US6197016B1 — Dual valve, flexible expandable sheath and method

Claim 1

Independent Claim 263 words

A large-diameter expandable sheath for use in introducing a catheter into a corporeal vessel, comprising: an elongate sheath tube formed of a flexible material having proximal and distal extremities and having a passage extending therethrough of a maximum predetermined diameter; the distal extremity of said sheath tube being folded longitudinally to a smaller folded diameter; a backflow adapter secured to the proximal extremity of said sheath tube; said backflow adapter having a central opening therein in registration with the passage in said sheath tube and having a valve disposed in the central opening of said backflow adapter and movable between open and closed positions; wherein the valve when open permits the catheter to be inserted into said sheath tube and when closed forms a hemostatic seal about the catheter; wherein the valve is in the form of a cylindrical member formed of a flexible material and having a bore therein in registration with the central opening of said backflow adapter; said backflow adapter having a rotatable device, said rotatable device configured to engage the opposite ends of the cylindrical member for causing relative rotation between the ends of the cylindrical member to cause the cylindrical member to be twisted to close the bore extending through the cylindrical member; and said rotatable device includes a retaining ring, a sheath tube adapter secured to opposite ends of the cylindrical member, a fixing device that fixes the sheath tube adapter to prevent rotation of the same within said backflow adapter, and a first sub-component that rotates the retaining ring with respect to the sheath tube adapter.

Claim 2

Dependent Claim 263 words

A large-diameter expandable sheath for use in introducing a catheter into a corporeal vessel, comprising: an elongate sheath tube formed of a flexible material having proximal and distal extremities and having a passage extending therethrough of a maximum predetermined diameter; the distal extremity of said sheath tube being folded longitudinally to a smaller folded diameter; a backflow adapter secured to the proximal extremity of said sheath tube; said backflow adapter having a central opening therein in registration with the passage in said sheath tube and having a valve disposed in the central opening of said backflow adapter and movable between open and closed positions; wherein the valve when open permits the catheter to be inserted into said sheath tube and when closed forms a hemostatic seal about the catheter; wherein the valve is in the form of a cylindrical member formed of a flexible material and having a bore therein in registration with the central opening of said backflow adapter; said backflow adapter having a rotatable device, said rotatable device configured to engage the opposite ends of the cylindrical member for causing relative rotation between the ends of the cylindrical member to cause the cylindrical member to be twisted to close the bore extending through the cylindrical member; and said rotatable device includes a retaining ring, a sheath tube adapter secured to opposite ends of the cylindrical member, a fixing device that fixes the sheath tube adapter to prevent rotation of the same within said backflow adapter, and a first sub-component that rotates the retaining ring with respect to the sheath tube adapter.

Claim 3

Dependent Claim 34 words

The sheath of claim 1 , wherein said rotatable device includes a ring gear secured to said retaining ring and a rack, said rack drives said ring gear to cause rotation of the same.

Claim 4

Dependent Claim 35 words

The sheath of claim 2 , further comprising a yieldable device that engages said rack and urges said rack into a position wherein said cylindrical member is moved to provide a normally closed valve device.

Claim 5

Dependent Claim 54 words

The sheath of claim 3 , wherein said rack extends tangentially through said body together with an actuator carried by the rack adapted to be engaged by the fingers of the hand that operates to move against the force of the yieldable device to move the normally closed valve device to an open position.

Claim 6

Dependent Claim 25 words

The sheath of claim 4 , further comprising a stabilizer rod slidably mounted within said body parallel to said rack and secured to said actuator.

Claim 7

Dependent Claim 36 words

The sheath of claim 5 , further comprising a second sub-component, said second sub-component carried by the rack and adapted to prevent said yieldable device from pulling said rack out of engagement with said cylindrical member.

Claim 8

Dependent Claim 174 words

A large-diameter expandable sheath for use in introducing a catheter into a corporeal vessel, comprising: an elongate sheath tube formed of a flexible material having proximal and distal extremities and having a passage extending therethrough of a maximum predetermined diameter; the distal extremity of said sheath tube being folded longitudinally to a smaller folded diameter; a backflow adapter having a central opening therein in registration with the passage in said sheath rube and having a valve disposed in the central opening of said backflow adapter and movable between open and closed positions; wherein the valve when open permits the catheter to be inserted into said sheath tube and when closed forms a hemostatic seal about the catheter; and a sheath introducer disposed in the passage of said sheath tube to form an assembly, said sheath introducer having a distal extremity extending beyond the proximal extremity of said sheath tube and a dilator mounted on the distal extremity of said sheath introducer with has a diameter greater than the folded diameter of said sheath tube.

