Systems and methods for creating curved paths through bone and modulating nerves within the bone

• US 9,775,627 B2
• Filed: 11/01/2013
• Issued: 10/03/2017
• 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., Flager, Robert
• Primary Examiner(s): Sevilla, Christian
• Application Number:
  US14/440,050
• Publication Number:
  US 20150297246A1
• Time in Patent Office: 1,432 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 channeling a path into bone, comprising:

an introducer having 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,

wherein the introducer is configured to be deployed through a cortical bone region and into a cancellous bone region of a vertebral body;

a curved cannula sized to be received in said central channel and delivered from the proximal end of the introducer toward said distal opening,

wherein the curved cannula comprises a straight tubular body and a curved distal end configured to be extended laterally outward from the distal opening of the introducer in a curved path extending away from the introducer,

wherein the curved path is generated through at least a portion of the cancellous bone region of the vertebral body,

wherein the curved cannula comprises a cannula channel configured to allow a treatment device to be delivered through the cannula channel; and

a treatment device configured to be delivered through the cannula channel of the curved cannula to a location at or beyond the curved path,

wherein the proximal end of the introducer comprises a handle comprising;

a proximal recess,

wherein the proximal recess is in communication with the central channel to allow reciprocation of the curved cannula 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 curved cannula such that a central axis of the straight tubular body is at an angle with respect to the central axis of the introducer when the curved distal end of the curved cannula is inserted into the proximal recess.

2. The system of claim 1, wherein the curved distal end of the curved cannula is deformable so as to be delivered in a straight configuration through the introducer and deployed in a curved configuration outward from the distal opening at an angle with respect to the central axis of the introducer.

3. The system of claim 1, wherein the lateral slot comprises a curvilinear bottom surface configured to allow the curved distal end of the curved cannula to be slideably advanced into the proximal recess and the central channel without having to pre-straighten the curved cannula.

4. The system of claim 3, wherein the curvilinear bottom surface comprises a radius substantially matching a radius of the curved distal end of the curved cannula, thereby promoting evenly distributed loading along the curved distal end while the curved distal end is advanced into the proximal recess and the central channel.

5. The system of claim 1, further comprising

a curved stylet comprising a straight proximal body and a preformed curved distal end.

6. The system of claim 5, wherein a proximal end of the curved cannula comprises a cannula handle comprising:

a central recess,

wherein the central recess is in communication with the cannula channel to allow reciprocation of the curved stylet within the cannula channel; and

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

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

7. The system of claim 6, wherein the lateral cannula slot comprises a curvilinear bottom surface configured to allow the preformed curved distal end of the curved stylet to be slideably, advanced into the central recess and the cannula channel, and wherein the curvilinear bottom surface of the cannula handle comprises a radius substantially matching a radius of the preformed curved distal end of the curved stylet.

8. The system of claim 6:

wherein the curved cannula comprises a stop nut threaded about a threaded portion, the threaded portion being distal to the cannula handle and proximal to the straight tubular body;

wherein the stop nut is configured to have a first position on the threaded portion, said stop nut being configured to restrain advancement of the curved cannula within the introducer such that the curved distal end of the cannula does not extend past the distal end of the introducer when the stop nut is in the first position.

9. A system for channeling a path into bone, 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;

a curved cannula sized to be received in said central channel and delivered from the proximal end of the introducer toward said distal opening,

wherein the curved cannula comprises a straight tubular body at a proximal end and a curved distal end,

wherein the curved distal end is configured to be extended laterally outward from the distal opening of the introducer in a curved path extending away from the introducer,

wherein the proximal end of the introducer comprises a handle comprising;

a proximal recess,

wherein the proximal recess is in communication with the central channel to allow reciprocation of the curved cannula 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 curved cannula such that a central axis of the straight tubular body is at an angle with respect to the central axis of the introducer when the curved distal end of the curved cannula is inserted into the proximal recess.

10. The system of claim 9, wherein the curved distal end of the curved cannula is 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.

