Dilation introducer for orthopedic surgery

• US 20060030872A1
• Filed: 08/03/2004
• Published: 02/09/2006
• Est. Priority Date: 08/03/2004
• Status: Abandoned Application

• Current Assignee: Interventional Spine, Inc (Johnson & Johnson)
• Original Assignee: Interventional Spine, Inc (Johnson & Johnson)
• Inventors: Warren, Christopher, Boomer, Mark C., Culbert, Brad
• Application Number:
  US10/911,215
• Publication Number:
  US 20060030872A1
• Time in Patent Office: Days
• US Class Current: 606/191
• CPC Class Codes: A61B 17/02 for holding wounds open; Tractors specula A61B1/32 ; drainage appliances for wounds A61M27/00
• CPC Class Codes: A61B 17/3417 Details of tips or shafts, e.g. grooves, expandable, bendable; Multiple coaxial sliding cannulas, e.g. for dilating syringe needles A61M5/32; dilators A61M29/00
• CPC Class Codes: A61B 17/3421 Cannulas
• CPC Class Codes: A61B 2017/00477 Coupling A61B2017/0046 takes precedence
• CPC Class Codes: A61B 2017/320044 Blunt dissectors
• 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

The dilation introducer has a locked assembled configuration for placement of the dilation introducer against a patient'"'"'s bone tissue to be treated, and an unlocked, collapsed configuration for dilating the patient'"'"'s soft tissue down to the bone tissue to be treated to a desired degree of dilation to permit minimally invasive surgical procedures on the patient'"'"'s bone tissue to be treated. Dilator tubes are successively released and advanced to progressively expand the patient'"'"'s soft tissue down to the bone tissue to be treated. A method for a minimally invasive procedure utilizing the telescoping dilation introducer to insert a bone fixation device into a patient'"'"'s spine for posterior spine fusion is also provided.

Claims

1. A dilation introducer for orthopedic surgery, the dilation introducer having a locked assembled configuration for initial placement of the dilation introducer against a patient'"'"'s bone tissue to be treated, and an unlocked, collapsed configuration dilating the patient'"'"'s soft tissue down to the bone tissue to be treated to a desired degree of dilation to permit minimally invasive surgical procedures on the patient'"'"'s bone tissue to be treated, comprising:

a first dilator tube having a distal end and a proximal end, the distal end having a tapered tip;

a second dilator tube, the first dilator tube being removably received in the second dilator tube for slidable telescoping movement within the second dilator tube, the second dilator tube having a distal end and a proximal end, an inner lumen with a distal opening and a proximal opening, the distal end having a tapered tip; and

means for removably connecting the first and second dilator tubes together in a locked configuration, whereby in the locked configuration the distal end of the first dilator tube can be pressed against the patient'"'"'s bone tissue to be treated, and whereby in the unlocked configuration the second dilator tube is permitted to slidably telescope over the first dilator tube to dilate the patient'"'"'s soft tissue at the distal end of the dilation introducer.

2. The dilation introducer of claim 1, further comprising at least one additional dilator tube, the second dilator tube being removably received in the at least one additional dilator tube for slidable telescoping movement within the at least one additional dilator tube, the at least one additional dilator tube having a distal end and a proximal end, an inner lumen with a distal opening and a proximal opening, the distal end having a tapered tip, the second dilator tube and the at least one additional dilator tube having an unlocked configuration in which the at least one additional dilator tube is permitted to slidably telescope over the second dilator tube to dilate the patient'"'"'s soft tissue at the distal end of the dilation introducer.

3. The dilation introducer of claim 2, further comprising means for removably connecting the second dilator tube and the at least one additional dilator tube together in a locked configuration, whereby in the locked configuration the distal end of the second dilator tube can be pressed against the patient'"'"'s bone tissue to be treated, and whereby in the unlocked configuration the at least one additional dilator tube is permitted to slidably telescope over the second dilator tube to dilate the patient'"'"'s soft tissue at the distal end of the dilation introducer.

4. The dilation introducer of claim 1, wherein the proximal end of the first dilator tube includes a pair of spaced apart rings, the proximal end of the second dilator tube includes a pair of spaced apart rings, and said means for removably connecting the first and second dilator tubes together in a locked configuration comprises a first locking clip removably connected to said first dilator tube between said pair of spaced apart rings of said first dilator tube and to said second dilator tube between said pair of spaced apart rings of said second dilator tube, and wherein removing said first locking clip allows the second dilator tube to slidably telescope over the first dilator tube to further dilate tissue at the distal end of the dilation introducer.

5. The dilation introducer of claim 4, wherein said first locking clip comprises a first portion and a second portion, and a cross-piece having a first end and a second end connected between the first portion and the second portion, the first portion including a pair of resilient arms each having a proximal narrow neck portion connected to said cross-piece and a distal gripping portion extending from the narrow neck portion, the pair of resilient arms having an inner rounded surface adapted to snap over the first dilator tube between the spaced apart rings of the first dilator tube, the second portion including a single arm having a proximal narrow neck portion connected to said cross-piece and a distal gripping portion extending from the narrow neck portion, the single arm having an inner rounded surface adapted to fit over the outer surface of the second dilator tube between the spaced apart rings of the second dilator tube, to connect the first and second dilator tubes.