Claim 9

Dependent Claim 174 words

A large-diameter expandable sheath for use in introducing a catheter into a corporeal vessel, comprising: an elongate sheath tube formed of a flexible material having proximal and distal extremities and having a passage extending therethrough of a maximum predetermined diameter; the distal extremity of said sheath tube being folded longitudinally to a smaller folded diameter; a backflow adapter having a central opening therein in registration with the passage in said sheath rube and having a valve disposed in the central opening of said backflow adapter and movable between open and closed positions; wherein the valve when open permits the catheter to be inserted into said sheath tube and when closed forms a hemostatic seal about the catheter; and a sheath introducer disposed in the passage of said sheath tube to form an assembly, said sheath introducer having a distal extremity extending beyond the proximal extremity of said sheath tube and a dilator mounted on the distal extremity of said sheath introducer with has a diameter greater than the folded diameter of said sheath tube.

Claim 10

Dependent Claim 251 words

A large-diameter expandable sheath tube assembly for use in a corporeal vessel, comprising: an elongate flexible sheath tube having proximal and distal extremities and having a passage extending therethrough of a maximum diameter; a backflow adapter mounted on the proximal extremity of said sheath tube; a sheath introducer disposed in said backflow adapter and extending through the passage in said sheath tube; said sheath introducer comprising an elongate tubular member having a proximal extremity and a distal extremity having a reduced diameter from the proximal extremity; the distal extremity of said sheath tube being folded over the distal extremity of the elongate tubular member of said sheath introducer to a folded diameter; said sheath introducer having a sleeve that covers the folded distal extremity of said sheath tube to prevent the folded distal extremity of the sheath tube from causing trauma to the vessel when the sheath tube is introduced into the vessel; a securing device that secures said sleeve on the elongate tubular member of said sheath introducer so that said sheath introducer can be pushed distally with respect to said sheath tube to cause said sleeve to be removed from the distal extremity of said sheath tube to permit said sheath tube to expand and to push the proximal extremity of said sheath introducer through the distal extremity of said sheath tube to expand said sheath tube; and said securing device includes a length of shrink tubing extending over said sleeve and having a diameter greater than said sleeve.

Claim 11

Dependent Claim 251 words

A large-diameter expandable sheath tube assembly for use in a corporeal vessel, comprising: an elongate flexible sheath tube having proximal and distal extremities and having a passage extending therethrough of a maximum diameter; a backflow adapter mounted on the proximal extremity of said sheath tube; a sheath introducer disposed in said backflow adapter and extending through the passage in said sheath tube; said sheath introducer comprising an elongate tubular member having a proximal extremity and a distal extremity having a reduced diameter from the proximal extremity; the distal extremity of said sheath tube being folded over the distal extremity of the elongate tubular member of said sheath introducer to a folded diameter; said sheath introducer having a sleeve that covers the folded distal extremity of said sheath tube to prevent the folded distal extremity of the sheath tube from causing trauma to the vessel when the sheath tube is introduced into the vessel; a securing device that secures said sleeve on the elongate tubular member of said sheath introducer so that said sheath introducer can be pushed distally with respect to said sheath tube to cause said sleeve to be removed from the distal extremity of said sheath tube to permit said sheath tube to expand and to push the proximal extremity of said sheath introducer through the distal extremity of said sheath tube to expand said sheath tube; and said securing device includes a length of shrink tubing extending over said sleeve and having a diameter greater than said sleeve.

Claim 12

Dependent Claim 36 words

The assembly of claim 8 , further comprising a preventing device carried by the distal extremity of the sheath introducer to prevent the shrink tubing from being separated from the distal extremity of the sheath introducer.

Claim 13

Dependent Claim 84 words

A sheath tube introducer, comprising: a flexible elongate tubular member having proximal and distal extremities; a fitting positioned at the proximal extremity of said tubular member; a sleeve positioned at the distal extremity of said tubular member; said sleeve having a proximal expandable extremity and a distal extremity; a securing device that prevents the distal extremity of said sleeve from being separated from the distal extremity of said tubular member; and said securing device includes a length of shrink tubing mounted on said sleeve.

