US5820600A — Adjustable introducer valve

Claim 1

Independent Claim 167 words

A introducer assembly for introducing elongate objects through a percutaneous penetration in a patient, the introducer assembly comprising: an elongate shaft having proximal and distal ends and an axial lumen therebetween; and a valve assembly pivotally coupled to the proximal end of the shaft, the valve assembly comprising: a first valve member defining an inner lumen for receiving elongated objects; a flexible membrane defining an aperture positioned in general alignment with the inner lumen; and a second valve member coupled to the membrane for moving the membrane between a first configuration, in which the aperture has a first area, and a second configuration, in which the aperture has a second area not equal to the first area so to sealingly receive elongated objects having different cross-sectional areas, wherein the second valve member is positioned radially outward from the inner lumen of the first valve member, and wherein said valve assembly pivots in response to transverse movement of an elongate object within the axial lumen of the shaft.

Claim 2

Dependent Claim 167 words

A introducer assembly for introducing elongate objects through a percutaneous penetration in a patient, the introducer assembly comprising: an elongate shaft having proximal and distal ends and an axial lumen therebetween; and a valve assembly pivotally coupled to the proximal end of the shaft, the valve assembly comprising: a first valve member defining an inner lumen for receiving elongated objects; a flexible membrane defining an aperture positioned in general alignment with the inner lumen; and a second valve member coupled to the membrane for moving the membrane between a first configuration, in which the aperture has a first area, and a second configuration, in which the aperture has a second area not equal to the first area so to sealingly receive elongated objects having different cross-sectional areas, wherein the second valve member is positioned radially outward from the inner lumen of the first valve member, and wherein said valve assembly pivots in response to transverse movement of an elongate object within the axial lumen of the shaft.

Claim 3

Dependent Claim 30 words

The introducer assembly of claim 1 further comprising a hub attached to the proximal end of the shaft, the first and second valve members being pivotally coupled to the hub.

Claim 4

Dependent Claim 34 words

The introducer assembly of claim 2 wherein the first and second valve members are gimballed to the hub for 360 degree pivotal movement about a plane transverse to the axial lumen of the shaft.

Claim 5

Dependent Claim 38 words

The introducer assembly of claim 1 further comprising a plurality of holding members coupled to the first valve member, the holding members each having ends facing each other to define a gap therebetween for receiving the elongated object.

Claim 6

Dependent Claim 41 words

The introducer assembly of claim 4 wherein the holding members are movable between a first position, in which the gap has a first area, and a second position, in which the gap has a second area larger than the first area.

Claim 7

Dependent Claim 96 words

A valve for sealingly receiving elongated objects, the valve comprising: a valve body defining an inner lumen for receiving elongated objects; a flexible membrane defining an aperture substantially aligned with the inner lumen, the aperture defining an area; and a valve member threadably coupled to the valve body for varying the area of the aperture so to sealingly receive elongated objects having different cross-sectional areas, wherein the valve member is rotatable to axially translate said valve member relative to the body and is non-responsive to elongated objects passing through the inner lumen of the valve body.

Claim 8

Dependent Claim 96 words

A valve for sealingly receiving elongated objects, the valve comprising: a valve body defining an inner lumen for receiving elongated objects; a flexible membrane defining an aperture substantially aligned with the inner lumen, the aperture defining an area; and a valve member threadably coupled to the valve body for varying the area of the aperture so to sealingly receive elongated objects having different cross-sectional areas, wherein the valve member is rotatable to axially translate said valve member relative to the body and is non-responsive to elongated objects passing through the inner lumen of the valve body.

Claim 9

Dependent Claim 60 words

The valve of claim 6 wherein the membrane is movable between a first configuration, in which the aperture has a first area for receiving a first elongated object with a first diameter, and a second configuration, in which the aperture has a second area for receiving a second elongated object with a second diameter not equal to the first diameter.

Claim 10

Dependent Claim 35 words

The valve of claim 7 wherein the aperture, in the first configuration, has a diameter of about 4 to 6 mm and, in the second configuration, has a diameter of about 11 to 13 mm.

Claim 11

Dependent Claim 19 words

The valve of claim 7 wherein the aperture has substantially the same shape in the first and second configurations.

Claim 12

Dependent Claim 11 words

The valve of claim 9 wherein the aperture is substantially circular.

Claim 13

Dependent Claim 28 words

The valve of claim 7 wherein the membrane offers a substantially equivalent frictional resistance to the first and second elongated objects in the first and second configurations, respectively.

Claim 14

Dependent Claim 31 words

The valve of claim 7 wherein the diameter of the aperture in the first and second configurations is slightly less than the diameter of the first and second elongated objects, respectively.

Claim 15

Dependent Claim 17 words

The valve of claim 6 wherein the flexible membrane is an annular membrane comprising an elastomeric material.

