Systems and methods for reducing post-surgical complications

• US 6,645,198 B1
• Filed: 09/20/2000
• Issued: 11/11/2003
• Est. Priority Date: 03/17/1999
• Status: Expired due to Fees

• Current Assignee: Ntero Surgical Incorporated
• Original Assignee: Ntero Surgical Incorporated
• Inventors: Laufer, Michael D., Bommannan, D. Bommi
• Primary Examiner(s): LEE, KEVIN L
• Application Number:
  US09/665,730
• Time in Patent Office: 1,147 Days
• Field of Search: 606/34, 606/41, 606/42, 606/45, 606/46, 606/47, 606/48, 606/49, 606/50, 607/101, 607/102
• US Class Current: 606/34
• CPC Class Codes: A61B 18/1487 Trocar-like, i.e. devices producing an enlarged transcutaneous opening
• CPC Class Codes: A61B 2017/00734 battery operated
• CPC Class Codes: A61B 2018/00648 using more than one sensed parameter
• CPC Class Codes: A61B 2018/00702 Power or energy
• CPC Class Codes: A61B 2018/00779 Power or energy
• CPC Class Codes: A61B 2018/00791 Temperature
• CPC Class Codes: A61B 2018/00875 Resistance or impedance

Abstract

The present invention provides systems and methods for applying RF energy to injured tissue, particularly the peritoneum, in order to prevent harmful post-surgical adhesions. One aspect of the invention is RF energy delivery systems employing trocars, which are designed for use in laparotomies and laparoscopies. Another aspect of the invention is an RF delivery system comprising a surgical sheet with one or more electrodes for delivering the RF energy to the injured tissue resulting from conventional surgical incisions into the abdominal wall. Additionally, another aspect of the invention provides methods for controlling the treatment dosage of RF heat to the injured tissue using parameters such as treatment time, change in tissue temperature, and change in tissue impedance.

Claims

1. A system for treating cut edges of tissue in surgical perforations comprising:

at least one member configured and dimensioned to have a surface, which surface may be placed on the cut edge of the tissue;

at least a first energy delivery element disposed on said member surface, positioned to be in contact with the cut edge when said member is positioned adjacent to the cut edge of tissue; and

an RF energy source communicating with the energy delivery element which applies energy to the cut edge in a controlled manner to reduce post-surgical complications,

wherein the member is either a trocar having a hollow channel further comprising a detachable unit, which mounts on a proximal end of said member and produces the controlled RF energy and wherein the energy delivery element is at least one electrode,

wherein the detachable unit has an electrical contact and the trocar has an electrical contact,

whereby the controlled RF energy is transmitted from the detachable unit to the delivery electrode located when the two electrical contacts are in electrical communication,

wherein the detachable unit further comprises an attachment means used to lock and unlock the detachable unit to said trocar,

wherein said attachment means are protruding latches that lock and unlock the detachable unit to the sleeve by twisting the detachable unit, relative to the position of the trocar, in one direction and in the opposite direction, respectively, or

the member is a non-conductive sheet.

2. A system according to claim 1, wherein the trocar has a second electrode providing a bipolar electrode configuration, wherein the second electrode is a ring electrode and the first electrode is a ring electrode.

3. The system according to claim 2 wherein the spacing between the two ring electrodes is between 0.5 and 3.0 millimeters.

4. The system according to claim 3 wherein the first ring electrode has a width between about 0.5 and 3.0 millimeters;

the second ring electrode has a width of between about 0.5 and 3.0 millimeters; and

the width of the first electrode is substantially smaller than the width of the second electrode.

5. The system according to claim 1 wherein the trocar sleeve comprises:

a hollow conical section on the distal end of the trocar sleeve, the conical section having one end that has a larger diameter portion and a distal end having a smaller diameter portion;

a hollow, rod-like sleeve portion;

a hollow cylindrical portion having a substantially larger diameter than the rod-like sleeve portion;

wherein the conical section connecting its larger diameter portion to one end of the rod-like portion;

the cylindrical portion connects to the other end of the rod-like portion such that a channel is created through the entire length of trocar;

a protruding lip formed between the rod-like portion and the conical portion; and

wherein the first electrode is positioned close to the lip.

6. The system according to claim 5 further comprising:

a return electrode that is not attached to the trocar.

7. The system according to claim 5 wherein the trocar sleeve does not have any return electrodes.

8. The system according to claim 1 wherein the sheet has multiple electrodes positioned on the sheet such that when the sheet is cut, the electrodes are in close proximity to the tissue incision.

9. The system according to claim 1 wherein the sheet is an insulating material having one side weakly adhesive to tissue or skin.

10. The system according to claim 1 wherein the detachable unit comprises:

means for starting RF treatment;

means for indicating sufficient electrode contact with tissue;

means for indicating that RF treatment is ongoing; and

means for indicating that RF treatment has been completed.

11. The system according to claim 10 wherein the means for starting RF treatment is a push button, and the means for indicating sufficient electrode contact with tissue, the means for indicating that RF treatment is ongoing, and the means for indicating that RF treatment has been completed are each an indicator light.

12. The system according to claim 10 wherein the means for starting RF treatment is a push button, and the means for indicating sufficient electrode contact with tissue, the means for indicating that RF treatment is ongoing, and the means for indicating that RF treatment has been completed are each an indicator audio signal.

13. The system according to claim 1, wherein said at least one member comprises a sleeve having distal and proximal ends, wherein said electrode is positioned on said sleeve adjacent the distal end and wherein the sleeve is configured and dimensioned to have an internal diameter and length to be received over a cannula of a trocar and place said electrode adjacent the cannula distal end.

14. The system according to claim 1, wherein said at least one member comprises an elongate wand-like member having distal and proximal ends, with a handle portion configured and dimensioned for gripping by hand;

and said energy delivery element is disposed at the distal end wherein said distal end includes a distal tip shaped to guide the tissue edge along said energy delivery element and wherein a thermosensor and a fluid delivery port are disposed on said tip.

15. The system according to claim 14, wherein said energy delivery element comprises at least one RF energy delivery electrode.

16. A method for treating injured tissue in conjunction with use of a trocar comprising:

placing an obturator within the trocar sleeve to form an assembly;

using the assembly to puncture the abdominal wall;

withdrawing the obturator from the trocar sleeve;

placing a detachable unit over the exposed portion of the trocar sleeve such that there is electrical contact between the detachable unit and the sleeve;

providing controlled RF energy from the detachable unit to an electrode located on the trocar sleeve to heat the proximately located injured tissue;

detaching the detachable unit; and

performing a surgical function through the trocar sleeve.

17. A method for treating incised tissue comprising:

placing a surgical sheet over the site of incision having a plurality of electrodes embedded in the sheet, which electrodes are still electrically accessible on either side of the sheet;

cutting through the surgical sheet and underlying tissue;

folding the surgical sheet in a manner to position the plurality of electrodes close to the incision; and

applying controlled RF energy through the electrode to heat the proximately located, incised tissue.