Nerve modulation systems

• US 9,017,325 B2
• Filed: 01/03/2014
• Issued: 04/28/2015
• 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:
  US14/147,024
• Publication Number:
  US 20140324051A1
• Time in Patent Office: 480 Days
• Field of Search: 606/41, 607/99, 607/101, 607/117
• US Class Current: 606/41
• 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 a vertebral body, the system comprising:

an introducer assembly comprising an introducer having a lumen and a first straight stylet;

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

a second straight stylet; and

a bipolar radiofrequency (“

RF”

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

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

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

wherein the cannula is configured to be inserted within the lumen of the introducer upon removal of the first straight stylet,

wherein a distal portion of the cannula is configured to curve to correspond to a curved distal portion of the curved stylet upon insertion of the curved stylet within the internal passageway of the cannula and advancement of a distal tip of the curved stylet to an open distal tip 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 corresponding curved distal portions of the cannula and the curved stylet,

wherein the curved cannula assembly is configured to form a curved path toward the target treatment site within an inner cancellous bone region of the vertebral body;

wherein the second straight stylet comprises a flexible channeling stylet configured to be inserted within the internal passageway of the cannula upon removal of the curved stylet,

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

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

wherein the energy delivered by the bipolar RF energy delivery device is configured to heat the target treatment site sufficient to denervate a basivertebral nerve at the target treatment site.

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

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

4. The system of claim 1, wherein the target treatment site is proximal to a junction of the basivertebral nerve.

5. The system of claim 1, wherein the target treatment site is in a region of the vertebral body located between 60% and 90% of the distance between the anterior and posterior ends of the vertebral body.

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 curved distal portion of the cannula is pre-curved.

8. The system of claim 1, wherein the distal tip of the first straight stylet is sufficiently sharp to pierce bone tissue.

9. A system for generating a path to a target treatment location within a vertebral body, 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,

wherein a portion of the cannula is curved off axis, thereby facilitating formation of a curved path within the vertebral body toward the target treatment location by a curved stylet inserted through the internal passageway of the cannula;

a straight channeling stylet configured to be inserted through the internal passageway of the cannula after removal of the curved stylet and advanced out of the opening at the distal tip of the cannula to form a linear path to the target treatment location beyond the curved path,

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

wherein the cannula has a length sufficient to provide access to the target treatment location within the vertebral body by the energy delivery device,

wherein the target treatment location is within an inner cancellous bone region of the vertebral body, and

wherein the energy is configured to heat the target treatment location sufficient to modulate a basivertebral 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 basivertebral nerve.

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

12. The system of claim 9, wherein the energy delivery device comprises a bipolar radiofrequency probe comprising two electrodes.

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 comprises an axial opening.

15. The system of claim 9, wherein the opening comprises a radial window.

16. The system of claim 9, wherein the curved portion of the cannula is pre-curved.

17. 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;

and

a straight channeling 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 portion,

wherein the curved stylet comprises a curved distal portion corresponding to the curved distal 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 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;

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

wherein a distal tip of the straight channeling stylet is configured to be advanced out of an open distal tip of the cannula to form a linear channel beyond the curved channel.

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

19. The system of claim 17, 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.

20. The system of claim 17, further comprising a flexible bipolar radiofrequency (“

RF”

) energy delivery device having two electrodes configured to deliver energy to the target region,

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

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