Flare insert for use with a catheter assembly

Abstract

The present invention discloses an apparatus comprising a cylindrical shaft and an outwardly flared feature. The cylindrical shaft is sized for insertion into an insertion port of a cardiovascular catheter guide sheath. The cylindrical shaft comprises a proximal end, a distal end, and a lumen extending from the proximal end to the distal end. The lumen is sized to receive an end effector and a catheter of a cardiovascular catheter device. The outwardly flared feature is located at the proximal end of the cylindrical shaft. The outwardly flared feature defines an angled surface leading to the lumen.

Description

[0001] priority

[0002] This application claims priority to U.S. Provisional Patent Application No. 62 / 924,443, filed on October 22, 2019, entitled “Flared Insert Member for Use with Catheter Assembly,” the disclosure of which is incorporated herein by reference in its entirety. Background Art

[0003] Arrhythmias, such as atrial fibrillation, occur when an area of ​​cardiac tissue conducts electrical signals abnormally. Procedures for treating arrhythmias include surgically interrupting the conduction pathways for such signals. By applying energy (e.g., radiofrequency (RF) energy) to selectively ablate cardiac tissue, it is possible to stop or alter the propagation of unwanted electrical signals from one part of the heart to another. The ablation process can provide a block to the unwanted electrical pathways by forming an electrically insulating lesion or scar tissue that effectively blocks the communication of abnormal electrical signals across tissue.

[0004] In some procedures, a catheter with one or more RF electrodes can be used to provide ablation within the cardiovascular system. The catheter can be inserted into a major vein or artery (e.g., the femoral artery) and then advanced to position the electrode within the heart or in cardiovascular structures adjacent to the heart (e.g., the pulmonary veins). One or more electrodes can be placed in contact with cardiac tissue or other vascular tissue and then activated with RF energy, thereby ablating the contacted tissue. In some cases, the electrodes can be bipolar. In some other cases, a monopolar electrode can be used in conjunction with a ground pad or other reference electrode in contact with the patient. Irrigation can be used to absorb heat from the ablation component of the ablation catheter; and to prevent the formation of blood clots near the ablation site.

[0005] Examples of ablation catheters are described in U.S. Publication 2013 / 0030426, entitled “Integrated Ablation System using Catheter with Multiple Irrigation Lumens,” published on January 31, 2013, the disclosure of which is incorporated herein by reference in its entirety; U.S. Publication 2017 / 0312022, entitled “Irrigated Balloon Catheter with Flexible Circuit Electrode Assembly,” published on November 2, 2017, the disclosure of which is incorporated herein by reference in its entirety; U.S. Publication 2018 / 0071017, entitled “Ablation Catheter with a Flexible Printed Circuit Board,” published on March 15, 2018, the disclosure of which is incorporated herein by reference in its entirety; and U.S. Publication 2018 / 0071017, entitled “Catheter with Bipole Electrode Spacer and Related Methods”, the disclosure of which is incorporated herein by reference in its entirety; U.S. Patent No. 10,130,422, published on November 20, 2018, entitled “Catheter with Soft Distal Tip for Mapping and Ablating Tubular Region”, the disclosure of which is incorporated herein by reference in its entirety; U.S. Patent No. 8,956,353, published on February 17, 2015, entitled “Electrode Irrigation Using Micro-Jets”, the disclosure of which is incorporated herein by reference in its entirety; and U.S. Patent No. 9,801,585, published on October 31, 2017, entitled “Electrocardiogram Noise Reduction”, the disclosure of which is incorporated herein by reference in its entirety.

[0006] Some catheter ablation procedures may be performed after using electrophysiological (EP) mapping to identify tissue areas that should be targeted for ablation. Such EP mapping may include the use of sensing electrodes on a catheter (e.g., the same catheter used to perform the ablation or a dedicated mapping catheter). Such sensing electrodes can monitor electrical signals emanating from the conductive endocardial tissue to precisely locate the location of abnormal conductive tissue sites that cause arrhythmias. An example of an EP mapping system is described in U.S. Patent No. 5,738,096, entitled "Cardiac Electromechanics," issued on April 14, 1998, the disclosure of which is incorporated herein by reference in its entirety. Examples of EP mapping catheters are described in the following documents: U.S. Patent 9,907,480, entitled “Catheter Spine Assembly with Closely-Spaced Bipole Microelectrodes,” published on March 6, 2018, the disclosure of which is incorporated herein by reference in its entirety; U.S. Patent 10,130,422, entitled “Catheter with Soft Distal Tip for Mapping and Ablating Tubular Region,” published on November 20, 2018, the disclosure of which is incorporated herein by reference in its entirety; and U.S. Publication 2018 / 0056038, entitled “Catheter with Bipole Electrode Spacer and Related Methods,” published on March 1, 2018, the disclosure of which is incorporated herein by reference in its entirety.

[0007] When using an ablation catheter, it may be desirable to ensure that one or more electrodes of the ablation catheter are in sufficient contact with the target tissue. For example, it may be desirable to ensure that the one or more electrodes contact the target tissue with sufficient force to effectively apply RF ablation energy to the tissue, but without applying a level of force that may tend to undesirably damage the tissue. To this end, it may be desirable to include one or more force sensors or pressure sensors for detecting sufficient contact between the one or more electrodes of the ablation catheter and the target tissue.

[0008] In addition to using force sensing or EP mapping, some catheter ablation procedures can also be performed using image-guided surgery (IGS) systems. An IGS system can enable a physician to visually track the position of a catheter within a patient relative to an image of the patient's anatomy in real time. Some systems can provide a combination of EP mapping and IGS functionality, including the CARTO Examples of catheters configured for use with the IGS system are disclosed in U.S. Patent No. 9,480,416, entitled “Signal Transmission Using Catheter Braid Wires,” issued November 1, 2016, the disclosure of which is incorporated herein by reference in its entirety, and various other references cited herein.

[0009] While several catheter systems and methods have been made and used, it is believed that no one prior to the inventors has made or used the invention described, shown, and claimed herein. BRIEF DESCRIPTION OF THE DRAWINGS

[0010] The following drawings and detailed description are intended to be illustrative only and are not intended to limit the scope of the invention as contemplated by the inventors.

[0011] Figure 1 A schematic diagram depicting a medical procedure for inserting a catheter of a catheter assembly into a patient;

[0012] Figure 2 Depicts Figure 1 a perspective view of a catheter assembly;

[0013] Figure 3 Depicts Figure 1 a perspective view of an end effector of a catheter assembly;

[0014] Figure 4 Describes the Figure 1 A perspective view of an example of an introducer sheath for use with a catheter assembly;

[0015] Figure 5 Depicts Figure 4 an end view of the proximal end of the introducer sheath;

[0016] Figure 6 Describes the Figure 1 Catheter components and Figure 4 A perspective view of an example of an insertion member for use with a guide sheath;

[0017] Figure 7 Depicts Figure 6 an end view of the proximal end of the insertion member;

[0018] Figure 8 Depicts the setting Figure 1 The distal portion of the catheter of the catheter assembly Figure 6 A perspective view of an insert member;

[0019] Figure 9A Depicts the setting Figure 1 The distal portion of the catheter of the catheter assembly Figure 6 A perspective view of an insertion member with the insertion member and catheter positioned for insertion Figure 4 a proximal end of the guide sheath;

[0020] Figure 9B Depicts the setting Figure 1 The distal portion of the catheter of the catheter assembly Figure 6 A perspective view of an insertion member of FIG. 1 , wherein the insertion member is being inserted into Figure 4 The catheter is not yet inserted into the proximal end of the guide sheath;

[0021] Figure 9C Depicts the setting Figure 1 The distal portion of the catheter of the catheter assembly Figure 6 A perspective view of an insertion member, wherein the insertion member and the catheter are inserted into Figure 4 a proximal end of the guide sheath;

[0022] Figure 9D Depicts full insertion into Figure 4 The guide sheath Figure 6 A perspective view of the insertion member, and the insertion member blocks Figure 1 The catheter assembly is inserted into the guide sheath;

[0023] Figure 10 Describes the Figure 1 Catheter components and Figure 4 A perspective view of another example of an insertion member for use with a guide sheath;

[0024] Figure 11 Depicts the Figure 10 The line 11-11 is intercepted Figure 10 a cross-sectional view of an insert member;

[0025] Figure 12A Depicts the Figure 10 The line 12-12 is intercepted Figure 10 a cross-sectional view of an insert member;

[0026] Figure 12B Depicts the Figure 10 The line 12-12 is intercepted Figure 10 A cross-sectional view of an insert member, wherein Figure 1 The catheter of the catheter assembly is disposed in the insertion member;

[0027] Figure 13 Describes the Figure 1 Catheter components and Figure 4 a cross-sectional side view of another example of an insertion member for use with a guide sheath;

[0028] Figure 14 Describes the Figure 1 Catheter components and Figure 4 a cross-sectional side view of a middle portion of another example of an insertion member for use with a guide sheath;

[0029] Figure 15 Describes the Figure 1 Catheter components and Figure 4 a cross-sectional side view of a middle portion of another example of an insertion member for use with a guide sheath;

[0030] Figure 16 Describes the Figure 1 Catheter components and Figure 4 A perspective view of another example of an insertion member for use with a guide sheath;

[0031] Figure 17A Depicts the Figure 16 The line 17-17 is intercepted Figure 16 a cross-sectional view of an insert member;

[0032] Figure 17B Depicts the Figure 16 The line 17-17 is intercepted Figure 16 A cross-sectional view of an insert member, wherein Figure 1 The catheter of the catheter assembly is disposed in the insertion member;

[0033] Figure 18 Describes the Figure 1 Catheter components and Figure 4 A perspective view of another example of an insertion member for use with a guide sheath;

[0034] Figure 19 Depicts Figure 18 an end view of an insert member;

[0035] Figure 20 Describes the Figure 1 Catheter components and Figure 4 A perspective view of another example of an insertion member for use with a guide sheath;

[0036] Figure 21 Depicts Figure 20 a side elevation view of an insertion member;

[0037] Figure 22 Describes the Figure 1 Catheter components and Figure 4 A perspective view of another example of an insertion member for use with a guide sheath;

[0038] Figure 23 Depicts Figure 22an end view of an insert member;

[0039] Figure 24 Depicts the Figure 23 The line 24-24 is intercepted Figure 22 a cross-sectional view of an insert member;

[0040] Figure 25 Describes the combination Figure 1 A perspective view of another example of a catheter in a catheter assembly;

[0041] Figure 26A Depicts the surrounding Figure 5 Catheter positioning Figure 22 a cross-sectional side view of an insertion member of the catheter, wherein the insertion member is in a first longitudinal position along the catheter;

