Methods and devices for visualization and ablation of tissue

• US 7,874,986 B2
• Filed: 11/28/2006
• Issued: 01/25/2011
• Est. Priority Date: 04/20/2006
• Status: Active Grant

• Current Assignee: Gynesonics, Inc.
• Original Assignee: Gynesonics, Inc.
• Inventors: Deckman, Robert K., Grossman, Jessica, Munrow, Michael, Gerbi, Craig
• Primary Examiner(s): Le; Long V
• Assistant Examiner(s): HOFFA, ANGELA MARIE
• Application Number:
  US11/564,164
• Publication Number:
  US 20070249936A1
• Time in Patent Office: 1,519 Days
• Field of Search: None
• US Class Current: 600/439
• 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 18/04 by heating by applying electromagnetic radiation A61B18/18; hyperthermia using electric or magnetic fields, radiation or ultrasound A61N
• CPC Class Codes: A61B 18/082 Probes or electrodes therefor
• CPC Class Codes: A61B 18/1477 Needle-like probes
• CPC Class Codes: A61B 18/18 by applying electromagnetic radiation, e.g. microwaves radiation therapy A61N5/00
• CPC Class Codes: A61B 2017/4216 Operations on uterus, e.g. endometrium
• CPC Class Codes: A61B 2018/00559 Female reproductive organs
• CPC Class Codes: A61B 2018/00577 Ablation
• CPC Class Codes: A61B 2018/1425 Needle
• CPC Class Codes: A61B 8/0833 involving detecting or locating foreign bodies or organic structures
• CPC Class Codes: A61B 8/0841 for locating instruments
• 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 8/445 Details of catheter construction

Abstract

Delivery systems, and methods using the same, having an ultrasound viewing window for improved imaging and a needle for ablation treatment of target tissues. In an embodiment, the target tissue is a fibroid within a female'"'"'s uterus. In an embodiment the delivery system includes a rigid shaft having a proximal end, and a distal end, and an axial passage extending through the rigid shaft. In an embodiment, the axial passage is configured for removably receiving the ultrasound imaging insert having an ultrasound array disposed on a distal portion.

Claims

1. A system for visualization and ablation of fibroid tissues within a patient'"'"'s body, comprising:

an ultrasound imaging insert having a distal end with a flat surface;

a rigid shaft having a proximal end, a distal end, a longitudinal axis, an axial passage extending through the rigid shaft and configured for removably receiving the ultrasound imaging insert therein, said passage having a flat inner surface at its distal end, said flat inner surface being asymmetrically inclined relative to the longitudinal axis for engaging the flat surface on the insert and axially and/or rotationally orienting the ultrasound insert when said insert is received within said axial passage, wherein the flat surface of the insert contacts the flat inner surface of the shaft after the insert is fully received in said axial passage; and

a needle extending adjacent to an exterior surface of the rigid shaft and having a body and a distal tip and configured to deliver radiofrequency energy to a target site within the patient'"'"'s body.

2. The system of claim 1, wherein at least a portion of the needle distal tip is an exposed conductive distal tip.

3. The system of claim 2, wherein the needle exposed conductive distal tip is distally extendable from a distal end of a retractable sheath extending on at least a portion of the exterior surface of the needle.

4. The system of claim 2, wherein at least a portion of the needle extending proximally from the exposed conductive distal end has a non-conductive coating thereon.

5. The system to claim 2, wherein the needle exposed conductive distal tip has an axial dimension ranging from 5 mm to about 3 cm.

6. The system of claim 1, wherein a retractable sheath extends on at least a portion of an exterior surface of the needle.

7. The system of claim 1, further comprising a radio frequency energy generator configured to deliver energy at a power ranging from about 1 to about 50 Watts.

8. The system of claim 7, wherein the radio frequency energy generator is configured to deliver energy at a power ranging from about 10 to about 40 Watts.

9. The system of claim 7, wherein the radio frequency energy generator is configured to deliver energy at a power ranging from about 20 to about 40 Watts.

10. The system of claim 7, wherein the radio frequency energy generator is configured to deliver energy at a power of about 30 Watts.

11. The system of claim 7, wherein the radio frequency energy generator is configured to provide a target temperature ranging from about 50 to about 110 degrees Celsius (°

C.) at the target site.

12. The system of claim 7, wherein the radio frequency energy generator is configured to provide a target temperature ranging from about 60 to about 100 °

C. at the target site.

13. The system of claim 7, wherein the radio frequency energy generator is configured to provide a target temperature of about 90°

C. at the target site.

14. The system of claim 7, wherein the radiofrequency energy generator is configured to deliver sufficient energy to ablate target tissue having an initial approximate diameter greater than about 2 centimeters (cm).

15. The system of claim 14, wherein the energy delivered to the target site is sufficient to ablate target tissue having an initial approximate diameter ranging in size from about 1 to about 6 cm.

16. The system of claim 14, wherein the energy delivered to the target site is sufficient to ablate target tissue having an initial approximate diameter of about 2 cm.

17. The system of claim 14, wherein the energy is delivered for a period of time so as to maintain a target temperature in the target site for a duration of time of about 6 minutes.

18. The system of claim 17, wherein the radiofrequency energy generator is configured to maintain a target temperature in the target site for a period of time ranging from about 1 to about 10 minutes.

19. The system of claim 18, wherein the energy is delivered for a period of time so as to maintain a target temperature in the target site for a period of time ranging from about 1 to about 8 minutes.

20. The system of claim 18, wherein the energy is delivered for a period of time so as to maintain a target temperature in the target site for a period of time ranging from about 5 to about 8 minutes.

21. The system of claim 18, wherein the energy is delivered for a period of time so as to maintain a target temperature in the target site for a period of about 6 minutes.

22. The system of claim 1, wherein the needle is disposed within a needle guide extending along an exterior of the rigid shaft.

23. The system of claim 1, wherein at least one external fluid lumen configured to deliver fluids for enhancing acoustic coupling between the ultrasound imaging insert and the target site, extends along at least a portion of the rigid shaft and terminates at an external port in fluid communication with an exterior of the system.

24. The system of claim 1, wherein at least one internal fluid lumen configured to deliver fluids for enhancing acoustic coupling between the ultrasound imaging insert and the target site, extends along at least a portion of the rigid shaft and terminates at an internal port within the axial passage.

25. The system of claim 1, wherein at least one fluid lumen extends along at least a portion of the rigid shaft and terminates at an external port at a distal portion of the needle at a shaft distal portion, the at least one lumen for delivery of contrasting dyes to target site.

26. A system for visualization and ablation of fibroid tissues within a patient'"'"'s body, comprising:

an ultrasound imaging insert having an ultrasound array with a flat surface at its distal end;

a delivery system comprising a rigid shaft having a proximal end, a distal end, a longitudinal axis, an axial passage extending through the rigid shaft and configured for removably receiving the ultrasound imaging insert, said passage having a flat surface at its distal end, said flat inner surface being asymmetrically inclined relative to the longitudinal axis for engaging the flat surface on the insert and axially and/or rotationally orienting the ultrasound insert when said insert is received within said axial passage, wherein the flat surface of the insert contacts the flat inner surface of the shaft after the insert is fully received in said axial passage; and

a needle extending adjacent an exterior surface of the rigid shaft and having a body and a distal tip;

a radio frequency energy generator attachable to the needle and configured to deliver to a target site within the patient'"'"'s body radio frequency energy;

an ultrasound system including a central processing unit connectable to the ultrasound insert.