Methods of treating nerves within bone using fluid

• US 9,259,241 B2
• Filed: 04/12/2013
• Issued: 02/16/2016
• Est. Priority Date: 09/26/2008
• Status: Active Grant

• Current Assignee: Relievant Medsystems, Incorporated (Boston Scientific Corporation)
• Original Assignee: Relievant Medsystems, Incorporated (Boston Scientific Corporation)
• Inventors: Pellegrino, Richard, Patel, Samit, Carrison, Harold
• Primary Examiner(s): DELLA, JAYMI E
• Application Number:
  US13/862,242
• Publication Number:
  US 20140039500A1
• Time in Patent Office: 1,040 Days
• Field of Search: 606/12, 606 44- 46, 606/92, 606/297, 606/185
• US Class Current: 1/1
• CPC Class Codes: A61B 17/16 Bone cutting, breaking or removal means other than saws, e.g. Osteoclasts; Drills or chisels for bones; Trepans arthroscopic bone cutters A61B17/320016; dental implant drills potentially for other surgical use A61C8/0089; bone grinders A61F2/4644, A22C17/06; A61B17/1662 takes precedence over all other subgroups except A61B17/17
• CPC Class Codes: A61B 17/1642 for producing a curved bore
• CPC Class Codes: A61B 17/1671 for the spine
• CPC Class Codes: A61B 17/34 Trocars; Puncturing needles pointed biopsy instruments A61B10/0233; devices for piercing the ear-lobes A44C7/001; seals or hemostasis valves A61M39/06
• CPC Class Codes: A61B 17/3403 Needle locating or guiding means guides for suture needles A61B17/0482; guiding or tracking by nuclear magnetic resonance G01R33/285
• CPC Class Codes: A61B 17/3421 Cannulas
• CPC Class Codes: A61B 17/3472 for bones, e.g. intraosseus injections
• CPC Class Codes: A61B 17/8819 characterised by the introducer proximal part, e.g. cannula handle, or by parts which are inserted inside each other, e.g. stylet and cannula A61B17/8825 takes precedence
• CPC Class Codes: A61B 18/0206 ultrasonic, e.g. for destroying tissue or enhancing freezing
• CPC Class Codes: A61B 18/14 Probes or electrodes therefor
• CPC Class Codes: A61B 18/148 having a short, rigid shaft for accessing the inner body transcutaneously, e.g. for neurosurgery or arthroscopy
• CPC Class Codes: A61B 18/1487 Trocar-like, i.e. devices producing an enlarged transcutaneous opening
• CPC Class Codes: A61B 18/149 bow shaped or with rotatable body at cantilever end, e.g. for resectoscopes, or coagulating rollers
• 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 18/20 using laser
• CPC Class Codes: A61B 2018/00011 with fluids
• CPC Class Codes: A61B 2018/00017 with gas
• CPC Class Codes: A61B 2018/00339 Spine, e.g. intervertebral disc
• CPC Class Codes: A61B 2018/00434 : Neural system
• CPC Class Codes: A61B 2018/00577 : Ablation
• CPC Class Codes: A61N 2007/0026 : Stimulation of nerve tissue
• CPC Class Codes: A61N 2007/025 : interstitial
• 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

System and methods are shown having a tube-within-tube assembly with a deployable curved deflectable tube or cannula that deploys from a straight cannula or trocar. The curved cannula has pre-curved distal end to create an angular range of 0° to 180° when fully deployed from the straight trocar. The curve is configured such that the flexible element carrying a treatment device can navigate through the angular range of deployment of the curved cannula. The curved cannula allows the flexible element to navigate through a curve within bone without veering off towards an unintended direction.

Claims

1. A method of treating a nerve within bone, comprising:

inserting an introducer into a region of the bone near a treatment location, the introducer having a central channel and an opening at a distal tip of the introducer;

delivering a curved cannula through said central channel of said introducer to said opening,

wherein the curved cannula comprises a deflectable distal tip having a preformed curve such that the deflectable distal tip straightens while being delivered through the introducer and transitions to a curved configuration upon exiting the introducer,

wherein the deflectable distal tip of the curved cannula is configured to arc to an angle between 5 degrees and 110 degrees within the region of the bone,

wherein a proximal portion of the curved cannula comprises a locking nut to control advancement of the curved cannula with respect to the introducer;

extending the curved cannula past the opening at the distal tip of the introducer to generate a curved path in the bone corresponding to the preformed curve of the deflectable distal tip;

advancing a fluid delivery catheter through said curved cannula to the treatment location;

advancing a straight flexible channeling stylet through the curved cannula to form a linear path beyond the curved path in the bone and removing the straight, flexible channeling stylet prior to advancing the fluid delivery catheter through the curved cannula,

wherein said advancing the fluid delivery catheter through said curved cannula to the treatment location comprises advancing a distal tip of the fluid delivery catheter along the linear path; and

ablating the nerve at the treatment location by delivering fluid to the treatment location using the fluid delivery catheter.

