Patent EP1053722A2 successfully refreshed from Google Patents.
EP1053722A2
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Stent delivery catheter system for primary stenting
Assignee: Cordis Corp
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Filing: 2000-05-19
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Granted: —
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Expires: 2020-05-19
Abstract
Abstract The present invention is a stent delivery catheter system for placing a stent within a stenosis in a vessel of a human body without the need for either pre-dilatation of the stenosis or post-dilatation of the stent. The primary stenting delivery catheter system utilizes the combination of low profile (i.e., a small outer diameter) with a continuous, smooth and lubricious outer surface extending backward from a tapered distal tip. This design makes it possible for the stent delivery catheter to be pushed through even very tight stenoses without requiring pre-dilatation. Two versions of the primary stent delivery system are envisioned. The first version is a sheathed primary stenting system with a two-part sheath having a thick-walled proximal section and an ultra-thin distal section that is shrunk down to secure it to the catheter's distal tip. This embodiment differs from the prior art Fischell et al. device that does not shrink its membrane sheath down over the stent and over the balloon catheter's distal tip.
Inventors
- 👤 Robert E. Fischell
- 👤 David R. Fischell
- 👤 Mark L. Pomeranz
- 👤 Nicholas A. Green
Bibliographic Details
Application Number
—
Jurisdiction
EP
Data Source
google_patents
Last Synchronized
2026-10-31 13:38
CPC Classifications
A; A61; A61F; A61F2/00; A61F2/95; A61F2/958; A61F2002/9583; A61F2250/00; A61F2250/0014; A61F2250/0036
Claims Analysis
Total Claims: 20
Claim 1
Independent Claim
299 words
A pre-deployment configuration for a primary stenting system for placing a stent
within a stenosis of a vessel in a human body, the system comprising: a flexible guide wire; a balloon angioplasty catheter having a distal portion, the balloon angioplasty catheter having an
inflatable balloon located at its distal portion, the inflatable balloon having a proximal end and
a distal end, the balloon angioplasty catheter also having a lumen through which the guide wire
can be slideably moved, the balloon angioplasty catheter also having a distal tip which extends
in the distal direction from the distal end of the balloon to the distal end of the balloon
angioplasty catheter, the distal tip having a proximal end and a distal end, a stent coaxially mounted around the inflatable balloon of the balloon angioplasty catheter the
stent having a proximal end and a distal end; and a sheath generally in the form of a cylindrical tube that is coaxially located around the balloon
angioplasty catheter with its coaxially mounted stent, the sheath having a proximal section and
an ultra-thin distal section, the proximal section of the sheath having a proximal end and a
distal end, the ultra-thin distal section of the sheath having a proximal end and a distal end, the
proximal end of the ultra-thin distal section of the sheath being fixedly attached to the distal
end of the proximal section of the sheath, the ultra-thin distal section of the sheath being
shrunk down onto the distal portion of the balloon angioplasty catheter including its coaxially
mounted stent, the sheath being adapted to be slideably retracted in a proximal direction so that
the distal end of the ultra-thin section of the sheath lies proximal to the balloon so that the stent
can be radially expanded when the balloon is inflated.
Claim 2
Dependent Claim
288 words
A pre-deployment configuration for a primary stenting system for placing a stent
within a stenosis of a vessel in a human body, the system comprising: a flexible guide wire; a balloon angioplasty catheter having a distal portion, the balloon angioplasty catheter having an
inflatable balloon located at its distal portion, the inflatable balloon having a proximal end and
a distal end, the balloon angioplasty catheter also having a lumen through which the guide wire
can be slideably moved, the balloon angioplasty catheter also having a distal tip which extends
in the distal direction from the distal end of the balloon to the distal end of the balloon
angioplasty catheter, the distal tip having a proximal end and a distal end, a stent coaxially mounted around the inflatable balloon of the balloon angioplasty catheter; a sheath generally in the form of a cylindrical tube that is coaxially located around the balloon
angioplasty catheter with its coaxially mounted stent, the sheath having an ultra-thin distal
section, the ultra-thin distal section of the sheath being shrunk down onto the distal portion of
the balloon angioplasty catheter including its coaxially mounted stent, the distal end of the
shrunk down ultra-thin distal section being situated between the distal end of the angioplasty
balloon and the distal end of the distal tip; and an elastomer securing tube having a proximal section and a distal section, the distal section being
fixedly attached to the distal end of the distal tip of the balloon angioplasty catheter and the
proximal section of the elastomer securing tube being adapted to cover the distal end of the
ultra-thin section of the sheath, the sheath being adapted to be slideably retracted in a proximal
direction from under the securing tube.
