ULTRASOUND-GUIDED DELIVERY OF A THERAPY DELIVERY DEVICE TO A NERVE TARGET

• US 20100204568A1
• Filed: 02/08/2010
• Published: 08/12/2010
• Est. Priority Date: 02/09/2009
• Status: Active Grant

• Current Assignee: Cleveland Clinic Foundation
• Original Assignee: Cleveland Clinic Foundation
• Inventors: Narouze, Samer
• Granted Patent: US 8,870,773 B2
• Time in Patent Office: Days
• US Class Current: 600/424
• CPC Class Codes: A61B 2034/107 Visualisation of planned trajectories or target regions
• CPC Class Codes: A61B 2090/378 using ultrasound
• CPC Class Codes: A61B 34/10 Computer-aided planning, simulation or modelling of surgical operations
• CPC Class Codes: A61B 5/4893 Nerves
• CPC Class Codes: A61B 8/08 Detecting organic movements or changes, e.g. tumours, cysts, swellings A61B8/02 - A61B8/06 take precedence
• CPC Class Codes: A61B 8/0833 involving detecting or locating foreign bodies or organic structures
• CPC Class Codes: A61B 8/0841 for locating instruments
• CPC Class Codes: A61B 90/11 with guides for needles or instruments, e.g. arcuate slides or ball joints
• CPC Class Codes: A61N 1/0551 Spinal or peripheral nerve electrodes
• CPC Class Codes: A61N 1/36017 with leads or electrodes penetrating the skin
• CPC Class Codes: A61N 1/36021 for treatment of pain

Abstract

A method for guiding a therapy delivery device to a sympathetic nerve chain target of a subject includes: (a) selecting a sympathetic nerve chain target; (b) using ultrasound imaging to obtain an ultrasound image of anatomical structures relevant to the sympathetic nerve chain target; (c) determining an implantation pathway based on the ultrasound image, the implantation pathway defining a trajectory that avoids the relevant anatomical structures and extends between an insertion point on the skin of the subject and a bony spinous target; (d) inserting an introducer into the insertion point, the introducer including a bevel located at a distal end thereof; (e) navigating the introducer through the implantation pathway until the distal tip is positioned adjacent or proximate to the bony spinous target; and (f) advancing the therapy delivery device through the introducer to the sympathetic nerve chain target. Steps (d)-(f) are performed using real-time ultrasound imaging.

Claims

1. A method for guiding a therapy delivery device to a sympathetic nerve chain target of a subject, said method comprising the steps of:

(a) selecting a sympathetic nerve chain target;

(b) using ultrasound imaging to obtain an ultrasound image of anatomical structures relevant to the sympathetic nerve chain target;

(c) determining an implantation pathway based on the ultrasound image, the implantation pathway defining a trajectory that avoids the relevant anatomical structures and extends between an insertion point on the skin of the subject and a bony spinous target;

(d) inserting an introducer into the insertion point, the introducer including a bevel located at a distal end thereof;

(e) navigating the introducer through the implantation pathway until the distal tip is positioned adjacent or proximate to the bony spinous target; and

(f) advancing the therapy delivery device through the introducer to the sympathetic nerve chain target;

wherein steps (d)-(f) are performed using real-time ultrasound imaging.

2. The method of claim 1, wherein the sympathetic nerve chain target is selected from the group consisting of a cervical ganglion, a stellate ganglion, a T1 ganglion, a T2 ganglion, and a T3 ganglion.

3. The method of claim 1, wherein said step of using ultrasound imaging to obtain an ultrasound image further comprises the step of:

obtaining a short axis ultrasound image of the root of the subject'"'"'s neck; and

identifying a plurality of anatomical structures selected from the group consisting of the trachea, the esophagus, the recurrent laryngeal nerve, the thyroid gland, the carotid artery, the internal jugular vein, the vagus nerve, the longus coli muscle, the inferior thyroid vessels, the vertebral vessels, and the sympathetic nerve chain.

4. The method of claim 3, wherein said step of identifying a plurality of anatomical structures further comprises identifying the plurality of anatomical structures along an anterior aspect of the longus coli muscle.

5. The method of claim 1, wherein said step of determining an implantation pathway further comprises identifying a bony spinous target at the level of C7.

6. The method of claim 1, wherein said step of navigating the introducer through the implantation pathway further comprises providing a securing mechanism to stabilize the introducer during navigation through the implantation pathway.

