Dilator

• US 9,566,086 B2
• Filed: 09/25/2014
• Issued: 02/14/2017
• Est. Priority Date: 10/18/2006
• Status: Active Grant

• Current Assignee: Boston Scientific Neuromodulation Corporation (Boston Scientific Corporation)
• Original Assignee: Veriflex, Inc. (Bravo Sports)
• Inventors: Tebbe, Shawn, Altarac, Moti, Cheng, Yang
• Primary Examiner(s): Prone, Christopher D
• Application Number:
  US14/496,820
• Publication Number:
  US 20150150598A1
• Time in Patent Office: 873 Days
• US Class Current: 1/1
• CPC Class Codes: A61B 17/025 Joint distractors
• CPC Class Codes: A61B 17/32093 for skin incisions
• CPC Class Codes: A61B 17/3211 Surgical scalpels, knives; Accessories therefor
• 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 17/7062 Devices acting on, attached to, or simulating the effect of, vertebral processes, vertebral facets or ribs rib fixation devices A61B17/8076; Tools for such devices
• CPC Class Codes: A61B 2017/0256 for the spine
• CPC Class Codes: A61B 2017/320044 Blunt dissectors blunt suture needles A61B2017/06085
• CPC Class Codes: A61B 2017/3454 Details of tips
• CPC Class Codes: A61B 2017/346 with wings
• CPC Class Codes: A61M 29/00 Dilators with or without means for introducing media, e.g. remedies instruments for performing visual medical inspections of cavities or tubes of the body A61B1/00

Abstract

A dilator that facilitates implantation of an interspinous spacer is provided. The dilator includes a proximal portion and a tapered distal portion interconnected by an elongated body portion. The tapered distal portion is ideally suited for splitting ligamentous tissue for creating a posterior midline pathway through the supraspinous ligament as well as for distracting the adjacent spinous processes. Two oppositely located and longitudinally extending channels or grooves are formed in the outer surface of the dilator for stabilizing the dilator with respect to the spinous processes. An accompanying cannula together with the dilator form a system for the distraction of the adjacent spinous processes, stabilization of the spinous processes with respect to the system and creation of a working channel for the implantation of an interspinous spacer.

Claims

1. A method comprising:

inserting at least a part of a distal portion of an insertion instrument through a supraspinous ligament and between adjacent spinous processes of a subject;

moving the insertion instrument in a direction substantially parallel to an anterior-to-posterior direction relative to the subject while the adjacent spinous processes are positioned between longitudinally-extending sidewalls of two oppositely located channels of the insertion instrument; and

moving a cannula such that the adjacent spinous processes move from the two channels of the insertion instrument to channels of the cannula.

2. The method of claim 1, further comprising:

removing the insertion instrument from a passageway of the cannula while the cannula is positioned in the subject; and

moving a treatment instrument through the passageway of the cannula positioned in the subject.

3. The method of claim 2, further comprising:

implanting an interspinous spacer in the subject using the treatment instrument, after implanting the interspinous spacer, removing the treatment instrument from the subject.

4. The method of claim 2, further comprising removing tissue from the subject using the treatment instrument.

5. The method of claim 4, further comprising performing at least a portion of a discectomy using the treatment instrument.

6. The method of claim 1, further comprising moving the insertion instrument to split ligamentous tissue of the subject while the adjacent spinous processes are located in the channels of the insertion instrument.

7. The method of claim 1, further comprising moving a sharp distal end of the insertion instrument through interspinous tissue between the adjacent spinous processes while a first channel of the two oppositely located channels faces a first one of the adjacent spinous processes and a second channel of the two oppositely located channels faces a second one of the adjacent spinous processes.

8. The method of claim 1, further comprising:

delivering a guidewire through the supraspinous ligament and between the adjacent spinous processes; and

moving the insertion instrument over the guidewire to insert the distal portion of the insertion instrument through the supraspinous ligament.

