WO2022090802A1 - Introducer for oblique vein of marshall - Google Patents

Abstract

An introducer (30) facilitating the positioning of catheter devices to a location of the vasculature, such as an Oblique Vein of Marshall (OVM). The disclosed introducer (30) is configured to cover, fully or partially, the potential locations of the OVM ostium inside the coronary sinus. The disclosed introducer (30) includes one or several lateral (radially oriented) openings (72") to cover, fully or partially, the position of the targeted ostium inside the coronary sinus. The distally located, lateral apertures (72") may cover a given angular span around sheath axis.

Description

x INTRODUCER FOR OBLIQUE VEIN OF MARSHALL

RELATED APPLICATIONS

This application claims the benefit of U.S. Provisional Patent Application No.

63/106,907 filed October 29, 2020, the disclosure of which is incorporated by reference in its entirety.

FIELD OF THE DISCLOSURE

The present disclosure is directed generally to introducers for positioning percutaneous devices inside the body by vasculature access. More particularly, the present disclosure relates to an introducer for use in cardiac procedures.

BACKGROUND

Introducers are commonly used to position other percutaneous devices, such as guidewires or catheters in a particular location inside the body accessible through the vasculature. An “introducer” is also commonly referred to as a “sheath” or an “access device” in the art. Herein, the fully assembled device is referred to as an introducer.

One application for introducer technology pertains to ethanol-infusion based ablation of the Oblique Vein of Marshall (OVM), which is accessed via an OVM ostium located inside the coronary sinus, the coronary sinus being accessed, for example, via the femoral vein and inferior vena cava (IVC).

Procedurally, conventional access via the OVM ostium generally involves localizing the OVM ostium by injecting a contrast fluid into the coronary sinus under fluoroscopic (X- ray) guidance. Injection of the contrast fluid is typically performed with a dedicated catheter that is positioned using a previously inserted introducer. A guidewire is then positioned inside the now localized OVM, usually with the previously inserted and positioned introducer. For correct positioning, a distal end of the guidewire is located past the OVM ostium, and at a given distance inside the OVM of up to 50 millimeters. Having positioned the guidewire, an auxiliary device such as an ethanol infusion device, a balloon catheter, or a functionally analogous device is threaded coaxially over the positioned guidewire within the OVM. Chemical ablation by ethanol injection can then be performed.

The position of the OVM ostium within the coronary sinus can vary substantially from patient to patient. See, e.g.: Valderrdbano, et al., “Vein of Marshall ethanol infusion for persistent atrial fibrillation: VENUS and MARS clinical trial design”, Am Heart J. 2019, and

Valderrdbano, et al., “The Human Left Atrial Venous Circulation as a Vascular Route for Atrial

Pharmacological Therapies: Effects of Ethanol Infusion”, JACC Clin Electrophysiol, 2017..

With conventional devices and procedures, positioning of the guidewire within the

OVM can be a challenging and time consuming procedural process, particularly for anatomical configurations where the OVM ostium is proximally located (i.e., close to the vicinity of the coronary sinus/IVC ostium). The proximal location adversely affects stabilization of the introducer. An introducer that overcomes or mitigates these shortcomings would be welcomed.

SUMMARY

Various embodiments of the disclosure present an introducer that is a multi-component elongated device for assisting the operator in positioning catheter devices, to a particular location of the vasculature, such as a branch vein of the coronary sinus. Such devices include, but not are limited to, guidewires, balloon catheters, and chemical infusers. In the context of the performance of epicardial ablation procedures mentioned above, such a branch vein of the coronary sinus can be the Oblique Vein of Marshall (OVM).

A complication with respect to accessing the OVM from the coronary sinus is that the location of the OVM ostium inside the coronary sinus shows a large anatomical variability from patient to patient. Accordingly, the disclosed introducer is configured to cover, fully or partially, the potential locations of the OVM ostium inside the coronary sinus.

The disclosed device includes one or several lateral (radially oriented) openings (herein referred to as “apertures”), typically over the distal 40 millimeters (or more, such as 60 millimeters, or less, such as 15 millimeters), typically to cover, fully or partially, the position of the OVM ostium inside the coronary sinus.

In addition, the distally located, lateral apertures may cover a given angular span around sheath axis. The apertures may be angularly located on the sheath as to be preferably directed towards the OVM ostium direction. Anatomically, this provides a desired angular positioning of the apertures in the superior-posterior directions, when the sheath is positioned adequately inside the coronary sinus, because the OVM ostium is located in a posterosuperior position on the coronary sinus roof.

In some embodiments, the disclosed introducer is configured to and methods presented for selectively injecting a contrast fluid readily identified on x-ray images for localization of the OVM ostium. Positioning the introducer for access to the OVM ostium may be accomplished using radiopaque markers that individually identify one or more lateral apertures on the introducer for alignment with the OVM ostium. In some embodiments, a deflector catheter is configured with radiopaque markers for both axial and rotational alignment with the selected access portal. The disclosed device enables alignment of the deflector catheter with the OVM ostium, while an outer sheath assembly remains stable within the coronary sinus, with a distal end portion in the vicinity of a distal location of the coronary sinus.

In some embodiments, auxiliary devices such as chemical infusers or balloon or ablation catheters are navigated into position over the positioned guidewire by the deflector, thereby reducing the risk of accidentally withdrawing the guidewire from the OVM. The deflector catheter may be removed, enabling access for atrial or ventricular procedures using the stabilized outer sheath assembly.

Conventional introducers that interface with the coronary sinus have a single, distally located lumen. As a consequence of the variability of the anatomy (such as the one characterizing the actual axial position of the OVM ostium inside the coronary sinus), positioning and stabilizing a guidewire, a balloon catheter, or more generally any catheter in the OVM can be a physically challenging and time consuming step in particular anatomical configurations. As such, conventional introducers are sometimes positioned outside the coronary sinus, or only minimally protrude into the coronary sinus, particularly in cases where the OVM ostium is located proximally inside the coronary sinus as only a short insertion length of the introducer within the coronary sinus is permitted.. Such an arrangement is inherently unstable and can cause difficulties for OVM localization, as well as for the subsequent steps

(e.g., guidewire threading, catheter threading).

The result is a challenging manipulation for routing the guidewire to and stabilizing the guidewire within the OVM.

In the context of the present disclosure, and for conciseness and clarity, the introducer apparatus, use, and benefits, are illustrated in an application pertaining to ethanol-infusion based ablation of the Oblique Vein of Marshall (OVM). The OVM is accessed an OVM ostium located inside the coronary sinus.

The disclosed introducer may also be used in other interventions to facilitate the positioning of a guidewire or catheter. For instance, while the disclosure is illustrated here in the context of coronary sinus access via the right femoral vein, the superior access of the coronary sinus via the right internal jugular vein, or the left subclavian vein is also within the device scope. In some embodiments, the disclosed device is used for accessing other vessels

(veins or arteries) which branch out of another, larger vessel (vein or artery). In some embodiments, the disclosed introducer is used in ablation procedures (e.g., chemical or radiofrequency ablation). The disclosed introducer may also be used to access target vessels for other procedures, such as implantation of pacemaker leads.

Structurally, various embodiments of the disclosure include an introducer for accessing a branch vein of the coronary sinus, comprising an outer sheath assembly including a body having a distal end portion, the body defining an inner diameter that is concentric about a central axis, with the distal end portion defining a first plurality of lateral apertures that are centered and axially spaced along a first side axis. In some embodiments, a deflector catheter includes a catheter shaft with a distal deflector disposed at a distal end thereof, the catheter shaft defining a primary lumen, and the distal deflector defining a main lumen having an axial inlet and a radial outlet. The axial inlet may be in alignment with the first lumen of the catheter shaft. The radial outlet is defined on an outer tangential surface of the distal deflector. The radial outlet is configured for selective alignment with any one of the first plurality of lateral apertures.

