Method and apparatus for sequentially performing multiple intraluminal procedures

• US 5,571,086 A
• Filed: 04/01/1994
• Issued: 11/05/1996
• Est. Priority Date: 11/02/1992
• Status: Expired due to Term

• Current Assignee: JW Medical Systems Ltd
• Original Assignee: LocalMed, LLC (Dental Intelligence, Inc.)
• Inventors: Kermode, James R., Kaplan, Aaron V., Klein, Enrique J.
• Primary Examiner(s): MCDERMOTT, CORRINE MARIE
• Application Number:
  US08/222,143
• Time in Patent Office: 949 Days
• Field of Search: 604/96, 604/101, 604/104, 606/108, 606/192, 606/194, 623/1
• US Class Current: 604/96.01
• CPC Class Codes: A61B 8/12 in body cavities or body tracts, e.g. by using catheters catheters per se A61M25/00
• CPC Class Codes: A61B 8/4488 the transducer being a phased array
• CPC Class Codes: A61F 2/958 Inflatable balloons for placing stents or stent-grafts
• CPC Class Codes: A61F 2250/0067 Means for introducing or releasing pharmaceutical products into the body
• CPC Class Codes: A61M 2025/0057 Catheters delivering medicament other than through a conventional lumen, e.g. porous walls or hydrogel coatings
• CPC Class Codes: A61M 2025/0063 having means, e.g. stylets, mandrils, rods or wires to reinforce or adjust temporarily the stiffness, column strength or pushability of catheters which are already inserted into the human body
• CPC Class Codes: A61M 2025/09183 having tools at the distal tip
• CPC Class Codes: A61M 2025/105 having a balloon suitable for drug delivery, e.g. by using holes for delivery, drug coating or membranes
• CPC Class Codes: A61M 2025/1075 having a balloon composed of several layers, e.g. by coating or embedding
• CPC Class Codes: A61M 2025/1079 having radio-opaque markers in the region of the balloon
• CPC Class Codes: A61M 2025/1081 having sheaths or the like for covering the balloon but not forming a permanent part of the balloon, e.g. retractable, dissolvable or tearable sheaths
• CPC Class Codes: A61M 2025/1084 having features for increasing the shape stability, the reproducibility or for limiting expansion, e.g. containments, wrapped around fibres, yarns or strands
• CPC Class Codes: A61M 25/0054 with regions for increasing flexibility
• CPC Class Codes: A61M 25/1002 characterised by balloon shape A61M25/1006, A61M25/1009 take precedence
• CPC Class Codes: A61M 25/104 used for angioplasty
• CPC Class Codes: A61M 29/02 Dilators made of swellable material balloon catheters for angioplasty A61M25/104
• CPC Class Codes: A61M 37/0092 using ultrasonic, sonic or infrasonic vibrations, e.g. phonophoresis

Abstract

Sleeve catheters having an interactive device near their distal ends are provided for introduction while disposed over conventional interventional and imaging catheters. Exemplary interactive devices on the sleeve catheters include ultrasonic imaging arrays, drug delivery lumens, and the like. The sleeve catheters are most commonly used with angioplasty catheters, stent placement catheters, atherectomy catheters, and the like.

Claims

1. A method for sequentially performing intraluminal procedures, said method comprising:

introducing over a guidewire a base catheter having a sleeve catheter slidably disposed thereover to a target location in a body lumen, wherein the base catheter has an inflatable balloon near its distal end and the sleeve catheter has a radially expandable region near its distal end and an interactive device on or within the radially expandable region;

positioning the balloon which is on the base catheter at the target location; and

axially translating the sleeve catheter relative to the base catheter to position the radially expandable region on the sleeve catheter over the balloon at the target location to position the interactive device over the balloon and perform a diagnostic or therapeutic procedure using the interactive device.

2. A method as in claim 1, wherein the interactive device is selected from the group consisting of a stent, a graft, and a drug infusion matrix and wherein the stent or graft is disposed over the radially expandable region on the sleeve catheter and the drug infusion matrix is disposed within the radially expandable region on the sleeve catheter, and wherein the procedure comprises revascularization of the stenosed region in a blood vessel.

