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WO1996019257B1 - Stent placement device with medication dispenser and method - Google Patents

Stent placement device with medication dispenser and method

Info

Publication number
WO1996019257B1
WO1996019257B1 PCT/US1995/016643 US9516643W WO9619257B1 WO 1996019257 B1 WO1996019257 B1 WO 1996019257B1 US 9516643 W US9516643 W US 9516643W WO 9619257 B1 WO9619257 B1 WO 9619257B1
Authority
WO
WIPO (PCT)
Prior art keywords
balloon
stent
conduits
inflation
diameter
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Ceased
Application number
PCT/US1995/016643
Other languages
French (fr)
Other versions
WO1996019257A1 (en
Filing date
Publication date
Priority claimed from US08/361,963 external-priority patent/US5755722A/en
Application filed filed Critical
Priority to EP95944171A priority Critical patent/EP0799073B1/en
Priority to JP51998796A priority patent/JP3756185B2/en
Priority to CA002206536A priority patent/CA2206536C/en
Priority to DE69532208T priority patent/DE69532208T2/en
Publication of WO1996019257A1 publication Critical patent/WO1996019257A1/en
Publication of WO1996019257B1 publication Critical patent/WO1996019257B1/en
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

Links

Abstract

An inflatable medical device and method for the placement of a stent in a body passageway by means of a two stage expansion of the stent and for the delivery of medications to precise location in the passageway. The device includes a catheter shaft (14) having a plurality of lumens (13, 22, 28) disposed therein. The catheter shaft has a distal end adapted to be disposed within a vascular passageway. An inflatable balloon is defined by a generally cylindrical wall and is adapted to receive inflation fluids. The balloon is disposed on the distal end of the shaft. An array of circumferentially arranged inflation conduits (40) is disposed in the wall. The conduits (40) are spaced from each other within the wall of the balloon whereby to form an annular array. An array of medication delivering conduits (25) can be disposed within the wall of the balloon. These conduits are adapted to deliver medications to predetermined locations within the body passageway being treated. A stent (30) is removably disposed around the exterior of the wall of the balloon and is expandable radially outwardly from a narrow insertion diameter to a larger second diameter by the expansion of the balloon (16) and then to a still larger third diameter by inflation of the inflation conduits (40) whereby to expand the body passageway and seat the stent.