In some embodiments, each of the first plurality of lateral apertures defines a maximum tangential width that extends about the central axis, the maximum tangential width being greater than a maximum tangential width of the radial outlet of the distal deflector of the deflector catheter. A ratio of the maximum tangential width of each of the first plurality of apertures to the maximum tangential width of the radial outlet is in a range of 1 to 2.5 inclusive.

In some embodiments, the outer sheath assembly defines a second plurality of lateral apertures centered and axially spaced along a second side axis. Each of the second plurality of lateral apertures may be tangentially aligned with a corresponding one of the first plurality of lateral apertures. In some embodiments, the outer sheath assembly defines a third plurality of lateral apertures centered and axially spaced along a third side axis. Each of the third plurality of lateral apertures may be tangentially aligned with a corresponding one of the second plurality of lateral apertures.

In some embodiments, the distal end portion of the outer sheath assembly includes means for marking each of the plurality of first apertures with an associated radiopaque marker.

The distal end portion of the outer sheath assembly may include a plurality of radiopaque markers, each being associated with a corresponding one of the first plurality of lateral apertures. The plurality of radiopaque markers may be disposed on an external surface of the outer sheath assembly. In some embodiments, each of the plurality of radiopaque markers is a band that extends tangentially about the central axis. The band may be axially adjacent a corresponding one of the first plurality of lateral apertures. In some embodiments, the corresponding one of the first plurality of lateral apertures passes through the band. Each of the radiopaque markers may include a feature at a known tangential location relative to the corresponding one of the first plurality of lateral apertures. In some embodiments, each of the plurality of radiopaque markers outlines a perimeter of the corresponding one of the first plurality of lateral apertures.

In some embodiments, the distal deflector of the deflector catheter includes a radiopaque marker associated with the lateral aperture of the distal deflector. The radiopaque marker may be disposed on an external surface of the distal deflector. The radiopaque marker may be a band that extends tangentially about the distal deflector to define an outer diameter of the distal deflector. In some embodiments, the radiopaque marker includes a feature at a known tangential location relative to the lateral aperture of the distal deflector.

In some embodiments, the catheter shaft includes a transition portion that transitions from a proximal shaft portion to a deflector shaft portion, the proximal shaft portion defining a first diameter, the deflector shaft portion defining a second diameter, the first diameter being greater than the second diameter. The deflector shaft portion may cooperates with the inner diameter of the outer sheath assembly to define an annulus that extends from the transition portion to the distal deflector. In some embodiments, the deflector catheter defines a secondary lumen that extends parallel to the primary lumen, the secondary lumen terminating at the transition portion to define an inlet to the annulus. The annulus may be an eccentric annulus.

In some embodiments, the proximal shaft is an extrusion that defines the primary lumen and the secondary lumen. The proximal shaft portion may include an outer sleeve that surrounds the extrusion to define the first diameter of the proximal shaft portion. The transition portion may define an outer diameter that is greater than the first diameter of the proximal shaft portion for sliding contact with the inner diameter of the outer sheath assembly. In some embodiments, the distal deflector defines a radial diameter that is greater than the second diameter of the deflector shaft portion. The radial diameter may be dimensioned for a sliding fit with the inner diameter of the outer sleeve.

In some embodiments, the main lumen of the distal deflector is non-linear and may be arcuate. The distal deflector defines an ancillary passage that extends axially through the distal deflector adjacent the main lumen. The ancillary passage may be one of a through-hole and a channel.

In some embodiments, the distal deflector includes an indexing mechanism that facilitates local registration of the distal deflector at discrete locations within the outer sheath assembly, the indexing mechanism being configured to align the radial outlet of the distal deflector with a designated lateral aperture when the indexing mechanism is engaged with the complementary structure. The indexing mechanism may include a biasing element that biases a detent radially outward for releasable engagement with a complementary structure on the outer sheath assembly. In some embodiments, the detent and the biasing element are unitary with the distal deflector. The biasing element may be a cantilever spring. The detent may include a radiused outer perimeter for releasable engagement with the complementary structure. In some embodiments, the complementary structure is an arbitrary one of the first plurality of lateral apertures. The arbitrary one of the first plurality of lateral apertures may be axially adjacent the designated aperture, and may be proximal to the designated aperture.

In various embodiments of the disclosure, the introducer includes a delivery device configured for translation through the primary lumen and the main lumen to extend in a radial direction from the radial outlet of the distal deflector. The delivery device may be one of a guide wire, a balloon catheter, and an ablation catheter. The radiopaque markers may include one of a radiopaque alloy and a radiopaque-filled polymer.

In various embodiments, a method for routing a percutaneous device through an ostium that branches from a coronary sinus of a patient is disclosed, comprising: providing a kit including an outer sheath assembly; and providing instructions for use of the kit on a tangible, non-transitory medium. The instructions may include: routing a distal end portion of the outer sheath assembly to a coronary sinus via an inferior vena cava; inserting the distal end portion into the coronary sinus so that a distal extremity of the distal end portion is proximate a transition between the coronary sinus and a great cardiac vein; and aligning a designated lateral aperture from one of a plurality of lateral apertures defined on the outer sheath assembly for insertion of a delivery device via the designated lateral aperture and through an ostium that branches from the coronary sinus.

In some embodiments, the instructions provided in the step of providing instructions include injecting a contrast fluid into the distal end portion of the outer sheath assembly for exiting the plurality of lateral apertures. The instructions provided in the step of providing instructions may include at least one of rotating and translating the outer sheath assembly within the coronary sinus to align the designated lateral aperture of the plurality of lateral apertures with the ostium. The instructions provided in the step of providing instructions may include using a radiopaque marker of the outer sheath assembly in the step of aligning. In some embodiments, the radiopaque marker of the outer sheath assembly provided in the step of providing the kit includes an asymmetry for discerning rotational positioning of the outer sheath assembly.

In some embodiments of the disclosure, the kit provided in the step of providing the kit includes a deflector catheter, the deflector catheter including a distal deflector having a radial outlet for routing the delivery device through the designated lateral aperture of the outer sheath assembly, and the instructions provided in the step of providing instructions includes routing the delivery device through the deflector catheter. The instructions provided in the step of providing instructions may include inserting the delivery device through the ostium at an angle relative to a primary lumen axis of the deflector catheter. The angle may be in a range of 60 to

80 degrees inclusive relative to a distal direction. For the various steps of the disclosed method, the ostium specified in the instructions is an ostium of an Oblique Vein of Marshall.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a perspective view of an assembled introducer with an inserted delivery device according to an embodiment disclosure;

FIG. 2 is a perspective view of the introducer of FIG. 1 unassembled according to an embodiment disclosure;

FIG. 3 A is a sectional view of the distal end portion at A- A of FIG. 3 according to an embodiment disclosure;

FIG. 3 is a perspective view of a distal end portion of the introducer of FIG. 1 according to an embodiment disclosure;

FIG. 4 is a perspective view of the introducer of FIG. 1 in a first manipulated configuration according to an embodiment disclosure;

FIG. 5 is a perspective view of the introducer of FIG. 1 in a second manipulated configuration according to an embodiment disclosure; FIG. 6 is a perspective view of a distal end portion of an introducer having a dense matrix of lateral apertures according to an embodiment of the disclosure;

FIG. 7 is a perspective view of a distal end portion of an introducer having a single column of lateral apertures according to an embodiment disclosure;

FIG. 8 is a perspective view of a distal end portion of an introducer having tangentially slotted apertures according to an embodiment disclosure;

FIG. 8A is a sectional view of the distal end portion at A-A of FIG. 8 according to an embodiment disclosure;

FIG. 9 is a perspective view of a distal end portion of an introducer having radiopaque bands with features that extend distally therefrom according to an embodiment disclosure;

FIG. 10 is an enlarged, partial view at inset X of FIG. 9 according to an embodiment disclosure;

FIG. 11 is a perspective view of a distal end portion of an introducer having radiopaque bands with features that extend proximally therefrom according to an embodiment disclosure;

FIG. 12 is a perspective view of a distal end portion of an introducer having lateral apertures that extend through radiopaque bands according to an embodiment disclosure;

