Systems for navigation and treatment within a vertebral body

• US 10,517,611 B2
• Filed: 03/29/2019
• Issued: 12/31/2019
• Est. Priority Date: 11/05/2012
• 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., Flagler, Robert
• Primary Examiner(s): Sevilla, Christian A
• Application Number:
  US16/370,264
• Publication Number:
  US 20190290296A1
• Time in Patent Office: 277 Days
• CPC Class Codes: A61B 17/1642 for producing a curved bore
• CPC Class Codes: A61B 17/1671 for the spine
• CPC Class Codes: A61B 17/1757 for the spine
• CPC Class Codes: A61B 17/320068 using mechanical vibrations, e.g. ultrasonic A61B17/22012 takes precedence; dental tooth drilling devices operated by vibration A61C3/03; removing intra-ocular material using mechanical vibrations A61F9/00745
• CPC Class Codes: A61B 17/3472 for bones, e.g. intraosseus injections
• CPC Class Codes: A61B 17/3478 Endoscopic needles, e.g. for infusion biopsy needles A61B10/0233; catheters with injection needles A61M25/0067
• 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 18/06 caused by chemical reaction , e.g. moxaburners
• 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 2017/00261 Discectomy
• CPC Class Codes: A61B 2017/00314 Separate linked members
• CPC Class Codes: A61B 2017/00331 with preformed bends
• CPC Class Codes: A61B 2018/0044 Spinal cord
• CPC Class Codes: A61B 2018/00577 Ablation
• CPC Class Codes: A61B 2018/00994 combining two or more different kinds of non-mechanical energy or combining one or more non-mechanical energies with ultrasound
• CPC Class Codes: A61B 2018/162 located on the probe body
• CPC Class Codes: A61B 2018/1807 : using light other than laser radiation

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 or near the distal end of the trocar. The system includes a curved cannula sized to be received in the central channel, and having a curved distal end configured to be extended laterally outward from the distal opening in a curved path extending away from the trocar. The curved 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 configured for navigation and treatment within a vertebral body, the system comprising:

an introducer, the introducer comprising a proximal handle and an elongate tube comprising a channel extending from the proximal handle to a distal end of the introducer;

a straight stylet configured to be received in the channel of the introducer,

wherein the straight stylet comprises a sharp-tipped distal end that, when installed fully within the introducer, extends slightly beyond the distal end of the introducer,

a steerable probe configured to be inserted through the introducer after removal of the straight stylet, wherein the steerable probe comprises;

a proximal handle;

an elongate tube, the elongate tube comprising a slotted distal portion configured to bend upon actuation,

a pair of electrodes configured to act as a bipolar pair; and

at least one temperature sensor.

2. The system of claim 1, wherein the slotted distal portion comprises a plurality of circumferentially relieved sections separated by a plurality of bosses.

3. The system of claim 2, wherein the plurality of bosses have an outside diameter that corresponds to the inside diameter of the channel of the introducer.

4. The system of claim 3, wherein the outside diameter of each boss is smaller than the inside diameter of the channel.

5. The system of claim 2, wherein the plurality of circumferentially relieved sections comprise recesses machine-formed in the steerable probe.

6. The system of claim 5, wherein the recesses comprise a pair of recesses configured to house the pair of electrodes.

7. The system of claim 6, further comprising a groove formed in the steerable probe between the pair of recesses.

8. A system configured for navigation and treatment within a vertebral body, the system comprising:

an introducer comprising a proximal end, a distal end and a central channel;

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

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

a treatment probe;

the treatment probe sized to be received in said central channel and delivered from the proximal end of the introducer toward said distal opening of the introducer;

the treatment probe comprising a straight proximal end and a curveable distal end;

the curveable distal end being deformable so as to be delivered in a straight configuration through the introducer and deployed in a curved configuration outward from the distal opening of the introducer at an angle with respect to the central axis of the introducer,

wherein the curveable distal end comprises a sharpened distal tip configured to channel through a cancellous bone region of the vertebral body; and

wherein the curveable distal end comprises a pair of electrodes configured to deliver a therapeutic dose of energy to a treatment location within the vertebral body.

9. The system of claim 8, wherein the curveable distal end comprises slots configured to facilitate curving of the curveable distal end.

10. The system of claim 8, wherein the therapeutic dose of energy is configured to denervate a basivertebral nerve associated with the vertebral body.

11. The system of claim 8, further comprising:

a straight stylet comprising a straight proximal body and a sharpened distal end;

the straight stylet configured to protrude from the distal opening of the introducer when installed in the introducer; and

the straight stylet comprising a striking surface for advancing the introducer through a cortical bone region of the vertebral body.

12. The system of claim 8, wherein the treatment probe comprises a handle having a striking surface for advancing the treatment probe through the cancellous bone region of the vertebral body.

13. The system of claim 8, wherein the curveable distal end of the treatment probe comprises a plurality of circumferentially relieved sections.

14. The system of claim 8, wherein the pair of electrodes comprises a pair of ring electrodes.