[0042] Figure 26B Depicts the surrounding Figure 5 Catheter positioning Figure 22 a cross-sectional side view of the insertion member, wherein the insertion member is in a second longitudinal position along the catheter;

[0043] Figure 27A Describes the Figure 1 Catheter components and Figure 4 A perspective view of an example of an insertion assembly for use with a guide sheath, wherein the insertion assembly is in an unclamped state;

[0044] Figure 27B Depicts Figure 27A A perspective view of the insertion assembly, wherein the insertion assembly is in a clamped state;

[0045] Figure 28 Depicts Figure 27A An exploded perspective view of an insert assembly;

[0046] Figure 29 Depicts Figure 27A a cross-sectional side view of a female member of the insert assembly;

[0047] Figure 30A Depicts Figure 27A an end view of the insert assembly, wherein the insert assembly is in an unclamped state; and

[0048] Figure 30B Depicts Figure 27A An end view of an insert assembly in a clamped state. DETAILED DESCRIPTION

[0049] The following description of certain examples of the present invention should not be used to limit the scope of the present invention. The accompanying drawings (not necessarily drawn to scale) depict selected embodiments and are not intended to limit the scope of the present invention. The detailed description illustrates the principle of the present invention by way of example and not by way of limitation. According to the following description shown by way of example, other examples, features, aspects, embodiments and advantages of the present invention will be apparent to those skilled in the art, and a best approach is envisioned for implementing the present invention. As will be appreciated, the present invention can have other different or equivalent aspects, all of which do not depart from the present invention. Therefore, the drawings and description should be considered to be illustrative and not restrictive in nature.

[0050] Any one or more of the teachings, expressions, versions, examples, etc. described herein may be combined with any one or more of the other teachings, expressions, versions, examples, etc. described herein. Therefore, the following teachings, expressions, versions, examples, etc. should not be considered separate from one another. Various suitable ways in which the teachings herein may be combined will be apparent to those skilled in the art with reference to the teachings herein. Such modifications and variations are intended to be within the scope of the claims.

[0051] As used herein, the term "about" or "approximately" for any numerical value or range indicates a suitable dimensional tolerance that allows the part or collection of elements to achieve its intended purpose as described herein. More specifically, "about" or "approximately" can refer to a range of ±20% of the value of the recited value, for example, "about 90%" can refer to a range of values ​​from 71% to 99%. In addition, as used herein, the terms "patient," "host," "user," and "subject" refer to any human or animal subject and are not intended to limit the systems or methods to human use, although use of the subject invention in human patients represents a preferred embodiment.

[0052] I. Overview of Examples of Catheter Systems

[0053] Figure 1 An exemplary medical procedure and associated components of a cardiac catheter system that can be used to provide EP mapping or cardiac ablation as mentioned above are shown. Specifically, Figure 1 A physician (PH) is shown grasping the handle assembly (110) of the catheter assembly (100) wherein the catheter (120) of the catheter assembly (100) ( Figures 2 to 3 Shown but not in Figure 1 The end effector (140) is positioned within a patient (PA) to map electrical potentials in tissue or to ablate tissue in or near a heart (H) of the patient (PA). Figure 2As shown, the catheter assembly (100) includes a handle assembly (110), a catheter (120) extending distally from the handle assembly (110), an end actuator (140) located at the distal end of the catheter (120), and a deflection drive actuator (114) associated with the handle assembly (110).

[0054] As will be described in greater detail below, the end effector (140) includes various components configured to deliver RF energy to a target tissue site, provide EP mapping functionality, track external forces applied to the end effector (140), track the position of the end effector (140), or disperse irrigation fluid. The deflection drive actuator (114) is rotatable relative to the housing (112) of the handle assembly (110), thereby deflecting the end effector (140) and the distal portion of the catheter (120) away from a central longitudinal axis (LA) defined by the proximal portion of the catheter (120). Various suitable components that can be coupled to the deflection drive actuator (114) and the catheter (120) to provide such functionality will be apparent to those skilled in the art in view of the teachings herein.

[0055] like Figure 3 As shown, the catheter (120) includes a slender flexible shaft (122) with an end effector (140) extending distally from the shaft (122). The proximal end of the catheter (120) extends distally from the nozzle member (116) of the handle assembly (110). In some versions, a heat shrink wrap (not shown) is provided around the catheter (120) at the junction of the proximal end of the catheter (120) and the nozzle member (116). The end effector (140) at the distal end of the catheter (120) will be described in more detail below. The catheter assembly (100) is coupled to the guidance and drive system (10) via a cable (30). The catheter assembly (100) is also coupled to a fluid source (42) via a fluid conduit (40). A set of field generators (20) are positioned below the patient (PA) and are coupled to the guidance and drive system (10) via another cable (22). The field generator (20) is only optional.

[0056] The guidance and drive system (10) of the present example includes a console (12) and a display (18). The console (12) includes a first driver module (14) and a second driver module (16). The first driver module (14) is coupled to the catheter assembly (100) via a cable (30). In some variations, the first driver module (14) is operable to receive EP mapping signals obtained via a microelectrode pair (320) of an end effector (140), as described in more detail below. The console (12) includes a processor (not shown) that processes such EP mapping signals and thereby provides EP mapping as known in the art.

[0057] The first driver module (14) of the present example is also operable to provide RF power (as will be described in more detail below) to the distal end member (142) of the end effector (140), thereby ablating tissue. The second driver module (16) is coupled to the field generator (20) via a cable (22). The second driver module (16) is operable to activate the field generator (20) to generate an alternating magnetic field around the heart (H) of the patient (PA). For example, the field generator (20) may include a coil that generates an alternating magnetic field in a predetermined working volume that accommodates the heart (H).

[0058] The first driver module (14) is further operable to receive a position-indicating signal from a navigation sensor assembly (127) in the catheter (120) near the end effector (140). In this type of embodiment, the processor of the console (12) is further operable to process the position-indicating signal from the navigation sensor assembly (127) to thereby determine the position of the end effector (140) within the patient (PA). In some versions, the navigation sensor assembly (127) includes two or more coils operable to generate a signal indicating the position and orientation of the end effector (140) within the patient (PA). The coils are configured to generate an electrical signal in response to the presence of an alternating electromagnetic field generated by the field generator (20). Other components and technologies that can be used to generate real-time position data associated with the end effector (140) may include wireless triangulation, acoustic tracking, optical tracking, inertial tracking, and the like. While navigation sensor assembly (127) is shown disposed in the distal end of catheter (120), navigation sensor assembly (127) may alternatively be positioned in end effector (140). Alternatively, catheter (120) and end effector (140) may not have navigation sensor assembly (127).

[0059] The display (18) is coupled to the processor of the console (12) and is operable to present an image of the patient's anatomy. Such images may be based on a set of images obtained before or during surgery (e.g., CT or MRI scans, 3D maps, etc.). The view of the patient's anatomy provided by the display (18) may also be dynamically changed based on signals from the navigation sensor assembly (127) of the end effector (140). For example, as the end effector (140) of the catheter (120) moves within the patient (PA), the corresponding position data from the navigation sensor assembly (127) may cause the processor of the console (12) to update the view of the patient's anatomy in real time in the display (18) to depict the area of ​​the patient's anatomy around the end effector (140) as the end effector (140) moves within the patient (PA). In addition, the processor of the console (12) may drive the display (18) to display the locations of abnormally conductive tissue sites detected via electrophysiological (EP) mapping using the end effector (140) or detected in other ways (e.g., using a dedicated EP mapping catheter, etc.). By way of example only, the processor of the console (12) may drive the display (18) to superimpose the locations of the abnormally conductive tissue sites on the image of the patient's anatomy, such as by superimposing an illuminated dot, crosshairs, or some other form of visual indication of the abnormally conductive tissue sites.

[0060] The processor of the console (12) can also drive the display (18) to superimpose the current position of the end effector (140) on the image of the patient's anatomy, such as by superimposing an illuminated dot, a crosshair, a graphical representation of the end effector (140), or some other form of visual indication. As the physician moves the end effector (140) within the patient (PA), this superimposed visual indication can also move in real time within the image of the patient's anatomy on the display (18), thereby providing the operator with real-time visual feedback regarding the position of the end effector (140) within the patient (PA) as the end effector (140) moves within the patient (PA). Thus, the image provided by the display (18) can effectively provide a video that tracks the position of the end effector (140) within the patient (PA) without having to have any optical instrument (i.e., a camera) to view the end effector (140). In the same view, the display (18) can simultaneously visually indicate the location of abnormal conductive tissue sites detected by EP mapping. Thus, the physician (PH) may view the display (18) to observe the real-time positioning of the end effector (140) relative to the mapped abnormal conductive tissue site and relative to an image of adjacent anatomical structures within the patient (PA).

[0061] The fluid source (42) of the present example comprises a bag containing saline or some other suitable flushing fluid. The conduit (40) comprises a flexible tube that is further coupled to a pump (44) operable to selectively drive fluid from the fluid source (42) to the catheter assembly (100). As described in more detail below, such flushing fluid may be discharged through an opening (158) of the distal tip member (142) of the end effector (140). Such flushing may be provided in any suitable manner that will be apparent to one skilled in the art in view of the teachings herein.

[0062] II. Examples of End Effectors

[0063] As described above, the end effector (140) includes various components configured to deliver RF energy to a target tissue site, provide EP mapping functionality, track external forces applied to the end effector (140), track the position of the end effector (140) within the patient (PA), and emit irrigation fluid. Figure 3 As shown, the end effector (140) of this example includes a distal end member (142), which also includes a cylindrical body (156) having a dome-shaped end. The cylindrical body (156) and the dome end can be formed of a conductive material (such as metal). A plurality of openings (158) are formed through the cylindrical body (156) and are in communication with the hollow interior of the distal end member (142). Thus, the openings (158) allow irrigation fluid to be transmitted from the interior of the distal end member (142) through the cylindrical body (156). The cylindrical body (156) and the dome end can also be operated to apply RF electrical energy to tissue, thereby ablating the tissue. Such RF electrical energy can be transmitted from the first driver module (14). The distal end member (142) can also include one or more thermocouples configured to provide temperature sensing capabilities. This can prevent overheating of the distal end member (142) or adjacent tissue.

