Dilator

• US 8,845,726 B2
• Filed: 01/22/2009
• Issued: 09/30/2014
• 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:
  US12/358,010
• Publication Number:
  US 20090125030A1
• Time in Patent Office: 2,077 Days
• Field of Search: 623/17.11, 606/13, 606/45, 606/57, 606/159, 606/172, 606/222, 606/223, 606/233, 606/248, 606/249, 606272-274, 606/90
• US Class Current: 623/17.11
• 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 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 as the cross-sectional area gets closer to a distal end; and

two oppositely located channels formed in the body portion and extending longitudinally into the distal portion, each channel configured to receive a spinous process of a human subject distracted by the distal portion and having a first end portion opposite a second end portion, wherein each of the first end portions commences in the distal portion and each of the second end portions terminates in the body portion at a location proximate to the distal portion,

wherein the two oppositely located channels are positioned to receive the spinous processes distracted by the distal portion and are configured to hold the distracted spinous process when the distracted spinous processes are positioned between longitudinally-extending sidewalls of the channels extending distally and proximally past the distracted spinous processes and the body portion extends in a direction generally perpendicular to a cephalad-caused direction.

2. The dilator of claim 1 wherein at least part of the distal portion is substantially pyramidal.

3. The dilator of claim 1 wherein the distal portion includes four flat faces angled towards each other in a distal direction.

4. The dilator of claim 3 wherein the four flat faces have a rhomboidal cross section taken perpendicular to a longitudinal axis of the dilator;

the rhomboidal cross-section having a major diagonal aligned with each of the two channels.

5. The dilator of claim 1 wherein the body portion includes two oppositely located flat surfaces extending longitudinally along at least a portion of the body portion, wherein each of the flat surfaces is located at a bottom of one of the channels.

6. The dilator of claim 1 wherein each channel includes a flat base between the two longitudinally-extending sidewalls.

7. The dilator of claim 6 wherein the body portion includes two flat surfaces formed on the body portion;

one of the flat surfaces being substantially parallel to one of the flat base of one channel and the other of the flat surfaces being substantially parallel to the flat bases of the other channel.

8. The dilator of claim 1 wherein:

the distal portion of the body portion includes four generally planar surfaces, wherein the four planar surfaces angle towards each other in a direction extending towards the distal portion; and

the first end portion of each channel intersects at least one of the planar surfaces.

9. The dilator of claim 8 the first end portion of each channel intersects two adjacent planar surfaces.

10. The dilator of claim 8 wherein

an intersection of a first one of the four generally planar surfaces and a second one of the four generally planar surfaces are aligned with the first end portion of a first one of the channels;

and

an intersection of a third one of the four generally planar surfaces and a fourth one of the four generally planar surfaces is aligned with the first end portion of a second one of the channels.

11. The dilator of claim 1 wherein the distal portion is configured to be inserted between adjacent spinous processes in a spinal segment.

12. The dilator of claim 1 wherein the channels are configured to cause distraction of the spinous processes when the spinous processes move along the channels.

13. The dilator of claim 1 wherein each of the second end portions defines a depth that decreases in a proximal direction such that spinous processes received by the channels are distracted as the spinous processes move along the second end portions.

14. The dilator of claim 1 wherein the locations at which the second end portions terminate in the body portion are closer to the distal end of the dilator than a proximal end of the dilator.

15. The dilator of claim 1 wherein the longitudinally-extending sidewalls are spaced apart from one another such that the spinous processes between the longitudinally-extending sidewalls contact bottom surfaces of the channels to maintain distraction of the distracted spinous processes.

16. The dilator of claim 1 wherein at least part of the distal portion is substantially conical.

17. The dilator of claim 1 wherein the distal portion includes two flat faces angled towards each other in the a distal direction;

each of the two flat faces being oppositely located between the two channels.

18. The dilator of claim 17 wherein the two flat faces form a tip having a rectangular or line cross-section taken perpendicular to a longitudinal axis of the dilator.

19. The dilator of claim 17 wherein the two flat faces form an intersection at the distal end of the dilator;

the intersection being aligned with the two channels.

20. The dilator of claim 19 wherein the intersection is a sharp edge.

21. The dilator of claim 19 further including an opening along the intersection.

22. The dilator of claim 1 wherein the dilator includes a passageway extending between an opening at the distal portion and an opening at the portion end.