FIG. 13 is a perspective view of a distal end portion of an introducer having radiopaque markers that outline perimeters of lateral apertures according to an embodiment disclosure;

FIG. 14 is a deflector catheter of the introducer of FIG. 2 according to an embodiment disclosure;

FIG. 15 is a distal perspective view of the transition portion of FIG. 14 according to an embodiment of the disclosure;

FIG. 16 is a sectional view of the deflector catheter at plane XVI-XVI of FIG. 15 according to an embodiment of the disclosure; FIG. 17 is an enlarged view of a distal deflector of the deflector catheter at inset XVII of FIG. 14 according to an embodiment disclosure;

FIG. 18 is a sectional view of the distal end deflector of FIG. 17 according to an embodiment disclosure;

FIG. 19 is an enlarged, partial view of a deflector catheter having a radiopaque marker disposed on a distal deflector according to an embodiment disclosure;

FIG. 20 is an enlarged perspective view of a distal end deflector having ancillary side channels according to an embodiment of the disclosure;

FIG. 21 is an enlarged perspective view of a distal end deflector with distally extending atraumatic deflection appendage according to an embodiment of the disclosure;

FIG. 22 is an enlarged perspective view of a distal end deflector with an integral local indexing mechanism according to an embodiment of the disclosure;

FIG. 23 is a sectional view of the distal end deflector of FIG. 22 coupled to a lateral aperture of an outer sheath assembly according to an embodiment of the disclosure;

FIG. 24 is an enlarged partial perspective view of the assembled introducer of FIG. 1 according to an embodiment of the disclosure;

FIG. 25 is a partial sectional side view of the assembled introducer of FIG. 24 according to an embodiment disclosure;

FIG. 25 A is a sectional view at A- A of FIG. 25 according to an embodiment disclosure;

FIG. 26 is a cutaway view of the introducer of FIG. 1 in operation in a heart according to an embodiment of the disclosure; and

FIG. 26 A is an enlarged view at inset A of FIG. 26 according to an embodiment of the disclosure.

DETAILED DESCRIPTION Referring to FIGS. 1 and 2, an introducer 30 is depicted according to an embodiment of the disclosure. The introducer 30 includes an outer sheath assembly 32 and a deflector catheter 34, the deflector catheter 34 being configured for translation and rotation within the outer sheath assembly 32. In some embodiments, the outer sheath assembly 32 and the deflector catheter 34 are fitted with terminations 36, 38 for coupling to a steering handle (not depicted). The introducer 30 is configured to accommodate a delivery device 40, such as a guide wire 42 through a designated lateral aperture 44. Other delivery devices include, for example, balloon catheters and infusion catheters (none depicted).

Referring to FIGS. 3 through 7, the outer sheath assembly 32 is described in greater detail according to an embodiment of the disclosure. The outer sheath assembly 32 includes a body 50 having a proximal end portion 52 and a distal end portion 54, 54a. The body 50 includes an exterior surface 56 and defines an inner diameter 58 and an outer diameter or gauge

59, the inner diameter 58 defining and being concentric about a central axis 60.

The distal end portion 54a of the outer sheath assembly 32 defines a first plurality of lateral apertures 72' that are centered and axially spaced along a first side axis 74' to define a first column 76' of lateral apertures 72'. In some embodiments, the distal end portion 54a defines a second plurality of lateral apertures 72" that are centered and axially spaced along a second side axis 74" to define a second column 76" of lateral apertures 72". In some embodiments, a distal end portion 54b (FIG. 6) defines a third plurality of lateral apertures 72'" that are centered and axially spaced along a third side axis 74'" to define a second column 76"' of lateral apertures 72"'. Embodiments having two or more columns 76 define an aperture matrix 78, with tangentially adjacent apertures (e.g., 72', 72") that define rows 82 of two or more apertures 72 that extend tangentially on the exterior surface 56. Each aperture 72 defines an axial dimension 83 and a tangential dimension 85, one or both of which may define a maximum dimension 84. Herein, the expressions “axial”, “radial”, and “tangential” are in relation to the cylindrical coordinate 80 (r,0,z) depicted at FIG. 3. The z-axis of the cylindrical coordinate 80 is concentric with the central axis 60 of the outer sheath assembly 32, but otherwise may be of arbitrary origin. “Axial" refers to directions parallel to the z-axis, “radial” refers to directions parallel to the r-axis, and “tangential” refers to directions. “Lateral” refers to directions that are orthogonal to the central axis 60. “Distal end portions” are referred to generically or collectively by the reference character 54 (“distal end portion(s) 54”) and individually with a letter suffix (e.g., “distal end portion 54a”). Apertures, side axes, and columns are indicated collectively and generically with reference characters 72, 74, and 76, respectively, and individually or specifically with one or more apostrophe suffixes (e.g., “lateral aperture(s) 72").

A distal extremity 86 of the distal end portion 54 may include or otherwise be configured to effect an atraumatic tip 88, and may define a distal end opening 90 (FIG. 5) of the outer sheath assembly 32. In some embodiments, the atraumatic tip 88 is tapered radially inward in the distal direction and comprises a material of soft polymer. In some embodiments, the hardness of the atraumatic tip is in a range of 30 to 50 Shore D. In some embodiments, an axial length of the atraumatic tip is in a range of 3 to 6 millimeters inclusive; The atraumatic tip may include a polymer containing radiopaque filler. The atraumatic tip 88 may include side anti-cavitation apertures (not depicted) as is common in the art. The atraumatic tip may also include lateral apertures (not depicted). In some embodiments, the distal end portion 54 includes a plurality of radiopaque markers 92.

In some embodiments, at least the distal end portion 54 of the outer sheath assembly 32 includes an outer coating or membrane 91 (FIG. 25). Portions of the membrane 91 that are over the lateral apertures 72 may define openings 93 that pass through the membrane 91. The coating or membrane 91 establishes a thin outer layer over the outer sheath assembly 32. In some embodiments, the openings 93 are formed by adhesion of the coating 91 to the outer sheath assembly 32. In some embodiments, the membrane 91 spans the lateral apertures 72 and the openings 93 are formed by puncturing the membrane 91 at the lateral apertures 72

(depicted at FIG. 25).

In some embodiments, a hardness of the membrane or coating is in a range from 10 to

50 Shore A inclusive. Example materials for the membrane or coating 91 include low shore D thermoplastic polyurethanes such as PELLETHANE®, provided by Lubrizol Corp, of

Wickliffe, Ohio, USA, and silicones such as NUSIL® MED-6640, provided by Avantor, Inc., of Radnor, Pennsylvania, USA. In some embodiments the thickness of the membrane or coating is within a range of 50 to 300 micrometers inclusive.

Functionally, the membrane or coating 91 provides a soft outer layer that enhances the atraumatic characteristics of the outer sheath assembly 32. The coating or membrane 91 effectively provides a rounding of the geometry of the outer sheath assembly 32 at the edges of the radiopaque markers 92, 120 and at the perimeter of the lateral apertures 72, making these edges less aggressive as they pass through the vasculature. The openings 93 enable passage of contrast fluid through the lateral apertures 72 for localization of the OVM ostium. The soft, complaint property of the coating or membrane 92 enables the delivery device 40 to readily pass through the membrane 91 or openings 93. Though depicted only in FIGS. 25 and 25 A, the membrane/coating 91 and associated openings 93 may be implemented with any of the distal end portions 54 of the outer sheath assemblies 32 depicted herein.

The distal end portion 54 may be deflectable as depicted at FIGS. 4 and 5 for purposes of steering and operational configuration. Deflection of the distal end portion 54 may be unidirectional, bidirectional, or multidirectional. In some embodiments, the distal end portion

54 may take on different shapes when deflected in different lateral directions, for example, the more gradual arcuate shape of FIG. 4 in one lateral direction and the tighter bend radius of

FIG. 5 in another lateral direction. The deflection shape of the distal end portion 54 may be gradual (FIG. 4), with a maximum deflection of up to 270 degrees, or more acute (FIG. 5), with a reduced radius of curvature. The deflection shape of FIG. 5 may be suited for adaptation to the coronary sinus/IVC anatomical bifurcation in IVC access relevant to OVM access and to the straight coronary sinus (FIG. 26, depicting the shape of FIG. 5 stabilized in the coronary sinus).

