catheter advances distally toward the target anatomical region. The sheath lumen 196 may also provide perfusion fluid to the target anatomical region.

[0045] Referring to FIG. 4A, according to some examples, the first body 110 of the introducer 100 may be removably coupled to the second body 150 of the introducer 100. As the basket catheter 184 advances distally along the longitudinal axis 70, the wall of the catheter guide 154 can push the basket catheter 184 into the folded position. As the basket catheter 184 further advances distally along the longitudinal axis 70, the distal end of the basket catheter 184 opens the valve 160 and the seal 166 retracts into the spring cavity. When the first body 110 is coupled to the second body 150, irrigation fluid can be supplied to the introducer 100 via the irrigation tube 40. In some examples, the irrigation fluid flows from the proximal portion 167 of the vent tube, through the hole 172 provided through the seal 166 of the valve 160, and into the distal portion 169 of the vent tube when the valve 160 is closed.

[0046] Referring to FIG. 4B, as the basket catheter advances through the valve 160, the seal 166 of the valve 160 abuts against the flexible shaft 180 of the catheter. In some examples, the valve stop 125 has an outer diameter that is slightly smaller than the inner diameter of the guide tube. As the basket catheter 184 is further advanced distally along the longitudinal axis 70 towards the sheath 190, the guide tube can hold the basket catheter 184 in the folded position so as to fit within the inner diameter of the sheath 190.

[0047] Referring to FIG. 4C, as the basket catheter 184 is further advanced distally into the sheath 190 along the longitudinal axis 70, when the basket catheter 184 is advanced towards the target anatomical region, the basket catheter 184 within the inner diameter of the sheath 190 holds the basket catheter 184 in the folded position. In some examples, the valve stop 125 has 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 space between the protrusions, and the space between the protrusions allows the irrigation fluid to continue to flow from the irrigation tube 40 through the sheath 190 when the valve stop 125 is disposed within the sheath 190.

[0048] Referring to FIG. 5, an exemplary method 500 for guiding the basket catheter 184 to a target position using the inserter 100 is shown. According to the exemplary method 500, a first step 502 includes coupling a first body 110 of the inserter 100 to a second body 150 of the inserter 100. After the first body 110 is coupled to the second body 150, in a second step 504, perfusion fluid is supplied to the chamber 152 of the second body 150. As described herein, the perfusion fluid may be supplied through the inserter 100. The perfusion fluid can further move through the sheath 190 to the target anatomical location. In a third step 506, the basket catheter 184 is advanced distally along the longitudinal axis 70, and the basket catheter 184 is inserted into a catheter guide 154 that facilitates folding of the basket catheter 184. As the basket catheter 184 advances distally through the inserter 100, the seal 166 of the valve 160 is pushed outward by the distal tip of the basket catheter 184, and the valve 160 opens. In a fourth step 508, the basket catheter 184 is moved from the distal portion 167 of the guide tube 168 into the sheath 190 while being held in a folded configuration. The basket catheter 18 can be advanced through the sheath 190 toward the target position. In some examples, when the basket catheter 184 exits the sheath 190, the basket is free to move into an expanded configuration.

[0049] The techniques of the present disclosure described herein can be further understood in accordance with the following clauses. Item 1: An inserter comprising a first body having a hemostatic valve, the hemostatic valve being configured to receive a flexible shaft and prevent fluid from flowing past the hemostatic valve, the first body, and 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 being connected distally of the chamber along the longitudinal axis of the second body and guiding the flexible shaft into a sheath, and a valve at least partially disposed within 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.

[0050] Item 2: The inserter according to Item 1, wherein the valve includes at least two seals biased towards each other, the at least two seals interfacing with each other to seal the guide tube and prevent backflow into the chamber.

[0051] Item 3: The inserter according to Item 2, wherein the at least two seals include silicone.

[0052] Item 4: The inserter according to Item 3, wherein the outer surfaces of the at least two seals have a hardness of about 20 Shore A to 40 Shore A.

[0053] Item 5: The inserter according to Item 2 or Item 3, wherein each of the two seals is biased by a compression spring.

[0054] Item 6: The inserter according to any one of Items 1 to 5, wherein the second body further includes an infusion coupling for coupling with an infusion line to receive infusion fluid into the chamber.

[0055] Item 7: The inserter according to any one of Items 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.

[0056] Item 8: The inserter according to Item 7, wherein opening of the valve blocks the vent tube.

[0057] Item 9: The distal end of the flexible shaft comprises a basket catheter, and the distal end of the chamber comprises a catheter guide configured to fold the basket catheter when the basket catheter is moved from the chamber into the guide tube, the introducer according to any one of Items 1 to 8.

[0058] Item 10: The first body is screwed onto the second body, the introducer according to any one of Items 1 to 9.