Claims

l uAMENDED CLAIMS[received by the International Bureau on 11 ϋune 1996 (11.06.1996); original claim 6 cancelled; original claim 4 amended; original claims 7-17 renumbered as claims 6-16; remaining claims unchanged (6pagesJJ
1. An inflatable medical device for the placement of a stent in a body passageway by means of a two-stage expan¬ sion of said stent, said device comprising: a catheter shaft (14) having at least two lumens (13, 22 or 28) disposed therein, said catheter shaft having a distal end adapted to be disposed within said body pas¬ sageway; a hollow, inflatable, balloon (16) defined by a gener¬ ally cylindrical wall and having a proximal end, the proxi- mal end of the balloon being disposed on the distal end of said catheter shaft, the interior of said balloon being in fluid flow relationship with one of said lumens whereby to provide the interior of said balloon with an inflation fluid; an array of circumferentially arranged inflation con¬ duits (40) disposed in said wall, said conduits (40) being spaced from each other within said wall whereby to form an annular array, the interior of said conduits being in fluid flow relationship with another of said lumens whereby to provide said conduits with an inflation fluid; a stent (30) removably disposed around the exterior of the wall of said balloon, said stent being expandable radi¬ ally outwardly from a narrow insertion diameter to a larger second diameter by the expansion of said balloon and then to a still larger third diameter by inflation of said inflation conduits whereby to expand said body passageway and seat said stent.
2. The medical device according to claim 1 wherein said inflation conduits (40) are uniformly arrayed and spaced from each other around said balloon (16) .
3. The medical device according to claim 1 wherein the stent is an interwoven plexus of at least two sets of helically disposed wires wound together with one set juxta¬ posed relative to the other set to form a tubular arrange- ment expandable to a plurality of diameters. 19
4. An inflatable medical device for the placement of a stent in a vascular passageway by means of a two stage expansion of said stent and for the intravascular delivery of medications, said device comprising: a catheter shaft (14) having a plurality of lumens
(13, 22, 28) disposed therein, said catheter shaft having a distal end adapted to be disposed within a vascular passage¬ way; an inflatable balloon defined by a generally cylindri- cal wall and adapted to receive inflation fluids, said balloon being disposed on the distal end of said shaft; an array of medication delivering conduits (25) dis¬ posed within the wall of said balloon (16), said conduits (25) being adapted to deliver medications from one of said lumens to predetermined locations within said vascular passageway; an array of circumferentially arranged inflation con¬ duits (40) also disposed in said wall and dispensing means disposed on at least some of said conduits, said conduits (40) being spaced from each other within the wall of said balloon (16) whereby to form an annular array; means for delivering an inflation fluid from one of said lumens in said shaft to said balloon (16) and means for the delivery of an inflation fluid comprising a medication from another of said lumens to said conduits (25, 40) where¬ by increases in balloon diameter can be provided in two stages by said balloon and said conduits; a stent (30) removably disposed around the exterior of the wall of said balloon, said stent being expandable radi- ally outwardly from a narrow insertion diameter to a larger second diameter by the expansion of said balloon and then to a larger third diameter by inflation of said inflation con¬ duits whereby to expand said body passageway and seat said stent. 20
5. The medical device according to claim 4 wherein said conduits are arranged around said balloon, said con¬ duits being spaced from each other on said balloon and individually segmented from each other.
6. The medical device according to claim 4 wherein said dispensing means includes perforations on said con¬ duits.
7. The medical device according to claim 4 wherein said medication dispensing conduits (25) are without perfo¬ rations over their lengths and terminate in apertures dis¬ posed at distal ends thereof whereby to provide egress for medications from said balloon.
8. A method of making a medication-dispensing and stent-delivering balloon for a catheter, said method com¬ prising: co-extruding two dissimilar polymeric materials, the first of the polymeric materials forming a tube and the other of said polymeric materials being disposed within said tube as a segmented array of discrete strands, said strands being individually enclosed within said tube; withdrawing said strands from said tube whereby to form conduits within said tube and then expanding a portion of said tube to form a balloon and expanding at least some of said conduits to form inflation conduits; removably disposing a stent (30) around the exterior of the wall of said balloon, said stent being expandable radi- ally outwardly from a narrow insertion diameter to a larger second diameter by the expansion of said balloon and then to a still larger third diameter by inflation of said inflation conduits.
9. The method according to claim 8 including the further step of perforating some of the conduits to form medication dispensing conduits. 21
10. The method according to claim 9 wherein the poly¬ mers are polyethylene terephthalate for the tube and poly¬ ethylene for the strands.
11. The method according to claim 9 wherein the wall thickness of the extruded tube is between 0.05 and 3.75 mm. and the diameter of the strands is between about 0.0125 and 2.5 mm.
12. A method of implanting a stent in a vascular passageway, said method comprising: disposing on a catheter shaft having at least two lumens a hollow, inflatable, balloon (16) defined by a generally cylindrical wall and having a distal and a proxi¬ mal end, the proximal end of the balloon being disposed on the distal end of said catheter shaft, the interior of said balloon being in fluid flow relationship with one of said lumens whereby to provide the interior of said balloon with an inflation fluid, said wall further having an array of circumferentially arranged spaced-apart inflation conduits (40) disposed therein, the interior of said conduits being in fluid flow relationship with another of said lumens whereby to provide said conduits with an inflation fluid; removably disposing a stent (30) around the exterior of the wall of said balloon, said stent being expandable radi¬ ally outwardly from a narrow insertion diameter to a larger second diameter by the expansion of said balloon and then to a larger third diameter by inflation of said inflation con- duits whereby to expand said body passageway and seat said stent. 22
13. The method according to claim 12 further including the steps inserting said balloon with said stent within a body passageway to a predetermined location, inflating said balloon to expand the diameter and initially site said stent, inflating said inflation conduits to expand the diameter said stent further and seat said stent in a prede¬ termined location and then withdrawing inflation fluids from both said balloon and said inflation conduits and withdraw¬ ing said balloon from said stent.
14. A method of implanting a stent in a body passage¬ way and dispensing medications to a predetermined site, said method comprising: disposing on a catheter shaft having at least three lumens a hollow, inflatable, balloon (16) defined by a generally cylindrical wall and having a distal and a proxi¬ mal end, the proximal end of the balloon being disposed on the distal end of said catheter shaft, the interior of said balloon being in fluid flow relationship with one of said lumens whereby to provide the interior of said balloon with an inflation fluid, said wall further having an array of circumferentially arranged spaced-apart inflation conduits (40) disposed therein, the interior of said inflation con¬ duits being in fluid flow relationship with another of said lumens whereby to provide said conduits with an inflation fluid, said wall further having an array of circumfer¬ entially arranged spaced-apart medication-dispensing con¬ duits disposed therein, the interior of said medication-dis¬ pensing conduits being in fluid flow relationship with said another of said lumens whereby to provide said conduits with a medication; 23
removably disposing a stent (30) around the exterior of the wall of said balloon, said stent being expandable radi¬ ally outwardly from a narrow insertion diameter to a larger second diameter by the expansion of said balloon and then to a larger third diameter by inflation of said inflation con¬ duits whereby to expand said body passageway and seat said stent.
15. The method according to claim 14 further including the steps inserting said balloon with said stent within a vascular passageway to a predetermined location, inflating said balloon to expand the diameter and initially site said stent, inflating said inflation conduits to expand the diameter said stent further and seat said stent in a prede¬ termined location, dispensing medications to a predetermined site through said medication-dispensing conduits and then withdrawing inflation fluids from both said balloon and said inflation conduits and withdrawing said balloon from said stent.
16. A method of implanting a stent in a body passage¬ way, said method comprising: disposing a stent having a first diameter that is expandable in diameter on a medical balloon, said balloon being expandable to a plurality of diameters by separate inflation mechanisms; inserting said stent and balloon in a body passageway; inflating said balloon to a second diameter with one of the mechanisms, thereby expanding the stent to said second diameter and enabling location of said stent within the body passageway; inflating said balloon to a still larger third diameter with another of the mechanisms, thereby expanding the stent to said third diameter and enabling seating of said stent within said body passageway.
PCT/US1995/016643 1994-12-22 1995-12-21 Stent placement device with medication dispenser and method Ceased WO1996019257A1 (en)

