VERTEBRAL BONE NAVIGATION SYSTEMS

• US 20120330301A1
• Filed: 07/06/2012
• Published: 12/27/2012
• Est. Priority Date: 01/07/2010
• 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
• Granted Patent: US 8,414,571 B2
• Time in Patent Office: Days
• US Class Current: 606/33
• CPC Class Codes: A61B 17/1671 for the spine
• CPC Class Codes: A61B 17/32002 with continuously rotating, oscillating or reciprocating cutting instruments
• CPC Class Codes: A61B 17/3415 for introducing tubes or catheters, e.g. gastrostomy tubes, drain catheters A61B17/3417 takes precedence; body piercing catheter guide needles A61M25/06
• CPC Class Codes: A61B 17/3472 for bones, e.g. intraosseus injections
• CPC Class Codes: A61B 17/8805 for introducing fluid filler into bone or extracting it A61B17/7097, A61B17/8833 take precedence
• CPC Class Codes: A61B 17/8811 characterised by the introducer tip, i.e. the part inserted into or onto the bone
• 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 18/02 by cooling, e.g. cryogenic techniques devices for cooling specific reflex points of the body within cell-life limits A61H39/06
• 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 18/1492 having a flexible, catheter-like structure, e.g. for heart ablation A61B18/1477 takes precedence
• CPC Class Codes: A61B 18/16 Indifferent or passive electrodes for grounding
• CPC Class Codes: A61B 18/18 by applying electromagnetic radiation, e.g. microwaves radiation therapy A61N5/00
• CPC Class Codes: A61B 2017/00261 Discectomy
• CPC Class Codes: A61B 2017/00331 with preformed bends
• CPC Class Codes: A61B 2017/00867 shape memory effect
• CPC Class Codes: A61B 2018/00017 with gas
• CPC Class Codes: A61B 2018/0044 Spinal cord
• CPC Class Codes: A61B 2018/00577 Ablation
• CPC Class Codes: A61B 2018/126 bipolar
• CPC Class Codes: A61B 2018/2244 Features of optical fibre cables, e.g. claddings
• 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 for channeling a path into bone include a trocar having a proximal end, distal end and a central channel disposed along a central axis of the trocar. The trocar includes a radial opening at or near the distal end of the trocar. The system includes a curveable cannula sized to be received in the central channel, the curveable cannula comprising a curveable distal end configured to be extended laterally outward from the radial opening in a curved path extending away from the trocar. The curveable cannula has a central passageway having a diameter configured allow a probe to be delivered through the central passageway to a location beyond the curved path.

Claims

1. A system for channeling a path into bone, comprising:

a trocar having a proximal end, distal end and a central channel;

wherein the central channel is disposed along a central axis of the trocar and extends from the proximal end toward the distal end;

wherein the trocar comprises a radial opening at or near the distal end of the trocar, the radial opening being in communication with the central channel;

a curveable cannula sized to be received in said central channel and delivered from the proximal end toward said radial opening;

the curveable cannula comprising a curveable distal end configured to be extended laterally outward from the radial opening in a curved path extending away from the trocar;

wherein the curveable cannula comprises a central passageway having a diameter configured allow a probe to be delivered through the central passageway to a location beyond the curved path,

wherein the distal end of the curveable cannula is deformable so as to be delivered in a straight configuration through the trocar and deployed in a curved configuration outward from the radial opening at an angle with respect to the central axis; and

a pull cord coupled to the distal tip of the curveable cannula, the pull cord extending to the proximal end of the trocar;

wherein the pull cord is configured to apply a tensile force to the distal end of the curveable cannula to bias the curveable cannula into a curved configuration.

2. The system of claim 1, wherein the tensile force applied to the distal tip of the curveable cannula may be controlled from the proximal end of the trocar to steer the curveable cannula along a desired path.

3. The system of claim 1, wherein a distal end of the curveable cannula comprises a plurality of mating links, the links configured to articulate into a curved shape.

4. The system of claim 3, wherein a distal link of the plurality of mating links comprises a beveled leading edge.

5. The system of claim 3, wherein the pull cord runs from a proximal body of the curveable cannula to an aperture in the distal link.

6. The system of claim 1, wherein the central channel of the trocar terminates at a ramp leading to the radial opening, said ramp facilitating deployment of said curveable cannula outward from said radial opening

7. The system of claim 1, wherein the trocar further comprises a sharp distal tip configured to pierce through bone to generate a linear path through bone tissue.

8. The system of claim 1, further comprising a probe sized to fit within the central channel of the cannula, the probe comprising a proximal end configured to be releasably restrained with respect to translation within the cannula proximal body.

9. The system of claim 8, further comprising a drive nut coupled to the curveable cannula, wherein the drive nut comprises a hardened proximal surface suitable for applying an impact force to advance one or more of the trocar, curveable cannula, or probe through bone.

10. The system of claim 9, wherein the drive nut comprises a threaded distal recess configured to house the proximal end of the probe, and wherein the probe comprises mating threads with the distal recess so as to allow controlled translation of the probe with respect to the drive nut.

11. The system of claim 10, wherein the proximal surface of the drive nut comprises an interchangeable cap, said interchangeable cap configured to provide access to the probe for providing therapeutic energy to a target region within the bone.

12. The system of claim 3, wherein the distal link of the plurality of mating links comprises a hard material to provide a rigid leading edge, and wherein the cord comprises a distal end terminating in a ball disposed in a retaining surface of an aperture in the distal link and a proximal end coupled to a rotatable dial that is configured to be rotated clockwise or counterclockwise to increase or decrease tension on the cord.

