Endometrium coagulating apparatus and surgical method for thermal destruction of the endometrium

• US 5,451,208 A
• Filed: 09/02/1993
• Issued: 09/19/1995
• Est. Priority Date: 05/03/1991
• Status: Expired due to Term

• Current Assignee: Minerva Surgical, Inc.
• Original Assignee: Milton H. Goldrath
• Inventors: Goldrath, Milton H.
• Primary Examiner(s): Green, Randall L.
• Assistant Examiner(s): ZUTTARELLI, ANTHONY
• Application Number:
  US08/115,994
• Time in Patent Office: 747 Days
• Field of Search: 604/27-28, 604/30, 604/43, 604/48-49, 604/54-55, 604/268, 604/117, 604/113, 604/279, 604/283, 606/27, 606/172, 128/4, 128/6-7, 128/24.1, 607/96, 607/104, 607/105
• US Class Current: 604/515
• 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 2017/4216 Operations on uterus, e.g. endometrium
• CPC Class Codes: A61B 2018/00101 low, i.e. thermally insulating
• CPC Class Codes: A61B 2018/00166 Multiple lumina
• CPC Class Codes: A61B 2018/00982 combined with or comprising means for visual or photographic inspections inside the body, e.g. endoscopes
• CPC Class Codes: A61B 2018/046 in liquid form
• CPC Class Codes: A61B 2090/3933 Liquid markers
• CPC Class Codes: A61F 2007/0059 with an open fluid circuit
• CPC Class Codes: A61F 7/12 Devices for heating or cooling internal body cavities

Abstract

Apparatus and surgical procedures are provided for completely coagulating endometrial tissue of the uterus by means of heated liquid in the distended uterus under direct view of a thermally insulated hysteroscope or under indirect view fluoroscopically using a thermally insulated hysterographic cannula and a radiopaque heated liquid.

Claims

1. Apparatus allowing direct visualization of a cervix, a uterus and its uterine cavity with an endometrial surface in a surgical procedures for coagulating the endometrial surface of the uterus comprising:

a hysteroscope having a proximal portion for endocervical insertion at a depth into the uterus and a distal portion, and including a hollow barrel having optical means for viewing the uterine cavity disposed therein and, in the proximal portion, forming a hollow probe having an exterior surface and channel means for delivering tissue-coagulating heated liquid for a period of time at a selected temperature in direct contact with endometrium tissue lining the uterine cavity;

thermally insulative sheath means disposed concentrically around said probe, which means is sufficiently insulative to avoid thermal damage to tissue other than said endometrial tissue during the period of said delivery;

liquid transfer means in fluid communication with said channel for delivering heated liquid through said probe to and from the uterine cavity; and

control means operatively associated with the probe for regulating the temperature of said liquid.

2. The apparatus of claim 1 wherein said thermally insulative sheath means further includes a shoulder means of increased lateral dimension contoured for contact with the exterior surface of the cervix.

3. Apparatus according to claim 1 where the probe is tubular in shape and the thermally insulative means comprises a tubular sheath telescopically engaging and covering the exterior surface of the probe.

4. Apparatus according to claim 3 where the tubular sheath comprises a tip end including thermocouple sensor means for determining the intrauterine temperature.

5. Apparatus according to claim 1 where the liquid transfer means comprises thermally insulated tubing in open communication with said hollow probe and channel means.

6. Apparatus according to claim 5 where the liquid transfer means comprises syringe means in open communication with said insulative tubing.

7. A surgical procedure for coagulating endometrial tissue of the uterus comprising distending the uterine cavity by filling the cavity and directly contacting the endometrial surface with a heated physiologically compatible solution under pressure sufficient to inflate and directly expose substantially the entire endometrial surface for a time sufficient to cause time and temperature dependent destruction of the endometrium.

8. A surgical procedure for coagulating endometrial tissue of a uterus adjacent to oviducts, Fallopian tubes, and a lower abdominal cavity, said uterus having a uterine cavity with an endometrial surface and an internal architecture, and further having a cervix with an exterior surface, comprising the steps of:

a) distending the uterine cavity with a physiologically compatible solution under direct vision by means of a hysteroscope having a proximal portion for endocervical insertion at a depth into the uterus, said proximal portion including probe means and insulative probe sheath means and further having channel means for delivering and introducing liquid to the uterine cavity under pressure sufficient to inflate and directly expose the endometrial surface;

b) confirming that the proximal portion of the hysteroscope is properly located within the uterine cavity and that the cavity is properly inflated by visualization of the internal architecture of the cavity relative to said proximal portion;

c) withdrawing said solution from the uterine cavity, thus causing the cavity to become substantially collapsed; and

d) distending the uterine cavity while said cavity is under direct vision by means of said hysteroscope, by delivering and introducing to the uterine cavity an aqueous solution that is heated to an endometrial tissue-coagulating temperature and under pressure sufficient to directly contact and expose the endometrial surface for a time sufficient to thereby cause the destruction thereof.

9. A surgical procedure for coagulating endometrial tissue of a uterus having, adjacent to oviducts, Fallopian tubes, and a lower abdominal cavity, a uterine cavity with an endometrial surface and an internal architecture, comprising the steps of:

a) distending the uterine cavity with a fluoroscopically radiopaque, physiologically compatible solution under indirect vision by means of a hysteroscopic cannula for endocervical insertion at a depth into the uterus, said cannula having a proximal portion including probe means and insulative probe sheath means and further having channel means for delivery and introducing liquid to the uterine cavity under pressure sufficient to inflate the endometrial surface;

b) confirming that the proximal portion of the hysteroscope is properly located within the uterine cavity and that the cavity is properly inflated by fluoroscopic visualization of the internal architecture of the cavity relative to said proximal portion;

c) withdrawing said solution from the uterine cavity, thus causing the cavity to become substantially collapsed; and

d) distending the uterine cavity while said cavity is under indirect fluoroscopic vision by means of said hysteroscopic cannula, by delivering and introducing to the uterine cavity aqueous, radiopaque solution heated to an endometrial tissue-coagulating temperature and under pressure sufficient to directly expose the endometrial surface, and keeping the heated solution in contact with said surface for a time sufficient to thereby cause the destruction thereof.