US5599305A — Large-diameter introducer sheath having hemostasi…

Claim 1

Independent Claim 85 words

A catheter introducing system comprising: a flexible sheath having a proximal end, a distal end, and a lumen extending therebetween; and an obturator removably receivable in the lumen of the flexible sheath, said obturator having a proximal end, a distal portion, and a deflecting mechanism actuable from the proximal end of the obturator for laterally deflecting at least the distal portion; wherein actuation of the deflecting mechanism manipulates the distal end of the sheath when the sheath extends over the distal portion of the obturator.

Claim 2

Dependent Claim 85 words

A catheter introducing system comprising: a flexible sheath having a proximal end, a distal end, and a lumen extending therebetween; and an obturator removably receivable in the lumen of the flexible sheath, said obturator having a proximal end, a distal portion, and a deflecting mechanism actuable from the proximal end of the obturator for laterally deflecting at least the distal portion; wherein actuation of the deflecting mechanism manipulates the distal end of the sheath when the sheath extends over the distal portion of the obturator.

Claim 3

Dependent Claim 27 words

A catheter introducing system as in claim 1, wherein the obturator has an outer diameter which is at least 75% of the inner diameter of the sheath.

Claim 4

Dependent Claim 28 words

A catheter introducing system as in claim 2, wherein the obturator has a tapered distal end which defines a smooth transition with the distal end of the sheath.

Claim 5

Dependent Claim 31 words

A catheter introducing system as in claim 3, wherein the obturator has a length which is in the range from one to one and one-half times that of the flexible sheath.

Claim 6

Dependent Claim 24 words

A catheter introducing system as in claim 3, wherein the obturator has a length which is at least twice that of the flexible sheath.

Claim 7

Dependent Claim 26 words

A catheter introducing system as in claim 1, wherein the deflecting mechanism comprises a pull wire attached off center at a distal end of the obturator.

Claim 8

Dependent Claim 29 words

A catheter introducing system as in claim 1, wherein the deflecting mechanism of the obturator is capable of inducing a deflection with a 1 cm radius in the sheath.

Claim 9

Dependent Claim 147 words

A catheter introducing system comprising: a flexible sheath having a proximal end, a distal end, and a lumen extending therebetween; and an obturator removably receivable in the lumen of the flexible sheath, said obturator having a proximal end, a distal portion, and a deflecting mechanism actuable from the proximal end of the obturator for laterally deflecting at least the distal portion; wherein the flexible sheath has a length in the range from about 30 cm to 60 cm and a lumen diameter in the range from about 4 mm to 10 mm and wherein the obturator has a length in the range from 35 cm to 65 cm and an outer diameter in the range from about 4 mm to 9 mm; and wherein actuation of the deflecting mechanism manipulates the distal end of the sheath when the sheath extends over the distal portion of the obturator.

Claim 10

Dependent Claim 147 words

A catheter introducing system comprising: a flexible sheath having a proximal end, a distal end, and a lumen extending therebetween; and an obturator removably receivable in the lumen of the flexible sheath, said obturator having a proximal end, a distal portion, and a deflecting mechanism actuable from the proximal end of the obturator for laterally deflecting at least the distal portion; wherein the flexible sheath has a length in the range from about 30 cm to 60 cm and a lumen diameter in the range from about 4 mm to 10 mm and wherein the obturator has a length in the range from 35 cm to 65 cm and an outer diameter in the range from about 4 mm to 9 mm; and wherein actuation of the deflecting mechanism manipulates the distal end of the sheath when the sheath extends over the distal portion of the obturator.

Claim 11

Dependent Claim 34 words

A catheter introducing system as in claim 8, wherein the obturator comprises an elongate body having a region of enhanced flexibility over the distal length in the range from 3 cm to 6 cm.

Claim 12

Dependent Claim 21 words

A catheter introducing system as in claim 9, wherein the region of enhanced flexibility comprises an axial series of articulated elements.

Claim 13

Dependent Claim 31 words

A catheter introducing system as in claim 9, wherein the flexible sheath has a region of enhanced flexibility over a distal length in the range from 5 cm to 15 cm.

Claim 14

Dependent Claim 80 words

A catheter introducing system as in claim 11, wherein the flexible sheath comprises a tubular inner liner, a flat wire helical coil wrapped over an exterior surface of the tubular inner liner, and a plastic coating formed over the helical coil which penetrates into the space between adjacent turns of the coil and is bonded to the tubular inner liner, said coil having spaced-apart adjacent turns which extend distally over at least a portion of the region of enhanced flexibility.

Claim 15

Dependent Claim 33 words

A catheter introducing system as in claim 12, wherein the turns of the coil at the region of enhanced flexibility are separated by a greater distance than a proximal portion of the sheath.

Claim 16

Dependent Claim 27 words

A catheter introducing system as in claim 8, wherein the obturator has an outer diameter which is at least 75% of the inner diameter of the sheath.

Claim 17

Independent Claim 87 words

A method for introducing a flexible sheath to a target location in a body lumen, said method comprising: introducing the sheath to the body lumen; advancing the sheath within the lumen toward the target location by laterally deflecting at least a distal portion of an obturator which is removably received in a lumen of the sheath so that the obturator deflects a distal portion of the sheath; and removing the obturator from the sheath to provide an access lumen through the sheath after reaching the target location.

