Spinal Stabilization Device

• US 20110301643A1
• Filed: 06/17/2011
• Published: 12/08/2011
• Est. Priority Date: 09/24/2003
• Status: Active Grant

• Current Assignee: Depuy Synthes Products Incorporated (Johnson & Johnson)
• Original Assignee: DePuy Synthes Products LLC (Johnson & Johnson)
• Inventors: Jahng, Tae-ahn
• Granted Patent: US 8,623,057 B2
• Time in Patent Office: Days
• US Class Current: 606/254
• CPC Class Codes: A61B 17/02 for holding wounds open; Tractors specula A61B1/32 ; drainage appliances for wounds A61M27/00
• CPC Class Codes: A61B 17/1757 for the spine
• CPC Class Codes: A61B 17/3421 Cannulas
• CPC Class Codes: A61B 17/3423 Access ports, e.g. toroid shape introducers for instruments or hands access sites for liquids A61M39/0247
• CPC Class Codes: A61B 17/3439 with means for changing the inner diameter of the cannula, e.g. expandable A61B17/3423, A61B17/3431 take precedence; catheters A61M25/0662
• 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 17/3472 for bones, e.g. intraosseus injections
• CPC Class Codes: A61B 17/7004 with a cross-section which varies along its length A61B17/7019 takes precedence
• CPC Class Codes: A61B 17/7007 Parts of the longitudinal elements, e.g. their ends, being specially adapted to fit around the screw or hook heads
• CPC Class Codes: A61B 17/701 Longitudinal elements with a non-circular, e.g. rectangular, cross-section A61B17/7005, A61B17/7007 take precedence
• CPC Class Codes: A61B 17/7032 Screws or hooks with U-shaped head or back through which longitudinal rods pass
• CPC Class Codes: A61B 17/88 Osteosynthesis instruments; Methods or means for implanting or extracting internal or external fixation devices A61B17/7074 takes precedence
• CPC Class Codes: A61B 17/8897 Guide wires or guide pins
• CPC Class Codes: A61B 2017/00004 (bio)absorbable, (bio)resorbable, resorptive for implantable prostheses A61F2210/0004
• CPC Class Codes: A61B 2017/00862 elastic or resilient for sutures A61B2017/0618
• CPC Class Codes: A61B 2017/0256 for the spine
• CPC Class Codes: A61B 2090/363 Use of fiducial points
• CPC Class Codes: A61B 2090/3916 Bone tissue
• CPC Class Codes: A61B 2090/3987 Applicators for implanting markers
• CPC Class Codes: A61B 90/39 Markers, e.g. radio-opaque or breast lesions markers

Abstract

A flexible connection unit for use in a spinal fixation device that includes: a longitudinal member having first and second ends and a flexible member interposed between the first and second ends, at least one of the first end and second end configured to be engaged by a first bone securing member; and at least one spacer located between the first and second ends, the spacer comprising a resilient element and a ring element encircling at least a portion of the resilient element, wherein the ring element is configured to be engaged by a second bone securing member.

Claims

1. A flexible, elongated connection unit for stabilizing a human spine where the flexible connection unit is configured to be surgically implanted into the human body adjacent the spine and held in place by at least a first and a second pedicle screw assembly that are configured to be anchored into a first and second, adjacent vertebra, respectively, the flexible, elongated connection unit comprising:

(a) a first, metallic rigid portion having an outer surface configured to be secured within the first pedicle screw assembly, the outer surface of the first rigid portion having a dimension;

(b) a second, metallic rigid portion;

(c) a cylindrical flexible member directly secured to the first rigid portion and to the second rigid portion, the flexible member having an outer surface having a diameter less than the dimension of the outer surface of the first rigid portion at a position between the first and second rigid portions;

(d) a longitudinally compressible spacer comprising;

(1) a metallic, rigid portion having a length and having an inner bore extending the length of the spacer metallic portion, the flexible member extending through the bore of the spacer metallic portion, the inner bore of the spacer metallic portion having a larger dimension than the diameter of the outer surface of the flexible member along the length of the spacer metallic portion bore such that the spacer metallic portion can slide along the outer surface of the flexible member, and where the spacer metallic portion has an outer surface configured to be secured within the second pedicle screw assembly, the spacer metallic portion being located entirely between the first rigid portion and the second rigid portion such that along the length of the connection unit no portion of the spacer metallic portion overlaps with any portion of the first or second rigid portion;

(2) a first elastomeric portion located at least partially between the first rigid portion and the spacer metallic portion, the first elastomeric portion having a length and having an inner bore extending the length of the first elastomeric portion with the flexible member extending through the bore of the first elastomeric portion;

(3) a second elastomeric portion located at least partially between the second rigid portion and the spacer metallic portion, the second elastomeric portion having a length and having an inner bore extending the length of the second elastomeric portion with the flexible member extending through the bore of the second elastomeric portion;

whereby the first and second elastomeric spacer portions limit the sliding of the spacer metallic portion along the flexible member.