[0059] Item 11: An introducer, comprising a first body with a hemostatic valve, the hemostatic valve being configured to receive a flexible shaft and prevent fluid from flowing past the hemostatic valve, the first body, a valve stop portion disposed on the outer surface of the flexible shaft and configured to prevent the distal end of the flexible shaft from passing beyond the hemostatic valve, and a second body configured to be removably coupled to the first body and defining a chamber, the second body, wherein the second body has, distally of the chamber, a guide tube disposed along the longitudinal axis of the second body and configured to guide the flexible shaft into the sheath, the guide tube, and a valve disposed at least partially within the guide tube and biased in a closed position to open and receive the flexible shaft and prevent fluid from flowing through the valve, the valve, the introducer.

[0060] Item 13: The valve stop portion is substantially annular, the introducer according to Item 12.

[0061] Item 14: The outer diameter of the valve stop portion is smaller than the inner diameter of the guide tube, the introducer according to Item 13.

[0062] Item 15: The valve stop portion comprises a plurality of protrusions extending from the outer surface of the flexible shaft, the introducer according to Item 13 or 14.

[0063] Item 15: The insertion device according to any one of Items 11 to 14, wherein the distal end of the flexible shaft comprises a basket catheter, and the valve stop is configured to prevent interaction between the basket catheter and the hemostatic valve.

[0064] Item 16: The insertion device according to any one of Items 11 to 15, wherein the distal end of the flexible shaft comprises a basket catheter, and the distal end of the chamber comprises a catheter guide configured to fold the basket catheter when the basket catheter is moved from the chamber into the guide tube.

[0065] Item 17: The insertion device according to any one of Items 11 to 16, wherein the first body is screwed onto the second body.

[0066] Item 18: The insertion device according to any one of Items 11 to 17, wherein the valve comprises at least two seals biased towards each other, and the at least two seals interface with each other to seal the guide tube and prevent backflow into the chamber.

[0067] Item 19: A method comprising coupling a first body to a second body, wherein the first body comprises a hemostatic valve configured to receive a flexible shaft and prevent fluid from flowing past the hemostatic valve, the flexible shaft extends through the hemostatic valve and comprises 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, the second body comprises a valve biased in a closed position, inserting the basket catheter longitudinally through the valve thereby opening the valve, and moving the basket catheter through a sheath towards a target position.

[0068] Item 20: The second body further comprises an irrigation coupling for coupling with an irrigation line, and the method further comprises supplying irrigation fluid to the second body after coupling the first body to the second body and before inserting the basket catheter through the valve, the method according to claim 19.

[0069] The above embodiments are cited as examples, and the present invention is not limited to what has been specifically illustrated and described hereinabove. Rather, the scope of the present invention includes both combinations of the various features described herein heretofore and partial combinations thereof, as well as those variations and modifications thereof that would occur to those skilled in the art upon reading the foregoing description and that are not disclosed in the prior art.

[0070] [Embodiment] (1) An inserter, comprising: a first body having a hemostatic valve, the hemostatic valve being configured to receive a flexible shaft and prevent fluid from flowing past the hemostatic valve; a second body coupled to the first body; wherein the second body comprises: a chamber; a guide tube smaller than the chamber, connected distally of the chamber along the longitudinal axis of the second body, and configured to guide a flexible shaft within a sheath; a valve at least partially disposed within the guide tube, biased to a closed position, and configured to prevent fluid from flowing through the valve when a flexible shaft is inserted through the valve. (2) The inserter according to embodiment 1, wherein the valve comprises at least two seals biased towards each other, the at least two seals interfacing with each other to seal the guide tube and prevent backflow into the chamber. (3) The inserter according to embodiment 2, wherein the at least two seals comprise silicone. (4) The outer surfaces of the at least two seals have a hardness of about 20 Shore A to 40 Shore A, the inserter according to Embodiment 3. (5) Each of the at least two seals is biased by a compression spring, the inserter according to Embodiment 2.

[0071] (6) The second body further comprises an infusion coupling for coupling with an infusion line to receive infusion fluid into the chamber, the inserter according to Embodiment 1. (7) The second body further defines a vent tube that forms a fluid passage from the distal portion of the guide tube to the chamber, the inserter according to Embodiment 1. (8) The opening of the valve blocks the vent tube, the inserter according to Embodiment 7. (9) The distal end of the flexible shaft comprises a basket catheter, and the distal end of the chamber comprises a catheter guide configured to fold the basket catheter when the basket catheter is moved from the chamber into the guide tube, the inserter according to Embodiment 1. (10) The first body is screwed onto the second body, the inserter according to Embodiment 1.

