CN117899334A

CN117899334A - Catheterization tool

Info

Publication number: CN117899334A
Application number: CN202311341357.1A
Authority: CN
Inventors: C·T·贝克勒; K·M·奥卡尔斯基; J·T·凯斯; K·J·埃雷拉; R·B·卡托
Original assignee: Biosense Webster Israel Ltd
Current assignee: Biosense Webster Israel Ltd
Priority date: 2022-10-18
Filing date: 2023-10-17
Publication date: 2024-04-19

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 tool

Cross Reference to Related Applications

The present application claims priority and benefit from U.S. provisional patent application number 63/417,162 filed on 10 months of 2022 and U.S. provisional patent application number 63/436,022 filed on 29 months of 2022, the disclosures of both of which are incorporated herein by reference in their entireties.

Background

Arrhythmia, such as atrial fibrillation, occurs when areas of cardiac tissue conduct electrical signals abnormally. Procedures for treating cardiac arrhythmias include surgical disruption of the conduction pathways for such signals. By selectively applying electrical energy to heart tissue, it is possible to stop or alter the propagation of unwanted electrical signals from one portion of the heart to another. Some such ablation treatments may include Radio Frequency (RF) ablation with Alternating Current (AC) electrical energy; and/or irreversible electroporation (IRE) via pulsed field Direct Current (DC) electrical energy. The ablation process may provide a barrier to unwanted electrical pathways by forming electrically insulating lesions or scar tissue that effectively block communication of abnormal electrical signals across the ablated tissue.

In some procedures, a catheter with one or more electrodes may be used to provide ablation within a patient. The catheter may be inserted into a main vein or artery (e.g., femoral artery) and then advanced to position the electrodes within the heart or in a structure adjacent to the heart (e.g., pulmonary vein). One or more electrodes may be placed in contact with heart tissue or other vascular tissue and then activated with electrical energy, thereby ablating the contacted tissue (e.g., via RF energy, IRE, etc.). In some cases, the electrodes may be bipolar. In some other cases, the monopolar electrode may be used in combination with a ground pad or other reference electrode that is in contact with the patient. Irrigation may be used to absorb heat from a component of the ablation catheter; and prevents the formation of blood clots near the tissue treatment site.

Examples of ablation catheters are described in the following documents: U.S. publication No. 2013/0030426, entitled "INTEGRATED ABLATION SYSTEM USING CATHETER WITH Multiple Irrigation Lumens", published on month 1, 31 of 2013, the disclosure of which is incorporated herein by reference in its entirety; U.S. publication 2017/0312022, entitled "IRRIGATED BALLOON CATHETER WITH Flexible Circuit Electrode Assembly", published on month 11 and 2 of 2017, the disclosure of which is incorporated herein by reference in its entirety; U.S. publication 2018/007137, entitled "absorption CATHETER WITH A Flexible Printed Circuit Board", published on 3/15/2018, the disclosure of which is incorporated herein by reference in its entirety; U.S. publication 2018/0056038, entitled "CATHETER WITH Bipole Electrode SPACER AND RELATED Methods," published on month 1 of 2018, the disclosure of which is incorporated herein by reference in its entirety; U.S. patent 10,130,422, entitled "CATHETER WITH Soft DISTAL TIP for MAPPING AND Ablating Tubular Region," published 11, 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 month 17 of 2015, the disclosure of which is incorporated herein by reference in its entirety; and U.S. patent 9,801,585, entitled "Electrocardiogram Noise Reduction," issued on 10/31/2017, the disclosure of which is incorporated herein by reference in its entirety.

Some catheter ablation procedures may be performed after using Electrophysiology (EP) mapping to identify a tissue region 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 lead to arrhythmias. An example of an EP mapping system is described in U.S. patent No. 5,738,096, entitled "Cardiac Electromechanics," issued 4/14/1998, 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 3/6/2018, the disclosure of which is incorporated herein by reference in its entirety; U.S. patent 10,130,422, entitled "CATHETER WITH Soft DISTAL TIP for MAPPING AND Ablating Tubular Region," published 11, 20, 2018, the disclosure of which is incorporated herein by reference in its entirety; and U.S. publication 2018/0056038 entitled "CATHETER WITH Bipole Electrode SPACER AND RELATED Methods," published on month 1 of 2018, the disclosure of which is incorporated herein by reference in its entirety.

Some catheter ablation procedures may be performed using Image Guided Surgery (IGS) systems. The IGS system may enable a physician to visually track the position of a catheter within a patient in real time relative to an image of an anatomical structure within the patient. Some systems may provide a combination of EP mapping and IGS functions, including CARTO from Biosense Webster limited, erwan, californiaThe system. Examples of catheters configured for use with IGS systems are disclosed in the following documents: U.S. patent 9,480,416, entitled "Signal TransmissionUsing CatheterBraidWires," published 11/1/2016, the disclosure of which is incorporated herein by reference in its entirety; as well as 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, illustrated, and claimed herein.

Disclosure of Invention

In some embodiments, 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, and 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 further 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.

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 along an axis of the lumen relative to the cylindrical shaft.

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 outwardly 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 the insertion port of the catheter delivery sheath.

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

In some embodiments, the coupling member is configured to threadably engage the 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 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 for longitudinal alignment 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 instrument and a coupler. The catheter apparatus comprises: a catheter having a distal end; and an end effector at a distal end of the catheter. The catheter and the end effector are sized to fit within the anatomy 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 sized to receive the end effector and the catheter. The coupling member is attached to the cylindrical shaft.

In some embodiments, the kit further comprises a catheter delivery sheath comprising an insertion port defining a longitudinal axis, and the coupling member is configured for selective fixation to the catheter delivery sheath and alignment of 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 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 instrument and a coupler. The catheter apparatus comprises: a catheter having a distal end; and an end effector at a distal end of the catheter. The catheter and the end effector are sized to fit within the anatomy and the end effector includes at least one electrode. The coupler comprises a cylindrical shaft and 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 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 functional equivalents 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 sized to receive an end effector of a catheter instrument and a catheter. The coupling member is attached to the cylindrical shaft. The act of securing includes aligning an axis of the lumen with a 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 comprises 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 the distal direction.

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

In some embodiments, a delivery sheath-catheter coupler includes a cylindrical shaft and a cap. 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 sized to receive an end effector of a catheter, the lumen including a frustoconical proximal portion. A cap is attached to the distal end of the cylindrical shaft and is configured for selective alignment with the catheter delivery sheath and for aligning 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 securement to the catheter delivery sheath.

In some embodiments, a 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 along the axis of the lumen relative to the cylindrical shaft.

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 configured to fit within the anatomical structure.

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

Drawings

The drawings and detailed description are intended to be illustrative only and are not intended to limit the scope of the invention which the inventors contemplate.

FIG. 1 depicts a schematic view of a medical procedure for inserting a catheter of a catheter assembly into a patient;

FIG. 2 depicts a perspective view of the catheter assembly of FIG. 1 with the end effector in an expanded state;

FIG. 3 depicts a perspective view of an example of a delivery sheath that may be used with the catheter assembly of FIG. 1;

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 a proximal end of the delivery sheath of fig. 3;

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

FIG. 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 screw cap;

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

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

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

Fig. 6D depicts a perspective view of the insertion member of fig. 5 secured to the handle assembly of fig. 5 and guiding 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 insert member assembly and an example of a sheath hub that may be used with the catheter assembly of FIG. 1 and the delivery sheath of FIG. 3, the insert member assembly including a coupling member in the form of a cap having at least one L-shaped bayonet slot;

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

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

FIG. 8C depicts a perspective view of the insert member assembly of FIG. 7 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 insert member assembly to the sheath mount;

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

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

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

FIG. 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 an insertion port of the sheath hub of FIG. 7;

FIG. 10C depicts a perspective view of the insert member assembly of FIG. 9 rotated to engage the J-shaped bayonet slot of the cap with the side port of the sheath mount of FIG. 7 to secure the insert member assembly to the sheath mount;

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

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

FIG. 12 depicts a 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 a cylindrical sidewall with at least one snap-fit slot;

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

FIG. 13B depicts a perspective view of the insert member assembly of FIG. 12 advanced distally to engage the snap-fit slot of the cap with the side port of the sheath mount of FIG. 7 to secure the insert member assembly to the sheath mount;

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

FIG. 14 depicts a 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 a pair of sidewalls with corresponding snap-fit slots;

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

FIG. 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;

FIG. 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 an insertion port of the handle assembly of FIG. 3;

Fig. 18B depicts a perspective view of the insertion member of fig. 17 advanced distally to position a cap of the insertion member over an insertion port of the handle assembly of fig. 3; and

Fig. 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 Description

The following description of certain examples of the invention is not intended to limit the scope of the invention. The drawings, which are not necessarily to scale, depict selected embodiments and are not intended to limit the scope of the invention. The detailed description illustrates by way of example, and not by way of limitation, the principles of the invention. Other examples, features, aspects, embodiments, and advantages of the invention will become apparent to those skilled in the art from the following description, which is by way of example, one of the best modes contemplated for carrying out the invention. As will be realized, the invention is capable of other different or equivalent aspects, all without departing from the invention. Accordingly, the drawings and description are to be regarded as illustrative in nature and not as restrictive.

Any one or more of the teachings, expressions, patterns, examples, etc. described herein can be combined with any one or more of the other teachings, expressions, patterns, examples, etc. described herein. Thus, the following teachings, expressions, versions, examples, etc. should not be considered as being separate from each other. Various suitable ways in which the teachings herein may be combined will be apparent to those skilled in the art in view of the teachings herein. Such modifications and variations are intended to be included within the scope of the appended 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 the purpose they are intended to achieve as described herein. More specifically, "about" or "approximately" may refer to a range of values of ±20% of the recited values, for example "about 90%" may refer to a range of values of 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 use of the subject invention in a human patient represents a preferred embodiment.

