Gynecological ablation procedure and system using an ablation needle

• US 20020022835A1
• Filed: 07/31/2001
• Published: 02/21/2002
• Est. Priority Date: 08/09/2000
• Status: Active Grant

• Current Assignee: Acessa Health Inc. (Hologic Incorporated)
• Original Assignee: Halt Medical, Inc. (Hologic Incorporated)
• Inventors: Lee, Bruce B.
• Granted Patent: US 6,840,935 B2
• Time in Patent Office: Days
• 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 method of treating a pelvic tumor comprising:

inserting an ablation device into a pelvic region;

positioning the ablation device proximate the pelvic tumor;

confirming placement of the ablation device with a laparoscope and an imaging device; and

delivering energy through the ablation device 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, further comprising inserting the ablation device into the pelvic tumor.

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

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

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

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

10. 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.

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

13. The method of claim 12, wherein the patient is in a dorsal position on the operating table.

14. The method of claim 12, wherein inserting the ablation device includes inserting the ablation device through an abdomen and into a uterus.

15. The method of claim 12, wherein inserting the ablation device includes inserting the ablation device through a cervix and into a uterus.

16. The method of claim 14, further comprising repositioning the uterus relative to the ablation device.

17. The method of claim 14, further comprising rotating the ablation device during insertion to reduce movement of the uterus.

18. The method of claim 12, further comprising inserting the ablation device into the pelvic tumor.

19. The method of claim 18, wherein the ablation device includes a plurality of deployable arms and further comprising deploying the plurality of arms of the ablation device within the pelvic tumor.

20. The method of claim 12, wherein the imaging device is an ultrasound machine.

21. The method of claim 14, further comprising inserting an ultrasound probe into an incision proximate a top of the uterus.

22. The method of claim 12, wherein delivering energy includes delivering RF energy to the pelvic tumor.

23. The method of claim 12, 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 12, further comprising removing the ablation device from the pelvic region, including cauterizing a track of the ablation device.

25. The method of claim 11, 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.

26. The method of claim 25, wherein the second pelvic tumor is located closer to a vasculature than a first pelvic tumor.

28. The surgical system of claim 27, wherein the imaging device is an ultrasound machine.

29. The surgical system of claim 27, wherein the energy source is an RF energy source.

12. 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, 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 an ablation device into a pelvic region of the patient;

positioning the ablation device proximate a pelvic tumor;

confirming placement of the ablation device with the laparoscope and the imaging device; and

delivering energy to the pelvic tumor to ablate the tumor.

27. A surgical system for ablating pelvic tumors in a patient, the system comprising:

an ablation device for insertion into a pelvic region of a patient;

an energy source coupled to the ablation device for providing energy to the ablation device;

a laparoscope for insertion into the patient; and

an imaging device for observing a location of the ablation device within the patient,

wherein the laparoscope and the imaging device are connected to at least one monitor, the at least one monitor being located across the operating table from a surgeon and proximate the patient'"'"'s waist, and wherein the energy source and the imaging device are located adjacent the first and second monitors and proximate the patient'"'"'s knees.

30. A method of treating pelvic tumors comprising:

inserting an ablation device into a puncture site in a pelvic region, the puncture site being approximately 1 mm to 2 mm in diameter;

positioning the ablation device proximate at least one pelvic tumor, the at least one pelvic tumor having a diameter of at least 1 cm;

confirming placement of the ablation device with a laparoscope and an imaging 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 puncture site substantially all of the at least one pelvic tumor is ablated.