2. The method of claim 1, wherein inserting the introducer into the region of bone comprises:

inserting a sharpened stylet into the introducer such that the sharpened stylet extends beyond the opening at the distal tip of the introducer; and

inserting the sharpened stylet and the introducer simultaneously into the region of bone such that the sharpened stylet pierces the bone as the introducer is being delivered to the treatment location.

3. The method of claim 1, wherein extending the curved cannula past the opening at the distal tip of the introducer comprises:

inserting a curved stylet into a central passageway of the curved cannula such that a distal tip of the curved stylet extends to at least a distal opening of the curved cannula; and

simultaneously extending the curved cannula and the curved stylet from the distal tip of the introducer such that the curved stylet blocks the distal opening of the curved cannula while being delivered into the bone.

4. The method of claim 1, wherein the treatment location is within a vertebral body and wherein the nerve comprises a portion of a basivertebral nerve.

5. The method of claim 1, wherein the fluid comprises steam.

6. The method of claim 1, wherein the fluid comprises a therapeutic agent.

7. The method of claim 1, wherein the fluid comprises cryogenic cooling fluid.

8. The method of claim 3, further comprising removing the curved stylet from the curved cannula prior to advancing the straight flexible channeling stylet through the curved cannula.

9. The method of claim 1, wherein the region of bone comprises a cancellous portion of a bone interior of an outer cortical bone region.

10. A method of treating a nerve within bone, comprising:

inserting an introducer into a cancellous region of the bone, the introducer having a central channel and an opening at a distal tip of the introducer;

delivering a curved cannula through said central channel of said introducer to said opening,

wherein the curved cannula comprises a deflectable distal tip having a preformed curve such that the deflectable distal tip straightens while being delivered through the introducer and transitions to a curved configuration upon exiting the introducer,

wherein the deflectable distal tip of the curved cannula is configured to arc to an angle between 5 degrees and 110 degrees within the cancellous region of the bone,

wherein a proximal portion of the curved cannula comprises a locking nut to control advancement of the curved cannula with respect to the introducer;

extending the curved cannula past the opening at the distal tip of the introducer to generate a curved path in the bone corresponding to the preformed curve of the deflectable distal tip;

advancing a fluid delivery treatment device through said curved cannula to a treatment location;

advancing a straight, flexible channeling stylet through the curved cannula to form a linear path beyond the curved path in the bone and removing the straight, flexible channeling stylet prior to advancing the fluid delivery treatment device through the curved cannula,

wherein said advancing the fluid delivery treatment device through said curved cannula to the treatment location comprises advancing a distal tip of the fluid delivery treatment device along the linear path; and

treating the nerve at the treatment location within the cancellous region of bone by delivering fluid to the treatment location using the fluid delivery treatment device.

11. The method of claim 10, wherein treating the nerve comprises denervating the nerve.

12. The method of claim 10, wherein treating the nerve comprises heating the nerve by fluidic heating.

13. The method of claim 10, wherein treating the nerve comprises stimulating the nerve.

14. The method of claim 11, wherein the bone comprises a vertebral body, and wherein the nerve comprises a basivertebral nerve of the vertebral body.

15. The method of claim 10, wherein the fluid comprises steam.

16. The method of claim 10, wherein the fluid comprises a therapeutic agent.

17. The method of claim 10, wherein the fluid comprises cryogenic cooling fluid.

18. A method of treating a nerve within bone, comprising:

inserting a first stylet through a central channel of a cannula and advancing the first stylet to a position in which a distal tip of the first stylet extends to or beyond an open distal tip of the cannula,

wherein the cannula comprises a deflectable distal tip having a preformed curve,

wherein the first stylet has a preformed curve corresponding to the preformed curve of the cannula;

inserting the cannula and the first stylet together into a cancellous region of a vertebral body to form a curved path within the cancellous region toward a treatment location,

wherein a proximal portion of the cannula comprises a locking nut to control advancement of the cannula,

wherein the deflectable distal tip of the cannula and the distal tip of the first stylet are configured to arc to an angle between 5 degrees and 110 degrees within the cancellous region;

removing said first stylet from the cannula;

advancing a fluid delivery device through the central channel of the cannula to the treatment location;

advancing a straight, flexible channeling stylet through the cannula to form a linear path beyond the curved path within the cancellous region and removing the straight, flexible channeling stylet prior to advancing the fluid delivery device through the cannula,

wherein said advancing the fluid delivery device through the cannula to the treatment location comprises advancing a distal tip of the fluid delivery device along the linear path; and

treating the nerve at the treatment location within the cancellous region of the vertebral body by delivering fluid to the treatment location using the fluid delivery device.

19. The method of claim 18, wherein the fluid comprises a heating fluid and wherein said treating the nerve comprises ablating the nerve using the heating fluid.

20. The method of claim 18, wherein said treating the nerve comprises cryogenically cooling the nerve.