An introducer sheath that is coupled to or integrated with a secondary device insertion hub, such as a hemostasis valve hub, wherein the secondary device insertion hub is received within a proximal portion of the introducer sheath. The introducer sheath may include one or more pull wire lumens, and the secondary device insertion hub does not cover or obstruct the proximal opening of each of the one or more pull wire lumens when coupled to or integrated with the introducer sheath. In this configuration one or more pull wires are free to exit the one or more pull wire lumens through a proximal face of the introducer sheath instead of a skive in a wall of the elongate body.

CROSS-REFERENCE TO RELATED APPLICATION

FIELD OF THE INVENTION

The present invention relates to skiveless sheath. In particular, the present invention relates to an introducer sheath that is coupled to or integrated with a secondary device insertion hub, such as a hemostasis valve hub, wherein the secondary device insertion hub is received within a proximal portion of the introducer sheath and does not obstruct one or more pull wire lumens within the introducer sheath.

BACKGROUND OF THE INVENTION

Intracardiac and intravascular procedures, commonly involve the use of an introducer sheath. The introducer sheath facilitates insertion of one or more medical devices, such as ablation catheters, mapping catheters, transseptal puncture devices, and the like, and their navigation through the patient's vasculature. An introducer sheath typically includes a hemostasis valve, which may be used to prevent the backflow of blood out of the introducer sheath during insertion of the medical devices into the sheath.

An introducer sheath may be attached to a hemostasis valve by inserting a proximal end of the sheath into a hemostasis valve hub and bonding the sheath and hub together. Thus, the hemostasis valve hub encloses the proximal end of the introducer sheath and therefore closes off any lumens within the sheath. In the case of steerable introducer sheaths, the sheath wall may include a skive hole that provides an exit from the sheath for each pull wire. As shown inFIG. 1, a currently known introducer sheath10may include a proximal portion12that is coupled to a hemostasis valve hub14. Further, the proximal portion of the pull wire16may exit the sheath through a skive hole18and, once outside the sheath10, may be connected to one or more steering elements and/or directly manipulated by an operator to navigate the sheath (not shown).

However, sheaths having skive holes18frequently develop leaks, and this may be due to the manner in which the pull wire16exits the sheath10and/or the mechanical means by which the skive holes18are created.

It is therefore desirable to provide a steerable introducer sheath having a hemostasis valve hub that eliminates the need for skive holes.

SUMMARY OF THE INVENTION

The present invention advantageously provides an introducer sheath that is coupled to or integrated with a secondary device insertion hub, such as a hemostasis valve hub, wherein the secondary device insertion hub is received within a proximal portion of the introducer sheath and does not obstruct one or more pull wire lumens within the introducer sheath. An introducer sheath may include an elongate body having a proximal portion, a distal portion, and a lumen therebetween and a secondary device insertion hub. The secondary device insertion hub may be received within the proximal portion of the elongate body, the lumen being unobstructed by the secondary device insertion hub. The lumen may be a pull wire lumen, the introducer device further comprising a main lumen that is substantially parallel to the pull wire lumen. Further, the main lumen may have a first inner diameter at the distal portion of the elongate body and a second inner diameter at the proximal portion of the elongate body, and the first inner diameter and the second inner diameter may be different. For example, the inner diameter at the proximal portion of the elongate body may be greater than the inner diameter at the distal portion of the elongate body. The pull wire lumen may be a distance from the main lumen, the distance being the same in the proximal portion of the elongate body as in the distal portion of the elongate body. The proximal portion of the elongate body may define a proximal face, and the device may further include a pull wire within the pull wire lumen, with at least a portion of the pull wire exiting the proximal portion of the elongate body through the proximal face. For example, the proximal face may define a proximal opening of the pull wire lumen and a proximal opening of the main lumen. The elongate body may define a longitudinal axis, and the proximal portion of the pull wire lumen may be at an angle of between approximately 10° and approximately 45° from the longitudinal axis, whereas the main lumen may lie entirely along the longitudinal axis. The secondary device insertion hub may be integrated with the proximal portion of the elongate body. Further, the secondary device insertion hub may be hemostasis valve hub.

An introducer sheath may include an elongate body having a proximal portion, a distal portion, and a longitudinal axis; a main lumen defined by the elongate body and extending between the proximal portion of the elongate body and the distal portion of the elongate body, the main lumen having a proximal opening; a pull wire lumen defined by the elongate body and extending between the proximal portion of the elongate body and the distal portion of the elongate body, the pull wire lumen having a proximal opening; and a secondary device insertion hub, the secondary device insertion hub being received within the proximal opening of the main lumen, the proximal opening of the pull wire lumen being unobstructed by the secondary device insertion hub. The main lumen may have a distal portion having a first inner diameter and a tapered portion between the distal portion and the proximal opening of the main lumen. The proximal opening of the main lumen may have a second inner diameter and the tapered portion may have a continuously decreasing inner diameter from the proximal opening to the distal portion of the main lumen. The proximal portion of the elongate body may define a proximal face, which may include the proximal opening of the pull wire lumen and the proximal opening of the main lumen.