6. The dilation introducer of claim 3, wherein the proximal end of the second dilator tube includes a pair of spaced apart rings, the proximal end of the at least one additional dilator tube includes a handle fixedly mounted to the proximal end of the at least one additional dilator tube, and said means for removably connecting the second dilator tube and the at least one additional dilator tube together in a locked configuration comprises a second locking clip removably connected to said first dilator tube between said pair of spaced apart rings of said second dilator tube and to said at least one additional dilator tube over said handle, and wherein removing said second locking clip allows the at least one additional dilator tube to slidably telescope over the second dilator tube to further dilate tissue at the distal end of the dilation introducer.

7. The dilation introducer of claim 6, wherein said second locking clip comprises a first portion and a second portion, and a cross-piece having a first end and a second end connected between the first portion and the second portion, the first portion including a pair of resilient arms each having a proximal narrow neck portion connected to said cross-piece and a distal gripping portion extending from the narrow neck portion, the pair of resilient arms having an inner rounded surface adapted to snap over the second dilator tube between the spaced apart rings of the first dilator tube, the second portion including a pair of resilient arms each having a proximal narrow neck portion connected to said cross-piece and a distal gripping portion extending from the narrow neck portion, the pair of resilient arms having an inner rounded surface adapted to snap over the at least one additional dilator tube to connect the second dilator tube and the at least one additional dilator tube.

8. The dilation introducer of claim 1, wherein said means for removably connecting the first and second dilator tubes together in a locked configuration comprises a latching member projecting from the proximal end of said first dilator tube toward the distal end of the first dilator tube, and the proximal end of said second dilator tube includes a head with a first radial aperture removably receiving a first locking pin, and a second longitudinal aperture for removably receiving said latching member, said latching member being engaged by said first locking pin, and whereby removing said first locking pin from said first radial aperture releases said latching member to permit the second dilator tube to slidably telescope over the first dilator tube to further dilate tissue at the distal end of the dilation introducer.

9. The dilation introducer of claim 3, wherein said means for removably connecting the second dilator tube and the at least one additional dilator tube together in a locked configuration comprises a latching member projecting from the proximal end of said second dilator tube toward the distal end of the second dilator tube, and the proximal end of said at least one additional dilator tube includes a first radial aperture removably receiving a second locking pin, and a second longitudinal aperture for removably receiving said latching member, said latching member being engaged by said second locking pin, and whereby removing said second locking pin from said first radial aperture releases said latching member to permit the at least one additional dilator tube to slidably telescope over the second dilator tube to further dilate tissue at the distal end of the dilation introducer.

10. The dilation introducer of claim 1, wherein said means for removably connecting the first and second dilator tubes together in a locked configuration comprises a bayonet fitting removably coupling the first and second dilator tubes together.

11. The dilation introducer of claim 10, wherein said bayonet fitting comprises a first pair of opposing bayonet pins extending from said proximal end of said first dilator tube, and interior opposing bayonet slots formed in said second dilator tube for receiving the first pair of opposing bayonet pins of the first dilator tube.

12. The dilation introducer of claim 10, wherein said bayonet fitting comprises a bayonet pin extending from the proximal end of the first dilator tube, and a bayonet slot formed in the proximal end of the second dilator tube for receiving the bayonet pin of the first dilator tube.

13. The dilation introducer of claim 3, wherein said means for removably connecting the second dilator tube and the at least one additional dilator tube together in a locked configuration comprises a bayonet fitting removably coupling the second dilator tube and the at least one additional dilator tube together.

14. The dilation introducer of claim 13, wherein said bayonet fitting comprises a pair of opposing bayonet pins extending from said proximal end of said second dilator tube, and interior opposing bayonet slots formed in said at least one additional dilator tube for receiving said pair of opposing bayonet pins of the second dilator tube.

15. The dilation introducer of claim 1, wherein said first dilator tube distal end has a tapered, beveled tip.

16. The dilation introducer of claim 1, wherein said second dilator tube distal end has a tapered, beveled tip.

17. The dilation introducer of claim 2, wherein said at least one additional dilator tube distal end has a tapered, beveled tip.

18. The dilation introducer of claim 2, further comprising at least one plastic sleeve slidably disposed over the at least one additional dilator tube.

19. The dilation introducer of claim 18, wherein said plastic sleeve has a proximal end and a distal end, and the distal end of said plastic sleeve has a tapered, beveled tip.

20. The dilation introducer of claim 1, further comprising a tubular bone drill removably received in the first dilator tube.

21. The dilation introducer of claim 20, further comprising a guide wire removably received in said tubular bone drill to contact the bone tissue to be treated.