In some embodiments, the lateral apertures 72 are uniformly spaced along the side axes

74. Each aperture 72 of the aperture column(s) 76 defines an aperture axis 94 (FIG. 3A) that extends radially from the central axis 60 and is perpendicular to the respective side axis 74.

For embodiments having two or more aperture columns 76, adjacent side axes 74 are separated by a separation angle 9s. A maximum tangential angle 0max of the aperture matrix 78 is defined as the tangential angle 0 covered by the rows 82 of adjacent apertures 72.

In some embodiments, the outer diameter 59 of the body 50 of the outer sheath assembly

32 is in a range of 8 to 15 French inclusive, with the inner diameter 58 being in a range of 6 to

12 French inclusive. Such dimensions provide desired flexibility and steerability, and may also be adapted for endocardial ventricular (transseptal access) ablation procedures that take place in the framework of the same access procedures described herein. The overall length of the body 50 may be in a range of 30 to 100 centimeters inclusive.

The maximum dimension 84 of the lateral apertures 72 may be in a range of one to five millimeters inclusive. The aperture axes 94 of the lateral apertures 72 of a given aperture column 76 may be separated by an axial distance 96 that is in a range of 2 to 15 millimeters inclusive. In some embodiments, the aperture matrix 78 has an aperture density that effectively forms a mesh, akin to distal end portion 54b of FIG. 6. The high density of apertures 72 can provide the same tangential range as the slotted distal end portion 54d (FIG. 8) but with more favorable thrombogenicity. The aperture column(s) 76 are distributed across an operating length 98, defined as the axial distance between aperture axes 94 of the proximal-most aperture and the distal-most apertures of the plurality of lateral apertures 72. In some embodiments, the operating length 98 is within a range of 15 to 60 millimeters inclusive from the distal extremity

86. The maximum tangential angle 0max may be in a range from 15 to 270 degrees inclusive.

The lateral apertures 72 may be circular in shape, or define other desirable shapes, such as squares, rounded squares, rectangles, rounded rectangles, or oblongs that define the maximum dimension 84. In some embodiments, the lateral apertures 72 are of uniform shape.

While the distal end portions 54a and 54b depicts two and three aperture columns 76 respectively, embodiments with up to six aperture columns 76 with anywhere from two to 25 apertures inclusive are contemplated. In some embodiments, a distal end portion 54c having only a single column 76 of apertures 72 is contemplated (FIG. 7).

Referring to FIGS. 8 and 8 A, a slotted distal end portion 54d is depicted according to an embodiment of the disclosure. The slotted distal end portion 54d includes many of the same components and attributes as the distal end portion 54a, some of which are indicated with same- labeled reference characters. For the slotted distal end portion 54d, the maximum dimension

84 of a given aperture 72, 72' is defined by a tangentially slotted aperture 112 that extends tangentially about the central axis 60. The maximum dimension 84 of the tangential slot 112 is the tangential dimension 85, which is greater than the axial dimension 83 for the slotted distal end portion 54d. The tangential dimension 85 defines the corresponding maximum tangential angle 0max about the central axis 60. The slotted distal end portion 54d may have a single column 76 of apertures 72 (depicted).

For the distal end portions 54a, 54b, 54c, and 54d, each of the plurality of radiopaque markers 92 is a band 120 that extends tangentially about and may surround the central axis 60.

Each band 120 is axially adjacent a corresponding one of the first plurality of lateral apertures

72' and also adjacent a corresponding one of the second plurality of lateral apertures 72. The plurality of bands 120 are disposed on an external surface of the outer sheath assembly 32. The radiopaque makers 92 may be the same number as the lateral apertures 72, the rows

82 or lateral apertures, or otherwise in a sufficient number as to allow identification of the lateral apertures 72.

Referring to FIGS. 9 through 13, various distal end portions 54 presenting a variety of configurations for the radiopaque markers 92 are depicted according to embodiments of the disclosure. The distal end portions 54 presented in FIGS. 9 through 13 include many of the same components and attributes as distal end portion 54a, some of which are indicated with same-labeled reference characters.

Each of the radiopaque markers 92 for a distal end portion 54e (FIGS. 9 and 10) includes a feature 122 that extends axially from the associated band 120 at a tangential location

124 that is between adjacent apertures 72' and 72". The radiopaque markers 92 of a distal end portion 54f (FIG. 11) includes features 122 at tangential locations 124 on the bands 120 that are in alignment with the respective side axes 74' and 74"and extend away axially from the associated lateral apertures 72' and 72". For the radiopaque markers 92 of a distal end portion

54g (FIG. 12), the associated lateral apertures 72' and 72" pass through the bands 120. The distal end portion 54h (FIG. 13) does not include bands but instead define rings 126 that are disposed on and outline a perimeter 128 of the associated lateral aperture 72.

In assembly, the radiopaque markers 92, 120 may be integrated or embedded into the body 50 of the outer sheath assembly 32. In one embodiment, the integration is accomplished in a lamination process, wherein the radiopaque markers 92, 120 are deposited on a braided sleeve. A jacket is then slid over the braid and radiopaque markers 92, 120 and the assembly constricted onto the mandrel using a shrink tube (e.g., fluorinated ethylene propylene (FEP) shrink tube). In some embodiments, a spine structure is used instead of the braid. An example of such a spine structure is depicted and described at U.S. Patent Application Publication No. 2011/0251519 to Romoscanu, the disclosure of which is hereby incorporated by reference herein in its entirety except for patent claims and express definitions contained therein.

After lamination, the shrink tube is removed, for example by peeling, and the mandrel removed. The mandrel may be coated with polytetrafluoroethylene (PTFE) to facilitate removal. By this or similar processes, the radiopaque markers 92, 120 are integral to and embedded within the body 50.

The radiopaque markers 92 may optionally be mounted to the exterior surface 56 of the body 50, as depicted for the various distal end portions 54 depicted herein, for example by a swaging process. In some embodiments, the radiopaque markers 92 are disposed on the inner diameter 58 or embedded in the body 50. Materials for the radiopaque markers 92 may include, for example, a radiopaque alloy or a radiopaque-filled polymer. Radiopaque alloys include platinum-iridium and tantalum alloys. Radiopaque-filled polymers include BaSO4.

Referring to FIGS. 14 through 16, the deflector catheter 34 is described in greater detail according to an embodiment of the disclosure. The deflector catheter 34 includes a catheter shaft 152 with a distal deflector 154 disposed at a distal end 156 thereof. In some embodiments, the catheter shaft 152 includes a transition portion 162 at a junction of a proximal shaft portion 166 and a deflector shaft portion 168. The deflector catheter 34 may be fitted with the termination 38.

The catheter shaft 152 defines a primary lumen 182 that defines an inner diameter 184 that defines and is concentric about a primary lumen axis 186. The primary lumen 182 may extend the full length of the catheter shaft 152, and may be contiguous through both the proximal shaft portion 166 and the deflector shaft portion 168. The primary lumen 182 of the catheter shaft 152 is configured to enable passage of the delivery device 40, for example a conventional guidewire, balloon catheter, or ablation catheter. In some embodiments, a non- limiting range for the inner diameter 184 of the primary lumen 182 is 0.5 to 2.5 millimeter inclusive.

In addition to the primary lumen 182, the proximal shaft portion 166 and transition portion 162 may define a secondary lumen 232. The secondary lumen 232 may be a circular lumen, a plurality of circular lumens, or of a profiled shape 234 such as an oblong shape

(depicted). In some embodiments, the proximal shaft portion 166 includes an extrusion 236 that defines the primary lumen 182 and the secondary lumen 232. In some embodiments, the proximal shaft portion 166 includes an outer sleeve 238 that surrounds the extrusion 236.

