Intrauterine cauterizing apparatus

• US 4,949,718 A
• Filed: 09/09/1988
• Issued: 08/21/1990
• Est. Priority Date: 09/09/1988
• Status: Expired due to Term

• Current Assignee: Gynelab Products
• Original Assignee: Gynelab Products
• Inventors: Neuwirth, Robert S., Bolduc, Lee R.
• Primary Examiner(s): HINDENBURG, MAX F
• Application Number:
  US07/242,730
• Time in Patent Office: 711 Days
• Field of Search: 128/6, 128/303.1-303.12, 128/399-402, 600/18, 604/99, 606/27, 606/28
• US Class Current: 607/27
• CPC Class Codes: A61B 17/42 Gynaecological or obstetrical instruments or methods ligaturing clamps or clips for the umbilical cord A61B17/122; curettage A61B17/320708; dilators A61M29/00
• CPC Class Codes: 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
• CPC Class Codes: A61B 18/08 by means of electrically-heated probes
• CPC Class Codes: A61B 2017/00017 Electrical control of surgical instruments
• CPC Class Codes: A61B 2017/00084 Temperature
• CPC Class Codes: A61B 2017/00132 Setting operation time of a device A61B2017/00123 takes precedence
• CPC Class Codes: A61B 2017/00539 hydraulically
• CPC Class Codes: A61B 2017/4216 Operations on uterus, e.g. endometrium
• CPC Class Codes: A61B 2018/00547 Prostate
• CPC Class Codes: A61B 2018/00559 Female reproductive organs
• CPC Class Codes: A61B 2018/00577 Ablation
• CPC Class Codes: A61B 2018/044 the surgical action being effected by a circulating hot fluid
• CPC Class Codes: A61B 2018/046 in liquid form
• CPC Class Codes: A61B 2090/062 penetration depth
• CPC Class Codes: A61B 2090/064 for measuring force, pressure or mechanical tension
• CPC Class Codes: A61B 2090/3937 Visible markers
• CPC Class Codes: A61B 90/06 Measuring instruments not otherwise provided for
• CPC Class Codes: A61F 2007/0054 with a closed fluid circuit, e.g. hot water
• CPC Class Codes: A61F 7/123 using a flexible balloon containing the thermal element

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° to 215° F. and preferably 210° 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.

Claims

1. An apparatus for effecting necrosis of an 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; and

control means connected to said distal end for regulating the inflating and heating of said bladder.

2. 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.

3. 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.

4. The apparatus of claim 3, wherein said pumping means comprises a hypodermic barrel.

5. The apparatus of claim 4, wherein said hypodermic barrel is connected to said flexible tubing by a three-way valve.

6. The apparatus of claim 3, wherein said fluid is non-circulating.

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

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

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

10. The apparatus of claim 9, wherein said positioning means comprises scale gradations on said catheter for indicating depth of insertion of said distendable bladder into the uterus.

11. 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.

12. 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°

Fahrenheit without carbonizing.

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

14. The apparatus of claim 1, wherein said control means comprises:

volume control means;

temperature control means

pressure control means; and

time control means.

15. 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.

16. 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.

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

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

19. 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; and

control means connected to said distal end for regulating inflation and heating of said bladder.

20. The apparatus of claim 19 further comprising a thermocouple for measuring the temperature of said inflation medium positioned internal to said bladder and connected to said control means via an electrical lead.