I. overview of examples of catheter systems

Fig. 1 shows an exemplary medical procedure and associated components that may be used to provide an EP mapping or cardiac ablation cardiac catheter system as mentioned above. In particular, fig. 1 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 fig. 2 but not shown in fig. 1) of the catheter assembly (100) is disposed within a Patient (PA) to map electrical potentials in tissue and/or ablate tissue in or near a heart (H) of the Patient (PA). As shown in fig. 2, 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 a distal end of the catheter (120), and a yaw-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 exerted on the end effector (140), track the position of the end effector (140), and/or disperse irrigation fluid. The yaw 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 with the yaw 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 elongate flexible shaft with an end effector (140) extending distally from the shaft. The proximal end of the conduit (120) extends distally from the nozzle member (116) of the handle assembly (110). In some versions, a heat shrink wrap (not shown) is provided around the catheter (120) at the junction of the proximal end of the catheter (120) and the nozzle member (116). The end effector (140) at the distal end of the catheter (120) will be described in more detail below. The catheter assembly (100) is coupled to the guidance and drive system (10) via a cable (30). The catheter assembly (100) is also coupled to a fluid source (42) via a fluid conduit (40). A set of field generators (20) is positioned underneath the Patient (PA) and coupled with the guidance and drive system (10) via another cable (22). The field generator (20) is 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 with the catheter assembly (100) via a cable (30). In some variations, the first driver module (14) is operable to receive EP mapping signals obtained via electrodes of the 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 still other versions, the end effector (140) does not provide EP mapping.

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

The second driver module (16) is coupled with 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 comprise coils generating an alternating magnetic field in a predetermined working volume accommodating the heart (H).

The first driver module (14) is also operable to receive a position indication signal from a navigation sensor assembly (not shown) in the catheter (120) proximate to the end effector (140). In such versions, the processor of the console (12) is also operable to process the position indication signal from the navigation sensor assembly to determine the position of the end effector (140) within the Patient (PA). In some versions, the navigation sensor assembly includes two or more coils operable to generate signals indicative of a position and orientation of the end effector (140) within a Patient (PA). The coil is configured to generate an electrical signal in response to the presence of an alternating electromagnetic field generated by a field generator (20). Other components and techniques that may 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 disposed in the distal end of the catheter (120), the navigation sensor assembly may alternatively be positioned in the end effector (140). Alternatively, the catheter (120) and the end effector (140) may not have a navigation sensor assembly.

A display (18) is coupled with the processor of the console (12) and is operable to present an image of the patient anatomy. Such images may be based on a set of pre-or intra-operative images (e.g., CT or MRI scans, 3D maps, etc.). The view of the patient anatomy provided by the display (18) may also be dynamically changed based on signals 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), corresponding position data from the navigation sensor assembly may cause the processor of the console (12) to update the view of the patient anatomy in the display (18) in real time to delineate the region of the patient anatomy around the end effector (140) as the end effector (140) moves within the Patient (PA). Further, the processor of the console (12) may drive the display (18) to display the location of abnormal electrically conductive tissue sites detected via Electrophysiology (EP) mapping with the end effector (140) or otherwise (e.g., using a dedicated EP mapping catheter, etc.). By way of example only, the processor of the console (12) may drive the display (18) to superimpose the location of the site of abnormal conductive tissue on the image of the patient anatomy, such as by superimposing an illuminated point, a cross-hair, or some other form of visual indication of the site of abnormal conductive tissue.

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 anatomy, such as by superimposing a graphical representation of the illuminated point, cross-hair, end effector (140), or some other form of visual indication. Such superimposed visual indications may also move in real time within the image of the patient's anatomy on the display (18) as the physician moves the end effector (140) within the Patient (PA), thereby providing real-time visual feedback to the operator regarding the position of the end effector (140) within the Patient (PA) as the end effector (140) moves within the Patient (PA). Thus, the image provided by the display (18) can effectively provide video tracking the position of the end effector (140) within the Patient (PA) without having 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 the abnormal electrically conductive tissue site detected by the EP mapping. Thus, the Physician (PH) can view the display (18) to view the real-time positioning of the end effector (140) relative to the mapped abnormal conductive tissue site and relative to the images of adjacent anatomical structures within the Patient (PA).

The fluid source (42) of this example includes a bag containing saline or some other suitable flushing fluid. The conduit (40) includes a flexible tube that is further coupled to a pump (44) operable to selectively drive fluid from a fluid source (42) to the catheter assembly (100). Such irrigation fluid may be expelled through an opening (not shown) of the end effector (140). Such flushing may be provided in any suitable manner that will be apparent to those skilled in the art in view of the teachings herein.

Example of end effector

As described above, 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 exerted on the end effector (140), track the position of the end effector (140) within a Patient (PA), and emit irrigation fluid. However, it should be understood that the version of the end effector (140) is merely one illustrative example. Various other types of end effectors may be used, including, but not limited to, end effectors having a helical configuration, end effectors having a basket configuration, end effectors having a wire frame configuration, or end effectors having any other suitable configuration.

As shown in fig. 2, the end effector (140) of the present example includes an inflatable balloon (142) and a set of electrode assemblies (150) angularly spaced from one another about the balloon (142). The balloon (142) is operable to transition between a non-inflated state (not shown) and an inflated state (fig. 2). The balloon (142) is inflatable with an irrigation fluid (e.g., saline) from a fluid source (42), wherein the pump (44) provides pressure to the fluid to transition from a non-inflated state to an inflated state. In the non-inflated state, the balloon (142) may fit 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 inflated state, the balloon (142) may be sized and configured 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 inextensible material.

Each electrode assembly (150) of the present example includes a flexible substrate and electrodes, which may be formed as a flexible circuit. The electrode of the present example is operable to ablate tissue in contact with the electrode. The electrode may be further constructed and operated in accordance with at least some of the teachings of U.S. publication 2017/0312022, entitled "IRRIGATED BALLOON CATHETER WITH Flexible Circuit Electrode Assembly," published 11/2, which publication is incorporated herein by reference.

In some versions, the electrodes are configured to provide both an electrical energy (e.g., RF or IRE, etc.) ablation function and an EP mapping function. In some other versions, the electrodes are configured to provide only electrical energy ablation functionality and not EP mapping functionality. In still other versions, the electrodes are configured only to provide EP mapping functionality and not 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. Other suitable configurations and functions that may be associated with an electrode will be apparent to those skilled in the art in view of the teachings herein.

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 2017/0312022, entitled "IRRIGATED BALLOON CATHETER WITH Flexible Circuit Electrode Assembly", published on 11/2 of 2017, the disclosure of which is incorporated herein by reference; and/or U.S. publication No. 2021/032994, entitled "Pressure Relief Feature for IRRIGATED RF balloon catheter", published on month 21 of 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, the end effector (140) may have any other suitable type of inflatable balloon configuration, any suitable type of inflatable basket configuration, or any other suitable type of inflatable configuration. In some versions, the end effector (140) may be configured to define a helical shape when in an expanded state. For example, the end effector (140) may be constructed and operated in accordance with one or more teachings of U.S. publication No. 2021/0085386, titled "Catheter Instrument WITH THREE Pull Wires," published 3/25 of 2021, the disclosure of which is incorporated herein by reference. In some other versions, the end effector (140) may include a plurality of ring members including respective pairs of spines configured to expand when in an expanded state. For example, the end effector (140) may be constructed and operated in accordance with one or more teachings of U.S. publication 2020/0345262, titled "MAPPING GRID WITH HIGH DENSITY electric Array," published at 11/5, 2021, the disclosure of which is incorporated herein by reference. Alternatively, the end effector (140) may take any other suitable form.

Example of delivery sheath

In some procedures, a Physician (PH) may desire to introduce a catheter (120) into a Patient (PA) via a delivery sheath. In some such procedures, the delivery sheath may be inserted into the Patient (PA) (e.g., via the leg or groin of the Patient (PA)); and then advanced along veins or arteries to reach locations in or near the heart (H). Once the delivery sheath is properly positioned within the Patient (PA), the Physician (PH) may then advance the end effector (140) and catheter (120) into the delivery sheath. The end effector (140) may be in a non-expanded state during transition from the insertion site to a target region within a 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 inflated by inflating the balloon (142) to the state shown in fig. 2 to bring the electrodes into contact with 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 kind of operation in or near the heart (H) of the Patient (PA). The end effector (140) may then be collapsed to a non-expanded configuration by deflating the balloon (142) and/or otherwise deflating the end effector (140) so as to retract through the delivery sheath.

Fig. 3 shows an example of a delivery sheath (200) that may 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 for grasping by the housing (212). The open distal end (240) of the hollow shaft (220) is operable to deflect laterally away from the Longitudinal Axis (LA) of the shaft. The deflection is controlled by a knob (214) at a distal end (216) of the handle assembly (210). The knob (214) is rotatable relative to the housing (212) about the Longitudinal Axis (LA) to actuate components that drive lateral deflection of the open distal end (240) of the hollow shaft (220). By way of example only, such actuation components may include one or more pull wires, straps, or any other suitable structure, as will be apparent to those skilled in the art in view of the teachings herein.

As shown in fig. 3, 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 an interior of the hollow shaft (220). The tube (202) of the present example is also in fluid communication with a fluid source (204). By way of example only, the fluid source (204) may comprise saline or any other suitable fluid. In some cases, fluid from the fluid source (204) is communicated through the tube (202), a hollow interior region defined within the handle assembly (210), and an interior of the hollow shaft (220), thereby flushing a 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 fig. 3, the proximal end (218) of the handle assembly (210) further 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 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 example insertion port (250) includes an annular protrusion (252) defining an opening (254). A protrusion (252) protrudes proximally from the housing (212) at a proximal end (218). In some versions, the protrusion (252) is omitted.

