# US 8,771,334 B2 · Catheter balloon systems and methods

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- Number: US 8,771,334 B2
- Document ID: US8771334B2
- Status: Granted
- Kind: B2
- Application number: 12/638,614
- Filed: 2009-12-15
- Published: 2010-04-08
- Granted: 2014-07-08
- Earliest claimed: 2003-07-18
- Assignees: Boston Scientific Scimed, Inc.
- Applicants: Eric Williams; Daryush Mirzaee; Michael Khenansho; Michael Schwartz
- Inventors: Eric Williams; Daryush Mirzaee; Michael Khenansho; Michael Schwartz
- Web page: https://patentgrep.com/patent/US8771334B2

## CPC

- A61M 25/1002: {characterised by balloon shape (A61M25/1006, A61M25/1009 take precedence)}
- A61F 2/856: Single tubular stent with a side portal passage
- A61F 2/954: for placing stents or stent-grafts in a bifurcation
- A61F 2/958: Inflatable balloons for placing stents or stent-grafts
- A61M 25/1011: {Multiple balloon catheters}
- A61P 35/00: Antineoplastic agents
- A61F 2002/821: {Ostial stents}
- A61M 25/1027: {Making of balloon catheters}
- A61M 2025/1045: {for treating bifurcations, e.g. balloons in y-configuration, separate balloons or special features of the catheter for treating bifurcations}
- A61M 2025/1056: {having guide wire lumens outside the main shaft, i.e. the guide wire lumen is within or on the surface of the balloon}
- A61M 2025/1072: {having balloons with two or more compartments}
- 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)}
- 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)
- A61P: SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS

## Abstract

An apparatus for treatment of a bifurcation of a body lumen, the bifurcation having a main vessel and a branch vessel, the apparatus includes a bifurcated balloon with a first branch portion and a second branch portion, the second branch portion including an inflatable portion adapted to extend toward the branch vessel, the bifurcated balloon also having a proximal shaft portion and a distal shaft portion connected to the inflatable portion of the second branch portion, and wherein the first branch portion and the second branch portion each have a longitudinal axis, the axis of the first branch portion being substantially parallel to the longitudinal axis of the second branch portion.

## Claims

### Claim 1

A stent delivery system comprising:
a catheter shaft including a proximal end portion, a distal end portion, and an inflation lumen;
a bifurcated balloon coupled to the distal end portion of the catheter shaft and in fluid communication with the inflation lumen, the bifurcated balloon including a first balloon branch and a second balloon branch, the first balloon branch including a first inflatable portion and the second balloon branch including a second inflatable portion, the second balloon branch having a proximal end and a distal end, wherein the proximal end of the second balloon branch is directly attached to the first balloon branch proximal of a proximal end of the first inflatable portion, and wherein the distal end of the second balloon branch is directly attached to the first balloon branch distal of a distal end of the first inflatable portion;
wherein the first and second inflatable portions each have a length extending along a longitudinal axis of the catheter shaft, wherein the length of the second inflatable portion is less than the length of the first inflatable portion.

### Claim 2 (depends on 1)

The stent delivery system of claim 1, further comprising a stent disposed about the bifurcated balloon, the stent including a proximal opening, a distal opening, and a side opening including an outwardly expandable portion, wherein the side opening is aligned with the second inflatable portion, and expansion of the second inflatable portion causes the outwardly expandable portion to expand.

### Claim 3 (depends on 1)

The stent delivery system of claim 1, wherein the second inflatable portion has a generally bulbous shape and is configured to extend radially away from the first inflatable portion upon inflation.

### Claim 4 (depends on 1)

The stent delivery system of claim 1, wherein the second inflatable portion is generally in the form of an offset cylinder.

### Claim 5 (depends on 1)

The stent delivery system of claim 1, wherein the second inflatable portion has a generally offset bulbous shape.

### Claim 6 (depends on 1)

The stent delivery system of claim 1, wherein the first inflatable portion is configured to define an indentation configured to receive a portion of the second inflatable portion.

### Claim 7 (depends on 1)

The stent delivery system of claim 1, wherein the catheter shaft defines a guidewire lumen extending coaxially with the first balloon branch.

### Claim 8 (depends on 1)

The stent delivery system of claim 1, further comprising a side branch sheath defining a side branch guidewire lumen, the side branch sheath extending along at least a portion of the catheter shaft.