2. The flexible connection unit of claim 1, wherein the spacer metallic portion is physically separate from and does not physically contact the first rigid portion or the second rigid portion.

3. The flexible connection unit of claim 1, wherein the spacer metallic portion is not integral with the first rigid portion or the second rigid portion.

4. The flexible connection unit of claim 1, wherein the second rigid portion has a longitudinal dimension that is shorter than the longitudinal dimension of both the first elastomeric portion and the second elastomeric portion individually.

5. The flexible connection unit of claim 1, wherein the first and second elastomeric spacer portions limit the sliding of the spacer metallic portion along the flexible member in response to external forces of the magnitude experienced from movement of the spine applied to the first rigid portion and the spacer metallic portion.

6. The flexible connection unit of claim 1, wherein the spacer is constructed such that the first elastomeric portion physically separates the first rigid portion and the spacer metallic portion and the second elastomeric portion physically separates the second rigid portion and the spacer metallic portion.

7. The flexible connection unit of claim 6, wherein the spacer metallic portion physically separates the first and second elastomeric portions.

8. The flexible connection unit of claim 6, wherein the entire outer, longitudinal surface of each of the first rigid portion and the spacer metallic portion is cylindrical and uniform.

9. The flexible connection unit of claim 6, wherein both the first and second spacer elastomeric portions comprise polycarbonate urethane.

10. The flexible connection unit of claim 8, wherein the first rigid portion is longer than the second rigid portion.

11. The flexible connection unit of claim 8, wherein both the first and second spacer elastomeric portions comprise polycarbonate urethane.

12. The flexible connection unit of claim 1, wherein the flexible member is metallic.

13. A flexible, elongated connection unit for stabilizing a human spine where the flexible connection unit is configured to be surgically implanted into the human body adjacent the spine and held in place by at least a first and a second bone coupling assembly that are configured to be anchored into a first and second, adjacent vertebra, respectively, the flexible connection unit comprising:

(a) a first, metallic rigid portion having an outer surface configured to be secured within the first bone coupling assembly;

(b) a second, metallic rigid portion;

(c) a flexible member connected with the first rigid portion and the second rigid portion, the flexible member having an outer surface;

(d) a longitudinally compressible spacer comprising;

(1) a metallic, rigid portion having a length and having an inner bore extending the length of the spacer metallic portion, the flexible member extending through the inner bore of the spacer metallic portion, the inner bore of the spacer metallic portion having a larger dimension than the outer surface of the flexible member along the length of the spacer metallic portion bore such that the spacer metallic portion can slide along the outer surface of the flexible member, and where the spacer metallic portion has an outer surface configured to be secured within the second bone coupling assembly, the spacer metallic portion being located entirely between the first rigid portion and the second rigid portion such that along the length of the connection unit no portion of the spacer metallic portion overlaps with any portion of the first or second rigid portion;

(2) a first elastomeric portion located at least partially between the first rigid portion and the spacer metallic portion, the first elastomeric portion having a length and having an inner bore extending the length of the first elastomeric portion with the flexible member extending through the bore of the first elastomeric portion;

(3) a second elastomeric portion located at least partially between the second rigid portion and the spacer metallic portion, the second elastomeric portion having a length and having an inner bore extending the length of the second elastomeric portion with the flexible member extending through the bore of the second elastomeric portion;

whereby the first and second elastomeric spacer portions limit the sliding of the spacer metallic portion along the flexible member.

14. The flexible connection unit of claim 13, wherein the spacer metallic portion is physically separate from and does not physically contact the first rigid portion or the second rigid portion.

15. The flexible connection unit of claim 13, wherein the spacer metallic portion is not integral with the first rigid portion or the second rigid portion.

16. The flexible connection unit of claim 13, wherein the second rigid portion has a longitudinal dimension that is shorter than the longitudinal dimension of both the first elastomeric portion and the second elastomeric portion individually.

17. The flexible connection unit of claim 13, wherein the spacer is constructed such that the first elastomeric portion physically separates the first rigid portion and the spacer metallic portion and the second elastomeric portion physically separates the second rigid portion and the spacer metallic portion.

18. The flexible connection unit of claim 17, wherein the spacer metallic portion physically separates the first and second elastomeric portions.

19. The flexible connection unit of claim 17, wherein the entire outer, longitudinal surface of each of the first rigid portion and the spacer metallic portion is cylindrical and uniform.

