CN117899334A - Catheterization tools - Google Patents

Abstract

A delivery sheath-catheter coupler includes a cylindrical shaft and a coupling member. A cylindrical shaft extends along an axis and is configured for longitudinal alignment with an insertion port of a catheter delivery sheath. The cylindrical shaft includes a proximal end, a distal end, and a lumen extending along an axis from the proximal end to the distal end. The lumen is sized to receive an end effector of a catheter. The coupling member is attached to the cylindrical shaft and is configured for selective fixation to the catheter delivery sheath. The coupling member is configured to align an axis of the lumen with a longitudinal axis of the insertion port when the coupling member is selectively secured to the catheter delivery sheath.

Description

Catheterization tools

CROSS-REFERENCE TO RELATED APPLICATIONS

This application claims priority to and the benefit of U.S. Provisional Patent Application No. 63/417,162 filed on October 18, 2022 and U.S. Provisional Patent Application No. 63/436,022 filed on December 29, 2022, the entire contents of both applications are incorporated herein by reference.

Background technique

Arrhythmias, such as atrial fibrillation, occur when an area of cardiac tissue abnormally conducts electrical signals. Procedures for treating arrhythmias include surgically interrupting the conduction pathways for such signals. By selectively applying electrical energy to cardiac tissue, it is possible to stop or alter the propagation of unwanted electrical signals from one part of the heart to another. Some such ablation treatments may include radiofrequency (RF) ablation using alternating current (AC) electrical energy; and/or irreversible electroporation (IRE) via pulsed field direct current (DC) electrical energy. The ablation process can provide a block to the unwanted electrical pathway by forming an electrically insulating lesion or scar tissue that effectively blocks the communication of abnormal electrical signals across the ablated tissue.

In some procedures, a catheter having one or more electrodes may be used to provide ablation in a patient. The catheter may 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 a structure adjacent to the heart (e.g., the pulmonary vein). One or more electrodes may be placed in contact with cardiac tissue or other vascular tissue and then activated with electrical energy to ablate the contacted tissue (e.g., via RF energy, IRE, etc.). In some cases, the electrodes may be bipolar. In some other cases, a monopolar electrode may be used in conjunction with a ground pad or other reference electrode in contact with the patient. Irrigation may be used to absorb heat from components of the ablation catheter; and to prevent the formation of blood clots near the tissue treatment site.

Examples of ablation catheters are described in the following: U.S. Publication No. 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 No. 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 No. 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 No. 2018/0071017, entitled “Catheter with Bipole Electrode Spacer and Related No. 2018/0056038, entitled “Methods”, the disclosure of which is incorporated herein by reference in its entirety; U.S. Patent No. 10,130,422, entitled “Catheter with SoftDistal Tip for Mapping and Ablating Tubular Region”, issued on November 20, 2018, the disclosure of which is incorporated herein by reference in its entirety; U.S. Patent No. 8,956,353, entitled “Electrode Irrigation Using Micro-Jets”, issued on February 17, 2015, the disclosure of which is incorporated herein by reference in its entirety; and U.S. Patent No. 9,801,585, entitled “Electrocardiogram Noise Reduction”, issued on October 31, 2017, the disclosure of which is incorporated herein by reference in its entirety.

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 conductive endocardial tissue to pinpoint 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 No. 9,907,480, entitled “Catheter Spine Assembly with Closely-Spaced Bipole Microelectrodes,” issued on March 6, 2018, the disclosure of which is incorporated herein by reference in its entirety; U.S. Patent No. 10,130,422, entitled “Catheter with Soft Distal Tip for Mapping and Ablating Tubular Region,” issued on November 20, 2018, the disclosure of which is incorporated herein by reference in its entirety; and U.S. Publication No. 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.

Some catheter ablation procedures can be performed using an image-guided surgery (IGS) system. An IGS system can enable a physician to visually track the position of a catheter in 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 on November 1, 2016, the disclosure of which is incorporated herein by reference in its entirety, and various other references cited herein.

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.

Summary of the invention

In some embodiments, a delivery sheath-catheter coupler includes a cylindrical shaft and a coupling member. The cylindrical shaft extends along an axis and is configured to be longitudinally aligned with an insertion port of a catheter delivery sheath. The cylindrical shaft includes a proximal end, a distal end, and a lumen extending from the proximal end to the distal end along the axis, and the lumen is sized to receive an end effector of the catheter. The coupling member is attached to the cylindrical shaft and is configured to be selectively fixed to the catheter delivery sheath. The coupling member is also configured to align the axis of the lumen with the longitudinal axis of the insertion port when the coupling member is selectively fixed to the catheter delivery sheath.

In some embodiments, the coupling member is fixedly attached to the cylindrical shaft.

In some embodiments, the coupling member is attached to the cylindrical shaft while also being movable relative to the cylindrical shaft.

In some embodiments, the coupling member is configured to translate relative to the cylindrical shaft along the axis of the lumen.

In some embodiments, the cylindrical shaft is sized for insertion into an insertion port of a catheter delivery sheath.

In some embodiments, the coupler further comprises an outward flare feature at one of the proximal end or the distal end of the cylindrical shaft.The outward flare feature defines an angled surface that opens into the lumen.

In some embodiments, an outward flare feature is disposed at the distal end of the cylindrical shaft and is configured to prevent insertion of the cylindrical shaft into an insertion port of a catheter delivery sheath.

In some embodiments, an outward flare feature is disposed at the proximal end of the cylindrical shaft and is configured to limit insertion of the cylindrical shaft into an insertion port of a catheter delivery sheath.

In some embodiments, the coupling member includes a vent opening for venting fluid from a space between the coupling member and the catheter delivery sheath when the coupling member is selectively secured to the catheter delivery sheath.

In some embodiments, the coupling member includes a cap.

In some embodiments, the coupling member is configured to threadably engage a catheter delivery sheath.

In some embodiments, the coupling member is configured to engage the catheter delivery sheath in a snap-fit manner.

In some embodiments, the coupling member is configured to engage the catheter delivery sheath in a bayonet-style manner.

In some embodiments, the coupler further comprises a catheter disposed in the lumen, and the catheter is configured to fit within the anatomical structure.

In some embodiments, the coupler further comprises a catheter delivery sheath having an insertion port configured to be longitudinally aligned with the cylindrical shaft. The insertion port defines a longitudinal axis, and the coupling member is configured to align the axis of the lumen with the longitudinal axis of the insertion port when the coupling member is selectively secured to the catheter delivery sheath.

In some embodiments, a kit includes a catheter apparatus and a coupler. The catheter apparatus includes: a catheter having a distal end; and an end effector at the distal end of the catheter. The catheter and the end effector are sized to fit in an anatomical structure, and the end effector includes at least one electrode. The coupler includes a cylindrical shaft and a coupling member. The cylindrical shaft includes a proximal end, a distal end, and a lumen extending along an axis from the proximal end to the distal end, the lumen being sized to receive the end effector and the catheter. The coupling member is attached to the cylindrical shaft.

In some embodiments, the kit also includes a catheter delivery sheath including an insertion port defining a longitudinal axis, and the coupling member is configured to be selectively secured to the catheter delivery sheath and to align the axis of the lumen with the longitudinal axis of the insertion port when the coupling member is selectively secured to the catheter delivery sheath.

In some embodiments, the coupling member is configured to engage the catheter delivery sheath in at least one of a threaded manner, a snap-fit manner, or a bayonet manner.

In some embodiments, a kit includes a catheter apparatus and a coupler. The catheter apparatus includes: a catheter having a distal end; and an end effector at the distal end of the catheter. The catheter and the end effector are sized to fit in an anatomical structure, and the end effector includes at least one electrode. The coupler includes a cylindrical shaft and a means for coupling. The cylindrical shaft includes a proximal end, a distal end, and a lumen extending along an axis from the proximal end to the distal end, the lumen being sized to receive the end effector and the catheter. The means for coupling is attached to the cylindrical shaft.

In some embodiments, the means for coupling comprises threads, snap-fit features, bayonet-fit features, or the functional equivalent of threads, snap-fit features, or bayonet-fit features.

In some embodiments, a method includes securing a coupler to a catheter delivery sheath, and the coupler includes a cylindrical shaft and a coupling member. The cylindrical shaft includes a proximal end, a distal end, and a lumen extending along an axis from the proximal end to the distal end, the lumen being sized to receive an end effector and a catheter of a catheter device. The coupling member is attached to the cylindrical shaft. The act of securing includes aligning the axis of the lumen with the longitudinal axis of an insertion port of the catheter delivery sheath.

In some embodiments, the act of securing includes providing at least one of a threaded engagement, a snap-fit engagement, or a bayonet engagement between the coupling member and the catheter delivery sheath.

In some embodiments, the lumen includes a frustoconical proximal portion.

In some embodiments, the frustoconical proximal portion extends distally from the proximal end.

In some embodiments, the frustoconical proximal portion tapers radially inward in a distal direction.

In some embodiments, the lumen includes a frustoconical proximal portion.

In some embodiments, the frustoconical proximal portion extends distally from the proximal end.

In some embodiments, the frustoconical proximal portion tapers radially inward in a distal direction.

In some embodiments, a delivery sheath-catheter coupler includes a cylindrical shaft and a cap. The cylindrical shaft extends along an axis and is configured to be longitudinally aligned with an insertion port of a catheter delivery sheath. The cylindrical shaft includes a proximal end, a distal end, and a lumen extending along the axis from the proximal end to the distal end, the lumen being sized to receive an end effector of the catheter, the lumen including a frustoconical proximal portion. The cap is attached to the distal end of the cylindrical shaft and is configured to be selectively aligned with the catheter delivery sheath and to align the axis of the lumen with the longitudinal axis of the insertion port when the coupling member is selectively aligned with the catheter delivery sheath.

In some embodiments, the cap is configured for selective securing to a catheter delivery sheath.

In some embodiments, the cap is fixedly attached to the distal end of the cylindrical shaft.

In some embodiments, the cap is attached to the distal end of the cylindrical shaft while also being movable relative to the cylindrical shaft.

In some embodiments, the cap is configured to translate relative to the cylindrical shaft along the axis of the lumen.

In some embodiments, the cap is configured to engage the catheter delivery sheath in at least one of a threaded manner, a snap fit manner, an interference fit manner, or a bayonet manner.

In some embodiments, the coupler further comprises a catheter disposed in the lumen, the catheter being configured to fit within the anatomical structure.

In some embodiments, the coupler further comprises a catheter delivery sheath having an insertion port configured to be longitudinally aligned with the cylindrical shaft. The insertion port defines a longitudinal axis, and the coupling member is configured to align the axis of the lumen with the longitudinal axis of the insertion port when the coupling member is aligned with the catheter delivery sheath.

BRIEF DESCRIPTION OF THE DRAWINGS

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.

FIG1 depicts a schematic diagram of a medical procedure for inserting a catheter of a catheter assembly into a patient;

FIG2 depicts a perspective view of the catheter assembly of FIG1 with the end effector in an expanded state;

FIG3 depicts a perspective view of an example of a delivery sheath that may be used with the catheter assembly of FIG1 ;

FIG. 4A depicts a perspective view of an example of an insertion member disposed on a distal portion of a catheter of the catheter assembly of FIG. 1 , wherein the insertion member and catheter are positioned for insertion into the proximal end of the delivery sheath of FIG. 3 ;

FIG. 4B depicts a perspective view of the insertion member of FIG. 4A disposed on the distal portion of the catheter of the catheter assembly of FIG. 1 , wherein the insertion member is being inserted into the proximal end of the delivery sheath of FIG. 3 , and the catheter has not yet been inserted into the proximal end of the delivery sheath;

Fig. 4C depicts a perspective view of the insertion member of Fig. 4A disposed on the distal portion of the catheter of the catheter assembly of Fig. 1 , wherein the insertion member and the catheter are both inserted into the proximal end of the delivery sheath of Fig. 3 ;

5 depicts an exploded perspective view of another example of an insertion member and another example of a handle assembly that may be used with the catheter assembly of FIG. 1 and the delivery sheath of FIG. 3 , the insertion member including a coupling member in the form of a threaded cap;

FIG. 6A depicts a perspective view of the insertion member of FIG. 5 positioned for coupling with the insertion port of the handle assembly of FIG. 5 ;

6B depicts a perspective view of the insertion member of FIG. 5 advanced distally to position a cap of the insertion member over the insertion port of the handle assembly of FIG. 5 ;

6C depicts a perspective view of the insertion member of FIG. 5 , the insertion member being rotated to threadably engage the threads of the cap with the threads of the insertion port of the handle assembly of FIG. 5 , thereby securing the insertion member to the handle assembly of FIG. 5 ;

6D depicts a perspective view of the insertion member of FIG. 5 secured to the handle assembly of FIG. 5 and guiding the insertion of the catheter assembly of FIG. 1 into the delivery sheath of FIG. 3 ;

FIG. 7 depicts an exploded perspective view of an example of an insertion member assembly and an example of a sheath seat that can be used with the catheter assembly of FIG. 1 and the delivery sheath of FIG. 3 , the insertion member assembly including a coupling member in the form of a cap having at least one L-shaped bayonet slot;

8A depicts a perspective view of the insertion member assembly of FIG. 7 positioned for coupling with a side port of the sheath hub of FIG. 7 ;

8B depicts a perspective view of the insertion member assembly of FIG. 7 , the insertion member assembly being advanced distally to position a cap of the insertion member assembly over at least the insertion port of the sheath hub of FIG. 7 ;

