Systems and methods for navigating an instrument through bone

• US 8,419,730 B2
• Filed: 09/25/2009
• Issued: 04/16/2013
• 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): Dvorak, Linda
• Assistant Examiner(s): DELLA, JAYMI E
• Application Number:
  US12/566,895
• Publication Number:
  US 20100094269A1
• Time in Patent Office: 1,299 Days
• Field of Search: 606/12, 606 44- 46, 606/86.A, 606 92- 94, 606104-105, 606/270, 606/914
• US Class Current: 606/41
• 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:

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

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

wherein the curved cannula comprises a deflectable distal tip with a preformed curve such that the deflectable distal tip straightens while being delivered through the trocar and regains its preformed curve upon exiting the trocar;

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

inserting a channeling stylet into the curved cannula,

wherein the channeling stylet is flexibly deformable to navigate the curved cannula yet rigid enough to retain a straight form upon exiting the deflectable distal tip of the curved cannula and wherein the channeling stylet is longer than the curved cannula;

creating a linear working channel starting at a distal end of the curved path formed by the curved cannula by extending the channeling stylet past the deflectable distal tip of the curved cannula;

removing the channeling stylet from the curved cannula; and

delivering a treatment device through a central passageway in said curved cannula to the treatment location within the linear working channel beyond the curved path.

2. A method as recited in claim 1, wherein inserting the trocar into the region of bone comprises:

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

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

3. A method as recited in claim 1, wherein delivering the curved cannula through the central channel comprises:

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

the straightening stylet comprising a rigid construction configured to straighten the deflectable distal tip of the curved cannula;

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

removing the straightening stylet from the curved cannula.

4. A method as recited in claim 3:

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

wherein the sharp distal end extends beyond a distal opening of the curved cannula;

wherein the straightening stylet and curved cannula are installed simultaneously along with the trocar as the trocar is delivered into the bone.

5. A method as recited in claim 1, wherein extending the curved cannula past the opening at the distal tip of the trocar 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 a distal opening of the curved cannula; and

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

6. A method as recited in claim 5:

wherein the curved stylet has a curved distal end corresponding to the preformed curve of the curved cannula; and

wherein the curved stylet reinforces a curved shape of the curved cannula as the curved cannula is extended past the opening at the distal tip of the trocar.

7. A method as recited in claim 6, wherein an angle on the inside of the curved distal end of the curved stylet is less than an angle on the outside of the curved distal end of the curved stylet.

8. A method as recited in claim 6, wherein the curved stylet comprises an alignment pin that is configured to engage with a notch of the curved cannula to facilitate alignment.

9. A method as recited in claim 5:

wherein the curved stylet has a sharp distal tip; and

wherein the curved stylet is advanced within the central passageway so that the curved stylet extends past the distal opening of the curved cannula such that the curved stylet pierces the bone as the curved cannula is delivered past the opening at the distal tip of the trocar.

10. A method as recited in claim 5, further comprising removing the curved stylet from the curved cannula.

11. A method as recited in claim 1:

wherein the trocar is inserted through a cortical bone region and into a cancellous bone region of a vertebrae; and

wherein the curved cannula is extended though at least a portion of the cancellous bone region to a location at or near the treatment location.

12. A method as recited in claim 1, wherein the treatment location comprises a basivertebral nerve (“

BVN”

) of the vertebrae, the method further comprising;

delivering treatment to the treatment location to denervate at least a portion of the BVN.

13. A method as recited in claim 12, wherein denervating a portion of the BVN comprises delivering focused, therapeutic heating to region of the BVN.

14. A method as recited in claim 12, wherein denervating a portion of the BVN comprises delivering an agent to the treatment region.

15. A method as recited in claim 12, wherein the treatment is focused on a location of the BVN that is downstream of one or more branches of the BVN.

16. A method as recited in claim 12, wherein delivering treatment to the treatment location to denervate at least the portion of the BVN comprises delivering radiofrequency energy to the treatment location to denervate at least the portion of the BVN.

17. A method as recited in claim 12, wherein delivering treatment to the treatment location to denervate at least the portion of the BVN comprises delivering ultrasonic energy to the treatment location to denervate at least the portion of the BVN.

18. A method as recited in claim 1, wherein the trocar comprises an elongate shaft having a handle at a proximal end of the elongate shaft.

19. A method as recited in claim 1, wherein the treatment device comprises a bipolar radiofrequency energy delivery device.

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

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

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

delivering a curved cannula through said central channel of said trocar to said axial opening at the distal tip of the trocar,

wherein the curved cannula comprises a deflectable distal tip with a preformed curve such that the deflectable distal tip straightens while being delivered through the central channel of the trocar and regains its preformed curve upon exiting the axial opening of the trocar;

extending the curved cannula past the axial opening at the distal tip of the trocar to generate a curved path toward the treatment location corresponding to the preformed curve of the deflectable distal tip of the curved cannula,

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 working channel starting at a distal end of the curved path formed by the curved cannula by inserting a channeling stylet within the curved cannula and extending the channeling stylet past the deflectable distal tip of the curved cannula,

wherein the channeling stylet is flexibly deformable to navigate the curved cannula yet rigid enough to retain a straight form upon exiting the deflectable distal tip of the curved cannula and wherein the channeling stylet is longer than the curved cannula;

removing the channeling stylet from the curved cannula;

delivering an energy delivery probe through a central passageway in said curved cannula and within the linear working channel beyond the curved path to the treatment location; and

activating the energy delivery probe at the treatment location to deliver energy to the treatment location.

21. A method as recited in claim 20, wherein the treatment location comprises an intraosseous nerve of the vertebral bone.

22. A method as recited in claim 20, wherein the treatment location comprises a basivertebral nerve of the vertebral bone.

23. A method as recited in claim 22, wherein the energy delivery probe comprises a radiofrequency ablation probe and wherein the step of activating the energy delivery probe at the treatment location to deliver energy to the treatment location comprises applying radiofrequency energy sufficient to denervate at least a portion of the basivertebral nerve at the treatment location.

24. A method as recited in claim 22, wherein the energy delivery probe comprises an ultrasonic ablation probe and wherein the step of activating the energy delivery probe at the treatment location to deliver energy to the treatment location comprises applying ultrasonic energy sufficient to denervate at least a portion of the basivertebral nerve at the treatment location.

25. A method as recited in claim 22, wherein the treatment location is posterior to a basivertebral nerve junction.

26. A method as recited in claim 20, wherein the step of inserting the trocar through the cortical bone region and into the cancellous bone region of the vertebral bone near a treatment location comprises:

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

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

27. A method as recited in claim 20, wherein the step of extending the curved cannula past the axial opening at the distal tip of the trocar 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 distal opening of the curved cannula; and

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

28. A method as recited in claim 27:

wherein the curved stylet has a curved distal end corresponding to the preformed curve of the curved cannula; and

wherein the curved stylet reinforces the curved shape of the curved cannula as the curved cannula is extended past the axial opening of the trocar.

29. A method as recited in claim 27:

wherein the curved stylet has a sharp distal tip; and

wherein the curved stylet is advanced within the central passageway so that the curved stylet extends past the distal opening of the curved cannula such that the curved stylet pierces the cancellous bone tissue as the curved cannula is delivered past the axial opening of the trocar.

30. A method as recited in claim 20, wherein the trocar comprises an elongate shaft having a handle at a proximal end of the elongate shaft.

31. A method as recited in claim 20, wherein the energy delivery probe comprises a bipolar radiofrequency energy delivery device.