7. The method of claim 1, wherein said step of navigating the introducer through the implantation pathway further comprises using an in-plane or out-of-plane approach to target the anterior aspect of the longus coli muscle.

8. The method of claim 1, wherein said step of navigating the introducer through the implantation pathway further comprises the steps of:

directing the bevel of the introducer caudally; and

advancing the therapy delivery device through the introducer until the therapy delivery device is positioned adjacent or proximate to at least one of a stellate ganglion, a T1 ganglion, a T2 ganglion, or a T3 ganglion.

9. The method of claim 1, wherein said step of navigating the introducer through the implantation pathway further comprises the steps of:

directing the bevel of the introducer in a cephalad direction; and

advancing the therapy delivery device through the introducer until the therapy delivery device is positioned adjacent or proximate to at least one of a stellate ganglion or a cervical ganglion.

10. A method for treating a medical condition in a subject, said method comprising the steps of:

(a) selecting a sympathetic nerve chain target;

(b) using ultrasound imaging to obtain an ultrasound image of anatomical structures relevant to the sympathetic nerve chain target;

(c) determining an implantation pathway based on the ultrasound image, the implantation pathway defining a trajectory that avoids the relevant anatomical structures and extends between an insertion point on the skin of the subject and a bony spinous target;

(d) inserting an introducer into the insertion point, the introducer including a bevel located at a distal end thereof;

(e) navigating the introducer through the implantation pathway until the distal tip is positioned adjacent or proximate to the bony spinous target;

(f) advancing the therapy delivery device through the introducer to the sympathetic nerve chain target; and

(g) applying an electrical current to the sympathetic nerve chain target;

wherein steps (d)-(f) are performed using real-time ultrasound imaging.

11. The method of claim 10, wherein said step of applying an electrical current to the sympathetic nerve chain target further comprises applying a sufficient amount of electrical current to substantially block nerve conduction at the sympathetic nerve chain target.

12. The method of claim 11, wherein said step of applying a sufficient amount of electrical current to substantially block nerve conduction includes blocking nerve conduction to alleviate pain.

13. The method of claim 10, wherein the sympathetic nerve chain target is selected from the group consisting of a cervical ganglion, a stellate ganglion, a T1 ganglion, a T2 ganglion, and a T3 ganglion.

14. The method of claim 10, wherein said step of using ultrasound imaging to obtain an ultrasound image further comprises the step of:

obtaining a short axis ultrasound image of the root of the subject'"'"'s neck; and

identifying a plurality of anatomical structures selected from the group consisting of the trachea, the esophagus, the recurrent laryngeal nerve, the thyroid gland, the carotid artery, the internal jugular vein, the vagus nerve, the longus coli muscle, the inferior thyroid vessels, the vertebral vessels, and the sympathetic nerve chain.

15. The method of claim 14, wherein said step of identifying a plurality of anatomical structures further comprises identifying the plurality of anatomical structures along an anterior aspect of the longus coli muscle.

16. The method of claim 10, wherein said step of determining an implantation pathway further comprises identifying a bony spinous target at the level of C7.

17. The method of claim 10, wherein said step of navigating the introducer through the implantation pathway further comprises providing a securing mechanism to stabilize the introducer during navigation through the implantation pathway.

18. The method of claim 10, wherein said step of navigating the introducer through the implantation pathway further comprises using an in-plane or out-of-plane approach to target an anterior aspect of the longus coli muscle.

19. The method of claim 10, wherein said step of navigating the introducer through the implantation pathway further comprises the steps of:

directing the bevel of the introducer caudally; and

advancing the therapy delivery device through the introducer until the therapy delivery device is positioned adjacent or proximate to at least one of a stellate ganglion, a T1 ganglion, a T2 ganglion, or a T3 ganglion.

20. The method of claim 10, wherein said step of navigating the introducer through the implantation pathway further comprises the steps of:

directing the bevel of the introducer in a cephalad direction; and

advancing the therapy delivery device through the introducer until the therapy delivery device is positioned adjacent or proximate to at least one of a stellate ganglion or a cervical ganglion.

21. The method of claim 10, wherein said step of applying an electrical current to the sympathetic nerve chain target further comprises delivering an amount of electrical current sufficient to prevent or mitigate an acute medical condition.