US5843031A — Large-diameter introducer sheath having hemostasi…

Claim 1

Independent Claim 220 words

An aortic introducer catheter for use with an 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, the aortic introducer catheter comprising: a flexible sheath having a proximal end, a distal end, and a lumen extending therebetween for removably receiving the obturator, wherein the length between the proximal and distal ends is in the range from 30 cm to 60 cm and the lumen diameter is in the range from 5 mm to 10 mm; and a hemostasis valve secured to the proximal end of the sheath; wherein the distal end of the sheath is sufficiently flexible so as to be laterally deflectable by the deflecting mechanism of the obturator when the obturator is within the lumen of the sheath, so that the obturator can steer the sheath within a tortuous blood vessel, and wherein the flexible sheath comprises: a tubular inner liner having a proximal end, a distal end, and a lumen therebetween; a flat wire helical coil wrapped over an exterior surface of the tubular inner liner, said coil having spaced-apart adjacent turns; and a plastic coating formed over the helical coil, penetrating into the space between adjacent turns of the coil, and bonded to the tubular inner liner.

Claim 2

Dependent Claim 220 words

An aortic introducer catheter for use with an 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, the aortic introducer catheter comprising: a flexible sheath having a proximal end, a distal end, and a lumen extending therebetween for removably receiving the obturator, wherein the length between the proximal and distal ends is in the range from 30 cm to 60 cm and the lumen diameter is in the range from 5 mm to 10 mm; and a hemostasis valve secured to the proximal end of the sheath; wherein the distal end of the sheath is sufficiently flexible so as to be laterally deflectable by the deflecting mechanism of the obturator when the obturator is within the lumen of the sheath, so that the obturator can steer the sheath within a tortuous blood vessel, and wherein the flexible sheath comprises: a tubular inner liner having a proximal end, a distal end, and a lumen therebetween; a flat wire helical coil wrapped over an exterior surface of the tubular inner liner, said coil having spaced-apart adjacent turns; and a plastic coating formed over the helical coil, penetrating into the space between adjacent turns of the coil, and bonded to the tubular inner liner.

Claim 3

Dependent Claim 233 words

An aortic introducer catheter for use with an 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, the aortic introducer catheter comprising: a flexible sheath having a proximal end, a distal end, and a lumen extending therebetween for removably receiving the obturator, wherein the length between the proximal and distal ends is in the range from 30 cm to 60 cm and the lumen diameter is in the range from 5 mm to 10 mm, and a hemostasis valve secured to the proximal end of the sheath; wherein the distal end of the sheath is sufficiently flexible so as to be laterally deflectable by the deflecting mechanism of the obturator when the obturator is within the lumen of the sheath, so that the obturator can steer the sheath within a tortuous blood vessel, and wherein the hemostasis valve comprises: a housing having an interior and axially aligned inlet and outlet ports; and a compressible insert disposed within the interior of the housing, said insert including a polymeric foam body having an open axial lumen and an exterior geometry which is similar to but larger than 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 4

Dependent Claim 233 words

An aortic introducer catheter for use with an 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, the aortic introducer catheter comprising: a flexible sheath having a proximal end, a distal end, and a lumen extending therebetween for removably receiving the obturator, wherein the length between the proximal and distal ends is in the range from 30 cm to 60 cm and the lumen diameter is in the range from 5 mm to 10 mm, and a hemostasis valve secured to the proximal end of the sheath; wherein the distal end of the sheath is sufficiently flexible so as to be laterally deflectable by the deflecting mechanism of the obturator when the obturator is within the lumen of the sheath, so that the obturator can steer the sheath within a tortuous blood vessel, and wherein the hemostasis valve comprises: a housing having an interior and axially aligned inlet and outlet ports; and a compressible insert disposed within the interior of the housing, said insert including a polymeric foam body having an open axial lumen and an exterior geometry which is similar to but larger than 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 5