8C depicts a perspective view of the insertion member assembly of FIG. 7 , the insertion member assembly being rotated to engage the L-shaped bayonet slot of the cap with the side port of the sheath mount of FIG. 7 , thereby securing the insertion member assembly to the sheath mount;

8D depicts a perspective view of the insertion member assembly of FIG. 7 secured to the sheath hub of FIG. 7 and preventing the catheter assembly of FIG. 1 from being inserted into the delivery sheath of FIG. 3 ;

FIG. 9 depicts an exploded perspective view of another example of an insertion member assembly that may be used with the catheter assembly of FIG. 1 and the delivery sheath of FIG. 3 , the insertion member assembly including a coupling member in the form of a cap having at least one J-shaped bayonet slot;

10A depicts a perspective view of the insertion member assembly of FIG. 9 positioned for coupling with a side port of the sheath hub of FIG. 7 ;

10B depicts a perspective view of the insertion member assembly of FIG. 9 advanced distally to position a cap of the insertion member assembly over at least the insertion port of the sheath hub of FIG. 7 ;

10C depicts a perspective view of the insertion member assembly of FIG. 9 rotated to engage the J-shaped bayonet slot of the cap with the side port of the sheath seat of FIG. 7 , thereby securing the insertion member assembly to the sheath seat;

10D depicts a perspective view of the insertion member assembly of FIG. 9 secured to the sheath hub of FIG. 7 and preventing the catheter assembly of FIG. 1 from being inserted into the delivery sheath of FIG. 3 ;

FIG. 11 depicts a perspective view of another exemplary coupling member in the form of a cap for use with the insert member assembly of FIG. 9 , the cap having at least one angled bayonet slot;

FIG12 depicts a perspective view of another example of an insertion member assembly that may be used with the catheter assembly of FIG1 and the delivery sheath of FIG3, the insertion member assembly including a coupling member in the form of a cap having a cylindrical sidewall with at least one snap-fit slot;

13A depicts a perspective view of the insertion member assembly of FIG. 12 positioned for coupling with a side port of the sheath hub of FIG. 7 ;

13B depicts a perspective view of the insertion member assembly of FIG. 12 advanced distally to engage the snap-fit slot of the cap with the side port of the sheath hub of FIG. 7 , thereby securing the insertion member assembly to the sheath hub;

Fig. 13C depicts a perspective view of the insertion member assembly of Fig. 12 secured to the sheath hub of Fig. 7 and preventing the catheter assembly of Fig. 1 from being inserted into the delivery sheath of Fig. 3;

FIG14 depicts a perspective view of another example of an insertion member assembly that may be used with the catheter assembly of FIG1 and the delivery sheath of FIG3, the insertion member assembly including a coupling member in the form of a cap having a pair of side walls with corresponding snap-fit slots;

15 depicts a perspective view of another example of an end effector that may be incorporated into the catheter assembly of FIG. 1 , the end effector having an expandable basket configuration, showing the end effector in an expanded state;

16 depicts a cross-sectional side view of the hollow shaft of the delivery sheath of FIG. 3 , showing the end effector of FIG. 15 positioned within the hollow shaft and in a non-expanded state;

17 depicts an exploded perspective view of the handle assembly of FIG. 3 and another example of an insertion member that may be used with the catheter assembly of FIG. 1 and the end effector of FIG. 15 , the insertion member including a coupling member in the form of a cap;

FIG. 18A depicts a perspective view of the insertion member of FIG. 17 positioned for coupling with the insertion port of the handle assembly of FIG. 3 ;

18B depicts a perspective view of the insertion member of FIG. 17 advanced distally to position the cap of the insertion member on the insertion port of the handle assembly of FIG. 3 ; and

18C depicts a perspective view of the insertion member of FIG. 17 secured to the handle assembly of FIG. 3 and guiding insertion of the catheter assembly of FIG. 1 into the delivery sheath of FIG. 3 .

Detailed ways

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 (one of the best modes envisioned for implementing the present invention), other examples, features, aspects, embodiments and advantages of the present invention will become apparent to those skilled in the art. 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.

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 each other. 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 included within the scope of the claims.

As used herein, the term "about" or "approximately" for any numerical value or range indicates a suitable dimensional tolerance that allows a collection of parts or components to achieve its intended purpose as described herein. More specifically, "about" or "approximately" may refer to a range of ±20% of the value of the recited value, for example, "about 90%" may 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 system or method to human use, but the use of the subject invention in human patients represents a preferred embodiment.

I. Overview of Examples of Catheter Systems

FIG1 illustrates 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. Specifically, FIG1 illustrates a physician (PH) grasping a handle assembly (110) of a catheter assembly (100), wherein an end effector (140) of a catheter (120) (shown in FIG2 but not shown in FIG1) of the catheter assembly (100) is disposed within a patient (PA) to map electrical potentials in tissue and/or ablate tissue in or near the heart (H) of the patient (PA). As shown in FIG2 , the catheter assembly (100) includes a handle assembly (110), a catheter (120) extending distally from the handle assembly (110), an end effector (140) located at the distal end of the catheter (120), and a deflection drive actuator (114) associated with the handle assembly (110).

As will be described in greater detail below, the end effector (140) includes various components configured to deliver electrical energy (e.g., RF energy and/or pulsed field DC energy, etc.) 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), and/or disperse irrigation fluid. The deflection drive actuator (114) is rotatable relative to the housing (112) of the handle assembly (110) to deflect 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 may 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.

As shown in FIG. 2 , the catheter (120) includes an elongated flexible shaft, wherein an end effector (140) extends distally from the shaft. 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 guide 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 guide and drive system (10) via another cable (22). The field generators (20) are only optional.

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) can be operated to receive EP mapping signals obtained via electrodes of an end effector (140). The console (12) includes a processor (not shown) that processes such EP mapping signals and thereby provides EP mapping as known in the art. In some other versions, the end effector (140) includes other electrodes configured to provide EP mapping signals. In yet other versions, the end effector (140) does not provide EP mapping.

First driver module (14) of the present example may also be operable to provide electrical energy to electrodes of end effector (140), as will be described in greater detail below, to ablate tissue. In some other versions, end effector (140) includes other electrodes configured to provide ablation. In still other versions, end effector (140) does not provide ablation.

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).

The first driver module (14) is also operable to receive a position-indicating signal from a navigation sensor assembly (not shown) in the catheter (120) near the end effector (140). In this type of version, the processor of the console (12) is also operable to process the position-indicating signal from the navigation sensor assembly to determine the position of the end effector (140) in the patient (PA). In some versions, the navigation sensor assembly includes two or more coils that are operable to generate signals indicating the position and orientation of the end effector (140) in the patient (PA). The coils are configured to generate electrical signals in response to the presence of an alternating electromagnetic field generated by the field generator (20). Other components and techniques 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. Although the navigation sensor assembly is shown as being disposed in the distal end of the catheter (120), the navigation sensor assembly may alternatively be positioned in the end effector (140). Alternatively, catheter ( 120 ) and end effector ( 140 ) may be devoid of a navigation sensor assembly.

The display (18) is coupled to the processor of the console (12) and is operable to present an image of the patient's anatomical structure. Such images may be based on a set of images obtained before or during surgery (e.g., CT or MRI scans, 3D mapping maps, etc.). The view of the patient's anatomical structure provided by the display (18) may also be dynamically changed based on a signal from the navigation sensor assembly 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 may cause the processor of the console (12) to update the patient's anatomical structure view in the display (18) in real time to depict the patient's anatomical structure 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 location of abnormal 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, a processor of console (12) may drive display (18) to superimpose the locations of abnormal conductive tissue sites on an image of the patient's anatomy, such as by superimposing illuminated dots, crosshairs, or some other form of visual indication of abnormal conductive tissue sites.

The processor of the console (12) may 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, crosshairs, 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), such superimposed visual indications may 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) may effectively provide a video tracking the position of the end effector (140) within the patient (PA) without having to have any optical instrument (i.e., camera) to view the end effector (140). In the same view, the display (18) may 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).

The fluid source (42) of the present example comprises a bag containing saline or some other suitable flushing fluid. 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). Such flushing fluid may be discharged through an opening (not shown) of the end effector (140). Such flushing may be provided in any suitable manner that will be apparent to one of ordinary skill in the art in view of the teachings herein.

II. Examples of End Effectors

As described above, the end effector (140) includes various components that are configured to deliver electrical energy (e.g., RF energy and/or pulsed field DC energy, etc.) 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. However, it should be understood that the type of end effector (140) is merely an illustrative example. Various other types of end effectors may be used, including but not limited to end effectors having a spiral configuration, end effectors having a basket configuration, end effectors having a wireframe configuration, or end effectors having any other suitable configuration.

As shown in FIG. 2 , the end effector (140) of this example includes an expandable balloon (142) and a set of electrode assemblies (150) that are angularly spaced apart from each other around the balloon (142). The balloon (142) is operable to transition between a non-expanded state (not shown) and an expanded state (FIG. 2). The balloon (142) can be inflated with a flushing fluid (e.g., saline) from a fluid source (42), wherein a pump (44) provides pressure to the fluid to transition from the non-expanded state to the expanded state. In the non-expanded state, the balloon (142) can be fitted within a sheath, such as a delivery sheath (200) described below or a sheath that is an integral part of the catheter (120). In the expanded state, the size and configuration of the balloon (142) can be set to push the electrodes of the electrode assembly (150) into contact with tissue (e.g., the inner wall of a pulmonary vein or a chamber of the heart (H)). In this example, the balloon (142) is formed of a flexible but non-extensible material.

Each electrode assembly (150) of this example includes a flexible substrate and electrodes, which can be formed into a flexible circuit. The electrodes of this example are operable to ablate tissue in contact with the electrodes. The electrodes can be further constructed and operated according to at least some of the teachings of U.S. Publication No. 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 some versions, the electrodes are configured to provide both electrical energy (e.g., RF or IRE, etc.) ablation functionality and EP mapping functionality. In some other versions, the electrodes are configured to provide only electrical energy ablation functionality without providing EP mapping functionality. In still other versions, the electrodes are configured to provide only EP mapping functionality without providing electrical energy ablation functionality. As yet another merely illustrative example, the end effector (140) may include some electrodes dedicated to providing only electrical energy ablation functionality and other electrodes dedicated to providing only EP mapping functionality. With reference to the teachings herein, other suitable configurations and functions that may be associated with the electrodes will be apparent to those skilled in the art.

In addition to the foregoing, the end effector (140) and other aspects of the catheter assembly (100) may be constructed and operated in accordance with at least some of the teachings of the following documents: U.S. Publication No. 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; and/or U.S. Publication No. 2021/0322094, entitled "Pressure Relief Feature for Irrigated RF Balloon Catheter," published on October 21, 2021, the disclosure of which is incorporated herein by reference. Alternatively, the end effector (140) may have any other suitable components, features, and capabilities.

As indicated above, end effector (140) may have any other suitable type of expandable balloon configuration, any suitable type of expandable basket configuration, or any other suitable type of expandable configuration. In some versions, end effector (140) may be configured to define a spiral shape when in an expanded state. For example, end effector (140) may be constructed and operated in accordance with one or more teachings of U.S. Publication No. 2021/0085386, entitled “Catheter Instrument with Three Pull Wires,” published on March 25, 2021, the disclosure of which is incorporated herein by reference. In some other versions, end effector (140) may include a plurality of ring members including corresponding pairs of spines that are configured to open when in an expanded state. For example, end effector (140) may be constructed and operated in accordance with one or more teachings of U.S. Publication No. 2020/0345262, entitled “Mapping Grid with High Density Electrode Array,” published on November 5, 2021, the disclosure of which is incorporated herein by reference. Alternatively, end effector (140) may take any other suitable form.

III. Examples of Delivery Sheaths

In some procedures, the physician (PH) may desire to introduce the catheter (120) into the patient (PA) via a delivery sheath. In some such procedures, the delivery sheath may be inserted into the patient (PA) (e.g., via the patient's (PA) leg or groin); and then advanced along a vein or artery to reach a location in or near the heart (H). Once the delivery sheath is properly positioned in the patient (PA), the physician (PH) may then advance the end effector (140) and the catheter (120) into the delivery sheath. The end effector (140) may be in a non-expanded state during the transition from the insertion site to the target area in the patient (PA). Once the end effector (140) is properly positioned near the target structure, the delivery sheath may be retracted relative to the end effector (140) (or the end effector (140) may be advanced relative to the delivery sheath). The end effector (140) may then be expanded to the state shown in FIG. 2 by inflating the balloon (142) so that the electrode contacts the tissue of the target structure. Additionally or alternatively, one or more resilient features of the end effector (140) may urge the end effector (140) from a non-expanded state (not shown) to an expanded state (FIG. 2). Once the end effector (140) is in the expanded state, the physician (PH) 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). The end effector (140) may then be collapsed to a non-expanded configuration by deflation of the balloon (142) and/or otherwise contraction of the end effector (140) for retraction through the delivery sheath.

FIG3 shows an example of a delivery sheath (200) that can be used in such a procedure. The delivery 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 laterally deflect 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) to actuate 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.

As shown in FIG3 , the tube (202) extends laterally from the proximal end (218) of the handle assembly (210). The tube (202) of this example is in fluid communication with a hollow interior (not shown) defined within the handle assembly (210), wherein the hollow interior is in fluid communication with the interior of the hollow shaft (220). The tube (202) of this example is also in fluid communication with a fluid source (204). By way of example only, the fluid source (204) may include saline or any other suitable fluid. In some cases, fluid from the fluid source (204) is transmitted through the tube (202), the hollow interior region defined within the handle assembly (210), and the interior of the hollow shaft (220), thereby flushing the fluid path defined by the tube (202), the hollow interior region defined within the handle assembly (210), and the interior of the hollow shaft (220).