9. The method of claim 1, further comprising:

aligning the channels of the insertion instrument with channels of the cannula; and

moving the cannula in a direction generally parallel to the anterior-to-posterior direction such that the adjacent spinous processes move from channels of the insertion instrument to the channels of the cannula.

10. The method of claim 1 wherein the channels of the insertion instrument are U-shaped channels.

11. A method comprising:

moving an insertion instrument through a supraspinous ligament of a subject;

inserting the insertion instrument between adjacent spinous processes of the subject while the insertion instrument extends through the supraspinous ligament;

moving the insertion instrument relative to the adjacent spinous processes to separate at least a portion of interspinous tissue of the subject;

positioning a cannula between the adjacent spinous processes; and

removing the insertion instrument from the cannula while the cannula is positioned between the adjacent spinous processes.

12. The method of claim 11 wherein moving an insertion instrument through a supraspinous ligament includes moving the insertion instrument in a direction substantially parallel to an anterior-to-posterior direction relative to the subject as the insertion instrument passes through the supraspinous ligament.

13. The method of claim 11, further comprising:

inserting a guide through the supraspinous ligament and between the adjacent spinous processes; and

moving the insertion instrument along the guide to move the insertion instrument through the supraspinous ligament.

14. The method of claim 11 wherein inserting the insertion instrument between the adjacent spinous processes comprises delivering the insertion instrument into the subject using a midline approach.

15. The method of claim 11, further comprising splitting interspinous ligamentous tissue of the subject by moving the insertion instrument relative to the adjacent spinous processes so as to provide a midline pathway through the interspinous ligamentous tissue.

16. A method comprising:

inserting a dilator into a subject via a posterior midline approach between adjacent spinous processes of the subject;

distracting the adjacent spinous processes by advancing the dilator relative to the adjacent spinous processes; and

positioning a cannula between the adjacent spinous processes such that the cannula maintains distraction of the adjacent spinous processes when the dilator is removed from the subject.

17. The method of claim 16 wherein inserting the dilator into the subject includes

delivering a guide into the subject, and

delivering the dilator over the guide.

18. The method of claim 16 wherein the adjacent spinous processes include first and second spinous processes, wherein the method further comprising:

positioning the first spinous process in a first longitudinal channel of the dilator;

positioning the second spinous process in a second longitudinal channel of the dilator; and

moving the dilator in an anterior direction relative to the subject while the first and second spinous processes slide along the respective first and second longitudinal channels.

19. The method of claim 16, further comprising positioning one of the adjacent spinous processes in a channel of the dilator.

20. The method of claim 19, further including positioning the other one of the adjacent spinous processes in another channel of the dilator.

21. The method of claim 16, further including:

placing a cannula over the dilator; and

aligning at least one channel formed on the cannula with at least one channel formed on the dilator.

22. The method of claim 21, further including distracting the adjacent spinous processes with advancement of the cannula over the dilator.

23. The method of claim 16, further including inserting the dilator through the supraspinous ligament.

24. The method of claim 16, further including:

stabilizing the dilator with respect to one of the adjacent spinous processes with a first channel formed in an outer surface the dilator; and

stabilizing the dilator with respect to the other of the adjacent spinous processes with a second channel formed in the outer surface of the dilator.

25. The method of claim 16, further including splitting ligamentous tissue with the dilator.

26. A method comprising:

moving at least a part of an insertion instrument through a subject'"'"'s supraspinous ligament and between adjacent spinous processes;

advancing the insertion instrument into the subject while the adjacent spinous processes are positioned in channels of the insertion instrument; and

moving a cannula into the subject such that the adjacent spinous processes move from the channels of the insertion instrument to channels of the cannula.

27. The method of claim 26, further comprising:

positioning the cannula between the adjacent spinous processes; and

removing the insertion instrument from the subject while the cannula maintains distraction of the adjacent spinous processes.

28. The method of claim 26 wherein the insertion instrument includes at least one dilator.