Nerve modulation systems

• US 9,421,064 B2
• Filed: 04/24/2015
• Issued: 08/23/2016
• Est. Priority Date: 09/30/2002
• Status: Expired due to Term

• Current Assignee: Relievant Medsystems, Incorporated (Boston Scientific Corporation)
• Original Assignee: Relievant Medsystems, Incorporated (Boston Scientific Corporation)
• Inventors: Pellegrino, Richard C., Patel, Samit, Carrison, Harold
• Primary Examiner(s): Peffley, Michael
• Assistant Examiner(s): GIULIANI, THOMAS ANTHONY
• Application Number:
  US14/695,330
• Publication Number:
  US 20150335349A1
• Time in Patent Office: 487 Days
• Field of Search: 606/41, 606/79, 607/99
• US Class Current: 1/1
• 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 17/3468 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 17/8805 for introducing fluid filler into bone or extracting it A61B17/7097, A61B17/8833 take 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 18/1206 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 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 2017/00331 with preformed bends
• CPC Class Codes: A61B 2017/3405 using mechanical guide means
• CPC Class Codes: A61B 2017/3454 Details of tips
• CPC Class Codes: A61B 2018/00017 with gas
• 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
• CPC Class Codes: A61B 2018/1475 : Electrodes retractable in or deployable from a housing
• CPC Class Codes: A61F 7/007 : characterised by electric heating
• CPC Class Codes: A61N 1/0551 : Spinal or peripheral nerve electrodes

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 generating a path to a target treatment site within bone, the system comprising:

a cannula comprising a pre-curved distal end portion;

a curved stylet comprising a pre-curved distal end portion having a curvature corresponding to the pre-curved distal end portion of the cannula;

a straight channeling 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 curved 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 pre-curved distal end portions of the cannula and the curved stylet,

wherein the curved cannula and the curved stylet are together configured to form a curved path toward the target treatment site within a cancellous region of the bone;

wherein the straight channeling stylet is configured to be inserted within the internal passageway of the cannula upon removal of the curved stylet,

wherein a distal end portion of the straight channeling stylet is configured to be advanced out of an open distal tip of the cannula to form a linear path beyond the curved path,

wherein the RF energy delivery device is configured to be inserted within the internal passageway of the cannula upon removal of the straight channeling stylet, and

wherein the energy delivered by 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 delivered energy is configured to heat the target treatment site sufficient to ablate the nerve.

3. The system of claim 1, wherein the delivered energy 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 alignment member of the cannula comprises a notch and wherein the second alignment member of the curved stylet comprises an alignment pin.

7. The system of claim 1, wherein the straight channeling stylet is flexible enough to navigate the pre-curved distal end portion of the cannula but rigid enough to form the linear path upon being advanced out of the open distal tip of the cannula.

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

9. A system for generating a path to a target treatment location within bone, the system comprising:

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

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

a stylet sized to be advanced through the internal passageway until a distal tip of the stylet extends to or beyond the opening at the distal tip of the cannula,

wherein a distal end portion of the cannula is curved off axis,

wherein a distal end portion of the stylet is curved to correspond to the curvature of the distal end portion of the cannula, thereby facilitating formation of a curved path within the bone toward the target treatment location;

wherein, after removal of the stylet, the energy delivery device is sized and configured to be advanced through the internal passageway and out of the opening at the distal tip of the cannula in a linear direction to the target treatment location beyond the curved path formed by the cannula,

wherein a diameter of the internal passageway of the cannula is configured to receive the energy delivery device, and

wherein the energy is configured to heat the target treatment location sufficient to modulate 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 tip of the cannula comprises an axial opening.

15. The system of claim 9, wherein the distal end portion of the cannula is pre-curved.

16. A system for generating a path to a target region within bone, the system comprising:

a curved cannula assembly comprising a cannula and a curved stylet;

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

wherein the cannula comprises a curved distal end portion,

wherein the curved stylet comprises a curved distal end portion corresponding to the curved distal end portion of the cannula,

wherein the curved stylet comprises a second alignment member configured to be aligned with the first alignment member of the cannula to facilitate proper alignment of the corresponding curved distal end portions of the cannula and the curved stylet,

wherein the curved cannula assembly is configured to form a curved channel toward the target region within the bone; and

a treatment device sized and configured to be delivered through the cannula and advanced out of an open distal tip of the cannula in a linear direction beyond the curved channel formed by the curved cannula assembly.

17. The system of claim 16, wherein the curved distal end portion of the cannula is pre-curved.

18. The system of claim 16, further comprising an introducer assembly comprising an introducer having a lumen and a straight sharpened stylet,

wherein the straight sharpened stylet is configured for insertion into the lumen of the introducer such that a distal tip of the straight sharpened stylet extends beyond an open distal tip of the introducer,

wherein the distal tip of the straight sharpened stylet is sufficiently sharp to pierce bone tissue, and

wherein the curved cannula assembly is configured to be delivered to the target region through the lumen of the introducer upon removal of the straight sharpened stylet.

19. The system of claim 16,

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 curved stylet, and

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

20. The system of claim 16, 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.