Systems and methods for treating tissue with radiofrequency energy

• US 10,363,089 B2
• Filed: 08/11/2017
• Issued: 07/30/2019
• Est. Priority Date: 09/22/2009
• Status: Active Grant

• Current Assignee: Mederi Rf, LLC
• Original Assignee: Mederi Rf, LLC
• Inventors: Shikhman, Oleg, Green, Ronald L., Radziunas, Jeffrey
• Primary Examiner(s): Peffley, Michael F
• Assistant Examiner(s): Vahdat, Khadijeh A
• Application Number:
  US15/675,584
• Publication Number:
  US 20170340382A1
• Time in Patent Office: 718 Days
• Field of Search: 606 20- 50
• 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 18/08 by means of electrically-heated probes
• CPC Class Codes: A61B 18/1206 Generators therefor
• CPC Class Codes: A61B 18/1477 Needle-like probes
• CPC Class Codes: A61B 18/1485 having a short rigid shaft for accessing the inner body through natural openings
• CPC Class Codes: A61B 18/1492 having a flexible, catheter-like structure, e.g. for heart ablation A61B18/1477 takes precedence
• CPC Class Codes: A61B 18/1815 using microwaves
• CPC Class Codes: A61B 2018/00029 open
• CPC Class Codes: A61B 2018/0022 Balloons
• CPC Class Codes: A61B 2018/00267 having a basket shaped structure
• CPC Class Codes: A61B 2018/00482 Digestive system
• CPC Class Codes: A61B 2018/00488 Esophagus
• CPC Class Codes: A61B 2018/00494 Stomach, intestines or bowel
• CPC Class Codes: A61B 2018/005 Rectum
• CPC Class Codes: A61B 2018/00553 Sphincter
• CPC Class Codes: A61B 2018/00577 Ablation
• CPC Class Codes: A61B 2018/00642 with feedback, i.e. closed loop control
• CPC Class Codes: A61B 2018/00678 upper
• CPC Class Codes: A61B 2018/00702 Power or energy
• CPC Class Codes: A61B 2018/00708 switching the power on or off
• CPC Class Codes: A61B 2018/00761 : Duration
• CPC Class Codes: A61B 2018/00791 : Temperature
• CPC Class Codes: A61B 2018/00815 : measured by a thermistor
• CPC Class Codes: A61B 2018/00916 : with means for switching or controlling the main function of the instrument or device
• CPC Class Codes: A61B 2018/0212 : using an instrument inserted into a body lumen, e.g. catheter
• CPC Class Codes: A61B 2018/044 : the surgical action being effected by a circulating hot fluid
• CPC Class Codes: A61B 2018/1425 : Needle
• CPC Class Codes: A61B 2018/143 : multiple needles
• CPC Class Codes: A61B 2018/1467 : using more than two electrodes on a single probe
• CPC Class Codes: A61B 2018/1475 : Electrodes retractable in or deployable from a housing
• CPC Class Codes: A61B 2018/1861 : with an instrument inserted into a body lumen or cavity, e.g. a catheter
• CPC Class Codes: A61B 2034/252 : indicating steps of a surgical procedure
• CPC Class Codes: A61B 2034/254 : being adapted depending on the stage of the surgical procedure
• CPC Class Codes: A61B 2218/002 : Irrigation
• CPC Class Codes: A61B 2218/007 : Aspiration
• CPC Class Codes: A61B 34/25 : User interfaces for surgical systems
• CPC Class Codes: A61B 90/04 : Protection of tissue around surgical sites against effects of non-mechanical surgery, e.g. laser surgery protection of eyes against laser radiation A61F9/022
• CPC Class Codes: A61N 7/022 : intracavitary
• CPC Class Codes: G06F 3/0481 : based on specific properties of the displayed interaction object or a metaphor-based environment, e.g. interaction with desktop elements like windows or icons, or assisted by a cursor's changing behaviour or appearance

Abstract

A system for controlling operation of a radiofrequency treatment device to apply radiofrequency energy to tissue to treat tissue to create lesions without ablating the tissue. The system includes a first treatment device having a plurality of electrodes. The electrodes are maintained in axial alignment and fixed radial spacing in retracted and extended positions. The device includes a basket having a plurality of arms. The arms are maintained in a fixed radial spacing in the collapsed position of the basket.

