Surgery – Means for introducing or removing material from body for... – Treating material introduced into or removed from body...
Reexamination Certificate
1999-09-10
2001-11-27
Seidel, Richard K. (Department: 3763)
Surgery
Means for introducing or removing material from body for...
Treating material introduced into or removed from body...
C604S167040, C137S844000
Reexamination Certificate
active
06322541
ABSTRACT:
FIELD OF THE INVENTION
The present invention generally relates to introducer sheaths for use in procedures requiring vascular access. More specifically, the present invention relates to hemostasis valves for use in such introducer sheaths.
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, thermolysis and embolization procedures. Vascular access systems typically include an introducer sheath for use in combination with a guide wire and a dilator. The introducer sheaths usually include a hemostatic or hemostasis valve which inhibits blood loss as guide wires, catheters and the like are introduced and manipulated in the vasculature via the sheath.
An example of a known hemostasis valve is disclosed in U.S. Pat. No. 5,520,655 to Davila et al. Davila '655 discloses a hemostasis valve including an inner housing, an end cap and a valve partition disposed between the inner housing and the end cap. The end cap includes a compression ring having a diameter which is less than the diameter of the valve partition but greater than the diameter of the aperture in the end cap and the bore in the inner housing. With this arrangement, the compression ring causes the valve partition to bow outwardly. Purportedly, the bowing enhances the sealing of the slit in the valve partition. However, the compression ring creates stress concentration points on the valve partition that may compromise the integrity of the valve partition. Furthermore, an excessive amount of compression must be applied by the compression ring against the valve partition to impart the bowing effect.
A similar hemostasis valve is disclosed in International Patent Publication No. WO 99/06099 to Paul. Paul '099 discloses a hemostatic valve including a gasket seal contained in a valve body and compressed therein by a cap connected to the valve body. The valve body includes a valve seat, which in turn includes a flange and a series of annular recessed steps. The flange serves to impart a concave shape to the gasket seal. The series of annular steps serve to prevent the gasket seal from being displaced. As with the hemostasis valve disclosed in Davila '655, the hemostasis valve disclosed in Paul '099 suffers from the creation of stress concentration points imparted by the flange onto the valve gasket. The annular steps recessed in the valve body, depending on the size, may also create stress concentration points on the gasket seal. These stress concentration points may compromise the integrity of the gasket seal and also require an excessive amount of compression to impart the desired curved shape of the gasket seal.
SUMMARY OF THE INVENTION
The present invention overcomes these disadvantages by providing, in an exemplary embodiment, a vascular introducer sheath for use with a vascular access system. The vascular introducer sheath includes a tubular shaft and a hemostasis valve assembly connected to the proximal end of the tubular shaft. The hemostasis valve assembly includes a hub, a cap and a gasket disposed therebetween. The gasket may be normally-flat and may have at least one normally-closed slit extending therethrough.
Both the hub and the cap include continuous contact surfaces facing the top and bottom surfaces of the gasket. The continuous contact surfaces may be flat or gently curved, and may be smooth or include a means to grip the gasket. At least one of the contact surfaces forms a non-orthogonal angle with the longitudinal axis of the assembly to cause the gasket to become curved in response to compression between the hub and the cap. The continuous contact surfaces uniformly distribute forces onto the perimeter of the gasket to avoid stress concentration points that may compromise gasket integrity. In addition, the continuous contact surfaces increase the contact surface area and thereby reduce the amount of pressure necessary to impart the desired curved shape of the gasket.
REFERENCES:
patent: 4000739 (1977-01-01), Stevens
patent: 4254773 (1981-03-01), Waldbillig
patent: 4366817 (1983-01-01), Thomas
patent: 4424833 (1984-01-01), Spector et al.
patent: 4430081 (1984-02-01), Timmermans
patent: 4436519 (1984-03-01), O'Neil
patent: 4798594 (1989-01-01), Hillstead
patent: 4874378 (1989-10-01), Hillstead
patent: 4895565 (1990-01-01), Hillstead
patent: 4929235 (1990-05-01), Merry et al.
patent: 4944729 (1990-07-01), Buckberg et al.
patent: 4946133 (1990-08-01), Johnson et al.
patent: 4950257 (1990-08-01), Hibbs et al.
patent: 5000745 (1991-03-01), Guest et al.
patent: 5045065 (1991-09-01), Raulerson
patent: 5059186 (1991-10-01), Yamamoto et al.
patent: 5092857 (1992-03-01), Fleischhacker et al.
patent: 5098393 (1992-03-01), Amplatz et al.
patent: 5114408 (1992-05-01), Fleischhaker et al.
patent: 5137519 (1992-08-01), Littrell et al.
patent: 5154701 (1992-10-01), Cheer et al.
patent: 5167637 (1992-12-01), Okada et al.
patent: 5188607 (1993-02-01), Wu
patent: 5234410 (1993-08-01), Graham et al.
patent: 5242410 (1993-09-01), Melker
patent: 5242413 (1993-09-01), Helliger
patent: 5267966 (1993-12-01), Paul
patent: 5295657 (1994-03-01), Atkinson
patent: 5300033 (1994-04-01), Miller
patent: 5330435 (1994-07-01), Vaillancourt
patent: 5350363 (1994-09-01), Goode et al.
patent: 5402982 (1995-04-01), Atkinson et al.
patent: 5499975 (1996-03-01), Cope et al.
patent: 5520655 (1996-05-01), Davila et al.
patent: 5520663 (1996-05-01), Patterson et al.
patent: 5538505 (1996-07-01), Weinstein et al.
patent: 5549576 (1996-08-01), Patterson et al.
patent: 5613956 (1997-03-01), Patterson et al.
patent: 5762630 (1998-06-01), Bley et al.
patent: 5807350 (1998-09-01), Diaz
patent: 5843031 (1998-12-01), Hermann et al.
patent: 5911710 (1999-06-01), Barry et al.
patent: 5944697 (1999-08-01), Biche
patent: 0 369 314 A2 (1990-05-01), None
patent: 0 442 194 A2 (1991-06-01), None
patent: 0 692 278 A1 (1994-07-01), None
patent: WO 99/06099 (1999-02-01), None
patent: WO99/06099 (1999-02-01), None
patent: WO 99/34849 (1999-07-01), None
Van Diver Mark H.
West Ronald L.
Crompton Seager & Tufte, LLC.
Sci-Med Life Systems, Inc.
Seidel Richard K.
Thanh Loan H.
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