[0072] (11) An inserter, A first body comprising a hemostatic valve, the hemostatic valve being configured to receive a flexible shaft and prevent fluid from flowing past the hemostatic valve, the first body; A valve stop disposed on the outer surface of the flexible shaft and configured to prevent the distal end of the flexible shaft from passing through the hemostatic valve; A second body configured to be removably coupled to the first body and defining a chamber, the second body; Comprising, the second body A guide tube disposed distally of the chamber and along the longitudinal axis of the second body, the guide tube being configured to guide the flexible shaft within a sheath; A valve at least partially disposed within the guide tube, biased to a closed position, opens to receive the flexible shaft, and is configured to prevent fluid from flowing through the valve, and a valve, and an inserter comprising the same. (12) The inserter according to embodiment 11, wherein the valve stop is substantially annular. (13) The inserter according to embodiment 12, wherein an outer diameter of the valve stop is smaller than an inner diameter of the guide tube. (14) The inserter according to embodiment 12, wherein the valve stop includes a plurality of protrusions extending from the outer surface of the flexible shaft. (15) 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. The inserter according to embodiment 11.

[0073] (16) The distal end of the flexible shaft includes a basket catheter, and the distal end of the chamber includes a catheter guide configured to fold the basket catheter when the basket catheter is moved from the chamber into the guide tube. The inserter according to embodiment 11. (17) The first body is screwed onto the second body. The inserter according to embodiment 11. (18) The valve includes at least two seals biased towards each other, and the at least two seals interface with each other to seal the guide tube and prevent backflow into the chamber. The inserter according to embodiment 11. (19) A method comprising Coupling a first body to a second body, wherein the first body comprises a hemostatic valve configured to receive a flexible shaft and prevent fluid from flowing past the hemostatic valve, the flexible shaft extending through the hemostatic valve and comprising a basket catheter disposed distal to the hemostatic valve and a valve stop configured to prevent removal of the flexible shaft through the hemostatic valve, and the second body comprises a valve biased to a closed position. Inserting the basket catheter through the valve along a longitudinal axis, thereby opening the valve. Moving the basket catheter through a sheath towards a target position. A method comprising the above. (20) The second body further comprises an irrigation coupling for coupling to an irrigation line, and the method further comprises supplying irrigation fluid to the second body after coupling the first body to the second body and before inserting the basket catheter through the valve, according to the method of embodiment 19.

Claims

1. An inserter comprising: a first body having a hemostatic valve configured to receive a flexible shaft and prevent fluid from flowing past the hemostatic valve; a second body coupled to the first body; wherein the second body comprises: a chamber; a guide tube smaller than the chamber and connected distally of the chamber along the longitudinal axis of the second body for guiding a flexible shaft into a sheath; a valve disposed at least partially within the guide tube, biased to a closed position and configured to prevent fluid from flowing through the valve when the flexible shaft is inserted through the valve.

2. The inserter of claim 1, wherein the valve comprises at least two seals biased towards each other, the at least two seals interfacing with each other to seal the guide tube and prevent backflow into the chamber.

3. The inserter of claim 2, wherein the at least two seals comprise silicone.

4. The inserter of 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 inserter of claim 2, wherein each of the at least two seals is biased by a compression spring.

6. The inserter of claim 1, wherein the second body further comprises an irrigation coupling for coupling to an irrigation line for receiving irrigation fluid into the chamber.

7. The inserter of claim 1, wherein the second body further defines a vent tube forming a fluid passage from a distal portion of the guide tube to the chamber.

8. The inserter of claim 7, wherein opening of the valve blocks the vent tube.

9. The inserter of claim 1, wherein the distal end of the flexible shaft comprises a basket catheter, and the distal end of the chamber comprises a catheter guide configured to fold the basket catheter when the basket catheter is moved from the chamber into the guide tube.

10. The inserter of claim 1, wherein the first body is screwed onto the second body.

11. An inserter comprising: A first body having a hemostatic valve, the hemostatic valve configured to receive a flexible shaft and prevent fluid from flowing past the hemostatic valve, the first body; A valve stop portion disposed on the outer surface of the flexible shaft and configured to prevent the distal end of the flexible shaft from passing through the hemostatic valve; A second body configured to be removably coupled to the first body, the second body defining a chamber, the second body; Comprising, the second body; A guide tube disposed distally of the chamber and along the longitudinal axis of the second body, the guide tube configured to guide the flexible shaft into a sheath, the guide tube; A valve at least partially disposed within the guide tube, the valve being biased in a closed position, opening to receive the flexible shaft, and configured to prevent fluid from flowing through the valve, the valve, an inserter.

12. The inserter according to claim 11, wherein the valve stop portion is substantially annular.

13. The inserter according to claim 12, wherein the outer diameter of the valve stop portion is smaller than the inner diameter of the guide tube.

14. The inserter according to claim 12, wherein the valve stop portion comprises a plurality of protrusions extending from the outer surface of the flexible shaft.

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

16. The inserter according to claim 11, wherein the distal end of the flexible shaft comprises a basket catheter, and the distal end of the chamber comprises a catheter guide configured to fold the basket catheter when the basket catheter is moved from the chamber into the guide tube.

17. The inserter according to claim 11, wherein the first body is screwed onto the second body.

18. The inserter according to claim 11, wherein the valve comprises at least two seals biased towards each other, the at least two seals interfacing with each other to seal the guide tube and prevent backflow into the chamber.

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