In some embodiments the length of the deflector shaft portion 168 exceeds the operating length 98 of the outer sheath assembly 32. For example, the deflector catheter 34 may be of sufficient torsional stiffness to eliminate the proximal shaft portion 166, thereby effectively having only a deflector shaft portion 168.

Referring to FIGS. 17 and 18, a distal deflector 154a of the deflector catheter 34 is described in greater detail according to an embodiment of the disclosure. Herein, distal deflectors are referred to generically or collectively by the reference character 154 (“distal end portion(s) 154”) and individually with a letter suffix (e.g., “distal end portion 154a”). The distal deflector(s) 154, 154a define an outer diameter 192 and a main lumen 190, the main lumen 190 defining an axial inlet 194 and a radial outlet 196, the axial inlet 194 being in alignment with the primary lumen 182 at the distal end 156 the deflector shaft portion 168.

The radial outlet 196 is defined on an outer tangential surface 198 of the distal deflector 154,

154a.

In some embodiments, the distal deflector 154, 154a defines one or more ancillary passages 211 that extend parallel to the primary lumen 182. For the distal deflector 154a, the ancillary passages 211 are one or more lumens 212 (FIG. 17). The main lumen 190 defines and is concentric about a main axis 214 that defines a main lumen diameter 216 and a deflector angle θd at the radial outlet 196, the deflector angle θd being relative to the primary lumen axis 186 in the distal direction. The main lumen 190 and corresponding main axis 214 may be arcuate or otherwise non-linear. In some embodiments, the deflector angle θd is in a range of 30 and 120 degrees inclusive. Accordingly, distal deflectors 154 may be configured to redirect the delivery device 40 along a vector that is normal to the main axis 214 (θd = 90 degrees) or that has an axial component in either the proximal direction ( θd > 90 degrees) or distal direction ( θd < 90 degrees; depicted). In some embodiments, the deflector angle θd is in a range of 60 to 80 degrees inclusive, which is more typical of the branching angle of the OVM relative to the wall of the coronary sinus. An example and non-limiting range for the main lumen diameter 216 is 0.5 and 2.5 millimeters.

An example and non-limiting length for the deflector shaft portion 158 is in a range of 20 to

80 millimeters inclusive.

In some embodiments, the outer diameter 192 of the distal deflector 154, 154a is configured to limit the flow of axial fluid that seeps between distal deflector 154, 154a and the inner diameter 58 of the outer sheath assembly 32. To such effect, the outer diameter 192 and inner diameter 58 may be dimensioned to define a clearance therebetween that is in a range of

0.01 to 0.2 millimeters. In some embodiments, the distal deflector 154, 154a defines a cylindrical portion 221 having a proximal end 222 and a distal end 224. The proximal end 222 of the cylindrical portion 221 may define a smaller diameter than the distal end 224, thereby defining a tapered cylinder 223 whereby the clearance is defined only at the distal end 224

(FIG. 17). In some embodiments, a difference between the (larger) diameter at the distal end

224 and the (smaller) diameter at the proximal end 222 that defines the tapered cylinder 223 is in a range of 0.1 to 1 millimeters inclusive. The distal deflector 154, 154a may include a sloped shoulder 225 that extends from the deflector shaft portion 168 to the proximal end 222. Referring to FIGS. 19 through 21, alternative distal deflectors 154b through 154d are depicted according to embodiments of the disclosure. The distal deflectors 154b through 154d may include components and attributes of the distal deflector 154a, some of which are indicated with same-labeled reference characters. The distal deflector 154b is distinguished by a radiopaque marker 218 (FIG. 19), such as the band 120 with axially extending feature 122

(depicted) or a radiopaque polymer compound that defines a desired shape on the distal deflector 154. The radiopaque marker 218 facilitates fluoroscopic visibility for axial and rotational positioning, for example relative to the radiopaque markers 92 of the outer sheath assembly 32. In some embodiments, two or more radiopaque markers (not depicted) are implemented on the distal deflector 154b, for example for wiring in an electrode configuration.

The radiopaque markers 92 disclosed for various of the distal end portions 54 of the outer sheath assembly 32 may also be implemented with the distal deflectors 154 disclosed herein. The skilled artisan, in view of this disclosure, can readily implement these configurations mutatis mutandis for the distal deflectors 154, including: the straight band 120 without an axial extending feature, akin to distal end portion 54a; axially extending features that extend proximally and/or distally from a known tangential location relative to the radial outlet 196, akin to distal end portions 54e and 54f; an aperture that passes through a radiopaque band from the radial outlet 196, akin to distal end portion 54g; and rings that are disposed on and outline a perimeter of the radial outlet 196, akin to distal end portion 54h.

In some embodiments, the radiopaque marker 218, is wired as an electrode, enabling localization with commercially available three-dimensional (3D) systems. The radiopaque markers 92, 120 may also be configured as electrodes for the same purpose. Such 3D systems include the ENSITE PRECISION™ Cardiac Mapping System provided by Abbott

Laboratories of Abbott Park, Illinois, USA. In some embodiments, the distal deflector 154 may include a magnetic device, such as a coil (not depicted), which can be configured to permit localization on 3D systems such as the CARTO® 3 imaging system provided by Biosense

Webster Inc. of Irvine, California, USA.

The distal deflector 154c (FIG. 20) is distinguished as having or one or more ancillary channels 213 that extend parallel to the primary lumen axis 186. The channels 213 may be easier to form in some circumstances than the lumens 212.

The distal deflector 154d is distinguished as having a flexible appendage 226 that extends distal to the distal end 224 of the cylindrical portion 221. In some embodiments, the flexible section includes a radiopaque-filled polymer 228. Functionally, the flexible appendage

226 deflects under an external force caused by contact. If the distal deflector 154d protrudes through the distal end opening 90 of the outer sheath assembly 32, the compliant yet visibly radiopaque appendage 226 provides visual feedback should the appendage 226 encounter an obstacle or the venous wall.

Referring to FIGS. 22 and 23, a distal deflector 154e is depicted according to an embodiment of the disclosure. The distal deflector 154e may include several components and attributes of the other distal deflectors 154, some of which are indicated by same-labeled reference characters. The distal deflector 154e includes an indexing mechanism 240 that facilitates local registration at discrete locations within the outer sheath assembly 32 that aligns the radial outlet 196 of the distal deflector 154e with the designated lateral aperture 44.

The indexing mechanism includes a biasing element 242 that biases a detent 244 radially outward, away from the primary lumen axis 186. The detent 244 may include a radiused perimeter 245 for releasable engagement with a complementary structure on the outer sheath assembly 32. The detent 244 defines and is symmetric about a first radial axis 246 and may be located at a predetermined distance 247 from a second radial axis 248 that is defined by and centered within the radial outlet 196 of the distal deflector 154e. The radial axes 246 and 248 are orthogonal to the primary lumen axis 186 and may be coplanar. In some embodiments, the biasing element 242 is a cantilever spring 252 that is unitary with the distal deflector 154e. The cantilever spring 252 may be formed by machining or otherwise defining a slot 254 that undercuts the detent 242, thereby defining a free end 256 of the cantilever spring 252. For the distal deflector 154e, the complementary structure on the outer sheath assembly 32 is one of the lateral apertures 72 adjacent the designated aperture 44.

The predetermined distance 247 corresponds to the axial distance 96 that separates lateral apertures 72 of a given aperture column 76.

In operation, the distal deflector 154e is routed to distal end portion 54 of the outer sheath assembly 32. Enroute, the biasing element 242 may contact and exert a radial outward force against the inner diameter 58 of the outer sheath assembly 32. As the distal deflector

154e approaches the designated aperture 44, it may be preferable to avoid registration of the indexing mechanism 240 within intermediate apertures 72 of the distal end portion 54. For a smoother translation to the designated aperture 44, the distal end portion 54 may be rotationally oriented so that the detent rides adjacent to or between aperture columns 76. In some embodiments, the distal end portion 54 may be rotationally oriented so that the detent faces away from the aperture matrix 78 during the approach to the designated aperture 44.

