# US 5,545,209 A · Controlled deployment of a medical device

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- Number: US 5,545,209 A
- Document ID: US5545209A
- Status: Granted
- Kind: A
- Application number: 08/269,064
- Filed: 1994-06-30
- Granted: 1996-08-13
- Earliest claimed: 1993-09-30
- Assignees: Texas Petrodet, Inc.
- Inventors: George T. Roberts; Kathleen L. Hess; Sepideh H. Nott; Michael S. H. Chu; Yem Chin
- Web page: https://patentgrep.com/patent/US5545209A

## CPC

- A61F 2/958: Inflatable balloons for placing stents or stent-grafts
- 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 25/1002: {characterised by balloon shape (A61M25/1006, A61M25/1009 take precedence)}
- A61M 2025/1059: {having different inflatable sections mainly depending on the response to the inflation pressure, e.g. due to different material properties}
- A61M 2025/1068: {having means for varying the length or diameter of the deployed balloon, this variations could be caused by excess pressure}
- 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 2210/125: Heart
- 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)
- 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 prosthesis delivery system having a balloon catheter with an inflatable balloon on its exterior. The balloon is inflatable by injection of fluid through a lumen in the catheter and the balloon is initially partially constrained against inflation by a constraint. A tubular prosthesis is disposed on the catheter over at least a portion of the balloon and a portion of the constraint. The tubular prosthesis has a contracted condition and an expanded condition. The tubular prosthesis is initially disposed on the catheter in the contracted condition. Further, a balloon catheter includes a constraint so that the balloon may be sequentially inflated for dilatation purposes such as in a valvuloplasty operation.

## Claims

### Claim 1

A prosthesis delivery system comprising:
a ballon catheter extending over a length and having an inflatable balloon on its exterior, said balloon being inflatable by injection of fluid through a lumen in said catheter, and said balloon being initially partially constrained against inflation by a slidable constraint surrounding a portion of said balloon, said constraint configured such that the injection of fluid into said balloon causes said constraint to slide axially along said balloon, permitting inflation of further portions of said balloon, and
a tubular prosthesis disposed on said catheter over at least a portion of said balloon and a portion of said constraint, said tubular prosthesis having a contracted condition and an expanded condition, said tubular prosthesis being initially disposed on said catheter in said contracted condition.

### Claim 2 (depends on 1)

The prosthesis delivery system of claim 1 wherein said sheath is designed to axially slide along a length of said balloon such that said balloon may be progressively incrementally inflated.

### Claim 3 (depends on 2)

The prosthesis delivery system of claim 2 wherein said slidable sheath is adapted to slide axially onto a shaft of said catheter so that said sheath may be retrieved from a patient with said shaft.

### Claim 4 (depends on 1)

The prosthesis delivery system of claim 1 wherein said tubular prosthesis is a stent.

### Claim 5 (depends on 4)

The system of claim 4 wherein said prosthesis is folded around said balloon and constraint.

### Claim 6 (depends on 1)

The prosthesis delivery system of claim 1 wherein said balloon is substantially inelastic.

### Claim 7 (depends on 6)

The prosthesis delivery system of claim 6 wherein said axially slidable sheath is formed of a low coefficient of friction polymer.

### Claim 8 (depends on 7)

The prosthesis delivery system of claim 7 wherein said polymer is Teflon.RTM..

### Claim 9 (depends on 1)

The system of claim 1 wherein said balloon and said prosthesis each have a length of about 5 cm or more.

### Claim 10 (depends on 9)

The system of claim 9 wherein the length of said balloon and prosthesis is in a range of about 8-12 cm.

### Claim 11 (depends on 1)

The system of claim 1 wherein said prosthesis includes a clot inducing fabric.

### Claim 12 (depends on 1)

The system of claim 1 wherein said catheter includes a single lumen for injection of said inflation fluid.

### Claim 13 (depends on 1)

The system of claim 1 wherein said inflation lumen includes an inflation port for directing fluid into said balloon, said port located at a region corresponding to a portion of said balloon not initially constrained by said constraint.

### Claim 14

A prosthesis delivery package comprising
a balloon catheter having an inflatable inelastic balloon on its exterior, said balloon being inflatable by injection of fluid through a lumen in said catheter and having a length of about 8-12 cm, said balloon being initially partially radially constrained against inflation by a slidable constraint having a length less than the length of said balloon and constructed as a slidable low coefficient of friction polymeric sleeve surrounding a portion of said balloon, said constraint configured such that the injection of fluid into said balloon causes said sleeve to slide axially along said balloon, permitting progressive incremental inflation of said balloon, and
a tubular prosthesis, having a length substantially corresponding to the length of said balloon, disposed on said catheter over at least a portion of said balloon and a portion of said constraint, said tubular prosthesis having a contracted condition and an expanded condition, said tubular prosthesis being initially disposed on said catheter in said contracted condition.

### Claim 15 (depends on 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13)

The system of any one of claims 1, 2, 3 or 4-13 wherein said constraint has a short length such that it remains entirely within the body after full inflation of said balloon.

### Claim 16 (depends on 1, 2, 3)

The system of any one of claims 1, 2, 3, or 4-13 wherein said constraint has a length that is less than the length of said balloon.
