Systems and methods for placing materials into bone

• US 6,613,054 B2
• Filed: 03/12/2001
• Issued: 09/02/2003
• Est. Priority Date: 08/14/1998
• Status: Expired due to Term

• Current Assignee: Orthophoenix, LLC (Marathon Patent Group, Inc.)
• Original Assignee: Kyphon Incorporated
• Inventors: Boucher, Ryan, Reiley, Mark A, Scribner, Robert M, Reo, Michael L
• Primary Examiner(s): Philogene, Pedro
• Application Number:
  US09/804,107
• Publication Number:
  US 20010034527A1
• Time in Patent Office: 904 Days
• Field of Search: 606/88, 606/92-96, 606/100, 606/102, 606/105, 606/192, 606/193.7, 606/194, 206/219, 604/57, 604/58, 604/87
• US Class Current: 606/93
• CPC Class Codes: A61B 17/1671 for the spine
• CPC Class Codes: A61B 17/3472 for bones, e.g. intraosseus injections
• CPC Class Codes: A61B 17/7097 Stabilisers comprising fluid filler in an implant, e.g. balloon; devices for inserting or filling such implants disc prostheses made of inflatable chambers or pockets filled with fluid A61F2/441; replacing the nucleus pulposus A61F2002/444
• CPC Class Codes: A61B 17/8805 for introducing fluid filler into bone or extracting it A61B17/7097, A61B17/8833 take precedence
• CPC Class Codes: A61B 17/8816 characterised by the conduit, e.g. tube, along which fluid flows into the body or by conduit connections
• CPC Class Codes: A61B 17/8822 characterised by means facilitating expulsion of fluid from the introducer, e.g. a screw pump plunger, hydraulic force transmissions, application of vibrations or a vacuum
• CPC Class Codes: A61B 17/8833 Osteosynthesis tools specially adapted for handling bone cement or fluid fillers; Means for supplying bone cement or fluid fillers to introducing tools, e.g. cartridge handling means
• CPC Class Codes: A61B 17/8855 inflatable, e.g. kyphoplasty balloons
• CPC Class Codes: A61B 2017/00261 Discectomy
• CPC Class Codes: A61B 2017/00464 for use with different instruments with hole for different instruments A61B2017/22072
• CPC Class Codes: A61B 2017/00867 shape memory effect for prostheses A61F2210/0014
• CPC Class Codes: A61B 2050/0065 Peelable cover
• CPC Class Codes: A61B 2090/062 penetration depth
• CPC Class Codes: A61B 50/33 Trays
• CPC Class Codes: A61B 90/39 Markers, e.g. radio-opaque or breast lesions markers
• CPC Class Codes: A61F 2/44 for the spine, e.g. vertebrae, spinal discs
• CPC Class Codes: A61F 2/4601 for introducing bone substitute, for implanting bone graft implants or for compacting them in the bone cavity
• CPC Class Codes: A61F 2/4603 for insertion or extraction of endoprosthetic joints or of accessories thereof
• CPC Class Codes: A61F 2002/2835 Bone graft implants for filling a bony defect or an endoprosthesis cavity, e.g. by synthetic material or biological material
• CPC Class Codes: A61F 2002/3008 radio-opaque, e.g. radio-opaque markers
• CPC Class Codes: A61F 2002/4662 : for measuring penetration depth
• CPC Class Codes: A61F 2250/0098 : radio-opaque, e.g. radio-opaque markers
• CPC Class Codes: A61F 2310/00353 : Bone cement, e.g. polymethylmethacrylate or PMMA

Abstract

Systems and methods for delivering material into bone deploy a cannula through soft tissue to establish a subcutaneous path into bone. A material is introduced into bone through the cannula. The systems and methods advance a tamping instrument through the cannula to urge material residing in the cannula into bone. The introducing step delivers material at a pressure no greater than about 360 psi.

Claims

1. Apparatus for delivering material into bone comprising

a cannula for establishing a subcutaneous path into bone and including at least one radiopaque marker, and

a tamping instrument having a tamping terminus,

the tamping instrument being sized and configured for manipulation independent of the cannula to enable insertion of the tamping instrument into the cannula, advancement of the tamping terminus in the cannula to urge material residing in the cannula into bone, and withdrawal of the tamping terminus from the cannula.

2. Apparatus according to claim 1

wherein the cannula has a length, and

wherein the length of the tamping instrument exceeds the length of the cannula.

3. Apparatus according to claim 1

wherein a removable handle is carried by the proximal end of the cannula.

4. Apparatus according to claim 1

wherein handle is carried by the proximal end of the tamping instrument.

5. Apparatus according to claim 4

wherein, when the tamping instrument is fully inserted into the cannula, the handle is adjacent the proximal end of the cannula.

6. Apparatus according to claim 1

wherein the cannula comprises a generally rigid material.