As shown in FIG3 , 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. In some versions, the interior of the hollow shaft (220) is sized to constrain the end effector (140) to a non-expanded state when the end effector (140) is positioned within the hollow shaft (220). 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.

Seal (260) is positioned within opening (254). By way of example only, seal (260) may include an elastomeric film 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., a catheter (120) or an 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 above-mentioned fluid path defined within handle assembly (210) via insertion port (250); and prevents air from entering the above-mentioned 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 above-mentioned fluid path defined within the handle assembly (210) via the insertion port (250); and preventing air from entering the above-mentioned 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, whether or not an instrument is disposed in the insertion port (250), the seal (260) can prevent fluid from leaking out through the insertion port (250) and prevent air from being drawn into the heart (H) of the patient (PA) via the insertion port (250).

In some versions, the delivery sheath (200) is a CARTO The invention is constructed and operated like a bidirectional delivery sheath.

IV. Example of a Cylindrical Insert Member with a Bell-mouth End

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 the end effector (140) and the catheter (120) are then advanced distally through the hollow interior of the cylindrical insertion member. The cylindrical insert may help provide the end effector (140) and the catheter (120) with initial penetration of the seal (260), which may otherwise be quite difficult for relatively small diameter end effectors (140) and catheters (120) and/or for flexible (e.g., expandable) end effectors (140). Such cylindrical insertion members may be shaped as a pure cylinder (e.g., a straight tube having uniform inner and outer diameters along its entire length). The catheter assembly (100) may be advanced distally to a point where the nozzle member (116) of the handle assembly (110) reaches the proximal end of the cylindrical insertion member. In such circumstances, the rigid proximal end of the cylindrical insertion member may 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 insertion member may cause a kink to form at the proximal end of the catheter (120). Therefore, it may be desirable to provide a certain type of insertion member that eliminates or otherwise reduces the risk of strain or kinking occurring in the catheter (120) at the proximal end of the insertion member.

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 the size of the catheter (120) and cylindrical insertion member used by the physician (PH) is smaller (e.g., 8 French) than the size of the catheter and cylindrical insertion member intended for use with the delivery 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 delivery 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 portions of the insertion port (250).

4A to 4C show examples of insertion members (300) that can be used to help insert an end effector (140) and a catheter (120) through an insertion port (250) of a delivery sheath (200). 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 (not shown), which terminates at the flared proximal portion (304) proximally and terminates at the distal end (310) of the insertion member (300) distally. The proximal portion (304) has a truncated cone shape leading to the lumen and defines the proximal end (312) of the insertion member (300). Therefore, the proximal portion (304) tapers inwardly toward the central longitudinal axis (LA) of the insertion member (300) in the proximal to distal direction. In this example, the insertion member (300) is substantially rigid.

The insertion member (300) is configured to receive the end effector (140) and the catheter (120) when the end effector (140) is in a non-expanded state, as shown in FIG. 4A. The lumen may be sized to closely complement the outer diameter of the catheter (120) while allowing the catheter (120) to slide freely through the insertion member (300). In some versions, the lumen is sized to constrain the end effector (140) to a non-expanded state when the end effector (140) is positioned within the lumen. The frustoconical shape of the proximal portion (304) may provide an introduction end that further aids in inserting the end effector (140) and the catheter (120) into the proximal end (312) of the insertion member (300). The length of the insertion member (300) may be substantially less than the length of the catheter (120) such that the end actuator (140) may protrude distally beyond the distal end (310) of the insertion member (300) while the insertion member (300) is disposed around the catheter (120).

In an example using an insertion member (300), the insertion member (300) may first be partially disposed around the distal end of the end effector (140) and the catheter (120), as shown in FIG. 4A. The combination of the insertion member (300), the end effector (140) and the catheter (120) may be positioned for insertion into the insertion port (250). Thus, the longitudinal axis (LA) of the catheter (120) may be aligned with the longitudinal axis (LA) of the delivery 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). As described above, at this stage, the end effector (140) may be constrained by the lumen to a non-expanded state.

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) so that the distal end (310) of the insertion member (300) penetrates the seal (260) at the slit arrangement (262), as shown in FIG. 4B. 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 so that the end effector (140) is advanced distally beyond the distal end (310) of the insertion member (300), as shown in FIG. 4C. As the catheter (120) is advanced, the end effector (140) and the catheter (120) pass distally through the interior of the shaft (220). At this stage, the end effector (140) may be constrained to a non-expanded state by 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). At this stage, the end effector (140) may no longer be constrained to a non-expanded state, such that the end effector (140) may selectively transition to an expanded state. In some versions of the procedure, after reaching the state shown in FIG. 4C , as the physician (PH) continues to advance the catheter (120) distally, 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 advanced distally into the delivery sheath (200), the distal end (310) of the insertion member (300) may be proximal to the insertion port (250).

In some scenarios, during normal operation of the catheter assembly (100) and delivery 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), delivery sheath (200), and insertion member (300) may 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).

As the physician (PH) 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). 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). Thus, 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).

While in the foregoing 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 member (300) from being inserted through insertion port (250).

In addition to preventing the insertion member (300) from being inserted distally 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).

In some variations of the above-described procedures, the insertion member (300) is inserted into the insertion port (250) prior to inserting the end effector (140) and the catheter (120) into the insertion member (300). In other words, upon 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 procedures, the insertion member (300) is first fully inserted into the insertion port (250) prior to inserting the end effector (140) and the catheter (120) into the insertion member (300), up to the point where the flared proximal portion (304) of the insertion member (300) engages the annular protrusion (252) of the insertion port (250).

V. Examples of Insertion Devices Having Coupling Members

In some scenarios, it may be desirable to secure an insertion device, such as an insertion member (300), to a sheath handle assembly, such as the handle assembly (210), wherein the longitudinal axis of the insertion member (300) is aligned with the longitudinal axis of the insertion port (250) and, therefore, with the longitudinal axis (LA) of the delivery sheath (200), such as to center the distal end of the catheter (120) relative to the slit arrangement (262) of the seal (260) as the catheter (120) is advanced through the insertion member (300), and/or to orient the longitudinal axis of the catheter (120) orthogonally relative to a plane defined by the seal (260) as the catheter (120) is advanced through the insertion member (300). Such securing of the insertion member (300) to the handle assembly (210) may facilitate insertion of the distal end of the catheter (120) through the seal (260) at a desired position and orientation relative to the seal (260), which may minimize the amount of force required to push the distal end of the catheter (120) through the seal (260) and inhibit damage to the seal (260) and/or the distal end of the catheter (120) including the end effector (140). Additionally or alternatively, such securing of the insertion member (300) to the handle assembly (210) may allow a physician (PH) or other operator to release the insertion member (300) after securing the insertion member (300) to the handle assembly (210), thereby enabling the operator to hold the handle assembly (210) in one of the operator's hands (e.g., without having to simultaneously hold the insertion member (300) with that hand) while inserting the catheter (120) through the seal (260) with the operator's other hand. With reference to the foregoing, it may be desirable to add a coupling member to insertion member (300) to facilitate such securing of insertion member (300) to handle assembly (210). Examples of various forms such a coupling member may take are described in greater detail below.

Although the examples described below are provided in the context of a catheter (120) being inserted through a seal (260) and into a delivery sheath (200), the teachings herein may be readily applied to other contexts, such as those in which some other type of instrument (e.g., a dilator, another non-catheter instrument, etc.) is inserted into a delivery sheath (200).

A. Example of a Cylindrical Insertion Member with a Threaded Distal Cap Portion

5 to 6D show the proximal portion of another example of a handle assembly (400) that can be incorporated into a delivery sheath (200) in place of the handle assembly (300), and an example of an insertion member (402) that can be selectively fixed to the handle assembly (400) and used in a manner similar to that described above for the insertion member (210). The handle assembly (400) and the insertion member (402) are similar to the handle assembly (210) and the insertion member (300) described above, respectively, except that the differences are described in addition below. The handle assembly (400) of this example is configured to be grasped by a housing (410) and includes a proximal end (412) and a distal end (not shown). The proximal end (412) has an insertion port (414) that defines a longitudinal axis (LA) and includes an annular protrusion (416) that defines an opening (418) and protrudes proximally from the housing (410) at the proximal end (412). Seal (420) is positioned within opening (418) and includes a slit arrangement (422) configured to facilitate insertion of an instrument (e.g., catheter (120), etc.) through seal (420). In the present example, slit arrangement (422) is in the form of a "+" sign, but any other suitable type of configuration may be used.

As shown, the insertion port (414) further includes threads in the form of a spiral ridge (430) extending radially outward from the generally cylindrical outer surface of the annular protrusion (416) for threadingly engaging a corresponding portion of the insertion member (402), as described in more detail below. In some versions, the ridge (430) can also be configured to threadingly engage a corresponding portion of a balloon dilation catheter assembly (not shown), such as the dilator cap of the HELIOSTAR ^™ balloon ablation catheter of Biosense Webster, Inc., Irvine, California. In this regard, the handle assembly (400) can be configured similarly to the handle assembly of the GUIDESTAR ^™ introducer sheath of Biosense Webster, Inc., Irvine, California.

The insertion member (402) of this example includes a tube (450) extending longitudinally between a proximal end (452) and a distal end (454). The tube (450) has a cylindrical main portion (456) and a flared distal portion (458). The main portion (456) is in the form of a right cylindrical body, while the distal portion (458) has a truncated conical shape, such that the distal portion (458) tapers radially outward from the main portion (456) of the tube (450) to the distal end (454). The main portion (456) and the distal portion (458) together define a lumen (460) that extends longitudinally between the proximal and distal ends (452, 454) of the tube (450) and is sized to closely complement the outer diameter of the catheter (120) while allowing the catheter (120) to slide freely through the tube (450). Lumen (460) may be sized to constrain end effector (140) to a non-expanded state when end effector (140) is positioned within lumen (460). In the present example, tube (450) is substantially rigid. In some variations, both proximal end (452) and distal portion (458) are flared. In some other variations, proximal end (452) is flared, but distal portion (458) is not flared.

The insertion member (402) of the present example also includes a coupling member in the form of a distal cap (470) disposed coaxially with the tube (450). The cap (470) includes a generally flat and/or domed proximal end wall (472) and a generally annular distal sidewall (474) that extends radially outward relative to the main portion (456) of the tube (450) at or near the interface between the main portion and the distal portion (456, 458), such as at a position slightly proximal to the distal portion (458). In the example shown, the side wall (474) of the cap (470) extends circumferentially around the distal portion (458) such that the generally cylindrical inner surface of the side wall (474) faces the generally frustoconical outer surface of the distal portion (458), and the clearance gap between the generally cylindrical inner surface of the side wall (474) and the generally frustoconical outer surface of the distal portion (458) is large enough to receive the annular protrusion (416) of the insertion port (414).

The cap (470) of the present example also includes threads in the form of a spiral groove (480) extending radially outward from the generally cylindrical inner surface of the sidewall (474) for threaded engagement with the ridge (430) of the insertion port (414). The groove (480) may extend along a spiral path similar to the spiral path of the ridge (430) to facilitate threaded engagement between the groove (480) and the ridge (430). It should be understood that the threads of the insertion port (414) and the cap (470) may be of any suitable form for threaded engagement with each other and are not limited to the particular configuration of the ridge (430) and groove (480) shown. For example, while in the present version the ridge (430) is disposed on the insertion port (414) and the groove (480) is disposed on the cap (470), in some other versions the ridge (430) may be disposed on the cap (470) and the groove (480) may be disposed on the insertion port (414).

The threaded engagement between the ridge (430) and the groove (480) can facilitate secure coupling of the insertion member (402) to the handle assembly (400), wherein the longitudinal axis of the insertion member (402) (and more specifically, the longitudinal axis of the lumen (460)) is aligned with the longitudinal axis (LA) of the insertion port (414). In this manner, when the insertion member (402) is secured to the handle assembly (400), the lumen (460) can be centered relative to the slit arrangement (422) of the seal (420) and can be oriented orthogonally relative to a plane defined by the seal (420). In some versions, the distal end (454) of the tube (450) can be configured to abut a proximal surface of the seal (420) when the insertion member (402) is secured to the handle assembly (400). In this regard, the flared configuration of the distal portion (458) of the tube (450) may allow the distal end (454) to enter the opening (418) of the annular protrusion (416) of the insertion port (414); but may prevent the distal end (454) from being inserted through the seal (420). For example, the outer diameter of the distal portion (458) may be selected to allow the distal end (454) to enter the opening (418) of the annular protrusion (416) of the insertion port (414) if the delivery sheath (200) is configured for use with a catheter (120) having a size of, for example, about 13.5 French to about 14 French on the French catheter scale. In some other versions, the flared configuration of the distal portion (458) of the tube (450) may prevent the distal end (454) from being inserted into the insertion port (414).

In the example shown, the side wall (474) of the cap (470) also includes a plurality of flat outer surfaces (490) configured to be gripped by a physician (PH) or other operator to assist the operator in rotating the cap (470) relative to the handle assembly (400) to threadably engage and/or disengage the groove (480) from the ridge (430). The cap (470) of this example also includes at least one vent or bleed hole (492) extending through the end wall (472) for discharging fluid (e.g., air) from a space between a distal surface of the end wall (472) of the cap (470) and the handle assembly (400) to the exterior of the cap (470) when the cap (470) is secured to the handle assembly (400).