A seal (260) is positioned within the opening (254). By way of example only, with reference to the teachings herein, the seal (260) may include an elastomeric film or other type of component, as will be apparent to those skilled in the art. The seal (260) of the present 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 the seal (260). In this example, the slot arrangement (262) is in the form of a "+" symbol, but any other suitable kind of configuration may be used. When no substance is inserted through the seal (260), the seal (260) is configured to provide a fluid-tight seal that prevents fluid from escaping through the insertion port (250) from the portion of the fluid path defined within the handle assembly (210); and prevents air from entering the aforementioned fluid path defined within the handle assembly (210) via the insertion port (250). When an instrument is inserted through the seal (260), the seal (260) still substantially maintains the fluid-tight seal of the port (250), thereby preventing fluid from escaping the aforementioned fluid path defined within the handle assembly (210) via the insertion port (250); and prevents air from entering the aforementioned fluid path defined within the handle assembly (210) via the insertion port (250), while still allowing translation of the inserted instrument relative to the seal (260). Thus, regardless of whether the instrument is disposed in the insertion port (250), the seal (260) prevents fluid from leaking out through the insertion port (250) and prevents air from being drawn into the heart (H) of the Patient (PA) via the insertion port (250).

In some versions, the delivery sheath (200) resembles a CARTO from Biosense Webster, inc. of Erwan, californiaThe bi-directional delivery sheath is constructed and operates as it were.

Example of cylindrical insertion Member with flare end

In some procedures, the end effector (140) and catheter (120) may be inserted directly into the insertion port (250) to enter the shaft (220) and thereby exit the distal end (240) of the shaft (220). In some such procedures, a rigid cylindrical insert member is first inserted through a seal (260) at a slit arrangement (262); and then distally advancing the end effector (140) and catheter (120) through the hollow interior of the cylindrical insertion member. The cylindrical insert may help provide initial penetration of the seal (260) for the end effector (140) and the catheter (120), which may otherwise be quite difficult for relatively smaller diameter end effectors (140) and catheters (120) and/or for flexible (e.g., expandable) end effectors (140). Such cylindrical insert members may be formed as pure cylinders (e.g., straight tubes having uniform inner and outer diameters along their entire length). The catheter assembly (100) may be advanced distally to a point where a nozzle member (116) of the handle assembly (110) reaches a proximal end of the cylindrical insertion member. In such cases, 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 promote kinking at the proximal end of the catheter (120). Accordingly, it may be desirable to provide some 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 the point where the proximal end of the cylindrical insertion member passes completely through the seal (260). This can be a particular risk in the case where the catheter (120) and cylindrical insertion member used by the Physician (PH) are smaller in size (e.g., 8 french) than 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 beyond the seal (260), it may be difficult or impossible to remove the cylindrical insertion member from the handle assembly (210). Additionally or alternatively, the jamming of the insert member into the seal (260) may prevent the seal (260) from providing a fluid-tight seal at the insert port (250) such that air or other fluid may leak out through the insert 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), such that the cylindrical insertion member undesirably deposits into the Patient (PA). Accordingly, it may be desirable to provide some type of insert member that eliminates or otherwise reduces the risk of the insert member passing completely through the seal (260) or other portion of the insert port (250).

Fig. 4A-4C illustrate examples of insertion members (300) that may be used to facilitate insertion of 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 flare proximal portion (304). The distal portion (302) is in the form of a right circular cylinder shaft and defines a lumen (not shown) that terminates proximally at the flared proximal portion (304) and distally at the distal end (310) of the insertion member (300). The proximal portion (304) has a frustoconical shape leading to the lumen and defines a proximal end (312) of the insertion member (300). Thus, the proximal portion (304) tapers inwardly in a proximal-to-distal direction toward a central Longitudinal Axis (LA) of the insertion member (300). In this example, the insert 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 freely slide 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 facilitates insertion of the end effector (140) and catheter (120) into the proximal end (312) of the insertion member (300). The length of the insertion member (300) can be substantially less than the length of the catheter (120) such that the end effector (140) can protrude distally beyond the distal end (310) of the insertion member (300), with the insertion member (300) disposed about the catheter (120).

In an example using the insertion member (300), the insertion member (300) can first be partially disposed about the distal end portion of the end effector (140) and 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 an 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 disposed longitudinally 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), end effector (140), and catheter (120) distally toward the insertion port (250) such that the distal end (310) of the insertion member (300) penetrates the seal (260) at the slit arrangement (262), as shown 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 such 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) advances, 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 the unexpanded state such that the end effector (140) may be selectively transitioned to the expanded state. In some versions of this procedure, after the state shown in fig. 4C is reached, the insertion member (300) is retracted proximally relative to the catheter (120) as the Physician (PH) continues to advance the catheter (120) distally. In other words, the distal end (310) of the insertion member (300) may be proximal to the insertion port (250) during at least a portion of a procedure in which the catheter (120) is advanced distally into the delivery sheath (200).

In some scenarios, during normal operation of the catheter assembly (100) and the 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) and the insertion member (300) of the handle assembly (110) are both proximally spaced 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 distally exposed from the shaft (220) and thus operate within the heart (H) of the Patient (PA) without the insertion member (300) contacting the insertion port (250); and the nozzle member (116) need not contact the insert member (300). In such a scenario, the insertion member (300) may simply be positioned around an area of the conduit (120) longitudinally interposed between the insertion port (250) and the nozzle member (116) of the handle assembly (110).

With the Physician (PH) continuing 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 ultimately 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 such interaction between the flared proximal portion (304) of the insertion member (300) and the annular protrusion (252) of the insertion port (250) will prevent the insertion member (300) from being advanced further distally into the insertion port (250).

While in the foregoing examples, the flare 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 flare proximal portion (304) and the seal (260). In such a scenario, the annular protrusion (252) may not exist at all. Alternatively, the outer diameter of the flare proximal portion (304) may be sized to pass through the opening defined by the annular projection (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 to prevent the flare proximal portion (304) of the insertion member (300) from passing through the seal (260). As another merely exemplary alternative, the insertion port (250) may include some other structure that engages the annular protrusion (252) and thereby prevents insertion of the insertion member (300) through the insertion port (250).

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

In some variations of the above procedure, 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 catheter (120) may be completely disengaged from the insertion member (300). In some such variations of this procedure, prior to inserting the end effector (140) and catheter (120) into the insertion member (300), the insertion member (300) is first fully inserted into the insertion port (250) until the point at which the flared proximal portion (304) of the insertion member (300) engages the annular projection (252) of the insertion port (250).

V. examples of insertion devices with coupling members

In some scenarios, it may be desirable to secure an insertion device like an insertion member (300) to a sheath-handle assembly like a handle assembly (210), wherein a longitudinal axis of the insertion member (300) is aligned with a longitudinal axis of the insertion port (250) and thus with a Longitudinal Axis (LA) of the delivery sheath (200), such as for centering a distal end of the catheter (120) relative to a slit arrangement (262) of the seal (260) when the catheter (120) is advanced through the insertion member (300), and/or for orthogonally orienting the longitudinal axis of the catheter (120) relative to a plane defined by the seal (260) when the catheter (120) is advanced through the insertion member (300). Such securement 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 securement 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 hand of the operator (e.g., without having to hold the insertion member (300) with that hand at the same time) while inserting the catheter (120) with the other hand of the operator through the seal (260). With reference to the foregoing, it may be desirable to add a coupling member to the insert member (300) to facilitate such securement of the insert member (300) to the handle assembly (210). Examples of the various forms that such coupling members may take will be described in more detail below.

Although the examples described below are provided in the context of insertion of a catheter (120) 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 kind of instrument (e.g., a dilator, another non-catheter instrument, etc.) is inserted into the delivery sheath (200).

A. examples of cylindrical insert member with threaded distal cap portion

Fig. 5-6D illustrate a proximal portion of another example of a handle assembly (400) that may be incorporated into a delivery sheath (200) in place of the handle assembly (300), and an example of an insertion member (402) that may be selectively secured 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 insert member (402) are similar to the handle assembly (210) and the insert member (300), respectively, described above, except as described further below. The handle assembly (400) of this example is configured to be gripped 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) defining a Longitudinal Axis (LA) and including an annular protrusion (416) defining an opening (418) and protruding proximally from the housing (410) at the proximal end (412). The seal (420) is positioned within the opening (418) and includes a slit arrangement (422) configured to facilitate insertion of an instrument (e.g., catheter (120), etc.) through the seal (420). In this example, the slot arrangement (422) is in the form of a "+" symbol, but any other suitable kind of configuration may be used.

As shown, the insertion port (414) also includes threads in the form of helical ridges (430) extending radially outwardly from the generally cylindrical outer surface of the annular projection (416) for threadably engaging corresponding portions of the insertion member (402), as described in more detail below. In some versions, the ridge (430) may also be configured to threadably engage a corresponding portion of a balloon dilation catheter assembly (not shown), such as a HELIOSTAR ^TM balloon ablation catheter's dilator cap by Biosense Webster, inc. In this regard, the handle assembly (400) may be configured similar to the handle assembly of GUIDESTAR ^TM introducer sheath of Biosense Webster, inc.

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 flare distal portion (458). The main portion (456) is in the form of a right circular cylinder, while the distal portion (458) has a frustoconical shape such that the distal portion (458) tapers radially outwardly from the main portion (456) to the distal end (454) of the tube (450). The main portion (456) and the distal portion (458) together define a lumen (460) extending longitudinally between the proximal and distal ends (452, 454) of the tube (450) and sized to closely complement the outer diameter of the catheter (120) while allowing the catheter (120) to freely slide through the tube (450). The lumen (460) may be sized to constrain the end effector (140) to a non-expanded state when the end effector (140) is positioned within the lumen (460). In this example, the tube (450) is substantially rigid. In some variations, both the proximal end (452) and the distal portion (458) are flared. In some other variations, the proximal end (452) is flared, but the 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) that is coaxially disposed with the tube (450). The cap (470) includes a generally flat and/or dome-shaped proximal end wall (472) and a generally annular distal side wall (474), the proximal end wall extending radially outward relative to the main portion (456) of the tube (450) at or near an interface between the main and distal portions (456, 458), such as at a location slightly proximal of the distal portion (458). In the example shown, the sidewall (474) of the cap (470) extends circumferentially around the distal portion (458) such that a generally cylindrical inner surface of the sidewall (474) faces the generally frustoconical outer surface of the distal portion (458), the clearance gap between the generally cylindrical inner surface of the sidewall (474) and the generally frustoconical outer surface of the distal portion (458) being sufficiently large to receive the annular projection (416) of the insertion port (414).