7. Apparatus according to claim 1

wherein the tamping instrument comprises a generally rigid material.

8. Apparatus according to claim 1

wherein the tamping instrument has a blunt distal end.

9. Apparatus according to claim 1

wherein the cannula has a blunt distal end.

10. Apparatus according to claim 1

wherein the tamping instrument and the cannula each have a blunt distal end.

11. Apparatus according to claim 1

further comprising a delivery device to convey material into the cannula.

12. Apparatus according to claim 1

wherein the tamping instrument includes at least one marking to visually gauge the advancement the terminus relative to the distal end of the cannula.

13. Apparatus according to claim 12

wherein the at least one marking indicates when the distal end of the tamping instrument is aligned with the distal end of the cannula instrument.

14. Apparatus according to claim 1

wherein the tamping instrument includes a set point marking spaced from the terminus at a distance generally equal to the length of the cannula.

15. Apparatus according to claim 13

wherein the tamping instrument includes at least one additional marking to visually gauge advancement of the terminus relative to the distal end of the cannula.

16. Apparatus according to claim 1

in the tamping instrument includes at least one radiopaque marker.

17. Apparatus according to claim 1

wherein the cannula is plastic.

18. Apparatus according to claim 17

wherein the tamping instrument is plastic.

19. Apparatus according to claim 1

wherein the tamping instrument has a substantially constant diameter along its length.

20. Apparatus according to claim 1

wherein the material is bone cement.

21. Apparatus according to claim 1

wherein the material comprises autograft material.

22. Apparatus according to claim 1

wherein the material comprises allograft material.

23. Apparatus according to claim 1

wherein the material comprises calcium carbonate.

24. Apparatus according to claim 1

wherein the material comprises demineralized bone matrix material.

25. Apparatus according to claim 1

wherein the material comprises calcium phosphate.

26. Apparatus for delivering material into bone comprising

a cannula for establishing a subcutaneous path into bone, and

a tamping instrument having a tamping terminus and including at least one marking to visually gauge the advancement of the terminus relative to the distal end of the cannula,

the tamping instrument being sized and configured for manipulation independent of the cannula to enable insertion of the tamping instrument into the cannula, advancement of the tamping terminus in the cannula to urge material residing in the cannula into bone, and withdrawal of the tamping terminus from the cannula.

27. Apparatus according to claim 26

wherein the at least one marking indicates when the distal end of the tamping instrument is aligned with the distal end of the cannula instrument.

28. Apparatus according to claim 26

wherein the tamping instrument includes a set point marking spaced from the terminus at a distance generally equal to the length of the cannula.

29. Apparatus according to claim 27

wherein the tamping instrument includes at least one additional marking to visually gauge advancement of the terminus relative to the distal end of the cannula.

30. Apparatus for delivering material into bone comprising

a cannula for establishing a subcutaneous path into bone, the cannula including at least one radiopaque marker and being sized and configured to accept insertion and withdrawal of a first instrument in the cannula, and

a tamping instrument separate from the first instrument having a tamping terminus,

the tamping instrument being sized and configured for manipulation independent of the cannula to enable insertion of the tamping instrument into the cannula and advancement of the tamping terminus in the cannula to urge material residing in the cannula into the bone.

31. Apparatus for delivering material into bone comprising

a cannula for establishing a subcutaneous path into bone, the cannula being sized and configured to accept insertion and withdrawal of a first instrument in the cannula, and

a tamping instrument separate from the first instrument having a tamping terminus,

the tamping instrument including at least one marking to visually gauge the advancement of the terminus relative to the distal end of the cannula and being sized and configured for manipulation independent of the cannula to enable insertion of the tamping instrument into the cannula and advancement of the tamping terminus in the cannula to urge material residing the cannula into bone.

32. Apparatus according to claim 31

wherein the at least one marking indicates when the distal end of the tamping instrument is aligned with the distal end of the cannula instrument.

33. Apparatus according to claim 31

wherein the tamping instrument includes a set point marking spaced from the terminus at a distance generally equal to the length of the cannula.

34. Apparatus according to claim 33

wherein the tamping instrument includes at least one additional marking to visually gauge advancement of the terminus relative to the distal end of the cannula.

35. Apparatus for delivering material into bone comprising

a cannula for establishing a subcutaneous path into bone and including at least one radiopaque marker;

and

a tamping instrument for advancement through the cannula comprising a body portion and a handle portion,

the handle portion having a cross-sectional area greater than the cross-sectional area of the body portion.

36. Apparatus for delivering material into bone comprising

a cannula for establishing a subcutaneous path into bone;

and

a tamping instrument for advancement through the cannula including at least one marking to visually gauge the advancement of the terminus relative to the distal end of the cannula and comprising a body portion and a handle portion,

the handle portion having a cross-sectional area greater than the cross-sectional area of the body portion.

