# US 5,571,086 A · Method and apparatus for sequentially performing multiple intraluminal procedures

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- Number: US 5,571,086 A
- Document ID: US5571086A
- Status: Granted
- Kind: A
- Application number: 08/222,143
- Filed: 1994-04-01
- Granted: 1996-11-05
- Earliest claimed: 1992-11-02
- Assignees: Localmed, Inc.
- Inventors: Aaron V. Kaplan; James R. Kermode; Enrique J. Klein
- Web page: https://patentgrep.com/patent/US5571086A

## CPC

- A61M 25/104: {used for angioplasty}
- A61B 8/12: in body cavities or body tracts, e.g. by using catheters
- A61B 8/4488: {the transducer being a phased array}
- A61F 2/958: Inflatable balloons for placing stents or stent-grafts
- A61M 29/02: Dilators made of swellable material {(balloon catheters for angioplasty A61M25/104)}
- A61F 2250/0067: Means for introducing or releasing pharmaceutical products into the body
- A61M 25/0054: {with regions for increasing flexibility}
- A61M 25/1002: {characterised by balloon shape (A61M25/1006, A61M25/1009 take precedence)}
- A61M 37/0092: {using ultrasonic, sonic or infrasonic vibrations, e.g. phonophoresis}
- A61M 2025/0057: {Catheters delivering medicament other than through a conventional lumen, e.g. porous walls or hydrogel coatings}
- 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}
- A61M 2025/09183: {having tools at the distal tip}
- A61M 2025/105: {having a balloon suitable for drug delivery, e.g. by using holes for delivery, drug coating or membranes}
- A61M 2025/1075: {having a balloon composed of several layers, e.g. by coating or embedding}
- A61M 2025/1079: {having radio-opaque markers in the region of the balloon}
- 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}
- 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}
- A61M: DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY (introducing media into or onto the bodies of animals A61D7/00; means for inserting tampons A61F13/26; devices for administering food or medicines orally A61J; containers for collecting, storing or administering blood or medical fluids A61J1/05); DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY (surgery A61B; chemical aspects of surgical articles A61L); DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR {(Electrotherapy, e.g. producing anaesthesia by the use of alternating or intermittent currents A61N1/36021)}
- A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D)
- A61F: FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS (dental prosthetics A61C)

## 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

### Claim 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.

### Claim 2 (depends on 1)

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.

### Claim 3 (depends on 1)

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.

### Claim 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.

### Claim 5 (depends on 4)

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.

### Claim 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.

### Claim 7 (depends on 6)

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.

### Claim 8 (depends on 7)

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.

### Claim 9 (depends on 6)

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.

### Claim 10 (depends on 6)

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.

### Claim 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.

### Claim 12 (depends on 11)

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

### Claim 13 (depends on 11)

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

### Claim 14 (depends on 11)

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

### Claim 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.

### Claim 16 (depends on 15)

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.

### Claim 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.

### Claim 18 (depends on 17)

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.