23. The dilator of claim 1 further including a retractable blade at the distal portion.

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

24. A system comprising:

a dilator comprising;

a proximal portion and a distal portion interconnected by an elongated body portion, wherein at least a part of the distal portion has a distal end and a cross-sectional area that decreases as the cross-sectional area gets closer to the distal end; and

two oppositely located channels formed in the body portion and extending longitudinally into the distal portion, each channel configured to receive a spinous process distracted by the distal portion and having a first end and a second end, wherein each of the first ends of the channels commences in the distal portion, wherein each channel is positioned to receive and hold the spinous process distracted by the distal portion; and

a cannula including two oppositely located channels on an outer surface and having a passageway configured to receive the dilator, wherein the channels of the cannula are positioned relative to the channels of the dilator such that the distracted spinous processes move from the channels of the dilator to the respective channels of the cannula when the cannula is moved along the dilator.

26. A system comprising:

a dilator including

a proximal end;

a distal portion that has a cross-sectional area that decreases towards a distal end of the dilator;

an elongated body portion between the proximal end and the distal portion;

a first channel configured to receive a first spinous process and including a distal first channel end at the distal portion and a proximal first channel end, the proximal first channel end is closer to the distal end of the dilator than the proximal end of the dilator; and

a second channel spaced apart from the first channel and configured to receive a second spinous process, the second channel including a distal second channel end at the distal portion and a proximal second channel end, the proximal second channel end is closer to the distal end of the dilator than the proximal end of the dilator,

wherein the first channel and the second channel are positioned to receive and laterally hold the respective first and second spinous processes distracted by the distal portion.

27. The system of claim 26 wherein the proximal first and second channel ends are ramped.

28. The system of claim 26 wherein the first and second channels are configured to distract the first spinous process and the second spinous process as the first spinous process and the second spinous process move in a proximal direction along the first channel and the second channel, respectively.

29. The system of claim 26, further comprising a cannula including a passageway, a first cannula channel, and a second cannula channel, wherein the first cannula channel and the second cannula channel are configured to receive the first spinous process and the second spinous process, respectively, when the cannula is advanced along the dilator.

30. The system of claim 29 wherein the first cannula channel is positioned to receive the first spinous process and the second cannula channel is positioned to receive the second spinous process when the cannula is moved along the dilator.

31. The system of claim 26 wherein the distal portion is configured to pass through a supraspinous ligament while keeping the first channel and the second channel substantially perpendicular to a cephalad-caudal direction.

32. The system of claim 26, further comprising:

a guidewire positioned in a passageway of the dilator such that the guidewire is capable of being moved distally from the distal end of the dilator.

33. A system for distracting a first spinous process and a second spinous process of a human subject, comprising:

a dilator including

a proximal portion;

a distal portion configured to distract the first spinous process and the second spinous process;

an elongated body portion between the proximal portion and the distal portion;

a first channel positioned along the body portion and including longitudinally-extending first sidewalls spaced apart to be positioned on either side of the first spinous process distracted by the distal portion; and

a second channel positioned along the body portion and spaced apart from the first channel, wherein the second channel includes longitudinally-extending second sidewalls spaced apart to be positioned on either side of the second spinous process distracted by the distal portion such that the first spinous process is between the first sidewalls of the first channel and the second spinous process is between the second sidewalls of the second channel while the dilator moves relative to the first and second spinous processes.

34. The system of claim 33 wherein the first channel and the second channel are positioned on opposite sides of the dilator.

35. The system of claim 33, further comprising a cannula including two cannula channels and a passageway configured to receive the dilator, wherein the cannula channels are positioned such that the first and second spinous processes move from the channels of the dilator to the cannula channels when the cannula is advanced along the dilator.

36. The system of claim 33 wherein the longitudinally-extending first sidewalls of the first channel and the longitudinally-extending second sidewalls of the second channel are oriented to extend distally and proximally past the first and second spinous processes such that the first spinous process is positioned directly between the first sidewalls of the first channel and the second spinous process is positioned directly between the second sidewalls of the second channel when the dilator is advanced distally into the subject.

37. The system of claim 33 wherein each channel has a flat bottom.