Systems for accessing nerves within bone

• US 10,265,099 B2
• Filed: 02/10/2016
• Issued: 04/23/2019
• 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:
  US15/040,268
• Publication Number:
  US 20160324541A1
• Time in Patent Office: 1,168 Days
• 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 for channeling a path into bone to a treatment location in a body of a patient, comprising:

selecting a set of treatment instruments out of a kit based on a diagnostic evaluation of the treatment location, the set of treatment instruments comprising an introducer, a curved cannula having a curvature selected based on the diagnostic evaluation, a channeling stylet, and a treatment device;

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

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

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

inserting the channeling stylet into the curved cannula,

creating a linear channel starting at a distal end of the curved path formed by the curved cannula by extending a distal end of the channeling stylet out of an open distal tip of the curved cannula;

removing the channeling stylet from the curved cannula; and

delivering the treatment device through said curved cannula to the treatment location through the linear channel.

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

inserting a stylet into the introducer such that the stylet extends beyond the opening of the introducer;

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

3. The method of claim 1, wherein delivering the curved cannula through the central channel comprises:

inserting a straightening stylet into a central passageway of the curved cannula;

the straightening stylet comprising a rigid construction configured to straighten the curved cannula;

inserting the straightening stylet and the curved cannula simultaneously into the introducer; and

removing the straightening stylet from the curved cannula.

4. The method of claim 3:

wherein the straightening stylet further comprises a sharp distal end to pierce the bone; and

wherein the sharp distal end extends beyond the open distal tip of the curved cannula.

5. 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 the open distal tip of the curved cannula; and

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

6. The method of claim 5, further comprising removing the curved stylet from the curved cannula.

7. The method of claim 1, wherein the treatment location corresponds to a location of a portion of a basivertebral nerve of a vertebra, the method further comprising delivering treatment to the treatment location sufficient to denervate at least the portion of the basivertebral nerve.

8. The method of claim 7, wherein denervating the portion of the basivertebral nerve comprises delivering focused, therapeutic heating to the treatment location.

9. The method of claim 7, wherein denervating the portion of the basivertebral nerve comprises delivering an agent to the treatment location.

10. The method of claim 1, wherein the kit comprises a set of cannulas comprising one or more cannulas with distal tips having varying preformed curvatures.

11. The method of claim 7, wherein delivering treatment to the treatment location to denervate at least the portion of the basivertebral nerve comprises delivering radiofrequency energy to the treatment location sufficient to denervate at least the portion of the basivertebral nerve.

12. The method of claim 7, wherein delivering treatment to the treatment location to denervate at least the portion of the basivertebral nerve comprises delivering ultrasonic energy to the treatment location sufficient to denervate at least the portion of the basivertebral nerve.

13. A method for channeling a path into vertebral bone to a treatment location in a body of a patient, comprising:

selecting a set of treatment instruments out of a kit based on a particular spine segment within which the vertebral bone is located, the set of treatment instruments comprising an introducer, a curved cannula having a curvature selected based on the particular spine segment, a channeling stylet, and a treatment device;

inserting the introducer through a cortical bone region and into a cancellous bone region of the vertebral bone near the treatment location,

wherein the introducer has a central channel along its longitudinal axis and an axial opening at a distal tip of the introducer;

delivering the curved cannula through said central channel of the introducer to the axial opening at the distal tip of the introducer;

extending the curved cannula past the axial opening at the distal tip of the introducer to generate a curved path toward the treatment location,

wherein the curved cannula is extended through at least a portion of the cancellous bone region to a location near the treatment location;

creating a linear channel starting at a distal end of the curved path formed by the curved cannula by inserting the channeling stylet within the curved cannula and extending a distal end of the channeling stylet out of an open distal tip of the curved cannula;

removing the channeling stylet from the curved cannula;

delivering a treatment probe through a central passageway in the curved cannula to the treatment location through the linear channel.

14. The method of claim 13, wherein the kit comprises a set of cannulas comprising one or more cannulas with distal tips having varying preformed curvatures.

15. The method of claim 13, wherein the treatment location comprises a basivertebral nerve of the vertebral bone.

16. The method of claim 15, wherein the treatment probe comprises a radiofrequency energy delivery probe.

17. The method of claim 15, wherein the treatment probe comprises an ultrasonic energy delivery probe.

18. The method of claim 15, wherein the treatment location is posterior to a basivertebral nerve junction.

19. The method of claim 13, wherein the step of inserting the introducer through the cortical bone region and into the cancellous bone region of the vertebral bone near the treatment location comprises:

inserting a stylet into the introducer such that the stylet extends beyond the axial opening of the introducer; and

inserting the stylet and introducer simultaneously into the vertebral bone such that the stylet pierces cancellous bone within the cancellous bone region as the introducer is being delivered toward the treatment location.

20. The method of claim 13, wherein the step of extending the curved cannula past the axial opening at the distal tip of the introducer comprises:

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

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