Insertion member (402) can be made of any suitable translucent (e.g., transparent) or opaque material, such as a polymeric material (e.g., plastic) or a metallic material. With reference to the teachings herein, other suitable materials that can be used to form insertion member (402) will be apparent to those skilled in the art. In the example shown, tube (450) and cap (470) are integrally formed with each other as a whole (e.g., a single) piece to define insertion member (402). In this regard, insertion member (402) can be manufactured via 3D printing, injection molding, investment casting, machining and/or any other suitable manufacturing technology. In other embodiments, tube (450) and cap (470) are independently formed as discrete parts and coupled to each other to define insertion member (402), so that insertion member (402) can be referred to as an assembly. It should be understood that tube (450) and cap (470) can be made of the same or different materials. While tube (450) of the present example is secured against movement relative to cap (470), tube (450) may alternatively be movable relative to cap (470). For example, tube (450) may be slidably coupled to cap (470) to facilitate longitudinal sliding of tube (450) relative to cap (470), such as in a manner similar to any of those described below in conjunction with FIGS. 7-14 .

Although the distal portion (458) of the tube (450) is flared in the present example, the distal portion (458) may alternatively be cylindrical. For example, the distal portion (458) may be in the form of a right cylindrical body having inner and outer dimensions similar to those of the main portion (456). Such a configuration of the distal portion (458) may allow the distal end (454) to be inserted through the seal (420) in a manner similar to any of those described above in conjunction with FIGS. 4A to 4C and/or described below in conjunction with FIGS. 7 to 14. In some such cases, the tube (450) may include a flared proximal portion (not shown) having a truncated conical shape such that the proximal portion tapers radially outward from the main portion (456) of the tube (450) to the proximal end (452), and the flared proximal portion cooperates with the main portion (456) to define a lumen (460). Such a flared proximal portion may provide a lead-in for aiding in inserting end effector (140) and catheter (120) into proximal end (452) of tube (450). In some other versions, tube (450) may include both a flared distal portion (458) and such a flared proximal portion.

Although not shown, the insert member (402) may include any one or more of a sealing member, an enhanced structural support feature (such as a rib), a torque drive feature (such as an external fin), and/or a catheter gripping feature (such as an internal fin). By way of example only, the insert member (402) may be constructed and operated in accordance with at least some of the teachings of U.S. Publication No. 2021/0113812, entitled “Flared Insert Member for Use with Catheter Assembly,” published on April 22, 2021, the disclosure of which is incorporated herein by reference in its entirety.

In an example using an insertion member (402), the longitudinal axis (LA) of the insertion member (402) can be aligned with the longitudinal axis (LA) of the insertion port (414), as shown in FIG6A. Next, the physician (PH) can advance the insertion member (402) distally toward the insertion port (414) so that the annular protrusion (416) of the insertion port (414) is at least partially received between the generally cylindrical inner surface of the side wall (474) of the cap (470) and the generally frustoconical outer surface of the distal portion (458) of the tube (450), as shown in FIG6B. The physician (PH) can then rotate the cap (470) relative to the handle assembly (400) to threadably engage the groove (480) of the cap (470) with the ridge (430) of the insertion port (414) and thereby secure the insertion member (402) to the handle assembly (400), as shown in FIG6C.

When the insertion member (402) is in the secured state shown in FIG. 6C , the longitudinal axis of the lumen (460) is aligned with the longitudinal axis (LA) of the insertion port (414), such that the lumen (460) is centered relative to the slit arrangement (422) of the seal (420) and is oriented orthogonally relative to the plane defined by the seal (420), and the distal end (454) of the tube (450) abuts the proximal surface of the seal (420). It should be understood that the seal (420) can remain unpenetrated during the securing of the insertion member (402) to the handle assembly (400), such that the securing of the insertion member (402) to the handle assembly (400) can be performed prior to inserting the end effector (140) and the catheter (120) into the insertion member (402). Once the insertion member (402) has been secured to the handle assembly (400), the catheter (120) is slid through the lumen (460) of the insertion member (402) and advanced distally beyond the distal end (454) to penetrate the seal (420) at the slit arrangement (422) so that the end effector (140) and the catheter (120) can be passed distally through the interior of the shaft (220), as shown in FIG6D. The end effector (140) eventually reaches a point where the end effector (140) is distal to the distal end (240) of the shaft (220), so that the end effector (140) can be selectively transitioned to an expanded state.

B. Example of an Insertion Member Assembly Having a Distal Cap with an L-Shaped Bayonet Slot

Fig. 7 to Fig. 8D show the example of sheath seat (500) for another handle assembly in delivery sheath (200) that can replace handle assembly (210), and the example of insertion member assembly (502) that can be selectively fixed to sheath seat (500) and used in a similar manner to the above-mentioned mode for insertion member (300).Sheath seat (500) can be incorporated into a handle assembly similar to handle assembly (210), and insertion member assembly (502) is similar to the above-mentioned insertion member (402), and the difference is as described in addition below.Specifically, sheath seat (500) can extend vertically from handle assembly and can be rigidly fixed relative to the shell of handle assembly, thereby providing mechanical basis for insertion member assembly (502) relative to the handle assembly of delivery sheath.The sheath seat (500) of this example has a main body (510), which is configured to be coupled to a housing (not shown) similar to housing (410) and includes a proximal end (512) and a distal end (513). The proximal end (512) has an insertion port (514) that defines a longitudinal axis (LA) and includes an annular projection (516) that defines an opening (518) and projects proximally from the body (510) at the proximal end (512). A seal (520) is positioned within the opening (518) and includes a slit arrangement (522) that is configured to facilitate insertion of an instrument (e.g., a catheter (120), etc.) through the seal (520). In this example, the slit arrangement (522) is in the form of an "*" symbol, but any other suitable type of configuration may be used.

As shown, the sheath seat (500) also includes a projection in the form of a side port (530), which extends radially outward from the main body (510) near the proximal end (512) for engaging the corresponding portion of the insertion member assembly (502), as described in more detail below. In the example shown, the sheath seat (500) also includes an elongated tab (532) extending radially outward from the main body (510) between the side port (530) and the proximal end (512). In some versions, the side port (530) can be configured to selectively couple with a fluid source (not shown). Such a fluid source can include saline, fluoroscopic contrast fluid and/or any other suitable type of fluid. Fluid from the fluid source can reach the hollow shaft (220) via the side port (530); and finally can be discharged from the open distal end (240) of the hollow shaft (220). By way of further example only, the sheath holder (500) may be configured similarly to the CARTO Sheath seat for the introducer sheath.

The insertion member assembly (502) of this example includes a tube (550) extending longitudinally between a proximal end (552) and a distal end (554). The tube (550) has a flared proximal portion (555) and a cylindrical main portion (556). The main portion (556) is in the form of a right cylindrical body, while the proximal portion (555) has a truncated cone shape, such that the proximal portion (555) tapers radially outward from the main portion (556) of the tube (550) to the proximal end (552). The main portion (556) and the proximal portion (555) together define a lumen (560) that extends longitudinally between the proximal and distal ends (552, 554) of the tube (550) and is sized to closely complement the outer diameter of the catheter (120) while allowing the catheter (120) to slide freely through the tube (550). The lumen (560) may be sized to constrain the end effector (140) to a non-expanded state when the end effector (140) is positioned within the lumen (560). In the present example, the tube (550) is substantially rigid. In some versions, the rigidity of the tube (550) may be enhanced by providing a thickened sidewall, as indicated by the dashed line (557) in FIG. 7 . In some variations, both the proximal end (552) and the distal end (554) are flared. In some other variations, the distal end (554) is flared, but the proximal end (552) is not flared. The proximal end (552) and/or the distal end (554) may still provide a conical lead-in/lead-out end in a version in which the tube has a thickened sidewall as indicated by the dashed line (557).

The insertion member assembly (502) of the present example also includes a coupling member in the form of a distal cap (570) that is coaxially arranged with the tube (550). The cap (570) includes a generally flat proximal end wall (572) and a generally cylindrical distal side wall (574), the generally flat proximal end wall extending radially outward relative to the main portion (556) of the tube (550). In the example shown, the cap (570) includes a central bore (576) that extends longitudinally through the end wall (572) and is configured to slidably receive the main portion (556) of the tube (550) so that the tube (550) can slide longitudinally relative to the cap (570). For example, the tube (550) can be configured to slide longitudinally relative to the cap (570) between a first position, in which the cap (570) is located at or near the distal end (554) of the tube (550), and a second position, in which the cap (570) is engaged with the proximal portion (555) of the tube (550), as described in more detail below. In this regard, the outer diameter of the main portion (556) of the tube (550) can be at least slightly smaller than the diameter of the central bore (576) to allow such longitudinal sliding, while the outer diameter of the proximal portion (555) of the tube (550) can be larger than the diameter of the central bore (576). In some versions, a gasket (not shown) can be disposed between the central bore (576) and the main portion (556) of the tube (550) for providing a fluid-tight seal therebetween while allowing such longitudinal sliding. Additionally or alternatively, a keyway (not shown) may extend radially outward from the central bore (576) for receiving a corresponding key (not shown) extending radially outward from the main portion (556) of the tube (550) to secure the tube (550) and the cap (570) from rotation relative to each other about the longitudinal axis of the insertion member assembly (502) while allowing such longitudinal sliding. In yet other variations, the tube (550) is rigidly fixed relative to the cap (570) such that the tube (550) cannot slide relative to the cap (570).

In the example shown, the side wall (574) of the cap (570) extends circumferentially around the area of the main portion (556) so that the generally cylindrical inner surface of the side wall (574) faces the generally cylindrical outer surface of the main portion (556), and the clearance gap between the generally cylindrical inner surface of the side wall (574) and the generally cylindrical outer surface of the main portion (556) is large enough to receive the body (510) of the sheath seat (500). In this regard, the generally cylindrical inner surface of the side wall (574) can be sized to closely complement the outer diameter of the body (510) of the sheath seat (500) while allowing the body (510) of the sheath seat (500) to be selectively inserted into and removed from the interior of the cap (570).

The cap (570) of the present example also includes a bayonet feature in the form of a generally L-shaped slot (580) extending radially outward from the generally cylindrical inner surface of the side wall (574) to the generally cylindrical outer surface of the side wall (574) for engaging the side port (530) of the sheath seat (500) in a bayonet manner. Although a single slot (580) is shown, other versions may include any other suitable number of slots (580), such as to allow selection of a particular slot (580) to engage the side port (530). In the example shown, the slot (580) includes a straight distal entrance passage portion (582) extending proximally from the distal end of the cap (570) and an end-enclosed proximal locking portion (584) extending orthogonally (e.g., at about 90°) from the entrance passage portion (582) (e.g., in a clockwise direction within the reference frame of FIG. 7) for facilitating the bayonet engagement between the slot (580) and the side port (530). For example, the entrance channel portion (582) may be configured to receive the side port (530) and be guided along it until the side port (530) reaches the proximal end of the entrance channel portion (582); and the locking portion (584) may be configured to subsequently receive the side port (530) and be guided along it until the side port (530) is sufficiently captured within the locking portion (584) to inhibit longitudinal movement of the cap (570) and the sheath seat (500) relative to each other (for example, to inhibit proximal translation of the cap (570) relative to the sheath seat (500)) in the absence of an accompanying rotational force applied between the cap (570) and the sheath seat (500).

It should be understood that the bayonet features of the sheath mount (500) and the cap (570) may be of any suitable form for engaging one another in a bayonet-like manner and are not limited to the particular configuration of the side port (530) and the slot (580) shown. For example, while in the present version the side port (530) is configured to engage the slot (580) in a bayonet-like manner, in some other versions the sheath mount (500) may include a separate protrusion extending radially outward from the body (510) and configured to engage the slot (580) in a bayonet-like manner.

The bayonet engagement between the side port (530) or any other such protrusion and the slot (580) can facilitate secure coupling of the cap (570) to the sheath seat (500), wherein the longitudinal axis of the insertion member assembly (502) (and more specifically, the longitudinal axis of the lumen (560)) is aligned with the longitudinal axis (LA) of the insertion port (514). In this manner, when the cap (570) is secured to the sheath seat (500), the lumen (560) can be centered relative to the slit arrangement (522) of the seal (520) and can be oriented orthogonally relative to the plane defined by the seal (520). In some versions, the distal end (554) of the tube (550) can be configured to be inserted through the seal (520) when the cap (570) is secured to the sheath seat (500). In this regard, the cylindrical configuration of the main portion (556) of the tube (550) may allow the distal end (554) to be inserted through the seal (520), and the slidable coupling of the main portion (556) of the tube (550) with the cap (570) may allow such insertion of the distal end (554) through the seal (520) to be performed while the cap (570) remains secured to the sheath adapter (500). Additionally or alternatively, the flared configuration of the proximal portion (555) of the tube (550) may provide a lead-in for aiding in inserting the end effector (140) and catheter (120) into the proximal end (552) of the tube (550), and/or the flared configuration may enable the proximal portion (555) to engage the proximal surface of the end wall (572) of the cap (570) and thereby limit distal advancement of the tube (550) into the insertion port (514). Although not shown, the cap (570) may also include at least one exhaust hole or bleed hole extending through the end wall (572), which is used to exhaust fluid (e.g., air) from the space between the distal surface of the end wall (572) of the cap (570) and the sheath seat (500) to the outside of the cap (570) when the cap (570) is secured to the sheath seat (500).