Claims

1. A method of treating tissue by applying non-ablative radiofrequency energy comprising the steps of:

a. providing a device having a plurality of electrodes each having a penetrating tip, the plurality of electrodes movable between a retracted position and an advanced position, the plurality of electrodes having a structure to maintain an equidistant radial spacing and to maintain longitudinal alignment of each of the penetrating tips of the plurality of electrodes in the retracted position;

b. inserting the device into a sphincter of a patient;

c. advancing the plurality of electrodes such that each penetrating tip of the plurality of electrodes penetrates sphincter tissue at a first location, the plurality of electrodes are configured to be longitudinally aligned in the advanced position and further being equidistantly radially spaced in the advanced position to prevent overheating or underheating of tissue;

d. applying non-ablative radio frequency energy to the plurality of electrodes to apply the non-ablative radiofrequency energy to sphincter tissue in a first area of the penetrating tips of the plurality of electrodes without causing tissue necrosis or tissue ablation, the non-ablative radiofrequency energy applied so a minimum distance is maintained between regions of sphincter tissue treated by the plurality of electrodes, the minimum distance preventing overheating of tissue which can cause tissue necrosis;

e. retracting the plurality of electrodes within the device;

f. rotating the device to a second position;

g. advancing the plurality of electrodes from the device so that the penetrating tips penetrate sphincter tissue at a second location, the penetrating tips of the plurality of electrodes being longitudinally aligned and maintained in an equidistant radial spacing; and

h. applying non-ablative radiofrequency energy to the plurality of electrodes to apply the non-ablative radiofrequency energy to sphincter tissue in a second area of the penetrating tips of the plurality of electrodes at the second location without causing tissue necrosis or tissue ablation, such fixed radial spacing and longitudinal alignment maintain the minimum distance between regions of tissue treated to avoid overlapping of tissue treatment area which could cause ablation of tissue and tissue necrosis.

2. The method of claim 1, wherein the device includes an expandable basket having a plurality of arms, and further comprising a step of expanding the expandable basket to dilate the sphincter, the plurality of arms having a second structure to maintain a desired radial spacing of the plurality of arms in a non-expanded position and in an expanded position of the expandable basket, the plurality electrodes movable within the plurality of arms.

3. The method of claim 2, wherein the arms are equidistantly spaced such that when the plurality of electrodes are advanced through the plurality of arms in step (g), the penetrating tips of the plurality of electrodes are not skewed by the plurality of arms.

4. The method of claim 1, wherein each penetrating tip of the plurality of electrodes has a defined treatment area and the structure for maintaining the radial spacing avoids undertreatment of tissue which could otherwise occur if each penetrating tip of the plurality of electrodes were not equidistantly radially spaced and the electrodes applied the non-ablative radiofrequency energy after rotation of the device to the second position.

5. The method of claim 1, further comprising an advancer slidably disposed within an outer tube of the device, the plurality of electrodes operably coupled to the advancer such that movement of the advancer advances the plurality of electrodes to the advanced position.

6. The method of claim 5, wherein the device includes a spacer and the advancer is slidable within the spacer.

7. The method of claim 1, wherein the device includes an aspiration port to enable aspiration through the device.

8. The method of claim 1, further comprising a step of injecting fluid through the device.

9. The method of claim 1, wherein the step of advancing the plurality of electrodes includes the step of sliding a slider on a handle of the device in a distal direction.

10. The method of claim 1, wherein the plurality of electrodes comprises four electrodes equidistantly spaced.

11. The method of claim 1, wherein the step of advancing the plurality of electrodes advances the plurality of electrodes to a depth ranging from about 5 mm to about 8 mm.

12. The method of claim 11, further comprising the step of cooling the mucosal surface during application of the non-ablative radiofrequency energy.

13. The method of claim 1, wherein the maintaining equidistant radial spacing and longitudinal alignment avoid undertreatment of tissue as the device is rotated and the non-ablative radiofrequency is applied to the second area.

14. The method of claim 13, wherein the fixed radial spacing and longitudinal alignment ensures the second area after device rotation does not exceed a maximum distance from the first area of step (d) prior to device rotation.

15. The method of claim 13, wherein the longitudinal alignment prevents application of the non-ablative radiofrequency energy to the mucosal layer.

16. The method of claim 1, wherein the second area includes spaced areas corresponding to the number of electrodes of the plurality of electrodes and are equidistantly spaced.

17. The method of claim 16, further comprising after step (h) a step of rotating the device and applying non-ablative radiofrequency energy to a third area, the third area including spaced areas corresponding to the number of electrodes of the plurality of electrodes and being equidistantly spaced.