Nerve modulation systems

• US 9,724,107 B2
• Filed: 08/19/2016
• Issued: 08/08/2017
• 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 C., Carrison, Harold
• Primary Examiner(s): GIULIANI, THOMAS ANTHONY
• Application Number:
  US15/241,528
• Publication Number:
  US 20160354093A1
• Time in Patent Office: 354 Days
• Field of Search: 606 41, 606 79, 606129, 607 99, 607116, 607117
• CPC Class Codes: A61B 17/1642 for producing a curved bore
• CPC Class Codes: A61B 17/1671 for the spine
• CPC Class Codes: A61B 17/3403 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 17/3423 Access ports, e.g. toroid shape introducers for instruments or hands access sites for liquids A61M39/0247
• CPC Class Codes: A61B 17/3468 for implanting or removing devices, e.g. prostheses, implants, seeds, wires devices for implanting seeds A61M37/0069
• CPC Class Codes: A61B 17/3472 for bones, e.g. intraosseus injections
• CPC Class Codes: A61B 18/1206 Generators 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 2017/00314 Separate linked members
• CPC Class Codes: A61B 2017/00323 Cables or rods
• CPC Class Codes: A61B 2017/00331 with preformed bends
• CPC Class Codes: A61B 2017/3405 using mechanical guide means
• CPC Class Codes: A61B 2018/00339 Spine, e.g. intervertebral disc
• CPC Class Codes: A61B 2018/0044 Spinal cord
• CPC Class Codes: A61B 2018/00565 Bone
• CPC Class Codes: A61B 2018/00577 Ablation
• CPC Class Codes: A61B 2018/126 bipolar

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 distal opening at the distal end of the trocar. The system includes a curved cannula sized to be received in the central channel, the curved cannula comprising a curved distal end configured to be extended outward from the distal opening to generate a curved path extending away from the trocar. The curved cannula has a central passageway having a diameter configured to allow a treatment device to be delivered through the central passageway to a location beyond the curved path.

Claims

1. A system for accessing and treating a target treatment site within bone, the system comprising:

an elongate shaft having a proximal end and a distal end,

wherein the proximal end comprises a handle,

wherein the elongate shaft comprises a central lumen extending from the proximal end to the distal end;

a cannula;

a first stylet;

a second stylet; and

a radiofrequency (“

RF”

) energy delivery device configured to deliver energy to the target treatment site,

wherein the cannula comprises an internal passageway and a first alignment member at a proximal portion of the cannula,

wherein the first stylet is sized such that at least a distal tip of the first stylet extends beyond an opening at a distal end of the cannula,

wherein the cannula and the first stylet are together configured to be introduced through the central lumen of the elongate shaft,

wherein the distal tip of the first stylet is configured to form a first path toward the target treatment site within a cancellous region of the bone as at least the distal tip of the first stylet is advanced beyond the distal end of the elongate shaft,

wherein the second stylet is configured to be inserted within the internal passageway of the cannula upon removal of the first stylet,

wherein a distal tip of the second stylet is configured to be advanced beyond the opening at the distal end of the cannula to form a second path beyond the first path,

wherein the RF energy delivery device is configured to be inserted within the internal passageway of the cannula upon removal of the second stylet and advanced until at least a distal end portion of the RF energy delivery device is beyond the opening at the distal end of the cannula and positioned along the second path, and

wherein the RF energy delivery device is configured to heat the target treatment site sufficient to denervate a nerve within the bone.

2. The system of claim 1, wherein the RF energy delivery device is configured to heat the target treatment site sufficient to ablate the nerve.

3. The system of claim 1, wherein the RF energy delivery device is configured to heat the target treatment site sufficient to denervate the nerve without necrosis of tissue.

4. The system of claim 1, wherein the RF energy delivery device comprises a bipolar electrode assembly.

5. The system of claim 4, wherein the bipolar electrode assembly comprises a tip electrode and a second electrode spaced apart from the tip electrode.

6. The system of claim 1, wherein the first stylet comprises a second alignment member configured to be aligned with the first alignment member of the cannula so as to facilitate proper alignment of the cannula and the first stylet.