The tube (550) and the cap (570) of the insert member assembly (502) can each be made of any suitable translucent (e.g., transparent) or opaque material, such as a polymeric material (e.g., plastic) or a metallic material. With reference to the teachings herein, other suitable materials that can be used to form the tube (550) and the cap (570) of the insert member assembly (502) will be apparent to those skilled in the art. In the example shown, the tube (550) and the cap (570) are independently formed as discrete parts and coupled to each other via a central bore (576) to define the insert member assembly (502). In this regard, the tube (550) and the cap (570) can each be manufactured via 3D printing, injection molding, investment casting, machining and/or any other suitable manufacturing technology. Although the tube (550) of this example can move relative to the cap (570), the tube (550) can alternatively be fixed to prevent movement relative to the cap (570). For example, the distal end (554) of the tube (550) may be configured to abut the proximal surface of the seal (520) when the cap (570) is secured to the sheath seat (500), such as in a manner similar to that described above in conjunction with Figures 5-6D.

Although the proximal portion (555) of the tube (550) is flared in the present example, the proximal portion (555) may alternatively be cylindrical. For example, the proximal portion (555) may be in the form of a right cylindrical body having inner and outer dimensions similar to the inner and outer dimensions of the main portion (556). In some such cases, the tube (550) may include a flared distal portion (not shown) having a truncated conical shape such that the distal portion tapers radially outward from the main portion (556) of the tube (550) to the distal end (554), and the flared distal portion cooperates with the main portion (556) to define a lumen (560). Such a flared distal portion may allow the distal end (554) to enter the opening (518) of the annular protrusion (516) of the insertion port (514); but may prevent the distal end (554) from being inserted through the seal (520). Alternatively, such a flared distal portion may prevent distal end (554) from being inserted into insertion port (514).In some other versions, tube (550) may include both a flared proximal portion (555) and such a flared distal portion.

Although not shown, the tube (550) of the insert member assembly (502) may include any one or more of a sealing member, an enhanced structural support feature (such as a rib), a torque drive feature (such as an external fin), and/or a catheter gripping feature (such as an internal fin). By way of example only, the tube (550) of the insert member assembly (502) may be constructed and operated in accordance with at least some of the teachings of U.S. Patent Publication No. 2021/0113812, entitled “Flared Insert Member for Use with Catheter Assembly,” published on April 22, 2021, the disclosure of which is incorporated herein by reference in its entirety.

In an example using an insertion member assembly (502), the longitudinal axis (LA) of the insertion member assembly (502) can be aligned with the longitudinal axis (LA) of the insertion port (514), and the entrance channel portion (582) of the slot (580) can be aligned with the side port (530), as shown in FIG8A. Next, the physician (PH) can advance the insertion member assembly (502) distally toward the insertion port (514) so that the body (510) of the sheath seat (500) is at least partially received between the generally cylindrical inner surface of the side wall (574) of the cap (570) and the generally cylindrical outer surface of the main portion (556) of the tube (550), and so that the side port (530) of the sheath seat (500) is at least partially received within the entrance channel portion (582) of the slot (580), as shown in FIG8B. The physician (PH) can then rotate the cap (570) relative to the sheath seat (500) to engage the slot (580) of the cap (570) with the side port (530) of the sheath seat (500) in a bayonet manner by capturing the side port (530) within the locking portion (584) of the slot (580), and thereby secure the cap (570) to the sheath seat (500), as shown in FIG. 8C.

When the cap (570) is in the fixed state shown in FIG8C, the longitudinal axis of the lumen (560) is aligned with the longitudinal axis (LA) of the insertion port (514), so that the lumen (560) is centered relative to the slit arrangement (522) of the seal (520) and is oriented orthogonally relative to the plane defined by the seal (520). When the cap (570) is initially placed in the fixed state, the distal end (554) of the tube (550) can abut the proximal surface of the seal (520) or be positioned proximal thereto so that the seal (520) can remain unpierced during the fixing of the cap (570) to the sheath seat (500), so that the fixing of the cap (570) to the sheath seat (500) can be performed before the end effector (140) and the catheter (120) are inserted into the insertion member assembly (502). Once the cap (570) has been secured to the sheath seat (500), the catheter (120) can be slid through the lumen (560) of the insertion member assembly (502) and the catheter (120) and/or tube (550) can be advanced distally so that the end actuator (140) and/or the distal end (554) penetrate the seal (520) at the slit arrangement structure (522) in a manner similar to that described above in conjunction with Figures 4A to 4C.

As the physician (PH) 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 assembly (502), the flared proximal portion (555) of the tube (550) may eventually engage the end wall (572) of the cap (570), as shown in FIG8D . As described above, while the outer diameter of the cylindrical main portion (556) of the tube (550) is at least slightly smaller than the diameter of the central bore (576), the outer diameter of the flared proximal portion (555) of the tube (550) is greater than the diameter of the central bore (576). Thus, the flared proximal portion (555) of the tube (550) will engage the periphery of the central bore (576), and this interaction between the flared proximal portion (555) of the tube (550) and the periphery of the central bore (576) will inhibit the tube (550) and thereby prevent the tube (550) from being further advanced distally into the insertion port (514).

Although the tube (550) is shown in FIGS. 8C to 8D as being slidable relative to the cap (570), some variations may provide a fixed relationship between the tube (550) and the cap (570) such that the tube (550) need not be slidable relative to the cap (570) in all versions. For example, the tube (550) and the cap (570) may be formed integrally with each other as a unitary (e.g., single) piece to define the insert member assembly (502). In this regard, the insert member assembly (502) may be manufactured via 3D printing, injection molding, investment casting, machining, and/or any other suitable manufacturing technique. In other versions, the tube (550) and the cap (570) are formed independently of each other as discrete parts and are coupled to each other to form the insert member assembly (502). Alternatively, the tube (550) and the cap (570) may have any other suitable relationship to each other and may be formed and/or coupled together using any other suitable technique.

C. Example of an Insertion Member Assembly Having a Distal Cap with a J-Shaped Bayonet Slot

Fig. 9 to Fig. 10D show another example of an insertion member assembly (602), which can be selectively fixed to a sheath seat (500) and used in a manner similar to that described above for the insertion member (300), so that the insertion member assembly (602) can be selectively coupled to a delivery sheath (200) via the sheath seat (500). The insertion member assembly (602) is similar to the above-mentioned insertion member assembly (502), except that it is described in addition below. In this regard, the insertion member assembly (602) of this example includes a substantially rigid tube (650) extending longitudinally between a proximal end (652) and a distal end (654). In some versions, the rigidity of the tube (650) can be enhanced by providing a thickened sidewall, as indicated by the dotted line (657) in Fig. 9. The tube (650) has a flared proximal portion (655) and a cylindrical main portion (656) that together define a lumen (660) that is sized to closely complement the outer diameter of the catheter (120) while allowing the catheter (120) to slide freely through the tube (650). The lumen (660) may be sized to constrain the end effector (140) to a non-expanded state when the end effector (140) is positioned within the lumen (660). In some variations, both the proximal end (652) and the distal end (654) are flared. In some other variations, the distal end (654) is flared, but the proximal end (652) is not flared. The proximal end (652) and/or the distal end (654) may still provide a tapered lead-in/lead-out end in a version where the tube has a thickened sidewall as indicated by the dashed line (657).

The insertion member assembly (602) of the present example also includes a coupling member in the form of a distal cap (670) having a generally dome-shaped proximal end wall (672) and a generally cylindrical distal side wall (674). In the illustrated example, the cap (670) includes a central bore (676) that extends longitudinally through the end wall (672) and is configured to slidably receive a main portion (656) of the tube (650) to facilitate longitudinal sliding of the tube (650) relative to the cap (670). In yet other variations, the tube (650) is rigidly fixed relative to the cap (670) such that the tube (650) cannot slide relative to the cap (670).

The cap (670) of the present example also includes a bayonet feature in the form of a generally J-shaped slot (680) extending radially outward from the generally cylindrical inner surface of the side wall (674) to the generally cylindrical outer surface of the side wall (674) for engaging the side port (530) of the sheath seat (500) in a bayonet-style manner. Although a single slot (680) is shown, other versions may include any other suitable number of slots (680), such as to allow selection of a particular slot (680) to engage the side port (530). In the example shown, the slot (680) includes a straight entrance channel portion (682) extending proximally from the distal end of the cap (670), a middle portion (683) extending proximally and obliquely (e.g., in a clockwise direction within the reference frame of FIG. 9) from the entrance portion (682), and an end closed locking portion (684) extending at least slightly distally and obliquely (e.g., in a clockwise direction within the reference frame of FIG. 9) from the middle portion (683) to facilitate a bayonet-type engagement between the slot (680) and the side port (530). For example, the entrance channel portion (682) may be configured to receive the side port (530) and be guided along it until the side port (530) reaches the proximal end of the entrance channel portion (682); the middle portion (683) may be configured to subsequently receive the side port (530) and be guided along it until the side port (530) reaches the proximal end of the middle portion (683); and the locking portion (684) may be configured to subsequently receive and fully capture the side port (530) to inhibit longitudinal movement of the cap (670) and the sheath seat (500) relative to each other (for example, to inhibit proximal translation of the cap (670) relative to the sheath seat (500)) in the absence of an accompanying rotational force applied between the cap (670) and the sheath seat (500). The bayonet-type engagement between the side port (530) and the slot (680) facilitates secure coupling of the cap (670) to the sheath seat (500), wherein the longitudinal axis of the insertion member assembly (602) (and more specifically, the longitudinal axis of the lumen (660)) is aligned with the longitudinal axis (LA) of the insertion port (514).

In an example using an insertion member assembly (602), the longitudinal axis (LA) of the insertion member assembly (602) can be aligned with the longitudinal axis (LA) of the insertion port (514), and the entrance channel portion (682) of the slot (680) can be aligned with the side port (530), as shown in FIG10A. Next, the physician (PH) can advance the insertion member assembly (602) distally toward the insertion port (514) so that the body (510) of the sheath seat (500) is at least partially received between the generally cylindrical inner surface of the side wall (674) of the cap (670) and the generally cylindrical outer surface of the main portion (656) of the tube (650), and so that the side port (530) of the sheath seat (500) is at least partially received within the entrance channel portion (682) of the slot (680), as shown in FIG10B. The physician (PH) can then rotate the cap (670) relative to the sheath seat (500) to engage the slot (680) of the cap (670) with the side port (530) of the sheath seat (500) in a bayonet manner by twisting the middle portion (683) of the slot (680) along the side port (530) and capturing the side port (530) within the locking portion (684) of the slot (680), and thereby secure the cap (670) to the sheath seat (500), as shown in FIG. 10C .

Once the cap (670) has been secured to the sheath seat (500), the catheter (120) can be slid through the lumen (660) of the insertion member assembly (602), and the catheter (120) and/or the tube (650) can be advanced distally so that the end effector (140) and/or the distal end (654) penetrate the seal (520) at the slit arrangement (522) in a manner similar to that described above in conjunction with FIGS. 4A to 4C. As the physician (PH) 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 assembly (602), the flared proximal portion (655) of the tube (650) can ultimately engage the end wall (672) of the cap (670), as shown in FIG. 10D. For example, interaction between flared proximal portion (655) of tube (650) and the perimeter of central bore (676) will arrest tube (650) and thereby prevent tube (650) from being further advanced distally into insertion port (514).

Although the tube (650) is shown in FIGS. 10C to 10D as being slidable relative to the cap (670), some variations may provide a fixed relationship between the tube (650) and the cap (670) such that the tube (650) need not be slidable relative to the cap (670) in all versions. For example, the tube (650) and the cap (670) may be formed integrally with each other as a unitary (e.g., single) piece to define the insert member assembly (602). In this regard, the insert member assembly (602) may be manufactured via 3D printing, injection molding, investment casting, machining, and/or any other suitable manufacturing technique. In other versions, the tube (650) and the cap (670) are formed independently of each other as discrete parts and are coupled to each other to form the insert member assembly (602). Alternatively, the tube (650) and the cap (670) may have any other suitable relationship to each other and may be formed and/or coupled together using any other suitable technique.

D. Example of a Distal Cap with Angled Bayonet Slot for Insertion Member Assembly

FIG. 11 shows another example of a coupling member in the form of a distal cap (770) that can be incorporated into an insertion member assembly similar to the insertion member assembly (602) in place of the cap (670) and can be selectively fixed to the sheath seat (500) and used in a manner similar to that described above for the cap (670) so that the insertion member assembly incorporating the cap (770) can be selectively coupled to the delivery sheath (200) via the sheath seat (500). The cap (770) is similar to the above-described cap (670), except that it is further described below. In this regard, the cap (770) of this example includes a generally dome-shaped proximal end wall (772) and a generally cylindrical distal side wall (774). Although not shown, cap (770) may further include a central bore extending longitudinally through end wall (772) and configured to slidably receive a portion of a tube, such as main portion (656) of tube (650), to facilitate longitudinal sliding of tube (650) relative to cap (770). Alternatively, a tube like tube (650) may be rigidly fixed relative to cap (770).

