Systems and methods for treating tissue with radiofrequency energy

• US 9,750,563 B2
• Filed: 05/09/2015
• Issued: 09/05/2017
• Est. Priority Date: 09/22/2009
• Status: Active Grant

• Current Assignee: Mederi Rf, LLC
• Original Assignee: Mederi Therapeutics, Inc. (Respiratory Technology Corp.)
• Inventors: Shikhman, Oleg, Green, Ronald L., Radziunas, Jeffrey
• Primary Examiner(s): Peffley, Michael
• Assistant Examiner(s): VAHDAT, KHADIJEH A
• Application Number:
  US14/708,210
• Publication Number:
  US 20150238251A1
• Time in Patent Office: 850 Days
• Field of Search: 606 41- 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 device for applying radiofrequency energy for sphincter treatment comprising:

a flexible outer tube;

an expandable basket having at least a first arm and a second arm, the first and second arms movable from a collapsed position to an expanded position, the first arm having a first opening and the second arm having a second opening;

first and second electrodes, the first electrode movable with respect to the first arm and the second electrode movable with respect to the second arm, the first and second electrodes movable from a retracted position to an extended position such that the first electrode is extendable through a first opening in the first arm and the second electrode is extendable through a second opening in the second arm, each of the first and second electrodes having a first engagement structure;

an electrode holder having a second engagement structure to cooperate with the first engagement structure of the first and second electrodes to maintain the first and second electrodes in a desired radial spaced position; and

an elongated advancer slidably disposed in a center position within the flexible outer tube, the first and second electrodes operably coupled to the advancer such that movement of the advancer advances the first and second electrodes to the extended position; and

a spacer having a central lumen to slidably receive the advancer within the central lumen of the spacer and maintain centering of the advancer during flexing of the outer tube.

2. The device of claim 1, wherein the first and second engagement structures maintain the first and second electrodes in longitudinal alignment so that distalmost tips of the first and second electrodes terminate at a longitudinally aligned position.

3. The device of claim 1, further comprising a retaining sleeve positioned over the first and second electrodes and the electrode holder.

4. The device of claim 1, wherein the electrode holder has a plurality of elongated receiving areas, each receiving area dimensioned to receive one of the first and second electrodes.

5. The device of claim 1, wherein each of the first and second electrodes terminates in a penetrating tip, the penetrating tips of the first and second electrodes being longitudinally aligned in the retracted position of the first and second electrodes.

6. The device of claim 1, further comprising a basket holder, wherein the first and second arms have a basket holder engagement structure engageable with an arm engagement structure on the basket holder to maintain a desired radial spaced position of the first and second arms.

7. The device of claim 6, wherein the basket holder has a plurality of longitudinal grooves formed in an outer wall thereof, and the arm engagement structure includes a plurality of projections.

8. The device of claim 1, wherein one of the first or second engagement structure includes a plurality of projections and the other engagement structure includes a plurality of grooves.

9. The device of claim 1, further comprising an actuator for moving the advancer from a first position to a second position to advance the first and second electrodes.

10. The device of claim 1, wherein the first and second electrodes have penetrating tips, the first and second electrodes movable with respect to the first and second arms so the penetrating tips of the first and second electrodes extend through the respective first and second openings in the first and second arms, the first engagement structure maintaining the penetrating tips in axial alignment in the retracted position and maintaining a desired radial spacing of the first and second electrodes in the retracted position, wherein upon movement of the first and second electrodes from the retracted to the extended position causing each of the penetrating tips of the first and second electrodes to extend through the respective first and second openings in the respective first and second arms, the engagement structure maintains the radial spacing of the first and second electrodes and axial alignment of the penetrating tips of the first and second electrodes in the extended position such that application of radiofrequency energy to tissue is provided in consistent and uniform manner to prevent overheating of tissue and thereby prevent ablation of tissue.

11. The device of claim 1, wherein a basket holder maintains the first and second arms in a desired radial spacing to provide consistent spacing when the basket is moved to the expanded position to maintain the desired spacing of penetrating tips of the first and second electrodes when in the extended position, the basket holder having a first longitudinal groove formed in an outer wall thereof to receive the first arm and a second longitudinal groove formed in the outer wall to receive the second arm.

12. A device for applying radiofrequency energy for sphincter treatment comprising:

a flexible outer tube;

an expandable basket having a plurality of arms movable from a collapsed position to an expanded position, each of the arms of the plurality of arms having an opening and a location feature;

a basket holder having a plurality of arm receiving structures to receive the plurality of arms wherein engagement of the location feature of the plurality of arms and the arm receiving structures of the basket holder maintains a desired radial spacing of the plurality of arms in the collapsed position and in the expanded position, the basket holder positioned proximal of an expandable portion of the expandable basket, the basket holder including a plurality of longitudinal grooves formed in and along an outer side wall of the basket holder creating a reduced transverse dimension of the basket holder, and each arm receiving structure is positioned within one of the plurality of longitudinal grooves and extends along a longitudinal length of the respective longitudinal groove;

a plurality of electrodes movable with respect to the arms, the plurality of electrodes movable from a retracted position to an extended position so that each electrode of the plurality of electrodes extends through one of the openings in the arms of the plurality of arms, the electrodes positioned external of the outer side wall of the basket holder; and

an advancer slidably disposed within the outer tube, the plurality of electrodes operably coupled to the advancer such that movement of the advancer advances the plurality of electrodes to the extended position.

13. The device of claim 12, wherein the arm receiving structures each include one of a plurality of projections or a plurality of grooves and the location feature on the plurality of arms includes one of a plurality of projections or plurality of grooves.

14. The device of claim 12, wherein the basket holder has a lumen to receive an aspiration tube and a balloon inflation tube.

15. The device of claim 12, wherein the basket holder has a first lumen to receive an aspiration tube and a second lumen to receive a balloon inflation tube.

16. The device of claim 12, wherein each of the plurality of arms comprises a first tube, a second tube and a third tube, the first tube receiving one of the electrodes of the plurality of electrodes, the second tube receiving a wire and the third tube receiving irrigation fluid, a proximal end of the first, second and third tubes axially spaced from each other.

17. The device of claim 16, wherein the first tube is positioned between the second and third tubes.

18. The device of claim 12, further comprising an actuator for moving the advancer from a first position to a second position to advance the plurality of electrodes and a spacer having a central lumen to receive the advancer.

19. The device of claim 18, further comprising an electrode holder to retain the plurality of electrodes.

20. The device of claim 12, further comprising a retaining sleeve positioned over the plurality of electrodes.