Dependent Claim 142 words

A catheter sheath for use with an 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, the sheath comprising: a tubular inner liner having a proximal end, a distal end, and a lumen therebetween for removably receiving the obturator, the distal end having a region of enhanced flexibility; a flat wire helical coil wrapped over an exterior surface of the tubular inner liner, said coil having consistently spaced-apart adjacent turns; and a plastic coating formed over the helical coil, penetrating into the space between adjacent turns of the coil, and bonded to the tubular inner liner; wherein the distal end of the sheath is laterally deflectable by the deflecting mechanism of the obturator when the obturator is within the lumen of the sheath.

Claim 6

Dependent Claim 142 words

A catheter sheath for use with an 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, the sheath comprising: a tubular inner liner having a proximal end, a distal end, and a lumen therebetween for removably receiving the obturator, the distal end having a region of enhanced flexibility; a flat wire helical coil wrapped over an exterior surface of the tubular inner liner, said coil having consistently spaced-apart adjacent turns; and a plastic coating formed over the helical coil, penetrating into the space between adjacent turns of the coil, and bonded to the tubular inner liner; wherein the distal end of the sheath is laterally deflectable by the deflecting mechanism of the obturator when the obturator is within the lumen of the sheath.

Claim 7

Dependent Claim 48 words

A catheter sheath as in claim 3, wherein the tubular liner is composed of a material selected from the group consisting of polyurethane, polytetrafluoroethylene, fluorinated ethylene-propylene polymer, polyether block amide copolymer, polyamide, and polyethylene and has a wall thickness in the range from 0.08 mm to 0.15 mm.

Claim 8

Dependent Claim 70 words

A catheter sheath as in claim 3, wherein the helical coil comprises a stainless steel ribbon having a width in the range from 0.5 mm to 1.5 mm and thickness in the range from 0.08 mm to 0.15 mm, wherein the ribbon is wrapped at from 5 turns to 15 turns per cm and wherein the spacing between adjacent turns is in the range from 0.5 mm to 1 mm.

Claim 9

Dependent Claim 48 words

A catheter sheath as in claim 3, wherein the plastic coating is composed of a material selected from the group consisting of polyurethane, polyether block amide copolymer, polyethylene, and polyamide, and has a thickness measured from tubular inner liner in the range from 0.08 mm to 0.15 mm.

Claim 10

Dependent Claim 27 words

A catheter sheath as in claim 3; having a region of enhanced flexibility over a distal length in the range from about 5 cm to 15 cm.

Claim 11

Dependent Claim 29 words

A catheter sheath as in claim 3, having a soft tip free from the helical coil over a distal length in the range of 2 mm to 10 mm.

Claim 12

Dependent Claim 20 words

A catheter sheath as in claim 3, further comprising a hemostasis valve secured to the proximal end of the sheath.

Claim 13

Dependent Claim 41 words

A catheter sheath as in claim 3, wherein the lumen diameter is in the range from 5 mm to 10 mm, and wherein the region of enhanced flexibility accepts a 1 cm radius curve without kinking or collapse of the lumen.

Claim 14

Dependent Claim 102 words

A steerable obturator for use with a flexible catheter sheath having a proximal end, a distal end, and a lumen extending therebetween, said obturator comprising: a flexible body having a proximal end and tapered distal tip, the flexible body removably receivable in the lumen of the sheath; and a deflecting mechanism actuable from the proximal end of the flexible body for laterally deflecting at least a distal portion of the flexible body; wherein the distal portion of the flexible body is capable of redirecting axial advancement of the sheath by actuating the deflecting mechanism while the sheath advances distally over the obturator.

Claim 15

Dependent Claim 102 words

A steerable obturator for use with a flexible catheter sheath having a proximal end, a distal end, and a lumen extending therebetween, said obturator comprising: a flexible body having a proximal end and tapered distal tip, the flexible body removably receivable in the lumen of the sheath; and a deflecting mechanism actuable from the proximal end of the flexible body for laterally deflecting at least a distal portion of the flexible body; wherein the distal portion of the flexible body is capable of redirecting axial advancement of the sheath by actuating the deflecting mechanism while the sheath advances distally over the obturator.

