# US 5,707,355 A · Apparatus and method for the treatment of esophageal varices and mucosal neoplasms

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- Number: US 5,707,355 A
- Document ID: US5707355A
- Status: Granted
- Kind: A
- Application number: 08/558,170
- Filed: 1995-11-15
- Granted: 1998-01-13
- Earliest claimed: 1995-11-15
- Assignees: Zimmon Science Corporation
- Inventors: David S. Zimmon
- Web page: https://patentgrep.com/patent/US5707355A

## CPC

- A61M 16/04: Tracheal tubes (catheters in general A61M25/00)
- A61B 17/12036: {partial occlusion}
- A61B 17/12099: {characterised by the location of the occluder}
- A61B 17/12136: {Balloons}
- A61B 17/22: Implements for squeezing-off ulcers or the like on inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; for invasive removal or destruction of calculus using mechanical vibrations; for removing obstructions in blood vessels, not otherwise provided for
- A61M 16/0409: {with mean for closing the oesophagus}
- A61M 16/0415: {with access means to the stomach}
- A61M 16/0459: {one cuff behind another}
- A61M 16/0461: {Nasoendotracheal tubes}
- A61M 16/0481: {through the cuff wall}
- A61M 16/0486: {Multi-lumen tracheal tubes}
- A61B 2017/22082: {after introduction of a substance}
- A61M 25/1011: {Multiple balloon 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)}
- A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D)

## Abstract

A method and apparatus for treating esophageal varices and mucosal neoplasms. In one form of the present invention a balloon tamponade device is utilized to deliver a dressing containing a sclerosant agent to bleeding esophogeal varices. The balloon tamponade delivery results in a uniformed coating of the inflamed site with the treatment agent. The thrombosant agent penetrates the esophageal mucosa, thrombosis esophageal veins and prevents bleeding by provoking an inflammatory response which replaces the squamous esophogeal mucosa with scar tissue to prevent further bleeding from the varices. Another form of the present invention applies therapeutic agents to portions of the esophagus, rectum and/or other mucosal sites such as the urethral bladder, larynx, bronchial tube axed vagina. Therapeutic agents containing anti-neoplastic and/or corrosive agents are applied to dressings which are placed in contact with the surface area containing the mucosal neoplasm. After the dressings have been delivered to the surface area they are maintained in contact with the lesion for a period of time. In one form of the present invention the delivery of the therapeutic agents to the lesions is accomplished through a balloon tamponade device.

## Claims

### Claim 1

A balloon tamponade device for treating esophageal varices, said device comprising:
a tube having proximal and distal open ends;
a bridle attached to said tube, said bridle being adapted to extend up the esophagus to allow said device to be secured in place while having said proximal open end of said tube positioned within the digestive tract whereby normal feeding and swallowing functions are permitted;
a treatment agent;
a first inflatable balloon mounted over said tube; said first inflatable balloon having said treatment agent connected thereto; and
a first inflation lumen for directing pressurized fluid to inflate said first balloon.

### Claim 2 (depends on 1)

The device of claim 1 wherein said first balloon is an inflatable esophageal balloon.

### Claim 3 (depends on 2)

The device of claim 2, wherein said treatment agent is contained in a dressing connected to said device.

### Claim 4 (depends on 3)

The device of claim 3, wherein said treatment agent provokes an inflammatory response in the tissue it contacts.

### Claim 5 (depends on 4)

The device of claim 4 wherein said treatment agent in one of an alkaline substances, an acidic substance, and a caustic substances.

### Claim 6 (depends on 4)

The device of claim 4, wherein said treatment agent is one of a tanic acid, a picric acid and a salicylic acid.

### Claim 7 (depends on 4)

The device of claim 4, wherein said treatment agent is one of sodium hydroxide, sodium carbonate, potassium carbonate, and potassium hydroxide.

### Claim 8 (depends on 4)

The device of claim 4, wherein said treatment agent is silver nitrate.

### Claim 9 (depends on 4)

The device of claim 4 which is for treating esophageal varices, and which additionally comprises:
a second inflatable balloon mounted over said tube near said distal open end, said second inflatable balloon being an inflatable gastric balloon; and
a second inflation lumen for directing pressurized fluid to inflate said gastric balloon;
said bridle being adapted to extend up the esophagus to allow said device to be secured in place while having said proximal open end of said tube positioned within said esophagus.

### Claim 10 (depends on 9)

The device of claim 9, wherein said tube has an inner diameter of about 1.5 cm.

### Claim 11 (depends on 10)

The device of claim 10, wherein said tube is approximately 8 cm in length.

### Claim 12 (depends on 11)

The device of claim 11, wherein said esophageal balloon is approximately 5 cm in length.

### Claim 13

A method of placing a balloon tamponade device for treating esophageal varices comprising:
providing a treatment agent;
providing a device having a tube having proximal and distal open ends, a first inflatable balloon mounted over said tube, and a first inflation lumen for directing pressurized fluid to inflate said first balloon;
backloading said device on an endoscope by passing said endoscope through said open ends of said tube;
passing said endoscope through the mouth and down said esophagus and using said endoscope to locate said bleeding site;
advancing said device along said endoscope and down said esophagus; and,
applying the treatment agent to the first balloon before advancing the device down said esophagus;
positioning and inflating said first balloon to cause the treatment agent to contact and treat the esophageal varices.

### Claim 14 (depends on 13)

The method of claim 13, wherein said applying includes providing a dressing and wherein uniformly covering a portion of the dressing with the treatment.

### Claim 15 (depends on 14)

The method of claim 14, wherein:
in said providing step, said device also has a second inflatable balloon mounted over the tube near the distal open end, and a bridal attached to the tube and being adapted to extend up the esophagus to allow the device to be secured in place, and wherein said positioning and inflating includes positioning said second inflatable balloon in the stomach, inflating said second inflatable balloon, and pulling on said bridal until said second inflatable balloon is felt to seat against the gastric cardia.

### Claim 16 (depends on 15)

The method of claim 15 wherein:
said positioning places the first inflatable balloon in the distal most 5 cm of the esophagus.

### Claim 17

A method of placing a balloon tamponade device for treating esophageal varices, comprising:
providing a device having a tube having proximal and distal open ends, a first inflatable balloon mounted over said tube, and a first inflation lumen for directing pressurized fluid to inflate said first balloon;
providing a treatment agent;
passing a guide means through said open ends of said tube, said guide means also being extended through the mouth and down said esophagus;
applying the treatment agent to the first balloon before said advancing step;
advancing said device along said guide means and down said esophagus; and
positioning and inflating said first balloon to treat said bleeding site with the treatment agent.

### Claim 18 (depends on 15)

The method of claim 15 wherein said providing step, said first balloon is an esophageal balloon, and said device also includes a bridle attached to said tube, said bridle being adapted to extend up the esophagus to allow said device to be secured in place while having said proximal open end of said tube positioned within said esophagus; and wherein said device also has a second inflatable balloon mounted over said tube, said second balloon being a gastric balloon mounted near said distal end; and
said positioning and inflating includes positioning said second inflatable balloon in the stomach, inflating the second balloon, and pulling on the bridal until the second balloon seats against time gastric cardia.

### Claim 19 (depends on 18)

The method of claim 18 wherein:
said guide means comprises an endoscope; and,
said method additionally comprises viewing the placement of said device with said endoscope.