The cap (770) of the present example also includes a bayonet feature in the form of a generally oblique keyhole-shaped slot (780) extending radially outward from the generally cylindrical inner surface of the side wall (774) to the generally cylindrical outer surface of the side wall (774) for engaging the side port (530) of the sheath seat (500) in a bayonet manner. Although a single slot (780) is shown, other versions may include any other suitable number of slots (780), such as to allow selection of a particular slot (780) to engage the side port (530). In the example shown, the slot (780) includes an oblique entrance passage portion (782) extending proximally and obliquely (e.g., in a clockwise direction within the reference frame of FIG. 11) from the distal end of the cap (770) and an end closure locking portion (784) extending proximally from the entrance passage portion (782) for facilitating the bayonet engagement between the slot (780) and the side port (530). For example, the inlet passage portion (782) can be configured to receive the side port (530) and be guided along it until the side port (530) reaches the proximal end of the inlet passage portion (782); and the locking portion (784) can be configured to subsequently receive and sufficiently capture the side port (530) to inhibit longitudinal movement of the cap (770) and the sheath seat (500) relative to each other (e.g., to inhibit the cap (770) from translating proximally relative to the sheath seat (500) in the absence of an accompanying rotational force applied between the cap (770) and the sheath seat (500). The bayonet-type engagement between the side port (530) and the slot (780) can facilitate secure coupling of the cap (770) to the sheath seat (500). In some versions, the locking portion (782) can be sized and configured to provide a snap-fit engagement with the side port (530) to help facilitate secure coupling of the cap (770) to the sheath seat (500).

E. Example of an insertion member assembly having a distal cap having a cylindrical portion with a snap-fit slot Shaped side wall

Figures 12 to 13C show another example of an insertion member assembly (802), which can be selectively fixed to a sheath seat (500) and used in a manner similar to that described above for the insertion member (300), so that the insertion member assembly (802) can be selectively coupled to a delivery sheath (200) via the sheath seat (500). The insertion member assembly (802) is similar to the above-mentioned insertion member assembly (502), except that it is described in addition below. In this regard, the insertion member assembly (802) of this example includes a substantially rigid tube (850) extending longitudinally between a proximal end (852) and a distal end (854). In some versions, the rigidity of the tube (850) can be enhanced by providing a thickened sidewall, as indicated by the dotted line (857) in Figure 12. The tube (850) has a flared proximal portion (855) and a cylindrical main portion (856) that together define a lumen (860) that is sized to closely complement the outer diameter of the catheter (120) while allowing the catheter (120) to slide freely through the tube (850). The lumen (860) may be sized to constrain the end effector (140) to a non-expanded state when the end effector (140) is positioned within the lumen (860). In some variations, both the proximal end (852) and the distal end (854) are flared. In some other variations, the distal end (854) is flared, but the proximal end (852) is not flared. The proximal end (852) and/or the distal end (854) may still provide a tapered lead-in/lead-out end in a version where the tube has a thickened sidewall as indicated by the dashed line (857).

The insertion member assembly (802) of the present example also includes a coupling member in the form of a distal cap (870) having a generally dome-shaped proximal end wall (872) and a generally cylindrical distal side wall (874). In the illustrated example, the cap (870) includes a central bore (876) that extends longitudinally through the end wall (872) and is configured to slidably receive a main portion (856) of the tube (850) to facilitate longitudinal sliding of the tube (850) relative to the cap (870). In yet other variations, the tube (850) is rigidly fixed relative to the cap (870) such that the tube (850) cannot slide relative to the cap (870).

The cap (870) of the present example also includes a pair of laterally opposed snap-fit features in the form of generally keyhole-shaped slots (880), each extending radially through the side wall (874) for snap-fit engagement with the side port (530) of the sheath seat (500). Although a pair of slots (880) are shown so that either slot (880) can be selected to engage the side port (530), other versions may include only a single slot (880) or any other suitable number of slots (880). In the example shown, each slot (880) includes a distal inlet passage portion (882) extending proximally from the distal end of the cap (870), an intermediate expandable locking portion (883) extending proximally from the inlet passage portion (882), and a proximal end closure elongated portion (884) extending proximally from the locking portion (883) for facilitating snap-fit engagement between the slot (880) and the side port (530). For example, the inlet channel portion (882) can be configured to receive the side port (530) and be guided along it until the side port (530) reaches the proximal end of the inlet channel portion (882); the locking portion (883) can be configured to then expand sufficiently to receive the side port (530) and resiliently contract sufficiently to capture the side port (530) to inhibit longitudinal movement of the cap (870) and the sheath seat (500) relative to each other in the absence of a threshold longitudinal force applied between the cap (870) and the sheath seat (500) (e.g., to inhibit the cap (870) from translating proximally relative to the sheath seat (500); and the elongated portion (884) can be configured to assist in achieving such expansion of the locking portion (883). The inlet channel portion (882) can taper or bend inwardly in the proximal direction to be engaged by the side port in a camming manner as the inlet channel portion (882) is guided along the side port (530), thereby assisting in the expansion of the locking portion (883). In the example shown, the cap (870) also includes a pair of elongated slots (890) on the sides of each of the keyhole-shaped slots (890) so that a portion of the side wall (874) between each of the keyhole-shaped slots (880) and the corresponding elongated slot (890) can be deflected into the corresponding elongated slot (880), such as during expansion of the corresponding locking portion (883).

It should be understood that the snap-fit features of the sheath seat (500) and the cap (870) can be any suitable form for engaging each other in a snap-fit manner, and are not limited to the particular configuration of the side port (530) and the slot (880) shown. For example, while in the present version the side port (530) is configured to engage the slot (880) in a snap-fit manner, in some other versions the sheath seat (500) may include a separate protrusion extending radially outward from the body (510) and configured to engage the slot (880) in a snap-fit manner. The snap-fit engagement between the side port (530) or any other such protrusion and the slot (880) can facilitate secure coupling of the cap (870) to the sheath seat (500), wherein the longitudinal axis of the insertion member assembly (802) (and more specifically, the longitudinal axis of the lumen (860)) is aligned with the longitudinal axis (LA) of the insertion port (514). In this manner, when cap (870) is secured to sheath hub (500), lumen (860) may be centered relative to slit arrangement (522) of seal (520) and may be oriented orthogonally relative to a plane defined by seal (520).

In examples using an insertion member assembly (802), the longitudinal axis (LA) of the insertion member assembly (802) can be aligned with the longitudinal axis (LA) of the insertion port (514), and the inlet channel portion (882) of any narrow slot (880) can be aligned with the side port (530), as shown in Figure 13A. Next, the physician (PH) can advance the insertion member assembly (802) distally toward the insertion port (514) so that the body (510) of the sheath seat (500) is at least partially received between the generally cylindrical inner surface of the side wall (874) of the cap (870) and the generally cylindrical outer surface of the main portion (856) of the tube (850), and so that the side port (530) of the sheath seat (500) is at least partially received within the entrance channel portion (882) of the narrow groove (880), and the physician can continue to advance the insertion member assembly (802) distally to engage the narrow groove (880) of the cap (870) with the side port (530) of the sheath seat (500) in a snap-fit manner by capturing the side port (530) in the locking portion (883) of the narrow groove (880), and thereby secure the cap (870) to the sheath seat (500), as shown in FIG. 13B.

Once the cap (870) has been secured to the sheath seat (500), the catheter (120) can be slid through the lumen (860) of the insertion member assembly (802), and the catheter (120) and/or the tube (850) can be advanced distally so that the end effector (140) and/or the distal end (854) penetrate the seal (520) at the slit arrangement (522) in a manner similar to that described above in conjunction with FIGS. 4A to 4C. As the physician (PH) 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 assembly (802), the flared proximal portion (855) of the tube (850) can ultimately engage the end wall (872) of the cap (870), as shown in FIG. 13C. For example, interaction between flared proximal portion (855) of tube (850) and the perimeter of central bore (876) will arrest tube (850) and thereby prevent tube (850) from being further advanced distally into insertion port (514).

Although the tube (850) is shown in FIGS. 13B to 13C as being slidable relative to the cap (870), some variations may provide a fixed relationship between the tube (850) and the cap (870) such that the tube (850) need not be slidable relative to the cap (870) in all versions. For example, the tube (850) and the cap (870) may be formed integrally with each other as a unitary (e.g., single) piece to define the insert member assembly (802). In this regard, the insert member assembly (802) may be manufactured via 3D printing, injection molding, investment casting, machining, and/or any other suitable manufacturing technique. In other versions, the tube (850) and the cap (870) are formed independently of each other as discrete parts and are coupled to each other to form the insert member assembly (802). Alternatively, the tube (850) and the cap (870) may have any other suitable relationship to each other and may be formed and/or coupled together using any other suitable technique.

F. Example of an insertion member assembly having a distal cap having a lateral distal end with a snap-fit slot Opposite side wall

FIG. 14 shows another example of an insertion member assembly (902) that can be selectively fixed to a sheath seat (500) and used in a manner similar to that described above for the insertion member (300) so that the insertion member assembly (802) can be selectively coupled to a delivery sheath (200) via the sheath seat (500). The insertion member assembly (902) is similar to the above-described insertion member assembly (802), with the difference being as described further below. In this regard, the insertion member assembly (902) of this example includes a substantially rigid tube (950) extending longitudinally between a proximal end (952) and a distal end (954). In some versions, the rigidity of the tube (950) can be enhanced by providing a thickened sidewall, as indicated by the dotted line (957) in FIG. 14. The tube (950) has a flared proximal portion (955) and a cylindrical main portion (956) that together define a lumen (960) that is sized to closely complement the outer diameter of the catheter (120) while allowing the catheter (120) to slide freely through the tube (950). The lumen (960) may be sized to constrain the end effector (140) to a non-expanded state when the end effector (140) is positioned within the lumen (960). In some variations, both the proximal end (952) and the distal end (954) are flared. In some other variations, the distal end (954) is flared, but the proximal end (952) is not flared. The proximal end (952) and/or the distal end (954) may still provide a tapered lead-in/lead-out end in a version where the tube has a thickened sidewall as indicated by the dashed line (957).

The insertion member assembly (902) of the present example also includes a coupling member in the form of a distal cap (970) having a generally dome-shaped proximal end wall (972) and a pair of laterally opposed generally arcuate distal side walls (974). Although not shown, the cap (970) may also include a central bore (976) extending longitudinally through the end wall (972) and configured to slidably receive a main portion (956) of the tube (950) to facilitate longitudinal sliding of the tube (950) relative to the cap (970). In yet other variations, the tube (950) is rigidly fixed relative to the cap (970) such that the tube (950) cannot slide relative to the cap (970).

The cap (970) of the present example also includes a pair of laterally opposed snap-fit features in the form of generally keyhole-shaped slots (980), each slot extending radially through a corresponding side wall (974) for snap-fit engagement with the side port (530) of the sheath seat (500). Although a pair of slots (980) are shown so that either slot (980) can be selected to engage the side port (530), other versions may include only a single slot (980) or any other suitable number of slots (980). In the example shown, each slot (980) includes a distal inlet passage portion (982) extending proximally from the distal end of the cap (970), an intermediate expandable locking portion (983) extending proximally from the inlet passage portion (982), and a proximal end closure elongated portion (984) extending proximally from the locking portion (983) for facilitating snap-fit engagement between the slot (980) and the side port (530). For example, the inlet channel portion (982) can be configured to receive the side port (530) and be guided along it until the side port (530) reaches the proximal end of the inlet channel portion (982); the locking portion (983) can be configured to then expand sufficiently to receive the side port (530) and resiliently contract sufficiently to capture the side port (530) to inhibit longitudinal movement of the cap (970) and the sheath seat (500) relative to each other in the absence of a threshold longitudinal force applied between the cap (970) and the sheath seat (500) (e.g., to inhibit the cap (970) from translating proximally relative to the sheath seat (500); and the elongated portion (984) can be configured to assist in achieving such expansion of the locking portion (983). The inlet channel portion (982) can taper or curve inwardly in the proximal direction to be engaged by the side port in a camming manner as the inlet channel portion (982) is guided along the side port (530), thereby assisting in the expansion of the locking portion (983). In the example shown, the cap (970) further includes a pair of laterally opposed elongated channels (990), each extending along an elongated portion (984) of a corresponding slot (980) for slidably receiving a tab (532) of the sheath seat (500) when the side port (530) is captured within a locking portion (983) of the corresponding slot (980). The snap-fit engagement between the side port (530) and the slot (980) facilitates secure coupling of the cap (970) to the sheath seat (500), wherein the longitudinal axis of the insertion member assembly (902) (and more specifically, the longitudinal axis of the lumen (960)) is aligned with the longitudinal axis (LA) of the insertion port (514).

VI. Examples of End Effectors with Expandable Basket Configurations

As described above, the end effector (140) may have any suitable configuration different from that shown in FIG. 2, such as any suitable type of expandable basket configuration. FIGS. 15-16 show another example of an end effector (1040) having such an expandable basket configuration and that may be incorporated into a catheter (120) in place of the end effector (140). The end effector (1040) is similar to the end effector (140) described above, except as further described below. In this regard, the end effector (1040) extends distally from an elongated flexible shaft, such as the shaft of the catheter (120), and may be selectively positioned within a hollow shaft, such as the hollow shaft (220) of the delivery sheath (200).

As shown in FIGS. 15-16 , the end effector ( 1040 ) of the present example includes an expandable basket assembly ( 1042 ) having a plurality of elastic spines ( 1044 ) and a plurality of electrodes ( 1050 ) fitted to the spines ( 1044 ). The basket assembly ( 1042 ) is operable to transition between a non-expanded state ( FIG. 16 ) and an expanded state ( FIG. 15 ). The basket assembly ( 1042 ) can be configured to elastically assume an expanded state when unconstrained, such as by being pushed out of a sheath, such as the delivery sheath ( 200 ) described above, or a sheath that is an integral part of the catheter ( 120 ). In the non-expanded state, the basket assembly ( 1042 ) can fit within the delivery sheath ( 200 ), as shown in FIG. 16 . In the expanded state, the basket assembly ( 1042 ) can be sized and configured to push the electrodes ( 1050 ) into contact with tissue, such as the inner wall of a pulmonary vein or a chamber of the heart ( H ) .