11. The system of claim 9, wherein the lateral slot comprises a curvilinear bottom surface configured to allow the curved distal end of the curved cannula to be slideably advanced into the proximal recess and the central channel.

12. The system of claim 11, wherein the curvilinear bottom surface comprises a radius substantially matching a radius of the curved distal end of the curved cannula.

13. The system of claim 9, further comprising:

a curved stylet comprising a straight proximal body and a preformed curved distal end,

wherein the curved cannula comprises a cannula channel configured to allow delivery of a treatment device to a location within the bone beyond the curved path.

14. The system of claim 13, wherein the proximal end of the curved cannula comprises a cannula handle comprising:

a central recess,

wherein the central recess is in communication with the cannula channel to allow reciprocation of the curved stylet within the cannula channel; and

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

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

15. The system of claim 14, wherein the lateral cannula slot comprises a curvilinear bottom surface configured to allow the preformed curved distal end of the curved stylet to be slideably advanced into the central recess and the cannula channel, wherein the curvilinear bottom surface of the cannula handle comprises a radius substantially matching a radius of the preformed curved distal end of the curved stylet.

16. The system of claim 14:

wherein the curved cannula comprises a stop nut threaded about a threaded portion of the curved cannula, the threaded portion being distal to the cannula handle and proximal to the straight tubular body;

wherein the stop nut is configured to have a first position on the threaded portion, said stop nut being configured to restrain advancement of the curved cannula within the introducer such that the curved distal end of the curved cannula does not extend past the distal end of the introducer when the stop nut is in the first position.

17. A method for channeling a path into a vertebral body of a patient, comprising:

inserting an introducer into the vertebral body, the 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,

wherein the proximal end of the introducer 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 curved cannula, the curved cannula comprising a straight tubular body at a proximal end of the curved cannula and a curved distal end,

wherein the curved distal end of the curved cannula is deformable so as to be delivered in a straight configuration through the introducer;

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

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

advancing the curved cannula within said central channel from the proximal end of the introducer toward the distal opening of the introducer; and

extending the curved distal end laterally outward from the distal opening to generate a curved path radially outward from the introducer.

18. The method of claim 17, further comprising delivering a treatment device through the curved cannula to a location beyond the curved path.

19. The method of claim 17, wherein the curved cannula comprises a cannula channel, the proximal end of the curved cannula comprising a cannula handle comprising a central recess in communication with the cannula channel and a lateral cannula slot in communication with said central recess, the lateral cannula slot extending radially outward from the central recess at a proximal surface of the cannula handle, the method further comprising:

inserting a curved stylet into the curved cannula;

the curved stylet comprising a straight proximal body and a preformed curved distal end;

inserting the preformed curved distal end of the curved stylet into the central recess through the lateral cannula slot such that a central axis of the straight proximal body is at an angle with respect to a central axis of the cannula channel of the curved cannula;

advancing the curved stylet into the central recess, thereby straightening the preformed curved distal end;

advancing the curved stylet within said curved cannula from the proximal end to the distal opening of the introducer; and

wherein generating the curved path radially outward from the introducer comprises extending the curved distal end of the curved cannula and the preformed curved distal end of the curved stylet in unison laterally outward from the distal opening of the introducer.

20. The method of claim 19:

wherein the curved cannula comprises a stop nut threaded about a threaded portion of the curved cannula, the threaded portion being distal to the cannula handle and proximal to the straight tubular body;

wherein the stop nut is configured to have a first position on the threaded portion;

wherein the curved stylet is advanced within said curved cannula with said stop nut in the first position to restrain advancement of the curved cannula within the introducer such that the curved distal end of the curved cannula does not extend past the distal end of the introducer,

wherein the stop nut comprises a second position on the threaded portion configured to allow further translation of the curved cannula with respect to the introducer, the method further comprising;

rotating the stop nut to the second position prior to extending the curved distal end laterally outward from the distal opening.