Gynecological ablation procedure and system using an ablation needle

• US 6,840,935 B2
• Filed: 07/31/2001
• Issued: 01/11/2005
• Est. Priority Date: 08/09/2000
• Status: Expired due to Term

• Current Assignee: Acessa Health Inc. (Hologic Incorporated)
• Original Assignee: Bekl Corporation
• Inventors: Lee, Bruce B.
• Primary Examiner(s): Peffley, Michael
• Assistant Examiner(s): VRETTAKOS, PETER J
• Application Number:
  US09/920,425
• Publication Number:
  US 20020022835A1
• Time in Patent Office: 1,260 Days
• Field of Search: 606 32- 52, 128/898, 600/439
• US Class Current: 606/34
• 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 18/1477 Needle-like probes
• CPC Class Codes: A61B 18/148 having a short, rigid shaft for accessing the inner body transcutaneously, e.g. for neurosurgery or arthroscopy
• CPC Class Codes: A61B 18/1487 Trocar-like, i.e. devices producing an enlarged transcutaneous opening
• CPC Class Codes: A61B 18/18 by applying electromagnetic radiation, e.g. microwaves radiation therapy A61N5/00
• CPC Class Codes: A61B 2018/00702 Power or energy
• CPC Class Codes: A61B 2018/00791 Temperature
• CPC Class Codes: A61B 2018/00797 measured by multiple temperature sensors
• CPC Class Codes: A61B 2018/00821 measured by a thermocouple
• CPC Class Codes: A61B 2018/1425 Needle
• CPC Class Codes: A61B 2090/378 using ultrasound
• CPC Class Codes: A61B 8/12 in body cavities or body tracts, e.g. by using catheters catheters per se A61M25/00
• CPC Class Codes: A61B 90/36 Image-producing devices or illumination devices not otherwise provided for

Abstract

A method for treating pelvic tumors, such as uterine leiomyomata, includes inserting an ablation apparatus into a pelvic region and positioning the ablation apparatus either proximate or into a pelvic tumor. The method further includes using a laparoscope and an imaging device, such as an ultrasound machine, to confirm the location of the pelvic tumor and placement of the ablation apparatus. Various ablation apparatuses may be used, including those with multiple needles or deployable arms that are inserted into the pelvic tumor and those without arms. The method further includes delivering electromagnetic energy or other energy through the ablation apparatus to the pelvic tumor to ablate the tumor. A surgical system for ablating pelvic tumors is also provided.

Claims

1. A meted of treating a pelvic tumor comprising:

inserting a tip of an ablation device into a pelvic region, wherein the ablation device includes three or more electrodes deployable from the tip;

deploying the three or more electrodes within a pelvic tumor to avoid contact with normal tissue outside of the pelvic tumor;

confining placement of the three or more electrodes completely within the pelvic tumor with a leparoscope and an imaging device including an intra-abdominal ultrasound probe separate from the ablation device; and

delivering energy through the three or more electrodes to the pelvic tumor to ablate the tumor.

2. The method of claim 1, wherein inserting the ablation device includes inserting the ablation device into a uterus.

3. The method of claim 2, wherein the ablation device is inserted through an abdomen and into the uterus.

4. The method of claim 2, wherein the ablation device is inserted through a cervix and into the uterus.

5. The method of claim 1, wherein the ablation device includes a plurality of deployable arms and further comprising deploying the plurality of arms completely within the pelvic tumor.

6. The method of claim 5, further comprising inserting the ultrasound probe into an incision proximate a top of a uterus.

7. The method of claim 1, wherein the Imaging device is an ultrasound machine.

8. The method of claim 1, wherein delivering energy includes delivering RF energy to the pelvic tumor.

9. The method of claim 1, wherein delivering energy includes heating the pelvic tumor to a temperature between approximately 65°

C. and approximately 100°

C. for at least 7 minutes.

10. The method of claim 9, wherein the pelvic tumor is maintained at the temperature for between approximately 7 and approximately 14 minutes.

