Endoscopic ultrasound ablation needle

• US 9,144,459 B2
• Filed: 07/19/2012
• Issued: 09/29/2015
• Est. Priority Date: 07/19/2012
• Status: Active Grant

• Current Assignee: Cook Medical Incorporated (Cook Group Incorporated)
• Original Assignee: Cook Medical Incorporated (Cook Group Incorporated)
• Inventors: Surti, Vihar, Sigmon, John
• Primary Examiner(s): Layno, Carl H
• Assistant Examiner(s): GHAND, JENNIFER LEIGH-STEWAR
• Application Number:
  US13/553,158
• Publication Number:
  US 20140025054A1
• Time in Patent Office: 1,167 Days
• Field of Search: 606/16, 606/41
• US Class Current: 1/1
• 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 2018/00029 open
• CPC Class Codes: A61B 2018/0016 Energy applicators arranged in a two- or three dimensional array
• CPC Class Codes: A61B 2018/00196 reciprocating lengthwise
• CPC Class Codes: A61B 2018/00267 having a basket shaped structure
• CPC Class Codes: A61B 2018/00577 Ablation
• CPC Class Codes: A61B 2018/00994 combining two or more different kinds of non-mechanical energy or combining one or more non-mechanical energies with ultrasound
• CPC Class Codes: A61B 2018/1437 whereby the windings of the spiral touch each other such as to create a continuous surface
• CPC Class Codes: A61B 2018/1465 Deformable electrodes
• CPC Class Codes: A61B 2018/1467 using more than two electrodes on a single probe
• CPC Class Codes: A61B 2090/378 using ultrasound
• CPC Class Codes: A61B 2090/3925 ultrasonic
• CPC Class Codes: A61N 2007/0043 intra-cavitary
• CPC Class Codes: A61N 7/00 Ultrasound therapy lithotripsy A61B17/22, A61B17/225; massage using supersonic vibration A61H23/00 ; using ultrasound for introducing media into the body A61M37/0092

Abstract

A radiofrequency tissue ablation device includes an elongate outer cannula having proximal and distal ends and an intermediate length therebetween where a longitudinal region of the intermediate length is configured as an ablation electrode. A cannula lumen extends longitudinally through the cannula. A stylet extends slidably through the lumen and is secured to the cannula between the ablation electrode and the cannula distal end. The ablation electrode includes a plurality of substantially parallel helical apertures disposed around and extending through a cannula circumference. The ablation electrode is configured to be circumferentially expandable such that in a first state, it is essentially cylindrical with a substantially uniform outer diameter along substantially its entire length, and in a second state, its parallel helical apertures are expanded such that the intervening portions of the cannula form an outer diameter greater than the outer diameter of cannula portions proximal and distal of the electrode.

Claims

1. A radiofrequency tissue ablation device comprising:

an elongate outer cannula including a cannula proximal end, a cannula distal end, and a cannula intermediate length between the proximal end and distal end, where a longitudinal region of the intermediate length near the distal end is configured as an ablation electrode and including a cannula lumen extending longitudinally through the length of the cannula; and

an elongate stylet extending slidably through the cannula lumen and secured to the cannula between the ablation electrode and the cannula distal end;

where the ablation electrode includes a plurality of substantially parallel helical apertures disposed around a circumference of the outer cannula, the apertures extending through the cannula;

where the ablation electrode is circumferentially expandable such that

in a first state, when the distal cannula end is disposed at a maximum device-length distance from the proximal cannula end, the outer cannula is essentially cylindrical with a substantially uniform outer diameter along substantially its entire length; and

in a second state, when the stylet and the secured cannula distal end are less than a maximum device-length distance from the proximal cannula end, the substantially parallel helical apertures of the ablation electrode are expanded and intervening portions of the cannula form an outer diameter greater than the outer diameter of cannula portions proximal of and distal of the ablation electrode.

2. The device of claim 1, where the outer cannula includes surface structure configured to enhance its echogenicity.

3. The device of claim 1, where the outer cannula, the stylet, or a combination thereof provides a penetrating distal tip.

4. The device of claim 1, where the plurality of substantially parallel helical apertures is configured as six slits of substantially equal length, each of which extends through the cannula from the cannula'"'"'s exterior surface to the cannula lumen.

5. The device of claim 1, where the stylet is insulated relative to the outer cannula such that the radiofrequency energy transmitted through the outer cannula is not contact-communicated to the stylet.

6. The device of claim 1, where the stylet includes a stylet lumen extending through at least a portion of its length.

7. The device of claim 6, where the stylet lumen is disposed in fluid communication with at least one stylet aperture underlying the ablation electrode region and configured to communicate irrigation fluid to a region external of the stylet and adjacent to the ablation electrode.

8. The device of claim 1, where the outer cannula is configured as a helically-cut nitinol cannula.

9. The device of claim 1, where the stylet is configured as an endoscopic ultrasound needle including a penetrating distal tip and at least one echogenicity-enhancing structural feature.

10. The device of claim 1, where the outer cannula is configured as a nitinol cannula between 18-gauge and 25-gauge, and the stylet is configured as a stainless steel endoscopic ultrasound needle including one or more echogenicity-enhancing surface features.

11. The system of claim 1, further comprising a radiofrequency energy generator in electronic communication with the ablation electrode.

12. A tissue ablation device comprising:

an elongate outer cannula including a cannula proximal end, a cannula distal end, and a cannula intermediate length between the proximal end and distal end, where a longitudinal region of the intermediate length near the distal end is configured as an ablation structure and including a cannula lumen extending longitudinally through the length of the cannula; and

an elongate stylet extending slidably through the cannula lumen and secured to the cannula between the ablation structure and the cannula distal end;

where the ablation structure includes a plurality of substantially parallel helical apertures disposed around a circumference of the outer cannula, the apertures extending through the cannula;

where the ablation structure is circumferentially expandable such that

in a first state, when the distal cannula end is disposed at a maximum device-length distance from the proximal cannula end, the outer cannula is essentially cylindrical with a substantially uniform outer diameter along substantially its entire length; and

in a second state, when the stylet and the secured cannula distal end are less than a maximum device-length distance from the proximal cannula end, the substantially parallel helical apertures of the ablation electrode are expanded and intervening portions of the cannula form an outer diameter greater than the outer diameter of cannula portions proximal of and distal of the ablation structure.

13. The device of claim 12, where the ablation device comprises an ablation structure selected from a microwave antenna;

a radiofrequency electrode;

an optical fiber;

a light pipe;

a tubular structure configured to allow closed or open passage therethrough of heated or cooled fluid with sufficient energy capacity to effect ablation;

alternating current conductive wire;

an ultrasound emitter; and

any combination thereof.

14. The device of claim 12, further comprising a sheath through which a proximal length of the stylet longitudinally slidably extends.

15. The device of claim 14, where a proximal portion of the cannula is affixed to the sheath such that an actuation of the device comprising a longitudinal distal movement of the sheath relative to the stylet and/or a longitudinal proximal movement of the stylet relative to the sheath will foreshorten the cannula and effect transition from the first state to the second state.

16. A method of ablating tissue in a patient, the method comprising steps of:

introducing the device of claim 15 adjacent to a target site within a patient body; and

actuating the device in a manner moving the sheath relative to the stylet and/or the stylet relative to the sheath to effect the second state.

17. The method of claim 16, wherein the step of introducing comprises directing the device through a working channel of an endoscope.

18. The method of claim 16, further comprising a step of directing energy through the cannula to ablate tissue in contact therewith.

19. The method of claim 18, where the energy is sufficient to necrotize animal tissue.