37. Apparatus according to claim 36

wherein the at least one marking indicates when the distal end of the tamping instrument is aligned with the distal end of the cannula instrument.

38. Apparatus according to claim 36

wherein the tamping instrument includes a set point marking spaced from the terminus at a distance generally equal to the length of the cannula.

39. Apparatus according to claim 38

wherein the tamping instrument includes at least one additional marking to visually gauge advancement of the terminus relative to the distal end of the cannula.

40. Apparatus for delivering material into bone comprising

a cannula for establishing a subcutaneous path into bone and including at least one radiopaque marker;

and

a tamping instrument for advancement through the cannula comprising a body portion and a handle portion, the body portion being sized and configured to substantially fill the cannula when the tamping instrument is fully inserted into the cannula.

41. Apparatus for delivering material into bone comprising

a cannula for establishing a subcutaneous path into bone;

and

a tamping instrument for advancement through the cannula including at least one marking to visually gauge the advancement of the terminus relative to the distal end of the cannula, and comprising a body portion and a handle portion, the body portion being sized and configured to substantially fill the cannula when the tamping instrument is fully inserted into the cannula.

42. Apparatus according to claim 41

wherein the at least one marking indicates when the distal end of the tamping instrument is aligned with the distal end of the cannula instrument.

43. Apparatus according to claim 41

wherein the tamping instrument includes a set point marking spaced from the terminus at a distance generally equal to the length of the cannula.

44. Apparatus according to claim 43

wherein the tamping instrument includes at least one additional marking to visually gauge advancement of the terminus relative to the distal end of the cannula.

45. Apparatus for delivering material into bone comprising

a cannula for establishing a subcutaneous path into bone and including at least one radiopaque marker;

and

a tamping instrument for advancement through the cannula comprising a body portion and a handle portion, the body portion having a substantially constant diameter along its length.

46. Apparatus for delivering material into bone comprising

a cannula for establishing a subcutaneous path into bone;

and

a tamping instrument for advancement through the cannula including at least one marking to visually gauge the advancement of the terminus relative to the distal end of the cannula and comprising a body portion and a handle portion, the body portion having a substantially constant diameter along its length.

47. Apparatus according to claim 46

wherein the at least one marking indicates when the distal end of the tamping instrument is aligned with distal end of the cannula instrument.

48. Apparatus for delivering material into bone comprising

a cannula for establishing a subcutaneous path into bone;

and

a tamping instrument for advancement through the cannula including a set point marking spaced from the terminus at a distance generally equal to the length of the cannula and comprising a body portion and a handle portion, the body portion having a substantially constant diameter along its length.

49. Apparatus according to claim 48

wherein the tamping instrument includes at least one additional marking to visually gauge advancement of the terminus relative to the distal end of the cannula.

50. Apparatus for delivering material into bone comprising

a cannula for establishing a subcutaneous path into bone,

the cannula comprising a generally rigid material and including at least one radiopaque marker,

a tamping instrument comprising a generally rigid material and having a tamping terminus,

the tamping instrument being sized and configured for manipulation independent of the cannula to enable insertion of the tamping instrument into the cannula, advancement of the tamping terminus in the cannula to urge material residing in the cannula into bone, and withdrawal of the tamping terminus from the cannula, and

a handle carried by the proximal end of the tamping instrument.

51. Apparatus according to claim 50

wherein the tamping instrument has a blunt distal end.

52. Apparatus according to claim 51

wherein the cannula is sized and configured to accept insertion and withdrawal of a first instrument in the cannula, and

wherein the tamping instrument is separate from the first instrument.

53. Apparatus according to claim 52

wherein the handle carried by the tamping instrument has a cross-sectional area greater than the cross-sectional area of the tamping terminus of the tamping instrument.

54. Apparatus according to claim 53

wherein the tamping instrument is sized an configured to substantially fill the cannula.

55. Apparatus according to claim 54

wherein the tamping instrument has a substantially constant diameter along its length.

56. Apparatus according to claim 50

wherein the cannula has a length, and

wherein the length of the tamping instrument exceeds the length of the cannula.

57. Apparatus according to claim 56

wherein the tamping instrument has a substantially blunt distal end.

58. Apparatus according to claim 57

wherein the cannula is sized and configured to accept insertion and withdrawal of a first instrument in the cannula, and

wherein the tamping instrument and the first instrument are different instruments.

59. Apparatus according to claim 58

wherein the handle carried by the tamping instrument has a cross-sectional area greater than the cross-sectional area of the tamping terminus of the tamping instrument.

60. Apparatus according to claim 59

wherein the tamping instrument is sized and configured to substantially fill the cannula.

61. Apparatus according to claim 60

wherein the tamping instrument has a substantially constant diameter along its length.

