# US 8,465,462 B2 · Rapid exchange balloon dilation catheter having reinforced multi-lumen distal portion

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- Number: US 8,465,462 B2
- Document ID: US8465462B2
- Status: Granted
- Kind: B2
- Application number: 13/188,109
- Filed: 2011-07-21
- Published: 2011-11-10
- Granted: 2013-06-18
- Earliest claimed: 2005-07-05
- Assignees: Bard Peripheral Vascular, Inc.
- Applicants: Lanny R. Pepper
- Inventors: Lanny R. Pepper
- Web page: https://patentgrep.com/patent/US8465462B2

## CPC

- A61M 29/02: Dilators made of swellable material {(balloon catheters for angioplasty A61M25/104)}
- A61M 25/0052: {Localized reinforcement, e.g. where only a specific part of the catheter is reinforced, for rapid exchange guidewire port}
- A61M 25/10: Balloon catheters ({A61M25/0125 takes precedence; embolectomy A61B17/22032; retractors A61B17/02;} inflatable balloons for placing stents or stent-grafts A61F2/958 {; stomach balloons for treatment of obesity A61F5/0003; oesophagal tubes A61J15/00})
- A61M 25/0053: {having a variable stiffness along the longitudinal axis, e.g. by varying the pitch of the coil or braid}
- 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 2025/0183: {Rapid exchange or monorail catheters}
- 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 rapid exchange balloon dilation catheter includes a catheter shaft with a proximal tubular member defining a proximal inflation/deflation lumen for conveying fluids therethrough with a distal portion of the bore of proximal tubular member filled with a fluid-impervious barrier, a distal body extending from the fluid-impervious barrier to the distal end of the shaft, a plurality of distal tubular members defining distal inflation/deflation lumens in fluid communication with the proximal inflation/deflation lumen and extending through the fluid-impervious barrier and the distal body to the distal end of the shaft distal portion, a guidewire tubular member having a bore extending from a side aperture formed in the distal body through the distal body alongside the distal tubular members in a multi-lumen arrangement, and a plurality of stiffening members extending from within the fluid-impervious barrier into the distal body to a point within the shaft distal portion.

## Claims

### Claim 1

A rapid exchange balloon dilation catheter, the catheter comprising:
a catheter shaft; and
a balloon having a proximal end, a distal end and an interior, the proximal end of the balloon being attached to the distal end of the catheter shaft;
the catheter shaft further including:
a fluid impervious barrier;
a plurality of distal tubular members associated with the fluid-impervious barrier and extending to the interior of the balloon;
a guidewire tubular member having a bore extending from a side aperture and through the interior of the balloon to the distal end of the balloon; and
a plurality of stiffening members for stiffening the catheter shaft, wherein the stiffening members include members of different lengths.

### Claim 2 (depends on 1)

The catheter of claim 1, wherein the catheter shaft further includes a proximal section proximal to the fluid impervious barrier, said proximal section including a single proximal lumen.

### Claim 3 (depends on 2)

The catheter of claim 2, wherein the plurality of distal tubular members are in communication with the proximal lumen for transferring inflation fluid to and from the balloon.

### Claim 4 (depends on 2)

The catheter of claim 2, wherein the fluid impervious barrier connects the proximal lumen to the distal tubular members.

### Claim 5 (depends on 1)

The catheter of claim 1, wherein the stiffening members are associated with the portion of the catheter shaft including the side aperture.

### Claim 6 (depends on 5)

The catheter of claim 5, wherein the stiffening members extend to various points of the catheter shaft distal to the side aperture such that the catheter shaft becomes less rigid toward a distal portion of the catheter shaft.

### Claim 7

A rapid exchange balloon dilation catheter, the catheter comprising:
a catheter shaft having a proximal end and a distal end; and
a balloon having a proximal end, a distal end, and an interior, the proximal end of the balloon being attached to the distal end of the catheter shaft;
the catheter shaft further including:
a fluid impervious barrier including at least one tubular member adapted for allowing the inflation fluid to reach the interior of the balloon;
a guidewire tube having a bore originating from a side aperture and extending through the interior of the balloon to the distal end of the balloon; and
a plurality of stiffening members extending through at least a portion of the catheter shaft.

### Claim 8 (depends on 7)

The catheter of claim 7, wherein the stiffening members are associated with a portion of the catheter shaft including the side aperture.

### Claim 9 (depends on 7)

The catheter of claim 7, wherein the stiffening members include members of different lengths.

### Claim 10 (depends on 7)

The catheter of claim 7, wherein the shaft becomes more flexible from the side aperture to the distal end of the shaft.

### Claim 11 (depends on 10)

The catheter of claim 10, wherein the flexibility of the shaft increases linearly toward the distal end of the shaft.

### Claim 12 (depends on 10)

The catheter of claim 10, wherein the flexibility of the shaft increases in a nonlinear fashion toward the distal end of the shaft.

### Claim 13 (depends on 7)

The catheter of claim 7, wherein at least one of the stiffening members has a cross section that varies along its length.

### Claim 14 (depends on 7)

The catheter of claim 7, further including a single lumen in the proximal end of the catheter shaft and multiple lumens in the distal end of the catheter shaft.

### Claim 15

A catheter shaft for use in a rapid exchange balloon dilation catheter with a guidewire, comprising:
a tubular member including a side aperture for receiving the guidewire;
a fluid impervious barrier positioned in the tubular member for selectively allowing inflation fluid to reach the balloon;
a single proximal inflation lumen and a plurality of distal inflation lumen;
a guidewire tube adapted for receiving the guidewire; and
a plurality of stiffening members extending through the catheter shaft.

### Claim 16 (depends on 15)

The shaft of claim 15, wherein the fluid impervious barrier diverts inflation fluid from the proximal inflation lumen to the distal inflation lumen.

### Claim 17 (depends on 16)

The shaft of claim 16, wherein the shaft increases in flexibility from the side aperture to a distal end of the shaft.

### Claim 18 (depends on 15)

The shaft of claim 15, wherein the fluid impervious barrier is bonded to the stiffening members.

### Claim 19

A rapid exchange balloon dilation catheter, the catheter comprising:
a catheter shaft; and
a balloon having a proximal end, a distal end and an interior, the proximal end of the balloon being attached to the distal end of the catheter shaft;
the catheter shaft further including:
a fluid impervious barrier;
a plurality of distal tubular members associated with the fluid-impervious barrier and extending to the interior of the balloon;
a guidewire tubular member having a bore extending from a side aperture and through the interior of the balloon to the distal end of the balloon; and
a plurality of stiffening members for stiffening the catheter shaft, wherein the stiffening members extend to various points of the catheter shaft distal to the side aperture such that the catheter shaft becomes less rigid toward a distal portion of the catheter shaft.

### Claim 20 (depends on 19)

The catheter of claim 19, wherein the catheter shaft further includes a proximal section proximal to the fluid impervious barrier, said proximal section including a single proximal lumen.

### Claim 21 (depends on 20)

The catheter of claim 20, wherein the plurality of distal tubular members are in communication with the proximal lumen for transferring inflation fluid to and from the balloon.

### Claim 22 (depends on 20)

The catheter of claim 20, wherein the fluid impervious barrier connects the proximal lumen to the distal tubular members.

### Claim 23 (depends on 19)

The catheter of claim 19, wherein the stiffening members are associated with the portion of the catheter shaft including the side aperture.