In the example shown, the end effector (1040) further includes a shaft (1060) extending longitudinally from the distal end of the elongated flexible shaft of the catheter (120). The shaft (1060) of this example includes a plurality of irrigation ports (1062) configured to deliver irrigation fluid to the corresponding electrodes (1050) and/or tissue contacted by the electrodes (1050) (e.g., the inner wall of a pulmonary vein or a chamber of the heart (H)).

In addition to the foregoing, the end effector (1040) and other aspects of the catheter assembly (100) may be constructed and operated in accordance with at least some of the teachings of U.S. Patent Application No. 17/470,751, the disclosure of which is incorporated herein by reference. Alternatively, the end effector (1040) may have any other suitable components, features, and capabilities.

VII. Examples of Insertion Devices for Use with Expandable Basket End Effectors

As described above, it may be desirable to enhance the rigidity of the tube of the insertion member, such as by providing a thickened sidewall as indicated by the dashed lines (557, 657, 857, 957) in Figures 7, 9, 12, and 14. In addition or alternatively, it may be desirable to provide an insertion member that can be used to assist in inserting the end effector (1040) and the catheter (120) through the insertion port (250) of the delivery sheath (200). Figures 17 to 18C show another example of an insertion member (1102) that can be selectively secured to the handle assembly (210) and used in a manner similar to that described above for the insertion member (300). The insertion member (1102) is similar to the insertion member (402) described above, except as further described below.

The insertion member (1102) of this example includes a tube (1150) extending longitudinally between a proximal end (1152) and a distal end (1154). The tube (1150) has a generally cylindrical proximal portion (1155) and a generally cylindrical main portion (1156). The main portion (1156) has a cylindrical interior, while the proximal portion (1155) has a frustoconical interior, such that the interior of the proximal portion (1155) tapers radially outward from the interior of the main portion (1156) to the proximal end (1152) of the tube (1150). The main portion (1156) and the proximal portion (1155) together define a lumen (1160) that extends longitudinally between the proximal and distal ends (1152, 1154) of the tube (1150) and is sized to closely complement the outer diameter of the catheter (120) while allowing the catheter (120) to slide freely through the tube (1150). The lumen (1160) can be sized to constrain the end effector (1040) to a non-expanded state when the end effector (1040) is positioned within the lumen (1160). In this example, the tube (1150) is substantially rigid. In this regard, the rigidity of the tube (1150) can be enhanced by having thickened sidewalls, at least as compared to an alternative scenario in which the thickness of the sidewalls of the proximal portion (1155) and the main portion (1156) is reduced (e.g., such that the proximal portion (1155) can be flared in a manner similar to that described above). In the example shown, the sidewall of the tube (1150) includes a plurality of flat outer surfaces (1159) configured to be gripped by a physician (PH) or other operator to assist the operator in manipulating the tube (1150) relative to the handle assembly (210) and/or the catheter assembly (100).

The insertion member (1102) of the present example also includes a coupling member in the form of a distal cap (1170) that is coaxially disposed with the tube (1150). The cap (1170) includes a generally flat and/or domed proximal end wall (1172) and a generally annular distal sidewall (1174) that extends radially outward relative to the main portion (1156) of the tube (1150) at or near the distal end (1154) of the tube (1150).

The cap (1170) of this example also includes a receptacle (1180) defined by the generally cylindrical inner surface of the sidewall (1174) for receiving the annular protrusion (252) of the insertion port (250). The receptacle (1180) may have a cross-sectional dimension (e.g., diameter) that is slightly less than, substantially equal to, or substantially greater than the cross-sectional dimension of the protrusion (252) to allow the protrusion (252) to be received by the receptacle (1180). In some versions, the cross-sectional dimension of the receptacle (1180) may be set relative to the cross-sectional dimension of the receptacle (1180) to allow the generally cylindrical inner surface of the sidewall (1174) to frictionally engage the generally cylindrical outer surface of the protrusion (252). For example, the receptacle (1180) may have a cross-sectional dimension that is slightly less than or substantially equal to the cross-sectional dimension of the protrusion (252) to provide an interference fit between the inner surface of the sidewall (1174) and the outer surface of the protrusion (252).

The frictional engagement between the inner surface of the sidewall (1174) and the outer surface of the protrusion (252) can facilitate secure coupling of the insertion member (1102) to the handle assembly (210), wherein the longitudinal axis of the insertion member (1102) (and more specifically, the longitudinal axis of the lumen (1160)) is aligned with the longitudinal axis (LA) of the insertion port (250). In this manner, when the insertion member (1102) is secured to the handle assembly (210), the lumen (1160) can be centered relative to the slot arrangement (262) of the seal (260) and can be oriented orthogonally relative to the plane defined by the seal (260). In some versions, the frustoconical interior of the proximal portion (1155) of the tube (1150) can provide a lead-in end for facilitating insertion of the end effector (1040) and the catheter (120) into the proximal end (1152) of the tube (1150). In this regard, the frustoconical interior of the proximal portion (1155) may have a substantially gradual (e.g., gentle) taper to inhibit kinking of the end effector (1040) and the catheter (120) during insertion of the end effector (1040) and the catheter (120). Although not shown, the cap (1170) may further include at least one vent or bleed hole extending through the end wall (1172) for venting fluid (e.g., air) from a space between a distal surface of the end wall (1172) of the cap (1170) and the handle assembly (210) to the exterior of the cap (1170) when the cap (1170) is secured to the handle assembly (210).

While the insertion member (1102) has been described as being securely coupled to the handle assembly (210) via frictional engagement between the inner surface of the sidewall (1174) and the outer surface of the protrusion (252), it should be understood that the insertion member (1102) may be securely coupled to the handle assembly (210) in any other suitable manner. For example, the cap (1170) and/or the handle assembly (210) may be equipped with suitable features that are configured to allow the cap (1170) to engage the handle assembly (210) in at least one of a threaded manner, a snap fit manner, an interference fit manner, or a bayonet manner, such as in any of the above-described manners. In some other versions, the receptacle (1180) may be configured to receive the protrusion (252) without the insertion member (1102) having to be securely coupled to the handle assembly (210). For example, receptacle (1180) may have a cross-sectional dimension that is substantially larger than the cross-sectional dimension of protrusion (252) to allow protrusion (252) to fit loosely within receptacle (1180).

The insert member (1102) may be made of any suitable translucent (e.g., transparent) or opaque material, such as a polymeric material (e.g., plastic) or a metallic material. For example, the insert member (1102) may be made of a thermoplastic elastomer, such as a polyether block amide (PEBA). In addition or alternatively, the insert member (1102) may be made of a material having a Shore hardness of about 63D. With reference to the teachings herein, other suitable materials that can be used to form the insert member (1102) will be apparent to those skilled in the art. In the example shown, the tube (1150) and the cap (1170) are integrally formed with each other as a whole (e.g., a single) piece to define the insert member (1102). In this regard, the insert member (1102) may be manufactured via 3D printing, injection molding, investment casting, machining, and/or any other suitable manufacturing technology. In other versions, tube (1150) and cap (1170) are separately formed as discrete parts independently of each other and coupled to each other to define insert member (1102), such that insert member (1102) can be referred to as an assembly. It should be understood that tube (1150) and cap (1170) can be constructed of the same or different materials. Although the tube (1150) of the present example is fixed to prevent movement relative to cap (1170), tube (1150) may alternatively be movable relative to cap (1170). For example, tube (1150) can be slidably coupled to cap (1170) to facilitate longitudinal sliding of tube (1150) relative to cap (1170), such as in a manner similar to any of those described above in conjunction with FIGS. 7 to 14.

Although not shown, the insert member (1102) may include any one or more of a sealing member, an enhanced structural support feature (such as a rib), a torque drive feature (such as an external fin), and/or a catheter gripping feature (such as an internal fin). By way of example only, the insert member (1102) may be constructed and operated in accordance with at least some of the teachings of U.S. Publication No. 2021/0113812, entitled “Flared Insert Member for Use with Catheter Assembly,” published on April 22, 2021, the disclosure of which is incorporated herein by reference in its entirety.

In examples where insertion member (1102) is used, the longitudinal axis (LA) of insertion member (1102) may be aligned with the longitudinal axis (LA) of insertion port (250), as shown in FIG18A. Next, the physician (PH) may advance insertion member (1102) distally toward insertion port (250) such that annular protrusion (252) of insertion port (250) is at least partially received within receptacle (1180) to frictionally engage the inner surface of sidewall (1174) with the outer surface of protrusion (252), and thereby secure insertion member (1102) to handle assembly (210), as shown in FIG18B.

When the insertion member (1102) is in the secured state shown in FIG. 18B , the longitudinal axis of the lumen (1160) is aligned with the longitudinal axis (LA) of the insertion port (250) such that the lumen (1160) is centered relative to the slot arrangement (262) of the seal (260) and is oriented orthogonally relative to the plane defined by the seal (260). It should be appreciated that the seal (260) may remain unpenetrated during the securing of the insertion member (1102) to the handle assembly (210), such that the securing of the insertion member (1102) to the handle assembly (210) may be performed prior to inserting the end effector (1040) and the catheter (120) into the insertion member (1102). Once the insertion member (1102) has been secured to the handle assembly (210), the longitudinal axis (LA) of the end effector (1040) and the catheter (120) can be aligned with the longitudinal axis (LA) of the insertion member (1102) and the insertion port (250), and the catheter (120) is slid through the lumen (1160) of the insertion member (1102) and advanced distally beyond the distal end (1154) to penetrate the seal (260) at the slit arrangement (262), so that the end effector (1040) and the catheter (120) can be passed distally through the interior of the shaft (220), as shown in FIG18C. The end effector (1040) eventually reaches a point where the end effector (1040) is distal to the distal end (240) of the shaft (220), so that the end effector (1040) can be elastically transformed to an expanded state. Catheter (120) may be collapsed within shaft (220), as shown in FIG. 16, while insertion member (1102) is brought into a secured state as shown in FIG. 18B.

While insertion member (1102) has been described as being for use with end effector (1040), insertion member (1102) may additionally or alternatively be used with any other suitable type of end effector, such as end effector (140) described above.

VIII. Example of combination

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 in the subsequent submissions of this patent application. It is not intended to make a disclaimer. The following examples are provided only for illustrative purposes. It is envisioned that the various teachings herein may be arranged and applied in a variety of other ways. It is also envisioned 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 explicitly indicated by the inventor or the successor with an interest in the inventor at a later date. If any claim proposed in this patent application or in the 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.

Example 1

A delivery sheath-catheter coupler, the coupler comprising: (a) a cylindrical shaft extending along an axis, the cylindrical shaft being configured to be longitudinally aligned with an insertion port of a catheter delivery sheath, the cylindrical shaft comprising: (i) a proximal end, (ii) a distal end, and (iii) a lumen extending along the axis from the proximal end to the distal end, the lumen being sized to receive an end actuator of the catheter; and (b) a coupling member attached to the cylindrical shaft, the coupling member being configured to be selectively secured to the catheter delivery sheath, the coupling member being configured to align the axis of the lumen with the longitudinal axis of the insertion port when the coupling member is selectively secured to the catheter delivery sheath.

Example 2

According to the coupler of embodiment 1, the coupling member is fixedly attached to the cylindrical shaft.

Example 3

According to the coupler of Embodiment 1, the coupling member is attached to the cylindrical shaft while being movable relative to the cylindrical shaft.

Example 4

In the coupler of Example 3, the coupling member is configured to translate relative to the cylindrical shaft along the axis of the lumen.

Example 5

According to any one of embodiments 1 to 4, the cylindrical shaft is sized for insertion into the insertion port of the catheter delivery sheath.

Example 6

[0013] The coupler of any one of embodiments 1 to 5 further includes an outward flare feature at one of the proximal end or the distal end of the cylindrical shaft, the outward flare feature defining an angled surface leading to the lumen.

Example 7

In accordance with the coupler of Example 6, the outward flare feature is at the distal end of the cylindrical shaft, the outward flare feature being configured to prevent the cylindrical shaft from being inserted into an insertion port of the catheter delivery sheath.

Example 8

In accordance with the coupler of Example 6, the outward flare feature is at the proximal end of the cylindrical shaft, the outward flare feature being configured to limit insertion of the cylindrical shaft into the insertion port of the catheter delivery sheath.

Example 9

According to the coupler of any one of Examples 1 to 8, the coupling member includes an exhaust opening for exhausting fluid from a space between the coupling member and the catheter delivery sheath when the coupling member is selectively fixed to the catheter delivery sheath.

Example 10

According to the coupler of any one of embodiments 1 to 9, the coupling member includes a cap.

Embodiment 11

According to the coupler of any one of Examples 1 to 10, the coupling member is configured to threadably engage the catheter delivery sheath.

Example 12

According to the coupler of any one of embodiments 1 to 10, the coupling member is configured to engage the catheter delivery sheath in a snap-fit manner.

Example 13

According to any one of embodiments 1 to 10, the coupling member is configured to engage the catheter delivery sheath in a bayonet manner.

Embodiment 14

The coupler according to any one of Examples 1 to 13 further includes a catheter disposed in the lumen, wherein the catheter is configured to fit within the anatomical structure.

Embodiment 15

The coupler according to any one of Examples 1 to 14 further includes a catheter delivery sheath having an insertion port configured to be longitudinally aligned with the cylindrical axis, the insertion port defining a longitudinal axis, and the coupling member being configured to align the axis of the lumen with the longitudinal axis of the insertion port when the coupling member is selectively secured to the catheter delivery sheath.