A medical device may include an elongate body having a proximal portion, a distal portion, and a longitudinal axis; a main lumen defined by the elongate body and extending between the proximal portion of the elongate body and the distal portion of the elongate body along the longitudinal axis of the elongate body, the main lumen having a distal portion, a proximal opening, and a tapered portion between the proximal opening and the distal portion of the main lumen; a pull wire lumen defined by the elongate body and extending between the proximal portion of the elongate body and the distal portion of the elongate body, the pull wire lumen having a distal portion, a proximal portion, and a proximal opening; and a secondary device insertion hub at least partially disposed within the proximal opening and tapered portion of the main lumen, the proximal opening of the pull wire lumen being unobstructed by the secondary device insertion hub, the distal portion of the pull wire lumen being at least substantially parallel to the longitudinal axis and the proximal portion of the pull wire lumen being at an angle from the longitudinal axis that follows an angle of the tapered portion of the main lumen. The proximal portion of the pull wire lumen may be at an angle of between approximately 10° and approximately 45° from the longitudinal axis of the elongate body.

DETAILED DESCRIPTION OF THE INVENTION

Referring now to the figures in which like elements are numbered alike,FIG. 2shows a skiveless introducer sheath with a hemostasis valve assembly. The sheath20may generally include an elongate body21including a distal portion22, a proximal portion24, and a main lumen26therebetween. The distal portion22of the sheath20may be configured for insertion into a patient's vasculature. The proximal portion24of the sheath10may be coupled to a hub30through with a secondary device may be introduced into the patient's vasculature through the sheath20. Accordingly, the hub30may be referred to as a “secondary device insertion hub.” For example, the proximal portion24may be coupled to a hemostasis valve hub. The sheath20may further include one or more pull wire lumens34and one or more pull wires36.

Referring now toFIGS. 3-8, the proximal portion of the skiveless sheath is shown in more detail. Unlike the proximal portion12of the prior art sheath10shown inFIG. 1, the sheath20may include a proximal portion24that is widened. That is, the proximal portion24may be tapered from the main lumen proximal opening40in a proximal-to-distal direction. As is shown inFIGS. 6 and 7, the main lumen26may include a distal portion42with a continuous inner diameter IDDthat is smaller than the inner diameter IDPof the proximal opening40of the main lumen26. The main lumen26may further include a tapered portion44between the distal portion42and the proximal opening40that has a continually decreasing inner diameter from the proximal opening40to the distal portion42of the main lumen26. The sheath may also have a shape, including a tapered portion that follows the shape of the main lumen26. The proximal opening40of the main lumen26may be sized to receive a hub30therein, such as a hemostasis valve hub. As shown inFIG. 6(cross-sectional view of the distal22portion of the sheath20along line6-6inFIG. 2) andFIG. 7(cross-sectional view of the proximal portion24of the sheath20along line7/8-7/8inFIG. 2, shown without the hub30), the inner diameter IDDof the distal portion22may be smaller than the inner diameter IDPof the proximal portion24. The main lumen26may be located in the center of the sheath20(that is, may lie along the central axis) or may be offset from the central axis of the sheath20.

As is shown inFIG. 4, the hub30may be received within a proximal opening40of the main lumen26. The hub30and the sheath20may be composed of the same material or different materials. The hub30and the sheath20may be affixed to each other by, for example, adhesives, friction fitting, chemical bonding, and/or other means known in the art. Alternatively, as shown inFIG. 5, the hub30A and the sheath20may be composed of the same material and may be coupled in a way that integrates the hub30A with the sheath20to create a single-piece hub/sheath device20A, such as along the hash marks shown inFIG. 5. As a non-limiting example, the hub/sheath device20A may be formed by Pebax reflow, or a soft thermoplastic valve may be fit into the shaft, with the sheath itself acting as the valve hub.

The one or more pull wire lumens34may be at least substantially parallel to the main lumen26and the proximal opening46may be located on the outside of the main lumen proximal opening40. If the sheath20includes more than one pull wire lumen34, the proximal openings46of the pull wire lumens34may be radially distributed about the main lumen proximal opening40, either symmetrically or non-symmetrically. Although one pull wire lumen34is shown inFIGS. 6-8, it will be understood that the sheath20may include more than one pull wire lumen34. Further, the proximal portion of each of the one or more pull wire lumens34may be angled (the angle is represented by a inFIG. 3) from the main longitudinal axis48of the pull wire lumen34, which is parallel to the longitudinal axis49of the main lumen26, so the proximal portion of each pull wire lumen34follows the taper of the main lumen26. In this manner, each pull wire lumen34may be a constant distance DLL from the main lumen26along the entire length of the sheath20(for example, as shown inFIGS. 6 and 7). As a non-limiting example, the proximal portion of each pull wire lumen34may be at an angle α of between approximately 5° and approximately 45° (±5°) from the longitudinal axis48. Accordingly, the taper of the proximal portion of the main lumen26may also be at an angle of between approximately 10° and approximately 45° (±5°) from the longitudinal axis48, with the angle of the taper being substantially the same as the angle at which the proximal portion of the pull wire lumen34lies from the longitudinal axis48.

As shown inFIG. 8(cross-sectional view of the proximal portion24of the sheath20taken along line7/8-7/8inFIG. 2, shown with the hub30), when the hub30is coupled to the proximal portion24of the sheath20, the proximal opening46of each of the one or more pull wires34may be left uncovered by the hub30. In this way, a pull wire36may be free to exit the sheath proximal portion24without the need for a skive hole. In use, a medical device may be inserted into an opening within the hub30(not shown) or an opening of a component coupled to the hub (not shown) and advanced through the introducer sheath20and into the patient's vasculature. As shown inFIGS. 6-8, the proximal portion24of the sheath20may define a proximal face50that includes the main lumen proximal opening40and the pull wire lumen proximal opening46. The proximal face50may lie in a plane that is at least substantially orthogonal to the longitudinal axis of the sheath20.