# US 2014/0155927 A1 · Integral dilation element for a balloon catheter

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- Number: US 2014/0155927 A1
- Document ID: US20140155927A1
- Status: Published application
- Kind: A1
- Application number: 13/690,507
- Filed: 2012-11-30
- Published: 2014-06-05
- Earliest claimed: 2012-11-30
- Assignees: Cook Medical Technologies LLC
- Inventors: David G. Burton
- Web page: https://patentgrep.com/patent/US20140155927A1

## CPC

- A61M 25/1029: {Production methods of the balloon members, e.g. blow-moulding, extruding, deposition or by wrapping a plurality of layers of balloon material around a mandril}
- A61M 25/1002: {characterised by balloon shape (A61M25/1006, A61M25/1009 take precedence)}
- A61M 25/1034: {Joining of shaft and balloon}
- A61M 25/104: {used for angioplasty}
- A61M 2025/1031: {Surface processing of balloon members, e.g. coating or deposition; Mounting additional parts onto the balloon member's surface}
- A61M 2025/1086: {having a special balloon surface topography, e.g. pores, protuberances, spikes or grooves}
- 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)}

## Abstract

A balloon catheter is provided for dilating hardened stenoses. The balloon catheter has dilation elements integrally formed on the outer surface of the balloon. The dilation elements have cross-sectional shapes that improve the performance of the balloon catheter.

## Claims

### Claim 1

A balloon catheter, comprising:
a catheter shaft comprising an inflation lumen extending longitudinally therethrough;
a balloon mounted on a distal end of said catheter shaft, said balloon comprising an interior cavity in communication with said inflation lumen, said inflation lumen thereby being adapted to communicate an inflation media to inflate and deflate said balloon;
said balloon comprising an integral dilation element extending along a length of an outer surface of said balloon, said dilation element being defined by an area moment of inertia of about 0.0875 mm4 to about 0.00045 mm4 and a polar moment of inertia of about 0.175 mm4 to about 0.0009 mm4.

### Claim 2 (depends on 1)

The balloon catheter according to claim 1, wherein said area moment of inertia is about 0.0083 mm4 to about 0.0008 mm4 and said polar moment of inertia is about 0.0166 mm4 to about 0.0016 mm4.

### Claim 3 (depends on 1)

The balloon catheter according to claim 1, wherein said area moment of inertia is about 0.003125 mm4 to about 0.0008 mm4 and said polar moment of inertia is about 0.00625 mm4 to about 0.0016 mm4.

### Claim 4 (depends on 1)

The balloon catheter according to claim 1, wherein said balloon and said dilation element are made from a material comprising an elastic modulus of about 1,000 MPa to about 2,000 MPa.

### Claim 5 (depends on 1)

The balloon catheter according to claim 1, wherein said dilation element and a wall forming said balloon are made from the same material.

### Claim 6 (depends on 1)

The balloon catheter according to claim 1, wherein an overall height of said dilation element is about 1.25 mm or less.

### Claim 7 (depends on 1)

The balloon catheter according to claim 1, wherein said dilation element comprises a pointed tip.

### Claim 8 (depends on 7)

The balloon catheter according to claim 7, wherein said dilation element comprises a trizoid cross-section.

### Claim 9 (depends on 8)

The balloon catheter according to claim 8, wherein a bottom width of said tip is about 1.0 mm to about 0.25 mm.

### Claim 10 (depends on 7)

The balloon catheter according to claim 7, wherein said dilation element comprises a triangle cross-section.

### Claim 11 (depends on 10)

The balloon catheter according to claim 10, wherein said tip comprises a radius of about 0.010 mm to about 0.050 mm.

### Claim 12 (depends on 1)

The balloon catheter according to claim 1, wherein said dilation element comprises a trapezoid cross-section with a flat tip.

### Claim 13 (depends on 1)

The balloon catheter according to claim 1, wherein said dilation element extends along an entire working length of said balloon.

### Claim 14 (depends on 1)

The balloon catheter according to claim 1, wherein said area moment of inertia is about 0.0083 mm4 to about 0.0008 mm4 and said polar moment of inertia is about 0.0166 mm4 to about 0.0016 mm4, said balloon and said dilation element are made from a material comprising a elastic modulus of about 1,000 MPa to about 2,000 MPa, and said dilation element and a wall forming said balloon are made from the same material.

### Claim 15 (depends on 14)

The balloon catheter according to claim 14, wherein an overall height of said dilation element is about 1.25 mm or less, and said dilation element extends along an entire working length of said balloon.

### Claim 16 (depends on 15)

The balloon catheter according to claim 15, wherein said dilation element comprises a pointed tip and a trizoid cross-section, a bottom width of said tip being about 1.0 mm to about 0.25 mm.

### Claim 17 (depends on 16)

The balloon catheter according to claim 16, wherein said area moment of inertia is about 0.003125 mm4 to about 0.0008 mm4 and said polar moment of inertia is about 0.00625 mm4 to about 0.0016 mm4.

### Claim 18 (depends on 15)

The balloon catheter according to claim 15, wherein said tip comprises a radius of about 0.010 mm to about 0.050 mm, and said dilation element comprises a triangle cross-section.

### Claim 19 (depends on 15)

The balloon catheter according to claim 15, wherein said dilation element comprises a flat tip and a trapezoid cross-section.

### Claim 20

A method of manufacturing a balloon catheter, comprising:
providing a tube comprising a generally circular wall surrounding a central lumen and a protrusion integrally attached to an outer surface of said circular wall and extending along a length thereof, said protrusion being defined by an area moment of inertia of about 0.70 mm4 to about 0.0035 mm4 and a polar moment of inertia of about 0.35 mm4 to about 0.007 mm4;
expanding said tube inside of a mold by heating said tube and pressurizing said central lumen, said mold comprising longitudinal grooves to receive said protrusions, said tube forming a balloon and said protrusion forming a dilation element after said expanding, wherein said dilation element is defined by an area moment of inertia of about 0.0875 mm4 to about 0.00045 mm4 and a polar moment of inertia of about 0.175 mm4 to about 0.0009 mm4;
bonding said balloon to a catheter shaft, an inflation lumen being in communication with an interior cavity of said balloon to inflate and deflate said balloon.
