Echogenic needle for transvaginal ultrasound directed reduction of uterine fibroids and an associated method

• US 6,936,048 B2
• Filed: 01/16/2003
• Issued: 08/30/2005
• Est. Priority Date: 01/16/2003
• Status: Expired due to Term

• Current Assignee: Gynesonics, Inc.
• Original Assignee: Charlotte Mecklenburg Hospital Authority
• Inventors: Hurst, Bradley Shawn
• Primary Examiner(s): PEFFLEY, MICHAEL F
• Application Number:
  US10/345,635
• Publication Number:
  US 20040143252A1
• Time in Patent Office: 957 Days
• Field of Search: 606/41, 606/42, 606 45- 50, 600/439, 600/459, 600461-464
• US Class Current: 606/41
• 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 18/02 by cooling, e.g. cryogenic techniques devices for cooling specific reflex points of the body within cell-life limits A61H39/06
• CPC Class Codes: A61B 18/1477 Needle-like probes
• CPC Class Codes: A61B 2017/00084 Temperature
• CPC Class Codes: A61B 2018/00559 Female reproductive organs
• CPC Class Codes: A61B 2018/00791 Temperature
• CPC Class Codes: A61B 2090/378 using ultrasound
• CPC Class Codes: A61B 2090/3782 transmitter or receiver in catheter or minimal invasive instrument
• CPC Class Codes: A61B 2090/3925 ultrasonic
• CPC Class Codes: A61B 90/11 with guides for needles or instruments, e.g. arcuate slides or ball joints

Abstract

The invention is a transvaginal ultrasound probe having an attached echogenic needle that is useful in the treatment of uterine fibroids. The echogenic needle has an echogenic surface near its tip that allows the physician to visualize its location using ultrasound imaging. In one embodiment, the needle has an active electrode at its distal end. The active electrode supplies radio frequency energy to a fibroids causing necrosis of the targeted fibroid or by destroying the fibroid'"'"'s vascular supply. The radio frequency needle preferably has a safety device that shuts-off energy if the needle punctures the uterine wall. In a second embodiment, the needle has a cryogen supply tube and cryogen supply. This embodiment destroys fibroid tissue by freezing it or its vascular supply when the tissue comes in contact with the needle'"'"'s frozen distal end. The invention further includes the method of using the ultrasound probe with the attached needle.

Claims

1. An echogenic medical needle for transvaginal ultrasound directed reduction of uterine myomas and fibroids comprising:

an electrically conductive outer tubular member having an inner surface, a distal end having a echogenic surface formed therein, and a proximal end;

an active electrode near said distal end;

a radiofrequency insulation sheath surrounding an outer portion of said outer member, said radiofrequency insulation defining a segment of said outer member that is insulated from radiofrequency and a segment of said outer member that is not radiofrequency-insulated, such that said radiofrequency insulation segment extends from said proximal end to said distal end;

an electrical connector attached to said proximal end that is in electrical communication with said active electrode; and

a vaginal ultrasonic probe baying an attached needle guide whereby said medical needle is positioned in said needle guide.

2. The medical needle according to claim 1, further comprising a radiofrequency power source in electrical communication with said electrical connector such that said power source provides electrical energy to said active electrode.

3. The medical needle according to claim 2, further comprising a safety device for shutting off said electrical energy to said active electrode comprising:

an inner cylindrical member disposed within said outer member having a blunt rear end that extends outwardly from said open beveled tip, a forward end, and an electrically conductive outer surface that defines a portion of said inner member that is electrically conductive and a portion that is non-electrically conductive;

a spring disposed within said outer member positioned at the proximal end of said outer member and attached to said forward end of said inner cylindrical member such that when pressure is applied to said blunt rear end said spring compresses and said blunt rear end retracts into said outer member;

a second and third electrically conductive surface disposed on said inner surface, wherein said second and third surface are not in contact with each other, said second surface in electrical communication with said electrical connector, and said third surface in electrical communication with said active electrode, whereby retraction of said spring causes said first electrically conductive surface to simultaneously contact said second and third surface such that said electrical connector is in electrical communication with said active electrode.

4. The medical needle according to claim 3, wherein said second conductive surface is not in electrical communication with said inner surface.

5. The medical needle according to claim 2, further comprising a safety device for shutting off said electrical energy to said active electrode comprising:

an inner cylindrical member disposed within said outer member having a blunt rear end that extends outwardly from said open beveled tip, a forward end, an active electrode disposed at said blunt rear end, and an electrically conductive outer surface that defines a portion of said inner member that is electrically conductive and a portion that is non-electrically conductive, said electrically conductive surface is in electrical communication with said active electrode;

a spring disposed within said outer member positioned at the proximal end of said outer member and attached to said forward end of said inner cylindrical member such that when pressure is applied to said blunt rear end said spring compresses and said blunt rear end retracts into said outer member;

a second electrically conductive surface disposed on said inner surface, wherein said second is in electrical communication with said electrical connector, whereby retraction of said spring causes said first electrically conductive surface to simultaneously contact said second surface such that said electrical connector is in electrical communication with said active electrode.