3. A method as in claim 1, wherein the balloon is positioned and an angioplasty procedure performed prior to positioning the interactive device over the balloon.

4. A method for positioning a sleeve catheter having a radially expandable region over a base catheter having an inflatable balloon, said method comprising:

visualizing a target location in a body lumen;

introducing the base catheter through the body lumen to the target location;

moving the sleeve catheter relative to the base catheter; and

aligning at least one marker visible on the sleeve catheter with a marker visible on the base catheter to position the radially expandable region on the sleeve catheter over the balloon on the base catheter.

5. A method as in claim 4, wherein the sleeve catheter has a pair of markers and the markers on the sleeve catheter are spaced-apart by a distance substantially equal to the width of the marker on the base catheter.

6. A method for placing a stent or graft into a blood vessel, said method comprising:

introducing a catheter having an inflatable balloon to a target region within the blood vessel;

inflating the balloon to dilate the target region;

deflating the balloon;

positioning over the balloon catheter a tubular catheter having (a) a radially expandable portion and (b) a stent or graft disposed over said radially expandable portion so that radially expandable portion is located over the balloon and in the target region; and

reinflating the balloon while said balloon lies within the radially expandable portion of the tubular catheter and the radially expandable portion lies within the target region, wherein the radially expandable portion is expanded to radially expand the stent or graft to anchor said stent or graft in place within the blood vessel.

7. A method as in claim 6, wherein the introducing step comprises introducing the tubular catheter simultaneously with the balloon to the blood vessel prior to the balloon-inflating step.

8. A method as in claim 7, wherein the radially expandable portion of the tubular catheter is disposed over the balloon catheter proximal to the balloon during the balloon-inflating step.

9. A method as in claim 6, wherein the tubular catheter is positioned over the balloon catheter by aligning radiopaque markers on the balloon and on the tubular catheter.

10. A method as in claim 6, wherein the stent is non-elastically deformable and expansion of the balloon within the radially expandable portion of the tubular catheter results in non-elastic deformation of the stent.

11. A sleeve catheter, said sleeve catheter comprising:

a tubular body having a proximal end, a distal end, and an axial lumen adapted to slidably receive a balloon catheter therethrough, wherein at least a portion of the tubular body is radially expandable in response to inflation of a balloon therein, wherein the radially expandable region does not itself comprise a balloon; and

an element selected from the group consisting of a radially expandable stent and a radially expandable graft disposed on the radially expandable portion of the tubular body, wherein inflation of a balloon within the axial lumen of the expandable portion of the tubular body will expand the element.

12. A sleeve catheter as in claim 11, wherein the radially expandable portion is composed of an elastomeric material.

13. A sleeve catheter as in claim 11, wherein the radially expandable portion is created by a plurality of axial slits in the tubular body.

14. A sleeve catheter as in claim 11, wherein the element is non-elastically deformable.

15. A cardiovascular treatment system comprising:

an intravascular catheter having a proximal end, a distal end, and an inflatable balloon near the distal end;

a sleeve catheter having proximal and distal ends, an axial lumen which slidably receives the intravascular catheter, and an expandable region, wherein the expandable region is adapted to receive the balloon and be expanded in response to balloon inflation; and

an interactive device disposed over or within the expandable region of the sleeve catheter.

16. A cardiovascular treatment system as in claim 15, wherein the interactive device is selected from the group consisting of a stent, a graft, and a drug infusion matrix.

17. A system comprising:

a base catheter having an inflatable balloon and at least one radiopaque marker near a distal end thereof, and

a sleeve catheter having a radially expandable portion, second interactive device and a lumen near its distal end and a radiopaque marker over the lumen, wherein the second interactive device is disposed over or within the radially expandable portion and wherein the radiopaque marker on the base catheter and the radiopaque marker on the sleeve catheter are respectively positioned so that the second interactive device on the sleeve catheter will be positioned over the first interactive device on the base catheter when the said markers are aligned.

18. A system as in claim 17, wherein the sleeve catheter includes a pair of spaced-apart markers which are aligned on either side of the marker on the base catheter when the base and sleeve catheters are properly aligned.