[0064] Also like Figure 3 As shown, the distal end member (142) of this example also includes one or more EP mapping microelectrodes (138) mounted to the cylindrical body (156). The EP mapping microelectrode (138) is configured to pick up an electrical potential from tissue in contact with the EP mapping microelectrode (138). Thus, the EP mapping microelectrode (138) can be used to determine the location of abnormal electrical activity in tissue within a cardiovascular anatomical structure (e.g., a pulmonary vein, etc.). The signal picked up by the EP mapping microelectrode (138) can be transmitted to the first driver module (14) of the console (12) via the cable (30). In accordance with the teachings of the various references cited herein, the first driver module (14) can process the EP mapping signal and provide corresponding feedback to the physician (PH) indicating the location of the abnormal electrical activity.

[0065] In a version in which the cylindrical body (156) is formed of a conductive material to provide RF electrical energy for tissue ablation, an electrically insulating material may be interposed between the cylindrical body (156) and the EP mapping microelectrode (138), thereby electrically isolating the EP mapping microelectrode (138) from the cylindrical body (156). The EP mapping microelectrode (138) may be constructed and operated in accordance with the teachings of the various patent references cited herein. Although only one EP mapping microelectrode (138) is shown, the distal end member (142) may include two or more EP mapping microelectrodes (138). Alternatively, the distal end member (142) may not have an EP mapping microelectrode (138) at all.

[0066] In some variations, the end effector (140) may further include a force sensor configured to sense external forces impacting the distal end member (142). By way of example only, such a force sensor may take the form of a strain gauge or any other suitable component. When the distal end (142) is subjected to external forces (e.g., when the distal end (142) is pressed against tissue), those external forces are transmitted from the distal end (142) to the force sensor so that the force sensor can generate a suitable signal corresponding to the magnitude and direction of the external force. The signal from the force sensor can be transmitted via a cable (30) to the first driver module (14) of the console (12). The first driver module (14) can process the strain signal in any suitable manner that will be apparent to those skilled in the art in view of the teachings herein. By way of example only, when the force sensor indicates that distal tip member (142) is experiencing a force exceeding a predetermined threshold, console (12) may provide audible feedback to alert the physician (PH), thereby preventing the physician (PH) from inadvertently damaging cardiovascular anatomy with distal tip member (142). In some versions, the force sensor may be omitted.

[0067] In addition to the foregoing, the end effector (140) and other aspects of the catheter assembly (100) may be configured and operated in accordance with at least some of the teachings of any one or more of the various patent documents incorporated herein by reference. Alternatively, the end effector (140) may have any other suitable components, features, and capabilities.

[0068] III. Examples of Guide Sheaths

[0069] In some procedures, the physician (PH) may desire to introduce the catheter (120) into the patient (PA) via a guide sheath. In some such procedures, the guide sheath may be inserted into the patient (PA) (e.g., via the patient's (PA's) leg or groin); and then advanced along a vein or artery to reach a location in or near the heart (H). Once the guide sheath is properly positioned in the patient (PA), the physician (PA) may advance the end effector (140) and catheter (120) into the guide sheath until the end effector (140) exits the distal end of the guide sheath. The physician (PA) may then operate the catheter assembly (100) to provide EP mapping, ablation, or any other type of procedure in or near the heart (H) of the patient (PA).

[0070] Figures 4 and 5 An example of a guide sheath (200) that can be used for such procedures is shown. The guide sheath (200) of this example includes a handle assembly (210) having a hollow shaft (220) extending distally from a distal end (216) of the handle assembly (210). The handle assembly (210) is configured to be grasped by a housing (212). The open distal end (240) of the hollow shaft (220) is operable to deflect laterally away from the longitudinal axis (LA) of the shaft. The deflection is controlled by a knob (214) at the distal end (216) of the handle assembly (210). The knob (214) can be rotated relative to the housing (212) about the longitudinal axis (LA), thereby actuating a component that drives the open distal end (240) of the hollow shaft (220) to deflect laterally. By way of example only, such actuation components may comprise one or more puller wires, ribbons, or any other suitable structure, as will be apparent to those skilled in the art in view of the teachings herein.

[0071] like Figure 4 As shown, tube (202) extends laterally from the proximal end (218) of handle assembly (210). Tube (202) of this example is in fluid communication with a hollow interior (not shown) defined within handle assembly (210), wherein the hollow interior is in fluid communication with the interior of hollow shaft (220). Tube (202) of this example is also in fluid communication with a fluid source (204). By way of example only, fluid source (204) may comprise saline or any other suitable fluid. In some cases, fluid from fluid source (204) is transmitted through tube (202), the hollow interior region defined within handle assembly (210), and the interior of hollow shaft (220), thereby flushing the fluid path defined by tube (202), the hollow interior region defined within handle assembly (210), and the interior of hollow shaft (220).

[0072] like Figures 4 and 5As shown, the proximal end (218) of the handle assembly (210) also includes an insertion port (250). The insertion port (250) is aligned with the longitudinal axis (LA) and provides a port for inserting the end effector (140) and the catheter (120) into the hollow shaft (220), as will be described in more detail below. The insertion port (250) of this example includes an annular protrusion (252) defining an opening (254). The protrusion (252) protrudes proximally from the housing (212) at the proximal end (218). In some versions, the protrusion (252) is omitted.

[0073] Seal (260) is positioned within opening (254). By way of example only, seal (260) may comprise an elastomeric membrane or other type of component, as will be apparent to one skilled in the art in view of the teachings herein. Seal (260) of this example also includes a slit arrangement (262) configured to facilitate insertion of an instrument (e.g., catheter (120) or insertion member (300) (described below), etc.) through seal (260). In this example, slit arrangement (262) is in the form of a "+" symbol, but any other suitable type of configuration may be used. When no material is inserted through seal (260), seal (260) is configured to provide a fluid-tight seal that prevents fluid from escaping the portion of the fluid path defined within handle assembly (210) via insertion port (250); and prevents air from entering the fluid path defined within handle assembly (210) via insertion port (250). When an instrument is inserted through the seal (260), the seal (260) still maintains a substantially fluid-tight seal of the port (250), thereby preventing fluid from escaping the aforementioned fluid path defined within the handle assembly (210) via the insertion port (250); and preventing air from entering the aforementioned fluid path defined within the handle assembly (210) via the insertion port (250), while still allowing the inserted instrument to translate relative to the seal (260). Therefore, regardless of whether an instrument is disposed in the insertion port (250), the seal (260) prevents fluid from leaking out through the insertion port (250) and prevents air from being drawn into the heart (H) of the patient (PA) via the insertion port (250).

[0074] IV. Example of a Cylindrical Insert Member with a Bell-End

[0075] In some procedures, the end effector (140) and the catheter (120) may be inserted directly into the insertion port (250) so as to enter the shaft (220) and thereby exit the distal end (240) of the shaft (220). In some such procedures, a rigid cylindrical insertion member is first inserted through the seal (260) at the slit arrangement (262); and then the end effector (140) and the catheter (120) are advanced distally through the hollow interior of the cylindrical insertion member. The cylindrical insert may help provide initial penetration of the seal (260) for the end effector (140) and the catheter (120), which may otherwise be quite difficult for an end effector (140) and the catheter (120) of a relatively small diameter. Such a cylindrical insertion member may be formed as a pure cylinder (e.g., a straight tube having a uniform inner and outer diameter along its entire length). The catheter assembly (100) can be advanced toward the distal end to a point where the nozzle member (116) of the handle assembly (110) reaches the proximal end of the cylindrical insert member. In such circumstances, the rigid proximal end of the cylindrical insert member can provide strain on the proximal end of the catheter (120), which may be undesirable because the strain may compromise the structural integrity of the catheter (120). Similarly, the rigid proximal end of the cylindrical insert member can promote the formation of a kink at the proximal end of the catheter (120). Therefore, it may be desirable to provide a type of insert member that eliminates or otherwise reduces the risk of strain or kinking occurring at the proximal end of the insert member in the catheter (120).

[0076] In some cases where a cylindrical insertion member is used, an operator may inadvertently insert the cylindrical insertion member too far through the insertion port (250), to a point where the proximal end of the cylindrical insertion member completely passes through the seal (260). This may be a particular risk in cases where a physician (PH) is using a catheter (120) and a cylindrical insertion member that is smaller in size (e.g., 8 French) than the catheter and cylindrical insertion member intended for use with the introducer sheath (200) (e.g., 10 French). In some cases where the proximal end of the cylindrical insertion member passes distally past the seal (260), it may be difficult or impossible to remove the cylindrical insertion member from the handle assembly (210). Additionally or alternatively, the insertion member becoming stuck in the seal (260) may prevent the seal (260) from providing a fluid-tight seal at the insertion port (250), allowing air or other fluids to leak out through the insertion port (250). In a worst-case scenario, the cylindrical insertion member may also pass through the shaft (220) of the guide sheath (200) and exit the distal end (216), causing the cylindrical insertion member to be undesirably deposited within the patient (PA). Therefore, it may be desirable to provide some type of insertion member that eliminates or otherwise reduces the risk of the insertion member completely passing through the seal (260) or other portion of the insertion port (250).

[0077] Figures 6 and 7 An example of an insertion member (300) that can be used to facilitate insertion of an end effector (140) and a catheter (120) through an insertion port (250) of a guide sheath (200) is shown. The insertion member (300) of this example includes a cylindrical distal portion (302) and a flared proximal portion (304). The distal portion (302) is in the form of a straight cylindrical shaft and defines a lumen (320) that terminates proximally at the flared proximal portion (304) and distally at the distal end (310) of the insertion member (300). The proximal portion (304) has a truncated conical shape that leads to the lumen (320) and defines a proximal end (312) of the insertion member (300). Thus, the proximal portion (304) tapers inwardly toward the central longitudinal axis (LA) of the insertion member (300) in a proximal-to-distal direction. In this example, the insertion assembly (300) is substantially rigid.

[0078] The insertion member (300) is configured to receive the end effector (140) and the catheter (120), as Figure 8 As shown. The lumen (320) is sized to closely complement the outer diameter of the catheter (120) while allowing the catheter (120) to slide freely through the insertion member (300). The frustoconical shape of the proximal portion (304) can provide an introduction end that further facilitates insertion of the end effector (140) and the catheter (120) into the proximal end (312) of the insertion member (300). In addition, Figure 8 As shown, the length of the insertion member (300) is substantially less than the length of the catheter (120) such that the end actuator (140) protrudes distally beyond the distal end (310) of the insertion member (300), while the insertion member (300) is disposed around the catheter (120).

[0079] In examples where an insertion member (300) is used, the insertion member (300) may first be partially positioned around the distal end of the end effector (140) and the catheter (120), as shown. Figure 9A As shown. The combination of the insertion member (300), the end effector (140), and the catheter (120) can be positioned for insertion into the insertion port (250). Thus, the longitudinal axis (LA) of the catheter (120) can be aligned with the longitudinal axis (LA) of the guide sheath (200). At this stage of the present example, the end effector (140) is longitudinally disposed between the distal end (310) of the insertion member (300) and the proximal end (312) of the insertion member (300).

