US5336178A
Expired / Lapsed
US
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Intravascular catheter with infusion array
Assignee: LocalMed Inc
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Filing: 1993-04-15
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Granted: 1994-08-09
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Expires: 2013-04-15
Abstract
Abstract An intravascular catheter provides means for infusing an agent into a treatment site in a body lumen and means for deploying the infusing means adjacent the treatment site which operate independently of one another. In a preferred embodiment, a flexible catheter body has an expansion member attached to its distal end in communication with an inflation passage, and an infusion array disposed about the expansion member in communication with one or more delivery passages. The infusion array includes a plurality of delivery conduits having laterally oriented orifices. The delivery conduits may be extended radially from the catheter body to contact a treatment site by expanding the expansion member with an inflation fluid. An agent may be introduced into the delivery passages and infused into the treatment site through orifices in the delivery conduits. The expansion member may be expanded for dilatation of the lumen before, during, or after infusion.
Inventors
- 👤 Aaron V. Kaplan
- 👤 James R. Kermode
- 👤 Enrique J. Klein
Bibliographic Details
Application Number
—
Jurisdiction
US
Data Source
google_patents
Last Synchronized
2026-10-23 02:15
CPC Classifications
A; A61; A61M; A61M25/00; A61M25/10; A61M25/104; A61B; A61B8/00; A61B8/12; A61B8/44; A61B8/4483; A61B8/4488; A61F; A61F2/00; A61F2/95; A61F2/958; A61M29/00; A61M29/02; A61F2250/00; A61F2250/0058; A61F2250/0067; A61M25/0043; A61M2025/0057; A61M2025/0063; A61M25/01; A61M25/09; A61M2025/09175; A61M2025/09183; A61M2025/1043; A61M2025/105; A61M2025/1075; A61M2025/1079; A61M2025/1081; A61M2025/1084; A61M25/0054; A61M25/1002; A61M37/00; A61M37/0092
Claims Analysis
Total Claims: 41
Claim 1
Independent Claim
121 words
A method of delivering an agent to a diseased treatment site on an interior wall of a blood vessel, the method comprising: positioning a catheter in the blood vessel so that an infusion array at the distal end of the catheter is disposed at the treatment site; positioning and expanding an expansion member within the distal end of the catheter to radially expand the infusion array against the treatment site, the expansion member being fluidly isolated from the infusion array; delivering an agent to the infusion array; and infusing the agent into the treatment site through a plurality of orifices in the infusion array while the expansion member remains expanded and the infusion array remains in contact with the treatment site.
Claim 2
Independent Claim
121 words
A method of delivering an agent to a diseased treatment site on an interior wall of a blood vessel, the method comprising: positioning a catheter in the blood vessel so that an infusion array at the distal end of the catheter is disposed at the treatment site; positioning and expanding an expansion member within the distal end of the catheter to radially expand the infusion array against the treatment site, the expansion member being fluidly isolated from the infusion array; delivering an agent to the infusion array; and infusing the agent into the treatment site through a plurality of orifices in the infusion array while the expansion member remains expanded and the infusion array remains in contact with the treatment site.
Claim 3
Dependent Claim
33 words
A method as in claim 1 wherein the infusion array comprises a delivery conduit disposed adjacent a lateral surface of the expansion member, the orifices disposed on a surface of the delivery conduit.
Claim 4
Dependent Claim
25 words
A method as in claim 2 wherein the infusion array further comprises a plurality of delivery conduits disposed adjacent lateral surfaces of the expansion member.
Claim 5
Dependent Claim
40 words
A method as in claim 1 wherein the expansion member is attached to a dilatation device removably disposed in an axial passage in the catheter, the method further comprising the step of positioning the dilatation catheter in the axial passage.
Claim 6
Dependent Claim
27 words
A method as in claim 1 wherein the step of positioning the catheter in the blood vessel comprises guiding the catheter into the vessel using a guidewire.
Claim 7
Dependent Claim
18 words
A method as in claim 1 wherein the treatment site comprises a atherosclerotic region of the blood vessel.
Claim 8
Dependent Claim
16 words
A method as in claim 6 further comprising expanding the expansion member to dilatate the vessel.
Claim 9
Dependent Claim
18 words
A method as in claim 7 wherein the step of dilatating is performed before the step of infusing.
Claim 10
Dependent Claim
18 words
A method as in claim 7 wherein the step of dilatating is performed after the step of infusing.
Claim 11
Dependent Claim
18 words
A method as in claim 7 wherein the step of dilatating is performed during the step of infusing.
Claim 12
Independent Claim
122 words
A method of delivering an agent to a diseased treatment site on a wall of a biliary duct, the method comprising: positioning an agent delivery catheter in the biliary duct so that an infusion array at the distal end of the catheter is disposed at the treatment site; positioning and expanding an expansion member within the distal end of the catheter to radially expand the infusion array against the treatment site, the expansion member being fluidly isolated from the infusion array; delivering an agent to the infusion array; and infusing the agent into the treatment site through a plurality of orifices in the infusion array while the expansion member remains expanded and the infusion array remains in contact with the treatment site.
