Systems and methods for treating tissue with radiofrequency energy

• US 10,292,756 B2
• Filed: 05/26/2017
• Issued: 05/21/2019
• 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:
  US15/607,301
• Publication Number:
  US 20170265928A1
• Time in Patent Office: 725 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 18/14 Probes or electrodes 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 18/18 by applying electromagnetic radiation, e.g. microwaves radiation therapy A61N5/00
• CPC Class Codes: A61B 18/1815 using microwaves
• CPC Class Codes: A61B 2018/00029 open
• 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 2018/00916 : 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: 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 device having flexible outer tube, an expandable basket having a plurality of arms movable from a collapsed position to an expanded position, a plurality of electrodes movable from a retracted position to an extended position to extend through the openings in the arms, and an advancer slidably disposed within the outer tube to move the electrodes. An elongated spacer is positioned within the outer tube, the spacer having a central lumen to receive the advancer and to maintain a central position of the advancer.

Claims

1. A method of treating gastrointestinal reflux disease comprising:

providing a treatment device having a plurality of electrodes, each of the plurality electrodes having an engagement feature to maintain distal tips of the plurality of electrodes in axial alignment when advanced from the treatment device, the treatment device further having a spacer with a central lumen to receive an electrode advancer to maintain centering of the electrode advancer within an outer tube of the treatment device during advancement;

applying non-ablative radiofrequency energy to the plurality of electrodes to thermally treat tissue below a tissue ablation threshold without causing tissue necrosis and create a plurality of tissue lesions along axially spaced tissue levels within the upper gastrointestinal tract;

monitoring tissue temperature throughout the procedure;

regulating power ensuring in response to the monitoring step that the tissue temperature does not exceed a predetermined value which would cause overheating of tissue which would cause tissue ablation and/or tissue necrosis; and

rotating the device and subsequently applying non-ablative radiofrequency energy, the plurality of electrodes remaining in axial alignment to prevent overheating of tissue which would cause tissue necrosis.

2. The method for claim 1, wherein the distal tips of the plurality of electrodes are sharp to penetrate a muscle layer in a lower esophageal sphincter of a patient.

3. The method of claim 1, wherein the distal tips of the plurality of electrodes are maintained by the engagement feature in an equidistant radially spaced relationship, the equidistant relationship preventing overheating of tissue which would cause tissue necrosis.

4. The method of claim 1, wherein the plurality of electrodes are repeatedly advanced or retracted and maintained in equidistant radial spacing and longitudinal alignment when in an advanced position to prevent overheating of tissue which would cause tissue necrosis.

5. The method of claim 1, wherein the distal tips of the plurality of electrodes are longitudinally aligned to maintain control of depth of penetration of the plurality of electrodes.

6. The method of claim 1, wherein the treatment device has an expandable member having a plurality of arms, the plurality of arms have an alignment feature engageable with an arm holder to maintain alignment of the plurality of arms and the method includes a step of expanding the expandable member.

7. The method of claim 6, wherein the engagement features of the plurality of electrodes maintain an equidistant spacing of the distal tips of the plurality of electrodes.

8. The method of claim 1, wherein the spacer includes a plurality of separable slits forming openable and closable flaps for loading at least one wire therein.

9. The method of claim 1, wherein the spacer has a plurality of ribs forming separate enclosed regions.

10. The method of claim 9, wherein one of the separate enclosed regions is configured to receive an aspiration tube.

11. The method of claim 9, wherein one of the separate enclosed regions is configured to receive an irrigation tube.

12. The method of claim 1, further comprising a step of delivering fluid through the plurality of electrodes.

13. The method of claim 1, wherein the spacer has at least one slit separable to insert an irrigation tube and aspiration tube into the spacer.

14. The method of claim 1, wherein treatment areas for the plurality of electrodes are spaced at a minimum of 5 millimeters apart.

15. The method of claim 1, further comprising a step of executing on a display screen a first graphical interface guiding use of the treatment device, the display screen prompting a user in a step-wise fashion to perform a process using the treatment device to create the plurality of tissue lesions along axially spaced tissue levels, each axially spaced tissue level including a plurality of circumferential spaced lesions.

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

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

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

c. advancing the plurality of electrodes to penetrate 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;

d. applying non-ablative radio frequency energy to the plurality of electrodes to apply the non-ablative radiofrequency energy to tissue in a first area of the penetrating tips of the plurality of electrodes without causing tissue necrosis or tissue ablation with a minimum distance maintained between regions of tissue treated by the plurality of electrodes;

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 in the advanced position; and

h. applying non-ablative radiofrequency energy to the plurality of electrodes to apply the non-ablative radiofrequency energy to tissue in a second area of the penetrating tips of the plurality of electrodes without causing tissue necrosis or tissue ablation, such equidistant 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.

17. The method of claim 16, wherein the device includes an expandable basket having a plurality of arms, and further comprising a step of expanding the basket to dilate the sphincter, each of the plurality of arms having a structure to maintain a desired radial spacing of the plurality of arms in an expanded position of the basket, and the plurality of electrodes are movable within the plurality of arms.

18. The method of claim 16, wherein each penetrating tip of each of the plurality of electrodes has a defined treatment area and the structure by maintaining the radial spacing avoids undertreatment of tissue which could otherwise occur if each of the penetrating tips of each of the plurality of electrodes were not equidistantly radially spaced and the plurality of electrodes applied energy after rotation of the device to the second position.

19. The method of claim 16, wherein treatment areas of the plurality of electrodes are spaced at a minimum of 5 millimeters apart.

20. The method of claim 16, wherein the advancer for the plurality of electrodes is maintained centered during flexing of the device.