Claim 3
Dependent Claim
192 words
A pre-deployment configuration for a primary stenting system for placing a stent
within a stenosis of a vessel in a human body, the system comprising: a flexible guide wire; a balloon angioplasty catheter having a distal portion, the balloon angioplasty catheter having an
inflatable balloon located at its distal portion, the inflatable balloon having a proximal end and
a distal end, the balloon angioplasty catheter also having a flexible, distal tip having a distal
end and a proximal end and also having a lumen through which the guide wire can be slideably
moved; a stent coaxially mounted around the inflatable balloon of the balloon angioplasty catheter; a coaxially mounted proximal elastomer band situated over the portion of the balloon angioplasty
catheter that lies just proximal to the stent; and a coaxially mounted distal elastomer band situated over the portion of the balloon angioplasty
catheter that lies just distal to the stent, the proximal and distal elastomer bands being adapted to
prevent the coaxially mounted stent from sliding off of the inflatable balloon in either a proximal
direction or a distal direction and each preferably including a high density material
for increased radiopacity.
Claim 4
Dependent Claim
293 words
A pre-deployment configuration for a primary stenting system for placing a stent
within a stenosis of a vessel in a human body, the system comprising: a flexible guide wire; a balloon angioplasty catheter having a distal portion, the balloon angioplasty catheter having an
inflatable balloon located at its distal portion, the inflatable balloon having a proximal end and
a distal end, the balloon angioplasty catheter also having a flexible, gradually tapered distal tip
having a distal end and a proximal end and also having a lumen through which the guide wire
can be slideably moved, the gradually tapered distal tip having a tapered proximal portion and
a tapered distal portion, both proximal and distal portions of the gradually tapered distal tip
having a gradual taper; and a stent coaxially mounted around the inflatable balloon of the balloon angioplasty catheter; a sheath generally in the form of an elongated cylinder that is coaxially located around the
balloon angioplasty catheter, the sheath having a proximal section and an ultra-thin distal
section, the proximal section of the sheath having a proximal end and a distal end, the ultra-thin
distal section of the sheath having a proximal end and a distal end, the proximal end of the
ultra-thin distal section of the sheath being fixedly attached to the distal end of the proximal
section of the sheath, at least a portion of the ultra-thin distal section being shrunk onto the
stent and also onto the tapered proximal portion of the gradually tapered distal tip, the sheath
being adapted to be slideably retracted in a proximal direction so that the distal end of the ultra-thin
section of the sheath can be placed proximal to the balloon so as to allow balloon
expansion for radial expansion of the stent.
Claim 5
Dependent Claim
41 words
The system of claim 1 or 4 wherein the wall thickness of the proximal section of
the sheath is greater than the wall thickness of the ultra-thin distal section, preferably more
than twice the wall thickness of the ultra-thin distal section.
Claim 6
Dependent Claim
31 words
The system of claim 1, 2 or 4 wherein the wall thickness of the ultra-thin distal
section of the sheath is less that 0.05 mm and preferably less than 0.025 mm
Claim 7
Dependent Claim
45 words
The system of claim 1, 2 or 4 wherein the ultra-thin distal section of the sheath is
made from a heat shrinkable plastic, such as nylon, or from a solvent swellable material,
and wherein the ultra-thin distal section of the sheath is preferably lubricity coated.