When the distal deflector 154e is near the designated aperture 84, the radial outlet 196 is translated and rotated into alignment with the designated aperture, and the indexing mechanism 240 registers in an adjacent lateral aperture 72. Accordingly, when the detent 244 is registered within a lateral aperture 72, the radial outlet 196 is in axial and rotational alignment with an axially adjacent aperture 72. The indexing mechanism 244 functions to provide a fine, precision alignment of the radial outlet 196 with the designated aperture 44. Registration of the detent 244 may be sensed by the operator, for example by a vibrative pulse that transmits through the deflector catheter 34 as the indexing mechanism 240 snaps into place, or merely by a sudden increase in the force required to manipulate the deflector catheter 34. The indexing mechanism 240 of the depicted distal deflector 154e registers in the lateral aperture that is axially proximal to the designated aperture 44. Registration in other neighboring lateral apertures is also contemplated, for example a given lateral aperture that is axially distal or tangentially adjacent to the designated aperture 44.

In some embodiments, the mechanical indexing mechanism may be other than the disclosed cantilever spring 252 (e.g., ball/spring, leaf, magnetic). Positive registration may be accomplished with structures other than the lateral apertures 72, for example complementary structures elsewhere on the outer sheath assembly 32 accessible from the inner diameter 58.

Alternatively, instead of registering the distal deflector 154 locally at the distal end portion 54 of the outer sheath assembly 32, a handle (not depicted) of the introducer 30 may be configured to establish rotational and translation limits of the deflector catheter 34 within the outer sheath assembly 32. The distal deflector 154 and outer sheath assembly 32 may be configured to exert de minimis axial force or torque on the inner diameter 58 of the outer sheath assembly 32. As such, by implementing the stiffness guidelines outlined attendant to the discussion of FIGS. 14 through 16, there is effectively a 1 :1 correlation between the rotation and translation of the deflector catheter 34 at the proximal termination 38 and the distal deflector 154. Accordingly, by controlling the translational (axial) and rotational tangential displacement at the proximal termination 38 of the deflector catheter 34, the corresponding translation and rotation of the distal deflector 154 is known.

Referring to FIGS. 24 through 25 A, the introducer 30 is depicted in operation according to an embodiment of the disclosure. The radial outlet 196 is in alignment with a selected lateral aperture 72 of the aperture matrix 78. Functionally, for embodiments that define the aperture matrix 78, the availability of tangentially adjacent apertures 72 enables rotational alignment of the radial outlet 196 of the distal deflector 154 with the OVM ostium without requiring the same degree of rotational alignment for the outer sheath assembly 32. That is, for embodiments having a plurality of aperture columns 76, the distal end portion 54 need only be rotated sufficient for alignment with the designated lateral aperture 44 (i.e., the lateral aperture 72 of the aperture matrix 78 that is nearest the OVM ostium). After an initial rough alignment of the distal end portion 54 within the coronary sinus CS, such rotation typically won’t exceed the separation angle θs between adjacent side axes 74.

Similarly, for the slotted configuration of the distal end portion 54d, the maximum tangential angle θmax provides extended rotational range for alignment of the radial outlet 196 of the deflector catheter 34 with the OVM ostium without need for rotation of the slotted distal end portion 54d. As such, the alignment of the radial outlet 196 with the OVM ostium may be accomplished without requiring the same degree of rotational alignment for the outer sheath assembly 32. Accordingly, the stability of distal end portions 54 that utilize either tangentially slotted apertures 112 is or the aperture matrix 78 of tangentially adjacent apertures 72 is enhanced during the alignment of the radial outlet 196 with the OVM ostium.

The radiopaque markers 92 of FIGS. 9 through 13 effectively introduce an asymmetry to the radiopaque markers 92 which enables determination of the position of adjacent side apertures 72', 72", as well as detection of the rotation of the outer sheath assembly 32. The radiopaque markers 92 may contribute to the relative positioning of other components, such as the distal deflector 154.

The terminations 36, 38 enable coupling of the introducer 30 to a handle (not depicted) for rotation and translation of the deflector catheter 34 within the outer sheath assembly 32.

The terminations 36, 38, as well as the introducer 30 generally, may be configured to accommodate steering of the introducer 30 with the handle.

The tapered cylinder 223 and sloped shoulder 225 mitigates seizing of the distal deflector 154 within the outer sheath assembly 32. In some embodiments, the tapered cylinder

223 and sloped shoulder 225 enables the distal deflector 154 to be returned to the outer sheath assembly 32 should the distal deflector 154 be translated distally beyond the distal end opening

90. The return capability enables the operator to extend the distal deflector 154 beyond the operating length 98 of the outer sheath assembly 32 should the need arise.

The transition portion 162 reduces or steps down from an outer diameter 256 of the proximal shaft portion 166 to an outer diameter 257 of the deflector shaft portion 168. The reduced outer diameter 257 of the deflector shaft portion 168 cooperates with the inner diameter

58 of the outer sheath assembly 32 to define an annulus 258 within the outer sheath assembly

32 that extends from the transition portion 162 to the distal deflector 154. The secondary lumen

232 terminates distally at the annulus 258. The annulus 258 may be an eccentric annulus 259

The secondary lumen 232 may be used to route contrast fluid into the annulus 258. The annulus 258 enables injection and circulation of contrast fluid. The contrast fluid may exit the annulus 258 via the lateral apertures 72 of the outer sheath assembly 32 and, when provided, through the ancillary passage(s) 211 of the distal deflector 154. The proximal shaft portion

166 transfers torsion and axial forces (both compression and tension) to the transition portion

162, enabling the user to manipulate the deflector catheter 34 for aligning the radial outlet 196 with a selected lateral aperture 72 of the outer sheath assembly 32. The primary and main lumens 182 and 190 cooperate to guide the delivery device 40 through the designated lateral aperture 44. The secondary lumen 232 may be utilized to channel contrast fluid toward the annulus 258 for diffusion through the lateral apertures 72 and ancillary lumens 212.

The deflector shaft portion 168 provides both axial and rotational coupling between the transition portion 162 and the distal deflector 154. In some embodiments, the deflector shaft portion 168 is configured for desired axial stiffness in both extension and compression, as well as in rotational stiffness to facilitate the axial and angular movements applied to the transition portion 162 by the proximal shaft portion 166 and transferred to the deflector shaft portion 168.

The axial stiffness of the deflector shaft portion 168 is balanced against the flexural compliance required for deflection of the distal end portion 154, so as not to interfere with the steering mechanism and the overall compliance of the distal end portion 154 of the outer sheath assembly 32.

Parameters that, in combination, may effectuate the balance between axial stiffness and flexural compliance include: inner diameter 58 of the body 50 in a range of 2.5 to

4.5 millimeters inclusive; outer diameter 59 of the body in a range of 2.75 to 6 millimeters inclusive; outer diameter 256 of the proximal shaft portion 152 of the deflector catheter 34 in a range of 2.5 to 4.5 millimeters inclusive; outer diameter 257 of the deflector shaft portion 168 of the deflector catheter 34 in a range of 1.5 to 4.5 millimeters inclusive; braided sleeve defining a braid in a range of 30 to 50 pics per inch (PPI); elastic modulus of the outer sheath is in a range of 30 to 800 megapascals (MPa); elastic modulus of the proximal and deflector shafts 152, 168 in a range of 200 to 3000 MPa inclusive; ratio of the outer diameter 256 of the proximal shaft portion 152 to the outer diameter 257 of the deflector shaft portion 168 in a range of 1:1 to 2:1 inclusive. Suitable materials for the body 50, the proximal shaft 152, and the deflector shaft 168 include: thermoplastic elastomers such as PEBAX® with a durometer hardness in a range of 35 to 72 Shore D; polyimide (Pl); thermoplastic polymers such as polyether ether ketone (PEEK) ; polyurethane; and PTFE. Suitable materials for the distal deflector 154 include: thermoplastic polymers such as polyether ether ketone (PEEK), polypropylene (PP), polyethylene (PE), polycarbonate (PC), PTFE, acrylonitrile butadiene styrene (ABS) or metals (such as stainless steel, titanium), with or without coating (PTFE, parylene). Polymers may loaded with a radiopaque filler such as BaSO4.

