Hemostasis valve

Details Hemostasis valve Hemostasis valve

2001-02-13

2003-02-18

Derakshani, Philippe (Department: 3754)

Surgery

Means for introducing or removing material from body for...

Treating material introduced into or removed from body...

C604S256000

Reexamination Certificate

active

06520939

ABSTRACT:

FIELD OF THE INVENTION
The present invention generally relates to devices incorporating hemostasis valves. More specifically, the present invention relates to hemostasis valves for use with vascular introducer sheaths, catheters, Y-adapters and the like.
BACKGROUND OF THE INVENTION
Vascular introducer sheaths are well known components of vascular access systems which are used in a wide variety of diagnostic and therapeutic vascular procedures, such as angiography, angioplasty and embolization procedures. Vascular access systems typically include an introducer sheath and a dilator. The introducer sheath usually includes a hemostasis valve which inhibits blood loss as guide wires, catheters and the like are introduced, passed through and manipulated in the sheath.
An example of a conventional vascular access system
10
is illustrated in FIG.
1
. The vascular access system
10
includes two primary components, namely an introducer sheath
12
and a dilator
14
. The introducer sheath
12
includes an elongate shaft
16
and a hemostasis valve assembly
18
. A flush tube subassembly
20
may be connected to a side port
22
of the hemostasis assembly
18
. Although not clearly visible, the hemostasis valve assembly
18
includes a hub, a cap and a gasket
30
(shown in
FIGS. 2A and 2B
) disposed therebetween.
The gasket
30
of the hemostasis valve assembly
18
forms a fluid seal about devices inserted therein to inhibit back-bleeding. The gasket
30
may comprise a disc of flexible polymeric material having a slit
32
extending therethrough as shown in
FIG. 2A
or a hole
34
as shown in FIG.
2
B. The slit
32
is sufficiently flexible and the hole
34
is sufficiently sized to form a seal about devices inserted therein. The slit
32
is normally closed such that a hemostatic seal is formed with or without devices inserted therein. By contrast, the hole
34
is normally open such that a hemostatic seal is formed only with a device inserted therein.
An advantage of the slit
32
design is that back-bleeding is prevented at all times—prior to, during and subsequent to device insertion. A disadvantage of the slit
32
design is that a significant amount of friction may be encountered when sliding devices therethrough. An advantage of the hole
34
design is that relatively little friction is encountered when sliding devices therethrough. A disadvantage of the hole
34
design is that back-bleeding may occur when no device is inserted therein (i.e., prior to and subsequent to device insertion). Accordingly, there is a need for a hemostasis valve which provides a fluid tight seal at all times to prevent back-bleeding, and offers relatively low friction when devices are inserted therein.
SUMMARY OF THE INVENTION
To address this need, the present invention provides an improved hemostasis valve for use with an intravascular device such as an introducer sheath, a catheter or the like. In all embodiments, the hemostasis valve may either be an integral part of the device, or releasable from the device as in a Y-adapter, a manifold or the like.
In one embodiment, the hemostasis valve is normally closed and is biased to a closed position in response to distal pressure to prevent back-bleeding. The hemostasis valve is also biased to an open position in response to proximal force or pressure to reduce friction when devices are inserted therein. For example, the hemostasis valve may comprise a plurality of flaps or leaflets, such as a bileaflet or trileaflet design. Preferably, the leaflets are cuspidate, such as a bicuspid or tricuspid design. Also preferably, the thickness of the leaflets is substantially less than the radial dimension thereof such that the leaflets readily deflect and conform. As an alternative, another hemostasis valve (e.g., a close-fit seal) may be utilized to ensure a fluid tight seal about devices inserted therein.
In another embodiment, the hemostasis valve is longitudinally actuated between an open position to reduce friction during device insertion and a closed position to prevent back-bleeding when no devices are inserted therein. The hemostasis valve may include a circular or helical pleat which changes in radial dimension upon longitudinal actuation. For example, the hemostasis valve may be bellows-shaped. The hemostasis valve may also include a radial compression member that toggles when the valve is closed to ensure a fluid tight seal.


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Product Brochure: Pinnacle® Introducer Sheaths, undated, 3 sheets.

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