Example 16

A kit comprising: (a) a catheter apparatus comprising: (i) a catheter having a distal end, and (ii) an end actuator at the distal end of the catheter, the catheter and the end actuator being sized to fit in an anatomical structure, the end actuator comprising at least one electrode; and (b) a coupler comprising: (i) a cylindrical shaft comprising: (A) a proximal end, (B) a distal end, and (C) a lumen extending along an axis from the proximal end to the distal end, the lumen being sized to receive the end actuator and the catheter, and (ii) a coupling member attached to the cylindrical shaft.

Embodiment 17

According to the kit of Example 16, it also includes a catheter delivery sheath, which includes an insertion port defining a longitudinal axis, and the coupling member is configured to be selectively fixed to the catheter delivery sheath, and the coupling member is configured to align the axis of the lumen with the longitudinal axis of the insertion port when the coupling member is selectively fixed to the catheter delivery sheath.

Embodiment 18

In accordance with the kit of Example 17, the coupling member is configured to engage the catheter delivery sheath in at least one of a threaded manner, a snap-fit manner, or a bayonet manner.

Embodiment 19

A kit comprising: (a) a catheter apparatus 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 in an anatomical structure, the end effector comprising at least one electrode; and (b) a coupler comprising: (i) a cylindrical shaft comprising: (A) a proximal end, (B) a distal end, and (C) a lumen extending along an axis from the proximal end to the distal end, the lumen being sized to receive the end effector and the catheter, and (ii) a means for coupling attached to the cylindrical shaft.

Embodiment 20

In the kit of embodiment 19, the means for coupling includes threads, snap-fit features, bayonet-fit features, or functional equivalents of threads, snap-fit features, or bayonet-fit features.

Embodiment 21

A method comprising: securing a coupler to a catheter delivery sheath, the coupler comprising: (i) a cylindrical shaft comprising: (A) a proximal end, (B) a distal end and (C) a lumen extending along an axis from the proximal end to the distal end, the lumen being sized to receive an end effector and a catheter of a catheter device, and (ii) a coupling member attached to the cylindrical shaft, the securing action comprising aligning the axis of the lumen with the longitudinal axis of an insertion port of the catheter delivery sheath.

Embodiment 22

In accordance with the method of Example 21, the act of securing includes providing at least one of a threaded engagement, a snap-fit engagement, or a bayonet engagement between the coupling member and the catheter delivery sheath.

Embodiment 23

According to any one of the couplers of embodiments 1 to 15, the lumen includes a frustoconical proximal portion.

Embodiment 24

In the coupler of Example 23, the frustoconical proximal portion extends distally from the proximal end.

Embodiment 25

According to the coupler of any one of embodiments 23 to 24, the frustoconical proximal portion tapers radially inward in the distal direction.

Embodiment 26

According to the kit of any one of Examples 16 to 20, the lumen includes a frustoconical proximal portion.

Embodiment 27

In accordance with the kit of embodiment 26, the frustoconical proximal portion extends distally from the proximal end.

Embodiment 28

According to the kit of any one of embodiments 26 to 27, the frustoconical proximal portion tapers radially inward in a distal direction.

Embodiment 29

A delivery sheath-catheter coupler, the coupler comprising: (a) a cylindrical shaft extending along an axis, the cylindrical shaft being configured for longitudinal alignment with an insertion port of a catheter delivery sheath, the cylindrical shaft comprising: (i) a proximal end, (ii) a distal end, and (iii) a lumen extending along the axis from the proximal end to the distal end, the lumen being sized to receive an end actuator of a catheter, the lumen comprising a frustoconical proximal portion; and (b) a cap attached to the distal end of the cylindrical shaft, the cap being configured for selective alignment with the catheter delivery sheath, the cap being configured to align the axis of the lumen with the longitudinal axis of the insertion port when the coupling member is selectively aligned with the catheter delivery sheath.

Embodiment 30

In accordance with the coupler of Example 29, the cap is configured to be selectively secured to the catheter delivery sheath.

Embodiment 31

According to the coupler of any of embodiments 29 to 30, the cap is fixedly attached to the distal end of the cylindrical shaft.

Embodiment 32

According to the coupler of any one of Examples 29 to 30, the cap is attached to the distal end of the cylindrical shaft while being movable relative to the cylindrical shaft.

Embodiment 33

In the coupler of Example 32, the cap is configured to translate relative to the cylindrical shaft along the axis of the lumen.

Embodiment 34

In accordance with the coupler of any one of embodiments 30 to 33, the cap is configured to engage the catheter delivery sheath in at least one of a threaded manner, a snap fit manner, an interference fit manner, or a bayonet manner.

Embodiment 35

The coupler of any one of Examples 29 to 34 further includes a catheter disposed in the lumen, the catheter being configured to fit within an anatomical structure.

Embodiment 36

The coupler according to any one of Examples 29 to 35 further includes a catheter delivery sheath having an insertion port configured to be longitudinally aligned with the cylindrical axis, the insertion port defining a longitudinal axis, and the coupling member being configured to align the axis of the lumen with the longitudinal axis of the insertion port when the coupling member is aligned with the catheter delivery sheath.

IX. Miscellaneous

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 radiation field 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. The device can also be sterilized using any other technique known in the art, 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).

It should be understood that any of the 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 of the examples described herein may also include one or more of the various features disclosed in any of the various references incorporated herein by reference.

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 isolated from each other. With reference to the teachings herein, various suitable ways in which the teachings herein may be combined will be apparent to those skilled in the art. Such modifications and variations are intended to be included within the scope of the claims.

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 listed in the present disclosure. Therefore, and to the extent necessary, the disclosure explicitly listed herein supersedes any conflicting material incorporated herein by reference. Any material or portion thereof allegedly incorporated herein by reference but conflicting with existing definitions, statements or other public materials listed herein will be incorporated only to the extent that there is no conflict between the incorporated material and the existing public materials.

Having shown and described various versions of the present invention, those skilled in the art may achieve further improvements to the methods and systems described herein by making appropriate modifications without departing from the scope of the present 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 illustrative and not required. Therefore, the scope of the present invention should be considered in light of the following claims and should be understood as not being limited to the details of the structure and operation shown and described in the specification and drawings.

Claims (36)

1. A delivery sheath-catheter coupler, the coupler comprising: (a) a cylindrical shaft extending along an axis, the cylindrical shaft being configured for longitudinal alignment with an insertion port of a catheter delivery sheath, the cylindrical shaft comprising: (i) the proximal end, (ii) a distal end, and (iii) a lumen extending along the axis from the proximal end to the distal end, the lumen being sized to receive an end effector of a catheter; and (b) a coupling member attached to the cylindrical shaft, the coupling member being configured to be selectively secured to the catheter delivery sheath, the coupling member being configured to align the axis of the lumen with the longitudinal axis of the insertion port when the coupling member is selectively secured to the catheter delivery sheath. 2. The coupler of claim 1, the coupling member being fixedly attached to the cylindrical shaft. 3. The coupler of claim 1, the coupling member being attached to the cylindrical shaft while also being movable relative to the cylindrical shaft. 4. The coupler of claim 3, the coupling member being configured to translate relative to the cylindrical shaft along the axis of the lumen. 5. The coupler of any one of claims 1, the cylindrical shaft being sized for insertion into an insertion port of the catheter delivery sheath. 6. The coupler of any one of claims 1, further comprising an outward flare feature at one of the proximal end or the distal end of the cylindrical shaft, the outward flare feature defining an angled surface leading to the lumen. 7. The coupler of claim 6, the outward flare feature being at a distal end of the cylindrical shaft, the outward flare feature being configured to prevent insertion of the cylindrical shaft into an insertion port of the catheter delivery sheath. 8. The coupler of claim 6, the outward flare feature being at a proximal end of the cylindrical shaft, the outward flare feature being configured to limit insertion of the cylindrical shaft into an insertion port of the catheter delivery sheath. 9. The coupler of any one of claims 1, wherein the coupling member comprises an exhaust opening for exhausting fluid from a space between the coupling member and the catheter delivery sheath when the coupling member is selectively secured to the catheter delivery sheath. 10. The coupler of any one of claims 1, the coupling member comprising a cap. 11. The coupler of any one of claims 1, the coupling member being configured to threadably engage the catheter delivery sheath. 12. The coupler of any one of claims 1, the coupling member being configured to engage the catheter delivery sheath in a snap-fit manner. 13. The coupler of any one of claims 1, the coupling member being configured to engage the catheter delivery sheath in a bayonet-style manner. 14. The coupler of any one of claims 1, further comprising a catheter disposed in the lumen, the catheter being configured to fit within an anatomical structure. 15. The coupler according to any one of claim 1 further comprises a catheter delivery sheath having an insertion port configured to be longitudinally aligned with the cylindrical axis, the insertion port defining a longitudinal axis, the coupling member being configured to align the axis of the lumen with the longitudinal axis of the insertion port when the coupling member is selectively secured to the catheter delivery sheath. 16. A kit, comprising: (a) A catheter device, the catheter device comprising: (i) a catheter having a distal end, and (ii) an end effector at a distal end of the catheter, the catheter and the end effector being sized to fit within an anatomical structure, the end effector comprising at least one electrode; and (b) a coupler, the coupler comprising: (i) A cylindrical shaft, the cylindrical shaft comprising: (A) Proximal end, (B) a distal end, and (C) a lumen extending along an axis from the proximal end to the distal end, the lumen being sized to receive the end effector and the catheter, and (ii) A coupling member attached to the cylindrical shaft. 17. The kit according to claim 16 further includes a catheter delivery sheath, the catheter delivery sheath including an insertion port defining a longitudinal axis, the coupling member being configured to be selectively secured to the catheter delivery sheath, the coupling member being configured to align the axis of the lumen with the longitudinal axis of the insertion port when the coupling member is selectively secured to the catheter delivery sheath. 18. The kit of claim 17, the coupling member being configured to at least one of threadably, snap-fit, or bayonetly engage the catheter delivery sheath. 19. A kit, comprising: (a) A catheter device, the catheter device comprising: (i) a catheter having a distal end, and (ii) an end effector at a distal end of the catheter, the catheter and the end effector being sized to fit within an anatomical structure, the end effector comprising at least one electrode; and (b) a coupler, the coupler comprising: (i) A cylindrical shaft, the cylindrical shaft comprising: (A) Proximal end, (B) a distal end, and (C) a lumen extending along an axis from the proximal end to the distal end, the lumen being sized to receive the end effector and the catheter, and (ii) means for coupling, the means for coupling being attached to the cylindrical shaft. 20. The kit of claim 19, the means for coupling comprising threads, snap-fit features, bayonet-fit features, or functional equivalents thereof. 21. A method comprising: A coupler is secured to the catheter delivery sheath, the coupler comprising: (i) A cylindrical shaft, the cylindrical shaft comprising: (A) Proximal end, (B) a distal end, and (C) a lumen extending along an axis from the proximal end to the distal end, the lumen being sized to receive an end effector and a catheter of a catheter device, and (ii) a coupling member attached to the cylindrical shaft, The act of securing includes aligning the axis of the lumen with the longitudinal axis of the insertion port of the catheter delivery sheath. 22. The method of claim 21, the act of securing comprising providing at least one of a threaded engagement, a snap-fit engagement, or a bayonet engagement between the coupling member and the catheter delivery sheath. 23. The coupler of any one of claims 1, the lumen comprising a frustoconical proximal portion. 24. The coupler of claim 23, the frustoconical proximal portion extending distally from the proximal end. 25. The coupler of any one of claims 23, the frustoconical proximal portion tapering radially inwardly in a distal direction. 26. The kit of any one of claims 16, the lumen comprising a frustoconical proximal portion. 27. The kit of claim 26, the frustoconical proximal portion extending distally from the proximal end. 28. The kit of any one of claims 26, the frustoconical proximal portion tapering radially inwardly in a distal direction. 29. A delivery sheath-catheter coupler, the coupler comprising: (a) a cylindrical shaft extending along an axis, the cylindrical shaft being configured for longitudinal alignment with an insertion port of a catheter delivery sheath, the cylindrical shaft comprising: (i) the proximal end, (ii) a distal end, and (iii) a lumen extending along the axis from the proximal end to the distal end, the lumen being sized to receive an end effector of a catheter, the lumen including a frustoconical proximal portion; and (b) a cap attached to the distal end of the cylindrical shaft, the cap being configured to be selectively aligned with the catheter delivery sheath, the cap being configured to align the axis of the lumen with the longitudinal axis of the insertion port when the coupling member is selectively aligned with the catheter delivery sheath. 30. The coupler of claim 29, the cap being configured for selective securability to the catheter delivery sheath. 31. The coupler of any one of claims 29, the cap fixedly attached to the distal end of the cylindrical shaft. 32. The coupler of any one of claims 29, the cap being attached to the distal end of the cylindrical shaft while also being movable relative to the cylindrical shaft. 33. The coupler of claim 32, the cap being configured to translate relative to the cylindrical shaft along the axis of the lumen. 34. The coupler of any one of claims 30, the cap being configured to at least one of threadably, snap-fit, interference-fit, or bayonet-engage the catheter delivery sheath. 35. The coupler of any one of claims 29, further comprising a catheter disposed in the lumen, the catheter being configured to fit within an anatomical structure. 36. The coupler of any one of claim 29, further comprising a catheter delivery sheath having an insertion port configured to be longitudinally aligned with the cylindrical axis, the insertion port defining a longitudinal axis, the coupling member being configured to align the axis of the lumen with the longitudinal axis of the insertion port when the coupling member is aligned with the catheter delivery sheath.