Claim 16

Dependent Claim 120 words

A pneumostasis valve for introduction of elongated objects into a patient's body, the valve comprising: a hollow tube defining an inner lumen with a proximal opening for receiving the elongated object; a flexible membrane defining an aperture positioned over the proximal opening and substantially aligned with the inner lumen; and a collar threadably secured to axially translate over the hollow tube and coupled to an outer edge of the flexible membrane, wherein the collar is rotatable to cause axial translation of the collar relative to the hollow tube and wherein distal movement of the collar relative to the hollow tube causes the aperture to open radially outward and proximal movement of the collar causes the aperture to close radially inward.

Claim 17

Dependent Claim 120 words

A pneumostasis valve for introduction of elongated objects into a patient's body, the valve comprising: a hollow tube defining an inner lumen with a proximal opening for receiving the elongated object; a flexible membrane defining an aperture positioned over the proximal opening and substantially aligned with the inner lumen; and a collar threadably secured to axially translate over the hollow tube and coupled to an outer edge of the flexible membrane, wherein the collar is rotatable to cause axial translation of the collar relative to the hollow tube and wherein distal movement of the collar relative to the hollow tube causes the aperture to open radially outward and proximal movement of the collar causes the aperture to close radially inward.

Claim 18

Dependent Claim 18 words

The valve of claim 14 wherein the flexible membrane is a thin, resilient membrane comprising an elastomeric material.

Claim 19

Independent Claim 115 words

A method for introducing elongated objects into a patient's body, the method comprising: providing a valve body having an opening for receiving elongated objects and a flexible membrane with an aperture substantially aligned with the opening; rotating a collar threadably coupled to the valve body to move the collar in a distal direction relative to the valve body, the collar being coupled to an outer portion of the membrane in order to stretch the membrane radially outward from a center of the proximal opening of the hollow tube to enlarge the diameter of the aperture; and after the rotating step, introducing an elongated object through the aperture and the flexible membrane into the patient's body.

Claim 20

Independent Claim 115 words

A method for introducing elongated objects into a patient's body, the method comprising: providing a valve body having an opening for receiving elongated objects and a flexible membrane with an aperture substantially aligned with the opening; rotating a collar threadably coupled to the valve body to move the collar in a distal direction relative to the valve body, the collar being coupled to an outer portion of the membrane in order to stretch the membrane radially outward from a center of the proximal opening of the hollow tube to enlarge the diameter of the aperture; and after the rotating step, introducing an elongated object through the aperture and the flexible membrane into the patient's body.

Claim 21

Dependent Claim 35 words

The method of claim 16 wherein the aperture, in a first configuration, has a diameter of about 4 to 6 mm and, in a second configuration, has a diameter of about 11 to 13 mm.

Claim 22

Dependent Claim 27 words

The method of claim 17 further comprising offering substantially the same frictional resistance to elongated objects extending through the flexible membrane in the first and second configurations.

Claim 23

Dependent Claim 17 words

The method of claim 17 wherein the aperture retains substantially the same shape as it is stretched.

Claim 24

Dependent Claim 10 words

The method of claim 16 wherein the aperture is circular.

Claim 25

Independent Claim 120 words

A method for introducing elongated objects into a patient's body comprising: introducing a first elongated object having a first diameter through an opening in a valve body and an aperture of a flexible membrane and into the patient's body; manipulating the first elongated object so that said object moves transversely relative to the valve body, wherein the membrane is pivotally attached to the valve body to allow the membrane to pivot in response to movement of said object; removing the first elongated object; enlarging the aperture; and after the enlarging step introducing a second elongated object having a second diameter through the opening and the aperture and into the patient's body, the second diameter being larger than the first diameter.

Claim 26

Independent Claim 120 words

A method for introducing elongated objects into a patient's body comprising: introducing a first elongated object having a first diameter through an opening in a valve body and an aperture of a flexible membrane and into the patient's body; manipulating the first elongated object so that said object moves transversely relative to the valve body, wherein the membrane is pivotally attached to the valve body to allow the membrane to pivot in response to movement of said object; removing the first elongated object; enlarging the aperture; and after the enlarging step introducing a second elongated object having a second diameter through the opening and the aperture and into the patient's body, the second diameter being larger than the first diameter.

Claim 27

Dependent Claim 21 words

The method of claim 21 wherein the first diameter is about 4-6 mm and the second diameter is about 10-15 mm.

Claim 28

Dependent Claim 36 words

The method of claim 21 wherein the enlarging step comprises moving an outer portion of the membrane in the distal direction to stretch an inner portion of the membrane radially outward and thereby enlarge the aperture.

Annuity Stage	Window Opens	Payment Deadline	Surcharge Period Until	Estimated Fee	Status
3.5 Years (Year 4)	2001-10-12	2002-04-13	2002-10-13	$2000.00	Window Closed / Lapsed
7.5 Years (Year 8)	2005-10-12	2006-04-13	2006-10-13	$3760.00	Window Closed / Lapsed
11.5 Years (Year 12)	2009-10-12	2010-04-13	2010-10-13	$7700.00	Window Closed / Lapsed

Adjustable introducer valve

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