# US 5,704,934 A · Heated ballon medical apparatus with fluid agitating means

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- Number: US 5,704,934 A
- Document ID: US5704934A
- Status: Granted
- Kind: A
- Application number: 08/478,565
- Filed: 1995-06-07
- Granted: 1998-01-06
- Earliest claimed: 1992-09-30
- Inventors: Robert S. Neuwirth; Bolduc R. Bolduc
- Web page: https://patentgrep.com/patent/US5704934A

## CPC

- A61B 18/00: Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body (eye surgery A61F9/007; ear surgery A61F11/00)
- A61B 18/08: by means of electrically-heated probes
- A61F 7/123: {using a flexible balloon containing the thermal element}
- A61B 17/42: Gynaecological or obstetrical instruments or methods {(ligaturing clamps or clips for the umbilical cord A61B17/122; curettage A61B17/320708)}
- A61B 90/06: {Measuring instruments not otherwise provided for}
- A61B 2017/00017: {Electrical control of surgical instruments}
- A61B 2017/00084: {Temperature}
- A61B 2017/00132: {Setting operation time of a device (A61B2017/00123 takes precedence)}
- A61B 2017/00539: {hydraulically}
- A61B 2017/00557: {inflatable (A61B2017/22051 takes precedence)}
- A61B 2017/4216: {Operations on uterus, e.g. endometrium}
- A61B 2018/00547: {Prostate}
- A61B 2018/00559: {Female reproductive organs}
- A61B 2018/00577: {Ablation}
- A61B 2018/044: {the surgical action being effected by a circulating hot fluid}
- A61B 2018/046: {in liquid form}
- A61B 2090/062: {penetration depth}
- A61B 2090/064: {for measuring force, pressure or mechanical tension}
- A61B 2090/3937: {Visible markers}
- A61F 2007/0054: {with a closed fluid circuit, e.g. hot water}
- A61F 2007/0086: {with a thermostat}
- A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D)
- 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)

## Abstract

A method and apparatus for effecting necrosis of a tissue lining of a mammalian body cavity, particularly a uterine endometrium, by introducing an applicator comprising a distendable bladder connected to a catheter into the uterus, distending the bladder by introducing a non-toxic fluid under pressure, heating the fluid by means located internal to the bladder to a temperature of 190.degree. to 215.degree. F. and preferably 210.degree. F. for a period of 4 to 12 minutes and preferably 6 minutes and regulating said apparatus by means located external to the uterus, thereby cauterizing substantially the entirety of the tissue lining, particularly the endometrium. An agitator circulates the fluid within the distendable bladder to help keep the fluid at a uniform temperature.

## Claims

### Claim 1

An apparatus for effecting necrosis of a uterine endometrium comprising:
a catheter having a proximal end and a distal end;
a distendable bladder means attached to said proximal end for insertion into and distending the uterus;
inflating means connected to said distal end for introducing an inflation medium into said bladder;
heating means for heating said inflation medium to a temperature sufficient to effect tissue necrosis positioned internal to said bladder;
control means connected to said distal end and communicating with said proximal end and said heating means for regulating the inflating and heating of said bladder;
agitating means for agitating said inflation medium positioned internal to said bladder; and
control means connected to said distal end and communicating with said agitating means for regulating agitation of said inflation medium.

### Claim 2 (depends on 1)

The apparatus of claim 1, wherein said catheter is comprised of rigid tubing at the proximal end of said bladder, and flexible tubing extending through said rigid tubing from said control means to said bladder.

### Claim 3 (depends on 2)

The apparatus of claim 2, wherein said rigid tubing is selected from the group comprising polytetrafluorothylene type tubing.

### Claim 4 (depends on 2)

The apparatus of claim 2, wherein said flexible tubing is selected from the group comprising polytetrafluorothylene type tubing.

### Claim 5 (depends on 2)

The apparatus of claim 2, further comprising a positioning means for positioning said distendable bladder in the uterus.

### Claim 6 (depends on 5)

The apparatus of claim 5, wherein said positioning means comprises scale gradations on the catheter for indicating depth of insertion of said distendable bladder into the uterus.

### Claim 7 (depends on 2)

The apparatus of claim 2, wherein said inflating means comprises a pump means connected to said flexible tubing for pumping said inflation medium through said flexible tubing so as to inflate said bladder.

### Claim 8 (depends on 7)

The apparatus of claim 7, wherein said fluid is non-circulating.

### Claim 9 (depends on 7)

The apparatus of claim 7, wherein said pumping means comprises a hypodermic barrel.

### Claim 10 (depends on 9)

The apparatus of claim 9, wherein said hypodermic barrel is connected to said flexible tubing by a three way valve.

### Claim 11 (depends on 1)

The apparatus of claim 1, further comprising means for disengaging said catheter from said control means so that the applicator and the control means may be separated.

### Claim 12 (depends on 1)

The apparatus of claim 1 wherein said distendable bladder is capable of resisting an internal pressure of at least 300 mmHg without rupturing and a temperature of at least 250.degree. Fahrenheit without carbonizing.

### Claim 13 (depends on 12)

The apparatus of claim 12, wherein said bladder is selected from the group comprising latex rubber.

### Claim 14 (depends on 1)

The apparatus of claim 1, wherein said control means for inflating and heating said bladder comprises:
volume control means;
temperature control means
pressure control means; and
time control means.

### Claim 15 (depends on 14)

The apparatus of claim 14, wherein said temperature control means comprises a thermocouple for measuring the temperature of said inflation medium fixed to the proximal end of said catheter and positioned internal to said bladder, said thermocouple connected to said control means via a second electrical lead.

### Claim 16 (depends on 14)

The apparatus of claim 14, wherein said pressure control means comprises:
a pressure sensor connected to said flexible tubing;
said pressure sensor connected to a pressure display means for displaying and regulating the pressure of said inflating means.

### Claim 17 (depends on 14)

The apparatus of claim 14, wherein said time control means comprises a clock.

### Claim 18 (depends on 17)

The apparatus of claim 17, wherein said clock is programmable-and connected to said temperature control means.

### Claim 19 (depends on 1)

The apparatus of claim 1, wherein said control means for regulating the agitation of said inflation medium comprises:
temperature control means; and
time control means.

### Claim 20 (depends on 19)

The apparatus of claim 19, wherein said temperature control means comprises a thermocouple for measuring the temperature of said agitating means fixed to the proximal end of said catheter and positioned internal to said bladder, said thermocouple connected to said control means for regulating the agitation of said inflation medium via a second electrical lead.

### Claim 21 (depends on 19)

The apparatus of claim 19, wherein said time control means comprises a clock.

### Claim 22 (depends on 21)

The apparatus of claim 21, wherein said clock is programmable and connected to said temperature control means.

### Claim 23

An apparatus for effecting necrosis of a tissue lining in a body cavity comprising:
a catheter comprising a length of flexible tubing having a distal end and a proximal end;
a bladder means for insertion into and distending the body cavity attached to a proximal end;
inflating means connected to said distal end for introducing an inflation medium through said flexible tubing and into said bladder;
a heating means for heating said inflation medium to a temperature sufficient to effect tissue necrosis positioned internal to said bladder;
a control means connected to said distal end and communicating with said proximal end and said heating means for regulating inflation and heating of said bladder; and
agitating means for agitating said inflation medium positioned internal to said bladder; and
a control means connected to said distal end and communicating with said agitating means for regulating agitation of said inflation medium.
