Dilator

• US 10,588,663 B2
• Filed: 02/13/2017
• Issued: 03/17/2020
• Est. Priority Date: 10/18/2006
• Status: Active Grant

• Current Assignee: Boston Scientific Neuromodulation Corporation (Boston Scientific Corporation)
• Original Assignee: Vertiflex, Inc. (Boston Scientific Corporation)
• Inventors: Tebbe, Shawn, Altarac, Moti, Cheng, Yang
• Primary Examiner(s): Prone, Christopher D.
• Application Number:
  US15/431,255
• Publication Number:
  US 20170245883A1
• Time in Patent Office: 1,128 Days
• 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 system comprising:

a dilator comprising;

a proximal portion and a distal portion interconnected by an elongated body portion;

at least a part of the distal portion has a cross-sectional area decreasing with distance towards a distal end; and

two oppositely located channels formed in the body portion and extending longitudinally into the distal portion; and

an instrument configured to be delivered through a subject'"'"'s supraspinous ligament, the instrument including a tubular body and two oppositely located channels on an outer surface of the tubular body, each of the channels of the instrument defining two sidewalls and a solid base between, and directly connecting, the two sidewalls, and the tubular body having an inner surface defining a passageway configured to receive the dilator and being positioned directly between the passageway and the base of each of the channels of the instrument.

2. The system of claim 1 wherein the instrument is configured to receive the dilator inside the passageway such that the channels of the instrument are aligned with the channels of the dilator.

3. A system comprising:

a dilator including an elongate body with a first dilator channel and a second dilator channel, wherein the first and second dilator channels extend along a sidewall of the elongate body, wherein the first dilator channel is configured to be positioned to hold a first spinous process of a subject and the second dilator channel is configured to be positioned to hold a second spinous process of the subject; and

an instrument including a tubular body, a passageway, a first instrument channel, and a second instrument channel, wherein the first instrument channel is configured to receive the first spinous process from the first dilator channel to the first instrument channel, wherein the second instrument channel is configured to receive the second spinous process from the second dilator channel, wherein the tubular body is directly between the passageway and each of the first and second instrument channels, each of the first and second instrument channels defining two sidewalls and a solid base between, and directly connecting, the two sidewalls.

4. The system of claim 3, wherein the dilator and the instrument are configured to be sequentially advanced into the subject to distract the first and second spinous processes.

5. The system of claim 3, wherein the first dilator channel has a solid base and sidewalls spaced apart by the solid base and configured to receive the first spinous process therebetween.

6. The system of claim 3, wherein the dilator has a tapered distal portion extending distally from the first and second dilator channels.

7. The system of claim 3, wherein the instrument is configured to be moved over a proximal end of the elongate body and advanced along the elongate body.

8. The system of claim 3, wherein the first and second instrument channels terminate at locations proximate to a distal portion of the instrument.

9. The system of claim 3, wherein the dilator and the instrument are configured to cooperate to align the first and second dilator channels with the first and second instrument channels, respectively.

10. The system of claim 3, wherein at least a portion of the first instrument channel is sloped and configured to cause distraction of the first and second spinous processes.

11. The system of claim 3, wherein a distal end of the instrument is configured to be positioned directly between the first and second spinous processes, and wherein a distance between the first and second instrument channels increases toward a proximal end of the instrument.

12. The system of claim 3, wherein the dilator is hollow.

13. The system of claim 3, wherein the dilator has a solid cross section.

14. The system of claim 3, wherein the first instrument channel is wider than the first dilator channel.

15. A system comprising:

a dilator configured to be delivered through a human subject'"'"'s supraspinous ligament and including

a body, and

a first dilator channel extending along the body and configured to receive a first spinous process of the human subject; and

an instrument movable over the dilator and including

an instrument body with a dilator-receiving passageway, and

a first instrument channel configured to receive the first spinous process while the dilator is positioned in the dilator-receiving passageway, wherein the instrument body is positioned directly between the first instrument channel and the dilator-receiving passageway, the first instrument channel defining two sidewalls and a solid base between, and directly connecting, the two sidewalls.

16. The system of claim 15, wherein the first dilator channel extends longitudinally along the body of the dilator.

17. The system of claim 15, further comprising a second dilator channel that extends longitudinally along the body, and wherein the first and second dilator channels are located on opposite sides of the body.

18. The system of claim 15, further comprising a second instrument channel that extends longitudinally along the instrument body, and wherein the first and second instrument channels are on opposite sides of the instrument body, the second instrument channel defining two sidewalls and a solid base between, and directly connecting, the two sidewalls.

19. The system of claim 15, wherein the first dilator channel and the first instrument channel are configured to be aligned when the dilator is positioned in the dilator-receiving passageway.

20. The system of claim 15, wherein the first dilator channel is narrower than the first instrument channel.

21. The system of claim 15, wherein the first instrument channel has a depth that gradually decreases toward a central region of the instrument.

22. The system of claim 15, wherein the instrument has a proximal end and a distal end, and wherein the first instrument channel has a depth that gradually decreases toward the distal end of the instrument.

23. The system of claim 15, wherein the first instrument channel is sloped and configured to cause distraction of the first and second spinous processes.

24. The system of claim 15, wherein the instrument is a dilator or a cannula.