The cap (470) of the present example also includes threads in the form of helical grooves (480) extending radially outward from the generally cylindrical inner surface of the sidewall (474) for threadably engaging the ridges (430) of the insertion port (414). The groove (480) may extend along a helical path similar to the helical path of the ridge (430) to facilitate threaded engagement between the groove (480) and the ridge (430). It should be appreciated that the threads of the insertion port (414) and cap (470) may be of any suitable form for threadably engaging one another, and are not limited to the particular configuration of ridges (430) and grooves (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) may facilitate secure coupling of the insertion member (402) with the handle assembly (400), wherein a longitudinal axis of the insertion member (402) (and more particularly, a longitudinal axis of the lumen (460)) is aligned with a Longitudinal Axis (LA) of the insertion port (414). In this way, when the insert member (402) is secured to the handle assembly (400), the lumen (460) may be centered with respect to the slit arrangement (422) of the seal (420) and may be orthogonally oriented with respect to a plane defined by the seal (420). In some versions, the distal end (454) of the tube (450) may be configured to abut a proximal surface of the seal (420) when the insert 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 projection (416) of the insertion port (414); but may prevent insertion of the distal end (454) 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) sized on a french catheter scale, for example, from about 13.5 french to about 14 french. In some other versions, the flared configuration of the distal portion (458) of the tube (450) may prevent insertion of the distal end (454) into the insertion port (414).

In the example shown, the sidewall (474) of the cap (470) further includes a plurality of flat outer surfaces (490) configured to be gripped by a Practitioner (PH) or other operator for assisting the operator in rotating the cap (470) relative to the handle assembly (400) to threadably engage the groove (480) with the ridge (430) and/or threadably disengage the groove (480) from the ridge (430). The cap (470) of the present example further includes at least one vent hole or bleed aperture (492) extending through the end wall (472) for venting 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 an exterior of the cap (470) when the cap (470) is secured to the handle assembly (400).

The insert member (402) may be constructed of any suitable translucent (e.g., transparent) or opaque material, such as a polymeric material (e.g., plastic) or a metallic material. Other suitable materials that may be used to form the insert member (402) will be apparent to those skilled in the art in view of the teachings herein. In the example shown, the tube (450) and the cap (470) are integrally formed with one another as a unitary (e.g., one piece) to define the insert member (402). In this regard, the insert member (402) may be manufactured via 3D printing, injection molding, investment casting, machining, and/or any other suitable manufacturing technique. In other versions, the tube (450) and the cap (470) are separately formed as discrete pieces independent of each other and coupled to each other to define the insert member (402), such that the insert member (402) may be referred to as an assembly. It should be appreciated that the tube (450) and cap (470) may be constructed of the same or different materials. Although the tube (450) of the present example is fixed against movement relative to the cap (470), the tube (450) may alternatively be movable relative to the cap (470). For example, the tube (450) may be slidably coupled to the cap (470) to facilitate longitudinal sliding of the tube (450) relative to the cap (470), such as in a manner similar to any of those described below in connection with fig. 7-14.

Although the distal portion (458) of the tube (450) is flared in this example, the distal portion (458) may alternatively be cylindrical. For example, the distal portion (458) may be in the form of a right circular cylinder having an inner and outer dimension similar to the inner and outer dimension 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 connection with fig. 4A-4C and/or below in connection with fig. 7-14. In some such cases, the tube (450) may include a flared proximal portion (not shown) having a frustoconical shape such that the proximal portion tapers radially outward from a main portion (456) to a proximal end (452) of the tube (450), and the flared proximal portion cooperates with the main portion (456) to define a lumen (460). Such a flare proximal portion may provide an introduction end for facilitating insertion of the end effector (140) and catheter (120) into the proximal end (452) of the tube (450). In some other versions, the tube (450) may include both a flare distal portion (458) and such a flare proximal portion.

Although not shown, the insert member (402) may include any one or more of a sealing member, a reinforcing 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. 2021/01102812, entitled "FLARED INSERT Member for Use WITH CATHETER Assembly," published on month 22 of 2021, the disclosure of which is incorporated herein by reference in its entirety.

In examples using the insertion member (402), the Longitudinal Axis (LA) of the insertion member (402) may be aligned with the Longitudinal Axis (LA) of the insertion port (414), as shown in fig. 6A. Next, the Physician (PH) may advance the insertion member (402) distally toward the insertion port (414) such that the annular projection (416) of the insertion port (414) is at least partially received between the generally cylindrical inner surface of the sidewall (474) of the cap (470) and the generally frustoconical outer surface of the distal portion (458) of the tube (450), as shown in fig. 6B. The Physician (PH) may 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 fig. 6C.

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 with respect to the slit arrangement (422) of the seal (420) and oriented orthogonally with respect to a 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 appreciated that the seal (420) may 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) may be performed prior to the insertion of the end effector (140) and 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 catheter (120) can pass distally through the interior of the shaft (220), as shown in fig. 6D. The end effector (140) eventually reaches a point of the end effector (140) distal to the distal end (240) of the shaft (220) such that the end effector (140) may be selectively transitioned to the expanded state.

B. Examples of insert member assemblies having distal caps with L-shaped bayonet slots

Fig. 7-8D illustrate examples of sheath mounts (500) for another handle assembly that may be incorporated into the delivery sheath (200) in place of the handle assembly (210), and examples of insert member assemblies (502) that may be selectively secured to the sheath mounts (500) and used in a manner similar to that described above for the insert member (300). The sheath mount (500) may be incorporated into a handle assembly similar to the handle assembly (210), and the insert member assembly (502) is similar to the insert member (402) described above, except as described further below. In particular, the sheath hub (500) may extend perpendicularly from the handle assembly and may be rigidly fixed relative to the housing of the handle assembly, thereby providing a mechanical basis for the insertion member assembly (502) relative to the handle assembly of the delivery sheath. The sheath mount (500) of this example has a body (510) configured to be coupled to a housing (not shown) similar to the housing (410) and including a proximal end (512) and a distal end (513). The proximal end (512) has an insertion port (514) defining a Longitudinal Axis (LA) and including an annular protrusion (516) defining an opening (518) and protruding proximally from the body (510) at the proximal end (512). The seal (520) is positioned within the opening (518) and includes a slit arrangement (522) configured to facilitate insertion of an instrument (e.g., catheter (120), etc.) through the seal (520). In this example, the slot arrangement (522) is in the form of a "#" symbol, but any other suitable kind of configuration may be used.

As shown, the sheath mount (500) further includes a protrusion in the form of a side port (530) extending radially outward from the body (510) near the proximal end (512) for engaging a corresponding portion of the insertion member assembly (502), as described in more detail below. In the example shown, the sheath hub (500) further includes an elongate tab (532) extending radially outward from the body (510) between the side port (530) and the proximal end (512). In some versions, side port (530) may be configured to be selectively fluidly coupled to a fluid source (not shown). Such fluid sources may include saline, fluoroscopic contrast fluid, and/or any other suitable kind of fluid. Fluid from a fluid source may reach the hollow shaft (220) via the side port (530); and finally can be expelled from the open distal end (240) of the hollow shaft (220). By way of further example only, the sheath hub (500) may be configured to resemble CARTO from Biosense Webster, inc. of Erwan, califA sheath hub of the introducer sheath.

The example insert member assembly (502) includes a tube (550) extending longitudinally between a proximal end (552) and a distal end (554). The tube (550) has a flare proximal portion (555) and a cylindrical main portion (556). The main portion (556) is in the form of a right circular cylinder, while the proximal portion (555) has a frustoconical shape such that the proximal portion (555) tapers radially outwardly from the main portion (556) to the proximal end (552) of the tube (550). The main portion (556) and the proximal portion (555) together define a lumen (560) extending longitudinally between the proximal and distal ends (552, 554) of the tube (550) and sized to closely complement the outer diameter of the catheter (120) while allowing the catheter (120) to freely slide 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 this 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/out in a version of the tube having a thickened sidewall as indicated by the dashed line (557).

The insert member assembly (502) of the present example also includes a coupling member in the form of a distal cap (570) that is coaxially disposed with the tube (550). The cap (570) includes a generally flat proximal end wall (572) that extends radially outward relative to the main portion (556) of the tube (550) and a generally cylindrical distal sidewall (574). In the example shown, the cap (570) includes a central bore (576) extending longitudinally through the end wall (572) and configured to slidably receive the main portion (556) of the tube (550) to facilitate longitudinal sliding of the tube (550) relative to the cap (570). For example, the tube (550) may 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) engages 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) may 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) may be greater than the diameter of the central bore (576). In some versions, a gasket (not shown) may be provided 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 cap (570) from rotating relative to one another about the longitudinal axis of the insert member assembly (502) while allowing such longitudinal sliding. In still other variations, the tube (550) is rigidly fixed relative to the cap (570) such that the tube (550) is not slidable relative to the cap (570).

In the example shown, the sidewall (574) of the cap (570) extends circumferentially around the region of the main portion (556) such that a generally cylindrical inner surface of the sidewall (574) faces a generally cylindrical outer surface of the main portion (556), and a clearance gap between the generally cylindrical inner surface of the sidewall (574) and the generally cylindrical outer surface of the main portion (556) is sufficiently large to receive the body (510) of the sheath mount (500). In this regard, the generally cylindrical inner surface of the sidewall (574) may be sized to closely complement the outer diameter of the body (510) of the sheath hub (500) while allowing the body (510) of the sheath hub (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 outwardly from a generally cylindrical inner surface of the sidewall (574) to a generally cylindrical outer surface of the sidewall (574) for bayonet-engaging the side port (530) of the sheath mount (500). Although a single slot (580) is shown, other versions may include any other suitable number of slots (580), such as to allow a particular slot (580) to be selected to engage a side port (530). In the example shown, the slot (580) includes a straight distal inlet channel portion (582) extending proximally from the distal end of the cap (570) and an end-closure proximal locking portion (584) extending orthogonally (e.g., at about 90 °) from the inlet channel portion (582) (e.g., in a clockwise direction within the frame of reference of fig. 7) for facilitating bayonet engagement between the slot (580) and the side port (530). For example, the inlet channel portion (582) may be configured to receive and be guided along the side port (530) until the side port (530) reaches the proximal end of the inlet channel portion (582); and the locking portion (584) may be configured to subsequently receive and guide the side port (530) along 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 (e.g., to inhibit proximal translation of the cap (570) relative to the sheath seat (500)) in the absence of an applied concomitant rotational force between the cap (570) and the sheath seat (500).