Claim 8
Dependent Claim
55 words
The system of claim 1 or 2 wherein the balloon angioplasty catheter further
comprises a coaxially mounted elastomer band, which preferably includes a high density
material for increased radiopacity, placed coaxially over the angioplasty catheter just
proximal to the stent, the elastomer band being adapted to prevent the stent from sliding in
a proximal direction.
Claim 9
Dependent Claim
49 words
The system of claim 8 when appendant on claim 1 wherein the elastomer band has a
proximal end and a distal end and the distal end of the proximal section of the sheath is
adapted to provide distally directed push force against the proximal end of the elastomer
band.
Claim 10
Dependent Claim
58 words
The system of claim 1, 2 or 8 wherein the balloon angioplasty catheter further
comprises a coaxially mounted distal elastomer band, which preferably includes a high
density material for increased radiopacity, placed coaxially over the angioplasty catheter
just distal to the stent, the distal elastomer band being adapted to prevent the stent from
sliding in a distal direction.
Claim 11
Dependent Claim
55 words
The system of claim 1 further comprising an elastomer securing tube having a
proximal section and a distal section, the distal section being fixedly attached to the distal
end of the distal tip and the proximal section of the elastomer securing tube being placed
over the distal end of the ultra-thin section of the sheath.
Claim 12
Dependent Claim
24 words
The system of claim 2 wherein the wall thickness of the securing tube is less than
0.05 mm and preferably less than 0.025 mm.
Claim 13
Dependent Claim
27 words
The system of claim 1 or 2 wherein the primary stenting system is an over-the-wire
stent delivery catheter system or a rapid exchange stent delivery catheter system.
Claim 14
Dependent Claim
78 words
The system of claim 3 wherein the distal tip has a gentle taper from a larger
diameter at the proximal end of the distal tip to a smaller diameter at the distal end of the
distal tip, the gently tapered distal tip and distal elastomer band together forming a smooth
outer surface to facilitate penetration of a tight stenosis and wherein the gently tapered
distal tip, distal elastomer band and proximal elastomer band are each preferably lubricity
coated.
Claim 15
Dependent Claim
14 words
The system of claim 4 wherein the gradually tapered distal tip is lubricity coated.
Claim 16
Dependent Claim
33 words
The system of claim 4 wherein the tapered proximal portion of the gradually
tapered distal tip has a length that is at least 25% of the length of the gradually tapered
distal tip.
Claim 17
Dependent Claim
46 words
The system of claim 4 wherein the balloon angioplasty catheter has a coaxially
mounted proximal elastomer band over the portion of the angioplasty balloon that lies proximal
to the stent, the proximal elastomer band being adapted to prevent the stent from sliding in a
proximal direction.
Claim 18
Dependent Claim
46 words
The system of claim 4 wherein the balloon angioplasty catheter has a coaxially
mounted distal elastomer band over the portion of the angioplasty balloon that lies distal to the
stent, the distal elastomer band being adapted to prevent the stent from sliding in a distal
direction.
Claim 19
Dependent Claim
77 words
The system of claim 17 wherein the balloon angioplasty catheter also has a
coaxially mounted distal elastomer band over the portion of the angioplasty balloon distal to the
stent, the distal elastomer band being adapted to prevent the stent from sliding in a distal
direction, the ultra-thin distal section of the sheath being shrunk down over the distal elastomer
band, the proximal elastomer band, the stent and the tapered proximal portion of the gradually
tapered distal tip.
Claim 20
Dependent Claim
58 words
The system of claim 4 further comprising an elastomer securing tube having a
proximal section and a distal section, the distal section being fixedly attached to the tapered
distal portion of the tapered distal tip and the proximal section of the elastomer securing tube
being placed snugly over the distal end of the ultra-thin section of the sheath.
References Cited (Backward Citations)
US5792144A
Cited
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