20. The flexible connection unit of claim 17, wherein the first rigid portion is longer than the first rigid portion.

21. The flexible connection unit of claim 17, wherein the spacer metallic portion is longer than the second rigid portion.

22. The flexible connection unit of claim 17, wherein both the first and second spacer elastomeric portions comprise polycarbonate urethane.

23. A flexible, elongated connection unit for stabilizing a human spine where the flexible connection unit is configured to be surgically implanted into the human body adjacent the spine and held in place by at least a first and a second bone coupling assembly that are configured to be anchored into a first and second, adjacent vertebra, respectively, the flexible connection unit comprising:

(a) a first rigid portion having an outer surface configured to be secured within the first bone coupling assembly;

(b) a second rigid portion;

(c) a flexible member connected to the first rigid portion and the second rigid portion, the flexible member having an outer surface;

(d) a longitudinally compressible spacer comprising;

(1) a rigid portion having a length and having an inner bore extending the length of the spacer rigid portion, the flexible member extending through the inner bore of the spacer rigid portion, the inner bore of the spacer rigid portion having a larger dimension than the outer surface of the flexible member along the length of the spacer rigid portion bore such that the spacer rigid portion can slide along the outer surface of the flexible member, and where the spacer rigid portion has an outer surface configured to be secured within the second bone coupling assembly, the spacer rigid portion being located entirely between the first rigid portion and the second rigid portion such that along the length of the connection unit no portion of the spacer rigid portion overlaps with any portion of the first or second rigid portion;

(2) a first elastomeric portion located at least partially between the first rigid portion and the spacer rigid portion, the first elastomeric portion having a length and having an inner bore extending the length of the first elastomeric portion with the flexible member extending through the bore of the first elastomeric portion;

(3) a second elastomeric portion located at least partially between the second rigid portion and the spacer rigid portion, the second elastomeric portion having a length and having an inner bore extending the length of the second elastomeric portion with the flexible member extending through the bore of the second elastomeric portion;

whereby the first and second elastomeric spacer portions limit the sliding of the spacer rigid portion along the flexible member.

24. The flexible connection unit of claim 23, wherein the spacer rigid portion is physically separate from and does not physically contact the first rigid portion or the second rigid portion.

25. The flexible connection unit of claim 23, wherein the spacer rigid portion is not integral with the first rigid portion or the second rigid portion.

26. The flexible connection unit of claim 23, wherein the second rigid portion has a longitudinal dimension that is shorter than the longitudinal dimension of both the first elastomeric portion and the second elastomeric portion individually.

27. The flexible connection unit of claim 23, wherein the spacer is constructed such that the first elastomeric portion physically separates the first rigid portion and the spacer rigid portion and the second elastomeric portion physically separates the second rigid portion and the spacer rigid portion.

28. The flexible connection unit of claim 27, wherein the spacer rigid portion physically separates the first and second elastomeric portions.

29. The flexible connection unit of claim 27, wherein the entire outer, longitudinal surface of each of the first rigid portion and the spacer rigid portion is cylindrical and uniform.

30. The flexible connection unit of claim 27, wherein the first and second rigid portions are metallic.

31. The flexible connection unit of claim 30, wherein the spacer rigid portion is metallic.

32. The flexible connection unit of claim 31, wherein both the first and second spacer elastomeric portions comprise polycarbonate urethane.

33. A flexible, spinal fixation assembly for stabilizing a human spine, comprising:

(a) a first bone coupling assembly having a distal portion configured to be secured to a first vertebra and a proximal portion;

(b) a second bone coupling assembly having a distal portion configured to be secured to a second vertebra and a proximal portion;

(c) a first rigid portion having an outer surface secured within the proximal portion of the first bone coupling assembly;

(d) a second rigid portion;

(e) a flexible member connected to the first rigid portion and the second rigid portion, the flexible member having an outer surface;

(f) a longitudinally compressible spacer comprising;

(1) a rigid portion having a length and having an inner bore extending the length of the spacer rigid portion, the flexible member extending through the inner bore of the spacer rigid portion, the inner bore of the spacer rigid portion having a larger dimension than the outer surface of the flexible member along the length of the spacer rigid portion bore such that the spacer rigid portion can slide along the outer surface of the flexible member, and where the spacer rigid portion has an outer surface secured within the proximal portion of the second bone coupling assembly;

(2) a first elastomeric portion located at least partially between the first rigid portion and the spacer rigid portion, the first elastomeric portion having a length and having an inner bore extending the length of the first elastomeric portion with the flexible member extending through the bore of the first elastomeric portion;

(3) a second elastomeric portion located at least partially between the second rigid portion and the spacer rigid portion, the second elastomeric portion having a length and having an inner bore extending the length of the second elastomeric portion with the flexible member extending through the bore of the second elastomeric portion;

whereby the first and second elastomeric spacer portions limit the sliding of the spacer rigid portion along the flexible member.