It should be appreciated that the bayonet features of the sheath hub (500) and cap (570) may be of any suitable form for engaging one another in a bayonet manner, and are not limited to the particular configuration of the side ports (530) and slots (580) shown. For example, while in the present version the side port (530) is configured to engage the slot (580) in a bayonet 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 manner.

The bayonet engagement between the side port (530) or any other such protrusion and slot (580) may facilitate secure coupling of the cap (570) with the sheath seat (500), with the longitudinal axis of the insert member assembly (502) (and more particularly, the longitudinal axis of the lumen (560)) aligned with the Longitudinal Axis (LA) of the insert port (514). In this way, when the cap (570) is secured to the sheath hub (500), the lumen (560) may be centered with respect to the slit arrangement (522) of the seal (520) and may be orthogonally oriented with respect to a plane defined by the seal (520). In some versions, the distal end (554) of the tube (550) may be configured to be inserted through the seal (520) when the cap (570) is secured to the sheath hub (500). In this regard, the cylindrical configuration of the main portion (556) of the tube (550) may allow for insertion of the distal end (554) through the seal (520), and the slidable coupling of the main portion (556) of the tube (550) with the cap (570) may allow for such insertion of the distal end (554) through the seal (520) to be performed while the cap (570) remains fixed to the sheath mount (500). Additionally or alternatively, the flare configuration of the proximal portion (555) of the tube (550) may provide an introduction end for facilitating insertion of the end effector (140) and catheter (120) into the proximal end (552) of the tube (550), and/or the flare configuration may enable the proximal portion (555) to engage a 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 further include at least one vent hole or bleed hole extending through the end wall (572) for venting fluid (e.g., air) from a space between a distal surface of the end wall (572) of the cap (570) and the sheath seat (500) to an exterior of the cap (570) when the cap (570) is secured to the sheath seat (500).

The tube (550) and cap (570) of the insert member assembly (502) may each be composed of any suitable translucent (e.g., transparent) or opaque material, such as a polymeric material (e.g., plastic) or a metallic material. Other suitable materials for forming the tube (550) and cap (570) of the insert member assembly (502) will be apparent to those skilled in the art in view of the teachings herein. In the example shown, the tube (550) and cap (570) are separately formed as discrete pieces independent of one another and are coupled to one another via a central bore (576) to define the insert member assembly (502). In this regard, the tube (550) and cap (570) may each be manufactured via 3D printing, injection molding, investment casting, machining, and/or any other suitable manufacturing technique. Although the tube (550) of the present example is movable relative to the cap (570), the tube (550) may 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 a 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 connection with fig. 5-6D.

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

Although not shown, the tube (550) of the insert member assembly (502) may include any one or more of a sealing member, a reinforcing 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. 2021/01102812, titled "FLARED INSERT Member for Use WITH CATHETER Assembly," published at 22, year 2021, the disclosure of which is incorporated herein by reference in its entirety.

In examples using the insert member assembly (502), the Longitudinal Axis (LA) of the insert member assembly (502) may be aligned with the Longitudinal Axis (LA) of the insert port (514) and the inlet channel portion (582) of the slot (580) may be aligned with the side port (530), as shown in fig. 8A. Next, the Physician (PH) may advance the insertion member assembly (502) distally toward the insertion port (514) such that the body (510) of the sheath seat (500) is at least partially received between the generally cylindrical inner surface of the sidewall (574) of the cap (570) and the generally cylindrical outer surface of the main portion (556) of the tube (550), and such that the side port (530) of the sheath seat (500) is at least partially received within the inlet channel portion (582) of the slot (580), as shown in fig. 8B. The Physician (PH) may then rotate the cap (570) relative to the sheath hub (500) to bayonet engage the slot (580) of the cap (570) with the side port (530) of the sheath hub (500) by capturing the side port (530) within the locking portion (584) of the slot (580), and thereby secure the cap (570) to the sheath hub (500), as shown in fig. 8C.

When the cap (570) is in the secured state shown in fig. 8C, the longitudinal axis of the lumen (560) is aligned with the Longitudinal Axis (LA) of the insertion port (514) such that the lumen (560) is centered with respect to the slit arrangement (522) of the seal (520) and oriented orthogonally with respect to a plane defined by the seal (520). When the cap (570) is initially placed in a secured state, the distal end (554) of the tube (550) may abut or be positioned proximal to a proximal surface of the seal (520) such that the seal (520) can remain unpenetrated during securing of the cap (570) to the sheath mount (500) such that securing of the cap (570) to the sheath mount (500) may be performed prior to insertion of the end effector (140) and catheter (120) into the insertion member assembly (502). Once the cap (570) has been secured to the sheath hub (500), the catheter (120) may be slid through the lumen (560) of the insertion member assembly (502), and the catheter (120) and/or tube (550) may be advanced distally such that the end effector (140) and/or distal end (554) penetrate the seal (520) at the slit arrangement (522) in a manner similar to that described above in connection with fig. 4A-4C.

With the Physician (PH) continuing to advance the catheter assembly (100) distally to the point where the nozzle member (116) of the handle assembly (110) engages the insert member assembly (502), the flare proximal portion (555) of the tube (550) may ultimately engage the end wall (572) of the cap (570), as shown in fig. 8D. 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 flare proximal portion (555) of the tube (550) will engage the periphery of the central bore (576), and this interaction between the flare proximal portion (555) of the tube (550) and the periphery of the central bore (576) will prevent the tube (550) and thereby prevent further distal advancement of the tube (550) into the insertion port (514).

Although the tube (550) is shown in fig. 8C-8D as 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 cap (570) may be integrally formed as a unitary (e.g., one piece) with one another 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 cap (570) are separately formed as discrete pieces independent of each other and coupled to each other to form the insert member assembly (502). Alternatively, the tube (550) and 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. Examples of insert member assemblies having distal caps with J-shaped bayonet slots

Fig. 9-10D illustrate another example of an insertion member assembly (602) that may be selectively secured to a sheath hub (500) and used in a manner similar to that described above for insertion member (300) such that insertion member assembly (602) may be selectively coupled with delivery sheath (200) via sheath hub (500). The insert member assembly (602) is similar to the insert member assembly (502) described above, except as described further below. In this regard, the example insert member assembly (602) 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) may be enhanced by providing a thickened sidewall, as indicated by the dashed 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) sized to closely complement the outer diameter of the catheter (120) while allowing the catheter (120) to freely slide 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 conical lead-in/lead-out in a version of the tube having a thickened sidewall as indicated by the dashed line (657).

The insert 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 example shown, the cap (670) includes a central bore (676) extending longitudinally through the end wall (672) and 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 still other variations, the tube (650) is rigidly fixed relative to the cap (670) such that the tube (650) is not slidable relative to the cap (670).

The cap (670) of the present example further includes a bayonet feature in the form of a generally J-shaped slot (680) extending radially outwardly from a generally cylindrical inner surface of the sidewall (674) to a generally cylindrical outer surface of the sidewall (674) for bayonet-engaging the side port (530) of the sheath mount (500). Although a single slot (680) is shown, other versions may include any other suitable number of slots (680), such as to allow a particular slot (680) to be selected to engage a side port (530). In the example shown, the slot (680) includes a straight inlet channel portion (682) extending proximally from a distal end of the cap (670), an intermediate portion (683) extending proximally and obliquely (e.g., in a clockwise direction within the frame of reference of fig. 9) from the inlet portion (682), and an end-closing locking portion (684) extending at least slightly distally and obliquely (e.g., in a clockwise direction within the frame of reference of fig. 9) from the intermediate portion (683) for facilitating bayonet engagement between the slot (680) and the side port (530). For example, the inlet channel portion (682) may be configured to receive and be guided along the side port (530) until the side port (530) reaches a proximal end of the inlet channel portion (682); the intermediate portion (683) may be configured to subsequently receive and be guided along the side port (530) until the side port (530) reaches a proximal end of the intermediate portion (683); and the locking portion (684) may be configured to subsequently receive and sufficiently capture the side port (530) to inhibit longitudinal movement of the cap (670) and the sheath mount (500) relative to each other (e.g., to inhibit proximal translation of the cap (670) relative to the sheath mount (500)) in the absence of an applied concomitant rotational force between the cap (670) and the sheath mount (500). The bayonet engagement between the side port (530) and the slot (680) may facilitate secure coupling of the cap (670) with the sheath seat (500), with the longitudinal axis of the insertion member assembly (602) (and more particularly, the longitudinal axis of the lumen (660)) aligned with the Longitudinal Axis (LA) of the insertion port (514).

In examples using the insert member assembly (602), the Longitudinal Axis (LA) of the insert member assembly (602) may be aligned with the Longitudinal Axis (LA) of the insert port (514) and the inlet channel portion (682) of the slot (680) may be aligned with the side port (530), as shown in fig. 10A. Next, the Physician (PH) may advance the insertion member assembly (602) distally toward the insertion port (514) such that the body (510) of the sheath hub (500) is at least partially received between the generally cylindrical inner surface of the sidewall (674) of the cap (670) and the generally cylindrical outer surface of the main portion (656) of the tube (650), and such that the side port (530) of the sheath hub (500) is at least partially received within the inlet channel portion (682) of the slot (680), as shown in fig. 10B. The Physician (PH) may then rotate the cap (670) relative to the sheath hub (500) to bayonet engage the slot (680) of the cap (670) with the side port (530) of the sheath hub (500) 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 hub (500), as shown in fig. 10C.