[0080] Next, the physician may advance the combination of the insertion member (300), the end effector (140), and the catheter (120) distally toward the insertion port (250) such that the distal end (310) of the insertion member (300) penetrates the seal (260) at the slit arrangement (262), as shown. Figure 9B As shown. In this example, the distal end (310) of the insertion member (300) passes through the seal (260) before the end effector (140) is advanced distally beyond the distal end (310) of the insertion member (300). Once the distal end (310) of the insertion member (300) has passed through the seal (260), the catheter (120) is advanced such that the end effector (140) is advanced distally beyond the distal end (310) of the insertion member (300), as shown. Figure 9C As the catheter (120) is advanced, the end effector (140) and the catheter (120) are advanced distally through the interior of the shaft (220). The end effector (140) eventually reaches a point where the end effector (140) is distal to the distal end (240) of the shaft (220). In some versions of the procedure, upon reaching Figure 9C After the illustrated state, as the physician (PA) continues to distally advance the catheter (120), the insertion member (300) is retracted proximally relative to the catheter (120). In other words, during at least a portion of the procedure in which the catheter (120) is distally advanced into the guide sheath (200), the distal end (310) of the insertion member (300) may be proximal to the insertion port (250).

[0081] In some scenarios, during normal operation of the catheter assembly (100) and the guide sheath (200), when the end effector (140) is positioned distally relative to the distal end (240) of the shaft (220), the nozzle member (116) of the handle assembly (110) and the insertion member (300) are both spaced proximally away from the insertion port (250). Thus, some versions of the catheter assembly (100), the guide sheath (200), and the insertion member (300) can be configured to allow the end effector (140) to be exposed distally from the shaft (220) and thus operated within the heart (H) of the patient (PA) without the insertion member (300) contacting the insertion port (250); and without the nozzle member (116) contacting the insertion member (300). In such a scenario, the insertion member (300) may simply be positioned around the area of ​​the catheter (120) that is longitudinally interposed between the insertion port (250) and the nozzle member (116) of the handle assembly (110).

[0082] As the physician (PA) continues to advance the catheter assembly (100) distally to the point where the nozzle member (116) of the handle assembly (110) engages the insertion member (300), the flared proximal portion (304) of the insertion member (300) may eventually engage the annular protrusion (252) of the insertion port (250), as shown. Figure 9D As shown. The outer diameter of the cylindrical distal portion (302) of the insertion member (300) is smaller than the diameter of the opening (254), while the outer diameter of the flared proximal portion (304) of the insertion member (300) is larger than the diameter of the opening (254). Therefore, the flared proximal portion (304) of the insertion member (300) will engage the annular protrusion (252) of the insertion port (250), and this interaction between the flared proximal portion (304) of the insertion member (300) and the annular protrusion (252) of the insertion port (250) will block the insertion member (300) and thereby prevent the insertion member (300) from being further advanced distally into the insertion port (250).

[0083] While in the aforementioned examples, the flared proximal portion (304) of the insertion member (300) engages the annular protrusion (252) of the insertion port (250), other configurations may provide engagement between the flared proximal portion (304) and the seal (260). In such scenarios, the annular protrusion (252) may not be present at all. Alternatively, the outer diameter of the flared proximal portion (304) may be sized to pass through the opening defined by the annular protrusion (252) but not through the seal (260). In either case, the slit arrangement (262) may be configured to allow the cylindrical distal portion (302) of the insertion member (300) to pass through the seal (260), but prevent the flared proximal portion (304) of the insertion member (300) from passing through the seal (260). As another merely illustrative alternative, insertion port (250) may include some other structure that engages annular protrusion (252) and thereby prevents insertion of insertion member (300) through insertion port (250).

[0084] In addition to preventing distal insertion of the insertion member (300) into the insertion port (250), the flared proximal portion (304) of the insertion member (300) may further eliminate or otherwise reduce strain that may occur at the junction of the proximal end (312) of the insertion member (300) and the catheter (120) by providing greater freedom for lateral deflection of the catheter (120) relative to the proximal end (312) of the insertion member (300).

[0085] In some variations of the above-described protocol, the insertion member (300) is inserted into the insertion port (250) before the end effector (140) and the catheter (120) are inserted into the insertion member (300). In other words, upon the initial insertion of the insertion member (300) into the insertion port (250), the end effector (140) and the catheter (120) may be completely disengaged from the insertion member (300). In some such variations of the protocol, before the end effector (140) and the catheter (120) are inserted into the insertion member (300), the insertion member (300) is first fully inserted into the insertion port (250) to the point where the flared proximal portion (304) of the insertion member (300) engages the annular protrusion (252) of the insertion port (250).

[0086] V. Example of a Cylindrical Insertion Member with a Sealing Member

[0087] As described above, it may be desirable to prevent air from entering the heart (H) of the patient (PA) via the insertion port (250). To the extent that the seal (260) substantially prevents air from entering the heart (H) of the patient (PA) via the insertion port (250), there may be circumstances where the insertion member (300) is disposed in the insertion port (250) and the catheter (120) is disposed in the lumen (320) of the insertion member (300), and air is able to pass through a gap defined between the inner diameter of the insertion member (300) and the outer diameter of the catheter (120). Therefore, it may be desirable to provide an improved form of the insertion member (300) that includes features that effectively close such a gap. Figures 10 to 12B An example of a modified form of the insertion member (300) is shown in FIG.

[0088] Figures 10 to 12B An insertion member (400) is shown that can be used in a similar manner to that described above for the insertion member (300). The insertion member (400) of this example includes a cylindrical distal portion (402) and a flared proximal portion (404). The distal portion (402) is in the form of a right circular cylinder that defines a lumen (420) that terminates proximally at the flared proximal portion (404) and distally at the distal end (410) of the insertion member (400). The proximal portion (404) has a truncated conical shape that leads to the lumen (420) and defines the proximal end (412) of the insertion member (400). In this example, the insertion assembly (400) is substantially rigid.

[0089] Unlike the insertion member (300), the insertion member (400) of this example further includes a sealing member (450) positioned in the lumen (420). The sealing member (450) is formed of a biocompatible elastic material (e.g., rubber, silicone, etc.). In some other versions, the sealing member (450) is not necessarily elastomeric, but may have a hardness lower than that of the cylindrical portion (402). The sealing member (450) includes a cylindrical body (452) having a plurality of integral tabs (454) extending radially outward from the body (452). The tabs (454) are disposed in a transverse opening (406) formed through the cylindrical distal portion (402) of the insertion member (400). Thus, the tabs (454) secure the position of the sealing member (450) within the cylindrical distal portion (402). Alternatively, any other suitable structure or technique may be used to secure the position of sealing member ( 450 ) within cylindrical distal portion ( 402 ).

[0090] The sealing member (450) further includes a pair of inclined inner surfaces (456) that converge at a ridge (458) at the longitudinal center of the sealing member (450). The ridge (458) defines an inner diameter that is smaller than the outer diameter of the catheter (120). Thus, when the catheter (120) is inserted through the insertion member (400) (e.g., Figure 12B As shown in FIG. 4 , the sealing member (450) is deformed relative to the outer diameter of the catheter (120). Thus, the sealing member (450) forms a fluid-tight seal between the inner diameter of the cylindrical distal portion (402) and the outer diameter of the catheter (120). This seal prevents air from passing between the inner diameter of the cylindrical distal portion (402) and the outer diameter of the catheter (120) to reach the heart (H) of the patient (PA). Although the sealing member (450) forms a fluid-tight seal against the catheter (120), the sealing member (450) still allows the catheter (120) to translate through the insertion member (400). Thus, the insertion member (400) can be inserted as described above in 9A to 9D The insertion member (300) is used in the same manner as described in the context of FIG.

[0091] While sealing member (450) is shown in this example as being positioned near the longitudinal center of insertion member (400), sealing member (450) may alternatively be positioned at any other suitable location along the length of insertion member (400). For example, sealing member (450) may alternatively be positioned near distal end (410). Alternatively, sealing member (450) may be positioned closer to the transition from cylindrical distal portion (402) to flared proximal portion (404).

[0092] Figure 13Another example of an insertion member (500) is shown, which can be used in a similar manner to that described above for the insertion member (300). The insertion member (500) of this example includes a cylindrical distal portion (502) and a flared proximal portion (504). The distal portion (502) is in the form of a right circular cylinder, which defines a lumen (520) that terminates proximally at the flared proximal portion (504) and distally at the distal end (510) of the insertion member (500). The proximal portion (504) has a truncated conical shape leading to the lumen (520) and defines the proximal end (512) of the insertion member (500). In this example, the insertion assembly (500) is substantially rigid.

[0093] Similar to the insertion member (400), the insertion member (500) of this example includes a sealing member (530) positioned in the tubular cavity (520). The sealing member (530) is formed of a biocompatible elastic material (e.g., rubber, silicone, etc.). In some other versions, the sealing member (530) is not necessarily elastomeric, but the hardness may be lower than the hardness of the cylindrical portion (502). The sealing member (530) includes a cylindrical body (532) that is fixedly fixed relative to the cylindrical distal portion (502). By way of example only, with reference to the teachings herein, the cylindrical body (532) may be fixed to the cylindrical distal portion (502) via a structure similar to the tab (454) and opening (406) described above, via an overmolding process, via an adhesive, or in any other suitable manner apparent to those skilled in the art.

[0094] The sealing member (530) further includes a curved inner surface (534) defining a contoured ridge (536) at the longitudinal center of the sealing member (530). The ridge (536) defines an opening (540) having a diameter smaller than the outer diameter of the catheter (120). Thus, when the catheter (120) is inserted through the lumen (520) of the insertion member (530), the sealing member (530) deforms relative to the outer diameter of the catheter (120). Thus, the sealing member (530) forms a fluid-tight seal between the inner diameter of the cylindrical distal portion (502) and the outer diameter of the catheter (120). This seal prevents air from passing between the inner diameter of the cylindrical distal portion (502) and the outer diameter of the catheter (120) to reach the heart (H) of the patient (PA). Although the sealing member (530) forms a fluid-tight seal against the catheter (120), the sealing member (530) still allows the catheter (120) to translate through the insertion member (500). Thus, the insertion member (500) may be inserted as described above in 9A to 9D The insertion member (300) is used in the same manner as described in the context of FIG.