6. The medical needle according to claim 2, further comprising a switch to turn off maid electrical energy to said active electrode comprising:

an inner cylindrical member disposed within said outer member having a forward end and a blunt rear end that extends outwardly from said open beveled tip, whereby applying pressure to said blunt rear end retracts said blunt rear end into said outer member;

a switch that is disposed within said outer member having an open and closed position such that when said switch is closed said electrical connection and said active electrode are in electrical, communication, said switch connected to said forward end such that when said blunt rear end is retracted into said outer member, said forward end applies pressure to said switch whereby said switch is closed and said electrical connection and said active electrode are in electrical communication.

7. The medical needle according to claim 1, further comprising a return electrode disposed on said outer member proximate to said active electrode.

8. The medical needle according to claim 7, wherein said return electrode is disposed about 2 to 20 mm from said active electrode.

9. The medical needle according to claim 1, further comprising a return electrode disposed on an outer surface of a patient'"'"'s body.

10. The medical needle according to claim 1, wherein said proximal end further comprises a finger grip for manually directing said distal end.

11. The medical needle according to claim 1, further comprising a temperature sensor that is disposed within said sheath near said active electrode, said sensor in communication with a temperature display means.

12. The medical needle according to claim 1, wherein said distal end further comprises a sharpened point for penetrating tissue.

13. The medical needle according to claim 1, wherein said attached needle guide is a plastic or metal clamp fitted around said probe having an opening through which the needle is inserted.

14. The medical needle according to claim 1, wherein said distal end further comprises an open beveled tip for penetrating tissue.

15. The medical needle according to claim 1, wherein the length of said outer member is about 25 to 50 centimeters.

16. The medical needle according to claim 1, wherein the length of said outer member is about 30 to 40 centimeters.

17. The medical needle according to claim 1, wherein the diameter of said outer member is about 12-18 gauge.

18. The medical needle according to claim 1, wherein the diameter of said outer member is about 16-18 gauge.

19. The medical needle according to claim 1, wherein said echogenic surface comprises grooves, recesses, bumps, indentations, or combinations thereof formed in the outer surface of said distal end.

22. The method according to claim 21, wherein the step of providing an echogenic needle further includes the step of providing an echogenic needle as described in claims 11, 13, or 14.

23. The method according to claim 22, wherein the step of penetrating said surface further includes the step of shutting off power to said active electrode if said distal end pierces said uterus.

20. A method for the electric surgery of myomas and fibroids in a uterus using a transvaginal ultrasound directed echogenic medical needle comprising the steps of:

a) providing an ultrasound probe having a transducer and a needle guide attached to said probe;

b) providing an echogenic needle, the echogenic needle including an electrically conductive outer tubular member having an inner surface, a distal end having a echogenic surface formed therein, a proximal end, an active electrode proximate to said distal end, a radiofrequency insulation sheath surrounding an outer portion of said outer member, said radiofrequency insulation defining a segment of said outer member that is insulated from radiofrequency and a segment of said outer member that is not radiofrequency-insulated, such that said radiofrequency insulation segment extends from said proximal end to said distal end and an electrical connector attached to said proximal end that is capable of being in electrical communication with said active electrode;

c) inserting said ultrasound probe into said uterus;

d) inserting said echogenic needle into said uterus through said needle guide;

l) sensing the location of said myomas and said echogenic needle within said uterus with imaging from said ultrasonic probe;

f) guiding said echogenic needle to a surface of said fibroid using said ultrasound imaging;

g) positioning said echogenic needle on said surface of said fibroid; and

h) passing a controlled amount of radio frequency currant through said active electrode while said echogenic needle is in contact with said fibroid.

21. The method according to claim 20, wherein the stop of positioning the echogenic needle in contact with said myoma further includes the step of penetrating said surface with said distal and of said echogenic needle.

24. The method according to claim 20, wherein the step of positioning the echogenic needle in contact with said fibroid further includes the step of positioning said needle in contact with the fibroid'"'"'s vascular supply.

25. The method according to claim 20, wherein the step of passing a controlled amount of radio frequency current through said active electrode while said echogenic needle is in contact with said fibroid further includes the step of monitoring the temperature changes in said fibroid.

26. The method according to claim 20, wherein said echogenic surface comprises grooves, recesses, bumps, indentations, or combinations thereof formed in the outer surface of said distal end.