Systems and methods for creating curved paths through bone

• US 10,357,258 B2
• Filed: 10/02/2017
• Issued: 07/23/2019
• 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:
  US15/722,392
• Publication Number:
  US 20180103964A1
• Time in Patent Office: 659 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 for delivering a self-guided treatment device into bone, comprising:

a trocar comprising a proximal end, a 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 distal opening at or near the distal end of the trocar, 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 toward said distal opening;

the treatment probe comprising a stylet comprising a straight proximal end and a curved distal end;

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

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

wherein the curved distal end comprises a treatment device configured to deliver a therapeutic dose of energy to a treatment location.

2. The system of claim 1,

wherein the therapeutic dose of energy is configured to denervate a basivertebral nerve associated with a vertebral body.

3. The system of claim 1, wherein the proximal end of the trocar comprises a handle comprising:

a proximal recess;

wherein the proximal recess is in communication with the central channel to allow reciprocation of the treatment probe within the central channel; and

a lateral slot in communication with said proximal recess, the lateral slot extending radially outward from the proximal recess at a proximal surface of the handle;

wherein the lateral slot is configured to allow insertion of the treatment probe such that a central axis of the straight proximal end of the stylet is at an angle with respect to the central axis of the trocar when the curved distal end of the treatment probe is inserted into the proximal recess.

4. The system of claim 3, wherein the lateral slot comprises a curvilinear bottom surface configured to allow the curved distal end of the treatment probe to be slideably advanced into the proximal recess and the central channel.

5. The system of claim 4, wherein the curvilinear bottom surface comprises a radius substantially matching a radius of the curved distal end of the treatment probe.

6. The system of claim 1, 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 trocar when installed in the trocar; and

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

7. The system of claim 2, 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.

8. The system of claim 1, wherein the distal end of the treatment probe comprises a plurality of circumferentially relieved sections.

9. A system as recited in claim 1, wherein the distal end of the treatment probe comprises a pair of ring electrodes forming a bipolar RF treatment device.

10. The system of claim 9, wherein the stylet comprises a longitudinal channel extending from the curved distal end to the straight proximal end, and wherein the channel is configured to house a flexible lead coupled to the pair of ring electrodes.

11. The system of claim 10, wherein the probe handle comprises a connector for coupling a power source to the flexible lead.

12. A method for delivering a self-guided treatment device into bone, comprising:

inserting a trocar into the bone;

the trocar comprising a proximal end, a 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 distal opening at or near the distal end of the trocar, the distal opening being in communication with the central channel;

wherein the proximal end of the trocar comprises a handle comprising a proximal recess in communication with the central channel and a lateral slot in communication with said proximal recess, the lateral slot extending radially outward from the proximal recess at a proximal surface of the handle;

wherein the central channel is sized to receive a treatment probe;

the treatment probe comprising a stylet comprising a straight proximal end and a curved distal end;

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

wherein the curved distal end comprises a treatment device configured to deliver a therapeutic dose of energy to a treatment location;

inserting the curved distal end of the treatment probe into said proximal recess through the lateral slot and such that a central axis of the straight proximal end is at an angle with respect to the central axis of the trocar;

advancing the treatment probe into the proximal recess, thereby straightening the curved distal end;

advancing the treatment probe within said central channel from the proximal end toward the distal opening;

extending the curved distal end laterally outward from the distal opening to generate a curved path radially outward from the trocar; and

delivering a therapeutic dose of energy to a treatment location within the bone.

13. The method of claim 12, wherein the curved distal end comprises a sharpened distal tip configured to channel through a cancellous bone region of a vertebral body;

wherein the therapeutic dose of energy is configured to denervate a basivertebral nerve associated with the vertebral body.

14. The method of claim 13, wherein the lateral slot comprises a curvilinear bottom surface configured to allow the curved distal end of the treatment probe to be slideably advanced into the proximal recess and the central channel.

15. The method of claim 14, wherein the curvilinear bottom surface comprises a radius substantially matching a radius of the curved distal end of the treatment probe.

16. The method of claim 12, wherein the treatment probe comprises a handle having a striking surface;

wherein extending the curved distal end laterally outward from the distal opening is achieved by striking the striking surface to advance the treatment probe through a cancellous bone region of the bone.

17. The method of claim 12, wherein the distal end of the treatment probe comprises a plurality of circumferentially relieved sections to promote advancement curved distal end through the trocar and self guiding of the curved distal end to generate a curved path through the bone.

18. The method of claim 12, wherein delivering a therapeutic dose of energy to the treatment location comprises delivering RF energy to denervate a basivertebral nerve within the bone.