Claim 14

Dependent Claim 84 words

A sheath tube introducer, comprising: a flexible elongate tubular member having proximal and distal extremities; a fitting positioned at the proximal extremity of said tubular member; a sleeve positioned at the distal extremity of said tubular member; said sleeve having a proximal expandable extremity and a distal extremity; a securing device that prevents the distal extremity of said sleeve from being separated from the distal extremity of said tubular member; and said securing device includes a length of shrink tubing mounted on said sleeve.

Claim 15

Dependent Claim 45 words

The sheath introducer of claim 10 , wherein the proximal extremity of the flexible elongate tubular member is of greater diameter to provide additional rigidity to the flexible elongate tubular member and to provide a dilator that dilates the distal extremity of the sheath tube.

Claim 16

Dependent Claim 103 words

A sheath tube introducer, comprising: a flexible elongate tubular member having proximal and distal extremities; a fitting positioned at the proximal extremity of said tubular member; a sleeve positioned at the distal extremity of said tubular member; said sleeve having a proximal expandable extremity and a distal extremity; a securing device that prevents the distal extremity of said sleeve from being separated from the distal extremity of said tubular member; and said tubular member having a flow passage therein together with an opening formed in said tubular member proximal of the proximal extremity of said sleeve and in communication with the flow passage.

Claim 17

Dependent Claim 103 words

A sheath tube introducer, comprising: a flexible elongate tubular member having proximal and distal extremities; a fitting positioned at the proximal extremity of said tubular member; a sleeve positioned at the distal extremity of said tubular member; said sleeve having a proximal expandable extremity and a distal extremity; a securing device that prevents the distal extremity of said sleeve from being separated from the distal extremity of said tubular member; and said tubular member having a flow passage therein together with an opening formed in said tubular member proximal of the proximal extremity of said sleeve and in communication with the flow passage.

Claim 18

Dependent Claim 128 words

A backflow adapter having a body with a central opening in fluid communication with a sheath tube, comprising: a first diaphragm disposed in the central opening of said backflow adapter, said first diaphragm having a first end and a second end and being movable between open and closed positions; a first retainer that engages said first diaphragm for causing relative rotation between the ends of said first diaphragm; a second diaphragm disposed in the central opening of said backflow adapter and adjacent the second end of said first diaphragm, said second diaphragm having a first end and a second end and being movable between open and closed positions; and a second retainer that engages said second diaphragm for causing relative rotation between the ends of said second diaphragm.

Claim 19

Dependent Claim 128 words

A backflow adapter having a body with a central opening in fluid communication with a sheath tube, comprising: a first diaphragm disposed in the central opening of said backflow adapter, said first diaphragm having a first end and a second end and being movable between open and closed positions; a first retainer that engages said first diaphragm for causing relative rotation between the ends of said first diaphragm; a second diaphragm disposed in the central opening of said backflow adapter and adjacent the second end of said first diaphragm, said second diaphragm having a first end and a second end and being movable between open and closed positions; and a second retainer that engages said second diaphragm for causing relative rotation between the ends of said second diaphragm.

Claim 20

Dependent Claim 33 words

The backflow adapter of claim 13 , wherein said second retainer includes a gear secured to the second diaphragm and a rack for driving the gear to cause rotation of the second diaphragm.

Claim 21

Dependent Claim 33 words

The backflow adaptor of claim 14 , wherein the second retainer further comprises a biasing device that urges the rack into a position wherein the second diaphragm is rotated to a closed position.

Claim 22

Dependent Claim 38 words

The backflow adaptor of claim 15 , wherein the second retainer comprises an actuator carried by the rack for moving the rack against the force of the biasing device to move the second diaphragm to an open position.

Claim 23

Dependent Claim 27 words

The backflow adaptor of claim 16 , wherein the second retainer further comprises a stabilizer rod slidably mounted parallel to the rack and secured to the actuator.

Claim 24

Dependent Claim 55 words

The backflow adapter of claim 17 , further comprising a sheath tube adapter secured to the body of said backflow adapter and secured to a sheath tube so as to prevent rotation of said sheath tube adapter when either said first diaphragm or said second diaphragm are rotated within the body of said backflow adapter.

Annuity Stage	Window Opens	Payment Deadline	Surcharge Period Until	Estimated Fee	Status
3.5 Years (Year 4)	2004-03-05	2004-09-04	2005-03-06	$2000.00	Window Closed / Lapsed
7.5 Years (Year 8)	2008-03-05	2008-09-04	2009-03-06	$3760.00	Window Closed / Lapsed
11.5 Years (Year 12)	2012-03-05	2012-09-04	2013-03-06	$7700.00	Window Closed / Lapsed

Dual valve, flexible expandable sheath and method

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