Claim 13
Independent Claim
122 words
A method of delivering an agent to a diseased treatment site on a wall of a biliary duct, the method comprising: positioning an agent delivery catheter in the biliary duct so that an infusion array at the distal end of the catheter is disposed at the treatment site; positioning and expanding an expansion member within the distal end of the catheter to radially expand the infusion array against the treatment site, the expansion member being fluidly isolated from the infusion array; delivering an agent to the infusion array; and infusing the agent into the treatment site through a plurality of orifices in the infusion array while the expansion member remains expanded and the infusion array remains in contact with the treatment site.
Claim 14
Independent Claim
121 words
A method of delivering an agent to a diseased treatment site in a lumen of the genital-uretal system, the method comprising: positioning an agent delivery catheter in the lumen so that an infusion array at the distal end of the catheter is disposed at the treatment site; positioning and expanding an expansion member within this distal end of the catheter to radially expand the infusion array against the treatment site, the expansion member being fluidly isolated from the infusion array; delivering an agent to the infusion array; and infusing the agent into the treatment site through a plurality of orifices in the infusion array while the expansion member remains expanded and the infusion array remains in contact with the treatment site.
Claim 15
Independent Claim
121 words
A method of delivering an agent to a diseased treatment site in a lumen of the genital-uretal system, the method comprising: positioning an agent delivery catheter in the lumen so that an infusion array at the distal end of the catheter is disposed at the treatment site; positioning and expanding an expansion member within this distal end of the catheter to radially expand the infusion array against the treatment site, the expansion member being fluidly isolated from the infusion array; delivering an agent to the infusion array; and infusing the agent into the treatment site through a plurality of orifices in the infusion array while the expansion member remains expanded and the infusion array remains in contact with the treatment site.
Claim 16
Dependent Claim
174 words
Apparatus for infusing an agent to a treatment site on the wall of a body lumen, the apparatus comprising: a flexible shaft having a distal end and a proximal end, with a guide passage and at least one delivery passage extending axially through the shaft, the guide passage being open at the distal end; an inflation tube slidably disposed in the guide passage having a distal end, a proximal end, an axial inflation lumen therebetween, and an expansion member attached to the distal end in communication with the inflation lumen, wherein the expansion member may be advanced distally from the distal end of the shaft; and a plurality of laterally-deflectable delivery conduits attached to the distal end of the shaft generally parallel thereto, each delivery conduit having an axial lumen in communication with at least one of the delivery passages and a plurality of orifices on a lateral surface thereof, wherein the expansion member is axially positionable adjacent to the delivery conduits for laterally positioning the delivery conduits in apposition to the treatment site.
Claim 17
Dependent Claim
174 words
Apparatus for infusing an agent to a treatment site on the wall of a body lumen, the apparatus comprising: a flexible shaft having a distal end and a proximal end, with a guide passage and at least one delivery passage extending axially through the shaft, the guide passage being open at the distal end; an inflation tube slidably disposed in the guide passage having a distal end, a proximal end, an axial inflation lumen therebetween, and an expansion member attached to the distal end in communication with the inflation lumen, wherein the expansion member may be advanced distally from the distal end of the shaft; and a plurality of laterally-deflectable delivery conduits attached to the distal end of the shaft generally parallel thereto, each delivery conduit having an axial lumen in communication with at least one of the delivery passages and a plurality of orifices on a lateral surface thereof, wherein the expansion member is axially positionable adjacent to the delivery conduits for laterally positioning the delivery conduits in apposition to the treatment site.
Claim 18
Dependent Claim
20 words
The apparatus of claim 13 further comprising means for maintaining relative alignment of the delivery conduits during lateral deflection thereof.
Claim 19
Dependent Claim
20 words
The apparatus of claim 14 wherein the means for maintaining alignment resiliently biases the delivery conduits to an undeflected configuration.
Claim 20
Dependent Claim
22 words
The apparatus of claim 14 wherein the alignment maintaining means comprises a stiffening element disposed axially in at least one delivery conduit.
Claim 21
Dependent Claim
16 words
The apparatus of claim 16 wherein the stiffening element comprises an axially rigid, laterally flexible rod.
Claim 22
Dependent Claim
44 words
The apparatus of claim 17 wherein the stiffening element has a geometry selected to provided low bending stiffness about a first axis perpendicular to the shaft, but high bending stiffness about a second axis perpendicular to the shaft and perpendicular to the first axis.
Claim 23
Dependent Claim
12 words
The apparatus of claim 17 wherein the rod is a resilient metal.
Claim 24
Dependent Claim
19 words
The apparatus of claim 16 wherein the stiffening element is disposed in the axial lumen of the delivery conduit.
Claim 25
Dependent Claim
15 words
The apparatus of claim 16 wherein at least a portion of stiffening element is radiopaque.