Once the cap (670) has been secured to the sheath mount (500), the catheter (120) may be slid through the lumen (660) of the insertion member assembly (602), and the catheter (120) and/or tube (650) may be advanced distally such that the end effector (140) and/or distal end (654) penetrate the seal (520) at the slit arrangement (522) in a manner similar to that described above in connection with fig. 4A-4C. With the Physician (PH) continuing 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) may ultimately engage the end wall (672) of the cap (670), as shown in fig. 10D. For example, the interaction between the flared proximal portion (655) of the tube (650) and the perimeter of the central bore (676) will inhibit the tube (650) and thereby prevent further distal advancement of the tube (650) into the insertion port (514).

Although the tube (650) is shown slidable relative to the cap (670) in fig. 10C-10D, 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 integrally formed with one another as a unitary (e.g., one piece) 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 separately formed as discrete pieces independent of each other and 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. examples of distal caps with angled snap slots for insertion member assemblies

Fig. 11 shows another example of a coupling member in the form of a distal cap (770) that may be incorporated into an insertion member assembly similar to the insertion member assembly (602) in place of the cap (670) and that may be selectively secured to the sheath mount (500) and used in a manner similar to that described above for the cap (670) such that the insertion member assembly incorporating the cap (770) may be selectively coupled with the delivery sheath (200) via the sheath mount (500). The cap (770) is similar to the cap (670) described above, except as described further 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, the cap (770) may also include a central bore extending longitudinally through the end wall (772) and configured to slidably receive a portion of a tube, such as a main portion (656) of the tube (650), to facilitate longitudinal sliding of the tube (650) relative to the cap (770). Alternatively, a tube like tube (650) may be rigidly fixed relative to the cap (770).

The cap (770) of the present example also includes a bayonet feature in the form of a generally beveled keyhole-shaped slot (780) extending radially outwardly from a generally cylindrical inner surface of the sidewall (774) to a generally cylindrical outer surface of the sidewall (774) for bayonet-type engagement with the side port (530) of the sheath mount (500). 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 a side port (530). In the example shown, the slot (780) includes a beveled inlet channel portion (782) extending proximally and obliquely (e.g., in a clockwise direction within the frame of reference of fig. 11) from the distal end of the cap (770) and an end closure locking portion (784) extending proximally from the inlet channel portion (782) for facilitating bayonet engagement between the slot (780) and the side port (530). For example, the inlet channel portion (782) may be configured to receive and guide the side port (530) along until the side port (530) reaches a proximal end of the inlet channel portion (782); and the locking portion (784) may be configured to subsequently receive and sufficiently capture the side port (530) to inhibit longitudinal movement of the cap (770) and the sheath hub (500) relative to each other (e.g., to inhibit proximal translation of the cap (770) relative to the sheath hub (500)) in the absence of an applied concomitant rotational force between the cap (770) and the sheath hub (500). The bayonet engagement between the side port (530) and the slot (780) may facilitate secure coupling of the cap (770) with the sheath mount (500). In some versions, the locking portion (782) may be sized and configured to provide a snap-fit engagement with the side port (530) to help facilitate secure coupling of the cap (770) with the sheath hub (500).

E. an example of an insert member assembly having a distal cap with a cylindrical sidewall with a snap-fit slot

Fig. 12-13C illustrate another example of an insertion member assembly (802) that may be selectively secured to a sheath hub (500) and used in a manner similar to that described above for insertion member (300) such that insertion member assembly (802) may be selectively coupled with delivery sheath (200) via sheath hub (500). The insert member assembly (802) is similar to the insert member assembly (502) described above, except as described further below. In this regard, the example insertion member assembly (802) includes a substantially rigid tube (850) extending longitudinally between a proximal end (852) and a distal end (854). In some versions, the rigidity of tube (850) may be enhanced by providing a thickened sidewall, as indicated by the dashed line (857) in fig. 12. The tube (850) has a flared proximal portion (855) and a cylindrical main portion (856) that collectively define a lumen (860) sized to closely complement the outer diameter of the catheter (120) while allowing the catheter (120) to freely slide 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 conical lead-in/out in a version of the tube having a thickened sidewall as indicated by the dashed line (857).

The insert 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 example shown, the cap (870) includes a central bore (876) extending longitudinally through the end wall (872) and 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 still other variations, the tube (850) is rigidly fixed relative to the cap (870) such that the tube (850) is not slidable relative to the cap (870).

The cap (870) of the present example also includes a pair of laterally opposing snap-fit features in the form of generally keyhole-shaped slots (880), each slot extending radially through the sidewall (874) for snap-fittingly engaging the side port (530) of the sheath mount (500). While a pair of slots (880) is shown such that either slot (880) may be selected to engage a 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 channel portion (882) extending proximally from a distal end of the cap (870), an intermediate expandable locking portion (883) extending proximally from the inlet channel portion (882), and a proximal end closing elongate 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) may be configured to receive and guide the side port (530) along until the side port (530) reaches the proximal end of the inlet channel portion (882); the locking portion (883) may be configured to subsequently expand sufficiently to receive the side port (530) and to resiliently contract sufficiently to capture the side port (530) to inhibit longitudinal movement of the cap (870) and the sheath hub (500) relative to one another in the absence of an applied threshold longitudinal force between the cap (870) and the sheath hub (500) (e.g., to inhibit proximal translation of the cap (870) relative to the sheath hub (500)); and the elongated portion (884) may be configured to assist in achieving such expansion of the locking portion (883). The inlet channel portion (882) may taper or curve inwardly in a proximal direction to be cammed engaged by the side port (530) as the inlet channel portion (882) is directed therealong to aid in the expansion of the locking portion (883). In the example shown, the cap (870) further includes a pair of elongated slots (890) flanking each of the keyhole-shaped slots (890) to enable a portion of the sidewall (874) between each of the keyhole-shaped slots (880) and the corresponding elongated slot (890) to deflect into the corresponding elongated slot (880), such as during inflation of the respective locking portion (883).

It should be appreciated that the snap-fit features of the sheath hub (500) and cap (870) may be of any suitable form for snap-fit engagement with one another, and are not limited to the particular configuration of the side ports (530) and slots (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 slot (880) may facilitate secure coupling of the cap (870) with the sheath seat (500), with the longitudinal axis of the insertion member assembly (802) (and more particularly, the longitudinal axis of the lumen (860)) aligned with the Longitudinal Axis (LA) of the insertion port (514). In this way, when the cap (870) is secured to the sheath hub (500), the lumen (860) may be centered with respect to the slit arrangement (522) of the seal (520) and may be orthogonally oriented with respect to a plane defined by the seal (520).

In examples using the insert member assembly (802), the Longitudinal Axis (LA) of the insert member assembly (802) may be aligned with the Longitudinal Axis (LA) of the insert port (514), and the inlet channel portion (882) of either slot (880) may be aligned with the side port (530), as shown in fig. 13A. Next, the Physician (PH) may advance the insertion member assembly (802) distally toward the insertion port (514) such that the body (510) of the sheath mount (500) is at least partially received between the generally cylindrical inner surface of the sidewall (874) of the cap (870) and the generally cylindrical outer surface of the main portion (856) of the tube (850), and such that the side port (530) of the sheath mount (500) is at least partially received within the inlet channel portion (882) of the slot (880), and the physician may continue to advance the insertion member assembly (802) distally to snap-fit the slot (880) of the cap (870) with the side port (530) of the sheath mount (500) by capturing the side port (530) within the locking portion (883) of the slot (880), and thereby secure the cap (870) to the sheath mount (500), as shown in fig. 13B.

Once the cap (870) has been secured to the sheath hub (500), the catheter (120) may be slid through the lumen (860) of the insertion member assembly (802), and the catheter (120) and/or tube (850) may be advanced distally such that the end effector (140) and/or distal end (854) penetrate the seal (520) at the slit arrangement (522) in a manner similar to that described above in connection with fig. 4A-4C. With the Physician (PH) continuing 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) may eventually engage the end wall (872) of the cap (870), as shown in fig. 13C. For example, the interaction between the flared proximal portion (855) of the tube (850) and the perimeter of the central bore (876) will inhibit the tube (850) and thereby prevent further distal advancement of the tube (850) into the insertion port (514).

Although the tube (850) is shown slidable relative to the cap (870) in fig. 13B-13C, 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 cap (870) may be integrally formed with one another as a unitary (e.g., one 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 cap (870) are separately formed as discrete pieces independent of each other and coupled to each other to form the insert member assembly (802). Alternatively, tube (850) and cap (870) may have any other suitable relationship with each other and may be formed and/or coupled together using any other suitable technique.

F. examples of insert member assemblies having distal caps with laterally opposing sidewalls with snap-fit slots

Fig. 14 illustrates another example of an insert member assembly (902) that may be selectively secured to a sheath hub (500) and used in a manner similar to that described above for insert member (300) such that insert member assembly (802) may be selectively coupled with delivery sheath (200) via sheath hub (500). The insert member assembly (902) is similar to the insert member assembly (802) described above, except as described further below. In this regard, the example insertion member assembly (902) 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) may be enhanced by providing a thickened sidewall, as indicated by the dashed line (957) in fig. 14. The tube (950) has a flared proximal portion (955) and a cylindrical main portion (956) that collectively define a lumen (960) sized to closely complement the outer diameter of the catheter (120) while allowing the catheter (120) to freely slide 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 distal end (954) may still provide a conical lead-in/out in a version of the tube having a thickened sidewall as indicated by the dashed line (957).

The insert 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) can further 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) is not slidable relative to the cap (970).

