SYSTEMS AND METHODS FOR NAVIGATING AN INSTRUMENT THROUGH BONE

• US 20100094269A1
• Filed: 09/25/2009
• Published: 04/15/2010
• 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: Patel, Samit, Pellegrino, Richard, Carrison, Harold
• Granted Patent: US 8,419,730 B2
• Time in Patent Office: Days
• US Class Current: 606/27
• 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 system for channeling a path into bone, comprising:

a trocar having a central channel and opening at its distal tip; and

a curved cannula sized to be received in said central channel and delivered to said distal opening;

the curved cannula having a deflectable tip with a preformed curve such that the tip straightens while being delivered through the trocar and regains its preformed curve upon exiting and extending past the distal opening of the trocar to generate a curved path in the bone corresponding to the preformed curve of the deflectable tip;

wherein the curved cannula comprises a central passageway having a diameter configured allow a treatment device to be delivered through the central passageway to a location beyond the curved path.

2. A system as recited in claim 1, further comprising:

a straight stylet configured to be installed in the trocar;

the straight stylet comprising a sharp distal tip that is configured to extend beyond the distal opening of the trocar to pierce the bone as the trocar is being delivered to a treatment location within the bone.

3. A system as recited in claim 2, further comprising:

a straightening stylet configured to be installed in the curved cannula;

the straightening stylet comprising a rigid construction configured to straighten the distal tip of the curved cannula when positioned in the trocar.

4. A system as recited in claim 3:

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

wherein the straightening stylet and curved cannula are configured to be installed in the trocar in place of the straight stylet as the trocar is delivered into the bone.

5. A system as recited in claim 1, further comprising:

a curved stylet having an outer radius sized to fit within the central passageway of the curved cannula;

wherein the curved stylet is configured to be installed in the curved cannula while the curved cannula is extended past the distal opening of the trocar, the curved stylet configured to block the distal opening of the curved cannula while being delivered into the bone.

6. A system as recited in claim 5, wherein the curved stylet has a curved distal end corresponding to the curve of the curved cannula.

7. A system as recited in claim 5, wherein the curved stylet has a sharp distal tip configured to extend past the curved cannula to pierce the bone as the cannula is delivered past the distal opening of the trocar.

8. A system as recited in claim 7, wherein the curved stylet and the curved cannula have mating proximal ends that align the curve of the curved stylet with the curve of the curved cannula.

9. A system as recited in claim 5, further comprising:

a straight channeling stylet configured to be installed in the cannula after removing the curved stylet;

wherein the straight channeling stylet is flexibly deformable to navigate the curved cannula yet retain a straight form upon exiting the curve cannula; and

wherein straight channeling stylet has a length longer than the curved cannula such that it creates a linear path beyond the distal end of the curved cannula when fully extended.

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

inserting a trocar into a region of bone near the treatment location;

the trocar having a central channel and opening at its distal tip; and

delivering a cannula through said central channel and to said distal opening;

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

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

delivering a treatment device through a central passageway in said cannula having to the treatment location beyond the curved path.

11. A method as recited in claim 10, wherein inserting a trocar into a region of bone comprises:

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

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 a treatment location.

12. A method as recited in claim 10, wherein delivering a cannula through the central channel comprises:

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

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

inserting the straightening stylet and straightened cannula simultaneously into the trocar.

13. A method as recited in claim 12:

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

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

14. A method as recited in claim 10, wherein extending the cannula past the distal opening 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 the distal opening of the curved cannula while being delivered into the bone.

15. A method as recited in claim 14:

wherein the curved stylet has a curved distal end corresponding to the 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 distal opening of the trocar.

16. A method as recited in claim 14:

wherein the curved stylet has a sharp distal tip; and

wherein 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 cannula is delivered past the distal opening of the trocar.

17. A method as recited in claim 14, further comprising:

removing the curved stylet from the curved cannula; and

inserting a straight channeling stylet into the curved distal end of the cannula;

wherein the straight channeling stylet is flexibly deformable to navigate the curved cannula yet retain a straight form upon exiting the curved cannula; and

wherein the straight channeling stylet is longer than the curved cannula to create a linear channel beyond the distal tip of the curved cannula.

18. A method as recited in claim 10:

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.

19. A method as recited in claim 18, wherein the treatment location comprises a BVN of the vertebrae, the method further comprising:

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

20. A method as recited in claim 19, wherein denervating a portion of the BVN comprises delivering focused, therapeutic heating to an isolated region of the BVN.

21. A method as recited in claim 19, wherein denervating a portion of the BVN comprises delivering an agent to the treatment region to isolate treatment to that region.

22. A method as recited in claim 19, wherein the treatment is focused on a location of the BVN that is downstream of one or more branches of the BVN.

23. A kit for channeling a path into bone, comprising:

a trocar having a central channel and opening at its distal tip; and

a cannula selected from a set of cannulas sized to be received in said central channel and delivered to said distal opening;

the cannula having a deflectable distal tip with a preformed curve such that the tip straightens while being delivered through the trocar and regains its preformed curve upon exiting and extending past the distal opening of the trocar to generate a curved path in the bone corresponding to the preformed curve of the deflectable tip;

wherein the cannula comprises a central passageway having a diameter configured allow a treatment device to be delivered through the central passageway to a location beyond the curved path; and

wherein the set of cannulas comprises one or more cannulas that have varying preformed curvatures at the distal tip.

24. A kit as recited in claim 23, wherein the one or more cannulas have a varying preformed radius at the distal tip.

25. A kit as recited in claim 23, wherein the one or more cannulas each have distal tips that terminate at varying angles with respect to the central channel of the trocar.

26. A kit as recited in claim 25, wherein the angle of the distal tip with respect to the central channel of the trocar varies from approximately 45°

to approximately 110°

.

27. A kit as recited in claim 23, further comprising:

a straight stylet configured to be installed in the trocar;

the straight stylet comprising a sharp distal tip that is configured to extend beyond the distal opening of the trocar to pierce the bone as the trocar is being delivered to a treatment location within the bone.

28. A kit as recited in claim 23, further comprising:

a set of curved stylets having an outer radius sized to fit within the central passageway of the curved cannula;

wherein each curved stylet is configured to be installed in the curved cannula while the curved cannula is extended past the distal opening of the trocar;

wherein the curved stylet configured to block the distal opening of the curved cannula while being delivered into the bone; and

wherein each curved stylet has a varying a curved distal end corresponding to the curve of a matching curved cannula in the set of curved cannulas.

29. A kit as recited in claim 28, wherein the curved stylet has a sharp distal tip configured to extend past the curved cannula to pierce the bone as the cannula is delivered past the distal opening of the trocar.

30. A kit as recited in claim 28, wherein the curved stylet and the curved cannula have mating proximal ends that align the curve of the curved stylet with the curve of the curved cannula.

31. A kit as recited in claim 28, further comprising:

a set of straight channeling stylets;

wherein one of the set of stylets is configured to be installed in the cannula after removing the curved stylet;

wherein the straight channeling stylet is flexibly deformable to navigate the curved cannula yet retain a straight form upon exiting the curve cannula; and

wherein each of the straight channeling stylets has a varying length longer than the curved cannula such that the straight channeling stylet creates a predetermined-length linear path beyond the distal end of the curved cannula when fully extended.