34. The spinal fixation assembly of claim 33, wherein the spacer rigid portion is located entirely between the first rigid portion and the second rigid portion such that along the length of the fixation assembly no portion of the spacer rigid portion overlaps with any portion of the first or second rigid portion.

35. The spinal fixation assembly of claim 34, wherein the first rigid portion and the second rigid portion are metallic.

36. The spinal fixation assembly of claim 35, wherein the spacer rigid portion is physically separate from and does not physically contact the first rigid portion or the second rigid portion.

37. The spinal fixation assembly of claim 36, wherein the spacer rigid portion is metallic.

38. The spinal fixation assembly of claim 33, wherein the spacer rigid portion is not integral with the first rigid portion or the second rigid portion.

39. The spinal fixation assembly of claim 36, wherein the second rigid portion has a longitudinal dimension that is shorter than the longitudinal dimension of both the first elastomeric portion and the second elastomeric portion individually.

40. The spinal fixation assembly of claim 36, wherein the spacer is constructed such that the first elastomeric portion physically separates the first rigid portion and the spacer rigid portion and the second elastomeric portion physically separates the second rigid portion and the spacer rigid portion.

41. The spinal fixation assembly of claim 40, wherein the spacer rigid portion physically separates the first and second elastomeric portions.

42. The spinal fixation assembly of claim 40, wherein the entire, longitudinal outer surface of each of the first rigid portion and the spacer rigid portion is cylindrical and uniform.

43. The spinal fixation assembly of claim 33, wherein the spacer rigid portion is physically separate from and does not physically contact the first rigid portion or the second rigid portion.

44. The spinal fixation assembly of claim 33, wherein the spacer rigid portion is not integral with the first rigid portion or the second rigid portion.

45. The spinal fixation assembly of claim 40, wherein both the first and second spacer elastomeric portions comprise polycarbonate urethane.

46. A kit for stabilizing a human spine, comprising:

(a) a first bone coupling assembly and a second bone coupling assembly, each having a distal portion configured to be secured to a vertebra and a proximal portion; and

(b) a flexible, connection unit comprising;

(1) a first rigid portion having an outer surface configured to be secured within the proximal portion of the first bone coupling assembly;

(2) a second rigid portion;

(3) a flexible member connected to the first rigid portion and the second rigid portion, the flexible member having an outer surface;

(4) a longitudinally compressible spacer comprising;

(i) a rigid portion having a length and having an inner bore extending the length of the spacer rigid portion, the flexible member extending through the inner bore of the spacer rigid portion, the inner bore of the spacer rigid portion having a larger dimension than the outer surface of the flexible member along the length of the spacer rigid portion bore such that the spacer rigid portion can slide along the outer surface of the flexible member, and where the spacer rigid portion has an outer surface configured to be secured within the proximal portion of the second bone coupling assembly;

(ii) a first elastomeric portion located at least partially between the first rigid portion and the spacer rigid portion, the first elastomeric portion having a length and having an inner bore extending the length of the first elastomeric portion with the flexible member extending through the bore of the first elastomeric portion;

(iii) a second elastomeric portion located at least partially between the second rigid portion and the spacer rigid portion, the second elastomeric portion having a length and having an inner bore extending the length of the second elastomeric portion with the flexible member extending through the bore of the second elastomeric portion;

whereby the first and second elastomeric spacer portions limit the sliding of the spacer rigid portion along the flexible member.

47. The kit of claim 46, wherein the spacer rigid portion is located entirely between the first rigid portion and the second rigid portion such that along the length of the connection unit no portion of the spacer rigid portion overlaps with any portion of the first or second rigid portion.

48. The kit of claim 47, wherein the first rigid portion and the second rigid portion are metallic.

49. The kit of claim 48, wherein the spacer rigid portion is physically separate from and does not physically contact the first rigid portion or the second rigid portion.

50. The kit of claim 49, wherein the spacer rigid portion is metallic.

51. The kit of claim 50, wherein the spacer is constructed such that the first elastomeric portion physically separates the first rigid portion and the spacer rigid portion and the second elastomeric portion physically separates the second rigid portion and the spacer rigid portion.

52. The kit of claim 51, wherein the spacer rigid portion physically separates the first and second elastomeric portions.

53. The kit of claim 52, wherein the entire, longitudinal outer surface of each of the first rigid portion and the spacer rigid portion is cylindrical and uniform.

54. The kit of claim 53, wherein both the first and second spacer elastomeric portions comprise polycarbonate urethane.

55. The kit of claim 47, wherein the spacer rigid portion is not integral with the first rigid portion or the second rigid portion.