The cap (970) of the present example also includes a pair of laterally opposing snap-fit features in the form of generally keyhole-shaped slots (980), each slot extending radially through a corresponding sidewall (974) for snap-fittingly engaging a side port (530) of a sheath mount (500). While a pair of slots (980) is shown, such that either slot (980) may be selected to engage a 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 channel portion (982) extending proximally from a distal end of the cap (970), an intermediate expandable locking portion (983) extending proximally from the inlet channel portion (982), and a proximal end closing elongate portion (984) extending proximally from the locking portion (983) for facilitating a snap-fit engagement between the slot (980) and the side port (530). For example, the inlet channel portion (982) may be configured to receive and guide the side port (530) along until the side port (530) reaches the proximal end of the inlet channel portion (982); the locking portion (983) may be configured to subsequently 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 hub (500) relative to each other (e.g., to inhibit proximal translation of the cap (970) relative to the sheath hub (500)) in the absence of an applied threshold longitudinal force between the cap (970) and the sheath hub (500); and the elongated portion (984) may be configured to assist in achieving such expansion of the locking portion (983). The inlet channel portion (982) may taper or curve inwardly in a proximal direction to cam engagement by the side port (530) as the inlet channel portion (982) is directed along the side port to assist in the expansion of the locking portion (983). In the example shown, the cap (970) further includes a pair of laterally opposing elongate channels (990), each elongate channel extending along an elongate portion (984) of a corresponding slot (980) for slidably receiving the tab (532) of the sheath mount (500) when the side port (530) is captured within the locking portion (983) of the corresponding slot (980). The snap-fit engagement between the side port (530) and the slot (980) may facilitate secure coupling of the cap (970) with the sheath seat (500), with the longitudinal axis of the insert member assembly (902) (and more particularly, the longitudinal axis of the lumen (960)) aligned with the Longitudinal Axis (LA) of the insert port (514).

Example of an end effector with an inflatable basket configuration

As described above, the end effector (140) may have any suitable configuration other than that shown in fig. 2, such as any suitable type of expandable basket configuration. Fig. 15-16 illustrate 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 an end effector (140). The end effector (1040) is similar to the end effector (140) described above, except as described further below. In this regard, the end effector (1040) extends distally from an elongate flexible shaft, such as the shaft of the catheter (120), and is selectively positionable within a hollow shaft, such as the hollow shaft (220) of the delivery sheath (200).

As shown in fig. 15-16, the end effector (1040) of the present example includes an expandable basket assembly (1042) having a plurality of resilient spines (1044) and a plurality of electrodes (1050) mated 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) may be configured to resiliently 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 unexpanded 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) may be sized and configured to urge the electrode (1050) into contact with tissue (e.g., 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 a distal end of the elongate flexible shaft of the catheter (120). The shaft (1060) of the present example includes a plurality of irrigation ports (1062) configured to deliver irrigation fluid to respective electrodes (1050) and/or tissue contacted by the electrodes (1050) (e.g., an 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.

Example insertion devices for use with an expandable basket end effector

As described above, it may be desirable to enhance the rigidity of the tube of the insert member, such as by providing a thickened sidewall as indicated by the dashed line (557,657,857,957) in fig. 7,9, 12, and 14. Additionally or alternatively, it may be desirable to provide an insertion member that may be used to facilitate insertion of the end effector (1040) and catheter (120) through the insertion port (250) of the delivery sheath (200). Fig. 17-18C illustrate another example of an insertion member (1102) that may be selectively secured to a handle assembly (210) and used in a manner similar to that described above for the insertion member (300). The insert member (1102) is similar to the insert member (402) described above, except as described further 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 and the proximal portion (1155) has a frustoconical interior such that the interior of the proximal portion (1155) tapers radially outwardly 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) extending longitudinally between the proximal and distal ends (1152, 1154) of the tube (1150) and sized to be closely complementary to the outer diameter of the catheter (120) while allowing the catheter (120) to freely slide through the tube (1150). The lumen (1160) may 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) may be enhanced by having thickened sidewalls, at least compared to alternative scenarios where 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) may 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 held by a Physician (PH) or other operator for assisting the operator in maneuvering the tube (1150) relative to the handle assembly (210) and/or 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 dome-shaped proximal end wall (1172) and a generally annular distal side wall (1174), the proximal end wall extending radially outward relative to a main portion (1156) of the tube (1150) at or near the distal end (1154) of the tube (1150).

The cap (1170) of the present example also includes a receptacle (1180) defined by a 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 smaller, 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 receptacle (1180) may be set relative to the cross-sectional dimension of receptacle (1180) to allow the generally cylindrical inner surface of sidewall (1174) to frictionally engage the generally cylindrical outer surface of 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) may facilitate secure coupling of the insertion member (1102) with the handle assembly (210), wherein the longitudinal axis of the insertion member (1102) (and more particularly the longitudinal axis of the lumen (1160)) is aligned with the Longitudinal Axis (LA) of the insertion port (250). In this way, when the insert member (1102) is secured to the handle assembly (210), the lumen (1160) may be centered with respect to the slit arrangement (262) of the seal (260) and may be orthogonally oriented with respect to a plane defined by the seal (260). In some versions, the frustoconical interior of the proximal portion (1155) of the tube (1150) may provide an introduction port for facilitating insertion of the end effector (1040) and 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 hole or vent hole extending through the end wall (1172) for venting fluid (e.g., air) from the space between the distal surface of the end wall (1172) of the cap (1170) and the handle assembly (210) to the outside of the cap (1170) when the cap (1170) is secured to the handle assembly (210).

While the insert 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 appreciated that the insert 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 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 manners described above. In some other versions, receptacle (1180) may be configured to receive protrusion (252) without insert member (1102) having to be securely coupled to handle assembly (210). For example, the receptacle (1180) may have a cross-sectional dimension that is substantially greater than a cross-sectional dimension of the protrusion (252) to allow the protrusion (252) to fit loosely within the receptacle (1180).

The insert member (1102) may be constructed 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 constructed of a thermoplastic elastomer, such as polyether block amide (PEBA). Additionally or alternatively, the insert member (1102) may be constructed of a material having a shore hardness of about 63D. Other suitable materials that may be used to form the insert member (1102) will be apparent to those skilled in the art in view of the teachings herein. In the example shown, the tube (1150) and cap (1170) are integrally formed as a unitary (e.g., one piece) with one another to define the insertion 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 technique. In other versions, the tube (1150) and cap (1170) are separately formed as discrete pieces independent of each other and coupled to each other to define the insertion member (1102), such that the insertion member (1102) may be referred to as an assembly. It should be appreciated that the tube (1150) and cap (1170) may be constructed of the same or different materials. Although the tube (1150) of the present example is fixed against movement relative to the cap (1170), the tube (1150) may alternatively be movable relative to the cap (1170). For example, the tube (1150) may be slidably coupled to the cap (1170) to facilitate longitudinal sliding of the tube (1150) relative to the cap (1170), such as in a manner similar to any of those described above in connection with fig. 7-14.

Although not shown, the insert member (1102) may include any one or more of a sealing member, a reinforcing 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. 2021/01102812, entitled "FLARED INSERT Member for Use WITH CATHETER Assembly," published on month 22 of 2021, the disclosure of which is incorporated herein by reference in its entirety.

In examples using the insertion member (1102), the Longitudinal Axis (LA) of the insertion member (1102) may be aligned with the Longitudinal Axis (LA) of the insertion port (250), as shown in fig. 18A. Next, the Physician (PH) may advance the insertion member (1102) distally toward the insertion port (250) such that the annular projection (252) of the insertion port (250) is at least partially received within the receptacle (1180) to frictionally engage the inner surface of the sidewall (1174) with the outer surface of the projection (252) and thereby secure the insertion member (1102) to the handle assembly (210), as shown in fig. 18B.

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 with respect to the slit arrangement (262) of the seal (260) and oriented orthogonally with respect 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 the insertion of the end effector (1040) and 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) 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) such that the end effector (1040) and the catheter (120) can pass distally through the interior of the shaft (220), as shown in fig. 18C. The end effector (1040) eventually reaches a point of the end effector (1040) distal to the distal end (240) of the shaft (220) such that the end effector (1040) may resiliently transition to an expanded state. Catheter (120) may collapse within shaft (220) as shown in fig. 16, while insertion member (1102) enters the secured state shown in fig. 18B.

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

Illustrative of the combinations

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 scope of coverage of any claim that may be provided at any time in this patent application or in a later filed of this patent application. No disclaimer is intended. The following examples are provided for illustrative purposes only. It is contemplated that the various teachings herein may be arranged and applied in a variety of other ways. It is also contemplated that some variations may omit certain features mentioned in the embodiments below. Thus, none of the aspects or features mentioned below should be considered decisive unless explicitly indicated at a later date by the inventors or by an inheritor of interest to the inventors. If any claim set forth in the present patent application or in a later-filed document related to the present patent application includes additional features beyond those mentioned below, such 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 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 sized to receive an end effector of a catheter; and (b) a coupling member attached to the cylindrical shaft, the coupling member configured for selective securement to the catheter delivery sheath, the coupling member 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.

Example 2

The coupler of embodiment 1, the coupling member being fixedly attached to the cylindrical shaft.

Example 3

The coupler of embodiment 1, wherein the coupling member is attached to the cylindrical shaft while also being movable relative to the cylindrical shaft.

Example 4

The coupler of embodiment 3, the coupling member configured to translate along an axis of the lumen relative to the cylindrical shaft.

Example 5

The coupler of any one of embodiments 1-4, the cylindrical shaft being sized for insertion into an insertion port of the catheter delivery sheath.

Example 6

The coupler of any one of embodiments 1-5, further comprising an outward flare feature at one of a proximal end or a distal end of the cylindrical shaft, the outward flare feature defining an angled surface that opens into the lumen.

Example 7

The coupler of embodiment 6, the outward flare feature at a distal end of the cylindrical shaft, the outward flare feature configured to prevent insertion of the cylindrical shaft into an insertion port of the catheter delivery sheath.

Example 8

The coupler of embodiment 6, the outward flare feature at a proximal end of the cylindrical shaft, the outward flare feature configured to limit insertion of the cylindrical shaft into an insertion port of the catheter delivery sheath.

Example 9

The coupler of any one of embodiments 1-8, the coupling member including 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.

Example 10

The coupler of any one of embodiments 1-9, the coupling member comprising a cap.

Example 11

The coupler of any one of embodiments 1-10, the coupling member configured to threadably engage the catheter delivery sheath.

Example 12

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

Example 13

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

Example 14

The coupler of any one of embodiments 1-13, further comprising a catheter disposed in the lumen, the catheter configured to fit within an anatomical structure.