22. The dilation introducer of claim 1, further comprising a pair of opposing handles on the proximal end of the second dilator tube.

23. The dilation introducer of claim 1, wherein said first dilator tube includes an inner lumen with a distal opening and a proximal opening.

24. The dilation introducer of claim 2, wherein at least one of said dilator tubes is radioluscent.

25. The dilation introducer of claim 2, wherein the tip of at least one of said dilator tubes includes a radiopaque marker.

26. The dilation introducer of claim 2, wherein the tip of at least one of said dilator tubes is provided with a surface that is rough.

27. The dilation introducer of claim 26, wherein the surface is scored.

28. The dilation introducer of claim 26, wherein the surface is grooved.

29. The dilation introducer of claim 2, wherein the dilator tubes are curved.

30. The dilation introducer of claim 2, wherein the dilator tubes are non-linear.

31. The dilation introducer of claim 2, wherein the dilator tubes have a non-cylindrical shape.

32. The dilation introducer of claim 31, wherein the non-cylindrical shape is oval.

33. The dilation introducer of claim 1, further comprising a guide wire over which said first dilator tube is received.

34. The dilation introducer of claim 33, wherein the guide wire comprises a proximal enlarged stop portion and a relatively narrow elongated body portion.

35. The dilation introducer of claim 33, wherein the relatively narrow elongated body portion comprises a proximal section having a relatively larger diameter, a main section having a relatively narrower diameter, and a blunt frustoconical distal end.

36. The dilation introducer of claim 35, wherein the main section of the relatively narrow body portion includes a relatively narrower middle section.

37. The dilation introducer of claim 2, further comprising a parallel guide insert adapted to be received in said at least one additional dilator tube, said parallel guide insert including a main cylindrical shaft having a proximal end connected to a cylindrical head, and a plurality of longitudinal bores extending the length of the parallel guide insert through the main cylindrical shaft and cylindrical head.

38. The dilation introducer of claim 37, wherein the cylindrical head of said parallel guide insert includes a distally projecting latching member, the proximal end of said at least one additional dilator tube includes a longitudinal aperture for receiving the distally projecting latching member, and the proximal end of said at least one additional dilator tube includes a radial aperture for receiving a locking pin that engages said distally projecting latching member for securing the parallel guide insert in a fixed position in said at least one additional dilator tube.

39. The dilation introducer of claim 17, further comprising a parallel guide insert adapted to be received in said at least one additional dilator tube, said parallel guide insert including a main cylindrical shaft having a proximal end connected to a cylindrical head, and a plurality of longitudinal bores extending the length of the parallel guide insert through the main cylindrical shaft and cylindrical head, and wherein said main cylindrical shaft of the parallel guide insert has an angled distal end.

40. The dilation introducer of claim 39, wherein the cylindrical head of said parallel guide insert includes a distally projecting latching member, the proximal end of said at least one additional dilator tube includes a longitudinal aperture for receiving the distally projecting latching member, and the proximal end of said at least one additional dilator tube includes a radial aperture for receiving a locking pin that engages said distally projecting latching member for securing the parallel guide insert in a fixed position in said at least one additional dilator tube.

41. The dilation introducer of claim 1, further comprising light conductance means to conduct light from the proximal end of the introducer in the distal end of the introducer.

42. The dilation introducer of claim 1, further comprising an imaging system to image the area near the distil end of the introducer and transmitting said image to a remote location.

43. A method for dilating a patient'"'"'s soft tissue down to bone tissue to be treated in orthopedic surgery, comprising the steps of:

locating an entry point on the bone tissue to be treated;

placing a tip of a guide wire down to the entry point on the bone tissue to be treated;

driving the guide wire into the patient'"'"'s soft tissue to a target point of the bone tissue to be treated;

forming a vertical midline incision to a desired depth in the patient'"'"'s soft tissue, using the entry point as a middle of the incision;

passing a first dilator tube of a dilation introducer over the guide wire until the first dilator tube reaches the target point of the bone tissue to be treated;

driving the guide wire into the bone tissue to be treated to a desired depth;

passing a second dilator tube of the dilation introducer over the first dilator tube to the bone tissue to be treated, and removing the first dilator tube, leaving the second dilator tube remaining in position in the patient'"'"'s soft tissue against the bone tissue to be treated;

passing at least one additional dilator tube of the dilation introducer successively over the prior dilator tube remaining in position in the patient'"'"'s soft tissue against the bone tissue to be treated, to progressively expand the patient'"'"'s soft tissue down to the entry point on the bone tissue to be treated;

passing a drill over the guide wire to the target point of the bone tissue to be treated, and into the bone tissue to be treated until the drill reaches an appropriate depth;

removing the drill leaving a last remaining dilator tube in place to allow minimally invasive implantation of a bone fixation device over the guide wire in the bone tissue to be treated;

removing the guide wire; and

removing the last remaining dilator tube.