Referring to FIGS. 26 and 26 A, the introducer 30 is depicted in operation according to an embodiment of the disclosure. The location of the OVM ostium within the coronary sinus can vary substantially from patient to patient. The typical length of the coronary sinus also varies between patients, typically ranging from 20 to 60 millimeters. A diameter of the coronary sinus is typically about 10 millimeters, with diameters of up to 20 millimeters or more in rare anatomies. The locations of the OVM ostium may vary in a continuum between a most proximal position P1 (i.e., closest to the ostium of the coronary sinus and the inferior vena cava), and a most distal position P4, that is, in vicinity of a transition between the coronary sinus CS and a great cardiac vein GCV. In FIG. 26, the OVM is depicted as located at a position P3 intermediate the coronary sinus CS and the IVC ostium.

In operation, the outer sheath assembly 32 or the fully assembled introducer 30 may be positioned through the IVC inside the coronary sinus with the distal extremity 86 in the vicinity of the distal-most position P4. By occupying a substantial length of the coronary sinus CS within the beating heart, stabilization of the outer sheath assembly 32 is enhanced. Contrast fluid may be injected through the secondary lumen 232, which exits the outer sheath assembly

32 at the distal end portion 54 via the plurality of lateral apertures 72 and, in some embodiments, via the ancillary passage(s) 211 (e.g., lumen(s) 212 or channel(s) 213). In this manner, the contrast fluid is selectively injected in the superior-posterior direction and over the operating length 98 of the outer sheath assembly 32. The diffusion of contrast fluid thereby occurs between the CS ostium and CS to GCV transition, a segment in which the OVM ostium is generally located.

The injection of the contrast fluid enables localization of the OVM ostium. While keeping the outer sheath assembly 32 steady, the operator, or any assisting device/software, can determine which of the plurality of radiopaque markers 92 of the outer sheath assembly 32 is closest to the localized OVM ostium. The outer diameter 59 of the outer sheath assembly 32 is generally smaller than the inner diameter of the coronary sinus CS. The position of the outer sheath assembly 32 is such that the distal end portion 54, and in particular the lateral apertures

72, will be adjacent the posterosuperior roof of the coronary sinus, where the OVM ostium is located. For fine tuning, the outer sheath assembly 32 may be translated and/or rotated slightly to align the designated (nearest) lateral aperture 44 with the localized OVM ostium. Additional injections of contrast fluid may confirm the location of the OVM ostium relative to the designated lateral aperture 72.

In some embodiments, the outer sheath assembly 32 maintained steadily and stabilized within the coronary sinus CS while the operator manipulates the deflector catheter 34 both axially and rotationally relative to the outer sheath assembly 32. The distal deflector 154 is maneuvered into position at the axial location of the radiopaque marker 92 previously identified as closest to the OVM ostium. The radial outlet 196 of the distal deflector 154 is aligned with the designated lateral aperture 72. Asymmetric aspects of radiopaque marker bands 120, described for example attendant to FIGS. 9 through 13, may facilitate rotational alignment.

The user threads a guidewire through the primary lumen 182 of the proximal shaft portion 166, for example via a dedicated port (not depicted)defined in the terminations 36, 38.

The distal deflector 154, axially and rotationally positioned as described above, deflects and thus guides the guidewire towards and into the localized OVM ostium.

In some embodiments, following positioning of the guidewire, the user threads a chemical infusion device, a balloon catheter, or other percutaneous devices (none depicted) over the positioned guidewire. The deflector also guides said catheter, thus reducing the risk of accidental withdrawal of the guidewire from the OVM. With respect to further endocardial

(e,g., LA, RA, LV, RV) ablations, the deflector catheter 34 is withdrawn from the outer sheath assembly 32. Before or after the procedures disclosed above, the outer sheath assembly 32 can be used for atrial and ventricular ablation procedures.

Functionally, the introducer 30 when utilized as described above is of particular utility when the OVM ostium is anatomically located proximally, in the vicinity of the coronary sinus/IVC ostium (proximate P1 in FIG. 26) or within approximately 10 millimeters of the coronary sinus/IVC ostium (proximate P2 in FIG. 26). In these scenarios, the OVM ostium can be accessed utilizing the proximally disposed lateral apertures 72 of the outer sheath assembly 32, with the distal extremity 86 positioned proximate P4 within the coronary sinus to promote stability.

In some embodiments, one or more of the disclosed introducers 30 are provided as a kit

270 (depicted at FIG. 1), complete with instructions 272 for use. The components of the kit

270 may include some or all of the outer sheath assembly 32, the deflector catheter 34, and the delivery device 40. The instructions 272 are provided on a tangible, non-transitory medium, and may be physically included with the kit 270 such as on a printed document (depicted), compact disc, or flash drive. Non-limiting examples of a tangible, non-transitory medium include a paper document and computer-readable media including compact disc and magnetic storage devices (e.g., hard disk, flash drive, cartridge, floppy drive). The computer-readable media may be local or accessible over the internet. The instructions 272 may be complete on a single medium, or divided among two or more media. For example, some of the instructions

272 may be written on a paper document that instruct the user to access one or more of the steps of the method over the internet, the internet-accessible steps being stored on a computerreadable medium or media. The instructions 272 may embody the techniques and methods depicted or described herein using text, photos, videos, or a combination thereof to instruct and guide the user. The instructions may be in the form of written words, figures, photos, video presentations, or a combination thereof to instruct and guide the user.

Each of the additional figures and methods disclosed herein can be used separately, or in conjunction with other features and methods, to provide improved devices and methods for making and using the same. Therefore, combinations of features and methods disclosed herein may not be necessary to practice the disclosure in its broadest sense and are instead disclosed merely to particularly describe representative and preferred embodiments. Various modifications to the embodiments may be apparent to one of skill in the art upon reading this disclosure. For example, persons of ordinary skill in the relevant arts will recognize that the various features described for the different embodiments can be suitably combined, un-combined, and re-combined with other features, alone, or in different combinations. Likewise, the various features described above should all be regarded as example embodiments, rather than limitations to the scope or spirit of the disclosure.

Persons of ordinary skill in the relevant arts will recognize that various embodiments can comprise fewer features than illustrated in any individual embodiment described above.

The embodiments described herein are not meant to be an exhaustive presentation of the ways in which the various features may be combined. Accordingly, the embodiments are not mutually exclusive combinations of features; rather, the claims can comprise a combination of different individual features selected from different individual embodiments, as understood by persons of ordinary skill in the art.

Any incorporation by reference of documents above is limited such that no subject matter is incorporated that is contrary to the explicit disclosure herein. Any incorporation by reference of documents above is further limited such that no claims included in the documents are incorporated by reference herein. Any incorporation by reference of documents above is yet further limited such that any definitions provided in the documents are not incorporated by reference herein unless expressly included herein.

Unless indicated otherwise, references to “embodiment(s)”, “disclosure”, “present disclosure”, “embodiments) of the disclosure”, “disclosed embodiments)”, and the like contained herein refer to the specification (text, including the claims, and figures) of this patent application that are not admitted prior art. For purposes of interpreting the claims, it is expressly intended that the provisions of

35 U.S.C. 112(f) are not to be invoked unless the specific terms “means for” or “step for” are recited in the respective claim.

Claims

CLAIMS What is claimed is:

1. An introducer for accessing a branch vein of the coronary sinus, comprising: an outer sheath assembly including a body having a distal end portion, said body defining an inner diameter that is concentric about a central axis, said distal end portion defining a first plurality of lateral apertures that are centered and axially spaced along a first side axis; and a deflector catheter including a catheter shaft with a distal deflector disposed at a distal end thereof, said catheter shaft defining a primary lumen said, distal deflector defining a main lumen having an axial inlet and a radial outlet, said axial inlet being in alignment with said first lumen of said catheter shaft, said radial outlet being defined on an outer tangential surface of said distal deflector, wherein said radial outlet is configured for selective alignment with any one of said first plurality of lateral apertures.