[0095] exist Figure 13In the example shown, curved interior surface (534) has the form of a three-dimensional annular bell curve, with ridge (536) formed by the peak of the bell curve. The bell curve defined by curved interior surface (534) is symmetrical about a transverse plane bisecting sealing member (530) at ridge (536). In some other versions, the curve is not symmetrical. Figure 14 An example of such a variation is shown. Figure 14 The middle region of the insert member (550) is shown including a sealing member (560) disposed within a cylindrical portion (552). Although not shown, the sealing member (560) may also include a flared portion, such as the flared portions (404, 504) described above. The insert member (550) may be configured and operable like the insert member (500), except for the differences described below.

[0096] The sealing member (560) of the insertion member (550) is similar to the sealing member (530) of the insertion member (500) in that the sealing member (560) is formed of a biocompatible elastomeric material (e.g., rubber, silicone, etc.); and the sealing member (560) includes a cylindrical body (562) that is fixedly secured relative to the cylindrical portion (552). The sealing member (560) of the insertion member (550) is also similar to the sealing member (530) of the insertion member (500) in that the sealing member (560) includes a curved interior surface (564) that defines a contoured ridge (570). The ridge (570) defines an opening (572) having a diameter that is smaller than the outer diameter of the catheter (120), such that the sealing member (560) can form a fluid-tight seal against the outer diameter of the catheter (120) inserted through the lumen (554) of the insertion member (550). Unlike the curved interior surface (534) of the sealing member (530), the curved interior surface (564) of the sealing member (560) is not symmetrical about a transverse plane that bisects the sealing member (560) at the ridge (570). Instead, the curved interior surface (564) includes a relatively shallow (i.e., having a larger concave radius of curvature) curved proximal region (566) that leads to the ridge (570); distal to the ridge (570), the curved distal region (568) is relatively steep (i.e., having a smaller concave radius of curvature). In addition, the longitudinal length of the proximal region (566) or the distal region (568) is longer. This configuration of the sealing member (560) can provide a smoother insertion path for the catheter (120) through the opening (572) of the sealing member (560).

[0097] Figure 15Another variation of an insert member (580) similar to the insert members (400, 500, 550) described above is shown. This example insert member (580) includes a sealing member (590) disposed within a cylindrical portion (582). Although not shown, the sealing member (580) may also include a flared portion, such as the flared portions (404, 504) described above. The insert member (590) may be configured and operable like the insert member (500), except for the differences described below.

[0098] The sealing member (590) of the insertion member (580) is similar to the sealing member (530) of the insertion member (500) in that the sealing member (590) is formed of a biocompatible elastomeric material (e.g., rubber, silicone, etc.); and the sealing member (590) includes a cylindrical body (592) that is fixedly secured relative to the cylindrical portion (582). The sealing member (590) of the insertion member (580) is also similar to the sealing member (530) of the insertion member (500) in that the sealing member (590) includes a curved interior surface (594) that defines a contoured ridge (596). The ridge (596) defines an opening (598) having a diameter that is smaller than the outer diameter of the catheter (120), such that the sealing member (590) can form a fluid-tight seal against the outer diameter of the catheter (120) inserted through the lumen (584) of the insertion member (580). Unlike the curved interior surface (534) of the sealing member (530), the curved interior surface (564) of the sealing member (560) is not shaped like a bell curve. Instead, the curved interior surface (564) is arcuate, defined by a single constant radius of curvature. Thus, the interior surface (564) has no concave surface and is only convex. Thus, the sealing member (590) can provide a sealing interface against the outer diameter of the catheter (120) that is similar to the sealing interface provided by an O-ring or other annular sealing member. Nevertheless, the sealing member (590) still functions substantially similarly to the sealing members (406, 530, 560) described above. In this example, the bell curve defined by the curved interior surface (564) is symmetrical about a transverse plane that bisects the sealing member (530) at the ridge (536). In some other versions, the curve is not symmetrical.

[0099] Figures 16 to 17BAnother example of an insertion member (600) having a sealing member (630) in the middle region of the length of the insertion member (600) is shown. The insertion member (600) of this example includes a cylindrical distal portion (602) and a flared proximal portion (604). The distal portion (602) is in the form of a right circular cylinder, which defines a lumen (620) that terminates proximally at the flared proximal portion (604) and distally at the distal end (610) of the insertion member (600). The proximal portion (604) has a truncated conical shape that leads to the lumen (620) and defines the proximal end (612) of the insertion member (600). In this example, the insertion assembly (600) is substantially rigid.

[0100] The sealing member (630) of this example has an accordion-shaped or corrugated profile defined by a series of longitudinally spaced annular peaks (632) and adjacent valleys (634). Within the lumen (620), the valleys (634) form a plurality of internal ridges (636) that together define a channel (638) having a diameter less than the outer diameter of the catheter (120). Figure 17B As shown, when the catheter (120) is inserted through the lumen (620), the outer diameter of the catheter (120) abuts against the ridge (636). The sealing member (630) is sufficiently flexible to deform and thereby accommodate the insertion of the catheter (120) through the channel (638), although the sealing member (630) is also sufficiently resilient to abut against the catheter (120) when the catheter (120) is disposed in the channel (638). Thus, the sealing member (630) forms a fluid-tight seal against the catheter (120).

[0101] In some versions, the sealing member (630) is formed of the same material as the rest of the insertion member (600), but with a reduced wall thickness to accommodate the deformation imposed by the catheter (120) as described above. In some other versions, the sealing member (630) is formed of an elastomeric material that is secured to the rest of the insertion member (600) in any other suitable manner. Instead of being formed of an elastomeric material, the sealing member (630) may be formed of the same material as the rest of the insertion member (600), but with an elastomeric coating on the interior of the sealing member (630). In some such versions, the elastomeric coating may deform in response to insertion of the catheter (120) through the passageway (638), without necessarily deforming the peaks (632) or valleys (634). In still other versions, the sealing member (630) is not necessarily elastomeric, but may have a hardness lower than that of the cylindrical portion (602). Sealing member (630) and cylindrical portion (602) may be formed simultaneously from different materials via coextrusion or using any other suitable process. Other suitable ways in which sealing member (630) may be formed and configured will be apparent to those skilled in the art in view of the teachings herein.

[0102] In addition to or in lieu of using the various sealing structures described above, the sealing member may alternatively include any other suitable type of structure to seal against the outer surface of catheter (120). Such alternative structures may include, but are not limited to, an annular wiper, a membrane having one or more slits formed therethrough, or any other suitable structure that would be apparent to one of ordinary skill in the art in view of the teachings herein.

[0103] VI. Examples of Cylindrical Insert Members with Enhanced Structural Support

[0104] In some scenarios, an insertion member, such as insertion member (300, 400, 500, 550, 580, 600), may be prone to deformation in response to a lateral load applied to the insertion member (300, 400, 500, 550, 580, 600) during use. Such a lateral load may be applied via the catheter (120), via the annular protrusion (252) of the insertion port (250), or via some other structure. Such deformation may include lateral bending of the insertion member (300, 400, 500, 550, 580, 600) away from the longitudinal axis of the insertion member (300, 400, 500, 550, 580, 600). Additionally or alternatively, such deformation may include radially inward bending of the insertion member (300, 400, 500, 550, 580, 600) toward the longitudinal axis of the insertion member (300, 400, 500, 550, 580, 600). In either case, deformation of the insertion member (300, 400, 500, 550, 580, 600) may cause the insertion member (300, 400, 500, 550, 580, 600) to couple to a catheter (120) disposed on the longitudinal axis of the insertion member (300, 400, 500, 550, 580, 600). Additionally or alternatively, deformation of the insertion member (300, 400, 500, 550, 580, 600) may otherwise prevent translation of the catheter (120) through the insertion member (300, 400, 500, 550, 580, 600) or otherwise make translation of the catheter (120) through the insertion member (300, 400, 500, 550, 580, 600) more difficult. In view of the foregoing, it may be desirable to add enhanced structural features to the insertion member (300, 400, 500, 550, 580, 600) to prevent the insertion member (300, 400, 500, 550, 580, 600) from inadvertent deformation during use.

[0105] Figures 18 and 19 An example of an insertion member (700) is shown that can be used in a similar manner to that described above for the insertion member (300). The insertion member (700) of this example includes a cylindrical distal portion (702) and a flared proximal portion (704). The distal portion (702) is in the form of a right circular cylinder that defines a lumen (720) that terminates proximally at the flared proximal portion (704) and distally at the distal end (714) of the insertion member (700). The proximal portion (704) has a truncated conical shape that opens into the lumen (720) and defines the proximal end (712) of the insertion member (700).

[0106] In this example, the insertion assembly (700) is substantially rigid. This rigidity is further enhanced by a plurality of longitudinally extending ribs (730). The ribs (730) protrude radially outward from the exterior of the cylindrical distal portion (702) and the flared proximal portion (704). The ribs (730) are equidistantly spaced angularly from one another around the central longitudinal axis of the insertion member (700). Although eight ribs (730) are shown, the insertion member (700) may alternatively have more or less than eight ribs (730). The insertion member (700) may also include any of the various other features described herein, including but not limited to the various sealing members (406, 530, 560, 590, 630) described herein. The ribs (730) of this example are configured to structurally enhance the rigidity of the insertion member (700), thereby reducing the risk of the insertion member (700) deforming away from, toward, or around the central longitudinal axis of the insertion member (700) during use of the insertion member (700), particularly when the insertion member (700) is inserted into the insertion port (250) of the guide sheath (200) and when the insertion port is retracted.

[0107] Figures 20 to 21 Another example of an insertion member (750) is shown that can be used in a similar manner to that described above for the insertion member (300). The insertion member (750) of this example includes a cylindrical distal portion (752) and a flared proximal portion (754). The distal portion (752) is in the form of a right circular cylinder that defines a lumen (770) that terminates proximally at the flared proximal portion (754) and distally at the distal end (764) of the insertion member (750). The proximal portion (754) has a truncated conical shape that opens into the lumen (770) and defines the proximal end (762) of the insertion member (750).

[0108] In this example, the insertion assembly (750) is substantially rigid. This rigidity is further enhanced by a plurality of ribs (780) extending at an angle. The ribs (780) protrude radially outward from the exterior of the cylindrical distal portion (752) and the flared proximal portion (754). The ribs (780) are spaced equidistantly from one another along the central longitudinal axis of the insertion member (750). Although seven ribs (780) are shown, the insertion member (750) may alternatively have more or less than seven ribs (780). The insertion member (750) may also include any of the various other features described herein, including but not limited to the various sealing members (406, 530, 560, 590, 630) described herein. In some embodiments, the insertion member (750) includes a combination of the longitudinally extending ribs (730) of the insertion member (700) and the annular ribs (780) of the insertion member (750). The ribs (780) of the present example are configured to structurally enhance the rigidity of the insertion member (750), thereby reducing the risk of the insertion member (750) deforming away from or toward the central longitudinal axis of the insertion member (750) during use of the insertion member (750), particularly when the insertion member (750) is inserted into and retracted from the insertion port (250) of the guide sheath (200).