Claim 18

Independent Claim 87 words

A method for introducing a flexible sheath to a target location in a body lumen, said method comprising: introducing the sheath to the body lumen; advancing the sheath within the lumen toward the target location by laterally deflecting at least a distal portion of an obturator which is removably received in a lumen of the sheath so that the obturator deflects a distal portion of the sheath; and removing the obturator from the sheath to provide an access lumen through the sheath after reaching the target location.

Claim 19

Dependent Claim 24 words

A method as in claim 15, wherein the sheath is advanced over the obturator after the obturator has been advanced toward the target location.

Claim 20

Dependent Claim 34 words

A method as in claim 15, wherein the target location is the aorta and sheath and obturator are advanced through the subclavian, external carotid, or axillary artery and the aortic arch to the aorta.

Claim 21

Dependent Claim 36 words

A method as in claim 17, wherein the sheath has a length in the range from 30 cm to 60 cm and an access lumen diameter in the range from about 5 mm to 10 mm.

Claim 22

Dependent Claim 25 words

A method as in claim 17, further comprising expanding a member on the exterior of the sheath within the aorta to partially occlude blood flow.

Claim 23

Dependent Claim 26 words

A method as in claim 17, further comprising introducing a vascular graft through the access lumen into the aorta, the right iliac, or the left iliac.

Claim 24

Dependent Claim 41 words

A method as in claim 20, further comprising expanding a member on the exterior of the sheath within the vascular graft after said graft has been positioned at the target location in order to anchor the graft at said target location.

Claim 25

Independent Claim 116 words

A method for introducing a flexible sheath to a target location in a body lumen, said method comprising: introducing the sheath to the body lumen; advancing the sheath within the lumen toward the target location by laterally deflecting at least a distal portion of an obturator which is removably received in a lumen of the sheath; manipulating a distal portion of the sheath by deflecting the distal portion of the obturator while the distal portion of the obturator is positioned within the distal portion of the sheath, and while the sheath and obturator are advanced together; and removing the obturator from the sheath to provide an access lumen through the sheath after reaching the target location.

Claim 26

Independent Claim 116 words

A method for introducing a flexible sheath to a target location in a body lumen, said method comprising: introducing the sheath to the body lumen; advancing the sheath within the lumen toward the target location by laterally deflecting at least a distal portion of an obturator which is removably received in a lumen of the sheath; manipulating a distal portion of the sheath by deflecting the distal portion of the obturator while the distal portion of the obturator is positioned within the distal portion of the sheath, and while the sheath and obturator are advanced together; and removing the obturator from the sheath to provide an access lumen through the sheath after reaching the target location.

Claim 27

Dependent Claim 90 words

A hemostasis valve comprising: a housing having an interior cavity and axially aligned inlet and outlet ports; and a compressible insert disposed within the interior cavity of the housing, said insert including a polymeric foam body having an open axial lumen when the insert is unconfined and an exterior cross-section which is similar to but larger than an interior cross-section of the cavity in the housing, wherein the insert is confined within the cavity to close the lumen with said closed lumen being aligned between the inlet and outlet ports.

Claim 28

Dependent Claim 90 words

A hemostasis valve comprising: a housing having an interior cavity and axially aligned inlet and outlet ports; and a compressible insert disposed within the interior cavity of the housing, said insert including a polymeric foam body having an open axial lumen when the insert is unconfined and an exterior cross-section which is similar to but larger than an interior cross-section of the cavity in the housing, wherein the insert is confined within the cavity to close the lumen with said closed lumen being aligned between the inlet and outlet ports.

Claim 29

Dependent Claim 19 words

A hemostasis valve as in claim 23, further comprising a second valve element in series with the compressible insert.

Claim 30

Dependent Claim 21 words

A hemostasis valve as in claim 24, wherein the second valve element is a duck bill or a slit disk structure.

Claim 31

Dependent Claim 15 words

A hemostasis valve as in claim 23, wherein the lumen is coated with a lubricant.

Claim 32

Dependent Claim 16 words

A hemostasis valve as in claim 23, wherein the lumen is coated with a protective layer.

Claim 33

Dependent Claim 21 words

A hemostasis valve as in claim 27, wherein the coating material is selected from the group consisting of polyurethane and silicone.

Claim 34

Dependent Claim 12 words

A hemostasis valve as in claim 23, wherein the housing is fixed.

Annuity Stage	Window Opens	Payment Deadline	Surcharge Period Until	Estimated Fee	Status
3.5 Years (Year 4)	2000-02-04	2000-08-05	2001-02-04	$2000.00	Window Closed / Lapsed
7.5 Years (Year 8)	2004-02-04	2004-08-05	2005-02-04	$3760.00	Window Closed / Lapsed
11.5 Years (Year 12)	2008-02-04	2008-08-05	2009-02-04	$7700.00	Window Closed / Lapsed

Large-diameter introducer sheath having hemostasis valve and removable steering mechanism

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