2. The introducer of claim 1, wherein said distal end portion is deflectable.

3. The introducer of claim 1, wherein said distal end portion is configured with an atraumatic tip.

4. The introducer of claim 1, wherein each of said first plurality of lateral apertures defines a maximum tangential width that extends about said central axis, said maximum tangential width being greater than a maximum tangential width of said radial outlet of said distal deflector of said deflector catheter.

5. The introducer of claim 4, wherein a ratio of said maximum tangential width of each of said first plurality of apertures to said maximum tangential width of said radial outlet is in a range of 1 to 2.5 inclusive.

6. The introducer of claim 1, wherein said outer sheath assembly defines a second plurality of lateral apertures centered and axially spaced along a second side axis.

7. The introducer of claim 4, wherein each of said second plurality of lateral apertures is tangentially aligned with a corresponding one of said first plurality of lateral apertures.

8. The introducer of claim 4, said outer sheath assembly defines a third plurality of lateral apertures centered and axially spaced along a third side axis.

9. The method of claim 8, wherein each of said third plurality of lateral apertures is tangentially aligned with a corresponding one of said second plurality of lateral apertures.

10. The introducer of claim 1, wherein said distal end portion of said outer sheath assembly includes means for marking each of said plurality of first apertures with an associated radiopaque marker.

11. The introducer of claim 1, wherein said distal end portion of said outer sheath assembly includes a plurality of radiopaque markers, each being associated with a corresponding one of said first plurality of lateral apertures.

12. The introducer of claim 11, wherein said plurality of radiopaque markers are disposed on an external surface of said outer sheath assembly.

13. The introducer of claim 11, wherein each of said plurality of radiopaque markers is a band that extends tangentially about said central axis.

14. The method of claim 13, wherein said band is axially adjacent a corresponding one of said first plurality of lateral apertures.

15. The method of claim 13, wherein said corresponding one of said first plurality of lateral apertures passes through said band.

16. The introducer of claim 11, wherein each of said radiopaque markers includes a feature at a known tangential location relative to said corresponding one of said first plurality of lateral apertures.

17. The introducer of claim 11, wherein each of said plurality of radiopaque markers outlines a perimeter of said corresponding one of said first plurality of lateral apertures.

18. The introducer of claim 1, wherein said distal deflector of said deflector catheter includes a radiopaque marker associated with said lateral aperture of said distal deflector.

19. The introducer of claim 11, wherein said radiopaque marker is disposed on an external surface of said distal deflector .

20. The introducer of claim 11 , wherein said radiopaque marker is a band that extends tangentially about the distal deflector to define an outer diameter of said distal deflector.

21. The introducer of claim 11, wherein said radiopaque marker includes a feature at a known tangential location relative to said lateral aperture of said distal deflector.

22. The introducer of claim 1, wherein: said catheter shaft includes a transition portion that transitions from a proximal shaft portion to a deflector shaft portion, said proximal shaft portion defining a first diameter, said deflector shaft portion defining a second diameter, said first diameter being greater than said second diameter; and said deflector shaft portion cooperates with said inner diameter of said outer sheath assembly to define an annulus that extends from said transition portion to said distal deflector.

23. The introducer of claim 22, wherein said deflector catheter defines a secondary lumen that extends parallel to said primary lumen, said secondary lumen terminating at said transition portion to define an inlet to said annulus.

24. The method of claim 23, wherein said annulus is an eccentric annulus.

25. The method of claim 23, wherein said proximal shaft is an extrusion that defines said primary lumen and said secondary lumen.

26. The method of claim 25, wherein said proximal shaft portion includes an outer sleeve that surrounds said extrusion to define said first diameter of said proximal shaft portion.

27. The introducer of claim 22, wherein said transition portion defines an outer diameter that is greater than said first diameter of said proximal shaft portion for sliding contact with said inner diameter of said outer sheath assembly.

28. The introducer of claim 22, wherein said distal deflector defines a radial diameter that is greater than said second diameter of said deflector shaft portion.

29. The method of claim 28, wherein said radial diameter is dimensioned for a sliding fit with said inner diameter of said outer sleeve.

30. The introducer of claim 1, wherein said main lumen of said distal deflector is arcuate.

31. The introducer of claim 1, wherein said distal deflector defines an ancillary passage that extends axially through said distal deflector adjacent said main lumen.

32. The introducer of claim 31, wherein said ancillary passage is one of a through-hole and a channel.

33. The introducer of claim 1 or claim 28, wherein: said distal deflector includes an indexing mechanism that facilitates local registration of said distal deflector at discrete locations within said outer sheath assembly; and said indexing mechanism is configured to align said radial outlet of said distal deflector with a designated lateral aperture when said indexing mechanism is engaged with said complementary structure.

34. The introducer of claim 33, wherein said indexing mechanism includes a biasing element that biases a detent radially outward for releasable engagement with a complementary structure on said outer sheath assembly.

35. The method of claim 34, wherein said detent and said biasing element are unitary with said distal deflector.

36. The method of claim 34, wherein said biasing element is a cantilever spring.

37. The method of claim 34, wherein said detent includes a radiused outer perimeter for releasable engagement with said complementary structure.

38. The method of claim 34, wherein said complementary structure is an arbitrary one of said first plurality of lateral apertures.

39. The method of claim 38, wherein said arbitrary one of said first plurality of lateral apertures is axially adjacent said designated aperture.

40. The method of claim 39, wherein said arbitrary one of said first plurality of lateral apertures is proximal to said designated aperture.

41. The introducer of claim 1, comprising a delivery device configured for translation through said primary lumen and said main lumen to extend in a radial direction from said radial outlet of said distal deflector.

42. The introducer of claim 41, wherein said delivery device is one of a guide wire, a balloon catheter, and an ablation catheter.

43. The introducer of claim 1, wherein said radiopaque markers include one of a radiopaque alloy and a radiopaque-filled polymer.

44. A method for routing a percutaneous device through an ostium that branches from a coronary sinus of a patient, comprising: providing a kit including an outer sheath assembly; and providing instructions for use of said kit on a tangible, non-transitory medium, said instructions including: routing a distal end portion of said outer sheath assembly to a coronary sinus via an inferior vena cava; inserting said distal end portion into said coronary sinus so that a distal extremity of said distal end portion is proximate a transition between said coronary sinus and a great cardiac vein; and aligning a designated lateral aperture from one of a plurality of lateral apertures defined on said outer sheath assembly for insertion of a delivery device via said designated lateral aperture and through an ostium that branches from said coronary sinus.

45. The method of claim 44, wherein said instructions provided in the step of providing instructions include injecting a contrast fluid into said distal end portion of said outer sheath assembly for exiting said plurality of lateral apertures.

46. The method of claim 44, wherein said instructions provided in the step of providing instructions includes at least one of rotating and translating said outer sheath assembly within said coronary sinus to align said designated lateral aperture of said plurality of lateral apertures with said ostium.

47. The method of claim 44, wherein said instructions provided in the step of providing instructions includes using a radiopaque marker of said outer sheath assembly in the step of aligning.

48. The method of claim 47, wherein said radiopaque marker of said outer sheath assembly provided in the step of providing said kit includes an asymmetry for discerning rotational positioning of said outer sheath assembly.

49. The method of claim 44, wherein: said kit provided in the step of providing said kit includes a deflector catheter, said deflector catheter including a distal deflector having a radial outlet for routing said delivery device through said designated lateral aperture of said outer sheath assembly; and said instructions provided in the step of providing instructions includes routing said delivery device through said deflector catheter.

50. The method of claim 49, wherein said instructions provided in the step of providing instructions includes inserting said delivery device through said ostium at an angle relative to a primary lumen axis of said deflector catheter.

51. The method of claim 50, wherein said angle is in a range of 60 to 80 degrees inclusive relative to a distal direction.

52. The method of any one of claims 44-51, wherein said ostium specified in said instructions is an ostium of an Oblique Vein of Marshall.