11. The method of claim 10, further comprising:

repositioning the ablation device proximate a second pelvic tumor;

confirming placement of the ablation device; and

delivering energy to the second pelvic tumor to ablate the second tumor.

12. The method of claim 11, wherein the second pelvic tumor is located closer to a vasculature than a first pelvic tumor.

13. A method of treating pelvic tumors comprising:

providing a patient on an operating table;

providing at least one monitor for a laparoscope and an imaging device including an intra-abdominal ultrasound probe, the at least one monitor being located across the operating table from a surgeon and proximate the patient'"'"'s waist;

providing an energy source and the imaging device adjacent to the at least one monitor, the energy source and the imaging device being located proximate the patient'"'"'s knees;

inserting a tip of an ablation device into a pelvic region of the patient, wherein the ablation device includes three or more electrodes deployable from the tip, and further wherein the ablation device is separate from the intra-abdominal ultrasound probe;

deploying the three or more electrodes within a pelvic tumor to avoid contact with normal tissue outside of the pelvic tumor;

confirming placement of the three or more electrodes completely within the pelvic tumor with the laparoscope and the imaging device; and

delivering energy through the tree or more electrodes to the pelvic tumor to ablate the tumor.

14. The method of claim 13, wherein the patient is in a dorsal position on the operating table.

15. The method of claim 13, wherein inserting the ablation device includes inserting the ablation device through an abdomen and into a uterus.

16. The method of claim 15, further comprising repositioning the uterus relative to the ablation device.

17. The method of claim 15, further comprising rotating the ablation device during insertion to reduce movement of the uterus.

18. The method of claim 15, further comprising inserting an ultrasound probe into an incision proximate a top of the uterus.

19. The method of claim 13, wherein inserting the ablation device includes inserting the ablation device through a cervix and into a uterus.

20. The method of claim 13, wherein the ablation device includes a plurality of deployable arms and further comprising deploying the plurality of arms of the ablation device completely within the pelvic tumor.

21. The method of claim 13, wherein the imaging device is an ultrasound machine.

22. The method of claim 13, wherein delivering energy includes delivering RF energy to the pelvic tumor.

23. The method of claim 13, wherein delivering energy includes heating the pelvic tumor to a temperature between approximately 65°

C. and approximately 100°

C. for at least 7 minutes.

24. The method of claim 13, further comprising removing the ablation device from the pelvic region, including cauterizing a track of the ablation device.

25. A method of treating pelvic tumors comprising:

inserting a tip of an ablation device including three or more electrodes deployable from the tip into a single puncture site in a pelvic region, the puncture site being approximately 1 mm to 2 mm in diameter;

deploying the three or more electrodes within at least one pelvic tumor to avoid contact with normal tissue outside of the at least one pelvic tumor, the at least one pelvic tumor having a diameter of at least 1 cm;

confirming placement of the three or more electrodes completely within the at least one pelvic tumor with a laparoscope and an imaging device including an intra-abdominal ultrasound probe separate from the ablation device;

delivering RF energy to the ablation device; and

heating the at least one pelvic tumor to a temperature between approximately 85°

C. and approximately 100°

C. for between approximately 7 and 14 minutes,

wherein from the single puncture site substantially all of the at least one pelvic tumor is ablated.

26. The method of claim 25, wherein the pelvic tumor is a uterine fibroid.

27. The method of claim 26, further comprising:

repositioning the ablation device proximate a second pelvic tumor from the single puncture site;

confirming placement of the ablation device; and

delivering energy to the second pelvic tumor to ablate the second tumor.

28. A method of treating a uterine fibroid comprising:

manipulating a uterus with an intra-abdominal ultrasound probe to position and stabilize the uterus, wherein the uterus has at least one uterine fibroid;

inserting a tip of an ablation device into the uterus, wherein the ablation device includes at least three electrodes deployable from the tip;

deploying the at least three electrodes within the uterine fibroid to avoid contact with normal tissue outside of the uterine fibroid;

confirming placement of the at least three electrodes completely within the uterine fibroid with a laparoscope and the intra-abdominal ultrasound probe; and

delivering energy through the at least three electrodes to the uterine fibroid to ablate the fibroid.