[0109] While longitudinally extending ribs (730) and annular ribs (780) have been described above as examples of structural reinforcement features, the insert member may have structural reinforcement features that take any other suitable form. By way of example only, some other structural reinforcement features may have a grid configuration, a spiral configuration, or any other suitable configuration.

[0110] VII. Examples of Cylindrical Insert Members with Torque Drive Features

[0111] During use of the catheter assembly (100), some operators may be inclined to directly grasp the catheter (120) near the point where the catheter (120) enters the port (250) of the guide sheath (200). In some scenarios, the presence of blood, saline, or other fluids on the catheter (120) may make gripping the catheter (120) difficult. In addition to facilitating insertion of the catheter (120) into the port (250) of the guide sheath (200), the insertion member may be configured to enhance the operator's grip on the catheter (120). This may include enabling the insertion member to be used to rotate the catheter (120) about its longitudinal axis (LA). Figures 22 to 24 An example of an insertion member (800) is shown that includes a number of features that enhance the operator's grip on the catheter (120), provide further stability to the operator's grip on the catheter (120), and facilitate rotation of the catheter (120) about the longitudinal axis (LA) of the catheter (120).

[0112] The insertion member (800) of this example includes a cylindrical body (802), a flared portion (812), and a flared proximal portion (814). The body (802) terminates distally in the flared distal portion (812) and proximally in the flared proximal portion (814). The distal portion (812) has a truncated conical shape that opens into the lumen (820) and defines the distal end (804) of the insertion member (800). The proximal portion (814) has a truncated conical shape that opens into the lumen (820) and defines the proximal end (806) of the insertion member (800). Although the distal portion (812) is flared in this example, other versions of the insertion member (800) may have a straight distal portion (e.g., similar to insertion members (300, 400, 500, 550, 580, 600, 700, 750)). In some versions, the flared configuration of distal portion (812) prevents distal portion (812) from being inserted into insertion port (250) of introducer sheath (200). In some other versions, the flared configuration of distal portion (812) allows distal portion (812) to enter opening (254) of annular protrusion (252) of insertion port (250); but prevents distal portion (812) from being inserted through seal (260). In any case, use of the term "insertion member" should not be construed as necessarily requiring that the "insertion member" be capable of being inserted into insertion port (250) or other structure.

[0113] In this example, the insert assembly (800) is substantially rigid. The insert member (800) also includes a plurality of external fins (830) that extend longitudinally and radially outward from the body (802). The external fins (830) are angularly spaced equidistantly about the longitudinal axis of the insert member (800). Although the insert member (800) has three external fins (830) in this example, other versions may have more or less than three external fins (830). Figure 24 As best shown, each external fin (830) has an outer edge (832) that extends along a curve from the proximal end of the external fin (830) to the distal end of the external fin (830). The external fins (830) can facilitate gripping of the insertion member (800). The external fins (830) can also facilitate rotation of the insertion member (800) about the longitudinal axis of the insertion member (800) by an operator (and thereby facilitate rotation of the catheter (120) about the longitudinal axis of the catheter (120), as described below).

[0114] like Figures 23 to 24As best seen in FIG, the insert member (800) further includes a plurality of internal fins (840) extending longitudinally and radially inwardly within the lumen (820). The internal fins (840) are angularly spaced equidistantly about the longitudinal axis of the insert member (800). While the insert member (800) has three internal fins (840) in this example, other versions may have more or less than three internal fins (840). Figure 24 As best shown, each internal fin (840) has an edge (842) that extends along a curve from a proximal end of the internal fin (840) to a distal end of the internal fin (840).

[0115] Internal fins (840) are configured to engage the exterior of catheter (120) and substantially (but removably) secure insert member (800) to catheter (120). This engagement can be enhanced when catheter (120) is modified to include two different outer diameters. Figures 25 to 26B An example of such an improved catheter (850) is shown in FIG. The catheter (850) can be easily incorporated into the catheter assembly (100) to replace the catheter (120). In this example, the catheter (850) includes a distal portion (852) and a proximal portion (854) with a transition region (856) between the portions (852, 856). Figures 26A to 26B As best shown, the distal portion (852) has a first outer diameter (OD1); while the proximal portion (854) has a second outer diameter (OD2). The second outer diameter (OD2) is greater than the first outer diameter (OD1). The transition region (856) provides a tapered transition from the first outer diameter (OD1) to the second outer diameter (OD2). In this example, the proximal portion (854) also includes a plurality of longitudinally extending recesses (858). The size and position of the recesses (858) are set to correspond to the size and position of the internal fins (840) of the insertion member (800). In some other versions, the recesses (858) are omitted because they are not necessarily required.

[0116] The insertion member (800) may be positioned distally along the length of the catheter (850). Figure 26A ) and proximal position ( Figure 26B ) between. The first outer diameter (OD1) is smaller than the effective inner diameter defined by the internal fins (840) of the insertion member (800). Therefore, although the insertion member (800) is in the distal position (such as Figure 26A ), the internal fins (840) may contact the exterior of the distal portion (852) of the catheter (850), but the internal fins (840) do not prevent the insertion member (800) from sliding freely along the distal portion (852) of the catheter (850).

[0117] When the insertion member (800) slides proximally to the proximal position (eg Figure 26B (shown in FIG. 1 ), the internal fins (840) engage the exterior of the proximal portion (854) of the catheter (850). In some versions, the second outer diameter (OD2) is larger than the effective inner diameter defined by the internal fins (840) of the insertion member (800). In some such versions, the engagement between the internal fins (840) and the exterior of the proximal portion (854) of the catheter (850) provides friction such that when the insertion member is in Figure 26B In the proximal position shown, insertion member (800) is effectively clamped to proximal portion (854) of catheter (850). In some other versions, internal fins (840) have a higher stiffness than catheter (850) so that when the insertion member is in the proximal position, the insertion member (800) is effectively clamped to proximal portion (854) of catheter (850). Figure 26B , internal fins (840) engage or otherwise deform a proximal portion (854) of catheter (850). In some versions, proximal portion (854) of catheter (850) includes an elastomeric coating, an elastomeric overmold, or other features that promote frictional or deformation engagement with internal fins (840). In either case, engagement between internal fins (840) and the exterior of proximal portion (854) of catheter (850) can enable insertion member (800) to serve as a gripping point for catheter (850), thereby facilitating manipulation of catheter (850) by an operator, including, but not limited to, rotating catheter (850) about its longitudinal axis. However, the engagement between the internal fins (840) and the exterior of the proximal portion (854) of the catheter (850) may also allow the operator to securely grasp the catheter (850) and the insertion member (800) simultaneously; and to slide the insertion member (800) distally along the catheter (850) back to the insertion member (800). Figure 26A 's distal position, thereby disengaging the internal fins (840) from the exterior of the proximal portion (854) of the catheter (850).

[0118] In some versions of the catheter (850) including the recess (858), the internal fins (840) do not necessarily provide a friction or deformation fit with the exterior of the proximal portion (854) of the catheter (850). In some such versions, the internal fins (840) are configured to simply enter the recess (858) and facilitate rotation of the catheter (850) about its longitudinal axis using the insertion member (800), wherein the insertion member (800) can slide freely along the proximal portion (854) of the catheter (850). Alternatively, when the internal fins (840) are disposed in the recess (858), the internal fins (840) can provide a friction or deformation fit with the exterior of the proximal portion (854) of the catheter (850). As described above, the recess (858) can be omitted in some versions.

[0119] VIII. Examples of Insertion Member Assemblies for Selectively Gripping Catheters

[0120] As described above, it may be desirable to provide an insertion member that facilitates gripping and other manipulation of the catheter (120) (e.g., rotation, etc.). While the insertion member (800) described above provides a selective locking engagement between the insertion member (800) and the proximal portion (854) of the catheter (850), it may be desirable to provide a selective locking engagement between the insertion member and other longitudinal regions of the catheter (120). In other words, it may be desirable to enable an operator to selectively secure the insertion member at different locations along the length of the catheter (120), rather than just the proximal portion of the catheter (120). Such selective positioning and locking may be based on operator preference, the anatomy of the patient at hand, or other factors. Figures 27A to 30B An insertion member assembly (900) is shown that is capable of performing such an operation.

[0121] The insertion member assembly (900) of this example includes a male member (910), a deformable member (950), and a female member (960). As described in more detail below, the deformable member (950) is configured to be captured between portions of the male and female members (910, 960) and selectively compressed to selectively lock the insertion member assembly to the exterior of the catheter (120).

[0122] The male member (910) of this example includes a cylindrical body (912), a flared portion (916), and a head portion (930). The body (912) terminates at one end (914) at the flared portion (916) and terminates at another end (934) at the head portion (930). The head portion (930) has an enlarged diameter relative to the body (912) and includes external threads (930). The male member (910) defines a lumen (920) sized to receive a catheter (120), wherein the flared portion (916) provides an introduction end to the lumen (920) when the catheter (120) is initially inserted into the insertion member assembly (900) via the male member (910).

[0123] The deformable member (950) of this example includes a cylindrical body (952) that defines a lumen (954). When the insertion member assembly (900) is fully assembled, the deformable member (950) is positioned adjacent the end (934) of the male member (910). In this example, the deformable member (950) is formed from a biocompatible, elastically deformable material. By way of example only, the deformable member (950) can be formed from silicone. Other suitable materials that can be used to form the deformable member (950) will be apparent to those skilled in the art in view of the teachings herein.

[0124] The female member (950) of this example includes a cylindrical body (962), a flared portion (966), and a head portion (970). The body (962) terminates at one end (964) at the flared portion (966) and terminates at another end (986) at the head portion (970). Figure 29 As best seen in FIG, head portion (970) has an enlarged diameter relative to body (962) and includes a recessed portion (980) having internal threads (982) and an internal boss surface (984). The internal threads (982) of female member (960) complement the external threads (932) of male member (910). Female member (950) defines a lumen (990) sized to receive catheter (120), wherein flared portion (966) provides an introduction end to lumen (990) upon initial insertion of catheter (120) into insertion member assembly (900) via female member (950).

