Surgical protocol for fixation of osteoporotic bone using inflatable device

• US 4,969,888 A
• Filed: 02/09/1989
• Issued: 11/13/1990
• Est. Priority Date: 02/09/1989
• Status: Expired due to Term

• Current Assignee: Kyphon SARL (Medtronic Plc)
• Original Assignee: Arie Scholten, Mark A. Reiley
• Inventors: Scholten, Arie, Reiley, Mark A.
• Primary Examiner(s): Hafer, Robert A.
• Assistant Examiner(s): ROONEY, KEVIN
• Application Number:
  US07/308,724
• Time in Patent Office: 642 Days
• Field of Search: 128/92 VP, 128/92 VQ, 606/94, 606/95, 606/60
• US Class Current: 606/94
• CPC Class Codes: A61B 17/8855 inflatable, e.g. kyphoplasty balloons
• CPC Class Codes: A61B 2010/0258 Marrow samples
• CPC Class Codes: A61B 2017/00539 hydraulically
• CPC Class Codes: A61B 90/39 Markers, e.g. radio-opaque or breast lesions markers
• CPC Class Codes: A61F 2/28 Bones joints A61F2/30
• CPC Class Codes: A61F 2/4003 Replacing only the epiphyseal or metaphyseal parts of the humerus, i.e. endoprosthesis not comprising an entire humeral shaft replacing only the epiphyseal or metaphyseal parts of the femur A61F2/3601
• CPC Class Codes: A61F 2/4261 for wrists
• CPC Class Codes: A61F 2/44 for the spine, e.g. vertebrae, spinal discs
• CPC Class Codes: A61F 2/441 made of inflatable pockets or chambers filled with fluid, e.g. with hydrogel
• 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 2/4606 of wrists or ankles; of hands, e.g. fingers; of feet, e.g. toes
• CPC Class Codes: A61F 2/4611 of spinal prostheses
• CPC Class Codes: A61F 2002/3008 radio-opaque, e.g. radio-opaque markers
• CPC Class Codes: A61F 2002/30581 having a pocket filled with fluid, e.g. liquid
• CPC Class Codes: A61F 2002/30583 filled with hardenable fluid, e.g. curable in-situ
• CPC Class Codes: A61F 2002/4635 using minimally invasive surgery
• CPC Class Codes: A61F 2210/0085 hardenable in situ, e.g. epoxy resins
• CPC Class Codes: A61F 2250/0098 radio-opaque, e.g. radio-opaque markers

Abstract

A method and apparatus for the fixation of osteoporotic bones and especially vertebral body compression fractures, Colles'"'"' fractures and fractures of the proximal humerus. The method of the present invention includes a series of steps including penetrating the bone having the fracture with a guide pin, drilling the osteoporotic bone marrow of the bone to enlarge the cavity to be treated, following which a bone specific inflatable device is inserted in the cavity and inflated. The expansion of the device causes a compacting of the osteoporotic bone marrow against the inner surface of the outer wall of the bone to be treated to further enlarge the cavity. When this occurs, a flowable synthetic bone material or methyl methacrylate cement is directed into the cavity and allowed to set to a hardened condition. Following this, the instruments are removed. In the fixation of vertebral body fractures, an elliptical inflatable device is first used to initiate the compacting of the osteoporotic bone marrow, following which a checker-shaped inflatable device is inserted into the cavity to further compact the osteoporotic bone marrow in all directions. In the fixation of Colles'"'"' fractures and proximal humerus fractures, a gourd-shaped inflatable device is used to compact the osteoporotic bone marrow.

Claims

1. A method of fixation of a fracture or impending fracture of an osteoporotic bone having osteoporotic bone marrow therein comprising:

forming a passage in the bone marrow;

compacting the bone marrow to increase the volume of said passage and

filling the passage with a flowable material capable of setting to a hardened condition.

2. A method as set forth in claim 1, wherein said compacting step includes forcing the osteoporotic bone marrow outwardly and against the site of the fracture or impending fracture.

3. A method as set forth in claim 1, wherein said compacting step includes forcing the osteoporotic bone marrow outwardly of the central portion of the bone.

4. A method as set forth in claim 3, wherein said forcing step includes direction the osteoporotic bone marrow against an inner surface of the bone within the fracture or impending fracture.

5. A method as set forth in claim 1, wherein said compacting step includes inflating an inflatable device in said passage to urge the osteoporotic bone marrow therein.

6. A method as set forth in claim 5, wherein is included the step of inserting the device in the passage before the inflating step.

7. A method as set forth in claim 1, wherein said forming step includes drilling said osteoporotic bone marrow to form said passage.

8. A method as set forth in claim 7, wherein said drilling step includes guiding a drill through into the proximate corticol bone marrow.

9. A method as set forth in claim 7, wherein said forming step includes drilling the osteoporotic bone marrow to a predetermined depth.

10. A method as set forth in claim 9, wherein said depth is in the range of approximately 60 to 80% of the maximum oblique dimension of the bone containing the osteoporotic bone marrow.

11. A method as set forth in claim 1, wherein the fracture is a fracture of a vertebral body of the human spine.

12. A method as set forth in claim 1, wherein said fracture is a Colles'"'"' fracture of the distal radius.

13. A method as set forth in claim 1, wherein said fracture is a fracture of the proximal humerus.

14. A method as set forth in claim 1, wherein said flowable material is selected from the group consisting of liquid synthetic bone and methyl methacrylate cement.

15. A method of fixation of an osteoporotic fracture of a bone containing osteoporotic bone marrow therein comprising:

drilling said bone to form a passage therein;

inserting an inflatable device in said recess;

inflating the device in the passage to increase the volume thereof and to force the osteoporotic bone marrow outwardly of the passage and against the bone to form a void in the bone; and

filling the void in the bone with a flowable material capable of setting to a hardened condition.

16. A method as set forth in claim 15, wherein said inflating step includes inflating a chambered bladder device having an elliptical configuration.

17. A method as set forth in claim 15, wherein said inflating step includes inflating a chambered bladder device having generally cylindrical configuration.

18. A method as set forth in claim 15, wherein is included the step of guiding a drill into the bone.

19. A method as set forth in claim 15, wherein said inflating step includes inflating the device with a radio-opaque material.

20. A method as set forth in claim 16, wherein said inflating step includes compacting the osteoporotic bone marrow against the bone at the fracture site thereof.

21. A method as set forth in claim 15, wherein said inflating step includes forcing the osteoporotic bone marrow outwardly of the central portion of the bone.

22. A method as set forth in claim 21, wherein said inflating step includes compacting the osteoporotic bone marrow against an inner surface of the bone.

23. A method as set forth in claim 15, wherein said drilling step includes guiding a drill into the bone, and rotating the drill about its longitudinal axis.

24. A method as set forth in claim 23, wherein said drilling step includes drilling the osteoporotic bone marrow to a predetermined depth.

25. A method as set forth in claim 24, wherein said depth is in the range of approximately 60 to 80% of the maximum oblique dimension of the bone.

26. A method as set forth in claim 15, wherein the fracture is a fracture of a vertebral body of the human spine.

27. A method as set forth in claim 15, wherein said fracture is a Colles'"'"' fracture of the distal radius.

28. A method as set forth in claim 15, wherein said fracture is a fracture of the proximal humerus.