Example 15

The coupler of any one of embodiments 1 to 14, further comprising a catheter delivery sheath having an insertion port configured for longitudinal alignment with the cylindrical shaft, the insertion port defining a longitudinal axis, the coupling member configured to align an 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, the kit comprising: (a) a catheter instrument, the catheter instrument comprising: (i) A catheter having a distal end, and (ii) an end effector at the distal end of the catheter, the catheter and end effector sized to fit in an anatomical structure, the end effector comprising at least one electrode; and (b) a coupler, 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 sized to receive the end effector and the catheter, and (ii) a coupling member attached to the cylindrical shaft.

Example 17

The kit of embodiment 16, further comprising a catheter delivery sheath comprising an insertion port defining a longitudinal axis, the coupling member configured for selective securement to the catheter delivery sheath, the coupling member configured to align an 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 18

The kit of embodiment 17, the coupling member configured to engage the catheter delivery sheath in at least one of a threaded manner, a snap fit manner, or a bayonet manner.

Example 19

A kit, the kit comprising: (a) a catheter instrument, the catheter instrument comprising: (i) A catheter having a distal end, and (ii) an end effector at the distal end of the catheter, the catheter and end effector sized to fit in an anatomical structure, the end effector comprising at least one electrode; and (b) a coupler, 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 sized to receive the end effector and the catheter, and (ii) means for coupling attached to the cylindrical shaft.

Example 20

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

Example 21

A method, the 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 sized to receive an end effector of a catheter instrument and a catheter, and (ii) a coupling member attached to the cylindrical shaft, the act of securing comprising aligning the axis of the lumen with a longitudinal axis of an insertion port of the catheter delivery sheath.

Example 22

The method of embodiment 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.

Example 23

The coupler of any one of embodiments 1-15, the lumen comprising a frustoconical proximal portion.

Example 24

The coupler of embodiment 23, the frustoconical proximal portion extending distally from the proximal end.

Example 25

The coupler according to any one of embodiments 23-24, wherein the frustoconical proximal portion tapers radially inward in a distal direction.

Example 26

The kit of any one of embodiments 16-20, the lumen comprising a frustoconical proximal portion.

Example 27

The kit of embodiment 26, the frustoconical proximal portion extending distally from the proximal end.

Example 28

The kit according to any one of embodiments 26-27, the frustoconical proximal portion tapering radially inward in a distal direction.

Example 29

A delivery sheath-catheter coupler, the coupler comprising: (a) A cylindrical shaft extending along an axis, the cylindrical shaft 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 sized to receive an end effector 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 configured for selective alignment with the catheter delivery sheath, the cap 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.

Example 30

The coupler of embodiment 29, the cap configured for selective securement to the catheter delivery sheath.

Example 31

The coupler according to any one of embodiments 29-30, the cap being fixedly attached to a distal end of the cylindrical shaft.

Example 32

The coupler according to any one of embodiments 29-30, wherein the cap is attached to a distal end of the cylindrical shaft while also being movable relative to the cylindrical shaft.

Example 33

The coupler of embodiment 32, the cap being configured to translate along an axis of the lumen relative to the cylindrical shaft.

Example 34

The coupler of any one of embodiments 30-33, the cap being 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.

Example 35

The coupler of any one of embodiments 29-34, further comprising a catheter disposed in the lumen, the catheter configured to fit within an anatomical structure.

Example 36

The coupler of any one of embodiments 29-35, further comprising a catheter delivery sheath having an insertion port configured for longitudinal alignment with the cylindrical shaft, the insertion port defining a longitudinal axis, the coupling member configured to align an 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 items

Any of the instruments described herein may be cleaned and sterilized before and/or after a procedure. In one sterilization technique, the device is placed in a closed and sealed container such as a plastic or TYVEK bag. The container and device may then be placed in a radiation field that is transparent to the container, such as gamma radiation, x-rays, or energetic electrons. The radiation may kill bacteria on the device and in the container. The sterilized device may then be stored in the sterile container for later use. The device may 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 gas phase sterilization (with or without a gas plasma or vapor).

It should be understood that any of the examples described herein may also include various other features in addition to or instead 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 by reference herein.

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

It should be understood that any patent, patent publication, or other disclosure material, in whole or in part, that is said to be incorporated herein by reference is incorporated herein only to the extent that the incorporated material does not conflict with existing definitions, statements, or other disclosure material set forth in this disclosure. Accordingly, and to the extent necessary, the disclosure as explicitly set forth herein supersedes any conflicting material incorporated herein by reference. Any material, or portion thereof, that is said to be incorporated by reference herein, but which conflicts with existing definitions, statements, or other disclosure material set forth herein will only be incorporated to the extent that no conflict arises between that incorporated material and the existing disclosure material.

While various forms of the invention have been shown and described, further modifications to the methods and systems herein described may be effected by those skilled in the art with appropriate modifications without departing from the scope of the invention. Several such possible modifications have been mentioned and other modifications will be apparent to persons skilled in the art. For example, the examples, versions, geometries, materials, dimensions, ratios, steps, and the like discussed above are illustrative and not required. The scope of the invention should, therefore, be considered in terms of the following claims and is understood not to be limited to the details of structure and operation shown and described in the specification and drawings.

Claims

1. A delivery sheath-catheter coupler, the coupler comprising:

(a) A cylindrical shaft extending along an axis, the cylindrical shaft configured for longitudinal alignment with an insertion port of a catheter delivery sheath, the cylindrical shaft comprising:

(i) The proximal end portion is configured to be coupled to a proximal end portion,

(Ii) A distal end, and

(Iii) A lumen extending along the axis from the proximal end to the distal end, the lumen sized to receive an end effector of a catheter; and

(B) A coupling member attached to the cylindrical shaft, the coupling member configured for selective fixation to the catheter delivery sheath, the coupling member configured to align an axis of the lumen with a longitudinal axis of the insertion port when the coupling member is selectively fixed to the catheter delivery sheath.

2. The coupler of claim 1, the coupling member fixedly attached to the cylindrical shaft.

3. The coupler of claim 1, the coupling member being attached to the cylindrical shaft while being movable relative to the cylindrical shaft.

4. The coupler of claim 3, the coupling member configured to translate along an axis of the lumen relative to the cylindrical shaft.

5. The coupler of any one of claims 1, the cylindrical shaft 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 a proximal end or a 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 at a distal end of the cylindrical shaft, the outward flare feature 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 at a proximal end of the cylindrical shaft, the outward flare feature configured to limit insertion of the cylindrical shaft into an insertion port of the catheter delivery sheath.

9. The coupler of any one of claim 1, the coupling member comprising 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.

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 configured to threadably engage the catheter delivery sheath.

12. The coupler of any one of claims 1, the coupling member configured to engage the catheter delivery sheath in a snap-fit manner.

13. The coupler of any one of claims 1, the coupling member configured to engage the catheter delivery sheath in a bayonet manner.

14. The coupler of any one of claim 1, further comprising a catheter disposed in the lumen, the catheter configured to fit within an anatomical structure.

15. The coupler of any one of claims 1, further comprising a catheter delivery sheath having an insertion port configured for longitudinal alignment with the cylindrical shaft, the insertion port defining a longitudinal axis, the coupling member configured to align an 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, the kit comprising:

(a) A catheter instrument, the catheter instrument comprising:

(i) A catheter having a distal end, and

(Ii) An end effector at a distal end of the catheter, the catheter and end effector sized to fit in 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) The proximal end portion is configured to be coupled to a proximal end portion,

(B) A distal end, and

(C) A lumen extending along an axis from the proximal end to the distal end, the lumen sized to receive the end effector and the catheter, and

(Ii) A coupling member attached to the cylindrical shaft.

17. The kit of claim 16, further comprising a catheter delivery sheath including an insertion port defining a longitudinal axis, the coupling member configured for selective securement to the catheter delivery sheath, the coupling member configured to align an 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 configured to engage the catheter delivery sheath in at least one of a threaded manner, a snap fit manner, or a bayonet manner.

19. A kit, the kit comprising:

(a) A catheter instrument, the catheter instrument comprising:

(i) A catheter having a distal end, and

(B) A coupler, the coupler comprising:

(i) A cylindrical shaft, the cylindrical shaft comprising:

(B) A distal end, and

(Ii) Means for coupling 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 of threads, snap-fit features, or bayonet-fit features.

21. A method, the method comprising:

securing a coupler to a catheter delivery sheath, the coupler comprising:

(i) A cylindrical shaft, the cylindrical shaft comprising:

(B) A distal end, and

(C) A lumen extending along an axis from the proximal end to the distal end, the lumen sized to receive an end effector of a catheter instrument and a catheter, and

(Ii) A coupling member attached to the cylindrical shaft,

The act of securing includes aligning an axis of the lumen with a longitudinal axis of an 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 inward 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 inward in a distal direction.

29. A delivery sheath-catheter coupler, the coupler comprising:

(Ii) A distal end, and

(Iii) A lumen extending along the axis from the proximal end to the distal end, the lumen sized to receive an end effector 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 configured for selective alignment with the catheter delivery sheath, the cap 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 configured for selective securement to the catheter delivery sheath.

31. The coupler of any one of claims 29, the cap being fixedly attached to a distal end of the cylindrical shaft.

32. The coupler of any one of claims 29, wherein the cap is attached to a distal end of the cylindrical shaft while being movable relative to the cylindrical shaft.

33. The coupler of claim 32, wherein the cap is configured to translate along an axis of the lumen relative to the cylindrical shaft.

34. The coupler of any one of claims 30, the cap being 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.

35. The coupler of any one of claims 29, further comprising a catheter disposed in the lumen, the catheter configured to fit within an anatomical structure.

36. The coupler of any one of claims 29, further comprising a catheter delivery sheath having an insertion port configured for longitudinal alignment with the cylindrical shaft, the insertion port defining a longitudinal axis, the coupling member configured to align an axis of the lumen with the longitudinal axis of the insertion port when the coupling member is aligned with the catheter delivery sheath.