[0125] When the insertion member assembly (900) is in a fully assembled state, the deformable member (950) is positioned in the recess (980) and is longitudinally captured between the end (934) of the male member (910) and the inner boss surface (984) of the female member (950). The threads (932) of the male member (910) are received in the threads (932) of the female member (960). The lumens (920, 954, 990) are longitudinally aligned with each other. With the insertion member assembly (900) fully assembled, the catheter (120) can be inserted into the lumens (920, 954, 990). When the insertion member assembly (900) is in an unlocked state (such as Figure 27A and Figure 30A ), the female member (950) is in a substantially relaxed state such that the lumen (954) defines a first inner diameter (ID1) that is at least as large as the outer diameter of the catheter (120). Thus, when the insertion member assembly (900) is in the unlocked state (as shown), the female member (950) is in a substantially relaxed state such that the lumen (954) defines a first inner diameter (ID1) that is at least as large as the outer diameter of the catheter (120). Figure 27A and Figure 30A ), the insertion member assembly (900) is free to slide along the exterior of the catheter (120).

[0126] When the operator wishes to lock the position of the insertion member assembly (900) at a selected longitudinal position along the length of the catheter (120), the operator can rotate the male member (910) relative to the female member (950); or rotate the female member (950) relative to the male member (910). This relative rotation can transform the insertion member assembly into a locked state, such as Figure 27B and Figure 30B As shown. Figure 27A and Figure 30A The unlocked state changes to Figure 27B and Figure 30BDuring the locked state, the engagement between the threads (932) of the male member (910) and the threads (932) of the female member (960) provides translation of the male member (910) toward the female member (960), which in turn provides longitudinal compression of the deformable member (950) between the end (934) of the male member (910) and the inner boss surface (984) of the female member (950). This longitudinal compression of the deformable member (950) causes the deformable member (950) to deform inwardly, which in turn reduces the inner diameter (ID2) of the lumen (954). In this state, the inner diameter (ID2) of the lumen (954) is smaller than the outer diameter of the catheter (120), causing the deformable member (950) to abut inwardly against the catheter (120). This causes the insertion assembly (900) to frictionally clamp the catheter (120).

[0127] The insert assembly (900) is Figure 27A and Figure 30B With catheter (120) frictionally gripped in the illustrated position, an operator can grasp insertion assembly (900) to further manipulate catheter (120) (e.g., translate the catheter, rotate catheter (120) about its longitudinal axis, etc.). Insertion assembly (900) may also include fins, ridges, knurling, or other features to facilitate gripping between the operator's hand and insertion assembly (900).

[0128] Although both ends (914, 964) of the insertion assembly (900) are flared in this example, some versions of the insertion assembly (900) may not have flared portion (916) or flared portion (966). For example, if it is desired to insert the end (914) through the seal (260) of the insertion port (250), the male member (910) may not have flared portion (916). Similarly, if it is desired to insert the end (964) through the seal (260) of the insertion port (250), the female member (960) may not have flared portion (966). In a version in which either end (914, 964) is capable of being inserted through the seal (260) of the insertion port (250), the compressed deformable member (950) can form a fluid-tight seal against the catheter (120), such that the deformable member (950) functions similarly to the various sealing members (406, 530, 560, 590, 630) described herein.

[0129] In the case where both ends (914, 964) of the insert assembly (900) are flared (e.g. Figures 27A to 30BIn some embodiments, the flared configuration of the ends (914, 964) prevents either end (914, 964) from being inserted into the insertion port (250) of the guide sheath (200). In some other embodiments, the flared configuration of the ends (914, 964) allows either end (914, 964) to enter the opening (254) of the annular protrusion (252) of the insertion port (250); but prevents either end (914, 964) from being inserted through the seal (260).

[0130] IX. Examples of combinations

[0131] The following examples relate to various non-exhaustive ways in which the teachings herein may be combined or applied. It should be understood that the following examples are not intended to limit the coverage of any claims that may be provided at any time in this patent application or subsequent submissions of this patent application. It is not intended to make a disclaimer. The following examples are provided solely for illustrative purposes. It is contemplated that the various teachings herein may be arranged and applied in a variety of other ways. It is also contemplated that some variations may omit certain features mentioned in the following examples. Therefore, any of the aspects or features mentioned below should not be considered decisive unless otherwise expressly indicated as such by the inventor or the inventor's successor at a later date, for example. If any claim set forth in this patent application or subsequent submissions related to this patent application includes additional features other than those mentioned below, these additional features should not be assumed to be added for any reason related to patentability.

[0132] Example 1

[0133] A device comprising: (a) a cylindrical shaft sized for insertion into an insertion port of a cardiovascular catheter guide sheath, the cylindrical shaft comprising: (i) a proximal end, (ii) a distal end, and (iv) a lumen extending from the proximal end to the distal end, the lumen sized to receive an end effector and a catheter of a cardiovascular catheter device; and (b) an outward flare feature located at the proximal end of the cylindrical shaft, the outward flare feature defining an angled surface leading to the lumen.

[0134] Example 2

[0135]

[00146] According to the apparatus of embodiment 1, the cylindrical shaft and the outwardly flared feature comprise a rigid material.

[0136] Example 3

[0137]

[00146] The apparatus of any one or more of Examples 1-2 further includes a sealing member disposed in the lumen, the sealing member configured to form a fluid-tight seal against a catheter disposed in the lumen.

[0138] Example 4

[0139] According to the device of embodiment 3, the sealing member comprises an elastomeric material.

[0140] Example 5

[0141]

[0014] According to the device of any one or more of Examples 3-4, the sealing member is positioned along the cylindrical shaft at an intermediate position between the proximal end and the distal end.

[0142] Example 6

[0143] In accordance with the device of any one or more of Examples 3 to 5, the sealing member includes one or more outwardly extending tabs configured to secure the position of the sealing member within the lumen.

[0144] Example 7

[0145] In the apparatus of Example 6, the cylindrical shaft defines one or more openings configured to receive one or more outwardly extending tabs.

[0146] Example 8

[0147]

[00146] The apparatus of any one or more of Examples 3 to 7, the sealing member comprising a pair of inclined interior surfaces converging at a ridge, the ridge configured to engage a conduit disposed in the sealing member.

[0148] Example 9

[0149]

[00146] The apparatus of any one or more of Examples 1-8, further comprising a catheter disposed in the lumen, the catheter configured to fit within the cardiovascular anatomy.

[0150] Example 10

[0151] In the apparatus of Example 9, the catheter includes a distal end having an end effector.

[0152] Example 11

[0153] In accordance with the device of Example 10, the end effector comprises at least one mapping electrode configured to pick up electrical potentials from tissue.

[0154] Example 12

[0155] In accordance with the apparatus of any one or more of embodiments 10 to 11, the end effector comprises at least one ablation electrode configured to ablate tissue.

[0156] Example 13

[0157]

[00106] The apparatus of any one or more of Examples 1-12, further comprising a cardiovascular catheter introducing sheath having an insertion port configured to receive the cylindrical shaft.

[0158] Example 14

[0159]

[00146] According to the apparatus of embodiment 13, the insertion port defines an opening having a seal positioned therein.

[0160] Example 15

[0161] According to the apparatus of embodiment 14, the cylindrical shaft is configured to pass through the seal.

[0162] Example 16

[0163]

[00106] In the apparatus of embodiment 15, the seal includes a slit arrangement configured to allow the shaft to pass through the seal.

[0164] Example 17

[0165]

[00146] The apparatus of any one or more of embodiments 13 to 16, the insertion port and the outward flare feature being configured to prevent the outward flare feature from passing through the insertion port.

[0166] Example 18

[0167] According to the apparatus of any one or more of embodiments 1 to 17, the outward flare feature has a frusto-conical shape.

[0168] Example 19

[0169] A kit comprising: (a) a catheter apparatus comprising: (i) a catheter having a distal end, and (ii) an end effector located at the distal end of the catheter, the catheter and the end effector being sized to fit within a cardiovascular anatomy; and (b) an insertion member comprising: (i) a cylindrical shaft comprising: (A) a proximal end, (B) a distal end, and (C) a lumen extending from the proximal end to the distal end, the lumen being sized to receive the end effector and the catheter, and (ii) an outward flare feature located at the proximal end of the cylindrical shaft, the outward flare feature defining an angled surface leading to the lumen.

[0170] Example 20

[0171] According to the kit of embodiment 19, the end effector includes at least one electrode.

[0172] Example 21

[0173] The kit of any one or more of Examples 19-20 further includes a cardiovascular catheter introducing sheath comprising an insertion port configured to receive the cylindrical shaft and the catheter.

[0174] Example 22

[0175] In the kit of embodiment 21, the outward flare feature is configured to prevent insertion of the insertion member into the insertion port.

[0176] Example 23

[0177]

[00146] The kit of any one or more of Examples 21-22, the outward flare feature is configured to prevent insertion of a catheter into the insertion port.

[0178] Example 24

[0179] A method comprises positioning an insertion member on a catheter, the insertion member comprising: (i) a cylindrical shaft comprising: (A) a proximal end, (B) a distal end, and (C) a lumen extending from the proximal end to the distal end, the lumen receiving the catheter, and (ii) an outward flare feature located at the proximal end of the cylindrical shaft, the outward flare feature defining an angled surface leading to the lumen; the catheter being sized for insertion into a cardiovascular anatomy.

[0180] Example 25

[0181] The method of Example 24 further includes passing the distal end of the cylindrical shaft through an insertion port of a cardiovascular catheter introducer sheath.

[0182] Example 26

[0183] According to the method of Example 25, the step of positioning the insertion member on the catheter is performed before the step of passing the distal end of the cylindrical shaft through the insertion port of the cardiovascular catheter introducing sheath.

[0184] Example 27

[0185] According to the method described in any one or more of Examples 25 to 26, the catheter has a distal end having an end actuator, and during the step of passing the distal end of the cylindrical shaft through the insertion port of the cardiovascular catheter guide sheath, the end actuator is positioned between the proximal end of the cylindrical shaft and the distal end of the cylindrical shaft.

[0186] Example 28

[0187] The method described in any one or more of Examples 25 to 27 further includes advancing the catheter distally relative to the insertion member and relative to the cardiovascular catheter guide sheath after performing the step of passing the distal end of the cylindrical shaft through the insertion port of the cardiovascular catheter guide sheath.

[0188] Example 29

[0189] The method of Example 28 further comprises engaging the outward flare feature with the insertion port of the cardiovascular catheter introducing sheath, the engaged outward flare feature preventing distal movement of the insertion member relative to the insertion port.