Claim 26
Dependent Claim
19 words
The apparatus of claim 13 further comprising means for maintaining patency of the axial lumen of each delivery conduit.
Claim 27
Dependent Claim
29 words
The apparatus of claim 22 wherein the means for maintaining patency comprises a flexible rod disposed axially in the axial lumen of at least one of the delivery conduits.
Claim 28
Dependent Claim
12 words
The apparatus of claim 23 wherein the rod is a resilient metal.
Claim 29
Dependent Claim
45 words
The apparatus of claim 13 further comprising a flexible distal tip having a proximal end secured to the distal end of the shaft, an open distal end, and an axial passage between the proximal and distal ends aligned with the guide passage of the catheter.
Claim 30
Dependent Claim
25 words
The apparatus of claim 25 wherein the distal tip is conically tapered such that the distal end has a smaller diameter than the proximal end.
Claim 31
Dependent Claim
39 words
The apparatus of claim 25 wherein the axial passage of the distal tip is conically tapered such that the axial passage has a diameter at the open distal end which is larger than the diameter of the guide passage.
Claim 32
Dependent Claim
26 words
The apparatus of claim 25 wherein the flexible distal tip is made of a polymer with a durometer of 30 Shore A to 50 Shore D.
Claim 33
Dependent Claim
34 words
The apparatus of claim 25 wherein the proximal end of the flexible distal tip comprises a plurality of prongs extending proximally from the tip and received in the axial lumens of the delivery conduits.
Claim 34
Dependent Claim
41 words
The apparatus of claim 29 further comprising at least one stiffening element disposed in the axial lumen of at least one delivery conduit, a distal end of the stiffening element being secured to one of said prongs of said distal tip.
Claim 35
Dependent Claim
20 words
The apparatus of claim 13 further comprising a single monolithic extrusion which defines the shaft, delivery passage and delivery conduits.
Claim 36
Dependent Claim
20 words
The apparatus of claim 31 wherein the delivery conduits are separated from one another by axial slots in said extrusion.
Claim 37
Independent Claim
181 words
A method of a delivering an agent to a treatment site on an interior wall of a blood vessel, the method comprising: positioning a first catheter in the blood vessel with an expansion member at a distal end of the first catheter near the treatment site; positioning a second catheter over the first catheter such that the first catheter is slidably disposed in an axial passage in the second catheter, whereby an infusion array at a distal end of the second catheter is near the treatment site with the expansion member of the first catheter positioned distal to the distal end of the second catheter; expanding the expansion member to dilatate the blood vessel at the treatment site; contracting the expansion member; axially aligning both catheters such that the infusion array is aligned with the treatment site and the expansion member is adjacent to the infusion array; expanding the expansion member so as to position the infusion array in adjacent to the treatment site; and infusing an agent into the treatment site through a plurality of orifices in the infusion array.
Claim 38
Independent Claim
181 words
A method of a delivering an agent to a treatment site on an interior wall of a blood vessel, the method comprising: positioning a first catheter in the blood vessel with an expansion member at a distal end of the first catheter near the treatment site; positioning a second catheter over the first catheter such that the first catheter is slidably disposed in an axial passage in the second catheter, whereby an infusion array at a distal end of the second catheter is near the treatment site with the expansion member of the first catheter positioned distal to the distal end of the second catheter; expanding the expansion member to dilatate the blood vessel at the treatment site; contracting the expansion member; axially aligning both catheters such that the infusion array is aligned with the treatment site and the expansion member is adjacent to the infusion array; expanding the expansion member so as to position the infusion array in adjacent to the treatment site; and infusing an agent into the treatment site through a plurality of orifices in the infusion array.
Claim 39
Dependent Claim
37 words
The method of claim 33 wherein the infusion array comprises a plurality of delivery conduits secured to the distal end of the second catheter, the delivery conduits having axial lumens for delivering an agent through said orifices.
Claim 40
Dependent Claim
30 words
The method of claim 33 wherein the step of axially aligning comprises aligning a radiopaque marker on the first catheter with at least one radiopaque marker on the second catheter.
Claim 41
Dependent Claim
24 words
The method of claim 35 wherein the radiopaque marker on the second catheter is disposed on a metallic stiffening element in the infusion array.
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USPTO Annuity & Maintenance Windows
| Annuity Stage | Window Opens | Payment Deadline | Surcharge Period Until | Estimated Fee | Status |
|---|---|---|---|---|---|
| 3.5 Years (Year 4) | 1997-08-08 | 1998-02-07 | 1998-08-09 | $2000.00 | Window Closed / Lapsed |
| 7.5 Years (Year 8) | 2001-08-08 | 2002-02-07 | 2002-08-09 | $3760.00 | Window Closed / Lapsed |
| 11.5 Years (Year 12) | 2005-08-08 | 2006-02-07 | 2006-08-09 | $7700.00 | Window Closed / Lapsed |