7. The system of claim 1, wherein the cannula comprises a deflectable tip with a preformed curve.

8. The system of claim 1, wherein the cannula comprises a Nitinol tube.

9. A system for accessing and treating a target treatment location within bone, the system comprising:

an elongate shaft having a proximal end and a distal end,

wherein the elongate shaft comprises a central lumen extending from the proximal end to the distal end;

a cannula having an internal passageway and an opening at a distal end of the cannula;

a first stylet sized to be advanced through the internal passageway of the cannula until a distal tip of the first stylet extends to or beyond the opening at the distal end of the cannula, thereby facilitating formation of a first path within the bone as the cannula and the first stylet are advanced through and beyond the central lumen of the elongate shaft toward the target treatment location within the bone;

a second stylet sized to be advanced through the internal passageway of the cannula until a distal tip of the second stylet extends beyond the opening at the distal end of the cannula to form a second path beyond the first path within the bone;

an energy delivery device configured to deliver energy to heat the target treatment location;

wherein, after removal of the second stylet, the energy delivery device is sized and configured to be advanced through the internal passageway of the cannula and out of the opening at the distal end of the cannula to a position along the second path, and

wherein the energy is configured to heat the target treatment location sufficient to denervate a nerve at the target treatment location.

10. The system of claim 9, wherein the energy is configured to heat the target treatment location sufficient to ablate the nerve.

11. The system of claim 9, wherein the energy is configured to heat the target treatment location sufficient to denervate the nerve without necrosis of tissue.

12. The system of claim 9, wherein the energy delivery device comprises a bipolar radiofrequency probe comprising a first tip electrode and a second electrode spaced apart from the first tip electrode.

13. The system of claim 9, wherein the energy delivery device comprises an ultrasound energy delivery device.

14. The system of claim 9, wherein the opening at the distal end of the cannula comprises an axial opening.

15. A system for accessing and treating a target region within bone, the system comprising:

an elongate shaft having a proximal end and a distal end,

wherein the elongate shaft comprises a central lumen extending from the proximal end to the distal end;

a cannula, wherein the cannula comprises an internal passageway;

a first stylet,

wherein the first stylet is configured for insertion into and through the internal passageway of the cannula such that a distal tip of the first stylet extends beyond an opening at a distal end of the cannula,

wherein the cannula and the first stylet are configured to together form a first channel toward the target region within the bone;

a second stylet configured to be inserted within the internal passageway of the cannula after removal of the first stylet from the cannula and sized to be advanced through the internal passageway of the cannula until a distal tip of the second stylet extends beyond the opening at the distal end of the cannula to form a second channel beyond the first channel within the bone; and

a treatment device sized and configured to be delivered through the internal passageway of the cannula and advanced out of the opening at the distal end of the cannula to a position along the second channel within the bone.

16. The system of claim 15,

wherein the treatment device comprises a flexible bipolar radiofrequency energy delivery device having two electrodes configured to deliver energy to the target region,

wherein the radiofrequency energy delivery device is configured to be inserted through the internal passageway of the cannula upon removal of the second stylet, and

wherein the energy is configured to heat the target region sufficient to ablate an intraosseous nerve within the target region.

17. The system of claim 15, wherein the treatment device is selected from the group consisting of:

a monopolar radiofrequency energy delivery device, a tripolar radiofrequency energy delivery device, an ultrasound device, a radiation device, a steam device, a microwave energy delivery device, a fluid delivery device, and a laser device.

18. The system of claim 15, wherein the cannula comprises a first alignment member at a proximal portion of the cannula and wherein the first stylet comprises a second alignment member configured to be aligned with the first alignment member of the cannula to facilitate proper alignment of the cannula and the first stylet.

19. The system of claim 15, wherein the cannula comprises a deflectable tip having a preformed curve.

20. The system of claim 15, further comprising a third stylet, wherein the third stylet is configured for insertion into and through the central lumen of the elongate shaft such that a distal tip of the third stylet extends beyond an opening at the distal end of the elongate shaft, and wherein the distal tip of the third stylet is sufficiently sharp to pierce the bone.