### Claim 9

A stent delivery system comprising:
a catheter including a proximal end portion and a distal end portion, the distal end portion defining a first branch and a second branch, each of the first and second branches defining an inflation lumen, the second branch having a proximal end and a distal end, each of the proximal and distal ends of the second branch being coupled to the first branch;
a first inflatable portion coupled to the first branch and in fluid communication with the inflation lumen of the first branch; and
a second inflatable portion coupled to the second branch and in fluid communication with the inflation lumen of the second branch, and, when inflated, the second inflatable portion being generally bulbous in shape and configured to extend radially away from the first inflatable portion, wherein a length of the second inflatable portion is less than a length of the first inflatable portion;
wherein the proximal end of the second branch is attached to the first branch adjacent a proximal end of the first inflatable portion and the distal end of the second branch is attached to the first branch adjacent a distal end of the first inflatable portion;
wherein only one of the first and second branches includes a guidewire lumen, where the guidewire lumen extends through the first or second branch and through the corresponding first or second inflatable portion, wherein the guidewire lumen is distinct from the inflation lumen of the corresponding inflatable portion.

### Claim 10 (depends on 9)

The stent delivery system of claim 9, further comprising a stent disposed about the first inflatable portion and the second inflatable portion.

### Claim 11 (depends on 10)

The stent delivery system of claim 10, wherein the stent defines a proximal opening, a distal opening, and a side opening including an outwardly expandable portion, wherein the side opening is aligned with the second inflatable portion, and expansion of the second inflatable portion causes the outwardly expandable portion to expand.

### Claim 12 (depends on 9)

The stent delivery system of claim 9, wherein the first inflatable portion is configured to inflate simultaneously with the second inflatable portion.

### Claim 13 (depends on 9)

The stent delivery system of claim 9, further comprising a side branch sheath defining a side branch guidewire lumen, the side branch sheath extending along at least a portion of the catheter.

### Claim 14 (depends on 9)

The stent delivery system of claim 9, wherein the first branch and the second branch each have a longitudinal axis, the longitudinal axis of the first branch being substantially parallel to the longitudinal axis of the second branch, and wherein, when inflated, the second inflatable portion is disposed offset from the longitudinal axis of the second branch.

### Claim 15

A stent delivery system, comprising:
an elongate shaft including a proximal region, a distal region, and an inflation lumen, the elongate shaft defining a first guidewire lumen;
a first balloon disposed about the distal region of the elongate shaft, wherein the first balloon is in fluid communication with the inflation lumen of the elongate shaft;
a second balloon disposed adjacent the first balloon, the second balloon including a balloon body portion and a first balloon leg and a second balloon leg, the first balloon leg extending proximally from the balloon body portion and the second balloon leg extending distally from the balloon body portion, the first balloon leg having a proximal end coupled directly to the elongate shaft proximal of a proximal waist of the first balloon, and the second balloon leg having a distal end coupled directly to the elongate shaft distal of a distal waist of the first balloon, wherein the second balloon is in fluid communication with the inflation lumen via the first balloon leg and/or the second balloon leg;
wherein the first and second balloons each have a length extending along a longitudinal axis of the elongate shaft, wherein the length of the second balloon body portion is less than the length of the first balloon.

### Claim 16 (depends on 15)

The stent delivery system of claim 15, wherein the first guidewire lumen extends through the elongate shaft and the first balloon.

### Claim 17 (depends on 15)

The stent delivery system of claim 15, further comprising a side branch sheath defining a side branch guidewire lumen, the side branch sheath extending along at least a portion of the elongate shaft.

### Claim 18 (depends on 15)

The stent delivery system of claim 15, further comprising a stent disposed about the first balloon and the second balloon, the stent including a proximal opening, a distal opening, and a side opening including an outwardly expandable portion, wherein the side opening is aligned with the second balloon, and expansion of the second balloon causes the outwardly expandable portion to expand.

### Claim 19 (depends on 15)

The stent delivery system of claim 15, wherein the second balloon has a generally bulbous shape and is configured to extend radially away from the first balloon upon inflation.

### Claim 20 (depends on 15)

The stent delivery system of claim 15, wherein the second balloon has a generally offset bulbous shape.