Priority Applications (4)

Application Number Priority Date Filing Date Title
EP95944171A EP0799073B1 (en) 1994-12-22 1995-12-21 Stent placement device with medication dispenser and manufacturing method
JP51998796A JP3756185B2 (en) 1994-12-22 1995-12-21 Stent placement device with dosing device and method thereof
CA002206536A CA2206536C (en) 1994-12-22 1995-12-21 Stent placement device with medication dispenser and method
DE69532208T DE69532208T2 (en) 1994-12-22 1995-12-21 STENT INTRODUCTION DEVICE WITH MEDICAMENT DISPENSER AND METHOD OF MANUFACTURE

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US08/361,963 US5755722A (en) 1994-12-22 1994-12-22 Stent placement device with medication dispenser and method
US08/361,963 1994-12-22

Publications (2)

Publication Number Publication Date
WO1996019257A1 WO1996019257A1 (en) 1996-06-27
WO1996019257B1 true WO1996019257B1 (en) 1996-07-25

Family

ID=23424125

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/US1995/016643 Ceased WO1996019257A1 (en) 1994-12-22 1995-12-21 Stent placement device with medication dispenser and method

Country Status (6)

Country Link
US (2) US5755722A (en)
EP (1) EP0799073B1 (en)
JP (1) JP3756185B2 (en)
CA (1) CA2206536C (en)
DE (1) DE69532208T2 (en)
WO (1) WO1996019257A1 (en)

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