62. Apparatus according to claim 61

wherein, when the tamping instrument fully occupies the cannula, the handle carried by the tamping instrument is adjacent the proximal end of the cannula.

63. Apparatus according to claim 62

wherein the cannula has a blunt distal end.

64. Apparatus according to claim 63

wherein a removable handle is carried by the proximal end of the cannula.

65. Apparatus according to claim 64

wherein the tamping instrument has a generally blunt distal end.

66. Apparatus according to claim 65

wherein the cannula is sized and configured to accept insertion and withdrawal of a first instrument in the cannula, and

wherein the tamping instrument is separate from the first instrument.

67. Apparatus according to claim 66

wherein the handle carried by the tamping instrument has a cross-sectional area greater than the cross-sectional area of the tamping terminus of the tamping instrument.

68. Apparatus according to claim 67

wherein the tamping instrument is sized and configured to substantially fill the cannula.

69. Apparatus according to claim 68

wherein the tamping instrument has a substantially constant diameter along its length.

70. Apparatus according to claim 50

wherein, when the tamping instrument fully occupies substantially the entire cannula, the handle carried the tamping instrument is adjacent the proximal end of the cannula.

71. Apparatus according to claim 70

wherein the tamping instrument has a blunt distal end.

72. Apparatus according to claim 71

wherein the cannula is sized and configured to accept insertion and withdrawal of a first instrument in the cannula, and

wherein the tamping instrument is separate from the first instrument.

73. Apparatus according to claim 72

wherein the handle carried by the tamping instrument has a cross-sectional area greater than the cross-sectional area of the tamping terminus of the tamping instrument.

74. Apparatus according to claim 73

wherein the tamping instrument is sized and configured to substantially fill the cannula.

75. Apparatus according to claim 74

wherein the tamping instrument has a substantially constant diameter along its length.

76. Apparatus according to claim 70

wherein the cannula has a blunt distal end.

77. Apparatus according to claim 76

wherein a removable handle is carried by the proximal end of the cannula.

78. Apparatus according to claim 77

wherein the tamping instrument has a blunt distal end.

79. Apparatus according to claim 78

wherein the cannula is sized and configured to accept insertion and withdrawal of a first instrument in the cannula, and

wherein the tamping instrument is separate from the first instrument.

80. Apparatus according to claim 79

wherein the handle carried by the tamping instrument has a cross-sectional area greater than the cross-sectional area of the tamping terminus of the tamping instrument.

81. Apparatus according to claim 80

wherein the tamping instrument is sized and configured to substantially fill the cannula.

82. Apparatus according to claim 81

wherein the tamping instrument has a substantially constant diameter along its length.

83. Apparatus according to claim 50

wherein the cannula has a blunt distal end.

84. Apparatus according to claim 83

wherein the tamping instrument has a blunt distal end.

85. Apparatus according to claim 84

wherein the cannula is sized and configured to accept insertion and withdrawal of a first instrument in the cannula, and

wherein the tamping instrument is separate from the first instrument.

86. Apparatus according to claim 85

wherein the handle carried by the tamping instrument has a cross-sectional area greater than the cross-sectional area of the tamping terminus of the tamping instrument.

87. Apparatus according to claim 86

wherein the tamping instrument is sized and configured to substantially fill the cannula.

88. Apparatus according to claim 87

wherein the tamping instrument has a substantially constant diameter along substantially its entire length.

89. Apparatus according to claim 83

wherein a removable handle is carried by the proximal end of the cannula.

90. Apparatus according to claim 89

wherein the tamping instrument has a blunt distal end.

91. Apparatus according to claim 90

wherein the cannula is sized and configured to accept insertion and withdrawal of a first instrument in the cannula, and

wherein the tamping instrument is separate from the first instrument.

92. Apparatus according to claim 91

wherein the handle carried by the tamping instrument has a cross-sectional area greater than the cross-sectional area of the tamping terminus of the tamping instrument.

93. Apparatus according to claim 92

wherein the tamping instrument is sized and configured to substantially fill the cannula.

94. Apparatus according to claim 93

wherein the tamping instrument has a substantially constant diameter along its length.

95. Apparatus according to claim 50

wherein a removable handle is carried by the proximal end of the cannula.

96. Apparatus according to claim 95

wherein the tamping instrument has a blunt distal end.

97. Apparatus according to claim 95

wherein the cannula is sized and configured to accept insertion and withdrawal of a first instrument in the cannula, and

wherein the tamping instrument is separate from the first instrument.

98. Apparatus according to claim 95

wherein the handle carried by the tamping instrument has a cross-sectional area greater than the cross-sectional area of the tamping terminus of the tamping instrument.

99. Apparatus according to claim 95

wherein the tamping instrument is sized and configured to substantially fill the cannula.

100. Apparatus according to claim 95

wherein the tamping instrument has a substantially constant diameter along its length.