13. The system of claim 3, wherein the plurality of mating links are configured to have interlocking surfaces that allow the distal end of the curveable cannula to curve in one direction, wherein the links comprise mating pairs, wherein the more proximal link of the pair has a depression which corresponds to an extension on the more distal link of the pair, which allows the links to rotate relative to one another to create a curved distal end.

14. The system of claim 8, wherein the distal tip of the probe comprises an electrode configured to deliver a therapeutic amount of radiofrequency energy to a target location.

15. The system of claim 14, wherein the probe comprises a bipolar probe with two electrodes.

16. The system of claim 14, wherein the therapeutic amount of radiofrequency energy is an amount of radiofrequency energy sufficient to denervate an intraosseous nerve.

17. The system of claim 14, wherein the therapeutic amount of radiofrequency energy is an amount of radiofrequency energy sufficient to denervate a basivertebral nerve of a vertebral body.

18. The system of claim 1,

wherein the system is configured to generate a curved path within the vertebral body for accessing one or more basivertebral nerves within a cancellous bone portion of the vertebral body,

wherein a target treatment zone for providing localized treatment using the probe is upstream of a junction separating a main trunk of a basivertebral nerve from a plurality of branches of the basivertebral nerve,

wherein the trocar is configured to be inserted using a transpedicular approach or a postereolateral approach, and/or

wherein the system further comprises a sensor to measure nerve conduction at the target treatment zone.

19. The system of claim 8,

wherein the treatment modality of the probe is selected from the group consisting of one or more of:

radiofrequency, ultrasound, radiation, steam, microwave, cryogenic cooling, therapeutic agent delivery, and/or mechanical cutting.

20. The system of claim 8, wherein the probe is configured to deliver therapeutic treatment that is targeted to block nerve conduction without ablating the nerve and without resulting in necrosis of tissue.

21. A system for channeling a path into bone, comprising:

a trocar having a proximal end, distal end and a central channel;

wherein the central channel is disposed along a central axis of the trocar and extends from the proximal end toward the distal end;

wherein the trocar comprises a radial opening at or near the distal end of the trocar, the radial opening being in communication with the central channel;

wherein the trocar further comprises a sharp distal tip configured to pierce through bone to generate a linear path through bone; and

a curveable cannula sized to be received in said central channel and delivered from the proximal end toward said radial opening;

the curveable cannula comprising a curveable distal end configured to be extended laterally outward from the radial opening in a curved path extending away from the trocar;

wherein the curveable cannula comprises a central passageway having a diameter configured allow a probe to be delivered through the central passageway to a location beyond the curved path, and

wherein the curveable cannula comprises a sharpened distal tip configured to pierce through bone to generate a curved path extending from a linear path generated by the trocar.

22. The system of claim 21, wherein the distal end of the curveable cannula is deformable so as to be delivered in a straight configuration through the trocar and deployed in a curved configuration outward from the radial opening at an angle with respect to the central axis.

23. The system of claim 22, further comprising:

a pull cord coupled to the distal tip of the curveable cannula, the pull cord extending to the proximal end of the trocar;

wherein the pull cord is configured to apply a tensile force to the distal end of the curveable cannula to bias the curveable cannula into a curved configuration.

24. The system of claim 23, wherein the tensile force applied to the distal tip of the curveable cannula may be controlled from the proximal end of the trocar to steer the curveable cannula along a desired path.

25. The system of claim 22, wherein a distal end of the curveable cannula comprises a plurality of mating links, the links configured to articulate into a curved shape.

26. The system of claim 21, wherein the central channel of the trocar terminates at a ramp leading to the radial opening, said ramp facilitating deployment of said curveable cannula outward from said radial opening.

27. The system of claim 21, further comprising a channeling stylet configured to pass through the curveable cannula and to create a working channel beyond the end of the curved path created by the curveable cannula.

28. The system of claim 21, further comprising a treatment probe configured to be inserted through the central passageway of the curved cannula to a target treatment zone beyond the curved path within the bone.

29. The system of claim 28, wherein the distal tip of the probe comprises an electrode configured to deliver a therapeutic amount of radiofrequency energy to the target treatment zone.

30. The system of claim 29, wherein the probe comprises a bipolar probe with two electrodes.

31. The system of claim 29, wherein the therapeutic amount of radiofrequency energy is an amount of radiofrequency energy sufficient to denervate an intraosseous nerve in the target treatment zone.

32. The system of claim 29, wherein the therapeutic amount of radiofrequency energy is an amount of radiofrequency energy sufficient to denervate a basivertebral nerve of a vertebral body in the target treatment zone.

33. The system of claim 21,

wherein the system is configured to generate a curved path within the vertebral body for accessing one or more basivertebral nerves within a cancellous bone portion of the vertebral body,

wherein a target treatment zone for providing localized treatment using the probe is upstream of a junction separating a main trunk of a basivertebral nerve from a plurality of branches of the basivertebral nerve,

wherein the trocar is configured to be inserted using a transpedicular approach or a postereolateral approach, and/or

wherein the system further comprises a sensor to measure nerve conduction at the target treatment zone.

34. The system of claim 28,

wherein the treatment modality of the probe is selected from the group consisting of one or more of:

radiofrequency, ultrasound, radiation, steam, microwave, cryogenic cooling, therapeutic agent delivery, and/or mechanical cutting.

35. The system of claim 28, wherein the probe is configured to deliver therapeutic treatment that is targeted to block nerve conduction without ablating the nerve and without resulting in necrosis of tissue.