Systems for percutaneous bone and spinal stabilization, fixation and repair

• US 6,127,597 A
• Filed: 03/06/1998
• Issued: 10/03/2000
• Est. Priority Date: 03/07/1997
• Status: Expired due to Term

• Current Assignee: Kyphon SARL (Medtronic Plc)
• Original Assignee: Discotech N.V.
• Inventors: Magal, Elad, Beyar, Mordechay, Globerman, Oren
• Primary Examiner(s): Hirsch, Paul J.
• Application Number:
  US09/036,719
• Time in Patent Office: 942 Days
• Field of Search: 623/11, 623/16, 623/20
• US Class Current: 606/86.00R
• CPC Class Codes: A61B 17/7266 with fingers moving radially outwardly
• CPC Class Codes: A61B 17/7275 with expanding cylindrical parts
• CPC Class Codes: A61B 17/7283 with special cross-section of the nail
• CPC Class Codes: A61B 17/7291 for small bones, e.g. in the foot, ankle, hand or wrist
• CPC Class Codes: A61B 2017/00535 pneumatically or hydraulically operated A61B2017/22051, A61B2090/401 take precedence
• CPC Class Codes: A61B 2017/00867 shape memory effect for prostheses A61F2210/0014
• CPC Class Codes: A61F 2/441 made of inflatable pockets or chambers filled with fluid, e.g. with hydrogel
• CPC Class Codes: A61F 2/442 Intervertebral or spinal discs, e.g. resilient non-disc-shaped intervertebral inflatable pockets A61F2/441; non-disc-shaped intervertebral fusion implants A61F2/4455
• CPC Class Codes: A61F 2/4455 for the fusion of spinal bodies, e.g. intervertebral fusion of adjacent spinal bodies, e.g. fusion cages intervertebral discs A61F2/442
• CPC Class Codes: A61F 2/446 having a circular or elliptical cross-section substantially parallel to the axis of the spine, e.g. cylinders or frustocones
• CPC Class Codes: A61F 2/4611 of spinal prostheses
• CPC Class Codes: A61F 2002/30092 using shape memory or superelastic materials, e.g. nitinol
• CPC Class Codes: A61F 2002/30293 Cylindrical body made by spirally rolling up a sheet or a strip around itself
• CPC Class Codes: A61F 2002/30579 with mechanically expandable devices, e.g. fixation devices
• CPC Class Codes: A61F 2002/4627 with linear motion along or rotating motion about the instrument axis or the implantation direction, e.g. telescopic, along a guiding rod, screwing inside the instrument
• CPC Class Codes: A61F 2210/0019 operated at only one temperature whilst inside or touching the human body, e.g. constrained in a non-operative shape during surgery, another temperature only occurring before the operation
• CPC Class Codes: A61F 2210/0033 electrically, e.g. heated by resistor
• CPC Class Codes: A61F 2230/0091 helically-coiled or spirally-coiled, i.e. having a 2-D spiral cross-section
• CPC Class Codes: C21D 9/26 for needles; for teeth for card-clothing
• CPC Class Codes: G01L 7/16 in the form of pistons

Abstract

Systems for bone and spinal stabilization, fixation and repair include intramedullar nails, intervertebral cages and prostheses, remotely activatable prostheses, tissue extraction devices, and electrocautery probes. The intramedullar nails, intervertebral cages and prostheses, are designed for expansion from a small diameter for insertion into place to a larger diameter which stabilizes, fixates or repairs the bone, and further can be inserted percutaneously. Remotely activatable prostheses can be activated from an external unit to expand and treat prosthesis loosening. Tissue extraction devices, and electrocautery probes are used to remove tissue from desired areas.

Claims

1. A medical device for treatment of broken bones having an intramedullary cavity, the bone being provided with a bore formed through the exterior surface of the bone and extending into the intramedullary cavity, comprising:

a bone fixture for insertion through the bore of the bone and into the intramedullary cavity, said bone fixture comprising a diameter-expandable, metallic balloon tube having an exterior circumferential surface, said tube having a reduced first diameter for insertion through the bore and into the intramedullary cavity and a second expanded diameter, wherein when fluid is introduced into said bone fixture it radially increases in diameter from said reduced first diameter to said second expanded diameter, at least a portion of said exterior circumferential surface coming into contact with a portion of the side wall of said intramedullary cavity.