[0190] Example 30

[0191]

[00106] The method of Example 29 further includes engaging a portion of the handle assembly with an outward flare feature at the proximal end of the catheter, the outward flare feature preventing distal movement of the catheter via engagement with the portion of the handle assembly.

[0192] Example 31

[0193] In accordance with any one or more of Examples 24 to 30, the insertion member further comprises a seal within the lumen that forms a fluid-tight seal against an outer surface of the catheter.

[0194] Example 32

[0195]

[00146] The method of Example 31, wherein the seal elastically deforms to form a fluid-tight seal against an outer surface of the catheter.

[0196] Example 33

[0197] The method of any one or more of Examples 24-32, further comprising positioning a distal portion of the catheter within the patient's cardiovascular anatomy.

[0198] Example 34

[0199] According to the apparatus of any one or more of embodiments 3 to 7, the sealing member includes an inner surface having a bell-curve shaped cross-sectional profile.

[0200] Example 35

[0201] According to the apparatus of any one or more of embodiments 3 to 7, the sealing member includes an inner surface having an arcuate cross-sectional profile.

[0202] Example 36

[0203] According to the apparatus of any one or more of embodiments 3 to 7, the sealing member has a corrugated configuration.

[0204] Example 37

[0205]

[00146] The apparatus of any one or more of Examples 1-36, further comprising a plurality of ribs extending outwardly from the cylindrical axis.

[0206] Example 38

[0207] According to the apparatus of embodiment 37, the ribs extend longitudinally along the cylindrical axis, and the ribs are angularly spaced from each other around the cylindrical axis.

[0208] Example 39

[0209] According to the apparatus of any one or more of embodiments 37-38, the ribs extend circumferentially around the cylindrical shaft, the ribs being longitudinally spaced apart from one another along the cylindrical shaft.

[0210] Example 40

[0211]

[00146] The apparatus of any one or more of embodiments 1-39 further comprising a plurality of external fins extending outwardly from the cylindrical axis, the external fins extending longitudinally along the cylindrical axis, the external fins being angularly spaced from one another about the cylindrical axis.

[0212] Example 41

[0213] The apparatus according to any one or more of Examples 1 to 39 further includes a plurality of internal fins extending inwardly within the lumen of the cylindrical shaft, the internal fins extending longitudinally along the lumen of the cylindrical shaft, and the internal fins being angularly spaced apart from each other around the lumen of the cylindrical shaft.

[0214] Example 42

[0215] According to Example 41, the device also includes a catheter disposed in the tubular cavity, the catheter being configured to fit within the cardiovascular anatomical structure, the catheter having a first longitudinal region and a second longitudinal region, the first longitudinal region having a first outer diameter, the second longitudinal region having a second outer diameter, the internal fins being configured to allow the cylindrical shaft to slide along the first longitudinal region of the catheter, and the internal fins being configured to resist sliding of the cylindrical shaft along the second longitudinal region of the catheter.

[0216] Example 43

[0217]

[00106] The apparatus of any one or more of Examples 1-42 further comprising an outward flare feature at the distal end of the cylindrical shaft, the outward flare feature defining an angled surface that opens into the lumen.

[0218] Example 44

[0219] According to the device described in any one or more of Examples 1 to 43, the cylindrical shaft includes a first segment and a second segment, the first segment having a convex engaging portion and the second segment having a concave engaging portion, the device also includes a deformable member captured between the convex engaging portion and the concave engaging portion, the first segment and the second segment can move relative to each other, thereby deforming the deformable member, the deformable member is configured to fix the position of the cylindrical tubular shaft to the catheter when in a deformed state, and the deformable member is configured to allow the cylindrical shaft to slide along the catheter when in an undeformed state.

[0220] X. Miscellaneous

[0221] Any of the instruments described herein can be cleaned and sterilized before and / or after the procedure. In one sterilization technique, the device is placed in a closed and sealed container such as a plastic bag or a TYVEK bag. The container and device can then be placed in a field of radiation that can penetrate the container, such as gamma radiation, x-rays, or high-energy electrons. The radiation can kill bacteria on the device and in the container. The sterilized device can then be stored in a sterile container for later use. Any other technique known in the art can also be used to sterilize the device, including but not limited to beta or gamma radiation, ethylene oxide, hydrogen peroxide, peracetic acid, and vapor phase sterilization (with or without gas plasma or steam).

[0222] It should be understood that any examples described herein may also include various other features in addition to or in place of those described above. By way of example only, any examples described herein may also include one or more of the various features disclosed in any one of the various references incorporated herein by reference.

[0223] It should be understood that any one or more of the teachings, expressions, embodiments, examples, etc. described herein may be combined with any one or more of the other teachings, expressions, embodiments, examples, etc. described herein. Therefore, the above teachings, expressions, embodiments, examples, etc. should not be considered in isolation from each other. Various suitable ways in which the teachings herein can be combined will be apparent to those skilled in the art with reference to the teachings herein. Such modifications and variations are intended to be included within the scope of the claims.

[0224] It should be understood that any patent, patent publication, or other public material, whether in whole or in part, allegedly incorporated herein by reference is incorporated herein only to the extent that the incorporated material does not conflict with existing definitions, statements, or other public materials set forth in this disclosure. Accordingly, and to the extent necessary, the disclosure expressly set forth herein supersedes any conflicting material incorporated herein by reference. Any material, or portion thereof, allegedly incorporated herein that conflicts with existing definitions, statements, or other public materials set forth herein will be incorporated only to the extent that no conflict arises between the incorporated material and the existing public materials.

[0225] While various versions of the present invention have been shown and described, further improvements to the methods and systems described herein may be achieved by appropriate modifications by those skilled in the art without departing from the scope of the invention. Several such possible modifications have been mentioned, and other modifications will be apparent to those skilled in the art. For example, the examples, versions, geometries, materials, dimensions, ratios, steps, etc. discussed above are exemplary and not required. Accordingly, the scope of the present invention should be considered in light of the following claims and should be understood not to be limited to the details of structure and operation shown and described in the specification and drawings.

Claims

1. An insert member, comprising: (a) a cylindrical shaft sized for insertion into an insertion port of a cardiovascular catheter introducer sheath, the cylindrical shaft comprising: (i) the proximal end, (ii) a distal end, and (iii) a lumen extending from the proximal end to the distal end, the lumen sized to receive an end effector and a catheter of a cardiovascular catheter device; and (b) an outward flare feature at the proximal end of the cylindrical shaft, the outward flare feature defining an angled surface that opens into the lumen, wherein the insert member further comprises a plurality of internal fins extending inwardly within the lumen of the cylindrical shaft, the internal fins extending longitudinally along the lumen of the cylindrical shaft, the internal fins being angularly spaced from one another around the lumen of the cylindrical shaft, and The insertion member also includes a catheter disposed in the lumen, the catheter configured to fit within a cardiovascular anatomical structure, the catheter having a first longitudinal region and a second longitudinal region, the first longitudinal region having a first outer diameter, the second longitudinal region having a second outer diameter, the internal fins configured to allow the cylindrical shaft to slide along the first longitudinal region of the catheter, and the internal fins configured to resist sliding of the cylindrical shaft along the second longitudinal region of the catheter. 2 . The insert member of claim 1 , said cylindrical shaft and said outward flare feature comprising a rigid material.

3. The insertion member of claim 1, further comprising a sealing member disposed in the lumen, the sealing member configured to form a fluid-tight seal against a catheter disposed in the lumen.

4. The insertion member of claim 3, the sealing member comprising a pair of inclined interior surfaces converging at a ridge, the ridge configured to engage a catheter disposed in the sealing member.

5. The insert member of claim 3, the sealing member comprising an inner surface having a bell-curve shaped cross-sectional profile.

6. The insert member of claim 3, the sealing member comprising an inner surface having an arcuate cross-sectional profile. The insert member of claim 3 , wherein the sealing member has a corrugated configuration.

8. The insert member of claim 1, further comprising a plurality of ribs extending outwardly from the cylindrical shaft.

9. The insert member of claim 8, the ribs extending longitudinally along the cylindrical shaft, the ribs being angularly spaced from one another about the cylindrical shaft.

10. The insert member of claim 8, the ribs extending circumferentially around the cylindrical shaft, the ribs being longitudinally spaced apart from one another along the cylindrical shaft.

11. The insert member of claim 1 further comprising a plurality of external fins extending outwardly from the cylindrical shaft, the external fins extending longitudinally along the cylindrical shaft, the external fins being angularly spaced from one another about the cylindrical shaft.

12. The insertion member of claim 1 further comprising an outward flare feature at the distal end of the cylindrical shaft, the outward flare feature defining an angled surface that opens into the lumen.

13. The insertion member of claim 1, further comprising a catheter disposed in the lumen, the catheter configured to fit within a cardiovascular anatomy.

14. The insertion member of claim 1 , further comprising a cardiovascular catheter guide sheath having an insertion port configured to receive the cylindrical shaft, the insertion port defining an opening having a seal positioned therein, the cylindrical shaft configured to pass through the seal, the insertion port and the outward flare feature configured to prevent the outward flare feature from passing through the insertion port.

15. An insertion member comprising: (a) a cylindrical shaft sized for insertion into an insertion port of a cardiovascular catheter introducer sheath, the cylindrical shaft comprising: (i) the proximal end, (ii) a distal end, and (iii) a lumen extending from the proximal end to the distal end, the lumen sized to receive an end effector and a catheter of a cardiovascular catheter device; and (b) an outward flare feature at the proximal end of the cylindrical shaft, the outward flare feature defining an angled surface that opens into the lumen, The cylindrical shaft includes a first section and a second section, the first section having a convex engagement portion, the second section having a concave engagement portion, the insertion member further comprising a deformable member captured between the convex engagement portion and the concave engagement portion, the first section and the second section being capable of moving relative to each other, thereby deforming the deformable member, the deformable member being configured to fix the position of the cylindrical shaft to the catheter in a deformed state, and the deformable member being configured to allow the cylindrical shaft to slide along the catheter in an undeformed state.

16. A catheter assembly comprising: (a) A catheter device, comprising: (i) a catheter having a distal end, and (ii) an end effector at the distal end of the catheter, the catheter and the end effector being sized to fit within cardiovascular anatomy, the end effector comprising at least one electrode; and (b) An insertion member according to any one of claims 1 to 15.

17. The catheter assembly of claim 16, further comprising a cardiovascular catheter introducing sheath comprising an insertion port configured to receive the cylindrical shaft and the catheter.

18. A method of assembling a catheter assembly, comprising: positioning an insertion member according to any one of claims 1 to 15 on a catheter; The catheter is sized for insertion into the cardiovascular anatomy.

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