Claim 16

Dependent Claim 53 words

A steerable obturator as in claim 11, wherein the deflecting mechanism can induce a bend in a catheter body having a length in the range from 45 cm to 60 cm and an outer diameter in the range from 4 mm to 5 mm by laterally deflecting the distal portion within the lumen.

Claim 17

Dependent Claim 31 words

A steerable obturator as in claim 12, wherein the flexible body has a region of enhanced flexibility over a distal length in the range from about 5 cm to 10 cm.

Claim 18

Dependent Claim 23 words

A steerable obturator as in claim 13, wherein the region of enhanced flexibility comprises an axial series of elements connected by pivoting joints.

Claim 19

Dependent Claim 26 words

A steerable obturator as in claim 11, wherein the deflecting means comprises a pull wire attached off center at the distal end of the flexible body.

Claim 20

Dependent Claim 61 words

A steerable obturator as in claim 15, wherein the deflecting means further comprises a handle assembly attached to the proximal end of the flexible body, wherein said handle assembly includes a first portion attached to the pull wire and a second portion attached to the flexible body, whereby relative movement of the two portions causes lateral deflection of the distal portion.

Claim 21

Dependent Claim 25 words

A steerable obturator as in claim 11, wherein the deflecting mechanism of the obturator induces a deflection with a 1 cm radius in the sheath.

Claim 22

Dependent Claim 26 words

A steerable obturator as in claim 11, wherein the obturator has an outer diameter which is at least 75% of an inner diameter of the sheath.

Claim 23

Dependent Claim 91 words

A hemostasis valve for use with a catheter having an outer surface, the hemostasis valve comprising: a housing having an interior cavity and axially aligned inlet and outlet ports; an elastomeric insert within the interior cavity of the housing, said insert having a forwardly disposed conical face, wherein the face is radially split to permit passage of a catheter therethrough and an annular ring disposed proximally of the face, the annular ring having an open lumen which is adapted to form a sliding seal with the outer surface of the catheter.

Claim 24

Dependent Claim 91 words

A hemostasis valve for use with a catheter having an outer surface, the hemostasis valve comprising: a housing having an interior cavity and axially aligned inlet and outlet ports; an elastomeric insert within the interior cavity of the housing, said insert having a forwardly disposed conical face, wherein the face is radially split to permit passage of a catheter therethrough and an annular ring disposed proximally of the face, the annular ring having an open lumen which is adapted to form a sliding seal with the outer surface of the catheter.

Claim 25

Dependent Claim 17 words

A hemostasis valve as in claim 19, wherein the annular ring is formed integrally with the insert.

Claim 26

Dependent Claim 18 words

A hemostasis valve as in claim 19, wherein the face is radially split along at least three lines.

Claim 27

Dependent Claim 15 words

A hemostasis valve as in claim 19, wherein the lumen is coated with a lubricant.

Claim 28

Dependent Claim 20 words

A hemostasis valve as in claim 22, wherein the lubricant is selected from the group consisting of polyurethane and silicone.

Claim 29

Dependent Claim 15 words

A hemostasis valve as in claim 19, wherein the housing adjacent the ring is fixed.

Annuity Stage	Window Opens	Payment Deadline	Surcharge Period Until	Estimated Fee	Status
3.5 Years (Year 4)	2001-11-30	2002-06-01	2002-12-01	$2000.00	Window Closed / Lapsed
7.5 Years (Year 8)	2005-11-30	2006-06-01	2006-12-01	$3760.00	Window Closed / Lapsed
11.5 Years (Year 12)	2009-11-30	2010-06-01	2010-12-01	$7700.00	Window Closed / Lapsed

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

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