2. A medical device as claimed in claim 1, wherein said metallic balloon tube is manufactured of a material selected from the group comprising:

titanium, stainless steel, SS316, and Nitinol.

3. A medical device as claimed in claim 1, wherein said reduced first diameter is sufficiently small such that said bone fixture can be inserted into the bore of the bone through a syringe.

4. A medical device as claimed in claim 1, wherein said device is basically cylindrical when expanded to said second expanded diameter.

5. A medical treatment device as claimed in claim 1, wherein said bone fixture is sized for treatment of a broken bone selected from the group comprising:

the hand, the foot, the leg, and the arm.

6. A medical device as claimed in claim 1, wherein said device further comprises a restraining means for restraining radial expansion of a portion of said device, when said device expands from said reduced first diameter to said expanded second diameter.

7. A medical device as claimed in claim 1, wherein said bone fixture increases in diameter by at least 40% when said fixture increases from said reduced first diameter to said expanded second diameter.

8. A medical device as claimed in claim 1 wherein said bone fixture will expand in diameter from said reduced first diameter to said expanded second diameter when fluid is supplied to the interior of said device.

9. A medical device as claimed in claim 8, wherein said bone fixture is supplied with a valve, at least allowing for one-way fluid flow, for selective entry of the fluid into the interior of said device.

10. A medical device as claimed in claim 9, wherein said valve is bi-directional.

11. A medical device as claimed in claim 1 further comprising at least one rib longitudinally extending along the exterior circumferential surface of said bone fixture.

12. A medical device as claimed in claim 1 wherein at least two ribs longitudinally extend along the exterior circumferential surface of said bone fixture.

13. A medical device as claimed in claim 12 wherein said ribs define wall web portions therebetween and said wall web portions are folded upon themselves prior to expansion of said bone fixture.

14. A medical device as claimed in claim 1 further comprising four ribs longitudinally extending along the exterior circumferential surface of said bone fixture.

15. A medical device as claimed in claim 13, wherein said wall web portions are initially, pre-expansion, folded into individual bulbous sections, said sections being approximately S-shaped.

16. A medical device as claimed in claim 13, wherein said device comprises four of said longitudinal ribs and wherein said wall web portions are initially, pre-expansion, folded into individual bulbous sections, said bulbous sections being approximately S-shaped.

17. A medical device as claimed in claim 13, wherein each of said wall web portions are folded, pre-expansion, into a hairpin-like loop.

18. A medical device as claimed in claim 13, wherein said device comprises four of said longitudinal ribs and wherein each of said wall web portions are curved, pre-expansion, into a hairpin-like loop.

19. A medical device as claimed in claim 11, wherein said reduced first diameter is sufficiently small such that said bone fixture can be inserted into the bone through a syringe.

20. A medical treatment device as claimed in claim 11, wherein said bone fixture is sized for treatment of a broken bone selected from the group comprising:

the hand, the foot, the leg, and the arm.

21. A medical device as claimed in claim 11, wherein said device further comprises a restraining element for restraining radial expansion of a portion of said device, when said device expands from said reduced first diameter to said expanded second diameter.

22. A medical treatment device as claimed in claim 11, wherein said bone fixture increases in diameter by at least 40% when said fixture increases from said reduced first diameter to said expanded second diameter.

23. A medical device as claimed in claim 11, wherein said bone fixture will expand in diameter from said reduced first diameter to said expanded second diameter when fluid is supplied to the interior of said device.

24. A medical device as claimed in claim 23, wherein said bone fixture is supplied with a valve, at least allowing for one-way fluid flow, for selective entry of the fluid into the interior of said device.

25. A medical device as claimed in claim 23, wherein said valve is bi-directional.

26. A medical device as claimed in claim 23 wherein said bone fixture is in the basic shape of a cylinder tapered on at least one end.

27. A medical device as claimed in claim 11, wherein said metallic tube is manufactured of a material selected from the group comprising:

titanium, stainless steel, SS316, and Nitinol.